Author Archives: Walter Jager

IEC/TC111 – Environmental standardization for electrical and electronic products and systems

The International Electrotechnical Commission (IEC) created technical committee TC111 in 2004 to develop internationally recognized standards to assist manufacturers in complying with emerging environmental legislation of Electronic Equipment. The use of harmonized standards reduces uncertainty and risk for international trade and helps enables communication and consistency across a global supply chain.

The TC111 work program includes development of international standards or specifications under the following work program:

Published Standards

  • IEC/TR 62476: Guidance for evaluation of product with respect to substance-use restrictions in electrical and electronic products
  • IEC 62430: Environmentally Conscious Design
  • IEC 62321: Test Methods of Six Hazardous Substances
  • IEC PAS 62596: Determination of restricted substances – Sampling procedure – Guidelines (Withdrawn — content has been integrated into IEC 62321-2
  • IEC 62321-X: Revised Test Methods partitioned into separate standards
  • IEC 62474: Materials Declaration
  • IEC/TR 62635: Guidelines for end-of-life information provided by manufacturers and recyclers and for recyclability rate calculation of electrical and electronic equipment
  • IEC/TR 62725: Analysis of quantification methodologies of greenhouse gas emissions for electrical and electronic products and systems
  • IEC 62542: Environmental standardization for electrical and electronic products and systems – Glossary of terms

Standards in Development

  • IEC/TR 62726: Quantification Methodology of greenhouse gas emission (CO2e) reductions for electrical and electronic products and systems from the project baseline
  • IEC/TR 62824: Guidance on consideration and evaluation on material efficiency of electrical and electronic products in environmentally conscious design
  • IEC 62321-6: Determination of certain substances in electrotechnical products – Part 6: Determination of polybrominated biphenyls and polybrominated diphenyl ethers in polymers and electronics by GC-MS, IAMS and HPLC-UV
  • IEC 62321-7-1: Determination of certain substances in electrotechnical products – Part 7-1: Determination of the presence of hexavalent chromium (Cr(VI)) in colourless and coloured corrosion-protected coatings on metals by the colorimetric method
  • IEC 62321-7-2: Determination of certain substances in electrotechnical products – Part 7-2: Determination of hexavalent chromium (Cr(VI)) in polymers and electronics by the colorimetric method.
  • IEC 62321-8: IEC 62321-8 Ed.1 – Determination of certain substances in electrotechnical products – Part 8: Determination of specific phthalates in polymer materials by mass spectrometry
  • IEC/TR 62474-1: Guidance to Implement IEC 62474

A Maturity Model for Sustainability in New Product Development

“A Maturity Model for Sustainability in New Product Development” was published in the January-February issues of the Research-Technology Management (RTM) journal.  The article is the culmination of work from an Industrial Research Institute (IRI) research-on-research (ROR) project to develop a maturity model and assessment tool that enables organizations to assess their sustainability practices during new product development (NPD). The assessment tool can help organizations leverage sustainability in their new product development and gain competitive advantage. ECD Compliance (with support provided by Intertek) had the opportunity to contribute to the development of the maturity model in 2012 and 2013.

The maturity model considers sustainability performance attributes in 14 dimensions which have been organized into two groups: Strategy Dimensions and Design Tools Dimensions. For each of the dimensions attributes were identified at four different maturity levels: Beginning, Improving, Succeeding, and Leading.

Strategy Dimensions

  • Corporate Sustainability Policy
  • Overall Sustainability Strategy
  • Government Policy & Regulation
  • Impact of Trends
  • Supply Chain (CSR)
  • Green labeling
  • Sustainability Design for Environment (DfE)

Design Tools Dimensions

  • Specifications/Customer Insights
  • Life Cycle Assessment (LCA) Process
  • DfE–Material and Part Selection
  • DfE–Supply Chain
  • DfE–Manufacturing Impact
  • DfE–Use Phase Impact
  • DfE–End of Life Impact

The article authors are: Jeff Hynds, Virginia Brandt, Susan Burek, Walter Jager, Peter Knox, Jamie Pero Parker, Lawrence Schwartz, John Taylor, and Miriam Zietlow.

