Category Archives: newsletter

used to tag posts for specific newsletter

Canada – Proposes Amendments to Mercury Regulation

On February 1, 2018, Environment and Climate Change Canada opened a public consultation on proposed changes to the Products Containing Mercury Regulations.

The amendments are organized into nine sub-sections 3.1 through 3.9 as shown in Table 3. The public consultation is open until April 2, 2018.  The “Consultation document: Proposed amendments to the Products Containing Mercury Regulations” is available on the Environment Canada website[1].

Table 3: Amendments to the Canadian Mercury Regulation

TitleSummary of Changes
3.1 Alignment with the requirements under the Minamata ConventionReduced levels of mercury in exemptions for fluorescent lamp to comply with Minamata convention
3.2 Amendments to further align with initiatives abroadAlignment of exemptions for mercury in lamps with EU RoHS Directive

Removal of exemption for mercury in compact fluorescent lamps (CFLs) by 2023 (this will essentially ban CFLs from sale in Canada)
3.3 Amendments to the automobile headlamps exemption (item 9 of the schedule)Removal of exemption of mercury in automobile headlamps by 2024
3.4 Amendments to the non-applications (section 2 of the regulations)Clarification that pest control lamps are included in the restrictions

Exclusion of import of products for own personal use
3.5 Adjustments to certain elements of the labelling requirements (sections 8 and 9 of the regulations)Clarification to labelling requirements, including

- use of both official languages
- Hg symbol
- New requirement to identify component containing mercury
3.6 Amendments to testing requirements to broaden the accreditation bodies recognized under the regulations (section 10 of the regulations)Broaden accreditation bodies for test laboratories
3.7 Amendments to the reporting requirements (section 12 of the regulations)Changes to reporting requirements with Canadian address and export quantity
3.8 Amendments to the record keeping requirements (sections 14 to 16 of the regulations)New requirements for record keeping to track quantity of products exported and to allow electronic records
3.9 Adjustments to clarify certain exemptions in the schedule of the regulationsClarification of exemptions for lab test reference materials and replacement parts.

[1] Proposed amendments to mercury regulation, https://www.canada.ca/en/environment-climate-change/services/canadian-environmental-protection-act-registry/products-mercury-regulations-proposed-amendments.html

EU – Results of ECHA Enforcement Project

The report on the REF-4 ECHA Enforcement project on restrictions was posted on the ECHA website[1].  The enforcement was conducted by inspectors in 27 European countries on 5,625 products, including 4,599 articles.  Overall, 18% of the products were found to not comply with substance restrictions.

The substances that were most frequently found in products above allowed thresholds were phthalates, cadmium, asbestos fibres, Polycyclic aromatic hydrocarbons (PAH), and hexavalent chromium.   Although EEE products were not specifically targeted in this enforcement project, the results indicate that there is still a significant non-compliance in the EU to substance restrictions and that authorities feel that additional actions need to be taken to reduce non-compliance

Recommendations arising from the project included:

  • A need for more enforcement targeting high-risk areas;
  • A need for companies to perform more due diligence in conformity assurance, especially analytical testing;
  • Organize national and EU-wide campaigns to raise awareness of the restrictions

Increased awareness of the issues in the EU could lead to importers and distributors requesting more information from product manufacturers.

The report provided a series of recommendations to companies, including the following excerpt:

Companies placing chemicals or articles on the market that may contain substances restricted in REACH Annex XVII should pay a lot of attention to making sure that they know their products and their own suppliers. This may also need proactive testing of the products and agreements between suppliers to ensure that the chemical composition of the products in the supply chain is in accordance with the chemicals legislation.

[1] REACH Enforcement Project, https://echa.europa.eu/documents/10162/13577/ref_4_report_en.pdf/b53f5cd9-64a4-c120-1953-e9e176b9c282

Sweden – Reports 16 Electronics Importers for Prosecution

Following an enforcement review of 19 importers (mostly of electronics products), the Swedish Chemicals Agency (KEMI) has reported 16 of the companies to prosecutors due to violations of hazardous chemicals in products.

