Second triennial review of the operation and implementation of the agreement on technical barriers to trade I. Introduction




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D. Conformity Assessment Procedures


1.At the First Triennial Review, the Committee had noted the growing concerns with respect to the restrictive effect on trade of multiple testing and conformity assessment procedures, and had agreed to further its discussions on ISO/IEC Guides; to exchange information on Members' experience in the various types of conformity assessment procedures and their conditions of application; to review the role of regional and international systems for conformity assessment; as well as the provisions containing disciplines with respect to recognition of results of conformity assessment procedures, including mutual recognition agreements (MRAs) and possible difficulties associated with them. The Committee, while recognizing the need for effective conformity assessment procedures to establish confidence between different players in the market-place, reiterated that these procedures should not create unnecessary obstacles to trade.

2.The Committee noted the existence of different mechanisms to facilitate acceptance of results of conformity assessments, e.g. mutual recognition agreements for conformity assessment to specific regulations; in the voluntary sector, co-operative arrangements between domestic and foreign conformity assessment bodies; the use of accreditation to qualify conformity assessment bodies; government designation; unilateral recognition of results of foreign conformity assessment; and manufacturer’s/supplier’s declarations. An indicative list describing these different approaches to facilitate acceptance of results of conformity assessment is attached (Annex 5). This list was not intended to prescribe particular approaches that Members might choose to adopt as it was recognized that the application of different approaches would depend on the situation of Members and the specific sectors involved. Governments and non-governmental bodies might choose to apply different approaches across different sectors, or apply more than one procedure within individual sectors, taking into account variations in procedures in different Members and perceived levels of risk in the acceptance of results in different sectors.

3.The Committee agreed to invite Members, on a voluntary basis, to supply further information on the different mechanisms used in their jurisdiction for acceptance of results of conformity assessment. The Committee would further discuss the different approaches with a view to analysing them in the light of Articles 5 and 6. The Committee reiterated that, irrespective of the mechanisms of conformity assessment procedures chosen by central government bodies of Members, in accordance with Articles 5.1, 5.2, and 5.6-5.9, these procedures must be non-discriminatory, transparent and should avoid unnecessary obstacles to trade. The same rules applied relating to conformity assessment procedures by local government bodies, non-governmental bodies and international and regional systems in accordance with Articles 7, 8 and 9. The Committee also noted that in some circumstances the adoption by exporting and importing countries of different mechanisms of conformity assessment for particular categories of products could give rise to difficulties. Members were encouraged to address such situations through cooperation aimed at identifying appropriate solutions.

4.The Committee also noted the usefulness of working towards the harmonization of practices and criteria on as wide a basis as possible through Members playing a full part, within the limits of their resources, in the preparation of international standards, guides and recommendations for conformity assessment procedures (according to Article 5.4), as well as conformity assessment bodies participating, wherever practicable, in confidence building and proficiency testing programmes of international systems in order to build confidence within all regimes.

5.In accordance with Articles 5.4, 6.1, 7, 8 and 9, the Committee reiterated the importance of using the relevant guides, standards and recommendations issued by international standardizing bodies on conformity assessment procedures. Meeting the requirements of the relevant international guides, standards and recommendations, where appropriate, was recognized as a useful way to benchmark the technical competence and performance of conformity assessment bodies, so that credibility and confidence in their assessment results could be obtained. Thus, the use of these guides, standards and recommendations could serve as a basis for the recognition of the competence of conformity assessment bodies, facilitate the acceptance of results of conformity assessments and help ensure a harmonized approach to conformity assessment procedures.

6.The Committee noted that in addition to relevant guides, standards and recommendations issued by international standardizing bodies, there were also reference documents developed by international or regional conformity assessment systems that could have effects on the results of conformity assessment. The Committee stressed the importance of ensuring that such reference documents were developed through a transparent, open and impartial process.

