Explanatory Memorandum to COM(2008)809 - Restriction of the use of certain hazardous substances in electrical and electronic equipment (recast) - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2008)809 - Restriction of the use of certain hazardous substances in electrical and electronic equipment (recast). |
|---|---|
| source | COM(2008)809  |
| date | 03-12-2008 |
Grounds for and objectives of the proposal Directive 2002/95/EC (RoHS Directive) aims to restrict hazardous substances in electrical and electronic equipment so as to contribute to the protection of human health and the environmentally sound recovery and disposal of waste electrical and electronic equipment. Its review is being carried out for two main reasons: 1. The Commission is committed to developing a better regulatory environment, one that is simple, understandable, effective and enforceable. The regulatory environment in which businesses operate influences their competitiveness, and their ability to grow and create jobs. The aim for better regulation is an important element in the EU’s Partnership for Growth and Jobs (Lisbon) strategy. There is room to improve the Directive in terms of implementation, enforcement and coherence. 2. The RoHS Directive calls on the Commission to review the measures provided for in the Directive in particular with regard to the inclusion of two additional categories of equipment in the scope (categories 8&9 : medical devices and monitoring and control instruments) and the adaptation of the list of restricted substances The objectives of the proposal are a clearer Directive that is simpler in its operation, improved enforcement at national level, adaptation to technical and scientific progress and coherence with other pieces of Community legislation.
General context Uncertainty about the scope, lack of clarity on legal provisions and definitions as well as disparities in Member States' approaches to product compliance and potential duplication of procedure with other pieces of EU legislation such as REACH generate unnecessary administrative costs. If the RoHS Directive is not reviewed, environmental benefits reaped from the legislation will remain sub-optimal; uncertainty among manufacturers about legal requirements for demonstrating compliance with the RoHS Directive and about enforcement methodologies in the 27 Member States will persist, maintaining or increasing administrative burden.
Existing provisions in the area of the proposal The acts related to the present proposal are the RoHS Directive itself.
Consistency with the other policies and objectives of the Union The RoHS review will enhance its complementarity and coherence with other relevant Community legislation, such as the 'Marketing of Products Package' i of legislation (regarding definitions and enforcement), REACH i (regarding the use of substances), the EuP Directive i (regarding the design of electrical and electronic equipment (EEE)) and legislation related to management of waste from EEE. It is aimed to reduce the administrative burden and make the RoHS Directive more cost effective.
Consultation of interested parties
Consultation methods, main sectors targeted and general profile of respondents Two stakeholder consultations have been launched via the EUROPA website. The first stakeholder consultation (22 March – 22 May 2007) invited for comments and information supply on potential RoHS Directive review topics. A second stakeholder consultation (13 December 2007 – 13 February 2008) was held with the main purpose of receiving feedback and information on proposed policy options during the first stakeholder event.
Summary of responses and how they have been taken into account The responses to the consultations covered a large stakeholder and geographical spectrum and there were considerable variations in the extent and quality of the contributions. In the first consultation (49 respondents), industry stakeholders focused on the need of streamlined and harmonised implementation (in particular with regard to scope and demonstration of compliance) and that of speeding up the exemptions mechanism. NGOs called for enhancing the environmental and health benefits of the Directive. In the second consultation (62 respondents) stakeholders responded in detail giving a clear idea as to their preferences on the individual options, and on the future orientations of the RoHS Directive in general. Some suggested phasing out of the RoHS Directive and entrusting the hazardous substances management to REACH, but the vast majority of stakeholders did not share this view. In general, stakeholders submitted ideas for clarifying concepts and reducing uncertainties. The results of the consultations are available at ec.europa.eu/environment/waste/weee
Scientific/expertise domains concerned A study regarding the possibility of including medical devices monitoring and control instruments, as requested by Article 6 of the RoHS Directive, was carried out in 2006 i. A study examining the need and feasibility of regulating under RoHS additional hazardous substances as required by Articles 4 i and 6 of RoHS Directive, was finalised in June 2008. A service contract to assist the Commission services with technical aspects of the impact assessment was finalised in July 2008. A study focusing on innovation and competition aspects of the WEEE and RoHS review was finalised in April 2008 i. The only substance for which updated science justified examining whether it should be removed from the ban is Deca-BDE. Since 2002, the use of Deca-BDE in EEE has been restricted by the RoHS Directive. In 2005 Deca-BDE was exempted from the restriction of use by Commission Decision 2005/717/EC.