8 New Substances of Very High Concern (SVHCs) Added to REACH Candidate List
On July 8, 2021, the European Chemicals Agency (ECHA) expanded its Candidate List by adding eight substances of very high concern (SVHCs):
- 2-(4-tert-butylbenzyl)propionaldehyde and its individual stereoisomers
- Orthoboric acid, sodium salt
- 2,2-bis(bromomethyl)propane1,3-diol (BMP); 2,2-dimethylpropan-1-ol, tribromo derivative/3-bromo-2,2-bis(bromomethyl)-1-propanol (TBNPA); 2,3-dibromo-1-propanol (2,3-DBPA)
- Glutaral
- Medium-chain chlorinated paraffins (MCCP)
- Phenol, alkylation products with C12-rich branched alkyl chains from oligomerization (PDDP)
- 1,4-dioxane
- 4,4'-(1-methylpropylidene)bisphenol
This addition brings the total number of substances on the list to 219.
SVHCs and the Candidate List
SVHC 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.”
Candidate List substances 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.
According to REACH Annex XV, a proposal is prepared that provides justification for identifying the substance as an SVHC, and provides additional information including uses and possible alternatives to the substance.
The proposal is published, and this is followed by a 45-day consultation period during which additional information and comments may be
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:
| # | Substance Name | CAS Number | EC Number | Reason for Inclusion |
|---|---|---|---|---|
| 1 | 2-(4-tert-butylbenzyl)propionaldehyde and its individual stereoisomers | -- | -- | Reprotoxic (Article 57 (c)) |
| 2 | Orthoboric acid, sodium salt | 13840-56-7 | 237-560-2 | Reprotoxic (Article 57 (c)) |
| 3 | 2,2-bis(bromomethyl)propane1,3-diol (BMP); 2,2-dimethylpropan-1-ol, tribromo derivative/3-bromo-2,2-bis(bromomethyl)-1-propanol (TBNPA); 2,3-dibromo-1-propanol (2,3-DBPA) | 3296-90-0; 36483-57-5; 1522-92-5 | 221-967-7; 253-057-0; 202-480-9 | Carcinogenic (Article 57 (a)) |
| 4 | Glutaral | 111-30-8 | 203-856-5 | Respiratory sensitizing (Article 57 (f)) |
| 5 | Medium-chain chlorinated paraffins (MCCP) | -- | -- | Persistent, bioaccumulative, and toxic (Article 57 (d)); Very persistent and very bio-accumulative (Article 57 (e)) |
| 6 | Phenol, alkylation products (mainly in para position) with C12-rich branched alkyl chains from oligomerization, covering any individual isomers and/ or combinations thereof (PDDP) | -- | -- | Reprotoxic (Article 57 (c)); Endocrine disrupting properties (Article 57 (f) – environment and human health) |
| 7 | 1,4-dioxane | 123-91-1 | 204-661-8 | Carcinogenic (Article 57 (a)); Equivalent level of concern having probable serious effects to the environment and human health (Article 57 (f)) |
| 8 | 4,4'-(1-methylpropylidene)bisphenol | 77-40-7 | 201-025-1 | Endocrine disrupting properties (Article 57 (f) – environment and human health) |
Source: European Chemicals Agency
A complete list of all SVHCs on the Candidate List may be found on the European Chemicals Agency website.
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