Explanatory Memorandum to COM(2013)75 - Amending a number of directives on the market surveillance of products - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2013)75 - Amending a number of directives on the market surveillance of products. |
|---|---|
| source | COM(2013)75  |
| date | 13-02-2013 |
The European Union needs a Single Market that is operating at maximum efficiency to help get its economy back on track. The free movement of goods is the most developed and best established of the four fundamental freedoms laid down in the Treaty on the Functioning of the European Union (TFEU) that make up the internal market. But it would be complacent to believe that the job is done. True, harmonisation rules have now been put in place for most products and the free movement provisions of the TFEU, supplemented by the mutual recognition principle, are sufficient for the rest. But even a good legislative framework is only as effective as those using it allow it to be. Alongside responsible economic operators, prepared to adapt their methods and incur the costs necessary to comply with the law, there will always be those traders who cut corners or deliberately flout the rules to ‘make a fast buck’ or gain a competitive edge.
These sharp practices not only skew the single market against the type of trader we wish to encourage, damaging its effectiveness and causing detriment to consumers and business, they also threaten the public interests that our legislation is designed to protect. In addition to financial burden, the European citizen is exposed to potentially dangerous products. The environment is put at risk. Public security may even be undermined.
Market surveillance is the answer. If high quality legislation, based on a sound evaluation of market needs is one side of the coin, market surveillance is the other. It should enable unsafe or otherwise harmful products to be identified and kept or taken off the market and unscrupulous or even criminal operators punished. It should also act as a powerful deterrent.
Market surveillance has not kept pace with developments in the Union regulatory framework. In a single market in which products circulate freely throughout 27 (and in some sectors up to 32) national territories, market surveillance needs to be highly coordinated and capable of reacting rapidly over a huge area. Advances have been made over the last decade, in particular with the implementation of Directive 2001/95/EC of the European Parliament and of the Council on general product safety (the 'General Product Safety Directive' or simply GPSD) which had to be transposed by 2004 and with the coming into application in 2010 of Regulation (EC) 765/2008 setting out the requirements for accreditation and market surveillance. However, overlap of market surveillance rules and obligations of economic operators laid down in various pieces of Union legislation (the GPSD, the Regulation (EC) 765/2008 and sector-specific Union harmonisation legislation) has led to confusion on the part of both economic operators and national authorities and has seriously hampered the effectiveness of market surveillance activity in the Union.
This proposal aims at clarifying the regulatory framework for market surveillance in the field of non-food products. It merges the rules on market surveillance of the GPSD, Regulation (EC) 765/2008 and many sector-specific pieces of Union harmonisation legislation into a single legal instrument that applies horizontally across all sectors.
Market surveillance action by national authorities has important implications for small and medium-sized enterprises. Consequently, their situation should be taken into account particularly in relation to action that could impose additional administrative burdens.
The proposal is part of the 'Product Safety and Market Surveillance Package' which also includes a proposal for a regulation on consumer product safety (replacing the GPSD) and a multi-annual action plan for market surveillance covering the period 2013-2015. After the Single Market Act (2011) had identified the revision of the GPSD and the drawing up of a multi-annual action plan for market surveillance as initiatives that will contribute to boosting growth and creating jobs, the Commission added this proposal for a single market surveillance regulation to the other two initiatives in response to calls from the European Parliament and from stakeholders in industry and public administrations. The Single Market Act II, adopted in 2012, confirms the 'Product Safety and Market Surveillance Package' as a key action 'to improve the safety of products circulating in the EU through better coherence and enforcement of product safety and market surveillance rules'.
Contents
From 2009 to 2011, the Commission held extensive public consultations on the revision of the GPSD (for more details see the Proposal for a Consumer Product Safety Regulation). One of the main substantive areas related to the improvement of market surveillance cooperation and coordination, including the functioning of RAPEX.
One of the outcomes of the public consultation process and the dialogue with interested parties was to transfer the market surveillance rules from the current GPSD into a new standalone Market Surveillance Regulation to be developed and adopted hand in hand with the proposal for the revision of the GPSD.
The impact assessment prepared by the Commission thus covers aspects related to both the GPSD revision and this proposal.
The Commission's Impact Assessment Board delivered a favourable opinion in September 2012.
The overarching objective of this new regulation is to simplify the Union market surveillance framework fundamentally so that it works better for its main users: market surveillance authorities and economic operators. At present, different product evaluation requirements and procedures apply depending on the category of product involved. Market surveillance authorities should be able to do their job of evaluating the risk presented by products without being hindered by unnecessary complexities and to share the results of their work efficiently.
The new Regulation will get rid of overlaps, close gaps, reduce the need to categorise products to a minimum and assimilate as far as possible the rules and procedures applicable to all products. This will result in a more even application of market surveillance rules across the Member States, providing better protection for consumers and other users, more uniform trading conditions for economic operators, reduced administrative burdens and enhanced information- and work-sharing between market surveillance authorities. This is particularly important in the context of the economic crisis and responds to the need to make the internal market for goods more efficient and competitive.
