One SVHC Added to REACH Candidate List – July 7, 2017

The European Chemical Agency (ECHA), on July 7, 2017, added one new SVHC substance group to the EU REACH Candidate List. The substance is listed in the table below. The IEC 62474 Validation Team has reviewed the SVHC for potential uses in EEE and has concluded that the substance group could be a constituent above the 0.1% threshold; however, no evidence was found that it is commonly used at the present time.  Additional information, including a list of reference substances in the group will be provided in the July monthly report.

The full REACH Candidate List is available at: .

Substance nameEC numberCAS numberExamples of use(s) in EEE
Perfluorohexane-1-sulfonic acid and its salts (PFHxS)--Impurity in production of PFOS and alternative for PFOS, a surfactant which can be found in protective coatings and adhesives which are resistant to water, dirt, oils etc.

In addition to adding the new SVHC, the hazard properties of BPA and four phthalate substances (DEHP, BBP, DBP, and DIBP) were updated on the candidate list to indicate endocrine disrupting properties.  These SVHCs were already on the Candidate List so there is no immediate impact on EEE manufacturers that import products into the EU.

EU – Scope Changes to the EU RoHS Directive

The European Commission has drafted an amendment to the EU RoHS Directive (2011/65/EU) updating the scope of the Directive to fix the various issues that have been identified since RoHS 2 was published in 2011.  This includes the provision in the Directive that prevents used medical devices, control and monitoring instruments and other EEE that did comply with the substance restrictions from being resold after July 2019.

The amendment will make the following changes to the Directive:

      • The July 2019 limitation on re-selling non-compliant re-used EEE (Article 2, paragraph 2) is deleted
      • An exclusion is added for Pipe organs
      • The definition of “non-road mobile machinery made available exclusively for professional use” is updated.
      • The requirement for category 11 “other EEE” to comply with the substance restrictions starting on 22 July 2019 is added to the end of paragraph 3 of Article 4. The revised paragraph will read:
        • 3. Paragraph 1 shall apply to medical devices and monitoring and control instruments which are placed on the market from 22 July 2014, to in vitro diagnostic medical devices which are placed on the market from 22 July 2016, to industrial monitoring and control instruments which are placed on the market from 22 July 2017 and to all other EEE that was outside the scope of Directive 2002/95/EC which is placed on the market from 22 July 2019.;
  • Category 11 “other EEE” put on the EU market before 22 July 2019 was added to the list of product categories that may be repaired/refurbished with non-compliant spare parts and cables (i.e., repair as originally sold).
  • For category 11 “other EEE”, the original Annex III exemptions are valid until 5 years from 22 July 2019
  • The statement “The Commission shall decide on an application for renewal of an exemption no later than 6 months before the expiry date of the existing exemption unless specific circumstances justify other deadlines.” In Article 5(5) is deleted.

The amendment is not official until it is published in the Official Journal of the EU.

IEEE 1680.1 – Revised Ecolabel Standard for Computers and Monitors

The draft for the revised IEEE 1680.1 “Standard for Environmental Assessment of Personal Computer Products, Including Notebook Personal Computers, Desktop Personal Computers, Slate/Tablets, Small Scale Servers, Signage Displays and Personal Computer Monitors” was completed by the Work Group in February 2017 and will be posted for balloting March 28, 2017.

The revised draft expands the scope of the standard to cover tablets and signage displays in addition to computers and monitors.  It also expands the scope of assessment criteria to include corporate social responsibility (CSR) and criteria that reach deep into the supply chain.

Anyone that is interested in voting/commenting on the ballot must register their interest in the IEEE Standards Association (SA) system by no later than Friday, March 24th.

Contact ECD Compliance for support on conformity to the IEEE 1680.X series of environmental assessment standards.

EU – Revised Draft for SVHCs in Articles

In early February 2017, ECHA posted a revised draft of its “Guidance on requirements for substances in articles“. The previous draft guidance caught several industry sectors by surprise when it drew the line for first article at a very early stage in the manufacturing of complex products. ECD Compliance has reviewed the latest draft guidance and found that not much has changed with respect to where EEE manufacturers will be expected to draw the line and their responsibilities.  Some sections have been moved around within the document and detailed calculations have been deleted from some examples; but the examples themselves are still there and the implications remain intact.

