Category Archives: Regulations

Canadian Mercury Regulations – Part 3 – Exemptions

In part 1 (Products Containing Mercury Regulations published in Canada) and part 2 (Canadian Mercury Regulations to Impose Tight Restrictions on Mercury in Batteries) of our series of articles on Canadian Products Containing Mercury Regulations we discussed the scope of the regulations and maximum concentration limits for batterieis and other products and how they compare to the EU RoHS Directive and the EU Battery Directive.  In this part 3 of the series we will look at mercury exemptions, harmonized standards for product testing and spare parts. There are still numerous applications, particularly with mercury containing lamps whereby mercury is critical to proper functioning of the product.

Prohibitions and Exemptions

Under the Canadian Regulations, a product that contains mercury may not be manufactured or imported in Canada unless there is an applicable exemption or if the manufacturer or importer holds a permit issued under the Regulations. The exemptions are listed in the Schedule to the Regulations and each entry includes the product category, the maximum total quantity of mercury in the product, and the end date of the exemption.

The exemptions are similar to the EU RoHS exemptions but not identical. In general, the Canadian exemptions are more flexible, allowing slightly higher levels of mercury content for lamps. For example, item 2(a) of the Schedule specifies that a compact fluorescent lamp for general lighting purposes (≤ 25 Watts) may have up to 4 mg of total mercury per lamp. The comparable exemption in the EU RoHS Directive (exemption 1(a)) allows up to 2.5 mg of mercury per burner (this was originally 5 mg but was reduced to 3.5 mg in 2012 and then 2.5 mg as of January 1, 2013).

The applications (product categories) specified in the exemptions do not align perfectly between the two regulatory instruments, so manufacturers will need to perform a careful comparison to ensure that a product containing mercury meets the Canadian Regulations.

A renewal of most of the EU RoHS exemptions will occur in 2016 and it’s possible that the EU maximum allowable mercury levels will decline further.

The Canadian Regulations provide exemptions for other product categories that are not exempted under the EU RoHS Directive. Other exempted products relevant to the electrotechnical industry include:

  • Scientific instrumentation for the calibration of medical devices or for the calibration of scientific research instruments;
  • Scientific instrumentation used as a reference for clinical validation studies;

Product Testing

For determining the level of mercury content in products, the Canadian Regulations references IEC 62321-4:2013, entitled Determination of certain substances in electrotechnical products — Part 4: Mercury in polymers, metals and electronics by CV-AAS, CV-AFS, ICP-OES and ICP-MS, which is also referenced by the EU RoHS harmonized standard for technical document (EN 50581).

Spare Parts

The Canadian Regulations provide an exemption for replacement parts – this is similar to the EU RoHS exclusion for spare parts.

Technical support on environmental product regulations

ECD Compliance provides manufacturers and suppliers with services to track global environmental product requirements and assess the impact to their products and markets, including the Canadian Products Containing Mercury Regulations.

China RoHS 2 – Expanded Scope takes Effect on July 1, 2016

After years of uncertainty surrounding China RoHS 2, China’s Ministry of Industry and Information Technology (MIIT) published the revised regulation on January 21, 2016. Starting July 1, 2016, companies that manufacture, import or sell Electrical and Electronic Products in China will need to comply with the new requirements. China RoHS 2 aligns more closely with EU RoHS than the original China RoHS but it still retains the unique labeling and documentation requirements and expands the requirements to many products that weren’t previously in scope.

The expanded scope combined with the short timeline for compliance will certainly be a challenge for many product manufacturers. Eliminating the exclusion for exported products also affects companies that have their products manufactured in China.

Manufacturers of products that are already EU RoHS compliant should have sufficient information on hand to compile the new China RoHS documentation; but products that aren’t yet EU RoHS compliant may present a challenge to their manufacturers.  For example, industrial monitoring and control instruments and products that fall into Category 11 “Other EEE not covered by any of the categories above” aren’t subject to EU RoHS requirements until 2017 and 2019 respectively, but both need to meet the China RoHS 2 requirements this year. The requirement to identify all presence of the six hazardous substance groups, including uses that are covered by EU RoHS exemptions, can create a particular challenge.

The Regulation

The regulation, officially titled “Management Methods for the Restriction of the Use of Hazardous Substances in Electrical and Electronic Products”, is generally aligned with the China RoHS 2 draft that was circulated in May 2015 with only a few minor surprises. As expected, the scope of the regulation is extended to all electrical and electronic products except for power generation, transmission and distribution equipment.

