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: A supplier notified our company that they have obligations under the Toxic Substances Control Act of 1976 (TSCA), and will be responsible for fees associated with importing goods containing a “priority assessed substance” (phosphoric acid, triphenyl ester [TPP]) into the U.S.. What are these fees, and what does it mean for our company?

Answer — Valerie Kuntz: Import fees associated with certain high-priority assessed substances are part of the U.S. TSCA. Phosphoric acid, triphenyl ester, or TPP, is one of these high-priority substances. The goal of this requirement is for manufacturers to either cease importing/using these substances or help defray some of the costs of administering certain provisions of the TSCA.

The fees are a sustainable source of funds for the Environmental Protection Agency (EPA), helping it fulfill its legal obligations, such as conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment.

Fee obligations include a total fee (currently set at $1.35 million USD) for EPA-initiated risk evaluations, with a reduced fee amount for small business concerns. The total fee is shared among all identified manufacturers (including importers). This includes:

  • Manufacturers and importers that import the chemical as part of an article.
  • Manufacturers or importers that manufacture/import chemical substances that are considered an impurity or byproduct.v
  • Manufacturers or importers that manufacture/import small amounts of chemical substances.
  • All other manufacturers or importers of these chemical substances.

All of these entities are subject to the TSCA Fees Rule requirements.

Since your supplier has self-identified as an importer of a high-priority substance, they will need to help with the fees defined under the TSCA. If your company manufactures goods containing TPP in the U.S. or imports goods containing TPP into the U.S., you may also have to self-identify to help share the fee costs.

For more information on the Toxic Substances Control Act, read our blog about upcoming TSCA requirements.

Question: When surveying suppliers for human trafficking and slavery compliance information for a company’s Code of Conduct (CoC), some smaller suppliers respond that they do not have written policies because they follow the laws of the countries they operate in. What is the best way to handle this? Does it matter if they are located in a lower-risk country?

Answer — Sarah Carpenter: For guidance in this situation, I suggest you refer to the UN Guiding Principles on Business and Human Rights. The principles are clear that the responsibility to respect human rights (as covered by your CoC) applies fully and equally to all businesses, regardless of size and location. They also state that businesses should have policies and processes in place to respect human rights.

While the principles do acknowledge that these policies and processes should be appropriate to the business’ size, the core fact that a business should have them in place does not change.

A few other points to consider:

  • In many parts of the world, the provisions within your CoC are unlikely to be met by compliance with local law alone.
  • There are many parts of the world where local law is not enforced in practice. Without enforcement, the presence of law carries little weight.
  • Respect for human rights is not more or less difficult for smaller businesses than larger ones; instead, it is difficult in some ways and simpler in others. With committed leadership and fewer staff, for instance, it can be easier for a small business to align relevant functions than it would be for a larger company.

Question: Can compliance data used for the European Union (EU) Restriction of Hazardous Chemicals (RoHS) Directive be used to determine compliance with the Eurasian Economic Union (EAEU) RoHS Directive?

Answer — Valerie Kuntz: There are many similarities between EU RoHS and EAEU RoHS (sometimes referred to as “Russian RoHS”), but there are also some differences.

The chemicals restricted under the EAEU RoHS Directive are the same “original six” chemicals listed by EU RoHS 2, so EU RoHS Directive compliance data can be used to verify whether products contain these same six chemicals for EAEU RoHS Directive compliance.

Additionally, the EU RoHS and EAEU RoHS directives have similar product scopes, although the scoping guidelines are not identical with the EAEU RoHS Directive, and fewer products are in scope. Furthermore, while exemptions are similar between both directives, there are some differences. The exemptions are also numbered differently in both directives.

Depending on your situation, EU RoHS compliance data may provide enough information to establish EAEU RoHS compliance. However, it is important to be aware of the differences between the two directives and to consider the data carefully, especially if your products have substances over threshold and exemptions are used.

Question: I understand that the EU RoHS Directive applies to electric or electronic equipment (EEE) in general, but are there any types of EEE that the directive does not apply to?

Answer — Steven Andrews: Yes, specific categories of EEE are excluded from the directive, as outlined in EU RoHS article 2 (see below). It is important to understand these exclusions only apply to EEE solely defined to the below uses. Electric or electronic equipment with end uses captured below that can also be used in a manner outside of the exclusions would be in scope:

  • Equipment that is necessary for the protection of the essential interests of the security of EU member states, including arms, munitions and war material intended for specifically military purposes.
  • Equipment designed to be sent into space.
  • Equipment that is specifically designed, and is to be installed, as part of another type of equipment that is excluded or does not fall within the scope of the EU RoHS Directive, which can fulfill its function only if it is part of that equipment, and which can be replaced only by the same specifically designed equipment.
  • Large-scale stationary industrial tools.
  • Large-scale fixed installations.
  • Means of transport for persons or goods, excluding electric two-wheel vehicles which are not type-approved.
  • Non-road mobile machinery made available exclusively for professional use.
  • Active implantable medical devices.
  • Photovoltaic panels intended to be used in a system that is designed, assembled and installed by professionals for permanent use at a defined location to produce energy from solar light for public, commercial, industrial and residential applications.
  • Equipment specifically designed solely for the purposes of research and development only made available on a business-to-business basis.

Question: As part of my company’s product compliance efforts, we are requesting information from many of our suppliers. Should we be requesting information from past suppliers we do not have any current business with, or is it safe to stick with our current suppliers?

Answer — Valerie Kuntz: In general, you can exclude suppliers that you have not done business with for some time. However, if you still have products from any past suppliers that are used in your product (i.e. if you are still using up stock purchased from them), you should communicate with those suppliers when lists of regulated substances update so you have the latest information for your new products.

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.

James Calder
SVP, Strategic Channels & Corporate Development

James leads the Corporate Development function at Assent, creating and executing on strategies to increase strategic partnerships and channel sales, and identify growth opportunities through mergers  Read More

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