13.8.2008   

EN

Official Journal of the European Union

L 218/1

(1)

Council Regulation (EC) No 788/96 of 22 April 1996 on the submission by Member States of statistics on aquaculture production (2) requires the Member States to submit annual data on the volume of production.

(2)

The increased contribution by aquaculture to the Community's total fisheries production requires a wider range of data for a rational development and management of this sector within the Common Fisheries Policy.

(3)

The increasing importance of hatcheries and nurseries for aquaculture activity requires detailed data for a suitable monitoring and management of this sector within the Common Fisheries Policy.

(4)

Information on both the volume and value of the production is required to review and assess the market for aquaculture products.

(5)

Information on the structure of the sector and on the technologies employed is required to ensure an environmentally sound industry.

(6)

Regulation (EC) No 788/96 should be repealed.

(7)

In order to ensure a smooth transition from the regime applicable under Regulation (EC) No 788/96, this Regulation should allow for a transitional period of up to three years to be granted to Member States where its application to their national statistical systems would require major adaptations and would be likely to cause significant practical problems.

(8)

Since the objective of this Regulation, namely the establishment of a common legal framework for systematic production of Community statistics on the aquaculture sector, cannot be sufficiently achieved by the Member States and can be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. 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.

(9)

Council Regulation (EC) No 322/97 of 17 February 1997 on Community Statistics (3) provides a reference framework for statistics in the field of fisheries. In particular, it requires conformity with principles of impartiality, reliability, relevance, cost-effectiveness, statistical confidentiality and transparency.

(10)

The collection and submission of statistical data is an essential tool for the sound management of the Common Fisheries Policy.

(11)

The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (4).

(12)

In particular, the Commission should be empowered to adopt technical changes to the Annexes to this Regulation. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(13)

The Commission should be assisted by the Standing Committee for Agricultural Statistics set up by Council Decision 72/279/EEC (5),

(a)

‘Community statistics’ as defined in Article 2 of Regulation (EC) No 322/97;

(b)

‘aquaculture’ as defined in Article 3(d) of Council Regulation (EC) No 1198/2006 of 27 July 2006 on the European Fisheries Fund (6);

(c)

‘capture-based aquaculture’ means the practice of collecting specimens from the wild and their subsequent use in aquaculture;

(d)

‘production’ means the output from aquaculture at first sale, including production from hatcheries and nurseries offered for sale.

(a)

the annual production (volume and unit value) of aquaculture;

(b)

the annual input (volume and unit value) to capture-based aquaculture;

(c)

the annual production of hatcheries and nurseries;

(d)

the structure of the aquaculture sector.

13.8.2008   

EN

Official Journal of the European Union

L 218/14

(1)

The Commission (Eurostat) needs to be in possession of sufficiently reliable, detailed and comparable data on the population and housing, in order to enable the Community to fulfil the tasks assigned to it, in particular by Articles 2 and 3 of the Treaty. Sufficient comparability must be ensured at Community level as regards methodology, definitions and the programme of the statistical data and the metadata.

(2)

Periodic statistical data on the population and the main family, social, economic and housing characteristics of persons are necessary for the study and definition of regional, social and environmental policies affecting particular sectors of the Community. In particular, there is a need to collect detailed information on housing in support of various Community activities, such as the promotion of social inclusion and the monitoring of social cohesion at regional level, or the protection of the environment and the promotion of energy efficiency.

(3)

In view of methodological and technological developments, best practices should be identified and the enhancement of the data sources and methodologies used for censuses in the Member States should be fostered.

(4)

In order to ensure the comparability of the data provided by the Member States and for reliable overviews to be drawn up at Community level, the data used should refer to the same reference year.

(5)

In accordance with Council Regulation (EC) No 322/97 of 17 February 1997 on Community Statistics (2), which constitutes the reference framework for the provisions of this Regulation, it is necessary for the collection of statistics to conform to the principles of impartiality, in particular objectivity and scientific independence, as well as transparency, reliability, relevance, cost-effectiveness and statistical confidentiality.

(6)

The transmission of data subject to statistical confidentiality is governed by Regulation (EC) No 322/97 and Council Regulation (Euratom, EEC) No 1588/90 of 11 June 1990 on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities (3). Measures that are taken in accordance with those Regulations ensure the physical and logical protection of confidential data and that no unlawful disclosure or non-statistical use occurs when Community statistics are produced and disseminated.

