Category Archives: How To

Information on how to report a material declaration based on the requirements specified in IEC 62474

Reporting REACH SVHCs using the is Article Flag in IEC 62474 Declarations

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.

 

Substances that are a Trade Secret

Material declarations are a sensitive topic for material and part manufacturers that are using certain chemicals that they consider a trade secret. The chemical, its application, and/or the exact composition usually provides a competitive advantage that the manfuacturer wishes to protect.

The IEC 62474 material declaration standard allows manufacturers flexibility on how much of the chemical composition of the product they wish to declare. A manufacturer could provide a full material declaration of all substances except for those that are trade secrets.

However, if the “trade secret” includes a substance or substance group that is listed on the IEC 62474 declarable substances list (DSL) with a mandaotry reporting requirement and it is present above the reporting threshold, then there is no flexibility; it must be included in the material declaration. The mandatory reporting requirement indicates that the substance is regulated and if it is used in a confidential manner, it can still cause a product to become non-compliant to a legal obligation. Therefore, it is not allowed to leave out or try to hide such a substance in the material declaration.

Which Substances should be Declared?

Only substances that remain in the product should be declared in the material declaration file. Manufacturing chemicals that react, form other chemicals or otherwise do not remain in the product should not be reported. However, in some cases, a chemical reaction may not be complete and some unreacted quantity of an intermediate chemical may remain in the finished product. These chemicals may be reported; in fact, if the intermediate chemical is listed in the IEC 62474 declarable substances list and a quantity above the reporting threshold could reamin in the final product, then it has to be reported m– otherwise the material declaration will not conform with the IEC 62474 requirements.

A common example is the resin and a hardener used to form epoxy. The final epoxy substance must be declared if it is a declarable substance or as a voluntary declaration if it isn’t. The individual resin and hardener chemicals would not be declared unless a residual amount of the chemical remains in the product and then only the residual amount would be declared.

A user may only state that they are in conformance with IEC 62474 if they have included all reportable substances and substance groups that are present in the product above the reporting threshold.

What Should be Reported when a Substance is Really a Mixture of other Substances

Substances with a CAS-number that contain other substances sometimes cause confusion in a material declaration. The CAS-number system does not exclude the possibility that a substance with a CAS-number consists of a number of other substances with CAS-numbers. Examples are:

  • Steel with CAS number 12597-69-2
  • Brass with CAS number 12597-71-6

Each of these substances have a variable composition and may or may not include a reportable substance such as Lead (Pb). Declaring only “Steel” does not give information if lead is a constituent of the alloy or not. If a mixture (whether a solid (e.g. metal alloy), liquid, or gas) contains a declarable substance or declarable substance group, then this declarable substance or declarable substance must always be explicitly reported if present above the reporting threshold and if the reportable application is met.

Another issue that sometime arises in material declarations is when a supplier lists the elements that make up a compound rather than reporting the chemical compound itself. Many declarable substances are compounds which must be reported as listed in the IEC 62474 list of declarable substances. IEC 62474 does not allow the material declaration to report the separate elements that make up the compound. For example Disodium tetraborate, decahydrate (Borax) (CAS-number 1303-96-4 ) consists of Sodium, Boron and Oxygen, with CAS-numbers 7440-23-5, 7440-42-8.and 7782-44-7. Using these elemental CAS-numbers in the declaration will hide the existence of the declarable substance and violates the reporting requirement of IEC 62474.

Calculating Mass Percent for the Material Declaration

Mass information needs to be provided for each of elements in a material declaration that correponds to a physical object or chemical (ie. product, product part, material, substance group, and substance in the figure below). The product element sits at the top of the declaration hierarchy therefore it must always include the mass (a mass percent would be meaningless). For the other elements, the responder who is creating a material declaration generally may provide either the mass or the mass percent.

