The vote on the postponement of the authorisation dossiers for these substances
Ethoxylated4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (covering well-defined substances and UVCB substances, polymers and homologues) should see its latest application date and sunset date postponed (respectively the deadline for submitting an authorisation dossier and the date from which the marketing and use of this substance will be prohibited without an authorisation dossier in Europe).
The European Commission's REACH Committee met on Friday 20th November to discuss this possibility and approved this postponement. The text is now subject to scrutiny by the European Parliament and the Council, however the European Commission should be able to publish it by the initial sunset date of 4th January 2021.
The latest application date should be postponed to 18 months after the entry into force of the text, while the sunset date should be postponed to 36 months after the entry into force.
The uses concerned by this postponement are the following:
- 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.
The context of this deferment
The inclusion of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated in Annex XIV of the REACH regulation dates back to June 2017. It had been subjected to authorisation for its endocrine disrupting properties that could have serious consequences on the environment. The deadline for the submission of applications was set to 4th July 2019, with an expiry date of 4th January 2021.
However, at the beginning of 2020, the WHO announced the global Covid-19 pandemic and, following this, the Member States of the European Union had to adopt numerous measures to combat this new virus. With a view to participating in this global effort, in May, ECHA invited companies affected by these substances to approach the Agency to assess their needs.
OPEs and NPEs, including substances such as Triton X-100, are used by the in vitro diagnostics and pharmaceutical industries. It is therefore one of the means chosen by ECHA to participate in the fight against Coronavirus.
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