· Reducing the number of pieces of legislation containing market surveillance rules
At first sight, this might seem to be a rather cosmetic objective but the current set of market surveillance rules is spread across the GPSD, Regulation 765/2008 and a range of sector-specific legislation (which is increasingly based on the reference provisions of Decision 768/2008). This ‘3-tier’ system causes problems for market surveillance authorities and economic operators alike and was expressly targeted for criticism by the European Parliament. The new Regulation would produce a one tier system in which all of those rules are brought together in a single instrument. It may be complemented by sector-specific rules laid down in the relevant Union harmonisation legislation.
· Eliminating overlaps in the current system
Regulation 765/2008 and sector-specific legislation apply to all harmonised products regardless whether they are intended (or likely) to be used by consumers or professionals. The GPSD applies to all consumer products regardless whether they are non-harmonised or harmonised. This obviously creates overlaps in relation to harmonised products intended or likely to be used by consumers. The current system tries to deal with this by means of complicated lex specialis provisions but this is universally regarded as unsatisfactory.
The new market surveillance Regulation would dispense with the distinction between consumer and professional products for market surveillance purposes. It would also avoid making a distinction between harmonised products and non-harmonised products except where this is unavoidable in applying certain specific provisions. To the greatest extent possible the applicable rules are the same for all products.
· Dovetailing the RAPEX and Union evaluation procedures
At present, two separate procedures operate, sometimes in parallel, which require the Member States to notify to the Commission and the other Member States certain market surveillance action taken at national level. This is an especially problematic aspect of the overlapping categories of products mentioned above. Under the new Regulation the two procedures become a single procedural flow with certain events triggering a single notification to the other Member States and the Commission (made using either the proven RAPEX rapid alert system or the Information and Communication System for Market Surveillance in accordance with the distinction made in this Regulation).
In the case of products which are subject to sector-specific Union harmonisation legislation, in the event of disagreement among Member States about action taken by one of their number, the proposal would empower the Commission to decide whether the measures taken by the original notifying Member State are reasonable, necessary and proportionate and should be followed by all Member States in the interests of the single market. In this way, the market surveillance process may be brought to a definite close. This is not extended to products not subject to sector-specific Union harmonisation legislation as such a decision cannot be taken in the absence of the essential requirements for products that are laid down in that legislation.
In urgent situations the Commission is empowered to adopt temporary or permanent measures requiring consistent action across the EU against products presenting a serious risk where the risk cannot be satisfactorily addressed by one or several individual Member States.
· Making the legislation more accessible and user-friendly
Apart from being spread across three tiers of EU legislation (and in the case of directives, also in national implementing measures), current market surveillance provisions are not based around a chronological flow of events - from the identification by market surveillance authorities of a product that may present a risk, through risk assessment, involvement of the economic operators, action by the national authorities, notification to the other Member States, up to possible action across the Union by all Member States and, where necessary, evaluation and decision by the Commission at Union level. Instead, market surveillance authorities and economic operators must hunt around in the legislation for the provisions that affect them directly.
The new Regulation sets out the whole process of a market surveillance exercise in a chronological, sequential manner. It presents a chain of events, incorporating relevant provisions on natural justice aspects, publication of information, notification etc. at each stage of the procedure. This approach substantially improves the accessibility and user-friendliness of the legislation, and hence its effectiveness.
The proposal is based on Articles 33, 114 and 207 of the Treaty on the Functioning of the European Union.
Market surveillance is an activity which is carried out by the authorities of the Member States of the Union. This will not change. However, in order to be effective, the market surveillance effort must be uniform across the Union. If market surveillance is ‘softer’ in some parts of the Union than others, weak spots are created which threaten the public interest and create unfair trading conditions. Furthermore, much of the risk presented by products to the various public interests that Union legislation tries to protect derives from products entering the Union from third countries. There must be effective market surveillance along the entire length of the Union’s external borders.
There is therefore a need for Union legislation which creates uniform obligations in relation to the activities to be carried out, the resources to be attributed and the powers and duties of market surveillance authorities. Equally, there must be an obligation to cooperate and to coordinate market surveillance and mechanisms and tools must be established to make possible and facilitate these endeavours. Penalties, financing and reporting also all need to be addressed at Union level.
In accordance with the principle of proportionality, the proposed modifications do not go beyond what is necessary to achieve the objectives set. The modifications introduced by the Regulation do not impose unnecessary burdens or costs on industry, having particular regard to small and medium-sized enterprises, or administrations. Many modifications to the existing legislative framework relate to improving its clarity and workability without introducing significant new requirements with cost implication. Where a modification has an impact on burdens or costs, the impact analysis indicated that it represents the most proportionate response to the problem identified.
The budgetary implications are already envisaged in existing or proposed programmes and respect the Commission proposal for the new multiannual financial framework. This initiative will be financed through redeployment of existing resources. The details are set out in the financial statement attached to this proposal.