Category Archives: Regulations

RoHS Takes Effect for Medical Devices and Control and Monitoring Instruments – July 22, 2014

The EU RoHS Directive (2011/65/EU) substance restrictions and other compliance requirements come into effect today for most medical devices (category 8) and monitoring and control instruments (category 9).

Key obligations for manufacturers to implement/document Compliance Assurance System are:

  • 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 harmonised standards demonstrating compliance, shall be presumed to comply with the requirements of the RoHS Directive

The RoHS Directive obligates manufacturers to draw up ‘Technical Documentation’ that demonstrates conformity prior to placing products on the EU market. The CENELEC EN 50581 standard specifies requirements for RoHS 2 technical documentation.

Contact ECD Compliance for additional information and support on RoHS compliance or for an independent assessment or guidance on your current RoHS conformity assessment procedures.

EU Ecodesign Requirements for Computers Come into Effect – July 1, 2014

The first phase of energy efficiency requirements specified in the European Ecodesign regulation for computers and computer servers (Commission Regulation (EU) No 617/2013) came into effect on July 1, 2014. Compliance with the regulation, an implementing measure under the Ecodesign (ErP) framework Directive, is a CE mark requirement and is mandatory for selling computers and computer servers in the EU.

The regulation established relatively aggressive energy efficiency requirements (in comparison to Energy Star version 5.2). In general, the Ecodesign regulation has a broader scope than the Energy Star specification for computers; however, there are a few important exclusions to the scope of the products covered. Energy efficiency requirements come into effect in two phases. The first phase took effect on July 1 2014 and the second (more aggressive) phase takes effect 18 months later on January 1 2016.

Article 1, paragraph 2 establishes the scope of the implementing measure as “the following products that can be powered directly from the mains alternating current (AC) including via an external or internal power supply: ”

  • desktop computers;
  • integrated desktop computers;
  • notebook computers (including tablet computers, slate computers and mobile thin clients);
  • desktop thin clients;
  • workstations;
  • mobile workstations;
  • small-scale servers;
  • computer servers.

However, Article 1, paragraph 3 goes on to exclude specific product groups including: blade system and components, server appliances, multi-node servers, computer servers with more than four processor sockets, game consoles, and docking stations.

Regulation 617/2013 employs a product categorization taxonomy similar to the US Energy Star Version 5.2 specification. For example, both documents categorize desktop computers as either category A, category B, category C, or category D depending on the performance characteristics of the system – category D is the highest performance desktop computer with a minimum of four physical cores in the CPU and other performance enhancing features as specified in the regulation. Similarly, notebook computers are categorized as Category A, Category B, or Category C based on the performance features. Energy Star moved away from this taxonomy in the Version 6.0 computer specification which makes a direct comparison more difficult.

With respect to energy efficiency targets, Commission Regulation (EU) No 617/2013 is generally more frugal than Energy Star (particularly the 5.2 specification). For example, Desktop category A computers must have a total annual energy consumption (ETEC) of no more than 133 kWh/year (starting July 1, 2014) and 94 kWh/year (starting January 1, 2016). This is aggressive in comparison to the 148 kWh/year specified in the Energy Star 5.2 specification.

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.

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.

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.

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.

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