Opinion of the Economic and Social Committee on 'Technical standards and mutual recognition`

(96/C 212/02)

On 4 July 1995, the Economic and Social Committee, acting under paragraph 2 of Rule 23 of its Rules of Procedure, decided to draw up an Opinion on 'Technical standards and mutual recognition`.

The Section for Industry, Commerce, Crafts and Services, which was responsible for preparing the Committee's work on the subject, adopted its Opinion on 8 May 1996. The rapporteur was Mr Jaschick.

At its 336th Plenary Session (meeting of 29 May 1996), the Economic and Social Committee adopted the following Opinion by a majority vote with one abstention.

1. The principle of free movement of goods

1.1. Long before the idea of subsidiarity was introduced, standards, testing, certification and supervision were dealt with by self-regulatory methods, with the emphasis on those directly involved, and a more limited role for the public authorities.

1.2. Basically in the EU it is axiomatic that quantitative restrictions and all 'measures having equivalent effect` be removed, as laid down in Articles 30 and 36 of the EEC Treaty. The term 'measures having an equivalent effect` can be explained using as a basis the so-called 'Dassonville Formula` elaborated by the European Court of Justice, which declares that: 'All trading rules enacted by Member States which are capable of hindering, directly or indirectly, actually or potentially, intra-Community trade are to be considered as measures having an effect equivalent to quantitative restrictions.`

1.3. This decision was supplemented by the path-breaking Court of Justice decision based on the 1979 Cassis de Dijon ruling () and states that:

'In the absence of common rules, obstacles to movement within the Community resulting from disparities between the national laws relating to the marketing of a product must be accepted insofar as those provisions may be recognized as being necessary in order to satisfy mandatory requirements relating in particular to the effectiveness of fiscal supervision, the protection of public health, the fairness of commercial transactions and the defence of the consumer.`

2. Activities of the ESC

2.1. In its Opinion () on the first Commission report on the operation of the Single Market the ESC undertook an in-depth analysis of the current situation. The results of this work were much appreciated by the European Parliament, the Council of Ministers and the Commission and consequently in June 1995 the Council welcomed the proposal to set up a Single Market Observatory in the ESC. The crux of the Opinion was a list with 62 serious obstacles preventing the general public and economic operators from benefitting fully from a frontier-free European Market.

2.2. Against this background, the ESC bureau instructed the Section for Industry, Commerce, Crafts and Services to draw up an Opinion specifically on the subject of technical barriers to trade. This essentially deals with restrictions on the free movement of goods within the EU caused by differing national regulations - and the national standards, testing, certification and supervisory procedures to which they sometimes refer or which they specify - and with the problem of inadequate mutual recognition between Member States.

2.3. Despite all the efforts and many successes, technical barriers to trade are still a major problem on the Single Market. The reasons for this are partly purely technical and partly general. A typical example is the as yet inadequate harmonization of testing procedures for the fire protection properties of construction products. The conduct of customers and private bodies can also lead to obstacles to trade, e.g. if insurance companies insist on certain non-harmonized specifications for vehicle anti-theft devices (). As already pointed out by the Committee in its Opinion on the Commission's report on the Single Market in 1995, the constant increase in technical rules enacted at national level is a matter for concern (). If solutions are to be found, this very special issue will need to be properly understood. This Opinion is designed to help provide such an understanding.

2.4. As part of the work of preparing the draft Opinion, two hearings were held: one in Stockholm on 23 January 1996 and the other in Milan on 25 January 1996. A questionnaire was also distributed to interested groups who were encouraged to send additional comments. The purpose of these hearings was to learn about the experience of one of the new EU Member States and one of the old EU Member States and to be informed of the problems which they are currently facing. The contributions made in the course of these hearings have been incorporated in this Opinion.

3. Terms

3.1. The meaning of several terms used in this Opinion is defined below. The definitions are taken largely from directives, standards and the relevant literature, but are somewhat shortened and simplified to make them easier to understand.

3.2. The essential requirements (safety or other requirements in the general interest) are binding technical criteria which are laid down in general form in the new approach directives. Products put into circulation which fall under these directives must satisfy the essential requirements.

