
Article 1 
Annex XIV to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to this Regulation.
Article 2 
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
It shall apply from 4 July 2019.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 18 December 2020.
For the Commission
The President
Ursula VON DER LEYEN
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)) 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.'
