EU LEGAL FRAMEWORK ON COSMETIC PRODUCTS
The Regulation (EC) No 1223/2009 establishes the rules that all cosmetic products made available on the European Union (EU) market must comply with, in order to ensure the functioning of the internal market and a high level of protection of human health.
Only cosmetic products for which a legal or natural person is designated as a “Responsible Person” (RP) can be placed on the EU market. The RP is fully responsible for safety and legal compliance. (see previous post)
According to Article 3 of this Regulation, “a cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use“. In order to demonstrate that a cosmetic product complies with Article 3, the RP must guarantee that the product has undergone a safety assessment and that a Cosmetic Product Safety Report (CPSR) is set up.
The CPSR must be carried out by a qualified safety assessor, with a university diploma (or other evidence of formal qualification) in pharmacy, toxicology, medicine or similar (recognized as equivalent by a Member State).
COSMETIC PRODUCT SAFETY REPORT (CPSR)
The CPSR consists of two parts (Part A and Part B) that should contain, as minimum, the following information:
- 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
The CPSR must be kept up to date, taking into acount relevant information generated after the product is placed on the market (e.g., amendments to Regulation).
The Cosmetic Product Safety Report is part of the Product Information File (PIF), which should be kept for a period of 10 years, counting on the date on which the last batch of the product was placed on the market.
In sum, the CPSR is a mandatory document for all cosmetic products in the EU, as it demonstrates the safety and efficacy of a cosmetic product.
Critical Catalyst has a team of qualified EU safety assessors with vast experience in conducting CPSRs. For more information, please feel free to contact us at info@criticalcatalyst.com.
References:
- Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
