Commission Regulation (EU) 2023/2482 of 13 November 2023 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards the substance bis(2-ethylhexyl) phthalate (DEHP) in medical devices

• CELEX: Regulation (EU) 2023/2482
• 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 .

Schedules & Appendices

ANNEX

ANNEX

In the table in Annex XIV to Regulation (EC) No 1907/2006, entry nr 4 concerning the substance bis(2-ethylhexyl) phthalate (DEHP) is amended as follows:

(1)

in column 4 ‘Latest application date’, point (c) is replaced by the following:

‘(c)

by way of derogation from point (a):

1 January 2029 for uses in medical devices within the scope of Regulations (EU) 2017/745 and (EU) 2017/746.’;

(2)

in column 5 ‘Sunset date’, point (c) is replaced by the following:

‘(c)

by way of derogation from point (a):

1 July 2030 for uses in medical devices within the scope of Regulations (EU) 2017/745 and (EU) 2017/746.’.