Explanatory Memorandum to COM(2007)37 - Requirements for accreditation and market surveillance relating to the marketing of products - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2007)37 - Requirements for accreditation and market surveillance relating to the marketing of products. |
|---|---|
| source | COM(2007)37  |
| date | 14-02-2007 |
- Grounds for and objectives of the proposal
Free movement of goods, a central pillar of the Single Market, is a major driver for competitiveness and economic growth in the EU. Moreover, Community technical legislation ensuring the free circulation of products has contributed considerably to the completion and operation of the Single Market. It provides for high levels of protection to be respected and generally also provides economic operators with the means to demonstrate conformity, thus ensuring free circulation through trust in the products..
Experience in the implementation of all this legislation has shown, however:
- a certain risk of distortion to competition because of differing practices in the designation of conformity assessment bodies by national authorities and unequal treatment in the case of non complying or dangerous products on the market, through very different national market surveillance infrastructures, rules and means.
- a certain lack of trust in conformity marking.
- a certain lack of coherence in its implementation and enforcement.
The proposals, following the Council's Resolution of 10 November 2003, have the objective to provide a common framework for the existing infrastructures for accreditation for the control of conformity assessment bodies, and market surveillance for the control of products and economic operators, by reinforcing and extending what exists and not weakening existing instruments such as the General Product Safety Directive which is very successful and effective. Secondly they set out agreed references for the organisation of the revision of existing product related Community harmonisation legislation, where necessary and for the development of future product related legislation.
- General context
The present proposals are very much within the framework of the overall Commission policy to promote simplification and better regulation as widely as possible. Originally the Council, in its Resolution of 10 November 2003, invited the Commission to review only the “new approach” directives. However faced with the possibility of bringing together harmonised instruments that could apply regardless of the legislative technique used (old/new approach legislation) the option followed has been to put forward proposals that can apply in as many sectors as possible within a coherent and transparent, harmonised manner, with standardised instruments. This covers in particular such issues as definitions such as placing on the market etc, the obligations for economic operators, the evaluation of the competence of conformity assessment bodies, conformity assessment procedures, control of products from third countries or conformity marking issues.
It also covers the issues relating to market surveillance in general. It is possible to put into place an overall policy and infrastructures throughout the Community without having to do so sector by sector and especially by building on the experience of the General Product Directive for consumer products, whose principles and mechanisms can be extended to the surveillance of all products, whether consumer products or products for professional use.
- Existing provisions in the area of the proposal
The Council Resolution of 7 May 1985 relating the new approach to technical harmonisation and standardisation is the founding document in this area, whilst Council Decision 93/465 of 22 July 1993 sets out the basic rules for CE marking and for the application of the harmonised conformity assessment procedures. These texts have been complemented by different resolutions on standardization as well as by Directive 98/34 recognising the role of the European standardization organizations and the priority for European standards, not to mention the 25 “new approach directives relating to different product sectors.
Directive 2001/95/EC of the European Parliament and of the Council on general product safety provides a market surveillance infrastructure and information exchange system for the non harmonised areas and sets obligations for economic operators and national authorities in relation to consumer products.
- Consistency with the other policies and objectives of the Union
These proposals are central to the completion of the Single market for products, and contribute to other policies such as in particular, protection of the consumer, of workers and of the environment. They are integral to the overall policies of the Commission within the Lisbon agenda on the chapters better regulation, simplification and market surveillance.
- Consistency with the other policies and objectives of the Union
These proposals are central to the completion of the Single market for products, and contribute to other policies such as in particular, protection of the consumer, of workers and of the environment. They are integral to the overall policies of the Commission within the Lisbon agenda on the chapters’ better regulation, simplification and market surveillance.
- Consultation of interested parties
Consultation methods, main sectors targeted and general profile of respondents
The content of the proposals was put together following 20 working documents which were widely circulated to all the major stakeholders. This brought some 250 contributions.
In 2006 an internet consultation via Your Voice in Europe (IPM) provoked 280 answers which mainly confirmed the results of the first consultations.
The Commission drew up 4 fact finding questionnaires dedicated to different stakeholder groups. The questionnaire for companies was used by the Euro Info Centre network to carry out a business panel operation (i.e. face to face interviews with 800 SMEs).
