What Is The CPSR And Why Is It Mandatory
The CPSR (Cosmetic Product Safety Report) is the safety report required under Regulation (EC) No 1223/2009 for a cosmetic product to be legally placed on the market in the European Union. It is not an administrative formality, but a scientific document demonstrating that the product is safe for human health under normal or reasonably foreseeable conditions of use.
The CPSR forms part of the Product Information File (PIF) and must be made available to the competent authorities for at least ten years following the date on which the last batch of the product was placed on the market. Its absence or inadequate preparation may lead to corrective measures, product withdrawal, or sanctions.
Applicable Regulatory Framework
The preparation of the CPSR is based on several regulatory and technical documents that must be interpreted together.
Regulation (EC) No 1223/2009
Regulation 1223/2009 constitutes the legal foundation of European cosmetics legislation. Annex I establishes the mandatory structure of the CPSR and defines the elements that must be included in the safety assessment.
This Regulation determines, among other aspects:
- The responsibility of the responsible person.
- The obligation to carry out a safety assessment before marketing.
- Labelling requirements.
- The documentation that must form part of the PIF.
SCCS Notes Of Guidance (12th Revision)
The SCCS Notes of Guidance (SCCS/1647/22) provide scientific criteria for the toxicological evaluation of cosmetic ingredients.
Although they do not replace the Regulation, they constitute the technical framework used by the Scientific Committee on Consumer Safety to assess substances.
These guidelines address aspects such as:
- Systemic exposure assessment.
- Selection of the toxicological point of departure (NOAEL, BMDL).
- Calculation of the Margin of Safety (MoS).
- Consideration of CMR substances, endocrine disruptors, and nanomaterials.
- Use of alternative methodologies (NAM).
Product Information File (PIF) Requirements
The CPSR is only one part of the PIF. The complete file must also include:
- Product description.
- Manufacturing method in compliance with GMP.
- Proof supporting claimed effects.
- Data on animal testing.
Consistency among all these documents is essential. A technically sound CPSR that is not aligned with the rest of the dossier may create regulatory inconsistencies.
Structure Of The CPSR According To Regulation 1223/2009
The CPSR must be divided into two clearly differentiated parts: Part A (Safety Information) and Part B (Safety Assessment).
Part A: Safety Information
Part A gathers all technical data necessary for the safety assessor to issue a reasoned conclusion.
Qualitative And Quantitative Composition
It must include the complete product formula, indicating the exact concentration of each ingredient and its INCI denomination. Relevant impurities and critical raw materials must also be identified.
Precision in this section is fundamental, as any modification of the formula may require a review of the safety assessment.
Physical-Chemical Characteristics And Stability
This section analyses parameters such as pH, viscosity, appearance, stability at different temperatures, and packaging compatibility.
Accelerated and real-time stability studies confirm that the product maintains its specifications throughout its shelf life.
Microbiological Quality
The microbiological assessment must demonstrate that the product meets appropriate criteria according to its category and target population. In this context, standards such as:
- ISO 17516 (microbiological limits for finished cosmetic products)
- ISO 11930 (Challenge Test for preservative efficacy)
may be applied.
Microbiological stability is particularly relevant for products containing an aqueous phase or intended for vulnerable populations.
Impurities, Traces And Packaging Material
The potential presence of:
- Heavy metals
- Manufacturing process impurities
- Migration of substances from packaging materials
- Substances classified as CMR
must be assessed.
This analysis requires both toxicological expertise and technical knowledge of the manufacturing process.
Intended Use And Exposure Assessment
The CPSR must describe the intended use of the product, the area of application, frequency of use, and target population. Based on these parameters, the Systemic Exposure Dose (SED) is calculated.
Correct exposure estimation is one of the pillars of the report, as it directly influences the subsequent Margin of Safety calculation.
Toxicological Profile Of Substances
For each relevant ingredient, available toxicological data must be evaluated, including:
- Acute toxicity
- Skin and eye irritation
- Sensitisation
- Repeated-dose toxicity
- Reproductive toxicity
- Genotoxicity
- Carcinogenic potential
- Possible endocrine activity
The SCCS guidelines provide detailed orientation on how to interpret these data.
Undesirable Effects And Post-Marketing Surveillance
Cosmetovigilance data, historical use, and known undesirable effects must also be considered.
Part B: Safety Assessment
Part B constitutes the scientific conclusion signed by the safety assessor. It establishes:
- Whether the product is safe under the described conditions.
- Necessary warnings or restrictions.
- Justification of product safety based on the data collected in Part A.
- The qualification and signature of the assessor.
This section transforms the collected data into a legal and scientific conclusion.
Who Can Sign A CPSR
The safety assessor must hold a university degree in pharmacy, toxicology, medicine, chemistry, or an equivalent discipline, together with appropriate training in risk assessment.
Not every technical professional can assume this responsibility. The signature implies legal accountability.
Common Errors In CPSR Preparation
Frequent issues include:
- Using outdated toxicological data.
- Failing to recalculate the MoS after formula changes.
- Omitting impurity assessments.
- Ignoring restrictions listed in the annexes of Regulation 1223/2009.
- Not reviewing the CPSR after packaging or manufacturing process modifications.
Such errors may compromise the validity of the dossier.
SHAPYPRO’s Technical Approach
Preparing a CPSR requires rigorous interpretation of the regulatory framework and a coherent scientific assessment. In this context, SHAPYPRO approaches the safety report as part of an integrated technical strategy that connects formulation, testing, toxicological evaluation, and regulatory requirements.
This approach ensures that the CPSR is aligned with Regulation 1223/2009, the SCCS guidelines, and the rest of the PIF, preventing documentary inconsistencies and strengthening the robustness of the cosmetic dossier.
Conclusion
The CPSR is the document that demonstrates a cosmetic product is safe before it is placed on the market in the European Union. Its proper preparation requires regulatory knowledge, scientific interpretation, and documentary consistency.
More than a formal requirement, the CPSR constitutes the technical foundation supporting consumer safety and the manufacturer’s responsibility within the European regulatory framework.