Definition of Electrical and Electronic Products

The definition of “Electrical and electronic products” refers to devices and accessory products which function by means of electric current or electromagnatic fields with rated working voltage up to and including 1500V DC and 1000V AC or which generate, transmit or measure such currents or electromagnetic fields. However, the definition explicitly excludes power generation, transmission and distribution equipment.

Hazardous Substances

The six original EU RoHS substances are still the basis for hazardous substances in China RoHS 2; although a seventh entry of “Other harmful substances as regulated by the State” leaves the door open to additional substances such as the four phthalate substances added to EU RoHS.

Labelling and Hazardous Substance Disclosure

A hazardous substances table that indicates presence of any of the six substances and where in the product they are located was carried forward from China RoHS to China RoHS2 (Article 13). The “environmental protection use period” (EPUP) label is also still required (Article 14). The regulation states that both the substance table and the EPUP label should be displayed directly on product; although the regulation provides an alternative if necessary.

With the expanded scope of China RoHS 2, many additional products will need to display the EPUP label and the hazardous substances table as of July 1, 2016. The details of the hazardous substances table and the environmental protection use period are specified in the China standard SJ/T 11364-2014.

Substance Restrictions

Similar to the substance restriction mechanism in its predecessor, China RoHS 2 includes a “Compliance Management Catalog” to implement substance restrictions, specify exemptions and provide timelines.

Compliance to China RoHS 2 will be based on a “conformity assessment system” instead of the CCC certification specified in the original China RoHS — details will be provided later. The regulation only states that MIIT working together with other organizations will “establish a creditable mechanism based on the result of the assessments”.

End of Life Information and Design for Environment

A number of subtle provisions have been added into the regulation for design for environment and to facilitate recycling. The exact expectations of these provisions aren’t specified in the regulation but may emerge over time in China national standards and the FAQ that’s expected sometime this year.

To provide some insight, we’ve pulled out a few examples of DfE implications from the regulation:

  • Article 13 states that the hazardous substances table should provide information on what parts of the product may be recycled and information on possible impact on inappropriate use or disposal on the environment or health.
  • Article 10 states that the producer/manufacturer shall adopt materials and technologies that protect the environment and human health, are easy to recycle and allow high product recyclability rates.

Product Packaging

In the draft regulation released in May 2015, MIIT had removed the requirements on product packaging that were included in the original China RoHS. However, packaging was added back into the final version of China RoHS 2, although somewhat ambiguously. The new requirement states that mandatory standards and laws related to packaging must be met and that packaging materials must be nonhazardous, recyclable/biodegradable, and comply with national or industry standards.

Exported Products

The China RoHS 2 regulation applies to EEE products manufactured in China, imported into China or otherwise sold in China. Unlike the original China RoHS, it does not provide an exemption for EEE products that are manufactured for export.

Impact on Manufacturers

Companies that manufacture their product in China or sell product into China will likely be impacted to some degree by the new China RoHS 2 regulation. Products that were previously out of scope will need to comply with all of the marking and labeling requirements as of July 1, 2016.

The China RoHS 2 regulation is available from the MIIT website (in Chinese). An English translation of the regulation has been made available by Foley & Lardner LLP: English reference translation of the new China RoHS 2 regulation.


EU – Commission Announces Circular Economy Package

The European Commission announced on December 2, 2015 that it is adopting an ambitious new Circular Economy Package. The Commission press release listed the key actions to be carried out under the current Commission’s mandate. Action items that are relevant to the EEE industry include:

  • Funding of over €650 million under Horizon 2020 and €5.5 billion under the structural funds;
  • Development of quality standards for secondary raw materials to increase the confidence of operators in the single market;
  • Measures in the Ecodesign working plan for 2015-2017 to promote reparability, durability and recyclability of products, in addition to energy efficiency;
  • A strategy on plastics in the circular economy, addressing issues of recyclability, biodegradability, the presence of hazardous substances in plastics, and the Sustainable Development Goals target for significantly reducing marine litter;

The broad range of actions making up the Commission’s circular economy package may have significant impact on the EEE industry and manufacturers over the upcoming decade. Impacts may include:

  • Ecodesign implementing measures that include design for reuse and recycling requirements in addition to the traditional energy efficiency requirements.
  • Requirements to make repair information available
  • Emphasis on implementing an environmental management system
  • Increased scrutiny of green claims
  • Product environmental footprint to measure and communicate environmental information
  • Increased Green Public Procurement (GPP)
  • Increased use of recycled plastics and recycled criterial materials
  • Development of quality standards for secondary raw materials
  • Increased exchange of information between manufacturers and recyclers

