Ask the Experts: September 27

Ask the Experts: September 27

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 four interesting questions our Regulatory team has responded to over the past month.

 Question: 

How long is a European Chemicals Agency (ECHA) enforcement inspection, and how extensive is the investigation with regard to the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation? 

 Answer:

Previously, it was possible the level of inspection and enforcement could vary between member states, as each could interpret legal texts differently. This is no longer the case as the European Union (EU) has established a central database for enforcement authorities to share information, and an effort has been made to improve enforcement authority training.

Companies are expected to have developed systems and processes to track the use of substances of very high concern (SVHCs) within products. As such, expect rigorous inspections that request all data to ensure organizations meet their reporting requirements down to the lowest level article.

It is important to note that the ECHA does no direct enforcement of the REACH Regulation, and it is the responsibility of each member state to enforce REACH Regulation requirements. The ECHA does, however, coordinate prioritization and best practices through the REACH Enforcement Forum.

Question:

As manufacturers, do we need to declare products from raw material suppliers under the EU Restriction of Harmful Substances (RoHS) Directive?

Answer:

Yes, in certain situations. If the suppliers’ material is considered homogenous and will be used in electrical and electronic equipment (EEE), they may have to provide evidence of compliance so the end EEE manufacturer can demonstrate compliance for all materials and parts of the product.

Question:

What are the REACH Regulation requirements for companies supplying military products with SVHCs as a component?

Answer:

The EU REACH Regulation (EC) No 1907/2006 pertains to the identification of SVHCs, which could then be further controlled via permits, authorized for specific use cases only or otherwise restricted outright. According to Article 2 (3) of the regulation: “Member States may allow for exemptions from this Regulation in specific cases for certain substances, on their own, in a mixture or in an article, where necessary in the interests of defence.”

This exemption was widely used in the early days of the regulation, as defence suppliers encountered supply chain continuity issues when SVHCs in their products became further regulated. European Union National Defence Authorities may argue defence suppliers need to show the same level of reasoning and due diligence as those obtaining an EU REACH Authorisation. No supplier can assume producing a part at a military spec level will guarantee a Defence Exemption. To receive such an exemption, the supplier must contact the relevant defence authority and present documentation to validate the exemption.

Each authority has unique procedures and processing, although steps have been taken to harmonize the process via the European Defence Agency.

Question:

Are companies that exist outside the EU, but sell into the EU market obligated to conform with the REACH Regulation?

Answer:

Importers are ultimately responsible for products placed on the EU market, but those importers will require data from the product manufacturers. Therefore, although companies outside the EU aren’t directly obligated to comply with the REACH Regulation, they will likely need to collect all relevant part information related to the regulation. Non-EU manufacturers may appoint Only Representatives to fulfill these obligations on behalf of importers.

Question:

The use of 12L14 steel currently falls under the Restriction of Hazardous Substances (RoHS) Directive exemption 6a. What is the expiration date for that exemption, and should an alternative be sought?

Answer:

Exemptions under the RoHS Directive are intended to allow industry to find suitable alternatives to restricted substances in specific uses. Over time, exemptions may either be discontinued or further restricted to eventually remove the substance over threshold.

Most exemptions that expired on July 21, 2016, received a request for extension, which allowed them to remain active as these requests were processed. They were officially extended with a final recommended date within one year to 18 months of the official filing. Exemption 6(a) included an official expiration date of July 1, 2019, for categories 1–7 and 10. After that date, Exemption 6(a)-I became active, which encompasses 12L14 steel, and the original 6(a) exemption remained live for categories 8,9 and 11.

It is important to note that exemption 6(a)-I is only valid until July 21, 2021, and exemption requests must be submitted before January 21, 2020 (18 months before expiration). Several groups are working on extension requests for this exemption, and it is anticipated that these requests will be submitted ahead of the deadline.

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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