DIBP Phthalate Dossier for RoHS Restriction – May 20, 2014

The consultants Oeko-Institut and eunomia research & consulting have completed their RoHS Annex II Dossier for DIBP. The dossier is required by the EU Commission to submit a proposal for restriction of a substance in electrical and electronic equipment under RoHS.

The dossier provides significant data justifying that DIBP is a hazardous substances; however there is no evidence that DIBP is used within the EEE industry.  This leaves the key concern as potential substition of other Phthalates such as DBP and BBP by DIBP (once these substances are restricted) .

The consultants provide the following conclusion in the report.

To conclude, there appears not to be a justification for currently restricting DIBP on its own. If DEHP, DBP and BBP are not to be restricted through RoHS, the consultants do not see a need for the restriction of DIBP in light of its limited applicability to EEE and the low probability for this to change.

There are, however, two options for action, should it be decided to restrict the other phthalates under the RoHS Directive. In both cases, it should be noted that since DIBP is on the REACH Regulation Authorisation List (Annex XIV), its trend of manufacture and use is not expected to change within the EU, whereas for imported goods and components there is a requirement to report its content in such articles to any recipient of the article (manufactures using components containing the substance or importers acquiring products containing the substance for the EU market).

For additional information, contact us

 

RoHS Exemptions for Monitoring and Control Instruments – May 20, 2014

The European Commission published its latest additions to the list of RoHS exemptions. Most of these new exemptions amend Annex IV of the RoHS 2 Directive and are focused on Industrial monitoring and control instruments (a subset of category 9). A few of the Annex IV exemptions are also applicable to medical devices and a couple other exemptions (4(g) and 41) were added to Annex III. The new exemptions are listed below. These exemptions entered the EU Commission’s RoHS exemptions review process in 2012.

RoHS exemptions – Annex IV (Product Categories 8 and 9 only)

35. Mercury in cold cathode fluorescent lamps for back-lighting liquid crystal displays, not exceeding 5 mg per lamp, used in industrial monitoring and control instruments placed on the market before 22 July 2017 Expires on 21 July 2024.’

36. Lead used in other than C-press compliant pin connector systems for industrial monitoring and control instruments. Expires on 31 December 2020. May be used after that date in spare parts for industrial monitoring and control instruments placed on the market before 1 January 2021.’

37. Lead in platinized platinum electrodes used for conductivity measurements where at least one of the following conditions applies: (a) wide-range measurements with a conductivity range covering more than 1 order of magnitude (e.g. range between 0,1 mS/m and 5 mS/m) in laboratory applications for unknown concentrations; (b) measurements of solutions where an accuracy of +/– 1 % of the sample range and where high corrosion resistance of the electrode are required for any of the following: (i) solutions with an acidity < pH 1; (ii) solutions with an alkalinity > pH 13; (iii) corrosive solutions containing halogen gas; (c) measurements of conductivities above 100 mS/m that must be performed with portable instruments. Expires on 31 December 2018.’

38. Lead in solder in one interface of large area stacked die elements with more than 500 interconnects per interface which are used in X-ray detectors of computed tomography and X-ray systems. Expires on 31 December 2019. May be used after that date in spare parts for CT and X-ray systems placed on the market before 1 January 2020.’

39. Lead in micro-channel plates (MCPs) used in equipment where at least one of the following properties is present: (a) a compact size of the detector for electrons or ions, where the space for the detector is limited to a maximum of 3 mm/MCP (detector thickness + space for installation of the MCP), a maximum of 6 mm in total, and an alternative design yielding more space for the detector is scientifically and technically impracticable; (b) a two-dimensional spatial resolution for detecting electrons or ions, where at least one of the following applies: (i) a response time shorter than 25 ns; (ii) a sample detection area larger than 149 mm2; (iii) a multiplication factor larger than 1,3 × 103. (c) a response time shorter than 5 ns for detecting electrons or ions; (d) a sample detection area larger than 314 mm2 for detecting electrons or ions; (e) a multiplication factor larger than 4,0 × 107. The exemption expires on the following dates: (a) 21 July 2021 for medical devices and monitoring and control instruments; (b) 21 July 2023 for in-vitro diagnostic medical devices; (c) 21 July 2024 for industrial monitoring and control instruments.’

