On October 5, 2023, UK released a guidance introducing the management of CMR substances (those classified as carcinogenic, mutagenic or toxic for reproduction) within the cosmetics regulatory framework. Applicable to England, Scotland, and Wales, the guidance outlines the regulatory requirements for CMR substances, and describes the exemption application process for their continued use.
Regulatory Requirements for CMR Substances
Article 15 of the UK Regulation (EC) 1223/2009 (Cosmetics Regulation) sets out provisions on the use of CMR substances in cosmetics. To ensure comprehensive protection of human health, CMR substances categorized as 1A, 1B, and 2 in the following documents are prohibited for use in cosmetics:
- The Regulation 1272/2008 on Classification, Labelling and Packaging of Substances and Mixturein Great Britain (GB CLP Regulation);
- The GB Mandatory Classification and Labelling List (GB MCL List).
However, where an exemption has been granted by the Secretary of State (SoS), such substances can be permitted for use in cosmetics. The exemption can only happen when an application is submitted by an interested party and when all the criteria for exemption listed in Article 31 of the UK Cosmetics Regulation are fulfilled.
|CMR Substance Category
|SoS considers that there is sufficient scientific evidence that the substance is safe for use in cosmetic products.
|a. The substance complies with the food safety requirements specified in Regulation (EC) No 178/2002;
b. An analysis of alternative substances has been undertaken, which concludes that no suitable alternatives are available;
c. An application is submitted to SoS for a particular use of the product category with a known exposure;
d. SoS considers that there is sufficient scientific evidence indicating that the substance has been evaluated* and found safe for use in cosmetic products.
* During the evaluation, the evaluator should take into account the product’s exposure and the overall exposure to the CMR substance from other sources, particularly for vulnerable population groups.
Exemption Application for CMR Substances
For CMR substances that meet the exemption criteria above, interested parties intending to apply for exemption should submit their applications to the Office for Product Safety and Standards (OPSS) via email at firstname.lastname@example.org. In the application, any scientific data submitted for the safety assessment should include all relevant elements as prescribed in The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation. Besides, it is required to submit original study reports and literature in full for all data referred to in the safety assessment. Confidential and commercially sensitive data should only be submitted if it is relevant to the exemption application, and be clearly marked in the submission.
Articles 37 and 37A of the GB CLP Regulation establish two procedures for substances to receive a mandatory 1A, 1B or 2 CMR classification, and be added to the GB MCL List by the Health and Safety Executive (HSE). During each procedure, a GB MCL Technical Report concerning the CMR substance is published at a specific step. Interested parties should submit their exemption application no later than 18 months from the date of the Technical Report’s publication. Upon receiving the application, OPSS requires an additional 12 months to conduct a substance evaluation. Following the evaluation, the substances deemed eligible for exemption will be included in the restricted or permitted ingredient lists, while those considered ineligible will be added to the prohibited ingredient list.
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