ECHA Programming Document(s)

2021 – 2024

Multiannual work programme / strategic plan

Work programme 2021
Draft work programme 2022
Programming Document(s) 2021-2024 1

ECHA Programming Document 2021-2024

Helsinki, 17 December 2020

Doc: MB/56/2020 final

Reference: ECHA-21-R-01-EN
ISBN: 978-92-9481-808-9
ISSN: 2467-4532
Cat. Number: ED-AS-21-001-EN-N
DOI: 10.2823/957085
Publ. date: January 2021
Language: EN

© European Chemicals Agency, 2021

Cover page © European Chemicals Agency

If you have questions or comments in relation to this document please send them (quote the
reference and issue date) using the information request form. The information request form
can be accessed via the Contact ECHA page at:
http://echa.europa.eu/contact

European Chemicals Agency

Mailing address: P.O. Box 400, FI-00121 Helsinki, Finland

Visiting address: Telakkakatu 6, 00121 Helsinki, Finland
Programming Document(s) 2021-2024 2

Table of Contents
Foreword .................................................................................................................... 4
List of Acronyms ......................................................................................................... 5
Mission statement ...................................................................................................... 8
READER’S GUIDE ........................................................................................................ 9
I GENERAL CONTEXT ................................................................................................ 10
ECHA’s role ............................................................................................................... 10
EU regulatory system for chemical safety................................................................. 10
Objectives of the legislation ..................................................................................... 11
ECHA’s strategic outlook - anticipating challenging times ahead .............................. 11
ECHA’s competences and impact .............................................................................. 12
II MULTIANNUAL WORK PROGRAMME 2021–2024 ................................................... 17
1. Multiannual priorities ......................................................................................... 18
2. Strategic priorities .............................................................................................. 19
2.1 Strategic priority 1: Identification and risk management of substances of concern......................... 21
2.2 Strategic priority 2: Safe and sustainable use of chemicals by industry ........................................ 22
2.3 Strategic Priority 3: Sustainable management of chemicals through the implementation of EU
legislation ......................................................................................................................... 24
2.4 Actions to invest in enabling components ................................................................................. 25

3. Human and financial resource outlook 2021-2024 ............................................. 26

3.1 Overview of the past and current situation ............................................................................... 29
3.2 Resource programming for 2021-2024 ..................................................................................... 30
3.2.1 Financial resources ............................................................................................................. 30
3.2.2 Human resources ............................................................................................................... 32

III WORK PROGRAMME 2021 ................................................................................... 34

Introduction ............................................................................................................. 34
0. REACH and CLP ..................................................................................................... 37
1.1 Registration dossier preparation .............................................................................................. 37
1.2 Dossier submission ................................................................................................................ 40
1.3 Screening and prioritisation .................................................................................................... 42
1.4 Evaluation ............................................................................................................................ 44
1.5 Authorisation ........................................................................................................................ 47
1.6 Restrictions .......................................................................................................................... 50
1.7 Classification and Labelling ..................................................................................................... 52
1.8 Safe and sustainable use of chemicals ..................................................................................... 54
1.9 Data management and dissemination ...................................................................................... 55

2. Biocides ................................................................................................................ 58
3. Environmental Directives and International Conventions ..................................... 62
3.1 Prior informed consent ........................................................................................................... 62
Programming Document(s) 2021-2024 3

3.2 Persistent organic pollutants ................................................................................................... 63

3.3 Waste Framework Directive .................................................................................................... 64
3.4 Drinking Water Directive ........................................................................................................ 65
3.5 Support to the 8th Environmental Action Programme of the EU .................................................... 66

4. Other tasks ........................................................................................................... 68

4.1 EU Observatory for Nanomaterials ........................................................................................... 68
4.2 EU Chemicals Legislation Finder .............................................................................................. 69
4.3 Support to occupational health legislation ................................................................................ 70
4.4 Instrument for Pre-Accession Assistance (IPA) .......................................................................... 71
4.5 Interaction with other legislation ............................................................................................. 72
4.6 IUCLID for EFSA.................................................................................................................... 72

5. Governance and enablers ..................................................................................... 74

5.1 Support to Forum .................................................................................................................. 74
5.2 Board of Appeal .................................................................................................................... 75
5.3 Management ........................................................................................................................ 76
5.4 ICT ...................................................................................................................................... 79
5.5 Financial resources ................................................................................................................ 80
5.6 Human resources .................................................................................................................. 82
5.7 Corporate services ................................................................................................................ 83

Annexes ................................................................................................................... 85
Annex I: A. Organisation chart of the Agency ................................................................................. 86
Annex I: B. Overview of regulatory tasks of the Agency................................................................... 87
Annex I: C. Process map of ECHA’s activities.................................................................................. 90
Annex II: Resource allocation per activity ...................................................................................... 91
Annex III: Financial resources ...................................................................................................... 95
Annex IV: Human resources - quantitative ................................................................................... 114
Annex V: Human resources - qualitative ...................................................................................... 120
Annex V: A. Recruitment policy .................................................................................................. 120
Annex V: B. Appraisal of performance and reclassification/promotions............................................. 123
Annex V: C. Gender representation ............................................................................................. 126
Annex V: D. Geographical balance .............................................................................................. 128
Annex V: E. Schooling ............................................................................................................... 131
Annex VI: Environment management .......................................................................................... 133
Annex VII: Building policy .......................................................................................................... 134
Annex VIII: Privileges and immunities ......................................................................................... 135
Annex IX: Evaluations and audits ............................................................................................... 136
Annex X: ECHA Integrated Management System and Framework .................................................... 137
Annex XI: Plan for grant, contribution or service-level agreements ................................................. 145
Annex XII: Strategy for cooperation with third countries and/or international organisations ............... 147
Annex XIII: Performance indicators............................................................................................. 150
Programming Document(s) 2021-2024 4

Foreword
With 13 years of experience, ECHA has built up a strong competence and has proven to be agile
in finding efficient and effective ways to implement the EU chemicals legislation within its
portfolio. This will be useful as we prepare for our next chapter and look to further contribute to
the EU’s priorities.
In 2021, our aim is to show the impact of ECHA’s work more clearly so it is more evident how
our activities safeguard European citizens and the environment from the effects of harmful
chemicals. To make this apparent, we will focus on implementing our Integrated Regulatory
Strategy where prioritising, evaluating and managing the risks of chemicals are central elements.
More than ever, our core mandate is our primary focus, and we have continued to allocate
resources accordingly in this programming document so we can fulfil our mandate.
Another important checkpoint in 2021 comes in anticipation of the Commission’s next review of
the REACH Regulation. We are preparing to submit our own report as input to this important
milestone. The report will show how the health and safety of consumers and workers, and the
environment are now better protected than they were five years ago.
To ensure this progress continues, it is more critical than ever that we are focused and have
clear priorities for the coming years, particularly as we face declining and volatile fee income
that is affecting our resources. However, we are confident that for our current tasks we have set
the right priorities and found the most agile way of working within the boundaries of the
Multiannual Financial Framework 2021-2027.
We also anticipate that we may receive further new and challenging tasks in the coming years.
The EU’s Green Deal, and particularly the Chemicals Strategy for Sustainability, includes several
areas where ECHA can have an important role in driving more sustainable products, better
working and living conditions, and a more competitive and innovative Europe.
As the Commission has not yet officially requested us to contribute to the work under the
Chemicals Strategy, at this point, we can only flag our preparedness and willingness, resources
allowing. But we firmly believe we are well placed to integrate further pieces of legislation, as
we have demonstrated with recent tasks under the Waste Framework and Drinking Water
directives. These examples prove our ability to find synergies with our existing work even under
difficult circumstances.
While the impact of COVID-19 has changed our ways of working, we have embraced this and
successfully made a digital leap forward that has allowed us to continue fulfilling our objectives
even while our working and meeting arrangements have become remote. Though the pandemic
may have lasting effects, we are confident that our work programme objectives will continue to
be met due to our highly engaged staff and stakeholders, as well as the support received from
Member States and institutions.
ECHA’s Management Board will in 2021 lead the work on revising our strategic plan. Once
finalised, this will give clarity and direction to our stakeholders, Member States and to ECHA’s
staff members on how the Agency positions itself for the next years.
We look forward to continuing to engage with policy makers, citizens and other interested parties
to achieve our common objectives. Our journey is a shared one and we thank you for buying
into our ambitions and your support in helping us to achieve our goals.
Stay safe.

Paul Krajnik Bjorn Hansen

Chair of the Management Board Executive Director
Programming Document(s) 2021-2024 5

List of Acronyms
AD Administrator
AST Assistant
BEF BPR-EN-FORCE (Forum-coordinated BPR enforcement project)
BPC Biocidal Products Committee
BPR Biocidal Products Regulation
BPRS BPR Subgroup of the Forum
C&L Classification and labelling
CA Contract agent
CCH Compliance check
CEFIC Conseil Européen des Fédérations de l'Industrie Chimique
CEN European Committee for Standardization
CEOS Conditions of Employment of Other Servants of the European Union
Chesar Chemical Safety Assessment and Reporting tool
CLP Classification, labelling and packaging (and the respective Regulation)
CMR Carcinogenic, mutagenic or toxic to reproduction
CoRAP Community rolling action plan
CSA Chemical safety assessment
CSR Chemical safety report
CSS Chemical Strategy for Sustainability
DNA Designated national authorities
DU Downstream user
DWD Drinking Water Directive 98/83/EC
EAP Environmental Action Programme
EIONET European Environment Information and Observation Network
EC European Commission
ECHA European Chemicals Agency
eChemPortal OECD Global Portal to Information on Chemical Substances
ECM Enterprise content management
ED Endocrine disruptor
EEA European Economic Area
EINECS European Inventory of Existing Commercial Chemical Substances
EFSA European Food Safety Authority
EMA European Medicines Agency
EMCDDA European Monitoring Centre for Drugs and Drug Addiction
ENES Exchange Network on Exposure Scenarios
ES Exposure scenario
eSDS Extended safety data sheets
Programming Document(s) 2021-2024 6

EU European Union
EUCLEF European Chemicals Legislation Finder
EUON European Union Observatory for Nanomaterials
EUSES European Union System for Evaluation of Substances
IED Industrial Emissions Directive 2010/75/EU
FTE Full-time equivalent
Forum Forum for Exchange of Information on Enforcement
HelpNet Network of national BPR, CLP and REACH helpdesks
HR Human resources
IAC Internal Audit Capability of ECHA
IAS Internal Audit Service of the Commission
ICCA International Council of Chemical Associations
IPA Instrument for Pre-Accession Assistance
ISO International Organisation for Standardisation
ICT Information communications technology
IPA Instrument for Pre-accession assistance
IR Information requirements
IRS Integrated Regulatory Strategy
IT Information technology
IUCLID International Uniform Chemical Information Database
MB Management Board
MFF Multiannual Financial Framework
MS Member State
MSC Member State Committee
MSCA Member State competent authority
NEA National enforcement authority
NeRSAP Network of REACH SEA and Analysis of Alternatives practitioners
OECD Organisation for Economic Co-operation and Development
OEL Occupational exposure limit
Odyssey ECHA’s tool to support evaluation tasks
OSH Occupational safety and health
PBT Persistent, bioaccumulative and toxic
PCN Poison Centre Notifications
PIC Rotterdam Convention on the prior informed consent procedure (and the
respective Regulation)
POPs Persistent organic pollutants (and the respective Regulation)
PPORD Product and Process Oriented Research and Development
PPPs Plant protection products
(Q)SAR (Quantitative) Structure-Activity Relationship
Programming Document(s) 2021-2024 7

R4BP Register for Biocidal Products

RAC Committee for Risk Assessment
REACH Registration, evaluation, authorisation and restriction of chemicals (and the
respective Regulation)
REACH-IT Central IT system providing support for REACH
REF REACH-EN-FORCE (Forum-coordinated REACH enforcement project)
RMOA Regulatory management option analysis
SEAC Committee Socio-economic Analysis Committee
SIEF Substance information exchange forum
SDS Safety data sheet
SME Small and medium-sized enterprises
SNE Seconded national expert
SPC Summary of product characteristics
SVHC Substance of very high concern
SWP Standing Working Party
TA Temporary agent
TP Testing proposal
TPE Testing proposal examination
UNECE United Nations Economic Commission for Europe
UNITAR United Nations Institute for Training and Research
vPvB Very persistent and very bioaccumulative
WFD Waste Framework Directive
WHO World Health Organisation
WP Work programme
WSSD World Summit on Sustainable Development
Programming Document(s) 2021-2024 8

Mission statement
ECHA’s legal mandate
The European Chemicals Agency (ECHA) is a European Union (EU) body established on 1 June
2007 by Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation
and Restriction of Chemicals (REACH).
ECHA’s mandate is to manage and carry out technical, scientific and administrative aspects of
REACH. ECHA was also established to manage tasks related to the classification and labelling of
chemical substances, which, since 2009, have been governed by Regulation (EC) No 1272/2008
on Classification, Labelling and Packaging of substances and mixtures (CLP). Since 2012, ECHA’s
mandate covers Regulation (EU) No 528/2012 concerning the making available on the market
and use of biocidal products (the Biocidal Products Regulation, BPR) and since 2014, also the
recast prior informed consent (PIC) Regulation (EU) No 649/2012 concerning the export and
import of hazardous chemicals.
Since 2018, ECHA carries out a specific task concerning substances in articles under Directive
(EU) 2018/851 on waste. In 2019, ECHA was allocated specific tasks to support the Commission
and the Member States in their scientific and reporting duties under the Regulation (EU)
1021/2019 on persistent organic pollutants (POPs).
Finally, in 2020, ECHA was allocated specific tasks of technical support during the preparatory
and operational phase under the recast of the Drinking Water Directive 98/83/EC.
The five regulations are directly applicable in all EU Member States without the need for
transposition into national law. The directives are transposed into national legislation, which is
the applicable law in the respective EU Member State. See further Annex IB for an overview.

ECHA’s mission
We, together with our partners, work for the safe use of chemicals.

ECHA’s vision
To be the centre of knowledge on the sustainable management of chemicals, serving a wide
range of EU policies and global initiatives, for the benefit of citizens and the environment.

ECHA’s values
Transparent
We actively involve our regulatory partners and stakeholders in our activities and are transparent
in our decision-making. We are easy to understand and to approach.
Independent
We are independent from all external interests and impartial in our decision making. We consult
members of the public openly before taking many of our decisions.
Trustworthy
Our decisions are science based and consistent. Accountability and the security of confidential
information are cornerstones of all our actions.
Efficient
We are goal-oriented, committed and we always seek to use resources wisely. We apply high
quality standards and respect deadlines.
Committed to well-being
We stimulate the safe and sustainable use of chemicals to improve the quality of human life in
Europe and to protect and improve the quality of the environment.
Programming Document(s) 2021-2024 9

READER’S GUIDE
This programming document has two parts: the multiannual work programme for 2021-2024
implementing ECHA’s strategic plan for this four-year period (Section II), accompanied by the
resource planning until 2024, and the work programme (Section III).
The annual work programme part covers two years, 2021 and 2022. For 2021, the work
programme constitutes ECHA’s financing decision and for 2022 it is the draft work programme
of the Agency as input to the budgetary process of the EU that runs in 2021.
All actions and outputs in the work programme section indicate whether they are planned for
2021 or 2022 or both years.
Programming Document(s) 2021-2024 10

I GENERAL CONTEXT
ECHA’s role

ECHA is an EU decentralised agency, set up to contribute to the implementation of the common

chemicals policy. As an EU agency, ECHA is a distinct EU body with its own legal personality. It
is a public body, serving the EU citizens, works transparently, and is independent of any specific
or policy interests, of national interests and of the EU institutions. The Agency provides opinions
to the European Commission on the scientific and technical aspects of hazard assessment, risk
assessment, risk management and the societal and economic consequences of risk management
decisions. The European Commission, together with the Member States, takes decisions based
on ECHA’s opinions. ECHA also takes decisions granting rights to or imposing duties on specific
economic operators.
For all its work ECHA consults and coordinates with the European Commission and the Member
State authorities. ECHA relies on the technical, scientific and administrative specialist expertise
from the Member State authorities and pools their knowledge through its committees to develop
opinions and agree on decisions. The staff of ECHA provides the secretariat for this close
collaboration, drafts dossiers and decisions for the committees’ opinion or agreement and in
certain cases drafts decisions without needing to involve the committees. Overall, ECHA supports
both the cooperation between the EU and national governments as well as between the EU and
international organisations concerning chemicals policy. ECHA also provides advice and support
for companies in fulfilling their duties under the legislation.
ECHA manages and in some cases carries out the technical, scientific and administrative aspects
of REACH, CLP, BPR, PIC and specific tasks under the Waste Framework Directive (WFD), the
recast of the Regulation on Persistent Organic Pollutants (POPs) as well as the recast of the
Drinking Water Directive (DWD). Box 1 describes these tasks.
Much of ECHA’s international work focuses on developing standards internationally and
implementing them in the EU. Within its remit, it aims to support the implementation of the
legislation and to provide technical and scientific support to the European Commission in the
implementation of the EU’s international agenda. This is described further in the individual
actions and outputs of the Work Programme Section and Annex XI below.

EU regulatory system for chemical safety

The EU has an extensive system of legislation controlling chemicals. REACH, CLP, BPR, PIC, POP
and the specific tasks under the respective Directives are an integral part of this system.
Excluding pharmaceuticals and veterinary products, the system starts with the basic regulation
REACH on industrial chemicals, the regulation on plant protection products, and the BPR on
biocides. They lay out the marketing and use conditions for these three types of chemicals. The
regulations have similar approaches: before a chemical is allowed on the market or to be used,
information on its hazards and uses must be generated. Authorities assess the information before
granting market access (or not). This assessment is in-depth within an authorisation system for
plant protection products, biocides and certain industrial chemicals and a screening level for all
other industrial chemicals. The three regulations have clear interfaces: all active plant protection
and biocidal ingredients are automatically registered under REACH.
Reaching across these three basic regulations, the CLP Regulation (on the classification and
labelling of chemicals), which implements the UN’s globally harmonised system into EU law, sets
harmonised rules on how to classify, package and label the industrial chemicals, plant protection
products and biocides. The application of the CLP rules forms an integral part of the authorities'
decision for market access for all three types of chemicals. Furthermore, product-specific
regulations, covering, for example, cosmetics, toys, food contact materials, detergents and
electronic equipment, form a second layer of legislation setting particular conditions for
chemicals in those products. Finally, there are regulations and directives involving chemicals, for
example, concerning the import and export of certain hazardous chemicals (PIC), the control of
Programming Document(s) 2021-2024 11

persistent organic pollutants (POP), chemical accidents, water, workers, ecolabelling, fertilisers,
industrial emissions or waste, which add conditions on the manufacture, marketing and use of
chemicals.
The second and third layer of EU legislation do not require the generation of hazard information.
They generally rely on REACH for the hazard information, always rely on CLP to determine
hazards, and often rely on REACH for risk management. REACH therefore interfaces with most
of the EU’s chemicals legislation, whereas most chemicals legislation depends on the CLP
classification.

Objectives of the legislation

The main aim of the regulations and the directives 1 that ECHA helps implement is to ensure a
high level of protection of human health and the environment, as well as the smooth functioning
of the EU internal market.
There are numerous factors determining the competitiveness and innovation of the EU industry.
One contributing factor is the chemicals legislation. REACH and the WFD aim explicitly to
enhance competitiveness. They establish a harmonised standard which ensures a high level of
protection for all products on the EU market. Through harmonised legal requirements, they also
internalise the cost of meeting the norm, thus eliminating the competitive advantage arising
from undercutting the standard. The BPR, although not as an explicit aim, contributes similarly
to competitiveness. CLP contributes by establishing transparency between substances and
mixtures regarding their hazards. REACH and BPR establish legal obligations and incentives as
to which substances need to be substituted, thus also providing clear directions for increased
investment in innovation.
REACH, BPR and POP are explicitly underpinned by the precautionary principle. The
precautionary principle can be invoked by the European Commission, together with the Member
States, when taking risk management decisions based on ECHA’s opinions.
Finally, REACH establishes the objective of promoting alternatives to testing of vertebrate
animals, which is relevant in the generation of hazard information and sharing of available
information among operators – applied also under BPR and CLP. ECHA therefore contributes to
the development of alternative methods, and requires testing using vertebrate animals to ensure
a high level of protection of human health or the environment where the same information
cannot be achieved through the use of alternative methods.

ECHA’s strategic outlook - anticipating challenging times ahead

During the time period 2019–2023, the EU has taken and will take further significant decisions
and agree on key aspects of its overall future political direction. The Commission has finalised a
series of activities assessing current policies against the political needs, in particular:
a) an in-depth evaluation of REACH under the Better Regulation Programme 2;
b) a fitness check under the Better Regulation Programme of all chemicals legislation,
including Biocides and CLP 3; and
c) an assessment of the interface between chemicals, product and waste legislation
under the Circular Economy Action Plan 4.
These have been used in the elaboration of the European Green Deal 5 and a number of more
specific strategies and agendas in 2019 and 2020, all having an impact on ECHAs future:

d) A New Industrial Strategy for Europe;

1
REACH, CLP, BPR, PIC, POP Regulations, Waste Framework Directive and Drinking Water Directive.
2
http://ec.europa.eu/smart-regulation/roadmaps/docs/2017_env_005_reach_refit_en.pdf.
3
http://ec.europa.eu/environment/chemicals/better_regulation/pdf/roadmap_chemicals_fc.pdf.
4
http://ec.europa.eu/smart-regulation/roadmaps/docs/plan_2016_116_cpw_en.pdf.
5
The European Green Deal COM(2019) 640 final, 11.12.2019.
Programming Document(s) 2021-2024 12

e) Europe's Digital Agenda 6;

f) The EU's Beating Cancer Action Plan 7;
g) A new Circular Economy Action Plan 8;
h) A new Chemicals Strategy for Sustainability 9;
i) The Commission’s proposal on a General Union Environment Action Programme to
2030 (8th Environment Action Programme (EAP) 10
ECHA concurs with the results of the assessments that the overall EU regulatory system for
chemical safety must increase efficiencies in the current work, increase integration and improve
consistency of the EU regulatory system and improve transparency. As a consequence, the
Agency has re-prioritised areas of work for the years to come, whilst awaiting clarity as to any
new activities resulting from the policy developments (see Box 2).
Furthermore, the UK left the EU in the beginning of 2020 and towards the end of 2020 there is
still insufficient clarity as to the future relations between the EU and the UK, both affecting ECHA.
The impact of the COVID-19 pandemic in Europe on the implementation of the EU’s chemicals
legislation by Member States, the Commission and ECHA, in a mid-to long-term perspective still
needs to be seen. In 2020, the Agency managed to maintain its outputs on the estimated level
and collaboration in ECHA’s bodies and with Member States continued remotely on basis of
robust remote IT infrastructure. Depending on the duration of the pandemic the sustainability of
the current working arrangements will require assessment and adjustment.
Parallel to the developing political processes, ECHA has to find a sustainable balance between
its regulatory role, transparency, stakeholder engagement and its independence. In this area,
public trust in EU institutions and agencies, and in evidence-based decision making, is at stake,
which creates high demands for ECHA in its communication towards and engagement with the
stakeholders and the public.
ECHA will need to proactively and regularly adapt to these, and any new, challenges. The Union-
wide discussions on the new Multiannual Financial Framework (MFF), running from 2021 to 2027,
will set the human and financial framework for ECHA to implement its current mandate and meet
these challenges.
Looking at ECHA’s activities, the years after the last REACH registration deadline marked a new
era in chemicals management and the beginning of a uniform EU system for market access for
chemicals. In the biocides field, the time period until 2023 marks the final years leading to the
2024 deadline for the finalisation of the review programme for active substances. Once the
review is completed, all biocides on the market will be subject to one uniform EU system.

ECHA’s competences and impact

Since its establishment in 2007 to implement REACH, ECHA has regularly taken on and
integrated new tasks: CLP in 2008, BPR in 2013, PIC in 2014, ad hoc tasks on persistent organic
pollutants (POPs) from 2015 to 2018, regularised by Regulation (EU) 2019/1021 on POPs as of
2019, delegated tasks for building and hosting the EU observatory on nanomaterials in 2016 ,
ad hoc tasks on occupational safety and health (OSH) since 2017, delegated tasks for the
implementation of the European Chemicals Legislation Finder (EUCLEF) in 2018, a specific task
under the WFD in 2018 and finally specific tasks under the Recast of the Drinking Water Directive
in 2020. ECHA has thereby built up competences on, inter alia:
1. Information: Tools for information submission, storage, access and web publication,
operational guidance and helpdesks (REACH, CLP, BPR and PIC) and data processing and
analytics tools (REACH, CLP, BPR and PIC).

6
Shaping Europe’s Digital Future. European Union, 2020. https://ec.europa.eu/info/sites/info/files/communication-
shaping-europes-digital-future-feb2020_en_4.pdf.
7
Further information available at https://ec.europa.eu/health/non_communicable_diseases/cancer_en.
8
COM(2020) 98 final, https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1583933814386&uri=COM:2020:98:FIN.
9
COM(2020) 667 final, https://ec.europa.eu/environment/pdf/chemicals/2020/10/Strategy.pdf.
10
COM(2020) 652 final, https://ec.europa.eu/environment/pdf/8EAP/2020/10/8EAP-draft.pdf.
Programming Document(s) 2021-2024 13

2. Assessment: Information generation (REACH and BPR), hazard assessment and hazard
identification (REACH, CLP and BPR), identification of safe levels (REACH, BPR and OSH),
exposure assessment and risk characterisation (REACH and BPR), efficacy assessment
(BPR).
3. Risk management: Authority (REACH, BPR and PIC) or industry (REACH and BPR)
assessment of risk leading to the determination of risk management needs, including
assessment of alternative substances or technologies.
4. Impacts: Authority (REACH and BPR) or industry (REACH) assessment of efficacy and the
socio-economic impacts of risk management.
5. Administration: Administering an independent EU agency.
6. Taking on tasks: New technical, scientific and administrative tasks using its competences.
ECHA has improved synergies and consistency between the pieces of legislation it implements.
There are numerous interfaces and interdependences: REACH, BPR, OSH and POPs all use the
hazard assessment of CLP; POPs and REACH share the identification of persistent, bio-
accumulative and toxic chemicals; and PIC rules apply to chemicals severely restricted by BPR,
POPs and REACH. The IT systems and methodologies applied in REACH, CLP and BPR have also
been made more consistent.

In 2018, ECHA obtained for the last REACH registration deadline information for all existing
substances brought on the EU market at between 1 and 100 tonnes per year. This closes the
transitional period since the entry into force of REACH. ECHA now holds the knowledge of all
chemicals on the EU market in amounts above 1 tonne, including all chemicals newly introduced
to the EU market. This marks an entirely new phase of understanding and being able to react to
the challenges of regulating chemicals compared to the past, where only a limited number of
substances were well characterised and regulated compared to the many chemicals that were
on the market already at that time. However, the experience from the first 10 years in operation
and ECHA’s ongoing regulatory work, confirmed by the Commission’s evaluation of REACH,
shows that the level of compliance with the requirements established by the EU legislator is not
at the expected level. Nevertheless, having obtained information on all chemicals in the EU is an
asset which provides for a unique opportunity to comprehensively and systematically identify all
chemicals needing regulatory action – serving not only REACH, CLP, BPR and PIC, but also all
the other legislation linked to chemicals safety.

In the past 10 years, ECHA has been instrumental in implementing REACH, CLP, BPR and PIC.
Exemplified by the conclusion of the Commission’s evaluation of REACH, the way how ECHA
fulfils its mandate shows steady improvement towards meeting the legislative objectives
addressing today's citizens' concerns about chemical safety. ECHA adds value through improving
synergies, consistency and efficiencies in implementing EU chemicals legislation, reduces costs
and improves predictability. At the same time, ECHA aims to be transparent, leading to
trustworthy scientific decision making. This supports a more effective internal market for
chemicals and contributes to the strategic priorities of the EU. Ultimately, EU citizens, workers,
and the environment benefit from the improved safety of chemicals. ECHA’s impact is enabled
by its competences, a strong regulatory framework, and strong cooperation with the European
Commission, Member State national authorities and all its stakeholders.
Programming Document(s) 2021-2024 14

Box 1
ECHA today
Today ECHA manages the implementation of the following pieces of legislation:
REACH requires companies to ensure that substances manufactured or imported above 1 tonne
per year are used safely. They must collect or generate specified chemical safety information,
use this information to develop and apply safe use instructions, and communicate these
instructions to users of the substances. Finally, to gain EU market access, they must document
this in a registration dossier and submit it to ECHA. Registrants of the same substance have to
share their data and submit their registration jointly, promoting the harmonised interpretation
of data and reducing registration costs and testing on animals. If the safety information collected
by industry is insufficient ECHA, working with the Member State competent authorities, will
require additional information. All companies – also those manufacturing, importing or using
substances below 1 tonne per year – must assess their substances against the CLP classification
criteria using all available chemical safety information and then package the chemical and label
the package accordingly. This obligation ensures that safety information (e.g. ‘Causes serious
eye irritation’, ‘Keep out of reach of children’) is available to workers and consumers. The
company must submit the classification to ECHA’s publicly available Classification and Labelling
Inventory and notify hazardous mixtures to authorities on the basis of harmonised (PCN)
templates.
Under CLP, a Member State can propose to harmonise the classification and labelling where this
is needed, and it is also obligatory for plant protection products and biocides. Similarly under
REACH, a Member State, ECHA on request of the European Commission, or ECHA on its own
initiative, can propose restrictions, i.e. a ban or a restriction of the use of the substance, if they
find that there are risks that need to be addressed on a Union-wide basis. ECHA assesses the
scientific and technical aspects of the proposal and based on it, the European Commission,
together with the Member States, takes the final decision. REACH authorisation checks that
substances of very high concern are used safely and are progressively replaced by suitable
alternatives. Substances of very high concern are subject to authorisation when the European
Commission and the Member States include them in the Authorisation List, based on a proposal
from ECHA. These substances cannot be placed on the market for a use after a given date,
unless an authorisation is granted for the specific use. ECHA assesses the scientific and technical
aspects of each authorisation application and based on it, the European Commission, together
with the Member States, takes the final decision.
The BPR establishes an authorisation system for the placing on the market and use of biocidal
products. ECHA coordinates the Member States’ evaluation of active substances and the Union-
wide authorisation of biocidal products containing approved active substances. ECHA assesses
the scientific and technical aspects of active substance approvals and Union authorisation
applications and based on this assessment, the European Commission, together with the Member
States, approves or refuses the active substance or the EU authorisation. ECHA decides on
requests to establish of technical equivalence, applications for alternative suppliers, data sharing
disputes. ECHA is also the central IT hub for all national authorisation applications.
PIC implements the UNs Rotterdam Convention in the EU. It applies to banned or severely
restricted chemicals within the EU and provides for information exchange mechanisms regarding
the export outside and import inside the EU of those chemicals. PIC thereby contributes to the
global efforts on chemical safety. ECHA contributes to the implementation of the POPs
Regulation by providing scientific and technical support to the Commission and the Member
States in the preparation of proposals to the UNs Stockholm Convention and in reporting.
Furthermore, ECHA is also supporting the EU Commission in their accession process by providing
technical support to (pre-)candidate countries.
Under the WFD, ECHA must develop and operate a database which tracks the presence of
substances of very high concern in articles throughout the supply chain. For the DWD, ECHA
provides technical support in the implementation of the Directive by generating a first EU positive
Programming Document(s) 2021-2024 15

list of materials that come into contact with water intended for human consumption and prepares
for the operational phase of the Directive as of 2025.
In addition, for all legislation, ECHA disseminates information, prepares guidance, develops
tailored IT systems, and promotes harmonised enforcement actions by Member States.
Box 2

ECHA tomorrow
The European Commission’s evaluation of REACH 11 concluded that REACH is effective but not
efficient and that its implementation is lagging behind in meeting its political objectives. Indeed,
there are gaps and severe shortcomings in the chemical safety information submitted by
industry, especially with regard to long-term effects on human health and the environment and
in relation to uses and exposure. ECHA’s assessment of the past and current situation on the
level of compliance in registration dossiers with information requirements has been and is in line
with the findings of the evaluation by the Commission indicating the absolute need for action.
Also, industry’s knowledge on substances in articles needs to improve, not only to meet REACH
obligations, but also to face the challenges coming from the EU’s objectives on Circular
Economy 12. Improvement and simplification are also needed in relation to the extended Safety
Data Sheets, evaluation, authorisation and restrictions. The issues requiring most urgent action,
as set out in the REACH Review, are 13: non-compliance of registration dossiers, simplification of
the application for authorisation process, ensuring a level playing field with non-EU companies
through effective restrictions and enforcement and clarifying the interface of REACH and other
EU legislation, in particular that on Occupational Safety and Health (OSH) and on waste.
Consequently ECHA’s, the Member States’ and the European Commission’s activities
implementing REACH and CLP will need, on all fronts, to be accelerated. The evaluation activity
must continue at higher intensity and for longer than planned and harmonised classification and
labelling, restrictions and authorisation activities must accelerate. Registration activities will no
longer have big peaks, but as of 2018 all substances above 1 tonne are in REACH, so there will
be a larger steady stream of updates and new registrations than before 2018. Total resources
will therefore need to be maintained, rather than decreased during the next Multiannual Financial
Framework.
In line with sustained efforts needed for the REACH processes, and to meet the political
objectives of BPR, ECHA will need to work with the Member States to increase efficiencies.
Biocides activities must intensify, using the accumulation of experience and competences to
progress as much as possible towards the objective that by 2024 only fit-for-purpose biocidal
active substances remain on the EU market. This provides the basis for the authorisation of all
biocidal products by the Member States and the Commission.
For PIC, a high level of efficiency has been achieved already. The expected continued increase
in the number of PIC notifications will test this capacity to handle PIC processes even more
efficiently. Given the global perspective of PIC, its implementation by the Agency makes
international trade in hazardous chemicals more transparent allowing third countries to control
the import of unwanted chemicals or by giving access to safety information if the import is
accepted.
For POP, ECHA aims at ensuring a more comprehensive reporting at Union level and seeking
synergies between REACH processes and the proposal of new POP candidates to the Stockholm
Convention.

11
COM(2018) 116 final - https://ec.europa.eu/growth/sectors/chemicals/reach/review_en.
12
Commission Roadmap for the Fitness check on the most relevant chemicals legislation (excluding REACH), as well as
related aspects of legislation applied to downstream industries and the Commission Communication on the
implementation of the circular economy package: options to address the interface between chemical, product and
waste legislation COM(2018)32 final.
13
REACH Review findings in section 2.1, p.3 of the Commission communication COM(2018) 116 final.
Programming Document(s) 2021-2024 16

The further integration of tasks such as under WFD, DWD, OSH and possible other legislation
should add to a higher level of coherence in chemicals management across sectors and make
efficient use of available competences.
Programming Document(s) 2021-2024 17

II MULTIANNUAL WORK PROGRAMME 2021–2024 14

The Multi-annual Work Programme corresponds to ECHA’s Strategic Plan covering the period
2019-2023. The overall political environment is changing rapidly. A new multi-annual financial
framework for the EU during 2021-2027 combined with an uncertain and variable fee income
set new limits to the funding of the Agency. Also, the specific environment on chemicals
legislation is different compared to 2018, following the initiation of the EU Green Deal in 2019
and the new Chemicals Strategy for Sustainability of the Commission as well as Europe's Beating
Cancer Plan, and the European Circular Economy, Industry and Data Strategies in 2020.
ECHA’s multi-annual priorities, established back in 2018, need to be considered in light of these
external factors. Furthermore, the Agency has to meet the increased expectations regarding
sustainability and demonstrating impact. Under the necessity to prioritise available resources,
starting in 2021, the Agency has deprioritised many non-essential regulatory tasks.
Consequently, the focus of the work of ECHA lies even more in implementing strategic priority 1
while the objectives under strategic priorities 2 and 3 are pursued to a lesser extent than initially
foreseen. The extent to which ECHA plans to carry out the tasks under each area of operation
for multi-annual strategic priorities 2 and 3 below during 2021 and 2022 is set out in the annual
planning.

14
The Agency will conduct in 2021 a mid-term review of the Strategic Plan 2019-2023 as ECHA’s Multiannual Work
Programme– see the corresponding action in section III, 5.3.
Programming Document(s) 2021-2024 18

1. Multiannual priorities
With the aim to keep serving the Union in an adequate and efficient manner, ECHA has set out
three strategic priorities. They take ECHA’s role as their basis, build on ECHA’s competences and
achieved impact, recognise the central importance of the legislation ECHA implements in the EU
regulatory system, and attempt to anticipate the challenges ahead. ECHA expects that through
the strategic priorities it will be able to better contribute in meeting the policy objectives of the
legislation and address its remaining challenges, including the outcome of the Commission’s
REACH Review 15. The following section includes a detailed description of the scope and purpose
of ECHA’s strategic priorities.
First and foremost, ECHA, together with its partners, will use its competences and
comprehensive knowledge of chemicals on the EU market to identify groups of substances of
concern to assist the Commission to determine which regulatory action is needed and take the
necessary action under REACH, BPR, CLP, POP, or under other relevant legislation (Strategic
Priority 1). Strategic Priority 2 takes the knowledge from Strategic Priority 1, uses the legislative
obligations of industry set out in REACH, CLP, BPR, PIC, WFD and DWD and ECHA’s mandate
therein, and aims to improve the knowledge and capacities in industry to take action before
ECHA does. Finally, Strategic Priority 3 takes the knowledge from Strategic Priority 1, and uses
it within ECHA’s mandate to improve the consistency and integration within the EU chemicals
regulatory system and towards the international work on chemicals management.
ECHA will thereby be ready to continue its track record since 2007 on delivering on its core tasks
while, should the EU decide to do so and based on an upfront evaluation, taking on additional
implementing tasks from more pieces of legislation 16, thus establishing synergies and
consistency between various pieces of legislation.
In implementing the strategic priorities, ECHA will build on its competences, knowledge and
experience, improve and focus its collaboration with the Member State competent authorities,
other national and EU agencies, and its stakeholders, as well as remaining focused on delivering
sound science-based opinions, decisions and advice. ECHA will also keep adapting its processes,
methodologies, tools and its staff competences to reflect the advancing science, technology and
changes in the regulatory environment. ECHA will actively explore the potential of IT-based
approaches, using opportunities offered by new developments in search and computing
algorithms. It is expected that the international dimension of ECHA’s work as a cross-cutting
element will further increase.

https://ec.europa.eu/growth/sectors/chemicals/reach/review_en.
15

Starting with REACH in 2006, CLP in 2008, BPR in 2012, PIC in 2012, POPs in 2018, a certain task regarding the
16

Waste Framework Directive in 2018 and certain tasks regarding the Drinking Water Directive in 2020.
Programming Document(s) 2021-2024 19

2. Strategic priorities 17
ECHA will pursue the three strategic priorities with their respective objectives. The strategic
priorities with their respective objectives come along with performance indicators that will
monitor how much progress has been made against the strategic priority will have been made.
Furthermore, each strategic priority contains areas of operation that are implemented by specific
actions and outputs as stipulated in the annual work programme of the Agency monitored
through specific indicators (see Section III below).

