Tag Archives: SVHC

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 Declarable Substance List – Jan 2017 Update

The IEC 62474 Declarable Substance List (DSL) was updated on January 12, 2017 following the European Chemical Agency (ECHA) addition of substances to the EU REACH Candidate List on the same day. The update includes those of newly added REACH SVHCs that may be constituents of EEE products. A few additional maintenance updates were also made.

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 and reportable applications.

The update includes:

  • two of the four SVHCs added to the EU REACH Candidate List on January 12, 2017
  • reference substances for one of the SVHCs that is a group of substances
  • an update to the reportable application field of one of the Lead/Lead compound substance groups
  • deletion of two reference substances

The IEC 62474 data exchange format (XML schema and developer’s table) was not updated during this maintenance cycle. There were no changes made to the Material Classes.

Declarable Substance List (DSL)

Additions and modifications to the DSL  are listed in the table below

IDSubstance GroupSpecific SubstanceCAS numberReportable ApplicationsReporting Threshold
001414,4’-isopropylidenediphenol (BPA, Bisphenol A)80-05-7AllIntentionally added or 0.1 mass% of article
00142Nonadecafluorodecanoic acid (PFDA) and its sodium and ammonium salts See Reference SubstancesSee Reference SubstancesAll0.1 mass% of article
00021Lead/Lead CompoundsSee Reference SubstancesSee Reference SubstancesAll, except for: 1. batteries, 2. surface coating material of cables/cords with thermoset or thermoplastic coatings, and 3. paint and similar surface coatings of toys and other articles intended for use by children
0.1 mass% of total Pb in homogenous material

Bisphenol A (BPA) was added to the REACH Candidate List and, given that the substance has several applications in EEE manufacturing, was included in the IEC 62474  DSL.

For the Lead/Lead Compounds entry with ID=00021 a clarification was made to the reportable application field.  There are a total of five different Lead/Lead Compound entries with different reporting thresholds for different reportable applications. The clarification helps ensure that the correct threshold is being applied for each application.

Reference Substance List

Additions and deletions to the Reference Substance List are listed in the tables below

Reference Substance List - Additions

IDSubstanceGroupSpecificSubstanceCASnumber
R00474Nonadecafluorodecanoic acid (PFDA) and its sodium and ammonium salts Nonadecafluorodecanoic acid335-76-2
R00475Nonadecafluorodecanoic acid (PFDA) and its sodium and ammonium salts Decanoic acid, nonadecafluoro-, sodium salt3830-45-3
R00476Nonadecafluorodecanoic acid (PFDA) and its sodium and ammonium salts Ammonium nonadecafluorodecanoate3108-42-7
R00477Chlorinated Flame Retardants (CFR)Tris(1,3-dichloro-2-propyl)phosphate13674-87-8

Reference Substance List - Deletions

IDSubstanceGroupSpecificSubstanceCASnumber
R00164Lead/Lead CompoundsLead hydroxidcarbonate1344-36-1
R00289Perfluorooctane sulfonates (PFOS)Perfluorooctanoic acid sodium salt335-95-5

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 typically 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 D13.00. The new and modified entries have a last revised date of 2017-01-12.

If anyone is aware of errors or omissions in the database (e.g. a regulated substances 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 information on IEC 62474 or for support on your substance management program, please contact ECD Compliance.

IEC 62474 Declarable Substance List Update – Version D9.00

The IEC 62474 online database was updated on July 15, 2015. Version D9.00 of the Declarable Substance List (DSL) and the Reference Substance List (RSL) are now available for use by EEE manufacturers, suppliers, and IT solution providers. The data exchange format (XML schema and developer’s table) is now version X6.01 (this is a minor editorial revision from X6.00). The database update is the final step in maintenance cycle (MC-2015-01) which was started earlier this year.

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. The IEC 62474 database is available online (free of charge); 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.

Additions to the Declarable Substance List (DSL)

A couple of regulatory changes drove the addition of two new entries to the DSL – the EU REACH Candidate List and the Canadian “Products Containing Mercury Regulations (SOR/2014-254) “. The new entries are listed in the table below

DSL Changes Based on Regulatory Changes (MC-2015-01)

Specific SubstanceCAS numberTypical ApplicationsReportable ApplicationsReporting ThresholdBasis
1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate (EC No. 201-559-5)68515-51-5, 68648-93-1Plasticisers, lubricants, adhesives, coatings, cable compounding, polymer foils, PVC compound coatings, paints, thinners, paint removers, fillers, putties, plasters, ink and toners, greases, release products, polymer preparations and compounds, and semiconductorsAll0.1 mass%REACH Candidate List
Mercury/Mercury Compounds-Silver-oxide button cells, alkaline batteries, zinc carbon batteriesBatteries0.005 mass%Canadian Products Containing Mercury Regulations

EU REACH Candidate List

One of the two SVHCs added to the REACH Candidate List on June 15, 2015 was found to have potential uses within the EEE industry and was therefore included in the DSL. The validation team did not find any evidence that the other SVHC added to the Candidate List (which is used as a fragrance) is applicable to EEE.