Conceptual Material Declaration with Optional Declaration of Product Parts and Materials

Conceptual Material Declaration with Optional Declaration of Product Parts and Materials

Mass percent is calculated relative to the element above it in the material declaration. For example, the mass percent of material X is calculated relative to the mass of Product part 1 and the mass percent of Product part 1 is calculated relative to the mass of Product. An exception to the above rule is that the mass percent of substances and substance groups are both calculated relative to the material (or product part / product if material is not declared). A substance mass percent is never calculated relative to the mass of a substance group. This is because substance groups are often unusual grouping of substances and the mass may represent only a part of the substance molecules. For example, Lead/Lead Compounds only considers the Lead atoms and not the entire mass of lead compounds.

If the reporting threshold of a substance or substance group is based on the material (e.g. the RoHS substance thresholds), then the the MatMassPercent element must be used to capture the mass information.

Declarable Substance List (DSL)

The IEC 62474 Declarable Substance List (DSL) is a list of regulated substances and substance groups (e.g. lead and lead compounds) that a manufacturer should declare to downstream manufacturers if present in the product. Each substance or substance group entry in the list is accompanied with a reportable application and a reporting threshold level. The supplier that is creating the material declaration will use this information to determine if the substance must be declared.

The DSL may be accessed from the IEC 62474 database via the menu bar on the left side of the introduction webpage – click on “Declarable substance groups and declarable substances” and then select the substance from the drop down list. For example, selecting “Lead/Lead Compounds” presents five entries with different reportable application / reporting threshold combinations – the first entry corresponds to the RoHS restriction. Clicking on the “Details” button reveals information about reference substances; typical EEE applications, regulations, and other information.

There is also an option on the website to export the entire DSL.

Interpretation of reporting threshold for declarable substances and declarable substance groups

For most of the declarable substance and declarable substance group entries in the IEC 62474 database, the reporting threshold is based on the mass percent of the product. This is represented by a reporting threshold that is listed as “0.1 mass%”. The reference to the mass of the product that is declared is implied in this threshold. However, there are other many declarable substances and declarable substance groups that have a reporting threshold that has a different calculation basis. The EU RoHS declarable substance groups are examples that use the mass of the homogeneous material as the basis for calculation.

How to interpret conditional fields in the IEC 62474 XML file

The IEC 62474 developer’s table includes a column (Obligation column) that indicates whether a specific data field (element or attribute) is mandatory or optional. Some data fields are listed as conditional. These fields are mandatory under certain material declaration conditions and optional under other conditions.

For example, Mass, MassPercent, and MatMassPercent are all listed as conditional. At least one of these data fields must be provided in a valid material declaration. The obligation column for Mass and MassPercent states: “Conditional (Either Mass or MassPercent is mandatory unless otherwise specified in IEC 62474 database)”. Basically, the data field is mandatory unless the information has been provided in one of the other mass related data fields. For most substance declarations, the supplier that is filling out the material declaration can decide whether they would like to provide the mass of the substance or the mass percent (weight/weight) of the substance.

The obligation description indicates that information provided in the IEC 62474 database may specify exactly which of these data fields needs to be provided. The most common situation for this is the EU RoHS substance groups which must be reported as a mass percent of the homogeneous material. In this case, the MatMassPercent element must be used to capture the mass information.

For substances that may be reported as a mass or mass percent, the standard technically allows the supplier to provide both data fields, but this is generally not recommended.  Experience with material declarations has shown that it’s easy to introduce errors (including rounding errors) when providing both numbers. This leaves the recipient of the material declaration uncertain as to which data field is actually correct.

June 30, 2014 update:  To prevent inconsistency between mass and mass percent information, the interpretation of allowing both mass and mass percent to be declared is being changed for the upcoming X5.00 version of the schema/developer’s table. The update will allow only mass or mass percent to be provided. X5.00 is forecast to be published in the fall of 2014 — an additional blog post will be provided when the new data exchange format is published on the IEC 62474 database.