For additional information, the RTM journal is available from the IRI website or contact us on implementing sustainability practices.

March 13, 2014 – Priority Products Identified for California Safer Consumer Products Regulation

The California Department of Toxic Substances control has announced their initial list of three priority products. As we had expected, there is minimal direct impact on the electrical and electronics industry. The first three priority products are:

    1. Spray Polyurethane Foam (SPF) Systems containing unreacted diisocyanates
    2. Children’s Foam Padded Sleeping Products containing Tris(1,3-dichloro-2-propyl) phosphate or TDCPP
    3. Paint and Varnish Strippers, and Surface Cleaners with methylene chloride

March 5, 2014 – Draft EU Conflict Minerals Regulation Focuses on importers of metals and ores

The EU Commission has proposed an EU Conflict Minerals regulation that will focus on controlling the importation of 3TG metals and ores (tin, tantalum, tungsten, and gold). The proposal which is titled “REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL setting up a Union system for supply chain due diligence self-certification of responsible importers of tin, tantalum and tungsten, their ores, and gold originating in conflict affected and high-risk areas” would directly impact importers of the ores and metals, who in turn, tend to be closely involved with the smelters. The regulation is proposed to be a self-certification.

Here’s a useful excerpt from the EU Commission press release:

The Commission proposes a draft Regulation setting up an EU system of self-certification for importers of tin, tantalum, tungsten and gold who choose to import responsibly into the Union. Self-certification requires EU importers of these metals and their ores to exercise ‘due diligence’ – i.e. to avoid causing harm on the ground – by monitoring and administering their purchases and sales in line with the five steps of the Organisation for Economic Cooperation and Development (OECD) Due Diligence Guidance. The aim is to act at the most effective level of the EU supply chain for these minerals and to facilitate the flow of due diligence information down to end users. The Regulation gives EU importers an opportunity to deepen ongoing efforts to ensure clean supply chains when trading legitimately with operators in conflict-affected countries.

Overall, this proposal is good news for EEE manufacturers that tend to be several levels removed from the smelters. However, the draft proposal will now enter the EU regulatory process, including review by the European Parliament which has traditionally taken a strong stand for environmental performance and human rights.

Stay tuned on this blog for further analysis of the draft regulation.

March 3, 2014 – EU Consultation of Four Substances for REACH SVHC Candidate List

ECHA has begun a public consultation on four substances for addition to the REACH SVHC Candidate List. The four substances were proposed by Denmark and Sweden based of their status as carcinogenic and/or toxic for reproduction. The four substances are:

  • 1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear
  • Cadmium chloride
  • Sodium perborate; perboric acid, sodium salt
  • Sodium peroxometaborate

The deadline for the public consultation is April 17, 2014

February 18, 2014 – DIBP draft dossier suggests minimal use in EEE

The draft RoHS Annex II dossier for the diisobutyl phthalate (DIBP) suggests that DIBP has minimal use within EEE products. One objective of the public consultation for DIBP is to update this information based on industry responses. DIBP may be used in nearly all of the same applications as the Phthalate DBP and is commonly used as a substitute; however, it also has similar hazard properties and environmental impact. The EU Commission is obviously concerned that the restriction of DBP under RoHS will cause significantly increased use in DIBP.

If the conclusion that DIBP is not significantly used in EEE stands — or likely to be used as a substitute; there will be little justification for the EU Commission to list DIBP as a RoHS Annex II restricted substance.