[6] On 1st April 2008, the European Court of Justice annulled the exemption decision in this respect, but maintained its effects until 30 June 2008 inclusive i. Since the 1st of July 2008 the original restriction of use of Deca-BDE in EEE applies again. In the present proposal, Deca-BDE remains included in the list of banned substances (Annex IV). There remain uncertainties about its toxicity and degradation to other banned substances (debromination to PBT/vPvB substances). The risk assessment concluded that there is no need for risk reduction measures beyond those which are being applied already with regard to risk to consumers, human health (physico-chemical properties), risks to the atmosphere and risks to micro-organisms in the sewage treatment plant, and that there is a need for further information and or testing with respect to risks to workers, to humans exposed via the environment and to the aquatic and terrestrial ecosystem, in order to adequately characterise the concerns regarding the persistent, bio-accumulative and toxic properties of the substance.[8] Commission Regulation 565/2006 required further studies to be carried out for the purpose of risk evaluation, including on developmental neurotoxicity, human bio-monitoring and environmental monitoring programmes.[9] The risks caused by the use of Deca-BDE in EEE are aggravated by recent findings i about uncontrolled dumping of waste in the EU and in particular about illegal trade of WEEE to countries with sub-standard waste management conditions. User industry can apply for temporary exemptions from the ban following the criteria of Article 5(1)(b) of the present proposal. In line with what is envisaged in Recital 7 of the present proposal, the current restriction of use will be kept under review and, if necessary, will be adjusted to take account of new technical and scientific information.
Methodology used The methodology used for the above mentioned studies included surveys, literature research, interviews with industry and Member States' enforcement authorities' and industry representatives. Moreover, technical workshops with stakeholders were held.
Main organisations/experts consulted Industry federations and individual companies, NGOs and Member States.
Key points of advice received and used include harmonisation of requirements, clarification and simplification of the Directive, improvement of exemptions' mechanism and inclusion of medical devices and control and monitoring instruments in the scope.
Means used to make the expert advice publicly available Publication of final reports on the EUROPA website.
Impact assessment The options considered included: not to make any clarifications or additions in the scope or definitions; to repeal the Directive altogether; to release a substance (DecaBDE) from the ban and to extend the list of restricted substances. They were rejected because the impact assessment showed that they would result in suboptimal benefits from the review of the Directive or because the potential costs outweighed the benefits. It is recommended to introduce clarifications and enforcement-related clauses, to align provisions where possible with other pieces of Community legislation such as REACH, to adapt the exemption mechanism and to include two new categories of equipment. The expected benefits are environmental (reduction of quantities of hazardous substances released in the environment from medical devices and control and monitoring instruments, reduction of number of non-compliant products in the market) and economic (reduction of administrative burden, avoidance of duplication of procedures, and increase of legal certainty).
The proposal has been subject to an impact assessment listed in the Commission's Legislative and Work Programme.
Contents
Summary of the proposed action It should be noted that the basic objectives and mechanisms of this Directive have not been changed. The ultimate aim is the elimination of certain hazardous substances from electrical and electronic equipment; where this is temporarily not possible, exemptions are granted. No new substances are proposed to be banned. The main proposed modifications are as follows: Article 2 (scope): Two new annexes describing the Directive scope are added, the first describing the broad product categories and the second, amendable by the Commission, providing binding product lists within each category. A harmonised scope improves implementation of the Directive and reduces administrative burden. 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 socioeconomic impacts are avoided Article 3 (definitions): 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. Harmonised definitions, coherent with related Community legislation enhance legal clarity and reduce administrative cost. Article 4 (substance ban): Maximum concentration values for the banned substances are set (incorporation in the Directive of a Commission Decision) and permission to use non-compliant spare parts is extended to equipment benefitting from an exemption when placed on the market, to prevent premature withdrawal of equipment from use; 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. Detailed rules of this process will be developed through comitology. When developing these detailed rules, the Commission will give priority to using the expertise available at the European Chemicals Agency (ECHA). The Commission will invite ECHA to evaluate the substances concerned as a priority. Article 5 (exemptions mechanism) : a 4-year maximum validity period for the exemptions is set to 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 introduced to take into account broader socio-economic aspects; a mandate is given to the Commission for establishing detailed rules for the applicants to apply when requesting an exemption for facilitating them and speeding the scrutiny process. Articles 6-8 are new and introduce product conformity assessment requirements and market surveillance mechanisms in line with the 'Marketing of products' package. Reducing number of non-compliant products through strengthened and harmonised market surveillance is a cost effective way for increasing the environmental benefit of the Directive; harmonised conformity assessment requirements increase legal certainty and reduce administrative cost for Member States and manufacturers
Legal basis Article 95 of the Treaty.
