HSE have published their latest bulletins:
REACH
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UK REACH application for authorisation: publication of final opinions
The Agency for UK REACH has published final opinions on the following applications for authorisation.
- Reference: AFA018-01
Applicant: Siemens Healthcare Diagnostics Products GmbH
Substances: 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO)
Use: Use of IVD kit reagents on diagnostic analyser systems by professional users. - Reference: AFA018-02
Applicant: Siemens Healthcare Diagnostics Products GmbH
Substances: 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO)
Use: Use of IVD wash solutions on diagnostic analyser systems by professional users. - Reference: AFA020-01
Applicant: Abbott Laboratories Limited
Substance: 4-(1,1,3,3 tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO)
Use: Professional use as a surfactant, in Wash Buffer components used in conjunction with Fluorescence in Situ Hybridisation (FISH) test kits and/or their Laboratory Developed Test (LDT) equivalents, in clinical diagnostic use for medical analysis of human tissue and blood samples to identify characteristic genetic abnormalities related to specific disease conditions. - Reference: AFA021-01
Applicant: Becton Dickinson U.K. Limited
Substance: 4-(1,1,3,3 tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO)
Use: Use of 4-(1,1,3,3 tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO) for the lysis of different types of cells in order to release the cell contents for subsequence analysis in diagnostics.
The opinions and other related documentation can be found on the HSE website.
- Reference: AFA018-01
Biocides
- Upcoming GB active substance renewal submission deadlines
Apply for active substance renewal by the deadlines to keep products on the GB market
Under the GB BPR, active substance approvals will expire unless a renewal application is submitted at least 550 days before their expiry date.
The 550-day deadlines are coming up for the following active substance/product type combinations under GB BPR:
- 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole (Propiconazole) (CAS 60207-90-1 EC 262-104-4) in product type 7 (deadline: 29 May 2025)
- 3-iodo-2-propynylbutylcarbamate (IPBC) (CAS 55406-53-6 EC 259-627-5) in product type 13
(deadline: 29 May 2025) - 5-chloro-2-(4-chlorphenoxy)phenol (DCPP) (CAS 3380-30-1 EC 429-290-0) in product types 1, 2 and 4 (deadline: 29 May 2025)
- Potassium (E,E)-hexa-2,4-dienoate (Potassium Sorbate) (CAS 24634-61-5 EC 246-376-1) in product type 8 (deadline: 29 May 2025)
Any person, company or task force/consortium can support an active substance/product type combination for renewal – it doesn’t have to be the original supporter.
Check the GB Article 95 List to see who the original supporters were.
If any of these active substance/product type combinations are important to you, consider contacting your supplier to let them know.
If a renewal application is not submitted for the above active substance/product type combinations under GB BPR, the approvals will expire. This means the active substances will no longer be able to be used in biocidal products of the relevant product types in GB. In addition articles treated with such products will no longer be able to be placed on the market in GB.
- 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole (Propiconazole) (CAS 60207-90-1 EC 262-104-4) in product type 7 (deadline: 29 May 2025)
- Upcoming GB active substance dossier submission deadline
Take action to keep your active substance in the GB Review Programme
The active substance/product type combinations listed below have been successfully notified into the GB Review Programme following an open invitation. The next step is for a full active substance dossier to be submitted to HSE by the following deadline:
- Chrysanthemum cinerariaefolium, extract from open and mature flowers of Tanacetum cinerariifolium obtained with hydrocarbon solvents (Redefined from Pyrethrins and Pyrethroids and Chrysanthemum cinerariaefolium, ext.) (CAS 89997-63-7 EC 289-699-3) in product types 18 and 19 (deadline: 23 May 2025)
Only the person, company or task force/consortium that successfully notified the active substance/product type combinations listed above can submit a dossier. If any of these active substance/product type combinations are important to you, consider contacting the notifier to let them know. You may even be able to join them in supporting the active substance.
Check the list of successful notifiers.
If a dossier is not submitted by the deadline, these active substance/product type combinations will be subject to a GB non-approval decision. This means the active substance will no longer be able to be used in biocidal products of the relevant product types in GB.
In addition articles treated with such products will no longer be able to be placed on the market in GB. HSE will provide separate updates on these where relevant.
