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IEC 62474 Material Declaration Exchange Format Adding Declaration for Compliance

On April 14, 2019, the revised IEC 62474 data exchange (DX) format — including XML schema and the Developer’s Table (DT) – was published on the IEC 62474 database.  It introduces several new capabilities to the International Material Declaration Standard for the Electrotechnical industry.

The material declaration information will now be organized in “sectionals”, similar to the way that IPC-1752A uses sub-sectionals and classes.   Each sectional represents a different type of information that may be included in the IEC 62474 material declaration and is represented as an element under ‘Product’ in Figure 1 below. The sectionals include:

  • Declaration for Compliance (represented by the Compliance element in figure below);
  • Composition Declaration (represented by the Composition element);
  • Material Class Declaration (represented by MaterialClassDeclaration);
  • Query Statement Declarations (represented by QueryList)

Note: the three additional elements shown under product (ProductID, Attachment, and Exemptions) provide additional information, but are not considered to be sectionals.

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.

Figure 1: Graphical Representation of Product Complex Type (generated using Liquid Studio)

 

 

 

 

 

 

 

 

 

Declaration for Compliance

The Declaration for Compliance is a true/false declaration against each entry in a Declarable Substance List (DSL), indicating whether or not 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 any information on product build hierarchy, but it includes sufficient information for the recipient of the material declaration to be able to assess compliance against the regulations covered by the DSL.

For a declaration for compliance, the supplier creating the declaration would select true for a given DS/DSG entry if:

  • The DS or DSG is a constituent of the product being declared;
  • The DS/DSG may be present above the reporting threshold level; and
  • the reportable application is applicable.

Composition Declaration

The Composition Declaration may be used by the supplier to provide information about product parts, materials and/or substances that make up the product.  IEC 62474 requires that at least declarable substances that are present in the product be reported, but the Composition Declaration may include other substances, up to and including a full material declaration (FMD).

The Composition Declaration also supports declaration and identification of articles (as per the EU REACH regulation) to help manufacturers meet EU REACH SVHC reporting requirements (see related post “Reporting REACH SVHCs using the is Article Flag in IEC 62474 Declarations”)

We will be adding additional information on the revised IEC 62474 material declaration exchange format once the new schema and Developer’s Table are published in the IEC 62474 database.

 

IEC 62474 –Exemption Lists to be Posted on IEC 62474 Database

The IEC 62474 ED2 (published November 2018) includes a provision to post and maintain substance exemption lists on the IEC 62474 database.   Three lists have been approved so far (see Table 5) and will be posted in March 2019 when the upgraded IEC 62474 database features come on line.

Table 5: Exemptions Lists Approved for Publication on IEC 62474 Database

Regulatory BasisList authorityList identityInitial List version
EU RoHS 2 Annex III
(2011/65/EU)
IEC62474EU-RoHS-AnnexIIIE1.0
EU RoHS 2 Annex IV
(2011/65/EU)
IEC62474EU-RoHS-AnnexIVE1.0
China RoHS 2IEC62474China-RoHSE1.0

The initial release of the EU RoHS Annex III exemptions will include all of the exemption renewals that were published in 2018 and the additional ten Delegated Directives published in February 2019.

Identification of Exemption Lists

Each exemption list will be identified by the List authority = “IEC62474”, a list identity, and a list version.  The list identity will remain fixed for a given regulation and the list version will be revised every time that an edit is made to the list. The list version is in the format Emmm.n where ‘mmm’ represents the major revision number and ‘n’ represents a minor editorial update.

Identification of Exemption Entries

Each exemption entry will also have a unique ID consisting of three parts: a base ID, a version ID, and a sub-exemption identity (explained below).  This IEC-ID is intended to uniquely and permanently identify a specific exemption even when a regulation re-uses an exemption number after significantly modifying the technical aspects or scope of an exemption.

The IEC-ID for each entry is of the format “nnnnn-vv-ss”, where nnnnn = base ID number, vv = version (alphabetic), and ss = sub-exemption ID (sub-identity).

Sub-exemptions: Exemption Details that Vary over Time or by Product Category

A unique aspect of the IEC 62474 exemption lists is that exemptions with technical requirements that change over time or have different effective/expiry dates based on product category will be subdivided into sub-exemptions that each have a unique technical requirement, effective date and/or expiry date. Each sub-exemption will share the base ID and version ID of its parent exemption but will have a unique sub-exemption identity (referred to as the sub-identity).