What Has Changed

ECHA moved some content from Appendices to the main body of the document and vice versa.  In general, the main body of the document provides specific guidance and calculation methods that manufacturers and importers are expected to use to comply with the regulation.  Whereas. Appendices provide some sector specific examples and other information that could be beneficial to applying the requirements to specific situations. By moving content around, ECHA is fine tuning what it considers as necessary information for meeting the regulatory requirements.

A new subsection on “How to determine the concentration and the tonnage of a Candidate List substance in articles (communication and notification obligations)” was created in the main body of the document as subsection 3.2.3 based on the previous content of Appendices 3 and 4.  This subsection provides basic examples of SVHC calculation in articles made (1) directly from a mixture; (2) by apply a mixture to an existing article; (3) combining two articles; and (4) by coating a simple article or complex object. The implications and calculation methods are the same as the previous guidance document.

The subsection on “5.1 Information via the supply chain” has been expanded to include “5.1.2 Voluntary information tools to exchange information on articles” and “5.1.4 Evaluation of information received from suppliers“. The new content suggests that the communication of materials declaration information down the supply chain may be an effective tool for collecting information needed to assess SVHC obligations and is supported by many IT systems. It also suggests that information such as Certificates of Compliance and Lab test reports need to diligently assessed to determine what information they are providing and their validity.  This is very similar to the factors that the EEE manufacturers have learned to consider for RoHS compliance.

The Capacitor Example

When the European Court of Justice ruling on first article came out in September 2015, the EEE industry had expected ECHA to find a practical interpretation of first article by stating that a component (such as a capacitor)  on a PCBA could be treated as a first article. However, when the previous draft guidance came out last year, ECHA provided a detailed example of how an electrolytic capacitor was made up of articles that had to be individually considered against the SVHC threshold.

The revised guidance still includes the PCBA example and still implies that the capacitor is made up of individual articles, but some of the details have been deleted or simplified, the tone has been softened and the guidance acknowledges that rules of thumb may need to be used if incomplete information isn’t available from the supply chain.  Given the deleted details, ECHA has added the note: “This example addresses only the main issues to be considered; it does not intend to be exhaustive.”

The revised guidance document still clearly implies that a capacitor is composed of multiple articles. In fact, other parts of the guidance document, provide examples of borderline cases where a wire is described as an article.

The PCBA example concludes by stating that the analysis that is described for the capacitor is also applicable to any other complex object (e.g. transistor, microprocessor, fan) in the printed circuit board.

Other Useful Information in the Guidance

The draft guidance includes a number of examples that illustrate how an article is to be interpreted as: “an object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition.”. The definition of ‘function’ plays a significant role in the interpretation:

Although the draft guidance warns against making broad conclusions and suggests that each situation must be uniquely assessed, it also implies that an object as simple and fundamental as a thread used to make a fabric may meet the definition of an article. In several of the examples, the first article equates to a homogeneous material in circumstances where the shape has been deliberately created.

USA – Issues Nano Reporting Rule

he U.S. Environmental Protection Agency (EPA) published a rule requiring one-time reporting and recordkeeping requirements for nanoscale chemical substances. The reporting requirements will take effect starting May 12, 2017. The rule is available on the US Federal Register[1].


[1] EPA nanomaterial rule,

EU – Four SVHCs Added to REACH Candidate List

On January 12, 2017, ECHA published its update to the REACH Candidate List by adding four SVHCs (Substances of Very High Concern), bringing the total number of SVHCs on the Candidate List to  173 entries.

The update typically occurs in December but was delayed by ECHA until January 2017 due to the timing of the Member State Committee (MSC) meeting (December 12-16, 2017). The MSC must approve each addition to the Candidate List before the update is implemented.

Four of the six SVHCs that were under consideration[1] for the Candidate List were unanimously approved by the MSC. The four that were added are listed in Table 1. Two of these four SVHCs are potential constituents of EEE products.  Please see the article “IEC 62474 – Declarable Substance List Updated” in this report for additional information.

