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Page 1 of 25
Cosmetic product safety report
Commercial Name: Wet wipes for intimate hygiene “AURA Beauty”, 20 pcs
Data issued: 09.05.2018.
Page 2 of 25
PART A - COSMETIC SAFETY REPORT
1. Qualitative and quantitative composition of the cosmetic product
INCI name Trade Name CAS number Function Concentration, (%)
Aqua Water 7732-18-5 Solvent to 100
Cetearyl Isononanoate Emulgade CM 111937-03-2 Emulsifiers 0.150 -0.300
Ceteareth-20 Emulgade CM 68439-49-6 Emulsifier 0.075 – 0.150
Ceterayl Alcohol Emulgade CM 67762-27-0 Emulsifier 0.075 – 0.150
Glyceryl Stearate Emulgade CM 31566-31-1 Emulsifier 0.015 – 0.075
Glycerin Emulgade CM 56-81-5 Emulsifier 0.015 – 0.075
Cetyl Palmitate Emulgade CM 95912-87-1 Emulsifier < 0.015
Ceteareth-12 Emulgade CM 68439-49-6 Emulsifier < 0.015
Polysorbate 20 Eumulgin SML 20 9005-64-5 Emulsifier, Solubilizer
0.300
Panthenol D-Panthenol 75 W 81-13-0 Skin Care
Component 0.100
Aloe Barbadensis Leaf Extract
Glycolic extract of aloe vera gel
85507-69-3 Skin Care
Component 0.150
Chamomilla Recutita Flower Extract
Chamomile Glycol extract
84082-60-0 Skin Care
Component 0.150
Phenoxyethanol Roconsal LJ-4 122-99-6 Preservative 0.075 – 0.120
2-Bromo-2-nitropropan-1,3-diol
Roconsal LJ-4 65-85-0 Preservative
0.030 – 0.045
Iodopropynyl Butylcarbamate
Roconsal LJ-4 520-45-6 Preservative
0.009
Lactic Acid Purac 80 79-33-4 Buffering 0.0318 – 0.0322
Parfum Silky Hands 471168
WS - Fragrance 0.15
Page 3 of 25
2. Physical/chemical characteristics of the cosmetic product
Fabric:
Parameter Result
Appearance Non-woven fabric with embossing
Color From white to light yellow
Composition, % 40% viscose / 60% polyester
Perfume Neutral
Weight, g/m2 45 ±5
Width, mm 150 ±5
Hydrogen generator, pH 6,0 – 7,0
Technological solution:
Parameter Result
Appearance Transparent, with a light blue hue
Perfume Properly used fragrance
Hydrogen generator, pH 4,5 – 7,0
Cosmetic product:
Parameter Result
Appearance, color Wipe made from non-woven fabric, color from white to light yellow, evenly impregnated with solution.
Perfume Properly used fragrance
Hydrogen generator, pH 4.5-7.0
Moisture content, at least, % 50
Wipes dimension, mm: length width
185±5 150±5
Page 4 of 25
3. Microbiology quality
Parameter Method Result
Candida albicans LVS EN ISO 18416:2009
Not detected in 0.5g (Sabouraud dextrose chloramphenicol agar)
Escheria coli LVS EN ISO 21150:2009
Not detected in 1g (MacConkey agar)
Mesophilic aerobic bacteria count LVS EN IS 21149:2009
<1 CFU/0,5g (Tryptone soy agar)
Pseudomona aeruginos LVS EN ISO 22717:2009
Note detected in 0,5g (Cetrimide agar)
Yeasts and molds ISO 16212:2008
<10 CFU/1g (Sabouraud dextrose chloramphenicol
agar)
Spahylococcus aureus LVS EN ISO 22718:2009
Not detected in 0,5g (Baird-Parker agar)
The cosmetic complies with the microbiological requirements Expected result (according to the
recommendations for cosmetic classified in Category 2).
Challenge Test (PN-EN ISO 11930:2012) - result confirms the effectiveness of conservation.
4. Stability of the cosmetic product and compatibility with package
Stability of the cosmetics product Stability test:
+40oC / +5oC – 4 weeks
No physicochemical changes. Stable
Compatibility with packaging Compatibility test: +40oC / +5oC – 4 weeks
No physicochemical changes. Consistent.
Shelf life is 2 years from the manufacturing date.
