The European Court of Justice has taken a first step in ruling that the REACH SVHC concentration threshold should be interpreted based on the “Once an Article, Always an Article” principle.
In its original guidance on reporting SVHCs in articles, the European Commission suggested that the 0.1% threshold should be based on the weight of the entire article as imported or as provided to the customer. However, six countries (Austria, Belgium, Denmark, France, Germany and Sweden) disagreed with this guidance. The dissenting countries argued that an SVHC that is above the 0.1% level in any individual article (component) within a product may pose a health or environmental risk and should trigger the reporting and communication obligations for the SVHC.
The difference in opinion between the two sides created a lot of ambiguity for industry, but industry generally followed the methodology given in the EC guidance document because of the sheer difficultly in meeting the obligations based on SVHC levels in each component in the product.
Legal proceedings were launched in France and are now forcing a resolution to the standoff. The European Court of Justice (ECJ), which has the final say in matters of EU regulatory interpretation, has been asked to rule on the question. As a first step toward a preliminary ruling, the Advocate General, an official legal advisor, has delivered his opinion. The Advocate General reviewed the regulatory text as written and found that there was no legal justification for the 0.1% w/w concentration to be applied to an article that is make up of many components that are themselves articles. He recommended that the preliminary ruling by the ECJ should interpret the REACH Article 33 communication obligations and REACH Article 7(2) notification to ECHA should be based on SVHC content in each original article (component) in the product.
The Advocate General’s opinion states:
V – Conclusion
124. I therefore propose that the Court answer the request for a preliminary ruling as follows:
(1) If the other conditions laid down in Article 7(2) of the REACH Regulation are satisfied,
(a) the producer of an entire article consisting of component articles which, despite being integrated into an entire article, retain a shape, surface or design of their own, but were made or assembled by other producers, is required to notify ECHA if a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) is present in the entire article above a concentration of 0.1% weight by weight (w/w); and
(b) the importer of an entire article consisting of component articles which, despite being integrated into an entire article, retain a shape, surface or design of their own is required to notify ECHA if a substance meeting the criteria laid down in Article 57 and identified in accordance with Article 59(1) is present in a component article above a concentration of 0.1% weight by weight (w/w).
(2) The supplier of an entire article consisting of component articles which, despite being integrated into an entire article, retain a shape, surface or design of their own is required to provide information to recipients and, on request, consumers under Article 33 of the REACH Regulation on a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) if it is present in a component article above a concentration of 0.1% weight by weight (w/w) and relevant information is available to the supplier.
If the Advocate General’s opinion is accepted by the ECJ, the impact on industry will be significant. Even manufacturers that have been collecting SVHC information from suppliers may be impacted. The declaration of SVHC content in supplier parts is typically triggered based on 0.1% weight of the part provided by the supplier. If the supplier part is itself composed of multiple articles, an SVHC in a subpart that exceeds the 0.1% threshold may be masked.
Many manufacturers would need to develop new material and SVHC risk assessment processes and collect new material declarations from their suppliers. Contact ECD Compliance for additional information on the impact of this ruling or for assistance in developing conformity assessment procedures.