Updating the GB mandatory classification and labelling list (GB MCL List)
Updating the GB MCL List is similar to how EU harmonised classification and labelling is updated, but there are differences. The list can be updated by revising an existing classification or by entering a new classification of a substance.
Introducing new or revising existing GB MCL comprises the following stages:
- 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
The GB MCL Proposal
The submission of a GB MCL Proposal occurs under the following circumstances:
GB-based manufacturers, importers and downstream users of substances have a legal duty to inform HSE (as the GB CLP Agency) and must make a GB MCL proposal when:
- there is evidence of a change in the classification of a priority hazard class:
- carcinogenicity - Category 1A, 1B or 2
- germ cell mutagenicity - Category 1A, 1B or 2
- reproductive toxicity - Category 1A, 1B or 2
- respiratory sensitisation - Category 1
- evidence of new scientific data or information that may lead to new or revised GB MCL, must submit a GB MCL proposal to HSE (as the GB CLP Agency)
For other hazard classes, GB-based manufacturers, importers and downstream users may submit proposals, if they have access to the scientific data and evidence.
Under the GB CLP Regulation, the Secretary of State, and Scottish and Welsh ministers are appointed GB CLP competent authorities and can propose new or revised GB MCL.
HSE (as the GB CLP Agency)
If evidence comes to the attention of HSE that may lead to new or revised GB MCL, then HSE has the scientific and regulatory expertise to prepare a GB MCL proposal.
HSE will continue to monitor international forums such as the ECHA Committee for Risk Assessment (RAC) for information that may lead to proposals for new or revised GB MCL. When a RAC opinion is published, HSE as the GB CLP Agency must reach an opinion of its own on whether to align with RAC under the Article 37 procedure in the GB CLP Regulation.
GB is free to determine its own GB MCLs where it is justified by supporting scientific data and wider policy considerations. In time, this may result in GB having a different MCL to the EU CLH for the same substance.
Drafting a proposal requires someone who is an expert, who is technically competent, and who understands what is required. They must know how to interpret the scientific data and evidence in line with the classification criteria set out in the GB CLP Regulation.
If you think you have information that may support a new or revised GB MCL, or want information on how to submit a proposal, you should first read the guidance on 'Submitting a new or revised GB mandatory classification and labelling proposal'
Fees and charges
Certain types of proposal may incur a fee for work undertaken by HSE regulatory scientists and specialists evaluating the proposal.
HSE does NOT charge a fee for the following types of proposal:
- GB MCL proposals made as part of an application for approval of an active substance under the GB Biocidal Products Regulation and the GB Plant Protection Products Regulation
- proposals on the following priority hazard classes: carcinogens, mutagens, reproductive toxicants or respiratory sensitisers
HSE charges a fee for:
- proposals for new or revised hazard classes other than carcinogens, mutagens, reproductive toxicants or respiratory sensitisers
- proposals for substances not regulated under the retained GB Biocidal Products Regulation and the GB Plant Protection Products Regulation
The fees and payment arrangements for activities under the GB CLP Regulation are set out in the amendments to the Health and Safety and Nuclear (Fees) Regulations 2016. The amendments can be found in paragraph 46(3) and 46(5) of Schedule 1 of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019.
HSE conducts public consultations on GB MCL proposals to gather information on:
- the scientific and technical aspects of proposed classifications
- the policy and socio-economic aspects of such a proposal
Separate public consultations will not be held for those substances covered by ECHA public consultations leading to RAC opinions.
Scientific and technical aspects
All interested parties (for example industry, other stakeholders, members of the public) are encouraged to take part in the public consultation. Comments can be submitted on general issues (such as substance identification, or the clarity of the information within the proposal), and on the proposed classification and labelling.
All hazard classes which have been assessed in the MCL proposal will be open for comments. We would particularly welcome further information (such as study reports) which may be relevant to the assessment. Comments supporting the proposed classification are also encouraged. Please note that all comments and non-confidential information submitted during the public consultation will be published.
The text of the MCL proposal will not be updated following the consultation. However, the proposal submitter will respond to all of the comments and information submitted, and these responses will be published on HSE's website. The information submitted during the consultation will also be reflected in the technical report and Agency opinion that are produced later in the process.
Policy and socio-economic aspects
Consulting on the policy, wider socio-economic and other aspects of new or revised classifications enables HSE and the ministers of England, Wales and Scotland to understand the potential economic impacts of new or revised GB mandatory classification and labelling, before deciding whether to accept new and revised GB MCLs.
Impacts might include the costs of:
- supplying a substance (on its own or in a mixture) with a more severe classification and the consequences for workers and customers
- changing labels and, potentially, packaging requirements
- potential restrictions on the supply and uses of the substance because of the control measures in other regimes such as UK REACH, or the exclusion criteria in GB Biocidal Products Regulation and the GB Plant Protection Products Regulation
Benefits might include:
- increased protection of people and the environment
- cost savings to suppliers as a result of having to use GB mandatory classification and labelling which means that classification has already been done for them
- the creation of a level playing field through a common mandatory classification and the additional trade opportunities
Types of public consultations
HSE relies on two types of public consultations for information:
HSE GB MCL public consultations
HSE only conducts public consultations on GB CLP Regulation proposals for new or revised mandatory classifications. As the EU CLH proposals have already been through the public consultation process under ECHA, there is no GB public consultation.