Page 5 of 25
5. Impurities, traces, information about the packaging material
Package and sticker:
PACKAGE
Parameter Result
Thickness, µm 68
Material grammage, g/m2 71,84
Composition PET 12 / PE 50
STICKER
Width, mm 45
Length, mm 86
Composition Fasson PP90 TOP Clear-R1490M-BG40WH
Print method Flexographic printing, UV
Material thickness, µm 92
Material grammage, g/m2 83
Possible contamination with prohibited substances, such as heavy metals or residues of prohibited
substances, which are permitted only in trace amounts, provided that their number from a technological
point of view (manufacturing process) is inevitable.
The content of undesirable substances, heavy metals resulting from the contamination of raw materials
and the migration of the material in contact with the cosmetic product should not affect the safety of the
cosmetic.
6. Normal and reasonably foreseeable use
Cosmetic product designed for hygiene / refreshing – wet wipes.
A detailed description of the application on the product packaging.
7. Exposure to the cosmetics product
The reasonably foreseeable use Wet wipes
The foreseeable amount of product applied 0,530 g
The estimated number of application per day 5
Relative amount applied per day 44.167 mg/kg/day
The site of application Product for hygiene;
Possible contact with mucous membranes
The surface of area of application 800 cm2
Exposure per day 3.312 mg/cm2
Rinse off / Leave on Leave on
Retained material per day 3.312 mg/cm2
Retention factor 1
Page 6 of 25
Routes of exposure (intentional and accidental):
Skin Contact.
Eye contact
Ingestion
Inhalation – unlikely that inhalation will be a rout of exposure
8. Toxicological profile of the substances
INCI name CAS numbers NOAEL mg/kg bw/day
SED mg/kg bw/day
MoS >100
Aqua 7732-18-5 - - -
Cetearyl Isononanoate 111937-03-2 1000 0,132 7 575
Ceteareth-20 68439-49-6 500 0,066 7 575
Ceterayl Alcohol 67762-27-0 1000 0,066 15 151
Glyceryl Stearate 31566-31-1 1000 0,033 30 303
Glycerin 56-81-5 1000 0,033 30 303
Cetyl Palmitate 95912-87-1 300 0,0066 45 454
Ceteareth-12 68439-49-6 500 0,0066 75 757
Polysorbate 20 9005-64-5 2000 0,132 15 151
Aloe Barbadensis Leaf Extract
85507-69-3 - - -
Chamomilla Recutita Flower Extract
84082-60-0 - - -
Phenoxyethanol 122-99-6 Annex V / 29. Max. authorized concentration: 1.0%
2-Bromo-2-nitropropan-1,3-diol
52-51-7 Annex V / 21. Max. authorized concentration: 0.1%
Iodopropynyl Butylcarbamate
55406-53-6 Annex V / 56. Leave-on products maximum concentration 0.01%
Lactic Acid 79-33-4 500 0,0142 35 211
Parfum - - - -
Page 7 of 25
9. Toxicological profile of substances
TRADE NAME: EMULGADE CM
INCI NAME: Cetearyl Isononanoate
CAS: 111937-03-2
EINECS: -
STRUCTURAL FORMULA:
INCI NAME: Ceteareth-20
CAS: 68439-49-6
EINECS: -
STRUCTURAL FORMULA:
INCI NAME: Cetearyl alcohol
CAS: 67762-27-0 / 8005-44-5
EINECS: 267-008-6 / -
STRUCTURAL FORMULA:
where n=2…100 and m=15 or 17
Page 8 of 25
INCI NAME: Glyceryl Stearate
CAS: 1566-31-1
EINECS: 250-705-4/286-490-9
STRUCTURAL FORMULA:
INCI NAME: Glycerin
CAS: 56-81-5
EINECS: 200-289-5
STRUCTURAL FORMULA:
INCI NAME: Cetyl Palmitate
CAS: 540-10-3
EINECS: 208-736-6
STRUCTURAL FORMULA:
Page 9 of 25
INCI NAME: Ceteareth-12
CAS: 68439-49-6
EINECS: -
STRUCTURAL FORMULA:
INCI NAME: Benzoic Acid
CAS: 65-85-0
EINECS: 200-618-
STRUCTURAL FORMULA:
Physical and chemical properties
Form: liquid
Odour: almost odourless
Colour: white
pH value: 3,0 – 3,3 (20oC)
Melting point: not determined
Boiling point: > 100 oC
Flash point: > 100 oC Aqueous preparation
Flammability: not flammable
Density: 0,970 - 0,980 g/cm3 (20oC)
Page 10 of 25
Margin of Safety
NOAEL
Cetearyl Isononanoate 1000 mg/kg b.w./day
Ceteareth-20 500 mg/kg b.w./day
Cetearyl alcohol 1000 mg/kg b.w./day
Glyceryl Stearate 1000 mg/kg b.w./day
Glycerin 1000 mg/kg b.w./day
Cetyl Palmitate 300 mg/kg b.w./day
Ceteareth-12 500 mg/kg b.w./day
Toxicological Summary:
Routes of entry for solids and liquids are ingestion and inhalation, but may include eye or skin
contact. Routes of entry for gases include inhalation and eye contact. Skin contact may be a route
of entry for liquefied gases.
