Cosmetic products must be safe under normal or reasonably foreseeable conditions of use. Manufacturers or importers of cosmetics are obliged to ensure product safety according to the new EU Cosmetics Regulation (No 1223/2009). Therefore a cosmetic safety assessment must be carried out for the relevant products and the resulting safety report must be available on site.
We offer authoring of safety reports. Learn more about this under “Regulatory Affairs” on this website or give us a call !
In addition, a notification of the products is required in the EU portal CPNP (Cosmetic Products Notification Portal) prior to marketing.
We will gladly answer your questions about the use of raw materials, labeling and other regulatory requirements.
According to Regulation (EC) No 1223/2009 a cosmetic product is defined as follows:
‘Cosmetic Product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors.
Cosmetic products covered by this definition are e.g. products for face and body care, sun protection, skin cleansing, hair removal, shaving, perfumes, tanning, hair and scalp care, hair styling and oral care as well as make-up, deodorants and antitranspirants.
The legal requirements are very preciously oriented, therefore a clear assignment of a cosmetic product to other product categories such as biocides, tattooing ink, drugs, medical devices or food is important.
Contents of the cosmetics safety assessment
According to European regulations, a safety assessment of cosmetic products is mandatory to ensure that no danger is emanating from the product for the consumers.
For each product category the following characteristics are different: the fate on the skin and the absorption through the skin, the amount of product and the frequency of application. For some user groups like children, pregnant women and nursing mothers special protection is considered with respect to the selection of raw materials and their specific impurities.
The legal requirements for cosmetic safety assessments are divided into two parts:
A) The product information file
The product information file contains the following data in an for the responsible authority easily understandable language (German or English):
- the description of the cosmetic product
- the purpose of the cosmetic product
- the safety report
- the production method in terms of good manufacturing practice
- proof of the claimed effect
- data on animal testing
The responsible person shall make the product information file easily accessible for the authority at his address specified on the label in electronic or another form.
The product information file is created for each cosmetic product that is sold on the market and kept up to date.
It shall be kept for a period of ten years from the date on when the last batch of the cosmetic product is placed on the market.
B) The safety report
1) The safety information covers all essential features of the cosmetic product and its ingredients, which may be relevant for the safety of the product:
- composition of the product
- physical / chemical properties and stability
- microbiological quality / conservation
- impurities, traces and packing material
- normal and reasonably foreseeable conditions of use
- human exposure to the product and the materials used
- toxicological profile of the substances
- (serious) adverse effects
- rating score
- information on efficacy studies
- complaints statistics
- validity, date, signature
- evidence of competence of the safety assessor for cosmetics
2) In the safety assessment of cosmetics the safety of the product is justified due to the data of the safety report and if necessary with the attachment of certain warnings.
Place and period to provide:
The product information file shall be kept for a period of ten years from the date on which the last batch of the cosmetic product was placed on the market. Place of storage is the address of the responsible person which is also indicated on the product label.
Definition of the responsible person
According to Article 4 of the EU Cosmetics Directive:
- Only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market.
- For each cosmetic product placed on the market, the responsible person shall ensure compliance with the relevant obligations set out in this Regulation.
- For a cosmetic product manufactured within the Community, and not subsequently exported and imported back into the Community, the manufacturer established within the Community shall be the responsible person. The manufacturer may designate, by written mandate, a person established within the Community as the responsible person who shall accept in writing.
- Where, for a cosmetic product manufactured within the Community, and not subsequently exported and imported back into the Community, the manufacturer is established outside the Community, he shall designate, by written mandate, a person established within the Community as the responsible person who shall accept in writing.
- For an imported cosmetic product, each importer shall be the responsible person for the specific cosmetic product he places on the market. The importer may, by written mandate, designate a person established within the Community as the responsible person who shall accept in writing.
- The distributor shall be the responsible person where he places a cosmetic product on the market under his name or trademark or modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected.
The translation of information relating to a cosmetic product already placed on the market shall not be considered as a modification of that product of such a nature that compliance with the applicable requirements of this Regulation may be affected.
Additional definitions in Art. 2 of the EU Cosmetics Directive should be noted.
The obligations of the responsible persons and traders are specified in Art. 5 and 6 of the EU Cosmetics Directive.
- the (exact) formulation of the preparation, if applicable confidentiality agreement
- material safety data sheets and specifications, certificates of analysis, microbiological status of the ingredients
- physical and chemical data of the preparation, if applicable (pH, viscosity, color, superfatting of soaps, particle size is important for nano-materials)
- description of the product, including amounts used (including labeling)
- product stability (eg. B. 3 months at 40 ° C)
- bioburden test
- skin tolerance tests (eg. B. Human Patch Test)
- effectiveness tests
- INCI declaration, IFRA certificates, if perfume oil available. (without IFRA Certificate may entail additional cost)
- documents for packaging (EC declaration of conformity according to 1935/2004 and (EU) 10/2011 and SVHC Declaration)
- information on microbiological contamination of the product (eg. bioburden testing of the last 3 batches)
- GMP certificate
- statistical complaint evaluation
- product information file without safety report
- information on animal experiments, concerning raw materials and product (confirmation “Cruelty Free”)
- Information on the manufacturing process
- toxicological profiles of the raw materials by the manufacture