KEMI checked a total of 261 products of which 23% were found to contain at least one restricted substance above threshold. In a press release[1], they stated that the most common non-compliance was the use of lead in solder in electronics. The second most common violation was the use of SCCP (short-chain chlorinated paraffins) in plastics. KEMI also expressed concern that manufacturers and importers may not be putting enough priority and effort into compliance to substance restrictions.

[1] KEMI press release (in Swedish), http://news.cision.com/se/kemikalieinspektionen/r/kemikalieinspektionen-har-anmalt-16-foretag-till-aklagare,c2449637

EU – Seven Substances Added to REACH Candidate List

In late December the European Chemical Agency (ECHA) announced that the Member State Committee approved seven substances of very high concern (SVHC) for addition to the REACH Candidate List and an update to the bisphenol A (BPA) entry as an Endocrine Disruptor. ECHA also indicated that the Candidate List update would be delayed from December to mid-January.

The Candidate List was subsequently updated on January 15, 2018. The new SVHCs and examples of EEE applications (identified by the IEC 62474 validation team) are listed in Table 1.

Table 1: SVHCs Added to REACH Candidate List (January 2018)

Substance NameDescriptionCAS no.Examples of EEE Applications
Benz[a]anthracene56-55-3, 1718-53-2Impurities in carbon black, which is used as coloring agent in plastics and softener in rubbers
Cadmium carbonate513-78-0n/a
Cadmium hydroxide21041-95-2It is generated in the anodes of nickel-cadmium and silver-cadmium batteries during the discharge
Cadmium nitrate10022-68-1, 10325-94-7n/a
Chrysene218-01-9, 1719-03-5Impurities in carbon black, which is used as coloring agent in plastics and softener in rubbers
Dodecachloropentacyclo [12.2.1.16,9.02,13.05,10] octadeca-7,15-diene (“Dechlorane Plus”™)covering any of its individual anti- and syn-isomers or any combination thereof-Flame retardant for electric wire and cable covering material
Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP)with ≥0.1% w/w 4-heptylphenol, branched and linear (4-HPbl)-n/a

Impact on EEE Manufacturers

Manufacturers, importers and distributors have immediate REACH Article 33 obligations to disclose information about any of these SVHCs in their products if above the threshold of 0.1% in an article. Four of the SVHCs are considered to be possible constituents of EEE products (as indicated in the table).

The other three SVHCs are unlikely to be present.  They are unintentional by-products of manufacturing and/or use. The Cadmium hydroxide would only be present above 0.1% if the product contains a certain type of battery which has gone through multiple charge-discharge cycles.

EU – Germany and Sweden Propose Restriction on Fluorinated Substances

German and Swedish agencies have submitted a joint proposal to ECHA to restrict six “per- and polyfluorinated substances” (PFASs) before they see wide-spread use as alternatives to other fluorinated substances such as perfluorooctanoic acid (PFOA) that have broad upcoming restrictions.

The proposal directly concerns perfluoronic acid (PFNA), perfluorodecanoic acid (PFDA), Perfluoroundecanoic acid (PFUnDA), perfluorododecanoic acid (PFDoDA), perfluoroethridecanoic acid (PFTrDA) and perfluorotetradecanoic acid (PFTeDA). However, several other fluorinated materials are also affected because they can break down to create one of these six substances. KEMI, the Swedish Chemicals Agency, estimates that the ban would affect a total of 200 highly fluorinated substances.

The proposal is available on the ECHA website in the section on “Submitted restrictions under consideration”[1]. The proposed scope of the restriction, as listed on the website, is:

  1. Shall not be manufactured, used or placed on the market
  • as substances,
  • as constituents of other substances,
  • in a mixture
  1.   Articles or any parts thereof containing one of the substances shall not be placed on the market.

The proposal is currently open to public consultation until June 20, 2018.

