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

SCIP Information in Declaration for Compliance

This is the fourth in a series of articles on how to use IEC 62474 for collecting supply chain information to meet the upcoming EU SCIP data information requirements.

The Declaration for Compliance is a true/false declaration against each entry in a Declarable Substance List (DSL), indicating whether the declarable substance (DS) or declarable substance group (DSG) is present in the product. This is similar to a Class C declaration in IPC-1752A. The Declaration for Compliance does not include information on product build hierarchy, but it includes sufficient information for the downstream manufacturer to be able to assess compliance against the regulations covered by the DSL.

Given that the Declaration for Compliance is intended to be a simple, product-level declaration, it’s not a natural mechanism to declare information about the articles containing SVHCs.  Never-the-less, Compliance Declarations are preferred by some organizations, so the data exchange format for the Compliance module is being expanded to support information needed for SCIP submissions.

Declaring REACH SVHCs in a Declaration for Compliance Continue reading

SCIP Information in IEC 62474 Composition Declaration

This is the third in a series of articles on how to use IEC 62474 for collecting supply chain information to meet the emerging EU SCIP data information requirements.

Note: some of the IEC 62474 data fields to support the EU SCIP database are being finalized and therefore some of the information and declaration guidelines below are subject  to change and approval. This article will be updated as new information is available.

SCIP Reporting in the Composition Declaration

The Composition Declaration is one of two substance declaration modules provided by IEC 62474:2018. It is used by a response (e.g. supplier) to provide a hierarchical declaration of substances within materials and/or product parts that make up the product.  IEC 62474 requires that at least DSL substances that are present in the product be reported in a composition declaration, but it may include other substances, up to and including a full material declaration (FMD).

The declaration of materials and product parts is usually optional, but this becomes mandatory if the material or product part contains a declarable substance based on that material or product part.  For example, if the declarable substance has a threshold based on battery then the battery must be declared as a product part.  This also applies to a (REACH) article that contains an SVHC on the REACH Candidate List.  The first article containing the SVHC must be declared as a product part so that downstream manufacturers can calculate the mass percent of the SVHC in the Article.

Note: Although the standard specifies that material and product parts are usually optional, a requester (e.g. manufacturer or a solution provider) may require that material and/or product part information be provided, even though the standard does not require it to be mandatory. That is, requester requirements may supplement and enhance the minimum requirements specified in the standard, but this information is subject to mutual agreement between requester and responder.

Article containing the REACH SVHC is reported as a ProductPart Continue reading

SCIP Information about Product in IEC 62474

This post is the second in a series of posts about how to use IEC 62474 to declare information through the supply chain so that an EU SCIP duty holder (manufacturer, importer, or distributor) can meet its submission obligations in the EU SCIP database.

The first article is available at: IEC 62474 Support for EU SCIP Database

A submission into the SCIP database requires that certain minimum information about the product being manufactured or imported into the EU is provided.  This includes the Article name, primary article identifier, article category (i.e. CN customs code), safe use instructions, production in the EU, and number of units.  The “production in the EU” indicator has the possibility of a default response “Unwilling to disclose” and for the top-level product being submitted, the number of units will normally be one.  For the other data fields, the material declaration will need to report this information.

The above data is provided in the ProductID element of the XML Schema as shown in the table below. Continue reading

Revised IEC 62474:2018 Flexibility for Material Declarations

The IEC 62474:2018 standard introduces several new and revised capabilities to the International Material Declaration Standard. The new capabilities based on emerging regulatory requirements, user feedback, and the needs of a broad range of industries. It provides significant flexibility for suppliers to provide material declaration information while ensuring that critical information for downstream manufacturers to assess product compliance is always available. The Data Exchange Format now includes a new Declaration for Compliance module and additional support for EU REACH compliance and the upcoming EU Substance of Concern in Products (SCIP) database.  The changes were also intended to make the standard useful to a broad range of industries and different stages in the supply chain given the intertwined nature of global supply chains. .

The material and substance information in the material declaration are organized into declaration modules referred to as “sectionals”.   A hierarchical data representation of the “Product” type in the XML schema was shown in Figure 2. The declaration modules (types of declarations) that may be included in the IEC 62474 material declaration are:

  • Declaration for Compliance;
  • Composition Declaration;
  • Material Class Declaration;
  • Query Statement Declarations (represented by QueryList)

A material declaration that conforms to IEC 62474:2018 needs to include at least a Declaration for Compliance or a Composition Declaration (it may also contain both).

The Composition Declaration is used by a responder (supplier) to provide a hierarchical declaration of substances within materials and/or product parts that make up the product.  IEC 62474 requires that at least DSL substances that are present in the product be reported in a composition declaration, but it may include other substances, up to and including a full material declaration (FMD).  Some of the declaration features in the Composition Declaration (most of which are optional) include:

  • The capability for the supplier to provide information about product parts in the build hierarchy and materials (optional). An indefinite hierarchy of product parts is allowed by the Composition Declaration (i.e. product parts may be further partitioned into product parts);
  • Declaration of a DSL that indicates the minimum set of declarable substances that have been declared if they are present in the product;
  • True/False flags enabling the responder to indicate if the Composition Declarations is a full material declaration (FMD) and/or if it includes required information for SCIP submission;
  • Information about the materials in the product including: material class (or material category), material properties and use descriptions
  • The ability to identify substances based on a variety of different conventions, including DSL entry, CAS registry number, EC number, REACH Candidate List entry, etc. If the substance is part of a declarable substance group, it’s also possibly to ‘tag’ the substance with a substance group ID – this assist the downstream manufacturers with compliance assessment;
  • Applicable exemptions to substance restrictions that are needed by downstream manufacturers in assessing compliance

The Declaration for Compliance is a simplified true/false declaration against each entry in a Declarable Substance List (DSL), indicating whether the declarable substance (DS) or declarable substance group (DSG) is present in the product. The Declaration for Compliance typically does not include information on product build hierarchy (see exception below), but it includes sufficient information for the downstream manufacturer to be able to assess compliance against the regulations covered by the DSL.

