STATEMENT OF FORMULA
Product Name : ASEAN FACIAL WATER Function Skin-Conditioning Skin-Conditioning Fragrance Preservative Preservative Solvent % w/w 10.0 2.0 0.5 0.3 0.1 q.s.to 100 100
Ingredient Acacia Senegal Gum Extract Butylene Glycol Perfume (Rose ver 1) Sodium Benzoate Methylparaben Water Total
The supplier of the perfume (Rose ver 1) is Max Fragrance Co. Ltd..
Part I . B Qualitative and Quantitative formula in INCI or ACD approved nomenclature. For Fragrance material, name and code number with the identity of the supplier. Part III. A Qualitative and Quantitative formula in INCI or ACD approved nomenclature. Should specify function of each raw material / ingredient.
Manufacturing Procedure
Product Name: ASEAN Facial Water
Manufacturer Name: ASEAN Thailand Co., Ltd. Address: 64846 Big Street, Bangkok, Thailand 18445
Description of the Process: 1. Add Phase 1 ingredients into Main Mix Tank and mix to dissolve completely. 2. Add Phase 2 to Main Mix Tank and mix to dissolve completely. 3. Add Phase 3 to Main Mix Tank and mix. 4. Transfer bulk product to storage tank.
Ingredient List: Phase
Phase 1 Phase 2 Phase 3
Ingredients
Butylene Glycol, Methylparaben, Water,
Acacia Senegal Gum Extract, Sodium Benzoate
Perfume
Part III. B Manufacturing Manufacturer contact details: name, country and address of manufacturer, assembler and packager Summary of the manufacturing process
FINISHED PRODUCT SPECIFICATIONS
PRODUCT NAME: ASEAN FACIAL WATER
SPECIFICATION Appearance Odor pH Specific Gravity Microbial Content Test (a) Total Plate Count (b) Specific bacteria not to be found - E.Coli - Pseudomonas aeruginosa - Staphylococcus aureus - Candida albicans
RELEASE CRITERIA A yellowish, clear lotion Match to standard 4.0 6.0 0.99 - 1.05
ANALYTICAL METHOD NUMBER 1476468 2846466 1649686 2987147
<= 100 cfu /g
9184535 9413173
Not Detected /0.1 ml sample Not Detected /0.1 ml sample Not Detected /0.1 ml sample Not Detected /0.1 ml sample
Part III. C Specification and test methods of the finished product
ASEAN COMPANY
Analytical Method
1476468
Appearance
PRINCIPLE AND SCOPE This method describes the procedure to be followed in comparing the physical appearance of a material with the physical description for that material in its given specification. PROCEDURE Open the sample and observe the actual material. If the material is adequately described by the specification, report as "PASS." If the material differs from the description given in the specification, report as "FAIL."
ASEAN Company
Analytical Method 9184535
Microbial Content Test Specific Bacteria Identification
PRINCIPLE AND SCOPE
This testing method has been prepared for checking the existence of specific bacteria in cosmetics by incubating the samples. After the cultivation, the growth of microorganisms or micro tubes is investigated.
