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Prioritization of Future RoHS Substances – June 2014

Oeko Institut, under contract with the European Commission, has continued prioritizing the potential RoHS substances that were identified by Umweltbundesamt (the Austrian Environment Agency) in their report “Study for the review of the list of restricted substances under RoHS 2 – Analysis of impacts from a possible restriction of several new substances under RoHS 2“. See our blog post “February 5, 2014: Final report of RoHS 2 restricted substances study – 71 priority substance areas identified” for information about the Umweltbundesamt study. The Oeko Institut work is considering those substances which are not already under final assessment for the RoHS Directive (ie. the three phthalates substances (DEHP, DBP, BBP) and the flame retardant HBCDD).

This latest review synthesizes information about applications, volume of usage, and whether or not the substances remain as final constituents of the finished product. Several of the substances identified by Umweltbundesamt are intermediate chemicals that react during the manufacturing process and therefore should not remain in the finished product. However, the RoHS Directives only restricts substances that are constituents of the final product, so there is little benefit to the environment or human health by restricting a substance that is consumed in the manufacturing process unless significant unreacted amounts remain in the product.

Oeko Institut organized the substances into six priority subgroups based on the following criteria:

  • Quantities in which the substance is in use in EEE manufacture;
  • Quantities present in EEE end products (in cases where substances are used as intermediates or reactive chemicals;
  • Possible differences in the use trend of a substance between EU manufacturers and other manufacturers in light of REACH authorisation processes;

They also note that several of the substances (i.e. indium phosphide, beryllium based compounds and cobalt based compounds) have been designated by the European Commission as critical materials that are essential to the EU economy.

Subgroup 1: High use volume in EEE
This first subgroup contains Polyvinyl Chloride (PVC) which is commonly used in EEE for wire/cable sheathing and in telecommunication systems for cable management. The listing of PVC is controversial to many manufacturers and suppliers. Oeko institute noted that concerns about PVC are being raised for different reasons and that a comprehensive assessment of the different types of PVC should be performed. In particular, the assessment should differentiate between flexible PVC that may include the phthalates DEHP, BBP, and DBP and other additives versus rigid PVC that typically does not include these additives.

The recommendation states “Higher priority to assess if environmental benefits justify restriction – check if there are sub-substances that need to be reviewed as with PVC rigid, soft and recycled.”

Subgroup 2: Medium use volume in EEE
This second subgroup includes:

  • Medium chained chlorinated paraffins (MCCP), C14–C17: alkanes, C14-17, chloro
  • Antimony trioxide
  • Tetrabromo-bisphenol A (TBBPA)

The recommendation is “Medium priority to assess if environmental benefits justify restriction – check if there are sub-substances that need to be reviewed as with PVC rigid, soft and recycled.”

Subgroup 3: Low use volume in EEE
The third subgroup includes:

  • Indium Phosphide
  • Beryllium metal and containing alloys
  • Beryllium oxide

The recommendation for these substances is “Lower priority to assess if environmental benefits justify restriction – check if there are sub-substances that need to be reviewed as with PVC rigid, soft and recycled.

Subgroup 4: Annex XIV substance assumed not to be in use in light of EU use trends and Annex XVII substance with restrictions applying both to EU and non EU production
These substances have seen significantly reduced use within the EU since their addition to REACH Annex XIV; however, Oeko Institut notes that the trend to eliminate these substances should be confirmed with the EEE supply chain given that Annex XIV authorization does not directly impact products that are brought into the EU as imported articles.

The substances in this subgroup are:

  • Di-arsenic trioxide
  • Di-arsenic pentoxide
  • Tris(2-chloroethyl) phosphate (TCEP)

For the Annex XIV substances, Oeko Institut recommends “Assessment can be made at a later stage in light of the lower relevance to EEE. Main focus would be to realize if there is an impact to competitiveness in light of the Authorisation requirement or if manufacture has just moved elsewhere). It may be beneficial to have a survey of the supply chain in cooperation with industry, to clarify if its use in EEE is relevant and would justify a restriction to ensure the level of environmental safety is the same and whether the different trend of use causes impacts on competition between EU and non EU manufacturers.

For the Annex XVII substances, Oeko Institut recommends “Assessment can be made at a later stage in light of the lower relevance to EEE. Main focus would be to realize if there is an environmental impact still expected from restriction.

