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17 NOVEMBER 2009 1 EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Industrial policy and economic reforms Sustainable Industrial Policy ENTR/B/1, LB-ME, D(2009) MINUTES OF MEETING Subject: Meeting of the Ecodesign Consultation Forum on voluntary agreements for medical imaging equipment and machine tools Place and date: Borschette Centre, Brussels on 17 November 2009 Chair: Martin Eifel EC participants: Laure Baillargeon, Kerstin Lichtenvort 1. Welcome and introduction THE CHAIR welcomed the participants and reminded that 2 voluntary agreements had already been discussed with the members of the Consultation Forum. Contrary to complex set top boxes and imaging equipment, the proposals for medical imaging equipment and machine tools had not been preceded by preparatory studies. In accordance with the Directive (recital 19), voluntary agreements were unilateral commitments, for which industry took full responsibility. The Commission, assisted by the Consultation Forum and the Committee, should assess the conformity with the criteria of Annex VIII, on the basis of information provided by industry. A specific format could not be imposed on industry. ECOS underlined the very diverse approaches of the 4 voluntary agreements already presented to the Consultation Forum, and asked for a general discussion on voluntary agreements to develop guidelines interpreting Annex VIII, especially its generic criteria such as monitoring and reporting, openness of participation, representativeness and involvement of civil society. This would save time for industry as well as for the members of the Consultation Forum. GERMANY asked whether voluntary agreements would be voted in the Committee. THE CHAIR explained that the Committee, when dealing with voluntary agreements, was not acting in its regulatory capacity, but in its advisory capacity. He explained that an internal discussion with DG TREN was necessary, before a feedback on these general issues could be given to the members of the Consultation Forum. 2. Medical imaging equipment COCIR presented its proposal (EDD-CF-2009-11-17-doc02). The voluntary agreement should build on existing international and European standards 1. COCIR explained that the 1 Standards dealing e.g. with measurement of energy consumption of medical imaging equipment and/or checklist of environmental parameters to be analysed at the design stage

17 NOVEMBER 2009 2 innovation cycle of medical imaging equipment was around 3 years and the useful lifetime up to 15 years, with frequent recycling and/or refurbishment (voluntary Good Refurbishment Practices GRP, had already been agreed by COCIR members). The proposed voluntary initiative gathered 11 companies and would cover 6 product categories. It would account for 80-100% of the market depending on the product category ( modality ). It based on a phased approach, where an additional product category would be addressed each year. Ultrasound equipment would be the first. For this product, analysis showed that the use phase was by far the most significant life cycle phase, mainly because of energy consumption during use. Other environmental aspects were already covered by existing legislation (e.g. WEEE, RoHS) or other voluntary practices such as GRP. COCIR members adopted a common methodology to collect data about sales and environmental impacts and to ensure their comparability and completeness. Since 2005, sales of ultrasound equipment had increased, leading to an increase in their aggregated energy consumption, despite a decrease in individual energy consumption of almost 20% (due to the shift from desktop ultrasound to laptop ultrasound). The energy consumption was calculated with a standard use pattern, which could be refined to take greater account of additional functions and use patterns. Specific targets would be set by product category: for ultrasound equipment, the objective was to reduce energy consumption by 6% by 2012, which would be a significant improvement compared to business as usual. The secretariat of COCIR would ensure continuous monitoring of progress and would report regularly to their Steering Committee. Stakeholder meetings would be organised regularly. Reports would be done on a yearly basis. The limited number of participants would facilitate monitoring. General discussion COCIR was asked to present further quantitative data about ultrasound equipment and other medical imaging equipment, in particular market statistics and figures on environmental impacts (ECOS, AUSTRIA). It should be better demonstrated whether implementation of existing legislation would be enough to fully address other environmental impacts than energy consumption, such as end of life and hazardous substances (EEB). COCIR should follow the main steps of the MEEuP, such as defining functional units and detailing technical options for improvement (NETHERLANDS, ECOS, GERMANY, BELGIUM). This would allow assessing the level of ambition of the 6% target for ultrasound equipment, and notably distinguishing between business as usual improvement, improvement in IT equipment (desktop vs. laptop) and improvement due to ecodesign actions, including energy management systems (SWEDEN, EEB). Specific targets by operating mode, by modality and by company should be set, as well as verification of results by independent third parties (BELGIUM, AUSTRIA, ECOS). COCIR members should commit to systematically use the presented Environmental Product Declaration (NETHERLANDS). The process for involving stakeholders, including Member States representatives, should be clearer (NETHERLANDS, DENMARK). Customers should be better informed about energy consumption of medical imaging equipment and COCIR members should provide information on the core environmental characteristics of their products, including end of life and recycling (AUSTRIA, GERMANY).

