An update to the IEC 62474 declarable substance list (DSL) and data exchange format was published on April 8, 2015. Regulatory changes prompted 5 new and modified substance entries. Nearly 30 other changes were implemented as part of a year-long DSL review to identify substances whos names have changed in regulatory usage and to implement common naming conventions.
Details of the update are provided on the IEC 62474 blog.
The Singapore National Environment Agency (NEA) is proposing a Singapore RoHS regulation. The proposal aligns with the EU RoHS Directive, but initially targets only 6 common consumer product categories. The six product categories targeted for RoHS compliance are: Mobile Phones, Mobile computers, Refrigerators, Air conditioners, Panel TVs and Washing Machines. A NEA study has found that 95% of these products are already compliant and intends to ensure compliance of all such products that are sold in Singapore. The proposal suggests that a one-year grace period (transition time) will be provided for manufacturers and importers to comply with the restrictions from the date the regulation is gazetted.
In their response to a public consultation on the proposed regulation, the NEA clarified that
The European Commission has clarified the impact of the upcoming RoHS 2 Phthalates restrictions on spare parts and cables for products that were put on the EU market before the new substance restrictions come into effect. The clarification was made March 13, 2015 in response to comments the EC had received to their WTO notification of the draft amendment adding the four phthalate substances to Annex II of the RoHS Directive (2011/65/EU).
The Commission proposed the following draft recommendation to be included in the ANNEX II amendment:
“The restriction of DEHP, BBP and DBP shall not apply to cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of the EEE of ANNEX I categories 1-7, 10 and 11 that is placed on the market before 22 July 2019, and the EEE of ANNEX I categories 8 and 9 that is placed on the market before 22 July 2021.”
ECD Compliance is providing services to assist manufacturers with implementing the phthalates restrictions in supply chain management and manufacturing operations efficiently and cost effectively.
BNST Use in Electrical and Electronic Products
As of March 14, 2015, the importation of products into Canada containing lubricants that use BNST as an additive will no longer be legal unless the importer has a permit from Environment Canada. BNST, a common abbreviation for the substance Benzenamine, N-phenyl-, Reaction Products with Styrene and 2,4,4-Trimethylpentene, provides benefit in lubricants as a antioxidant, corrosion inhibitor, scavenger, and anti-scaling agent; therefore, eliminating the BNST can impact performance and long-term reliability which needs to be carefully assessed during substitution. The substance is effective in improving reliability but is also toxic to human health and the environment.
The BNST ban has been a major challenge for the electrical, electronics and automotive industries; particularly any products that contain motors and sliding mechanisms that use lubricant. For example, BNST lubricants were commonly used in many brands of computer hard disk drives (HDD). It may also be used in motors in HVAC equipment to improve reliability. BNST is not currently listed on the EEE industry standard (IEC 62474) declarable substances list (DSL) which has caused a lack of visibility and declaration of the substance down the supply chain. (Note: BNST will be added to the IEC 62474 DSL during the next update cycle (late March).
Many EEE manufacturers throughout the supply chain started re-designing products with BNST-free lubricants in 2014, but some of the design changes will not be completed until 2015. Many downstream manufacturers and importers have been learning about the use of BNST in their product just recently. They may also have large inventory of parts and products that may contain BNST, creating logistical challenges. In some cases, manufacturers are also having difficulty in obtaining confirmation from their supply chain as to whether BNST is used or not. Spare parts that are in inventory and may no longer be in production will be a particular challenge for many organizations. Environment Canada has suggested that manufacturers and importers should use a conservative approach in such situations when it’s not possible to confirm that the product is BNST-free.
Additional background information on the BNST Regulation in Canada is provided in our previous article “BNST Restriction in Lubricants Takes Effect in Two Months“.
BNST Permits / Foreign Manufacturers
The Canadian Prohibition of Certain Toxic Substances Regulations, 2012 anticipated that it may not be possible to eliminate BNST for all products and it provides a mechanism for manufacturers and importers to obtain permits for up to an additional three years if requirements specified in the Regulations are met. If your organization needs additional time to eliminate BNST or to confirm it’s absence, obtaining a permit for March 2015-March 2016 can help reduce business risk and avoid customer issues.