Subgroup 5: Varying use volume with low anticipation for presence in final product in light of intermediate applications
Recommendation: “Assessment can be prepared at later stage as restriction aimed at quantities present in end product and thus impact on use needs to be revisited.

The substances include:

  • Nickel sulphate
  • Nickel bis (sulfamidate) /Nickel sulfamate
  • Cobalt dichloride
  • Cobalt sulphate

Subgroup 6: Low use volume in EEE and Assumed not to be in use in light of EU use trends
Oeko Institut sees minimal evidence at this time that restricting these substances would provide significant benefit. The substances in the subgroup include:

  • Cobalt metal
  • DEP
  • 2,3-dibromo-1-propanol
  • Dibromoneopentyl glycol

Recommendation: Assessment can be made at a later stage. It may be beneficial to have a survey of the supply chain in cooperation with industry, to clarify if its use in EEE is relevant and would justify a restriction to ensure the level of environmental safety is the same and whether the different trend of use causes impacts on competition between EU and non EU manufacturers.

Oeko Institut suggests that the assumption of “not to be in use” needs to be confirmed in the supply chain, particularly of articles imported from outside the EU.

ECD Compliance provides additional information and support on regulatory requirements and restricted substance controls for new substances.

BNST Substances Restricted in Canada – July 2014

The substance group BNST was added to the Canadian Regulation “Prohibition of Certain Toxic Substances Regulations, 2012 (the Prohibition Regulations)” under the Canadian Environmental Protection Act, 1999, and these regulations came into force on March 14, 2013. BNST is an abbreviation for “Benzenamine, N-phenyl-, Reaction Products with Styrene and 2,4,4-Trimethylpentene”. Risk assessment under the Canadian chemical management plan led to the identification of risk management measures that were necessary and the subsequent restriction of BNST.

BNST may be found in lubricants that are sometimes used for high-speed electrical motors in electronic products such as DVD players.

The Prohibition Regulations prohibit the manufacture, use, sale, offer for sale or import of BNST and is also applicable to products containing BNST with a limited number of exemptions. The restriction takes effect starting March 14, 2015. Permits to continue using the substance for up to three years after the 2015 prohibition date are also possible. An application for a permit must be submitted to the Minister of the Environment and it must contain the information specified in Schedule 4 of the Prohibition Regulations.

The Prohibition Regulation is available for download from the Canada Gazette.

ECD Compliance can assist manufacturers with this regulation.

Final Draft of Energy Star Computer Specification 6.1 – June 2014

The final draft specification of the Energy Star Computer Specification 6.1 was released by the U.S. EPA (operators of the US Energy Star program). The focus of the 6.1 specification versus the 6.0 specification is the inclusion of slates, tablets, and two-in-one notebook computers. “Slates” refers to app based tablets such as the Apple iPAD and Android tablets. There has been significant pressure from purchasers to develop a specification for these products given their increasing use within the work place. The Computer 6.0 specification came into effect on June 2, 2014, but does not include these devices in scope.

The Energy Star program operators were trying to release the 6.1 specification for the same June 2nd effective date as the 6.0 specification; however, challenges with clearly defining and differentiating between the different types of computer products on the market and with identifying the appropriate energy efficiency thresholds and measurement tests for each type of computer has caused a couple months of delays. Energy Star is an important marketing tool for computer manufacturers, especially for sales to institutional purchasers. There was significant feedback and lobbying by manufacturers to ensure the new product types and test methods fit with their new computer and tablet models.

A summary of changes made to the 6.1 specification based on stakeholder feedback is provided in the cover letter to the final draft 6.1 specification:

The approach outlined in this final draft reflects extensive engagement with a wide range of stakeholders over the past several months. Changes of note include:

  • EPA has defined Portable All-In-One Computers but no longer includes these products under the Integrated Desktop Computer category as was previously proposed. Further, Portable-All-In-One Computers are now in scope.
  • Clarification has been provided regarding diagonal screen size for both the Slate/Tablet and Portable All-In-One Computer definitions to more clearly separate these two products types that share a similar form factor but have different use cases.
  • Portable All-In-One Computer requirements have been added in Table 2 of the power management requirements (Section 3.3), and in the energy criteria (Section 3.6).
  • EPA has included guidance on future consideration for battery charging efficiency in Slates/Tablets in Version 7.0.
  • Based on stakeholder feedback, DOE has changed the display brightness requirement for Slates/Tablets from 200 cd/m2 to 150 cd/m2.

