The European Chemicals Agency (ECHA) announced the addition of two entries to the Candidate List of substances of very high concern (SVHC) on January 19. This marks not only the first of two additions this year, but the first time ever that changes to the list will impact both the European Union (EU) Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) Regulation and the EU Waste Framework Directive.
ECHA — the body responsible for the Candidate List and maintaining the Substances of Concern In articles, as such or in complex objects (Products) (SCIP) database — added the following substances believed to be toxic to human reproduction:
- Bis(2-(2-methoxyethoxy)ethyl)ether (CAS number 143-24-8).
- Dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivatives, and any other stannane, dioctyl-, bis(fatty acyloxy) derivatives wherein C12 is the predominant carbon number of the fatty acyloxy moiety.
In addition to the new substance and substance group, additional substances were added to the list under existing substance group entries. The SVHC Candidate List now consists of 211 unique substances and their substance group breakdowns. When these breakdowns are added, the true total of reportable substance groups and substances is nearly 400.
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The Candidate List additions had a pronounced effect on the ECHA SCIP database, which updates simultaneously with changes to the list. The database added 96 reportable substances as a result of the SVHC changes.
The Impact on Companies
REACH
Companies operating in the European Economic Area (EEA) that manufacture, import, or otherwise use Candidate List substances have legal obligations to notify downstream users of their products. Substances on the list may also be escalated to the REACH Authorisation List, which legally prevents said substances from being placed on the market.
EU Waste Framework Directive
Since January 5, 2021, the revised EU Waste Framework Directive has required companies producing, importing, or distributing articles containing SVHCs above a 0.1 percent weight over weight (w/w) threshold to submit detailed dossiers to the SCIP database. Each individual article, including complex objects made up of two or more articles, must have its own dossier. This represents a substantial effort for companies manufacturing products with multiple components containing SVHCs.
The SVHC Candidate List Going Forward
The new SCIP requirements aren’t the only change companies can expect concerning SVHCs. For years, the European Parliament has signalled a shift toward stronger regulations to safeguard the environment and public health, including more robust enforcement. Since the inception of REACH in 2007, SVHCs have been added twice per year. However, the EU Chemicals Strategy for Sustainability outlines a plan to substantially grow the SVHC Candidate List to meet policy objectives.
The strategy calls for ambitious action, including:
- Banning the most harmful chemicals in consumer products.
- Phasing out the use of per- and polyfluoroalkyl substances (PFAS) in the EU.
- Establishing a “one substance one assessment” process for risk and hazards.
To meet these objectives outlined in the European Green Deal and other landmark policy initiatives, the EU could turn to the SVHC list as a mechanism of limiting harmful substances and compelling companies to find alternatives. While this has long been the stated goal of both REACH and other regulations, the EU is becoming increasingly impatient with those that are non-compliant. The EU Market Surveillance Regulation (MSR) aligns enforcement standards across the bloc and earmarks additional powers to raise the profile of enforcement authorities and enhance their efforts through a shared network of information. The result will be more robust enforcement and consistency across all 27 member states.
How Assent Can Help
Your regulatory requirements expand every time the SVHC Candidate List grows. Unlocking supply chain transparency with tools like the Assent Compliance Platform is the best way to ensure compliance with constantly evolving regulations. Leveraging automation and expert insights, Assent provides unmatched security from supply chain risks posed by non-compliance. To learn more, contact our experts.
