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.

 

IEC 62474 Database Update with Exemption Lists – July 2019

The IEC 62474 (Material Declaration) Database was updated on July 21-22, 2019. This was a very extensive and complex update:

  • There were a significant number of additions and changes made to the IEC 62474 declarable substances list (DSL) and references substance list (RSL) during this update. The new DSL/RSL version is D18.00.
    • One of the four SVHCs added to the REACH Candidate List in July 2019 is a possible constituent of electrotechnical products and therefore included in the DSL;
    • Several other substance groups and substances were added due to emerging regulatory changes;
    • A major review of substance names and synonyms was performed. Changes reflecting this review were included in this update;
    • DSL and RSL entries that are new or changed have a last revised date of 2019-07-21;
    • Entries that were removed can be identified by comparing the new DSL and RSL with D17.01 (see archive section).
  • An update to the complementary list was also posted (CL18.00). This is a list of REACH Candidate List SVHCs that were screened out and not added to the EEE industry DSL.
  • The initial release of exemption lists for EU RoHS Annex III and China RoHS were published as of July 22, 2019. The EU RoHS Annex IV exemption is in final review and will be published soon.
  • There were no changes made to the Material Class List (MCL) — update coming soon
  • The data exchange format (DX) had a major revision (X8.00) based on the revised IEC 62474:2018 standard published last year.
    • The revised XML schema and developer’s table were posted on April 14, 2019.
    • The revision supports a new  Declaration for Compliance module that enables suppliers to provide a summary declaration against a DSL.  It is similar to the IPC-1752A Class C declaration.

Additional information on the Database update is provided below.  For technical support, consulting, or training on this database update or on the full set of new features and changes that were recently added to IEC 62474 or the revised IEC 62474-2018 data exchange format and XML schema, please contact ECD Compliance.

Declarable Substances List (D18.00)

The DSL is used globally by EEE manufacturers, suppliers, and IT solution providers as a common list of substances that should be declared throughout the supply chain, allowing downstream manufacturers to access product compliance to substance regulations around the world. The DSL includes declarable substances and substance groups together with reporting thresholds, reportable applications, and other information that is important for creating a material declaration.

Three new Declarable Substance Groups (DSG) were added to the DSL based on regulatory developments.  This includes TNPP, one of the four SVHC added to the REACH Candidate List on July 16, 2019.  TNPP was the only SVHC that the IEC 62474 Validation Team (VT62474) found may be a constituent of an EEE product above the reporting threshold.  The other three SVHCs were added to the Complementary List (CL18.00) of SVHCs that have been screened out by the team.  Anyone that is aware of new information that a screened out SVHC may exist in EEE above threshold, should contact the VT or ECD Compliance.

The new DSG entries added to the DSL are listed in the table title “New DSL entries”.

New DSL Entries (D18.00)

IDSubstance GroupSpecific SubstanceCAS numberReportable ApplicationsReporting Threshold
00160Perfluorooctanoic acid and its saltsSee Reference Substance worksheet for more detailsSee Reference Substance worksheet for more detailsAll0.0000025 mass% of PFOA including its salts in article or mixture
00161PFOA-related substancesSee Reference Substance worksheet for more detailsSee Reference Substance worksheet for more detailsAll0.0001 mass% of one or a combination of PFOA-related substances, in article or mixture
00162Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP)See Reference Substance worksheet for more detailsSee Reference Substance worksheet for more detailsAll0.1 mass% of article

Several other updates to declarable substance entries were also made, mostly to adjust declarable substance and declarable substance group names to align with the names used in regulations. There was also an extensive update to the formatting of CAS numbers and Basis Descriptions (i.e. the regulations that are the basis for adding the substance to the DSL).  The use of a standardized format will make it easier for IT systems to automatically parse and extract the relevant information.

The recently added substance clarification data field in the DSL now includes the substance description specified in the REACH Candidate List.  This is a normative field in the DSL and needs to be used to determine whether or not a given substance or mixture falls under the DSL entry.  Substance clarification may also include other information and notes to assist users with the DSL entry. The substance clarifications were simplified in D18.00 compared to version D17.01 – this will make it easier to identify which DSL entries have a substance clarification.

