REACH Candidate List Expanded with the Addition of N-(hydroxymethyl)acrylamide
Concerns over N-(hydroxymethyl)acrylamide's carcinogenic and mutagenic effects led to its being proposed for identification as a substance of very high concern (SVHC) earlier this year. On June 10, 2022, the European Chemicals Agency (ECHA) expanded its growing Candidate List with the addition of this chemical.
|CAS Registry Number||924-42-5|
Here we review N-(hydroxymethyl)acrylamide and consider the process of adding SVHCs to the Candidate List.
N-(hydroxymethyl)acrylamide is a monomer with reactive hydroxymethyl and vinyl groups. It has seen a variety of uses, including as a monomer for polymerization, in papermaking and textiles, in antistatic agents, and as a component in paints and various surface coatings.
N-(hydroxymethyl)acrylamide’s addition to the Candidate List brings the total number of substances on the list to 224.
SVHCs and the Candidate List
Within the European Union, SVHC use has been recommended to be subject to authorization under the REACH Regulation. The ECHA notes that the following properties must be exhibited by SVHCs:
- “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 on the Authorization List (REACH Annex XIV).
A multistep process is involved in the addition of substances to the Candidate List:
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, and this is followed by a consultation period of 45 days during which additional information and comments on it may be submitted.
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 SVHC status.
If there is unanimous agreement by the Committee, the substance may be added to the Candidate List.
Manufacturers of articles containing a Candidate List substance must notify the ECHA within six months of the substance's inclusion on the list. Moreover, consumers must be made aware if articles contain a substance on the list at any concentration of > 0.1% w/w.
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.