Summary of responses and how they have been taken into account The contributions received confirm that the proposals should build on what exists as opposed to creating a new system. Thus the existing accreditation system requires a legal base as opposed to being replaced by another system. They reaffirm it as a public authority activity and that, as such, should be free of commercial competition. The conformity assessment body system requires stricter selection criteria and harmonised national selection processes. Support was given to the harmonised definitions and the obligations set out for the economic operators. It was confirmed that a systematic requirement for authorised representatives did not solve the problem of traceability. Practically all contributions supported a Community market surveillance system with information and cooperation system between national authorities in extension to the mechanisms of the GPSD and without creating new tools. The option of abandoning the CE marking was contested and clarifying its meaning and protecting it legally were supported..
An open consultation was conducted over the internet from 01/06/2006 to 26/07/2006. The Commission received 280 responses. The results are available on ec.europa.eu/enterprise/newapproach/review_en. Collection and use of expertise
Professionals in the fields of Conformity assessment, accreditation, market surveillance, standardisation and technical harmonisation were involved as well as experts from trade, consumer protection and other associations.
The experts were consulted on the working documents, participated in meetings and were the addressees of the questionnaires.
The national experts responsible for standardization and horizontal issues have been consulted as have been those responsible for the implementation of Community legislation. The experts in the field of accreditation and conformity assessment have also been consulted as have professional trade and consumer associations.
The vast majority of experts have expressed agreement with the contents of the proposals which were drawn up on the basis of their contributions.
The option of placing their contributions on the new approach website with the results of the consultations is being examined.
- Impact assessment
Basically there are three general options:
1. The first option consists in keeping the current situation unchanged. Products covered by Community harmonisation legislation would be marketed under the conditions created by the existing legal framework and the non-legislative measures currently in place.
2. The second option comprises non-regulatory measures which could be taken without a need to change the existing or introducing new legislation. There are however two limitations to the potential scope of this option:
3. Problems originating in the existing legal provisions can only be eliminated through a change in the legislation.
4. The Commission has made extensive use of non-regulatory instruments. In the area of market surveillance and evaluation/monitoring of notified bodies they have so far been insufficient to address effectively the problems related to the uneven level of enforcement by national authorities.
5. The third option comprises measures requiring the intervention of the Community legislator accompanied by the reinforcement of non regulated instruments.
The only option which answers the feedback from all the stakeholders and which provides the solutions to the problems exposed is option 3.
The Commission carried out an impact assessment listed in the Work Programme, whose report is accessible on ec.europa.eu/enterprise/newapproach/review_en.
Contents
- LEGAL ELEMENTS OF THE PROPOSAL
- Budgetary implication
- CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT
- Scientific/expertise domains concerned
- Methodology used
- Main organisations/experts consulted
- Summary of advice received and used
- Means used to make the expert advice publicly available
- Additional information
- Summary of the proposed action
The proposals complete the different existing legislative tools by putting forward reinforced Community policies on market surveillance and accreditation; to bring coherence to existing sectoral instruments and to examine how these horizontal instruments can be applied to all sectors regardless of whether they are 'old' or 'new' approach.
The proposals consist in: a regulation for the introduction of accreditation and reinforcement market surveillance, and a sui generis decision to set the framework for future legislation.
The regulation should:
- organise accreditation at the national and European levels; irrespective of the different sectors of activity in which accreditation is used. The proposal insists on the public authority nature of accreditation in order for it to be the last level of public authority control, and sets the framework for the recognition of the existing organisation European co-operation for Accreditation (EA) so as to ensure the proper functioning of a rigorous peer evaluation.
- ensure, when not foreseen in other applicable Community legislation, that national authorities are given equivalent means of intervention and the necessary authority to intervene in the market to be able to restrict or withdraw non compliant or unsafe products. It ensures cooperation as between the internal authorities and the customs authorities controlling products entering the market from third countries and sets the framework for the exchange of information between national authorities and cooperation between them in the case of products on the markets of more than one Member State.
The decision should:
- set the general framework for future sectoral legislation and give guidance on how to use the common elements to ensure as much coherence in future sectoral legislation as can be politically and technically possible.
- set out harmonised definitions, common obligations for the economic operators, criteria for the selection of the conformity assessment bodies, criteria for the national notifying authorities and rules for the notification process. These elements are supported by the provisions on accreditation. It also sets out the rules for the selection of conformity assessment procedures as well as the harmonised range of procedures.
- provide a single definition for the CE marking and rules of responsibility for those who affix it and provide for its protection as a Community collective mark, for those directives which already provide for it.
- put into place a proper information and market surveillance procedure as a prolongation of the GPSD system, for the effective enforcement of Community harmonisation legislation and to make the link with the safeguard clauses of such legislation.
- provide harmonised provisions for the future safeguard mechanisms as a complement to those for market surveillance.
- Legal basis
The proposals are based on Article 95 of the Treaty. The Regulation is also based on Article 133 for the control of products from 3rd countries.
