Considerations on 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. |
|---|---|
| document | COM(2013)75  |
| date | February 13, 2013 |
(2) Market surveillance activities covered by this Regulation should not be directed exclusively towards the protection of health and safety but should also be applicable to the enforcement of Union legislation which seeks to safeguard other public interests, for example, by means of regulating the accuracy of measurement, electromagnetic compatibility and energy efficiency.
(3) It is necessary to establish an overall framework of rules and principles in relation to market surveillance which should not affect the substantive rules of existing Union legislation designed to protect public interests such as health and safety, consumer protection and the protection of the environment, but should aim at enhancing their operation.
(4) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products[8] was adopted to establish a framework for market surveillance to complement and strengthen existing provisions in Union harmonisation legislation relating to market surveillance and the enforcement of such provisions.
(5) For the purpose of ensuring the equivalent and consistent enforcement of Union harmonisation legislation, Regulation (EC) No 765/2008 introduced a Union market surveillance framework, defining minimum requirements against the background of the objectives to be achieved by Member States and a framework for administrative cooperation including the exchange of information among Member States.
(6) Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety[9] established rules to ensure the safety of products intended for or likely to be used by consumers. Regulation (EC) No 765/2008 maintained the possibility for market surveillance authorities to take the more specific measures available to them under that Directive.
(7) In its Resolution of 8 March 2011 on the revision of the General Product Safety Directive and market surveillance[10] the European Parliament states that having one single regulation is the only way to have one single market surveillance system for all products and therefore urges the Commission to establish a single market surveillance system for all products, based on one act covering both Directive 2001/95/EC and Regulation (EC) No 765/2008.
(8) This Regulation should therefore integrate the provisions of Regulation 765/2008, Directive 2001/95/EC and several sector-specific acts of Union harmonisation legislation relating to market surveillance into a single regulation which covers products in both the harmonised and non-harmonised areas of the Union legislation, regardless whether they are intended for use, or are likely to be used, by consumers or professionals.
(9) Union legislation applicable to products and processes of the food chain, and in particular Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules[11], establishes a comprehensive framework for the performance of official controls and other official activities to verify compliance with feed and food law, rules on animal health and welfare, genetically modified organisms, plant health and plant reproductive material, plant protection products, and pesticides. These areas should therefore be excluded from the scope of this Regulation.
(10) Union legislation concerning medicinal products, medical devices, in vitro diagnostic medical devices and substances of human origin contain special provisions to ensure post-market safety based in particular on sector-specific vigilance and market surveillance systems. Those products should therefore also be excluded from the scope of this Regulation, with the exception of its provisions on control of products entering the Union market which should apply insofar as the relevant Union legislation does not contain specific rules relating to the organisation of border controls.
(11) Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment[12] applies not only to new transportable pressure equipment for the purpose of making it available on the market but also to certain other transportable pressure equipment for the purposes of its periodic inspections, intermediate inspections, exceptional checks and use. It provides for the specific Pi-marking and for a Union safeguard procedure and particular procedures for dealing with transportable pressure equipment presenting a risk at national level, with compliant transportable pressure equipment which presents a risk to health and safety and with formal non-compliance. Therefore, the procedures for the controls of products within the Union laid down in this Regulation should not apply to transportable pressure equipment subject to Directive 2010/35/EU.
(12) This Regulation should establish a comprehensive framework for market surveillance in the Union. It should define the scope of the products covered and those excluded, impose an obligation on Member States to organise and carry out market surveillance, require Member States to appoint market surveillance authorities and to specify their powers and duties, and make Member States responsible for setting up general and sector-specific market surveillance programmes.
(13) Some Union harmonisation legislation contains provisions on market surveillance and safeguard clauses. These may be based on the reference provisions on market surveillance and safeguard clauses contained 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[13]. This Regulation should contain all of the market surveillance provisions applicable to the products falling within its scope. This Regulation should therefore include the reference provisions on market surveillance and safeguard clauses contained in Decision No 768/2008/EC. Provisions in existing Union harmonisation legislation that relate to market surveillance and safeguard clauses, whether drafted before the adoption of Decision No 768/2008/EC or based on its reference provisions, should be removed from that harmonisation legislation unless there are specific sectoral reasons for retaining them. Exemptions from the safeguard provisions should be made in relation to products subject to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), certain fittings subject to Directive 2009/142/EC of the European Parliament and of the Council of 30 November 2009, certain pressure equipment subject to Directive 97/23/EC of the European Parliament and of the Council of 29 May 1997 and certain pressure vessels subject to Directive 2009/105/EC of the European Parliament and of the Council of 16 September 2009.