(7)

In the production and dissemination of Community statistics under this Regulation, the national and Community statistical authorities should take account of the principles set out in the European Statistics Code of Practice adopted on 24 February 2005 by the Statistical Programme Committee, established by Council Decision 89/382/EEC, Euratom (4) and attached to the Recommendation of the Commission on the independence, integrity and accountability of the national and Community statistical authorities.

(8)

Since the objectives of this Regulation, namely the collection and compilation of comparable and comprehensive Community statistics on population and housing, cannot be sufficiently achieved by the Member States, due to the absence of common statistical features and quality requirements as well as a lack of methodological transparency, and can therefore, by way of a common statistical framework, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. 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 those objectives.

(9)

The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (5).

(10)

In particular, the Commission should be empowered to establish the conditions for the establishment of subsequent reference years and the adoption of the programme of the statistical data and the metadata. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(11)

The Statistical Programme Committee has been consulted in accordance with Article 3 of Decision 89/382/EEC, Euratom,

(a)

‘population’ shall mean the national, regional and local population at its usual residence at the reference date;

(b)

‘housing’ shall mean living quarters and buildings as well as housing arrangements and the relationship between the population and living quarters at the national, regional and local levels at the reference date;

(c)

‘buildings’ shall mean permanent buildings that contain living quarters designed for human habitation, or conventional dwellings that are reserved for seasonal or secondary use or that are vacant;

(d)

‘usual residence’ shall mean the place where a person normally spends the daily period of rest, regardless of temporary absences for purposes of recreation, holidays, visits to friends and relatives, business, medical treatment or religious pilgrimage.

The following persons alone shall be considered to be usual residents of the geographical area in question:

Where the circumstances described in point (i) or (ii) cannot be established, ‘usual residence’ shall mean the place of legal or registered residence;

(e)

‘reference date’ shall mean the date to which the data of the respective Member State refer, in accordance with Article 5(1);

(f)

‘national’ shall mean on the territory of a Member State;

(g)

‘regional’ shall mean at NUTS level 1, NUTS level 2 or NUTS level 3, as defined in the classification of territorial units for statistics (NUTS), established by Regulation (EC) No 1059/2003 of the European Parliament and of the Council (6) in its version applicable at the reference date;

(h)

‘local’ shall mean at Local Administrative Units level 2 (LAU level 2);

(i)

‘essential features of population and housing censuses’ shall mean individual enumeration, simultaneity, universality within a defined territory, availability of small-area data and defined periodicity.

(a)

conventional censuses;

(b)

register-based censuses;

(c)

a combination of conventional censuses and sample surveys;

(d)

a combination of register-based censuses and sample surveys;

(e)

a combination of register-based censuses and conventional censuses;

(f)

a combination of register-based censuses, sample surveys and conventional censuses; and

(g)

appropriate surveys with rotating samples (rolling censuses).

—

‘relevance’ shall refer to the degree to which statistics meet the current and potential needs of users,

—

‘accuracy’ shall refer to the closeness of estimates to the unknown true values,

—

‘timeliness’ and ‘punctuality’ shall refer to the delay between the reference period and the availability of results,

—

‘accessibility’ and ‘clarity’ shall refer to the conditions under and modalities by which users can obtain, use and interpret data,

—

‘comparability’ shall refer to the measurement of the impact of differences in applied statistical concepts and measurement tools and procedures when statistics are compared between geographical areas, sectoral domains, or over time, and

—

‘coherence’ shall refer to the adequacy of the data to be reliably combined in different ways and for various uses.

(a)

technical specifications of the topics as required by this Regulation as well as of their breakdowns as provided for in Article 5(4);

(b)

the establishment of the appropriate technical format as provided for in Article 5(5); and

(c)

modalities and structure of the quality reports as provided for in Article 6(3).

(a)

the establishment of the reference years, as provided for in Article 5(1); and

(b)

the adoption of the programme of the statistical data and the metadata, as provided for in Article 5(3).

13.8.2008   

EN

Official Journal of the European Union

L 218/21

(1)

The internal market comprises an area without internal frontiers, in which the free movement of goods is ensured under the Treaty, which prohibits measures having effects equivalent to quantitative restrictions on imports. That prohibition covers any national measure which is capable of hindering, directly or indirectly, actually or potentially, intra-Community trade in goods.

(2)

Obstacles to the free movement of goods between Member States may be unlawfully created by the Member States' competent authorities applying, in the absence of harmonisation of legislation, to products lawfully marketed in other Member States, technical rules laying down requirements to be met by those products, such as rules relating to designation, form, size, weight, composition, presentation, labelling and packaging. The application of such rules to products lawfully marketed in another Member State can be contrary to Articles 28 and 30 of the Treaty, even if they apply without distinction to all products.

