Ask the Experts: April 12 Edition

Ask the Experts: April 12 Edition

Our regulatory subject matter experts are always available to educate compliance professionals through content, webinars and events. They also provide advice to Assent clients. Here are the top five questions our team has received in the past weeks.

Question: What does the impending July 22, 2019 deadline for the RoHS 2 update mean for my clients who have yet to perform supply chain engagement? What does it mean for my suppliers?

Valerie Kuntz: Article II of 2015/863/EU reads: “Member States shall adopt and publish, by 31 December 2016 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions. They shall apply those provisions from 22 July 2019.”

“Those provisions” refers to the provision that product categories 1-7, 10, and 11 cannot be placed on the EU market after July 22, 2019 if they contain any of the four phthalates over a threshold of 1000 ppm.

While the requirement does not have specific supply chain engagement requirements, most companies will need to acquire data from their supply chain in order to show compliance with the directive.

Question: Some of our major customers have questions about the impact Brexit could have on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). In a no-deal scenario, how do we determine the status and filing requirements of registrations?

Raj Takhar: In the event of a no-deal Brexit scenario, companies may need to file separate registrations in both the EU REACH-IT (ECHA) and the UK REACH-IT systems.

Non-UK based companies will need to appoint an Only Representative located within the UK to complete any substance notification requests (>1 tonne) into the UK REACH-IT system. As the UK REACH-IT system develops, additional data will need to be inputted into the UK REACH-IT system such as authorisation requests. Non-UK based companies will still need to report data where required into the EU REACH-IT system as the currently do today.

UK-based companies will need to perform registrations on the UK REACH-IT system, as well as appoint an Only Representative located in the EU to register on the EU REACH-IT system (where required).

The UK REACH-IT system does not integrate with the EU REACH-IT system, so companies will need to maintain two unique records of substance registrations. This will result in duplication of information, which will result in industry needing to record and maintain large volumes of additional information.

The UK REACH-IT requires companies to register substance notification requests first, followed by the completion of more detailed information dossiers within an 18 month period. Please note that the UK REACH-IT system is not yet fully-defined in terms of how to submit for authorizations, restrictions, etc. Updates and expansions to the system will take place on a phased timeline.

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Question: I’ve heard a lot about perfluorooctanoic acid (PFOA) lately, especially in relation to the Stockholm Convention on Persistent Pollutants (POPs). Should I be concerned?

Bruce Jarnot: PFOA is a substance of very high concern (SVHC) on the REACH Annex XVII Restricted List (and PFOS), and it has been proposed for listing under the Stockholm Convention on POPs. Collecting full material disclosures for your products can help you immediately assess them for substances and thresholds.

Question: If a supplier in China is exporting to a client’s business unit, do they have to include a China RoHS label, as well as a substance declaration? Must they also declare safe use if the parts contain substances above threshold?

Valerie Kuntz: If your product is a part and not the final assembly, you must submit a declaration including information about its environment friendly use period (EFUP) years and any hazardous substances over the allowable threshold. Your final product should be shipped with the full Hazardous Substances Table and information about how it applies to your part. Use your EFUP number to determine how many years which value to label your product with.

Note: China RoHS 2 applies to electrical and electronic products (EEP) placed on the consumer market, so if your part is not sold as a standalone product, you are not required to include the actual labels or Hazardous Substances Table. If your product is sold on its own, the Hazardous Substances Table and label are required if your product contains hazardous substances over threshold.

Question: I am unclear about the communication requirements associated with the lead found in brass and steel components. What are the threshold levels for lead under REACH and RoHS requirements, and how do I determine the correct weight to make the calculation against?

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James Calder: Annex II of the EU RoHS Directive puts maximum concentration values of lead compounds at a level of 0.1 percent. If your product exceeds this threshold, you may not sell your product into the EU without an exemption. Meanwhile, you would also have downstream communication requirements under REACH. These thresholds apply at the homogeneous level, so you can only calculate the percentage if the part or product in question is made up of one homogeneous material (a material of uniform composition throughout that cannot be mechanically separated into different materials).

For example, if a screw is made purely of stainless steel you would be able to take the weight of the entire screw and look for the exceedance based on the total weight of the screw as a denominator. If you have a complex article like a microchip, for example, you would need to look at each homogeneous material individually for the exceedance calculations (eg. resin, metal parts, each layer inside a capacitor, etc.).

In the case of REACH SVHC (Article 33), downstream communication is required when any listed SVHC is contained at the article level over the 0.1% w/w threshold with potential Notification and the total volume of the SVHC above 0.1% w/w is also imported into the EU at more than 1 tonne/year. An article, under REACH is defined as follows: ‘…an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition’. Articles must comply with various requirements under REACH, but they are only required to meet the substance’s registration requirements when there is an intended release of a substance from an article in question.

For more questions and answers, visit the last edition of Assent’s Ask the Experts blog.

Assent’s regulatory subject matter experts frequently participate in events such as webinars to educate compliance professionals. They also inform our clients’ regulatory programs. To learn more, contact