The European Certification Schemes for Electrical Products offer third party certification for all products in the area of the European Low Voltage Directive (LVD). They provide Manufacturers with proof of compliance with European Standards and contribute to the traceability and safety of products on the European market. The Schemes give consumers the reassurance that they are purchasing quality products that are safe and remain safe. The Contribution of Third Party Conformity Assessment To the Safety of Electrical Products on the European Market 1. Introduction The New Approach Principles have established a successful European regulatory regime that encourages the free movement of electrical goods within Europe based upon manufacturers declaration of conformity with the Essential Requirements of the relevant EU Directives. Most reputable manufacturers of electrical products voluntarily seek third party assessment of their products to support their Declaration of Conformity and to demonstrate due diligence under the law, even when the law does not require them to do so. The majority of manufacturers marketing electrical products in Europe use Independent Certification by Certification Bodies operating within the framework of the long established CENELEC Certification Agreement (CCA) because of the proven quality of operation of the scheme and the certification it provides. This paper outlines the principles and procedures that form the basis of the CCA and Harmonised Mark Schemes through the provision of conformity assessment, traceability, market surveillance and the effective handling of safety problems as they occur. The paper also discusses a number of the problem areas which have been identified by the European Commission Review of the New Approach, shows how Third Party Conformity Assessment Schemes have been addressing these issues for many years, and makes proposals as to how the experience and resources of the Certification Bodies and Test Laboratories operating these Schemes can be brought to bear in support of the enforcement authorities, for the benefit of both Manufacturers and Consumers in the European Market. 2. Developments in European Safety Legislation The Low Voltage Directive (LVD), laying out the essential legal safety requirements for the safety of electrical products on the European market, has been in place since 1973. In 1993 it was amended to incorporate CE marking requirements, and became one of the New Approach Directives. In the light of experience of the operation of the New Approach Directives, the European Commission has identified shortcomings both in the legal requirements of the Directives and in the practical enforcement of them. As a consequence the European Commission has taken a number of recent initiatives including: * public consultation on the Review of certain elements of the New Approach. * establishment of a Working Party to propose changes to the LVD. * publication of a revision of the General Products Safety Directive (GPSD). 2.1 Public Consultation on the New Approach The public consultation by the European Commission broadly covered the application of all the New Approach Directives. It acknowledged that there were areas where improvements were needed, and sought the views of all sectors in the market. Two important areas addressed were the choice of conformity assessment modules and policies for market surveillance. 2.2 Working Party on Changes to the LVD Early in 2001 it was decided to set up a Working Party to prepare the basis for a limited revision of the LVD, and two of the key areas to be addressed were Market Surveillance and Traceability. Concern had been growing over the number of unsafe products appearing on the European market. It had become clear that the arrangements in Member States for surveillance of products on the market were inadequate, and that the activity throughout the European Union was under-resourced. Additionally, when the Authorities had reason to trace the source of defective products, particularly those manufactured outside Europe, they were frequently unable to do so. 2.3 The Revised GPSD The revised GPSD, published at the beginning of 2002, aims to ensure that all relevant safety provisions apply to all consumer products, while preserving sectoral safety requirements where they exist. A number of aspects bearing on consumer safety were identified as inadequately covered in current Directives, and it therefore introduced several new requirements which apply to products already covered by sectoral Directives such as the LVD. These new measures aim to ensure that consumers have the information needed to assess risks, and that safety problems are properly dealt with when they emerge. They include: * a new obligation on producers to keep registers of complaints and where appropriate to carry out sample testing of marketed products (Article 5.1) * a new obligation on producers to be in a position to recall products from consumers (Article 5.1) * a requirement on producers to notify dangerous products to the enforcement authorities (Article 5.3) * a power for enforcement authorities to order a product recall (Article 8(f)). 3. The Origins of Third Party Conformity Assessment Third party conformity assessment originated because there was seen to be a need, by the manufacturers on the one hand, and by the consumers and those concerned with public safety on the other, for an independent assessment to be carried out of products which might present hazards in use. Most reputable manufacturers of electrical products voluntarily seek third party assessment of their products in order to demonstrate due diligence under the law, even when the law does not require them to do so. Furthermore, the fact that legislation requires independent assessment of ranges of products deemed particularly dangerous (e.g. gas products) demonstrates that all parties have increased confidence in the safety of products which have been independently assessed. Thus the market recognised initially, and continues to recognise today, the value of independent assessment. 4. The Development of Conformity Assessment Schemes Certification Bodies throughout Europe initially developed their own procedures for the independent assessment of products, each defining a set of requirements which had to be met before a licence to use their Mark was issued. These ' national' Marks became well known in their own markets both in the industry and among consumers. Whilst all these national mark schemes were based on type testing to safety Standards, the Standards used initially were national Standards. There were also other differences in the basic requirements for these individual Marks relating to factory inspection and product surveillance after certification. With the development of harmonised safety Standards in Europe in the 1970s a group of well-established Certification Bodies in Europe came together to respond to a need in the market and formed the CENELEC Certification Agreement. Through this Agreement testing by one Certification Body for its Mark could be accepted by others for their additional Marks without the need for further testing. This process required the development of certification scheme Procedures and the harmonisation of practices so that all the members of the group were working to the same requirements and could have confidence in the test reports prepared by others. These procedures include: * a requirement for testing to European harmonised safety Standards; * annual factory inspection to requirements agreed within the CCA Group * product surveillance in production and the market after