4 Substances Added to SVHC Candidate List

ECHA has added four new substances to the Candidate List due to their toxicity to reproduction, endocrine disruption and a combination of other properties of concern. The Candidate List of substances of very high concern (SVHCs) for authorisation now contains 201 substances.

Detailed information of the four substances:

Substance Name	EC No.	CAS No.	Reason for Inclusion	Examples of use(s)
2-methoxyethyl acetate	203-772-9	110-49-6	Toxic for reproduction (Article 57 (c))	Not registered under REACH.
Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP)	-	-	Endocrine disrupting properties (Article 57(f) – environment)	Primarily used as an antioxidant to stabilise polymers.
2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid, its salts and its acyl halides (covering any of their individual isomers and combinations thereof)	-	-	Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment) Equivalent level of concern having probable serious effects to human health (Article 57(f) – human health)	Processing aid in the production of fluorinated polymers.
4-tert-butylphenol	202-679-0	98-54-4	Endocrine disrupting properties (Article 57(f) – environment)	Used in coating products, polymers, adhesives, sealants and for the synthesis of other substances.

Authorisation

The authorisation process aims to ensure that substances of very high concern (SVHCs) are progressively replaced by less dangerous substances or technologies where technically and economically feasible alternatives are available.

The route to authorisation starts when a Member State or ECHA, at the request of the Commission, proposes a substance to be identified as an SVHC.

Substances with the following hazard properties may be identified as SVHCs:

• Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction (CMR) category 1A or 1B in accordance with the CLP Regulation.
• Substances which are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to REACH Annex XIII.
• Substances on a case-by-case basis, that cause an equivalent level of concern as CMR or PBT/vPvB substances.

The SVHC identification process includes a 45-day public consultation. Once a substance is identified as an SVHC, it is included in the Candidate List. The inclusion in the Candidate List brings immediate obligations for suppliers of the substance, such as:

• supplying a safety data sheet
• communicating on safe use
• responding to consumer requests within 45 days and
• notifying ECHA if the article they produce contains an SVHC in quantities above one tonne per producer/importer per year and if the substance is present in those articles above a concentration of 0.1% (w/w).

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