Other changes to DSL entries in this update include:

  • DIBP was added to “Phthalates, Selected Group 1 (DEHP, DBP, BBP, DIBP)” (ID=00036)
  • Several substance and substance group names (including several PAH substances) were adjusted to match the current names in legislation

The revised entries are shown in the table titled “Modified DSL Entries (D18.00)

Modified DSL Entries (D18.00)

IDSubstance GroupSpecific SubstanceCAS numberReportable ApplicationsReporting Threshold
00016Dimethylfumarate (DMF)624-49-7All0.00001 mass% of the part
00036Phthalates, Selected Group 1 (DEHP, DBP, BBP, DIBP)See Reference Substance worksheet for more detailsSee Reference Substance worksheet for more detailsChildren's toy or child care article0.1 mass% as the sum of the phthalate concentrations in plasticized material
00044Polybrominated biphenyls (PBB)See Reference Substance worksheet for more detailsSee Reference Substance worksheet for more detailsAll0.1 mass% in homogenous material
00045Polybrominated diphenyl ethers (PBDE)See Reference Substance worksheet for more detailsSee Reference Substance worksheet for more detailsAll0.1 mass% in homogenous material
00048Polychlorinated naphthalenesSee Reference Substance worksheet for more detailsSee Reference Substance worksheet for more detailsAllIntentionally added
00056Tris(2-chloroethyl) phosphate115-96-8All0.1 mass% of article
000801,2-Benzenedicarboxylic acid, dipentyl ester, branched and linear84777-06-0All0.1 mass% of article
00081Diisopentyl phthalate605-50-5All0.1 mass% of article
00105Imidazolidine-2-thione (2-imidazoline-2-thiol)96-45-7All0.1 mass% of article
00108Benzo[a]pyrene (BaP)50-32-8Rubber or plastic parts that come into direct, prolonged or repetitive skin or oral cavity contact except those for toys or childcare articles0.0001 mass% of the plastic or rubber part
00109Benzo[e]pyrene (BeP)192-97-2Rubber or plastic parts that come into direct, prolonged or repetitive skin or oral cavity contact except those for toys or childcare articles0.0001 mass% of the plastic or rubber part
00110Benzo[a]anthracene (BaA)56-55-3Rubber or plastic parts that come into direct, prolonged or repetitive skin or oral cavity contact except those for toys or childcare articles0.0001 mass% of the plastic or rubber part
00111Chrysen (CHR)218-01-9Rubber or plastic parts that come into direct, prolonged or repetitive skin or oral cavity contact except those for toys or childcare articles0.0001 mass% of the plastic or rubber part
00112Benzo[b]fluoranthene (BbFA)205-99-2Rubber or plastic parts that come into direct, prolonged or repetitive skin or oral cavity contact except those for toys or childcare articles0.0001 mass% of the plastic or rubber part
00113Benzo[j]fluoranthene (BjFA)205-82-3Rubber or plastic parts that come into direct, prolonged or repetitive skin or oral cavity contact except those for toys or childcare articles0.0001 mass% of the plastic or rubber part
00114Benzo[k]fluoranthene (BkFA)207-08-9Rubber or plastic parts that come into direct, prolonged or repetitive skin or oral cavity contact except those for toys or childcare articles0.0001 mass% of the plastic or rubber part
00115Dibenzo[a,h]anthracene (DBAhA)53-70-3Rubber or plastic parts that come into direct, prolonged or repetitive skin or oral cavity contact except those for toys or childcare articles0.0001 mass% of the plastic or rubber part
00116Benzo[a]pyrene (BaP)50-32-8Rubber or plastic parts of toys and childcare articles that come into direct, prolonged or repetitive skin or oral cavity contact0.00005 mass% of the plastic or rubber part
00117Benzo[e]pyrene (BeP)192-97-2Rubber or plastic parts of toys and childcare articles that come into direct, prolonged or repetitive skin or oral cavity contact0.00005 mass% of the plastic or rubber part
00118Benzo[a]anthracene (BaA)56-55-3Rubber or plastic parts of toys and childcare articles that come into direct, prolonged or repetitive skin or oral cavity contact0.00005 mass% of the plastic or rubber part
00119Chrysen (CHR)218-01-9Rubber or plastic parts of toys and childcare articles that come into direct, prolonged or repetitive skin or oral cavity contact0.00005 mass% of the plastic or rubber part
00120Benzo[b]fluoranthene (BbFA)205-99-2Rubber or plastic parts of toys and childcare articles that come into direct, prolonged or repetitive skin or oral cavity contact0.00005 mass% of the plastic or rubber part
00121Benzo[j]fluoranthene (BjFA)205-82-3Rubber or plastic parts of toys and childcare articles that come into direct, prolonged or repetitive skin or oral cavity contact0.00005 mass% of the plastic or rubber part
00122Benzo[k]fluoranthene (BkFA)207-08-9Rubber or plastic parts of toys and childcare articles that come into direct, prolonged or repetitive skin or oral cavity contact0.00005 mass% of the plastic or rubber part
00123Dibenzo[a,h]anthracene (DBAhA)53-70-3Rubber or plastic parts of toys and childcare articles that come into direct, prolonged or repetitive skin or oral cavity contact0.00005 mass% of the plastic or rubber part
00138Benzo[def]chrysene (Benzo[a]pyrene)50-32-8All0.1 mass% of article

