The Agency for UK REACH has published final opinions on the following applications for authorisation.
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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.
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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.
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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
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.
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