Cosmetic Product Safety Report (CPSR)
Definition
Cosmetic Product Safety Report (CPSR), commonly translated into Chinese as the Cosmetic Product Safety Report, is the product safety assessment document established under Regulation (EC) No 1223/2009 on cosmetic products. Its content and structure are specified in Article 10 and Annex I of that Regulation.[1] CPSR is the core technical document used to demonstrate that a cosmetic product is safe for human health under normal or reasonably foreseeable conditions of use. Under Article 10 of Regulation (EC) No 1223/2009, the Responsible Person must ensure, before placing a cosmetic product on the EU market, that a safety assessment has been completed on the basis of relevant information and that a Cosmetic Product Safety Report has been prepared in accordance with Annex I.[1]
CPSR is also part of the Product Information File (PIF). The European Commission's implementation guidance describes CPSR as one of the most important components of the PIF from a product-safety perspective.[2]
A CPSR cannot be signed at will by ordinary company personnel. Under Article 10(2) of Regulation (EC) No 1223/2009, the safety assessment must be performed by a qualified Safety Assessor—someone with a university degree and theoretical and practical training in pharmacy, toxicology, medicine or a similar discipline, or equivalent qualifications recognised by an EU Member State.[1][2]
Therefore, CPSR is neither a test report nor an EU certification issued by a third-party body. It is, in substance, a product safety risk assessment document based on the product formulation, toxicological data, exposure data, stability, microbiological data and other safety evidence, completed by a qualified Safety Assessor.[1][2]
A CPSR is not prepared once and then left unchanged forever. The Responsible Person must keep it up to date in light of relevant new information arising after the product is placed on the market. For example, changes to the formulation or raw-material specifications, new toxicological data, changes to conditions of use, or material changes in the nature, severity or frequency of adverse reactions may require the safety assessment to be reviewed and updated.[1][2]
Within the EU cosmetics compliance system, it can be understood simply as follows:
CPSR demonstrates whether the product is safe → PIF retains the complete product technical and compliance documentation → CPNP provides for electronic notification of product information to the EU.
The three are not substitutes for one another; they are interlinked compliance steps under Regulation (EC) No 1223/2009.[1][2]
References
- [1]Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, Article 10 and Annex I — Cosmetic Product Safety Report.
- [2]Commission Implementing Decision 2013/674/EU of 25 November 2013 on Guidelines on Annex I to Regulation (EC) No 1223/2009 on cosmetic products.
