ECHA published a final screening report (Final v1, dated 7 May 2025) assessing whether use of tetraethyllead (a substance subject to authorisation under REACH Annex XIV, Entry 55) in articles could trigger the need for an Annex XV restriction dossier under REACH Article 69(2). After screening available information sources (including registrations, authorisation applications, notifications of SVHCs in articles, SCIP, and other sources), ECHA reported it found no information indicating tetraethyllead is present in articles placed on the EU market, and therefore concluded there is currently no need to prepare an Annex XV restriction dossier. Compliance teams managing legacy Annex XIV substances should note ECHA’s documented conclusion and monitor for new evidence that could reopen Article 69(2) considerations.
Commission Regulation (EU) 2023/2482 amends REACH Annex XIV to align the latest application date and sunset date for DEHP (bis(2-ethylhexyl) phthalate, EC No. 204-211-0) when used in medical devices. This modification provides adjusted timing requirements for companies seeking authorisation for DEHP uses specifically in medical device applications, addressing the unique regulatory pathway for this sector.
ECHA issued its 11th recommendation for inclusion in Annex XIV (Authorisation List), recommending glutaral (EC 203-856-5), ethylenediamine (EC 203-468-6), and diisohexyl phthalate for addition to the authorisation list. Substances recommended for Annex XIV inclusion require companies to apply for authorisation before the sunset date if they wish to continue using them. The European Commission makes the final decision on which substances are added to Annex XIV and their associated dates.