3.3. A standard is a technical specification which has been approved by a recognized standards body for repeated or continuous application, but with which compliance is not compulsory.

3.4. 'Harmonized standards` are specifications drawn up by a European standards organization on the basis of instructions issued by the Commission pursuant to Directive 83/189/EEC and in accordance with the general directives on cooperation between the European standards organizations and the Commission. After publication of the reference in the Official Journal of the European Communities by the Commission and implementation in at least one Member State, compliance with the standard leads to presumption of conformity with the relevant essential requirements ().

3.5. In the regulated sector the putting into circulation of products is governed by laws, regulations and the like in order to protect citizens. A distinction is made between the harmonized sector governed by EC directives and the non-harmonized sector governed by national legislation. Conformity with requirements is assessed by notified bodies, which, on the basis of EC directives, have to be authorized and notified as such to the European Commission; they thus form part of the harmonized regulated sector.

3.6. In the non-regulated sector the putting into circulation of products is not governed by laws, regulations and the like as the products do not represent any danger.

4. Previous attempts to remove technical barriers to trade

4.1. The old approach

One area into which the EU is putting a great deal of effort is the removal, by aligning national rules, of restrictions on the free movement of goods. Under the old approach, even the EC directives themselves contained, besides the basic provisions, all the technical specifications as appendices - e.g. the precise measuring procedures for noise emissions from lawnmowers. This approach proved too lengthy, cumbersome and detailed. Its use has, however, been retained in a number of sectors, such as motor-vehicles, where it has proved its worth.

4.2. The new approach to technical harmonization and standards

4.2.1. With the Single Market programme, the EU set out its priorities for action. This brought with it the requirement for a new, accelerated harmonization procedure to deal with technical barriers to trade in the light of the 'Cassis de Dijon` ruling. To meet this requirement, the Council of Ministers adopted the so-called 'new approach` () to technical harmonization and standards in 1985.

4.2.2. The new approach moves away from the previous detail-based system. Community legislation (directives - used mainly for harmonization) now concentrates on establishing the essential requirements (), e.g. establishing the necessary level of protection. The description of recognized possible technical solutions for complying with the essential requirements is contained in separate harmonized standards () formulated on the Commission's instructions (mandates) by the European standardization bodies, CEN, Cenelec and ETSI.

4.2.3. The use of harmonized standards is voluntary rather than mandatory. They do, nonetheless, provide a refutable presumption of conformity of the product with the essential requirements of the directives. Harmonized European standards are, however, not the only way of achieving conformity with the essential requirements set out in directives. Manufacturers and conformity assessment bodies can also opt for other suitable technical solutions, such as the use of other - mainly national - standards. In such cases, however, there is no presumption of conformity and manufacturers themselves must, where appropriate, provide proof of conformity with the directive's essential requirements. This may make it necessary to apply stricter conformity assessment procedures.

4.2.4. The safety and health aspects of certain products are so crucial that trade in these products without reference to precise technical specifications could lead to problems. Tests directly on the basis of the directives' requirements are more difficult and can give rise to differing interpretations. This applies especially to, for instance, the directives on medical devices and personal protective equipment. European - and as far as possible international - standards for the protection of health, safety and the environment are therefore important for the success of the Single Market. It is precisely in these sectors that it is very important not to reduce the responsibility of the public bodies.

4.3. Global approach to conformity assessment

4.3.1. Testing and certification go hand in hand with standardization. In 1990 the new approach to technical harmonization and standards was therefore supplemented, in respect of testing and certification, by the global approach to conformity assessment. The aim of the global approach is to create conditions that will enable mutual recognition to work in both regulated () and non-regulated () sectors.

4.3.2. In the non-regulated sectors, it is possible to ask for mutual recognition agreements between conformity assessment bodies to be approved by the competent sectoral committees of the European Organization for Testing and Certification (EOTC), set up especially for this purpose, in accordance with principles and procedures in which all parties have confidence. This makes for a transparent, one-stop conformity assessment system for the European market.

