Explanatory Memorandum to COM(2013)78 - Consumer product safety - Main contents
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| dossier | COM(2013)78 - Consumer product safety. |
|---|---|
| source | COM(2013)78  |
| date | 13-02-2013 |
The free movement of safe consumer products is one of the cornerstones of the European Union. It is an important pillar of the single market and gives consumers confidence when purchasing products.
This proposal for a Regulation on consumer product safety, which will replace Directive 2001/95/EC of the European Parliament and of the Council on general product safety (the 'General Product Safety Directive' or simply GPSD), concerns manufactured non-food consumer products. Like the GPSD also the proposed Regulation requires that consumer products must be 'safe', sets certain obligations on economic operators and contains provisions for the development of standards in support of the general safety requirement.
However, the operation of the proposed Regulation and its interface with other Union legislation will be significantly streamlined and simplified whilst maintaining a high level of protection of the health and safety of consumers.
Overlaps of market surveillance rules and obligations of economic operators laid down in various pieces of Union legislation (the GPSD, the Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and sector-specific Union harmonisation legislation that also covers consumer products) 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 consumer products taking into account legislative developments in recent years such as the New Legislative Framework on the Marketing of Products adopted in 2008, the alignment of sector-specific Union harmonisation legislation to that new framework and the entry into application on 1 January 2013 of a new Regulation on European standardisation.
The proposal is part of the 'Product Safety and Market Surveillance Package' which also includes a proposal for a single market surveillance regulation and a multi-annual action plan for market surveillance covering the period 2013-2015. The Single Market Act (2011) i identified the revision of the GPSD and the drawing up of a market surveillance plan as initiatives that will contribute to boosting growth and creating jobs. The Single Market Act II[7], 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 concerning the scope of the impact assessment. Following the definition of the scope of the impact assessment, the Commission proceeded to the second round of public consultation which concentrated on four main substantive areas for improvement in the EU product safety regime: (i) procedures for mandating standards under the GPSD for non-harmonised products, (ii) harmonisation of safety evaluations, (iii) market surveillance cooperation and coordination, including the functioning of the EU Rapid Information System (RAPEX) and on-line distribution channels, and (iv) alignment with the Free Movement of Goods Package.
The second round of public consultation on problems identified and the solutions proposed by the Commission took place between May and December 2010. Between 18 May and 20 August 2010, the Commission held an internet public consultation focussing on those four areas. The Commission sought feedback through four consultation papers and nine online questionnaires targeting various groups of stakeholders. 55 national authorities responded, from all EU Member States except one and from Norway, Iceland and Switzerland. Various other stakeholders, including more than thirty business associations, seventeen consumer organisations, and over fifty individual economic operators (including several SMEs) contributed to the consultation. In total, 305 replies were received to the nine online questionnaires. In addition, thirteen business and consumer organisations provided separate position papers. A number of presentations and direct exchanges with stakeholders (with both business and consumer organisations) were also held during the consultation period.
The second round of public consultation ended with an international stakeholder conference on the 'Revision of the General Product Safety Directive' on 1 December 2010 during which the Commission received feedback from the stakeholders on key conclusions of the public internet consultation.
The third round of public consultation took place between January and March 2011. It took the form of targeted stakeholder meetings with the participation of experts in the relevant areas. These meetings covered structural topics, including the organisation of market surveillance coordination, the impact of the new definitions of obligations of economic operators (in particular traceability obligations), procedures for establishing mandates leading to the establishment of European standards under the GPSD and ways to establish a clear and understandable structure for non-food product safety rules.
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 stand-alone Market Surveillance Regulation to be developed and adopted hand in hand with the present proposal for the revision of the GPSD.
The impact assessment prepared by the Commission thus covers aspects related to both this proposal and the proposal for a new Market Surveillance Regulation. The Commission's Impact Assessment Board delivered a favourable opinion in September 2012.
· Scope and definitions
The proposed Regulation clearly delimits its scope of application compared to sectoral Union harmonisation legislation. Whilst the general principle that all non-food consumer products must be safe applies across the board, the more detailed obligations on economic operators only apply to those operators that are not subject to corresponding obligations laid down in harmonising legislation covering a specific product sector. The Commission envisages drawing up guidance which will help businesses, in particular small and medium-size enterprises, to identify which legislation applies to the consumer products they manufacture or distribute.
The definitions section has been updated and, where applicable aligned with the New Legislative Framework for the Marketing of Products[8].
· General safety requirement and obligations of economic operators
The requirement that all consumer products must be safe when placed or made available on the Union market is a fundamental pillar of EU legislation in the field of product safety. This general product safety requirement, laid down already in the GPSD, has been kept. However, its operation in practice will be significantly simplified due to the introduction of a clear link with sector-specific legislation and a simplification of the rules on standards.
Consumer products that comply with sector-specific Union harmonisation legislation that aims at ensuring the health and safety of persons shall be presumed to be safe also under this proposed Regulation. If they do not comply with the applicable harmonisation legislation, they would not benefit from the safety presumption but correction of such situation would be governed by the sector-specific legislation in conjunction with the future single market surveillance regulation.
