California – OEHHA Proposes New Proposition 65 Warning Labels

The California Office of Environmental Health Hazard Assessment (OEHHA) has issued a notice proposing changes to California Proposition 65 with the warning labels and other information provided to consumers. The new regulatory text, which is titled “Clear and Reasonable Warning”, is available on the OEHHA website. A public hearing on the proposed changes will be held on March 25, 2015.

Proposition 65 requires manufacturers and importers to provide a warning to purchasers when a user can potentially be exposed to any of the listed substances. Although over 900 substances are included in Proposition 65, only about a dozen of them (including lead, cadmium, and hexavalent chromium) are frequently litigated. When such a substance is present, organizations have typically labelled the product with the vague statement “This product contains chemicals known to the State of California to cause cancer and birth defects or other reproductive harm”. Under the revised regulation, more specific information about the substance and the risk it poses to the user must be provided.

EnergyStar – Update on Large Network Equipment (LNE) Test Method

For the emerging large network equipment (LNE) Energy Star specification , the U.S. EPA and DOE are requesting stakeholders to provide comments and proposals on two test method issues that were discussed at the January 30th, 2015 meeting: the use of the snaked traffic topology, and the ambient temperature requirement. Additional information on the issues and the request for proposals is provided in the request letter posted on the Energy Star LNE website.

The U.S. EPA will also be hosting a series of working group sessions to discuss outstanding issues related to developing an LNE specification.

On January 30th, 2015, the U.S. Environment Protection agency (EPA) and the U.S. Department of Energy (DOE) hosted a meeting to discuss the ENERGY STAR® Large Network Equipment (LNE) program. In acknowledgement of the complexity of LNE products, during that call, EPA proposed hosting a series of phone – based working sessions over the coming months to discuss key outstanding issues. With this letter, EPA is outlining the topics and timing for those conference calls. EPA welcomes stakeholder feedback on additional topics for discussing during the working calls.

 

California – 14 substances added to California Proposition 65

The California Office of Environmental Health Hazard Assessment (OEHHA) added 14 substances to the California Prop 65 list of chemicals known to the State to cause cancer. The newly added substances include:

  • the substance group dibenzanthracenes and the individual substances making up the group that were not already listed.
  • N- nitrosomethyl-n-alkylamines with alkyl chain lengths of 3 to 12 and 14carbons (The N-nitrosomethyl-n-alkylamines with 1 and 2 carbons were already listed in prop 65.)

Table 4: Fourteen (14) Substances Added to California Proposition 65

ChemicalCAS No.Toxicological Endpoints
Dibenzanthracenes---cancer
Dibenz[ a,c ]anthracene215-58-7cancer
Dibenz[ a,j ]anthracene224-41-9cancer
N-Nitrosomethyl- n -propylaminecancer
N-Nitrosomethyl- n -butylaminecancer
N-Nitrosomethyl- n -pentylaminecancer
N-Nitrosomethyl- n -hexylaminecancer
N-Nitrosomethyl- n -heptylaminecancer
N-Nitrosomethyl- n -octylamine cancer
N-Nitrosomethyl- n -nonylaminecancer
N-Nitrosomethyl- n -decylaminecancer
N-Nitrosomethyl- n -undecylaminecancer
N-Nitrosomethyl- n -dodecylaminecancer
N-Nitrosomethyl- n -tetradecylaminecancer

Organizations have 12 months to comply with the prop 65 warning requirements once a substance is added to the list; therefore products that are an exposure risk for any of these substances must be labelled by December 26, 2015.

 

 

California – Sacramento Judge Rejects ACC’s Bid to Overturn BPA Listing

BPA (Bisphenol-A) was added to the California Prop 65 list of substances. It is commonly used as an ingredient in the manufacture of polycarbonate plastic. If there are any residual unreacted quantities of BPA left in a plastic that could be an exposure risk to users, the Prop 65 warning requirement may apply.

The American Chemistry Council (ACC) has been fighting the listing of Bisphenol A (BPA) as a Proposition 65 reproductive toxicant since the California OEHHA (Office of Environmental Health Hazard Assessment)  first listed the substance in 2013 using a back-door mechanism. However, ACC received a setback in late December when a Sacramento Superior Court Judge ruled that OEHHA did not abuse its discretion when it listed BPA. The judge rejected the lawsuit brought on by the ACC to reverse the listing of BPA.