Permit applications must be submitted by the Canadian manufacturer or the importer.This creates a challenge for U.S. or other foreign manufacturers that sell products to several Canadian importers. There is no mechanism in the regulations for a foreign manufacturer to obtain a permit (e.g. through an only representative as would be the case in the EU) and then have the permit available to downusers importers. However, there is a workaround. A foreign manufacturer may compile a group BNST permit application on behalf of its downstream importers. In this way the manufacturer is supporting their customers by off-loading the permit application process. This ensures that they can continue their business operations without interruption (once the permit is granted).
Obtaining a BNST Permit as Quickly as Possible
The key to expediting a BNST permit application is to ensure that all of the information needed by Environment Canada to assess and grant the permit is provided in the application. Environment Canada cannot issue the permit if any of the permit requirements specified in the regulation are not met. If Environment Canada needs to request additional information, the process will be delayed.
The official BNST permit application processing time is 60 business days; however, Environment Canada has been able to process applications in signfiicantly less time when complete information is provided during the initial submission and is in a format that is easy to assess.
The permit application requires information on BNST use in products, sales data, sales forecast data, customer information and justification for continued use of BNST. Environment Canada has provided interpretation and guidance on some of these requirements which can help simplify the data collection. Also, confidential business information can be protected by using a slightly modified submission process.
ECD Compliance can assess your situation and quickly compile the permit application with the necessary information. The permit application can be compiled and submitted within a few days and will leverage our experience with the industry supply chain and the efforts underway to design out BNST. We have successfully worked with the electronics, HVAC, and automotive industries on BNST requirements and permits. If you are a foreign manufacturer that would like to submit a permit application for your importers, utilizing ECD Compliance as an independent third party can be ideal to protect your importers’ confidential information.
The European Court of Justice has taken a first step in ruling that the REACH SVHC concentration threshold should be interpreted based on the “Once an Article, Always an Article” principle.
In its original guidance on reporting SVHCs in articles, the European Commission suggested that the 0.1% threshold should be based on the weight of the entire article as imported or as provided to the customer. However, six countries (Austria, Belgium, Denmark, France, Germany and Sweden) disagreed with this guidance. The dissenting countries argued that an SVHC that is above the 0.1% level in any individual article (component) within a product may pose a health or environmental risk and should trigger the reporting and communication obligations for the SVHC.
The difference in opinion between the two sides created a lot of ambiguity for industry, but industry generally followed the methodology given in the EC guidance document because of the sheer difficultly in meeting the obligations based on SVHC levels in each component in the product.
Legal proceedings were launched in France and are now forcing a resolution to the standoff. The European Court of Justice (ECJ), which has the final say in matters of EU regulatory interpretation, has been asked to rule on the question. As a first step toward a preliminary ruling, the Advocate General, an official legal advisor, has delivered his opinion. The Advocate General reviewed the regulatory text as written and found that there was no legal justification for the 0.1% w/w concentration to be applied to an article that is make up of many components that are themselves articles. He recommended that the preliminary ruling by the ECJ should interpret the REACH Article 33 communication obligations and REACH Article 7(2) notification to ECHA should be based on SVHC content in each original article (component) in the product.
The Advocate General’s opinion states:
V – Conclusion
124. I therefore propose that the Court answer the request for a preliminary ruling as follows:
(1) If the other conditions laid down in Article 7(2) of the REACH Regulation are satisfied,
(a) the producer of an entire article consisting of component articles which, despite being integrated into an entire article, retain a shape, surface or design of their own, but were made or assembled by other producers, is required to notify ECHA if a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) is present in the entire article above a concentration of 0.1% weight by weight (w/w); and
(b) the importer of an entire article consisting of component articles which, despite being integrated into an entire article, retain a shape, surface or design of their own is required to notify ECHA if a substance meeting the criteria laid down in Article 57 and identified in accordance with Article 59(1) is present in a component article above a concentration of 0.1% weight by weight (w/w).
(2) The supplier of an entire article consisting of component articles which, despite being integrated into an entire article, retain a shape, surface or design of their own is required to provide information to recipients and, on request, consumers under Article 33 of the REACH Regulation on a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) if it is present in a component article above a concentration of 0.1% weight by weight (w/w) and relevant information is available to the supplier.
If the Advocate General’s opinion is accepted by the ECJ, the impact on industry will be significant. Even manufacturers that have been collecting SVHC information from suppliers may be impacted. The declaration of SVHC content in supplier parts is typically triggered based on 0.1% weight of the part provided by the supplier. If the supplier part is itself composed of multiple articles, an SVHC in a subpart that exceeds the 0.1% threshold may be masked.
