Understanding cosmetic legal safety requirements: the Cosmetic Product Safety Report (CPSR)
As stated in Regulation (EC) No 1223/2009, «a cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use» and to demonstrate that, the Responsible Person must ensure that the cosmetic product has undergone a safety assessment and that a Cosmetic Product Safety Report (CPSR) is set up.
What is the CPSR?
The CPSR is a comprehensive report resulting from a detailed technical and scientific review of the safety of a cosmetic product. This report is a legal requirement in the European Union (EU) under Regulation (EC) No 1223/2009 and it ensures that cosmetic products conform to the highest standards of safety, safeguarding the health of consumers.
Content of the CPSR
The CPSR comprises two parts: Cosmetic Product Safety Information (Part A) and Cosmetic Product Safety Assessment (Part B). The minimum information requirements to set up each part of the report are set out in Annex I to Regulation (EC) No 1223/2009 and clarified in Commission Implementing Decision 2013/674/EU.
Part A of the CPSR gathers all the necessary and relevant data to carry out the safety assessment, including product formulation, exposure assessment and risk characterisation. Part B is the final statement on the safety of the cosmetic product, under its normal and reasonably foreseeable use, based on all the information provided in part A.
The safety assessor
Under Article 10 of Regulation (EC) No 1223/2009, the cosmetic product safety assessment «shall be carried out by a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State», commonly known as the Safety Assessor.
Importance of the CPSR
In addition to being a legal obligation for market access, the CPSR is an essential document to guarantee the safety of the cosmetic product. By conducting a comprehensive assessment, potential risks can be identified and mitigated before the product reaches the market.
In conclusion, performing the cosmetic product safety assessment and documenting it through the CPSR is a crucial step in the process of placing a cosmetic product on the EU market. By adhering to regulatory requirements and conducting thorough assessments, cosmetic companies contribute to a safer and more reliable market for beauty and personal care products.
References:
Related articles
