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Document 52021XC1116(05)

    Summary of European Commission Decisions on authorisations for the placing on the market for the use and/or for use of substances listed in Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Published pursuant to Article 64(9) of Regulation (EC) No 1907/2006 (OJ L 396, 30.12.2006 , p. 1.)) (Text with EEA relevance) 2021/C 463/14

    C/2021/7876

    OJ C 463, 16.11.2021, p. 15–15 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

    16.11.2021   

    EN

    Official Journal of the European Union

    C 463/15


    Summary of European Commission Decisions on authorisations for the placing on the market for the use and/or for use of substances listed in Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

    (Published pursuant to Article 64(9) of Regulation (EC) No 1907/2006 (1))

    (Text with EEA relevance)

    (2021/C 463/14)

    Decision granting an authorisation

    Reference of the decision (2)

    Date of decision

    Substance name

    Holder of the authorisation

    Authorisation number

    Authorised use

    Date of expiry of review period

    Reasons for the decision

    C(2021) 7876

    9 November 2021

    4-(1,1,3,3-Tetra methylbutyl)phenol, ethoxylated

    (4-tert-OPnEO)

    EC No: -, CAS No:-

    Abbott Diagnostics GmbH, Max Planck Ring 2, D-65205 Delkenheim, Germany

    REACH/21/10/0

    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

    4 January 2028

    In accordance with Article 60(4) of Regulation (EC) No 1907/2006, the socio-economic benefits outweigh the risk to human health and the environment from the use of the substance and there are no suitable alternative substances or technologies.


    (1)  OJ L 396, 30.12.2006 , p. 1.

    (2)  The decision is available on the European Commission website at: Authorisation (europa.eu)


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