(3)

The principle of mutual recognition, which derives from the case-law of the Court of Justice of the European Communities, is one of the means of ensuring the free movement of goods within the internal market. Mutual recognition applies to products which are not subject to Community harmonisation legislation, or to aspects of products falling outside the scope of such legislation. According to that principle, a Member State may not prohibit the sale on its territory of products which are lawfully marketed in another Member State, even where those products were manufactured in accordance with technical rules different from those to which domestic products are subject. The only exceptions to that principle are restrictions which are justified on the grounds set out in Article 30 of the Treaty, or on the basis of other overriding reasons of public interest and which are proportionate to the aim pursued.

(4)

Many problems still exist as regards the correct application of the principle of mutual recognition by the Member States. It is therefore necessary to establish procedures to minimise the possibility of technical rules' creating unlawful obstacles to the free movement of goods between Member States. The absence of such procedures in the Member States creates additional obstacles to the free movement of goods, since it discourages enterprises from selling their products, lawfully marketed in another Member State, on the territory of the Member State applying technical rules. Surveys have shown that many enterprises, in particular small and medium-sized enterprises (SMEs), either adapt their products in order to comply with the technical rules of Member States, or refrain from marketing them in those Member States.

(5)

Competent authorities also lack appropriate procedures for the application of their technical rules to specific products lawfully marketed in another Member State. The lack of such procedures compromises their ability to assess the conformity of products in accordance with the Treaty.

(6)

The Council Resolution of 28 October 1999 on mutual recognition (3) noted that economic operators and citizens did not always make full and proper use of the principle of mutual recognition because they were not sufficiently aware of the principle and its operational consequences. It called upon the Member States to develop appropriate measures in order to provide economic operators and citizens with an effective framework for mutual recognition, inter alia, by dealing effectively with requests from economic operators and citizens and by replying rapidly to those requests.

(7)

The European Council of 8 and 9 March 2007 underlined the importance of giving fresh impetus to the internal market in goods by strengthening mutual recognition, while guaranteeing a high level of safety and consumer protection. The European Council of 21 and 22 June 2007 stressed that the further strengthening of the four freedoms of the internal market (the free movement of goods, persons, services and capital) and improving its functioning remain of paramount importance for growth, competitiveness and employment.

(8)

The smooth functioning of the internal market in goods requires adequate and transparent means of solving the problems that result from applying technical rules of a Member State to specific products lawfully marketed in another Member State.

(9)

This Regulation should not prejudice further harmonisation of technical rules, where appropriate, with a view to improving the functioning of the internal market.

(10)

Trade barriers may also result from other types of measures falling within the scope of Articles 28 and 30 of the Treaty. Those measures may, for example, include technical specifications drawn up for public procurement procedures or obligations to use official languages in the Member States. However, such measures should not constitute technical rules within the meaning of this Regulation and should not therefore fall within its scope.

(11)

Technical rules within the meaning of this Regulation are sometimes applied during and by means of mandatory prior authorisation procedures, established by the law of a Member State and in accordance with which, before a product or type of product may be placed on that Member State's market or on a part thereof, the competent authority of that Member State should give its formal approval following an application. The existence of such procedures in itself restricts the free movement of goods. Therefore, in order to be justified with regard to the fundamental principle of the free movement of goods within the internal market, a mandatory prior authorisation procedure should pursue a public-interest objective recognised by Community law, and should be non-discriminatory and proportionate; that is to say, it should be appropriate to ensure achievement of the aim pursued but not go beyond what is necessary in order to achieve that aim. The compliance of such a procedure with the principle of proportionality should be assessed in the light of the considerations set out in the case-law of the Court of Justice.

(12)

A requirement that the placing of a product on the market be subject to prior authorisation should, as such, not constitute a technical rule within the meaning of this Regulation, so that a decision to exclude or remove a product from the market exclusively on the grounds that it does not have valid prior authorisation should not constitute a decision to which this Regulation applies. When, however, an application for such mandatory prior authorisation of a product is made, any intended decision to reject the application on the basis of a technical rule should be taken in accordance with this Regulation, so that the applicant could benefit from the procedural protection which this Regulation provides.

(13)

Decisions of national courts or tribunals assessing the legality of cases in which, on account of the application of a technical rule, products lawfully marketed in one Member State are not granted access to the market of another Member State, or applying penalties, should be excluded from the scope of this Regulation.