STRATEGIC PRIORITY OBJECTIVE PERFORMANCE INDICATOR(S)

1. Identification and [1] Accelerate data generation and 1. Screening of substances with
risk management of intensify identification of assignment of the particular
substances of concern substances of concern substances or group to any of the
three priority groups:
[2] Accelerate regulatory action on • High priority for risk
substances of concern management
• Need for data generation
• Low priority for regulatory action.

Indicators based on measuring

progress in the number of the
substances in each of the three
priority groups.

2. Number of conclusions on the

need for information generation for
high priority substances.

3. Number of substances for which

regulatory risk management has
been initiated.

2. Safe and [3] Effective communication up Qualitative measurement with use of

sustainable use of and down the supply chain sub-indicators where possible.
chemicals by industry becomes mainstream This may include improved
methodologies for linking submission
tools to those for chemical safety,
developed standardised tools and
formats for EU supply chain
communication and for substances in
articles, broadened scope of the CSA
methodologies.

3. Sustainable [4] ECHA’s information, knowledge Qualitative assessment of the

management of and competences on safe use of milestones may include
chemicals through the chemicals support the areas/legislation where ECHA has
implementation of EU implementation of EU legislation. initiated contact and achieved a
legislation successful interaction/collaboration
with the responsible authorities,
synergies when implementing new
assigned tasks, intensified
cooperation with international
partners or relevant pieces of
new/existing legislation being
implemented by the Agency over
time.

17
As contextual background, see the box at the beginning of the present section.
Programming Document(s) 2021-2024 20

Progress in achieving each of these priorities is monitored via the performance management
system of the Agency. ECHA’s aim and commitment towards the priorities are not self-standing
but have to be seen in light of the UN’s 2030 Agenda for Sustainable Development 18. Indeed,
ECHA’s contribution to the 2030 Agenda honours the commitment of the EU and its Member
States to reduce the negative impacts of urban activities and of chemicals which are hazardous
for human health and the environment, including through the environmentally sound
management and safe use of chemicals and the reduction and recycling of waste. It is already
clear that the full achievement of this work will take considerable time and effort. The 2030
Agenda for Sustainable Development functions as the guiding goal for any regulatory work which
the Agency and its partners contribute to.

By putting the three strategic priorities into practice by 2023 – by the end of the duration of
ECHA’s current strategic plan – ECHA intends to demonstrate that progress has been made
towards the objectives of the legislation ECHA implements, the objectives of the overall EU
regulatory system and the Sustainable Development Goals.
In the context of ECHA’s strategic plan for the next years, and to make as much progress as
possible on it, ECHA considers that putting the 2030 Agenda for Sustainable Development into
practice means that:
1. Robust data is available on all chemicals in Europe.
a) Registration dossiers are up to date and contain appropriate and complete data
covering the hazards and uses of substances. This allows the substances to be
adequately classified, labelled and used safely. Companies can use the information
for substituting hazardous substances, and by that spur innovation.
b) Hazard data is generated using non-animal testing methods and new approaches
wherever appropriate to fulfil the REACH information requirements.
c) ECHA has concluded for each of the registered high-volume substances (above 100
tonnes per year) submitted by the 2018 deadline, preferably in cooperation with the
relevant stakeholders, if it is:
i. a priority for regulatory risk management;
ii. of low priority for further regulatory action;
iii. or has requested information under compliance check where needed.
d) Divergence in industry self-classification has decreased significantly.
2. Effective regulatory risk management of the most hazardous chemicals takes place.
a) Substances of concern are identified, either individually or in groups. The most
appropriate regulatory risk management measure to protect health or the
environment, either under REACH, CLP, BPR and POP or other pieces of legislation
has been initiated.
b) The processes for authorisation, restriction, and harmonised classification and
labelling are fully optimised and operate based on fit-for-purpose dossiers. They allow
efficient opinion forming in the committees and swift decision making by the
Commission.
3. Effective communication takes place about the safe use of chemicals up and down the
supply chain.
a) Information about substances flows effectively up and down the supply chain.
Companies that use chemicals inform their suppliers about what they do with them,
and in return, manufacturers and importers provide information on how to use them
safely.

18
https://sustainabledevelopment.un.org/post2015/transformingourworld.
Programming Document(s) 2021-2024 21

b) Importers and EU producers of articles have improved their knowledge on the

substances present in their articles to provide adequate safe use advice to their
customers and promote substitution.
4. A step-change for citizens, businesses and the regulators takes place.
a) Information on chemicals is reliable, understandable, freely available, and easy to
use. This allows citizens, stakeholders, businesses and regulators to make informed
choices on using and substituting hazardous substances, and to increase their
confidence in the safety of chemicals – not just in Europe, but around the world.
b) The experience of REACH, CLP and BPR, and the information, methods and tools
developed, are increasingly recognised and used worldwide.
c) Companies experience firm and fair enforcement focusing on ensuring the safe use of
hazardous chemicals and fostering a level playing field.

2.1 Strategic priority 1: Identification and risk management of

substances of concern

ECHA aims to have addressed all REACH substances of concern above 1 tonne by 2027, and to
have provided opinions on all active substances for which dossiers have been submitted by
Member States with a view to complete the objective of the completion of the BPR active
substance review programme by 2024, which forms the basis for having all biocidal products on
the EU market authorised under the BPR by 2030. Addressing means determining whether the
substances are of concern, and which further information is needed, or which regulatory action
is required.
To achieve this aim, ECHA, together with the European Commission and the Member State
competent authorities, will use the knowledge on all REACH substances on the EU market and
all BPR substances to identify groups of substances of concern, identify which regulatory action
Programming Document(s) 2021-2024 22

is needed and subject them to the action. ECHA, the European Commission and the Member
States must also improve efficiencies, including those related to enforcement, as requested for
REACH and CLP under the European Commission’s evaluation of REACH and the slower-than-
expected assessment of active substances. Extra efforts are needed on REACH evaluation and
BPR active substance approvals, as this first step determines how fast regulatory action can be
taken.
For REACH, CLP and BPR, there will be a need to evolve the risk assessment and management
approaches and research over time and to accommodate emerging priorities, such as managing
substances with endocrine-disrupting properties and addressing combined effects of chemicals.
Areas of operation for Strategic Priority 1
1. Prioritise groups of substances
• REACH, CLP, BPR: Use all relevant data sources, including new approach
methodologies, to group all substances.
• REACH, CLP, POP: ECHA, the European Commission and Member State competent
authorities prioritise groups of substances for concerted regulatory action and identify the
required regulatory actions 19, considering also the need for a level playing field for all
parties involved.
2. Concerted regulatory action
• REACH, CLP, POP: Execute the required regulatory actions for prioritised groups of
substances using evaluation, harmonised classification and labelling, restrictions and
authorisation, and proposals for POP candidates to the Stockholm Convention, in an
integrated manner. 20
• BPR, PIC: Execute the required regulatory actions in an integrated manner.
• REACH, CLP, BPR: ECHA, the European Commission and the Member State competent
authorities increase efficiency of the regulatory decision making and increase
transparency by, for example, communicating explicitly on the progress made in taking
regulatory action.
3. Induce faster action by industry
• REACH, CLP, BPR, PIC: Provide guidance, advice and assistance, with special attention
to the needs of SMEs, including promoting best proactive behaviour.
• REACH, CLP: Identify and apply measures such as legal obligations, incentives or
targeted enforcement for continued updating of data by industry for improving the
information on their substances and the way they document and communicate the
chemical safety.
• REACH, CLP: Explore how ECHA could, prior to concerted regulatory action and without
deviating from its role, give advice to registrants on specific groups of substances.

2.2 Strategic priority 2: Safe and sustainable use of chemicals by

industry

ECHA is required under REACH and BPR, and now also by its new tasks under the WFD, to work
on substances in articles. It must make available its information on chemicals of concern used
for and present in articles, and in particular assess this knowledge to prioritise its actions.
Through investing on better knowledge on the presence and fate of substances in the service
life of articles, including those imported into the EU, and waste stages, ECHA can make a
significant contribution to moving towards non-toxic material cycles and making the EU economy
more circular.

19
See Action 13(2) of the REACH Review.
20
See Actions 2, 7, 8, 9, 10, 11 and Action 13(2) of the REACH Review.
Programming Document(s) 2021-2024 23

Companies comply with their responsibility for the safe manufacturing and use of chemicals on
their own, in mixtures and in articles by characterising the risks, communicating up and down
the supply chain on how to handle harmful chemicals safely, implementing appropriate risk
management measures, and substituting from harmful to safer chemicals.
A significant improvement in compliance is achieved if more companies make full use of the
tools, templates and guidance that ECHA has developed in collaboration with industry
associations. ECHA will improve and focus its support and information activities, thus helping
companies to improve their safety advice, which will also help them with their obligations under
environmental, product and in particular worker protection legislation.
While sustainability has become an important element of corporate agendas, chemicals
management is generally seen to be more connected to regulatory compliance. Nevertheless,
many companies focus on establishing safer production processes and substituting substances
of concern as part of their business models, responding also to an increasing demand from
retailers and consumers. ECHA will cooperate with interested stakeholders to increase the skill
base of companies in substitution towards safer substances and sustainable portfolio
management.
The guiding principle of REACH and BPR to substitute harmful substances mandates ECHA to
support this aim and to work on the more sustainable use of chemicals in line with the WSSD
2030 goals. 21 Such activities ultimately improve the functioning of the REACH authorisation
system and industry responsibility for safe use.
Areas of operation for Strategic Priority 2
1. Strengthen the knowledge base on substances in articles
• REACH: Support industry in generating chemical safety assessments and associated
exposure assessments that adequately cover the full article service life, waste and
recycling stages.
• REACH, WFD: Develop standardised tools and formats to track substances of concern
throughout the supply chain. Provide access to relevant information to waste operators
and consumers.
• REACH: Improve the availability of relevant information on the presence of substances
entering the EU, in particular through engaging in collaborations with proactive private
and public initiatives aimed at avoiding substances of concern in imported goods.
• REACH: Develop and implement approaches to identify priority materials that would
require further regulatory actions and define the most appropriate EU regulatory risk
management measure.
2. Support to substitution and sustainable use of chemicals
• REACH: Make available data from registration, classification and risk management to
support sustainable substitution. Support associated tools (e.g. QSAR Toolbox) 22.
• REACH, BPR: Support capacity building in companies and Member States, in particular
through the development of networks that can coordinate and help advancing the practice
of substitution. Promote carrying out analyses of alternatives to substances of concern –
through showing concrete examples, as appropriate 23.
• REACH: Explore ways in which companies can better link good chemicals management
(including compliant registration dossiers) to their integrated corporate sustainability

21
On 25 September 2015, the United Nations General Assembly formally adopted the 2030 Agenda for Sustainable
Development. The adoption of the 2030 Agenda and its SDGs represent a change of paradigm of the international
policies on development cooperation. The EU has committed to implement the SDGs both in its internal and external
policies. https://ec.europa.eu/europeaid/policies/european-development-policy/2030-agenda-sustainable-
development_en.
22
See Action 5 of the REACH Review.
23
This links to Action 11 of the REACH Review (using Article 69(2) of REACH early) – analyses of alternatives is one of
the key issues in this.
Programming Document(s) 2021-2024 24

strategies and goals.

3. Improve supply chain communication
• REACH: Facilitate that downstream users receive more consistent and useful safety
advice from their suppliers through the (extended) safety data sheets, covering the full
article service life and waste stages. Create synergies by connecting this advice to
industry’s obligations under occupational safety and health legislation, the control of
environmental emissions and product safety legislation. 24
• REACH: Identify the barriers to the more comprehensive uptake by industry of supply
chain communication related tools and methodologies and initiate further actions to
overcome these.
• REACH: Support the further development of the exposure assessment tools and broaden
the scope of the chemical safety assessment (CSA) methodologies, thereby improving
supply chain communication.

2.3 Strategic Priority 3: Sustainable management of chemicals

through the implementation of EU legislation

ECHA aims to improve the consistency and integration of the EU regulatory system on chemicals
safety. The two-way interfaces and interdependencies of REACH, CLP and BPR with other pieces
of legislation on chemicals safety have been explained (see above). ECHA also aims to improve
consistency and integration between the legislation ECHA implements and the implementation
of the international agenda on chemicals management.
ECHA must therefore coordinate and aim to converge in the implementation of ECHA’s legislation
with the implementation of other legislation and the international agenda, in cooperation with
other EU agencies, national authorities and international partners.
Over the last 10 years, ECHA’s information, knowledge and competences have been increasingly
used to support the implementation of other pieces of legislation and policy areas related to the
safe use of chemicals. This improves consistency between the legislation ECHA implements and
creates synergies and cost savings. ECHA therefore expects this to continue with other new
responsibilities in the years to come. This will require a request from the Commission to carry
out certain tasks or the extension of ECHA’s legal mandate, accompanied by the necessary
resources.
Creating synergies, consistency and efficiencies will help public authorities at national and EU
level, as resources are scarce. But it will also help industry and the citizen. For example, enabling
safety information and data to be provided in a manner that allows companies to use it to fulfil
multiple regulatory needs beyond those implemented by ECHA reduces costs and increases
predictability and efficiency.
Similar gains exist at the international level. By influencing and aligning with international work,
consistency and synergies increase. In addition, ECHA will participate in technical assistance and
capacity building activities on sound management of chemicals in developing countries.
Areas of operation for Strategic Priority 3
1. Consistency and integration of the EU regulatory system for chemicals safety
• REACH, CLP, BPR, PIC, POP, WFD: Coordinate and aim to converge the
implementation of the legislation ECHA implements with other legislation to achieve
consistency and synergies. This includes cooperation with EU agencies implementing
other, related legislation relevant within the EU regulatory system for chemicals safety.
• Where new tasks are assigned to ECHA and resources are made available, ensure
successful integration of the tasks, monitor and report on the implementation, including

24
See Action 3(2) of the REACH Review.
Programming Document(s) 2021-2024 25

how the benefits and synergies are realised.

2. Foster synergies at international level
• REACH, CLP, BPR, PIC, POP, WFD: Contribute to the OECD chemicals programme and
to main international instruments (SAICM 25 and the global chemical conventions) with
the objective of developing OECD standards and tools that can be directly used in the EU
and in exchanging implementation experiences.
• REACH, CLP, BPR, PIC, POP, WFD: Intensify cooperation with international partners,
sharing EU implementation experiences, learn from other international chemicals
management programmes, and provide capacity building support for countries that are
developing their chemicals management schemes.

2.4 Actions to invest in enabling components

Successfully executing the three strategic priorities requires sufficient resources, infrastructure,
knowledge and competences to be available while maintaining a high level of efficiency,
motivation and staff well-being. New regulatory tasks should be combined with adequate
additional resources when redeployment of available resources is not possible.
ECHA will analyse possibilities to benefit from alternative funding sources, in line with discussions
at institutional level about the funding structures of EU agencies. To be able to manage the
changes in its legal mandate and policy objectives, ECHA will further invest in proactively building
the necessary staff competences and in having flexibility in reallocating resources. Furthermore,
ECHA depends on the active contribution and fulfilment of the respective duties of other
authorities, industry and stakeholders in implementing this strategic plan.
Enabling areas of operation
1. Maintain and build identified staff competence for current and future tasks
• Develop and strengthen sufficient scientific, technical and administrative competence for
current responsibilities and future needs by ensuring robust processes for people and
resource management.
• Adapt ECHA’s communications to a fast-changing environment.
• Foster a culture of flexibility and adaptability that supports agile internal deployment and
mobility within a dynamic collaborative organisational structure.
2. Continuous investment in IT and data to deliver ECHA’s mandate and improve
efficiency
• Further develop ECHA’s IT architecture of tools and cloud services to support the
implementation of the strategic priorities and the overall efficiency of the Agency.
• Optimise the cost of operating IT on well-established IT services while simultaneously
and efficiently implementing new IT services and new delivery models to address new
needs and opportunities.
• Enable regulatory assessors and decision makers to use ECHA’s data, and promote its
use to third parties, via an easy-to-use access to the underlying information and via
development of data analytics and intelligence.
• Analyse what strategic opportunities the implementation of the EU digital agenda can
provide and how ECHA can contribute to it.
3. Sustainable and flexible finance and governance structures
• Examine, with the European Commission, options and the best way to ensure sustainable
income for ECHA in a context of reduced own fee income and to smoothen the annual
income variations.

25
Strategic Approach to International Chemicals Management.
Programming Document(s) 2021-2024 26

3. Human and financial resource outlook 2021-2024

General comments
The objective of this section is to provide a description of the future activities of the Agency by
taking into consideration consequences on staff policy. At the outset, it is to be noted that the
core mandate and the specific tasks of ECHA, as laid down in the five Regulations and two
Directives that it implements, will continue to be the backbone of its future activities. As a result,
the majority of human and financial resources will continue to be consumed to ensure that the
registration, evaluation, restriction, authorisation and classification processes under REACH and
CLP deliver the impact that the legislator has attributed to them. The basic philosophy
underpinning ECHA’s capacity to resource existing tasks and the assumption of new tasks is that
ECHA should be adequately resourced from the planning phase, in particular in the pertinent
legislative and financial statements.
The four-year timeframe of this document contains a number of inherent uncertainties for ECHA
that have a significant impact on its planning process. It is, therefore, important to clearly signal
these uncertainties so that the budgetary authority is fully aware that further refinement of
ECHA’s activities, and associated resource allocation, may be necessary as more clarity on these
uncertainties emerges. Firstly, ECHA is required to accurately forecast its fee income streams,
for both REACH/CLP and BPR, to calculate the required EU balancing subsidy. This will continue
to be problematic, as fee income is dependent on market behaviour and the strategies of
individual companies and, therefore, this inherent uncertainty will continue to negatively impact
ECHA’s business operations and budget planning. In this context, and in line with the
recommendations of the Commission’s REACH Review, a priority for ECHA is to work with the
Commission in its assessment of alternative options to ensure sustainable total income,
comprised of the fee income and the EU contribution, which will enable ECHA to implement its
strategic plan. The 2019 fee forecasting model and its subsequent updates will be used as a
reference point in estimating the REACH registration fee income.
The year 2021 is a landmark year, as it is the first year of the EU’s new Multiannual Financial
Framework (MFF) 2021-2027. Even if the programmed level of EU contribution is stable during
the period in real terms, a high degree of uncertainty remains in ECHA’s overall budget due to
the reliance on uncertain and declining fee income to a sizable portion of ECHA’s budget.
Therefore, a sustainable solution to ensure stable overall financing of ECHA’s operations is
required.
In order to achieve efficiencies between ECHA’s legislative mandate under the five EU
Regulations and the two EU Directives in its mandate, as well as additional tasks carried out on
behalf of the Commission under the various cooperation agreements (grants, SLAs, delegation
agreements), the Agency applies a FTE-based accounting approach. To facilitate this approach,
ECHA uses a time tracking system to enable the correct reporting of the time spent in the various
tasks. This also ensures that ECHA has the staff members with the best expertise in a given
topic, working on these tasks. The tasks ECHA carries out on behalf of the Commission, through
delegated tasks and other agreements, are not part of the establishment plan of the Agency.
In providing a description of its future activities, the development in existing tasks and the
proposed new tasks for the Agency will be reviewed.
The Agency has carefully analysed the allocation of resources to the different activities, given
the resource constraints of the next MFF and will continue to focus its work on legally required
tasks for ECHA under the EU’s chemicals legislation. This necessitates the establishment of
negative priority to work that has already started, has been planned, that needs to be paused
now. The Agency will closely monitor the situation every six months for such negative priorities,
this is, the work on supply chain, support to the Forum via the Forum secretariat, Helpdesk and
Communication, and re-adjust the priority setting, where needed.
Programming Document(s) 2021-2024 27

Growth of existing tasks

Strategic Priority 1
This priority covers the main regulatory tasks of ECHA under the five regulations, such as
evaluation tasks under REACH and forming Committee opinions to support to Commission
decision making. However, within this priority certain activities will increase, either due to an
increase in the workload drivers (in particular, REACH dossier evaluation, REACH restrictions,
REACH authorisation, BPR substance approval and harmonised classification and labelling and,
to a lesser extent, identification of substances with PBT or endocrine-disrupting properties), or
as a result of changes in the ways of working, focusing on obtaining increased impact with the
resources invested (e.g. screening and priority setting of groups of substances for further action,
efficiently addressing the compliance-related issues in registration dossiers and inducing
proactive action by industry). These activities aim at enhanced mapping and prioritisation of
substances of potential concern, faster action by industry to either generate compliant
information or improve risk management, including via grouping of substances, and more
efficient introduction of regulatory risk management interventions by authorities.
Strategic Priority 2
As a result of the increased priority to Strategic Priority 1, ECHA has to decrease its investment
in the promotion of safe and sustainable use of substances under its Strategic Priority 2. With
the sufficient resourcing of ECHA’s task under the WFD at the interface between the chemicals,
products and waste legislation ECHA’s activities on substances in articles can increase.
Strategic Priority 3
Under this priority, the activities will focus to improve the consistency and integration of the EU
regulatory system on chemical safety, which can include analysing new opportunities for ECHA
to support other pieces of EU legislation or policy areas. This will be done largely in project mode,
and the actual implementation of new opportunities will depend on additional available
resources. This work is based on ECHA’s legal mandate to provide, at the Commission’s request,
technical and scientific support to improve cooperation relating to safety of substances, as well
as active participation in capacity building activities on sound management of chemicals in
developing countries. ECHA will regularly identify legislation and policy areas which are a priority
for it to work on to create further synergies and efficiencies in the implementation of EU
legislation and policy areas related to safety of chemicals. Furthermore, ECHA will analyse how
it can best contribute to capacity-building activities of non-EU countries that are developing their
chemicals management systems.
BPR Regulation
The Review Programme is the work programme for the examination of existing biocidal active
substances contained in biocidal products and which were present on the EU market before
14 May 2000. The Review Programme will ensure that only the biocidal active substances that
can be used without causing harm to people, non-target organisms or the environment remain
on the EU market. Member States will need to increase their progress towards meeting the
established timelines set in the BPR and in the review Regulation (EU) No 1062/2014. ECHA will
continue identifying barriers for companies and authorities for enhancing progress and enhancing
the communication with and support to parties in the programme. In addition to this, ECHA’s
work on Union authorisation is also foreseen to increase following the progress of the assessment
by the Member States of the applications. Therefore, ECHA’s BPR work is perceived as a growing
activity in which the workload will increase in the period 2021–2024, requiring additional
resources. It is in the interest of both the Commission services and ECHA to ensure that ECHA
has the necessary resources (human and financial) to effectively manage these important tasks
and provide support to the Member States.
PIC Regulation
For the PIC Regulation, relating to the export and import of hazardous chemicals, it is proposed
to follow the legislative financial statement and the Commission Communication COM(2013)519
with respect to the number of temporary agent (TA) posts for PIC tasks. However, it is to be
Programming Document(s) 2021-2024 28

noted that the number of notifications is increasing annually by a higher number than initially
estimated (with approximately a 19% annual increase, as opposed to the 10 % increase stated
in COM(2013)519), requiring additional support for handling the work. The UK’s withdrawal from
the EU made the UK a third country and therefore all exports of listed hazardous chemicals to
the UK will be subject to prior notifications, thus increasing the volume of work. This will require
additional human and financial resources.
POP Regulation
Under Regulation (EU) 1021/2019 on persistent organic pollutants (POPs) that entered into force
in 2019, ECHA has set-up a new process to provide technical and scientific support to the
Commission and Member States in the proposal of new POP candidates to the Stockholm
Convention, and to regularly report on the implementation of the Convention at Union level. As
ECHA was given only one contractual agent post to undertake these new activities strong annual
priority setting is needed to keep ECHA’s contribution within the allowed human resource
allocated.
Waste Framework Directive
Under Directive 2008/98/EC on waste (Waste Framework Directive, WFD), the Agency
establishes a database on the presence of Candidate List substances in articles, establishes (IT)
tools to allow any EU suppliers of articles to submit the required information to ECHA and
provides access to the database to waste treatment operators and to consumers. The Agency
has recruited 8 contract agents for carrying out these tasks and it is expected that a similar
staffing level is needed in the future following the rolling out of the tool as well as during the
further implementation phase.
Drinking Water Directive
Pursuant to the Recast of the Drinking Water Directive, ECHA shall provide technical support in
the implementation of establishing an EU positive list on materials that come into contact with
water intended for human consumption. The preparatory phase starts in 2021 by converting
existing national positive lists on substances into the first EU positive. ECHA furthermore
supports the Commission in preparing the implementing and delegated acts to establish
information requirements, risk assessment methods and the application process. In 2025 the
operational phase starts with a review programme to update all entries on the EU positive list
(by 2040). For the preparatory phase, there are 3 temporary agents and 2 contract agents
ensured and for the operational phase 6 temporary agents in 2025, 7 in 2026 and 8 in 2027
while the level of contract agents remains in this phase at 3.
Support to the 8th Environmental Action Programme and Chemicals Strategy for
Sustainability
In the Commission’s proposal for the 8th EAP, the Commission proposes that EEA and ECHA
monitor the implementation of the European Green Deal and foresees 2 posts for ECHA to do
so. ECHA and EEA are elaborating what ECHAs tasks and work this entails.
Delegated tasks
EU Observatory for Nanomaterials
ECHA hosts the EU Observatory for Nanomaterials (EUON) based on a contribution agreement
with the European Commission. The EUON aims to increase the transparency and availability of
information on nanomaterials in the EU. It collects existing information from databases,
registries and research, and generates new data through additional studies and surveys on
nanomaterials on the EU market.
EU Chemicals Legislation Finder
Similarly to EUON, ECHA hosts the EU Chemical Legislation Finder (EUCLEF) via a contribution
agreement from the European Commission. EUCLEF provides EU companies, and SMEs in
particular, centralised access to information on legislations applicable to a given chemical
substance.
Programming Document(s) 2021-2024 29

Instrument for Pre Accession Assistance to the EU (IPA)

ECHA has provided capacity building activities in relation to EU chemical legislation for candidate
and pre-candidate countries to the EU through the project 2018/403-813 Preparatory measures
of future participation of candidate countries and potential candidates in the work of the
European Chemicals Agency in implementing REACH, CLP, BPR and PIC, (Contribution of EUR
450 000 with addendum to the latter amending the contribution to EUR 785 000). This work
enables candidate countries to build up their knowledge and expertise ahead of accession and
thereby become an active contributor to EU wide work in relation to the EU acquis on chemicals.
Service Level Agreements
Occupational exposure limits
Under the Carcinogens and Mutagens Directive 2004/37/EC (CMD) and the Chemical Agents
Directive 98/24/EC (CAD), the Commission can request scientific advice from the Committee for
Risk Assessment (RAC) in relation to chemical exposure in the workplace. Since 2017, ECHA has
received requests from the Commission for RAC to develop opinions on OELs. Based on a service
level agreement as resourcing channel, ECHA has allocated three contractual agent posts for
developing three-five a year.
IUCLID for EFSA
EFSA and ECHA are collaborating under a Service Level Agreement to enable the use of IUCLID
by EFSA. The continued collaboration of both agencies will be subject to a new long term Service
Level Agreement that will cover the target architecture and service level of the IT solution that
will support the regular use of IUCLID for plant protection products and potentially other food
regulated products covered by EFSA.
New tasks
The present Programming Document foresees a number of new tasks for ECHA that are under
discussion with the Commission services which will require additional human and financial
resources in the period 2021-2024, subject to agreement.

3.1 Overview of the past and current situation

Staff population overview

Detailed data is provided in Tables 1 and 2 of Annex III.
Staff-related expenditure in 2021 and 2022
Detailed data provided in Table 1 of Annex II.
Financial resources
ECHA’s primary own income source (REACH registration fees), that originated from the three
distinct phase-in registration deadlines, has significantly reduced. Despite the flow of income
that is expected to continue from new (and updates of) registrations and authorisation fees,
ECHA has become increasingly dependent on the EU balancing subsidy financing for its
REACH/CLP activities. Similarly, although a certain level of fee financing from BPR activities is
expected, this will cover only a minor part of the related overall expenditure. For the year 2021,
ECHA will be bound by the EU balancing subsidy ceilings contained in the new MFF decision
covering the years 2021-2027. The 2021 fee income estimates are based on ECHA’s fee
forecasting model for the REACH registration fees. In this context, it is to be noted that the point
estimates derived from the model cannot have a satisfactory level of accuracy and that only
estimate ranges can be derived through statistical modelling. The other REACH fee income
streams in the budget, as well as the BPR fees, are estimated based on collected market
intelligence. Due to the high level of embedded uncertainty, a sustainable solution to ensure
stable overall financing of ECHA’s operations is required.
Programming Document(s) 2021-2024 30

Human resources
During the period of this Programming Document, it is anticipated that a key challenge for ECHA
will be, in the context of the growth in existing tasks and the assumption of new tasks, the
continued allocation of resources to strategic priority 1. In addition, the key areas identified to
enable achievement of new strategic priorities include maintaining and building staff
competences, ensuring that staff members are kept up to date with respect to scientific and
technical advances, trends and challenges and instilling a culture of versatility and flexibility in
the use of resources that will be supported by a dynamic organisational structure. As one of the
key actions under the multiannual human resources (HR) strategy, a competency mapping
exercise has been conducted and staff are empowered to maintain their personal profile. Hence,
competency gaps are evident at organisational level and colleagues with specific skill can be
identified for new tasks and projects. Finally, the attraction and retention of performing staff is
central to ECHA’s continued success and that key human resources issues to be addressed
include the allocation of staff to identified priority areas, competency development and
performance management.

3.2 Resource programming for 2021-2024

3.2.1 Financial resources

Detailed data is provided in Tables 1-3 in Annex II.

3.2.1.1 REVENUES

REACH/CLP
ECHA’s REACH/CLP income is comprised of fees and charges and the EU balancing contribution.
The fee income has reduced significantly, following the 2018 deadline, and it is problematic to
accurately estimate the registration fee income level in the post-deadline era. The total fees and
charges are currently estimated at c. EUR 28 million per year during 2021-2024, taking into
account of the estimates provided by ECHA’s forecasting model and the in-house developed
estimates based on market intelligence.
The REACH balancing subsidy for 2021 is based on the Commission’s Draft EU budget.
Considering the indicated level of available EU contribution and the decreased estimate for fee
financing, ECHA has undertaken a thorough expenditure review to compile its 2021 draft budget.
In the event that the income will not materialise to the extent presently forecasted, ECHA may
require an additional EU contribution during 2021 to honour its long-term legal obligations. The
balancing EU contribution for 2021 is EUR 63.6 million, in accordance with the Commission’s EU
draft budget. From 2021 onwards, the balancing EU contribution levels reflect the currently
available draft estimates for the MFF (2021-2027) period.
BPR
ECHA’s BPR activities are funded by fee income and the EU balancing subsidy. The inherent
uncertainty continues with respect to the budgeted revenue from fees and charges, which is
based on estimated dossier application volumes. For 2021, the fees are presently estimated at
c. EUR 2.3 million and the indicated available EU contribution, based on an amending letter to
the budgetary authority to increase the initial amount, is c. EUR 9.1 million. For 2022, ECHA will
need a higher balancing contribution compared to the currently available Commission estimate
as contained in the draft MFF (2021-2027) proposal. Therefore, ECHA adds EUR 1.7 million to
the currently available Commission draft estimate for 2022.
Environmental Directives and International Conventions (PIC, POPs, Waste
Framework Directive, Drinking Water Directive and 8th Environmental Action
Programme)
ECHA’s PIC activities continue to be fully funded by the EU subsidy over the planning period. As
stated above, the increase in the number of export notifications processed (originally estimated
Programming Document(s) 2021-2024 31

at c. 10 % per year) has actually been, on average, 19% per year. The resources needed for
processing notifications, related tasks and stakeholder support are, therefore, higher than
foreseen and require additional support from operational interim staff. The PIC IT submission
system (ePIC) also continues to require further development to further increase automation of
tasks to mitigate the additional workload and increase the efficiency of the work of DNAs,
exporters, Commission and ECHA secretariat.
Following the adoption of the recast of the POPs Regulation, ECHA has commenced its
implementation. Furthermore, based on the Waste Framework Directive, ECHA has established
(IT) tools to allow any EU supplier of articles to submit the required information on the presence
of Candidate List substances in their articles to the Agency. Moreover, as ECHA is providing
support and technical advice to Commission services under the revised Drinking Water Directive
98/83/EC, the subsidy request for the related activities has been included in the estimates from
2021 onwards, when the work is expected to commence. Finally, also the subsidy reflecting the
resources allocated to the tasks under the 8th Environmental Action Programme have been
incorporated.
The subsidy financing for the above tasks have been combined with the PIC subsidy, with the
subsidy amount requested for PIC being based on the current MFF figures and the amounts for
POPs, Waste Framework Directive, Drinking Water Directive and the 8th Environmental Action
Programme related tasks are based on the financial fiches accompanying the legal texts

3.2.1.2 EXPENDITURE

Title 1
REACH/CLP
For 2021, the needs for staff-related expenditure (Title 1) total EUR 65.2 million, unchanged
from 2020. The estimated need for 2022 totals EUR 67.7 million, that is, 4% above the 2021
levels.
BPR
The estimated needs for staff-related expenditure in 2021 total c. EUR 7.9 million, unchanged
from 2020. The estimated need for 2022 totals EUR 8.4 million, that is, 6% above the 2021
levels.
Environmental Directives and International Conventions (PIC, POPs, Waste
Framework Directive, Drinking Water Directive and 8th Environmental Action
Programme)
The total amount for staff-related expenditure is estimated at c. EUR 2.2 million in 2021 and
EUR 2.3 million in 2022, representing an increase of 5%.
Title 2
The overall Title 2 (infrastructure and operating expenditure) expenditure for 2021 amounts to
14.8 million and for 2022 amounts to c. EUR 15.4 million, representing an increase of 4%.
Operational titles
Title 3 (REACH/CLP)
The overall Title 3 expenditure for 2021 and 2022 amount to c. EUR 15.2 and 16.3 million
respectively.
Title 4 (BPR)
The overall Title 4 expenditure for 2021 and 2022 amount to c. EUR 2.4 and 2.6 million
respectively.
Title 5 (PIC, POPs, Waste Framework Directive, Drinking Water Directive and 8th
Environmental Action Programme
Programming Document(s) 2021-2024 32

The overall Title 5 expenditure for 2021 and 2022 amount to c. EUR 2.9 and 1.8 million
respectively.
The Global Budgetary Envelope reserved for procurements to be initiated in 2021 to support the
Agency’s operations totals € 15.8 million.

