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Safe Use Instructions for EU SCIP

The IEC 62474 data exchange format has the opportunity to declare safe use instructions (if applicable) for substances in the product. IEC 62474 allows the safe use information to be declared as either a free-text field or as an entry from a reference list published by an authority.

In the Composition Declaration, safe use information may be reported with the Substance or the Material.

In the Declaration for Compliance module, the safe use information may be assigned to either the declaration substance/declarable substance group (DsDsg) or to ArticleInformation if the DSL entry is a REACH Candidate List entry.  However, if the DsDsg entry is a REACH Candidate List entry and the declaration is intended to be used for SCIP submission, then the SafeUse element in ArticleInformation is used for the safe use instructions needed for SCIP.  The reason for using ArticleInformation SafeUse is that the safe use instructions may vary based on the article (for example, whether the SVHC is accessible to the user or not).

Note: ECHA has suggested a possible default statement for safe use instructions in the event that no special instructions are applicable. This has been proposed as “No need to provide safe use information beyond the identification of the Candidate List substance”  If this phrase is updated by ECHA, please use the latest recommendation provided by ECHA.

IEC 62474 DSL updated with PIP (3:1) – April 28, 2021

On April 28, 2021, the IEC 62474 declarable substances list (DSL) was updated to include recent U.S. TSCA restrictions of PIP (3:1) and decaBDE. The restriction of PIP (3:1) is a particular challenge for manufacturers and suppliers given the incredibly short timeframe and that many manufacturers have not been tracking this substance in their supply chain.

Early indication is that PIP (3:1) may be contained in a variety of EEE products and components – wire sheathing and foam gaskets are emerging as examples. However, most manufacturers do not yet know the full extent of the potential applications. These compliance challenges made PIP (3:1) a priority for addition to the IEC 62474 DSL before the next planned update in July.

The updated DSL (version D22.00) includes a new entry for PIP (3:1) (ID=00174) and modifications to the entry for decaBDE (ID=00064) for reporting threshold and regulatory basis.

The latest IEC 62474 DSL may be referenced with the UniqueID authority=IEC62474, identity= IEC62474-DSL, and version=D22.00.

The DSL is available online from the IEC 62474 database at http://std.iec.ch/iec62474 ; the standard itself which specifies the material declaration rules may be purchased in the same manner as any other IEC standard — from the IEC webstore or a reseller.

SCIP Information in Declaration for Compliance

This article was updated  based on changes made by VT62474 at its January 29-31, 2020 meeting.

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.

This article was updated  based on adjustments made by VT62474 at its January 29-31, 2020 meeting.

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 make it 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 article was updated  based on changes made by VT62474 at its January 29-31, 2020 meeting.

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 →

IEC 62474 Declarable Substance List Updated – January 16, 2020

The IEC 62474 DSL and RSL were updated on January 16, 2020 to version D19.00. The update included edits to a few existing DSL entries and the addition of two new entries corresponding to two of the four substances (relevant to EEE) that ECHA added to the REACH Candidate List substances on same day.

Changes to Existing DSL Entries

  • The previous declarable substance group “Disodium tetraborates” was modified to “Disodium tetraborate, anhydrous” to align with the REACH Candidate List designation by separating out “Tetraboron disodium heptaoxide, hydrate” as a new declarable substance entry (ID=00163)
  • Notes were added to DSL entries 00138, 00144, 00145, and 00148 to indicate that these substances are polycyclic aromatic hydrocarbon (PAH)
  • A note was added to entry 00046 (Polychlorinated Biphenyls (PCBs) and specific substitutes” to clarify that an EU REACH Regulation Annex XVII entry applies to one or more reference substances in this Declarable Substance Group.
  • Updates that had been made by ECHA to CAS numbers were also made to DSL entries: 00144, 00145, 00157, 00159.

New Entries

  • Two of the four SVHCs that were added to the REACH Candidate List by ECHA on January 16, 2020 were added to the DSL: “Perfluorobutane sulfonic acid (PFBS) and its salts” and “Diisohexyl phthalate”. The other two Candidate List entries were screened and are not added. Four reference substances were added to the RSL for PFBS.

Additional Information

The updated DSL version is D19.00. The new and modified entries have a last revised date of 2020-01-16.

If anyone is aware of errors or omissions in the database (e.g. a regulated substance that is not included in the DSL but has potential EEE applications) or a regulatory reference that is out of date, please send an email to ECD Compliance and we will raise the issue with the IEC 62474 validation team.

For further support on IEC 62474 or your substance management program, please contact ECD Compliance.

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.

Exemption List Added for EU RoHS Annex IV

On November 30, 2019, the IEC 62474 exemption List was added for EU RoHS Annex IV.

This is the initial version of the IEC 62474 EU RoHS Annex III Exemption List.
– There may be some adjustments to the lists based on feedback. Please check back regularly.

In a material declaration, the following identity information is applicable:
– List Authority=”IEC62474″;
– List Identity=”EU-RoHS-AnnexIV”;
– List Version=”E1.0″.
– The Entry IDs of individual exemptions are provided in column D of the list.

All entries have a last revised date of 2019-11-30.

Anyone identifying an error in any of the exemption lists or other parts of the International Standard that are posted on the IEC 62474 database is asked to contact the Validation Team (VT62474) at iec62474(at)rohs.ca   Thanks.

Material Class List (MCL) Revised to M2.00

Revised Material Class List (M2.00)

On August 21, 2019, the IEC 62474 Material Class List (MCL) was updated to version M2.00. This was a major revision to the MCL, including the material class categories and the download format. There are now only two levels of material class categories (versus the three in the initial version of the MCL).

This is the first update to the MCL since it was initially published in 2012.  The original MCL was kept to relatively broad material classifications to make it easier for manufacturers and suppliers to classify the materials in their products.  But the downside was that it didn’t provide enough information to contribute real business value in conducting environmental assessments such as LCA, recyclability analysis or other circular economy objectives.  In the revised MCL, the number of material classes has been expanded to better identify material classifications for Life Cycle Assessment (LCA) and material recycling streams.

MCL Categories

The revised MCL includes three levels of material class identification.  The first level (Cat1) distinguishes between inorganic materials, organic materials and materials for product operation. The second level (Cat2) identifies a general category of material (such as steels and ferrous materials) and the third level (the Material Class) provides enough specificity for LCA or to identify the applicable recycling stream (such as PolyEthylene (PE) which has material class ID = M-201).

Given that fillers can have a significant impact on the recycling opportunity for thermoplastics, Thermoplastics are subdivided at level 2 between Unfilled Thermoplastics resin (M-20) and Filled Thermoplastics resin (M-25).

Every level 2 material category in the MCL is assigned a two-digit MC code (e.g. M-10 for steels and ferrous materials). This level 2 code may be used in the material declaration in the situation when a supplier does not know the level 3 code (which are represented by a 3-digit code).  This provides a migration path from broader classifications to more detailed classifications when know. However, the level 2 material categories will typically not provide enough information for a good LCA.

When using the IEC 62474 MCL, the declaration need need to identify the list by authority, identity, and version as follows:

  • authority=”IEC62474″
  • identity=”IEC62474-MCL”
  • version=”M2.00″

For support or training on the correct implementation of IEC 62474 material declarations, contact ECD Compliance.