At the beginning of the post-Brexit era, the UK Cosmetics Regulation (UKCR) was initially aligned with the European Cosmetics Regulation. However, over time, it appears that the UK has been diverging from EU regulation, particularly in the area of ingredient management. A clear example of this shift is evident in the recently released guide by the Office for Product Safety & Standards (OPSS) on 5 October 2023. The guide outlines exemptions from the prohibition on using CMR (Carcinogenic, Mutagenic, or Toxic for Reproduction) substances in cosmetics.
Background
CMR substances under UK Cosmetics Regulation
Article 15 of the UK Cosmetics Regulation (UKCR) prohibits the use of substances classified as category 1A, 1B or 2 carcinogenic, mutagenic and toxic for reproduction substances (‘CMR substances’) under the GB Classification, Labelling and Packaging Regulation (‘GB CLP Regulation’) and which are included in the GB Mandatory Classification and Labelling List (‘GB MCL List’). However, such substances can be allowed for use in cosmetic products where an exemption has been granted by the Secretary of State (SoS).
The exemption can be granted only when an exemption application is submitted by an interested party and when all the criteria for exemption are fulfilled as listed in Article 31 of the UK Cosmetics Regulation. These criteria 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 which include compliance with food safety requirements, an analysis of alternative substances to conclude that there are no suitable alternative available and an exemption application is made for a particular use with a known exposure.
GB CLP Regulation Procedures for Mandatory CMR Substance Classification and Labelling
The GB CLP Regulation outlines two procedures for the mandatory classification and labeling of CMR (Carcinogenic, Mutagenic, or Toxic for Reproduction) substances and their inclusion in the GB Mandatory Classification and Labelling List (‘GB MCL List’). This responsibility falls upon the Health and Safety Executive (HSE), acting as the GB CLP Agency.
The first procedure is triggered when the EU Risk Assessment Committee (RAC) publishes an opinion. The second procedure involves the HSE, acting as the GB CLP Agency, proposing a new or revised GB MCL.
Exemption process under UK Cosmetics Regulation
Companies shall submit exemption applications for continued use of the CMR substance to OPSS, 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.
The exemption application is submitted by email to cmrenquiries@beis.gov.uk.
Any scientific data submitted for the safety assessment must include all relevant elements as prescribed in the Scientific Committee on Consumer Safety Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation. The Scientific Advisory Group on Chemical Safety (SAG-CS) will use 70 kg as their default bodyweight assumption for adults in new safety assessments. Original study reports and literature shall be submitted in full for all data relied upon in the safety assessment. This is particularly important for the pivotal studies, those which support the critical No Observed Adverse Effect Level (NOAEL) and point of departure and the dermal absorption value.
The exemption application shall be evaluated by OPSS and the Scientific Advisory Group on Consumer Safety (SAG-CS) 12 months after receipt of the exemption dossier by the industry.
UKCR annexes will be amended approximately 8 months from the publication of the SAG-CS opinion.
The entry into force of amended annex entries of UKCR, particularly regarding the placing on the market deadline for specific substances, is synchronized with the application date of the mandatory CMR (Carcinogenic, Mutagenic, or Toxic for Reproduction) classification specified in the GB MCL (Great Britain Mandatory Classification and Labelling) List entry for that particular substance.
However, the UKCR will have a 6 months transition period for making available (off-shelf) deadline.
Lastly, note that this timeframe might be longer or shorter depending on possible delays in the process.