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. They also provide advice directly to Assent’s clients. Here are the top five questions our Regulatory team has responded to over the past month.
Question: Beyond requirements under the European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation, what additional responsibilities do manufacturers outside of the EU have under the EU Waste Framework Directive (WFD) if their products are sold to EU-based importers? Will they be required to report to the Substances of Concern In articles, as such or in complex objects (Products) (SCIP) database, or can they simply collect data and provide it to their customers in the EU?
Answer — Raj Takhar: While an EU-based importer may perform SCIP database submissions, in practice they may be unwilling or unable to perform these tasks. An EU importer may set up contractual agreements with their non-EU article suppliers to act on their behalf (as a “foreign user”) with regard to SCIP database submissions. However, the responsibility for the SCIP notification and its content still lies with the EU article importer. Please be aware, third-party users (“foreign users”) will see the same information as all other users in the European Chemicals Agency (ECHA)’s IT Tools.
It is also worth noting SCIP database submissions must go beyond REACH data requirements. The REACH Regulation was implemented primarily to enable downstream article users to be aware of the presence of any Substances of Very High Concern (SVHCs) in products, allowing them to take appropriate safety measures. To that end, the EU REACH Regulation requires companies provide (at a minimum) basic information about an SVHC present in an article above the 0.1 percent weight by weight (w/w) threshold to users of the article.
The reporting requirements are much more complex for the SCIP database. Mandated under the EU WFD, the SCIP database is intended to help end-of-life waste stream operators identify articles containing SVHCs over that same threshold. By the time a product enters its end-of-life phase, it is possible a significant amount of time will have passed since a REACH declaration was last received by a consumer. The SCIP database thus seeks to enable progress towards the EU circular economy, since the presence of SVHCs is seen as a major hindrance to this goal.
The SCIP database requires a granular-level of data collection analysis, which extends throughout the supply chain for products destined for the EU market, regardless of where they were manufactured.
For more information, download our whitepaper, EU Waste Framework Directive: Understanding SCIP Database Requirements.
Question: Some inks used in manufacturing contain SVHCs, but the substance is burned out during the sintering process and is not present in the final product. Would a company need to declare for this chemical under the EU REACH Regulation?
Answer — Bruce Jarnot: It is not unusual for the regulatory status of some materials to change during industrial processing. Notable examples include paints and coatings (such as applied inks, epoxy coatings, electrocoating or powder coats) and sintering fluxes. If it can be reasonably expected SVHCs were removed during these processes, they do not need to be declared under REACH Article 33 communication requirements. Please note, this is specific to communication requirements under Article 33 of the REACH Regulation. If the manufacturing process takes place in the EU, the manufacturer may still have other responsibilities under the REACH Regulation.
Question: My company is considering using Guibourtia wood for a product that will come in contact with food. What regulatory considerations apply to wood products, particularly those in contact with food? Do regulatory bodies such as the Food and Drug Administration (FDA) or equivalent authorities in the European Commission maintain any lists of food-safe woods?
Answer — Bruce Jarnot: No, the FDA and its EU counterparts do not maintain lists of approved food-safe woods. Evaluating material options requires a review of the wood type’s toxicity, though some woods are well-known for food-safe use, such as maple, cherry and hickory.
Other regulatory considerations when evaluating wood use include:
- Source tree toxicity and/or history of negative allergic or physical reactions.
- Source tree species status on the International Union for Conservation of Nature (IUCN) Red List of Threatened Species.
- Source tree species status under the Convention on International Trade in Endangered Species (CITES).
Furthermore, when working with wood, note that worker exposure to wood dust has been associated with nasal cancer in carpenters, which led to wood dust’s inclusion as a carcinogen under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65).
Guibourtia has low toxicity, but exposure may cause skin irritation and/or lesions. Please consider adding a clear coat to wood parts to help prevent consumer exposure. Guibourtia is not evaluated on the IUCN Red List, but three Guibourtia species (commonly known as Bubinga) are listed on CITES Appendix II. As a result, international trade in Bubinga wood and finished goods has been banned under CITES since January 2017.
Question: How are substance concentrations calculated under the EU Restriction of Hazardous Substances (RoHS) Directive? Is it similar to the REACH Regulation, where concentrations are based on the weight of the article where the SVHC is found, or is it based on a different total weight?
Answer — Steven Andrews: Chemical concentration levels under the RoHS Directive are not calculated as a percentage of the weight of the component article or finished product, but instead as a percentage of the specific homogenous material in which the chemical is found. The ECHA’s EU RoHS FAQ defines homogenous materials as “a material with a uniform composition throughout; or a material that consists of a combination of materials, that cannot be disjointed or separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding or abrasive processes.”
Homogenous materials may include plastic covers on computer screens or the copper wire inside a cable. Most electrical and electronic equipment consists of many different homogenous materials, and the maximum concentration values are applied to each material individually.
Question: My company has been asked to submit compliance documentation for products we manufacture from recycled plastic materials. Since we cannot trace the original material components, how should we proceed?
Answer — Valerie Kuntz: First, determine the actual substances contained in recycled materials. Ideally you could request information from your suppliers about the supply stream for these materials. Alternatively, you may want to declare for any substances likely to be included throughout the life cycle of the source materials you are using (based on the assumption that the substance is likely to be found in the recycled material as well, even if it has been diluted by other additions).
Testing is another option, but keep in mind that it will only establish the contents of the specific batch of the material tested. As a general best practice, research and understand any declarable substances likely to exist in your recycled material throughout its life cycle, and consider declaring for any of these that are declarable under the regulation(s) in question. Specific concentrations are more difficult to establish, and may depend on factors earlier in the recycled material’s life cycle.
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 us today.