Annex

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. (1)

   the text of column 4 ‘Latest application date’ is replaced by the following text:

   1. (a)

      ‘4 July 2019 (*);

   2. (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^f1, 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. (2)

   the text of column 5 ‘Sunset date’ is replaced by the following text:

   1. (a)

      ‘4 January 2021 (**);

   2. (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.’