Mapping of Directive 2011/65/EU (RoHS)

The SAL comprises the following steps:

1. Scope of Application – Is the product electrical or electronic equipment (EEE) within the scope of Directive 2011/65/EU?

2. Substance Restrictions (Article 4 and Annex II) – Does the product comply with the RoHS substance restrictions?

Exemptions (Article 5, Annexes III and IV) – If the Annex II concentration limits are exceeded, does a valid exemption apply?

3. Technical Documentation and Conformity Assessment – Is compliance demonstrated through appropriate technical documentation in accordance with EN IEC 63000?

4. Restricted Substances Control (RSC) – Has the manufacturer implemented appropriate processes and controls to ensure ongoing compliance during product development, sourcing, and production?

5. CE Marking and EU Declaration of Conformity – Has the manufacturer completed the conformity assessment procedure and issued the required declaration of conformity?

6. WEEE Interfaces – Are related obligations under Directive 2012/19/EU (e.g. marking, registration, and user information obligations) fulfilled?

Note: SAL is not an end in itself. It provides a repeatable methodology that translates regulatory principles into a clear, structured assessment logic. In practice, compliance with RoHS requires not only the assessment of substance restrictions, but also the establishment of robust Restricted Substances Controls (RSC) and appropriate technical documentation.

This diagram illustrates the SAL workflow visually:

Scope of Application (EEE)

↓

Substance Restrictions (Annex II), including exemptions (Annex III / IV / Article 5)

↓

Technical Documentation (EN IEC 63000)

↓

Restricted Substances Control (RSC)

↓

CE Marking and Declaration of Conformity

↓

Interfaces to WEEE Obligations

Interfaces to Related Legislation

When applying RoHS, there are often interfaces with other regulatory frameworks that must be considered in parallel:

• Directive 2012/19/EU (WEEE)

• Regulation (EC) No 1907/2006 (REACH)

• Waste Framework Directive 2008/98/EC – Article 9(1)(i) (SCIP notification)

• Other substance-related regulations (e.g. biocidal products, fluorinated greenhouse gases, ozone-depleting substances, persistent organic pollutants)

A coordinated assessment is therefore necessary to avoid regulatory gaps or duplicated evaluations.

Overview of the Directive 2011/65/EU

• Number of the Directive: 2011/65/EU

• Title: Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment

• Publication: OJ L 174, 1.7.2011, p. 88

• Summary: Restricts the use of hazardous substances in electrical and electronic equipment (EEE)

• Public interest: Protection of human health and the environment

• Guidelines on the RoHS Directive 2011/65/EU: FAQ key guidance document

Scope

Directive 2011/65/EU applies to electrical and electronic equipment (EEE) falling within the categories listed in Annex I unless specifically excluded under Article 2(4).

EEE means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields.

Key Regulatory Requirements

Substance Restrictions (Article 4 and Annex II)

The restricted substances currently include:

• Lead (Pb)

• Mercury (Hg)

• Cadmium (Cd)

• Hexavalent chromium (Cr VI)

• Polybrominated biphenyls (PBB)

• Polybrominated diphenyl ethers (PBDE)

• Bis(2-ethylhexyl) phthalate (DEHP)

• Butyl benzyl phthalate (BBP)

• Dibutyl phthalate (DBP)

• Diisobutyl phthalate (DIBP)

Exemptions (Article 5, Annexes III and IV)

If the concentration limits in Annex II are exceeded, the manufacturer must determine whether a valid exemption applies.

Exemptions may be established:

• in Annex III (general exemptions);

• in Annex IV (medical devices and monitoring/control instruments); or

• through delegated acts adopted under Article 5.

The manufacturer must verify:

• the applicability of the exemption;

• the scope and technical conditions of the exemption;

• the validity period; and

• the exact applications and materials covered.

Technical documentation and EN IEC 63000

Manufacturers must carry out an internal production control procedure and establish technical documentation demonstrating compliance with RoHS.

EN IEC 63000 provides a harmonised approach for the assessment of electrical and electronic products with respect to the restriction of hazardous substances.

According to EN IEC 63000, compliance documentation must exist for materials, parts, and sub-assemblies relevant for RoHS compliance.

The documentation may include:

• supplier declarations;

• material declarations;

• analytical test reports;

• contractual compliance commitments;

• certificates;

• process specifications;

• bills of materials;

• drawings and material specifications; and

• other technical records.

The type and depth of documentation should reflect the risk that restricted substances are present.

This risk-based approach requires consideration of:

• the probability of restricted substances being present;

• the complexity and criticality of the component;

• supplier reliability; and

• available historical evidence and analytical data.

The collected documentation must be:

• reviewed for correctness and plausibility;

• linked to the relevant materials, parts, and sub-assemblies; and

• maintained as part of the technical documentation.

Analytical testing may support compliance assessment but is not necessarily required for every component if sufficient documentary evidence exists.

Restricted Substances Control (RSC)

A key element of effective RoHS compliance is the implementation of Restricted Substances Controls (RSC).

RSC refers to the organisational and technical measures established by the manufacturer to ensure ongoing compliance with RoHS substance restrictions throughout the product lifecycle.

Typical RSC elements include:

• supplier qualification and monitoring;

• material declaration management;

• incoming material controls;

• change management procedures;

• product and process specifications;

• analytical verification testing;

• traceability systems;

• corrective and preventive actions;

• internal audits; and

• integration into the quality management system.

IEC TR 62476 provides guidance on the implementation of Restricted Substances Controls.

The existence of robust RSC processes is particularly important because RoHS compliance must not only be demonstrated at the time of assessment but also ensured continuously during sourcing and production.

RCE Marking and EU Declaration of Conformity

EEE covered by RoHS 2011/65/EU must bear the CE marking before being placed on the EU market as proof of conformity with the RoHS substance restrictions. The marking must be visible, legible, and indelible on the product (or data plate) and on the packaging; it may be smaller than 5 mm if still clearly visible.

Interfaces to WEEE Obligations

Electrical and electronic equipment within the scope of RoHS is frequently also subject to Directive 2012/19/EU on waste electrical and electronic equipment (WEEE).

Typical WEEE-related obligations include:

• marking of EEE with the crossed-out wheeled bin symbol;

• registration in national WEEE registers;

• financing obligations;

• information obligations towards users;

• reporting obligations; and

• obligations regarding take-back and environmentally sound disposal.

Conclusion

With SAL, the mapping as a roadmap, and consideration of interfaces to related legislation, it becomes clear how Directive 2011/65/EU (RoHS) is systematically applied.

The resulting assessment logic provides a clear and practical roadmap from scope determination and substance restrictions through exemptions, technical documentation, Restricted Substances Controls (RSC), and CE marking to related WEEE obligations.

Particular importance must be attached to:

• the establishment of technical documentation in accordance with EN IEC 63000; and

• the implementation of effective Restricted Substances Controls (RSC).

These elements are essential to demonstrate and maintain robust and sustainable RoHS compliance throughout the product lifecycle.