PRIMARY ROUTES OF ENTRY: Dermal contact. ACUTE ORAL TOXICITY: LD50 > 2000 mg/kg PRIMARY SKIN IRRITATION: Not irritating to the skin PRIMARY EYE IRRITATION: Not irritating to eyes SKIN SENSITIZATION: Not sensitizing
Page 11 of 25
TRADE NAME: Eumulgin SML 20
INCI NAME: Polysorbate 20 CAS: 9005-64-5
EINECS: 500-018-3
STRUCTURAL FORMULA:
Physical and chemical properties
Form: liquid
Odour: slight odour
Colour: slight yellow
pH value: 6,0 – 7,5 Potassium chloride solution 0,03%, 20oC)
Melting point: approx.. 15oC
Boiling point: > 100 oC
Flash point: > 101 oC
Flammability: not flammable
Density: 1,0 – 1,2 g/cm3 at 20oC
Solubility in water: soluble
Margin of Safety
NOAEL 2000 mg/kg b.w./day
Page 12 of 25
Toxicological Summary:
EUMULGIN® SML 20 (INCI: Polysorbate 20) is mainly used as a foaming agent in toothpaste, mouth gargles, and body cleansing preparations.
ACUTE ORAL TOXICITY: Assessment of acute toxicity: Virtually nontoxic after a single ingestion. Experimental/calculated data: LD50 2000 mg/kg (rat) PRIMARY IRRITATION:
Assessment of irritating effects: Not irritating to the skin. Nor irritating to the eyes
Experimental/calculated data: Skin corrosion/irritation rabbit: non-irritant Serious eye damage/irritation rabbit: Slightly irritating. RESPIRATION/SKIN SENSITIZATION:
Assessment of sensitization: There is no evidence of a skin-sensitizing potential.
TRADE NAME: D-Panthenol 75 W INCI NAME: Panthenol
CAS: 81-13-0, 7732-18-, 77-92-9
EINECS: -
STRUCTURAL FORMULA:
Physical and chemical properties
Form: liquid
Odour: characteristic
Colour: slightly tellowish
pH value: 5,5 – 7,0
Flash point: > 101oC (Aqueous preparation)
Flammability: Based on the structure or composition there is no indication of flammability
Density: approx. 1.16 g/cm3 (25 °C)
Solubility in water: readily soluble
Page 13 of 25
Margin of Safety
NOAEL – 1000 mg/kg b.w./day
Toxicological Summary:
D-Panthenol W 75 is an aqueous solution of D-Panthenol stabilized with citric acid.
The active ingredient in the product is D-Panthenol, and the toxicological data provided below refer
only D-Panthenol.
ACUTE ORAL TOXICITY: LD50 > 10000 mg/kg (rat) ACUTE DERMAL TOXICITY: LD50 > 2000 mg/kg (rat) ACUTE INHALATION TOXICITY: no mortality after 7 h exposure (rat) PRIMARY SKIN IRRITATION: Not irritating (Rabbit) PRIMARY EYE IRRITATION: Not irritating (Rabbit) SKIN SENSITIZATION: Not sensitizing (Guinea pig) HUMAN SKI IRRITATION: No irritating effects observed
TRADE NAME: GLYCOLIC EXTRACT OF ALOE VERA GEL
INCI NAME: Aloe Vera extract
CAS: 85507-69-3
EINECS: 287-390-8
STRUCTURAL FORMULA:
Physical and chemical properties
Form: clear liquid
Odour: characteristic odour
Colour: yellow – green
pH value: 5,0 – 7,5
Boiling point: 190 oC
Flash point: 1036 oC
Auto-ignition temperature: 410 oC
Solubility in water: soluble
Margin of Safety
NOAEL –
Page 14 of 25
Toxicological Summary:
ACUTE ORAL TOXICITY: LD50 20000 mg/kg (rat) ACUTE DERMAL TOXICITY: LD50 20000 mg/kg (rabbit) PRIMARY SKIN IRRITATION: Prolonged contact is not actually irritating to the skin.
