Ask the Experts: March 29 Edition

Ask the Experts: March 29 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: If my product is compliant with the Restriction of Hazardous Substances (RoHS) recast, is it also compliant with halogen presence standards?

Answer: No. Compliance with RoHS does not cover compliance with all the halogen-related standards.

Polybrominated biphenyl flame retardants (PBB) and polybrominated diphenyl ethers (PBDE) are the only halogenated substances restricted under RoHS.

Additional halogen-related standards include:

IEC 61249-2-21:2003

  • Covers only printed circuit boards — Materials for printed boards and other interconnecting structures — Part 2-21: Reinforced base materials, clad and unclad — Non-halogenated epoxide woven e-glass reinforced laminated sheets of defined flammability (vertical burning test), copper-clad.
  • Halogen free printed circuit board:
    • Max total halogens: 1,500 ppm.
    • Max bromine: 900 ppm.
    • Max chlorine: 900 ppm.

IPC: IPC/JEDEC J-STD-709  

  • Covers everything else used in electronic products.
  • Each material within an electronic product (excluding printed board laminates) shall contain <1,000 ppm (0.1 percent) by weight of bromine if the bromine source is from BFRs, and <1,000 ppm (0.1 percent) by weight of chlorine if the chlorine source is from CFRs, PVC, PVC congeners, PVC block polymers, PVC copolymers, or polymer alloys containing PVC.
  • Higher concentrations of bromine and chlorine are allowed in plastics contained within electronic products (other than printed board laminates contained within those devices) as long as their sources are not flame retardants, PVC, PVC congeners, PVC block polymers, PVC copolymers, or polymer alloys containing PVC.

Question: Why is it important to have separate declarations for RoHS and the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation?  

Answer: First, RoHS does not cover all REACH Substances of Very High Concern (SVHCs). Additionally, even though a substance restriction/disclosure may have the same percentage threshold maximum for both RoHS and REACH, it’s very important to understand how each regulation expects you to make that calculation. The RoHS threshold is at the homogeneous level, while the REACH threshold is at the article level.

This means that, while both RoHS and REACH might impose a limit of 0.1 percent weight by weight (w/w), a screw with a coating would be considered two different homogeneous materials under RoHS, but one article under REACH. Further, declarations for either must contain wordage explicitly demonstrating compliance. For example, if a declaration wordage focuses on thresholds, then a REACH declaration may not be sufficient for RoHS.

To learn more, there is a RoHS recast FAQ available on the European Commission’s website, as well as a guidance on ECHA Substances in Articles.  

Question: Is the European Commission’s Persistent Organic Pollutants (POPs) Regulation 850/2004 and its amendments separate and distinct from REACH and RoHS, and are electronics companies in scope?

Answer: The EU’s regulation on persistent organic pollutants (POPs), also known as Regulation (EC) No. 850/2004, implements commitments set out in the Stockholm Convention aiming to minimize the environmental release of substances with properties that are potentially hazardous to human health and the environment. The POPs regulation restricts substances in both chemical products and articles.

The regulation is completely separate and distinct from REACH and RoHS, and all products manufactured and sold in the European Union are in scope of the regulation. Due to the potentially destructive nature of the pollutants covered by the regulation, it also contains provisions concerning unintentionally arisen substances, waste management and environmental monitoring. More details can be found here.

Question: If a part is made of pure stainless steel, is it out of scope of Proposition 65?

Answer: Potentially, yes. Chromium in stainless steel is typically Cr0, meaning that it is in its pure elemental form. Stainless steels are considered inherently non-hazardous, with many grades approved for food contact.

You can read more about the requirements for Proposition 65 in our whitepaper, Understanding the Safe Drinking Water & Toxic Enforcement Act.

Question: None of the labels we print come in direct contact with the device they’re attached to, only the packaging. Does the EU Medical Device Regulation (MDR) apply to us?

Answer: A product label on a medical device can fall under EU MDR, EU REACH and EU RoHS.

Under the EU MDR, a product label is considered in scope if it comes into direct contact with humans. If that is the case, the label is potentially subject to the same requirements and approval processes for the medical device it is labeling. There is a specific requirement under the EU MDR for product labeling that highlights substances that are carcinogenic, mutagenic or toxic for reproduction (CMR) and found in medical devices.

A product label is also considered an article under EU REACH, and will also fall under EU RoHS if the label is affixed to a product in scope that meets the definition of electrical and electronic equipment (EEE).

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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