[1] EU PFAS restriction proposal, https://echa.europa.eu/restrictions-under-consideration/-/substance-rev/18115/term

One SVHC Added to REACH Candidate List – July 7, 2017

The European Chemical Agency (ECHA), on July 7, 2017, added one new SVHC substance group to the EU REACH Candidate List. The substance is listed in the table below. The IEC 62474 Validation Team has reviewed the SVHC for potential uses in EEE and has concluded that the substance group could be a constituent above the 0.1% threshold; however, no evidence was found that it is commonly used at the present time.  Additional information, including a list of reference substances in the group will be provided in the July monthly report.

The full REACH Candidate List is available at: http://echa.europa.eu/candidate-list-table .

Substance nameEC numberCAS numberExamples of use(s) in EEE
Perfluorohexane-1-sulfonic acid and its salts (PFHxS)--Impurity in production of PFOS and alternative for PFOS, a surfactant which can be found in protective coatings and adhesives which are resistant to water, dirt, oils etc.

In addition to adding the new SVHC, the hazard properties of BPA and four phthalate substances (DEHP, BBP, DBP, and DIBP) were updated on the candidate list to indicate endocrine disrupting properties.  These SVHCs were already on the Candidate List so there is no immediate impact on EEE manufacturers that import products into the EU.

EU – Scope Changes to the EU RoHS Directive

The European Commission has drafted an amendment to the EU RoHS Directive (2011/65/EU) updating the scope of the Directive to fix the various issues that have been identified since RoHS 2 was published in 2011.  This includes the provision in the Directive that prevents used medical devices, control and monitoring instruments and other EEE that did comply with the substance restrictions from being resold after July 2019.

The amendment will make the following changes to the Directive:

      • The July 2019 limitation on re-selling non-compliant re-used EEE (Article 2, paragraph 2) is deleted
      • An exclusion is added for Pipe organs
      • The definition of “non-road mobile machinery made available exclusively for professional use” is updated.
      • The requirement for category 11 “other EEE” to comply with the substance restrictions starting on 22 July 2019 is added to the end of paragraph 3 of Article 4. The revised paragraph will read:
        • 3. Paragraph 1 shall apply to medical devices and monitoring and control instruments which are placed on the market from 22 July 2014, to in vitro diagnostic medical devices which are placed on the market from 22 July 2016, to industrial monitoring and control instruments which are placed on the market from 22 July 2017 and to all other EEE that was outside the scope of Directive 2002/95/EC which is placed on the market from 22 July 2019.;
  • Category 11 “other EEE” put on the EU market before 22 July 2019 was added to the list of product categories that may be repaired/refurbished with non-compliant spare parts and cables (i.e., repair as originally sold).
  • For category 11 “other EEE”, the original Annex III exemptions are valid until 5 years from 22 July 2019
  • The statement “The Commission shall decide on an application for renewal of an exemption no later than 6 months before the expiry date of the existing exemption unless specific circumstances justify other deadlines.” In Article 5(5) is deleted.

The amendment is not official until it is published in the Official Journal of the EU.

IEEE 1680.1 – Revised Ecolabel Standard for Computers and Monitors

The draft for the revised IEEE 1680.1 “Standard for Environmental Assessment of Personal Computer Products, Including Notebook Personal Computers, Desktop Personal Computers, Slate/Tablets, Small Scale Servers, Signage Displays and Personal Computer Monitors” was completed by the Work Group in February 2017 and will be posted for balloting March 28, 2017.

The revised draft expands the scope of the standard to cover tablets and signage displays in addition to computers and monitors.  It also expands the scope of assessment criteria to include corporate social responsibility (CSR) and criteria that reach deep into the supply chain.

Anyone that is interested in voting/commenting on the ballot must register their interest in the IEEE Standards Association (SA) system by no later than Friday, March 24th.

Contact ECD Compliance for support on conformity to the IEEE 1680.X series of environmental assessment standards.