Subsidiarity principle The subsidiarity principle applies insofar as the proposal does not fall under the exclusive competence of the Community.
The objectives of the proposal cannot be sufficiently achieved by the Member States for the following reasons:
Environmental impacts of electrical and electronic products and their free movement in the internal market are shared competences between the Community and the Member States;
Reduced environmental protection and problems in the internal market might result in case of individual initiatives from the Member States.
Community action will better achieve the objectives of the proposal for the following reasons:
The transnational nature of the problems makes them appropriate for being regulated at Community level; harmonisation of requirements for manufacturers and authorities throughout the Community will increase cost-efficiency and foster simplification.
The need for more advanced harmonisation of the RoHS requirements can only be addressed through a recast of the Directive; simplification of EU legislation can only take place at Community level.
Fragmented national RoHS-related administrative requirements would increase cost of compliance for manufacturers.
This recast is an integral part of developing a better regulatory environment at Community level.
The proposal therefore complies with the subsidiarity principle.
Proportionality principle The proposal complies with the proportionality principle for the following reasons:
The proposed measure is the recast of an existing Directive on the points indicated by Council and European Parliament. It is also part of the simplification exercise and increases coherence and synergies with other relevant Community legislation affecting the same products.
The clarifications on scope and definitions, the introduction of harmonised enforcement-related clauses and the improvement of the mechanism for granting exemptions to the restrictions will increase legal certainty and reduce administrative burden.
Proposed instruments: Directive.
Other means would not be adequate for the following reasons: The proposed measure is a recast of an existing Directive; it incorporates, as necessary, elements from guidance documents, the harmonisation effect of which was deemed insufficient. Self-regulatory activities only would not be sufficient for achieving the policy objectives; the option of repealing the Directive was examined and discarded during the impact assessment.
The proposal has no implication for the Community budget.
Simplification
The recast proposal provides for simplification of legislation: simplification of administrative procedures for public authorities (EU and national); simplification of administrative procedures for private parties.
It clarifies definitions and scope; harmonises compliance assessment of products and market surveillance activities; adapts and improves the efficiency of the mechanism for granting exemptions to technical and scientific progress.
Structured coordination of market surveillance authorities and activities (including exchange of information), clarification of scope and definitions and streamlining of the mechanism for granting exemptions will facilitate the work of the authorities in implementing and enforcing the Directive.
Clarifications on scope and definitions will facilitate decisions on whether a given product falls within and the scope and which measures must be taken for achieving compliance; harmonising conformity assessment procedures gives to manufacturers legal certainty as to what they have to provide as proof of compliance to the authorities throughout the Community.
The proposal is included in the Commission's rolling programme for up-date and simplification of the acquis communautaire and its Work and Legislative Programme under the reference 2008/ENV/001.
Recast of existing legislation The adoption of the proposal will lead to the recast of existing legislation, namely the existing Directive 2002/95/EC. As the Annex V listing exemptions from the substance ban of Article 4 i of the RoHS Directive is being updated on regular basis according to technical and scientific progress through the comitology procedure, this Annex is not part of the current co-decision proposal.
The proposal does not include a review clause. However, the Commission will closely monitor the need for revision, in light of the outcome of the review carried out under Article 138 i of Regulation (EC) No 1907/2006.
Correlation table The Member States are required to communicate to the Commission the text of national provisions transposing the Directive as well as a correlation table between those provisions and this Directive.
European Economic Area The proposed act concerns an EEA matter and should therefore extend to the European Economic Area.
ê 2002/95/EC (adapted)