The state’s Developmental and Reproductive Toxicant Identification Committee (DART-IC) had declined to list BPA in July 2009 after reviewing relevant scientific literature. OEHHA subsequently listed BPA anyway using the authoritative body listing mechanism. It was this alternative listing mechanism that the ACC was challenging.

 

 

Canadian Mercury Regulations to Impose Tight Restrictions on Mercury in Batteries

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

  • the mercury exemptions provided by the Regulations and how the exemptions compare to those provided in the EU RoHS Directive
  • what if your product requires mercury, but there is no exemption listed — how manufacturers and importers may apply for a temporary permit
  • marking, labeling and reporting requirements for products that contain mercury above the maximum concentration limit
  • accreditation of test labs

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 Lubricants Takes Effect in Two Months

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.

EEE Environmental Compliance Challenges and Future Directions Discussed at Going Green – Care Innovation Conference

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:

  •  Supply chain information on material content
  • Collaboration in the supply chain
  • Better education and understanding
  • Common tools
  • Harmonization in regulations
  • Better understanding of regulations

Strategic Roadmap for International Environmental Standards provides Insight for Manufacturers

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:

  • Chemical Substance
    • Standardized substance testing methodologies
    • Maintenance and improvement activities related to material declaration
    • Demonstration of due diligence for substance restriction conformity.
    • Definition of “low halogen” materials used in electrotechnical products.
  • Environmental Conscious Design (ECD)
    • Environmentally Conscious Design (the intention is to progress IEC 62430 to a dual logo ISO/IEC standard that is applicable to all products)
    • Product Category Rules (for full LCA of multiple environmental impacts)
  • Recovery/Recycling/Reuse
    • Treatment, collection and logistics of Waste Electrical and Electronic Equipment (WEEE)
  • Greenhouse Gases (GHG)
    • Methodologies and rules for Carbon footprint calculation of EEE
    • Electrotechnical specific secondary data
  • Resource efficiency
  • SMART Cities
  • Environmental Product Declarations and Eco labels
    • Environmental Performance Criteria that may be used in eco labels used for green electronics purchasing
    • Product Category Rules (for full LCA of multiple environmental impacts)

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.

 

 

New Substances for RoHS Directive Notified to WTO

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.

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%

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.

Six Substances added to REACH SVHC Candidate List – December 17, 2014

The European Chemical Agency (ECHA) added six additional substances to the SVHC Candidate List on December 17, 2014. This brings the total number of substances on the Candidate List to 161. Manufacturers, importers and distributors have communication obligations in the EU if any of their products contain one of these substances above the reporting threshold of 0.1% w/w.

REACH SVHCs Added to Candidate List on December 17, 2014

Substance_NameEC_NumberCAS_NumberReason_for_proposing
Cadmium fluoride232-222-07790-79-6Carcinogenic (Article 57 a);
Mutagenic (Article 57 b);
Toxic for Reproduction (Article 57 c);
Equivalent level of concern having probable serious effects to human health (Article 57 f)
Cadmium sulphate233-331-610124-36-4; 31119-53-6Carcinogenic (Article 57 a);
Mutagenic (article 57 b);
Toxic for Reproduction (Article 57 c);
Equivalent level of concern having probable serious effects to human health (Article 57 f)
2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320)223-346-63846-71-7PBT (Article 57 d);
vPvB (Article 57 e)
2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328)247-384-825973-55-1PBT (Article 57 d);
vPvB (Article 57 e)
2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE)239-622-415571-58-1Toxic for Reproduction (Article 57 c)
Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE and MOTE)--Toxic for Reproduction (Article 57 c)

In addition to the six new entries on the Candidate List, the existing entry Bis(2-ethylhexyl) phthalate (DEHP) was updated based on “Equivalent level of concern having probable serious effects to the environment (Article 57 f)”

The REACH Candidate List SVHCs are available on the ECHA website. Additional information on the REACH SVHC obligations for organizations that manufacture or ship products into the EU are available on the ECD Compliance REACH web page.