On June 10, 2022, ECHA published the updated candidate list of SVHC (Substances of Very High Concern). Adding to the list one more substance: NMA, which is N-(hydroxymethyl)acrylamide. The list is now composed of 224 entries.
Name of the substanceEC numberCAS numberReason for inclusionExamples of use N-(hydroxymethyl)acrylamide 213-103-2 924-42-5 Carcinogenic; Mutagenic As a monomer for polymerization, as a fluoroalkyl acrylate copolymer, and in paints and coatings.
The update followed a proposal from Sweden for a SVHC identification of the substance . NMA is classified for carcinogenicity 1B and germ cell mutagenicity 1B.
Being part of the CLP (Classification, Labelling, Packaging)classification since 2020, the inclusion of this substance in the candidate list was urgent, according to the European Environmental Bureau (EEB).
Their reaction was in part against the NMA's push for acrylamide substitution. Tatiana Santos, EEB's policy officer, said that indeed such substitution would be dangerous:
"We’ve witnessed a decades-long pattern of regrettable substitution to avoid regulation. Therefore, there is a need to urgently list NMA as a substance of very high concern to discourage companies to perform regrettable substitution".
The impact for companies
As a reminder, NMA is used in polymers or for the manufacture of chemicals, textiles, leather or fur. The substance has 525 notifiers to CLP and requires a REACH registration at 1000-10000 tons per year.
When a substance is included in the candidate list, this creates obligations for companies. These obligations apply to any substance alone, in mixtures or in articles.
To secure the use of these substances, when a concentration is higher than 0.1% (weight by weight), suppliers will have to provide all necessary information to their customers and consumers. Suppliers are also obliged to provide their customers with an SDS (Safety Data Sheet) . It is the consumers' right to ask the suppliers if the purchased products contain SVHC.
With the SDS Factory software,you have the possibility to generate SDS in only a few clicks. The software also allows the management, translation and distribution of your SDS. Combined with MAT Factory, allowing international regulatory monitoring, you will receive alerts when your substances are subject to new obligations.
An importer or producer of articles that contain NMA, has the obligation to notify ECHA (which will be available in the SCIP database), within 6 months from the date of inclusion in the list.
EcoMundo proposes its SVHC Factory software, offering you the possibility to trace your substances. SVHC Factory integrates the collection of SCIP UUIDs from your suppliers and allows the automated or assisted generation of SCIP declaration files:
- Collection of SCIP data from your suppliers
- Edition of the SCIP declarations of your finished product and follow-up of the status
Point of caution: The substances included in the candidate list are likely to be placed on the authorization list. This would result in a ban on the use of these substances without an authorization approved by the European Commission.
Inclusion of a substance in the candidate list
The SVHC candidate list is updated twice a year, in January and June/July. Four new substances were added to the list in January 2022, including the first endocrine disruptor.
The substances on the list are selected according to their level of hazard. Indeed, a substance which involves risks for human health or the environment has a strong chance to be added to the candidate list. We find in particular:
- CMR substances (Carcinogenic, Mutagenic or Reprotoxic) of category 1A or 1B,
- PBT (Persistent, Bioaccumulative and Toxic) or vPvB (Very Persistent and Very Bioaccumulative) substances,
- substances, on a case by case basis, presenting a level of risk similar to that of CMR or PBT/vPvB substances.
To learn more about SVHC products and SCIP notification, watch the replay of our webinar “SVHC in articles & SCIP notifications, are you compliant?”.
