Ask the Experts: February 15 Edition

Ask the Experts: February 15 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 Regulatory team has recently received.   

Q: How do we calculate safe harbor levels under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65)?

Neil Smith and Valerie Kuntz: There are many factors that determine safe harbor levels in a product. If we were to use an example of a part that carries the risk of skin exposure, factors to consider in determining the safe harbor level are:

  • The concentration of the substance.
  • The number of times in a day skin contact is made, and length of skin contact with the product.
  • The surface area of the skin contact.
  • The dermal uptake/absorption rate.
  • The weight of the product user.

Q: What is the reporting threshold for cobalt in the new Cobalt Reporting Template (CRT)?

Jared Connors: Cobalt reporting follows the same guidelines as Section 1502 of the Dodd-Frank Wall Street Reform and Consumer Protection Act for conflict minerals, which means the intentional use at any amount should be declared when filling out a CRT.

Q: How can a company ensure distributors provide a Conflict Minerals Reporting Template (CMRT) when asked?

Travis Miller: Distributors are frequently out of scope of conflict minerals rules and may not have manufacturer data readily available. A key to receiving support from distributors is to provide them with advance notice and include contractual provisions that require the disclosure of compliance information.

If a distributor can’t provide this information, the client could obtain the manufacturer’s contact details and solicit the documentation from the manufacturer directly, provided the distributor is locked into using that specific manufacturer. Should these approaches prove unsuccessful, the client could switch to an alternative vendor to obtain the same parts, which are frequently available through either the manufacturer or a competing distributor.

Q: Are pallets considered in scope of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation and the Restriction of Hazardous Substances (RoHS) Directive?

Neil Smith: Pallets are considered out of scope of RoHS because they do not meet the definition for electrical or electronic equipment (EEE). However, they would be in scope of REACH as articles, as noted in the following guidance: “The packaging is not a part of the substance, mixture or article being packaged. It is therefore to be considered as a separate article under REACH and the same requirements apply to it as for any other article.”

Q: Would a label-maker be considered in scope of product compliance regulations such as REACH and RoHS?

Raj Takhar: Both laws consider labels differently.

A label has to indirectly meet RoHS substance restriction requirements if affixed to an in-scope product that meets the definition of EEE under the directive.  Labels are in scope of REACH, since they are defined as articles or multiple articles, depending on the complexity of the label itself.

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