The other two substances under consideration did not receive unanimous agreement among the MSC members. These are: 4-tert-butylphenol (PTBP) (endocrine disruptor), and benzene-1,2,4-tricarboxylic acid 1,2-anhydride (trimellitic anhydride, TMA) (respiratory sensitiser). Both substances had been identified as equivalent to CMR/PBT; making the determination more subjective. ECHA will submit the MSC opinions for these substances to the European Commission for review — the Commission has three months to prepare draft proposals and take final decisions. Additional information is available in a press release posted by ECHA[2] on December 19, 2016.

Table 1: SVHCs Added to the REACH Candidate List on January 12, 2017

Substance nameEC numberCAS numberSVHC propertyExamples of use(s)
4,4’-isopropylidenediphenol (bisphenol A; BPA)201-245-880-05-7Toxic for reproduction (Article 57c)Manufacture of polycarbonate epoxy resins and chemicals; hardener in epoxy resins
Nonadecafluorodecanoic acid (PFDA) and its sodium and ammonium salts206-400-3, 221-470-5335-76-2, 3830-45-3, 3108-42-7Toxic for reproduction (Article 57c) PBT (Article 57d)Lubricant, wetting agent, plasticiser and corrosion inhibitor
p-(1,1-dimethylpropyl)phenol201-280-980-46-6Equivalent level of concern having probable serious effects to environment (Article 57f)Manufacture of chemicals and plastic products
4-heptylphenol, branched and linear [substances with a linear and/or branched alkyl chain with a carbon number of 7 covalently bound predominantly in position 4 to phenol, covering also UVCB- and well-defined substances which include any of the individual isomers or a combination thereof]--Equivalent level of concern having probable serious effects to environment (Article 57f)Manufacture of polymers; formulation into lubricants

Note: although ECHA included the commonly used synonyms of bisphenol A and BPA as part of the substance name in its press release, the official Candidate List only includes the proper substance name (4,4’-isopropylidenediphenol) without any synonyms.

[1] EU REACH Candidate List of SVHCs,

[2] ECHA press release,

IEC 62474 – Declarable Substance List Updated

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 newly added REACH SVHCs that may be constituents of EEE products. A few additional maintenance updates were also made to the DSL.

Link to IEC62474 article

OECD – Additional Guidance Documents on Responsible Sourcing

The Organization for Economic and Cooperative Development (OECD), which publishes the guidance on conflict minerals due diligence, is developing two additional guidance documents to provide practical support to companies. The new draft guidance documents include:

  • OECD Due Diligence Guidance for Responsible Business Conduct (Draft 2.1)[1], and
  • Due Diligence Companion (Draft)[2]

The OECD is currently accepting public comments on both documents until February 9, 2017.

[1] OECD draft,

[2] OECD Due Diligence Companion,

EU – Six Substances under Consultation as SVHCs

The European Chemical Agency (ECHA) has launched their fall consultation of additional substances for the REACH Candidate List of SVHCs. Six substances (see Table 1) have been proposed.

The IEC 62474 Validation Team is currently reviewing the substances for potential applicability to the EEE industry.

Table 1: Proposed SVHCs under Consultation

4,4’-isopropylidenediphenol (bisphenol A)201-245-880-05-7
4-Heptylphenol, branched and linear [substances with a linear and/or branched alkyl chain with a carbon number of 7 covalently bound predominantly in position 4 to phenol, covering also UVCB- and well-defined substances which include any of the individual isomers or a combination thereof]
Benzene-1,2,4-tricarboxylic acid 1,2-anhydride (trimellitic anhydride)209-008-0552-30-7
Nonadecafluorodecanoic acid (PFDA) and its sodium and ammonium salts206-400-3,

Singapore – RoHS Regulation Published

The Singapore Ministry of the Environment and Water Resources (MEWR) has published its anticipated RoHS-like regulation (No S 263). The regulation restricts the six original EU RoHS substances but only for a subset of the products included in the EU RoHS Directive. The restrictions and other obligations under the regulation were implemented by amending the Environmental Protection and Management Act (Chapter 94A) and will take effect starting June 1, 2017. Products include:

  • mobile phones;
  • laptops;
  • refrigerators;
  • air conditioners;
  • panel television sets; and
  • washing machines.

The regulation excludes batteries (rechargeable and non-rechargeable) and products designed for industrial use only.

The Singapore National Environment Agency (NEA) says that manufacturers and importers of EEE products will be required to submit a RoHS declaration of conformity before selling products in Singapore.