40. Lead in dielectric ceramic in capacitors for a rated voltage of less than 125 V AC or 250 V DC for industrial monitoring and control instruments. Expires on 31 December 2020. May be used after that date in spare parts for industrial monitoring and control instruments placed on the market before 1 January 2021.’

RoHS Exemptions – Annex III (All product categories)

4(g) Mercury in hand crafted luminous discharge tubes used for signs, decorative or architectural and specialist lighting and light-artwork, where the mercury content shall be limited as follows: (a) 20 mg per electrode pair + 0,3 mg per tube length in cm, but not more than 80 mg, for outdoor applications and indoor applications exposed to temperatures below 20 °C; (b) 15 mg per electrode pair + 0,24 mg per tube length in cm, but not more than 80 mg, for all other indoor applications.

Expires on 31 December 2018

41. “Lead in solders and termination finishes of electrical and electronic components and finishes of printed circuit boards used in ignition modules and other electrical and electronic engine control systems, which for technical reasons must be mounted directly on or in the crankcase or cylinder of hand-held combustion engines (classes SH:1, SH:2, SH:3 of Directive 97/68/EC of the European Parliament and of the Council(*)

Expires on 31 December 2018

(*) Directive 97/68/EC of the European Parliament and of the Council of 16 December 1997 on the approximation of the laws of the Member States relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery (OJ L 59, 27.2.1998, p. 1).’”

 

The new exemptions were published as Directives 2014/69/EU through 2014/76/EU.

RoHS is On Deck for Medical devices and Monitoring and Control Instruments

The clock is ticking! Most medical devices (category 8) and monitoring and control instruments (category 9) will come under the EU RoHS Directive (2011/65/EU) compliance requirements in three months’ time. The specific compliance dates for category 8 and 9 products are:

  • July 22, 2014 – Medical devices and monitoring and control instruments
  •  July 22, 2016 – In-Vitro diagnostic medical devices
  • July 22, 2017 – Industrial monitoring and control instruments

RoHS compliance has been a significant challenge especially for the category 8 and 9 product manufacturers. Use of small market suppliers and materials/part selection that did not consider RoHS restrictions in the original product design add to the challenge, especially for custom parts. For example, many non-conforming metal alloys or plastic materials have been commonly used by mechanical design engineers. It’s similarly common for a supplier to procure such materials, especially in North America or Asia if they are not otherwise provided specific instructions.

The technical documentation requirement of RoHS 2 is also non-trivial. The documentation must be sufficiently complete to allow an enforcement authority to assess the conformity of the product to RoHS substance restrictions. To avoid having to redo conformity assessment work, the technical documentation should be considered simultaneously with the design/re-design of the product.

Substance Restrictions and Design Conversion

The substance restrictions, at least for the time being, include the four heavy metals Lead, Mercury, Cadmium, and Hexavalent Chromium and the flame retardants Polybrominated biphenyl (PBB) and Polybrominated diphenyl ethers (PBDE). These are the same substances that were restricted under the original RoHS Directive.

Although many generic electronic components migrated to RoHS compliant in 2006, category 8 and category 9 equipment manufacturers generally still need to expend significant effort in converting other parts and assemblies. Even with commodity parts, manufacturers should be aware of parts with exemptions that will be expiring in the near future. Exemptions typically expire a few years later for category 8 and 9 products; however, material and technology changes being made by suppliers may impact the parasitics of certain components which are often utilized by test and measurement products. This has been a key concern expressed by some test and measurement equipment manufacturers.

Manufacturer obligations

The RoHS 2 Directive introduced mandatory requirements for conformity assessment and other specific obligations for manufacturers, importers, and distributors. A summary of the manufacturer obligations is provided below; for the exact wording, please refer to Article 7 of the Directive:

  • draw up the required technical documentation and carry out the internal production control procedure;
  • ensure that their products have been designed and manufactured in accordance with the requirements for substance restrictions;
  • ensure that procedures are in place for series production to remain in conformity;
  • take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured products with the technical documentation and with the requirements of the RoHS Directive;
  • EU declaration of conformity
  •  register of non-conforming EEE and product recalls, and keep distributors informed;
  • ensure that their EEE bears a type, batch or serial number or other element allowing its identification;
  • materials, components and EEE which have been tested or measured in accordance with harmonized standards demonstrating compliance, shall be presumed to comply with the requirements of the RoHS Directive;

RoHS Exemptions for Category 8 and 9 Products

In anticipation of category 8 and 9 products coming into scope of the RoHS2 Directive, manufacturers and industry associations have been requesting additional RoHS exemptions that are needed.

