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Are you a cosmetic product manufacturer looking to obtain market authorizations across the European Union? Do you know what consists of your mandatory technical documentation need to be submitted for cosmetic products’ market approvals? Well, to market the cosmetic products in the EU, manufacturers as per the EU Cosmetic Regulation should submit a Product Information File (PIF), which should contain necessary safety details (in the form of Cosmetic Product Safety Report [CPSR]) about the products, along with the information on product description, method of manufacturing, GMP compliance evidence, animal testing data (if any), labeling etc.
As an essential element of the PIF, the CPSR must include:
- Part A – cosmetic product safety Information
- Part B – cosmetic product safety assessment
What consists of Safety Information?
As a critical aspect of the data, Part A of CPSR (i.e. safety information) should contain all the toxicological profiles of ingredients that are used in cosmetic product manufacturing along with other relevant data such as:
- Quantitative and qualitative composition of the cosmetic product
- Physical/chemical characteristics of the substances or mixtures and stability of cosmetic product under foreseeable storage conditions
- the microbiological specifications of the substance or mixture and the cosmetic product
- purity/impurity of substances, traces of prohibited substances, relevant characteristics of packaging material
- normal and foreseeable use of cosmetic product in the light of warnings in the labeling
- exposure to cosmetic product and substances
- toxicological profile of the substances
- data on undesirable effects and serious undesirable effects
What consists of Safety Assessment?
As a critical aspect of PIF, Part B of CPSR (i.e. safety assessment) should contain data related to Safety Assessment such as:
- Assessment conclusion in relation to Article 3
- Statement on the need to label warnings and instructions, if any, in accordance with Article 19(1)(d)
- Proper explanation and scientific reasoning leading to assessment conclusion which is to be based on interaction of the substances and Part A of the Safety Reports, i.e. safety information
- Valid justification of consideration and non-consideration of toxicological profiles
- Consideration of stability impacts on the cosmetic product safety
- Name, address, proof of the qualification, date and signature of the safety assessor
The aim of cosmetic product safety report (CPSR) is to ensure the safety of the consumers and to avoid hazardous effects related to the use of the cosmetic product. While Part A of CPSR can be obtained from suppliers of raw materials and manufacturers of the products, to conclude part B of CPSR, organizations require a pool of qualified safety assessors with a complete understanding of chemistry and toxicology with a proven knowledge. Prepare a compliant CPSR for successful PIF compilation.
