Ask the Experts: July 19 Edition

Ask the Experts: July 19 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 questions our Regulatory team has responded to over the past month.

Question: Declarations are a necessary part of importing spare parts into the European Union, Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation . Under the European Union (EU) Restriction of Hazardous Substances (ROHS) Directive, will parts containing hazardous substances over the threshold without an exemption be stopped at customs? Furthermore, can a product be imported into the EU if it contains RoHS substances over threshold, without an exception?

Steven Andrews: Spare parts that are not compliant with substance restrictions such as RoHS can still be shipped, sold and used within the EU, provided they are being incorporated into products and equipment placed on the market before the relevant date. This date varies both by product category and substance.

For example, parts for Category 1 products placed on the market before July 1, 2006, that contain lead or cadmium can be imported into the EU. The same is true of parts for the same Category 1 product, using one of the four phthalates provided the product was placed on the market prior to July 22, 2019.

As for products containing RoHS substances over the threshold, without an exemption, no, they cannot be legally placed on the market. Any part of the product containingRoHS substances above the accepted threshold renders the entire product non-compliant with legislative requirements, if the product is within the scope of the directive.

Question: Does the California Safe Drinking Water and Toxic Enforcement Act (Proposition 65) apply to non-consumer products, such as fuses in enclosures that don’t come into contact with skin?

Bruce Jarnot: Proposition 65 is intended to protect both workers and consumers from listed substances that are known to cause cancer, birth defects or otherwise impact reproductive health. Manufacturers must provide a clear and reasonable warning about potential exposure to listed substances in their products from intended or foreseeable use.

For the example of fuses within enclosures, it’s likely a service or repair technician will handle the enclosures while replacing a fuse. This would constitute foreseeable use of the product, so a Proposition 65 warning should be considered.

It’s important to consider all possible uses of a product within the scope of Proposition 65 and ensure appropriate warnings are provided.

Question: Lead is naturally occurring in soil. Do fruits and vegetables therefore need a Proposition 65 warning?

Neil Smith: Chemicals and substances such as lead do occur naturally in the soil, and as a result, Office of Environmental Health Hazard Assessment (OEHHA) regulations have an exemption for listed chemicals in food.  Some of the listed substances and chemicals occur naturally in foods, either as an inherent part of composition, through the absorption of substances in the soil or for other reasons.

However, businesses selling fruits and vegetables with trace amounts of these chemicals and substances in California must demonstrate listed chemicals are naturally occurring and at the “lowest level currently feasible.” In the state of California, the term “naturally occurring” is defined in very specific terms; see the California Code of Regulations, Title 27, Section 25501 for more information.

Provided fruits and vegetables meet this definition, there is no need for the addition of Proposition 65 warnings.

Question: For clothing within the scope of Proposition 65, do warnings have to go on the garment itself, or can they remain on the plastic polyethylene bag (polybag) the garment is shipped in?

Valerie Kuntz: Proposition 65 requires  a clear and reasonable warning to customers about hazardous substance exposure the might result from products they purchase and use. Additional tags or labels on garments may give some manufacturers and retailers pause, but a clear and reasonable warning is still necessary. Ultimately, manufacturers, importers and retailers are responsible for ensuring customers make informed purchases.

With this in mind, a Proposition 65 warning on the bag alone is sufficient if consumers will see the polybag a garment is shipped in prior to purchase. However, if customers will not see the polybag prior to purchase, then a warning on the garment itself may be necessary. If you are selling into a retail environment where clothes are displayed out of packaging, it’s recommended that you provide California locations with signage for these garments.

Finally, remember that products sold online must also display product warnings to ensure consumers are always aware of exposure potential.

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