In order to comply with Regulation (EC) No 1223/2009, a Product Information File (PIF) must be completed for all Cosmetics intended to be marketed within the EU.
As mentioned in Article 10 (1), one of the main elements of the Product Information File (PIF) is the Cosmetic Product Safety Report (CPSR).
“In order to demonstrate that a cosmetic product complies with Article 3, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I.- Article 10 (1) of Regulation (EC) No 1223/2009.”
The CPSR is comprised of two parts; Part A: Cosmetic Product Safety Information and Part B: Cosmetic Product Safety Assessment.
In accordance with Annex I of Regulation (EC) No 1223/2009, Part A of the CPSR is intended to collect the necessary data to justify the safety of the cosmetic product. As a minimum, it is required to contain the following:
- Quantitative and qualitative formula of the cosmetic product
- Physicochemical characteristics and stability of the cosmetic product
- Microbiological quality
- Impurities, traces, information about the packaging material
- Normal and reasonably foreseeable use
As per Article 3, Part B of the CPSR is the actual evaluation of the safety of the cosmetic product and contains the following:
- Conclusion of the evaluation
- Warning and instructions for use on the label
- References of the assessor and approval of Part B
The Intertek Advantage
Intertek’s experts provide cosmetics companies with complete scientific and regulatory support required to comply with all aspects of Regulation (EC) No 1223/2009.
In the research and development phase of your products, Intertek can assist in performing pre-evaluations of your cosmetic formulas to determine and verify that the safety margins calculated for each ingredient are acceptable. Our Cosmetics team will guide you through the necessary tests, analytical or clinical, to ensure the safety of your product.
Additionally, Intertek provides solutions to support the collection of all relevant information to evaluate the safety of your cosmetic products, as well as the ability to conduct a detailed gap analysis and fill all compliance requirements.