EU – Revised Draft for SVHCs in Articles

In early February 2017, ECHA posted a revised draft of its “Guidance on requirements for substances in articles“. The previous draft guidance caught several industry sectors by surprise when it drew the line for first article at a very early stage in the manufacturing of complex products. ECD Compliance has reviewed the latest draft guidance and found that not much has changed with respect to where EEE manufacturers will be expected to draw the line and their responsibilities.  Some sections have been moved around within the document and detailed calculations have been deleted from some examples; but the examples themselves are still there and the implications remain intact.

What Has Changed

ECHA moved some content from Appendices to the main body of the document and vice versa.  In general, the main body of the document provides specific guidance and calculation methods that manufacturers and importers are expected to use to comply with the regulation.  Whereas. Appendices provide some sector specific examples and other information that could be beneficial to applying the requirements to specific situations. By moving content around, ECHA is fine tuning what it considers as necessary information for meeting the regulatory requirements.

A new subsection on “How to determine the concentration and the tonnage of a Candidate List substance in articles (communication and notification obligations)” was created in the main body of the document as subsection 3.2.3 based on the previous content of Appendices 3 and 4.  This subsection provides basic examples of SVHC calculation in articles made (1) directly from a mixture; (2) by apply a mixture to an existing article; (3) combining two articles; and (4) by coating a simple article or complex object. The implications and calculation methods are the same as the previous guidance document.

The subsection on “5.1 Information via the supply chain” has been expanded to include “5.1.2 Voluntary information tools to exchange information on articles” and “5.1.4 Evaluation of information received from suppliers“. The new content suggests that the communication of materials declaration information down the supply chain may be an effective tool for collecting information needed to assess SVHC obligations and is supported by many IT systems. It also suggests that information such as Certificates of Compliance and Lab test reports need to diligently assessed to determine what information they are providing and their validity.  This is very similar to the factors that the EEE manufacturers have learned to consider for RoHS compliance.

The Capacitor Example

When the European Court of Justice ruling on first article came out in September 2015, the EEE industry had expected ECHA to find a practical interpretation of first article by stating that a component (such as a capacitor)  on a PCBA could be treated as a first article. However, when the previous draft guidance came out last year, ECHA provided a detailed example of how an electrolytic capacitor was made up of articles that had to be individually considered against the SVHC threshold.

The revised guidance still includes the PCBA example and still implies that the capacitor is made up of individual articles, but some of the details have been deleted or simplified, the tone has been softened and the guidance acknowledges that rules of thumb may need to be used if incomplete information isn’t available from the supply chain.  Given the deleted details, ECHA has added the note: “This example addresses only the main issues to be considered; it does not intend to be exhaustive.”

The revised guidance document still clearly implies that a capacitor is composed of multiple articles. In fact, other parts of the guidance document, provide examples of borderline cases where a wire is described as an article.

The PCBA example concludes by stating that the analysis that is described for the capacitor is also applicable to any other complex object (e.g. transistor, microprocessor, fan) in the printed circuit board.

Other Useful Information in the Guidance

The draft guidance includes a number of examples that illustrate how an article is to be interpreted as: “an object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition.”. The definition of ‘function’ plays a significant role in the interpretation:

Although the draft guidance warns against making broad conclusions and suggests that each situation must be uniquely assessed, it also implies that an object as simple and fundamental as a thread used to make a fabric may meet the definition of an article. In several of the examples, the first article equates to a homogeneous material in circumstances where the shape has been deliberately created.

USA – Issues Nano Reporting Rule

he U.S. Environmental Protection Agency (EPA) published a rule requiring one-time reporting and recordkeeping requirements for nanoscale chemical substances. The reporting requirements will take effect starting May 12, 2017. The rule is available on the US Federal Register[1].

 

[1] EPA nanomaterial rule, https://www.federalregister.gov/documents/2017/01/12/2017-00052/chemical-substances-when-manufactured-or-processed-as-nanoscale-materials-tsca-reporting-and