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Q&A on the revised directive on RoHS

No. 43/2008 Description of main measures
A. Clarification of the Scope and Definitions

What is proposed? Two new annexes describing the scope of the directive have been added, the first describing the broad product categories and the second, amendable by the Commission, providing binding product lists within each category

Medical devices and monitoring and control instruments are included in the scope in a staged manner

The definitions for economic operators are aligned to the "Marketing of products" package and new definitions, such as for "medical devices" and "homogeneous material" are added B. Substance Ban
What is proposed? The current directive's list of banned substances and the maximum concentration values are moved to an Annex to be amended through comitology

The list of banned substances is not changed, however, 4 substances are identified for priority assessment in view of a possible future inclusion in the list of banned substances

Permission to use non-compliant spare parts is extended to equipment benefitting from an exemption when placed on the market

A new annex with exemptions specific to the new product categories (medical devices and control and monitoring instruments) is added for cases where substitution is currently not feasible

A mechanism for introducing new substance bans in line with the REACH methodology is inserted to ensure coherence and maximise synergy with the work carried out under the chemicals' legislation C. Exemption mechanism

What is proposed? The 4-year review has been replaced with a 4-year maximum validity period for exemptions, with a possibility of requesting renewals

New exemption criteria have been introduced covering the availability and reliability of substitutes and the inclusion of socio-economic impacts

The Commission now has a mandate to establish detailed rules for exemption requests to establish legal certainty for economic operators pending a Commission decision on a renewal request D. Product conformity assessment requirements and market surveillance mechanisms

What is proposed? Articles 7-17 are new and introduce product conformity assessment requirements and market surveillance mechanisms in line with the "Marketing of products" package (Commission decision 768/2008/EC on a common framework for the marketing of products).
Information Source
RoHS II Q&A SGS Taiwan LTD. Taipei Multi Chemical Laboratory t: +886 2 2299 3279
f: +886 2 2299 3237
SGS Taiwan SGS Taiwan LTD. Kaohsiung Multi Chemical Laboratory t: +886-7-3012121
Ext. 4101 ~ 4106
f: +886-7-3010867

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