ECHA Adds 6 Substances of Very High Concern (SVHCs) to REACH Candidate List
On January 15, 2019, the European Chemicals Agency (ECHA) expanded its Candidate List by adding six substances of very high concern (SVHCs). These are 2,2-bis(4'-hydroxyphenyl)-4-methylpentane, benzo[k]fluoranthene, fluoranthene, phenanthrene, pyrene, and 1,7,7-trimethyl-3-(phenylmethylene)bicyclo[2.2.1]heptan-2-one. The addition brings the total number of substances on the list to 197.
SVHCs and the Candidate List
SVHCs can have serious impacts on human health and the environment. They are chemical substances whose use within the European Union 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 a case-by-case basis, that cause an equivalent level of concern as CMR or PBT/vPvB substances.”
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 Annex XV to REACH, that provides justification (data, etc.) for identifying the substance as an SVHC, and provides 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, it and its comments are referred to the Member State Committee to determine the SVHC status.
If the Committee unanimously agrees, the substance may be added to the Candidate List.
The New SVHCs
The new SVHCs were added to the Candidate List for several reasons:
- 2,2-bis(4'-hydroxyphenyl)-4-methylpentane is reprotoxic.
- benzo[k]fluoranthene, fluoranthene, phenanthrene, and pyrene (all polycyclic aromatic hydrocarbons) exhibit either persistent, bioaccumulative, and toxic (PBT) properties or very persistent and very bioaccumulative (vPvB) properties.
- 1,7,7-trimethyl-3-(phenylmethylene)bicyclo[2.2.1]heptan-2-one is an endocrine disruptor.
| # | Substance Name | EC Number | CAS Number | Reason for Inclusion |
|---|---|---|---|---|
| 1 | 2,2-bis(4'-hydroxyphenyl)-4-methylpentane | 401-720-1 | 6807-17-6 | Toxic for reproduction (Article 57c) |
| 2 | Benzo[k]fluoranthene | 205-916-6 | 207-08-9 | Carcinogenic (Article 57a), PBT (Article 57d), vPvB (Article 57e) |
| 3 | Fluoranthene | 205-912-4 | 206-44-0 | PBT (Article 57d), vPvB (Article 57e) |
| 4 | Phenanthrene | 201-581-5 | 85-01-8 | vPvB (Article 57e) |
| 5 | Pyrene | 204-927-3 | 129-00-0 | PBT (Article 57d), vPvB (Article 57e) |
| 6 | 1,7,7-trimethyl-3-(phenylmethylene)bicyclo[2.2.1]heptan-2-one | 239-139-9 | 15087-24-8 | Endocrine disrupting properties (Article 57(f) - environment) |
Source: European Chemicals Agency
More Information on SVHCs
To learn more about the Candidate List, and for a complete list of all SVHCs on it, visit the European Chemical Agency website.
To learn more about SVHCs, and to access more detailed information on individual substances, contact ToxPlanet and register for a Free Trial.
