Our regulatory subject matter experts help a range of stakeholders solve compelling regulatory challenges associated with supply chain data management. We compile their insights to help educate compliance professionals through content, webinars, and events. Assent’s experts also provide advice directly to clients. Here are the top five questions our Regulatory team has responded to over the past month.
Can a company that did not submit a European Union (EU) Restriction of Hazardous Substances (RoHS) Directive exemption request individually or via an industry group still use an approved exemption?
Valerie Kuntz: While the European Commission is making a decision and once an exemption is approved, anyone can use it. Historically, it was rare for each stakeholder to request an exemption or an extension, but those who did included similar reasons for requesting the extension this is why the Umbrella Project was started. It allowed the multiple stakeholders impacted by the exemptions to create one extension request rather than the multiple they had tried in the past.
It is worth noting that not all regulations function this way; for example, the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) Regulation Authorisation (Annex XIV substances) is company-specific, and only a company and its downstream customers applying for the use authorization can use it.
Are all the substances on the Aerospace and Defence Declarable Substances List (AD-DSL), and the regulations covered by the list, publicly available?
Raj Takkar: The latest version of the AD-DSL is publicly available, however, the substance list cross-referenced with specific regulations is not. That level of detail is only available to International Aerospace Environmental Group (IAEG) working group members that work to create the list.
If similar parts are sourced from different manufacturers, are they considered different parts/suppliers under product compliance regulations such as EU REACH?
Valerie Kuntz: In my experience, I have seen parts from various suppliers, one of which contained a declarable substance, and one of which did not.
Products, while similar in nature, can be made differently by different manufacturers, which is why the cost is often different, as it reflects the different materials and/or substances that were used. Form/fit/function requirements are not equal to material requirements, so it is necessary to receive information from each supplier.
The EU Directive 2017/1000 for REACH and Perfluorooctanoic Acid (PFOA) came into effect on July 4 this year. Are articles placed on the market for order prior to July 4, 2020, exempt based on the following wording included in Section 6: Point 2(c) shall not apply to: (a) articles placed on the market before 4 July 2020?
Valerie Kuntz: The EU Directive 2017/1000 is actually going to be removed because of an update to the EU POPs Recast Regulation. The start dates are the same as the Annex XVII restriction dates, but there are different exemptions and applicable begin dates, and some of the exemptions related to semiconductors have been removed. Once the EU POPs Recast is approved, the European Commission will make the applicable changes to the REACH Regulation.
The placed on the market language goes beyond the first time a product was ever placed on the market, and impacts products going into the EU after that date. For the PFOA restriction, that means all products in the EU before July 4, 2020, can have PFOA over threshold, and any products going into the EU after July 4, 2020, must have PFOAs below threshold.
Packaging is part of the EU REACH Regulation, but where is the line? Does it include all shipping labels, such as a fragile sticker?
Steven Andrews: The Guidance on Substances in Articles provides the following:
“Substances, mixtures and articles can be contained inside packaging, such as a carton, a plastic wrapping or a tin can. In principle, the main functions of packaging may be containment and delivery of e.g. substances or mixtures, protection for the product packaged, and presentation or aesthetic purpose. In many cases, it also contributes to the safety of humans and the environment during handling or use of the content. Therefore, packaging is to be considered as an article because its shape, surface or design is more important than its chemical composition for the above mentioned functions. The packaging is not a part of the substance, mixture or article being packaged. It is therefore to be considered as a separate article under REACH and the same requirements apply to it as for any other article”
For more questions and answers, visit the last edition of Assent’s Ask the Experts blog.
Assent’s regulatory subject matter experts provide invaluable insight and guidance. Learn more about how they can help your company by contacting us today.
