Transitional applications for authorisation (UK REACH)
Updated 19 June 2023
Applies to England, Scotland and Wales
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Authorisation is the process under UK REACH that phases out the use of hazardous substances of very high concern (SVHCs). It ensures that these SVHCs are progressively replaced by safer alternatives. Granting an authorisation allows the use of substances on the authorisation list to continue temporarily when the relevant criteria are met.
UK REACH contains transitional measures for authorisation applications that were submitted by GB-based companies under EU REACH. If the application was at the final decision stage before the end of the transition period it can be submitted directly to the Secretary of State for Environment, Food and Rural Affairs to make a decision. The Secretary of State’s decisions are published on the authorisation decisions page.
This applies to applications where the European Chemicals Agency (ECHA) had adopted final opinions but the European Commission had not made a final decision before 31 December 2020. Consent from the Scottish ministers and Welsh ministers is required for these decisions where the matter relates to devolved competence.
Further information about this UK REACH transitional measure is on the Health and Safety Executive (HSE) website.
Transitional applications for authorisation submitted to the Secretary of State for Environment, Food and Rural Affairs
Non-confidential documents relating to each application, including ECHA’s opinions, are on the ECHA website. Links are in the table under ‘Description of use’. Access to these documents is free of charge and not exclusive. See terms and conditions of use for ECHA’s website.
| Substance name | Applicant(s) | Description of use | Date application received | Application status |
|---|---|---|---|---|
| 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (referred to as 4-tert-OPnEO) | Ortho-Clinical Diagnostics | Formulation of 4-tert-OPnEO (as Triton X-100) for use in the manufacture of in vitro diagnostic VITROS® products used for infectious disease screening, endocrinology, and oncology testing. Further information on the ECHA website. | 27 January 2021 | Authorisation granted |
| 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (referred to as 4-tert-OPnEO) | Beckman Coulter UK Ltd | Downstream, clinical use of 4-tert-OPnEO-containing laboratory products that require registration, licensing, approval and monitoring by country-based health authorities, designed for use in dedicated clinical chemistry, immunology, haematology and flow cytometry laboratory instruments and assays. Further information on the ECHA website. | 16 February 2021 | Authorisation granted |
| 4-Nonylphenol, branched and linear, ethoxylated (referred to as 4-NPnEO) | Beckman Coulter UK Ltd | Downstream, clinical use of 4-NPnEO-containing laboratory products that require registration, licensing, approval and monitoring by country-based health authorities, designed for use in dedicated clinical chemistry, immunology, haematology and flow cytometry laboratory instruments and assays. Further information on the ECHA website. | 16 February 2021 | Authorisation granted |
| 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (referred to as 4-tert-OPnEO) | Beckman Coulter UK Ltd | Downstream, non-clinical use of 4-tert-OPnEO-containing laboratory products designed for use in flow cytometry, genomics and particle characterisation laboratory instruments and assays for quality control and research and development. Further information on the ECHA website. | 16 February 2021 | Authorisation granted |
| 4-Nonylphenol, branched and linear, ethoxylated (referred to as 4-NPnEO) | Beckman Coulter UK Ltd | Downstream, non-clinical use of 4-NPnEO-containing laboratory products designed for use in flow cytometry, genomics and particle characterisation laboratory instruments and assays for quality control and research and development. Further information on the ECHA website. | 16 February 2021 | Authorisation granted |
| 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (referred to as 4-tert-OPnEO) | Beckman Coulter UK Ltd | Phasing out of 4-tert-OPnEO-containing laboratory products from the market, due to obsolescence or next generation formulations. Further information on the ECHA website. | 16 February 2021 | Authorisation granted |
| 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (referred to as 4-tert-OPnEO) | PPG Industries (UK) Ltd, Boeing Distribution (UK) Inc, Wesco Aircraft EMEA (UK) Ltd | The formulation of a hardener component containing 4-tert-OPnEO in aerospace and defence two-part polysulphide sealants. Further information on the ECHA website. | 17 February 2021 | Authorisation granted |
| 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (referred to as 4-tert-OPnEO) | PPG Industries (UK) Ltd, Boeing Distribution (UK) Inc, Wesco Aircraft EMEA (UK) Ltd | Mixing, by aerospace and defence companies, and their associated supply chains, including the applicants, of base polysulfide sealant components with 4-tert-OPnEO-containing hardener, resulting in mixtures containing <0.1% w/w of 4-tert-OPnEO for aerospace and defence uses that are exempt from authorisation under UK REACH Art. 56(6)(a). Further information on the ECHA website. | 17 February 2021 | Authorisation granted |
| 4-Nonylphenol, branched and linear, ethoxylated (referred to as 4-NPnEO) | Chemetall Limited | Mixing, by aerospace companies and their associated supply chains, including the applicant, of base polysulfide sealant components with 4-NPnEO - containing hardener, resulting in mixtures containing <0.1 % w/w of 4-NPnEO for aerospace uses that are exempt from authorisation under UK REACH Art. 56(6)(a). Further information on the ECHA website. | 5 May 2021 | Authorisation granted |
| 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (referred to as 4-tert-OPnEO) | Siemens Healthcare Diagnostics Products Ltd | Use of 4-tert-OPnEO as detergent in the production of bead components for in-vitro diagnostic kits for an immunoassay platforms. Further information on the ECHA website. | 20 May 2021 | Authorisation granted |
| 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (referred to as 4-tert-OPnEO) | Lonza Biologics, plc | Use of 4-tert-OPnEO for virus inactivation via solvent/detergent treatment in the manufacture of recombinant medicinal active pharmaceutical ingredients (APIs) from mammalian cell cultures. Further information on the ECHA website. | 23 June 2021 | Authorisation granted |
| 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (referred to as 4-tert-OPnEO) | FUJIFILM Diosynth Biotechnologies UK Ltd | Use of 4-tert-OPnEO as a detergent in the purification process of G-CSF (Granulocyte Colony Stimulating Factor) inclusion bodies. Further information on the ECHA website. | 28 June 2021 | Authorisation granted |
| Chromium trioxide, Sodium dichromate | Tata Steel UK Ltd | Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP). Further information on the ECHA website. | 29 June 2021 | Authorisation granted |
| Chromium trioxide | Tata Steel UK Ltd | The use of Chromium (VI) Trioxide for the manufacture of Electrolytic Chromium/Chromium oxide Coated Steel (ECCS). Further information on the ECHA website. | 29 June 2021 | Authorisation granted |
| 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (referred to as 4-tert-OPnEO) | DiaSorin Italia S.p.A. | Industrial use of 4-tert-OPnEO as non-ionic surfactant, employed in the purification of antigens in in vitro diagnostics tests for infectious diseases, auto-immunity markers, bone metabolism, hepatitis and retrovirus, oncology and endocrinology. Further information on the ECHA website. | 12 July 2022 | Authorisation granted |