APPARATUS
Clean bench Dry-heat sterilizer High-pressure steam sterilizer
CRITERIA (SUGGESTED TYPE OR SOURCE)
capable of maintaining 160 ~ 180 C capable of maintaining 121 C by pressurizing one atmosphere
Thermostat, 2 units Thermobath pH meter Microscope Stereoscopic microscope Balance Gas burner Colony counter Stirrer Pipette Inoculating loop
capable of maintaining 20 ~ 25 C, 30 ~ 35 C respectively capable of maintaining 40 ~ 50 C
capable of using 100-fold objective lens magnification being 2 ~ 50-fold capable of weighing 0.001g ~ 1,000g
stirring rod, stirrer beads
inoculating needle, Nichrome wire, and pre-sterilized plastic
Conradi Deltoid flask Rubber plug for deltoid flask Test tube Rubber plug for test tube Metal plug Cotton plug Messpipette Messcylinder
L-shaped glass, pre-sterilized plastic
rubber-like silicon plug
silicone plug
cap
glass product, pre-sterilized plastic product
Beakers Slide glass Glass beads Spatula Scissors Tweezers
PROCEDURE FOR MEASRUREMENT
E. Coli. growth and confirmation medium Lactose bouillon (LB) medium Meat extract Gelatin peptone Lactose Water 3.0g 5.0g 5.0g 1,000mL
Pseudomonas aeruginossa confirmation medium Cetrimide agar Gelatin peptone Magnesium chloride Potassium sulfate Cetrimide Agar Water Glycerin 20.0g 3.0g 10.0g 0.30g 13.6g 1,000mL 10mL
Staphylococcus aureus differntial medium Vogel-Johnson agar (V-J) Casein peptone Yeast extract D-mannitol Potassium monohydrogen phosphate Lithium chloride Glycine Phenol red Agar Water 10.0 g 5.0 g 10.0 g 5.0 g 5.0 g 10.0 g 0.025 g 16.0 g 1,000 ml
Candida albicans differential medium Pyocianin detection pseudomonas agar Casein peptone
Meat peptone Potassium hydrogen phosphate Magnesium sulfate Agar Water Glycerine
10.0g 1.5g 1.5g 15.0g 1,000mL 10mL
Sample Preparation and Measurement
1. E.coli To 1 g or 1 ml of a sample, add to the medieum to obtain a 10 to 100 ml sample solution. The solution is then cultured at 30 to 35 C for 24 to 72 hours. The result of the test on Escherichia coli is considered negative if no red-brick colonies of Gram negative bacteria with reddish precipitation lining the peripheral area are detected.
2. Pseudomonas aeruginosa 1 g or 1 ml of a sample is weighed out and added to medium containing no bactericides in order to obtain a 10 to 100 ml solution. The solution is then cultured at 30 to 35 C for 24 to 72 hours. If no growth of microorganisms is observed, the sample is considered to be Pseudomonas aeruginosa-negative.
3. Staphylococcus aureus 1 g or 1 ml of a sample is weighed out and added to containing no bactericides in order to obtain a 10 to 100 ml solution. The solution is then cultured at 30 to 35 C for 24 to 72 hours. If the black colored colony surrounded with yellow area is not found, the sample is considered to be Staphylococcus aureus-negative.
4. Candida albicans To 1 g or 1 ml of a sample, add to medium to obtain a 10 to 100 ml sample solution. The solution is then cultured at 30 to 35 C for 24 to 72 hours. If the black or green colony is not found, the sample is considered to be Candida albicans-negative.
ASEAN Company
Analytical Method 9184535
Microbial Content Test Total Plate Count
PRINCIPLE AND SCOPE
This testing method has been prepared for measurement of the total number of bacteria and fungi existing in cosmetics by incubating the samples.
APPARATUS
Clean bench Dry-heat sterilizer High-pressure steam sterilizer
CRITERIA (SUGGESTED TYPE OR SOURCE)
capable of maintaining 160 ~ 180 C capable of maintaining 121 C by pressurizing one atmosphere
Thermostat, 2 units Thermobath pH meter Microscope Stereoscopic microscope Balance Gas burner Colony counter Stirrer Pipette Inoculating loop
capable of maintaining 20 ~ 25 C, 30 ~ 35 C respectively capable of maintaining 40 ~ 50 C
capable of using 100-fold objective lens magnification being 2 ~ 50-fold capable of weighing 0.001g ~ 1,000g
stirring rod, stirrer beads
inoculating needle, Nichrome wire, and pre-sterilized plastic
Conradi Deltoid flask Rubber plug for deltoid flask Test tube Rubber plug for test tube Metal plug Cotton plug Messpipette
L-shaped glass, pre-sterilized plastic
rubber-like silicon plug
silicone plug
cap
glass product, pre-sterilized plastic product
Messcylinder Beakers Slide glass Glass beads Spatula Scissors Tweezers
PROCEDURE FOR MEASRUREMENT Sample Preparation Take the sufficient amount of product, neutralize the preservatives and dilute.