Repeated exposure may cause peeling or softening of the skin.
PRIMARY EYE IRRITATION: May cause slight transient (temporary) eye irritation. Damage to the cornea is unlikely. Mist may cause eye irritation.
SKIN SENSITIZATION: No sensitizing effect known.
TRADE NAME: CHAMOMILE GLYCOL EXTRACT INCI NAME: Chamomilla Recutita Flower Extract
CAS: 84082-60-0
EINECS: 282-006-5
Physical and chemical properties
Form: liquid not totally clear
Odour: characteristic
Colour: yellow-green
pH value: 5,0 – 7,5
Boiling point: 190oC
Ignition point: 103oC
Self-ignition point: 410oC
Margin of Safety
NOAEL –
Toxicological Summary:
Natural raw material. It has anti-inflammatory, antibacterial, antifungal, antiviral, astringent. Used
as a food.
Page 15 of 25
ACUTE ORAL TOXICITY: LD50 > 20000 mg/kg (rat) can not be absorbed through skin Prolonged exposure to harmful amounts of material.
PRIMARY SKIN IRRITATION: Not irritating to the skin PRIMARY EYE IRRITATION: Not irritating to eyes SKIN SENSITIZATION: Not sensitizing
TRADE NAME: ROCONSAL LJ-4 INCI NAME: Phenoxyathenol
CAS: 122-99-6
EINECS: 204-589-7
STRUCTURAL FORMULA:
INCI NAME: 2-Bromo-2-nitropropane-1,3-diol
CAS: 52-51-7
EINECS: 200-143-0
STRUCTURAL FORMULA:
Page 16 of 25
INCI NAME: Iodopropynyl Butylcarbamate
CAS: 55406-53-6
EINECS: 259-627-5
STRUCTURAL FORMULA:
Physical and chemical properties
Appearance: Liquid Colour: yellow Odour: noticeable pH: 8.0 (20oC) Melting point/freezing point: no data available Boiling point/boiling range: > 150 oC Flash pint: 100oC Flammability (solid, gas): no data available Solubility(ies):
Water solubility: 6 g/l (20oC) Solubility in other solvents: No data available Margin of Safety
NOAEL -
Page 17 of 25
Toxicological Summary:
ACUTE TOXICITY Phenoxyethanol Acute oral toxicity: LD50 (rat): 1,850 mg/kg
Acute inhalation toxicity: Assessment: No adverse effect has been observed in acute inhalation toxicity tests
2-Bromo-2-nitropropane-1,3-diol Acute oral toxicity: LD50 (rat, female): 342 mg/kg LD50 (rat, male): 307 mg/kg Acute dermal toxicity: LD50 (rat): 1,600 mg/kg Iodopropynyl Butylcarbamate Acute oral toxicity: LD50 (rat): > 300 - 500mg/kg Acute inhalation toxicity: LC50 (rat): > 0,67 mg/l Exposure time: 4 h Test atmosphere: dust/mist Acute dermal toxicity: LD50 (rat): > 2,000 mg/kg Remarks: Not mortality observed at this dose SKIN CORROSION/IRRITATION Product Result: Repeated exposure may cause skin dryness or cracking Remarks: May cause skin irritation and/or dermatitis. Phenoxyethanol Species: Rabbit Result: No skin irritation 2-Bromo-2-nitropropane-1,3-diol
Species: Rabbit
Method: OECD Test Guideline 404
Result: Irritating to skin
Iodopropynyl Butylcarbamate
Result: Mildly irritating to skin
SERIOUS EYE DAMMAGE/EYE IRRITATION
Causes serious eye damage.
Product
Remarks: May cause irreversible eye damage
Phenoxyethanol Species: Rabbit Result: Irritating to eyes
Page 18 of 25
2-Bromo-2-nitropropane-1,3-diol
Species: Rabbit
Method: Draize test
Result: Corrosive
Iodopropynyl Butylcarbamate
Result: Corrosive
RESPIRATORY OR SKIN SENSITISATION
Skin sensitisation: May cause an allergic skin reaction.