3.2.2 Human resources

Detailed data is provided in Tables 1 and 2 in Annex III.
Negative priorities/decrease of existing tasks
As stated above, ECHA requires long-term human and financial resources stability so that the
necessary competences to fulfil its increasing mandate can be adequately developed and
retained. Since the completion of the third REACH registration process in 2018, the secretariat
has reallocated a significant number of full-time equivalents (FTEs) to other priority activities
within the organisation. ECHA’s focus has been on strategic priority 1 (that is, the identification
and risk management of chemicals of concern) and, specifically, on evaluation, classification and
labelling, restriction and authorisation activities, together with the BPR implementation priority
work areas.
This refocusing will continue in 2021 when, as part of the process of balancing of resources and
outputs, the resourcing in the areas proposed as negative priorities (that is, support to
communication in the supply chain, support to the work of the Forum for enforcement, the
Helpdesk and HelpNet, and communication activities) will be reduced, in line with the approach
discussed with the Management Board in September 2020. More specifically, the following work
areas are proposed as negative priorities:

• Support to Communication in the supply chain (-5 FTE): no work on Exchange Network
on Exposure Scenarios, as foreseen in the draft ENES Development Plan 26: including
method for mixtures; minimum requirements for exposure scenarios; standardised XML
format or other aspects of the downstream supply chain;
• Support to the work of the Forum for enforcement (-1,5 FTE): reduced activities and
projects;
• Helpdesk and HelpNet (-1,5 FTE): transferring part of the questions to national
helpdesks;
• Communication (-1 FTE): reduced activities and projects.
In adopting this approach, the secretariat aims at maintaining the actions and outputs for priority
areas under strategic priority 1.
ECHA has, in previous years, engaged external service providers (interims) for addressing
(temporary) shortages in staff due to peaks in workload, specific projects or longer-term
absences. In particular, in order to manage the 2018 registration deadline, ECHA engaged c. 80
interims to support ECHA’s statutory staff in handling the workload stemming from processing
the incoming registration dossiers and providing support to the registrants. Since 2018, however,
ECHA has been decreasing the number of interims engaged. For 2021 and beyond, the budgetary
outlook requires a substantial adjustment to this practice and, as a result, operational interims
will principally be allocated to the SME verification (6 FTEs) and technical completeness check
(7 FTEs) tasks for 2021, in line with proposals previously endorsed by the Management Board.
In addition, a small number of interims are budgeted to cater for potential absences and/or peak
workload periods. This decision does not apply to interims engaged to provide services under
delegated tasks or grant agreements (for example, EUCLEF), for which specific contribution
agreements are in place.
On a practical level, ECHA will continue to maintain its low vacancy rate for all regulations and
implement proactive human resource management practices to ensure a healthy level of staff
turnover. ECHA will also continue to cooperate closely with the Commission services and the
26
Latest version submitted to the November CARACAL https://circabc.europa.eu/ui/group/a0b483a2-4c05-4058-addf-
2a4de71b9a98/library/5813b94a-5d93-4f90-bbd3-e6c9df573f62/details.
Programming Document(s) 2021-2024 33

Network of EU Agencies Network (EUAN) in areas of HR management that are of common

interest.
The continued operation of existing tasks and the implementation of its new tasks, as previously,
is no longer feasible under the present resource constraints. The continuous focus on seeking
efficiencies has been brought to a level where only limited additional gains may be achieved.
Strategy for efficiency gains
Based on the efficiency gains achieved by further integrating ECHA’s activities and its re-
organisation in 2019, ECHA will continue to identify areas to further improve efficiency of its
operational and administrative processes, with the aim of increasing its operational output. As
outlined above, efficiencies have been achieved through reallocating a significant number of FTEs
towards strategic priority 1 since 2018, with additional FTEs proposed to be reallocated in 2021.
There is limited room for the achievement of further efficiencies in ECHA’s horizontal services,
following the implemented staff reductions, as part of the previous reform of the Staff
Regulations, and the internal reallocations, as part of the 2018 reorganisation. Finally, the
significant reduction in engagement of interims in 2021, as outlined above, will further drive
internal efficiency gains.
ECHA is largely an IT-based agency, viewing IT as key enabler for the regulatory work that it
carries out. The availability of all data in digital format ensures accessibility and automation in
the processing of that data. Through this, ECHA is able to process a high number of submissions
respecting the legally binding deadlines, and to perform automated checks on those dossiers
and automated dissemination of the data. Therefore, ECHA will continue to invest in IT tools to
enable efficiencies, both for companies who have regulatory obligations to submit data to the
Agency and to Member States, and for authorities who are using those data under the regulatory
processes under the five regulations, and for any potential future roles in adjacent areas of
chemicals regulation. The Agency will continue to report on its efficiency gains in the context of
the Commission’s annual Job Screening Exercise.
Conclusion on evolution of resources compared to the Commission Communication
2014-2020
As stated above, since the publication of the Commission Communication COM(2013)519, ECHA
has complied fully with the imposed REACH/CLP and PIC temporary agent posts programming,
while its BPR activity was under-resourced in comparison with this Communication. From 2021
onwards, ECHA considers that the resource requirements for the implementation of the strategic
priorities, and the assumption of potential new tasks, demonstrate the need for sustainable
resources to be programmed in the new MFF. As a learning organisation, ECHA is committed to
maintaining its drive for efficiency and building up competence. However, it is ECHA’s view that
its ‘buffer capacity’ for new tasks is severely restricted, particularly as the Agency will be less
reliant on interim engagements to the extent of previous years. It is, therefore, essential that
additional staff resources are provided for these new tasks to ensure their efficient and effective
preparation and/or implementation.
Programming Document(s) 2021-2024 34

III WORK PROGRAMME 202127

Introduction
In 2021, ECHA will have implemented its strategic priorities 28 for two years and has adjusted its
work towards increased impact. ECHA has thereby given more priority to activities under
Strategic Priority 1, and consequentially less to Strategic Priorities 2 and 3. This is reflected in
this biannual Work Programme.
ECHA’s first strategic priority remains the key driver. ECHA focuses on increasing its regulatory
actions in the areas of REACH compliance evaluation, REACH restrictions, REACH authorisation,
CLP harmonised classification and labelling and Biocides active substance approval and on further
streamlining the interplay between these core areas of REACH and CLP. These activities are the
bulk of the annual work and obtain the largest part of ECHA’s operational resources. At the same
time, under the current resource constraints set by the next MFF, the Agency has to reduce its
efforts towards the two other strategic priorities.
Aiming at increasing the regulatory output and streamlining between the regulatory actions,
ECHA developed the Integrated Regulatory Strategy. The next section describes the strategy in
brief. It seeks to identify early the need for REACH evaluation or further risk management under
REACH or CLP, through a comprehensive screening and priority setting of groups of chemicals.
These activities are carried out together with Member States, allowing for better identification of
substances of potential concern. In addition, more targeted interaction with industrial sectors on
groups of substances take place in an attempt to address registration dossier compliance issues.
This work enables ECHA, in collaboration with the Member States, to identify for all substances
on the EU market whether they need regulatory intervention or not.
By carrying out this work, the Agency addresses the findings of the REACH Review, aiming to
ensure that REACH is an effective instrument working as efficiently as initially planned. In
addition, the foreseen impact this Regulation would have on contributing to the initial 2020
WSSD goals has not yet been achieved and further efforts is needed towards meeting the 2030
WSSD goals. Therefore, in 2021, ECHA will maintain most of its resources dedicated to the key
regulatory areas under REACH as in previous years. In particular, high workloads in evaluation,
authorisation and restrictions are foreseen. At the same time, ECHA will continue to be faced
with new or updated incoming registrations, to be checked for completeness before granting
access to the EU market, adding the data to ECHA’s IUCLID database and disseminating them.
The well-established frame of sharing information and knowledge with Member States continues.
The activities implementing BPR and PIC remain important and well-established to ensure the
safe use of substances. Intensified support to Member States for the assessment of biocidal
active substances in the review programme is a priority for ECHA, and continued increase of PIC
export notifications are foreseen.
Improved communication up and down the supply chain with the view to increase safe and
sustainable use of chemicals and substitution of substances of very high concern remains an
important topic for ECHA under its second strategic priority. 29 However, under the current
resource constraints, the Agency will not be able to support industry in the implementation of
the ENES tools and related work identified under REACH Review Action 3 30 as initially planned
under this priority and as set out above in section 3.2.2.

27
Including the draft Work Programme 2022. In the following, the year in square brackets indicates if an activity is to
be carried out in 2021 or 2022 or both.
28
See Sections I and II above.
29
Making a difference in the safe and sustainable use of chemicals by industry.
30
Action 3. Improving the workability and quality of extended Safety Data Sheets
(1) The Commission encourages more industry sectors to develop and use harmonised formats and IT tools that would
provide more user-targeted information and simplify the preparation and use of extended Safety Data Sheets as well
as facilitate their electronic distribution.
(2) The Commission will consider including minimum requirements for the exposure scenarios for substances and
mixtures in Safety Data Sheets and request ECHA to develop a methodology for Safety Data Sheets of mixtures.
Programming Document(s) 2021-2024 35

In relation to ECHA’s third strategic priority 31, the agency aims at improving the consistency and
integration of the EU regulatory system on chemical safety with the resources available for
specific work items. Data management has a central role in this. The cooperation between ECHA,
Member States and stakeholders requires robust technical solutions and integration of data
across different sources including more targeted data utilisation for other regulatory purposes.
A specific focus will be on the new task to support the implementation of the Drinking Water
Directive. Furthermore, ECHA makes available the EU Observatory for Nanomaterials (EUON)
and the EU Chemicals Legislation Finder (EUCLEF), as well as continues developing occupational
exposure limits.
ECHA has considered carefully that financial and human resources available under the next MFF
and prioritised its work accordingly. While there are remaining uncertainties in relation to funding
and potential new tasks, the continuation of the legally required core business activities paired
with work that creates the largest impact is ensured. This includes a sustainable basis for the
supporting IT tools.
ECHA’s Integrated Regulatory Strategy
Building on the experience gained during the first years of implementing REACH and the CLP
Regulation, ECHA has developed an Integrated Regulatory Strategy (IRS) that brings together
the various regulatory processes. The strategy provides a clear and coherent basis for achieving
the aims of the regulations and contributing to the United Nations Sustainable Development
Goals concerning chemicals.
In line with ECHA’s Strategic Priority 1 described in the Multiannual work programme (section
II.2.1) the aim of the IRS is to efficiently select substances or groups of substances that raise
potential concern 32. Where further hazard information is needed to assess their safety, this is
generated so that the relevant actors with the right of initiative pursuant to the respective piece
of legislation can address any remaining concerns through the most suitable regulatory risk
management measures. This work needs close collaboration with and appropriate and timely
intervention by all actors – ECHA, Member States, the European Commission and industry. It
provides confidence among stakeholders that registrants meet REACH information requirements.
To speed up the identification of chemicals that need regulatory action, ECHA and the Member
States authorities address groups of structurally related substances rather than single
substances. Based on first good experience, this grouping approach brings consistency and
improves the coherence of regulatory work, makes it faster to identify substances that need
regulatory action as well as those for which no further action is needed at this stage.
The screening of registered substances started after the first registration deadline in 2010. It
focused on substances that had enough hazard information to conclude on the need for, and to
initiate, the required regulatory risk management. This systematic screening work has over time
enabled the identification of most of such substances that could go directly to regulatory risk
management. As a result, most of the remaining substances are those requiring generation of
further hazard information.
The progress with this screening work can be monitored through the chemical universe which is
a mapping tool of all registered substances under REACH, in which each substance is assigned
to a pool that indicates the regulatory actions already started or under consideration for that
substance 33.
An analysis is done at an early stage where the main question is if further information needs to
be generated to decide on whether and which regulatory action needs to be taken. This analysis
is revisited after further information is generated or when new insights on uses are available.

31
Sustainable management of chemicals through the implementation of EU legislation.
32
Substances (or groups of substances) of potential concern are those substances which need further regulatory risk
management and for which authorities need to take action without undue delay. These include substances for which
further information is needed to clarify their hazard properties or substances with confirmed hazards (e.g. those already
on the Candidate List or with a harmonised classification) and for which further regulatory action needs to be considered
due to their uses and potential exposure to workers, consumers or the environment.
33
https://echa.europa.eu/universe-of-registered-substances.
Programming Document(s) 2021-2024 36

For each group of substances, authorities consider whether there is a need to initiate further
regulatory risk management activities for the whole group, for a subgroup or for individual
substances within the group. There is no formal obligation to develop such an analysis. They can
be carried out by ECHA or by a Member State and the responsibility for the content rests with
the authority that developed them. The outcomes are shared through the Public Activities
Coordination Tool (PACT) in order to increase transparency and predictability of authorities’
work. Even if the analysis concludes that regulatory action should be initiated, such an outcome
does not have any direct legal implications. Any authority can initiate a regulatory process but
should indicate this by appropriate means, such as through the Registry of Intentions.
Every year, in April, ECHA publishes a report that provides an overview of the progress made
and main outcomes of the regulatory processes covered by the IRS.
Programming Document(s) 2021-2024 37

0. REACH and CLP

1.1 Registration dossier preparation 34

Overview
ECHA supports companies, who want to access and remain on the EU
single market, meet their registration obligations. To this end, ECHA
takes decisions requiring data sharing across the EU and ECHA
provides companies with EU harmonised advice and assistance and as
well as EU or Organisation for Economic Co-operation and
Development (OECD) harmonised IT tools for preparing registration
dossiers.
Tasks
The ECHA secretariat supports the European Commission in further developing OECD
harmonised test guidelines meet the REACH information requirements and via the CLP
Regulation enables the direct application of the UN’s Globally Harmonised System of
Classification and Labelling of Chemicals (UN GHS).
The ECHA secretariat further develops IUCLID (International Uniform Chemical Information
Database) in cooperation with the OECD, staying aligned with UN GHS. IUCLID is an OECD
harmonised dossier preparation IT tool used by the EU. A growing number of regulatory systems
in the OECD member countries also use it.
The ECHA secretariat further develops Chesar (Chemical Safety Assessment and Reporting tool)
and EUSES (European Union System for the Evaluation of Substances) in cooperation with
Member States and stakeholders. Chesar is an EU harmonised IT tool supporting companies in
performing the chemical safety assessment and documenting it in the chemical safety report. It
works hand in hand with IUCLID and will be merged by 2022 with EUSES which is the EU
Authorities’ environmental risk assessment tool for REACH and Biocides.
The ECHA secretariat co-manages the development of the OECD QSAR (Quantitative Structure-
Activity Relationship) Toolbox with OECD. The QSAR Toolbox is an OECD harmonised IT tool
helping companies provide robust scientific justifications when using non-animal methods and
grouping of chemicals.
The ECHA secretariat has a helpdesk helping duty holders comply with their legal obligations and
using ECHA’s IT submission tools and coordinating Member State helpdesks. The ECHA
secretariat supports companies registering the same substance get in contact in order to share
data, and when disputes between companies occur, resolves them.

34
Section 1.1 covers only REACH registration dossier preparation. The support to the preparation of other REACH and
CLP dossiers are covered by the relevant sections.
Programming Document(s) 2021-2024 38

Outcome and impact

ECHA makes available harmonised IT tools and advice to companies preparing REACH
registrations. This improves the consistency of risk management and safety information; and
promotes its exchange across and between industry and regulatory authorities. Furthermore,
the EU- and OECD-level harmonisation reduces costs for companies operating on a global scale
and enhances EU competitiveness.
ECHA’s support to developing OECD test methods implements the ‘Three Rs’ principle (to replace,
reduce and refine testing on vertebrate animals). Furthermore, ECHA’s data-sharing tasks help
avoiding unnecessary tests, also on vertebrate animals and the QSAR Toolbox task directly
promotes use of non-animal alternatives.
This activity makes the information submitted in activity 1.2 more harmonised, both in structure
and in content which enables the processing and analysing the data to be more efficient.
Main actions and outputs of 2021 and 2022

Data generation and compliance

• Update of ECHA’s IT tools and support materials in line with regulatory developments,
such as the amendment of the REACH information annexes [Joint Action Plan Actions 5
and 6]. [2021, 2022]
• Support and promote the implementation of the Commission implementing regulation on
dossier updates [REACH Review Action 1] with actions, such as screening and support
materials, including screening of dossiers that remained without updates and seek
collaboration with the national enforcement authorities on cases of potential breaches of
the dossier update obligation. [2021, 2022] Review of the effectiveness and efficiency of
the task based on appropriate input and outcome indicators. [2022]
• Implement actions to improve dossier compliance ahead of submission. [2021, 2022]
[REACH Review Action 1] [REACH Review Action 14]
• Provide advice to registrants related to registration and preparation of complete and
compliant registration dossiers taking into account the specific obligations after the end
of the transition period of the UK withdrawal from the EU. [2021, 2022]
• Run a study on circular economy and chemical recycling to better understand current
status of the various chemical recycling processes and the potential consequences on
registration (or exemptions of registration) and what happens with the presence of SVHCs
in these processes. [2021]
Data sharing
• Develop and implement an effective policy regarding the possibility for registrants to use
data submitted more than 12 years ago without compensation pursuant to REACH Articles
25(3) and 26. [2021]
• Handle disputes on data sharing. [2021, 2022]
IUCLID
• Ensure progressive maintenance of IUCLID to incorporate (international) regulatory
requirements (e.g. adaptations to new requirements following the amendment of REACH
Annexes, other technical and scientific progress under REACH and CLP such as the PCN
format or requirements from our OECD international partners). In close collaboration with
the OECD, further position IUCLID at the heart of the Global Chemicals Knowledge Base
that is under development. [2021, 2022]
Cloud Services
• Finalise by Q1/2021 the assessment of the (financial) feasibility of an approach for ECHA
Cloud Services whether it should become the sole delivery model for IUCLID and whether
other tools (e.g. Chesar) or services could be added to facilitate and speed up interaction
Programming Document(s) 2021-2024 39

with the registrants in particular on data availability and compliance. The report to the
Management Board will be drawn up in cooperation with stakeholders. [2021] [REACH
Review Action 14]
Chesar and exposure tools
• Maintain version 3 of Chesar so that it remains available to registrants as the mainstream
tool for preparing chemical safety reports (CSRs) under REACH, providing support to
ensure new CSRs are generated with an appropriate level of quality and updated where
relevant. [2021, 2022] [REACH Review Action 1] [REACH Review Action 3]. In parallel,
continue developing a new risk assessment tool which harmonises assessments under
both REACH and biocides, including the establishment of a scientific governance for the
methodologies used by the tool. This development will take place under a merged
Chesar/EUSES project [2021, 2022] and will ultimately replace version 3.
• Determine which exposure information is used in REACH evaluation to reach a decision
and is needed in REACH restrictions and authorisation to obtain an opinion and based on
that consider what further exposure tool development work is needed. [2020, 2021]
Promotion of alternative methods
• Contribute to OECD activities related to further development of alternatives and
integration of regulatory relevant alternatives in the OECD test guidelines. [2021, 2022]
• Jointly coordinate and contribute to an activity 35 together with US EPA and Health Canada
to further investigate the use new alternative methods in regulatory processes (jointly
with activity 1.3). [2021]
• Promote alternatives to animal test methods through the OECD QSAR Toolbox, e.g. by
integrating developed adverse outcome pathways or extending its applicability to other
types of substances (jointly with activity 1.3). [2021, 2022]

Indicators type estimate estimate

2021 2022
Effective working time for processing inquiries performance 0.35 person 0.3 person
day/inquiry day/inquiry
Inquiries received and concluded output 4 200 4 200

Resources estimate 2021 estimate 2022

Financial resources (costs, EUR) 7 474 686 7 565 021

Human resources (FTE) 25 25

35
Accelerating the Pace of Chemicals Risk Assessment (APCRA) https://www.ncbi.nlm.nih.gov/pubmed/29600706.
Programming Document(s) 2021-2024 40

1.2 Dossier submission 36

Overview
ECHA grants access to the European single market to companies
manufacturing chemicals in or importing chemicals into the EU and
enables them to maintain the access, allows temporary continued use
in the European single market to companies manufacturing, importing
or using substances undergoing authorisation and receives certain
specialised dossiers required under REACH and CLP. ECHA also takes
decisions related to confidentiality where publication may harm
companies’ commercial interests.
Tasks
The ECHA secretariat verifies dossier submissions arising from registration, requests for
temporary exemption of registration obligations for product and process orientated research and
development (PPORD), applications for authorisation, requests for alternative names for
substances in mixtures, notifications by producers and importers of substances of very high
concern contained in articles, reports submitted by downstream users and C&L notifications.
For registration dossiers the verification includes checking the completeness of the information
and payment of the fee when applicable. For complete registration dossiers, the ECHA secretariat
verifies the justification of any confidentiality claims submitted by the company. When a
registrant claimed eligibility for a fee reduction, the verification also covers checking the
correctness of the claim. The submission system also ensures compliance with the requirement
to submit information jointly, i.e. following the one substance-one registration (OSOR)
requirement. For PPORD notifications, the Agency assesses the notified activities and may ask
notifiers for additional information or set conditions where it matters for safe use, after
consultation with the Member State competent authorities.
The ECHA secretariat continues the development of REACH-IT in cooperation with Member State
competent authorities and industry. REACH-IT is the IT submission tool for industry dossier
submissions, providing a central and secure communication channel between industry, ECHA
and Member State competent authorities concerning submissions.
The ECHA secretariat also supports industry by providing support materials, training and specific
communication activities on the IT submission tools.
Outcome and impact
ECHA assigning a registration number grants access to the EU single market with its 450 million
consumers while companies with an incomplete registration are denied this access. ECHA’s
completeness check ensures that companies have all the necessary information and have
included it in the registration dossier. This increases the level playing field between companies
manufacturing different substances, thus enhancing competitiveness (both within the EU and
between the EU and other regions) and innovation. PPORD exemptions granted by the Agency
support innovation. Monitoring the aggregate notifications provides indications of the level of
innovation in the EU market. The harmonised submission of information, both in structure and
in content, also provides efficiencies to ECHA’s other activities which use the information.
The dossier submission provides ECHA and the Member States with the documentation of how
companies see that they have complied with their obligations under REACH and CLP. It therefore
supports Member State enforcement of companies’ REACH and CLP obligations as well as that
of other legislation such as OSH and IED. It also helps Member States, the Commission and the
ECHA secretariat comply with their obligations.

36
Section 1.2 covers all industry submissions for REACH and CLP to ECHA, except notifications to national poison
centres covered in Section 1.7.
Programming Document(s) 2021-2024 41

Main actions and outputs of 2021 and 2022

In 2015, the Management Board asked the ECHA secretariat to extend the completeness check
from a predominantly automated check to include a manual completeness check. The manual
verifications ensure the completeness of content that is provided in free text format, such as
justifications for adaptations and the chemical safety report. Overall, the registration activity
remains high due the dynamic nature of the chemicals market, and the legal obligation to keep
dossiers up to date.
• Process the continuous flow of registration dossiers (new and updates). Perform
completeness checks, including manual verifications with a revised scope that covers the
chemical safety report; and assess confidentiality requests. [2021, 2022] [REACH Review
Action 1]
• Apply the approach developed in 2019 to the SME size verification to complete the
verifications of the 2018 registrations deadline by 2023. [2021, 2022]
• Provide input to the Commission on the review of the Commission Recommendation
concerning the definition of micro, small and medium-sized enterprise. [2021, 2022]
• Revoke registrations to prevent inactive operators from having access to the EU single
market. This is particularly relevant due to the end of the transition period after the UK
withdrawal from the EU. [2021]
• Process PPORD notifications and monitoring high level indications for innovation and new
kind of substances.
• Ensure the further development and maintenance of REACH-IT, including increased
usability (migration of online dossiers to ECHA cloud services and C&L automated
notifications), the end of the 12-year data protection rule and new functionalities to
support Evaluation. Further assess REACH-IT technical upgrade and explore future
alternatives. [2021, 2022] [REACH Review Action 1, 2, 14]
• Support to Forum in its work assisting inspectors during the operational phase of the pilot
project on exemption for recovered substances and preparing the project report. [2021,
2022]
Indicators type estimate estimate
2021 2022
Number of PPORD notifications received input 340 340

Number of C&L notifications received input 25 000 26 000

Number of Registration dossiers received (incl. updates) input 13 500 13 500

Effective working time for processing a registration dossier performance 0.60 – 0.70 0.60 – 0.70
(first submission) person days person days
Registrations stopped for manual verification at technical input 5 800 5 800
completeness check
Number of registrations failing first technical completeness output 1 860 1 860
check
Share of registration dossiers over 100 tonnes in the outcome 48% 56%
database that has passed the enhanced technical
completeness check

Resources estimate 2021 estimate 2022

Financial resources (costs, EUR) 7 408 415 7 435 575

Human resources (FTE) 34 34

Programming Document(s) 2021-2024 42

1.3 Screening and prioritisation

Overview
ECHA screens the information submitted by companies, developed by
ECHA or by Member State competent authorities on groups of
substances, and identifies substances of priority or not of priority for
further EU regulatory action. Typically, at various steps in the
screening process, e.g. if new information becomes available, ECHA or
the Member States analyse the need for regulatory action to address
the identified concerns. Working on groups of substances increases the
number of substances scrutinised and aims to reduce the time before
action is taken, where needed.
Tasks
The ECHA secretariat creates groups of similar substances based on their chemical structure,
screens all the available information and concludes for each substance whether further hazard
information is needed or whether it can be concluded that further regulatory risk management
is needed based on the available information. The ECHA secretariat and the Member States use
the regulatory management option analysis (RMOA) framework to select at different steps in the
process the most appropriate risk management instrument(s) to address any identified concern.
The outcome, which is documented to foster transparency and collaboration amongst authorities,
identifies where further data generation is needed to confirm or refute the concern and where
harmonised classification under CLP, or REACH Restrictions, REACH Authorisation or measures
under other legislation can best address any identified concerns. As the Member States play a
key role in progressing with these follow-up actions, effective exchange and close collaboration
with Member States is essential for the implementation of the integrated regulatory strategy.
Specific expert groups on Endocrine Disruptors, PBTs and vPvBs and Nanomaterials have been
set up to support these processes. These groups aim to reach scientific agreement among
Member States on general issues and case specific questions, hereby facilitating decision making
under REACH, POP, CLP and Biocides.
Outcome and impact
ECHA’s identification and prioritisation of groups of chemicals aims to accelerate regulatory risk
management action, which improves the protection of human health and the environment. The
limited resources available to the EU and Member State authorities are directed towards
chemicals where regulatory risk management is expected to have the highest impact for human
health and environment protection. Coordination with and among Member State competent
authorities ensures efforts are not duplicated, that the best expertise is available when needed,
and the appropriate risk management instrument is selected and implemented. In addition,
addressing chemicals in groups accelerates the work further by better leveraging the available
data to increase the impact of decisions, as well as reducing the risk of “regrettable substitution”.
This activity is at the heart of ECHA’s Integrated Regulatory Strategy and provides efficiencies
to ECHA’s activities on evaluation, classification and labelling, restrictions and authorisation. The
impact of the activity is visible in the timeline and efficiency of implementation of these other
REACH and CLP processes, as well as in the effectiveness of risk management measures,
accelerating the overall identification of hazardous substances and their substitution and risk
management.
Main actions and outputs of 2021 and 2022
As a means to accelerate risk management following the 2018 Commission REACH Review, ECHA
has implemented since 2019 a process to systematically screen groups of substances.
Identification and prioritisation of groups of substances for all REACH/CLP processes:
• Identify groups of substances and screen them to identify cases for further information
Programming Document(s) 2021-2024 43

generation and regulatory risk management. [2021, 2022]

• Prioritise the groups for screening with the view of concluding, without delay, for
substances registered above 100 tonnes/y if they are i) of priority for regulatory risk
management, ii) currently of low priority for further regulatory action, or iii) need more
data for a judgement to be made. The status of this work will be presented through the
so-called ‘chemical universe’ which has for the first time been published end of 2019 and
will be refreshed in spring 2021. Automation of the refresh in 2021 to enable more
frequent updates from 2022. [2021, 2022] [REACH Review Action 2] [REACH Review
Action 8]
• Based on the experience gained on petroleum stream substances, expand the learnings
to progress on further hazard information generation and initiating regulatory risk
management actions on other substances of concern due to presence of hazardous
constituents and impurities. [2021, 2022]
• Continue together with Member State competent authorities using the most appropriate
approaches to generate hazard information and initiate regulatory risk management
action, where necessary, on the groups of substances. Continue targeted collaboration
with industry (sectors). [2021, 2022] [REACH Review Action 2]
• To enhance the implementation of the integrated regulatory strategy continue supporting
the alignment of the views and optimising the way the collaboration and sharing of work
between authorities is implemented. To this end, continue optimising the collaboration
structures (e.g. RIME+). [2021, 2022] [REACH Review Action 2]
• Publish the annual report on the implementation of the Integrated Regulatory Strategy.
[2021, 2022]
Development of approaches:
• Further increase transparency and predictability of the authorities work by increasing
information on groups of substances on the website. [2021]
• Based on the experience gained with working on groups of substances since 2019 across
tonnage bands, further develop the grouping and group management approaches and
harvest the results of the information generated and assessed to adapt the work for the
substances registered in lower tonnage bands. [2021]
• Further develop high throughput new approach methodologies (NAM) in cooperation with
ECHA’s international partners. This shall allow developing novel, effective regulatory
means to inform prioritisation, classification, evaluation, risk assessment and risk
management of chemicals and have a positive impact on the level of compliance with
information requirements. Following the finalisation of the collaborative project of Tier 2
(in vitro assays and modelling), Tier 2 (NAM enhanced in vivo short-term verification
studies) will be initiated followed by preparation for Tier 3 (NAM enhanced in-vivo longer-
term regulatory studies). [2021, 2022] [REACH Review Action 2]
• Augment the registration data with external sources containing in vivo and in vitro
(eco)toxicological information, results from predictive models and chemical safety data
exchanged with other authorities (e.g. Canada, US EPA). [2021,2022]
Endocrine Disruptor (ED), PBT and Nanomaterial (NMEG) Expert groups work:
• Reach scientific agreement among Member States on general issues and case specific
questions, hereby facilitating decision making under REACH, POP, CLP and Biocides. This
entails further improvement of interfaces between evaluating Member State Competent
Authority, Expert Groups and the MSC. [2021, 2022]
• ED Expert Group: Gain experience in the implementation of endocrine disruptor
identification guidance based on the increasing number of cases in substance evaluation,
SVHC candidate listing and biocides. It will align the practice with ED identification for
plant protection products in EFSA and assess the need for guidance updates. [2021,
2022]
Programming Document(s) 2021-2024 44

• PBT Expert Group: Progress in methodological approaches for PBT testing of difficult and
UVCB substances. [2021, 2022]
• PBT Expert Group: Support development of methodologies for addressing substances that
are Persistent, Mobile and Toxic (PMT) substances. [2021, 2022].
• NMEG: Provide a forum for methodological approaches for testing substances in the
nanoform to MSCAs and stakeholders. [2021, 2022]
• NMEG: Provide support of the nanomaterials guidance updates. [2021, 2022]
Other items - Work with industrial sectors to improve the information basis and to support the
sustainability efforts of industry as well as authorities’ work:
• Continue the work with industrial sectors to address in particular petroleum and coal
stream substances and metal UVCBs. [2021]
• Completion of the postponed work on outstanding technical and methodological issues in
line with the agreement signed with the metals sector (MISA). Continue monitoring
updates of hazard and risk assessment in registration dossiers and subsequent risk
management of metals and inorganics. [2021] [REACH Review Actions 1, 14]
• Support to the implementation of the action plan of the EU chemical’s industry on pro-
actively reviewing and updating registration dossiers in line with the cooperation
agreement signed. Participate to expert discussions on scientific and technical challenges,
support industry in disseminating learnings from these discussions and, for a limited
number of cases, provide feedback to testing strategies proposed by industry. [2021,
2022] [REACH Review Action 1]

Indicators type estimate estimate

2021 2022

Number of substances registered above 100 t/y for which Outcome tbd tbd
a conclusion on potential regulatory follow up was drawn
Number of groups of substances taken into the screening Outcome 70 70
process

Resources estimate 2021 estimate 2022

Financial resources (costs, EUR) 9 501 822 9 439 309

Human resources (FTE) 58 58

1.4 Evaluation

Overview
ECHA, together with the Member States, checks if manufacturers and
importers comply with the obligations for having access to the European
Single Market. Where the obligations are met, but additional information
is needed to ensure safe use in the EU, ECHA, together with the Member
States, requires such information to be generated by manufacturers and
importers.
Programming Document(s) 2021-2024 45

Tasks
ECHA checks registration dossiers compliance with the safety information requirements. The
Agency also examines if the testing of substances proposed by registrants to meet the safety
information requirements, will do so and that any test using vertebrate animals is necessary.
Under substance evaluation, ECHA adopts the annual list of substances requiring substance
evaluation (the Community rolling action plan) and coordinates and supports Member State
competent authorities identify any additional information, beyond that already submitted by
companies, needed to ensure safe use. ECHA also analyses the data submitted by companies in
response to compliance and testing proposal evaluation decisions and identifies chemicals that
may need further regulatory action to ensure safe use.
ECHA’s tasks under evaluation involve the ECHA secretariat and ECHA’s Member State
Committee (MSC). The secretariat drafts dossier evaluation decisions and proposals for the
Community rolling action plan, whereas the MSC reviews all evaluation decisions and adopts the
Community rolling action plan with participation of all Member States. The ECHA secretariat also
supports the MSC aiming for efficiency, consistency and quality of outputs and identifies
chemicals that may need further regulatory action.
Outcome and impact
ECHA’s evaluation activity generates primarily hazard data on chemicals, which increases the
knowledge on these chemicals and the broader chemical groups they belong to. Firstly,
companies are required to use this knowledge, for example, to improve the risk management,
to decide to substitute, or to market the substance as a substitute for a more hazardous
alternative. Secondly, ECHA uses this knowledge in the context of the integrated regulatory
strategy, to identify regulatory actions 37 that may be needed to better protect human health and
environment. Thirdly, Member States are also expected to use this knowledge. The improved
hazard knowledge increases the level of protection within the European Single Market.
ECHA selects industry dossiers for compliance checking that raise concerns and for which
additional information is needed, using its integrated regulatory strategy. The implementation
of the REACH Joint Evaluation action plan 38 increases the number of industry dossiers that are
checked for compliance.
This activity protects the compliance investment made by companies, and thereby facilitates the
level playing field, the smooth functioning of the EU’s single market and increases the level of
protection. Finally, the consistent, transparent and scientifically sound application of the "last
resort" requirement ensures that the animal testing needed to generate the necessary chemical
safety data is kept to a minimum. The cost of closing data gaps also acts as incentive to explore
the use of alternative methods.
Main actions and outputs of 2021 and 2022
REACH compliance evaluation have received considerable attention in the past years from
different stakeholders and the Commission in the REACH Review. The ECHA secretariat and the
Commission developed a Joint Action Plan to address the concerns and ECHA and several
industrial organisations worked to sign a memorandum of understanding aiming at addressing
these concerns. As a consequence dossier evaluation is a priority activity for 2021-2022. The
actions in this programming period are:
• Compliance check industry dossiers for the higher-tier hazard endpoints for substances
of potential concern in the higher tonnage bands (over 1000 tonnes dossiers and
100-1000 tonnes dossiers) or groups of substances of concern containing at least one
such substance. [2021, 2022] [REACH Review Action 2; Joint Action Plan Action 4]
• Examine testing proposals included in the registrations from the 2018 deadline by 1 June
2022 and any new testing proposals within the legal deadlines. [2021, 2022] [REACH
Review Action 2]

37
For example, classification and labelling (Activity 1.7), restrictions (Activity 1.6) and authorisation (Activity 1.5)
38
https://echa.europa.eu/documents/10162/21877836/final_echa_com_reach_evaluation_action_plan_en.
Programming Document(s) 2021-2024 46

• Nanomaterials: Compliance check dossiers updated with the additional requirements for
substances in nanoforms with an initial focus on substance identity and justifications for
sets of nanoforms, and examine testing proposals within the legal deadlines[2021, 2022].
• Examine the compliance of any information submitted in consequence of ECHA’s dossier
evaluation decisions with the decision. Communicate to the Commission and Member
State competent authorities the conclusions made, as well as inform the concerned
national enforcement authorities in case of non-compliance with the decision. Where
appropriate, draft follow-up decisions. Ensure that the information submitted and any
conclusions made are used, through ECHA’s integrated regulatory strategy, to identify
substances that may need regulatory action to better protect human health and
environment. [2021, 2022] [REACH Review Action 2]
• Ensure, together with Member States, that substance evaluation contributes in an
effective manner to the implementation of the integrated regulatory strategy. This entails
updating the CORAP with substances for which substance evaluation is the most
appropriate tool to generate further hazard information, in line with the outcome of
screening and prioritisation based on the grouping approach; it may result in a lower
number of substance evaluation cases comparing to previous years, as data relevant for
regulatory risk management could be generated to a large extent through compliance
check. Applying compliance check in parallel with substance evaluation will be considered
where appropriate. [2021, 2022] [REACH Review Action 2, Joint Action Plan Action 10]
• Ensure together with the Member States that the substance evaluation is concluded as
fast as possible to enable initiating appropriate regulatory risk management measures;
the aim is to reduce the number of substance evaluation cases currently opened. [2021;
2022]
• Report on the progress made in evaluation as part of the report on the Integrated
Regulatory Strategy and publish the updated recommendations to registrants stemming
from evaluation. [2021, 2022] [REACH Review Action 2]
• Contribute to the Caracal sub-groups in support of the Commission in their policy
activities. This concerns: 1) Amendment of the REACH information annexes in accordance
with the Joint Action Plan [Joint Action Plan Actions 5 and 6] [2021, 2022]; 2) Information
requirements for polymers requiring registration; 3) Legislative and policy issues in
relation to endocrine disruptors. [2021, 2022].
• Continue verification of compliance with good laboratory practice requirements for
(eco)toxicological tests analysis. This entails requesting targeted study audits in case a
concern about compliance with principles of good laboratory practice is identified by ECHA
or a Member State. [2021, 2022] [REACH Review Action 2]
• Progress the scientific and technical review of the received extended one-generation
reproductive toxicity studies in collaboration with the Member State Competent
Authorities to inform the Commission on the possible need to revise the relevant REACH
information with regard to this issue annexes. [2021, 2022] [REACH Review Action 2]
• Update ECHA Guidance on information requirements, based on the Commission’s decision
to revise the REACH information annexes in accordance with the Joint Action Plan [2022].
When updating reflect the latest developments in methodologies for substances in
nanoforms. (Human health [2021]; Environment [2021, 2022])
• Provide regulatory advice to registrants and other interested parties on information
requirements including on nanoforms of the substances and on dossier and substance
evaluation processes. [2021, 2022] [REACH Review Action 2, Joint Action Plan Action 15]
Programming Document(s) 2021-2024 47

Indicators type estimate estimate

2021 2022
Compliance checks concluded: draft decisions or no output 300 300
action 39
Final decisions on dossier evaluation (testing proposals output 300 300
and compliance checks) 40
Number of substances for which a conclusion was reached outcome 200 200
in the follow-up to dossier evaluation
Substance evaluation final decisions issued output 15 15

Number of substances for which a conclusion was reached outcome 15 15

in substance evaluation

Resources estimate 2021 estimate 2022

Financial resources (costs, EUR) 18 628 642 19 009 306

Human resources (FTE) 110 113

1.5 Authorisation

Overview
ECHA identifies substances that are candidates for authorisation based
on their hazard (Substances of Very High Concern) and recommends to
the Commission substances that should next be subject to
authorisation. The Agency provides scientific opinions on the different
elements of companies’ applications for authorisation, including the
risks, the benefits and the availability of suitable alternatives and
possibilities to substitute. The opinions are provided to the Commission
who decides whether to grant or refuse an authorisation for using the
substance in the EU.
Tasks
The Member State Committee (MSC), based on proposals prepared by Member States or the
ECHA secretariat on request of the Commission, identifies SVHCs as candidates for authorisation
and places them on a Candidate List.
The ECHA secretariat prioritises regularly the chemicals on the Candidate List and proposes the
MSC which chemicals should be recommended to the Commission for inclusion in the
Authorisation List.
The Committees for Risk Assessment (RAC) and the Committee for Socio-economic Analysis
(SEAC), with the support of the ECHA secretariat, develop opinions on applications for
authorisation submitted by industry, and thereby facilitate the European Commission’s decision-
making on granting or refusing an authorisation.
In order to improve the knowledge on alternative chemicals and techniques, the ECHA secretariat
arranges open consultation processes for each application for authorisation, which then feeds
into the opinion-making process by the Committees.

