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CPSR PartB - 900115 Washing Emulsion Intimate - 2024
CPSR PartB - 900115 Washing Emulsion Intimate - 2024
according to
I Product Description
Function:
The product was developed as a washing Emulsion for intimate Care. It is a cosmetically
product for external, dermal Use.
The galenical form is a Tenside.
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Product name: Eubos Intimate Woman Washing Emulsion / Eubos Intimate Woman
Waschemulsion Version: 09.03.2024
Cosmetic Product Safety Report of the finished product Eubos Intimate Woman
Washing Emulsion / Eubos Intimate Woman Waschemulsion for human health
according to
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Product name: Eubos Intimate Woman Washing Emulsion / Eubos Intimate Woman
Waschemulsion Version: 09.03.2024
3 Reasoning ..................................................................................................................................................... 5
The conclusions set out in Part B (1) are based on the following factors: ............................ 5
3.1 Composition of the finished product............................................................................................. 5
3.2 Microbiological quality and stability of the finished product ............................................... 6
3.3 Information on packaging ................................................................................................................ 6
3.4 Normal and reasonably foreseeable use ..................................................................................... 6
3.5 Raw materials, impurities, traces, toxicological profile ......................................................... 6
3.6 Safety distances of the individual ingredients .......................................................................... 7
3.7 Fragrances; allergenic ingredients ................................................................................................ 7
3.8 Undesirable effects and serious adverse effects ...................................................................... 7
3.9 Other information on the cosmetic product ............................................................................... 7
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Product name: Eubos Intimate Woman Washing Emulsion / Eubos Intimate Woman
Waschemulsion Version: 09.03.2024
The product is classified as safe for human health in accordance with the Cosmetic
Regulation (EC) Nr. 1223/2009 of the European Parliament and of the Council of 30
November 2009 on cosmetic products.
The assessment is done in regard of the general toxicological profile of the constituents,
its chemical composition and the exposure, in accordance with the principles of good
manufacturing practice, taking into account the conditions of use and a reasonably
foreseeable use.
The product does not contain any substances which require special conditions or
warnings on the label for cosmetic products, under Regulation (EC) No 1223/2009.
Furthermore, the product does not contain substances which require special conditions of
use or special warnings on the label, due to their properties and their content in the final
product,
End product specific indications (as for aerosol packs or sun protection preparations) are
likewise not to be offered. For the application of the product there are on the packaging
sufficient indications and instructions.
3 Reasoning
The conclusions set out in Part B (1) are based on the following factors:
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Product name: Eubos Intimate Woman Washing Emulsion / Eubos Intimate Woman
Waschemulsion Version: 09.03.2024
Panthenol 0,1 – 1
Hydrolyzed Milk Protein 0,1 – 1
Hydrolyzed Wheat Protein 0,1 – 1
p-Anisic Acid 0,1 – 1
Bisabolol 0,1 – 1
Citric Acid < 0,1
Sodium Hydroxide < 0,1
Tocopherol < 0,1
Hydrogenated Vegetable Glycerides Citrate < 0,1
Attention should be taken to the fact that for the preparation of the qualitative
Composition for compounded raw materials, the maximum contents of the individual
ingredients specified by the raw material producer have been taken as a basis. It is
therefore possible that the composition listed here differs from the list on the product. In
addition, listing of the ingredients with a content of <1% is possible in freely selectable
order.
The raw materials used correspond to the requirements for cosmetics according to the
attached analytical certificates / specifications / safety data sheets.
The examination of the total germ count according to the product specification as well as
the microbiological challenge test confirm that it satisfies the microbiological
requirements for cosmetics.
The primary packaging used complies with the relevant regulations and
recommendations and is suitable as a packaging for cosmetic products.
A chemical interaction of the cosmetic product with the packaging is not to be expected
under normal storage conditions.
The product is intended for use on the female genital area (external). It is destined to be
rinsed off. Due to the unambiguous application instructions on the product another use
can be excluded.
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Product name: Eubos Intimate Woman Washing Emulsion / Eubos Intimate Woman
Waschemulsion Version: 09.03.2024
The raw materials used correspond to the requirements according to the Cosmetics
Ordinance and as far as verifiable to the present analytical certificates / specifications /
safety data sheets.
The use in the present product with the stated concentration corresponds to the
Cosmetics Regulation. The test of the present formula showed that there are no
conditions for nitrosamine formation, no formaldehyde has been added, and no
formaldehyde donatores are added in the formula.
The formula is to be assessed as safe with regard to these substances.
A safe product has Margin of safety (MoS) of at least 100. Differing from this can also be
argued about "Reasoning" and "Weight of Evidence Approach". The present product is
considered to be safe because of its exposure considerations and calculation.
The product does not contain perfume oils / natural perfume oils which contain allergenic
components subject to labeling.
The "introduction" of these 26 known allergens on extracts and natural oils can also be
excluded.
The product has been successfully on the market for several years and has no serious
adverse effects.
Confirming documents may be inspected at the production site Dr. Hobein, Meckenheim
on request by the Authority.
Datum: 09.03.2024
Winnie Hortenbach
M.Sc. Food Chemistry
Safety Assessor (DGK)
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Product name: Eubos Intimate Woman Washing Emulsion / Eubos Intimate Woman
Waschemulsion Version: 09.03.2024
Experience:
Education:
1991 – 1996 Technical University Dresden
Graduation: Master of Science (Food Chemistry)
Skills / Qualifications:
• Basics of dermatology
• Modern skin care products: development, manufacture and testing
• Theory and practice of sunscreens
• Patent research and statistical analysis
• Principles of the safety assessment of cosmetic products (DGK-Exame)
• Development, production of natural cosmetics (Cosmos, Ecocert, Natrue)
• Regular participation in seminars for safety assessors (DGK, IKW)
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Product name: Eubos Intimate Woman Washing Emulsion / Eubos Intimate Woman
Waschemulsion Version: 09.03.2024
Leipzig, 09.03.2024
Winnie Hortenbach
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