4.3.3. In the sectors regulated by European directives, the global approach establishes a system of modules which form the building-blocks of the conformity assessment procedure for each individual directive, depending on the possible risks associated with the particular product; once this procedure has been completed, manufacturers can affix the CE mark and market their products in all countries in the EEA without any need for further national tests or approval. The supplier can freely choose certification bodies or notified bodies or other approval authorities in either its own country or in one of the other EEA countries.

5. The current situation with regard to standards and testing and certification procedures

5.1. General situation

5.1.1. The general situation is typified by the fact that standardization, testing and certification are largely carried out by non-governmental organizations. The preparation and application of standards - and in many instances testing, certification and supervision too - are voluntary.

5.1.2. The legislator can avail himself of the present voluntary standards and, with certain reservations, recognize them as a way of complying with legal provisions. He can also, insofar as appears necessary and on his own responsibility, make their use compulsory by specifying date and reference.

5.2. Standards and trade policy

5.2.1. The stated aim of European economic and trade policy - besides a smoothly functioning internal market - is to promote the worldwide trade in goods and services. Thus, as far as possible, European standards are derived from the results of international work, amended for use in Europe where necessary.

5.2.2. There is significant cooperation between the European standards organizations and the relevant international organizations on the basis of special agreements. Such cooperation is ensured in particular by the fact that the same national institutes and groups collaborate at both levels.

5.3. Mutual recognition of national provisions, notified bodies and test findings

5.3.1. The regulated, non-harmonized sector () is governed by the principle of mutual recognition of legal provisions on the basis of Articles 30 and 100b of the EC Treaty.

5.3.2. In the regulated, harmonized sector (), mutual recognition of conformity assessment results and the competence of the notified bodies is laid down by European directives. The hearings and the responses to the questionnaire show quite clearly that this mutual recognition is still deficient and lacking in credibility ().

5.3.3. In the non-regulated sector () there are still, despite the support given to the agreement on mutual recognition, many difficulties entailed in the acceptance of test results and certificates, and the certification of firms and their quality management systems. Another feature of the present situation is that, for want of confidence in the competence of testing bodies, the mutual recognition of proofs of conformity cannot be enforced by users through legal channels.

5.4. High demand for standards

5.4.1. Ever keener competition, increased quality awareness and safety requirements on the part of users, product complexity and user demands for proof of conformity are a few of the reasons for the rising number of applications for standards to European and international standardization bodies. Demand has also been growing recently in the economically ever more important services sector.

5.4.2. Well over ten thousand European standards are currently being prepared, the lion's share (about 2/3) at the instigation of industry and other interested circles. The Commission has solicited several thousand standards on the basis of mandates set out in directives, in accordance with the new approach to technical harmonization and standards or in pursuit of other Community policies. They are expected to be completed by the end of the century.

5.4.3. Despite the intensive work being carried out on standards in Europe, an increasing volume of criticism is being voiced by industry about the time taken to draw up standards and the cumbersome procedures. There is growing pressure - mainly from industry - on the European standardization organizations to re-examine their structures, policies and working methods. The competent bodies in the European standardization organizations are therefore currently considering proposals for tightening up and simplifying the standardization process.

6. The Committee's recommendations

6.1. Standardization and trade policy

6.1.1. The Committee welcomes and supports all efforts to improve standardization procedures and working methods and to make them more flexible, (e.g. through the use of electronic aids). The strategies, procedures and structures within and between European standardization bodies should also be constantly scrutinized and improved. In particular the Committee would point out that effective mechanisms are needed for assessing market requirements so that the limited resources of the European standards organizations and their members can be used as efficiently as possible.

6.1.2. The Committee considers that the current organization of the European standardization system as a community of national institutes under one European umbrella has proved its worth. It attaches considerable importance to cooperation with the international standardization bodies and compatibility between European and international standards.

6.2. Transparency and legal status of standards

6.2.1. One matter of concern for many users is the specific and clear indication of standards in legislation and clarification of their legal status (). Confusion between voluntary technical standards and mandatory technical rules can lead to misunderstandings and rejection of the new approach.

