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On 5 October 2023, The Office for Product Safety and Standards (OPSS) published the process to manage substances classed as CMR (carcinogen, mutagen, reprotoxic) under the UK Cosmetics Regulation (UKCR).
Background
Article 15 of the UKCR bans the use of substances classed as CMR under the GB Mandatory Classification List (MCL) of the GB Classification Labelling and Packaging (CLP) Regulation. However, some of these substances may still be used in cosmetic products under specific exemption criteria outlined in Article 15 of the UKCR.
Companies are also advised to familiarise with the mandatory classification process under GB CLP.
For more information on these processes and requirements, please visit the below resources.
CTPA webinar on UK chemicals management
CLP and Cosmetics Regulation infographic
Health and Safety Executive GB MCL page
The process
The CMR management process under the UKCR takes into account the key steps and timelines of the GB MCL.
- Companies shall submit to OPSS an exemption application (defence dossier) within 18 months from the publication of the Technical Report proposing a GB MCL under GB CLP for a substance used as a cosmetic ingredient. This is for both workstreams for the GB MCL process.
- The exemption application shall be submitted to [email protected]. 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 (however, please note that SAG-CS will use 70 kg as their default bodyweight assumption for adults in new safety assessments). Please submit original study reports and literature in full for all data relied upon in the safety assessment.
- The exemption application shall be evaluated by OPSS and the Scientific Advisory Group on Consumer Safety (SAG-CS) within 12 months after receipt of the exemption dossier by industry.
- The UKCR Annexes shall be amended to implement a ban or restriction (if defence by industry is successful) within 8 months from publication of the SAG-CS opinion.
- It is expected that the entry into force of the UKCR provisions are aligned with the application date of the GB MCL under GB CLP.
- However, the UKCR will have a 6 months transition period for making available (off-shelf) deadline.
- There can be flexibility on the timelines, depending on any possible delays to the process.
IMPORTANT NOTE: OPSS will not issue specific notifications on substances that are undergoing the GB MCL process; interested parties are expected to monitor substances undergoing the GB MCL process. CTPA is monitoring and will continue to monitor the GB MCL process and alert industry of any relevant cosmetic ingredient being proposed for CMR classification under GB CLP. The Association is also implementing a formal defence process for cosmetic ingredients under this workstream.
CTPA and OPSS will hold a webinar in the coming month (please stay tuned on the CTPA website and the events section) to explain the CMR management process under the UKCR, as well as the CTPA ingredients defence workstreams.
