1.1.3 「ニューアプローチ」及び「グローバルアプローチ」

The Cassis de Dijon case is well known for its important role in promoting the mutual recognition principle but it also played an immense role in modifying the EU approach to technical harmonisation on three fundamental counts:

—in stating that Member States could only justify forbidding or restricting the marketing of products from other Member States on the basis of non-conformity with ‘essential requirements’, the Court opened a reflection on the content of future harmonisation legislation: since non-respect of non-essential requirements could not justify restricting the marketing of a product, such non-essential requirements need no longer figure in EU harmonisation texts. This opened the door to the New Approach and the consequent reflection on what constitutes an essential requirement and how to formulate it in such a manner that conformity can be demonstrated;

—in stating this principle, the Court clearly placed the onus on national authorities to demonstrate where products did not conform to essential requirements but it also begged the question of the appropriate means for demonstrating conformity in a proportionate manner;

—by noting that Member States were obliged to accept products from other Member States except in circumscribed conditions, the Court identified a legal principle but did not produce the means to create the trust in the products that could help authorities to accept products they could not vouch for. This led to the need to develop a policy on conformity assessment.

The New Approach legislative technique approved by the Council of Ministers on 7 May 1985 in its Resolution on a new approach to technical harmonisation and standards (11) was the logical legislative follow up to the Cassis de Dijon case. This regulatory technique established the following principles:

—Legislative harmonisation should be limited to the essential requirements (preferably performance or functional requirements) that products placed on the EU market must meet if they are to benefit from free movement within the EU;

—The technical specifications for products meeting the essential requirements set out in legislation should be laid down in harmonised standards which can be applied alongside the legislation;

—Products manufactured in compliance with harmonised standards benefit from a presumption of conformity with the corresponding essential requirements of the applicable legislation, and, in some cases, the manufacturer may benefit from a simplified conformity assessment procedure (in many instances the manufacturer’s Declaration of Conformity, made more easily acceptable to public authorities by the existence of the product liability legislation).

—The application of harmonised or other standards remains voluntary, and the manufacturer can always apply other technical specifications to meet the requirements (but will carry the burden of demonstrating that these technical specifications answer the needs of the essential requirements, more often than not, through a process involving a third party conformity assessment body).

The operation of Union harmonisation legislation under the New Approach requires harmonised standards to offer a guaranteed level of protection with regard to the essential requirements established by the legislation. This constitutes one of the major preoccupations of the Commission in pursuit of its policy for a strong European standardisation process and infrastructure. Regulation (EU) No 1025/2012 on European Standardisation (12) gives the Commission the possibility of requesting, after consultation with the Member States, the European standardisation organisations to draw up harmonised standards and it establishes procedures to assess and to object to harmonised standards.

Since the New Approach calls for common essential requirements to be made mandatory by legislation, this approach is appropriate only where it is possible to distinguish between essential requirements and technical specifications. Further, as the scope of such legislation is risk-related, the wide range of products covered has to be sufficiently homogeneous for common essential requirements to be applicable. The product area or hazards also have to be suitable for standardisation.

The principles of the New Approach laid the foundation for European standardisation in support of Union harmonisation legislation. The role of harmonised standards and the responsibilities of the European standardisation organisations are defined in Regulation (EU) No 1025/2012 together with relevant Union harmonisation legislation.

The principle of reliance on standards in technical regulations has also been adopted by the World Trade Organisation (WTO). In its Agreement on Technical Barriers to Trade (TBT) it promotes the use of international standards (13).

The negotiation of the first Union harmonisation texts under the New Approach immediately highlighted the fact that the determination of essential requirements and the development of harmonised standards were not sufficient to create the necessary level of trust between Member States and that an appropriate horizontal conformity assessment policy and instruments had to be developed. This was done in parallel to the adoption of the directives (14).

Hence in 1989 and 1990 the Council adopted a Resolution on the Global Approach and Decision 90/683/EEC (updated and replaced by Decision 93/465/EEC) (15) laying down the general guidelines and detailed procedures for conformity assessment. These have now been repealed and updated by Decision No 768/2008/EC of 9 July 2008 on a common framework for the marketing of products (16).

The major thrust of these policy instruments was to develop common tools for conformity assessment across the board (for both regulated and non-regulated areas).

The policy on product standards was first developed to ensure that the standards set technical specifications to which conformity could be demonstrated. However, at the request of the Commission, CEN and CENELEC adopted the EN 45000 series of standards for the determination of the competence of third parties involved with conformity assessment. This series has since become the EN ISO/IEC 17000 harmonised series of standards. Under the New Approach legislation a mechanism was set up whereby national authorities notified the third parties they designated to carry out conformity assessments based on recourse to these standards.

On the basis of ISO/IEC documentation, the Council in its Decisions developed consolidated conformity assessment procedures and the rules for their selection and use in directives (the modules). The modules are set out in a manner to favour their selection from the lightest (‘internal control of production’) for simple products or products not necessarily presenting serious risks, moving to the most comprehensive (full quality assurance with EU-design examination), where the risks are more severe or the products/technologies more complex. In order to face up to modern manufacturing processes, the modules foresee both product conformity assessment processes and quality management assessment, leaving the legislator to decide which are the most appropriate in each sector, as it is not necessarily effective to provide for individual certification for each mass produced product, for example. To reinforce the transparency of the modules and their effectiveness, at the request of the Commission, the ISO 9000 series of standards on quality assurance were harmonised at the European level and integrated into the modules. Thus, economic operators who use these tools in their voluntary quality management policies to reinforce their quality image on the market, can benefit from the use of the same tools in the regulated sectors.

These different initiatives were all geared to directly reinforcing the assessment of conformity of products prior to their marketing. Alongside these, the Commission, in close cooperation with the Member States and the national accreditation bodies, developed European cooperation in the field of accreditation in order to constitute a last level of control and reinforce the credibility of the third parties involved in carrying out product and quality assurance conformity assessment. This remained a political, rather than a legislative initiative, but it was nevertheless effective in creating the first European infrastructure in this area, and in placing European players very much in the lead in this field at international level.

These developments led to some 27 directives being adopted on the basis of New Approach elements. They are far fewer in number than traditional directives in the field of industrial products (some 700), but their wide hazard-based scope means that entire industrial sectors have benefited from free movement through this legislative technique.