The European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation Candidate List of Substances of Very High Concern (SVHCs) grows every six months, and did so again in January 2020 as the European Chemicals Agency (ECHA) added four new substances to the list. This recent addition increases the published Candidate List to 205 substances, but there are hundreds more substances companies must be aware of to fully comply with the regulation.
The four new substances added to the Candidate List are:
- Diisohexyl phthalate: Used in various cosmetics (CAS 71850-09-4), among other products.
- 2-benzyl-2-dimethylamino-4’-morpholinobutyrophenone (CAS 119313-12-1): Used in coatings and surface treatments, among other uses.
- 2-Methyl-1-(4-(methylthio)phenyl)-2-morpholinopropan-1-one (CAS 71868-10-5): Used in polymer coatings, among other uses.
- Perfluorobutane sulfonic acid (PFBS) (CAS 375-73-5): Used in preparative chemistry, among other uses.
Companies using these substances have six months, or until July 16, 2020, to notify the ECHA.
The Candidate List & Breakout Substances
To do business in the EU, companies must register substances for each specific use when they manufacture or import that substance in quantities above the 0.1 percent weight by weight (w/w) threshold, or more than one ton per year. Registered substances are evaluated by authorities such as the ECHA and may be considered for placement on the Candidate List if it is decided they pose a risk to the public or environment.
Following this determination, the substance is considered an SVHC and begins a 45-day consultation period, after which it may be included in the Candidate List.
The 205 substances on the Candidate List don’t represent every substance that carries communication or other compliance requirements. This is because the Candidate List is also comprised of substance groups and derivatives of substances on the published list. These are sometimes called breakout substances. They contain unique substance identifiers such as CAS or EC numbers, but are not traditionally referred to as Candidate List substances. When these substances are tallied, the SVHC Candidate List grows to approximately 300 specific substances.
Companies unaware of this distinction may underestimate their REACH obligations.
These new substances also impact the EU Waste Framework Directive (WFD)’s Substances of Concern In articles, as such or in complex objects (Products) (SCIP) database, which has numerous data requirements for manufacturers, importers and distributors in the EU. Companies are required to report against the REACH Candidate List in order to comply with the EU WFD.
Understand your data requirements for the SCIP database. Learn more in our whitepaper, EU Waste Framework Directive: Understanding SCIP Database Requirements.
To successfully submit data to the SCIP database, companies must reference each in-scope substance according to its proper identifiers (EC/CAS numbers). Only referencing the identifiers of the parent substances rather than more specific breakout substances will be considered an inaccurate submission and may lead to penalties for non-compliance.
The SCIP database will require companies to manage their data effectively, as data requirements are highly dynamic and may require updates to submissions. Companies must keep their dossiers relevant, amending submissions each time new SVHCs are added to the Candidate List, SCIP data field requirements change or article composition evolves.
Identifying Breakout Substances
Breakout substances can be found on the ECHA Candidate List table. Breakout substance groupings can be found when reviewing supporting documentation attached to each substance. For example, the substance 4-Nonylphenol, branched and linear, ethoxylated, contains 10 associated CAS numbers when the supporting document is reviewed. A full substances dataset can be downloaded here.
How Assent Can Help
Assent Compliance enables companies to efficiently collect and manage supply chain data to meet their requirements for REACH and other regulations. The Assent Compliance Platform leverages automation and centralization to help companies identify risks presented by SVHCs in the supply chain, and seamlessly updates as the Candidate List grows. To learn how Assent can support your company, contact us today.