6.2.2. When legislation refers to standards, the Committee calls for a clear and unambiguous indication of the relationship between the mandatory and the voluntary and of the status of the standard in each case. It must be absolutely clear that the legislator is not delegating his powers improperly to private standardization bodies. In cases where standards are 'de facto` binding, measures must be taken to ensure that all interested parties participate in an appropriate way in the process of establishing standards ().

6.3. Consistency and uniform transposition of directives

6.3.1. Different directives sometimes apply when a product is being put into circulation and during its subsequent use. The precise specification of the purpose and scope of a technical rule is of special importance.

6.3.2. The Committee points to the need for the EU to observe consistency and uniformity in its directives, so that products subject to the provisions of directives under Article 100a of the EC Treaty and correctly put into circulation do not encounter barriers to their use, and hence ultimately also to trade, on account of provisions in other areas where the Member States are allowed to impose stricter requirements. The same applies to additional national standards referred to in national legislation.

6.3.3. The Committee supports the application of the principles of the new approach in areas other than directives under Article 100a and calls for the Commission's examination of this sector to be followed up vigorously and turned to practical account in the preparation of directives.

6.3.4. The Committee would point out that it has already called for the drawing-up of rules in the field of health, consumer and environmental protection and for greater emphasis to be given to the development of European standards on industrial emissions and other preventive and protective measures [Opinion of 26 May 1993 on the second amendment of Directive 83/189/EEC ()]. In some areas there is still a considerable need for rules ().

6.3.5. The Committee would point out that an essential precondition for the operation of the Single Market is that EU directives are transposed on time and properly into national law. However, it is imperative that barriers to trade do not arise as a result of differences in the interpretation of EU directives in the Member States. Improved cooperation between the national authorities charged with the application of the directives' provisions is therefore absolutely essential. Cases such as those of the construction products directive, which was adopted in 1988 but which has still not contributed greatly to achieving freedom of movement for construction products because it is ineffective and harmonized standards are lacking, are unsatisfactory.

6.3.6. In view of the problems to be expected in the future regarding a timely and proper transposition of EU directives into national law, the Committee recommends that more use be made of the regulation as a legal instrument.

6.4. Clear and timely mandate

6.4.1. The Committee would point out that problems can be avoided when mandates are issued if sufficiently clear instructions are given. Particular care should be taken to ensure that unsolved political problems are not shifted on to subsequent stages.

6.4.2. Mandates for standards pursuant to Community directives must be issued as early as possible so that sufficient time is left for technical consultation and consensus-forming in the standardization bodies, and so that the standards can be available in good time for the entry into force of the directives.

6.5. Participation of groups concerned

6.5.1. The active professional participation of all interested parties, irrespective of their financial strength, is of great importance for the preparation of balanced standards which can be applied by all concerned. However, in view of the time required to draw up standards, as mentioned earlier, the European standardization organizations should ensure through efficient procedures that such participation does not result in any delays in the standardization process.

6.5.2. Clearly, employees, SMEs and consumers must also participate at national level in the preparation of European standards in the early, opinion-shaping stage in the standards institutes. They should belong to national delegations and collaborate in making practical use of the findings, organizing the programmes and fixing priorities.

6.5.3. The Member State governments should encourage the participation of these parties in standardization work and - if they do not have sufficient funds of their own - also support them financially, as already happens in other cases.

6.5.4. The Committee welcomes and supports the initiative of the Commission and the European Parliament to provide assistance (including financial) for interested parties, such as SMEs, trade unions and consumer associations (), so that they can participate in both the preparation and the application and dissemination of European standards. The Committee calls on the Commission to increase the economic and financial support for such participation.

6.6. Language barriers and lack of information

6.6.1. Language barriers and translation difficulties show that centralized structures are problematical, especially for SMEs and the general public. Generally the relevant national language must be used when the results of the work are submitted to national bodies and transposed by them.

