HSE have published their latest bulletins:
Biocides
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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 of the approvals until the following dates:
- 2,3,5,6-tetrafluoro-4-(methoxymethyl)benzyl (EZ)-(1RS,3RS;1SR,3SR)- 2,2-dimethyl-3-prop-1-enylcyclopropanecarboxylate (Metofluthrin) (CAS 240494-71-7 EC n/a) in product type 18 (From 31 October 2023 to 31 October 2024)
- Reaction mass of (R)-α-cyano- 3-phenoxybenzyl (1S,3S)-3-[(Z)-2- chloro-3,3,3-trifluoropro- penyl]-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-[(Z)-2-chloro-3,3,3- trifluoropropenyl]-2,2- dimethylcyclopropanecarboxylate (1:1) (lambda-cyhalothrin) (CAS 91465-08-6 EC 415-130-7) in product type 18 (From 30 September 2023 to 31 March 2026)
- (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromovinyl)-2,2- dimethylcyclopropane carboxylate (Deltamethrin) (CAS 52918-63-5 EC 258-256-6) in product type 18 (From 30 September 2023 to 31 March 2026)
- Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 (CAS n/a EC n/a) in product type(s) 18 (From 30 September 2023 to 31 March 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.
Prior Informed Consent (PIC) Regulation
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Notifying exports of PIC chemicals for 2024: HSE, the GB PIC Designated National Authority (DNA), is inviting companies to submit notifications for exports of chemicals in the GB PIC List that are expected to take place during 2024.
The GB PIC Regulation requires the first export of a listed chemical in any calendar year, to any country, to be notified to the DNA at least 35 days before the intended date of export. Export includes the movement of a listed chemical from GB to Northern Ireland (NI).
Early notification ensures HSE has sufficient time to process notifications and seek the explicit consent of the importing country, where required, or to consider evidence for the granting of a waiver where there is no response to repeated requests for consent.
What you need to do
Export notifications
- Complete a GB PIC export notification form (.docx)
- You can find information on the notification process on HSE’s PIC website, as well as supporting guidance on how to complete the form (PDF)
- Please send completed forms to ukdna@hse.gov.uk
- To avoid delays in processing export notifications, please include the following details in the subject line of your email:
GB PIC – notification – company name – chemical/mixture – importing country name – 2024
- When submitting your export notifications, please attach only one export notification form and accompanying safety data sheet (SDS) to each email
- In addition to an SDS in English, please provide an SDS in the official language of the importing country, if available, or in one of its principal languages. If you do not attach an SDS, sections 4 and 5 of the form become mandatory
- Some countries have more than one DNA. To ensure HSE sends your notification to the relevant authority in the destination country, please be as accurate as possible in describing the foreseen use in the importing country (section 3.3 of the export notification form). This will also be helpful to the importing DNA when making decisions on consent, where applicable
- If you are intending to export a number of mixtures containing a chemical in the GB PIC List to the same importing country, where those mixtures differ only, for example, by colour and there are no differences in their classification and labelling or intended use, we can accept a single notification covering several mixtures
- Whenever changes in the concentration of PIC chemical(s) in a mixture trigger new labelling requirements, a new notification will be required
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Special reference identification numbers (RINs): Special RINs are required for PIC chemicals exported for the purpose of research or analysis in quantities of 10kg or less per exporter, per year and per importing country and are otherwise exempt from the requirements of the Regulation.
A Special RIN is also required where an importing country has waived its right to receive an export notification and has notified a positive import response under the Rotterdam Convention for the chemical being exported.
You can now submit Special RIN requests for 2024:
- Complete a Special RIN request form (.docx)
- Please send completed forms to ukdna@hse.gov.uk
- Please include the following details in the subject line of your email:
GB PIC – Special RIN request – company name – chemical/mixture – importing country name – 2024
- For exports of PIC chemicals to the EU, each Special RIN covers exports of up to 10kg of the substance for research and analysis purposes to each EU importing country
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GB active substance expiry date postponed: Active substance expiry date postponed whilst the renewal evaluation is completed in GB
For reasons beyond the control of the applicant, the approval of the active substance/product type combination listed below was likely to expire before a decision could be taken on its renewal under the GB BPR.
To allow sufficient time for the renewal evaluation to be completed, a decision has been taken to postpone the expiry date of the following approval:
- Creosote (CAS 8001-58-9 EC 232-287-5) in product type 08 (From 24 July 2023 to 13 February 2025)
If you want to supply new biocidal products containing this active substance, you can still apply for GB BPR product authorisation. New products (including new trade names) must not be supplied in GB until product authorisation is granted. HSE will provide a separate update on the renewal decision when relevant.
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Reminder – GB active substance open invitation deadline: Submit a notification by the deadline to keep active substances in the GB Review Programme
HSE has published an open invitation (.pdf) 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 GB Review Programme for the following active substance/product type combination.
Anyone wishing to support one of the active substance/product type combination listed below in GB will need to submit a notification to HSE by the following deadline:
- Silver nitrate (CAS 7761-88-8 EC 231-853-9) in product type 01 (Deadline 16 February 2024)
If a notification to take over the role of participant is not received, this active substance/product type combination will be subject to a GB non-approval decision. Biocidal products containing active substances with GB non-approval decisions for the relevant product types will have to be removed from the GB market.
HSE will provide separate updates on these where relevant.
If you are aware of any disproportionate negative effects that are likely to arise from the non-approval of any of the active substance/product type combination listed above, please contact us.
Classification Labelling and Packaging (CLP)
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ECHA public consultation: call for comments (Deadline: 29 September 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):
- 4,4′-methylenediphenol; bisphenol F (EC: 210-658-2; CAS: 620-92-8). Chemical registered under REACH. Health hazard class open for commenting.
- bronopol; 2-bromo-2-nitropropane-1,3-diol (EC: 200-143-0; CAS: 52-51-7). Biocide 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 29 September 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 mandatory classification and labelling (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 Committee for Risk Assessment (RAC) published a RAC Opinion under Article 37(4) of EU CLP during 2022 and 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.
REACH
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UK REACH application for authorisation: publication of final opinion: The Agency for UK REACH has published a final opinion on the below application for authorisation.
- Reference: AFA006-01
Substance: Trichloroethylene (TCE) (EC: 201-167-4, CAS: 79-01-6)
Use: Use of trichloroethylene as an extraction solvent for removal of process oil and formation of the porous structure in polyethylene-based separators used in lead-acid batteries
HSE sent the final opinion to the appropriate authorities on 27 April 2023.
The Defra Secretary of State with the consent of the appropriate authorities has 6 months from receipt of the final opinion in which to make a decision on whether to grant the authorisation.
The opinion and other related documentation can be found on the HSE website:
List of UK REACH authorisations – granted and applications in progress
- Reference: AFA006-01