February 14, 2014 – EU Commission identifies fifth substance for RoHS 2 restriction

The “Study for the Review of the List of Restricted Substances under RoHS2” had already recommended four substances for potential restriction under the RoHS 2 Directive (see February 5, 2014 blog post). The EU Commission has now signalled that they intend to consider a fifth substance for possible restriction by requesting a detailed assessment of the impacts of a possible restriction of diisobutyl phthalate (DIBP) in EEE. DIBP had been identified as one of eight the highest priority substances in the study. The EU Commission is concerned that the restriction of the DBP Phthalate will lead to additional use of DIBP as a substitute. However, DIBP has many of the same hazards as DBP and these hazards will become more prevalent with increased use of the substance.

The EU Commission is undertaking the new study to (1) conduct a detailed assessment of DIBP, and (2) capture additional usage data for 21 of the priority substances in EEE. The EU Commission expects the consultants to conduct Stakeholder consultations as part of the process.

The public consultation closes on April 4, 2014. The overall duration of the contract is expected to be 5 months, suggesting that the EU Commission will try to hit it’s July 22, 2014 goal for completing the review of the RoHS 2 Annex II list of restricted substances and producing a delegated act to amend the Annex.

RoHS 2 Technical Documentation

The technical documentation for compliance to RoHS 2 is the greatest challenge for manufacturers of products that were already RoHS compliant. We can provide a template for technical documentation and assist you to compile conformity documentation that aligns with the RoHS-2 harmonized standard.

For RoHS 2 compliance, manufacturers must carry out conformity assessment based on internal production control procedures that are in conformance with EU Decision 768/2008/EC and EU Regulation 765/2008/EC. The RoHS 2 Directive Article 7(b) specifies:

b) manufacturers draw up the required technical documentation and carry out the internal production control procedure in line with module A of Annex II to Decision No 768/2008/EC or have it carried out;

Products may not be sold on the EU market unless the manufacturer has drawn up the technical documentation.
The RoHS 2 Technical documentation File (TDF) must meet specific requirements

  • makes it possible to assess the products’ conformity and includes an adequate analysis and assessment of the risk(s).
  • Shall specify the applicable requirements for design and manufacture of the product.

Harmonized and referenced Standards for Technical Documentation

  • EN 50581: Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances
  • IEC/TR62476: Guidance for evaluation of product with respect to substance-use restrictions in electrical and electronic products
  • IEC 62321: Analytical Test Methods
  • IEC 62474: Materials Declaration

EN 50581 specifies that technical documentation shall include at least:

  • a general description of the product (product category and exemptions)
  • documents for materials, parts, and/or sub-assemblies
  • information showing the relationship between the technical documents identified and the corresponding materials, parts and/or sub-assemblies in the product;
  • list of harmonized standards and/or other technical specifications that have been used to establish the technical documents or to which such documents refer.

Assessing Product for Substance Use Restrictions (IEC 62476)

IEC/TR 62476 “Guidance for evaluation of product with respect to substance use restrictions in electrical and electronic equipment” provides a framework and guidance for restricted substance controls (RSC). The framework and recommendations are aligned with the requirements specified in the RoHS2 harmonized standard EN 50581 — in fact, EN 50581 subclause “4.3.4 Evaluation of information” references IEC/TR 62476.

The guidance document suggests internationally accepted standards, tools and practices and is applicable to companies that produce finished EEE product and to their supply chain. It segments restricted substance control (RSC) requirements into three areas: product planning and design, sources of information and data, and product evaluation.

A risk based approach is recommended when evaluating products for potential non-conformity. This is particularly relevant when assessing compliance to the RoHS Directive, given the large number of homogeneous materials in most EEE products. A risk based approach helps ensure that effort is directed where it can provide the most benefit. IEC/TR 62474 also discusses the possible sources of information and data, considerations for data selection and supplier information such as material declaration. ANNEX 2 – Elements to be evaluated in test reports provides a list of information that is important for a manufacturer to review and consider when they receive an analytical test report (whether the report is received from a supplier or directly from a test lab).

IEC/TR 62476 is useful to organizations in providing a high-level framework for restricted substance controls; however it stops short of providing sufficient information on how an organization may implement the framework. Contact us for additional information on IEC/TR 62476 or how to implement the framework in your organization’s RoHS/REACH confomity assurance system.