39
The estimate reflects the number of substances that will be checked for compliance. The overall number of dossiers
concerned by that compliance check depends on the number of companies having registered jointly. It can vary
significantly depending on whether the substance is a commodity or a specialty. Therefore, the final number of dossiers
that have undergone a compliance check will be communicated a posteriori in ECHA’s annual report.
40
This estimate reflects the number of substances for which a final evaluation decision has been taken under dossier
evaluation. A breakdown per type of process will be given in ECHA’s annual report.
Programming Document(s) 2021-2024 48

The ECHA secretariat also supports companies and in particular potential applicants by providing
regulatory advice and reaching out through the national helpdesks and specific communication
activities.
Outcome and impact
ECHA’s work in the area of authorisation results either in substitution, and thereby replacement
of SVHCs with safer alternatives, in reduced emissions or exposure or in ceasing the use of the
substance. All these elements improve the level of protection for human health and the
environment and stimulate innovation. Already the listing of a chemical on the candidate list has
shown to induce substitution and spur research and development for alternatives 41. Moreover,
the preparation of an application for authorisation requires the applicant to systematically review
the safety measures in place. This leads usually already at this stage to reduced risks to workers,
consumers and the environment. Finally, ECHA’s consultation processes improve the knowledge
on alternatives that in turn improves substitution efforts.
Eventually, only justified uses are authorised by the Commission. Authorisations remain valid
until the Commission decides to amend or withdraw the authorisation in the context of a review.
The authorisation process, from the identification of SVHC, candidate listing, inclusion in Annex
XIV to the applications for authorisation, provides transparency, enhances predictability, level
playing field and increased legal certainty for companies, supporting innovation.
Main actions and outputs of 2021 and 2022
REACH Authorisations have received considerable attention in the past years from different
stakeholders. ECHA has clarified the process and the role of the Committees and has updated
the authorisation opinion formats and related guidance accordingly. ECHA strives to provide fit
for purpose recommendations for the inclusion of substances on the Authorisation lists as well
as fit for purpose opinions, providing scientific advice to the European Commission for their
decision making.
As a consequence of the REACH review, authorisation is a priority activity for 2021-2022. The
actions in this programming period are:
• MSC decides on the identification of SVHCs. An increasing proportion of SVHC dossiers
are expected to cover groups of substances, substances with a complex composition and
PBTs and EDs. An increased involvement by the respective expert groups and the MSC is
therefore expected. The identification process is adapted to make further use of the
identified improvements in the interfaces between dossier submitters, Expert Groups and
the MSC. [2021, 2022]
• Provide a well-founded Annex XIV recommendation. [2021] In 2022 work on the next
Annex XIV recommendation will commence with the view of finalising the 11th Annex XIV
recommendation in 2023.
• RAC and SEAC deliver fit-for-purpose quality opinions, providing sufficiently detailed
scientific justification of all elements as requested by REACH with about 50 opinions for
substances that have endocrine-disrupting properties, another 50 opinions for substances
with other properties as well as evaluate the substitution plans of 12 applicants if they
have suitable alternatives available in general. The opinions will be sent to the
Commission. [2021, 2022]
• Work with the Commission and Member States in implementing the results of the
improvement activities identified under Action 6 of the REACH Review (simplification for
a more workable authorisation process) and other suggestions for improvement in the
subsequent Review. [2021, 2022]
• Taking into account the feedback received from the Commission, Member States,
European Parliament, General Court as well as industry and non-governmental

41
Impacts of REACH restrictions and authorisation on substitution in the EU (ECHA, 2020) available at
https://echa.europa.eu/documents/10162/24152346/impact_rest_auth_on_substitution_en.pdf.
Programming Document(s) 2021-2024 49

stakeholders continuously improve the authorisation process. This comprises, inter alia,
the updating of application and opinion formats to ensure fit-for-purpose quality and
consistency, provision of technical and scientific support to RAC and SEAC rapporteurs
during opinion making, the assessment of the suitability of alternatives in general and for
the applicant as well as active participation in Application for Authorisation Task Force.
[2021, 2022] [REACH Review Actions 6, 10]
• Depending on the Commission’s decisions RAC and SEAC may receive Review Reports
submitted by ‘upstream’ authorisation holders, including the respective downstream user
reports, for evaluation. This experience will allow ECHA to establish how effective the
communication between the upstream authorisation holders and their downstream users
has been. Based on this experience, ECHA seeks to reduce the uncertainties that were
inherent in the original upstream applications. [2022] [REACH Review Action 6]
• Support the Commission during the decision making on authorisations. [2021, 2022]
• Carry out market research to estimate the substitution effort taken and the likely number
of applications to be received to plan well the opinion making process. [2021, 2022]
• Develop further the analysis of alternatives activities under the Network of REACH SEA
and Analysis of Alternatives Practitioners (NeRSAP) and hold one or two meetings to
improve the knowledge and skills of European applied economists, providing analysis in
regulatory settings for restrictions or in applications for authorisation. Hosting NeRSAP in
2021. Joint activity between restrictions and applications for authorisation. [2021, 2022]
[REACH Review Actions 8, 9]
• Provide web-based training to interested stakeholders on analysis of alternatives and
informed substitution from substances subject to regulatory risk management. Joint
activity between applications for authorisation and restrictions supporting substitution
[2021, 2022] [REACH Review Action 5]
• Provide timely notes on methodological questions, including socio-economic issues.
[2021, 2022][REACH Review Action 6]
• ECHA will provide timely and transparent support to applicants and authorisation holders
through a streamlined process, including teleconference-based information sessions,
updated information documented in, for instance, updates of the Guidance document,
practical guide, application formats, ‘reference’ DNELs and dose-response relationships
of substances. [2021, 2022]
• Support to Forum in preparing the ninth coordinated enforcement project (REF-9) on
authorisation and supporting inspectors during the operational phase. The lessons learnt
will be communicated, including those learnt from the downstream user notifications.
[2021, 2022]

Indicators type estimate estimate

2021 2022
Number of new entries in the Candidate List output 15 15

Recommendation for inclusion of substances in the output 1

authorisation list
Cumulative number of downstream user notifications of outcome 3 000 3 000
authorised uses of SVHCs
Number of RAC and SEAC opinions adopted on output 50 50
applications for authorisation (number of uses)
Effective working time of ECHA staff per opinion performance 38-46 38-46
person days person days

Applications for authorisation received (number of uses) input 60 35

Programming Document(s) 2021-2024 50

Resources estimate 2021 estimate 2022

Financial resources (costs, EUR) 6 191 114 7 464 547

Human resources (FTE) 32 40

1.6 Restrictions

Overview
ECHA provides scientific opinions on proposals to restrict substances
made by Member States or by the ECHA secretariat either based on a
request of the Commission or in limited cases 42 on their own decision.
The opinions address the different elements of the proposals, including
the risks and possible mitigation measures, availability of alternatives
and socio-economic aspects, enabling the Commission to weigh the
elements together when deciding whether and how to restrict
substances on the EU single market.
Tasks
On request of the Commission, the ECHA secretariat develops dossiers proposing to restrict
substances on the EU single market. For substances on the Authorisation List (Annex XIV), the
ECHA secretariat proposes restrictions if they consider there is an unacceptable risk.
The Committees for Risk Assessment (RAC) and the Committee for Socio-economic Analysis
(SEAC), with the support of the ECHA secretariat, develop scientific opinions on proposals to
restrict substances, made by Member States or by the ECHA secretariat and thereby facilitate
the European Commission’s decision-making on restricting substances.

Outcome and impact

ECHA’s work in the area of restrictions promotes the substitution and replacement of chemicals
of concern with safer alternatives, results in improved risk management and stimulates
innovation. The listing of a chemical in the registry of intentions has been shown to increase the
substitution activity of companies, and also to support research and development for
alternatives. Moreover, the commenting on a restriction proposal by companies leads in certain
cases to increased safety for workers and consumers.
The harmonised approach by ECHA ensures a level playing field and increased legal certainty for
companies, supporting innovation.
Main actions and outputs of 2021 and 2022

The ECHA secretariat, along with Member States and the Commission, has made efforts to
improve the efficiency of the restriction process through the Restriction Task Force (RTF). The
work of the RTF has also been instrumental in delivering on the actions of the 2nd REACH review.
Nearly 100 recommendations have been made and implemented, which along with additional
internal efforts related to efficiencies in the Committees, has increased the resources available
for restriction work:
• Work with the Commission in implementing various improvement activities identified
under Actions 8 to 11 of the REACH Review to improve the restriction procedure as such
and enhance the Member State involvement in it. Continue to speed up the screening of
substances on the Authorisation List (Annex XIV) for REACH for action under Article
69(2). [2021]

42
Article 69 of the REACH Regulation.
Programming Document(s) 2021-2024 51

• Submit fit-for-purpose restriction proposals or restriction reports to address the identified

concerns for (groups of) substances, as requested by the Commission, or for substances
of very high concern used in articles, addressing the specific aspects of groups of
substances where appropriate. Support to the Member States to identify candidate and
prepare restrictions, for example, in pre-restriction information and support meetings and
in restriction workshops. [2021, 2022] [REACH Review Actions 8, 9, 10, 11]
• Timely, targeted and fit-for-purpose opinions on submitted restriction proposals. Consider
further options on how to better express uncertainties in the RAC and SEAC opinions.
[2021, 2022] [REACH Review Actions 8, 10]
• Provide web-based training to interested stakeholders on analysis of alternatives and
informed substitution from substances subject to regulatory risk management. Joint
activity between applications for authorisation and restrictions supporting substitution.
[2021, 2022] [REACH Review Action 5]
• Additional capacity building for Member States, RAC and SEAC on regulatory impact
assessment, in particular on methods used in socio-economic analysis relevant for
restrictions or in applications for authorisation. [2021, 2022] [REACH Review
Actions 5, 9]
• Develop further the analysis of alternatives activities under the Network of REACH SEA
and Analysis of Alternatives Practitioners (NeRSAP) and hold one or two meetings to
improve the knowledge and skills of European applied economists, providing analysis in
regulatory settings for restrictions or in applications for authorisation. Hosting NeRSAP in
2021. Joint activity between applications for authorisation and restrictions. [2021, 2022]
[REACH Review Actions 8, 9]
• Further develop methodologies related to socio-economic analysis in particular in the
context of the OECD. This comprises both the valuation of health and environmental
endpoints and learning lessons from regulatory risk management cases in different OECD
member countries. [2021, 2022]
• Based on initial work carried out in 2020 of indicators that would allow for an ex-post
evaluation of the most relevant impacts of restrictions further develop these and find
ways of getting annual information of substances based on the EU market. The insights
will help in improving the preparation of restriction proposals by ECHA and Member States
and in making the restriction process more effective. [2021, 2022]
• Continue to provide input to the opinion making processes of other EU agencies or
committees with a view to explaining ECHA’s opinions and understanding the reasons for
any differences. [2021]
• Together with the Commission and Member States, compare ECHA’s guidance on socio-
economic analysis of restrictions with the Commission’s Better Regulation guidelines and
adapt where possible and necessary. [2021]
• When developing new restriction proposals, ECHA integrates better, where relevant,
circularity and sustainability aspects, including possible trade-offs, to the analysis with
view of learning from this experience. [2021, 2022]
• Support the Commission, stakeholders and enforcement authorities to clarify the existing
restriction entries by developing public Q&As. [2021]

Indicators type estimate estimate

2021 2022
Number of RAC and SEAC opinions on restriction output 2** 10
proposals
Restriction proposals 69(1) or reports developed under output 4 4
Article 69(2)
Programming Document(s) 2021-2024 52

Effective working time of ECHA staff per opinion (ECHA performance 240 – 290 240 – 290
dossier)* person days person days
Effective working time of ECHA staff per opinion (Member performance Approx. 200 Approx. 200
State dossier)* person days person days

* The effective working time per dossier depends greatly on the complexity of the dossier. Additional time for ECHA
dossiers is due to fulfilling the Dossier Submitter responsibilities.
** This is lower than in previous years as the number of dossiers prepared was lower in 2020 than expected due to
reasons beyond the control of ECHA.

Resources estimate 2021 estimate 2022

Financial resources (costs, EUR) 6 512 245 6 508 301

Human resources (FTE) 34 34

1.7 Classification and Labelling

Overview
ECHA provides scientific opinions on Member State’s or industry
proposals for harmonised classification and labelling enabling the
Commission to decide if harmonised classification is required and be
applied across the EU single market.
In the case of poison centre notifications (PCN), ECHA provides access
for authorities to this information through a dedicated central
searchable database.

Tasks
The Committee for Risk Assessment (RAC), with the support of the ECHA secretariat, develop
opinions on proposals for harmonised classification, and thereby facilitate the European
Commission’s decision-making on harmonising or not in the EU single market the substances
classification and labelling.
The ECHA secretariat promotes the harmonisation and consistency of self-classifications included
in the CLP inventory.
The ECHA secretariat has a helpdesk for (potential) notifiers to help comply with their legal
obligations and to use ECHA’s IT CLP tools and coordinates the Member State helpdesks. The
ECHA secretariat approves company proposals for using an alternative name of the substance,
where disclosing the name may disclose confidential information.
In addition, ECHA secretariat supports national poison centres and industry by providing a
common IT tool for submission (ECHA submission portal) and a common database tool for
Member State authority access to notifications used for emergency health response.
Outcome and impact
Classification and labelling is an important instrument in chemicals regulation for ensuring safe
use. Risk assessment is carried out to determine if additional risk management, beyond that
induced by classification and labelling is needed.
The C&L inventory held by the ECHA secretariat helps companies to find and apply classifications
where no harmonisation has taken place yet. Harmonised classification and self-classification
has the capability, in particular for more detrimental hazard endpoints, at an early stage to work
as an incentive to substitute and change to less harmful alternatives. The list of both harmonised
Programming Document(s) 2021-2024 53

and self-made classifications by companies is a point of reference at global level to access

information about hazards of substances in commerce.
The harmonised classification of a substance sets one EU standard for the classification, labelling
and packaging across all uses within the EU single market. The EU focuses in particular on
carcinogenic, mutagenic and reprotoxic (CMR) chemicals and respiratory sensitisers, which in
addition, results in use restrictions through sector specific legislation and limits thereby
effectively the use of hazardous chemicals in the industrial supply chains and by consumers. The
harmonisation thereby not only improves the level of protection of human health and the
environment, but also increases legal certainty and the functioning of the EU single market and
supports innovation.
Providing IT tools and support to the appointed bodies and poison centres, in relation to the
notifications of emergency health response, reduces the cost for companies and Member States
to fulfil their obligations while increasing information quality and consistency across Europe.
Main actions and outputs of 2021 and 2022
• Process incoming CLH dossiers and the upward trend in industrial chemicals from the
outcome of screening and prioritisation based on the grouping approach as well as the
continued high number of PPP and Biocides dossiers resulting from the joint Commission,
EFSA and ECHA efforts to encourage timely submission of dossiers. [2021, 2022]
• Continue to develop the CLH dossier submitter support package with a guidance
document and a Workshop to help Member States in preparing fit-for-purpose dossiers
in an efficient manner. [2021]
• Provide scientific and technical support to the Commission in the context of the further
development of the United Nations Globally Harmonised System of classification and
labelling of chemicals (UNGHS), including the work of selected GHS working groups,
notably the working group on the use of non-animal testing methods for classification.
[2021, 2022]
• Improve the visibility and clarity of the information in the C&L Inventory to make the C&L
data more accessible and facilitate the analysis of the data for any purpose (see also
Dissemination section (1.9)). [2021, 2022]
• Update the CLP guidance, to reflect changes in information requirements as well as
updates to reflect revised practises in applying criteria and to ensure consistency in
decision making; starting with the environmental sections and then the human health
sections. [2021, 2022]
Poison Centres Notification Portal 43
• Consolidate standard formats and tools (product categorisation system) and notification
(PCN) format) and revise guidance for the poison centres notifications according to the
new Commission Regulation amending the CLP Regulation adopted in 2020. [2021, 2022]
• Maintain the Unique Formula Identifier (UFI) generator [2021, 2022]
• Ensure further development and maintenance of the notification portal and system-to-
system submission channel to provide the features to support the reception and
processing of the notifications received with the 2021 first compliance date as well as
communication, including the development of group submission, removal of product,
support multi-component submissions and alignment with IUCLID. [2021, 2022]
• Continue to develop the searchable central database, to be used by the national appointed
bodies and Poison Centres, based on the Commission’s mandate, the outcome of the
consultation initiated in 2019 and the feedback from national authorities on the use of
the database. [2021]

43
Executing the actions and outputs for the Poison Centres Notification portal, including necessary adaptation to the
legislative amendments to Annex VIII of CLP, is subject to the availability of sufficient resources and will be
confirmed/adjusted in the mid-year budget review of the Agency.
Programming Document(s) 2021-2024 54

• Continue the promotion of the PCN activities with duty holders and consumers. [2021,
2022]

Indicators type estimate estimate

2021 2022
Number of RAC opinions on proposals for harmonised output 65 65
classification and labelling
Decisions made on requests to use alternative (Article 24) output 40 40

Effective working time for processing RAC opinions performance 45-55 45-55
person days person days

Proposals for harmonised classification and labelling input 70 70

Resources estimate 2021 estimate 2022

Financial resources (costs, EUR) 6 437 623 6 478 436

Human resources (FTE) 27 27

1.8 Safe and sustainable use of chemicals

Overview
ECHA supports companies in meeting their obligations to implement
appropriate risk management measures.
Tasks
Under REACH, ECHA is mandated to provide technical and scientific
guidance and tools to assist the development of Chemical Safety
Reports. This has led to the development of robust guidance for the
Chemical Safety Assessment process and the provision of the Chesar
tool (Section 1.1) to enable registrants to perform an effective CSA,
demonstrating (i) safe use to the authorities via the registration and
(ii) delivering safe use advice for inclusion in the SDS. Subsequent implementation in company
supply chain systems, including making consolidated safe use advice for mixtures, is solely an
industry obligation.
The ECHA secretariat also supports Member States and other stakeholders to organise
workshops exchange experiences and capacity building regarding safer alternative substances
assessment and substitution.
Outcome and impact
ECHA seeks to provide better information to the producers of articles, supporting a high level of
protection across the EU single market, reducing costs, increasing legal certainty and improving
the functioning of the internal market and support the transfer to a circular economy.
Main actions and outputs of 2021 and 2022
• Concerning substances in articles:
o Work further on the strategy to support a safer use of chemical substances in articles,
including any specific questions arriving via the Commission in relation to the
development and implementation of the Circular Economy policy [2021, 2022]
o Based on the activities carried out in 2020, define further work for 2021. [2021, 2022]
Programming Document(s) 2021-2024 55

• Concerning substitution, ECHA will, subject to the availability of resources, carry out its
substitution activities coordinated with the Commission as well as any other activities of
EU in this field:
o Help Member States and other stakeholders in the organisation of substitution
collaborative supply chain workshops. [2021, 2022] [REACH Review Action 5]
o Continue providing input to the work performed at the OECD level on safe and
sustainable chemistry and disseminate the outcomes. [2021, 2022]
o Support the relevant services of the Commission, when requested, to promote the
enhancement of EU financial and technical support for substitution and safe and
sustainable innovation. [2021, 2022]

Resources estimate 2021 estimate 2022

Financial resources (costs, EUR) 1 568 075 1 568 389

Human resources (FTE) 8 8

1.9 Data management and dissemination

Overview
ECHA was set up as a digital-first organisation. ECHA operates by
collecting, organising, assessing, generating and finally making data
available both directly or embedded into regulatory decisions and
opinions.
The data management activity aims to exchange, organise and
process data, to support the various regulatory processes, by
developing corresponding tools, formats and services.
Dissemination makes data available to external stakeholders via the
‘Information on Chemicals’ section of the ECHA website.
Tasks
ECHA develops, operates and supports a number of data management and dissemination tools.
In particular its data integration and scientific data platforms provide advanced analytics,
visualisation, simulations and predictions (including machine learning) that are used for
substance grouping and prioritisation and help aggregating information into higher-level views
that are used for analysis, decision making, reporting and dissemination for instance through
the chemical universe. Case management and external interaction tools support efficient
execution of regulatory processes within ECHA Secretariat and when collaborating with others.
ECHA manages different dissemination tools and authority portals which provide the gateways
to access and analyse ECHA's data, both in machine-readable and human-readable format.
The Agency furthermore provides analytics services insights to address scientific and regulatory
questions through the analysis of data. They are provided internally to ECHA, as well as to
institutional stakeholders, such as Member States and the Commission.
Outcome and impact
Data management and analytics improve the execution of regulatory processes, contribute to
the effectiveness of grouping and prioritisation, the quality of scientific opinion making, the speed
of regulatory execution and the overall effectiveness of ECHA.
The dissemination portal is the world’s largest public database on the properties of industrial
Programming Document(s) 2021-2024 56

chemicals and its usage is about to pass the 50 million mark of user page views per year.
Dissemination improves the transparency on chemicals and their hazards and uses, which allows
better informed decisions on chemical safety by regulators, companies, workers and citizens
worldwide. Furthermore, the visibility of past, ongoing and upcoming regulatory actions
promotes regulatory predictability and a well-functioning internal market.
Infocards on chemicals make available key safety information in a compact and easy to
understand way, enabling companies and citizens to use it in their everyday decision making.
Dissemination of chemicals information in machine-readable formats, together with tools for
analysing the data, enables for a multiplier effect, as data delivered by ECHA can be reused and
republished e.g. by authorities and through consumer apps.
Finally, the use of interoperable formats and common platforms promotes smooth data flows
across actors and legislations, enabling better linking of regulatory processes which is at the
core of the one-substance-one-assessment approach.
Main actions and outputs of 2021 and 2022
Data management
• Identify a data strategy and implement actions prioritised in it, which includes integrating
different data sources and facilitating the re-use of REACH, CLP, and BPR data as well as
other sources as relevant. [2021, 2022]
• Further invest in the consistency of substance identity information to allow for
unambiguous reference of registration data and making links to other legislations and
data sources, among other for dissemination of regulatory lists and in the EU Chemicals
Legislation Finder (EUCLEF). [2021]
• Promote the common usage of data by interested parties, in cooperation with other EU
agencies, particularly EFSA, aiming for a higher level of consistency. [2021, 2022]
• Continue to provide data analysis services as a response to internal and external requests
for example supporting the implementation of the Implementing Regulation on dossier
updates or the review of information requirements for low tonnage substances [2021,
2022]
Dissemination
• Implement the Data availability roadmap according to agreed priorities and resources.
Integrate new and existing data sources into the dissemination portal such as the revamp
of the C&L inventory, PIC data, and the public version of the SCIP database, to achieve
a robust and sustainable publication solution. Increase visibility of substances in
regulatory processes and implement the reviewed publication policy of registration data.
[2021, 2022]
• Pursue the analysis and development of approaches to make data available in machine-
readable formats for effective data exchange across systems, facilitating on-boarding of
new tasks and integrated data management and collaboration. [2021, 2022]
• Maintain and further develop the OECD Global Portal to Information on Chemical
Substances (eChemPortal). Maintain the synchronisation of the eChemPortal with ECHA’s
dissemination website. [2021, 2022]

Indicators type estimate estimate

2021 2022
Number of user page views for published information on outcome 48.0 M 48.0 M
chemicals
Description and number of data requests outcome Internal:60 Internal: 60
External:30 External: 30
Programming Document(s) 2021-2024 57

Average time taken for publication (days) performance 3 3

Resources estimate 2021 estimate 2022

Financial resources (costs, EUR) 7 081 602 7 171 821

Human resources (FTE) 23 23

Programming Document(s) 2021-2024 58

2. Biocides
Overview
The Biocidal Products Regulation (BPR) concerns the placing on the
market and use of biocidal active substances and products. Biocides
are used to protect humans, animals, materials or articles against
harmful organisms, like pests or bacteria, through the action of the
active substances contained in the biocidal product.
Via its Biocidal Products Committee (BPC), the Agency develops
opinions for and upon request of the European Commission to support
decision making on biocidal active substances and products. ECHA
coordinates and supports the Member States Competent Authorities for the evaluation of active
substances and Union authorisations. The Agency functions as the central hub for all national
and EU applications and manages the participation to the Review Programme as well as
maintains the Article 95 list.
ECHA’s role includes establishment of technical equivalence, assessment of applications for
alternative suppliers, resolution of data-sharing disputes, development and maintenance of IT
tools, dissemination and preparation of guidance.
Outcome and impact
Biocidal products have an intended effect on harmful organisms, which needs to be effective and
targeted. By ensuring that active substances approved for the EU meet the efficacy criteria,
implementing BPR brings certainty that everybody can rely on the proper functioning of the
product. This improves hygiene, food safety and durability/sustainability of products.
At the same time, human health and the environment need to be protected from adverse effects
of the biocidal product. More specifically, the BPR exclusion criteria prevent, in principle, approval
of active substances that are carcinogens, mutagens, reprotoxic, endocrine disruptors, (very)
persistent and (very) bioaccumulative and toxic. This incentivises the finding or less harmful but
equally effective substitutes.
While BPR is different from REACH in requiring a prior approval of active substances and
authorisation of biocidal products, it improves the functioning of the internal market in the EU
by creating a level playing field (exemption: substances in the review programme – see box
below). Economic operators can rely on the simplified procedure for authorising products with a
more favourable environmental or health profile and, for products with similar use patterns,
Union authorisation without the need to seek for market access in each Member State
individually.
The evaluation of applications for Union authorisations accumulated significant delays because
of insufficient resources in Member States and the complexity of the evaluation. Depending on
resources availability ECHA may provide MSs with targeted support on specific items, for
example coordination activities on cases with the same active substance, improving and
simplification of the working procedures.
BPR serves as a frontrunner for new and emerging areas of concern. With the inclusion of
assessment criteria for endocrine disruptors and nanomaterials, the regulatory work ensures
that specific risks are understood and well managed avoiding negative effects to human health,
in particular on specific vulnerable groups, and the environment.
Review Programme: The biocides active substances review programme has accumulated
significant delays over the years that are mostly related to the following causes: insufficient
resources in Member States to perform the evaluations, delays by applicants in the provision of
requested information, the complexity of the assessment and in particular new requirements to
conclude according to the new criteria for endocrine disrupting properties introduced since June
2018. In addition, the scope of the review programme has been significantly extended with the
addition since 2017 of 92 active substance – product type combinations following the redefinition
of the in situ generated active substances. So far after more than fifteen years, only around 40%
Programming Document(s) 2021-2024 59

of all active substance – product type combinations have been finalised in the review
programme. To achieve the legal objective to finalise the review programme by 2024 would
require that the evaluating Member States would be able to submit altogether active substances
assessments at the average pace of at least 100 dossiers per year during the period 2021-2024.
This is in contrast with the current trend and the input of the Member States on the progress of
the reports to be delivered. Based on ECHA’s proposal, the Commission and Member States have
agreed to an Action Plan that aims to advance progress on the review programme. This would
also lead to a progress in the subsequent authorisation of biocidal products. ECHA is closely
cooperating with Member States, providing support and coordination beyond its initially foreseen
role. The Action Plan has a positive impact and based on the plans of Member States for the
period 2021-2024 communicated to ECHA we can expect an increase of finalised assessments
in 2021 and even more in subsequent years. This would lead to an increase of peer reviews and
BPC opinions that is reflected in the revised output indicators for 2021 and 2022 Nevertheless,
current indicators still show that the 2024 target for the review programme is at serious risk of
not being met.
The data sharing provisions that are supported by ECHA avoid the repetition of tests on
vertebrates.
Main actions and outputs of 2021 and 2022

• The support provided by ECHA to MSCAs to accelerate the review programme include:
specific advice and guidance with special attention to the assessment of ED criteria, direct
or indirect support in different sections of the assessment (e.g. exposure, substance
identity, toxicological assessment), best practices and simplification of approaches (e.g.
focused assessment of safety and efficacy, improved synergy with REACH and CLP),
guidance to harmonise confidentiality assessment. ECHA also contributes to the MSCAs
capacity building by providing training and may provide advice in priority setting, planning
and relationship with applicants. [2021, 2022]
• Support the Member State competent authorities in the preparation of complementary
BPC opinions on the endocrine-disrupting properties of active substances evaluated
before June 2018 following the request by the Commission. Ten such opinions have been
adopted in 2020 and the remaining 6 opinions are foreseen for in 2021. [2021, 2022]
• Support the Member State competent authorities in the preparation of BPC opinions on
the early review of already approved active substances (according to Article 15) following
the adoption of the endocrine-disrupting criteria. Such opinions are foreseen to be
requested by the Commission for at least three active substances. [2021, 2022]
• Improvements in the analysis of alternatives as part of BPC opinions based on the
experience gained in a pilot project started in 2020. [2021]
• Support the Member State competent authorities in the preparation of BPC opinions on
the renewal of the approval of active substances. [2021, 2022]
• Support the Member State competent authorities following the requests from Commission
for Article 75(1)g opinions on active substances and Union Authorisation. [2021, 2022]
• Support the Member State competent authorities with the identification of potential
endocrine-disrupting properties for biocidal active substances and biocidal products under
evaluation, including scientific advice from the Endocrine Disruptor Expert Group and the
provision of training. [2021, 2022]
• Support the Member State competent authorities in the preparation of BPC opinions on
Union authorisation of biocidal products, with a special emphasis on the efficiency of the
opinion-forming process and the coordination between Member States competent
authorities dealing with related applications. In addition to enabling the evaluating
competent authorities to deliver their assessment in a timely manner, identifying and
addressing issues during this phase and ECHA proposing harmonised approaches,
facilitates the finalisation of the peer review phase within the challenging 180-day
Programming Document(s) 2021-2024 60

timeline. [2021, 2022]

• Set up a functional interface and synergies between the assessment of endocrine
disruptor properties of non-active substances in biocidal product authorisation and the
screening and assessment of same substances in a group approach under REACH. [2021]
• Prepare ECHA’s opinions on Union authorisation of same biocidal products and on
administrative and minor changes to Union authorisations. [2021, 2022]
• Timely perform assessments of applications for technical equivalence, inclusion in the
Article 95 list and classification for changes. [2021, 2022]
• Support the Member State competent authorities in the checking of the translations of
summaries of product characteristics for the Union authorisation of biocidal products.
[2021, 2022]
• Support the Member State competent in preventing and resolving disagreements in the
mutual recognition process and in harmonising the practices for biocidal product
authorisation. [2021, 2022]
• Prepare the BPC opinions requested by the Commission according to Article 38 BPR on
scientific and technical questions related to mutual recognition disagreements and
derogations to mutual recognitions. [2021, 2022]
• The development of the Register for Biocidal Products (R4BP 3) and the SPC Editor
(additional functionalities to facilitate the work of industry and competent authorities and
the implementation of the Northern Ireland Protocol, further integration with other tools)
is foreseen to resume in 2022 after a pause in 2021. [2022]
• Support in the development of a new tool combining EUSES and CHESAR to harmonise
assessments under both REACH and BPR (see REACH Activity 1.1) that was started in
2020 is foreseen to continue until 2022. [2021, 2022]
• The development of IT support tools (in particular ECHA Interact) and their integration
to facilitate the work of Member States competent authorities during the peer review
phases for active substances and Union authorisation is foreseen to be resumed in 2022
after a pause in 2021. Notwithstanding the possibility to address short term critical needs
that will be considered in 2021. [2022]
• Assess the feasibility of extending dissemination to cover the full assessment reports of
active substances. [2021]
• Revision of BPR guidance Volume I to IV in line with the amendments to the Annexes II
and III of the BPR. [2021, 2022]
• Cooperation with EFSA where appropriate and in particular within the framework of the
assessment of endocrine disruptors to seek high level of harmonisation and alignment,
including cooperation in related procurements. [2021, 2022]
• Cooperation with EFSA with the aim to develop common guidance document (e.g. impact
of water treatment processes on residues of active substances in drinking water) and
complementary guidance documents (e.g. guidance document on bees for biocides).
[2021, 2022]
• Handle disputes on data sharing. [2021, 2022]
• ECHA will provide input to the Commission for its report to the European Parliament and
Council on the implementation of the Biocidal Products Regulation (2021).
• Support to BPRS in preparing the manual and assisting inspectors in the operational
phase of the second Forum-coordinated BPR enforcement project (BEF-2) on approved
substances in biocidal products. [2021, 2022]
Programming Document(s) 2021-2024 61

Indicators type estimate estimate

2021 2022

Number of BPC opinions on active substances approval output 38 52

Number of BPC opinions on the renewal of active output 4 6

substances approval
Number of BPC opinions on Article 15, Article 38 and output 20 20
Article 75(1)(g) requests
Number of BPC opinions on Union authorisation of output 26 35
biocidal products
Number of ECHA opinions on Union authorisations (same output 36 48
biocidal products, administrative and minor changes)
Support actions on evaluation of Active substance output 23 23
approvals
Support actions on evaluation of Union authorisation output 3 3
applications

Resources estimate 2021 estimate 2022

Financial resources (costs, EUR) 9 441 105 10 080 907

Human resources (FTE) 53 52

Programming Document(s) 2021-2024 62

3. Environmental Directives and International Conventions

3.1 Prior informed consent

Overview
ECHA contributes to the implementation of the EU Prior Informed
Consent (PIC) regulation, which in turn implements, with additional
obligations, the UN Rotterdam Convention relating to the international
trade in hazardous substances.
Tasks
The ECHA secretariat develops and maintains the IT tool used for
receiving and processing the notifications from companies. These
notifications originate from companies in the EU who are exporting
chemicals falling under the EU PIC. The ECHA secretariat also facilitates the access to the
notifications by national enforcement authorities and customs authorities.
The ECHA secretariat provides scientific and technical support to the Commission in the context
of PIC implementation and UN Rotterdam Convention.
The ECHA secretariat provides technical and scientific guidance and support to companies,
designated national authorities (DNAs), both from the EU and those from third countries.
The ECHA secretariat has a helpdesk for exporters to help comply with their legal obligations
and to use ePIC tools.
The ECHA secretariat publishes reports annually on actual volumes of exports from and imports
into the EU for certain severely restricted hazardous substances.
Outcome and impact
The UN Rotterdam Convention provides a framework to enable countries to be aware of foreseen
imports of hazardous substances into their territory, to receive information necessary to ensure
their safe use, and to protect themselves against unwanted imports of certain hazardous
chemicals.
Through the effective implementation of technical-scientific tasks of the EU’s contribution to the
convention, ECHA allows the concerned countries to take informed safety decisions about the
transboundary movement of hazardous chemicals. ECHA thereby contributes to reducing
exposure to humans and the environment to hazardous chemicals in third countries by managing
the export notifications of chemicals falling under the PIC Regulation and ensuring the quality of
the information provided. This allows EU companies to fulfil their responsibility and increases the
knowledge of potential risk for the receiving country when trading chemicals. The work plays an
important role for striving toward the principle of “ensuring that no one is left behind” as, for
example, farmers around the globe daily use toxic pesticides as well as workers and the general
public all together are exposed to harmful effects of industrial chemicals.
Main actions and outputs of 2021 and 2022
• Process a continuously increasing number of notifications and related tasks such as
stakeholder support. [2021, 2022]
• Produce and publish the annual report on PIC exports and imports. [2021, 2022]
• Produce and publish the third biannual report on the exchange of information under the
PIC Regulation. [2022]
• Provide scientific and technical support the Commission in proposing substances for
inclusion in the PIC Regulation and in notifying the Rotterdam Convention Secretariat.
[2021, 2022]
Programming Document(s) 2021-2024 63

• Support the Commission in their participation to the 10th Conference of the Parties to the
Rotterdam Convention [2021], the regular meetings of the designated national
authorities and the international capacity building activities. [2021, 2022]
• Based on the outcome of the stakeholders’ consultation on PIC dissemination, further
adapt PIC data publication to ECHA’s dissemination portal improving the visibility and
clarity of the information published and performing the necessary technological upgrades.
[2021, 2022]
• Maintain ePIC and further develop it to increase the efficiency of the process by facilitating
the work of DNAs, exporters, Commission and ECHA secretariat. [2021, 2022]
• Manage the changes arising from the UK withdrawal from the EU and the implementation
of Protocol on Ireland and Northern Ireland. [2021, 2022]

Indicators type estimate estimate

2021 2022
Scientific and technical support provided to the output 3 600 3 800
Commission, EU and non-EU DNAs
Export notifications processed (validated, rejected, output 13 200 14 500
resubmissions)
Share of notifications validated/accepted by ECHA outcome 90% 90%

Resources estimate 2021 estimate 2022

Financial resources (costs, EUR) 993 815 1 038 755

Human resources (FTE) 7 7

3.2 Persistent organic pollutants

Overview
ECHA carries out certain scientific and technical tasks supporting the
implementation of the EU Persistent Organic Pollutants 44 (POP)
Regulation, which in turn implements the UN Stockholm Convention
relating to the international use and trade in POPs.
Tasks
ECHA prepares and supports processing the technical dossiers that
the European Commission uses when proposing to list a substance as
a POP in the Convention. The technical dossiers identify the POP and
propose risk management. Such work is only done if significant work has already occurred under
REACH, CLP, PIC and BPR.
ECHA facilitates the reporting obligations on behalf of the Member State competent authorities
and compiles the Union overview of the implementation. It also supports the Commission and
the Member States scientifically and technically in their work under the Convention and
coordinates enforcement activities via the Forum for Exchange of Information on Enforcement
(Forum).
Outcome and impact
The Stockholm Convention on Persistent Organic Pollutants (POPs) is a global treaty aiming at
protecting human health and the environment from forever-chemicals that remain intact in the