For example, the revised exemption 6(a) that comes into effect on July 1, 2019 is excerpted in Table 6. The example lists three sub-exemptions with different expiry dates for most category 8/9 products, category 8 in vitro, and category 9 industrial.  The IEC-IDs for the three sub-exemptions are: 00033-B-01, 00033-B-02, 00033-B-03 – the last two digits indicate the sub-identity. The original exemption as specified in the regulation always has the sub-identity ‘00’.

Table 6: Selected columns for the revised exemption Annex III 6(a)

IEC-IDregIndexDescriptionScope and dates of applicabilityEffective DateExpiry Date
00033-B-006(a)Lead as an alloying element in steel for machining purposes and in galvanised steel containing up to 0.35 % lead by weightExpires on:
− 21 July 2021 for categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments;
− 21 July 2023 for category 8 in vitro diagnostic medical devices;
− 21 July 2024 for category 9 industrial monitoring and control instruments, and for category 11.
July 1, 2019Multiple
00033-B-016(a)Lead as an alloying element in steel for machining purposes and in galvanised steel containing up to 0.35 % lead by weightExpires on:
− 21 July 2021 for categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments;
July 1, 2019July 21, 2021
00033-B-026(a)Lead as an alloying element in steel for machining purposes and in galvanised steel containing up to 0.35 % lead by weightExpires on:
− 21 July 2023 for category 8 in vitro diagnostic medical devices;
July 1, 2019July 21, 2023
00033-B-036(a)Lead as an alloying element in steel for machining purposes and in galvanised steel containing up to 0.35 % lead by weightExpires on:
− 21 July 2024 for category 9 industrial monitoring and control instruments, and for category 11.
July 1, 2019July 21, 2024

Other Information Included in the Exemption List File

The IEC 62474 exemption lists also provide additional information about each exemption such as the regulatory basis for the exemption and the DSL entry that the exemption applies to. “First Added” and “Last Revised” dates are provided to record when a specific entry was added or changed in the exemption list.

Format of the Exemption Lists (xls vs XML)

The IEC 62474 exemption lists are initially provided only as spreadsheets in xls format but may be migrated to an XML format in the future.  The XML format will make it easier for IT systems to automatically import revisions to the exemption list.

Additional Support

For additional support on the exemption lists or in implementing other features associated with the 2nd edition IEC 62474:2018, contact ECD Compliance.

IEC 62474 – Amendment 1 to Broaden Use Across Industries

IEC 62474 Ed 2 is undergoing a quick amendment to broaden its use across multiple industries by allowing alternate Declarable Substance Lists (DSL) to be used in creating a material declaration.

A few other clarifications are also being made. The voting period for the IEC 62474 AM1 Committee Draft for Vote (CDV) closes on April 19th. If all National Committees (NC) approve the document, the amendment can skip the final draft (FDIS) voting and go straight to publication.

There are no other technical changes in Am1 that impact the data exchange format or the information on the IEC 62474 database.

IEC 62474:2018 is available from the IEC webstore and standards resellers worldwide.  The revision has also been approved as a European Standard (EN 62474).

IEC 62474 – Ed.2 Data Exchange Format to be Released in March 2019

The IEC 62474 data exchange format, including XML schema and developer’s table (DT) are being updated based on the requirements specified in the updated ED2 standard. Several new features have also been requested, including:

  • Flag to indicate that the declaration is a full material declaration
  • Safe use information, identifying a safe use condition from a list or a separate statement
  • A tag to identify declarable substance groups associated with a substance in a composition declaration
  • Identification of standardized or industry specified query lists
  • Attachments at Material and Product Part levels

The revised format has been approved, including all of the proposed new features. A final review and adjustments are being made. The revised data exchange format will be published around mid-March.

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.

 

January 21, 2014: IEC 62474 replaces JIG-101 declarable substance list

The Consumer Electronics Association (CEA),  DIGITALEUROPE, and the Japanese Green Procurement Survey Standardization Initiative (JGPSSI) officially announced that the JIG-101 standard that has provided the electronics industry with a list of substances of concern since 2005 is obsolete and has been replace by the International IEC 62474 standard on materials declaration.  The press release is available on the CEA website (http://www.ce.org/News/News-Releases/Press-Releases/2013-Press-Releases/Joint-Industry-Guide-%28JIG%29-101-Transitions-to-%281%29.aspx)

January 31, 2013: IEC 62474 substance list is updated

IEC 62474 Declarable Substance List (DSL) was updated with additional regulated substances that may be found in electrical and electronic equipment (EEE).  Most of the substances that were added are REACH Candidate List SVHCs.  The International Standard  IEC 62474 DSL replaces the JIG-101 substance list that was commonly used by industry since 2006. The IEC 62474 database is available at:  http://std.iec.ch/iec62474