The 2015 ECJ ruling on the interpretation of articles in REACH (Registration, Evaluation, Authorisation and restriction of CHemicals) will impact producers, importers and suppliers.
On 10 September 2015, the ECJ (European Court of Justice) confirmed in a preliminary ruling that the 0.1% threshold for notifying SVHC (Substances of Very High Concern), as identified in the Candidate List, applies at the level of each individual component rather than the whole finished article.
Consequently, producers, importers and suppliers have to face the possibility that their products, under this new interpretation, may no longer comply with REACH notification and information rules.
This new ruling is contrary to the position the European Commission and the European Chemicals Agency (ECHA) had taken previously, advising that notification is required only if the SVHC exceeds 0.1% in the entire article.
This interpretation was challenged by several European member states including France, whose Conseil d’État referred the case to the European Court for clarification. A preliminary ruling of the interpretation was made applicable immediately however, and did not require any further implementation or amendment of the REACH regulations.
Some national authorities could still apply a grace period - companies however must be prepared for immediate enforcement, particularly in countries that had already endorsed the ECJ's interpretation prior to the ruling - France, Germany, Belgium, Denmark, Sweden, Austria and Norway.
Here we summarise four things you need to know about these changes and how they could affect your business:
REACH requires that suppliers notify the ECHA if their product contains a substance on the Candidate List, i.e. a substance of very high concern (SVHC) - except if a previous registration already exists for a particular use of this substance.
As per original ECHA guidance, the threshold for this requirement takes effect when a SVHC “is present in articles above one ton per year and in a concentration above 0.1% weight by weight”.
What exactly is defined as an article? The ECHA defines an article as “any object which during production is given a shape, surface or design which determines its function to a greater degree than its chemical composition”.
This definition, the court argued, did not specifically address the situation of complex products containing several articles and so ruled that: “Each of the articles, incorporated as a component of a complex product, is covered by the relevant duties to notify and provide information, when they contain an SVHC in a concentration above 0.1% of their mass.”.
The court also clarified a number of obligations for importers, producers and suppliers.
The importer of a complex product, comprising one or more of the components defined as articles, must also be considered to be the importer of those articles – the court rejects the argument that importers find it difficult to obtain information from their (often non-EU based) suppliers.
However, a producer's duty to notify the ECHA only applies to those articles the producer himself has made or assembled.
Finally, it ruled that the obligation to provide information on SVHC to the product's final recipients – at minimum the name of the substance - applies to all operators along the supply chain and is not restricted to producers and importers alone.
Shortly after the ECJ ruling, the ECHA confirmed that it would update its guidance to reflect the court's decision, signaling that little change was expected with regards to the ruling.
The revised definition prompted the European retailers trade body EuroCommerce to call for a moratorium on its enforcement. It warned that the ruling “upsets sourcing practices that have been developed over decades” and urged the European Commission to review the relevant REACH regulations “to see whether the burdens arising from the court’s ruling are proportionate”.
Asking for extra time for supply chains to adapt, EuroCommerce feared that the ruling meant “a lot more testing” of materials and components, adding “to what are already complex rules for importers”.
Other industry professionals also raised concerns over producers’ ability to obtain the necessary information and data from their suppliers, noting that products that were currently in compliance would have to be re-tested to ensure the SVHC calculations were in line with the new interpretation.
In a December announcement on their website the ECHA advised that it had published a quick update to its Guidance on requirements for substances in articles, and that a more comprehensive update would follow in 2016.
The quick update corrects parts of the current guidance that is no longer consistent with the conclusions of the Court judgement. Going forward the ECHA foresees a more detailed review of its documents and examples, which will be subject to the usual three-step guidance consultation process, including consultation of accredited stakeholders.
Do you have a question on REACH and how these recent developments could affect your business?
If you have any queries don’t hesitate to get in touch with the ecosurety team at email@example.com or on 0845 094 2228.
International compliance product manager
Fran works within the compliance team as our international compliance product manager, joining us in the spring of 2015. She brings a wealth of experience to the role having previously work for Apple in Ireland for six years, looking after the company’s WEEE, battery and packaging submissions across Europe. Needless to say she has gained extensive knowledge of European legislation!
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