March 3, 2022
By Susana Planas MunGaving, BSc, MSc, regulatory specialist, UL’s Supply Chain team
On Dec. 1, 2021, the U.K.’s Health and Safety Executive (HSE) regulatory scientists finalized a set of Great Britain Mandatory Classification List (GB MCL) Technical Reports for several substances. Environmental hazard experts from the Environmental Agency, the Scottish Environmental Protection Agency and Natural Resources Wales also contributed to the GB MCL Technical Reports. Since June 2021, a set of 100 technical reports have been drafted, and the latest reports have been uploaded on the HSE relating to 10 specific substances.
From Jan. 1, 2021, the classification, labeling and packaging of chemicals placed on the market in Great Britain (England, Scotland and Wales) is regulated by the Retained CLP Regulation (EU) No. 1272/2008 as amended for Great Britain, known as GB CLP.
The EU CLP Regulation was retained in GB law with modifications to address deficiencies arising from the U.K.'s withdrawal from the EU, the Withdrawal Agreement and the Northern Ireland Protocol. Modifications to EU CLP were made in order to adapt the enforcement of CLP in GB post-Brexit and were made under the Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 No. 720 as amended, which address any failures of retained EU law to operate effectively and address any other deficiencies arising from the withdrawal of the United Kingdom from the European Union.
The GB CLP Agency, HSE, is required under Article 37 of the GB CLP Regulation to prepare technical reports for substances for which the Committee for Risk Assessment (RAC) of the European Chemicals Agency (ECHA) produces an opinion. For example, in the Technical Report of June 2021 relating to substance 1,4-dimethylnaphthalene (1,4-DMN), CAS 571-58-4, the Agency agrees with RAC’s assessment of the data and that the criteria for the classification of 1,4-DMN as Specific Target Organ Toxicity-Repeated Exposure is not met.
In the technical report on 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol (Bisphenol AF), CAS 1478-61-1, issued September 2021, the dossier submitter (DS; ), which refers to the country in charge of the evaluation of the substance for its Harmonised Classification and Labelling (CLH) — in this case, the DS was Sweden — submitted a CLH report to ECHA in December 2019 and only assessed the reproductive toxicity endpoint. Bisphenol AF has not previously been assessed for mandatory (GB) or harmonized (EU) classification and labeling. This substance is not listed as an entry in the GB MCL list or Annex VI of EU CLP; however, the classification of analog substances, such as Bisphenol S (BPS), was acknowledged by RAC and in view of the data submitted, the RAC Opinion and Agency (HSE) technical report concluded that Bisphenol AF meets the classification criteria for adverse effects on sexual function and fertility in Category 1B – Repr. 1B; H360F (may damage fertility or the unborn child).
Further recommendations are made to U.K. ministers for new or revised GB MCL classifications, based on GB MCL Agency Opinions addressing the main issues concluded in the GB MCL Technical Reports, associated assessments and potential policy issues and impacts of new or revised GB MCL proposals. The HSE will then agree to introduce or revise a GB MCL within 12 months of publication of the GB MCL Agency Opinion and presenting any necessary classification recommendations to the Secretary of State (ministers). HSE may introduce GB MCL changes once a year based on the concluding GB MCL Agency Opinions. The final ministers' decision and consent of the Devolved Administrations (Scotland and Wales) is required for the GB MCL List to be updated, and the effective date of the decision concerning the substance new or revised entry into the MCL is established.
The new batch of technical reports is to be published in January 2022.
A full list of GB MCL technical reports is available on the HSE MCL Excel Table.
Recommended action items
- Review the list of substances listed at the end of the GB MCL Excel table and assess whether any are being used or handled at the workplace
- Review updated associated substance documentation, such as classification, labeling and SDSs.
- The new batch of HSE GB MCL technical reports is now available for download at the end of the HSE MCL Excel table.
- The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 No. 720