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Europe - Five new substances of very high concern added to Candidate List of SVHCs and an existing entry updated
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Trace One
The Candidate List
The authorization process begins when a Member State or the European Chemicals Agency (ECHA), acting on the Commission's request, proposes a substance for identification as a Substance of Very High Concern (SVHC). This process aims to ensure that SVHCs are gradually replaced with less dangerous substances or technologies where technically and economically feasible alternatives are available. This identification process includes a 45-day consultation period. Once a substance is identified as an SVHC, it is added to the Candidate List. Substances on this list are considered for eventual inclusion in the authorisation list (REACH Annex XIV). The inclusion of a substance in the Candidate List creates law obligations for the companies producing, importing or using these substances as such, in preparations or in articles.
What substances?
On January 21st 2025, ECHA's Member State Committee (MSC) confirmed the addition of five substances to the Candidate List, expanding the total number of entries from 242 to 247:
- 6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid (EC: 701-118-1, CAS: 2156592-54-8) for reproductive toxicity (Article 57c)
- O,O,O-triphenyl phosphorothioate (EC: 209-909-9, CAS: 597-82-0) for its PBT properties (Article 57d)
- Octamethyltrisiloxane (EC: 203-497-4, CAS: 107-51-7) for its vPvB properties (Article 57e)
- Perfluamine (EC: 206-420-2, CAS: 338-83-0) for its vPvB properties (Article 57e)
- Reaction mass of: triphenylthiophosphate and tertiary butylated phenyl derivatives (EC: 421-820-9, CAS: 192268-65-8) for its PBT properties (Article 57d)
In addition, an entry for the substance Tris(4-nonylphenyl, branched and linear) phosphite has been updated. This replaces the existing entry for Tris(4-nonylphenyl, branched and linear) phosphite with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP). The entry shall clarify that the substance meets the criteria for identification as an endocrine disruptor to the environment on the basis of its own properties and separately on the basis that it contains ≥ 0.1%4 NP.
Trace One has planned a regulatory analysis regarding this topic and will keep you updated on it.
For more information on the Candidate List, visit these links: