Ask the Experts: March 1 Edition

Ask the Experts: March 1 Edition

Our regulatory subject matter experts are always helping a range of stakeholders solve compelling regulatory challenges associated with supply chain data management. This insight is compiled 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 responded to over the past month.

Question: Are cleaners used in the production process considered articles under regulations such as REACH and RoHS? For example, if sheet metal is cleaned with an industrial cleaner, do we have to report on the substances in that cleaner?

Valerie Kuntz: Industrial cleaners used in manufacturing processes are in scope of product compliance requirements if any part of the cleaner substances remain on the final product. If none remains, it is not considered to be part of the final product.  

There are some manufacturers that may request information about process substances to understand the operational issues that could arise should those cleaners become restricted in some way.

However, if the cleaner itself is sold within the European Union (EU) (placed on the market), it would be in scope for the SVHCs, and potentially for any Authorisations (Article XIV) or Restrictions (Article XVII), depending on the substances contained. Furthermore:

  • SVHC information would need to be shared with downstream recipients in the supply chain and consumers, if requested.  
  • If substances are on the authorisation list, authorisation for the uses of the substances in the cleaner would need to be in place after the sunset date.
  • Substances listed on the Restricted list must meet requirements, whether they are “found over-a-specified-level” or “use-based” restrictions.

Question: How do Proposition 65 warning requirements apply to furniture products? Do I need to use long-form or short-form messaging?

Bruce Jarnot: On August 30, 2018, the California Environmental Protection Agency updated the warning requirements for furniture products that can cause exposure to substances listed under Proposition 65. Labeling for furniture must contain:

  • A warning for consumer product exposures.
    • Warning must be printed on or affixed to the furniture product, and must include:
      • The symbol described in Section 25603(a)(1).
      • The word “WARNING” in all capital letters and bold print.
      • The words: “This product can expose you to chemicals including [name of one or more chemicals known to cause cancer, name of one or more chemicals known to cause reproductive toxicity, or name of one or more chemicals known to cause both cancer and birth defects or other reproductive harm], which is [are] known to the State of California to cause cancer or birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov/furniture.
  • A notice displayed pursuant to Section 25607.12(a)(1)(A) or stamped on a receipt pursuant to Section 25607.12(a)(1)(B) that includes:
    • The words: “NOTICE: Some furniture products can expose you to chemicals known to the State of California to cause cancer and/or birth defects or other reproductive harm. Please check the product label for warning information.”

Question: Does the EU Medical Device Regulation (MDR) apply to labels that don’t come in direct contact with products, only the labeling?

Raj Takhar: According to the text of EU MDR Section 10.4.1, the regulation applies to devices, or those parts thereof or those materials used therein that:

  • Are invasive and come into direct contact with the human body
  • (Re)administer medicines, body liquids or other substances, including gases, to/from the body, or
  • Transport or store such medicines, body fluids or substances, including gases, to be (re)administered to the body.

So under the terms of the EU MDR, unless a label comes into direct contact, it isn’t strictly in scope. However, to remain diligent, consider reporting the substances on a label, as it may in the future be required to be placed in a specific visible location, as part of the product approval process, whereby human contact may occur.

Labels on medical devices can also be affected by other regulations. For example, under (i) EU REACH, a label can be defined as an article, and is therefore subject to the regulation; (ii) EU RoHS, the label has to meet the requirements of RoHS if affixed to a product in scope that meets the definition of electrical and electronic equipment.

Question: I’ve encountered supplier declarations for the same product that declares “No SVHCs” for REACH, and “Contains lead according to exemption 7c-I” under EU RoHS.” Why is this?

Valerie Kuntz: Substances regulated by EU RoHS include lead and lead compounds, while  REACH regulates certain lead substances, but not all. Follow up with the supplier in these cases to confirm which specific lead substance is being declared under EU RoHS. In general, lead in glass (the 7(c)-I exemption) is usually lead oxide rather than pure lead. That’s why it wouldn’t be declared under REACH.

Also, under EU RoHS, the threshold for compliance is calculated at the homogeneous level. EU REACH sets thresholds at the article level. So the threshold calculation is made against the article level of the part the substance is found in, rather than the final product in its entirety.

Question: Under the requirements of Proposition 65, how do I determine which pieces of packaging are a part of my product and which are not? What packaging do I need to report on?

Bruce Jarnot: Unless the packaging is considered to be part of the product, such as a bottle of spray cleaner or a storage box for drill bits, it does not fall within the scope of Proposition 65. You do not have to report on substances used in any disposable product packaging not affixed to the product, including boxes, bags and clamshells.

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