HSE have published their latest bulletins:
REACH
- Publication of the second recommendation to include diisohexyl phthalate in the list of substances subject to authorisation (Annex 14) for UK REACH
In September 2023, HSE published a draft recommendation for the inclusion of diisohexyl phthalate (EC: 276-090-2 and CAS: 71850-09-4) in Annex 14 of UK REACH. The 3-month commenting period on this draft recommendation closed in December. The recommendation has been updated and now finalised as the second recommendation from HSE (as the Agency for UK REACH) to the Appropriate Authorities (the (Defra) Secretary of State and the Scottish and Welsh Ministers), who will make a decision on the inclusion into Annex 14.
Documents can be found in “Recommendations to add substances to Annex XIV” available on the HSE website.
- 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: AFA014-01
Applicant: Roche Diagnostics Limited
Substances: 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (Octylphenolethoxylates, OPnEO) and 4-Nonylphenol, branched and linear, ethoxylated (Nonylphenolethoxylates, NPnEO)
Use: Use of OPnEO and NPnEO in 10 in vitro diagnostic (IVD) assays used for example in Clinical Chemistry (CC) and Drug Monitoring (DM) products.HSE sent the final opinion to the Appropriate Authorities on 20 September 2023. - Reference: AFA015-01
Applicant: Bonaprene Products Limited
Substance: 2,2′-dichloro-4,4′-methylenedianiline (MOCA, MbOCA) (EC: 202-918-9, CAS: 101-14-4)
Use: MbOCA is used as a reactant in the manufacture of cast polyurethanes at an industrial site.
HSE sent the final opinion to the Appropriate Authorities on 11 October 2023. - Reference: AFA017-01
Applicant: Becton, Dickinson U.K. Limited
Substance: 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328) (EC: 247-384-8, CAS: 25973-55-1)
Use: Use of an imported polymer containing UV-328 as an additive for UV stabilisation in the manufacture of a mechanical separator component used in Barricor blood collection tubes.
HSE sent the final opinion to the Appropriate Authorities on 20 September 2023.
The Defra Secretary of State with the consent of the Appropriate Authorities has 6 months from receipt of the final opinions in which to make decisions on whether to grant the authorisations.
The opinions and other related documentation can be found on the HSE website:
List of UK REACH authorisations – granted and applications in progress
- Reference: AFA014-01
- ‘Comply with UK REACH’ IT users should log in to keep their Government Gateway account active
HSE are advising all ‘Comply with UK REACH’ users to log in to their Government Gateway accounts registered with the service if they haven’t done so recently.
On 1 January 2024 the ‘Comply with UK REACH IT’ service will have been operational for 3 years.
Accessing the ‘Comply with UK REACH IT’ service requires the creation of a Government Gateway account. Government Gateway is a platform used to access a variety of government services.
Users must log in to their Government Gateway account at least once every 3 years, or they will lose access to their Government Gateway account and its associated data. Some users of the ‘Comply with UK REACH’ service may not have accessed their Government Gateway account since they fulfilled their initial regulatory obligations.
Anyone needing help accessing ‘Comply with UK REACH’ should call the UK Chemicals Helpline on 0330 159 1985.
HSE recommends users always assign more than one administrator (admin) for each ‘Comply with UK REACH’ account. This will prevent loss of access if an individual admin leaves your organisation, or they can no longer access their Government Gateway account.
Important Note: Data that users have previously submitted via ‘Comply with UK REACH’ will not be deleted. However, if you lose access to your Government Gateway account, you will no longer be able to access your submission data via ‘Comply with UK REACH’.
This may mean you are unable to update or progress a previous submission associated to your account.
Biocides:
- 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:
- Sulfur dioxide generated from sulfur by combustion (CAS n/a EC n/a) in product type 04
- Formic acid (CAS 64-18-6 EC 200-579-1) in product types 02, 03, 04 and 05
Action for biocidal product suppliers
If you supply biocidal products containing sulfur dioxide generated from sulfur by combustion in product type 04, you must apply for EU BPR product authorisation by 1 October 2024 to keep them on the NI market.
If you supply biocidal products containing formic acid in product types 02, 03, 04, and/or 05, you must apply for EU BPR product authorisation by 1 November 2024 to keep them on the NI market.
New products must not be supplied in NI until product authorisation is granted. Find out more about applying for EU BPR product authorisation
Action for active substance suppliersIf 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.