44
Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic
pollutants.
Programming Document(s) 2021-2024 64

environment, have a wide distribution geographically, are able to accumulate in fatty tissue of
humans and wildlife, and have harmful impacts on human health or on the environment.
Exposure to POPs may lead to adverse health effects such as cancers, birth defects, dysfunctional
immune and reproductive systems, greater susceptibility to disease and damages to the central
and peripheral nervous systems. Given the transboundary movement of POPs, it requires
countries to work together to limit their effects.
ECHA contributes to identifying and limiting the emissions of forever-chemicals in the
environment. Through the work of ECHA, new substances are be added to the Stockholm
Convention and as a result banned or severely restricted globally.
Main actions and outputs of 2021 and 2022
ECHA prepares, in close collaboration with the Commission and the competent authorities under
the POPs Regulation, the tasks, workflows and necessary IT tools. The main actions and
deliverables can be outlined as follows.
• Support to the Commission when they or a party proposes substances for inclusion in the
Stockholm Convention and related work. [2021, 2022]
• Ensure that the platform for data submission and reporting by the Member States is
provided in a timely manner [2021]

Resources estimate 2021 estimate 2022

Financial resources (costs, EUR) 201 732 173 315

Human resources (FTE) 1 1

3.3 Waste Framework Directive

Overview
ECHA documents the presence of articles containing Substances of
Very High Concern on the EU market and provides access to that
information to waste treatment operators and to consumers.
Tasks
The ECHA secretariat establishes and maintains a database on the
presence of Candidate List substances in articles, provides tools to
allow any EU supplier of articles to submit the required information to
ECHA and provides access to the database to waste treatment
operators and to consumers.
Outcome and impact
The requirement to submit the information to ECHA and ECHA making it available increases
the knowledge on the presence, the release potential and the risks of Candidate List
substances in articles. Increased knowledge within the supply chain supports the development
of safer articles. The tasks under the WFD will in particular support the substitution of
Candidate List substances in articles and contribute to a circular economy by facilitating waste
prevention and waste treatment operations and will help companies comply with a similar
requirement under REACH.
Programming Document(s) 2021-2024 65

Main actions and outputs of 2021 and 2022 45

• In close interaction with the Commission, Member States and interested parties establish
a database of articles containing Candidate List substances that industry will need to
notify to ECHA as from 5 January 2021. This may include exploring the possible exchange
of non-confidential data in a structured format with the AskREACH project that focusses
on final, off-the-shelf products for consumers once the SCIP database has been filled with
data. [2021]
• Raise awareness and provide support to duty holders to allow any EU suppliers of articles
to submit the required information to ECHA. [2020, 2021]
• Plan for and implement the necessary tools for providing access to information in the
database to “waste treatment operators” and to consumers once this has been made
available by industry. [2020, 2021]

Resources estimate 2021 estimate 2022

Financial resources (costs, EUR) 2 108 161 1 355 952

Human resources (FTE) 7 7

3.4 Drinking Water Directive

Overview
With the revision of the Drinking Water Directive (DWD) ECHA will
assume new responsibilities related to setting up and maintaining
European positive lists of substances that are authorised to be used
for the manufacturing of materials coming into contact with drinking
water.
Tasks
ECHA’s tasks during the first four years from the entry into force of
the recast DWD will cover i) preparing the first EU positive lists of
the substances and ii) preparing the necessary methods and tools as well as setting up the
procedure for the operational phase starting in 2025. The operational phase will involve review
of all entries in the first EU positive lists based on applications by industry (by 2040) and
processing applications by industry and proposals by Member States to add new entries and
revise or remove existing entries.
Outcome and impact
Using ECHA’s expertise in hazard and risk assessment as well as in setting up and managing
transparent and predictable regulatory processes will ensure a smooth preparation for full
operation of the EU harmonised authorisation of substances allowed to be used in manufacturing
of the drinking water contact materials. This supports a holistic approach to chemicals
management across different pieces of legislation and uses synergies of available resources at
ECHA.
Main actions and outputs of 2021 and 2022
Support the Commission in setting up an EU system for the assessment of substances used in
manufacturing of materials coming in contact with drinking water, under the revised Drinking
Water Directive by the end of 2024:

45
Executing the actions and outputs related to the WFD is subject to the availability of sufficient resources and will be
confirmed/adjusted in the mid-year budget review of the Agency.
Programming Document(s) 2021-2024 66

• Compile the existing national positive lists based on the notification by competent
authorities. [2021]
• Develop an approach to prioritise the substances on the existing national lists for review
under the operational phase. [2021, 2022]
• Draft the information requirements for and the risk assessment methods used in
preparing the applications. [2021, 2022]
• Prepare a proposal for the procedure from the submission of the applications until the
opinion of the Risk Assessment Committee is submitted to the Commission. Develop the
IT infrastructure needed to support the process. [2021, 2022]

Resources estimate 2021 estimate 2022

Financial resources (costs, EUR) 1 476 348 1 503 682

Human resources (FTE) 4 4

3.5 Support to the 8th Environmental Action

Programme of the EU

Overview
Together with the European Environment Agency (EEA) ECHA
supports achieving the objectives of the 8th Environmental Action
Programme (EAP) by establishing a new monitoring and reporting
framework. This will include, to the largest extent possible, existing
monitoring tools and indicators mainly based on European statistics
and data from the EEA and ECHA, thus avoiding duplication and
limiting administrative burden for Member States. In particular, ECHA
provides information on the sustainable use of chemicals.
The monitoring framework should ensure ownership of and delivery on commitments and clear,
result-based indicators to measure progress and build on, and be consistent with, existing
monitoring frameworks and reporting tools operated in particular, but not exclusively, by the
European Environment Agency and its EIONET network. The resources for this activity come
from the LIFE programme.
Tasks
Supporting the new monitoring, measuring and reporting framework of the 8th EAP by ensuring
a sound, accessible and transparent knowledge and evidence base.
Outcome and impact
Support the implementation of the strategic priorities of the European Green Deal and the
assessment of progress under the 8th EAP.
Main actions and outputs of 2021 and 2022
• Management and consolidation of databases. [2021, 2022]
• Provision of chemical data in order to complete the respective emerging risk reports and
contribution to chemical policy indicators and other inputs to EEA’s work. [2021, 2022]
Programming Document(s) 2021-2024 67

Resources estimate 2021 estimate 2022

Financial resources (costs, EUR) 322 000 287 546

Human resources (FTE) 2 2

Programming Document(s) 2021-2024 68

4. Other tasks
The European Commission may entrust tasks to ECHA in form of contribution or service level
agreements, provided that these tasks that fall within the scope of the Agency's objectives, are
compatible with the Agency's mandate as set out in the REACH Regulation and do not form part
of the tasks assigned to the Agency therein either.
The purpose of the agreements is to define the tasks, to lay down the rules applicable to their
implementation, and to define the rights and obligations of the parties in their implementation.
According to ECHA’s Financial Regulation 46, the tasks performed under contribution agreements
shall be referred to in the annual Work Programme for information purposes only, and the
Executive Director shall inform the Management Board before signing any such agreement.

4.1 EU Observatory for Nanomaterials

The EU Observatory for Nanomaterials integrates available

information, and communicates it to decision-makers, authorities and
the general public in a balanced, user-friendly and easily
understandable way. It is a response to the concerns expressed by
policy makers and stakeholders on the lack of information about
nanomaterials on the EU market, in articles sold to consumers and in
workplaces.

Overview
The EU Observatory for Nanomaterials (EUON) systematically collects
available information on nanomaterials, with a specific focus on their markets and how they are
used, their hazards and risks, and ongoing nano-safety research activities and their main results.
ECHA uses various information sources for the observatory including its own regulatory activities
(e.g. dissemination of registration data, evaluation decisions, risk management processes),
information from the implementation of other EU legislation, national inventories or registers,
market studies and/or related databases and EU-funded research activities. The observatory
does not create any legal obligations for companies to report.
The current EUON contribution agreement runs through the year 2021. Discussions on the
renewal of the contribution agreement took/will take place in 2020/2021.

Key objective

The objective of the observatory is to provide better access to information on nanomaterials on

the EU market, their uses and safety aspects, and related research activities. Objective
information on nanomaterials on the EU market allows both professional and general audiences
to review and increase their understanding of how nanomaterials are used in the EU, what safety
information is available on them, and what safety research is ongoing.

Main actions and outputs of 2021 and 2022

• Update the EUON website, incorporating feedback from the ongoing customer insight
project [2021]
• Update the EUON search tool with new search features to further integrate the content
from national nanomaterial inventories and improve integration with data from REACH
dossiers. [2021]

46
MB/29/2019, Article 7.
Programming Document(s) 2021-2024 69

• Continue to promote the EUON via different channels to increase its outreach to a wide
variety of audiences. [2021, 2022]
• Perform a technology upgrade to the NanoData knowledge base. [2021, 2022]
• Update the data hosted on the NanoData knowledge base, following completion of the
relevant data update contract with DG RTD. [2022]

Indicators type estimate estimate

2021 2022
All traffic to EUON websites input 70 000 47 70 000

Resources estimate 2021 estimate 2022

Financial resources (costs, EUR) TBD TBD

Human resources (FTE) 3 3

4.2 EU Chemicals Legislation Finder

The EU Chemicals Legislation Finder (EUCLEF) provides a single point

of entry and aims at facilitating the access to information on various
pieces of EU legislation applicable to a given chemical substance
reducing costs and burden, in particular for SMEs.
Overview
The Commission requested ECHA at the end of 2016 to undertake a
feasibility study with a view to creating an ‘EU Chemicals Legislation
Finder’ (EUCLEF) to improve the business environment for EU
companies, and SMEs in particular, with regard to access to
information on legislations applicable to a given chemical substance.
The study concluded that it was feasible to build such a tool, proposed 55 pieces of EU legislation
within the scope as a first priority, and identified ECHA as the most suitable body to host the
tool. The first version of the tool went live in March 2020, covering 35 pieces of legislation in
addition to those under ECHA’s remit. EUCLEF is now part of ECHA’s database on information on
chemicals and it displays if a substance is subject to several pieces of EU legislation pursuing
different objectives: REACH, BPR, legislation on plant protection products, cosmetics, fertilisers,
drug precursors, explosives, detergents, worker protection, toy safety, etc. In 2021, EUCLEF will
be expanded with 16 additional pieces of legislation.

The current EUCLEF contribution agreement runs through the year 2021. Discussions on the
renewal of the contribution agreement will take place in 2020/2021.

Key objective

Improve transparency for the public and the business environment for EU companies and SMEs
in particular with regard to access to information on legislation applicable to a given substance.

Main actions and outputs of 2021 and 2022

47 Traffic to the EUON’s main site.

Programming Document(s) 2021-2024 70

• Launch version 1.2 of EUCLEF covering 16 additional pieces of legislation. [2021]

• Run the corresponding helpdesk. [2021, 2022]
• Run external review on whether EUCLEF meets its original objectives and suggest a way
forward. [2021]

Resources estimate 2021 estimate 2022

Financial resources (costs, EUR) TBD TBD

Human resources (FTE) 1 TBD

4.3 Support to occupational health legislation

Overview
ECHA contributes with its scientific expertise in hazard, exposure and
risk assessment to the establishment of occupational exposure limits
(OELs) for the implementation of the EU occupational safety and
health (OSH) legislation, namely the Carcinogens and Mutagens
Directive 2004/37/EC (CMD) and the Chemical Agents Directive
98/24/EC (CAD).
Key objective
ECHA produces fit for purpose opinions of high scientific, technical
and regulatory quality on OELs to the Commission.
Main actions and outputs of 2021 and 2022
• At the Commission’s request and based on a service level agreement, RAC issues
opinions, based on the preparatory work by the Secretariat, to underpin the Commission’s
possible proposals for occupational exposure limit (OEL) values. [2021, 2022]
• Process the two opinions on OELs received in the second request and initiate the process
for a further five opinions foreseen in the third request. [2021, 2022].

Indicators type estimate estimate

2021 2022
Number of OEL requests received under SLA output 3-5 3-5

Number of RAC opinions on OELs completed output 2 3-5

Resources estimate 2021 estimate 2022

Financial resources (costs, EUR) 120 000 per

opinion 48
Human resources (FTE) 4 49 447

48
According the service level agreement currently in place, subject to renewal in 2021.
49
As per the arrangements currently in place including secured advanced funding.
Programming Document(s) 2021-2024 71

4.4 Instrument for Pre-Accession Assistance

(IPA)

Overview
The Instrument for Pre-accession Assistance (IPA) is the means by
which the EU supports reforms to align the (pre-)candidate countries
with financial and technical help. Through the use of this instrument
ECHA support these countries to build up their capacities throughout
the accession process. Current beneficiaries are Albania, Bosnia and
Herzegovina, Kosovo 50, Montenegro, North Macedonia, Serbia, and
Turkey.
Key Objective
ECHA’s implementation of these pre-accession funds are a sound investment into the future of
both the (pre-)candidate countries as well as EU wide ambition in the context of safe
management of chemicals. Through the supportive efforts from ECHA the beneficiaries can make
necessary reforms towards a harmonization with REACH, CLP, BPR, PIC and POPs and build up
necessary capacity to enable an effective implementation of these regulations ahead of
accession. ECHA provides training and an inclusive approach to the beneficiaries preparing them
for the rights and obligations that come with EU membership. Subsequently, these adaptations
to national regulatory management of chemicals, provide their citizens and companies with
better information on safe use of chemicals by allowing for development of standards equal to
the ones we enjoy as citizens of the EU.
Main actions and outputs of 2021 and 2022
An in-depth study to assess their readiness and capacity to implement and enforce the EU acquis
for chemicals in Montenegro and Serbia has produced an action plan to address identified gaps
leading up to their accession. A similar study will be conducted in the remaining five beneficiaries.
These action plans are foreseen to guide ECHA support to (pre-)candidate countries under the
IPA framework in the years to come. The action plans are expected to enable a more tailored
support and also increase ownership among the beneficiaries for the gaps identified.
The two studies under IPA funds has significantly enhanced ECHA's organisational knowledge
with regards to challenges facing countries developing legal frameworks for chemicals and what
methodologies are relevant for capacity building in general.

Resources estimate 2021 estimate 2022

Financial resources (costs, EUR) 785 000 EUR – April 2019 to June 2022

Human resources (FTE) 1 1

50
This designation is without prejudice to positions in status, and is in line with UNSCR 1244/99 and the ICJ Opinion
on the Kosovo Declaration of Independence.
Programming Document(s) 2021-2024 72

4.5 Interaction with other legislation

Overview
ECHA aims to ensure that its information, knowledge and
competences are increasingly used to support the implementation
of other pieces of EU legislation and policy areas related to the safe
use of chemicals. This may comprise interaction, meaning for
example that ECHA has an advisory or support role and helps
authorities responsible for other legislation in identifying and
managing the risks of chemicals. It may also take the form of
integration, where ECHA is formally given a role in the
implementation of other legislation. This work aims to support the
Commission in the implementation of the ‘one substance - one assessment’ approach.
Key objective
ECHA actively promotes and supports the use of the REACH/CLP data and expertise under
other EU regulatory schemes. Similarly, ECHA aims at getting access and using efficiently the
data and/or expertise available from other EU regulatory frameworks.
Main actions and outputs of 2021 and 2022
ECHA continues to collaborate with the Commission and Member States and explore further
possibilities to mobilise its expertise in enabling efficient use of REACH/CLP information and
approaches in the implementation of other legislation, including:
• Sustaining active input to the review of the Best Available Techniques Reference
documents (BREF) under the Industrial Emissions Directive [2021, 2022]
• Continue supporting the Commission services in implementing the chemicals related parts
of the ecolabel and eco-design schemes. [2021, 2022]
• Contribute to EFSA’s work to re-evaluate the risks related to plasticisers used in food
contact materials, in particular, by identifying, grouping and prioritising substances for
further work. [2021]

Resources estimate 2021 estimate 2022

Financial resources (costs, EUR) tbc

Human resources (FTE) 3 3

4.6 IUCLID for EFSA

Overview
Following the confirmation that IUCLID may meet the needs of EFSA
for implementing its regulatory tasks for plant protection products,
EFSA and ECHA are collaborating under a service level agreement
to enable the use of IUCLID for the purpose of the new transparency
provisions under EFSA’s revised founding Regulation (EU)
2019/1381. The required resource needs for an initial pilot have
been provided by EFSA to ECHA. The continued collaboration of both
agencies under a new and long term Service Level Agreement will
decide on the target architecture and service level of the IT solution
that will support the regular use of IUCLID for plant protection products and potentially other
food regulated products covered by the same transparency provisions.
Programming Document(s) 2021-2024 73

Key objective
Roll-out the use of IUCLID for the handling of active substance applications and product
authorisations for plant protection products. Assessing its potential extension to other cases.
Main actions and outputs of 2021 and 2022
• Agree on the follow-up of the pilot on IUCLID for plant protection products. [2021]
• Assess applicability of IUCLID to other food regulated products [2021, 2022].
• Support EFSA in defining the target IT architecture and level of support required by EFSA
to perform its regulatory work. Estimate resources and compensation mechanisms.
Establish and start the execution of a new Service Level Agreement for implementation
and regular service accordingly [2021, 2022].

Resources estimate 2021 estimate 2022

Financial resources (costs, EUR) 771 836

Human resources (FTE) 4 4

Programming Document(s) 2021-2024 74

5. Governance and enablers

5.1 Support to Forum

Overview
The Forum for Exchange of Information on Enforcement (Forum) is a
formal network of Member State authorities responsible for the
enforcement of REACH, CLP, BPR, PIC and POPs, with the aim of
harmonising enforcement of the legislation in the EU.
Tasks
The Forum and its subgroup on biocides (BPRS) hold three plenary
meetings per year, including an open session to liaise with accredited
stakeholder organisations. The Forum and the BPRS discuss and aim at
finding harmonised solutions to practical challenges faced by inspectors while enforcing. Many
process specific projects and support of the Forum and the BPRS to ECHA’s operational activities
are covered under Sections 1-3 of this work programme, while this section covers Forum’s
horizontal activities that address several legislations or processes.
The ECHA Secretariat provides technical, scientific and administrative support for the Forum. It
supports and facilitates the work of the Forum with a view to promote harmonised enforcement
of REACH, CLP, BPR, PIC and POPs efficiently and effectively. The support covers as well the
Biocidal Products Regulation Subgroup (BPRS).
Outcome and impact
Harmonised enforcement by Member States promotes an equal level playing field for economic
operators in the EU covering as well imported substances and articles. It ensures that the
actual use of substances and products complies with the legal obligations and is thereby safe
for professional users and consumers, and do not harm the environment. Shortcomings
identified by enforcement can be used to trigger additional regulatory actions. Harmonised
enforcement also supports innovation and competitiveness amongst operators that can rely on
functioning regulatory mechanisms.
Main actions and outputs of 2021 and 2022
• Continue preparing, executing and reporting on Forum-coordinated REACH enforcement
projects 51 described in other sections of this document. In particular select the subject of
eleventh Forum-coordinated REACH enforcement project (REF-11). [2021]
• Prepare the report of the eighth Forum-coordinated REACH enforcement project (REF-8)
focusing on internet sales of chemicals and a guide for enforcement based on the
experience gathered in that project. [2021, 2022]
• Prepare the manual for the tenth Forum-coordinated REACH enforcement project (REF-
10), on REACH and POP restrictions on hazardous substances in various mixtures and
articles, and support inspectors during implementation phase. [2021, 2022]
• Continue establishing best practice in enforcement and testing enforcement approaches
by running Forum pilot projects. [2021, 2022]
• Preparing the pilot project on classification of mixtures including detergents and cleaning
products. [2022]
• Continue to examine enforcement proposals and deliver advice on enforceability of
restrictions. [2021, 2022]

51
REACH-EN-FORCE (REF) are designed to harmonise enforcement in each Member State and check the current level
of compliance with regard to particular obligations imposed on industry by the REACH, CLP and PIC regulations. The
REF projects are carried out by inspectors based in the national authorities in the participating Member States. The
resulting information is collected by ECHA and the Forum Working Group. A final report on the findings of the REF
project is then produced.
Programming Document(s) 2021-2024 75

• Continue to ensure efficient and timely enforcement of ECHA decisions, such as non-
compliance with ECHA’s dossier evaluation decisions. Make best use of data and expertise
to maintain interlinks between ECHA regulatory processes and national enforcement.
[2021, 2022]
• Continue to support enforcement authorities by developing and delivering training
programmes for national trainers and inspectors. [2021 (BPR only), 2022]
• Continue to support enforcement by the national enforcement authorities via
improvement and thereafter maintenance of the IT tools available to inspectors (modules
of ECHA Interact Portal for National Enforcement Authorities). [2021, 2022]
• Prepare a guide for enforcement focusing on imported substances and articles in
cooperation with customs authorities. [2021]
• Start with the volunteering Member States the implementation phase of the annual
reporting of national enforcement activities to ECHA. [2022] [REACH Review Action 13]

Indicator type estimate estimate

2021 2022
Number of enforcement trainers trained by the Forum output 25 52 55/80 53

Resources estimate 2021 estimate 2022

Financial resources (costs, EUR) 1 597 708 1 527 104

Human resources (FTE) 54 7 7

5.2 Board of Appeal

Overview
The Board of Appeal ensures an independent review of certain ECHA
decisions that are challenged. The Board of Appeal is composed of
members appointed by the Management Board and is supported by a
Registry, which, like the Board of Appeal itself, acts entirely
independently from the Secretariat.
The Board of Appeal decides on appeals against certain decisions that
the Agency adopts under REACH and BPR.
Outcome and impact
The decisions of an independent appellate body strengthen the regulatory system of chemicals
management and stakeholders’ trust in it. The Board of Appeal is a first layer of jurisdiction and
helps to reduce the number of cases that are brought before the Court of Justice of the European
Union. The decisions of the Board of Appeal are decisions of the Agency. They develop further
the interpretation of REACH and BPR, ensure that the objectives of the legislation are met, that
the Agency observes procedures provided therein, and that the rights of registrants and
interested parties are effectively safeguarded.

52
25 is the estimate of BPR trainers; only BPR training will be delivered in 2021.
53
55 is the estimate for REACH and CLP trainers and 80 the estimate for REACH, CLP and BPR trainers subject to
budget availability.
54
Biocides resources are not included in this estimate but under the Biocide Activity in section 1.3 of the Work
Programme.
Programming Document(s) 2021-2024 76

Main actions and outputs of 2021 and 2022

• Process and decide on appeals following decisions of the Agency related in particular to
dossier evaluation and substance evaluation, as well as decisions adopted under the BPR.
[2021, 2022]
• Adopt procedural decisions in appeal cases, as needed. [2021, 2022]
• Publish a robust body of high-quality decisions online, thereby facilitating proper
implementation of REACH and BPR, and strengthening the trust of different ECHA
stakeholders in that regard. [2021, 2022]
• Provide clear, accurate and timely communication to the parties in appeal proceedings
and to the interested public in relation to appeal process. [2021, 2022]
Resources estimate 2021 estimate 2022

Financial resources (costs, EUR) 1 968 818 2 003 706

Human resources (FTE) 12 12

5.3 Management

Overview
ECHA is governed by European public law and equipped with own legal
personality. The governance structure features close ties between the
Management Board and the executive management, with a clear
division of the respective roles and responsibilities.
ECHA’s organisational structure follows the main scientific and
administrative competences and comprises six directorates.
The Agency applies the EU Staff and Financial Regulations, the European
Commission’s Internal Control Framework and the EU's frameworks for planning and reporting,
internal audit, data protection and good administration. These frameworks are integrated with
the Agency’s activity and process-based ISO:9001 and ISO:14001 certifications to form an
Integrated Management System (IMS), as an overall framework for performance-based
governance, stakeholder engagement, sustainability and continuous improvement. ECHA’s
Integrated Management System strategy is presented in Annex X.
Tasks
The Management Board is the highest decision-making body and provides governance and
strategic steer to enable the Agency to deliver its mission and vision. It has a supervisory role
with general responsibility for budgetary, planning and reporting matters, appoints the Executive
Director, members of the Board of Appeal and the accounting officer.
The Executive Director is in charge of the day to day management and ECHA’s legal
representative. The Executive Director heads the secretariat, composed of the Agency’s staff
and committee chairs, manages the day to day administration, and implements the decisions of
the Management Board.
External and internal communication activities address the needs of the key stakeholder groups.
ECHA identifies and proactively addresses topics with a propensity to attract public attention,
enhance its relations with influencers, including employee advocacy, and increasingly makes use
of social media.
International cooperation activities are carried upon request of or on the basis of separate
agreements with the Commission services and in line with the framework established for EU
agencies. Details are set out in ECHA’s strategy for cooperation with third countries and/or
Programming Document(s) 2021-2024 77

international organisations (Annex XII).

The Secretariat is prepared to defend itself in legal proceedings and is capable of providing legal
advice to its operations and on issues relating to financial interests, human resources,
procurement, intellectual property and access to documents. Complaints are analysed from the
legal perspective.
Outcome and impact
ECHA’s governance approach ensures that the management of the agency is in a position to lead
the organisation in an agile way, enabling the competences of staff to be used in the best suitable
way. Furthermore, the governance approach also safeguards that the Agency complies with
applicable rules and provisions.
The governance includes performance-based planning and implementation of activities, flexible
allocation of resources, risk management, communication and stakeholder engagement, and
provides an assurance of the conformity and quality of outputs. It ensures that effective policies,
for example related to transparency and prevention of conflict of interest are in place.
By continuously developing and adapting ECHA’s Integrated Management System, the Agency
is able to respond to its developing environment, institutional expectations and identified risks,
and to allocate resources flexibly when implementing of its dynamically evolving legal mandate.
This ensures that public funds and fees are used in accordance with the principles of sound
financial management, that synergies are lifted, and that the reputation of the Agency and its
organisational development are facilitated.
By providing effective support to the Management Board and transparently reporting on
performance, the Executive Director enables the Board to fulfil its supervisory and steering
function, to ensure that ECHA’s work is aligned with its mandate and coherent with EU priorities.
ECHA’s organisation structure in turn aims at supporting staff development, to apply
competences flexibly across regulatory processes, efficient and flexible way of working and the
readiness for integrating new regulatory tasks in support of implementing EU legislation.
Proactive engagement with its institutional partners allows ECHA to understand and take into
account their perspectives. Proactive, timely and tailored communication to all stakeholders,
including the general public, helps to build and maintain public trust in science-based decision
making. The Agency actively works with other EU agencies to seek synergies and exchange best
practices in order to increase the overall performance and value added of the EU’s
administration. This concerns foremost EU agencies working in the same policy field 55 and more
broadly the Network of EU agencies.
By applying the highest standards of transparency and proactively engaging with accredited
stakeholders, the Agency makes sure that their views are heard and taken into account.
With its international activities the Agency supports the implementation of EU objectives related
to global chemicals management and creates efficiencies for authorities and industry via
promotion of harmonised tools and methodologies for the assessment of chemicals.
Main actions and outputs of 2021 and 2022
• Complete the follow-up of the actions and recommendations relevant to the Agency
arising from the Commission’s 2018 REACH Review evaluation that remained open.
[2021]
• Support the Management Board in performing its duties, through the preparation of
plenary and working group meetings and the administration of all relevant procedures.
[2021, 2022]
• Prepare and coordinate the activities of the senior management team, including
management strategies, decisions, delegations and policies. [2021, 2022]

55
European Food Safety Authority (EFSA), European Environment Agency (EEA), European Centre for Disease
Prevention and Control (ECDC), European Medicines Agency (EMA).
Programming Document(s) 2021-2024 78

• Support strategic alignment with Member States’ priorities on policies relevant to ECHA’s
mandate. [2021, 2022]
• Develop the Agency’s relationship with institutional (policy) stakeholders of the European
Parliament and the Commission. [2021, 2022]
• Seek synergies and align, where appropriate, on strategic and/or work programme level
with peer agencies working in the area of health and environmental protection. [2021,
2022]
• Steer relationships with peer agencies on strategic matters, including active participation
and leadership of the EU Agencies’ Network. [2021, 2022]
• Coordinate the Agency’s international activities. [2021, 2022]
• Continue to develop and implement ECHA's change management agenda following the
organisational review process, to continue adapting and improving ECHA's performance.
Streamline ECHA's integrated management and internal control systems to support ECHA
operations while successfully maintaining relevant ISO standards [2021, 2022]
• Complete a mid-term review of the Strategic Plan 2019-2023 to take account of ECHA’s
current operating environment and new EU strategies taking into account stakeholder
perceptions. [2021]
• Review external communication channels for better targeted communication and activate
inter-institutional collaboration to maximise outreach. Revamp ECHA websites to take
into account the various needs of different stakeholder groups. [2021, 2022]
• Manage the Agency’s reputation by: gathering feedback on the Agency’s performance,
including on new activities, from stakeholders through surveys and by daily media and
social media monitoring; and acting on the feedback received. [2021, 2022]
• Maintain sound managerial overview of the various implemented regulations and
delegated tasks, to achieve maximum integration, synergy of shared services and
transparency of performance. Support activities initiated under Strategic Priority 3
ensuring recognition of ECHA’s competences, knowledge and expert advice, as well as
data held to support the efficient on-boarding and implementation of other pieces of
legislation and policy areas related to the safe use of chemicals. [2021, 2022]
• Perform audits and evaluations in line with the annual audit plan, and act on the feedback
generated. [2021, 2022]
• Complete preparation for ECHA’s five-year report on the operation of the REACH
Regulation under Article 117(2) as input to the Commission’s five-year general report.
[2021]
• Follow-up and bring to maintenance mode ECHA’s relations with the UK as a third country
after its withdrawal from the EU. [2021, 2022]
• Review and refine in Q1/2021 in consistency with establishing a new monitoring and
reporting framework under the 8th EAP (see section 3.5 above) performance indicators
for chemicals with a view of measuring effectiveness, efficiency and impact for priorities
and activities allowing for a quantitative and qualitative assessment. [2021]
Programming Document(s) 2021-2024 79

Indicators type estimate estimate

2021 2022
Areas where audits and evaluations results (including intermediate 4
prevention of conflicts of interest and fraud) have been impact
taken into account in future strategic decisions
Combined neutral and positive feedback monitored in outcome >90 % >90 %
media publications
outcome 4.0 M 4.1 M
Website unique visitors/traffic to the web content

Resources estimate 2021 estimate 2022

Financial resources (costs, EUR) 5 662 784 5 671 297

Human resources (FTE) 31 34

5.4 ICT

Overview
ECHA's ICT services enable the efficient execution of the Agency's
operational activities and are integral part of the implementation of
ECHA's strategy.
The ICT activity provides and manages the ICT services for the Agency
and for external users, in industry, in national authorities, and general
public.
The needed functionalities are delivered with high availability,
performance and security.
Tasks
This activity includes horizontal tasks that serve all of ECHA’s ICT landscape, such as ICT
governance, process analysis and design, procurement, delivery, management of ICT tools and
management of ICT assets.
The IT governance, as part of ECHA governance, ensures that ICT services are aligned with
ECHA priorities and enable ECHA's activities. The design and continuous improvement of ECHA's
operational processes from an IT perspective plays a key role in delivering efficiencies in ECHA's
activities.
The ICT activity also ensures an optimised use of ECHA's own ICT's resources. According to
ECHA's ICT governance model, applications are assessed for architectural, business continuity
and security requirements, while fulfilling the identified user needs.
A key resource managed by this activity are the outsourcing contracts used for the delivery of
services.
The ICT activity includes the delivery of the core tools of ECHA's digital workplace, personal
equipment, applications and tools to manage internal administration, regulatory workflows and
collaboration / interaction with external stakeholders.
This activity also includes less visible enabler modules and services, such as the integrated
access management services, that serve multiple administrative and scientific IT applications.
Outcome and impact
The activity ensures that the IT services of the Agency are operated at an appropriate level of
user satisfaction, continuity and security in the most cost-efficient way.
Programming Document(s) 2021-2024 80

It ensures that staff are able to operate with highest availability and efficiency, including while
teleworking, and that external stakeholders can collaborate with ECHA in fit-for-purpose, reliable
and efficient manner.
With the increase in number of contracted partners, a growing area of focus is maintaining
coherence and coordination across contractors to optimise the overall delivery. The overall level
of outsourcing is continuously monitored and balanced according to industry best practices.
Main actions and outputs of 2021 and 2022
• Plan and prepare the establishment of replacement framework contracts for HR
management system as well as for REACH-IT, ECOMOD, IUCLID, SPC Editor, R4BP, ePIC,
ECHA Cloud Services, IDM, Data Management Platform, Scientific Data Analysis Platform,
Text Analytics, Printing Services and others. An important focus is to ensure continuity in
operations in the most cost-effective manner[2021]
• Continue to evolve the workplace service to ensure an appropriate service for ECHA staff,
adjusting to the demands of a more mobile workforce, triggered by COVID-19 situation.
[2021, 2022]
• Complete the overhaul of the Identity and Access Management solution in order to
prepare for the continued expansion of ECHA’s user base. [2021]
• Managing and maintaining IT security on ECHA infrastructure, systems and data while
worldwide IT threats are continuously increasing, becoming more sophisticated and are
more difficult to remediate. Ensuring appropriate security is in place for an increasingly
mobile workforce. [2021, 2022]
• Updating the approach to IT business continuity service to the needs of ECHA, addressing
the changes in ICT infrastructure and increased use of cloud services. [2021]
• Implement the targets agreed in Enterprise Architecture 2020-2023 and IT Master Plan.
[2021]
• Prepare the roadmap for the future of the ICT infrastructure services, including an
analysis of the use of public cloud as an approach to be more cost efficient. [2021, 2022]
• Ensure that services can continue to be run at the required level of quality, in an efficient
and cost-effective manner, by continuously investing in evolving the tools and practices.
[2021, 2022] [REACH Review Action 15]
Resources estimate 2021 estimate 2022

Financial resources (costs, EUR) 8 244 302 8 807 938

Human resources (FTE) 53 54

5.5 Financial resources

Overview
ECHA’s total expenditure budget amounts to over € 100 million and is
financed through fee income and EU contribution. The Secretariat
manages the budget in line with the principles of economy, efficiency
and effectiveness.
Tasks
The financial resources management covers the financial programming,
income modelling, monitoring and reporting, implementation of the
budget in line with the Financial Regulation, including procurement operations, as well as the
accounting and treasury operations.
Programming Document(s) 2021-2024 81

Outcome and impact

The Agency has sufficient resources at its disposal, taking into account the resource constraints
and the funds are allocated efficiently contributing to the achievement of the objectives set in
the Programming Document.
Main actions and outputs of 2021 and 2022
• Prepare the Agency’s budget and manage its implementation, including budget
amendments and transfers, revenue collection and cash management, procurement and
contracting, financial accounting and reporting. [2021, 2022]
• Continue regular exchange with Commission partner services, including reporting on
actual budget implementation, communicating revenue and expenditure estimates for
the future and discussing ways of handling any shortfall or surplus during the budget
year. [2021, 2022]
• Examine, with the European Commission, alternative options for ensuring sustainable
financial model for ECHA in particular with a view to the Multiannual Financial Framework
of the EU (2021-2027). [2021, 2022] [REACH Review Action 15(1)]
• Monitor and report on transfer of fees to Member States and prepare updates to the
related Management Board rules. [2021, 2022]
• Implement further efficiency measures, including automation and financial process re-
engineering as part of the financial management information system development.
[2021, 2022]
• Working with the Commission, and based on the available data since 2007, conduct a
thorough analysis on the correlation between the fees and charges paid registrants and
the workload of the Agency per regulatory activity and propose scenarios of adjustments
to the current fees and charges systems to the Commission in Q1/2021. [2021]

Indicators type estimate estimate

2021 2022
Level of budget implementation: commitment rate and performance min. 95 % min. 95 %
cancelled carry-over rate and max. and max.
5% 5%
respectively respectively
Processing of payments within legal deadlines performance no less than no less than
99% 99%

Resources estimate 2021 estimate 2022

Financial resources (costs, EUR) 2 435 120 2 797 451

Human resources (FTE) 16 17

Programming Document(s) 2021-2024 82

5.6 Human resources

Overview

The Secretariat manages ECHA's human resources effectively, efficiently

and in compliance with applicable EU rules and good management
practice. It implements the human resources strategy, established in
2019, as an enabler for the achievement of ECHA’s strategic priorities
and objectives by ensuring a work environment that facilitates a culture
of high performance and flexibility while, simultaneously, recognising the
framework within which ECHA operates.

Tasks

The human resource activity covers Agency’s staff planning and reporting on an organisational
basis, including implementation of ECHA’s selection and recruitment plans and the engagement
of seconded national experts, trainees and interim placements. It also includes the development
and implementation of Implementing Rules and policies, in line with the Staff Regulations and
taking account of ECHA’s specific circumstances.

Furthermore, this area includes: the management of personnel and payroll administration, in
line with applicable rules and regulations; the management of staff welfare and well-being
actions including matters related to individual well-being, (European) schooling matters and the
integration of staff with Helsinki City; the management of performance appraisal, reclassification
and related HR exercises to ensure that organisational objectives are met and that staff receive
accurate feedback and recognition on their performance; and the management of ECHA’s
learning and development function.

Outcome and impact

Maintaining and developing staff competences ensures that the Agency can implement its
regulatory tasks within a forward-looking, knowledge-based organisation. Sustainable human
resource management facilitates knowledge transfer and adaptation to changing requirements
maintains the enabling base for implementing the legislation under ECHA’s remit.

