Cosmetic Product Safety Report (CPSR)
The Safety Report, identified in Annex I of the EC 1223/2009, is one of the essential elements when building the Product Information File of a cosmetic product.
The Safety Report always includes two parts:
- Part A: Safety Information
- Part B: Safety Assessment
Part A: Safety Information
The Safety Information, identified in the Annex I of the Regulation, is Part A of the Safety Report within the Product Information File of a cosmetic product.
The Safety Information includes but is not limited to:
- The quantitative and qualitative composition of the cosmetic product;
- The physical-chemical characteristics, microbiological specifications and stability of the cosmetic product;
- The physical-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 is to be obtained from the suppliers of the raw materials and the producers of the finished product (easily accessible when producing according to Good Manufacturing Practices) and with the support of laboratory tests.
Part B: EU Safety Assessment
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 the "Safety Assessor", a qualified person with a European degree in pharmacy, medicine, toxicology or a related discipline. 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.
- Scope & Classification
- The Regulation: EC 1223/2009
- EU Responsible Person
- Product Information File
- Good Manufacturing Practices
- Mandatory Safety Testing
- EU Labeling
- Pre-Market Notification: Cosmetic Product Notification Portal (CPNP)
- Post-Market Surveillance
- Risks of Non-Compliance
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