| Front page | | Contents | | Previous | | Next |

The New Approach in Setting Product Standards for Safety, Environmental Protection and Human Health

Summary and conclusions

The New Approach has proven an effective and flexible instrument for developing a number of product standards aimed at providing a high level of protection for the public, particularly with respect to product safety. At the same time, concerns have been raised with respect to certain applications of the New Approach, particularly where long-term impacts on human health and environmental protection may be in question and where political decisions may be required.

In recent years, the debate among stakeholders concerning the role of the New Approach to develop health or environment-related standards has become highly polarised. It is in this context that the Workshop on the New Approach in Setting Product Standards for Safety, Environmental Protection and Human Health (Copenhagen, 29-30 November 2001) was convened, with the aim of bringing all parties together for constructive discussions on possible solutions.

In the final plenary discussion of the Workshop, one participant described conventional legislation as not just the "Old" Approach, but as the "Stone Age" approach. Use of this imagery in New Approach discussions conveys two concepts. The first is one of transience: different forms succeeding each other as time progresses. The other is the implicit concept of progress: that each succeeding form is in some way superior to the form that it supersedes.

From the discussions that took place at the Copenhagen Workshop, it can be concluded that neither concept is valid. However "Stone Age" and "Old" are defined, there is still a natural role for different types of legislation, coexisting and relevant in their own context. For example, in areas where there is either a high risk or where restrictions could have high costs for certain sections of society, significant political decisions may be required. There is general agreement that such decisions should not be delegated to the private standardisation organisations such as CEN, CENELEC and ETSI. At the same time, there is general consensus concerning the need to complement traditional regulation with other mechanisms, and to achieve more balance among the different forms of regulation.

It is important to recognise the significant differences that exist between conventional regulation and the New Approach. For those areas where the EU has not yet enacted legislation or where EU legislation has been adopted under Article 175 of the Treaty, Member States may strengthen conventional regulations according to national needs, in particular to address special concerns for the environment. But New Approach Directives have until now been adopted under Article 95 of the Treaty. Since they are aimed at achieving the internal market, they do not permit Member States to enact stronger national regulations in those areas.

In some cases, conventional "command and control" legislation may be required. A very recent example is the Restrictions on Hazardous Substances Directive proposed for the control of hazardous substances in electrical and electronic waste. In other cases, technical requirements may need to be developed in intergovernmental forums, such as an EU or other governmental working groups comprising Member States representatives together with other stakeholders. This can be a viable solution in situations where it is not possible to draw a clear line between political and technical issues.

Nor is the New Approach a static, well-defined concept. For example, one European Commission official suggested that the Packaging and Packaging Waste Directive - listed as a New Approach Directive in official Commission reviews of the New Approach -- should not be regarded as a conventional New Approach Directive. Indeed, the essential requirements of this Directive do not address issues of safety in the conventional sense at all, but rather relate to the manufacturing and composition of packaging, its potential for reuse and the possibility of recovering the waste.

At the same time, other Directives not considered New Approach Directives share a number of characteristics of such Directives, as per several examples set forth in the background papers prepared for Session I of the Workshop.

In short, the image of the New Approach as a well-defined entity, replacing and superseding earlier forms of less satisfactory legislation, is not a conclusion that can be sustained on the basis of the Workshop discussions. Rather, the New Approach is a successful legislative initiative that has functioned well in the many years it has been used to develop safety standards for specific product groups.

The New Approach has evolved since its original introduction more than 16 years ago, and a narrow definition of this legislative instrument hardly does justice to the different ways in which it has led to the incorporation of standardisation as a part of current EU legislation. This evolution is likely to continue.

For example, although product safety issues were tendentious when the New Approach was first used to develop standards in this area, these issues have become less and less so with time, and are no longer regarded as especially problematic. The creation of a technical forum with all relevant parties actively involved in a process of finding consensus solutions has almost certainly helped to foster this development. The framework Product Safety Directive and the Product Liability Directive are also contributing factors.

Such a development could also occur with respect to human health and environmental protection concerns. However, the difficulties experienced by environmental interest groups in participating in standardisation working groups and in raising environmental awareness in the development of standards, together with the absence of general environmental liability legislation, would suggest that progress in this direction is unlikely to be easy.

In the application of standardisation with respect to the Packaging and Packaging Waste Directive, the process was complicated by an inadequate recognition of the different roles of the two parties involved -- the legislative system’s duty to find solutions to political issues, and the standardisation bodies’ duty to find solutions to technical issues. A particular problem was the lack of appropriate feedback mechanisms between the two entities.