Main actions and outputs of 2021 and 2022

• Implement ECHA’s human resources strategy to continue to ensure high-quality services

to staff and optimal use of its human resources. [2021, 2022]
• Provide relevant competence development activities to ensure continuous capacity-
building of staff and support more flexible deployment of staff. [2021, 2022]
• Ensure efficient allocation of resources by providing sufficient staffing to the identified
priority areas. [2021, 2022]
• Support the Agency staff in adapting to the new ways of working. [2021]
• Conduct the job screening exercise as part of a wider inter-Agency benchmarking exercise
initiated by the Commission. [2021, 2022]
• Maintain positive relations and dialogue with ECHA’s Staff Committee, the European
School of Helsinki and other key stakeholders. [2021, 2022]
• Conduct necessary management development actions to ensure a high level of people
management by ECHA and to maintain a healthy working culture throughout the Agency.
[2021, 2022]
• Implement the agreed action plan to advance gender balance in ECHA’s management
team and at organisational level. [2021, 2022]
Programming Document(s) 2021-2024 83

• Implement, in close consultation with senior management, the agreed approach to

decrease the number of interims engaged by the Agency [2021, 2022]
Indicator type estimate estimate
2021 2022

Percentage of Establishment Plan posts filled performance 95% 95%

Turnover of Temporary Agents performance <5% <5%

Turnover of Contract Agents performance <10% <10%

Resources estimate 2021 estimate 2022

Financial resources (costs, EUR) 3 145 911 3 527 091

Human resources (FTE) 20 21

5.7 Corporate services

Overview
Corporate services unit manages ECHA’s building and related facilities
and services. They provide secure and healthy office premises and
adequate facilities for the staff and external visitors and maintain
effective internal and external communication.
Tasks
The activity covers coordination of ECHA’s physical security and business
continuity. It involves providing both physical and virtual
events/meetings with logistical, audio-visual and secretarial support, implementing ECHA’s
environmental management system aspects, providing travel management services, the
purchase and maintenance of office furniture and supplies and the coordination of postal and
courier services and in addition, Corporate Services is responsible for translation and library
services.
Outcome and impact
Corporate services provide the infrastructure and services to facilitate all scientific-technical work
and decision-making at ECHA and ensure smooth cooperation with the Member States
Competent Authorities, Committee members, experts from international organisations and
stakeholders. The implementation of ECHA’s environmental management systems prepares for
the carbon neutrality era of the Agency.
Key objective
Main actions and outputs of 2021 and 2022
• Ensure operations under the responsibility of Corporate Services continue to run smoothly
following the transition to the new premises and investigate alternative modes of service
delivery, while striving to reduce building and other service-related costs and
environmental impact. [2021, 2022].
• Implement further efficiency measures and improvements in services delivery models
following the move to the new building. [2021, 2022].
• Monitoring the settling-in phase in the new building. [2021]
• Developing and implementing approaches to new ways of working and related
infrastructure and service needs. [2021]
Programming Document(s) 2021-2024 84

• Implement environmental aspects of ECHA’s integrated management system. [2021]

Resources estimate 2021 estimate 2022

Financial resources (costs, EUR) 2 679 223 3 024 270

Human resources (FTE) 17 18

Programming Document(s) 2021-2024 85

Annexes
Annex I: Organisation
A. Organisation chart of the Agency
B. Overview of regulatory tasks of the Agency
C. Process map of ECHA’s activities
Annex II: Resource allocation per activity
Annex III: Financial Resources (Tables)
Table 1: Revenue
Table 2: Expenditure
Table 3: Budget outturn and cancellation of appropriations
Annex IV: Human resources - quantitative
Table 1: Staff population and its evolution; Overview of all categories of staff
Table 2: Multiannual staff policy plan N+1 – N+3
Table 3: Recruitment forecasts N+1 following retirement/mobility or new requested
posts
Annex V: Human resources - qualitative
A. Recruitment policy
B. Appraisal of performance and reclassification/promotions
Table 1: Reclassification of temporary staff/promotion of officials
Table 2: Reclassification of contract staff
C. Gender representation
Table 1: Data on 31/12/Year N-1
Table 2: Data regarding gender evolution over 5 years of the Middle and Senior
management
D. Geographical balance
Table 1: Data on 31/12/Year N-1
Table 2: Evolution over 5 years of the most represented nationality in the
Agency
E. Schooling
Annex VI: Environment management
Annex VII: Building policy
Annex VIII: Privileges and immunities
Annex IX: Evaluations and audits 2021
Annex X: ECHA Integrated Management System and Framework
Annex XI: Plan for grant, contribution or service-level agreements
Annex XII: Strategy for cooperation with third countries and/or international
organisations
Annex XIII: Performance indicators
Programming Document(s) 2021-2024 86

Annex I: A. Organisation chart of the Agency

 Programming Document(s) 2021-2024 87

Annex I: B. Overview of regulatory tasks of the Agency

Legal act Date of legal act Mission/Tasks/Functions Remarks

18/12/2006
Regulation (EC) No 1907/2006 Manage and carry out technical, scientific and The Agency, established on 1 June 2007, will
concerning the Registration, administrative aspects of REACH and CLP manage the registration, evaluation,
Evaluation, Authorisation and Regulations authorisation and restriction processes for
Restriction of Chemicals (REACH), chemical substances as well the classification and
The REACH and CLP processes are designed to
establishing a European Chemicals labelling of substances and mixtures to ensure
ensure a high level of protection of human
Agency, amending Directive consistency across the European Union. These
health and the environment, including the
1999/45/EC and repealing Council REACH processes are designed to provide
promotion of alternative methods for
Regulation (EEC) No 793/93 and additional information on chemicals, to ensure
assessment of hazards of substances, as well as
Commission Regulation (EC) their safe use, and to ensure competitiveness of
the free circulation of substances on the internal
No 1488/94 as well as Council the European industry.
market while enhancing competitiveness and
Directive 76/769/EEC and Commission
innovation In its decision-making, the Agency will take the
Directives 91/155/EEC, 93/67/EEC,
best available scientific and technical data and
93/105/EC and 2000/21/EC Provide the Member States and the institutions
socio-economic information into account. It will
of the Union with the best possible scientific and
also provide information on chemicals and
technical advice on questions relating to
technical and scientific advice.
Regulation (EC) No 1272/2008 of 16 16/12/2008 chemicals which fall under REACH or CLP
December 2008 on classification,
Manage IT based guidance documents, tools
labelling and packaging of substances
and data bases
and mixtures, amending and repealing
Directives 67/548/EEC and Support national helpdesk and run a helpdesk
1999/45/EC, and amending Regulation for registrants
(EC) No 1907/2006 (CLP)
Make information on chemicals publicly
accessible
Develop a poison centre notification portal

Regulation (EU) No 528/2012 of the 22/05/2012 Manage and carry out technical, scientific, and Under the Biocidal Products Regulation, adopted
European Parliament and the Council administrative aspects of the Biocidal Products in 2012, ECHA is responsible for specific tasks
of 22 May 2012 concerning the making Regulation with regard to applications for active substance
available on the market and use of approval and Union authorisation and other
The purpose of the Biocides Regulation is to
biocidal products (BPR) related tasks such as data sharing inquiries. The
improve the functioning of the internal market
Biocidal products Committee has been
through the harmonisation of the rules on the
established within the Agency to provide opinions
placing on the market and use of biocidal
to the Commission on scientific and technical
products, whilst ensuring a high level of
 Programming Document(s) 2021-2024 88

protection of both human and animal health and matters relating to applications under the
the environment. The provisions of the Regulation.
Regulation are underpinned by the
precautionary principle, the aim of which is to
safeguard the health of humans, animals and
the environment.
Establish and maintain the Register for Biocidal
Products
Coordinate and manage the processing and
evaluation of the applications covered by the
Regulation (including active substance approval,
Union authorisation, data sharing, technical
equivalence, alternative suppliers)
Provide guidance, support national helpdesks
and assist and advise application (thought the
ECHA Helpdesk)
Make information on biocides publicly
accessible.

Regulation (EU) No 649/2012 of the 04/07/2012 Manage and carry out technical, scientific, and The recast PIC Regulation, adopted in 2012,
European Parliament and of the administrative aspects related to export and further adds to the remit of the Agency, and
Council of 4 July 2012 concerning the import of dangerous chemicals under the PIC complements it with scientific, technical, and
export and import of hazardous Regulation administrative tasks related to export and import
chemicals (PIC) of dangerous chemicals.
The objectives of the PIC Regulation are to
implement the Rotterdam Convention on the
Prior Informed Consent Procedure for Certain
Hazardous Chemicals and Pesticides in
International Trade, and to promote shared
responsibility and cooperative efforts in the
international movement of hazardous chemicals
in order to protect human health and the
environment from potential harm. Through its
provisions it contributes to the environmentally
sound use of hazardous chemicals.
Manage the tasks related to and the cooperation
with Member States on export notifications and
explicit import consents
 Programming Document(s) 2021-2024 89

Manage guidance documents and IT tools

Make information publicly available

Regulation (EU) 2019/1021 on 20/06/2019 Support the Commission and the Member States The proposed recast of the POPs-Regulation also
persistent organic pollutants (POPs) in fulfilling their obligations under the recast adds to the remit of the Agency, and
POPs – Regulation – proposal. complements it with scientific, technical, and
administrative tasks related to persistent organic
The objective of the POPs-Regulation is to
pollutants.
implement international obligations of the Union
and the Member States for eliminating
Persistent Organic Pollutants in order to protect
human health and the environment from these
substances. Through its provisions the
Regulation ensures the elimination of hazardous
chemicals or, in exceptional cases, their
environmentally sound use.
Carry out certain technical, scientific, and
administrative tasks allocated in the proposal to
ECHA related to the identification of new POPs,
enforcement and reporting on the
implementation of the Regulation.
Make information on POPs publicly available.

Directive (EU) 2020/2184 on the 16/12/2020 Preparing the first EU positive lists of
quality of water intended for human substances and preparing the necessary
consumption methods and tools as well as setting up the
procedure for the operational phase starting in
2025.
Programming Document(s) 2021-2024 90

Annex I: C. Process map of ECHA’s activities

Programming Document(s) 2021-2024 91

Annex II: Resource allocation per activity

2020
2021 planned FTEs 2021 Draft
WP activity planned FTEs
2020 Budget (TA/CA/SNE)* Budget
(TA/CA/SNE)
Total TA CA/SNE Total
1. REACH and CLP
1.1 Dossier preparation 26 7,622,369 17 8 25 7,474,686
1.2 Registration and dossier
35 7,830,956 18 16 34 7,408,415
submission
1.3 Screening and prioritisation 45 7,469,550 53 5 58 9,501,822
1.4 Evaluation 116 20,052,238 93 17 110 18,628,642
1.5 Authorisation 40 7,434,946 27 5 32 6,191,114
1.6 Restrictions 24 4,853,034 29 5 34 6,512,245
1.7 Classification and labelling 30 7,081,080 21 6 27 6,437,623
1.8 Safe and sustainable use of
13 2,088,324 5 3 8 1,568,075
chemicals
1.9 Data management and
20 6,778,472 18 5 23 7,081,602
dissemination
Governance and enablers 152 27,809,828 94 41 135 22,622,003
TOTAL 501 99,020,798 375 111 486 93,426,227
in EP 404 107 511
2. Biocides
Operations 55 8,842,517 42 11 53 9,441,105
Governance and enablers 21 3,118,866 12 6 18 2,606,819
TOTAL 76 11,961,383 54 17 71 12,047,924
in EP 52 17 69
3. Export/import of hazardous
chemicals and circular economy

3.1 Prior Informed Consent 9 714,084 4 3 7 993,815

3.2 Persistent organic pollutants 1 168,322 1 0 1 201,732
3.3 Waste Framework Directive 8 1,813,626 2 5 7 2,108,161
3.4 Drinking water directive 0 4 0 4 1,476,348
3.5 8th Environmental Action
Programme (subject to approval by 1 1 2 322,000
the Parliament)
Governance and enablers 3 360,967 3 2 5 505,044
TOTAL 21 3,057,000 15 11 26 5,607,100
in EP 11 13 24
4. Other tasks
4.1 EU Observatory for
3 892,000 3 0 3 TBC
Nanomaterials
4.2 EU Chemicals Legislation Finder 1 1,199,000 1 0 1 TBC
4.3 Support to Occupational health
4 240,000 4 0 4 TBC
legislation
4.4 Instrument for Pre-Accession
Assistance (IPA)***
4.5 Support to other legislation 6 2 1 3
4.6 IUCLID as a service for EFSA 3 2 2 4 771,836
TOTAL 17 2,331,000 12 3 15 771,836
in EP 12 12
Overall TOTAL 615 116,370,181 456 142 598 111,853,087

in EP 467 149 616

Programming Document(s) 2021-2024 92

2021 2022

Governance
and enablers,
PIC/POP/
planned FTEs PIC/POPs/Waste/
REACH Biocides Budget REACH Biocides WFD/DWD Budget
DWD/8EAP
/8EAP

CA/ CA/ CA/

TA Total TA Total TA Total Total Total Total
SNE SNE SNE

5.1 Support to
5.3 1.8 7.0 1.4 0.5 1.9 0.1 0.0 0.1 1 597 708 7.0 1.9 0.0 1 527 104
Forum

5.2 Board of
8.1 2.9 11.0 0.6 0.1 0.7 0.2 0.0 0.2 1 968 818 11.0 1.0 0.0 2 003 706
Appeal

5.3
23.2 3.1 26.3 2.5 0.9 3.4 0.7 0.7 1.4 5 662 784 30.0 3.0 0.8 5 671 297
Management

5.4 ICT 29.0 16.4 45.4 3.7 2.2 5.9 1.0 0.6 1.6 8 244 302 47.0 5.5 1.0 8 807 938

5.5 Financial
10.4 3.0 13.4 1.3 0.4 1.7 0.3 0.2 0.5 2 435 120 15.0 1.6 0.4 2 797 451
Resources

5.6 Human
11.1 6.1 17.2 1.5 0.9 2.4 0.4 0.2 0.6 3 145 911 19.0 2.0 0.4 3 527 091
Resources

5.7 Corporate
7.0 7.7 14.7 0.9 1.0 2.0 0.3 0.3 0.6 2 679 223 16.0 2.0 0.4 3 024 270
services

TOTAL 94.0 41.0 135.0 12.0 6.0 18.0 3.0 2.0 5.0 25 733 867 145.0 17.0 3.0 27 358 856

TOTAL posts planned =

For 2021: 616 posts in establishment plan - REACH/CLP (511 posts), Biocides (69 posts),
PIC/POP/Waste/DWD/8EAP (24 posts), Other tasks (12 posts). The planned posts include the TAs, CAs,
SNEs.
For 2022: 616 posts in establishment plan- REACH/CLP (511 posts), Biocides (69 posts),
PIC/POP/Waste/DWD/8EAP (24 posts), Other tasks (12 posts).

* The planned FTEs per WP activity takes account of the known or estimated long-term leaves (for
example, maternity leave and parental leave) as replacements are limited due to reductions in the
interims budget.

In order to achieve efficiencies between ECHA’s legislative mandate under the five EU Regulations and
the one EU Directive within its mandate, as well as additional tasks carried out on behalf of the
Commission under various cooperation agreements (for example, grants, SLAs and contribution
agreements), the Agency applies a FTE-based accounting approach, utilising a time tracking system to
enable the correct reporting of the time spent on the various tasks. This also ensures that those staff
members with the best expertise in a given topic work on these tasks. Finally, the tasks that ECHA
carries out on behalf of the Commission under such cooperation agreements are not part of the
establishment plan of the Agency.

** The budget allocation per activity for the years 2022-2024, has been made based on the high-level
estimates for the years, and the operational expenditure has been assumed to follow the same
distribution as in the Draft Budget 2021.

*** Resources planned for Instrument for Pre-Accession Assistance (IPA), section 4.4., are accounted for
under Governance and enablers.
 Programming Document(s) 2021-2024 93

planned Budget planned Budget planned Budget

WP activity
FTEs for forecast FTEs for forecast FTEs for forecast
2022* 2022** 2023* 2023** 2024* 2024**

1. REACH and CLP

1.1 Dossier preparation 25 7,565,021 25 7,767,723 25 8,096,564
1.2 Registration and dossier
submission 34 7,435,575 34 7,610,786 36 8,229,234
1.3 Screening and prioritisation 58 9,439,309 58 9,623,928 58 9,921,845
1.4 Evaluation 113 19,009,306 113 19,390,792 113 20,006,695
1.5 Authorisation 40 7,464,547 41 7,787,929 43 8,387,822
1.6 Restrictions 34 6,508,301 33 6,488,419 32 6,546,622
1.7 Classification and labelling 27 6,478,436 28 6,800,217 28 7,063,326
1.8 Safe and sustainable use of
chemicals 8 1,568,389 8 1,603,236 8 1,659,600
1.9 Data management and
dissemination 23 7,171,821 23 7,365,773 23 7,680,459
Governance and enablers 145 24,303,013 145 24,789,379 142 25,072,424
TOTAL 507 96,943,718 508 99,228,182 508 102,664,591
in EP 511 511 0 511 0
2. Biocides
Operations 52 10,080,907 52 10,731,149 52 11,517,327
Governance and enablers 17 2,688,093 17 2,794,419 17 2,973,461
TOTAL 69 12,769,000 69 13,525,568 69 14,490,788
in EP 69 69 0 69 0

3. Export/import of hazardous
chemicals and circular economy
3.1 Prior Informed Consent 7 1,038,755 7 1,075,563 8 1,100,011
3.2 Persistent organic pollutants 1 173,315 2 179,456 2 183,536
3.3 Waste Framework Directive 7 1,355,952 7 1,376,470 7 1,380,154
3.4 Drinking water directive 4 1,503,682 4 1,535,362 4 1,109,852
3.5 8th Environmental Action
Programme (subject to approval by
the Parliament) 2 287,546 2 297,253 2 302,524
Governance and enablers 3 367,750 3 368,896 3 361,923
TOTAL 24 4,727,000 25 4,833,000 26 4,438,000
in EP 24 25 26
4. Other tasks
4.1 EU Observatory for
Nanomaterials 3 3 3
4.2 EU Chemicals Legislation Finder 1 1 1
4.3 Support to Occupational health
legislation 4 4 4
4.4 Instrument for Pre-Accession
assistance (IPA) ***
4.5 Support to other legislation 3 3 3
4.6 IUCLID as a service for EFSA 4 4 4
TOTAL 15 15 15
in EP 12 12 12

Overall TOTAL 615 114,439,718 617 117,586,750 618 121,593,379

in EP 616 617 618
Programming Document(s) 2021-2024 94

** The budget allocation per activity for the years 2022-2024, has been made based on the high-level estimates for
the years, and the operational expenditure has been assumed to follow the same distribution as in the Draft Budget
2021.

*** Resources planned for Instrument for Pre-Accession Assistance (IPA), section 4.4., are accounted for under
Governance and enablers.
Programming Document(s) 2021-2024 95

Annex III: Financial resources

Table 1: Revenue
ECHA
2020 2021 2022

Revenues As requested by the As requested by the

Executed Budget
agency agency

EU contribution 71 944 520 79 569 824 80 377 000

Other revenue 38 275 442 33 483 263 34 062 718
Total revenues 110 219 962 113 053 087 114 439 718

2019 2020 2021 2022

Revenues Revenues As VAR

REVENUES Executed estimated estimated requested 2022 / 2023 2024
Budget by the by the by the 2021
agency agency agency

1 REVENUE FROM FEES AND CHARGES 44 385 256 32 292 704 30 382 277 31 756 378 5% 33 767 180 34 672 109

2. EU CONTRIBUTION 62 888 415 71 944 520 79 569 824 80 377 000 1% 81 533 000 84 538 000

of which Administrative (Title 1 and Title 2) 52 094 648 58 987 467 63 160 161 65 518 521 4% 66 350 786 68 650 646
of which Operational (Title 3) 10 793 767 12 957 053 15 472 325 14 858 479 -4% 15 182 214 15 887 354

of which assigned revenues deriving from previous years'

5 774 865 3 651 680 1 513 862 61 140 -96% 0 0
surpluses

3 THIRD COUNTRIES CONTRIBUTION (incl. EFTA and

1 615 033 1 850 992 2 329 150 2 306 340 -1% 2 286 570 2 383 270
candidate countries)

of which EFTA 1 615 033 1 850 992 2 329 150 2 306 340 -1% 2 286 570 2 230 730

of which Candidate Countries 0 0 0 0 - 0 0

4 OTHER CONTRIBUTIONS 0 0 0 0 - 0 0
Programming Document(s) 2021-2024 96

5 ADMINISTRATIVE OPERATIONS 228 318 284 491 0 0 - 0 0

6 REVENUES FROM SERVICES RENDERED AGAINST

3 166 928 3 847 255 771 836 0 -100% 0 0
PAYMENT

7 CORRECTION OF BUDGETARY IMBALANCES 0 0 0 0 - 0 0

112 283 110 219 113 053 114 439
TOTAL REVENUES 1% 117 586 750 121 593 379
950 962 087 718

REACH/CLP
2020 2021 2022

Revenues As requested by the As requested by the

Executed Budget
agency agency

EU contribution 61 879 520 63 614 564 66 700 000

Other revenue 31 443 963 29 811 663 30 243 718
Total revenues 93 323 483 93 426 227 96 943 718

2019 2020 2021 2022

Revenues As VAR 2022

REVENUES 2023 2024
Executed Executed estimated requested / 2021
Budget Budget by the by the
agency agency

1 REVENUE FROM FEES AND CHARGES 34 740 608 29 743 629 28 130 616 28 489 508 1% 28 105 592 28 257 841

2. EU CONTRIBUTION 58 346 000 61 879 520 63 614 564 66 700 000 5% 69 300 000 72 500 000

of which Administrative (Title 1 and Title 2) 48 492 262 51 830 082 52 992 759 55 594 595 5% 57 630 369 60 046 741
Programming Document(s) 2021-2024 97

of which Operational (Title 3) 9 853 738 10 049 438 10 621 805 11 105 405 5% 11 669 631 12 453 259

of which assigned revenues deriving from previous years'

4 664 235 3 051 863 1 353 559 -100%
surpluses

3 THIRD COUNTRIES CONTRIBUTION (incl. EFTA and

1 412 237 1 441 278 1 681 047 1 754 210 4% 1 822 590 1 906 750
candidate countries)

of which EFTA 1 412 237 1 441 278 1 681 047 1 754 210 4% 1 822 590 1 754 210

of which Candidate Countries -

4 OTHER CONTRIBUTIONS -

5 ADMINISTRATIVE OPERATIONS 203 892 259 056 -

6 REVENUES FROM SERVICES RENDERED AGAINST

-
PAYMENT

7 CORRECTION OF BUDGETARY IMBALANCES -

TOTAL REVENUES 94 702 737 93 323 483 93 426 227 96 943 718 4% 99 228 182 102 664 591

BIOCIDES
2020 2021 2022

Revenues As requested by the As requested by the

Executed Budget
agency agency

EU contribution 7 008 000 10 348 160 8 950 000

Other revenue 2 982 077 2 899 764 3 819 000
Total revenues 9 990 077 13 247 924 12 769 000
Programming Document(s) 2021-2024 98

2019 2020 2021 2022

Revenues As VAR 2022 /
REVENUES Executed Executed estimated requested 2023 2024
2021
Budget Budget by the by the
agency agency
1 REVENUE FROM FEES AND CHARGES 9 644 648 2 549 075 2 251 661 3 266 870 45% 5 661 588 6 414 268
2. EU CONTRIBUTION 2 978 415 7 008 000 10 348 160 8 950 000 -14% 7 400 000 7 600 000
of which Administrative (Title 1 and Title 2) 2 619 328 6 127 921 7 509 917 7 133 926 -5% 5 804 617 5 926 413
of which Operational (Title 3) 359 087 880 079 1 900 904 1 816 074 -4% 1 595 383 1 673 587
of which assigned revenues deriving from previous years'
1 096 245 577 292 134 997 -100% 0 0
surpluses
3 THIRD COUNTRIES CONTRIBUTION (incl. EFTA and
202 796 409 714 648 103 552 130 -15% 463 980 476 520
candidate countries)
of which EFTA 202 796 409 714 648 103 552 130 -15% 463 980 476 520
of which Candidate Countries -
4 OTHER CONTRIBUTIONS -
5 ADMINISTRATIVE OPERATIONS 24 358 23 288 -
6 REVENUES FROM SERVICES RENDERED AGAINST
-
PAYMENT
7 CORRECTION OF BUDGETARY IMBALANCES -
TOTAL REVENUES 12 850 217 9 990 077 13 247 924 12 769 000 -4% 13 525 568 14 490 788

PIC, POPs, Waste Framework Directive, Drinking Water Directive and 8th Environmental Action Programme

2020 2021 2022

Revenues As requested by the As requested by the

Executed Budget
agency agency

EU contribution 3 057 000 5 607 100 4 727 000

Other revenue 2 148 0 0
Total revenues 3 059 148 5 607 100 4 727 000
Programming Document(s) 2021-2024 99

2019 2020 2021 2022

Revenues As VAR 2022 /
REVENUES Executed Executed estimated requested 2023 2024
2021
Budget Budget by the by the
agency agency
1 REVENUE FROM FEES AND CHARGES 0 0 0 0 - 0 0
2. EU CONTRIBUTION 1 564 000 3 057 000 5 607 100 4 727 000 -16% 4 833 000 4 438 000
of which Administrative (Title 1 and Title 2) 983 058 1 029 463 2 657 484 2 790 000 5% 2 915 800 2 677 492
of which Operational (Title 5) 580 942 2 027 537 2 949 616 1 937 000 -34% 1 917 200 1 760 508
of which assigned revenues deriving from previous years'
14 385 22 525 25 306 61 140.00 142%
surpluses
3 THIRD COUNTRIES CONTRIBUTION (incl. EFTA and
0 0 0 0 - 0 0
candidate countries)
of which EFTA 0 0 0 0 - 0 0
of which Candidate Countries -
4 OTHER CONTRIBUTIONS -
5 ADMINISTRATIVE OPERATIONS 68 2 148 -
6 REVENUES FROM SERVICES RENDERED AGAINST
-
PAYMENT
7 CORRECTION OF BUDGETARY IMBALANCES -
TOTAL REVENUES 1 564 068 3 059 148 5 607 100 4 727 000 -16% 4 833 000 4 438 000

Table 2: Expenditure
ECHA
2020 2021 2022
Expenditure Commitment Payment Commitment Payment Commitment Payment
appropriations appropriations appropriations appropriations appropriations appropriations
Title 1 73 013 484 73 013 484 75 274 991 75 274 991 78 374 800 78 374 800
Title 2 13 288 897 13 288 897 14 823 572 14 823 572 15 396 000 15 396 000
Titles 3-9 22 721 403 22 986 203 22 535 522 22 954 524 20 890 918 20 668 918
Total
109 023 783 109 288 584 112 634 085 113 053 087 114 661 718 114 439 718
expenditure
Programming Document(s) 2021-2024 100

EXPENDITURE Commitment appropriations

2022
VAR
2019 2020 2021 Agency 2023 2024
2022/2021
request
Title 1 Staff Expenditure 70 453 710 73 013 484 75 274 991 78 374 800 4% 80 340 296 82 916 776
11 Salaries & allowances 64 069 860 67 309 484 70 609 236 73 306 800 4% 75 170 936 77 628 776
- of which establishment plan posts 53 714 369 56 413 594 60 148 236 61 823 443 3% 63 268 192 65 400 278
- of which external personnel 7 416 761 7 709 348 7 991 000 8 852 357 11% 9 099 424 9 357 498
12 Expenditure relating to Staff recruitment 718 867 794 534 723 525 740 000 2% 754 800 774 000
Employer's pension contributions 2 938 730 3 209 165 2 470 000 2 631 000 7% 2 803 320 2 871 000
13 Mission expenses 38 013 7 084 31 000 33 000 6% 33 660 37 000
14 Socio-medical infrastructure 1 821 733 1 723 113 1 939 729 2 081 000 7% 2 122 620 2 169 000
15 Training 647 877 358 621 563 000 775 000 38% 790 500 808 000
16 External Services 3 157 359 2 820 648 1 408 501 1 439 000 2% 1 467 780 1 500 000
17 Receptions and events 0 0 0 0 - 0 0
Title 2
Infrastructure and operating expenditure 17 180 600 13 288 897 14 823 572 15 396 000 4% 15 703 920 16 385 000
20 Rental of buildings and associated costs 7 297 639 6 652 160 7 450 952 7 664 000 3% 7 817 280 7 975 000
21 Information and communication technology 6 993 292 6 012 422 6 767 801 6 907 000 2% 7 045 140 7 540 000
22 Movable property and associated costs 2 410 033 297 820 343 000 400 000 17% 408 000 417 000
23 Current administrative expenditure 472 702 323 283 252 117 413 000 64% 421 260 438 000
24 Postage / Telecommunications 0 0 0 0 - 0 0
25 Meeting expenses 6 934 3 212 9 702 12 000 24% 12 240 15 000
Title 3
Operational expenditure 16 376 586 14 485 889 15 180 494 16 362 918 8% 16 731 326 17 456 603
30 REACH 14 822 095 12 966 292 13 936 494 14 990 918 8% 15 359 326 16 284 603
3003 Registration, datasharing and dissemination 456 296 63 820 97 000 200 000 106% 200 000 200 000
3004 Evaluation 1 910 0 85 500 86 000 1% 86 000 100 000
3005 Risk Management 318 391 182 776 504 000 698 000 38% 698 000 797 000
3006 Classification and labelling 31 818 2 607 40 000 40 000 0% 40 000 50 000
3007 Advice and assistance through guidance and
76 361 60 853 49 250 140 000 184% 140 000 180 000
helpdesk
3008 Scientific IT tools 9 482 856 9 714 661 9 134 611 9 329 918 2% 9 598 326 9 921 603
3009 Scientific and technical advice to EU
256 027 259 880 360 000 410 000 14% 410 000 410 000
institutions and bodies
3011 Committees and Forum 1 298 080 172 401 727 292 800 000 10% 800 000 950 000
Programming Document(s) 2021-2024 101

3012 Board of Appeal 36 299 62 999 64 000 76 000 19% 76 000 100 000
3013 Communications including Translations 1 765 483 1 732 858 1 890 352 2 046 000 8% 2 146 000 2 246 000
3014 International cooperation 4 831 1 143 30 000 30 000 0% 30 000 30 000
3022 Management Board and management of the
661 213 656 147 746 489 900 000 21% 900 000 1 050 000
Agency
3030 Missions 432 531 56 150 208 000 235 000 13% 235 000 250 000
3031 External training 0 0 0 0 - 0 0
31 MULTIANNUAL ACTIVITIES 1 354 510 740 192 644 000 872 000 35% 872 000 672 000
3111 Committees and Forum (Multiannual) 1 354 510 740 192 644 000 872 000 35% 872 000 672 000
38 INTERNATIONAL ACTIVITIES 199 980 779 405 600 000 500 000 -17% 500 000 500 000
3801 Cooperation with international organisations
199 980 779 405 600 000 500 000 -17% 500 000 500 000
for IT programmes
Title 4
Operational expenditure 3 697 185 1 321 733 2 433 576 2 591 000 6% 2 916 008 3 191 000
4000 Substances, products and technical
0 0 169 736 170 000 0% 170 000 170 000
equivalence
4003 Submissions, datasharing, dissemination 0 0 0 0 - 0 0
4007 Advice assistance through guidance and
18 997 600 24 750 50 000 102% 50 000 50 000
helpdesk
4008 Scientific IT tools 3 162 919 1 184 439 1 792 064 1 842 000 3% 2 026 008 2 199 000
4009 Scientif technic advice to EU institut and
0 0 0 0 - 0 0
bodies
4011 Biocidal products Committee and Forum 341 314 37 489 193 600 269 000 39% 410 000 500 000
4012 Board of Appeal 3 777 7 350 11 500 12 000 4% 12 000 20 000
4013 Communications including Translations 54 586 51 487 116 647 125 000 7% 125 000 125 000
4022 Management Board and management of the
59 590 27 761 85 279 87 000 2% 87 000 87 000
Agency
4030 Missions 56 000 12 607 40 000 36 000 -10% 36 000 40 000
4031 External training 0 0 0 0 - 0 0
4901 Preparatory work BPR 13/3938 Norwegian 0 0 0 0 - 0 0
Title 5
Operational expenditure 572 056 2 013 652 2 949 616 1 937 000 -34% 1 917 200 1 466 000
5000 Studies and consultants 0 0 110 000 100 000 -9% 100 000 60 000
5007 Advice assistance through guidance and
0 0 0 0 - 0 0
helpdesk
5008 Scientific IT tools 527 071 1 833 082 2 661 620 1 662 000 -38% 1 642 200 1 291 000
5011 Meetings with the DNAs and experts on PIC
0 0 68 000 68 000 0% 68 000 38 000
implem
5013 Communications including Translations 23 983 179 932 58 010 63 000 9% 63 000 33 000
Programming Document(s) 2021-2024 102

5022 Management Board and management of the

0 0 17 586 19 000 19 000 19 000
Agency
5030 Missions 21 001 638 34 400 25 000 -27% 25 000 25 000
5031 External training 0 0 0 0 - 0 0
Title 6
Other tasks 3 240 365 4 900 128 771 836 0 -100% 0 0
6000 IPA programme 358 508 499 013 0 0 - 0 0
6010 EUON 930 512 843 336 0 0 - 0 0
6011 EUCLEF 967 680 1 415 045 0 0 - 0 0
6020 OELs 199 236 304 601 0 0 - 0 0
6021 Further development of IUCLID (as co-
784 428 1 838 133 771 836 0 -100% 0 0
investments from third parties)
Title 9
Operational expenditure
9101 Payment appropriation for a Negative budget
1 200 000
result prior year BIOCIDE
TOTAL EXPENDITURE 111 520 501 109 023 783 112 634 085 114 661 718 2% 117 608 750 121 415 379

2022
VAR
2019 2020 2021 Agency 2023 2024
2022/2021
request
Title 1 Staff Expenditure 70 453 710 73 013 484 75 274 991 78 374 800 4% 80 340 296 82 916 776
11 Salaries & allowances 64 069 860 67 309 484 70 609 236 73 306 800 4% 75 170 936 77 628 776
- of which establishment plan posts 53 714 369 56 413 594 60 148 236 61 823 443 3% 63 268 192 65 400 278
- of which external personnel 7 416 761 7 709 348 7 991 000 8 852 357 11% 9 099 424 9 357 498
12 Expenditure relating to Staff recruitment 718 867 794 534 723 525 740 000 2% 754 800 774 000
Employer's pension contributions 2 938 730 3 209 165 2 470 000 2 631 000 7% 2 803 320 2 871 000
13 Mission expenses 38 013 7 084 31 000 33 000 6% 33 660 37 000
14 Socio-medical infrastructure 1 821 733 1 723 113 1 939 729 2 081 000 7% 2 122 620 2 169 000
15 Training 647 877 358 621 563 000 775 000 38% 790 500 808 000
16 External Services 3 157 359 2 820 648 1 408 501 1 439 000 2% 1 467 780 1 500 000
17 Receptions and events 0 0 0 0 - 0 0
Title 2
Infrastructure and operating expenditure 17 180 600 13 288 897 14 823 572 15 396 000 4% 15 703 920 16 385 000
20 Rental of buildings and associated costs 7 297 639 6 652 160 7 450 952 7 664 000 3% 7 817 280 7 975 000
21 Information and communication technology 6 993 292 6 012 422 6 767 801 6 907 000 2% 7 045 140 7 540 000
Programming Document(s) 2021-2024 103

22 Movable property and associated costs 2 410 033 297 820 343 000 400 000 17% 408 000 417 000
23 Current administrative expenditure 472 702 323 283 252 117 413 000 64% 421 260 438 000
24 Postage / Telecommunications 0 0 0 0 - 0 0
25 Meeting expenses 6 934 3 212 9 702 12 000 24% 12 240 15 000
Title 3 -
Operational expenditure 15 779 489 14 750 689 15 599 496 16 140 918 3% 16 709 326 17 634 603
30 REACH 14 822 095 12 966 292 13 936 494 14 990 918 8% 15 359 326 16 284 603
3003 Registration, datasharing and dissemination 456 296 63 820 97 000 200 000 106% 200 000 200 000
3004 Evaluation 1 910 0 85 500 86 000 1% 86 000 100 000
3005 Risk Management 318 391 182 776 504 000 698 000 38% 698 000 797 000
3006 Classification and labelling 31 818 2 607 40 000 40 000 0% 40 000 50 000
3007 Advice and assistance through guidance and
76 361 60 853 49 250 140 000 184% 140 000 180 000
helpdesk
3008 Scientific IT tools 9 482 856 9 714 661 9 134 611 9 329 918 2% 9 598 326 9 921 603
3009 Scientific and technical advice to EU
256 027 259 880 360 000 410 000 14% 410 000 410 000
institutions and bodies
3011 Committees and Forum 1 298 080 172 401 727 292 800 000 10% 800 000 950 000
3012 Board of Appeal 36 299 62 999 64 000 76 000 19% 76 000 100 000
3013 Communications including Translations 1 765 483 1 732 858 1 890 352 2 046 000 8% 2 146 000 2 246 000
3014 International cooperation 4 831 1 143 30 000 30 000 0% 30 000 30 000
3022 Management Board and management of the
661 213 656 147 746 489 900 000 21% 900 000 1 050 000
Agency
3030 Missions 432 531 56 150 208 000 235 000 13% 235 000 250 000
3031 External training 0 0 0 0 - 0 0
31 MULTIANNUAL ACTIVITIES 525 259 1 112 001 922 002 650 000 -30% 850 000 850 000
3111 Committees and Forum (Multiannual) 525 259 1 112 001 922 002 650 000 -30% 850 000 850 000
38 INTERNATIONAL ACTIVITIES 432 135 672 396 741 000 500 000 -33% 500 000 500 000
3801 Cooperation with international organisations
432 135 672 396 741 000 500 000 -33% 500 000 500 000
for IT programmes
Title 4
Operational expenditure 3 697 185 1 321 733 2 433 576 2 591 000 6% 2 916 008 3 191 000
4000 Substances, products and technical
0 0 169 736 170 000 0% 170 000 170 000
equivalence
4003 Submissions, datasharing, dissemination 0 0 0 0 - 0 0
4007 Advice assistance through guidance and
18 997 600 24 750 50 000 102% 50 000 50 000
helpdesk
4008 Scientific IT tools 3 162 919 1 184 439 1 792 064 1 842 000 3% 2 026 008 2 199 000
4009 Scientif technic advice to EU institut and
0 0 0 0 - 0 0
bodies
Programming Document(s) 2021-2024 104