Many manufacturers would need to develop new material and SVHC risk assessment processes and collect new material declarations from their suppliers. Contact ECD Compliance for additional information on the impact of this ruling or for assistance in developing conformity assessment procedures.
In our December post titled “Products Containing Mercury Regulations published in Canada,” we discussed the scope and general prohibitions and exemptions of the recently published Canadian “Products Containing Mercury Regulations (SOR/2014-254)“. In this second article on the Regulations, we examine some of the technical aspects of the Regulations including the maximum concentration limits and how these compare with the EU RoHS Directive and the EU Battery Directive.
Maximum Concentration Limit
The concentration of mercury allowed in the Canadian Regulations aligns with the EU RoHS restriction of 0.1% mercury in homogeneous materials. This allows EEE manufacturers and importers to leverage their conformity assessment procedures and to use existing supplier material declarations, test reports and other technical documentation (as per EN 50581).
Batteries
For batteries, the maximum concentration levels specify the same numerical percentage as in the EU Battery Directive; however, there are important differences in the basis of calculation. The Canadian mercury regulations reference the weight of mercury in homogeneous materials whereas the weight of the entire battery is the basis for calculation in the EU Battery Directive.
Canadian Products Containing Mercury Regulations
(l) a battery, other than a button cell battery, that has a mercury concentration of 0.0005% or less by weight in homogeneous materials; [are excluded]
EU Battery Directive
1.(a) all batteries or accumulators, whether or not incorporated into appliances, that contain more than 0,0005 % of mercury by weight; and [are prohibited]
As a result, the Canadian Regulations are much stricter than the EU Directive and battery manufacturers may have more difficulty in verifying conformity to this requirement.
Button Cell Batteries
Both Canadian and EU restrictions provide short-term allowances for mercury in button cell batteries that phase out in 2015. The Schedule in the Canadian Regulations provides an exemption for up to 25mg per button cell battery that expires on December 31, 2015. In the EU Battery Directive, the mercury prohibitions in button cell batteries are specified in Article 4, paragraph 2, allowing up to 2% mercury by weight of the battery:
4(2). The prohibition set out in paragraph 1(a) shall not apply to button cells with a mercury content of no more than 2 % by weight until 1 October 2015.
The Canadian Regulations set the long-term mercury threshold at 0.0005% based on the weight of each homogeneous material; whereas the EU Battery Directive sets the threshold based on the weight of the entire battery. The Canadian Regulations specify the concentration limits in subsections 2(m) and 2(n).
(m) beginning on January 1, 2016, a button cell battery that has a mercury concentration of 0.0005% or less by weight in homogeneous materials; [are excluded]
(n) from January 1, 2016 until December 31, 2019, a button cell battery that is incorporated into a medical device that is intended to remain in the body for at least 30 consecutive days; [are excluded]
The Canadian Regulations provide an exclusion for button cell batteries in implanted medical devices; whereas, the EU Battery Directive provides an broader exclusion to the mercury prohibition for all portable batteries in medical devices.
Testing
An earlier draft of the Canadian mercury regulations proposed mandatory testing of products containing mercury; however this requirement was removed in the final regulations (to the relief of manufacturers and importers).
Future Articles on the Mercury Regulations
In future articles examining the Products Containing Mercury Regulations, we will discuss
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.
The Products Containing Mercury Regulations (SOR/2014-254) is available from the Canada Gazette.
BNST Restriction in Canada and Impact on EEE Industry
The two-year transition period for the use of BNST (Benzenamine, N-phenyl-, Reaction Products with Styrene and 2,4,4-Trimethylpentene) as a substance in lubricants in products manufactured and imported into Canada is coming to an end on March 14, 2015. Products and parts containing lubricants with BNST may not be imported into Canada after this date. In general, all types of products containing such lubricants (including IT equipoment, consumer electronics and appliances) are impacted by the restriction. BNST has been used in lubricants in motors and other sliding mechanisms in many types of electrical and electronic products to improve performance and reliability. Additional information on the Regulations is provided below.
Many EEE manufacturers and suppliers have substituted the lubricants in their motors and sliding mechanisms or are in the final stages of qualifying new lubricants and ramping production of the redesigned parts and products. BNST provides benefits in the lubricant as a antioxidant, corrosion inhibitor, scavenger, and anti-scaling agent; therefore, eliminating the BNST can impact performance and long-term reliability which needs to be carefully assessed during substitution. Another commmon challenge in eliminating BNST has been in getting material declaration information from suppliers. Lubricant manufacturers often consider their formulations to be proprietary so information about constituents may be difficult to obtain.
