HSE have published their latest bulletins:
Biocides
- Upcoming EU active substance expiry dates
Biocidal products must be phased off the NI market
The active substance/product type combinations listed below are due to expire under the EU BPR on the following dates. This affects NI:
- (RS)-4-hydroxy-3-(3-oxo-1-phenylbutyl)coumarin (Warfarin) (CAS 81-81-2 EC 201-377-6) in product type 14 (deadline: 30 June 2024)
- Polyhexamethylene biguanide hydrochloride with a mean number-average molecular weight (Mn) of 1600 and a mean polydispersity (PDI) of 1.8 (PHMB (1600;1.8)) (CAS 27083-27-8 / 32289-58-0 EC n/a) in product types 2, 3 and 11 (deadline: 30 June 2024)
- 1-(4-chlorophenyl)-4,4-dimethyl-3-(1,2,4-triazol-1-ylmethyl)pentan-3-ol (Tebuconazole) (CAS 107534-96-3 EC 403-640-2) in product types 7 and 10 (deadline: 30 June 2025)
Once the approvals expire, the active substances will no longer be able to be used in biocidal products of the relevant product types in NI. In addition articles treated with such products will no longer be able to be placed on the market in NI.
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 expiry of any of the active substance/product type combinations listed above, please contact us.
- (RS)-4-hydroxy-3-(3-oxo-1-phenylbutyl)coumarin (Warfarin) (CAS 81-81-2 EC 201-377-6) in product type 14 (deadline: 30 June 2024)
- 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 evaluations to be completed, decisions have been taken to postpone the expiry dates of the following approvals.
This affects NI:
- (3β,5Z,7E)-9,10-secocholesta-5,7,10(19)-trien-3-ol (Cholecalciferol) (CAS 67-97-0 EC 200-673-2) in product type 14 (From 30 June 2024 to 31 December 2025)
- Aluminium phosphide releasing phosphine (CAS 20859-73-8 EC 244-088-0) in product types 14 and 18 (From 30 July 2024 to 31 January 2026)
- Reaction mass of methyl (S)-and methyl(R)-7-chloro-2,3,4a,5-tetrahydro-2-[methoxycarbonyl-(4-trifluoromethoxyphenyl)carbamoyl]indeno[1,2-e][1,3,4]oxadiazine-4a-carboxylate (75:25) (Indoxacarb) (CAS 144171-61-9 EC 604-398-2) in product type 18
(From 30 June 2024 to 31 December 2026)
The decision on the below 7 substance/product type combinations can be found here.
Expiry date postponement from 30 June 2024 to 31 December 2026:
- 3-[3-(4′-bromobiphenyl-4-yl)-1,2,3,4-tetrahydro-1-napthyl]-4-hydroxycoumarin (Brodifacoum) (CAS 56073-10-0 EC 259-980-5) in product type 14
- 3-[3-(4’-bromo[1,1’-biphenyl]-4-yl)-3-hydroxy-1-phenylpropyl]-4-hydroxy-2H-1-benzopyran-2-one (Bromadiolone) (CAS 28772-56-7 EC 249-205-9) in product type 14
- Chlorophacinone (CAS 3691-35-8 EC 223-003-0) in product type 14
- Coumatetralyl (CAS 5836-29-3 EC 227-424-0) in product type 14
- 3-(3-biphenyl-4-yl-1,2,3,4-tetrahydro-1-naphthyl)-4-hydroxycoumarin (Difenacoum) (CAS 56073-07-5 EC 259-978-4) in product type 14
- 3-[3-(4′-bromo[1,1′biphenyl]-4-yl)-1,2,3,4-tetrahydronaphth-1-yl]-4-hydroxy-2H-1-benzothiopyran-2-one (Difethialone) (CAS 104653-34-1 EC 600-594-7) in product type 14
- 4-hydroxy-3-[(1RS,3RS;1RS,3RS)-1,2,3,4-tetrahydro-3-[4-(4-trifluoromethylbenzyloxy)phenyl]-1-naphthyl]coumarin (Flocoumafen) (CAS 90035-08-8 EC 421-960-0) in product type 14
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.