On January 9, 2014, the EU updated the RoHS 2 Annex IV list of substance exemptions with 14 new exemptions and a modification of exemption 12. The Annex IV exemptions are applicable only to Category 8 and 9 products. A complete list of the exemptions is available on our blog.

CE Marking for medical devices

The CE marking applied to products to indicate compliance with the Medical Devices Directive also meets the requirements of the RoHS Directive — only the single CE marking should be applied. However the manufacturer’s EU Declaration of Conformity needs to be updated to include attestation to the RoHS Directive.

Manufacturers of class III medical devices who submit documentation to Notified Bodies are not required to submit the RoHS technical documentation; however, they should address this in their EU Declaration of Conformity (DoC) to avoid misinterpretation by customers and authorities.

Aside from the Notified Body assessment described above, some manufacturers (medical devices and other products) will contract a certification body to assess against all CE marking requirements for the product. For these assessments, the RoHS technical documentation and other RoHS requirements should be assessed; however, not all certification bodies are performing a proper RoHS review. Manufacturers should be clear with the certification body on the level of due diligence that is being performed so that they can assess their risk exposure.

April 10, 2014 – EICC/GeSI release Conflict Minerals Reporting Template Version 3.0

The EICC and GeSI industry associations have released their version 3.0 Conflict Minerals Reporting Template (CMRT).  The new template is intended to align with the new IPC-1755 conflict minerals declaration standard, but is not backward compatible with the previous version 2.03a CMRT which was used by many manufacturers for collecting their 2013 conflict minerals data.   The CMRT template is available through the EICC/GeSI conflict-free sourcing initiative .

IEC 62474 database update released – April 9, 2014

The international IEC 62474 declarable substances list (DSL) and data exchange format was updated on April 9, 2014. IEC 62474 provides the electrical and electronics industry with a material declaration standard and an internationally recognized list of substances that should be declared by suppliers to downstream manufacturers.

Additions and modifications to the Declarable Substance List (DSL)
There were several additions and modifications to the Declarable substance groups and declarable substances and to the reference substances. Details of the changes are provided in the IEC 62474 blog (see table 1).

Changes to the Data Exchange Format

A significant number of changes were made to the XML schema and accompanying developer’s table which together define the format for communicating material declaration files between upstream suppliers and downstream manufacturers. Details of the changes are available in the IEC 62474 blog.

Additional background information on IEC 62474 International Standard and the IEC 62474 online database is available from the home page from the home page of the IEC 62474 blog.

 

Conflicts Minerals Reports due May 31, 2014

The first reports for US conflict minerals reporting are due on May 31, 2014.   Although only companies that report to the SEC are officially impacted by the regulation, we’ve seen many other companies become impacted when they receive requests from customers for conflict minerals information.

The SEC’s conflict minerals rules require manufacturers to investigate and report on the origin of tin, tungsten, tantalum, and gold (3TG) in their products and whether or not the minerals came from a source that potentially funded conflict in the DRC.

As a first step, manufacturers are expected to perform a reasonable country of origin enquiry. Given that the mineral ores are acquired many levels up the supply chain, this is continuing to prove to be quite the challenge for most companies.

Many companies are expected to use the “indeterminate origin” category for the first couple years. However, the “reasonable country of origin enquiry” must be performed and all other requirements of the rules must be met (including SEC filing).

EICC/GeSI Version 3 template for 2014

EICC/GeSI are about to publish version 3 of their Conflict Minerals Reporting Template. Unfortunately, the template is not backwards compatible with the current version 2.03 template; therefore, EICC/GeSI is suggesting manufactures adopt the version 3 template for the 2014 calendar year purchasing of products, parts, and material that contain any of the 3TG metals.

