Ask the Experts: December 20 Edition

Ask the Experts: December 20 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 Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65), there is an exemption for naturally-occurring heavy metals in consumable products. Does this mean all food is automatically out of scope? 

Bruce Jarnot:

Food is not automatically outside the scope of Proposition 65. For instance, edible or consumable products that produce acrylamide when cooked or baked, such as french fries, and products that absorb lead from tools during processing, such as cocoa and chocolate, often face enforcement under Proposition 65. 

The exemption is for naturally occurring chemicals found in consumable goods under certain circumstances. If chemicals are introduced during processing, they would not be considered naturally occurring. 

Question: 

Under the Restriction of Hazardous Substances (RoHS) Directive, is it the responsibility of the part supplier or final product manufacturer to ensure exemptions are valid for a particular use case? 

Valerie Kuntz: 

Exemptions under the RoHS Directive are typically use-based, so it is up to the manufacturer of the final product to ensure that the exemption applies for their use case. However, many companies expect their suppliers to be compliant or eligible for an exemption, even if they do not know the final use of the part.

To meet these expectations, suppliers can include any exemptions in their declaration that would apply for the supplied part. If the supplier is unsure if a part is eligible for an exemption, it is acceptable to declare the part as non-compliant and allow the final manufacturer to apply for the exemption, if applicable. 

Question : 

Most RoHS exemptions are set to expire on July 21, 2021. Is there a possibility of this date being extended? 

Valerie Kuntz: 

A coalition of over 30 trade associations representing manufacturers of electrical and electronic equipment, known as the Umbrella Project, has been formed to prepare and submit RoHS exemption renewal requests. They will be generating requests to expand exemptions for 4f, 6a, 6b, 6c, 7a, 7cI, 7cII, 7cIV, 8b, 13a, 13b, 15 and 34 beyond July 21, 2021, for categories 1–10 (exemptions for in vitro and industrial equipment already have later expiration dates). 

As long as the requests are received by January 20, 2020 — 18 months before the expiration date — the exemptions will continue to apply after the expiration. 

It is important to note that 6a, 6b, 8b, 13b and 15 have all received alternative exemptions that further restricted their uses defined under the previous exemptions. However, they still expire on July 21, 2021. These alternative exemptions are expected to be covered under these same requests.

Companies should also note that the Umbrella Project will consider other exemptions should the need arise, but at this time, none of the Annex IV exemptions are being reviewed. Companies impacted by these expirations will need to create their own requests for January 2020. 

Question:

Are all-natural products — such as hemp — outside the scope of Proposition 65? 

Neil Smith & Bruce Jarnot: 

Natural products are only out of scope for Proposition 65 if they are food products with naturally occurring substances. While hemp may not meet that requirement, it is also unlikely to contain significant levels of chemicals listed under Proposition 65. 

Bounty hunter firms that initiate enforcement cases tend to look for a sure deal rather than fringe cases. However, it ultimately comes down to individual companies’ appetite for risk. 

Question:

Several conflicting dates in 2020 and 2021 have been suggested as potential effective dates for the Substances of Concern In articles, as such or in complex objects (Products) (SCIP) database. When are companies actually expected to submit? 

James Calder:

The conflicting effective dates are likely different deadlines for various stakeholders. Companies with products containing SVHCs over the 0.1 percent w/w threshold, also referred to as duty holders, must submit data to the SCIP database by January 5, 2021. 

The legal basis for the SCIP database comes from the European Union (EU) Waste Framework Directive (WFD). Unlike regulations, EU directives must be transposed into national law, and the member states are required to transpose the EU WFD into national law by July 5, 2020.

The European Chemicals Agency (ECHA), the agency responsible for developing and overseeing the EU WFD, is also approaching its SCIP database deadlines. Originally, the ECHA was required to have the first version of the SCIP database accessible to duty holders by January 5, 2020. This deadline will likely be missed, and the ECHA is currently targeting dates between February 2020 and November 2020. 


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 info@assentcompliance.com.

Newsletter