Suppliers and users of 4-(1,1,3,3-tetramethylbutyl)phenol should submit a REACH application for authorisation to maintain market access. The sunset date for the substance is 22 December 2023.
This deadline applies only for the following uses:
- 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 (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)), 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.
The substance has a number of trade names including Triton X-100.
The substance has the following hazard:
- Endocrine disrupting properties according to Article 57 (f) of Regulation (EC) No 1907/2006 (REACH).
Complying with REACH authorisation
Companies that want to continue using a substance included in the REACH Authorisation List (Annex XIV) after the sunset date need to prepare an application for authorisation, submit it before the latest application date and have a positive authorisation decision by the European Commission, unless an exemption applies.
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