Assent’s Regulatory experts answer your questions about REACH SVHCs, Proposition 65, and other product compliance requirements.
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.
Question: The European Union (EU) Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) substance of very high concern (SVHC) list is updated twice a year. Are the Annex XIV and XVII lists updated on the same schedule? How can I verify I’m using the correct version of these lists?
Raj Takhar: Unlike the REACH SVHC list, Annex XIV (Authorisations) and Annex XVII (Restrictions) are updated on an ad-hoc basis. In the case of Annex XIV, updates are the culmination of a long and involved process of public consultation and reviews. As a result, they take longer to finalize and often introduce entire substance groups. Annex XVII updates are usually focused on a specific or similar use case, which then restricts a substance or group of similar substances related to the specific use case, and are therefore more frequent. In case of doubt, always use the lists as published by the European Chemicals Agency (ECHA).
Question: My company is assessing a new product for compliance with the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65), and some substance safe harbor levels are inconsistent and difficult to document. How should we approach this?
Neil Smith & Bruce Jarnot: When in doubt, we recommend you include a Proposition 65 warning on the product. This is a pragmatic approach to satisfying the scrutiny of enforcement bodies, and safeguarding against unpredictable manufacturing variances and exposure scenarios. If your company chose not to apply the warning labels, a law firm or similar entity could bring enforcement action against you if they found even one instance of non-compliance. This could lead to a whole range of financial penalties for the infraction, as well as court processes and costs.
If you believe a warning label would be detrimental to your business due to customer perception, you need to either avoid selling products with exposure uncertainty and/or clearly show that hazardous substances are below the safe harbor level.
Question: My company produces a product containing chloroform, which is also known as trichloromethane. Which term should we use on the Proposition 65 warning label? May we use the term we prefer?
Bruce Jarnot: On Proposition 65 warning labels, you should always use the substance name as it appears on the California Office of Environmental Health Hazard Assessment’s list of Chemicals Considered or Listed Under Proposition 65. In this case, that means you should use the term chloroform.
Question: Are resellers in scope of the EU Waste Framework Directive? Do I need to make a submission to the Substances of Concern In articles, as such or in complex objects (Products) (SCIP) database for any products that contain SVHCs?
Raj Takhar: If the supplier that provides you these goods is located outside of the EU, then the submission requirements fall on the party that imports and distributes the article (product) in the EU. If you are that party, then you will have a legal obligation to submit a product dossier to the SCIP database.
If your supplier is located within the European Economic Area (EEA), the supplier is the “duty holder,” and retains the submission requirement. However, you still need to make a Simplified Submission Notification (SSN) using the product’s SCIP identification number and article data (in an Excel file), which must be provided to you by your supplier. This process means:
- Submitting the data acquired from your supplier to the ECHA Submission Portal.
- Receiving a unique, supplier-specific identification number for the SSN.
This is a time-intensive task for resellers with large product catalogs, although the ECHA is evaluating simpler methods to manage the data.
Question: A customer has asked for a full material disclosure (FMD) for one of our products. Should we include the product’s packaging in the FMD?
Valerie Kuntz: Packaging materials are typically not included in an FMD. Full material disclosures only include information on the final product itself. However, it’s still important to ensure that packaging materials meet any applicable compliance requirements. For instance, some packaging and packing materials are in scope of the REACH Regulation.
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.
