How to Assess Product Safety according to EU and UK Cosmetic Regulations (CPSR)

Cosmetic products are regulated by both the European Union (EU) and the United Kingdom (UK) to ensure their safety for human use. A critical part of this process is the Cosmetic Product Safety Report (CPSR), which outlines the safety information for each cosmetic product.

What is a CPSR?

A CPSR is a report that outlines the safety information for each cosmetic product. This report is required by both the EU and UK cosmetic regulations and is an essential part of ensuring the safety of cosmetic products for human use. The CPSR is a comprehensive document that includes information on the formulation, manufacturing process, and the safety assessment of each cosmetic product. Annex I part B of the regulations provides the list of information to be included in this report.

EU and UK Regulatory Requirements

The requirements for a CPSR are similar in both the EU and the UK. Both regulations require that the CPSR contain the following information:

1. Product Information: a description of the cosmetic product, including its intended use, the name and address of the responsible person, and the product category.

2. Formulation: a full and detailed list of ingredients in the product, including their concentration.

3. Manufacturing Process: the CPSR must describe the manufacturing process of the product, including information on quality control, batch control, and stability testing.

4. Safety Assessment: this assessment should take into account the potential risks associated with the product's ingredients and the manufacturing process. The safety assessment should also consider the likelihood and severity of adverse effects resulting from the product's use.

5. Post-Marketing Surveillance: the information on post-marketing surveillance activities should detail the measures taken to monitor the safety of the product after it has been placed on the market.

How to Make a CPSR

Making a CPSR can be a complex process that requires the expertise of a qualified assessor who has the necessary scientific knowledge and expertise in toxicology, dermatology, and microbiology. The assessor must have a sound knowledge of cosmetic product safety, including the relevant regulations and guidelines. The safety assessment must be based on all the available data and information about the product, including the quantitative and qualitative composition, physical and chemical properties, microbiological quality, normal and foreseeable use, exposure to the product, and any potential hazards.

Annex I Part B outlines several scientific criteria that must be considered when conducting the safety assessment:

1. Threshold of Toxicological Concern (TTC): the TTC is a concept used to assess the potential risk of substances that have limited toxicity data. It is based on the principle that substances with similar structures and properties are likely to have similar toxicity profiles.

2. Exposure Assessment: this is used to determine the level of exposure to the cosmetic product and its ingredients. It includes assessing the duration, frequency, and area of application, as well as any potential for exposure through inhalation or ingestion.

3. Hazard Identification: this involves assessing the toxicological profile of the product and its ingredients. It includes assessing the potential for acute and chronic toxicity, skin and eye irritation, skin sensitization, and phototoxicity.

4. Risk Characterization: this involves evaluating the potential risk of the product based on the hazard identification and exposure assessment. It includes assessing the margin of safety, which is the difference between the exposure level and the no-observed-adverse-effect level (NOAEL) or lowest-observed-adverse-effect level (LOAEL).

5. Safety Factors: these are used to account for any uncertainties in the safety assessment. These include factors such as individual susceptibility, variability in exposure, and extrapolation from animal data.

Examples of Non-Compliance

Non-compliance with CPSR requirements can lead to serious consequences, including product recalls and legal action. It is, therefore, essential to ensure that CPSRs are completed accurately and in compliance with regulatory requirements.

In 2015, the UK Advertising Standards Authority (ASA) banned a mascara advert due to its non-compliant CPSR. The advert claimed that the mascara gave "up to 60% longer lashes", but the product information file (PIF) failed to provide adequate substantiation for this claim. The company was also found to have failed to adequately assess the potential for eye irritation from the product.

In 2018, another multinational was fined €344 million by the European Commission for failing to disclose information about the possible carcinogenic risks of its talc-based products in its CPSRs. The CPSRs also failed to adequately assess the potential for asbestos contamination in the products.

In 2019, a famous cosmetic brand was fined €2.3 million by the French Competition Authority for non-compliant CPSRs. The CPSRs failed to provide adequate safety assessments for several of its products, including a brow pencil, a mascara, and a concealer. The safety assessments did not adequately consider the potential risks of the products for certain target groups, such as pregnant women.

In 2021, the UK Cosmetic, Toiletry, and Perfumery Association (CTPA) issued a warning to a cosmetic Group over non-compliant CPSRs for its products. The CPSRs failed to adequately assess the potential for skin irritation and other adverse effects from the products, which are used for skin cleansing and exfoliation.

Conclusion

A CPSR is a critical document that must be prepared by manufacturers and importers of cosmetic products in compliance with the EU and UK cosmetic regulations. The CPSR ensures the safety of the product by evaluating its composition, potential hazards, and exposure to consumers. The safety assessment must be conducted by a qualified person with expertise in toxicology, dermatology, and microbiology, and it must take into account any additional safety concerns and the potential for cumulative effects from exposure to multiple products or substances. The CPSR should include a post-market surveillance plan to monitor the safety of the product and address any potential issues. Non-compliance with CPSR requirements can result in fines, product recalls, and damage to brand reputation. Adequate safety assessments and substantiation of product warnings/claims are essential components of a compliant CPSR.