Slates and Tablets

The U.S. EPA had originally intended to use the battery charging standard (BCS) for evaluating tablets and slates; but given that the BCS program is being discontinued, the EPA proposed using the notebook test methods and energy consumption levels to assess the tablet/slate products. In most cases, the slates/tablets will need to meet the lowest total energy consumption (TEC) specified for notebooks (category 0).

The new specification defines slates and tables as:

4) Slate/Tablet: A computing device designed for portability that meets all of the following criteria:

a) Includes an integrated display with a diagonal size greater than 6.5 inches and less than 17.4 inches;

b) Lacking an integrated, physical attached keyboard in its as-shipped configuration;

c) Includes and primarily relies on touchscreen input; (with optional keyboard);

d) Includes and primarily relies on a wireless network connection (e.g., Wi-Fi, 3G, etc.); and

e) Includes and is primarily powered by an internal battery (with connection to the mains for battery charging, not primary powering of the device).

Slate/tablet computers must support a “Display Sleep Mode” but are not required to have “System Sleep Mode”, “Wake on LAN”, or “Wake Management” functionality that is required for most other types of computers. Slates and tablets generally have a very low power long idle mode that is intended to minimize energy consumption and maximize batter life when the product is not being used. Section 3.6 of the 6.1 specification provides the technical energy consumption requirements for slates/tablets and portable all-in-one computers. In general, slates/tablets must meet the energy consumption requirements specified for notebook computers in section 3.5 and portable all-in-one computers must meet the energy consumptions requirements specified for integrated desktop computers.   Please see section 3.6 of the specification document for further details – the link to the document is provided below.

Energy Star specifications are usually set so that only the top tier of products on the market qualify for Energy Star; however, it will be difficult to precisely anticipate how this will play out for slates and tablets. The U.S. EPA has stated that “EPA intends to further evaluate Slate/Tablet product data to inform the development of future Slate/Tablet energy consumption requirements in Version 7.0.” and “EPA has included a permanent note in this section stating that it intends to create independent Slate/Tablet requirements in Version 7.0 if the data from the Version 6.1 certification process can support sufficient differentiation of these products. EPA will also monitor other sources of product energy performance, such as CEC battery charger data, to help inform future Version 7.0 development.”

Products already included in the 6.0 Specification

The 6.1 specification does not change any of the definitions or energy efficiency requirements for the desktop, notebook and other computers that were already within the scope of the 6.0 specification.

Additional Requirements of Energy Star

The Energy Star specification also requires that products meet certain other design for environment provisions such as substance restrictions and appropriate design for recyclability. These requirements were included in the Energy Star partner commitments for the 6.0 specification and are expected to carry forward to the 6.1 specification.

Resources

The Computer Specification 6.1 final draft is available from the U.S. EPA Energy Star website.

 

HCBD Alternatives Assessment Completed by U.S. EPA DfE Program – June 2014

The U.S. EPA published in June 2014 their final report on “Flame Retardant Alternatives for Hexabromocyclododecane (HBCD). Note: Hexabromocyclododecane is sometimes also abbreviated as HBCDD. The project was executed under the U.S. EPA’s Design for Environment (DfE) program, being launched in 2011 and having been completed this year. The DfE program concluded that the dominant use of HBCD is in expanded and extruded polystyrene foam (EPS and XPS) insulation under current manufacturing processes. HBCD is also used as a flame retardant for High impact polystyrene (HIPS) often in electronic audio/video products. This application accounts for a small percentage of the total HBCD used, but it is still a significant impact for electronic products using this substance.

HBCD is being phased out because of its high concerns in the area of human development, very high aquatic toxicity, high persistence and very high bioaccumulation in the environment. Many countries are in the process of implementing restrictions on the use of HBCD and it is likely to become one of the restricted substances under the RoHS Directive. HBCD is already on the REACH Annex XIV authorization list and therefore also listed as a REACH Candidate List SVHC.

Given the dominant use of HBCD in the building and construction industry, the DfE project focused on these applications. Therefore the results of the study itself are not particularly useful for the electrical and electronics (EEE) industry. Instead, the final report refers EEE manufacturers to the results from the earlier DfE study on “An Alternatives Assessment For The Flame Retardant Decabromodiphenyl Ether (DecaBDE)” — we provide more information on this topic later in the blog posting.

