# Commission Regulation (EU) 2020/2160 of 18 December 2020 amending Annex XIV to Regulation (EU) No 1907/2006 of the European Parliament and of the Council as regards the substance group 4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated (covering well-defined substances and substances of unknown or variable composition, complex reaction products or biological materials, polymers and homologues) (Text with EEA relevance), Annex

Extent: E+W+S+N.I.

In the table in Annex XIV to Regulation (EC) No 1907/2006, entry 42 concerning 4-(1,1,3,3 Tetramethylbutyl)phenol, ethoxylated (covering well-defined substances and UVCB substances, polymers and homologues) is amended as follows:
(1) the text of column 4 ‘Latest application date’ is replaced by the following text:
(a) ‘4 July 2019 (*);
(b) by way of derogation from point (a), 22 June 2022 for uses as follows:
for the research, development and production of medicinal products falling within the scope of Directive 2001/83/EC or medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746 of the European Parliament and of the Council, in view of their use for the diagnosis, treatment or prevention of the coronavirus disease (COVID-19),
in medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, for the diagnosis, treatment or prevention of COVID-19.’;
(2) the text of column 5 ‘Sunset date’ is replaced by the following text:
(a) ‘4 January 2021 (**);
(b) by way of derogation from point (a), 22 December 2023 for uses as follows:
for the research, development and production of medicinal products falling within the scope of Directive 2001/83/EC or medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, in view of their use for the diagnosis, treatment or prevention of COVID-19,
in medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, for the diagnosis, treatment or prevention of COVID-19.’

---
Source: https://www.legislation.gov.uk/eur/2020/2160/annex (the official version)
Page: https://openlegislation.uk/eu-regulation-2020-2160/annex
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.