17 NOVEMBER 2009 3 COCIR clarified that its Ecodesign Steering Committee was open to all members of the Consultation Forum (as observers ). In its next meeting(s), the Steering Committee would ensure that the proposal is based on extensive technical background comparable as for preparatory studies. Work on the definition of functional units was ongoing in COCIR. Specific targets would be set for each modality covered by the initiative, but targets by company would imply publishing confidential market shares. COCIR explained that the Environmental Product Declaration was used, in principle, on a voluntary basis, but announced that the Ecodesign Steering Committee would soon examine the possibility that COCIR members commit to use it systematically. At least, information about the energy consumption and environmental performance of medical imaging equipment would be available in the report and Environmental Product Declarations published voluntarily by manufacturers would be posted on the COCIR website (subject to their agreement). THE CHAIR considered that the analysis done for ultrasound equipment should be refined, including detailed targets per operating mode, figures on energy consumption and detailed technical solutions for improvement. Such measures should also apply to the other modalities covered by the proposal. COCIR members should preferably commit to systematically use the Environmental Product Declaration. The admissibility of the self regulation proposal was assessed against the criteria of Annex VIII. No specific issues were raised regarding criteria, 1, 3, 5, 7 and 9. Added value and quantified and staged objectives (criteria 2 and 4 of Annex VIII) COCIR was asked to provide more background information to allow a sound assessment of its proposal on ultrasound equipment, including a base case, the variance of energy consumption of ultrasound equipment below and above the average, the method and tolerance level(s) for measuring energy consumption, stock figures in units, quantified targets beyond 2012, energy savings in absolute terms and detailed technical background on improvement options. Clear and reliable indicators and scientific and technological background data mentioned in criterion 4 of Annex VIII was missing (ECOS, BELGIUM, GERMANY). COCIR argued that no additional energy savings would happen without the proposed initiative, which was ambitious but realistic. COCIR expressed its willingness to provide the members of the Consultation Forum with more information. THE CHAIR agreed that further quantitative information was necessary to assess the actual level of ambition of the proposal (e.g. stock figures), but reminded that voluntary agreements could not be preceded by an indepth preparatory study as for Regulations, considering the principles of Better Regulation and in particular avoiding administrative burden and ensuring cost-effectiveness. Monitoring and reporting (criterion 6 of Annex VIII) ECOS asked which sanctions the Commission would apply in case of failure of the voluntary initiative, and whether the Joint Research Centre of the Commission could check the validity and accuracy of data submitted by industry. FINLAND asked when targets would be set for other modalities than ultrasound equipment and whether Member States representatives would be consulted. THE UNITED KINGDOM added that national market surveillance

17 NOVEMBER 2009 4 authorities would need more information in order to test products covered by the agreement. THE CHAIR stated that the Commission had not considered that the JRC should check data, but hoped that COCIR would be able to provide sufficient information. He explained that, although voluntary initiatives are unilateral commitments by industry, members of the Consultation Forum should be consulted each time new targets are set. In case of failure of the voluntary agreement, the Commission would urge industry to work on developing standards. This would pave the way for quicker adoption of mandatory requirements, in case the Commission would consider appropriate to legislate. He invited market surveillance authorities in charge of the Ecodesign Directive to coordinate actions with market surveillance authorities in charge of the Medical Devices Directive. The issue could perhaps be discussed in the ADCO group. Sources of data, including when audited under other Directives and related harmonised standards, should be systematically indicated by COCIR. COCIR agreed to facilitate market surveillance activities and to be proactive in establishing standards. Sustainability (criterion 8 of Annex VIII) BELGIUM asked when the voluntary agreement would be reviewed. SWEDEN asked to clarify in the report which operating modes and product features would actually be tackled by the proposal, acknowledging that safety and health remained priorities. DENMARK asked for another meeting of the Consultation Forum before the Commission could recognise the proposal. COCIR explained that the exact date of the review could not be precisely foreseen and that the 6% target was a maximum commitment given health and safety constrains. Conclusion THE CHAIR concluded that criteria 1, 3, 5, 7 and 9 were deemed to be fulfilled and that there was general concern among the members of the Consultation Forum about the proposal s level of ambition, which was difficult to assess given the large amount of missing information, notably: market statistics and stock figures in units; detailed data on energy consumption (e.g. variance, measurement method and tolerance levels); detailed description of technical solutions for improvement; specific targets by modality, by operating mode and preferably by company; targets beyond 2012; systematic indication of sources of data. A commitment by signatories to systematically use Environmental Product Declarations would be welcome. The methodology should also be refined over time. He concluded that the COCIR proposal would be acceptable in principle, if the aforementioned conditions would be fulfilled. COCIR was asked to submit an amended version of its proposal, on which the members of the Consultation Forum would be consulted by written procedure in principle, and in another meeting only if necessary. He encouraged members of the Consultation Forum to attend to meetings of the COCIR Ecodesign Steering Committee. 3. Machine tools THE CHAIR reminded that machine tools were included in the Ecodesign Working Plan, and that a preparatory study on this product group was to be launched at the beginning of January 2010.