(14) In order to make the entire market surveillance process transparent and easy to follow for both market surveillance authorities and economic operators, the Regulation should clearly set out the chronological steps of that process, from the moment when market surveillance authorities identify a product which they believe may present a risk, to the assessment of the risk presented, the corrective action to be taken by the relevant economic operator within a specified period and the measures to be taken by market surveillance authorities themselves if economic operators do not comply or in cases of urgency.
(15) Market surveillance should be based on the assessment of the risk presented by a product taking all relevant data into account. A product that is subject to Union harmonisation legislation which lays down essential requirements relating to protection of certain public interests should be presumed not to present a risk to those public interests if it complies with those essential requirements.
(16) Products subject to Union harmonisation legislation that does not lay down essential requirements but which is designed to ensure the protection of certain public interests should be presumed not to present a risk to those public interests provided that they comply with that legislation.
(17) Similarly, a product that is not subject to Union harmonisation legislation but which complies with national rules on the health and safety of persons or with European standards referenced in the Official Journal of the European Union should be presumed not to present a risk to health and safety.
(18) For the purposes of this Regulation risk assessment should be carried out to identify products which have the potential to affect adversely the public interests protected by [Regulation (EU) No xxxx (on consumer product safety)], sector-specific Union harmonisation legislation and other Union legislation on products that are subject to this Regulation. It should include, where available, data on risks that have materialised previously with respect to the product in question. Account should also be taken of any measures that may have been taken by the economic operators concerned to alleviate the risks. The particular potential vulnerability of consumers, as opposed to professional users, should be taken into account as should the increased vulnerability of certain categories of consumer such as children, the elderly or the disabled.
(19) Both new and second hand products originating outside the Union may be placed on the market only after they have been released for free circulation. Effective controls are required at the external borders of the Union to suspend the release of products that may present a risk if placed on the market in the Union pending evaluation and a final decision by market surveillance authorities.
(20) Obliging the authorities responsible for the control of products entering the Union market to carry out checks on an adequate scale therefore contributes to a safer Union market for products. In order to increase the effectiveness of such checks, cooperation and exchange of information between those authorities and market surveillance authorities concerning products presenting a risk should be enhanced.
(21) Market surveillance authorities should be given the power to destroy products, render inoperable or order their destruction by the relevant economic operator, if they deem it necessary and proportionate to ensure that such goods cannot pose any further threats.
(22) The release for free circulation of products that are imported in the physical possession of persons entering the Union for their personal, non-commercial use should not be suspended or refused under this Regulation by the authorities responsible for the control of products entering the Union market.
(23) There should be effective, speedy and accurate exchange of information among the Member States and between the Member States and the Commission. It is therefore necessary to provide for effective tools for such exchange. The Union rapid information system (RAPEX) has proved its effectiveness and efficiency. RAPEX enables measures to be taken across the Union in relation to products that present a risk beyond the territory of a single Member State. To avoid unnecessary duplication, this system should be used for all alert notifications required by this Regulation relating to products presenting a risk.
(24) Coherent and cost-effective market surveillance activity throughout the Union also requires well-structured, comprehensive archiving and sharing among Member States of all pertinent information on national activities in this context, including a reference to notifications required by this Regulation, to form a complete database of market surveillance information. The Commission has established a database called ‘Information and Communication System for Market Surveillance’ which is suited for this purpose and should therefore be used.
(25) Given the size of the Union market for goods and as there are no internal borders, it is imperative that the market surveillance authorities of the Member States are willing and able to cooperate with each other effectively and to coordinate joint support and action. Accordingly, mechanisms for mutual assistance should be established.
(26) In order to facilitate market surveillance of products entering the Union market from third countries, this Regulation should provide a basis for cooperation between market surveillance authorities of Member States and the authorities of those countries.
(27) A European Market Surveillance Forum composed of representatives from market surveillance authorities should be established. The Forum should provide a means of involving all stakeholders concerned, including professional organisations and consumer organisations, in order to take advantage of available information relevant for market surveillance when establishing, implementing and updating market surveillance programmes.
(28) The Commission should provide support for cooperation between market surveillance authorities and participate in the Forum. The Regulation should set out a list of tasks to be performed by the Forum. An executive secretariat should organise the Forum's meetings and provide other operational support for the accomplishment of its tasks.