For HBCD in EPS and XPS, the report identifies three alternatives that tend to have lower human health and environment endpoint concerns than HBCD: a butadiene styrene brominated copolymer (CAS 1195978-93-8), a TBBPA-bis brominated ether derivative (CAS 97416-84-7), and TBBPA bis(2,3-dibromopropyl) ether (CAS 21850-44-2). Of these three alternatives, butadiene styrene brominated copolymer (CAS 1195978-93-8) appears to have the lowest human health and environmental impacts; however, the overall impact will also be influenced by the end application.

For the electronics industry, the U.S. EPA points manufacturers to the DfE study on alternatives to Decabromodiphenyl Ether (DecaBDE) because decBDE was commonly used as a flame retardent for HIPS prior to the decaBDE ban in the EU RoHS Directive. Therefore, the alternatives for replacing decaBDE in HIPS may also be applicable to replacing HBCD in HIPS (depending on the specific performance aspects that are required by your application). The alternatives that were considered for HIPS include: Antimony trioxide (as a synergist only); Bis (hexachlorocyclopentadieno) cyclooctane; Brominated Epoxy Polymer(s); Mixture of Brominated Epoxy Polymer(s) and Bromobenzyl Acrylate; Brominated epoxy resin end-capped with tribromophenol; Brominated poly(phenylether); Decabromodiphenyl ethane; Ethylene bis-tetrabromophthalimide; and Tris(tribromophenoxy) triazine.

The DfE report does not specifically recommend any of the alternatives given that each alternative has its own pros and cons. However, the report provides information about a variety of human toxicity and environmental impact endpoints for each alternative to help manufacturers identify and assess potential alternatives for use in their materials. The potential real impact of any of these chemicals also depends on the application and the use of the final product itself. Some of the alternatives have some significant human toxicity or environmental impacts and may not be any better than HBCD. The DfE report for decaBDE is available from the project website.

The DfE alternatives assessment report is available from the project website.

Contact ECD Compliance for additional information

Four Substances added to REACH SVHC Candidate List – June 16, 2014

The European Chemical Agency (ECHA) has added four additional substances to the SVHC Candidate List. Manufacturers, importers and distributors have communication obligations in Europe if any of their products contain one of these substances above the reporting threshold.

REACH SVHCs added to the Candidate List on June 16, 2014

Substance Name EC Number CAS Number Reason for inclusion
1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear271-093-568515-50-4Toxic for reproduction (Article 57 c)
Sodium perborate; perboric acid, sodium salt239-172-9; 234-390-0-Toxic for reproduction (Article 57 c)
Sodium peroxometaborate231-556-42093666Toxic for reproduction (Article 57 c)
Cadmium chloride233-296-710108-64-2Carcinogenic (Article 57a); Mutagenic (Article 57b); Toxic for reproduction (Article 57c); Equivalent level of concern having probable serious effects to human health (Article 57 f)

Additional information on the REACH SVHC obligations for organizations that manufacture or ship products into the EU are available on our ECD Compliance REACH web page.

New Test Method proposed for Energy Star Computers Version 6.1 – May 23, 2014

The US Energy Star for computers program will include tablets, slates and two in one notebook computers within scope of the computer 6.1 specification. There has been significant pressure from purchasers to develop a specification for these products given the increased use of such products within the work place. The U.S. EPA (operators of the US Energy Star program) had originally intended to use the battery charging standard (BCS) for evaluating tablets and slates; but given that the BCS program is being discontinued, the EPA has now proposed using the notebook test methods and energy consumption levels to assess the tablet/slate products. In most cases, the slates/tablets would need to meet the lowest total energy consumption (TEC) specified for notebooks (category 0).

The U.S. EPA has now distributed a Draft Version 6.1 Energy Star Computers Test Method for stakeholder comments.  The EPA is requesting that comments be submitted on or before June 13, 2014. The draft revised test method is available on the Energy Star website.

The Energy Star computers version 6.1  specification also requires that products meet certain other design for environment provisions such as substance restrictions and appropriate design for recyclability.

The EPA had intended to release version 6.1 of the computer specification and certification requirements such that it takes effect on June 2, 2014 to align with the effective date for version 6.0. However, given that the test method will not be finalized until after the June 13, 2014 closing date for stakeholder comment; it’s more likely that the version 6.1 specification will become effective a few months later than planned.

ECD Compliance is a stakeholder in the development of several new Energy Star specifications and can assist manufacturers. For additional additional information or support with new Energy Star specifications, contact us.

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 .