17 NOVEMBER 2009 5 CECIMO presented its proposal (EDD-CF-2009-11-17-doc08) and explained that CECIMO gathered 1,600 companies, of which 80% were SMEs, collected extensive market statistics and provided its members with technical support for complying with safety and environmental legislation. Machine tools being highly complex investment goods, the usual functional unit had been replaced by a modularised approach. Modules integrated into machine tools (e.g. electric motors, hydraulic systems) could be either standard or improved in terms of energy efficiency. Technical improvement options could therefore be identified for each module (compared to the standard module) and the energy saving potential assessed, taking also into account improved operating modes such as stand-by and power-safe modes. The energy consumption of the real machine, based on a given scenario (combination of improved and standard modules and operating modes) would be compared with the energy consumption of the standard machine ( business as usual scenario), and the difference expressed as a percentage. The minimum requirements could therefore be expressed as a minimum percentage of improvement compared to the standard machine. The functional unit would be defined for each specific machine, whatever its size, modules and operating modes. By 2012, CECIMO members would report on the actual energy consumption of their machines (through standardised calculator and product fiches, based on standardised definition of modules and operating modes). CECIMO would then establish a list of technical improvement options by module and associated energy saving potentials. The various combinations of existing modules for all types of machine tools could lead to the identification of 2,000 sub-types of machine tools, but there would not be more than 100 technical options for improving the modules. The methodology would be supported by a measurement standard for energy consumption (ISO or CEN), which should become the international reference. Added value and quantified and staged objectives (criteria 2 and 4 of Annex VIII) The general concept and process were welcomed by participants (NETHERLANDS, AUSTRIA) but it was argued that additional quantitative information was necessary before it could be evaluated by the members of the Consultation Forum. CECIMO was asked to further develop its proposal, notably as regards sufficiently ambitious quantified targets and/or minimum requirements (ECOS, DENMARK). CECIMO was invited to cooperate closely with the contractor of the preparatory study (NETHERLANDS, AUSTRIA, ECEEE), and was asked to clarify the timeline of its initiative compared to that of the preparatory study (EEB). ECEEE stressed that an implementing measure should remain a possibility (machine tools, although complex and diverse, share some common features such as stand-by operating mode, which could easily be regulated). CECIMO expressed its willingness to cooperate closely with the contractor. CECIMO could be ready to set quantified targets by end 2011, but could also wait until end 2012 that the preparatory study is completed. They would however continue to progress quickly with its initiative, notably as regards standards (work already started in ISO and CEN). CECIMO members not complying with the quantified targets (to be discussed with the members of the Consultation Forum beforehand) would be excluded from the voluntary initiative. THE CHAIR stated that the Commission would require the contractor to have close contacts with industry and clarified that the outcome of the study

17 NOVEMBER 2009 6 would remain open. Furthermore, in case the voluntary agreement would not succeed, the Commission could choose to go ahead with legislation combined with mandating harmonised standards. He highlighted key elements of the proposal, which should be especially well documented: definition of the standard machine (which should reflect the state-of-the-art), identification of technical options for improvement of modules, and assessment of their energy saving potential. Representativeness (criterion 3 of Annex VIII) AUSTRIA asked whether all 1,600 CECIMO members would participate in the voluntary agreement and CECIMO explained that it would be easy to know the percentage of participants since manufacturers would be required to fill the product fiche(s) for their machine(s). Sustainability (criterion 8 of Annex VIII) ECOS stated that recycling and the use of natural resources deserved greater attention, the latter being significant for big machine tools (it could be added to the product fiches). GERMANY asked whether data on individual companies would be available and SWEDEN asked whether the system integration of modules, which can also have a significant impact on energy consumption, would also be taken into consideration. CECIMO explained that energy consumption in the use phase was by far the most significant impact and that existing legislation such as the WEEE Directive was already covering recycling, but declared that CECIMO would further examine whether end of life aspects could be included in the product fiches. CECIMO indicated that data on individual companies would be available but that machine models would remain anonymous, for confidentiality reasons. Conclusion THE CHAIR concluded that this innovative proposal was welcomed by the members of the Consultation Forum, although it would need to be further developed. Much work would still be necessary to collect information on modules and machine models, sales and stock figures, and to establish measurement standards. CECIMO could progress quickly while cooperating with the contractor of the preparatory study. The report would help the Commission and the members of the Consultation Forum to assess the future proposal.