Cosmetic product safety report - Vento Bohemia spol. s r.o. · INCI name CAS numbers NOAEL mg/kg...

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Cosmetic product safety report

Commercial Name: Wet wipes for intimate hygiene “AURA Beauty”, 20 pcs

Data issued: 09.05.2018.

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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

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

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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, % 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

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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 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

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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 - - -

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%


55406-53-6 Annex V / 56. Leave-on products maximum concentration 0.01%

Lactic Acid 79-33-4 500 0,0142 35 211

Parfum - - - -

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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

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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:

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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)

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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

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TRADE NAME: Eumulgin SML 20

INCI NAME: Polysorbate 20 CAS: 9005-64-5

EINECS: 500-018-3

STRUCTURAL FORMULA:


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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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:


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

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Margin of Safety

NOAEL – 1000 mg/kg b.w./day


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:


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 –

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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


Form: liquid not totally clear


Colour: yellow-green

pH value: 5,0 – 7,5

Boiling point: 190oC

Ignition point: 103oC

Self-ignition point: 410oC

Margin of Safety

NOAEL –


Natural raw material. It has anti-inflammatory, antibacterial, antifungal, antiviral, astringent. Used

as a food.

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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:

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INCI NAME: Iodopropynyl Butylcarbamate

CAS: 55406-53-6

EINECS: 259-627-5

STRUCTURAL FORMULA:


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 -

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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


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

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2-Bromo-2-nitropropane-1,3-diol

Species: Rabbit

Method: Draize test

Result: Corrosive


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


Assessment: May cause sensitization by skin contact

TRADE NAME: PURAC 80 INCI NAME: Lactic Acid

CAS: 79-33-4

EINECS: -

STRUCTURAL FORMULA:

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Physical state: liquid (20oC)

Appearance: clear


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


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

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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: -


Appearance: clear pale yellow to brown liquid

Odour: not determined

pH value: not determined

Flash point: >100 oC

Relative density: 1,0630 – 1,0670


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

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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: 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.

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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, 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.

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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: 09.05.2018

Prepared by: Technologist Viktorija Aksjonova

Cosmetic product safety report - Vento Bohemia spol. s r.o. · INCI name CAS numbers NOAEL mg/kg...

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Transcript of Cosmetic product safety report - Vento Bohemia spol. s r.o. · INCI name CAS numbers NOAEL mg/kg...