"Hardly anyone talks about it. Yet it's incredibly useful for every manufacturer."
Material Compliance expert Simon Brack on IEC 63000 – and what it delivers for manufacturers today.
Simon, what is EN IEC 63000:2018 – and why does it matter?
IEC 63000:2018 is the international standard that defines how manufacturers of electrical and electronic equipment must document compliance with legal substance restrictions. It was originally developed in 2018 as the foundation for RoHS. But it became clear over time that it’s actually applicable to many regulations in the field of material compliance.
So why does hardly anyone talk about this standard?
Because most companies know they need to comply with REACH and RoHS, for example. They jump straight in and then ask themselves: how do I actually prove compliance reliably? That’s exactly the question IEC 63000 answers – almost like a guidebook. But most people never look at it.
What exactly does IEC 63000 cover?
It gives manufacturers a structured approach to material compliance. That approach comes down to three steps: first, risk assessment – where are the critical materials, components, and suppliers? Then, supplier inquiry – follow up where the risk requires it or where there are gaps in documentation. And finally, product assessment – the documented statement that the product is compliant.
“IEC 63000 makes audits easier. If you can demonstrate clear material compliance processes based on this standard, it’s very likely you have everything under control.”
There’s been recent discussion about a “risk-based approach” revision. What does that actually mean?
In the first three drafts of the standardization mandate, the Commission had specified that mandatory evidence – such as lab tests – should be required whenever it cannot be confirmed that certain substances are below the threshold. Regardless of risk.
The CENELEC Technical Board rejected those drafts. In the fourth draft, the risk-based approach was reinstated – and only then was the mandate adopted. I think that’s the right call. Moving away from the risk-based approach would have created significant extra work for companies.
“The risk-based approach keeps material compliance manageable and implementable.”
What exactly does risk-based approach mean in practice?
Simply put: you assess the risk and act accordingly. If a long-standing, reliable supplier delivers an uncritical metal component made from a well-known material, the risk is low – additional evidence isn’t necessarily required. But if a new supplier delivers a component with an unknown composition that could potentially contain hazardous substances, you should ask questions or request documentation.
And how does IEC 63000 help manufacturers with that?
The standard gives manufacturers the ability to act on the basis of risk assessments. It provides flexibility – including for lean processes. That’s reassuring, because you’re following a recognized standard rather than building your own logic from scratch, which a market surveillance authority could then question.
And the decision to keep the risk-based approach in place is a huge relief for manufacturers. It keeps the standard implementable without adding yet more bureaucracy.
Speaking of market surveillance: what does IEC 63000 mean legally?
When you document according to this standard, the so-called presumption of conformity applies. The authority assumes you meet the requirements of the RoHS directive. They don’t check everything in detail. That’s a real advantage – especially in audits. If an auditor comes to your material compliance department, you can say straight away: we work according to IEC 63000. The auditor immediately understands that your material compliance process is clearly structured and that you know how to assess risks.
“Whoever communicates openly and proactively meets the regulatory requirements – or can demonstrate that they take them seriously.”
What’s your advice for manufacturers and suppliers implementing IEC 63000?
I genuinely think IEC 63000 is a solid guidebook for material compliance processes. But behind the process, there’s much more: material compliance is also a question of communication, trust, and building good relationships with your suppliers.
In my view, IEC 63000 leads to better material compliance work.
How does Substantio help companies implement IEC 63000 in practice?
Substantio helps exactly where the standard focuses: systematic collection and structured documentation of evidence from the supply chain. We support the risk-based approach by incorporating all item-related information relevant to the risk assessment. When we know what an article is made of, we don’t have to wait for every supplier response. The information is in the material itself – stored in the system, for example as a full material declaration.
Your takeaway – for anyone starting out now:
“Good processes lead to good material compliance.”
Thank you for the conversation, Simon!
