What is a CPSR and Why is it Mandatory?
The Cosmetic Product Safety Report (CPSR) is a mandatory document under Article 10 of the EU Cosmetics Regulation (EC) No. 1223/2009. It documents the complete safety assessment of a cosmetic product and must be in place before the product is placed on the market in the European Economic Area.
Without CPSR: no CPNP registration, no legal distribution, no insurance coverage for product damages. The CPSR is the foundation on which the entire regulatory structure of a cosmetic product rests.
The report must be prepared and signed by a qualified Cosmetic Product Safety Assessor. This person bears personal legal responsibility for their assessment.
Structure: Part A — Safety Information
The CPSR consists of two mandatory parts. Part A contains all relevant safety information for the product:
A.1 Quantitative and qualitative composition: Complete ingredient list with INCI designations and exact concentration data (in % w/w), including fragrances and colorants.
A.2 Physical/chemical properties: Appearance, color, odor, pH value, viscosity, density, solubility — as relevant to the product.
A.3 Microbiological quality: Microbial count determination, preservative testing (Challenge Test), proof of microbiological stability over shelf life.
A.4 Impurities and traces: Proof that regulated impurities (e.g. heavy metals, pesticides, nitrosamines) are below permitted limits.
A.5 Packaging information: Material of primary packaging, migration potential from packaging material.
A.6 Intended use and exposure assessment: How is the product applied? How frequently? On which skin or mucous membrane area? This exposure assessment is the basis for toxicological evaluation.
A.7 Toxicological profile of ingredients: Assessment of all ingredients based on available safety data, RIFM reports, SCCS opinions, literature data.
A.8 Undesirable effects: Documentation of known adverse effects, if applicable.
Structure: Part B — Safety Assessment
Part B contains the actual assessment by the safety assessor:
B.1 Assessment conclusion: The safety assessor reaches a clear judgment: Is the product safe for humans when used as intended?
B.2 Warnings and conditions of use: All instructions that must appear on the label or in the instructions for use to ensure safety (e.g. "Avoid contact with eyes", "Keep out of reach of children").
B.3 Reasoning for conclusion: Detailed scientific reasoning explaining why the product is safe — with reference to the data from Part A.
B.4 Assessor qualifications: Proof of academic training (pharmacy, toxicology, medicine or comparable) and relevant professional experience. Without the correct qualifications, the signature is not legally valid.
B.5 Date and signature: Legally binding signature of the assessor with date.
Who Can Create a CPSR?
The requirements for the safety assessor are clearly defined in Annex I of the EU Cosmetics Regulation:
Qualification requirements:
- Degree in pharmacology, toxicology, medicine, dermatology or a comparable field of study
- At least three years of relevant professional experience
- Proof of continuing education
In practice: Safety assessors are typically freelance toxicologists, specialized laboratories or consulting companies for regulatory cosmetics matters. Manufacturers without appropriately qualified personnel must commission external assessors.
Important: A technical product developer or perfumer without the above academic qualifications may not sign a CPSR, regardless of their practical experience.
Timeline and Process
Creating a CPSR typically takes 3 to 6 weeks in practice from the time all documents are provided. The process typically unfolds as follows:
- Submission of the complete formulation with INCI list and concentration data
- Submission of raw material safety data sheets (SDS) and technical data sheets
- Submission of the IFRA compliance certificate for the fragrance
- Processing by the safety assessor (including possible queries)
- Draft for review
- Final signature
The process can take longer with incomplete documents or queries. We recommend starting the CPSR process in parallel with formulation development, not after product development is complete.
CPSR Service at NEROPI
We coordinate the complete CPSR creation for all our customers through certified and experienced safety assessors. Our process:
- Complete provision of all product-related raw data (formulation, INCI, SDS, IFRA certificates)
- Coordination with our network of accredited safety assessors
- Transparent tracking of progress until signing
- Filing of the final CPSR in the Product Information File (PIF)
- Update management for formulation changes
The completed CPSR is a prerequisite for all subsequent steps (CPNP, labeling, market launch) — we ensure it is available on time and correctly.
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