EU – REACH SVHCs added to Candidate List on December 17, 2015

The European Chemical Agency (ECHA), on December 17, 2015, added five new substances to the REACH SVHC Candidate List. The substances are listed in the table below. The Article 33 communication obligations specified in the REACH regulation (Regulation (EC) No 1907/2006) came into effect as soon as the SVHCs were added to the Candidate List,

SVHCs Added to the REACH Candidate List on December 17, 2015

Substance NameEC numberCAS number
2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327)223-383-83864-99-1
2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350)253-037-136437-37-3
Perfluorononan-1-oic-acid and its sodium and ammonium salts206-801-3375-95-1, 21049-39-8, 4149-60-4

The substance, Dicyclohexyl phthalate, had been proposed for addition to the Candidate List during this update, but was withdrawn by the dossier submitter (Sweden) and postponed to a later submission date. The substance hexamethylene diacrylate (hexane-1,6-diol diacrylate) had also been proposed for the REACH Candidate List but did not get added. The full Candidate List is available on the ECHA website.

For additional information on developing or assessing an effective REACH SVHC compliance program, contact ECD Compliance.

IEC –Analytical Test Methods Published for PBBs and PBDEs

IEC 62321-6/Ed.1:2015 revising analytical test methods for presence of Polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDEs) in plastic parts was published by the IEC in June 2015. IEC 62321-6 replaces the previous informative test method specified in annex A of IEC 62321:2008. This test method is applicable to all EEE products and suppliers.

The standard, titled “DETERMINATION OF CERTAIN SUBSTANCES IN ELECTROTECHNICAL PRODUCTS – Part 6: Polybrominated biphenyls and polybrominated diphenyl ethers in polymers by gas chromatography-mass spectrometry (GC-MS)” specifies 3 test method; one is normative and the other two are informative.

The test methods are:

  • The gas chromatography-mass spectrometry (GC-MS) (Normative);
  • The ion attachment mass spectrometry (IAMS) technique (Informative) and
  • The high-pressure liquid chromatography technique (Informative).

The informative test methods (IAMS and HPLC-UV) did not have sufficient accuracy and repeatability during Intra-laboratory testing trials and therefore could not be included as normative tests but they may still be useful to users and test laboratories. However, if a dispute arises over PBB/PBDE concentration, only the GC-MS method is considered a reliable test method for purposes of regulatory enforcement. Work is expected to continue in improving the accuracy of the informative test methods.

The test method standard is available from the IEC webstore and resellers.

The use of harmonized test methods has proven to be extremely important in ensuring that manufacturers, suppliers, and enforcement bodies are getting consistent results from analytical testing when performing regulatory assessments.

IEC 62321 is referenced by the European harmonized standard for RoHS technical documentation (EN 50581) as the test method that should be used for any test reports that are included in the technical documentation.

EEE Manufacturers that request test reports from suppliers should request and ensure that the revised test methods are being used (IEC 62321-1 through IEC 62321-6) instead of the original IEC 62321:2008.

EU – EcoDesign for enterprise servers and data equipment

The draft report on policy scenarios (task 7) for the EcoDesign (ErP) Directive lot 9 review on enterprise servers and data equipment was published in June 2015. The report emphasizes the same challenges that have been discussed throughout the lot 9 review – the difficulty in characterizing and specifying environment performance requirements of computer servers given the large variation in configuration, applications, and operating conditions.

The draft report included enterprise servers and enterprise storage within its scope, but excludes networking equipment because of the large variation in equipment. The report recommends that a future preparatory study should investigate networking equipment.

For the scope of enterprise servers, the report indicated that it is not excluding specific types of enterprise servers, such as server appliances, but does provide a caution to the European Commission… “However, it is strongly recommended to check the technical, economical and operational feasibility of particular eco-design measures for these products due to the fact that they could be custom made and utilized for high available or mission critical computing processes.”

Policy Recommendations
Five general policy measures and several sub measures were identified; however, there were few detailed technical recommendations other than the usual power supply efficiency which is also specified by U.S. Energy Star. The general policy measures and sub measures presented for further analysis and consideration by the European Commission are:

1.5.1. Product information before and during the operation Active State Information Criteria Idle State Information Criteria Energy proportional design / Dynamic Range

1.5.2. Product hardware components and configuration Power Supply Efficiency Reduction of Idle Power

1.5.3. Energy requirement on the overall energy performance
1.5.4. Product software components and configuration
1.5.5. Product operating conditions and energy management

1.5.6. Resource efficiency requirements Requirements on dismantling, re-use and recycling Requirements for technical documentation Critical raw material (CRM) voluntary declaration Energy consumption of servers and storage with reused components

1.5.7. Energy labelling

Minimizing idle state power has been a common requirement in many other Eco-design implementing measures (regulations). However, for enterprise servers the report recognizes that optimizing idle power could result in an overall negative environment impact.