- New EU active substance non-approval decisions
Biocidal products must be phased off the NI market
Following evaluation under the EU BPR, a decision has been taken not to approve the following active substance/product type combination. This will affect NI:
Biocidal products containing this active substance in the relevant product type can no longer be:
- supplied in NI after 18 December 2024; or
- used in NI after 18 June 2025
You must manage your stocks of the affected products to ensure they are removed from the NI supply chain by 18 December 2024.
New treated articles containing this active substance in the relevant product type cannot enter the supply chain or be imported into NI after 15 June 2024. Treated articles that have entered NI supply chains before this date can continue to be supplied and used.
Find out more about treated articles.
Any affected NI product approvals under the Control of Pesticides Regulations (COPR) will be revoked in line with the above dates. 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.
- EU active substance expiry date postponed
Active substance expiry date postponed whilst the renewal evaluation is completed in the EU
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 EU 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. This affects NI:
- Hydrochloric acid (CAS 7647-01-0 EC 231-595-7) in product type 02 (From 30 April 2024 to 31 October 2026)
If you want to supply new biocidal products containing this active substance, 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 a separate update on the renewal decision when relevant.
- Upcoming EU active substance renewal submission deadlines
Apply for active substance renewal by the deadlines to keep products on the NI market
Under the EU BPR, active substance approvals will expire unless a renewal application is submitted to ECHA at least 550 days before their expiry date.
The 550-day deadlines are coming up for the following active substance/product type combinations under EU BPR. This affects NI:
- Nonanoic acid (Pelargonic acid) (CAS 112-05-0 EC 203-931-2) in product type 02 (deadline: 29 March 2024)
- Bis(1-hydroxy-1H-pyridine-2-thionato-O,S)copper (Copper pyrithione) (CAS 14915-37-8 EC 238-984-0) in product type 21 (deadline: 29 June 2024)
- Copper flakes (coated with aliphatic acids) (CAS 7440-50-8 EC 231-159-6) in product type 21 (deadline: 29 June 2024)
- Copper thiocyanate (CAS 1111-67-7 EC 214-183-1) in product type 21 (deadline: 29 June 2024)
- Dichloro-N-[(dimethylamino)sulphonyl] fluoro-N-(ptolyl)methanesulphenamide (Tolylfluanid) (CAS 731-27-1 EC 211-986-9) in product type 21 (deadline: 29 June 2024)
- Dicopper oxide (CAS 1317-39-1 EC 215-270-7) in product type 21 (deadline: 29 June 2024)
- N-(Dichlorofluoromethylthio)-N′,N′-dimethyl-N-phenylsulfamide (Dichlofluanid) (CAS 1085-98-9 EC 214-118-7) in product type 21 (deadline: 29 June 2024)
- N-(trichloromethylthio)phthalimide (Folpet) (CAS 133-07-3 EC 205-088-6) in product type 06 (deadline: 29 June 2024)
- Pythium oligandrum, Chromista – Stramenopila (CAS n/a EC n/a) in product type 10 (deadline: 29 June 2024)
- Zinc ethylenebis(dithiocarbamate) (polymeric) (Zineb) (CAS 12122-67-7 EC 235-180-1) in product type 21 (deadline: 29 June 2024)
- [1α(S*),3α]-(α)-cyano-(3-phenoxyphenyl)methyl 3-(2,2-dichloroethenyl)-2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate (alpha-Cypermethrin) (CAS 67375-30-8 EC 614-054-3) in product type 18 (deadline: 27 December 2024)
- Bacillus sphaericus 2362, strain ABTS-1743 (CAS 143447-72-7 EC 604-356-3) in product type 18 (deadline: 27 December 2024)
- Bacillus thuringiensis subsp. israelensis, strain SA3A (CAS n/a EC n/a) in product type 18 (deadline: 27 December 2024)
- Propan-2-ol (CAS 67-63-0 EC 200-661-7) in product types 01, 02 and 04 (deadline: 27 December 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 type 08 (deadline: 27 December 2024)
- Copper, granulated (CAS 7440-50-8 EC 231-159-6) in product type 08 (deadline: 29 June 2025)
- Cyclohexylhydroxydiazene 1-oxide, potassium salt (K-HDO) (CAS 66603-10-9 EC 613-953-8) in product type 08 (deadline: 29 June 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 EU 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 EU BPR, the approvals will expire. This means the active substances can no longer be used in biocidal products or treated articles of the relevant product types in NI.
- Nonanoic acid (Pelargonic acid) (CAS 112-05-0 EC 203-931-2) in product type 02 (deadline: 29 March 2024)