Reference Substances List (D18.00)

Reference Substances were added for each of the new substance group entries and to a few existing substance groups — see table titled “New Reference Substances in RSL (D18.00).

New Reference Substances in RSL (D18.00)

IDSubstance GroupSpecific SubstanceCAS number
R00513Phthalates, Selected Group 1 (DEHP, DBP, BBP, DIBP)Diisobutyl phthalate (DIBP)84-69-5
R00496Chlorinated Flame Retardants (CFR)1,4:7,10-Dimethanodibenzo[a,e]cyclooctene, 1,2,3,4,7,8,9,10,13,13,14,14-dodecachloro-1,4,4a,5,6,6a,7,10,10a,11,12,12a-dodecahydro-13560-89-9
R00497Chlorinated Flame Retardants (CFR)1,4:7,10-Dimethanodibenzo[a,e]cyclooctene, 1,2,3,4,7,8,9,10,13,13,14,14-dodecachloro-1,4,4a,5,6, 6a,7,10,10a,11,12,12a-dodecahydro-, (1R,4S,4aS,6aS,7S,10R,10aR,12aR)-rel-135821-74-8
R00498Chlorinated Flame Retardants (CFR)1,4:7,10-Dimethanodibenzo[a,e]cyclooctene, 1,2,3,4,7,8,9,10,13,13,14,14-dodecachloro-1,4,4a,5,6,6a,7,10,10a,11,12,12a-dodecahydro-, (1R,4S,4aS,6aR,7R,10S,10aS,12aR)-rel-135821-03-3
R00499Perfluorooctanoic acid and its saltsPentadecafluorooctanoic acid335-67-1
R00500Perfluorooctanoic acid and its saltsAmmonium pentadecafluorooctanoate3825-26-1
R00501Perfluorooctanoic acid and its saltsSodium pentadecafluorooctanoate335-95-5
R00502Perfluorooctanoic acid and its saltsPotassium pentadecafluorooctanoate2395-00-8
R00503Perfluorooctanoic acid and its saltsSilver pentadecafluorooctanoate335-93-3
R00504PFOA-related substancesPentadecafluorooctanoic acid335-67-1
R00505PFOA-related substancesAmmonium pentadecafluorooctanoate3825-26-1
R00506PFOA-related substancesSodium pentadecafluorooctanoate335-95-5
R00507PFOA-related substancesPotassium pentadecafluorooctanoate2395-00-8
R00508PFOA-related substancesSilver pentadecafluorooctanoate335-93-3
R00509PFOA-related substancesPentadecafluoroctanoyl fluoride335-66-0
R00510PFOA-related substancesMethyl pentadecafluorooctanoate376-27-2
R00511PFOA-related substancesEthyl pentadecafluorooctanoate3108-24-5
R00512PFOA-related substances3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-Heptadecafluordecan-1-ol678-39-7
R00514Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP)Phenol, 4-nonyl, phosphite3050-88-2
R00515Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP)Phenol, p-isononyl-, phosphite31631-13-7
R00516Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP)Phenol, p-sec-nonyl-, phosphite106599-06-8

Most of the changes to existing RSL entries were due to adjustments in the names of Declarable Substance Groups. This included:

  • Azocolourants and Azodyes which form certain aromatic amines
  • Phthalates, Selected Group 1 (DEHP, DBP, BBP, DIBP)
  • Polybrominated biphenyls (PBB)
  • Polybrominated diphenyl ethers (PBDE)
  • Polychlorinated naphthalenes

Additional changes to the RSL:

  • The name of the reference substance “Mercuric chloride” (ID=R00174) was changed to “Mercury, chloro(cyclohexylmethyl)-“
  • The duplicate reference substance Lead phosphate (ID=R00157) was deleted – this substance is also listed as Lead (II) phosphate (ID=R00165) (same CAS number) . Lead phosphate was added as a synonym to entry R00165 for completeness.

