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Cosmetic product safety report
Commercial Name: Refreshing wet wipes “AURA Beauty”, 15 pcs
Data issued: 25.05.2018.
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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
Glycerine Glycerine 56-81-5 Humectants protections
0.300
Propylene Glycol Propylene Glycol 57-55-6 Humectants, Solubilizer,
moisturizing 0.100
Cocamidopropyl Betaine
Dehyton PK 45 147170-44-3 Surfactant 0.200
Polysorbate 20 Eumulgin SML 20 9005-64-5 Solubilizer 0.150
Oenothers Biennis Oil (Evening Primrose)
Vitamin A, E & F extract complex
90028-66-3
Skin Care Component
0.00002 – 0.002
Retinyl Palmitate Vitamin A, E & F extract complex
79-81-2 Skin Care
Component 0.00002 – 0.002
Tocopheryl Acetate
Vitamin A, E & F extract complex
7695-91-2 Skin Care
Component 0.00002 – 0.002
Phenoxyethanol Dekaben PBH 122-99-6 Preservative 0.400 – 0.600
Benzoic Acid Dekaben PBH 65-85-0 Preservative 0.080 – 0.200
Dehydroacetic Acid
Dekaben PBH 520-45-6 Preservative
0.080 – 0.200
Citric Acid Citric Acid 5949-29-1 Buffering 0.020
Parfum Starflower &
Argan 298963 - Parfum 0.150
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2. Physical/chemical characteristics of the cosmetic product
Fabric:
Parameter Result
Appearance Non-woven fabric with embossing
Color From white to light yellow
Composition, % 20% viscose / 80% polyester
Perfume Neutral
Weight, g/m2 40 ±5
Width, mm 125 ±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±5 125±5
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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.
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5. Impurities, traces, information about the packaging material
Package and sticker:
PACKAGE
Parameter Result
Thickness, µm 69
Material grammage, g/m2 70,82
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
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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 - - -
Glycerine 56-81-5 1000 0.132 7575
Propylene Glycol 57-55-6 1700 0.025 68 000
Cocamidopropyl Betaine 147170-44-3 5000 0.088 56 818
Polysorbate 20 9005-64-5 2000 0.066 30 303
Oenothers Biennis Oil (Evening Primrose)
90028-66-3
- - -
Retinyl Palmitate 79-81-2 - - -
Tocopheryl Acetate 7695-91-2 500 0,00088 568 181
Phenoxyethanol 122-99-6 Annex V / 29. Max. authorized concentration: 1.0%
Benzoic Acid 65-85-0 Annex V / 1 . Leave-on products maximum concentration 0.5%
Dehydroacetic Acid 520-45-6 Annex V/13 . Maximum concentration 0.6% (as acid)
Citric Acid 5949-29-1 1200 0,0088 136 363
Parfum - - - -
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9. Toxicological profile of substances
TRADE NAME: GLYCERINE
INCI NAME: Glycerin
CAS: 56-81-5
EINECS: 200-289-5
STRUCTURAL FORMULA:
Physical and chemical properties
Form: viscous liquid
Odour: odourless
Colour: colourless
pH value: not determined
Melting point: ~ 18 °C
Boiling point: ~ 290 oC
Flash point: 180 oC
Density: ~ 1,26 g/cm3 (20oC)
Sollubility in water: fully miscible
Margin of Safety
NOAEL 1000 mg/kg b.w./day
Toxicological Summary:
ACUTE ORAL TOXICITY: LD50 12600 mg/kg (rat) ACUTE DERMAL TOXICITY: LD50 >18700 mg/kg (rabbit) PRIMARY SKIN IRRITATION: Longer lasting and/or repeated skin contact may cause
irritation. PRIMARY EYE IRRITATION: Short time, reversible irritating effect SKIN SENSITIZATION: No sensitizing effect known.
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TRADE NAME: PROPYLENE GLYCOL
INCI NAME: Propylene Glycol
CAS: 57-55-6
EINECS: 200-338-0
STRUCTURAL FORMULA:
Physical and chemical properties
Form: viscous liquid
Odour: odourless
Colour: colourless
pH value: 6,4 (500 g/kg, 20oC)
Melting point: -59 oC
Boiling point: 184oC (1003,2 hPa)
Flash point: 104oC
Flammability: not readily ignited
Density: 1,03 g/cm3 (20oC)
Margin of Safety
NOAEL - 1700 mg/kg b.w./day
Toxicological Summary:
Propylene glycol is an aliphatic alcohol widely used in cosmetics that functions as a skin conditioning
agent, viscosity decreasing agent, solvent, and a fragrance ingredient. Propylene glycol is generally
non-toxic and is non-carcinogenic.
