ECHA Adds 2 Reprotoxic Chemicals to REACH Candidate List
On January 19, 2021, the European Chemicals Agency (ECHA) expanded its Candidate List by adding two substances of very high concern (SVHCs):
- Dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivatives (and any other stannane, dioctyl-, bis(fatty acyloxy) derivatives where C12 is the predominant carbon of the fatty acyloxy moiety)
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, 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, 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
If the Committee unanimously agrees, the substance may be added to the Candidate List.
The New SVHCs
The two newest SVHCs were added to the Candidate List as they are both reprotoxic:
|Substance Name||CAS Number||EC Number||Reason for Inclusion|
|Bis(2-(2-methoxyethoxy)ethyl)ether||143-24-8||205-594-7||Toxic for reproduction (Article 57 (c))|
|Dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivatives (and any other stannane, dioctyl-, bis(fatty acyloxy) derivatives where C12 is the predominant carbon of the fatty acyloxy moiety)||--||--||Toxic for reproduction (Article 57 (c))|
Source: European Chemicals Agency
Reprotoxic chemicals yield harmful effects on normal reproductive function in both males and females, often causing decreased fertility.
The addition of these chemicals brings the total number of substances on the Candidate List to 211.
More Information on SVHCs
A full list of all SVHCs on the Candidate List may be found on the European Chemicals Agency website. Additionally, you can visit the ToxPlanet website and blog regularly for relevant information about the List and changes to it. ToxPlanet offers an abundance of authoritative content on SVHCs of all types (reprotoxic, carcinogenic, and mutagenic), as well as on a host of other chemical substances. Be sure to contact us and register for a Free Trial to learn how our robust suite of solutions can help address your chemical hazard information needs.