REACH Candidate List Expanded with the Addition of 4 New Substances of Very High Concern
On January 17, 2022, the European Chemicals Agency (ECHA) further expanded its growing Candidate List with the addition of four new substances of very high concern (SVHCs):
- 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol
- tris(2-methoxyethoxy)vinylsilane
- (±)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one covering any of the individual isomers and/or combinations thereof (4-MBC)
- S-(tricyclo(5.2.1.02,6)deca-3-en-8(or 9)-yl O-(isopropyl or isobutyl or 2-ethylhexyl) O-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate
This addition brings the total number of substances on the list to 223.
SVHCs and the Candidate List
Within the European Union, the use of SVHCs has been recommended to be subject to authorization under the REACH Regulation. According to the ECHA, SVHCs must exhibit the following properties:
- “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.”
Substances on the Candidate List are candidates for eventual inclusion on the Authorization List (REACH Annex XIV).
The addition of substances to the Candidate List involves a multistep process:
An intention to propose a substance for identification as an SVHC is published in the registry of intentions to signal a forthcoming submission.
A proposal is prepared, according to REACH Annex XV, to provide justification for identifying the substance as an SVHC, and to provide additional information (including uses and possible alternatives to the substance).
The proposal is published, followed by a 45-day consultation period during which additional information and comments on it may be provided.
If the proposal for SVHC identification is not challenged, the substance may be added directly to the Candidate List.
If the proposal for SVHC identification is challenged, both the proposal and its comments are referred to the Member State Committee to determine the SVHC status.
If the Committee unanimously agrees, the substance may then be added to the Candidate List.
Within six months of a substance's inclusion on the Candidate List, manufacturers of articles containing the substance must notify the ECHA. Moreover, consumers must be made aware if articles contain a substance on the List at any concentration of > 0.1% w/w.
4 New SVHCs
Several reasons for inclusion were noted for the new SVHCs on the Candidate List:
| # | Substance Name | CAS Number | EC Number | Reason for Inclusion |
|---|---|---|---|---|
| 1 | 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol | 119-47-1 | 204-327-1 | Toxic for reproduction (Article 57 (c)) |
| 2 | tris(2-methoxyethoxy)vinylsilane | 1067-53-4 | 213-934-0 | Toxic for reproduction (Article 57 (c)) |
| 3 | (±)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one covering any of the individual isomers and/or combinations thereof (4-MBC) | - | - | Endocrine disrupting properties (Article 57 (f) – human health) |
| 4 | S-(tricyclo(5.2.1.02,6)deca-3-en-8(or 9)-yl O-(isopropyl or isobutyl or 2-ethylhexyl) O-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate | 255881-94-8 | 401-850-9 | Persistent, bioaccumulative, and toxic (Article 57 (d)) |
Source: European Chemicals Agency
Learn More About SVHCs
A complete list of all SVHCs on the Candidate List can be found on the European Chemicals Agency website.
For more information on SVHCs, and to access detailed data on an abundance of additional chemical substances, contact ToxPlanet and register for a Free Trial.
