Submitting a new or revised GB mandatory classification and labelling proposal
The following pages provide guidance on how to submit a new or revised GB mandatory classification and labelling (GB MCL) proposal for a substance placed on the GB market. You can submit a new or revised GB MCL proposal if you are a:
- GB CLP Competent Authority
- GB-based manufacturer, importer or downstream user
HSE, as the GB CLP Agency, can also propose new and revised GB MCLs. This includes GB MCL for pesticide and biocide active substances.
New or revised GB MCLs MUST be proposed:
- where GB-based manufacturers, importers or downstream users have new information that may lead to a revision to an existing mandatory classification
New or revised GB MCLs MAY be proposed:
- where a substance has no existing GB MCL for the hazard classes involved and the GB-based manufacturer, importer or downstream user has the scientific data to submit a proposal
An overview of the GB MCL process can be found on the 'Updating the mandatory classification and labelling list (GB MCL list)' webpages.
Submitting a GB MCL proposal
Before you prepare a GB MCL proposal, please contact us to discuss your plans. This is to ensure that the proposal is prepared in line with regulatory requirements and contains the necessary scientific and technical information.
Discussing the proposal at an early stage also helps us co-ordinate substances going through the mandatory classification and labelling process, both nationally and internationally.
You can contact HSE GB CLP specialists at: [email protected]. The specialists will send you:
- the name of an HSE lead contact person assigned to the proposal
- the template needed to prepare the proposal
- information on how to progress the proposal
- any information regarding similar GB MCL proposals that HSE is aware of
If required, the proposal can be discussed in a pre-submission meeting. This can be arranged directly with the HSE lead contact.
You may be asked to provide study reports that support the proposal.
If you lack the technical ability to submit a proposal, it may be possible for HSE specialists to undertake the work on your behalf. If you fall into this category, please contact us for further information at [email protected].
Communicating with stakeholders
Information about planned GB MCL proposals is included in HSE's GB CLP e-Bulletin. The e-Bulletin alerts interested parties to the preparation of a GB MCL proposal, so that they can prepare for the public consultation. It also prevents duplication of work.
If you wish to receive alerts about proposed GB MCLs, you can sign-up to the GB CLP e-Bulletin.
Validation check
Once received, a validation check of the proposal is carried out by HSE specialists to ensure that it meets the standards set out in the GB CLP Regulation. If the proposal does not pass the validation check, HSE will inform you about:
- the grounds for the refusal
- how the required standards for a successful proposal can be met
When the proposal passes the validation check, it is formally accepted by HSE for evaluation.
Fees and charges
For some GB MCL proposals, you may be charged for the work undertaken by HSE specialists. Once the proposal is accepted, if a fee is chargeable, an invoice is issued. The details of the costs are provided with the invoice.
Further information on fees and charges can be found on the Fees section on the 'Updating the mandatory classification and labelling list (GB MCL list)' webpages.
Public consultation on GB MCL proposals
Your proposal will then be subject to public consultation. The proposal is published on Citizen Space, the UK government's public consultation platform, together with a webform for public responses.
Any confidential material supporting the proposal is redacted, before it is published.
The public consultation lasts for 8 weeks and asks duty-holders and any interested stakeholders to provide comments and relevant information on the proposed mandatory classification. This will include information on the scientific content and the likely policy and socio-economic impacts of the proposal.
At this stage, GB MCL published proposals do NOT reflect HSE's scientific Opinion. Further information can be found on the 'Updating the mandatory classification and labelling list (GB MCL list)' webpages.
Once received, HSE collates the responses to the public consultation. You will have an opportunity to respond to them.
Consultation responses, comments and information received
GB CLP Agency (HSE) GB MCL Technical Report
HSE specialists will use the proposal and relevant information received from the public consultation to write the Agency Technical Report on the proposed GB MCL.
The Agency Technical Report is produced by the Agency's regulatory scientists and the Environment Agency (EA) for environmental hazards (the Scottish Environment Protection Agency (SEPA) and Natural Resources Wales (NRW) may also contribute views). No policy or socio-economic factors are considered at this stage. The Agency Technical Report is a scientific assessment of a substance's intrinsic hazardous properties in the context of the CLP classification criteria.
Specialists in HSE and the Environment Agency will carry out a detailed scientific analysis of the available data, including information submitted during the public consultation, and decide on the substance's intrinsic hazardous properties by evaluating the data against the GB CLP classification criteria. As the GB CLP Agency, HSE can, if needed, also seek views from relevant external experts in, for example, matters relating to carcinogenicity, mutagenicity or reproductive toxicity.
On completion, Agency Technical Reports are published on the HSE's website.
GB CLP Agency (HSE) GB MCL Opinion
The Agency Technical Report together with an assessment of possible socio-economic costs and benefits and policy impacts of the proposal, are combined to produce the Agency Opinion on the proposed GB MCL, which is also published on the HSE website.
Further information about the production of the Agency Opinion can be found on the 'Updating the mandatory classification and labelling list (GB MCL list)' webpages.
GB MCL Recommendation and Decision
The Agency Opinion informs the Recommendation made by the Agency to the Secretary of State, about whether to give legal effect to the proposed new or revised GB MCL. The ministers of the Scottish and Welsh Governments are also made aware of the Agency's Recommendation. The final Decision on the new or revised GB MCL is made by the Secretary of State, with the consent of the Scottish and Welsh Governments.
Recommendations are expected to be submitted to ministers once a year and will include all the Agency Opinions published in the previous year.
More information about this process can be found on the 'Updating the mandatory classification and labelling list (GB MCL list)' webpages.