When a GB MCL proposal is accepted, HSE begins a public consultation hosted the government's Citizen Space public consultation platform. The public consultation lasts for 8 weeks and the responses are collated and assessed. A summary of responses to the public consultation is published on the HSE website after the original proposer has had the opportunity to consider and comment on them.
ECHA harmonised classification and labelling (CLH) public consultations
HSE, on behalf of the UK, will continue to contribute to ECHA CLH public consultations, as a third country, where we have comments on the scientific assessment or additional information to share. Comments at this stage will be based on a consideration of the scientific data and will not address broader impacts of the proposal.
HSE will continue to encourage GB-based businesses to contribute to ECHA's public consultations by alerting interested stakeholders to ECHA public consultations via the GB CLP e-Bulletin.
GB-based businesses and other interested parties are encouraged to respond to ECHA CLH public consultations. GB-based business should also share any information on the potential impact of proposed EU CLH changes with HSE at the earliest stage. As HSE will consider all future published RAC opinions, this information will be important for any final GB MCL decision.
In addition to the technical and scientific aspects of the ECHA public consultation, the GB CLP e-Bulletin alerts GB-based suppliers to start thinking about the potential impacts and benefits of the intended proposals on their supply chains. HSE (as the GB Agency) encourages UK businesses to share concerns about potential impacts with us at this early stage together with supporting evidence. Comments should be made via email to [email protected]
The GB MCL Technical Report
The GB MCL Technical Report is an independent evaluation of the information submitted under the stand-alone GB mandatory classification and labelling process or as part of the EU CLH process. It sets out whether there is adequate evidence to support a new or revised GB MCL of a substance and what that GB MCL should be.
HSE's regulatory scientists, expert in hazard classification, will draft the GB MCL Technical Report with contributions made by experts on environmental hazards (for example, the Environment Agency, the Scottish Environmental Protection Agency and Natural Resources Wales). No policy or socio-economic factors are considered at this stage. The Technical Report is essentially a scientific assessment of a substance's intrinsic hazardous properties in the context of the GB CLP classification criteria.
GB MCL Technical Reports are drafted using the following sources of information:
GB MCL proposals
The GB MCL Technical Report reflects the scientific aspects and combines information from the GB MCL proposal itself and responses to the public consultation. The Technical Report is drafted and published on the HSE website. The Technical Report will summarise the proposal and will consider any comments on the scientific basis for the proposal received during public consultation.
The RAC opinion is used as the basis to draft a GB MCL Technical Report, which must be published on the HSE website within six months of the RAC opinion being published. The rationale which supports RAC's opinion is considered and, if necessary, any additional scientific evidence that may have been made available to HSE. These considerations are evaluated against the criteria for classification and labelling in the GB CLP Regulation.
The GB MCL Technical Reports are published on the HSE GB CLP publication table
GB MCL impact and policy assessment
Decisions about GB MCLs are made based on available scientific data. However, HSE (as the GB CLP Agency) also considers the potential policy and socio-economic impacts (costs and benefits) of the proposed GB MCL. For example, the new or revised classification might trigger additional controls under other chemical regulations. If the impacts are significant, HSE might 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.
HSE may consult further with a wide range of interested stakeholders when considering the potential impacts.
GB-based suppliers should provide HSE with any information that might influence how the downstream impacts and consequences might be better managed. Such information should be submitted to the HSE via the email [email protected]
The GB MCL Agency Opinion
The GB MCL Agency Opinion summarises the GB MCL Technical Report and the assessment of the potential policy issues and impacts of the new or revised GB MCL proposal and forms the basis of the recommendation made to ministers for new or revised GB MCL.
The GB MCL Agency Opinion is published on the HSE website.
GB MCL recommendation and decision
Where HSE considers it appropriate to introduce or revise a GB MCL, it must, within 12 months of the publication of the GB MCL Agency Opinion, make a recommendation to the Secretary of State (ministers) to give effect to the Opinion.
The Secretary of State will make a decision whether or not to accept the recommendation, with the consent of the Devolved Administrations (Scotland and Wales).
HSE recommends GB MCL changes once a year based on the GB MCL Agency Opinions published that year. However, the GB CLP Regulation allows HSE to recommend changes whenever necessary if justified. This flexibility allows HSE and businesses to better manage downstream consequences and the timing of entry into force dates.
The ministers' decision, made with the consent of the Devolved Administrations (Scotland and Wales), is published on HSE's website together with a short reason for that decision.
Amending the GB MCL List
Where the decision is to support the recommendation, the GB MCL List is updated without undue delay including the entry into force date from which the new or revised entry should be complied with.