The EU REACH regulation applies significant requirements on product manufacturers to identify REACH Candidate List SVHCs (substances of very high concern) that are present in their products. Following a European Court of Justice ruling, the European Chemical Agency (ECHA) published a guidance document clarifying that the threshold level for reporting the SVHC is 0.1% of the first article in a product and not the finished product (as suggested in earlier ECHA guidance documents). According to the ECHA guidance, the first article is when a substance is applied such that an article is first created and not based on a complex object that is made up of individual parts that are themselves articles.
This creates challenges for product manufacturers and requires them to obtain additional information from their supply chain on whether a SVHC is present (above 0.1%) in the first article of which it is a constituent. For compliance assessment, a key piece of information needed by downstream manufacturers is the mass percent of a SVHC in its first article.
To provide this information in a material declaration, the substance and mass relative to the first article needs to be provided. The challenge is how to communicate this within a material declaration.
How does IEC 62474 support REACH SVHC assessment
The IEC 62474 material declaration standard supports this information requirement by allowing materials and subproducts to be reported in the declaration. The data exchange format also provides an (isArticle) flag for materials, subproducts, and the product so that the supplier can identify which objects in the declaration are articles. This may be either a material (that meets the defn of article) or a product part.
How to determine if the mass percent of a substance is above 0.1% of the article
When a substance is reported in a declaration it includes mass information – this may be either the mass of the substance or a mass percent (the mass of the substance divided by the mass of the material, product part, or product). However, the recipient of the declaration may not know enough about the manufacturing of the product (or its parts) to identify the first article. It’s best if the supplier identifies this first article and passes sufficient information down the manufacturing chain for downstream manufacturers to assess compliance requirements. For the recipient to be able to determine the mass percent of the SVHC in the first article, the supplier needs to include the first article as an object in the declaration (this could be a material, subproduct or the product) and it needs to be identified as an article.
Examples of a single SVHC in the product
Figure 1 illustrates a simple declaration hierarchy of an SVHC (S1) that is included in a material (M1) which is included in part (P1) (which is the first article). Material M1 is identified as not an article (isArticle=False) and subproduct P1 is identified as the first article (isArticle=True) therefore the recipient is able to calculate that the mass percent of S1 in the first article (P1) is 0.2g / 10g = 2% (which is above the 0.1% threshold that triggers the REACH communication requirements). The top-level product is a higher level article (may be referred to as a complex object) and therefore also has isArticle=True.
There are instances where a material may have a specific shape and meets the definition of an article (see second example in Figure 2). In this case, the isArticle flag for material M1 is set to True and the SVHC mass percent in an article is 0.2g / 1.0g = 20%.
Figure 1: Simple example of a declaration with an SVHC in an article (subproduct)
Figure 2: Example with a material that is an article
In both of these examples, the SVHC content is above 0.1% triggering REACH communication obligations, but there are cases where only a small amount of the SVHC is present and the selection of the first article will impact whether or not the SVHC is present above or below this threshold. It’s up to the supplier that first incorporates an SVHC into an article to identify this to downstream manufacturers
When there are multiple SVHCs added at different stages of Manufacturing
There may also be products that contain more than one SVHC. In some cases, the SVHCs may be applied at different stages during manufacturing, resulting in a complicated declaration hierarchy. One such example is illustrated in Figure 3.
- The substance S1 (an SVHC) is included in a plating material (M1) which is applied to a lead frame (SP1) which then becomes a plated lead frame (SP2).
- SP2 is the first article that includes S1, therefore the mass % of S1 in an article is the (mass of S1) / (mass of SP2).
- If this mass % is above 0.1%, then S1 has REACH obligations.
- The substance S2 (another SVHC) is a constituent of die attach material that is applied to the die (SP3) and the plated lead frame (SP2) to become the die assembly (SP4).
- In this case, SP4 is the first article for substance S2 and is used as the basis of the mass % calculation to compare to 0.1%.
- Overall, in this declaration hierarchy of the IC, subproducts SP4 and SP2 are both first articles for different SVHCs, which creates a complex declaration.
For the recipient of a declaration to properly assess REACH obligations, it’s necessary for the supplier to declare the material or subproduct (or product) that is the first article and identify that it as an article (by using the isArticle flag).
Note: in some cases (for simple products), the product may be the first article (e.g. the product provided by a supplier may be a single piece of molded plastic) or the product may be a mixture (e.g. wet paint) and there is no article.
Support on Interpretation and Guidance on IEC 62474
ECD Compliance provides support and guidance on interpretations to software solution providers, manufacturers and suppliers for the implementation of IEC 62474 and other material declaration standards. We can work with you on the transition to the new requirements. For additional information, contact ECD Compliance.