Preparation of the Cosmetic Product Safety Report – CPSR
The Cosmetic Product Safety Report (CPSR) is an essential part of the Product Information File (PIF) required by Regulation (EC) No 1223/2009.
BSI's approach guarantees a rigorous report that complies with the requirements of the European Cosmetics Regulation, while ensuring consumer safety.
The importance of producing a Cosmetic Product Safety Report (CPSR)
The Safety Report is the essential element proving that your cosmetic product is safe for human health. Without this report, validated by a qualified safety assessor, no cosmetic product can legally be marketed in Europe.
The main challenges :
- Protecting consumer health through rigorous risk analysis;
- Complying with the legal obligations of Regulation (EC) No 1223/2009;
- Prevent penalties and market withdrawals in the event of inspections by the authorities;
- Strengthen your brand's credibility with partners and distributors.
What does the Cosmetic Product Safety Report (CPSR) contain?
PART A contains information on the safety of cosmetic products, such as :
- Quantitative and qualitative composition of the cosmetic product;
- Physicochemical characteristics and stability of the cosmetic product;
- Microbiological quality;
- Impurities, traces, information on packaging material;
- Normal and reasonably foreseeable use;
- Exposure to the cosmetic product;
- Exposure to substances;
- Toxicological profile of substances;
- Adverse effects and serious adverse effects;
- Information on the cosmetic product.
PART B comprises the safety assessment of cosmetic products, namely :
- Conclusion of the assessment
- Labelled warnings and instructions for use
- Explanation of the scientific reasoning leading to the conclusion of the assessment
- References from the assessor and approval of Part B.
Why entrust us with the preparation of your RSPC cosmetic product safety report
Outsourcing your RSPC to experts such as BSI saves you time on a complex and time-consuming regulatory task, allowing you to focus on your core activities : formulation, marketing and development.
A compliant RSPC significantly reduces the risk of
- of non-compliance during an inspection,
- product recall,
- or even damage to your brand image in the event of a product safety issue.
At BSI, we have qualified assessors, in accordance with the requirements of Regulation (EC) No. 1223/2009, who are able to carry out in-depth safety assessments in accordance with Annex I of the Regulation.
We are experts in the toxicology of cosmetic ingredients, the latest SCCS assessments, restrictions on use, methodologies for calculating safety margins and much more.