Moreover, the proposal lays down the elementary obligations of economic operators (manufacturers, importers, distributors) involved in the supply chain of consumer products insofar as they are not subject to corresponding requirements under sector-specific Union harmonisation legislation. The obligations are based on the reference provisions set out in Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products i and address, among others, issues related to labelling, product identification, corrective actions to be taken in case of unsafe products and information of the competent authorities. Proportionate to the potential risks of their products, manufacturers will be obliged to establish a technical documentation regarding their products which shall contain the necessary information to prove that their product is safe.
Equally based on Decision No 768/2008/EC, the proposal requires economic operators to be able to identify the operators who supplied them with the product and to whom they supplied it. Where justified due to the risks inherent to specific types of products, the Commission should be empowered to adopt measures requiring economic operators to establish or adhere to an electronic traceability system.
· Use of European standards
Like the GPSD, also the proposal for the new Regulation favours the use of standards in support of the implementation of the general safety requirement. However, the process to identify existing European standards or to ask for the development of European standards that would give rise to presume that a product is safe has been significantly simplified and aligned to Regulation (EU) No 1025/2012 that sets a new overarching framework for European standardisation[10]. This underlines the importance the Commission gives to an approach of co-regulation and will enhance the use of European standards in support of the proposed Regulation.
· Transfer of rules on market surveillance and RAPEX to a new Market Surveillance Regulation
In line with the objective to strengthen and streamline market surveillance for all products, whether harmonised or not and whether intended for consumers or for professionals, the provisions regarding market surveillance and RAPEX that are currently contained in the GPSD have been transferred to the proposal for a new single Market Surveillance Regulation. That new Regulation would produce a one-tier system in which all market surveillance rules are brought together in a single instrument and in which RAPEX will be the single alert system regarding products presenting a risk. Further information is given in the proposal for a Regulation on market surveillance of products.
· Union competence, subsidiarity, proportionality and legal form
The proposal is based on Article 114 of the Treaty on the Functioning of the European Union (TFEU) which provides for the same legal base for the establishment and functioning of the internal market on which the current GPSD was adopted. In regulating product safety, the Union is exercising its shared powers under Article 4 of the TFEU.
Within the internal market where products can circulate freely, the rules on product safety can effectively be adopted only at Union level. This is necessary in order to guarantee a high level of consumer protection (in line with Article 169 TFEU) and also to prevent Member States from adopting diverging product regulations which would result in fragmentation of the single market. In accordance with the principles of proportionality and subsidiarity, as set out in Article 5 of the Treaty on European Union, this proposal does not go beyond what is necessary in order to achieve those objectives.
The proposal takes the form of a Regulation. This is the appropriate legal instrument as it imposes clear and detailed rules which will become applicable in a uniform manner and at the same time throughout the Union. It will avoid diverging transposition by Member States which is liable to lead to different levels of health and safety protection and to create obstacles to the internal market. Replacing the national transposition measures also has a strong simplification effect since it allows economic operators to conduct their business on the basis of a single regulatory framework, rather than a patchwork of Member States' national laws.
· Fundamental rights
In line with the Charter of Fundamental Rights of the EU, this proposal seeks to ensure a high level of human health protection (Article 35 of the Charter) and consumer protection (Article 38) by assuring a high level of safety of consumer products made available on the Union market. The proposal affects the freedom of economic operators to conduct business (Article 16) but the obligations imposed on manufacturers, importers and distributors of consumer products are necessary to guarantee a high level of safety of those products.
The proposal does not have other budgetary implications than those related to the proper management of the Regulation which, in form of the GPSD, is already part of the Union law acquis. The budgetary implications are already foreseen in the existing or proposed programmes and respect the Commission proposal for the new multiannual financial framework. The details are set out in the financial statement attached to this proposal.
This proposal contributes to the simplification of EU legislation and adheres to the principles of smart regulation. When preparing this proposal the Commission has taken stock of the important advancement of sector-specific legislation that aims at ensuring the safety of products and which usually does not make a distinction whether the products covered are intended for consumers or professional users. Contrary to the situation 10 or 15 years ago, it is not necessary any more to apply a second layer of obligations to economic operators who are already appropriately regulated by sector-specific legislation. At the same time, the obligations for those who produce, import or distribute consumer products that are not covered by specific legislation are to a large extent aligned with those applicable to harmonised products.
This approach will reduce administrative burdens and compliance costs for businesses, in particular for small and medium-sized enterprises. In the future, they can easily identify the set of rules applicable to their commercial activity so that they will save on costs caused by legal uncertainty.
Due to the subject-matter and objective of the proposed Regulation, micro-enterprises as defined in Commission Recommendation 2003/361/EC[11] cannot be exempted from its requirements because rules aiming at protecting the health and safety of persons must apply regardless of the size of the economic operator. But micro-enterprises are likely to benefit most from the simplification that the new piece of legislation will bring about which is fit for purpose and replaces two directives that have become out of date. The Commission is committed to providing further guidance to businesses, in particular to small and medium-sized enterprises, and consumers to help them to easily identify their respective rights and obligations.