- Subsidiarity principle
For over 20 years, in spite of Community policy initiatives for cooperation and development of common tools, the national instruments continue to vary and create problems for an equivalent level of protection throughout the Community. Experience in the implementation of Community legislation has shown that national non harmonised initiatives have the effect of creating discrepancies which counteract the advantages of harmonisation and the internal market.
Most of the contents of the proposal are geared to completing and bringing coherence to the legislative instruments used by the Community institutions to harmonise the national legislations which have created barriers to trade in the past or could create them in the future. They are not designed to create a new European superstructure but to set a framework for better coordination and operation of infrastructures at the national level.
The objective of Community legislation is to create a sufficient level of trust as between national authorities and as between operators throughout the Union. This can only be done if the criteria for the operation of legislative requirements are fixed in common and that the national systems put in place for their implementation can show that that they follow similar rules, processes and give equivalent results.
If these activities are not harmonised the legislation misses its major objective which is to contribute to the protection of the citizen and to the operation of the Internal Market.
- Proportionality principle
The present proposals are in most cases built on existing practices, procedures and infrastructures and constitute more their consolidation and extension than the creation of new measures and infrastructures. In the field of accreditation the proposals confirm the existing system giving it a Community legal basis and framework. In the field of market surveillance, the objective of the proposals is to coordinate the effective functioning of subsidiarity activities and responsibilities by the national authorities. The information tools will be geared to extending existing tools (such as RAPEX) as opposed to creating new ones. The contents of the sui generis decision, by definition, do not create in themselves any measures which impound on national powers and responsibilities. The implementation of these measures in future sectoral EU legislation will also be based on the techniques used today in the field of the elimination of technical barriers to trade, i.e. based very much on national implementation and intervention as opposed to Commission action. Community intervention is reduced to coordination, cooperation and information in most cases. Where the Community intervenes is in cases of safeguard clauses where only the Community can take decisions. The objective of these proposals is to reinforce the operation of Community legislation in the field and to avoid as much as possible the need for further Community intervention.
- Choice of instruments
The Commission has taken the option of splitting its proposal into two separate legal texts in order to take on board the consequences in legal terms of the contents of the proposals: the regulation sets the overall framework that completes all the existing legislation in relation to accreditation and market surveillance. This Regulation does not modify existing EU legislation but complements it and helps make the notification of conformity assessment bodies and the operation of safeguard clauses more operational The Decision sets guidelines for the future legislator. For this purpose a sui generis decision is proposed, as was done in 1993 in this same area, in order to set out the common elements for the future, accompanied by guidelines for their implementation. Future sectoral legislation, new or revisions of existing legislation, should use these elements wherever possible to ensure coherence, simplification and to follow rules of better regulation.
The Community financial contribution is extremely reduced in overall terms. In the field of accreditation a financial contribution of some 15% of the operational costs of EA which correspond to 75.000 €, is foreseen for the purpose of ensuring the proper operation of the European peer evaluation system and therefore remains very modest. Moreover, it is foreseen to provide a budget intervention of one million € for inter comparison testing which represents 10% of possible costs if all safeguard clause cases were to lead to inter comparison testing. In the field of market surveillance a 1.2 million € contribution for the cooperation of all national market surveillance as well as the exchange of information procedures between them covering the full range of industrial products and covering controls of products manufactured in the Community and imported from third countries is minute compared to the present non coordinated costs of national market surveillance
- Simplification
The proposal provides for simplification of legislation, simplification of administrative procedures for public authorities (EU or national), simplification of administrative procedures for private parties.
The simplification will concern the contents of legislation and the manner in which it is drawn up with consolidated ranges of solutions which have already been tested and have proven their effectiveness, meaning that the legislator will be faced with a catalogue of best practices.
The proposals set standard rules and processes to operate across all sectors, in the form of best practices. By consolidating the rules and procedures into a set range, life should be simpler for the national public authorities, for economic operators and the consequence should be a clearer legislative and administrative image of the Community and greater legal stability.
Standardised rules across all legislative sectors which apply to the same economic operators will lead to greater clarity, greater legal stability more coherence in the measures applicable to them and eventually a reduction of some of the burdens in conformity assessment when a harmonised market surveillance policy can take some of the weight off the pre marketing requirements.
The proposal is included in the Commission's Work and Legislative Programme under the reference CWLP 2006/ENTR 001.
- Repeal of existing legislation
The adoption of the proposal will lead to the repeal of Council regulation 93/339 EEC.
- European Economic Area
The proposed act concerns an EEA matter and should therefore extend to the European Economic Area.