Respiratory sensitisation: Not classified based on available information.
Product
Remarks: May cause allergic skin reaction.
Phenoxyethanol Species: Guinea pig
Assessment: Does not cause skin sensitization
Method: OECD Test Guidline 406
2-Bromo-2-nitropropane-1,3-diol
Assessment: Does not cause skin sensitization
Iodopropynyl Butylcarbamate
Assessment: May cause sensitization by skin contact
TRADE NAME: PURAC 80 INCI NAME: Lactic Acid
CAS: 79-33-4
EINECS: -
STRUCTURAL FORMULA:
Page 19 of 25
Physical and chemical properties
Physical state: liquid (20oC)
Appearance: clear
Odour: characteristic
Colour: colourless / yellowish
pH value: > 1,2 (20oC)
Melting/freezing point: not information available
Boiling point/boiling range: 120-130oC (1013hPa)
Solubility: miscible (water)
Density: 1,2 g/cm3
Margin of Safety
NOAEL 500 mg/kg b.w./day
Toxicological Summary:
ACUTE TOXICITY
Ingestion No known effect
Skin contact No known effect (LD50 Dermal, Rabbit > 2000 mg/kg)
Inhalation No known effect
Chemical name LD50 Oral LD50 Dermal LC50 Inhalation
L-(+)-lactic acid 3543 mg/kg (Rat, female)
4936 mg/kg (Rat, male)
>2000 mg/kg (Rabbit) >7,94 mg/l (rat) 4 h
SKIN CORROSION/IRRITATION
Mixture: Causes skin irritation
SERIOUS EYE DAMMAGE/IRRITATION
Mixture: causes serious eye damage
Chemical name Skin corrosdion/irritation Serious eye damage/irritation
L-(+)-lactic acid OECD 404, in vivo, Rabbit,
solution (88 %)
Result: corrosive
CEET, Ex vivo, solution (88 %)
Result: Servere eye irritation
Page 20 of 25
RESPIRATORY OR SKIN SENSITISATION
Not known effect
ASPIRATION HAZARD
No known effect
TRADE NAME: SILKY HANDS 471168 WS
Fragrance supplier certify that the fragrance compound is in compliance with the Standards of the
INTERNATIONAL FRAGRANCE ASSOCIATION (IFRA – 48th Amendment, notified 10.06.2015)
INCI NAME: Parfum
CAS: -
EINECS: -
STRUCTURAL FORMULA: -
Physical and chemical properties
Appearance: clear pale yellow to brown liquid
Odour: not determined
pH value: not determined
Flash point: >100 oC
Relative density: 1,0630 – 1,0670
Toxicological Summary:
This mixture has not been tested as a whole for health effects. The health effect have been
calculated using the methods outlined in Regulation (EC) No 1272/2008 (CLP)
ACUTE TOXICITY: Based on available data the classification criteria are not
met.
Oral: > 5000
Dermal: >5000
Inhalation: not available
SKIN CORROSION/IRRITATION: Based on available data the classification criteria are not
met.
SERIOUS EYE DAMMAGE/IRRITATION: Based on available data the classification criteria are not
met.
RESPIRATORY OR SKIN SENSITIZATION: Sensitization - Skin Category 1
Page 21 of 25
10. Undesirable effect and serious undesirable effects
Not known.
If the supplier is aware of an abnormally high level of customer complaints the supplier must bring
this to the attention of the safety assessor and submit this formulation for reassessment and notify
the competent authorities of corrective actions taken.
11. Information on the cosmetic product
The product, wet wipes, with combination of ingredients that are commonly used in cosmetic
products of this type. All ingredients are legally permitted and are in concentrations allowed to be
used in cosmetics of this type. Concerning the skin tolerance the product is expected to be well
tolerated and to have a good cosmetic acceptability.
Page 22 of 25
PART B – COSMETIC PRODUCT SAFETY ASSESSMENT
1. Assessment conclusion
Product: Wet wipes for intimate hygiene “AURA Beauty”, 20 pcs
It has been certified that the assessed cosmetic product meets the requirements established by
the European Parliament and Council Regulation (EC) No 1223/2009 of 30 November 2009. on
cosmetic products (OJ L 342, 22.12.2009) and applied in accordance with the specified purpose
and directions for use – does not constitute a threat to health.
