Ask the Experts November 8 Edition

Ask the Experts November 8 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:

When compiling full material disclosure (FMD) data from multiple FMDs, what percentage of completion is sufficient for risk assessment purposes?

Valerie Kuntz: 

Gaps in material data — whether the result of a part without an FMD or the omission of certain proprietary information — can introduce risk. To ensure their full bill of materials is covered with some form of valid supporting documentation, companies often use a combination of FMDs and negative declarations, which are documents providing evidence that a product has no negative effect on the environment.

If a gap in material data still remains, companies must assess the possibility of material risk based on the ingredients and processes used to manufacture the product. Companies should ask a few questions regarding suppliers:

  1. Are there processes and contractual obligations in place to support supplier reliability and consistency in raw material or component selection?
  2. Is there a robust quality management system in the manufacturing process?
  3. Are storage controls in place to prevent mixing compliant and non-compliant materials and components?

In cases where the answers to these questions raise red flags for non-compliance, companies may test product composition as a final resort to ensure they are covered.

Question: 

How will Brexit impact a medical company that imports small volumes of chemicals (less than one metric ton) from the UK into the European Union (EU)? Will products need to be registered under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation?

Raj Takhar:

There is still a great deal of ambiguity surrounding companies’ post-Brexit regulatory obligations. Several possibilities exist. If a “No Deal” agreement takes place, the UK will drop out of all EU bodies and current EU REACH Regulation registrations will lapse, requiring an EU-27 based office, importers or an Only Representative to perform new registrations.

There is a possibility that the European Union (Withdrawal Agreement) Bill, which is currently paused pending a general election, will eventually pass. This will allow for free trade between Europe and the UK until a formal agreement is prepared to replace it.

The UK may also agree to leave without legislation in place to deal with the REACH Regulation. In this case, the UK will not recognize EU registrations, and the EU will not recognize UK registrations for an unknown period.

If a UK company imports close to one metric ton of chemicals, The Department for Environment, Food and Rural Affairs suggests registering to be safe. However, the threshold for registration in the EU will remain one metric ton, so companies in the EU will not have to alter their practices.

Question:

The Restriction of Hazardous Substances (RoHS) Directive states that by July 22, 2019, it will apply to all electronic and electrical equipment (EEE) dependent on electric current or electromagnetic fields for at least one intended function. Would tape cartridges that must be placed in an electric drive to function fall under this EEE category?

Neil Smith, Valerie Kuntz & Raj Takhar:

Tapes and similar consumables would be in scope of the EU RoHS Directive, although there may be differences in legislative interpretation by each member state authority. Companies can minimize risk by including it in scope. Importantly, these tapes would also be in scope of the Waste Electrical and Electronic Equipment (WEEE) Directive and should be handled accordingly.

Question:

Who can apply for a deadline extension under the EU Medical Device Regulation (MDR)?

Raj Takhar:

Unfortunately, there are no extensions under EU MDR. The onus is on medical device manufacturers to be ready to identify MDR substances and seek approval once the regulatory framework is in place in 2020. However, companies with a device registered under the legacy system at the 2020 deadline have until the end of their existing registry period to register under EU MDR. After this point, they must continue to register under the EU MDR, even if the legacy registration would otherwise still be in effect. The last possible date a device could be registered under the old system is 2024, at which point, all devices will fall under the EU MDR.

Question: 

Six new substances were added to the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) in September, 2019. What types of parts or products are at risk for containing these substances?

Bruce Jarnot: 

The substances most recently added to Proposition 65 are mostly antiquated and unlikely to be found in modern products, with the occasional exception of fabric or apparel. Although, most products have a low risk of using these substances, demonstrating compliance still requires some form of due diligence.


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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