4011 Biocidal products Committee and Forum 341 314 37 489 193 600 269 000 39% 410 000 500 000
4012 Board of Appeal 3 777 7 350 11 500 12 000 4% 12 000 20 000
4013 Communications including Translations 54 586 51 487 116 647 125 000 7% 125 000 125 000
4022 Management Board and management of the
59 590 27 761 85 279 87 000 2% 87 000 87 000
Agency
4030 Missions 56 000 12 607 40 000 36 000 -10% 36 000 40 000
4031 External training 0 0 0 0 - 0 0
4901 Preparatory work BPR 13/3938 Norwegian 0 0 0 0 - 0 0
Title 5
Operational expenditure 572 056 2 013 652 2 949 616 1 937 000 -34% 1 917 200 1 466 000
5000 Studies and consultants 0 0 110 000 100 000 -9% 100 000 60 000
5007 Advice assistance through guidance and
0 0 0 0 - 0 0
helpdesk
5008 Scientific IT tools 527 071 1 833 082 2 661 620 1 662 000 -38% 1 642 200 1 291 000
5011 Meetings with the DNAs and experts on PIC
0 0 68 000 68 000 0% 68 000 38 000
implem
5013 Communications including Translations 23 983 179 932 58 010 63 000 9% 63 000 33 000
5022 Management Board and management of the
0 0 17 586 19 000 19 000 19 000
Agency
5030 Missions 21 001 638 34 400 25 000 -27% 25 000 25 000
5031 External training 0 0 0 0 - 0 0
Title 6
Other tasks 3 240 365 4 900 128 771 836 0 -100% 0 0
6000 IPA programme 358 508 499 013 0 0 - 0 0
6010 EUON 930 512 843 336 0 0 - 0 0
6011 EUCLEF 967 680 1 415 045 0 0 - 0 0
6020 OELs 199 236 304 601 0 0 - 0 0
6021 Further development of IUCLID (as co-
784 428 1 838 133 771 836 0 -100% 0 0
investments from third parties)
Title 9
1 200 000 0 -100% 0 0
Operational expenditure
9101 Payment appropriation for a Negative budget
1 200 000
result prior year BIOCIDE
TOTAL EXPENDITURE 110 923 404 109 288 584 113 053 087 114 439 718 1% 117 586 750 121 593 379
Programming Document(s) 2021-2024 105

REACH/CLP

2020 2021 2022

Expenditure Commitment Payment Commitment Payment Commitment Payment
appropriations appropriations appropriations appropriations appropriations appropriations
Title 1 64 509 578 64 509 578 65 196 822 65 196 822 67 691 000 67 691 000
Title 2 11 567 261 11 567 261 12 629 909 12 629 909 13 111 800 13 111 800
Title 3 14 485 889 14 750 689 15 180 494 15 599 496 16 362 918 16 140 918
Total
90 562 727 90 827 528 93 007 225 93 426 227 97 165 718 96 943 718
expenditure

2022
VAR
2019 2020 2021 Agency 2023 2024
2022/2021
request
Title 1 Staff Expenditure 62 624 112 64 509 578 65 196 822 67 691 000 4% 69 144 820 71 083 988
11 Salaries & allowances 56 943 979 59 549 728 61 108 000 63 263 000 4% 64 628 260 66 471 988
- of which establishment plan posts 48 083 627 49 995 809 52 678 000 54 103 800 3% 55 285 876 56 942 323
- of which external personnel 6 374 294 6 703 674 6 160 000 6 843 200 11% 6 980 064 7 119 665
12 Expenditure relating to Staff recruitment 674 233 759 136 630 560 644 000 2% 656 880 671 000
Employer's pension contributions 2 486 058 2 850 245 2 270 000 2 316 000 2% 2 362 320 2 410 000
13 Mission expenses 32 801 6 415 26 412 27 000 2% 27 540 29 000
14 Socio-medical infrastructure 1 594 015 1 499 114 1 652 648 1 771 000 7% 1 806 420 1 844 000
15 Training 585 105 316 379 490 800 671 000 37% 684 420 699 000
16 External Services 2 793 979 2 378 805 1 288 402 1 315 000 2% 1 341 300 1 369 000
17 Receptions and events 0 0 0 0
Title 2
Infrastructure and operating expenditure 15 029 985 11 567 261 12 629 909 13 111 800 4% 13 374 036 13 946 000
20 Rental of buildings and associated costs 6 373 921 5 790 716 6 348 210 6 529 000 3% 6 659 580 6 793 000
21 Information and communication technology 6 119 269 5 230 807 5 766 165 5 883 000 2% 6 000 660 6 422 000
22 Movable property and associated costs 2 108 779 258 770 292 236 340 800 17% 347 616 355 000
23 Current administrative expenditure 421 902 284 132 214 801 350 000 63% 357 000 366 000
24 Postage / Telecommunications 0 0 0 0 - 0 0
25 Meeting expenses 6 114 2 835 8 497 9 000 6% 9 180 10 000
Title 3
Operational expenditure 16 376 586 14 485 889 15 180 494 16 362 918 8% 16 731 326 17 456 603
Programming Document(s) 2021-2024 106

30 REACH 14 822 095 12 966 292 13 936 494 14 990 918 8% 15 359 326 16 284 603
3003 Registration, datasharing and
456 296 63 820 97 000 200 000 106% 200 000 200 000
dissemination
3004 Evaluation 1 910 0 85 500 86 000 1% 86 000 100 000
3005 Risk Management 318 391 182 776 504 000 698 000 38% 698 000 797 000
3006 Classification and labelling 31 818 2 607 40 000 40 000 0% 40 000 50 000
3007 Advice and assistance through guidance
76 361 60 853 49 250 140 000 184% 140 000 180 000
and helpdesk
3008 Scientific IT tools 9 482 856 9 714 661 9 134 611 9 329 918 2% 9 598 326 9 921 603
3009 Scientific and technical advice to EU
256 027 259 880 360 000 410 000 14% 410 000 410 000
institutions and bodies
3011 Committees and Forum 1 298 080 172 401 727 292 800 000 10% 800 000 950 000
3012 Board of Appeal 36 299 62 999 64 000 76 000 19% 76 000 100 000
3013 Communications including Translations 1 765 483 1 732 858 1 890 352 2 046 000 8% 2 146 000 2 246 000
3014 International cooperation 4 831 1 143 30 000 30 000 0% 30 000 30 000
3022 Management Board and management of the
661 213 656 147 746 489 900 000 21% 900 000 1 050 000
Agency
3030 Missions 432 531 56 150 208 000 235 000 13% 235 000 250 000
3031 External training 0 0 0 0 - 0 0
31 MULTIANNUAL ACTIVITIES 1 354 510 740 192 644 000 872 000 35% 872 000 672 000
3111 Committees and Forum (Multiannual) 1 354 510 740 192 644 000 872 000 35% 872 000 672 000
38 INTERNATIONAL ACTIVITIES 199 980 779 405 600 000 500 000 -17% 500 000 500 000
3801 Cooperation with international
199 980 779 405 600 000 500 000 -17% 500 000 500 000
organisations for IT programmes
TOTAL EXPENDITURE 94 030 683 90 562 727 93 007 225 97 165 718 4% 99 250 182 102 486 591

EXPENDITURE Payment appropriations

2022
VAR
2019 2020 2021 Agency 2023 2024
2022/2021
request
Title 1 Staff Expenditure 62 624 112 64 509 578 65 196 822 67 691 000 4% 69 144 820 71 083 988
11 Salaries & allowances 56 943 979 59 549 728 61 108 000 63 263 000 4% 64 628 260 66 471 988
- of which establishment plan posts 48 083 627 49 995 809 52 678 000 54 103 800 3% 55 285 876 56 942 323
- of which external personnel 6 374 294 6 703 674 6 160 000 6 843 200 11% 6 980 064 7 119 665
Programming Document(s) 2021-2024 107

12 Expenditure relating to Staff recruitment 674 233 759 136 630 560 644 000 2% 656 880 671 000
Employer's pension contributions 2 486 058 2 850 245 2 270 000 2 316 000 2% 2 362 320 2 410 000
13 Mission expenses 32 801 6 415 26 412 27 000 2% 27 540 29 000
14 Socio-medical infrastructure 1 594 015 1 499 114 1 652 648 1 771 000 7% 1 806 420 1 844 000
15 Training 585 105 316 379 490 800 671 000 37% 684 420 699 000
16 External Services 2 793 979 2 378 805 1 288 402 1 315 000 2% 1 341 300 1 369 000
17 Receptions and events 0 0 0 0 - 0 0
Title 2
Infrastructure and operating expenditure 15 029 985 11 567 261 12 629 909 13 111 800 4% 13 374 036 13 946 000
20 Rental of buildings and associated costs 6 373 921 5 790 716 6 348 210 6 529 000 3% 6 659 580 6 793 000
21 Information and communication
6 119 269 5 230 807 5 766 165 5 883 000 2% 6 000 660 6 422 000
technology
22 Movable property and associated costs 2 108 779 258 770 292 236 340 800 17% 347 616 355 000
23 Current administrative expenditure 421 902 284 132 214 801 350 000 63% 357 000 366 000
24 Postage / Telecommunications 0 0 0 0 - 0 0
25 Meeting expenses 6 114 2 835 8 497 9 000 6% 9 180 10 000
Title 3
Operational expenditure 15 779 489 14 750 689 15 599 496 16 140 918 3% 16 709 326 17 634 603
30 REACH 14 822 095 12 966 292 13 936 494 14 990 918 8% 15 359 326 16 284 603
3003 Registration, datasharing and
456 296 63 820 97 000 200 000 106% 200 000 200 000
dissemination
3004 Evaluation 1 910 0 85 500 86 000 1% 86 000 100 000
3005 Risk Management 318 391 182 776 504 000 698 000 38% 698 000 797 000
3006 Classification and labelling 31 818 2 607 40 000 40 000 0% 40 000 50 000
3007 Advice and assistance through guidance
76 361 60 853 49 250 140 000 184% 140 000 180 000
and helpdesk
3008 Scientific IT tools 9 482 856 9 714 661 9 134 611 9 329 918 2% 9 598 326 9 921 603
3009 Scientific and technical advice to EU
256 027 259 880 360 000 410 000 14% 410 000 410 000
institutions and bodies
3011 Committees and Forum 1 298 080 172 401 727 292 800 000 10% 800 000 950 000
3012 Board of Appeal 36 299 62 999 64 000 76 000 19% 76 000 100 000
3013 Communications including Translations 1 765 483 1 732 858 1 890 352 2 046 000 8% 2 146 000 2 246 000
3014 International cooperation 4 831 1 143 30 000 30 000 0% 30 000 30 000
3022 Management Board and management of
661 213 656 147 746 489 900 000 21% 900 000 1 050 000
the Agency
3030 Missions 432 531 56 150 208 000 235 000 13% 235 000 250 000
3031 External training 0 0 0 0 - 0 0
Programming Document(s) 2021-2024 108

31 MULTIANNUAL ACTIVITIES 525 259 1 112 001 922 002 650 000 -30% 850 000 850 000
3111 Committees and Forum (Multiannual) 525 259 1 112 001 922 002 650 000 -30% 850 000 850 000
38 INTERNATIONAL ACTIVITIES 432 135 672 396 741 000 500 000 -33% 500 000 500 000
3801 Cooperation with international
432 135 672 396 741 000 500 000 -33% 500 000 500 000
organisations for IT programmes
TOTAL EXPENDITURE 93 433 586 90 827 528 93 426 227 96 943 718 4% 99 228 182 102 664 591

BIOCIDES
2020 2021 2022
Expenditure Commitment Payment Commitment Payment Commitment Payment
appropriations appropriations appropriations appropriations appropriations appropriations
Title 1 7 693 871 7 693 871 7 909 603 7 909 603 8 405 000 8 405 000
Title 2 1 509 258 1 509 258 1 704 745 1 704 745 1 773 000 1 773 000
Title 4 1 321 733 1 321 733 2 433 576 2 433 576 2 591 000 2 591 000
Title 9 1 200 000
Total
10 524 862 10 524 862 12 047 924 13 247 924 12 769 000 12 769 000
expenditure

2022 VAR
2019 2020 2021 Agency 2023 2024
2022/2021
request
Title 1 Staff Expenditure 7 102 324 7 693 871 7 909 603 8 405 000 6% 8 801 100 9 409 788
11 Salaries & allowances 6 558 444 7 150 578 7 497 591 7 947 000 6% 8 333 940 8 927 788
- of which establishment plan posts 5 132 368 5 845 984 6 302 591 6 528 643 4% 6 767 516 7 218 855
- of which external personnel 973 404 945 674 995 000 1 103 357 11% 1 125 424 1 247 933
12 Expenditure relating to Staff recruitment 33 482 30 229 40 450 42 000 4% 42 840 45 000
Employer's pension contributions 452 672 358 920 200 000 315 000 58% 441 000 461 000
13 Mission expenses 4 629 585 3 565 4 000 12% 4 080 5 000
14 Socio-medical infrastructure 202 213 196 432 223 069 240 000 8% 244 800 251 000
15 Training 56 370 37 516 56 000 81 000 45% 82 620 85 000
16 External Services 247 186 278 531 88 928 91 000 2% 92 820 96 000
17 Receptions and events 0 0 0 0 - 0 0
Programming Document(s) 2021-2024 109

Title 2
Infrastructure and operating expenditure 1 909 868 1 509 258 1 704 745 1 773 000 4% 1 808 460 1 890 000
20 Rental of buildings and associated costs 820 332 754 907 856 860 882 000 3% 899 640 918 000
21 Information and communication
776 140 685 416 778 298 795 000 2% 810 900 868 000
technology
22 Movable property and associated costs 267 514 34 241 39 445 46 000 17% 46 920 48 000
23 Current administrative expenditure 45 109 34 322 28 994 48 000 66% 48 960 53 000
24 Postage / Telecommunications 0 0 0 0 - 0 0
25 Meeting expenses 773 372 1 148 2 000 74% 2 040 3 000
Title 4 0
Operational expenditure 3 697 185 1 321 733 2 433 576 2 591 000 6% 2 916 008 3 191 000
4000 Substances, products and technical
0 0 169 736 170 000 0% 170 000 170 000
equivalence
4003 Submissions, datasharing,
0 0 0 0 - 0 0
dissemination
4007 Advice assistance through guidance and
18 997 600 24 750 50 000 102% 50 000 50 000
helpdesk
4008 Scientific IT tools 3 162 919 1 184 439 1 792 064 1 842 000 3% 2 026 008 2 199 000
4009 Scientif technic advice to EU institut and
0 0 0 0 - 0 0
bodies
4011 Biocidal products Committee and Forum 341 314 37 489 193 600 269 000 39% 410 000 500 000
4012 Board of Appeal 3 777 7 350 11 500 12 000 4% 12 000 20 000
4013 Communications including Translations 54 586 51 487 116 647 125 000 7% 125 000 125 000
4022 Management Board and management of
59 590 27 761 85 279 87 000 2% 87 000 87 000
the Agency
4030 Missions 56 000 12 607 40 000 36 000 -10% 36 000 40 000
4031 External training 0 0 0 0 - 0 0
4901 Preparatory work BPR 13/3938
0 0 0 0 - 0 0
Norwegian
Title 9
1 200 000
Operational expenditure
9101 Payment appropriation for a Negative
1 200 000 -100%
budget result prior year BIOCIDE
TOTAL EXPENDITURE 12 709 376 10 524 862 13 247 924 12 769 000 -4% 13 525 568 14 490 788
Programming Document(s) 2021-2024 110

PIC, POPs, Waste Framework Directive, Drinking Water Directive and 8th Environmental Action Programme

2020 2021 2022

Expenditure Commitment Payment Commitment Payment Commitment Payment
appropriations appropriations appropriations appropriations appropriations appropriations
Title 1 810 036 810 036 2 168 566 2 168 566 2 278 800 2 278 800
Title 2 212 377 212 377 488 918 488 918 511 200 511 200
Title 5 2 013 652 2 013 652 2 949 616 2 949 616 1 937 000 1 937 000
Total
3 036 065 3 036 065 5 607 100 5 607 100 4 727 000 4 727 000
expenditure

EXPENDITURE Commitment and Payment appropriations

2022
VAR
2019 2020 2021 Agency 2023 2024
2022/2021
request
Title 1 Staff Expenditure 727 274 810 036 2 168 566 2 278 800 5% 2 394 376 2 423 000
11 Salaries & allowances 567 437 609 178 2 003 645 2 096 800 5% 2 208 736 2 229 000
- of which establishment plan posts 498 373 550 781 1 167 645 1 191 000 2% 1 214 800 1 239 100
- of which external personnel 69 064 58 397 836 000 905 800 8% 993 936 989 900
12 Expenditure relating to Staff
11 153 5 169 52 515 54 000 3% 55 080 58 000
recruitment
Employer's pension contributions 0 0 0 0 0% 0 0
13 Mission expenses 584 84 1 023 2 000 96% 2 040 3 000
14 Socio-medical infrastructure 25 505 27 568 64 012 70 000 9% 71 400 74 000
15 Training 6 402 4 725 16 200 23 000 42% 23 460 24 000
16 External Services 116 194 163 312 31 171 33 000 6% 33 660 35 000
17 Receptions and events 0 0 0 0 - 0 0
Title 2
Infrastructure and operating expenditure 240 747 212 377 488 918 511 200 5% 521 424 549 000
20 Rental of buildings and associated
103 386 106 536 245 882 253 000 3% 258 060 264 000
costs
21 Information and communication
97 884 96 199 223 338 229 000 3% 233 580 250 000
technology
Programming Document(s) 2021-2024 111

22 Movable property and associated costs 33 740 4 809 11 319 13 200 17% 13 464 14 000
23 Current administrative expenditure 5 690 4 828 8 322 15 000 80% 15 300 19 000
24 Postage / Telecommunications 0 0 0 0 - 0 0
25 Meeting expenses 47 5 57 1 000 1654% 1 020 2 000
Title 5
Operational expenditure 572 056 2 013 652 2 949 616 1 937 000 -34% 1 917 200 1 466 000
5000 Studies and consultants 0 0 110 000 100 000 -9% 100 000 60 000
5007 Advice assistance through guidance
0 0 0 0 - 0 0
and helpdesk
5008 Scientific IT tools 527 071 1 833 082 2 661 620 1 662 000 -38% 1 642 200 1 291 000
5011 Meetings with the DNAs and experts
0 0 68 000 68 000 0% 68 000 38 000
on PIC implem
5013 Communications including
23 983 179 932 58 010 63 000 9% 63 000 33 000
Translations
5022 Management Board and management
0 17 586 19 000 19 000 19 000
of the Agency
5030 Missions 21 001 638 34 400 25 000 -27% 25 000 25 000
5031 External training 0 0 0 0 - 0 0
TOTAL EXPENDITURE 1 540 077 3 036 065 5 607 100 4 727 000 -16% 4 833 000 4 438 000

Other tasks

EXPENDITURE Commitment and Payment appropriations

2022 VAR
2019 2020 2021 Agency 2023 2024
2020/2019
request
Title 6
Operational expenditure 3 240 365 4 900 128 771 836 0 -100% 0 0
6000 IPA programme 358 508 499 013 0 - 0 0
6010 EUON 930 512 843 336 0 - 0 0
6011 EUCLEF 967 680 1 415 045 0 - 0 0
6020 OELs 199 236 304 601 0 -
6021 Further development of IUCLID (as
784 428 1 838 133 771 836 0 -
co-investments from third parties)
TOTAL EXPENDITURE 3 240 365 4 900 128 771 836 0 -100% 0 0
Programming Document(s) 2021-2024 112

Table 3: Budget outturn and cancellation of appropriations

REACH/CLP

Budget outturn 2017 2018 2019 2020

Revenue actually received (+) 101 116 704 108 394 240 97 869 666 97 170 738
Payments made (-) -86 619 437 -90 955 611 - 84 708 367 - 85 031 180
Carry-over of appropriations (-) -11 552 378 -16 391 960 - 14 454 732 -13 741 895
Cancellation of appropriations carried over (+) 340 062 254 479 282 690 285 159
Adjustment for carry over of assigned revenue appropriations from previous year (+) 1 239 326 1 753 813 2 368 321 3 889 291
Exchange rate differences (+/-) -1 644 -3 099 -4 018 -6 497
Adjustment for negative balance from previous year (-)

Total 4 522 634 3 051 862 1 353 559 2 575 616

The amount of EUR 1 241 280 remained uncommitted and is cancelled.

BIOCIDES

Budget outturn 2017 2018 2019 2020

Revenue actually received (+) 12 190 390 11 476 166 12 850 217 9 990 077
Payments made (-) -8 840 459 -10 040 895 -9 615 867 - 9 625 057
Carry-over of appropriations (-) -2 232 401 -871 752 -3 128 502 - 947 175
Cancellation of appropriations carried over (+) 19 490 24 234 23 130 72 221
Adjustment for carry over of assigned revenue appropriations from previous year (+) 603 10 623 10 643 24 358
Exchange rate differences (+/-)
Adjustment for negative balance from previous year (-)
Total 1 137 622 598 375 139 621 - 485 576
The amount of EUR 340 150 remained uncommitted and is cancelled.
Programming Document(s) 2021-2024 113

The total negative outturn of EUR -485 576 is expected to be covered in the year N+1 by through an additional contribution by the EU
Commission, totalling EUR 469 069, and by the Swiss Confederation totalling EUR 16 507.

PIC / POPs / WFD

Budget outturn 2017 2018 2019 2020

Revenue actually received (+) 1 185 919 1 096 902 1 564 068 3 057 000
Payments made (-) -982 931 -887 410 -1 032 332 - 1 602 061
Carry-over of appropriations (-) -204 728 -187 534 -508 380 -1 436 188
Cancellation of appropriations carried over (+) 4 479 551 1 383 5 969
Adjustment for carry over of assigned revenue appropriations from previous year (+) 11 646 16 567 68
Exchange rate differences (+/-)
Adjustment for negative balance from previous year (-)
Total 14 385 22 525 25 306 - 26 936
The amount of EUR 20 967 remained uncommitted and is cancelled.
Programming Document(s) 2021-2024 114

Annex IV: Human resources - quantitative

Table 1: Overview of all categories of staff – REACH/CLP – BPR – PIC/POPs/Waste/DWD/8th EAP – Other
A: Statutory staff and SNE
Programming Document(s) 2021-2024 115

B: Additional external staff expected to be financed from grant, contributions or service-level agreements

Year 2021 Year 2022 Year 2023 Year 2024

Human Resources
Envisaged FTE Envisaged FTE Envisaged FTE Envisaged FTE

Contract Agents (CA)* 12 12 12 12

Seconded National Experts (SNE) 0 0 0 0

TOTAL 12 12 12 12
*CAs marked also under Other tasks in part A above.
 Programming Document(s) 2021-2024 116

C. Other Human Resources

Structural service Actually in place Interim workers Total FTEs in year

providers 56 as of 31/12/2020 2020

Security 5 Number 53.76

IT 0

Other (specify)
……………
Other (specify)
………………

56
Service providers are contracted by a private company and carry out specialised outsourced tasks of a horizontal/support nature. At the Commission, following general criteria should
be fulfilled: 1) no individual contract with the Commission 2) on the Commission premises, usually with a PC and desk 3) administratively followed by the Commission (badge, etc.)
and 4) contributing to the added value of the Commission.
Programming Document(s) 2021-2024 117

Table 2: Multiannual staff policy plan 2020-2024

Programming Document(s) 2021-2024 118

• External personnel

Contract Agents

FTE corresponding to Headcount as of FTE corresponding to FTE corresponding to FTE corresponding to FTE corresponding to
Executed FTE as of
Contract agents the authorised budget 31/12/2020* the authorised budget the authorised budget the authorised budget the authorised budget
31/12/2020 2022 2023 2024
2020 2021
Function Group IV 39 32,58 38 53 53 54 55
Function Group III 71 57,12 56 61 61 61 61
Function Group II 20 32,87 32 20 20 20 20
Function Group I 0 0 0 0 0 0 0
TOTAL 130 122.57 126 134 134 135 136
*Data in the table includes statutory staff in place on the indicated date. Posts under recruitment are not included.

Seconded National Experts

FTE corresponding to Headcount as of FTE corresponding to FTE corresponding to FTE corresponding to FTE corresponding to
Executed FTE as of
Seconded National Experts the authorised budget 31/12/2020 the authorised budget the authorised budget the authorised budget the authorised budget
31/12/2020
2020 2021 2022 2023 2024
TOTAL 15 3 3 15 15 15 15

Table 3: Recruitment forecasts for 2021 following retirement/mobility or new requested posts
(information on the entry level for each type of posts: indicative table)

Job title in the Type of contract TA/Official CA

Agency
(Official, TA or CA) Function group/grade of recruitment internal Recruitment
( k ) d l( i l d ) Function Group (I,
Due to foreseen New post requested Internal (brackets) External (brackets) II, III and IV)
i / bili d ddi i l k
Director Due to foreseen AD 11-13 AD 12
( ) i
Programming Document(s) 2021-2024 119

Head of Unit Due to mobility AD 9-10 AD 9

( )
Legally Qualified Due to mobility n/a AD 10
b f h d
Scientific / Drinking Water FG IV; AD 5-8 AD 6-7
l ffi i i
Regulatory Assistant Drinking Water FG III
( ) i i
Regulatory Officer Waste Framework FG IV
( ) i i
Legal Advisor Due to mobility AD 5

Scientific Officer Due to mobility AD 5

Regulatory Assistant Due to mobility FG III

Administrative / Due to mobility AST 2

* Indication of both is required

** Justification to be added

Number of inter-agency mobility in 2020: 1 staff member joined ECHA with continuity of contract via inter-agency job market call, 1 staff member left ECHA with
continuity of contract
Programming Document(s) 2021-2024 120

Annex V: Human resources - qualitative

Annex V: A. Recruitment policy

Implementing rules in place:

Yes No If no, which other implementing rules are in place

Engagement of CA Model Decision C(2019)3016 X

Engagement of TA Model Decision C(2015)1509 X

Middle management Model decision C(2018)2542 X

Type of posts Model Decision C(2018)8800 X

Selection procedures
ECHA has a set of comprehensive staff selection and recruitment procedures in place covering all the key stages of the process in a clear and detailed
manner. The aim of the selection and recruitment procedures is to recruit staff that best fit the job profile in a timely and transparent manner and
to ensure that staff members are selected and appointed in accordance with the Staff Regulations and with due regard to the principles of professional
qualification, transparency, equal access and non-discrimination. The selection procedure information is available on ECHA’s website.
Employment conditions
The employment conditions of staff members employed by ECHA are governed by the Staff Regulations of Officials (SR), the Conditions of
Employment of Other Servants of the European Union (CEOS) and the Implementing Rules adopted by ECHA. These temporary agent (TA) and
contract agent (CA) staff are referred to as statutory staff. While both TA and CA staff are financed from staff-related expenditure (Title 1), CAs are
engaged by ECHA’s Appointing Authority in positions that are not included in the Establishment Plan.
a. Officials
ECHA does not engage officials.
b. Temporary agents
All temporary agents employed by ECHA are temporary agents that fall under Article 2(f) and 2(a) of the Staff Regulations. The Decision of ECHA’s
Management Board MB/01/2018, dated 23 March 2018, is the Implementing Rule that sets out the procedure governing the engagement and the
Programming Document(s) 2021-2024 121

use of temporary agents at ECHA. Furthermore, Decision of ECHA’s Management Board MB/48/2018, dated 14 December 2018, establishes internal
rules concerning procedure for the selection and appointment of middle managers.
Temporary agent posts are classified according to the nature and responsibility of the duties, as follows:
• Administrator function group (AD) comprises eleven grades, from AD 5 to AD 14, corresponding to scientific, technical, administrative and
legal duties.
• Assistant function group (AST) comprises eleven grades, from AST 1 to AST 9, corresponding to administrative, technical and clerical duties.
TAs are recruited by open calls for expressions of interest and may be selected for employment using either a selection procedure conducted by
ECHA, the European Personnel Selection Office (EPSO) or a selection procedure organised through the Inter-Agency Job Market. ECHA engages the
services of an executive search consultancy to assist in the selection of candidates for management posts and certain high-level specialist posts
involving supervisory/key coordination responsibilities. The consultancy assists in assessing candidates’ management capabilities and their suitability
for the post utilising modern selection methods.
ECHA adopts a systematic approach to selection planning, involving an identification of its staffing needs on a quarterly basis and the development
and implementation of related staffing plans. TAs are appointed on five-year contracts, which may be renewed for an additional five years, with the
possibility of a second renewal for an indefinite period. In line with the necessity for staffing flexibility, ECHA also organises selection procedures for
short-term assignments under the Temporary Agent contract, in accordance with the Article 8 of the Conditions of Employment of Other Servants
of the European Union. For the period 2020-2024, ECHA does not intend to recruit any secretaries at AST level and is therefore not requesting any
posts at AST/SC level.
c. Contract agents
The Decision of ECHA’s Management Board MB/26/2019, dated 20 June 2019, is the Implementing Rule that sets out the procedure governing the
engagement and the use of contract agents at ECHA. Contract agent positions are classified in four function groups corresponding to the nature and
responsibilities involved:
• Function Group I: administrative and manual support service tasks
• Function Group II: clerical and secretarial tasks, office management and other equivalent tasks
• Function Group III: administrative, finance and other equivalent technical tasks; and
• Function Group IV: operational, scientific and equivalent technical tasks.
Contract agents are appointed on three-year contracts, which may be renewed for an additional three years, with the possibility of a second renewal
for an indefinite period. ECHA may also use specific short-term CA contracts for project related activities.
Programming Document(s) 2021-2024 122

d. Seconded national experts 57

ECHA engages seconded national experts (SNEs) for highly specialised positions requiring a high level of expertise by publishing a call for
expressions of interest on its website. While, typically, the length of secondment is for one year (renewable), ECHA has engaged experts for
shorter periods.
e. Structural service providers 58
f. External staff for occasional replacement 59
ECHA has traditionally engaged two types of structural service providers, or external staff for occasional replacement; administrative interims
(who temporarily provide assistance while we fill a vacant post or those who replace staff on leave or part-time work) and operational interims
(who are engaged in assignments to provide support in temporary peaks in workload or on specific projects). Due to imposed budgetary
constraints in 2021, ECHA intends to principally engage interims in SME verification tasks, Technical Completeness Checks and specific delegated
tasks (that is, those tasks that have been specifically agreed by ECHA’s Management Board or are funded directly to carry out delegated tasks).
This new approach will demand that ECHA continues its work to foster a flexible work environment to be in a position to, for example, bridge
temporary absences with ECHA colleagues. ECHA’s management team is analysing the consequences of a reduced number of structural service
providers, and external staff for occasional replacement, on the 2021 Work Programme and will keep the Management Board fully informed.

g. Traineeships
Traineeships are targeted at university graduates who are aiming for a career-related to chemicals or activities in ECHA’s stakeholder community.
For the period 2020-2024, ECHA estimates the following intake of graduate trainees:

Year 2021 2022 2023 2024

Trainees 50 50 50 50

57
SNEs are not employed by the Agency.
58
Structural service providers are not employed by the Agency.
59
External staff for occasional replacements are not employed by the Agency.
Programming Document(s) 2021-2024 123

Annex V: B. Appraisal of performance and reclassification/promotions

Table 1: Reclassification of temporary staff/promotion of officials

Implementing rules in place:

Yes No If no, which other implementing rules are in place

Reclassification of TA Model Decision C(2015)9560 X

Reclassification of CA Model Decision C(2015)9561 X

How many staff members were promoted/ Average number of years in grade of reclassified/
Category Staff in activity reclassified in 2020 promoted staff members in 2020
and on 1.1.2019
grade
Officials TA Officials TA TA
AD 16 N/A N/A N/A

AD 15 N/A N/A N/A

AD 14 4 N/A N/A N/A

AD 13 10 N/A 1 5.63

AD 12 8 N/A N/A N/A

AD 11 21 N/A 1 4.00

AD 10 34 N/A 2 4.50

AD 9 49 N/A 1 6.00

AD 8 56 N/A 6 4.84

AD 7 86 N/A 11 3.31

AD 6 48 N/A 17 3.34

AD 5 13 N/A 1 N/A
Programming Document(s) 2021-2024 124

Total AD 329 N/A 40 3.80

AST 11 N/A N/A N/A

AST 10 N/A N/A N/A

AST 9 2 N/A N/A N/A

AST 8 4 N/A N/A N/A

AST 7 7 N/A 2 4.50

AST 6 13 N/A 1 5.00

AST 5 23 N/A 4 3.75

AST 4 29 N/A 8 4.02

AST 3 18 N/A 4 3.67

AST 2 13 N/A 3 3.35

AST 1 N/A N/A N/A

Total AST 109 N/A 22 3.92

Total 438 N/A 62 3.84

Table 2: Reclassification of contract staff

Function Grade Staff in How many staff members were Average number of years in grade of reclassified
Group activity on reclassified in 2020 staff members in 2020
1.1.2019

CA IV 18 N/A N/A

17 1 N/A N/A

16 4 1 6.38

15 4 1 2.00

14 12 3 3.95
Programming Document(s) 2021-2024 125

13 6 1 2.92

CA III 12 N/A N/A

11 8 1 5.00

10 21 3 4.02

9 30 7 4.11

8 1 1 8.84

CA II 7 N/A N/A

6 6 1 4.00

5 24 4 4.72

4 7 N/A N/A

CA I 3 N/A N/A

2 N/A N/A

1 N/A N/A

Total 124 23 4.38

The Agency's policy on performance appraisal and promotion/reclassification – short description

Following the extensive work of the Inter-Agency Standing Working Group, ECHA’s has adopted by analogy in 2015 a new policy with respect to
performance appraisal articulated in the ECHA Decision (MB/27/2015) on performance appraisal of temporary agents and contracts agents dated
18 June 2015, (implementing Article 15(2) of the CEOS and first paragraph of Article 44 of the Staff Regulations (for temporary agents) and Article
87(1) of the CEOs and first paragraph of Article 44 of the Staff Regulations (for contract agents).
ECHA’s policy with respect to promotion/reclassification is articulated in the ECHA Decision (MB/05/2016) on the policy and procedure for the
reclassification of temporary agents dated 17 March 2016 (implementing Article 54 of the CEOS) and in the ECHA Decision (MB/06/2016) on the
policy and procedure for the reclassification of Contract Agents dated 17 March 2016 (implementing Article 87(3) of the CEOS).
As a guiding principle, ECHA’s establishment plan evolution and the annual reclassification exercise is carried out in line with the multiplication rate
for guiding the average career equivalence as provided for in Article 6 and Annex IB of the Staff Regulations, and on the basis of comparative merit
and budgetary availability. This is applicable for temporary agents.
Programming Document(s) 2021-2024 126

Annex V: C. Gender representation

Table 1 - Data on 31/12/2020 statutory staff (only officials, TA and CA)*

Official Temporary Contract Agents Grand Total

Staff % of Grand % of Grand % of Grand

% Staff Staff Staff
Total Total Total

Female Administrator 148 33% 20 16% 168 29%

level

Assistant 81 18% 55 44% 136 24%

level (AST &
AST/SC)

Total 229 52% 75 60% 304 53%

Male Administrator 191 43% 18 14% 209 37%

level

Assistant 24 5% 33 26% 57 10%

level (AST &
AST/SC)

Total 215 48% 51 40% 266 47%

Grand Total 444 100% 126 100% 570 100%

*Data in the table includes statutory staff in place on the indicated date. Posts under recruitment are not included.
Programming Document(s) 2021-2024 127

Table 2 - Data regarding gender evolution over 5 years of the Middle and Senior management* 60

2016 2020

Number % Number %

Female Managers 9 36% 8 26%

Male Managers 16 64% 23 74%

*Data in the table includes statutory staff in place on the indicated date. Posts under recruitment are not included.

In case of significant continuous imbalance, please explain and detail action plan implemented in the agency.
a) Actions related to diversity and inclusion:
• Raise staff awareness through dedicated content on intranet, including finding synergies with the currently ongoing ‘Collaboration culture
project’;
• Raise awareness of managers through dedicated content in management seminars and sharing best practices;
• Raise awareness of external audience of ECHA’s commitment to diversity, inclusive organisational culture, well-being and work-life balance
through social media and revamp of the ‘Jobs’ section on ECHA website;
• Strengthen the employer brand by updating the ‘Life’ section of ECHA’s LinkedIn page;
• Engage with the European Institute for Gender Equality (EIGE) to review recommended strategies and actions in this area;
• Remove any gender-biased language and imagery in internal and external communications.

b) Actions dedicated to addressing the gender gap at management level:

• Commence a dialogue with ECHA’s Staff Committee and managers on their views regarding gender balance at management level and the
reasons behind it to determine if further actions are needed;
• Encourage qualified women to apply for managerial calls in the vacancy notice and social media posts;
• Targeting LinkedIn advertising of managerial posts to a female audience;
• Promote managerial calls on websites/events dedicated to female leaders;
• Liaise with the Commission on any initiatives/programmes that it is pursuing in this area;
• Vacancy notice to be accompanied by a video job advertisements with relevant focus on gender balance and equal opportunities;
• Strive for gender balanced representation in succession planning programme and mentoring activities;
• Increase visibility of ECHA’s female managers in social media and website;
• Ensure gender balance in internal and external selection committees (already in place for external calls).

