ECHA has recently issued revised guidance on substances in articles under REACH. The guidance follows a September 2015 ruling from the European Court of Justice that invalidated ECHA’s prior interpretation – effectively turning this aspect of REACH compliance on its head.
The REACH Regulation
The REACH Regulation addresses the production and use of chemical substances in the European Union. REACH implements reporting requirements for producers, importers and suppliers of products entering the European Union.
REACH defines an article as:
“an object which during production is given a special shape, surface or design, which determines its function to a greater degree than does its chemical composition.”
The ECJ’s ruling focuses on two REACH provisions.
Article 7(2) requires producers and importers of articles to notify the European Chemicals Agency (ECHA) if:
- The articles contain a substance on the SVHC Candidate List,
- The total amount of the substance in all articles produced or imported into the EU exceeds one ton per year, and
- The substance is present in a concentration higher than 0.1% weight by weight.
Article 33 requires suppliers of articles containing an SVHC above the 0.1% threshold to inform the recipient of the article, and to provide similar information in response to consumer inquiries within 45 days.
ECHA issued guidance in 2011 stating that the substance of an entire article had to be taken into account when determining the relevant concentrations for SVHC notification.
For example, under ECHA’s guidance, a laptop was not subject to reporting requirements as long as the average concentration of SVHC in the laptop did not exceed 0.1% by weight. No reporting was required even if some of the individual components, like motherboards or processors, contained SVHCs above the reporting threshold.
The Court assessed two particular issues – the actual meaning of an “article” under REACH, and how it affects reporting duties under Articles 7(2) and 33.
- An ‘Article’ Extends to the Component Level
Contrary to prior understanding under REACH, the Court concluded:
“[T]here is no need to draw a distinction . . . between the situation of articles incorporated as a component of a complex product and that of articles present in an isolated manner.”
As a result, an article “does not cease to be an article when it is assembled or joined with other objects in order to form with them a complex product.”
The calculation of the 0.1% threshold must be made for each individual component that qualifies as an article within the larger product. This may result in SVHC notification requirements even if the concentration of SVHC in the overall product does not exceed the threshold.
- Changes in Reporting Duties
The ECJ concluded that a producer’s duty to notify for articles under Article 7(2) concerns articles that “they make or assemble themselves.” The duty to notify does not extend to articles made by third parties, even if the producer used that article as a component in a complex product. However, an importer of an assembled product must determine whether any of the components that make up the product exceed thresholds for reporting.
Component suppliers now need to provide information on SVHC downstream “through to the final customer.”
ECHA has called the revised guidance a “fast-track update to make ‘quick’ corrections” to the prior guidance based on the ECJ ruling. ECHA will issue new, complete guidance after a thorough review and consultation. These quick corrections consist only of deletions of sections describing how to calculate concentration levels for SVHC notifications. We don’t know at this time when Member States will begin enforcement under this new interpretation, and impacted parties are already seeking to stay enforcement until ECHA issues meaningful guidance. We will continue to update this issue as it develops.