REACH COMPLIANCE: Update on European Court Ruling

REACH COMPLIANCE: Update on European Court Ruling

Component Articles Now Covered Under REACH SVHC Regulation

The Court of Justice of the European Union (CJEU) has decided that under the Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), a product is the sum of its parts.

In its long-awaited decision on September 10, the CJEU ruled articles incorporated as components of a complex product must be notified to the European Chemicals Agency (ECHA) when they contain a substance of very high concern (SVHC) in a concentration above 0.1 percent weight by weight (w/w).

What Does This Mean for Your Company?

Importers of products into the EU will experience the full brunt of this change, as it now means they must assess the need for notification of every component article that is present in an imported product. While the CJEU recognizes this is a burden, it says “the fact that it can be difficult for importers to obtain the required information from their suppliers established in non-EU countries does not alter their duty to notify.”

Suppliers will also need to amend their REACH compliance programs to align with the CJEU’s decision. They must now assess their duty to communicate for every component article present in a supplied product.

Krystal Cameron, Director of Regulatory Affairs with Assent Compliance, said the ruling is significant for businesses operating under REACH.

“Businesses will now be required to consider the presence of SVHCs at the part level rather than at the product level,” she said. “The change is significant in that communication of SVHCs, when present above the threshold, is a requirement all along the chain at the part level and not simply at the product level. The change to notification is less impactful in that notifications are rare due to the 0.1 percent threshold requirement, and the one tonne per annum requirement.”

“Nonetheless, raising awareness of the need to assess notification requirements and part-level analysis is essential.”

Unlike importers and suppliers, producers will continue to deal with the REACH SVHC threshold at the level of the article as a whole. Producers are not required to notify the ECHA of components they don’t produce.

The CJEU’s ruling states “the producer’s duty to notify covers only those articles which the producer itself has made or assembled. That duty is therefore not applicable to an article which, although used by that producer as input, was made by a third party. Nonetheless, that third party is also subject to the duty to notify in respect of the article which it makes or assembles.”

Producers are exempt from component-level notification because those individual articles will already have been reported to the ECHA either by their own producers, importers or suppliers.

The Motivation Behind the Ruling

The ruling provides clarity on Article 7(2) of the REACH Regulation, which deals with notification requirements. It states:

Any producer or importer of articles shall notify the Agency, in accordance with paragraph 4 of this Article, if a substance meets the criteria in Article 57 and is identified in accordance with Article 59(1), if both the following conditions are met: (a) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year; (b) the substance is present in those articles above a concentration of 0.1 percent weight by weight (w/w).

It also clarifies Article 33 of the REACH Regulation, which deals with communication requirements. It states:

  1. Any supplier of an article containing a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0.1 percent w/w shall provide the recipient of the article with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance.
  2. On request by a consumer any supplier of an article containing a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0.1 percent w/w shall provide the consumer with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance. The relevant information shall be provided, free of charge, within 45 days of receipt of the request.

According to the REACH Regulation, an ‘article’ is “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.”

“Once an item meets the definition of an article, whether it is defined by a business as a subassembly or component, whether it will be included in another component or not, the SVHC content must be assessed and applicable requirements complied to,” said Cameron.

This ruling is a change from the regulation’s original interpretation, laid out in a 2011 guide published by ECHA, which did not break down complex articles into its parts. Notifications were only required when SVHCs were present in 0.1 percent of the article as a whole, by mass, and in quantities totalling more than one tonne per year. Five European Union (EU) member states, and Norway, disagreed with that interpretation, leading to a challenge from French authorities and this recent CJEU ruling.

It should be noted, the court’s decision, in general, followed the opinion of CJEU Advocate General Kokott, issued earlier this year on February 12.

How a Software Solution Can Help With Your REACH Compliance Program

Complying with this ruling means businesses must adjust their programs to evaluate all articles in their supply chain. A software solution such as Assent Compliance’s REACH compliance platform makes the adjustment easy by providing access to its existing, comprehensive database of parts-level SVHC information, reviewing declarations based on industry standard criteria and completing declaration roll-ups to both the component and product level.

For help determining your role in the supply chain (producer, importer or supplier) and the requirements associated under REACH, contact Assent Compliance at info@assentcompliance.com.

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