Electrical and Electronic Equipment

Progress on environmental measures that may affect devices

There is currently much work being done at EU level to reduce the environmental impact of products by minimising degradation caused by their handling at all phases of their life-cycles. This is being undertaken under the umbrella of the Integrated Product Policy (IPP), a strategy which was outlined in a European Commission communication adopted in June 2003^1,2. It involves:

• identification and launching of pilot projects on particular products on the basis of stakeholder suggestions to the Commission (comments accepted until October 2003);
• a handbook on best practice with life-cycle assessment (LCA), due in 2005;
• a discussion document on the need for product design obligations on producers, due in 2005;
• a Commission action programme for `greening' its procurement, due in 2006; and
• identification of a first set of products with the greatest potential for environmental improvement and the beginning of action to tackle them, due in 2007.

Electronic and electrical medical devices fall under the scope of some of the measures suggested under the IPP and the progress to date of a number of initiatives is outlined below.

Eco-design requirements for energy-using products

One of the projects under the IPP is a framework directive for the setting of eco-design requirements for energy-using products (previously referred to as the End Use Equipment Directive - EuE Directive³), and on 9 September 2003 the Commission adopted a proposal for the framework^4,5. This directive will define the conditions and criteria for setting requirements regarding environmentally relevant product characteristics and will require such equipment to be CE marked and supported by a declaration of conformity with the implementing measures for its specific product group (to be adopted at a later date by the Commission). It is not yet clear whether this directive will apply to medical devices as the Commission points out that not `all energy consuming products will be obliged to apply eco-design criteria, rather, those products that show sufficient scope for environmental improvement'. As previously mentioned in RAJ Devices the European Coordination Committee of the Radiological and Electromedical Industry (COCIR) has suggested that the products of the medical device industry do not qualify<sup>3</sup>. The Environmental Focus Group of the European Medical Technology Industry Association, Eucomed, is also studying the proposal at present and is to discuss it again at its meeting in mid-November 2003, with a view to formulating a position<sup>6</sup>. Although the directive notes that `end-of-life management is a major constituent' for medical devices, specific inclusion/exclusion of product types will not take place at this point. The directive states that `instead of trying to define a restricted scope, it is proposed that the framework directive lay down eligibility criteria for adopting implementing measures'.

Amendment of financial responsibility for `historical WEEE'

Also part of the IPP is the recently adopted directive governing waste electronic and electrical equipment (WEEE Directive )³. On 1 October 2003, the Parliamentary Committee on Environment, Public Health and Consumer Policy (ENVI) adopted a report approving unchanged a proposal to amend a key provision of the directive on the financing of the collection, treatment, recovery and recycling of WEEE from businesses and other non-household users, and on 21 October 2003 the European Parliament adopted its opinion under the first reading. This amendment is being made in fulfilment of a promise, made on adopting the directive, to examine this issue and make any necessary amendments to the directive⁷. The proposal would transfer the responsibility for the financing of these activities for products placed on the market before the provisions come into force on 13 August 2005 (historical waste), from producers of these products to the producers of replacement equipment or, if the equipment is not being replaced, to the end user.

In relation to this the Commission has issued a mandate to the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC) and the European Telecommunications Standards Institute (ETSI), to develop standards for a mark on appliances to identify when a product is placed on the market, and by whom⁸. The mark is intended to provide the basis for the proper apportionment of liability of producers for the costs of collection and treatment.

Environmental aspects of standardisation

Finally, the Commission has recently published the results of a consultation exercise on a proposed communication on the integration of environmental aspects into European standardisation⁹. The IPP refers to standardisation as a potential tool to reduce the environmental impacts of products, and European standards are thought to be potentially helpful in establishing methods for measuring or, in some cases, better describing environmental parameters under the measures to be implemented through the framework directive for the setting of eco-design requirements for energy-using products (see above). The feedback obtained from the consultation will feed into the extended impact assessment which is already underway for the communication and will help to finalise the text of the communication itself and to make sure that it will cover the main issues in a balanced and appropriate manner.

References

1. Communication from the Commission to the Council and the European Parliament - Integrated Product Policy, Building on Environmental Life-Cycle Thinking, COM(2003) 302 final, 18 June 2003

2. Commission press release, IP/03/858, 18 June 2003

3. The Regulatory Affairs Journal - Devices, 2003, 11 (2), 92-94

4. Proposal for a Directive of the European Parliament and of the Council on establishing a framework for the setting of Eco-design requirements for Energy-Using Products and amending Council Directive 92/42/EEC, COM(2003) 453 final, COD/2003/0172

5. Commission press release, IP/03/1223, 9 September 2003

6. Personal communication, Eucomed, 12 September 2003

7. Proposal for a Directive of the European Parliament and of the Council amending Directive 2002/96/EC on waste electrical and electronic equipment, COM/2003/0219 final, COD 2003/0084, 29 April 2003

8. European Association for the Co-ordination of Consumer Representation in Standardisation (ANEC) Newsletter, Number 53, July/August 2003, www.anec.org

9. The integration of environmental aspects into European standardisation: Public consultation, 2 October 2003, www.europa.eu.int/comm/environment/standardisation/index_en.htm