Mapping of Restricted Substance Controls (RSC)

To implement restricted substance requirements in a transparent and structured way, the evaluation process can be represented using a Structured Assessment Logic (SAL), based on the principles of IEC TR 62476.

Restricted substance controls follow a risk-informed and evidence-based approach, taking into account:

• the probability of restricted substances being present, and

• the trustworthiness of the supplier.

Compliance is established through the systematic evaluation of materials, parts, sub-assemblies and processes, supported by appropriate documentation and, where necessary, analytical verification.

The SAL comprises the following steps:

1. Product planning and design – Are restricted substance requirements identified and considered at product planning and design stage?

This includes:

• identification of applicable substance restrictions (regulatory, contractual, customer-specific),

• consideration of design aspects impacting substance content,

• definition of specifications for procurement,

• review of process requirements (e.g. segregation of lead / lead-free processes).

  
  

2. Procurement – risk-based supplier evaluation – Is the required type and level of technical documentation determined based on the probability of restricted substances being present and the supplier’s trustworthiness?

This includes:

Step 2.1 – Assessment of the probability of restricted substances being present and the supplier’s ability to comply with the specified requirements - Has the probability of restricted substances being present and the supplier’s ability to meet requirements been assessed?

Relevant criteria include:

• material type and historical risk,

• available material composition data,

• internal knowledge and screening results,

• supplier information (e.g. SDS),

• supplier experience and industry context,

• supplier’s implementation of Restricted Substance Controls (RSC).

Supplier trustworthiness shall be assessed considering:

• knowledge of regulatory requirements,

• implementation of RSC processes,

• use of analytical testing for high-risk parts.

Step 2.2 – Determination of required documentation - Is the type and level of supplier documentation appropriate to the identified risk?

Possible documentation includes:

• Supplier declarations / contractual agreements→ limited evidential value; suitable for low-risk / high-trust cases

• Quantitative material declarations(e.g. according to IEC 62474)

• Analytical test results(e.g. according to IEC 62321)

Step 2.3 – Escalation (if needed) - Are additional measures taken where risk or uncertainty is high?

This includes:

• additional supplier information,

• independent analytical testing,

• alternative evaluation methods.

3. Manufacturing control – Are manufacturing processes controlled to ensure compliance with restricted substance requirements?

This includes ensuring that:

• incoming materials and parts meet requirements,

• production and storage processes are controlled,

• contamination is prevented (e.g. process segregation, handling controls),

• personnel are appropriately trained.

4. Product evaluation – Has the product been evaluated based on complete and valid information?

To be verified:

• Is sufficient information available for all materials, parts and sub-assemblies?

• Do all components meet the restricted substance requirements?

If not:

• additional data must be obtained, and

• the evaluation must be repeated.

Re-evaluation is required where:

• requirements change,

• suppliers or materials change,

• manufacturing processes change.

5. Documentation – Are procedures and results documented in a structured and traceable manner?

   
   

Documentation shall demonstrate:

• how restricted substance compliance is ensured,

• how risk-based decisions were made,

• which evidence supports the evaluation.

Note: SAL is not an end in itself. It provides a repeatable and risk-informed methodology that translates restricted substance requirements into a structured evaluation logic.

In the context of restricted substance controls, SAL ensures that compliance is not assumed, but demonstrated based on risk assessment, supplier evaluation, and appropriate evidence.

This diagram illustrates the SAL workflow visually:

Product planning & design

↓

Procurement – risk-based evaluation

↓

Supplier documentation & verification

↓

Manufacturing control

↓

Product evaluation

↓

Documentation