Latest amendment of the ‘Authorisation List’ of REACH Regulation affecting medical device (incl. IVD) manufacturers

Posted on 30.06.2017

The amendment of Annex XIV (‘Authorisation List’) of REACH Regulation 1907/2006/EC has been published in the Official Journal. Annex XIV of REACH Regulation includes a list of substances that are subject to authorisation.

The ‘Authorisation List’ includes among other substances, 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO – including the Triton X-100 family), also referred to as octylphenol ethoxylate (OPEs), which are known to be used in small amounts in life sciences, inter alia in IVDs and medical devices. The main uses of OPEs in IVDs and medical devices that are known to MedTech Europe include uses for viral inactivation and removal of protein impurities.

OPEs are listed in Annex XIV for their endocrine disrupting properties for the environment (Article 57(f)) and the date from which the placing on the market and the use of the substance shall be prohibited unless an authorisation is granted (the sunset date) is 4 January 2021.

The latest date for application for authorisation for the use of substance is 4 July 2019.

Twelve new substances are now subject to authorisation for being used after the sunset date. The text of the Commission Regulation (EU) 2017/999 of 13 June 2017 amending REACH Annex XIV can be accessed here.