Ask the Experts: October 25 Edition

Ask the Experts: October 25 Edition

Our regulatory subject matter experts are always helping a range of stakeholders solve compelling regulatory challenges associated with supply chain data management. We compile these insights to help educate compliance professionals through content, webinars and events. They also provide advice to Assent clients. Here are the top five questions our Regulatory team has responded to over the past month.

Question: Under the Russian version of the Restriction of Hazardous Substances (RoHS) Directive, is self-certification sufficient or do I need to perform lab testing on my product and its components?

Valerie Kuntz: For Russia RoHS, confirmation assessment procedures are carried out by the applicant on the basis of their evidence. Testing can be carried out in the manufacturer’s laboratory.

Declarations of conformity must be accepted by the manufacturer’s local representative in the Eurasian Economic Union (EAEU), and the Eurasian Conformity mark (EAC) should be applied.

Note that additional electrical regulations may apply, depending on the product type. In these cases, an EAEU Certificate of Conformity (CoC) and Declaration of Conformity (DoC) may be required. The main difference between these documents is that the CoC must be conducted by a third party, while a DoC may be accepted on the merit of its own evidence.

In summary, for Russia RoHS, self-testing and documentation is acceptable, but other electrical regulations may require third-party involvement and testing. Similar to how the European CE marking covers the EU RoHS Directive and, depending on product type, also covers other CE marking laws (e.g. Electromagnetic Compatibility Directive, Radio Equipment Directive, Low Voltage Directive).

Find out about how Assent can help you acquire the full range of supply chain data with our guide the Assent Compliance Platform: Building Value Into Your Supply Chain Data Management Program.

Question: My company purchases bare boards to connect coils and caps together to make cable replacements. One of our subcontractors keeps a stock of this board on hand for repairs, however, the company has identified a 0.18 percentage of lead (Pb) in some of the backstock. Can we use a component that is not RoHS-compliant for the repair and service of units sold before July 22 2019 throughout the transition period of 10 years?

Bruce Jarnot: Category 11 “Other” electronics with the July 22, 2019 compliance date can use non-compliant parts to upgrade or repair product equipment placed on the market before the due date or coming into force date, so it depends upon both the specific substance and its category of electrical and electronic equipment (EEE).

For Category 3 “IT equipment,” lead in components above the 0.1 percent threshold may only be used to repair or upgrade equipment placed on the market before July 1, 2006, unless using a specific application exemption (e.g. lead in high melting point solder). Meanwhile, the deadline for Category 8 “medical devices” is July 22, 2014.

The other complicating factor is whether the use of the lead or other restricted substances is subject to or benefits from one of the specific exemptions, in which case the exemption’s sunset date could apply.

In summary, the substance in question, the product category under which the equipment falls, the relevant date and exemptions all may impact this decision. In your case, usage of the products is compliant, provided the details in your question are accurate.

Question: My company uses parts that are only RoHS 2 compliant due to being Category 9 products used in the manufacture a Category 11 products in scope of RoHS 3. Do I treat the subpart as Category 9 or 11? 

Valerie Kuntz: The final assembly defines which category the product falls under. So even if a subpart is defined as Category 9, it is required to be compliant when added to a Category 11 product. If the Category 9 subpart were sold as a standalone product on the EU market, it could use the Category 9 extension for RoHS 2 amendment (EU) 2015/863 for the four phthalates (sometimes referred to as RoHS 3).

All sub-parts in a Category 11 assembly must comply with requirements for all 10 substances defined under EU RoHS 2 2011/65/EU and amendment (EU) 2015/863.

Question: Is there an industry standard or regulation that outlines tolerance limits, proprietary data percentages and weight ranges for full material disclosures (FMDs)?

Raj Takhar: By nature, FMDs are statements of all the substances and materials contained within a product. The key is to provide a full account.

There are no commonly-accepted best practices for the data types you’ve outlined. Companies can either provide precise weight and substance amounts, or they can provide ranges, which ensure any proprietary data is protected. Report values for substances where regulations state a threshold limit.

Provide a full account of all substances, including names and Chemical Abstracts Service (CAS) and European Community (EC) numbers, with ranges to protect intellectual property rights Review and update substance data on a regular basis.

Find out how Assent’s REACH module can help you acquire the substance data you need to satisfy both EU market access requirements, and submit documentation to the upcoming SCIP database.

Question: One of our products weighs five grams, and we ship 200,000 pieces per year. It may contain an SVHC under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation. Do we have communication requirements, as outlined in this guidance.

James Calder: To meet communication requirements under Article 33, there is no weight threshold for REACH candidate SVHCs in products over the 0.1% weight over weight (w/w) threshold. The same will apply to the upcoming Substances of Concern In Products (SCIP) database.

For notification under Article 7(2), there needs to be a total import of the respective SVHCs above 0.1 percent w/w across all imports over one metric ton per year, and not been registered for the specific use.

Section 3.2.1 of the guidance you’ve referenced clarifies the specific issue with the following:

As concerns the obligations to communicate information on substances in articles in general (i.e. communication towards recipients and consumers), note that:

  • The Candidate List substance concentration threshold of 0.1% w/w applies to every article supplied. This threshold applies to each article of an object made up of more than one article, which were joined or assembled together (complex objects). 
  • There is no tonnage trigger for these obligations. 
  • A distributor supplying articles to consumers does not comply with his communication obligation toward a consumer upon request, just by referring the consumer to his own supplier, or the producer/importer of the articles.
  • The communication obligations arise from the presence of the Candidate List substance in the article. These obligations apply regardless of whether or not the supplier is aware of the presence of the substances. Therefore, it is in the interests of the supplier to seek information on the presence of Candidate List substances.
  • The communication of information at the request of a consumer is independent of whether the article was purchased by that particular consumer.

For more questions and answers, visit the last edition of Assent’s Ask the Experts blog. Assent’s regulatory subject matter experts frequently provide actionable insight into regulatory programs through webinars and other events. To learn more, contact

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