If standardisation bodies are to be used in future to agree technical solutions in areas of political polarisation, better mechanisms will need to be developed to ensure that the different issues are resolved in the appropriate context.

Several speakers underlined the increasingly important role of the International Organization for Standardisation (ISO) in the standardisation process. This is clearly a tendency that is likely to increase in the future, with the European Committee for Standardisation (CEN) playing a role as a regional standardisation organisation in wider, global agreements. Development of legislation involving standardisation needs to recognise this, and ensure that European Union developments can contribute to wider ranging solutions without becoming technical barriers to trade.

The "Stone Age" Approach, the "Old" Approach and the "New Approach" can perhaps be better seen as developments, where the legislative repertoire has evolved, and become enriched by more and more refined instruments, with their own particular strengths and weaknesses. Seen from this perspective, the art in developing new legislation is to ensure that the most relevant form of instrument is chosen.

The range of approaches available was highlighted in the session on the use of the New Approach in developing innovative solutions to reduce the environmental impacts of products. The issue was not whether legislation to encourage innovation towards environmentally more friendly products should strictly follow the New Approach. Rather, there was recognition that the elements already in use for encouraging environmental innovation in products – ranging from bans on substances to market-based incentives such as eco-labelling – could be supplemented and improved by elements of the New Approach.

For example, in the context of the Commission’s working paper including a draft text for a directive on Electrical and Electronic Equipment (EEE)², it was argued that in the case of broad product groups, where specific environmental concerns were not yet clearly defined, the use of the New Approach to set performance (i.e., management) standards could play an important role in encouraging life cycle thinking in product design. Transparency of information and solid documentation could be driving forces for management-based systems that lead to environmental innovation. As knowledge and experience was gained, more definitive product standards and/or legislative requirements could then be set in place.

Several participants emphasised the need to continue to set essential requirements as minimum standards for placing a product on the Internal Market. Others called for framework legislation placing responsibility on producers for the environmental safety of their products. Product-oriented environmental management systems (POEMS) were applauded as a way to encourage environmental thinking at the design and production stages.

Development of comparable and verifiable benchmarks for environmental innovation in product design, based on LCA-derived criteria for specific product groups and linked to a system of environmental product declarations (EPDs), could enable consumers to make more informed choices and encourage producers towards more environmental innovation. The EU eco-labelling criteria agreed by the EU Eco-labelling Board (EUEB) could serve as benchmarks. Alternatively, benchmarks could be defined by standardisation working groups or even specially convened product panels.

One vision put forward at the Workshop was a system of EPDs within a legislative framework that minimum health and environmental protection requirements, perhaps via the "New Approach". The benchmarks set within this system would go even beyond eco-labelling criteria, thus helping to drive producers towards more environmental innovation.

From workshop discussions it emerged that the following elements in combination might enable the New Approach and standardisation to go beyond conventional regulation and to stimulate environmental innovation:

	mandatory minimum requirements to establish definitions, common understanding, and a minimum level of environmental protection (where possible, within a product group);
	voluntary but verifiable schemes such as benchmarking to inspire the market to compete specifically on environmental parameters;
	mutually agreed scientific fundament for identification of criteria based on an LCA methodology;
	systems such as EPDs and POEMS to stimulate a flow of reliable data throughout the product chain, thereby providing minimum data quality, reliability and openness between stakeholders in the market;
	groups of experts, comprising different stakeholders, to assess and refine product criteria on technically sound bases, so as to ensure independently set parameters;
	consultation among stakeholders at all relevant levels of the standard-setting process;
	economic instruments provided at EU and national level to encourage innovation in the private sector, including small and medium sized enterprises.

In this context, the "New Approach" can be seen as an organic legislative instrument. Its use in the areas where it has traditionally been applied has proved its usefulness. Its adaptability, as seen in the many areas where elements of the approach have been used, underlines its ability to be used, where necessarily modified, in a wider context.

In the background papers prepared for the Workshop, some of the questions raised for discussion suggested a choice to be made between alternative forms of legislation that were mutually exclusive. Perhaps the art of finding appropriate solutions lies rather in finding appropriate combinations of instruments in the existing legislative repertoire to be used to address the different issues, rather than insisting on the exclusive appropriateness of any one form of legislation.