certification; * regular meetings of testing experts to discuss problems of testing and to agree methods; * peer assessment procedures aimed at maintaining and improving the quality of testing and certification operations within the Scheme; * assessment criteria for potential new members of the Scheme In operating the Scheme the Certification Body making the initial certification, Body A, holds the master file on the product and the manufacturer, but other Certification Bodies, Bodies B, have access to that information if required. In effect, the Scheme rules ensure that a technical file on certified products is held by a European Certification Body and accessible to others if required. The Scheme also ensures that testing is uniform throughout the participating laboratories, that the production factory is regularly inspected, and that checks are carried out from time to time to ensure that products continue to conform to the relevant safety Standards, and that modifications have been assessed. These Procedures have become a model for other certification schemes around the world. The manufacturers who recognise the value of independent certification use it to support their Declaration of Conformity to the essential requirements of the relevant European Directives. They benefit from the CCA Scheme by having a quicker and cheaper route to obtaining the Marks they required for their chosen markets. The Scheme has also led to better recognition throughout Europe of the range of 'national' Marks, and that has opened the opportunity for manufacturers to be more selective about which Marks they choose to use. 5. The Operation of Harmonised Marks Schemes The experience of the CCA Scheme was subsequently used to develop three European harmonised Mark Schemes in the field of electrotechnical products. The first of these was the HAR Scheme developed shortly after the CCA Scheme for the certification of cables and supply cords. More recently, the second, the ENEC Mark Scheme, was developed initially for luminaires and luminaire components with the full support of those industries. It has subsequently expanded its scope, at the request of the relevant sectors of industry, into other product categories. The third of these schemes, the Keymark EMS01 Scheme, covers the full range of Household Appliances. The members of these Schemes, most of whom are also members of the CCA Scheme, all license the use of a common Mark, which nevertheless is traceable to the issuing certification body by the use of an identifying code. Many of the Procedures developed for these Schemes are identical to those used in the CCA Scheme. There is now a high degree of harmonisation in the management of the European Schemes and the Procedures that have been developed for them, and this is facilitated by the common Secretariat provided by EEPCA, the European Electrical Products Certification Association. 6. How the Schemes address the Problems identified by the European Commission All these Schemes address the main problems which have been identified by the European Commission in the operation of the New Approach Directives: traceability, market surveillance, and the effective handling of safety problems when they occur. The Certification Body which issues a licence has a file of information about the product, the production factory, and the holder of the licence, and is in communication with them during the lifetime of production of the product, thus ensuring full traceability. The information is held not only when the product is in production, but also for many years after production has ceased, a period when safety problems often manifest themselves. Product surveillance is an integral part of these certification Schemes. In every Mark scheme the owner of the Mark has a vested interest in maintaining the integrity of the Mark, and built into their procedures are requirements for regular factory inspection and for the taking of samples of certified products from the factory or the marketplace for examination and limited testing. It should be noted that factory inspection is not confined to Europe but extends to factories worldwide. The harmonised Mark Schemes, HAR, ENEC and Keymark, have developed agreed procedures covering these aspects which are applied by all the signatories of the Schemes. The resource to manage and carry out surveillance on certified products is already in place, and the participating Certification Bodies have many years of experience in its operation. Many of the new requirements of the GPSD are also addressed by the Schemes, since producers are required to keep the Certification Bodies informed of complaints relating to the safety of certified products, and certification may be withdrawn pending the recall, investigation, and if necessary modification of products carrying the Third Party Marks. In a number of other respects these Schemes have arrangements in place to deal with relevant issues: * The Certification Bodies are already involved with manufacturers in tackling the problems of copying and counterfeiting, which frequently lead to safety problems in the marketplace. * The Schemes have groups of technical experts set up to ensure consistency of testing practices and the interpretation of the requirements of Standards. These experts come from a large number of Notified Bodies within Europe. The processes which support these voluntary Mark Schemes give both an enhanced assurance of conformity to the requirements and increased traceability, contributing significantly to product compliance on the European market, and it is important to secure recognition by the European Commission and the Enforcement Authorities of this fact. The elements of the process should be defined in a modified Module H and recognised as an alternative to Module A within the Low Voltage Directive. 7. CENELEC's View on Market Surveillance As a contribution to the public consultation on the New Approach, CENELEC developed a paper giving its view on market surveillance and making a number of proposals aimed at strengthening this activity in Europe. The central proposal was to develop a harmonised market surveillance policy in Europe, including an infrastructure which better utilises the expertise that already exists within CENELEC and the related conformity assessment structures. It advocates developing this policy on the basis of the expertise already available in a number of Notified Bodies operating in the field of voluntary conformity assessment, through their experience of operating a set of harmonised rules and procedures for sampling programmes, product surveillance, and factory inspection. This infrastructure is envisaged as one charged with the co-ordination of market surveillance policy and processes in the electrotechnical area, with the participation of all conformity assessment bodies with special competence in this field. 8. Further Contributions to be made by the Certification Bodies The Certification Bodies managing voluntary Mark Schemes already play a significant role in ensuring the confidence of public authorities, economic operators, and consumers with regard to product compliance, and that contribution could be extended to the benefit of all the market players. With their experience of working together to create harmonised conformity assessment Schemes these Certification Bodies could form the core of the new infrastructure proposed by CENELEC. Many of their existing procedures and arrangements, including the meetings of experts, are suitable for adaptation to the needs of a harmonised market surveillance policy for Europe, and others could be developed if necessary.