60
Staff defined as middle manager by the applicable General Implementing provisions on middle management
Programming Document(s) 2021-2024 128

Annex V: D. Geographical balance

Explanatory figures to highlight nationalities of staff (split per Administrator/CA FG IV and Assistant /CA FG I, II, III)

Table 1 - Data on 31/12/2020 - statutory staff only (officials, TA and CA)*

AD + CA FG IV AST/SC- AST + CA FGI/CA FGII/CA FGIII TOTAL

Nationality Number % of total staff Number % of total staff members Number % of total staff
members in AD and in AST SC/AST and FG I, II
FG IV categories and III categories

Austrian 4 1% 2 1% 6 1%

Belgian 16 4% 3 2% 19 3%

British 7 2% 1 1% 8 1%

Bulgarian 7 2% 8 4% 15 3%

Cypriot 1 0% 0 0% 1 0%

Czech 1 0% 2 1% 3 1%

German 32 8% 4 2% 36 6%

Danish 2 1% 1 1% 3 1%

Dutch 17 5% 3 2% 20 4%

Estonian 2 1% 6 3% 8 1%

Spanish 23 6% 11 6% 34 6%

Finnish 99 26% 82 42% 181 32%

Programming Document(s) 2021-2024 129

French 32 8% 9 5% 41 7%

Greek 22 6% 10 5% 32 6%

Hungarian 5 1% 6 3% 11 2%

Irish 14 4% 2 1% 16 3%

Icelandic 1 0% 0 0% 1 0%

Italian 40 11% 12 6% 52 9%

Liechtenstein 1 0% 0 0% 1 0%

Lithuanian 3 1% 3 2% 6 1%

Latvian 2 1% 4 2% 6 1%

Maltese 2 1% 1 1% 3 1%

Norwegian 0 0% 1 1% 1 0%

Polish 13 3% 5 3% 18 3%

Portuguese 12 3% 2 1% 14 2%

Romanian 6 2% 9 5% 15 3%

Slovakian 3 1% 1 1% 4 1%

Slovenian 3 1% 4 2% 7 1%

Swedish 7 2% 1 1% 8 1%

*Data in the table includes statutory staff in place on the indicated date. Posts under recruitment are not included.
Programming Document(s) 2021-2024 130

Table 2 - Evolution over 5 years of the most represented nationality in the Agency

Most represented nationality 2016 2020

Number % Number %

Finnish 174 31% 181 32%

*Data in the table includes statutory staff in place on the indicated date. Posts under recruitment are not included.

In case of significant continuous imbalance, please explain and detail action plan implemented in the agency:
• ECHA’s commitment to diversity is highlighted in a dedicated section for equal opportunities in the vacancy notice. Furthermore, qualified
candidates of under-represented nationalities are encouraged to submit their application;
• Vacancies advertised on EU-wide platforms;
• Raise awareness of managers regarding diversity and inclusion through dedicated content in management seminars and sharing best
practices;
• Raise awareness of external audience of ECHA’s commitment to diversity, inclusive organisational culture, well-being and work-life balance
through social media and revamp of the ‘Jobs’ section on ECHA website;
• Geographical balance of staff is considered at the stage of recruitment.
Programming Document(s) 2021-2024 131

Annex V: E. Schooling

Legal basis
The European School of Helsinki (ESH) opened in September 2008 to provide education for the children of ECHA staff, following the enactment of
the ESH Act on 1 January 2008. The ESH is maintained by the State of Finland and it annually concludes an attainment contract with the Finnish
National Agency for Education. It is organised on the basis of the educational structure of the European Schools, providing education based on the
syllabi of the European Schools. It is an Accredited European School and is administered and funded by the Finnish Government, which receives EU
subsidies 61, and own revenues generated through certain fees. The Act provides that the children of ECHA staff (category I pupils) have an
entitlement to cost free priority enrolment at ESH. In 2009, an amendment to the Act on European Schooling Helsinki was adopted to facilitate
admission of category II (non-ECHA) pupils to the School. Category II pupils may apply for enrolment in the ESH since 2010 and, presently,
approximately 45% of the pupils are of category II.
Administration
The School is managed by a Director and an Administrative Board (consisting of a chair, a vice-chair and a maximum of eight members), which is
appointed for a term of four years. Although being the main stakeholder of the ESH, ECHA has only one vote on the Administrative Board.
The School has three language sections – Finnish, French and English – and education is divided into a two-year nursery cycle (Years NI-N2); a five-
year primary cycle (Years P1-P5) and a seven-year secondary cycle (Years S1-S7). The total number of ECHA-related children is 144, and it is
envisaged that this number will remain relatively stable within the next years.
Accreditation
The ESH is linked to the European Schools system through an Accreditation and Cooperation Agreement, which was initially signed on 20 January
2009. Following an audit of ESH, conducted in December 2010, the Secretary General, representing the Board of Governors of the European Schools,
signed an Additional Agreement to the Accreditation and Cooperation Agreement on 26 May 2011, recognising the European schooling provided by
European School of Helsinki for secondary years 6 and 7 and the European Baccalaureate. The School has offered the European Baccalaureate for
the first time in 2013. Accreditation is confirmed for three years following an audit conducted under the responsibility of the Secretary General of
the European Schools.
The ESH joined the network of Accredited European Schools in 2011. ECHA participates in the meetings of the network together with other EU
agencies to exchange best practices and to further strengthen the provision of European schooling, which is essential for staff recruitment and
retention.
Issues

61
Note: As of 1 July 2011, based on the EU Contribution Agreement entered into with the European Commission, Finland received financial contributions from the EU budget based on
the number of Category I children enrolled in the ESH in the given year. This system was amended in 2013 with the consequence that, since the school year 2018/2019, ECHA had to
pay the subsidy from its own budget, which amounts to approximately EUR 1.4 million annually. ECHA has raised this issue with the European Commission in the context of its new
financial realities.
Programming Document(s) 2021-2024 132

The availability of a high quality of education in Helsinki is a critical attraction and retention factor for ECHA and, in this respect, the ESH is a key
stakeholder for ECHA. There is a clear requirement for the School’s budget – and, specifically, the subsidy from the Finnish state – to be maintained
at a sufficient level to continue to ensure the provision of a high quality of education at the School. ECHA will, through its presence on the
Administrative Board and interactions with other stakeholders, continue to represent the interests of ECHA staff on this issue.
ECHA co-chairs the Sub-Network of EU Agencies on Accredited European Schools (SNAES) within the Network of the Heads of Administration to
ensure coordination and mutual support among Agencies on this important topic.

Agreement in place with the European School(s) of Helsinki

Contribution agreements signed with the EC on type I European schools Yes No X

Contribution agreements signed with the EC on type II European schools Yes X No

Number of service contracts in place with international schools: N/A

Description of any other solutions or actions in place:

N/A
Programming Document(s) 2021-2024 133

Annex VI: Environment management

Context of the Agency and its environmental management strategy

ECHA has put in place a quality and environmental management system, which is aligned with the Integrated Management System strategy, which
commits itself to incorporate sustainability as a part of the internal follow-up and reporting.

Overview of the Agency's environmental management system

ECHA was certified according to the ISO 9001 and 14001 standards in 2016 and introduced an environmental management system which includes
an environmental policy, environmental objectives and a multi-annual environmental work programme.

Environmental aspects, indicators and targets

The multi-annual environmental work programme was updated in 2020 to include new objectives with targets to reduce CO 2 emission related to
travel and infrastructure for the period 2020-2022. In June 2020, ECHA’s Executive Director pledged to the Management Board that ECHA will be
carbon-neutral by 2030 and, also in 2020, ECHA moved to its new offices which cover a smaller surface area and has automated building control
systems. This facilitates ECHA in improving its environmental performance through a reduction in the overall consumption of utilities (electricity,
water, heating/cooling) and save rental and utility costs. As part of ECHA’s environmental aspects, other measures have been taken:
- Integrating environmental standards into ECHA procurement (including the canteen services) and Eco-labels are taken into account in ECHA’s
purchases.
- Removing parking facilities for cars to encourage alternative modes of transport to the office;
- Adapting the programming in building management systems and improving automation of technology;
- Ensuring high availability of recycling bins in common areas and removal of personal waste bins;
- Staff information campaigns; and
- Reducing waste volume and the amount of landfill waste.

Actions to improve and communicate environmental performance

In addition to the ISO 14001 environmental recertification (which takes place in 2020), ECHA will undertake EMAS certification in 2021 which
includes additional planning and reporting on ECHA’s environmental performance. To assist implementation, ECHA has established an Environmental
Compliance and Sustainability team to implement the actions identified in ECHA’s environmental work programme (2020-2022).
Programming Document(s) 2021-2024 134

Annex VII: Building policy

Current building(s)
Name, location and Other comments
type of building

Information to be provided Telakkakatu 6 New lease agreement commenced on 23 January 2020.

per building
Surface area (in square 18 071 m2 Of non-office space, 4 601 m2 is conference /meeting facilities, 1 184 m2
metres) is canteen and lobby areas.
- of which office space 11 021 m2
- of which non-office
space 7 050 m2

Annual rent EUR 5 504 119 (net

rent) subject to
indexation
Type and duration of rental Lease contract until New lease agreement commenced on 23 January 2020.
contract 22.01.2030
Host country grant or Partial (with respect to
support VAT waiver).
Present value of the building
Not applicable.

Other:
The return of ECHA’s former premises was concluded on 09 January 2020.
Building projects in planning phase

Not applicable.
Building projects to be submitted to the European Parliament and the Council

Not applicable.
Programming Document(s) 2021-2024 135

Annex VIII: Privileges and immunities

The privileges and immunities of staff and the Agency are contained in the respective Protocol to the EU Treaty. Moreover, further effect is given
by the Seat Agreement signed between Finland and ECHA on 28 June 2007.

Privileges granted to staff

Agency privileges
Protocol of privileges and immunities/diplomatic status Education/day care

Same access to day care organised by municipalities as

Inviolability Immunity from jurisdiction regarding official capacity
Finnish nationals

Exemption from registration requirements

Duty free import of goods upon taking up services
Reimbursement of VAT between 1 June 2007 and 31 May 2009
(no longer in place)
Right to free export when leaving the service
Exemption from taxes on EU salaries
Facilitations for communications Access to Finnish school system
Exemption from national car tax once every three years
Executive Director and Directors join diplomatic status
Temporary residence permits to family members who are not
EU/EEA nationals
Issuance of personal cards through the Foreign Ministry
Issuance of Finnish identity numbers
Assistance and cooperation in Access to European Schooling through the European
security matters School of Helsinki
Exemption from all duties and
taxes
Programming Document(s) 2021-2024 136

Annex IX: Evaluations and audits

Evaluations and audits planned for 2021 Timeline

Ex-post evaluation / strategic assessment of the European Union Chemical Legislation Finder (EUCLEF) April – October 2021

Follow-up to consultative audit of the “Harmonised C&L” October 2021

Follow-up audit to the “Applications for authorisation” December 2021

Assurance audit on planning, reporting and monitoring tools to support effective and efficient decision-making on operational level for February - August 2021
achievement of Programming Document objectives

Assurance audit on identification and evaluation of environmental aspects at ECHA March – May 2021

Assurance audit on biocidal active substances approval (under the Review Programme) September – December
2021
Programming Document(s) 2021-2024 137

Annex X: ECHA Integrated Management System and Framework

I. INTEGRATED MANAGEMENT SYSTEM STRATEGY

The objective of the Integrated Management System strategy is to enable the achievement of ECHA’s strategic priorities by ensuring a flexible
and performance-based governance, well adapted to its priorities and ECHA’s operational structure, while simultaneously recognising the legislative
framework within which ECHA operates, including applicable requirements in the fields of internal control, quality, security, environmental and
sustainability management.

The strategy includes ECHA’s top management commitment and is supported by an Integrated Management System Framework. The framework
further details the common principles and characteristics to be implemented in ECHA’s operational and governance processes.

ECHA’s management commits to:

1. One-ECHA culture. ECHA implements a culture of internal cooperation and alignment of goals and resources around common priorities.
ECHA commits to effective execution across organisational boundaries, taking advantage of the available capabilities and maximising
efficiencies. ECHA strives for continuous alignment with external contributors to its processes, leading to effective and efficient cooperation
in developing outputs. ECHA implements a culture of delegation and trust, where decisions and controls are implemented at the lowest level
compatible with the risks.
2. Contribute to political priorities and values of the European Union as regularly defined by the European Institutions.
3. A quality mind-set to provide services and products that consistently meet the needs and expectations of ECHA regulatory partners and
stakeholders, including ECHA’s governing body, institutional partners, industry, other relevant organisations and the citizens. ECHA
maintains an open and transparent, two-way dialogue with its partners and stakeholders.
4. An internal control system based on performance and efficiency without compromising the effectiveness, while maintaining
compliance with legal, financial and regulatory requirements. Effective and efficient internal control to be used to ensure proportionate
controls based on a good cost/risk-benefit ratio, where strategic and operational opportunities and continual improvements are uncovered
and pursued, and resources are allocated in the most economical manner contributing to the achievement of the Agency’s strategic and EU
political priorities.
5. Flexibility, risk tolerance and simplicity. ECHA strives to minimise bureaucracy and formalism, in executing its activities. ECHA
endeavours to maximise the organisation’s confidence in handling risks and opportunities, executing activities efficiently, adapting to
circumstances, while complying with the applicable regulations and protecting legitimate interest of third parties.
6. Promote transparency as a default operating mode of the Agency.
Programming Document(s) 2021-2024 138

7. Ensure physical security of staff and visitors, as well as protection of confidential business information and data entrusted to the
Agency,
8. Increase sustainability in the day-to-day operations of ECHA by carefully using natural resources and making corresponding choices
when selecting products and services from external vendors.

The progress towards the achievement of the strategy will be measured annually. The assessment will be based on the criteria as stipulated in the
following framework.

II. INTEGRATED MANAGEMENT SYSTEM FRAMEWORK

ECHA’s Integrated Management System Framework is the tool to implement ECHA’s Integrated Management System Strategy through four high-
level components: (1) Governance, (2) Strategy, planning and risk management, (3) Operations and operational structure, and (4)
Evaluation and improvement.

Each component includes a number of respective principles and characteristics to be deployed into operational and governance processes, aiming
to maintain oversight, track progress and adjust accordingly. The structure of the framework and its components follows the Internal Control
Framework’s structure as stipulated in the Financial Regulation. Quality, environmental, security and business continuity
management, sustainability and efficiency principles, including a continual improvement focus are embedded as an integral part of that
structure. There is an explicit focus on the need to ensure both a high level of performance of ECHA and compliance with relevant legislations
and ECHA’s Financial Regulation.

1. GOVERNANCE

Component: 1.1 Mission and vision

Principles: Demonstrating what ECHA believes it is there for and what it wants to achieve, through its commitment to stakeholders and in alignment
with ECHA’s strategy.

Characteristics

Senior management is clearly defining the Agency’s Mission and Vision in alignment to its strategy, and communicating them to staff and
external stakeholders, aiming to ensure stakeholders’ understanding and commitment.

Component: 1.2 Ethical and organisational values

Programming Document(s) 2021-2024 139

Principles: Promoting commitment to transparency, integrity and ethical values

Characteristics

Senior management defines the ethical and organisational values it stands by, through an open and transparent dialogue, involving
management, staff and stakeholders.

The Agency’s management and staff members are aware and uphold the values through their own behaviour, working methods and decision-
making.

The Agency deploys cost-effective measures to prevent harassment, conflict of interests and fraud, as well as to ensure whistleblowing
channels exist.

Component: 1.3 Management responsibility

Principles: Establishing authority and responsibility to support accountability and empowerment, ensuring proportionality and decision-making at
a level corresponding to the risk.

Characteristics

The Agency’s management is committed to implementing and improving its Integrated Management System, combining the elements of
quality, internal control, sustainability, environmental, security and business continuity aspects. The Integrated Management System is aligned
with ECHA’s strategy, mission and vision while minimising bureaucracy and formalism.

The Agency’s management is supporting effective decision-making by clear definition of responsibilities, authority and appropriate segregation
of duties, where decisions are taken at the lowest possible level corresponding to the process risk.

The Agency’s management actively promotes staff empowerment and delegation of powers in order to contribute to the efficiency of processes,
competence development and flexibility, while keeping the balance between cost, risk and benefit.

Component 1.4 Human Resources

Programming Document(s) 2021-2024 140

Principles: Committing to competence, high performance and staff development as part of ECHA’s Human Resource Strategy 62

Characteristics

The Agency’s management continuously enhances staff and competence development, management and leadership capabilities, needed for the
achievement of the strategic priorities of the organisation, thus effectively and efficiently contributing to a motivating and flexible work
environment with focus on high performance and adequate work-life balance for staff.

Senior management is ensuring that the available competencies as well as staff selection and recruitment contribute to the achievement of the
Agency´s strategic plan and priorities, via regularly identifying competency gaps and needs, and monitoring and assessing staff performance in
an objective, equal and transparent way.

Component 1.5 Stakeholders and partners engagement

Principles: Maintaining an open and transparent, two-way dialogue with the Agency’s regulatory partners and stakeholders, including for effective
on-boarding of new tasks.

Characteristics

ECHA’s engagement with regulatory partners and stakeholders is based on the Agency’s corporate values and their involvement in the
Agency’s operations, enhanced through an effective communication strategy.

ECHA’s internal and external communication is consistent, cost-effective and relevant to the audience being targeted to ensure internal and
external partners and stakeholders can both obtain and provide sufficient and timely information for the performance of their responsibilities.

The Agency is monitoring and adjusting its stakeholders’ and partners’ policy in line with its evolving role aiming for synergies and consistency
between its legislations, new and existing tasks, where common objectives and shared tasks are becoming more frequent between ECHA and
its external stakeholders and partners.

2. STRATEGY, PLANNING AND RISK MANAGEMENT

62
Management Board document MB/52/2018.
Programming Document(s) 2021-2024 141

Component 2.1. Priorities planning and resource allocation

Principles: Demonstrating commitment to objectives, priorities and respective steering including activity-based resource allocation.

Characteristics

The Agency’s management under the supervision of the Management Board is defining ECHA’s strategic and operational priorities, both positive
and negative, and their implementation in view of the set political priorities and values of the European Union, as well as ECHA’s strategy,
mission, vision and values.

The Senior management is defining the strategic and annual priorities clearly in a way that makes it possible to measure their outcome and
impact, identify the risks related to them and cascade them to all levels of the organisation.

The Agency is ensuring that human and financial resources are allocated based on the Agency’s strategic priorities, activities and objectives in
line with the principles of effectiveness, efficiency and economy.

Component 2.2. Risk management

Principles: Identifying and analysing risks and significant changes, uncovering opportunities and using cost-risk-benefit analysis to remove
unnecessary controls.

Characteristics

The Agency has adequate mechanisms in place to mitigate risks and ensure uninterrupted operations, continuity, security and everyday
protection of the Agency’s staff, assets and information. Corporate risk assessment includes all elements of ECHA Integrated Management
System and all types of risks 63.

The Agency is integrating risk management into the annual planning and reporting cycle, embedding it in the decision–making process at all
levels, using cost/risk-benefit analysis and other appropriate techniques at process and project level, aiming at higher risk tolerance where

63
Risks could be broadly defined as follows: governance and strategic risks, operational risks, human resources risks, risks of fraud, risks of conflict of interests, business continuity
risks, security risks, reputational risks, communication and information risks, risks related to legality and regularity, external risks, as well as significant external and internal changes
that may pose both risks and opportunities.
Programming Document(s) 2021-2024 142

opportunities are pursued, and designing control activities in a cost-effective and efficient way, proportionate to the underlying risks. 64

3. OPERATIONS AND OPERATIONAL STRUCTURE

Component 3.1. Activity management

Principles: Defining the activities, processes and their interactions, ensuring one-ECHA cooperation and alignment to the strategic priorities to
ensure objectives are met, and allow for measurement of outcome and impact.

Characteristics

The Agency defines its activities, processes and their interactions in alignment with its strategic priorities and objectives, aiming to clearly
identify the outcomes, the expected performance and efficiency, as well as intermediate and long-term impact.

The Agency ensures that its activities and processes are managed towards achieving effectiveness and efficiency, executed through one-ECHA
contribution by relevant competencies and functions, and they deliver quality output according to ECHA possibilities and stakeholder needs and
allow for efficiencies and synergies both internally and with external parties.

ECHA aims at ensuring that its suppliers are managed in the most cost-effective and economic way in line with the applicable environmental
and sustainability criteria.

Component 3.2. Information and data management

Principles: Aiming at effective, efficient, integrated information, communication and data solutions

Characteristics

The Agency is ensuring that its technology, information and data solutions are aligned to its strategy, including its data management strategy,
are well integrated to support efficiency and automation of the Agency’s activities, while increasing the knowledge base for more effective
regulatory work, sharing information on safe use of chemicals, proactively making the data re-usable to target users, better leveraging the

64
Pursuant to the provisions of Article 30 FR on efficient internal control.
Programming Document(s) 2021-2024 143

data for stakeholders and partners through interoperability, providing a “digital by default” and paperless environment, where information is
secure, protected and, where relevant, submitted only once while serving multiple purposes.

The Agency is ensuring that the technology, assets and the IT systems used for running its processes are reliable, secure, comply with the
applicable legislation, provide adequate audit trails and are in line with the principles of data protection, availability, confidentiality and
integrity.

Component 3.3. Change management

Principles: Aiming at agility and flexibility to respond to changes while ensuring continuity

Characteristics

The Agency’s management system and operational structure support flexibility and agility in response to changes in the external and internal
environment while maintaining effectiveness and increasing efficiency.

The Agency is assessing external and internal major changes as a result of evolving stakeholders’ requirements, which may potentially have an
impact on the Agency’s priorities, and consecutively on its strategies and on ECHA Integrated Management System.

4. EVALUATION AND IMPROVEMENT

Component 4.1. Performance management

Principles: Aiming at performance-based management where continual improvement is pursued and ex-ante and ex-post controls are risk-based

Characteristics

The Agency aims at having adequate and performance-based monitoring and measurement structures, including procedures for monitoring the
effectiveness and efficiency of its operations to ensure accuracy, completeness and timeliness of data and related information on the use of the
Agency’s resources, activities, processes and products, as well as reliability of reporting.

The Agency aims at having adequate ex-ante and ex-post controls which are proportionate to the risk, to detect, assess and manage gaps,
Programming Document(s) 2021-2024 144

non-conformities, complaints, deficiencies, as well as continual improvements.

Component 4.2. Assessments, audits and evaluations

Principles: Conducting risk-based assessments, audits and evaluations, driven by operational and strategic needs to identify gaps, assess
benefits, impact and added value of specific ECHA activities

Characteristics

Evaluations of strategies, activities, programmes and projects are driven by ECHA’s strategic and operational needs and are performed to
assess the benefits, results, gaps, impacts and the added value of those activities for ECHA’s partners and stakeholders.

The Internal Audit Capability, the Evaluation Coordination Function 65, the Internal Control Officer, the Quality Manager and other qualified staff
members supporting audits, assessments and ex-post evaluations are providing independent and objective assurance, as well as performance
consulting, based on risk assessment, designed to add value and improve the operations of the Agency.

Senior management is reviewing periodically and carrying out a management review on the effectiveness, adequacy and suitability of the
Agency’s Integrated Management System in line with the existing strategic priorities, and the applicable legal and regulatory requirements.

65
The Evaluation Coordination Function is responsible for coordinating and performing ex-post evaluations.
Programming Document(s) 2021-2024 145

Annex XI: Plan for grant, contribution or service-level agreements 66

General information Financial and HR impacts

Actual or
expected
date of Total
signature amount Duration Counterpart Short description 2020 2021 2022 2023
Grant agreements
1. IPA 01.03.2019 785 000 40 months Commission See section 4.4 Amount 0 0 0 N/A
DG NEAR Number of CA 1 1 1 N/A
Number of SNEs
Amount 0 0 0 N/A
Total grant agreements
Number of CA 1 1 1 N/A
Number of SNEs
Contribution agreements
1. EUCLEF 12.12.2019 2 349 000 3 years Commission See section 4.2 Amount 1 199 000 N/A N/A N/A
DG GROW Number of CA 1 1 N/A N/A
Number of SNEs
2. EUON 30.11.2020 3 427 700 5 years Commission See section 4.1 Amount 827 700 N/A N/A N/A
(AM2) (2016- DG GROW Number of CA 3 3 N/A N/A
2020) Number of SNEs
Amount 2 026 700 N/A N/A N/A
Total contribution agreements Number of CA 4 4 N/A N/A
Number of SNEs
Service-level agreements
1. IUCLID 22.04.2020 3 200 000 15 months EFSA See section 4.6 Amount 1 305 505 771 836 N/A N/A
for EFSA Number of CA 3 4 N/A N/A
Number of SNEs
2. OEL 26.11.2019 120 000 18-24 Commission See section 4.3 Amount 240 000 N/A N/A N/A
per opinion months per DG EMPL Number of CA 3 3 N/A N/A
case Number of SNEs
Total service-level agreements Amount 1 545 505 771 836 N/A N/A

66
The human and financial resources of this annex form part of the resource allocation in Annex II using an FTE based approach: In order to achieve efficiencies between ECHA’s
legislative mandate under the five EU Regulations and the one EU Directive within its mandate, as well as additional tasks carried out on behalf of the Commission under various
cooperation agreements, the Agency applies a FTE-based accounting approach, utilising a time tracking system to enable the correct reporting of the time spent on the various tasks.
This also ensures that those staff members with the best expertise in a given topic work on these tasks. Finally, the tasks that ECHA carries out on behalf of the Commission under
such cooperation agreements are not part of the establishment plan of the Agency.
Programming Document(s) 2021-2024 146

Number of CA 6 7 N/A N/A

Number of SNEs
Amount 3 572 205 771 836 N/A N/A
Number of CA 11 12 N/A N/A
TOTAL
Number of
SNEs
Programming Document(s) 2021-2024 147

Annex XII: Strategy for cooperation with third countries and/or

international organisations

Overview
Article 77(2)(l) of the REACH Regulation and Article 76(1)(h) of the BPR Regulation foresee in
terms of tasks, among others, for the ECHA Secretariat: “at the Commission's request, providing
technical and scientific support for steps to improve cooperation between the Community, its
Member States, international organisations and third countries on scientific and technical issues
relating to the safety of substances, as well as active participation in technical assistance and
capacity building activities on sound management of chemicals in developing countries.” In
addition, Article 13 of the REACH Regulation underlines the importance of OECD Test Guidelines
and tools for an effective implementation of chemicals legislation and hence the operational need
to ensure such are developed.

Furthermore, Articles 6(1)(e) and 21 of the Prior Informed Consent Regulation (PIC) as well as
Articles 11(1) and 12 of the Persistent Organic Pollutants Regulation (POP) stipulate a need for
Commission, Member States and the Agency to address the needs of developing countries, to
cooperate in promoting technical assistance and training to support the development of
necessary infrastructure, capacity and expertise to manage chemicals properly throughout their
life cycles.

The aim of ECHA’s international cooperation activities is, therefore, to support the
implementation of the legislation within ECHA’s remit, and to provide technical and scientific
support to the European Commission in the implementation of the EU’s international agenda.
Since 2014 an exchange of letters between the Commission services and ECHA sets out the
framework for ECHA’s international activities 67. In 2021 and 2022 the Agency foresees resources
of 2.5 FTE in the development of standards and tools for risk assessment and 0.5 FTE for
scientific support to the Commission and EU agenda for international chemical management.
Any additional activities are contractually agreed under specific grant agreements. Currently this
is the case for ECHA’s work under the Instrument for Pre-Accession to the EU (IPA), see section
4.4 of the Work Programme above.

ECHA focuses on contributing to the international development and harmonisation of tools and
methods needed for an effective implementation of EU legislation. This is done through
agreement on international standards and tools which are benefitting not only the EU, but
authorities and industry beyond EU borders. Common technical standards, tools, and practices
save resources by reducing trade barriers and allow for test results and assessments to be shared
between jurisdictions.

This work is predominantly done via the OECD Chemicals Programme. However, it is also
underpinned by bilateral engagements with peer agencies in other OECD countries (US, Canada
and Australia among others).

ECHA provides furthermore support to the European Commission in the implementation of the
Rotterdam and Stockholm Conventions and for the United Nations Globally Harmonised System
for Classification and Labelling of Chemicals (UN GHS). In addition, ECHA provides, at the
request of the Commission, technical and scientific support for the Commission under the
Strategic Approach to International Chemicals Management (SAICM) and the forthcoming
“beyond 2020” framework.

Main actions and outputs 2021 and 2022

Contribution to world-wide development of standards and tools for risk assessment of

67
The Secretariat is currently discussing with the Commission services an update of this exchange of letters.
Programming Document(s) 2021-2024 148

chemicals

• Continued contributions to the OECD Chemicals Programme via the Joint Meeting,
relevant Working Parties (especially those for Hazard Assessment, Exposure Assessment,
Risk Management, and Nanomaterials) Test Guidelines programme, and the relevant
expert groups and project working under them. [2021, 2022]
• Ensure progressive maintenance of IUCLID to incorporate (international) regulatory
requirements (e.g. adaptations to new requirements following the amendment of REACH
Annexes, other technical and scientific progress under REACH and CLP such as the PCN
format or requirements from our OECD international partners). In close collaboration with
the OECD, further position IUCLID at the heart of the Global Chemicals Knowledge Base
that is under development. [2021, 2022]
• Contribute to OECD activities related to further development of alternatives and
integration of regulatory relevant alternatives in the OECD test guidelines [2021, 2022]
• Jointly -coordinate and contribute to an activity 68 together with US EPA and Health
Canada to further investigate the use new alternative methods in regulatory processes
• Promote alternatives to animal test methods through the OECD QSAR Toolbox, e.g. by
integrating developed adverse outcome pathways or extending its applicability to other
types of substances. [2021, 2022]
• Continue providing input to the work performed at the OECD level on safe and sustainable
chemistries and disseminate the outcomes. [2021, 2022]
• Maintain and further develop the OECD Global Portal to Information on Chemical
Substances (eChemPortal). Further automate the synchronisation with ECHA’s
dissemination website to increase efficiency. [2021, 2022]
• Further develop methodologies related to socio-economic analysis in particular in the
context of the OECD. This comprises both the valuation of health and environmental
endpoints and learning lessons from regulatory risk management cases in different OECD
member countries.

Scientific support to the Commission and EU agenda for international chemical

management

• Support the Commission in their participation to the 10th Conference of the Parties to
the Rotterdam Convention [2021], the Chemical Review Committee’s work, and the
international capacity building activities. [2021, 2022]
• Support to the Commission when they or a party proposes substances for inclusion in the
Stockholm Convention and related work. [2021]
• Provide scientific and technical support to the Commission in the context of the further
development of the United Nations Globally Harmonised System of classification and
labelling of chemicals (UN GHS), including the work of selected GHS working groups,
notably the working group on the use of non-animal testing methods for classification.
[2021, 2022]

Capacity building in support of developing chemical management systems in third

countries

• Continue developing, in close cooperation with Commission services, a more systematic

approach for capacity building towards third countries. ECHA thereby plans to start

68
Accelerating the Pace of Chemicals Risk Assessment (APCRA) https://www.ncbi.nlm.nih.gov/pubmed/29600706.
Programming Document(s) 2021-2024 149

gaining practical experience through a capacity building project preferably to carried out
with international partners such as the World Health Organisation (WHO) and/or the
United Nations Institute for Training and Research (UNITAR), EU Member States and
potentially also through engagement of relevant industry actors (ICCA/Cefic). Based on
practical experience gained, ECHA will assess how to best develop further such activities.
• Develop, with the relevant commission services, a framework for ECHA to enable support
to third countries by the use of the European Neighbourhood instrument, TAIEX or
Twinning project to contribute to improve chemicals safety in the region. Such work would
also aim at increasing the harmonisation of technical standards for chemicals which is a
fundament for trade between neighbouring countries and the EU.
• Continue to support (potential) EU accession candidate countries through the Instrument
for Pre-accession assistance (IPA) as outlined in the grant agreement agreed between
the Agency and the Commission with an extension under IPA II until June 2022. The in-
depth study to assess their readiness and capacity to implement and enforce the EU
acquis for chemicals in Montenegro and Serbia has produced an action plan to address
identified gaps leading up to their accession. A similar study will be conducted in the
remaining 5 beneficiaries. These action plans are foreseen to guide ECHA support to (pre-
)candidate countries under the IPA framework in the years to come. The action plans are
expected to enable a more tailored support and also increase ownership among the
beneficiaries for the gaps identified.
The two studies under IPA funds have significantly enhanced ECHA's organisational
knowledge with regards to challenges facing countries developing legal frameworks for
chemicals and what methodologies are relevant for capacity building in general.
Programming Document(s) 2021-2024 150

Annex XIII: Performance indicators

1.1 Dossier preparation

indicator type estimate 2021 estimate 2022
Effective working time for processing inquiries performance 0.35 person day/inquiry 0.3 person day/inquiry
Inquiries received and concluded output 4 200 4 200

1.2 Registration and dossier submission

indicator type estimate 2021 estimate 2022
Number of PPORD notifications input 340 340
Number of C&L notifications received input 25 000 26 000
Number of Registration dossiers received (incl. updates) input 13 500 13 500
Effective working time for processing a registration dossier (first performance 0.60-0.70 person days 0.60-0.70 person days
submission)
Registrations stopped for manual verification at technical input 5 800 5 800
completeness check
Number of registrations failing first technical completeness check output 1 860 1 860
Share of registration dossiers over 100 tonnes in the database that outcome 48% 56%
has passed the enhanced technical completeness check

1.3 Screening and prioritisation

indicator type estimate 2021 estimate 2022
Number of substances registered above 100 t/y for which a outcome TBD TBD
conclusion on potential regulatory follow-up was drawn
Number of groups of substances taken into the screening process outcome 70 70

1.4 Evaluation
indicator type estimate 2021 estimate 2022
Compliance checks concluded: draft decisions or no action output 300 300
Final decisions on dossier evaluation (testing proposals and output 300 300
compliance checks)
Number of substances for which a conclusion was reached in the outcome 200 200
follow-up to dossier evaluation
Substance evaluation final decisions issued output 15 15
Number of substances for which a conclusion was reached in outcome 15 15
substance evaluation
Programming Document(s) 2021-2024 151

1.5 Authorisation
indicator type estimate 2021 estimate 2022
Number of new entries in the Candidate List output 15 15
Recommendation for inclusion of substances in the authorisation output 1
list
Cumulative number of downstream user notifications of authorised outcome 3 000 3 000
uses of SVHCs
Number of RAC & SEAC opinions adopted on applications for output 50 50
authorisation (number of uses)
Effective working time of ECHA staff per opinion performance 38-46 person days 38-46 person days
Applications for authorisation received (number of uses) input 60 35

1.6 Restrictions
indicator type estimate 2021 estimate 2022
Number of RAC & SEAC opinions on restriction proposals output 2** 10
Restriction proposals 69(1) or reports developed under Article output 4 4
69(2)
Effective working time of ECHA staff per opinion (ECHA dossier)* performance 240-290 person days 240-290 person days
Effective working time of ECHA staff per opinion (Member State performance approx. 200 person days approx. 200 person days
dossier)*
* The effective working time per dossier depends greatly on the complexity of the dossier.
** This is lower than in previous years as the number of dossiers prepared was lower in 2020 than expected due to reasons beyond the control of ECHA.

1.7 Classification and Labelling

indicator type estimate 2021 estimate 2022
Number of RAC opinions on proposals for harmonised classification output 65 65
and labelling
Decisions made on requests to use alternative (Art 24) output 40 40
Effective working time for processing RAC opinions performance 45-55 person days 45-55 person days
Proposals for harmonised classification and labelling input 70 70

1.9 Data management and dissemination

indicator type estimate 2021 estimate 2022
Number of user page views for published information on chemicals outcome 48.0 M 48.0 M
Description and number of data requests outcome Internal:60 Internal:60
External: 30 External: 30
Average time taken for publication (days) performance 3 3
Programming Document(s) 2021-2024 152

2. Biocides
indicator type estimate 2021 estimate 2022
Number of BPC opinions on active substances approval output 38 52
Number of BPC opinions on the renewal of active substances output 4 6
approval
Number of BPC opinions on Article 15, Article 38 and Article output 20 20
75(1)(g) requests
Number of BPC opinions on Union authorisation of biocidal products output 26 35
Number of ECHA opinions on Union authorisations (same biocidal output 36 48
products, administrative and minor changes)
Support actions on evaluation of Active substance approvals output 23 23
Support actions on evaluation of Union authorisation applications output 3 3

3.1 PIC – prior informed consent

indicator type estimate 2021 estimate 2022
Scientific and technical support provided to the Commission, EU output 3 600 3 800
and non-EU DNAs
Export notifications processed (validated, rejected, resubmissions) output 13 200 14 500
Share of notifications validated/accepted by ECHA outcome 90% 90%

4.1 EU Observatory for Nanomaterials

indicator type estimate 2021 estimate 2022
All traffic to EUON websites input 70 000 69 70 000

4.3 Support to occupational health legislation

indicator type estimate 2021 estimate 2022
Number of OEL requests received under SLA output 3-5 3-5
Number of RAC opinions on OELs completed output 2 3-5

5.1 Forum
indicator type estimate 2021 estimate 2022
Number of enforcement trainers trained by the Forum output 25 70 55/80 71

69 Traffic to the EUON’s main site.

70
25 is the estimate of BPR trainers. Only BPR training will be delivered in 2021.
71
55 is the estimate for REACH and CLP trainers and 80 the estimate for REACH, CLP and BPR trainers subject to budget availability.
Programming Document(s) 2021-2024 153

5.3 Management
indicator type estimate 2021 estimate 2022
Areas where audits and evaluations results (including prevention of intermediate impact 4
conflicts of interest and fraud) have been taken into account in
future strategic decisions
Combined neutral and positive feedback monitored in media outcome >90% >90%
publications
Website unique visitors / traffic to the web content outcome 4.0 M 4.1 M

5.5 Financial resources

indicator type estimate 2021 estimate 2022
Level of budget implementation: commitment rate and cancelled performance min. 95% and max. 5% min. 95% and max. 5%
carry-over rate respectively respectively
Processing of payments within legal deadlines performance no less than 99% no less than 99%

5.6 Human resources

indicator type estimate 2021 estimate 2022
Percentage of Establishment Plan posts filled performance 95% 95%
Turnover of Temporary Agents performance <5% <5%
Turnover of Contract Agents performance <10% <10%
EUROPEAN CHEMICALS AGENCY
P.O. BOX 400,
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