January 9, 2014 – RoHS 2 exemptions for Annex IV

The EU has updated the substance exemptions in RoHS 2 Annex IV with 14 new exemptions and a modification of exemption 12. The Annex IV exemptions are applicable to Category 8 and 9 products. The new exemptions are:

21. Cadmium in phosphor coatings in image intensifiers for X-ray images until 31 December 2019 and in spare parts for X-ray systems placed on the EU market before 1 January 2020.

22. Lead acetate marker for use in stereotactic head frames for use with CT and MRI and in positioning systems for gamma beam and particle therapy equipment. Expires on 30 June 2021.

23. Lead as an alloying element for bearings and wear surfaces in medical equipment exposed to ionising radiation. Expires on 30 June 2021.

24. Lead enabling vacuum tight connections between aluminium and steel in X-ray image intensifiers. Expires on 31 December 2019.

25. Lead in the surface coatings of pin connector systems requiring nonmagnetic connectors which are used durably at a temperature below -20°C under normal operating and storage conditions. Expires on 30 June 2021.

26. Lead in
– solders on printed circuit boards,
– termination coatings of electrical and electronic components and coatings of printed circuit boards,
– solders for connecting wires and cables,
– solders connecting transducers and sensors,
that are used durably at a temperature below -20°C under normal operating and storage conditions. Expires on 30 June 2021.

27. Lead in
— solders,
— termination coatings of electrical and electronic components and printed circuit boards,
— connections of electrical wires, shields and enclosed connectors,
which are used in
(a) magnetic fields within the sphere of 1 m radius around the isocentre of the magnet in medical magnetic resonance imaging equipment, including patient monitors designed to be used within this sphere, or
(b) magnetic fields within 1 m distance from the external surfaces of cyclotron magnets, magnets for beam transport and beam direction control applied for particle therapy.
Expires on 30 June 2020.’

28. Lead in solders for mounting cadmium telluride and cadmium zinc telluride digital array detectors to printed circuit boards. Expires on 31 December 2017.

29. Lead in alloys, as a superconductor or thermal conductor, used in cryo-cooler cold heads and/or in cryo-cooled cold probes and/or in cryo-cooled equipotential bonding systems, in medical devices (category 8) and/or in industrial monitoring and control instruments. Expires on 30 June 2021.

30. Hexavalent chromium in alkali dispensers used to create photocathodes in X-ray image intensifiers until 31 December 2019 and in spare parts for X-ray systems placed on the EU market before 1 January 2020.

31. Lead, cadmium and hexavalent chromium in reused spare parts, recovered from medical devices placed on the market before 22 July 2014 and used in category 8 equipment placed on the market before 22 July 2021, provided that reuse takes place in auditable closed-loop business-to-business return systems, and that the reuse of parts is notified to the consumer. Expires on 21 July 2021.

32. Lead in solders on printed circuit boards of detectors and data acquisition units for Positron Emission Tomographs which are integrated into Magnetic Resonance Imaging equipment. Expires on 31 December 2019.

33. Lead in solders on populated printed circuit boards used in Directive 93/42/EEC class IIa and IIb mobile medical devices other than portable emergency defibrillators. Expires on 30 June 2016 for class IIa and on 31 December 2020 for class IIb.
Lead as an activator in the fluorescent powder of discharge lamps when used for extracorporeal photopheresis lamps containing BSP (BaSi2O5:Pb) phosphors. Expires on 22 July 2021.

34. Lead as an activator in the fluorescent powder of discharge lamps when used for extracorporeal photopheresis lamps containing BSP (BaSi2O5:Pb) phosphors. Expires on 22 July 2021.

The modified wording for exemption 12 is:
12. Lead and cadmium in metallic bonds creating superconducting magnetic circuits in MRI, SQUID, NMR (Nuclear Magnetic Resonance) or FTMS (Fourier Transform Mass Spectrometer) detectors. Expires on 30 June 2021.