July 22, 2021
Great Britain and the CLP Mandatory Classification List (MCL)
By Eleanor Grimes, senior regulatory specialist, UL Supply Chain
At the end of June, the U.K. Health and Safety Executive (HSE) published the first set of technical reports for substances that are to be potentially included on the Great Britain (GB) MCL. These technical reports are part of the U.K.’s process for evaluating substances to be included on the GB MCL, which is outlined below. The substances currently in the evaluation process come from the Committee for Risk Assessment’s (RAC) published RAC Opinions under Article 37(4) of EU CLP during 2019 and 2020. There are around 80 substances submitted for evaluation under the EU CLP system that now need to be separately evaluated within the U.K..
The current process for substance evaluation: A GB MCL proposal can be submitted by any GB importer, manufacturer or downstream user if they have evidence that may lead to a new or revised substance classification. The current priority is for substances with the following classifications:
- The GB MCL proposal
- Public consultation
- The GB MCL Technical Report
- The GB MCL impact and policy assessment
- The GB MCL Agency Opinion
- GB MCL Recommendation and Decision
- Amending the GB MCL List
A GB MCL proposal can be submitted by any GB importer, manufacturer or downstream user if they have evidence that may lead to a new or revised substance classification. The current priority is for substances with the following classifications:
- Carcinogenicity 1A, 1B, 2
- Germ cell mutagenicity 1A, 1B, 2
- Reproductive toxicity 1A, 1B, 2
- Respiratory sensitization 1
Proposals may also be submitted by the Secretary of State, and Scottish and Welsh ministers, as under U.K. law they are considered GB CLP competent authorities, with the HSE being the GB CLP agency. The HSE is planning on continuing to monitor international forums such as the European Chemicals Agency (ECHA) Committee for Risk Assessment and will propose any classifications they believe suitable for inclusion in U.K. law.
The drafting of these proposals does require an expert who understands the technicalities of what is required. For further information on what is required, and any fees that may be incurred, please review the HSE guidance document.
Substances that have been proposed via the ECHA consultation route will not need to undergo a second public consultation phase. However, substances that are proposed via other routes will undergo two separate public consultations to cover the following aspects of adopting the new classification:
- The scientific and technical aspects of proposed classifications
- The policy and socioeconomic aspects of such a proposal
These public consultations are hosted on the government's Citizen Space public consultation platform, where they are open for eight weeks. After this, all of the responses will be collected and assessed before being published on the HSE website.
The technical report process, which is the stage where the chemicals mentioned above are currently situated, is an independent evaluation of the information submitted. It sets out whether there is adequate evidence to support a new or revised GB MCL of a substance and how it is classified.
The reports are drafted by HSE technical experts and take no account of the socio or political factors. Instead, they are purely looking at the technical aspects of the classification criteria.
Alongside the technical aspects, the HSE will consider the social and political aspects of substance classification, especially where it triggers additional measures under the various regulations that cover chemical products. If it is believed that the impact of the classification will cause significant social or political issues, the HSE may recommend to ministers that the GB MCL is implemented in a way that will reduce or mitigate these impacts while maintaining the level of protection for people and the environment. GB companies are asked to contact the HSE via email if they have information on how to best manage the consequences of changing the classification of a substance.
The above technical report and the social and political consequences are condensed and published on the HSE website to form the GB MCL Agency Opinion, which is the basis of the recommendation made to the ministers.
Within 12 months of the publication of this opinion, it must be put in front of the Secretary of State ministers, who will decide, with the consent of the Scottish and Welsh devolved administrations, whether or not to accept the recommended classification change. The aim is for this to be a once a year process. However, the HSE does have within its power to recommend a change whenever necessary, meaning there is flexibility to this schedule if required.
The final stage of the process is to include the agreed upon classifications into the GB MCL. This entry will include the date of entry and the date by which one must comply with the classification.
Although the general idea is to update the GB MCL yearly, the HSE has just released a v1.1, which corrects several errors and areas of confusion in the initial release.
The HSE is asking all interested GB parties to be involved in the GB MCL process, whether that is by submitting a proposal, commenting during the public consultation process, or contacting them if they find errors within the current list.