Decision

UK REACH authorisations for Beckman Coulter UK Ltd, 31 January 2022

Decision on application for authorisation under UK REACH.

Documents

UK REACH authorisation for Beckman Coulter UK Ltd, 31 January 2022

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Beckman Coulter response document, 24 March 2021

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Details

Decision on a transitional application for authorisation under UK REACH.

Substance name

4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO) and 4-Nonylphenol, branched and linear, ethoxylated (4-NPnEO).

Authorised use

Downstream, clinical use of 4-tert-OPnEO and 4-NPnEO-containing laboratory products that require registration, licensing, approval, and monitoring by country-based health authorities. These products are designed for use in dedicated clinical chemistry, immunology, haematology and flow cytometry laboratory instruments and assays (use 3).

Downstream, non-clinical use of 4-tert-OPnEO and 4-NPnEO-containing laboratory products designed for use in flow cytometry, genomics and particle characterization laboratory instruments and assays for quality control and research and development (use 4).

Downstream use of 4-tert-OPnEO-containing laboratory products which are being phased out from the market due to obsolescence or next generation formulations (use 5).

Holder of the authorisation and authorisation numbers

Use 3: Beckman Coulter UK Ltd. (UKREACH/22/03/0) and (UKREACH/22/03/1).

Use 4: Beckman Coulter UK Ltd. (UKREACH/22/03/2) and (UKREACH/22/03/3).

Use 5: Beckman Coulter UK Ltd. (UKREACH/22/03/4).

Date of decision

31 January 2022.

Updates to this page

Published 14 February 2022

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