As products transition to non-BNST lubricants, there will be logistical challenges as existing inventories are used up. Spare parts, which are also subject to the restrictions, are a particular challenge especially if the absense of BNST cannot be confirmed. It’s quite common that spare parts may no longer be in production and only available from existing inventory, Environment Canada suggested that manfuacturers and importers should use a conservative approach in such situations when it’s not possible to confirm that the product is BNST-free.
Permits for BNST
The Canadian Prohibition of Certain Toxic Substances Regulations, 2012 anticipated that it may not be possible to eliminate BNST for all products and it provides a mechanism for manufactuturers and importers to obtain permits for up to an additional three years if requirements specified in the Regulations are met. If your organization needs additional time to eliminate BNST or to confirm it’s absense, obtaining a permit for March 2015-March 2016 can help reduce business risk and avoid customer issues.
Permit applicatoins must be submitted by the Canadian manufacturer or importer. Permits are granted to the individual organizations that have submitted an application; therefore every organization that needs a permit must submit their own application or participate in a group permit application. The permit application includes requirements for information on BNST use and plans for phasing out the substance from your products. Environment Canada has stated that applications not meeting specific minimum requirements cannot be approved. ECD Compliance can assist your organization in assessing your situation against the permit requirements specified in the Regulations and to compile the application with the necessary information.
Background Information on the Regulations restricting BNST
BNST is restricted in Canada under the Prohibition of Certain Toxic Substances Regulations, 2012 beginning on March 14, 2013; however, a 2 year exemption for use of BNST as an additive in lubricants has extended the use period for applications in the EEE industry. The Prohibition Regulation is available for download from the Canada Gazette (part II). The regulation bans any intentional use; there is no numerical maximum concentration threshold.
The 2014 Going Green – Care Innovation conference took place November 17, 2014 to November 20, 2014. The conference is held once every four years and brings together a critical mass of environmental managers, engineers, corporate executives, government representatives and academic researchers that are focused on environmental performance and compliance. The conference provided the best opportunity in 2014 for insight to the upcoming direction and priorities related to environmental management and tools.
This year’s conference theme was “Towards a Resource Efficient Economy”. The most notable environmental focus areas during the conference were: compliance to environmental legislation, end of life management (recycling), circular economy, eco-design including material selection and efficiency, eco-labels and green procurement.
The opening keynote “Challenges in the field of Resource efficiency, Eco-innovation and Circular economy – for the EU and within the new Commission” was delivered by Luisa Prista from the European Commission. It was the first of several presentations that highlighted the Commission’s forward looking emphasis on increased use of recycled materials in products and increased material recycling (particularly scare and environmentally sensitive materials) to meet the demand.
Ms. Prista noted that the new European Commission president, Jean-Claude Juncker, has received letters from several corporate executives emphasizing the need to invest and develop the circular economy. Consequently, the Commission is launching several pilot projects to develop capability and prove concepts where there are currently gaps. As with other similar previous EU initiatives, the general expectation is that the pilot programs will eventually lead to regulations once the concepts are proven and systemic capability begins to emerge.
Opening Panel Discussion
During a subsequent panel discussion Ms. Prista and executives from Siemens Healthcare, Philips, Electrolux, and Toshiba identified several other urgent priorities including:
The IEC technical committee responsible for environmental standards for the EEE industry (IEC/TC111) recently updated its strategic roadmap to highlight areas that have emerging needs for international standardization. This roadmap provides EEE manufacturers and suppliers with insight into areas with emerging conformity requirements and where more well defined methods and/or guidance are needed. These requirements are typically driven by new regulations or divergent requirements that are causing trade barriers or supply chain issues.
Background
In 2004, the International Electrotechnical Commission (IEC) created technical committee TC111 to develop internationally recognized standards to assist manufacturers in complying with emerging environmental regulations of Electrical and Electronic Equipment (EEE) and other voluntary initiatives. The use of harmonized standards reduces uncertainty and risk for international trade and helps enable communication and consistency across a global supply chain. IEC standards are recognized by the World Trade Organization (WTO) and member countries of the WTO have agreed to harmonize their national standards with IEC standards wherever possible.
