In accordance with Article 3 of Cosmetics Regulation (EC) No 1223/2009, the responsible person, which could be the manufacturer, importer, or trader, must demonstrate the product's compliance by ensuring a thorough safety assessment and the preparation of a safety report prior to introducing the cosmetic item to the market. The specific responsible person varies based on the product's origin: the manufacturer for products made within the Community, the importer for those brought into the Community, and the distributor for products marketed under their name or trademark.
The safety report comprises two main components: safety information and safety assessment.
Part A Cosmetic product safety information
- Quantitative and qualitative composition of the cosmetic product
- Physical/chemical characteristics and stability of the cosmetic product
- Microbiological quality
- Impurities, traces, information about the packaging material
- Normal and reasonably foreseeable use
- Exposure to the cosmetic product
- Exposure to the substances
- Toxicological profile of the substances
- Undesirable effects and serious undesirable effects
- Information on the cosmetic product
Part B Cosmetic product safety assessment
- Assessment conclusion
- Labelled warnings and instructions of use
- Reasoning
- Assessor’s credentials and approval of part B
A qualified safety assessor must conduct the safety assessment to guarantee the product's safety and mitigate any potential risks to the consumer. Should You have inquiries regarding raw material usage or product labeling, we are more than happy to provide assistance.
The product information file
The responsible person needs to meet specific requirements, including the maintenance of a product information file (PIF) for each product, as stated in Article 11(1) of the Cosmetics Regulation. This file must be accessible to the competent authority at the address indicated on the label and easily understandable (German or English).
The PIF should include:
- Description of the cosmetic product (for clear product attribution)
- Safety report, encompassing the safety assessment
- Manufacturing method and a statement of good manufacturing practice (GMP)
- Evidence supporting claimed effects
- Data regarding performed animal testing
The product information file must be retained for 10 years after the last placement of the cosmetic product on the market.
