UK enables carcinogenic, mutagenic and reprotoxic chemical use in cosmetics under strict exemptions

06 Oct 2023 --- The Office for Product Safety & Standards (OPSS) yesterday published “Cosmetic products: exemption process for CMR substances,” a guide on allowing the use of carcinogenic, mutagenic and reprotoxic substances in cosmetic products. The document outlines timelines for such use, and only the Secretary of State can grant the exemptions for England, Scotland and Wales.

Under Article 15 of the UK Cosmetics Regulation, CMR substances are prohibited unless an exemption is granted. The GB CLP Regulations (Classification, Labeling and Packaging) categorizes these substances as 1A, 1B or 2 CMR.

So, to be allowed to use CMR substances, companies must submit an application and fulfill the criteria listed in Article 31 of the UK Cosmetics Regulation.

These criteria include demonstrating the substance’s safety, adherence to food safety requirements (particularly for category 1A and 1B substances), analyzing alternative substances to conclude that no suitable alternatives are available, and a clear specification of the intended use with known exposure levels.

Mandatory classification and labeling (MCL)
CMR substances can receive mandatory classifications (1A, 1B, or 2) under the GB CLP Regulation via two procedures:Only the Secretary of State can grant CMR exemption for use in cosmetics.

Article 37 involves a timeline that includes public consultation and approval by the Secretary of State. It takes approximately 18 months from including a substance in the Registry of CLH Intentions to the GB MCL becoming fully applicable.

Article 37A is opted when the Health and Safety Executive (HSE) proposes a new or revised GB MCL. This procedure involves public consultation, and the timeline is roughly 18 months from the update to the GB MCL List.

Monitoring and submission
One key aspect of the regulations is the responsibility placed on interested parties to monitor substances undergoing mandatory classification. Unlike some other regulatory bodies, the OPSS does not issue specific notifications.

Instead, parties are expected to keep an eye on various sources for updates, including the European Chemicals Agency’s (ECHA) website, the ECHA Registry of Harmonised Classification and Labelling (CLH) Intentions, the ECHA Weekly Newsletter, the HSE GB CLP e-Bulletin and the HSE GB CLP publication table.Companies must submit an application and fulfill the criteria listed in Article 31 to use CMR substances.

Other developments by OPSS
In August, the OPSS launched two “calls for data” on nanomaterials used in cosmetics and the safety of cosmetic chemicals.

The office invites “interested parties, including academia and manufacturers of cosmetic products,” to share scientific information on safety assessments. The deadline for submission for this group is June 27, 2025.

Earlier in the same month, OPSS opened a safety consultation for modernizing product safety laws to “ensure they are fit for the digital age.” The government is “set to overhaul” the rules, including the Cosmetics Regulation, to regulate emerging technologies and new shopping habits.

In related news this week, the International Fragrance Association and Cosmetics Europe welcomed the EU Parliament’s adoption of new rules to classify, label and package chemical substances and mixtures.

By Venya Patel

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