REACH Compliance: A Q&A From the Supply Chain Summit Series

REACH Compliance: A Q&A From the Supply Chain Summit Series

Meeting evolving requirements under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation is key to maintaining market access in the European Union (EU). At the Supply Chain Summit Series event in San Diego, Travis Miller, Assent’s General Counsel, discussed core issues and best practices for managing REACH compliance.

Conference attendees had the opportunity to ask follow-up questions about his presentation. This blog features those questions and his responses.

How do you see the upcoming EU Medical Device Regulation (MDR) impacting the REACH Regulation? Will this make REACH compliance more or less challenging?

This will depend on whether the medical device community is successful at driving all suppliers toward full material disclosures (FMDs). If they are, the FMD data from suppliers can be leveraged to support REACH. If not, there will be little impact or efficiencies gained.

How should we manage compliance from distributors?

Compliance documentation acquisition has to be either contracted at the outset, paid for as a service or voluntarily offered by the distributor. The alternative is to skip the distributor and chase manufacturer declarations for all purchased parts.

Only some of our electronic component suppliers are reporting lead as a Substance of Very High Concern (SVHC), while others are not. Who’s right?

Lead is an SVHC under EU REACH. You can view the full list here.

Do you have any guidance on REACH Annex V?

Annex V of REACH lists 13 broad categories of substances for which registration is deemed inappropriate or unnecessary. The registration exemption applies to the substances as such, provided they meet the conditions given in the relevant category of Annex V. Annex V is well established, and you can find the official guidance document here.

REACH seems to be expanding over time to cover more and more chemicals. Do you see this trend ending?

The way we understand the materials we use has changed as a result of REACH. REACH is more than a list of rules; it is a shift away from the assumption that all chemicals are safe until proven harmful. Instead, it assumes all chemicals are dangerous until proven to be safe. This is known as the precautionary principle.

Lead is listed as an SVHC and is one component of brass. Brass has an end use in almost every product with a contact. How do I manage this in my reporting?

At this stage, lead is declarable as an SVHC. Assent would recommend engaging with the appropriate substance information exchange forum (SIEF) and/or trade associations to ensure timely applications for authorization are submitted.

What’s the best way to approach REACH to ensure you are mitigating risk while being cost-efficient in terms of testing?

First, develop a multi-strategy approach to compliance that aligns with industry-standard due diligence, specifically IEC 63000. Then, incorporate supply chain declaration sourcing and contractual language as primary sources of due diligence. Finally, only use third-party testing as a last resort, as it is the most expensive and least stable option for REACH compliance.

If my company is a distributor, am I only dealing with articles?

The answer depends on what you are distributing. If you are only distributing articles, then yes.  If you are distributing substances and mixtures as well, then those requirements would also apply.

REACH still allows SVHCs in products as long as they’ve been reported, so why are suppliers so afraid of having SVHCs in their materials?

Though having an SVHC in an article only obligates disclosure, they are always being evaluated for exclusion for the European Union market. Many companies will seek to preemptively phase components that contain SVHCs out of product design in anticipation of restrictions on certain substances.

What’s the difference between Restriction of Hazardous Substances (RoHS) Directive and REACH calculations?

In practice, they are very similar. Legally speaking, RoHS is defined as the homogeneous material level, REACH is defined as the article level.

If the SVHC level is less than 1 percent, do you need to disclose it on your compliance certificate?

The disclosure threshold for an SVHC under REACH is 0.1 percent weight by weight at the article level. You can read more about your obligations under REACH here, or download Assent’s eBook, The REACH Handbook: Your Guide to SVHC Compliance.

Travis Miller is an international trade and compliance attorney specializing in product compliance, trade compliance and corporate social responsibility. He manages Assent’s worldwide legal activities, such as advising the board of directors on legal matters and overseeing corporate compliance, governance initiatives and other commercial transactions. Travis provides legal support and insight to every team at the company, from sales to services, and partner organizations.

Assent’s solution streamlines and automates data collection and reporting for REACH. To learn more about Assent’s REACH solution, contact