Cosmetic Product Safety Report (CPSR)
The Safety Report always includes two parts:
The Safety Information includes but is not limited to:
- The quantitative and qualitative composition of the cosmetic product;
- The physic-chemical characteristics, microbiological specifications and stability of the cosmetic product;
- The physic-chemical characteristics, microbiological and toxicological specifications of the raw materials;
- The impurities, traces, information about the packaging material;
- Normal and reasonably foreseeable use of the cosmetic product;
- Exposure to the cosmetic product and substances;
- Undesirable effects and serious undesirable effects
The safety information can be obtained through the suppliers of the raw materials and the producers of the finished product (easily accessible when producing according to Good Manufacturing Practices) or with the support of external testing laboratories.
The Safety Assessment, identified in the Annex I of the Regulation, is Part B of the Safety Report within the Product Information File of a cosmetic product. The Safety Assessment includes but is not limited to:
- Statement on the safety of the cosmetic product in relation to Article 3;
- Statement on the need to label any particular warnings and instructions of use in accordance with Article 19(1) (d);
- Explanation of the scientific reasoning leading to the assessment conclusion which is to be based on the possible interactions of the substances contained in the cosmetic product and also on the Safety Information documentation;
- Justification of the consideration and non-consideration of the raw materials’ toxicological profiles;
- Consideration of the impact of the stability on the safety of the cosmetic product;
- Assessor’s credentials and approval (name and address, proof of qualification, date and signature).
The safety assessment is to be completed by a qualified person with a European degree in pharmacy, medicine, toxicology or a related discipline otherwise known as a “Safety Assessor”. When the qualification degree diploma is not obtained from a European University, the Safety Assessor must have it recognized by the appointed national bodies within one of the EU Member States.
A special safety assessment needs to be issued in case the products are:
- Intended for use on children under 3 years old.
- Intended exclusively for use in external intimate hygiene.