4 New Substances of Very High Concern (SVHCs) Added to REACH Candidate List
On January 16, 2020, the European Chemicals Agency (ECHA) further expanded its growing Candidate List with the addition of four new substances of very high concern (SVHCs):
- Diisohexyl phthalate
- Perfluorobutane sulfonic acid (PFBS) and its salts
This latest addition brings the total number of substances on the list to 205.
SVHCs and the Candidate List
The use of SVHCs 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 the Candidate List are candidates for eventual inclusion in 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 (e.g., uses, 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 there is no challenge to the proposal for SVHC identification, 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 there is unanimous agreement by the Committee, the substance may be added to the Candidate List.
The New SVHCs
There were several reasons for inclusion of the new SVHCs on the Candidate List:
- Diisohexyl phthalate, 2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone, and 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one are reprotoxic.
- Perfluorobutane sulfonic acid (PFBS) and its salts exhibit equivalent levels of concern having probable serious effects to the environment and health, respectively.
|#||Substance Name||EC Number||CAS Number||Reason for Inclusion|
|1||Diisohexyl phthalate||276-090-2||71850-09-4||Toxic for reproduction (Article 57 (c))|
|2||2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone||404-360-3||71850-09-4||Toxic for reproduction (Article 57 (c))|
|3||2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one||400-600-6||71868-10-5||Toxic for reproduction (Article 57 (c))|
|4||Perfluorobutane sulfonic acid (PFBS) and its salts||-||-|
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)
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.