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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
TRADE NAME: DEHYTON PK 45
INCI NAME: Cocamidopropyl Betaine
CAS: 61789-40-0
EINECS: 263-058-8
STRUCTURAL FORMULA:
Physical and chemical properties
Form: liquid
Odour: odourless
Colour: yellow
pH value: 4,6 – 5,5 (25oC)
Dcomposition point: >= 208oC
Boiling point: > 100oC
Flash point: > 100oC
Flammability: not flammable
Density: 1,0600 – 1,0850 g/cm3 at 20oC
Margin of Safety
NOAEL - 5000 mg/kg b.w./day
Toxicological Summary:
ACUTE ORAL TOXICITY: LD50 > 5000 mg/kg (art) ACUTE DERMAL TOXICITY: LD50 > 2000 mg/kg (rat) PRIMARY SKIN IRRITATION: Not irritating to the skin PRIMARY EYE IRRITATION: May cause severe damage to the eyes SKIN SENSITIZATION: Not sensitizing
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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
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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
TRADE NAME: VITAMIN A, E & F COMPLEX
INCI NAME: Tocopheryl Acetate
CAS: 7695-91-2
EINECS: 231-710-0
STRUCTURAL FORMULA:
INCI NAME: Oenothera Biennis (Evening Primrose) Oil
CAS: 90028-66-3
EINECS: 289-859-2
INCI NAME: Retinyl Palmitate
CAS: 79-81-2
EINECS: 201-228-5
STRUCTURAL FORMULA:
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Physical and chemical properties
Appearance: clear pale yellow to yellow liquid
Odour: not determined
pH value: not determined
Melting point/freezing pint: not determined
Initial boiling pint/range: not determined
Flash pint: > 100oC
Relative density: 1,0950 – 1,1150
Toxicological Summary:
ACUTE TOXICITY: Based on available data the classification criteria are not met
Oral – Not Applicable
Dermal – Not Applicable
Inhalation – Not Available
SKIN IRRITATION: Based on available data the classification criteria are not met
EYE IRRITATION: Based on available data the classification criteria are not met
SKIN SENSITIZATION: Based on available data the classification criteria are not met
TRADE NAME: CITRIC ACID
INCI NAME: Citric Acid
CAS: 5949-29-1
EINECS: 201-069-1
STRUCTURAL FORMULA:
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Physical and chemical properties
Form: solid, crystalinne
Odour: odourless
Colour: white
pH value: 1,7 (100g/l)
Melting point: approx.. 153oC at 1,013 hPa
Boiling point: decomposes before boiling
Flash point: Not known
Flammability: non flammable
Density: 1,665 g/cm3 at 20oC
Margin of Safety
NOAEL 1200 mg/kg b.w./day
Toxicological Summary:
INGESTION: LD50 5400 mg/kg bw (mouse)
INHALATION: no data
SKIN CONTACT: LD50 > 2000 mg/kg bw (dermal)
SKIN IRRITATION: mild skin irritation
EYE CONTACT: irritating
SKIN SENSITIZATION: not sensitizer
TRADE NAME: DEKABEN PBH
INCI NAME: Phenoxyethanol
CAS: 122-99-6
EINECS: 204-589-7
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STRUCTURAL FORMULA:
INCI NAME: Benzoic Acid
CAS: 65-85-0
EINECS: 200-618-2
STRUCTURAL FORMULA:
INCI NAME: Dehydroacetic Acid
CAS: 520-45-6
EINECS: 208-293-9
STRUCTURAL FORMULA:
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Physical and chemical properties
Physical state: liquid
Odour: characteristic
Colour: light yellow - yellow
pH value: not determined
Melting point: not determined
Freezing point: not determined
Boiling point: not determined
Flash point: not determined
Flammability: not relevant
Relative density: 1,126 – 1,132 at 20oC (water = 1)
Margin of Safety
NOAEL
Phenoxyethanol 200 mg/kg bw (oral feed, Wistar rat)
600 mg/kg bw (dermal, New Zealand white rabbit)
Benzoic Acid 500 mg/kg bw (rat)
Dehydroacetic Acid -
Toxicological Summary:
Test data are not available for complete mixture
ACUTE TOXICITY Harmful if swallowed
Acute toxicity estimate (ATE) of components of the mixture
Name of substance Exposure route ATE
Phenoxyethanol Oral 1,840 mg/kg
Benzoic Acid Dermal 2,000 mg/kg
Dehydroacetic Acid Oral 500 mg/kg
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Acute toxicity of components of the mixture
Name of
substance Exposure route Endpoint Value Species
Phenoxyethanol oral LD50 2,740 mg/kg rat
Benzoic Acid
oral LD50 2,250 mg/kg mouse
Ingalation:
dust/mist LC50 >12,200 mg/m3/4h rat
dermal LD50 >2,000 mg/kg rabbit
Dehydroacetic
Acid oral LD50 500 mg/kg rat
SKIN CORROSION/IRRITATION: Causes skin irritation
SERIOUS EYE DAMMAGE/EYE IRRITATION: Causes serious eye damage
RESPIRATORY OR SKIN SENSITISATION: Shall not be classified as a respiratory or skin sensitiser.
Based on available data, the classification criteria are
not met.
CARCINOGENICITY: Shall not be classified as carcinogenic.
Based on available data, the classification criteria are
not met.
TRADE NAME: STARFLOWER & ARGAN 298963
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: liquid
Color: characteristic
Odour: characteristic
pH value: not available
Melting point/freezing point: not available
Boiling point: not available
Flash point: Closed cup: 110 oC
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Solubility in water: Non water-soluble liquid
Toxicological Summary:
There are no data available on the mixture itself
POTENTIAL ACUTE HEALTH EFFECTS
Eye Contact: No known significant effects or critical hazards
Inhalation: No known significant effects or critical hazards
Skin contact: Causes mild skin irritation. May cause an allergic
reaction
Ingestion: No known significant effects or critical hazards
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.
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PART B – COSMETIC PRODUCT SAFETY ASSESSMENT
1. Assessment conclusion
Product: Refreshing wet wipes “AURA Beauty”, 15 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.
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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.
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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, Glycerine,
Propylene Glycol, Cocamidopropyl Betaine, Polysorbate 20, Oenothers Biennis Oil (Evening
Primrose), Retinyl Palmitate, Tocopheryl Acetate, Phenoxyethanol, Benzoic Acid, Dehydroacetic Acid,
Citric 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.
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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: 25.05.2018
Prepared by: Technologist Viktorija Aksjonova