The Power of IEC 62474 for Product Compliance and Eco-design

An article about the application and flexibility of material declarations (IEC 62474 in particular) was published in the April 2014 issue of In Compliance magazine. The article titled “The Power of IEC 62474 for Product Compliance and Eco-design” discusses the industry need to identify regulated substances in EEE products and the value of material declarations to assess and document product compliance. EN 50581 – the RoHS 2 harmonized standard for technical documentation – specifically references IEC 62474 because the material declaration standard was written to provide manufacturers with sufficient information to calculate product conformity to substance regulations.

A synopsis of the article and hyperlink to its location in the in compliance website are provided in the post on the IEC62474 blog.

March 26, 2014 – EU identifies 120 substances for evaluation as possible SVHCs

The emergence of regulated substances is not likely to slow down anytime soon.  The European Union, on March 26, 2014, identified its list of 120 substances that EU Member States will evaluate over the next three years from 2014 to 2016. The substances are included in the EU’s Community rolling action  plan. Of these 120 substance, 53 of the substances were newly added this year — 67 of the substances were already in the plan.

The substance evaluations are spread across the 3 years: 51 substances in 2014; 48 substances in 2015; and 21 substances in 2016.

To avoid duplication of work, each substance is assigned to a specific EU member state who is responsible for performing the evaluation is accordance to the requirements specified in REACH Chapter 2 (Substance Evaluation).

The results of each evaluation will then be reviewed to assess whether the substance should be considered for the SVHC Candidate List (REACH Article 48) and/or for possible restriction in REACH Annex XVII (Article 69).  When a substance is added to the SVHC Candidate list, disclosure obligations are immediately triggered for manufacturers and importers of products that contain the substance above the threshold.  Once on the SVHC Candidate List, the substance also becomes eligible for the REACH Annex XIV Authorisation List (Article 57).

How the Plan helps industry!

This substance evaluation plan provides industry with some indication of the number and identity of substances that will be proposed for the SVHC Candidate List and Annex XVII restrictions over the next few years.  It’s always possible (even likely ) that new information will cause a few other substances to suddenly jump the priority list, but these will be rare exceptions.

Assessing which of these substances are relevant to  our industry

The plan includes  quite a few substances that  the electronics industry or supply chain may be using. Manufacturers can use this information as advance notice of potential issues with the long-term  use of these substances and the need to start to investigate alternatives.   In particular, 4 phthalates are currently identified on the 2014-2016 plan. Phthalates are commonly used  as plasticizers in PVC and other plastics.

Many of the other substances on the list are intermediate manufacturing chemicals, which ideally would not remain in a finished product; however, in many manufacturing processes, there a possibly that some unreacted quantity of the substance remains in the product.  The possibility of an unreacted substance remaining above the 0.1% w/w threshold depends on many factors including the manufacturing process, ratio of chemicals used, quality controls in manufacturing, etc.

Once the substances have been evaluated, some of the substances will be proposed for the  SVHC Candidate List and undergo an initial public consultation.  Once this happens, an industry-led International group of experts will screen the substance for potential relevanance to the electrical and electronics industry.  This group of International experts make up the validation team for the International materials declaration standard IEC 62474. IEC 62474 is an International Standard on material declaration. It includes an internationally recognized Declarable Substance List (DSL), a material declaration procedure and an XML-schema for data exchange.  The validation Team is responsible for regularly  updating the DSL  (usually twice a year).

Additional information on IEC 62474 and the validation team is available on the IEC 62474 blog at http://iec62474.rohs.ca.

For assistance in developing a roadmap of substances to conerns for your engineering teams and suppliers, contact ECD Compliance.

Standards – Sustainability for and by Information Technology (JTC1/SC39)

The joint ISO and IEC standards committee JTC1/SC39 titled “Sustainability for and by Information Technology” was created in 2012 and has the scope

Standardization related to the intersection of resource efficiency and IT which supports environmentally and economically viable development, application, operation and management aspects.

Current standards that are in development are focused on environmental performance of data centers and other Information Technology Equipment.

The work programme includes:

  • ISO/IEC NP 30131: Information technology — Data Centres — Taxonomy and Maturity ISO/IEC NP 30132: Information technology — IT Sustainability — Guidance for the Development of Energy Efficient ICT Products
  • ISO/IEC NP 30134-1: Information Technology — Data Centres — Key performance indicators — Part 1: Overview and general requirements
  • ISO/IEC NP 30134-2: Information Technology — Data Centres — Key performance indicators — Part 2: Power usage effectiveness (PUE)

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