Exemption Lists

The initial release of exemption lists for EU RoHS Annex III and China RoHS were posted. The EU RoHS Annex IV exemption list is in final review and will be published soon.

When creating a material declaration, the following identity information is applicable:

  • List Authority=”IEC62474″;
  • List Identity=”EU-RoHS-AnnexIII” or “China-RoHS”
  • List Version=”E1.0″.
  • The Entry IDs of individual exemptions are provided in column D of the list.

Based on user input, some of the IEC 62474 exemptions lists have exemptions that are split into sub-exemptions when there are multiple expiry dates or technical requirements that change over time. Each sub-exemption has a sub-exemption ID (referred to as sub-identity). This has the benefit of enabling suppliers who are creating material declarations for their products to more precisely identify the specifics of the exemption they are declaring, including the product categories for which the exemption is valid.  However, the sub-exemption concept has the disadvantage of making the exemption lists more complex, although suppliers do not need to use the sub-exemptions. If a supplier’s part or material is used in many different product categories, they can select the original exemption (sub-identity=’00’).

For additional information on sub-exemptions, see the IEC 62474 blog article on exemption lists.

Given that this is the first release of the IEC 62474 exemption lists, there may be some adjustments based on feedback. Please check the IEC 62474  database regularly for any updates.

Background

The IEC 62474 DSL is an internationally recognized and harmonized list of substances and substance groups that are regulated and may be constituents of electrical and electronic products and systems. Electrical and electronic manufacturers and suppliers use the DSL in their design and supply chain management operations to specify and control substances of concern. The list is updated as needed based on regulatory changes. For additional information about IEC 62474, see the article About IEC 62474. The IEC 62474 database is available online; the standard itself which specifies the material declaration requirements and rules may be purchased in the same manner as any other IEC standard — from the IEC webstore or a reseller.

 Additional Information

The updated DSL version is D18.00. The new and modified entries have a last revised date of 2019-07-21.

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.

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.

 

New Features in IEC 62474 Database Upgrade on March 15, 2019

The IEC 62474 database received a software upgrade on Friday March 15, 2019. You will notice that some of the menu names in the left hand ribbon have changed — the naming is now more consistent — and menu options have been added for exemption lists and supplementary lists and information (which now includes the REACH SVHC Complimentary List).

New Information in Declarable Substance List

The Declarable Substance List has two new data fields as specified in IEC 62474:2018. These fields are: “Substance Clarification” and “Mass Info Requirements”. Both fields are currently blank but will be updated in late March to include the new information.

New Location for EU REACH Complimentary List  (D17.00)

The EU REACH Complimentary List (CL) is now posted in the section in “Supplementary Lists and Information” instead of in the Archive section. The Complimentary List includes the REACH Candidate List substances that the validation team (VT) for IEC 62474 is screening out and not including on the DSL.  These are the Candidate List entries for which the evidence available to the validation team (VT) suggests that the substances are not present (above threshold) in materials that may be used in EEE products. If anyone is aware is aware of substances that are listed on the CL and may be present in EEE, please contact the VT 62474 with the information.  An email address for technical feedback is provided on the contact page of the IEC 62474 database.

Background on IEC 62474

IEC 62474 is an International Standard for the electrical and electronics industry on material declaration that includes an internationally recognized Declarable Substance List (DSL), a material declaration procedure and an XML-schema for data exchange. IEC standards are recognized by the WTO for International harmonization and regulatory cooperation.

The IEC 62474 DSL is an internationally recognized and harmonized list of substances and substance groups that are regulated and may be constituents of electrical and electronic products and systems. Electrical and electronic manufacturers and suppliers use the DSL in their design and supply chain management operations to specify and control substances of concern. The list is typically updated as needed based on regulatory changes. For additional information about IEC 62474, see the article About IEC 62474.

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.