7.The Committee noted that a supplier's declaration of conformity, when used in appropriate circumstances and for certain sectors, was considered by some Members to be a less-onerous approach for the assurance of conformity. From a manufacturer’s perspective, supplier’s declaration allowed flexibility and non-discriminatory treatment in the choice of location for testing or other conformity assessment procedures, reduced the uncertainty associated with mandatory testing by designated laboratories based in foreign countries as well as associated costs. Reliance on a supplier’s declaration of conformity could also be a cost saving and efficient tool for regulators to ensure that regulatory requirements and legitimate policy objectives were met. The Committee noted that this could be enhanced by introducing deterrents to suppliers for not meeting conformity assessment requirements, such as penalties being imposed for non compliance, and affording opportunities for market participants to inform regulatory authorities of perceived non conformance.

8.The Committee, however, acknowledged that supplier's declarations might not always be appropriate. Consideration needed to be given to the particular characteristics of the sector, the relevant product risks, as well as health, consumer safety and environment issues. An appropriate legislative framework, including safeguards against non compliance of dangerous products, such as market surveillance and product liability laws were relevant considerations in this regard. The Committee noted the absence of appropriate infrastructure in some Members, in particular developing country Members. The Committee invited Members, on a voluntary basis, to further exchange information on their experience in the use of supplier’s declaration. Such experience could include the following: an indication of the sectors/product categories where supplier’s declaration of conformity is used in relation to technical regulations and standards; a further definition of the conditions supporting effective use of such an approach and the costs of these conditions; considerations that may deem such an approach inappropriate from a regulatory perspective; and an identification of technical infrastructure to support reliance on this approach.

9.Concerning MRAs, as referred to in Article 6, the Committee noted the importance of technical competence, openness and linking them to regulatory and market-needs to serve the objective of facilitating market access and that they should be targeted to selected areas of trade interest. The use of relevant international conformity assessment standards, guides and recommendations, as well as harmonized conformity assessment procedures could facilitate the conclusion of MRAs at different levels. The Committee reiterated the importance of Members notifying mutual recognition agreements in accordance with Article 10.7. In this connection, it was noted that only 29 notifications had been made since the entry into force of the Agreement. The Committee also noted the role that regional and international systems for conformity assessment (as referred to in Article 9) could contribute to solving the problems of multiple testing and certification/registration for traders and industries.

10.In the area of conformity assessment, the Committee noted a number of problems expressed by developing country Members. Developing country exporters, in particular SMEs, in some cases found themselves faced with conformity assessment requirements in export markets that were difficult to meet. This could be due to the limited physical and technical resources for national conformity assessment; insufficient number of accredited laboratories at the national or regional level, high costs as well as legal difficulties in obtaining foreign accreditation, difficulties in establishing internationally recognized accreditation bodies, difficulties in participating in international conformity assessment systems, as well as difficulties related to the implementation of ISO/IEC guides on conformity assessment procedures. The Committee noted the technical and financial assistance already being provided by a number of national and international bodies to developing countries, such as the training of conformity assessment practitioners; training packages focussed on establishment of accreditation and certification bodies; the design of quality strategies targeting policy-makers, conformity assessment practitioners and industry; as well as the funding of developing country participation in regional and international meetings of conformity assessment systems. The Committee also noted the work that was being conducted at the regional level to address the various common concerns relating to conformity assessment, such as the pooling of resources to facilitate accreditation at the regional level, and eventually at the international level.

11.The Committee noted that it took a long period of time for a country to develop a national conformity assessment system. Different infrastructure might be needed at different stages of development and for different sectoral needs. Priorities needed to be identified by developing countries concerning certain basic elements of a domestic conformity assessment infrastructure. Technical assistance in this area was an evolving process, given the need to nurture skills and institutional development over a long time-frame. In order to build a structure for domestic conformity assessment which could ultimately facilitate the recognition of conformity assessment results, it was important to raise awareness and develop a national strategy for quality management. Assistance to implement the relevant international guides and standards could be useful to obtain the confidence of the competence of conformity assessment bodies by import markets, to facilitate entering into negotiations of MRAs and participating in international systems. Technical assistance of this kind could be enhanced through regional and international cooperation.

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