Low idle power is easier to meet in low performance servers than in high performance servers that are optimized for performance per Watt at high usage levels. Enterprise servers (if configured efficiently using virtualization, etc.) tend to have high usage levels and are not often in an idle state. Therefore, mandating low idle power could result in purchasing of more low performance servers versus fewer high performance servers.

The current challenge in specifying practical requirements for Enterprise servers is epitomized by the statement in subsection 1.5.3. (Energy requirement on the overall energy performance) that reads

“The Lot 9 study recommends that in case reliable measurement methods will permit to provide a quantitative ranking between products in the future, specific requirements on the overall energy performance could be envisaged.”

Energy Star – Large Network Equipment Specification

The Energy Star program has published the second draft of the Large Network Equipment (LNE) Specification Version 1.0 and the final draft of the LNE test method. The U.S. EPA is requesting stakeholder comments on these documents until July 24, 2015.

The specification focuses on reporting energy consumption data, power supply efficiency and energy efficiency features. The EPA is expecting that testing and reporting of energy consumption data will help towards developing additional energy efficiency requirements for version 2.0 of the specification. The changes in the specification from the first draft to the second draft are listed in a cover letter from the EPA:

  • EPA proposed several significant changes to key definitions including LNE, modular and fixed, a new definition for module, and an expanded definition of product family for modular products. Physical Network Ports now also include fiber-optic ports.
  • EPA proposes inclusion of fiber-optic ports within the scope of this specification up to 40Gb/s or greater link rate capability.
  • EPA has clarified that power factor requirements only apply to ac input power supplies.
  • EPA has clarified that active state efficiency requirements will not be included in Version 1.0 of this specification, rather certified products will be required to generate and report data that will support setting active levels in Version 2.0. The other pass/fail requirements such as power supply efficiency and energy efficiency features will ensure Version 1.0 delivers savings.
  • EPA has proposed a family structure for modular products and stated the Agency’s interest in and considerations for a family structure for fixed products, though a fixed product family structure is not proposed in this draft.
  • EPA has added standard language on the definition of a representative model(s) in a product family.

Additionally, the following are some key elements of the proposed changes in LNE Final Draft Test Method:

  • DOE has added test procedures for High Port Count products, as well as configuration requirements pertaining to High Port Count testing.
  • DOE has increased the center-point and widened the range of the allowable ambient temperature required during testing.
  • DOE has changed the requirements for how to measure the power of products that have multiple PSUs.

The current draft Specification excludes the following products from the scope of LNE Energy Star certification:

  • Small Network Equipment;
  • Computer Servers, including blade switches sold within a Blade Server configuration;
  • Storage Products, including Blade Storage;
  • Storage Networking Products;
  • Security Appliances;
  • Access Point Controllers;
  • DSLAM/CMTS equipment;
  • Network Caching Devices; and
  • Load Balancing Devices.

Two Substances added to REACH SVHC Candidate List

The European Chemical Agency (ECHA), on June 15, 2015, added two new substances to the REACH SVHC Canadidate List. The substances are listed in the table below. The Article 33 communication obligations specified in the REACH regulation (Regulation (EC) No 1907/2006) came into effect as soon as the SVHCs were added to the REACH Candidate List,

Name of Substance or Substance GroupEC number CAS number
1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate (EC No. 201-559-5) 271-094-0
5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any combination thereof] --

The first substance is a mixture of two alkyl diesters when the mixture contains greater than 0.3% of dihexyl phthlate (DnHP). This SVHC listing will likely be confusing and a challenge for industries to manage. The two primary ingredients with the CAS numbers and EC Tnumbers listed are themselves not SVHCs; the mixture only becomes an SVHC with the Article 33 reporting obligations when it includes greater than 0.3% DnHP.

The second new listing in the REACH Candidate List is a substance group. The primary example listed by ECHA of this substance group is the product sold under the name “karanal” . ECHA indicates that the main use, according to public information, is as a fragrance.

For additional information on developing or assessing an effective REACH SVHC compliance program, contact ECD Compliance.