IEC 62474 Declarable Substances List Update – January 2019

The IEC 62474 Declarable Substance List (DSL) was updated to Version D17.00 on January 15, 2019. The update includes relevant SVHCs from the January 15 update to the EU REACH Candidate List.

Declarable Substance List (DSL)
Five of the six SVHCs added to the Candidate List were also added to the IEC 62474 DSL based on their potential presence in EEE products. The substance review for possible EEE uses was conducted by the IEC 62474 Validation Team (VT62474) with experts from Asia, Americas, and Europe. Note: if anyone is aware of information that may be relevant to whether or not one of the substances may be present in EEE products, please forward the information to the VT (by sending an email to iec62474(at)rohs.ca).

The additions to the DSL are listed in Table below.

IDSubstanceGroupSpecific SubstanceCAS numberReportable ApplicationsReporting Threshold
001552,2-bis(4'-hydroxyphenyl)-4-methylpentane 6807-17-6All0.1 mass% of article
00156Benzo[k]fluoranthene207-08-9All0.1 mass% of article
00157Fluoranthene206-44-0; 93951-69-0All0.1 mass% of article
00158Phenanthrene85-01-8All0.1 mass% of article
00159Pyrene129-00-0; 1718-52-1All0.1 mass% of article

Reference Substances List (RSL)

No changes were made to the reference substance List during this update

Material Class List (MCL)
No changes were made to the MCL during this update to the IEC 62474 database. However, a major revision to the Material Class List is currently underway — the changes will better support Life Cycle Assessment (LCA) of EEE products.

Upcoming Major Changes to the IEC 62474 Database
The IEC 62474 standard was due for its periodic review (like any other IEC standard). The standard was revised based on feedback from stakeholders and IEC 62474 Ed.2 was published in November 2018 and is currently available from IEC webstore and standards resellers.

For immediate guidance, ECD Compliance supports manufacturers, solution providers, and suppliers on the implementation of IEC 62474. We can work with you on the transition to the new requirements and provide implementation guidance. For additional information, contact ECD Compliance.

The IEC 62474 Database
The IEC 62474 DSL is available on the IEC 62474 database at: http://std.iec.ch/iec62474. The new entries have a last revised date of 2019-01-15.

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.

 

IEC 62474 Ed. 2 Pre Release Version is Publicly Available

The IEC 62474 Edition 2 is out for final voting as a Final Draft International Standard (FDIS).  The IEC (Interrnational Electrotechnical Commission) has made the draft publicly available as a Pre Release Version (PRV) from the IEC webstore at https://webstore.iec.ch/publication/63827

Several new features have been added to the standard, including:

  • a new “Declaration for compliance” option;
  • additional support for substance in article (SiA) to meet EU REACH regulation requirements, including an isArticle flag
  • support for other Declarable Substance Lists (DSL)
  • ability for requester to request declaration content
  • ability for requester to request declaration content
  • information on what declaration data is provided in a declaration file
  • exemption lists (that are available to regulators and material declaration users)
  • additional data fields in the IEC 62474 DSL for declarable substance descriptions and to provide clarification of mass reporting requirements

For the declaration data exchange format, the standard now includes a “Declaration for compliance” option in addition to the “Composition declaration”.  The standard requires that at least one of these declaration is included in the declaration file.  For those who are familiar with IPC-1752A, the “Declaration for compliance” is similar to the Class C declaration.

“Substance Group” elements have been removed from the declaration hierarchy of a composition declaration in the material declaration file.  Declarable Substance Groups (DSGs) are still an important part of the IEC 62474 DSL, but removing substance groups  from the hierarchy of a composition declaration was necessary because of the large number of emerging substance groups in regulations and the fact that many substance groups overlap with the substances that they include. This overlap created issues in the declaration hierarchy as to where to assign a substance that was part of several declarable substance groups.

The IEC 62474 Validation Team (VT62474) is currently updating the xml schema and developer’s table and other parts of the database to implement the new requirements in IEC 62474 Ed. 2. We’ll be posting additional information as the new standard rolls out.

Support on Interpretation and Guidance for Users and Solution Providers

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.

Voting on the IEC 62474 Ed. 2 FDIS

The FDIS is currently open for comments and voting by National Committees. The voting period closes on October 12, 2018.  ECD Compliance will be providing comments for National Committee submission.