The Guide for EU and UK Cosmetic Product Safety Report (CPSR)
What Is a Cosmetic Product Safety Report?
Cosmetic Product Safety Report (CPSR) is an important document to prove the safety of cosmetics and is also a prerequisite for products to enter the EU and UK market. It is essential that cosmetic products made available on the market be safe for human health when used under normal and reasonably foreseeable conditions of use. To that end, Regulation (EC) No 1223/2009 and UK Schedule 34 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 requires that, the Responsible Person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I.
What Information Is Required for a CPSR?
In accordance with Annex I to Regulation (EC) No 1223/2009 and UK Schedule 34 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, the CPSR is to contain, ‘as a minimum’, the information required under each of the headings of Part A and Part B. Part A aims to gather all the data necessary for the safety assessment of the product, while Part B sets out the reasoning, starting from the data, for drawing conclusions as to the safety of the product.
The relevant data of the cosmetic products and the substance in the cosmetic product involved are as follows:
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Quantitative and qualitative composition (cosmetic product formula).
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Physical/chemical characteristics of the substance in the cosmetic product.
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Stability of cosmetic products and compatibility with packaging.
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Microbiological specifications and results of preservation challenge test.
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In the case of traces of prohibited substances, evidence for their technical unavoidability.
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The relevant characteristics of packaging material.
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Warnings and instructions for use in the product labelling.
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Relevant toxicological endpoints of the substance in the cosmetic product.
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All available data on the undesirable effects and serious undesirable effects.
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Other relevant information, e.g. existing studies from human volunteers.
How Can REACH24H Help You?
- EU&UK RP Service as a Third Party
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Cosmetic Product Safety Report (CPSR)
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Product Information File (PIF)
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Consulting Service
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Customized Training
Why Choose REACH24H?
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Expert Team: Comprises multiple seasoned safety assessors with extensive knowledge of EU and UK cosmetics regulations and cosmetic product safety assessments.
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Strong Collaborations: Benefit from our extensive network and partnerships with prominent organizations around the globe.
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Regulatory Information Platform: We own a dedicated platform for real-time regulatory tracking, in-depth analysis, and reliable database support, keeping you up-to-date with the latest requirements in the industry.
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Trusted by Global Brands: We have successfully served over 1000 cosmetic companies worldwide, including well-known Fortune Global 500 companies, earning their trust and satisfaction through our reliable services.
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Global Reach: With our global branches and multilingual capabilities, we offer efficient international services, ensuring effective communication and comprehensive support throughout the compliance process.
Conclusion
Every completed Cosmetic Product Safety Report marks the beginning of a new market opportunity, one built on verified safety and regulatory confidence. REACH24H streamlines the entire process with comprehensive solutions, from expert CPSR preparation and EU/UK Responsible Person representation to CPNP submissions, ensuring your products meet all regulatory requirements for smooth market entry.
FAQ
1. What are the requirements for assessors who compile CPSR?
The cosmetic product safety assessment shall be carried out by a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognized as equivalent by a Member State.
2. Can the EU CPSR be used for UK cosmetic compliance?
The CPSR requirements for the EU and the UK are similar. However, it is necessary to additionally verify whether the ingredients used in the product are restricted or prohibited under UK regulations.
3. Will animal testing data conducted outside the EU to comply with cosmetic regulations in other countries trigger the animal testing ban?
Animal testing data conducted outside the EU to comply with cosmetic regulations in other countries will not trigger the animal testing ban, provided that the data is not used for the safety assessment of cosmetics in the EU.
4. Does the CPSR have a validity period, and does it need to be updated?
The CPSR does not have a validity period, but it is necessary to update the CPSR when one or more of the following situations occur:
(a) new scientific findings and toxicological data on the substances are available which could modify the result of the existing safety assessment;
(b) changes occurring in the formulation or specifications of raw materials;
(c) changes occurring in the conditions of use;
(d) a rising trend in terms of the nature, severity and frequency of undesirable effects, both under reasonably foreseeable conditions of use and in the case of misuse.