The Role of IEC Environmental Standards
Several of the IEC/TC111 standards are commonly used for assessing compliance to regulations such as EU RoHS (and other global RoHS regulations), EU REACH (declaration of SVHCs), WEEE, and emerging carbon footprint and environmental footprint regulations. The standards provide tools for material declaration, assessing restricted substance controls, analytical testing, environmentally conscious design, etc.
For a list of all IEC/TC111 published standards and standards under development, see the RoHS news post IEC/TC111 – Environmental standardization for electrical and electronic products and systems.
IEC is often not the first standards organization to create a standard on a specific topic, but it can help harmonize approaches across national or regional standards.
What’s New in the Revised Roadmap
The standardization topics in the roadmap are organized into seven categories:
The IEC/TC111 roadmap is included in the Strategic Business Plan (SBP) which may be downloaded from the IEC website.
The standardization topics under Environmental Product Declarations (EPD) and Eco labels are newly added and have been gaining considerable interest.
Environmental Performance Criteria
The standardization area of “Environmental Performance Criteria” is in response to the plethora of eco label criteria emerging around the world. Environmental labelling programs and registries specify criteria for assessing environmental performance of a variety of electrical and electronic products. Programs exist for computers, monitors, imaging equipment, TVs, tablets, phones, and many other EEE products. These programs give purchasers an easy, predefined mechanism to set green procurement requirements. However, many of the environmental labelling programs have overlapping scope and sometimes establish inconsistent (or even incompatible) environmental criteria. Inconsistencies can create significant challenges for manufacturers and suppliers who try to optimize environmental performance of products and manufacturing operations simultaneously for all markets around the world.
An IEC International Standard on Environmental Performance Criteria would enable users, ecolabelling bodies and registries, manufacturers and supplies (from around the world) to leverage and build upon a harmonized set of baseline environmental performance criteria. A harmonized set of baseline criteria provides benefits to all stakeholders.
Product Category Rules (PCR) for Life Cycle Assessment (LCA)
An International standard for EEE product category rules has also been gaining interest. Conducting LCAs that provide meaningful information is challenging for the electronics industry. With a complex supply chain and significant impacts from raw material extraction and part manufacturing in several environmental impact categories, the assumptions made with respect to setting scope, boundary conditions, cut-off rules, product use, electricity generation, and the use of primary vs. secondary data are very important in the usefulness and comparability of the results. This is particularly important as governments around the world tighten rules to avoid green washing with environment claims.
A baseline set of internationally harmonized PCR across the electrotechnical industry can provide a significant opportunity for the industry to better utilize the results of a LCA. The International Standard may also provide rules and guidance for the development of supplemental sector specific PCR that may be needed for specific types of products. A baseline PCR across the entire EEE industry will also provide consistency for the supply chain which may be providing parts and materials to a number of different sectors.
ECD Compliance uses published and emerging International Standards to support manufacturers and suppliers in meeting current and future product environmental compliance and sustainability requirements. We can also provide a window for your organization into emerging environmental standards. For additional information, contact ECD Compliance.
Future posts will examine some of these standardization areas in more detail.
The European Commission moved forward with its update of the List of Restricted Substances in the RoHS Directive, Annex II. The Commission has notified the World Trade Organization that the four phthalate substances will be added to the RoHS substance restrictions. The restrictions take effect beginning in July 22, 2019 for all EEE except category 8 (medical devices) and category 9 (monitoring and control instruments) which will have an additional 2 years and need to comply by July 22, 2021. This provides most EEE manufacturers and the global supply chain with four and a half years to prepare.
| Substance Name | CAS Number | Maximum Concentration in homogeneous material |
|---|---|---|
| Bis(2-ethylhexyl) phthalate (DEHP) | 117-81-7 | 0.1% |
| Benzyl butyl phthalate (BBP) | 85-68-7 | 0.1% |
| Dibutyl phthalate (DBP) | 84-74-2 | 0.1% |
| Diisobutyl phthalate (DIBP) | 84-69-5 | 0.1% |
The maximum concentration value for the phthalates will be 0.1% w/w in homogeneous material.
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.
Additional information on RoHS 2 compliance and RoHS 2 Technical Documentation is available. ECD Compliance provides services to assess your product requirements for compliance to environmental regulations and to implement compliance procedures.
The notified Directive is available on the WTO website.
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