Guidance

Management of CMR substances under the UK Cosmetics Regulation

Published 5 October 2023

Applies to England, Scotland and Wales

Background

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.

Mandatory classification and labelling

Mandatory classification and labelling under the GB CLP Regulation (GB MCL) – CMR substances

There are two procedures under the GB CLP Regulation by which a substance can receive a mandatory category 1A, 1B or 2 CMR classification and the substance be added to the GB MCL List by HSE as the GB CLP Agency. Each of these GB MCL procedures and associated timelines are detailed below.

Article 37: Procedure for GB mandatory classification and labelling where the EU Risk Assessment Committee publishes an opinion (RAC Opinion)

• Publication of an intention to prepare a harmonised classification and labelling (CLH) report (also known as a dossier) in the Registry of CLH Intentions until outcome (RoI) by the European Chemicals Agency (ECHA).
• Submission of the CLH report by an EU Member State competent authority or by industry to ECHA: (approx. 6 to 12 months after the publication of the intention).
• Completion of the accordance check by ECHA: (approx. 6 months after the CLH report submission).
• Launch of an ECHA public consultation on the CLH report: (60 days).
• Adoption of the opinion of the Committee for Risk Assessment (RAC) on the CLH – the RAC Opinion – following a RAC meeting: (at the latest, 18 months after completion of the ECHA accordance check).
• Publication of the RAC Opinion on the CLH: (approx. 30-36 months from inclusion in the RoI).
• Publication of the GB MCL Technical Report (‘Technical Report’) and proposed GB MCL by HSE as the GB CLP Agency: 6 months from the publication date of the RAC Opinion.
• Publication of the GB MCL Agency Opinion (‘Agency Opinion’) on the proposed GB MCL by HSE as the GB CLP Agency: 12 months from the publication of the Technical Report.
• Submission of recommendation to Secretary of State (SoS) (DWP) on the proposed GB MCL and compliance date by HSE as the GB CLP Agency: 12 months from the publication of the Agency Opinion.
• Decision by the SoS with the consent of Scottish and Welsh Ministers on the GB MCL and compliance date: within 3 months of submission of the recommendation.
• GB MCL List updated, and the new/revised GB MCL enters into force immediately following publication in the GB MCL List on a voluntary basis before the compliance date in the HSE GB CLP Publication Table: within 1 month of the decision by the SoS.
• The GB MCL becomes fully applicable in accordance with the compliance date in the decision and published in the HSE GB CLP Publication Table. 18 months from the update to the GB MCL List.

Article 37A: Procedure for GB mandatory classification and labelling where HSE as the GB CLP Agency proposes a new or revised GB MCL

• Preparation of a GB MCL proposal by HSE as the GB CLP Agency or following receipt of a GB MCL proposal submitted by industry or competent authority (Scotland and Wales governments).
• HSE public consultation on the GB MCL proposal on the HSE website: 60 days.
• Publication of the Technical Report and proposed GB MCL by HSE as the GB CLP Agency: 12 months from receipt of a GB MCL proposal.
• Publication of the Agency Opinion and proposed GB MCL by HSE as the GB CLP Agency: 6 months from the publication of Technical Report.
• Submission of recommendation to the Secretary of State (SoS) (DWP Ministers) on the proposed GB MCL and compliance date by HSE as the GB CLP Agency: 12 months from the publication of the Agency Opinion.
• Decision by SoS (DWP Ministers) with the consent of Scottish and Welsh Ministers on the GB MCL and compliance date: within 3 months of submission of the recommendation.
• GB MCL List updated, and new/revised GB MCL enters into force immediately following publication in the GB MCL List on a voluntary basis: within 1 month of the decision by the SoS (DWP Ministers).
• GB MCL becomes fully applicable in accordance with the compliance date in the decision and published in the HSE GB CLP Publication Table: 18 months from the update to the GB MCL List.

Note: OPSS understands that the standard time between the publication of the new/revised GB MCL in the GB MCL List and the compliance date – the full application date of the mandatory CMR classification – is 18 months. However, it is possible that this time may be shorter than 18 months for some substances undergoing classification where the hazard classification is more severe, for example, substances classified as CMR category 1A or 1B. OPSS will work with applicants and industry to ensure that they are aware of any shorter timescales to ensure that substances are assessed, and annexes of UKCR are amended, in time for the compliance date.