Soybean-Casein-Digest Agar (SCDA) Casein peptone Soybean peptone Sodium chloride Agar Water 15.0g 5.0g 5.0g 15.0g 1,000mL
Total Plate Count
Sterilized plates are used in this test method. In order to obtain accurate plate counts, two or more agar plates are used per dilution level. 1ml or 1 g of a sample, a solution of the sample or a dilution of the sample solution are sterilely pipetted into the plates. Next, 15 to 20 ml of previously sterilized and molten agar at a temperature of 40 to 45 are added to the plates. The mixture is then stirred until it becomes
homogeneous. After solidification of the agar, the plates are cultured under the prescribed conditions of culture temperature and time.
Bacterial colonies are generally counted after cultivation at 30 to 35 C for at least five days. Fungous colonies are counted after cultivation at 20 to 25 C for at least five days.
ASEAN Company
Analytical Method # 1649686 pH
PRINCIPLE AND SCOPE
The classical definition of pH is -log [H+ (aq)]. For the practical purposes, it can be thought of as the value given by a suitable, properly standardized, potentiometric instrument, which uses an indicator electrode. Measurements are typically made at 25 C.
APPARATUS
pH Meter Electrode
CRITERIA (SUGGESTED TYPE OR SOURCE)
Capable of reading +/- 0.01 pH units General Purpose
REAGENTS AND SOLUTIONS
Water (if sample dilution is required)
GRADE & TYPICAL SOURCE
Distilled or deionized water
PROCEDURE
Instrument Operation Follow the electrode manufacturers instructions to operate the meter.
Operation Before use, the pH meter should be standardized. pH varies with temperature, the variation being greatest with high pH buffers.
Preparation of Samples If no dilution is required in the finished product specifications, the product is to be analyzed at full concentration. If dilution is required, distilled water must be used for dilution unless directed. Analysis Place the electrode in the sample, wait for the reading to stabilize and record the sample pH. Remove the electrode for the sample and immediately rinse with distilled water.
ASEAN Company
Analytical Method # 2846466 Odor
PRINCIPLE AND SCOPE This method describes the procedure to be followed in comparing the odor of a material with the description for that material in its given specification. When there is no written description, the material is compared to a standard.
PROCEDURE Prepare the sample for evaluation as is appropriate to that particular material. The sample is graded versus the approved standard. Carefully sniff the sample and the standard. If the material is matches to the standard, report as "PASS." If the material differs from the standard, report as "FAIL."
ASEAN Company
Analytical Method 2987147
Specific Gravity
PRINCIPLE AND SCOPE The density of a substance measures its mass per unit volume. the ratio of its mass to that of an equal volume of water at 4C. The specific gravity of a substance is Density has units of kg/Liter or g/mL.
Specific gravity, however, is unitless. The principle of the digital densitometer is based on the change of the natural frequency of a hollow, U-shaped oscillator when filled with different liquids.
APPARATUS Digital density meter Syringes
CRITERIA (SUGGESTED TYPE OR SOURCE)
Suitable for density meter tube
PROCEDURE FOR MEASRUREMENT Calibration This should be checked using water. Compare the result obtained at the measurement temperature with the table value given in the instrument manual.
Temperature Equilibration High differences in temperature between oscillator and sample lead to erroneous results. The density reading will only be valid when the temperature indicated for the oscillator filled with the sample does not differ by more than + 3C from the temperature initially displayed for the empty oscillator. Filling the Sample Tube Fill the sample to the tube using the suitable syringes. measuring cell. Ensure that there are no air bubbles in the If the density display does not show properly, the oscillator tube is not properly filled
and the filling procedure must be repeated.
Reading density and specific gravity The display on density meter shows the density of the sample. the densities of sample and water at the same temperature. Density of sample specific gravity = ________________ Density of Water Specific gravity can be calculated with
Stability Assessment
Product Name: ASEAN Facial Water
Formula Code/Version: 1689748 -001 --------------------------------------------------------------------------------------------The product shelf life is expected to be 2 years with the rationale below.
Rationale: Samples had been stored at 40 C / 75% RH for 6 months. were within specification. It was confirmed all the results As the confirmatory assessment, samples had been stored at 25
C / 60 % RH for 2 years, with all favorable results within specification.
Part III. D Product Stability Summary Report for product durability below 30 months The stability testing data and report or stability assessment to support the expiry dates
