Our regulatory subject matter experts help 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: If a substance is on the REACH Restricted Substances List (Annex XVII), does that mean it is also automatically on the Candidate List of SVHCs?

Valerie Kuntz: Not necessarily. The Candidate List of SVHCs and the Restricted Substances List are two different stages in the control process, and a substance may be on either without currently being listed on the other. For an example of how this can happen, let’s look at lead and asbestos.

Lead use in jewelry has been banned, per Annex XVII, since April 2015. However, lead used in non-jewelry applications was only recently added to the Candidate List of SVHCs; up until that point, lead was unrestricted under REACH unless used in jewelry.

Asbestos, on the other hand, is restricted regardless of its usage. Asbestos is not on the Candidate List of SVHCs because it is technically a list of substances that are candidates for restriction—and asbestos is not a candidate, since it is already restricted.

Question: I’m with an Australian company, and I recently heard about a filing we are supposed to do for Australian modern slavery due diligence. Do you have more information about our requirements in 2019, and in the future?

Abiola Okpechi: The regulation you’re referring to is the Australian Modern Slavery Act (MSA), which came into force on January 1, 2019. For entities in scope of the act, the first report submitted must cover the first full reporting period following commencement of the act, which is the 2019/2020 financial year. The exact timing of your submission depends on your financial reporting year.

If you report on the Australian fiscal year (July to June), the first reporting period will be July 1, 2019, to June 30, 2020. If you report finances on a calendar-year basis, the first reporting period will be January 1, 2020, to December 31, 2020. In either case, your company will have six months from the end of its financial year to file its modern slavery report. This means that even though your company’s report will account for a portion of 2019, the filing itself was not due in 2019.

Download our guide, Human Trafficking & Slavery: What It Means for Your Company. to find out how Assent can help you mitigate more risk.

Question: I recently received a request for information under the European Union (EU) Medical Device Regulation (MDR). How is this different from similar requests for hazardous substance data? If I’ve already responded to requests under the EU Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation, why do I have to respond to EU MDR requests?

Raj Takhar: REACH and the EU MDR are two different regulations. They have different aims, and the requirements are different. Under EU REACH, substance data must be collected from suppliers and provided to customers when a Substance of Very High Concern (SVHC) is present over the allowed threshold. The EU MDR lists far more substances with regulatory requirements than EU REACH, so compliance with one does not indicate compliance with the other. Meanwhile, the EU MDR has product labeling requirements exclusive to the regulation, and an obligation to include additional substance information for the customer, which is not required under REACH.

Question: How are EU Restriction of Hazardous Substances (RoHS) Directive exclusions for large-scale stationary industrial tools (LSSIT) and large-scale fixed installations (LSFI) determined and documented? What does “large scale” mean in this context?

Steve Andrews: Article 2(4) of the RoHS Directive has a list of equipment that is excluded from its scope. Two of these are LSSIT and LSFI. Page 9 of the RoHS 2 FAQ document provides details on what these two exclusions mean, but the term “large scale” is not defined. The onus is placed on the company that wishes to take advantage of these exclusions to justify why they think their “stationary industrial tool” or “fixed installation” is large scale. The member state enforcement authority may challenge the company’s justification if they disagree.

One should err on the side caution when determining exclusions purely to benefit the business, since authorities will apply their own interpretation to better protect their citizens and the environment through reduction of hazardous substances.

Are your RoHS exemptions expiring in 2020? Assent’s RoHS Directive can help you acquire the data to keep your products on the market.

Question: When U.S. Customs and Border Protection (CBP) receives a forced labor petition, is this enough documentation to halt trade of the identified merchandise in the U.S. market?

Sarah Carpenter: U.S. CBP regulations state that any person who has reason to believe that merchandise produced by forced labor is being, or is likely to be, imported into the United States may report it to the CBP. They can do so via the e-Allegations portal on the CBP website. However, receipt of a petition alone is not enough for CBP to detain the merchandise.

First, petitions are reviewed to ensure the information supplied meets the standards outlined in the CBP regulations prior to the issue of a withhold release order (WRO). They need to reasonably, but not conclusively, indicate that merchandise is being, or is likely to be, imported in violation of the Trade Facilitation and Trade Enforcement Act’s forced labor prohibition. If this is done effectively, the CBP may issue a WRO. In other words, the agency can take action on “reasonable suspicion” — a fairly low evidential threshold.

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 us today.

James Calder
SVP, Strategic Channels & Corporate Development

James leads the Corporate Development function at Assent, creating and executing on strategies to increase strategic partnerships and channel sales, and identify growth opportunities through mergers  Read More

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