Canadian Products Containing Mercury Regulations

The Products Containing Mercury Regulations specifies its mercury thresholds based on homogeneous materials. The 0.1 mass% of homogeneous materials for most products is harmonized with the mercury/mercury compounds threshold of EU RoHS. However, the 0.0005 mass% of homogeneous materials in batteries is stricter than the EU Battery Directive’s threshold of 0.0005 mass% of the entire battery.

The Canadian restriction is clearly stricter than the EU Battery Directive; however, there are other emerging battery regulations in Asia that are also stricter then the EU Directive but still based on the mass of the whole battery (0.0001 mass% of battery). This creates a dilemma in specifying the threshold that is the strictest. The Canadian regulation will typically be stricter in small batteries and the 0.0001 mass% of the battery may be stricter in larger batteries. Given the challenge in specifying which threshold is stricter, both thresholds are now specified as separate entries in the IEC 62474 DSL. Suppliers of a battery containing mercury or a product containing such a battery need to consider both thresholds when determining their declaration requirements. However, even if both thresholds are exceeded, the mercury/mercury compounds would be declared only once for each instance of mercury in the product. If both thresholds are exceeded, both thresholds should be listed in the declaration. In a future article, we’ll be providing information on how to do this in a material declaration.

Substance Groups with an Exhaustive List of Reference Substances.

For most declarable substance groups that are included in the DSL, the reference substance list (RSL) provides a list of example substances that are included in the substance group. These reference substance lists are indicative and no attempt has been made to provide an exhaustive set of such substances.

However, for a few declarable substance groups, the reference substance list is a complete (i.e. exhaustive) list of substances as specified in a regulation. For these substance groups with a complete substance list on the RSL, additional comments have been added to the DSL entries to clarify that the list is complete. The comment field now includes “Note: This declarable substance group has a complete list of substances that is specified in the reference substance list”. This should provide users with additional clarity.

The substance groups with a complete list of reference substances are provided in the table below.

Substance Groups with a complete list of reference substance

IDSubstance Group
00003Asbestos
00004Azocolourants and azodyes which form certain aromatic amines
00020Hexabromocyclododecane (HBCDD) and all major diastereoisomers identified: Alpha-hexabromocyclododecane Beta-hexabromocyclododecane Gamma-hexabromocyclododecane
00036Phthalates, Selected Group 1 (BBP, DBP, DEHP)
00037Phthalates, Selected Group 2 (DIDP, DINP, DNOP)
00103Perfluorooctanoic acid (PFOA) and individual salts and esters of PFOA
00104Perfluorooctanoic acid (PFOA) and individual salts and esters of PFOA

Changes to the Reference Substance List (RSL)

A few changes were made to the Reference Substance List (RSL).

  • The reference substances that are part of a complete list (as discussed above) had a comment added “This reference substance is part of a complete list as specified in the regulation or standard indicated in the BasisDescription field of the DSL entry”
  • The reference substance ” Trichlorotetrafluoropropane” (HCFC-224cc) included in the substance group “Ozone Depleting Substances (CFC, Halon, HBFC, HCFC & others)” had an incorrect CAS number listed. The CAS number was updated to 422-51-5.

 Material Classes

There were no changes to the Material Classes.

 Data Exchange Format (Developer’s Table and XML Schema)

The IEC 62474 Developer’s Table has been updated with one minor editorial change and no technical changes:

  • The definition of the “aboveThresholdLevel” attribute (ACB122) was revised to better explain how the field is used. The revised definition states: True/False response stating whether the substance is contained in the product above or below the stated threshold. If the substance is or may be at or above the stated Threshold, the response shall be “True”. If the substance is known to be below the stated Threshold, the response would be “False”.

There were no changes to the XML schema.

Entries that are new or revised will have a LastRevised date of 2015-07-15.

If anyone is aware of errors or omissions in the database (e.g. a regulated substances that is not included in the DSL but has potential EEE applications), please send an email to ECD Compliance and we will review and address with the  validation team.

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

IEC 62474 database: http://std.iec.ch/iec62474