An exception to including build hierarchy information in the Declaration for Compliance is when the declaration provides information needed for an EU SCIP database submission.  In the SCIP use case, information about the lowest-level (first) Articles containing the REACH Candidate List SVHCs are needed. This use case will be described in future blog posts once the functionality has been finalized and published by the IEC 62474 Validation Team.

If the material declaration is intended to cover multiple DSLs, then multiple instances of ‘Compliance’ may be declared – one for each DSL. The Compliance declaration module also includes a flag to indicate if the sufficient information has been provided for a

A material declaration that conforms to IEC 62474:2018 needs to include at least a Declaration for Compliance or a Composition Declaration but it may also include both.

Strategic and Technical Support on IEC 62474

For consulting support or training on IEC 62474 or your substance management program, contact ECD Compliance.

Material Names

If one or more materials are declared in the material declaration, a name for the material is mandatory and a Identifier (MaterialID) of the material is optional. This material name is the name or other text identifier of the material within the product. Material name may describe the material and/or describe the use or location of the materials in the part. The MaterialID field in material can be used to identify a declared material based on specifications defined in a standard (e.g., ISO 1043, parts 1 through 4 for plastics).

When declaring a material in the declaration, the material class to which the material belongs should be reported in the “materialClassID” field. This is recommended by subclause 4.5.3(e) in the standard.

IEC 62474 Support for EU SCIP Database

EU SCIP Database Requirements

The reporting obligations for manufacturers, importers and distributors to have submitted information about their products and first Articles that contains REACH Candidate List SVHCs starts on January 5, 2021. This new regulatory requirements will be a significant challenge for many industries, including automotive, aerospace, defense, heavy equipment, and electronics given that many of these products contain one or more SVHCs due to a lack of technical alternatives. The specifications include several new data requirements that supply chains do not typically report. The ECHA is developing the SCIP database and has said they expect to have it ready for formal submission by October 2020. For additional information on the SCIP, related articles are available on the ECD Compliance news blog.

Support for Supplier Data Declaration for EU SCIP Database Continue reading

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.

 

How To

IEC 62474 includes a material declaration procedure (rules) and an XML schema for data exchange. The procedure is specified in the document portion of IEC 62464 and the XML schema is available from the IEC 62474 database. The IEC 62474 XML schema is similar to the well known IPC 1752 XML format.

A key objective in the development of IEC 62474 was to ensure that the recipient of a material declaration has sufficient information to properly assess the conformity of a material or product. For example, a material declaration that reports only a single ‘highest’ concentration of lead in the product can be deceiving – the highest concentration may be covered by a RoHS exemption, potentially masking a lower concentration of lead in another material.

The blog will provide some posting that provide specific information on how to create and interpret material declarations that conform to IEC 62474. This section is still UNDER DEVELOPMENT and currently only addresses a few specific topics. Please contact us for additional information and support on implementing IEC 62474.

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.

Is my material declaration in conformance with IEC 62474?

The IEC 62474 consists of several parts, including the data exchange format (DXF), the Declarable Substances List (DSL), Material Class List (MCL) and Exemption Lists (EL). A material declaration may utilize any and all of these parts. IEC 62474:2018 AM1 states that a material declaration may be in full conformance with IEC 62474 or it may be in conformance with just specific part(s) of the standard. However, if the declaration conforms to only to part(s) of the standard it can only declare conformance to the part(s) that are used. Acceptable statements for declaring conformance are provided in IEC 62474:2018 AM1.

Full conformance to IEC 62474 would require that the responder (supplier or solution provider) use, at a minimum, the IEC 62474 data exchange format, the DSL, and the MCL. The standard also states that a material declaration may be in conformance only with the “IEC 62474 data exchange format” or only with the “IEC 62474 DSL”. This separation of conforming to parts of the standard was done to support the use of IEC 62474 in other declaration requirements and standards.

For a declaration to conform to the IEC 62474 data exchange format, it meets the declaration requirements specified in the IEC 62474:2018 document (Clause 4), the format requirements specified in the IEC 62474 XML schema and the additional requirements in the Developer’s Table. T

The opportunity to declare conformance to just the IEC 62474 data exchange format, enables the declaration against other lists. For example, the IEC 62474 is adopted as the official European material declaration standard (EN 62474) and as such the data exchange format needs to support declaration against a list of regulated EU critical raw materials as per the EU standard EN 45552. If the material declaration meets the requirements of the IEC 62474 data exchange format, but utilizes an alternate DSL, the material declaration can be claimed to conform to the “IEC 62474 data exchange format”.

Technical Support on IEC 62474

ECD Compliance provides consulting support and training to manufacturers, suppliers and solution providers on the emerging capabilities of IEC 62474 and  the supply chain communication. Contact ECD Compliance for additional information.