Ask the Experts: November 22 Edition

Ask the Experts: November 22 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: 

How should weight by weight (w/w) concentrations be calculated to ensure compliance under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation?

Valerie Kuntz & Travis Miller:

To understand how w/w concentrations are calculated, you first need to understand the definition of an article under the REACH Regulation. For example, if the product in question is a cell phone case, it is likely made of two pieces: a hard shell to protect against scratches and a soft interior piece to absorb impact. Even before the two pieces are put together to form the case, they are more than substances or materials. The form and design of the pieces define their use, so under the REACH Regulation, each piece is considered an article. The w/w calculation must be performed for every article in an object.

Imagine the hard shell of the phone case contains a Substance of Very High Concern (SVHC) in its pigment, such as Bis(2-ethylhexyl) phthalate. To calculate the w/w concentration, divide the weight of the phthalate used in the hard shell by the full weight of the hard shell. If the resulting percentage is greater than 0.1, the company that produced, imported or sells this article by itself or combined with other articles (i.e. complex object) would be required to communicate the presence of the phthalate to customers so safe-use information can be identified.

Question: 

The Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) and the California Cleaning Product Right to Know Act of 2017 seem to overlap heavily. Are there any key differences companies should be aware of if they are already compliant with Proposition 65?

Valerie Kuntz & Bruce Jarnot:

Although there are some similarities, the two regulations are distinct. Unlike Proposition 65, the California Cleaning Product Right to Know Act of 2017 is only a labeling requirement, not a specific declarable substance list (DSL). The act requires cleaning product manufacturers to disclose ingredient information on the product label and on their website. The label must also include the manufacturer’s toll-free phone number and website where customers can find additional product information.

Products in scope of the California Cleaning Product Right to Know Act of 2017 include the following products sold in California:

  • Air fresheners.
  • Odor removers.
  • Automotive cleaning products.
  • General cleaning products.
  • Dish soap.
  • Fabric or dish detergent.
  • Polish and floor maintenance products.

Question:

If a harmful chemical is found in a product, but it is not listed under Proposition 65, is an action required by the manufacturer?

Travis Miller & Neil Smith:

If the substance is not covered under Proposition 65, then no action is required for that specific regulation. However, there are numerous other state and federal requirements beyond Proposition 65 that govern which substances can be included in products and at what concentration. Many of these requirements include stipulations about labeling and warning consumers based on the product type and materials contained. The manufacturer’s next step should be to determine whether another regulation applies to the hazardous substance in question.

Question:

Do the recent additions to the Proposition 65 list of chemicals mean that companies will be required to immediately get their products retested?

Valerie Kuntz:

Under Proposition 65, companies are given a one-year grace period to meet new requirements when substances are added to the list. Testing may also be an overly expensive and/or technically impractical method of obtaining composition information. Companies should first attempt to identify risks by assessing supplier-provided documentation or other forms of available proof of compliance.

Question: 

Under the REACH Regulation and the Restriction of Hazardous Substances (RoHS) Directive, is there an industry standard for the number of part-level responses required before a declaration of conformity can be issued?

Bruce Jarnot & Valerie Kuntz: 

No such threshold exists. For both the REACH Regulation and RoHS Directive, regulatory authorities want to see demonstrable evidence of a robust, ongoing compliance program with incremental improvement in the collection of third-party supplier data. Demonstrating strong due-diligence is key.

It is also important to understand and communicate that parts are compliant based on your due diligence and alert customers if this information changes.


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 info@assentcompliance.com.

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