Cancer-causing substances: UK outlines process to grant exemption in cosmetics

By Julia Wray | Published: 10-Oct-2023

The OPSS has laid out the criteria for exemption to use substances classified as category 1A, 1B or 2 CMR under the UK Cosmetics Regulation

The UK government has clarified how certain carcinogenic, mutagenic or reprotoxic (CMR) substances can gain exemption for use in cosmetics. 

The Office for Product Safety and Standards (OPSS) has published a process to manage substances classed CMR under the UK Cosmetics Regulation (UKCR) and which are included in the GB Mandatory Classification and Labelling List (GB MCL List).

Article 15 of the UKCR prohibits the use of substances classified as category 1A, 1B or 2 CMR under the GB Classification, Labelling and Packaging Regulation (GB CLP).

1A is the category for chemical substances for which there is scientific evidence based on humans that the substance is carcinogenic, mutagenic or reprotoxic, while 1B stands for chemical substances for which there is scientific evidence based on animals that the substance is carcinogenic, mutagenic or reprotoxic.

Category 2 is for substances suspected to be CMR, but derived from limited evidence from humans or animal studies. 

However, such substances can be allowed for use in cosmetic products where an exemption has been granted by the UK Secretary of State, for which the UK government has now outlined the criteria.

According to the OPSS, an exemption can be granted only when an exemption application is submitted by an interested party and when all the criteria for exemption are fulfilled.

These criteria are listed in Article 31 of the UK Cosmetics Regulation and include that sufficient scientific evidence is available to show that the substance is safe for use in cosmetic products. 

For substances classified as CMR category 1A or 1B, additional criteria must be fulfilled. 

These include compliance with food safety requirements; an analysis of alternative substances to conclude that there are no suitable alternatives available; and that an exemption application is made for a particular use with a known exposure.

Exemption application submissions to must be no later than 18 months from the publication of the Technical Report proposing a GB MCL of CMR category 1A, 1B or 2 for the given substance under the GB CLP Regulation.

According to the UK’s Cosmetic, Toiletry and Perfumery Association (CTPA), exemptions shouldnt be a cause for public concern as CMR properties may only be seen under specific circumstances or exposure conditions, making it possible to define conditions of use and exposure that do not constitute a risk of harm to human health. 

The OPSS has said it will not issue specific notifications on substances that are undergoing the GB MCL process and that interested parties are expected to monitor substances undergoing the GB MCL process. 

Earlier this year, the European Union flagged several CMR cosmetic ingredients for a 1 December prohibition, namely ammonium bromide; benzophenone; acetamiprid; 2,4,6-tri-tert-butylphenol; dibutyltin di(acetate); and 2-ethylhexanoic acid and its salts, with the exception of those specified in Annex VI of the EU Cosmetics Regulation.

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