Ask the Experts: December 6 Edition

Ask the Experts: December 6 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 

Should a software company without part or material suppliers include office vendors in its human trafficking and slavery (HTS) program?

Sarah Carpenter

Yes, companies should include vendors that keep their office running such as meal providers, utility companies or drug screenings in their HTS program. This aspect of due diligence is especially important because service providers often use workers who are highly vulnerable to forced labor.

Question

How should a company respond when the Restriction of Hazardous Substances Directive (RoHS) Directive or the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation are updated, but compliance data has already been captured?  Should part and product drawings be updated to indicate compliance or non-compliance? 

Valerie Kuntz & Travis Miller 

Drawings should not be labeled to indicate compliance status. The REACH Regulation is updated periodically, and as a result, labeled drawings would also have to be updated. Instead, data should be collected in an easily accessible database to demonstrate due diligence during audits. Compliance to restricted and declarable substance lists is a moving target since almost all of the laws continue to add substances. Therefore, your process will need to clearly demonstrate the applicable compliance dates related to your statements.

If a company wants a statement on the drawing, we recommend they prepare a materials compliance specification, then reference that the supplier must provide parts that align to the spec in the drawing.

Question

If a supplier affixes a Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) warning label on a part, but the end client does not want any labels on the final product, can the label be removed?

Neil Smith & Valerie Kuntz

It is not necessary to include a Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) label if the product is being sold into a business-to-business process. However, standards put into place by the Occupational Safety and Health Administration (OSHA) require manufacturers to communicate the presence of chemicals in scope of Proposition 65 to their customers. Manufacturers must receive a receipt from the company that purchased the product verifying that they were made aware of the chemicals present in the product.

Standards outlined by California OSHA require companies purchasing products sold into a business-to-business process to provide appropriate signage, safety training and equipment for individuals who will be exposed to restricted substances through the use, installation, repair or maintenance of the product.

Question

If a product such as paint is not compliant with Proposition 65 before it is used, but becomes compliant once it has been applied and cured or baked on by the original equipment manufacturers (OEMs) that purchase it, is it necessary to label for Proposition 65? If so, is it necessary to report on its status before or after it has been applied?

Bruce Jarnot

Many materials, including paints, coatings, adhesives and epoxies, can have a different Proposition 65 compliance status when sourced uncured from a vendor versus as a cured finished product. Unless coating pigments use heavy metals, cured or baked on coatings will not likely require Proposition 65 warnings. Please see the answer above for more about business to business labeling requirements.

Question

If a customer requests compliance documents on parts that have not been in production for a number of years, can we submit documents from when the parts were manufactured?

Steve Andrews

That depends on when the final product or equipment is or was placed on the European Union (EU) market for sale or distribution.

If the parts are already incorporated into products placed on the market, the declaration of compliance needs to be relevant for the date they were placed on the market. If they have not yet been placed on the market, new documentation is necessary once the products are placed on the market. Old supporting documentation can be used to demonstrate compliance for obsolete parts so long as the documentation has sufficient information to prove compliance, and it is still valid.


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.

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