- (3β,5Z,7E)-9,10-secocholesta-5,7,10(19)-trien-3-ol (Cholecalciferol) (CAS 67-97-0 EC 200-673-2) in product type 14 (From 30 June 2024 to 31 December 2025)
- Live online workshop: biocides efficacy (11, 12 & 13 June 2024)
This workshop will be delivered online over 3 morning sessions and will help develop an understanding of the regulatory approach to efficacy assessment under the GB BPR. It will focus on helping attendees understand how to improve the quality of their efficacy data packages by illustrating how these dossiers are assessed by HSE as the regulator responsible for authorisations and approvals under GB BPR. We will share our experience and worked examples to demonstrate best practice and common issues and data gaps that we encounter during assessments.
Who should attend?
The course is suitable for all those involved in the creation and submission of an efficacy data package for GB BPR applications, including test houses, applicants, consultants, etc.
No prior experience is assumed; the course will provide both a good starting point for beginners and an opportunity to develop and update the knowledge of those experienced in producing dossiers.
Topics covered
- identifying the label claims for a product and using the guidance to find the correct data requirements for these claims
- generating and presenting data to meet these requirements
- options when guidance is limited or unavailable
- product type (PT) specific considerations and requirements for: PT 1 – 5 (Disinfectants), PT 18 (Insecticides) and PT 19 (Repellents and Attractants)
- specific common issues for other product types
- efficacy data requirements for product families
- efficacy data requirements to demonstrate that a co-formulant is not an active substance in a product
- question and answer sessions
Registration
Find out more and register for this fee paid workshop. The closing date for registration is 3 June 2024.
CLP
- HSE Public consultation: call for comments and relevant information (Deadline: 14 June 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).
HSE has published a public consultation on the following proposals for GB MCLs:
- Copper (I) oxide (EC: 215-270-7; CAS: 1317-39-1)
- Copper (II) hydroxide, copper dihydroxide (EC: 243-815-9; CAS: 20427-59-2)
- Copper (II) carbonate – copper (II) hydroxide (1:1) (EC: 235-113-6; CAS: 12069-69-1)
- Dicopper chloride trihydroxide (EC: 215-572-9; CAS: 1332-65-6)
- Copper thiocyanate (EC: 214-183-1; CAS: 1111-67-7)
- Copper sulphate pentahydrate (EC: 231-847-6; CAS: 7758-98-7)
- Tetracopper hexahydroxide sulphate [1], tetracopper hexahydroxide sulphate hydrate [2] (EC: 215-582-3; CAS: 1333-22-8 [1] 12527-76-3 [2])
- Bordeaux mixture, reaction products of copper sulphate with calcium dihydroxide (EC: -; CAS: 8011-63-0)
- Copper flakes (coated with aliphatic acid) (EC: -; CAS: -)
Scientific or technical information and/or wider policy and impact considerations should be submitted using the HSE commenting webform by 14 June 2024. Comments will be published on HSE’s website.
Anyone with relevant information is encouraged to share it with HSE. Relevant information includes scientific or technical information relating to the proposed classification, as well as information on the potential impacts of the classification (positive and negative).
If your business is affected by the GB CLP Regulation, please consider if you are likely to be affected by any of the classification and labelling proposals and submit information if you anticipate any significant impacts or benefits.
For further information on what to submit during the public consultation, please visit the GB MCL webpages on the HSE website.
Under the GB CLP Regulation, HSE will consider all public consultation submissions before publishing Agency Technical Reports and Agency Opinions, so any information you provide will be important in any final GB MCL decision.
- ECHA public consultation: call for comments (Deadline: 24 May 2024)
The GB MCL process includes the consideration of information gathered from public consultations, conducted by HSE or international bodies such as ECHA.
ECHA has announced a public consultation on the following proposal for harmonised classification and labelling (CLH):
- propyl [3-(dimethylamino)propyl]carbamate monohydrochloride; propamocarb hydrochloride (EC: 247-125-9; CAS: 25606-41-1). 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 24 May 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.