RoHS Amendment adding Phthalates to Restricted Substances is Published

The European Delegated Directive (EU) 2015/863 officially adding the four (4) Phthalate substances to the EU RoHS Directive was published today, June 4, 2015.  The new phthalate restrictions take effect beginning July 22, 2019 for all EEE except category 8 (medical devices) and category 9 (monitoring and control instruments). Category 8 and 9 products have an additional 2 years and need to comply by July 22, 2021. EEE manufacturers and their suppliers now have just over four years to prepare.

The amendment adds the four phthalates shown below to Annex II (Restricted substances referred to in Article 4(1) and maximum concentration values tolerated by weight in homogeneous materials) of the the RoHS Directive . A maximum concentration value of 0.1% w/w in homogeneous material was specified for the phthalates in the amendment.

Four Phthalate Substances to be Added to RoHS Directive

Substance NameCAS NumberMaximum Concentration
in homogeneous material
Bis(2-ethylhexyl) phthalate (DEHP)117-81-70.1%
Benzyl butyl phthalate (BBP)85-68-70.1%
Dibutyl phthalate (DBP)84-74-20.1%
Diisobutyl phthalate (DIBP)84-69-50.1%

Spare Parts and Cables

The official publication of the amendment was delayed by a few months to allow the European Commission time to add verbiage clarifying the implication on cables and spare parts.  This new text aligns with the general RoHS intention to allow products to be repaired using the same parts that were used in the original product when if was first put on the EU market.  The published amendment states:

The restriction of DEHP, BBP, DBP and DIBP shall not apply to cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of EEE placed on the market before 22 July 2019, and of medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, placed on the market before 22 July 2021.

Phthalates in Electrical/Electronic Toys

The amendment is also explicit that the phthalates in toys restriction in Annex XVII of the REACH regulation takes precedence over the maximum concentration levels in the RoHS Directive.

What’s the Impact? How to Proceed?

The four phthalates are already listed on the REACH SVHC Candidate List — this gives manufacturers that have REACH SVHC information from their suppliers a head start in assessing  the parts and materials that require substitution.  However, the different basis for calculating concentration level between REACH and RoHS (article vs. homogeneous material) will undoubtedly create some surprises.

In electrical and electronic equipment (EEE), DEHP is generally considered to be the most commonly used of the four phthalates. DBP and BBP also have known applications; whereas DIBP is considered to have minimal usage within the EEE supply chain.

The results of a study published in 2010 at the IPC APEX conference “Where are REACH SVHC in Electronic Products and Parts?” may provide some insight to the use and prevalence of these substances.  The study investigated and compiled analytical test results for the initial batch of SVHCs added to the REACH Candidate List (including 3 of the phthalates just added to RoHS). The analytical testing was performed in Asia, North America, and Europe on EEE and materials typically used in EEE.  DEHP was detected above the SVHC threshold (0.1% wt/wt in the article) in 64 of 391 testing results (16%). The study was focused on the REACH SVHC threshold which is based on articles.  However, had the study considered a concentration threshold based on homogeneous material, the number of products above the threshold would likely have been much higher.

In the time since 2010, many manufacturers that have been trying to eliminate SVHCs from their product have removed the phthalates from external cables (where they are above 0.1% in the article); but DEHP may still be present in internal cables which are relatively small and for which the phthalate content did not trigger the 0.1% threshold based on imported article.

Additional information on RoHS 2 compliance and RoHS 2 Technical Documentation is available. The amendment to the RoHS Directive is posted on the Official Journal of the EU. ECD Compliance provides services to track environmental regulations and can assist in upgrading your RoHS program to address the phthalate restrictions.

European Parliament Votes Mandatory Conflict Minerals Regulation – May 2015

The European Parliament vote on May 20, 2015 to push back on the European Commission’s proposed voluntary self-certification scheme for a mandatory system of

  • certification for importers of minerals to produce tin, tungsten, tantalum, and gold (3TG),
  • third-party audits for refiners and smelters to their check due diligence practices and
  • information on due diligence measures by downstream companies.

The European Parliament press release states:

In addition, “downstream” companies, that is, the 880 000 potentially affected EU firms that use tin, tungsten, tantalum and gold in manufacturing consumer products, will be obliged to provide information on the steps they take to identify and address risks in their supply chains for the minerals and metals concerned.

The EU proposal potentially covers sourcing from any conflict area, not limiting the scope of the due diligence measures to only the Democratic Republic of Congo (DRC) region.

The press release is available from European Parliament press release.

ECD Compliance clients will be receiving additional analysis and potential impacts of the Parliament’s approved changes in the upcoming Environmental Report.