IEC 62474 – Updated to Align with “Article” Interpretation for SVHCs

The IEC 62474 Declarable Substance List (DSL) was updated (D11.00) on March 28, 2016 to reflect the September 2015 European Court of Justice (ECJ) interpretation of the term “article”. The ECJ ruling is important for OEMS and suppliers in determining whether a REACH Candidate List SVHC is above the 0.1 mass% threshold that triggers communication and notification obligations under the EU REACH regulation.

With the ECJ ruling addressed, the new “ReportingLevel” field, which was recently added to the database, was populated.  The ReportingLevel field is intended to simplify for users the interpretation of the more complex reporting thresholds. Some of the reporting thresholds are difficult to interpret because of how they are written in the regulation.

There were a couple of additional minor changes were made to declarable substance groups and reference substances.

A more comprehensive summary is provided in our IEC 62474 blog.

Contact us for additional information on how ECD Compliance can assist your organization in using IEC 62474 for environmental compliance.

 

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

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

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

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

The Regulation

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

Definition of Electrical and Electronic Products

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

Hazardous Substances

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

Labelling and Hazardous Substance Disclosure

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

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

Substance Restrictions

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

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

End of Life Information and Design for Environment

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

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

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

Product Packaging

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

Exported Products

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

Impact on Manufacturers

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

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

 

UAE Updates RoHS Proposal to Address Phthalates

The United Arab Emirates has updated its RoHS proposal to align the timing of the phthalate restrictions with those of the EU RoHS Directive. The original proposal had the phthalate restrictions coming into effect at the same time as all other substance restrictions.Picture1

The restriction on the four phthalate substances is now specified in the proposal (clause 9.1.2) as coming into effect on July 22, 2019 for most EEE products (see text box).  The reference to clause 9.1.1 is with respect to medical devices and monitoring and control instruments.

In a subsequent comment from the EU, the EU reiterated additional concerns about the mechanism by which exemptions were being implemented and maintained.

EU – Consultation on Four Substance Proposed for REACH Candidate List

The EU has launched a public consultation on four substances (see Table 1) that have been proposed for addition as SVHCs to the REACH Candidate List.  The validation team for IEC 62474 is currently screening the four substances for potential applications in the electronic industry.  One of the substances, Dicyclohexyl phthalate (DCHP), was also proposed in the previous REACH consultation last fall, but was subsequently withdrawn by Sweden (the proponent). It’s now been re-submitted.

Table 1: Four Substances for Public Consultation

Substance_NameEC numberCAS number
(±)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptane-2-one (4-methylbenzylidene camphor)253-242-636861-47-9
1,7,7-trimethyl-3-(phenylmethylene)bicyclo[2.2.1]heptan-2-one (3-benzylidene camphor)239-139-915087-24-8
Benzo[def]chrysene (Benzo[a]pyrene)200-028-550-32-8
Dicyclohexyl phthalate (DCHP)201-545-984-61-7

The deadline for submitting comments is April 14, 2016. The consultation is posted on the ECHA website.

Proposed Scope Changes to EU RoHS

Shortly after the EU RoHS 2 Directive was published in 2011, a few concerns were identified about some of the wording in RoHS 2 and its interpretation.

Some manufacturers in the medical devices industry raised a concern that the use of the term “made available on the market until 22 July 2019” in referring to substance restrictions for products newly in scope of RoHS 2 will prevent those products from being refurbished and then resold after 2019. The medical equipment industry is especially impacted in that it frequently refurbishes its products and then re-sells to health care providers that can’t afford the new equipment.

The language in RoHS 2 also missed an exclusion for spare parts for products that are newly in scope (other than medical devices and monitoring and control instruments).

The European Commission plans to publish an amendment to the scope of the RoHS 2 Directive to address the issues. In an Inception Impact Assessment , the Commission indicates that its preferred option is to:

  • remove the “made available” clause and simply provide a requirement that all other EEE that did not previously need to be compliant, must be compliant by 22 July 2019.
  • Add in a spare parts exclusion for such products.

In this way there are no limitations in refurbishing products or in repairing products that were legally put on the market.

California – Approves New Prop 65 Website

California’s Office of Environmental Health Hazard Assessment (OEHHA) has approved the adoption of the “Lead Agency Website” regulation (Section 25205). The regulation requires OEHHA to create a website providing information to the public on exposure to chemicals that require warning disclosure under Proposition 65. The regulation has been very controversial with industry, including several trade groups.

Under the Regulation, which takes effect on 1 April, 2016, a manufacturer, producer, distributor or importer of a product giving a Prop 65 warning will have to provide, within 90 days of the agency’s request:

  • the name of the listed chemical(s) for which warning is given;
  • the location of the chemical(s) in products that require warning under Prop 65;
  • the concentration of the chemical(s) in these final products;
  • anticipated routes or pathways of exposure to listed chemicals; and
  • estimated levels of exposure to the chemical(s).

The regulation and additional information is available on the OEHHA website.

EU – Commission Proposes New and Revised RoHS Exemptions

The European Commission has sent out WTO TBT notices for two RoHS exemptions.

The first exemptions is a new exemption for Cadmium anodes in Hersch cells

In Annex IV to Directive 2011/65/EU, the following point 43 is added:

“43. Cadmium anodes in Hersch cells for oxygen sensors used in industrial monitoring and control instruments, where sensitivity below 10 ppm is required. Expires on [OP, please insert, as concrete date, 7 years after the date of entry into force of this directive].,

The second exemption narrows the scope of the existing exemption Annex IV(26):

In Annex IV, point 26 is replaced by the following:

’26. Lead in the following applications that are used durably at a temperature below –20°C under normal operating and storage conditions:

– (a) solders on printed circuit boards;
– (b) termination coatings of electrical and electronic components and coatings of
printed circuit boards;
– (c) solders for connecting wires and cables;
– (d) solders connecting transducers and sensors.

Lead in solders of electrical connections to temperature measurement sensors in devices which are designed to be used periodically at temperatures below –150°C. These exemptions expire on 30 June 2021.’

China – Guidelines on Conflict Minerals

On December 2, 2015, China published guidelines for responsible mineral supply chains. The guidelines were developed in cooperation between the China Chamber of Commerce of Metals, Minerals and Chemicals Importers & Exporters (CCCMC) and the OECD. The guidelines align with the OECDs due diligence guidelines on conflict minerals and will initially be voluntary. The announcement of the guidelines was made at the 2015 International Workshop on Responsible Mineral Supply Chains held in Beijing, China.

 

 

 

Sweden – Proposes Nanomaterial Reporting

The Swedish Chemicals Agency (KEMI), on December 1, 2015, proposed mandatory reporting of nanomaterials in chemicals products. This would include reporting of intentionally added nanomaterials in most chemical products, but nanomaterials in articles (per REACH definition) would be excluded from the reporting requirements.

The Swedish Chemicals Agency proposes that companies should have a duty to report if chemical products contain nanomaterials. The aim of this proposal is to improve knowledge about which nanomaterials there are on the Swedish market.

Sweden is one of several EU member states that has or is planning to implement nanomaterial reporting requirements. The full report leading up to the KEMI proposal is available on the KEMI website.

Belgium – Nanomaterial Registration

Requirements of a Belgium regulation that requires manufacturers and importers to register chemical products containing nanomaterials came into effect starting January 1, 2016. Existing substances produced in nanoparticle state were to be registered by January 1, 2016. Manufacturers and importers of chemical mixtures containing a substance produced in a nanoparticle state have an additional year to register – until January 1, 2017. Additional information on the Belgium regulation and the registration process are available on the nanoregistry portal.