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)

• CELEX: Regulation (EU) 2020/2160
• Articles: 3

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.

Schedules & Appendices

ANNEX

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.

( (**) )   Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU ( OJ L 117, 5.5.2017, p. 176 ).’;"

(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.’

( (**) )   Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU ( OJ L 117, 5.5.2017, p. 176 ).’;’