(29) Where appropriate, reference laboratories should be established with a view to providing expert, impartial technical advice and conducting tests on products required in relation to market surveillance activities.
(30) This Regulation should strike a balance between transparency through the release of the maximum possible amount of information to the public and maintaining confidentiality, for example for reasons of personal data protection, commercial secrecy or the protection of investigations, in accordance with rules on confidentiality pursuant to applicable national law or, as regards the Commission, Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents[14]. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data[15] and Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data[16] apply in the context of this Regulation.
(31) Information exchanged between competent authorities should be subject to the strictest guarantees of confidentiality and professional secrecy and be handled in a way that investigations are not compromised and that the reputations of economic operators are not prejudiced.
(32) Member States should provide means of redress in the competent courts and tribunals in respect of restrictive measures taken by their authorities.
(33) Member States should lay down rules on penalties applicable to infringements of this Regulation and ensure that they are implemented. Those penalties must be effective, proportionate and dissuasive.
(34) Market surveillance should be financed at least in part by fees charged to economic operators where they are required by market surveillance authorities to take corrective action or where those authorities are obliged to take action themselves.
(35) In order to achieve the objectives of this Regulation, the Union should contribute to the financing of activities required to implement policies in the field of market surveillance such as the drawing-up and updating of guidelines, preliminary or ancillary activities in connection with the implementation of Union legislation and programmes of technical assistance and cooperation with third countries as well as the enhancement of policies at Union and international level.
(36) Union financing should be made available in accordance with Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union[17], depending on the nature of the activity to be financed, in particular for support to the executive secretariat of the EMSF.
(37) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards national measures taken and notified by a Member State in relation to products subject to Union harmonisation legislation and the establishment of Union reference laboratories.
(38) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards uniform conditions for the carrying out of checks by reference to particular product categories or sectors, including the scale of checks to be carried out and the adequacy of samples to be checked. Implementing powers should also be conferred as regards the modalities for the provision of information to market surveillance authorities by economic operators, as regards establishing uniform conditions for determining cases in which such information need not be provided. Implementing powers should also be conferred as regards the modalities and procedures for the exchange of information through RAPEX and as regards the adoption of temporary or permanent marketing restrictions on products presenting a serious risk, where appropriate, specifying the necessary control measures to be taken by the Member States for their effective implementation where other Union legislation does not provide a specific procedure to address the risks in question. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of its implementing powers[18].
(39) The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to restrictive measures relating to products that present a serious risk, imperative grounds of urgency so require.
(40) The market surveillance provisions of Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment[19], Directive 93/15/EEC of 5 April 1993 on the harmonization of the provisions relating to the placing on the market and supervision of explosives for civil uses[20], Directive 94/9/EC of the European Parliament and the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres[21], Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft[22], European Parliament and Council Directive 95/16/EC of 29 June 1995 on the approximation of the laws of the Member States relating to lifts[23], Directive 97/23/EC of the European Parliament and of the Council of 29 May 1997 on the approximation of the laws of the Member States concerning pressure equipment[24], Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity[25], Directive 2000/9/EC of the European Parliament and of the Council of 20 March 2000 relating to cableway installations designed to carry persons[26], Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors[27], Directive 2001/95/EC, Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility[28], Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery[29], Directive 2006/95/EC of the European Parliament and of the Council of 12 December 2006 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits[30], Directive 2007/23/EC of the European Parliament and of the Council of 23 May 2007 on the placing on the market of pyrotechnic articles[31], Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 on the interoperability of the rail system within the Community[32], Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys[33], Directive 2009/105/EC of the European Parliament and of the Council of 16 September 2009 relating to simple pressure vessels[34], Directive 2009/142/EC of the European Parliament and of the Council of 30 November 2009 relating to appliances burning gaseous fuels[35], Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment[36], Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products[37], and Regulation (EC) No 765/2008 overlap with the provisions of this Regulation. Therefore, these provisions should be deleted. Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC should be amended accordingly[38].
(41) Since the objective of this Regulation, namely to ensure that products on the market covered by Union legislation fulfil the requirements providing a high level of protection of health and safety and other public interests while guaranteeing the functioning of the internal market by providing a framework for coherent market surveillance in the Union, cannot be sufficiently achieved by the Member States as the attainment of this objective requires a very high degree of cooperation, interaction and uniformity of operation among all of the competent authorities of all Member States, and can therefore, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.
(42) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union. in particular this Regulation seeks to ensure full respect for obligation to ensure a high level of human health protection and consumer protection as well as full respect of the freedom to conduct a business and the right to property.