6.6.2. It is especially important to provide specific and clear information. The public must be informed about the position as regards the technical rules to be observed and the authorities must be informed about the technical rules applying in their area and their many ramifications.

6.6.3. It is also important to provide information on the technical rules being drawn up in individual bodies, so that interested parties have the opportunity to participate in appropriate fashion in the preparatory process.

6.6.4. On-the-spot advice, information and assistance with regard to the application of standards are also essential, together with the provision of technical texts translated into the national language using the correct specialist terminology.

6.6.5. The Committee would point out that in previous Opinions () it has already referred to the need for appropriate data banks on national and European standards and for an overview of current standardization activities.

6.7. Notified bodies and CE mark

So that mutual confidence in results is not undermined, it is essential to avoid different national requirements being imposed on the notified bodies, to which considerable powers are allocated under the new approach directives. An intensive pooling of experience and information between these bodies is necessary. The Committee would point out that any conformity marks in addition to the CE mark, e.g. national quality marks, are permitted, but that only the CE mark guarantees access to the Single Market.

6.8. Market supervision

6.8.1. Efforts should be made in the regulated sector to organize better cooperation and coordination between the national market supervision systems, including common objectives for the safety of users and products, so that products which are entitled to bear the CE mark or have been properly manufactured in one Member State under the mutual recognition system are guaranteed uniform access to the market.

6.8.2. The extent to which the system recently adopted by the Community of providing information on measures derogating from the principle of free movement of goods () will be successful remains to be seen. If necessary, additional appropriate complaints bodies should be set up or existing bodies entrusted with this task.

6.8.3. The Committee would also mention the need for close cooperation between the national authorities responsible for supervising the market and the bodies responsible for accrediting testing laboratories and certification and supervisory bodies.

6.8.4. The Committee welcomes and supports all measures which help to build confidence in and general recognition of one-stop conformity assessment results, especially in the non-regulated sector. In this context the Committee proposes implementing appropriate programmes designed to establish greater mutual confidence. The aim must be for one-stop certificates to be recognized throughout the Single Market to avoid repeated testing and certification, be it of products or quality management systems. The various possible procedures - from manufacturer's declaration, through mutual recognition of test results and certificates, to the granting of a uniform European mark - must be selected according to the relevant market requirements.

Done at Brussels, 29 May 1996.

The President

of the Economic and Social Committee

Carlos FERRER

() Court of Justice ruling 120/78 of 20. 2. 1979.

() OJ No C 393, 31. 12. 1994. The problem of standards has been discussed in various subsequent Opinions, in particular that of 22 November 1995 (OJ No C 39, 12. 2. 1996) on the second Commission report which includes a chapter on legal technical barriers.

() In this connection, interested parties also mention cycling helmets, lawnmowers, microwave ovens, equipment for children, e.g. prams and push-chairs.

() Point 3.2.6 of the Opinion on the Report from the Commission to the Council and the European Parliament on the Single Market in Europe in 1995.

() This concept differs from that of a harmonized standard pursuant to the low-voltage Directive and also the concept of a harmonized standard pursuant to ISO/IEC Guide 2.

() OJ No C 136, 4. 6. 1985.

() See point 3 above.

() E.g. the case of Swedish diesel motors in Italy. There are also interpretation problems with national certificates. Swedish motor vehicle manufacturers complain about the excessive formal documentation requirements for the testing of motor vehicles in Germany and Italy.

() The Commission is currently preparing a study on this matter.

() Cf. more detailed observations in point 6.5 below.

() OJ No C 201, 26. 7. 1993.

() E.g. child safety, all-terrain vehicles, construction scaffolding, staple guns.

() As it has already done in the case of ANEC (European Association for the Coordination of Consumer Representation in Standardization), TUTB (European Trade Union Technical Bureau for Health and Safety) and NORMAPME, which is linked to UEAPME (European Union of Craft Industries and Small and Medium-Sized Enterprises).

() OJ No C 120, 6. 5. 1991; OJ No C 201, 26. 7. 1993.

() OJ No L 321, 30. 12. 1995; ESC Opinion: OJ No C 195, 18. 7. 1994.