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Follow UsUK: Here is a clarification of the scope and definitions on the new RoHS2 directive.
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. Implementation 2014 thro’ 2017.
* 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.
Why is it being proposed?
* A harmonised scope improves implementation of the directive and the proper functioning of the internal market;
* Medical devices and control and monitoring instruments are included to reap the environmental and health benefits from the reduction of use of hazardous substances in such equipment but in a staged manner so that adverse socio-economic impacts are avoided;
* Harmonised definitions coherent with related Community legislation will enhance legal clarity and reduce administrative cost.
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.
Why is it being proposed?
* Four substances have been identified as presenting potential environmental risks when used in electrical and electronic equipment. These substances need to be kept under close scrutiny in view of a possible future inclusion in the list of banned substances;
* Permission to use non-compliant spare parts in equipment which benefitted from an exemption is necessary to prevent premature withdrawal of equipment from use;
* The exemptions for medical devices and control and monitoring instruments are justified as substitution is currently not feasible.
C. Exemption mechanism:
What is proposed?
The four-year review has been replaced with a four-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.
Why is it being proposed?
* The 4-year maximum validity period for the exemptions should stimulate substitution efforts, provide legal security and shift the burden of proof to the applicant, in line with REACH.
* New criteria such as availability and reliability for granting exemptions are being introduced to take into account broader socio-economic aspects.
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).
Why is it being proposed?
* Reducing the number of non-compliant products through strengthened and harmonised market surveillance is a cost effective way for increasing the environmental benefits provided by the directive;
* Harmonised conformity assessment requirements increase legal certainty and reduce administrative cost for Member States and manufacturers.
The author is Customer Support Manager, Legislation and Environmental Affairs, Premier Farnell.