HSE have published their latest bulletins:
e-bulletin
- Upcoming EU active substance open invitation deadline
Submit a notification by the deadline to keep active substances in the EU Review Programme
The European Chemicals Agency (ECHA) has published an open invitation to provide an opportunity for a person, company or task force/consortium to notify an intention to take up or take over the role of participant in the EU Review Programme for the following active substance. This affects NI.
Anyone wishing to support the active substance listed below in the EU will need to submit a notification to ECHA by the following deadline:
- Tetrahydro-1,3,4,6-tetrakis(hydroxymethyl)imidazo[4,5-d]imidazole-2,5 (1H,3H)-dione (TMAD) (CAS 5395-50-6 EC 226-408-0) in product type 12 (deadline: 31 January 2025)
If a notification to take over the role of participant is not received, this active substance will be subject to an EU non-approval decision. This means the active substance will no longer be able to be used in biocidal products of the relevant product type in NI.
In addition articles treated with such products will no longer be able to be placed on the market in NI. HSE will provide separate updates on these where relevant.
If you are aware of any disproportionate negative impacts that are likely to arise from the non-approval of the active substance/product type combination listed above, please contact us.
- New EU active substance approval decisions
Apply for product authorisation by the deadline to keep your products on the NI market
Following evaluation under the EU BPR, a decision has been taken to approve the following active substances. This will affect NI:
- Pentapotassium bis(peroxymonosulphate) bis(sulphate) (CAS 70693-62-8 EC 274-778-7) in product types 2, 3, 4 and 5
- Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12-16)) (CAS 68424-85-1 EC 270-325-2) in product type 2
Action for biocidal product suppliers:
If you supply biocidal products containing these active substances in the relevant product types, you must apply for EU BPR product authorisation by 1 July 2025 to keep them on the NI market. New products must not be supplied in NI until product authorisation is granted.
Action for active substance suppliers:
If you supply these active substances for use in biocidal products of the relevant product types, you may need to apply for technical equivalence. If you haven’t demonstrated technical equivalence for your manufacturing source, EU BPR product authorisation cannot be granted for biocidal products containing your active substance.
- EU active substance expiry dates postponed
Active substance expiry dates postponed whilst the renewal evaluation is completed in the EU
For reasons beyond the control of the applicants, the approvals of the active substance/product type combinations listed below were likely to expire before a decision could be taken on their renewal under the EU BPR.
To allow sufficient time for the renewal evaluation to be completed, a decision has been taken to postpone the expiry dates of the following approvals. This affects NI:
- Disodium tetraborate, pentahydrate (CAS 12179-04-3 EC 215-540-4 ) in product type 8 (From 28 February 2024 to 31 August 2026)
- Boric acid (CAS 10043-35-3 EC 233-139-2 ) in product type 8 (From 28 February 2024 to 31 August 2026)
If you want to supply new biocidal products containing these active substances, you can still apply for EU BPR product authorisation. New products (including new trade names) must not be supplied in NI until product authorisation is granted. HSE will provide separate updates on the renewal decisions when relevant.
Classification Labelling and Packaging (CLP)
- Publication of GB mandatory classification and labelling (GB MCL) Agency Opinions
A GB MCL Agency Opinion formally proposes the GB mandatory classification and labelling for chemical substances, based on the scientific and technical assessment of the scientific data in line with the GB CLP Regulation, together with an assessment of the policy and socio-economic impacts on the UK.
It sets out whether there is adequate scientific evidence to support a new or revised GB MCL of a substance and what the potential impact of the proposed GB MCL may be.
The next batch of 10 GB MCL Agency Opinions are now available for download in the GB MCL publication table (.xlsx).
These GB MCL Agency Opinions relate to substances for which HSE (as the GB CLP Agency) published an Agency Technical Report under Article 37 of the GB CLP Regulation in February 2023. At the time of publication, the classification and labelling proposed in this Agency Opinion has not been agreed and/or adopted in GB.
For information on the next steps in the process, please see our webpage on the GB MCL system.
We expect to publish our next batch of Agency Opinions in May 2024. CLP ebulletin alerts will be issued when Agency Opinions are published on the HSE website. If you have any questions or feedback on the GB MCL Agency Opinions, please contact us at: GBCLP.GBMCL@hse.gov.uk Journalists should contact HSE’s press office for further information.
- ECHA public consultation: call for comments
Deadline: 19 April 2024
The Great Britain Mandatory Classification and Labelling (GB MCL) process includes the consideration of information gathered from public consultations, conducted by HSE or international bodies such as the European Chemicals Agency (ECHA).
ECHA has announced public consultations on the following proposals for harmonised classification and labelling (CLH):
- 1-nitropropane (EC: 203-544-9; CAS: 79-24-3). Chemical registered under REACH. Health hazard class open for commenting.
- nitroethane (EC: 201-188-9; CAS: 79-24-3). Chemical registered under REACH. Health hazard class open for commenting.
- nitromethane (EC: 200-876-6; CAS: 75-52-5). Chemical registered under REACH. Health hazard class open for commenting.
- sulcotrione (ISO) (EC: -; CAS: 99105-77-8). Pesticide active substance. All hazard classes open for commenting.
View the consultation on the ECHA website.
UK-based businesses with an interest in the proposal are strongly encouraged to share any relevant information.
Scientific and technical information should be submitted directly to ECHA using their commenting webform by 19 April 2024. Comments will be published on ECHA’s website.
If your business is affected by the GB CLP Regulation, please also consider if you are likely to be affected by the classification and labelling proposal and let us know at an early stage if you anticipate any significant impacts or benefits.
Information on wider policy and impact considerations can be submitted to HSE at GBCLP.GBMCL@hse.gov.uk.
Under the GB CLP Regulation, HSE will consider all published opinions of the Committee of Risk Assessment of ECHA (RAC) before publishing its own Agency Technical Reports and Agency Opinions, so any information you provide will be important in any final GB MCL decision. More information on the new GB MCL system is available on the HSE website.
