EDIBLE OIL PROCESSORS FORTIFICATION IMPLEMENTATION GUIDE
EDIBLE OIL PROCESSORS FORTIFICATION IMPLEMENTATION GUIDE
Aim: to show the steps on how to produce the fortified edible oil and get the product registration certificate prior getting into the market.
Scope: this guide is applicable to edible oil processors to produce fortified edible oil and to get the product registration certificate.
Core Activities Detailed criteria needed Purpose Service provider Duration
Continuous -microdosing Capable of delivering premix with installed production To buy effective o Edible oil machinery suppliers 1-3
pump/micro-dozer capacity - compatible with the production capacity and efficient o But not limited to above months
(≥ 200 MT/day production Directions for installation and maintenance in desired dossifier suppliers only/and others
capacity) language or can be translated.
All surfaces in-contact with premix are food-grade and
non-corrosive.
Adjustable delivery control for calibration.
220 volts ± 10% 50/60 Hz single & 400 volt ± 20% for
three phase power
Easy accessibility for operator to check pre-blend and
flow rate
Batch Mixing – mixer. Capable of delivering premix with installed production To buy effective o Local manufacturers and 1-3
capacity - compatible with the production capacity and efficient suppliers, dominantly months
Directions for installation & maintenance dossifier o Edible oil machinery suppliers
All surfaces in-contact with premix are food-grade and o With in the industry workshop.
non-corrosive.
Speed: 70-90 rpm, Time:30-40 min & Temperature: 40 oC
220 volts ± 10% 50/60 Hz single & 400 volt ± 20% for
three phase power
Easy accessibility for operator to check.
Dosing machine Select the appropriate installation area (5-10 meter To install o Supplier installation is highly 15-30
Installation before buffer or storage tank). properly preferable. days
o Continuous Installation shall be done supplier or by the qualified o Qualified technical professionals
technical professional.
Integrated with PLC system. Calibration shall be done by
Select the appropriate installation area. Ethiopian Metrology Institute (EMI) 2-5 days
Installation shall be done supplier or by the qualified
o Batch Mixing technical professional.
Shall be calibrated.
EDIBLE OIL PROCESSORS FORTIFICATION IMPLEMENTATION GUIDE
Premix purchase Prepare the storage facility for premix based on the To avail quality o Ethiopian Industry Input 1-3
recommended storage condition. & safe premix Development Enterprise (EIIDE): months
Order the premix based on food fortification premix and http://www.eiide.com.et/
fortificants specification - ES 6724 and fortified edible oil o BASF:
specification - CES 310 o Muehlenchemie:
Fulfill the regulatory requirements (Certificate of analysis https://muehlenchemie.com
(CoA), raw material, finished product & packaging o DSM:
material specification, stability study, material safety data https://www.dsm.com/corporate/
sheet, packing list, letter of declaration, certificate of home.html#
origin, commercial invoice, health certificate & technical o Mirpain Pina San.:
data sheet) https://mirpain.com
Shelf life – minimum 18 months remaining at dry port o Hexagon:
arrival. https://hexagonnutrition.com/
o Importers & distributors - local
suppliers
o But not limited to above
suppliers only/and others
Certificate of Competency The industry shall refer the EFDA pre-licensing directive. To get the CoC o Ethiopian Food and Drug 15 – 30
(CoC) application Submit the application and necessary documents using certificate Authority (EFDA): days
eRIS: www.eris.efda.gov.et http://www.efda.gov.et/
Pre-screening the application will be done, 2010 E.C
(Service fee, lease or map, employment agreement,
sanitary design, production process flow-chart, machine
installation design, bank statement or investment license,
food safety training).
If the above requirements fulfilled, onsite inspection will
be done. If not, the application we be returned to
applicant.
If the industry fulfilled, CoC will be issued or generated,
valid for 1 year.
The license shall be renewed on yearly bases.
EDIBLE OIL PROCESSORS FORTIFICATION IMPLEMENTATION GUIDE
Trial production Cleaning and maintenance of the micro-dozer or mixing To produce o Avail the premix & protective 1-5 days
tank. quality & safe materials from local supplies by
Make ready/avail the premix, product industry.
Prepare the necessary materials: sample bag, sensitive o Technical support will be
digital analytical balance, personal protective devices - provided by Food and Beverage
gloves, dust mask, hairnet, and gown. Industry Research and
Getting the fortification technical assistance (TA). Development Center
Produce the sample product. (FBIRDC)/qualified private
Perform or check the product compliance. consultant
o Using internal laboratory facility if any
o Third party lab. testing organization, if necessary
Product Certification Submit the application for conformity assessment bodies. To get the o Ethiopian Conformity 1-2
Review the application, correction of the gaps if any. certificate Assessment Enterprise (ECAE): months
Correction of the gaps https://ecae.org.et/
Make ready for site assessment, correction of the gaps if o Bless agri-food laboratory
any. service PLC:
Industry will be evaluated, and sample be sample taken. https://www.blesslaboratory.com/
getting certificate from conformity, o other accredited laboratory
Prepare for surveillance audit, quarterly bases
Application for registration Refer the food registration directive for fortified food and To get the o Ethiopian Food and Drug 1 month
fortificant control directive, 2016 E.C. registration Authority (EFDA):
Submit the application through: www.eris.efda.gov.et certificate http://www.efda.gov.et/
Requirements: CoC, ECAE product/Bless certificate,
EFDA audit inspection report, raw material and packaging
material specification, CoA from accredited laboratory,
stability study, labelling information based on CES 73 and
fortification logo.
Prescreening, if complies ready evaluation.
Document evaluation,
certificate generation, if complies the requirements. Valid
for 5 years.
