European Regulation of Consumer Product Safety book

United Kingdom

This is the first detailed study of EU regulatory controls on a wide range of consumer products. The analysis ranges widely, over the vertical regimes the cover pharmaceuticals, cosmetics, biocides, tobacco and products covered by the Community's New Approach (including medical devices, machinery, toys, electrical products, personal protective equipment and so on), and the horizontal regime for consumer products under the General Product Safety Directive.

The book analyses the various mechanisms found in these different pieces of legislation that are used to control safety. It points out that the various regulatory regimes, and safety mechanisms, were not planned as part of a coherent approach, but do display broad similarities of approach, although a different range of mechanisms are found for all product sectors.

The book draws the following main conclusions. First, the legal basis of all the European Community legislation on product safety is that of ensuring harmonized trading rules within the EU internal market. The issue that is raised is whether such an approach will prove to be satisfactory in ensuring product safety, if issues of trade rather than safety are the explicit governing legal principles. Should the legal basis be changed so as to explicitly be that of achieving safety in use?

Secondly, there is a total absence of conformity in the tests specified in the legislation that authorise the placing on the market, or withdrawal from the market, of the different product types. Quite different language is used for such tests in the different Directives governing different product sectors, and there is a lack of consistency. Whilst these tests, and the legislation as a whole, are clearly aimed at ensuring safety, the concepts used are inconsistent both with that aim and with each other. Should they not be standardised?

That lack of coherence reflects the third problem, which is that there is no agreement on what level of safety should apply. Statements by the media and politicians tend to give the impression that no product should ever cause harm. Yet absolute safety is unattainable in practice. Dr Hodges calls for greater public understanding of the risks and benefits of using products, and greater public debate about what level of safety is acceptable. Should different levels of risks be acceptable for different products, particularly if they offer differing benefits.

Many decisions on safety issues involve fine judgements by experts in balancing extensive and technically complex information. The European system involves many expert committees. The involvement of experts brings advantages but raises issues of transparency and democratic accountability and problems of communicating complex information to ordinary people. How should these problems be overcome?

The ongoing maintenance of public safety is the responsibility of surveillance and enforcement authorities. Yet the European systems rely on a confusing matrix of Community and national competent authorities, and on semi-private notified bodies. Issues arise of inadequacies or inconsistencies in competence, communications and coherence in both policies and operations, which need to be addressed.

In particular, there are strong arguments for streamlining various bodies into a coherent European Product Safety Agency. This would require greater operational power than most European Agencies are currently granted, since they are currently merely advisory and competence is retained by the Commission. This is a curious system, since the Commission has neither expert competence or resources nor sufficient democratic responsibility.