Category Archives: Regulations

RoHS Enforcement – Feb 2015

Information on several EU RoHS non-conformity issues have come to light over the past couple months.

Slovenia identified two RoHS non-compliant products on the EU RAPEX rapid alert system. European countries use the RAPEX system to facilitate the rapid exchange of information between Member States and the Commission about product non-conformities.

  1. Product: HAND BLENDER; Brand: SIMPEX; Name: Stabmixer; Risk: Certain solders on PCB and on motor contain lead (measured value up to 80.0%). The product does not comply with the Directive 2011/65/EC (RoHS 2) on the restriction of the use of certain hazardous substances in electric and electronic equipment.
  2. Product: AVIA Clock radio with alarm; Risk: The black plastic of the antenna wire, the orange plastic of the capacitor and brass component contain lead (measured value up to 0.19%), while some solders on PCB and brass component contain cadmium (measured value up to 0.071%). The product does not comply with the Directive 2011/65/EC (RoHS 2) on the restriction of the use of certain hazardous substances in electric and electronic equipment.

The UK RoHS enforcement authority, the National Measurements Office (NMO), published the results of a RoHS and Battery Directive compliance study on EEE toys. The report, released on February 20, 2015, highlights that 40% of the 15 products assessed had failed compliance for substance content, marking or batteries. The study focused on higher priced toys that ranged from £30 to over £100. The toys included: Educational Toys (x3), Sports and Outdoor Toys (x3), Musical Toys (x3), 0-3 Years Toys (x3), and 3+ Years Toys (x3).

Prior to testing, the NMO assessed each of the products and companies in terms of risk (previous history of company, product risk, subjectivity, size of company and market reach). The NMO is trying to develop a comprehensive risk assessment model and will use the results to help refine the model.

The report states that 2 out of 3 of the educational toys and 2 out of 3 of the 0-3 years toys were non-compliant. Of particular concern were riding toys of which 3 out of a total of 6 were non-compliant across the product categories.

In usual NMO fashion, none of the brand names or retailers/importers were identified in the report. The report indicates that investigations were opened into the non-compliant products and have progressed to what the NMO refers to as “appropriate outcomes”.

Conflict Minerals Reports due June 1, 2015 – Apple First to File

For those companies that are required to disclose their conflict minerals status under U.S. SEC rules, the 2014 Conflict Minerals disclosure (SEC Form SD) and conflict minerals report are due on Monday June 1, 2015.

Apple was the first company to file their 2014 conflict minerals report, several months ahead of the deadline. In being first, the Apple sets the bar before some other U.S. electronics manufacturers have even started writing their report. To no one’s surprise, Apple declared that the use of conflict minerals within their supply chain to be conflict indeterminate – this is the last of two years when they may claim this status.

In the conflict minerals report, Apple explains the steps that they have taken and the progress that they have made towards eliminating conflict minerals that directly or indirectly fund armed groups in the DRC. Apple explains that its Conflict Minerals program is driving its supply chain to use only smelters and refiners that have been certified to the Conflict-Free Sourcing Initiative’s Conflict-Free Smelter Program (CFSP). The report provides statistics that 199 of 225 smelters and refiners in its supply chain have been verified as conflict free or are in the audit process for certification. This is more than double the number of smelters and refiners identified in 2013.

The main body of the Apple Conflict Minerals Report is less than 10 pages in length. An additional 10 pages is provided for a table (Annex I) listing all of the smelters and refiners that were identified in Apple’s supply chain.

SVHC Threshold based on Components – ECJ Takes First Step in Ruling

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.

 

Argentina – Proposed WEEE Bill Includes RoHS Restrictions

Argentina proposed a waste electronics (WEEE) bill in November 2014 that includes RoHS substance restrictions that would come into effect 2 years after the regulation enters into force. The bill, 9042-D-2014 titled “Management of Waste Electrical and Electronic Equipment”, would cover all 10 categories of EEE products as specified in the EU WEEE Directive and also batteries.

The proposed substance restrictions include the same six substances controlled by the EU’s RoHS Directive – lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE). Products containing these substances would be banned from sale in the Argentine market.

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.

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.

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.