Exemption process under the UK Cosmetics Regulation

Exemption process under the UK Cosmetics Regulation for the continued use of substances of interest in cosmetic products undergoing mandatory classification and labelling as CMR substances under the GB CLP Regulation

The following points broadly describe the exemption process and associated timelines for the continued use of substances of interest in cosmetic products that are undergoing mandatory classification and labelling as CMR category 1A, 1B or 2 substances under the GB CLP Regulation.

• Submission of an exemption application by an interested party: 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.
• Complete exemption application evaluation according to the requirements in Article 31 of UKCR: 12 months after the receipt of the exemption dossier by OPSS.
• Amendments to the annexes of UKCR via a Statutory Instrument (SI): approximately 8 months after the publication of the SAG-CS final opinion, approved by the Secretary of State (DBT).
• Entry into force of amended annex entries of UKCR i.e. placing on the market deadline: according to the compliance dates in the HSE GB CLP Publication Table i.e. the full application date of the mandatory CMR classification set out in the GB MCL List entry for a given substance.
• Making available on the market (off-shelf) deadline: usually 6 months after entry into force date i.e. 6 months after the compliance date in the HSE GB CLP Publication Table i.e. the full application date of the mandatory CMR classification in the GB MCL List entry for the given substance. This timeframe may change if there is a significant reason, such as significant public health concerns.

Note: Any potential amendments to the annexes of UKCR will depend on the outcome of the evaluation of exemption application. The evaluation will involve the safety assessment by the Scientific Advisory Group on Chemical Safety (SAG-CS). Additionally, an evaluation of exemption application for CMR substances of category 1A and 1B may involve a review by other scientific and policy experts within OPSS. 8 months and 2 months ‘buffer’ time has been accounted for in the exemption process for HSE’s Article 37 and Article 37A procedures respectively. This ‘buffer’ time is included to account for any unforeseen delays in the CMR exemption process under UKCR e.g., additional data requests from applicant, ministerial changes, delays due to parliamentary procedures etc. Depending on the changes being made, this timeframe might be longer or shorter.

Timelines for submitting exemption applications to OPSS

In the case of substances of interest in cosmetic products undergoing HSE’s Article 37 or Article 37A procedures as CMR category 1A, 1B or 2 under the GB CLP Regulation, any interested parties are required to submit exemption applications for continued use of the substance to OPSS, no later than 18 months from the date when the Technical Report is published on the HSE GB CLP Publication Table.

Timelines for changes to the annexes of the UKCR

OPSS will expect exemption dossiers to be submitted for any substances that industry seeks to defend no later than 18 months after the publication of the Technical Report on the HSE GB CLP Publication Table. OPSS will not issue specific notifications on substances that are undergoing mandatory classification through either the Article 37 or Article 37A procedures. Interested parties are expected to monitor substances undergoing mandatory classification under the GB CLP Regulation via the:

• ECHA website
• ECHA Registry of CLH Intentions until outcome
• ECHA Weekly Newsletter
• HSE GB CLP e-Bulletin
• HSE GB CLP publication table

By the compliance date of the mandatory classification and labelling that appears in the GB MCL List, substances will either be added to Annex II or III, or permitted to remain in Annexes III-VI.

• Substances for which the evaluation of the exemption application is complete, and which have been found to qualify for an exemption, will be added to Annex III or otherwise permitted to remain in Annexes III-VI.
• Substances will be added to Annex II under any other circumstance.

How to submit exemption applications

Please submit exemption applications 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. This aligns with other UK groups, such as the UK Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment, who carry out chemical risk assessments across a range of sectors and have agreed that a default adult bodyweight of 70 kg is representative for the UK adult population.

Read more information about SAG-CS.

Please submit original study reports and literature 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 data submitted may be subjected to the Freedom of Information Act 2000. Any confidential and commercially sensitive data should ONLY be submitted if it is relevant to the exemption application. Any confidential and commercially sensitive data must be very clearly marked in a submission. Any data that is not marked as confidential and /or commercially sensitive may be liable for release under an appropriate request.

Data Protection

OPSS is committed to processing information in accordance with the UK General Data Protection Regulation (UK GDPR) and the Data Protection Act 2018 (DPA 2018). The personal data collected on this form will be held securely and will only be used for administrative purposes. If you would like to understand what personal information OPSS collects about you, how we use this personal information, and what rights you have regarding your personal information, then please refer to our privacy notice.

Read the OPSS privacy notice.