European CPSR: Does an Existing Report Guarantee Cosmetic Product Safety?
With Ukraine’s transition to European principles for the regulation of cosmetic products, importers often receive ready-made Cosmetic Product Safety Reports (CPSRs) from manufacturers and expect to use them to demonstrate the safety of their products in Ukraine.
This raises a logical question: if a product has already undergone a safety assessment in the EU, does the assessment need to be repeated in Ukraine?
A European CPSR can serve as the basis for a safety assessment in Ukraine, but its suitability must be verified. It is important to determine whether the report complies with the requirements of the Ukrainian Technical Regulation, whether it contains sufficient data, and whether the safety conclusion for the specific product is scientifically justified.
When reviewing CPSRs received from European manufacturers and importers, experts at “Conformity Assessment Body Eurotechstandard”, LLC regularly encounter issues relating to the completeness, reliability, and relevance of the data, as well as the scientific substantiation of the safety assessment.
In this article, we examine three levels of CPSR review and ten common issues that may affect whether an existing report can be used to assess cosmetic product safety in Ukraine.
I. Formal Completeness: Does the CPSR Contain the Required Sections and Information?
The first question when reviewing a report may seem straightforward: Does the CPSR contain all the required sections and data specified for a Cosmetic Product Safety Report?
Annex I to Regulation (EC) No 1223/2009 establishes the minimum content of a CPSR and divides it into two parts:
Part A — Cosmetic Product Safety Information;
Part B — Cosmetic Product Safety Assessment.
Part A includes, among other things, the product’s composition, physical and chemical characteristics and stability, microbiological quality, impurities and information on packaging material, normal and reasonably foreseeable use, exposure, toxicological profiles of ingredients, and other relevant information. Part B contains the safety conclusion, warnings and instructions for use, the scientific rationale, and details of the Safety Assessor.
Therefore, the first level of review is to determine whether the CPSR contains the required sections. The next question is: Does each section provide sufficient information for the expert to use it in the safety assessment?
II. Reliability and Relevance of the Data in the CPSR
Even a complete report may contain data that do not correspond to the actual formulation or conditions of use of the cosmetic product.
Common Issues in European CPSRs: Is There Sufficient Data to Assess Safety?
Quantitative and Qualitative Composition (Part A)
Safety assessments often list only the main active ingredients. Auxiliary substances (e.g., preservatives present in extracts, stabilizers, antioxidants, etc.) may not be assessed toxicologically or included in the final list of ingredients (INCI).
Stability Study Protocols
Stability reports are often limited to summary graphs or template tables. They lack descriptions of the test methods used (e.g., stress tests and temperature conditions), clear expert conclusions, and adequate justification for the stated expiration date (EXP) or period after opening (PAO).
Description of the Primary Packaging and Packaging Manufacturer
Many CPSRs provide only a general description of the packaging material (e.g., “plastic bottle”). Information on the exact chemical composition of the packaging material and its manufacturer may be missing, along with an assessment of the safety of the material in contact with the relevant cosmetic product.
Data on the Migration of Substances from Packaging
The description of the primary packaging and assessment of its compatibility with the product are often missing or insufficient, as is the justification for the potential risk of substance migration from the packaging into the product.
Inadequate Quality of Microbiological Testing
Microbiological quality data are often limited to a specification or a certificate of analysis issued by the manufacturer, without supporting test reports from an independent, accredited microbiological laboratory.
Deficiencies in Microbiological Test Reports and Challenge Tests
Microbiological testing and preservative efficacy testing (challenge tests) are often inadequately documented:
References to relevant ISO standards (e.g., ISO 11930) are missing.
The evaluation criterion (Criterion A or Criterion B) is not specified.
The laboratory’s final conclusions regarding the adequacy of the preservation system are missing.
Inappropriate Exposure Scenarios
Safety assessors sometimes use average standard values without taking into account the actual and reasonably foreseeable conditions of product use, including the application site, frequency of use, and contact area.
Inappropriate Toxicological Reference Values (NOAEL)
A common issue is the use of excessively high or irrelevant NOAEL/NOAEC values. In addition, references to authoritative and peer-reviewed sources of toxicological data (e.g., SCCS opinions, ECHA, CIR) are often missing.
Lack of Justification for the Safety of Substances for Which the MoS Cannot Be Calculated
For complex ingredients for which a NOAEL cannot be reliably established or an MoS cannot be calculated, an appropriate, scientifically justified approach to safety assessment must be applied, and the rationale for selecting that approach must be explained.
Inappropriate Calculations for Children’s Products
Children’s Cosmetics: Exposure scenarios and SED and MoS calculations do not always take into account the relevant age group, body weight, and specific conditions of product use.
The key question is whether the data used reflect the product’s actual composition, packaging, and intended use.
III. Scientific Justification: Is the Safety Conclusion Adequately Substantiated?
The most challenging issue arises when a CPSR contains a substantial amount of information but fails to explain how that information supports the Safety Assessor’s final conclusion.
The presence of SED and MoS calculations or references to toxicological sources does not, in itself, guarantee that the assessment is correct.
It is necessary to verify whether the parameters used are justified, whether the calculations reflect actual exposure, and whether product-specific risks have been taken into account. It is also essential that the conclusion in Part B follows logically from the data presented in Part A.
The quality of a CPSR is determined not by the number of pages, but by the soundness of the safety conclusion for the specific product.
What Should Importers Do?
A European CPSR can provide an effective basis for a safety assessment in Ukraine, but before using it, three aspects should be reviewed:
1. Completeness — Is all the required information available?
2. Relevance — Does the information correspond to the specific product?
3. Scientific justification — Does the information support the safety conclusion?
This approach helps determine whether the existing report can be used as is, whether additional documentation should be requested, whether certain calculations need to be clarified, or whether a further assessment is required.
Conclusion
A European CPSR is not a guarantee that the report will be automatically accepted, but rather a basis for professional review and substantiation of the product’s safety.
Not all reports provide the same level of scientific substantiation. Preparing a high-quality CPSR requires a thorough analysis of the available data, significant expert resources, and continuous updating of knowledge in line with scientific guidance and regulatory requirements.
It is also important to note that the issues identified are not limited to European CPSRs and may affect any cosmetic product safety report, regardless of who prepared it or in which country. Therefore, when reviewing a report, the focus should be on the completeness, reliability, and relevance of the data, as well as the scientific soundness of the safety assessment, rather than on the document’s origin.
The aim of the expert review is not to duplicate work that has already been carried out, but to determine whether the available data are sufficient to support a scientifically sound conclusion on the safety of the cosmetic product.
For this purpose, you can contact the specialists at CAB Eurotechstandard LLC for a consultation, an expert review of your existing CPSR, and to order cosmetic product safety assessment services.
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