HSE have published their latest bulletins:
CLP
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ECHA public consultation: call for comments (Deadline: 13 October 2023)
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):
- 3,4-dimethyl-1H-pyrazol-1-ium dihydrogen phosphate (EC: 424-640-9; CAS: 202842-98-6). Chemical registered under REACH. Health hazard classes open for commenting.
- 3,4-dimethyl-1H-pyrazole (EC: 429-130-1; CAS: 2820-37-3). Chemical registered under REACH. Health hazard classes open for commenting.
- 3,5-dimethylpyrazole (EC: 200-657-5; CAS: 67-51-6). Chemical registered under REACH. Health hazard classes open for commenting.
- ulexite (EC: 296-662-5; CAS: 1319-33-1); colemanite (EC: 296-640-5; 1318-33-8);
tincalconite (EC: -; 12045-88-4). Borate minerals. Health hazard class open for commenting. - rape oil; rape seed oil (EC: 232-299-0; CAS: 8002-13-9). 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 13 October 2023. 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.
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Publication of GB MCL technical reports
A GB MCL technical report is an independent scientific evaluation of the information submitted under the stand-alone GB MCL process or as part of the EU harmonised classification and labelling process.
It sets out whether there is adequate scientific evidence to support a new or revised GB MCL of a substance and what that GB MCL should be. The next batch of GB MCL technical reports is now available for download at the end of the GB MCL publication table (.xlsx). These GB MCL technical reports relate to substances for which the RAC published a RAC Opinion under Article 37(4) of EU CLP during 2023, based on information submitted under the EU CLP Regulation. The scientific information supporting the RAC Opinion is evaluated under the GB MCL system.
At the time of publication, the classification and labelling proposed in these technical reports has not been agreed and/or adopted in Great Britain. 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 technical reports in late November 2023. CLP ebulletin alerts will be issued when technical reports are published on the HSE website. If you have any questions or feedback on the GB MCL technical reports, please contact us at: GBCLP.GBMCL@hse.gov.uk Journalists should contact HSE’s press office for further information.
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Publication of 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 12 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 August 2022.
At the time of publication, the classification and labelling proposed in this agency opinion has not been agreed and/or adopted in Great Britain. 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 November 2023. 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.
Biocides
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GB guidance has been updated
Update to the GB guidance document on endocrine disruptor assessments of biocidal non-active substances
HSE has updated the GB guidance document: Bridging the endocrine disruptor assessment of biocidal non-active substances with UK and EU REACH screening and assessment. This update includes:
- removal of the requirement for applicants to provide a literature review for non-target organisms
- correction of broken links to external websites
GB had previously retained the requirement to conduct a literature review for non-target organisms to provide wider assurance on the potential for endocrine disruption (ED) impacts on the environment. Whilst HSE considers that the literature review added value, we have determined that the database checks outlined in the bridging document are sufficient to capture all relevant information on potential ED properties of co-formulants. HSE is confident that this will adequately address the potential risk to non-target organisms.
The guidance should be used for applications with immediate effect. The updated guidance is available on our website.
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New EU active substance non-renewal decision
Biocidal products must be phased off the NI market
Following evaluation under the EU BPR, a decision has been taken not to renew the following active substance approval. This affects NI:
Along with the non-renewal, Implementing Decision (EU) 2023/1423 repeals the previous decision on the postponement of the expiry date for acrolein.
If you hold an affected EU BPR product authorisation or Control of Pesticides Regulations (COPR) product approval, we will contact you about cancelling or revoking your authorisation or approval. You will have an opportunity to submit comments or additional information and we will take account of these when finalising our decision. If you are aware of any disproportionate negative impacts that are likely to arise from the non-renewal of any of the active substance/product type combinations listed above, please contact us.
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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 substance/product type combinations. This will affect NI:
- Chrysanthemum cinerariaefolium, extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical CO2 (CAS 89997-63-7 EC 289-699-3) in product type 18
- Chrysanthemum cinerariaefolium, extract from open and mature flowers of Tanacetum cinerariifolium obtained with hydrocarbon solvents (CAS 89997-63-7 EC 289-699-3) in product type 18
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 February 2025 to keep them on the NI market. New products (including new trade names) 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.
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Upcoming EU active substance approval dates
Apply for product authorisation by the deadlines to keep your products on the NI market
The following EU BPR active substance approval dates are coming up:
- L-(+)-lactic acid (CAS 79-33-4 EC 201-196-2) in product type 06 (deadline: 1 November 2023)
- Chrysanthemum cinerariaefolium, extract from open and mature flowers of Tanacetum cinerariifolium obtained with hydrocarbon solvents (CAS 89997-63-7 EC 289-699-3) in product type 19 (deadline: 1 February 2024)
- Chrysanthemum cinerariaefolium, extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical CO2 (CAS 89997-63-7 EC 289-699-3) in product type 19 (deadline: 1 February 2024)
- N,N-Didecyl-N,N-dimethylammonium chloride (Didecyldimethylammonium chloride) (DDAC) (CAS 7173-51-5 EC 230-525-2) in product types 01 and 02 (deadline: 1 February 2024)
If you supply biocidal products containing these active substances in the relevant product types, don’t forget to apply for EU BPR product authorisation by the dates above to keep them on the Northern Ireland market
- L-(+)-lactic acid (CAS 79-33-4 EC 201-196-2) in product type 06 (deadline: 1 November 2023)