2. Labelled warning and instructions of use
Specific warnings and instructions of use are written on the primary packaging as follows:
- DIRECTIONS: -
- CAUTION:
The product labelling and the general description of the product indicate the explicit use of the
finished product as a leave-on wet wipes for babies intended for daily use. A reasonably
foreseeable mistaken use additional to this use (not a misuse) is not recognisable.
The materials used in the assessed product are commonly applied within the cosmetics industry in
Europe and worldwide. All ingredients are used in accordance with their purpose and in the
correct proportions. The product is safe according to current state of science.
3. Reasoning
Physical/chemical characteristics, stability and microbiological quality of the cosmetic product
The stability data (microbiological and physical-chemical stability) of the formula after storage
meet the previously specified characteristics of the product specifications. They confirm a
sufficient stability of the tested formula.
Based on the tests of accelerated stability program that includes physical stability results,
analytical results and microbiological results: The shelf life for the final product is 24 months. The
final product is released with a date of minimum durability (DOMD) of 24 months. Based on the
above mentioned physico‐chemical and microbiological test results the product is rated as safe.
Page 23 of 25
Packaging information The packaging of the product is made to protect the product during shelf life and use and to
enable the safe use of the product. Based on that the packaging is rated to be suitable and safe for
this specific product type. The package consists of a Printed foil (PET and LDPE) bags. This package
does not contain hazardous materials that require special markings or labelling on the shippers.
Normal and reasonably foreseeable use
The directions for use and the general description of the product on the label indicate the explicit
use of the finished product as a leave on wet wipes for babies. A reasonably foreseeable mistaken
use, (not a misuse) is not recognizable.
Exposure to the cosmetic product and the substances
The calculated margin of safety for ingredients, for which toxicological data were available, found
the safety factor to be acceptable.
In the case of components, in which no NOAEL makes impossible to calculate the margin of safety
of the traditional method, it can be concluded that at the concentrations used substances do not
pose a threat due to their low toxicity and a long history of safe use. These components do not
show a danger to people and do not adversely affect the safety of the final product.
Raw materials (impurities, traces, toxicological profile)
All materials used in the formula have been applied in accordance with their purpose, in a permitted quantity and do not constitute a threat to human health. The raw materials used to formulate this product are all well-known ingredients with a long
history of safe use.
Undesirable effects and serious undesirable effects
Not known.
If the supplier is aware of an abnormally high level of customer complaints the supplier must bring
this to the attention of the safety assessor and submit this formulation for reassessment and notify
the competent authorities of corrective actions taken.
Page 24 of 25
Information on the cosmetic product
The product wet wipes may be used on daily basis.
The packaging of cosmetic product should include the following information in indelible, easily
legible and visible lettering
- Brand name
- Name of the product
- Function of the cosmetic product (unless it is clear from its presentation)
The following ingredients must be written on the packaging of the product: Aqua, Cetearyl
Isononanoate, Ceteareth-20, Ceterayl Alcohol, Glyceryl Stearate, Glycerin, Cetyl Palmitate,
Ceteareth-12, Polysorbate 20, Panthenol , Aloe Barbadensis Leaf Extract, Chamomilla Recutita Flower
Extract, Phenoxyethanol, 2-Bromo-2-nitropropane-1.3-diol, Iodoprpynyl Butylcarvamate, Lactic
Acid, Parfum.
Concerning the skin tolerance, the final product is expected to be well tolerated and to have a good
cosmetic acceptability.
SUMMARY
The safety assessment is based on the chemical specification and toxicological profile of the ingredients as supplied at the time of assessment and an assessment of the final cosmetic product. The supplier to this safety assessment is advised to ask for a new safety evaluation if any change in formulation occurs, change in raw materials used, abnormally high number of adverse events are recorded, changes in recommended uses or other circumstances that may affect the safety of this product. Based on the outlined considerations the product is rated to be SAFE as stated in B.1.
Page 25 of 25
Date and signature
All statements in this safety assessment were elaborated on the recent level of knowledge. Every change in
the formulation or changes and/or additional information of relevant data respectively will require an
immediate re-evaluation of this safety assessment.
Data issued: 09.05.2018
Prepared by: Technologist Viktorija Aksjonova