In early February 2017, ECHA posted a revised draft of its “Guidance on requirements for substances in articles“. The previous draft guidance caught several industry sectors by surprise when it drew the line for first article at a very early stage in the manufacturing of complex products. ECD Compliance has reviewed the latest draft guidance and found that not much has changed with respect to where EEE manufacturers will be expected to draw the line and their responsibilities. Some sections have been moved around within the document and detailed calculations have been deleted from some examples; but the examples themselves are still there and the implications remain intact.
What Has Changed
ECHA moved some content from Appendices to the main body of the document and vice versa. In general, the main body of the document provides specific guidance and calculation methods that manufacturers and importers are expected to use to comply with the regulation. Whereas. Appendices provide some sector specific examples and other information that could be beneficial to applying the requirements to specific situations. By moving content around, ECHA is fine tuning what it considers as necessary information for meeting the regulatory requirements.
A new subsection on “How to determine the concentration and the tonnage of a Candidate List substance in articles (communication and notification obligations)” was created in the main body of the document as subsection 3.2.3 based on the previous content of Appendices 3 and 4. This subsection provides basic examples of SVHC calculation in articles made (1) directly from a mixture; (2) by apply a mixture to an existing article; (3) combining two articles; and (4) by coating a simple article or complex object. The implications and calculation methods are the same as the previous guidance document.
The subsection on “5.1 Information via the supply chain” has been expanded to include “5.1.2
Voluntary information tools to exchange information on articles” and “5.1.4 Evaluation of information received from suppliers“. The new content suggests that the communication of materials declaration information down the supply chain may be an effective tool for collecting information needed to assess SVHC obligations and is supported by many IT systems. It also suggests that information such as Certificates of Compliance and Lab test reports need to diligently assessed to determine what information they are providing and their validity. This is very similar to the factors that the EEE manufacturers have learned to consider for RoHS compliance.
The Capacitor Example
When the European Court of Justice ruling on first article came out in September 2015, the EEE industry had expected ECHA to find a practical interpretation of first article by stating that a component (such as a capacitor) on a PCBA could be treated as a first article. However, when the previous draft guidance came out last year, ECHA provided a detailed example of how an electrolytic capacitor was made up of articles that had to be individually considered against the SVHC threshold.
The revised guidance still includes the PCBA example and still implies that the capacitor is made up of individual articles, but some of the details have been deleted or simplified, the tone has been softened and the guidance acknowledges that rules of thumb may need to be used if incomplete information isn’t available from the supply chain. Given the deleted details, ECHA has added the note: “This example addresses only the main issues to be considered; it does not intend to be exhaustive.”
The revised guidance document still clearly implies that a capacitor is composed of multiple articles. In fact, other parts of the guidance document, provide examples of borderline cases where a wire is described as an article.
The PCBA example concludes by stating that the analysis that is described for the capacitor is also applicable to any other complex object (e.g. transistor, microprocessor, fan) in the printed circuit board.
Other Useful Information in the Guidance
The draft guidance includes a number of examples that illustrate how an article is to be interpreted as: “an object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition.”. The definition of ‘function’ plays a significant role in the interpretation:
Although the draft guidance warns against making broad conclusions and suggests that each situation must be uniquely assessed, it also implies that an object as simple and fundamental as a thread used to make a fabric may meet the definition of an article. In several of the examples, the first article equates to a homogeneous material in circumstances where the shape has been deliberately created.