(14)

Weapons are products that can constitute a serious risk to the health and safety of persons and to the public security of Member States. Several specific types of weapons lawfully marketed in one Member State might, on grounds of the protection of the health and safety of persons and the prevention of crime, be subject to restrictive measures in another Member State. Such measures might consist of specific controls and authorisations before weapons lawfully marketed in one Member State are placed on the market of another Member State. Member States should therefore be permitted to prevent weapons being placed on their markets until their national procedural requirements are fully met.

(15)

Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (4) specifies that only safe products may be placed on the market and lays down the obligations of producers and distributors with respect to the safety of products. It entitles the authorities to ban any dangerous product with immediate effect or, for the period needed for the various safety evaluations, checks and controls, to ban temporarily a product that could be dangerous. It also entitles the authorities to take the necessary action to apply with due dispatch appropriate measures such as those referred to in Article 8(1)(b) to (f) thereof, in the case of products posing a serious risk. Therefore, measures taken by the competent authorities of the Member States pursuant to national laws adopted in implementation of Article 8(1)(d) to (f) and Article 8(3) of that Directive should be excluded from the scope of this Regulation.

(16)

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (5) establishes, inter alia, a rapid alert system for the notification of a direct or indirect risk to human health deriving from food or feed. It obliges the Member States to notify the Commission immediately under the rapid alert system of any measure they adopt which is aimed at restricting the placing on the market of, withdrawing from the market or recalling food or feed in order to protect human health, and which requires rapid action. Measures taken by the competent authorities of the Member States pursuant to Article 50(3)(a) and Article 54 of that Regulation should therefore be excluded from the scope of this Regulation.

(17)

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 (6) lays down general rules for the performance of official controls to verify compliance with rules intended, in particular, to prevent, eliminate or reduce to acceptable levels risks to humans and animals, either directly or through the environment, guaranteeing fair practices in feed and food trade and protecting consumer interests, including feed and food labelling and other forms of consumer information. It lays down a specific procedure to ensure that economic operators remedy a situation of non-compliance with feed and food law, animal health and animal welfare rules. Measures taken by the competent authorities of the Member States pursuant to Article 54 of that Regulation should therefore be excluded from the scope of this Regulation. However, measures taken or intended to be taken by competent authorities on the basis of national technical rules, insofar as they do not concern the objectives of Regulation (EC) No 882/2004, should be subject to this Regulation.

(18)

Directive 2004/49/EC of the European Parliament and of the Council of 29 April 2004 on safety on the Community's railways (Railway Safety Directive) (7) provides for a procedure for authorisation of the placing in service of existing rolling stock, leaving scope for the application of certain national rules. Measures taken by the competent authorities pursuant to Article 14 of that Directive should therefore be excluded from the scope of this Regulation.

(19)

Council Directive 96/48/EC of 23 July 1996 on the interoperability of the trans-European high-speed rail system (8) and Directive 2001/16/EC of the European Parliament and of the Council of 19 March 2001 on the interoperability of the trans-European conventional rail system (9) provide for the gradual harmonisation of systems and operations through the progressive adoption of Technical Specifications for Interoperability. Systems and interoperability constituents that fall within the scope of those Directives should therefore be excluded from the scope of this Regulation.

(20)

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 (10) establishes a system of accreditation which ensures the mutual acceptance of the level of competence of conformity-assessment bodies. The competent authorities of the Member States should therefore no longer refuse test reports and certificates issued by an accredited conformity-assessment body on grounds related to the competence of that body. Furthermore, Member States may also accept test reports and certificates issued by other conformity-assessment bodies in accordance with Community law.

(21)

Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (11) obliges Member States to communicate to the Commission and the other Member States any draft technical regulation concerning any product, including agricultural and fish products, and a statement of the grounds which make the enactment of that regulation necessary. It is necessary, however, to ensure that, following the adoption of such a technical regulation, the principle of mutual recognition is correctly applied in individual cases to specific products. This Regulation lays down a procedure for the application of the principle of mutual recognition in individual cases, by means of the obligation on the competent authority to indicate the technical or scientific grounds on which the specific product in its current form cannot be marketed in its Member State, in accordance with Articles 28 and 30 of the Treaty. In the context of this Regulation, evidence should not be understood as meaning legal proof. The authorities of the Member States are not obliged, in the context of this Regulation, to justify the technical rule itself. However, they should justify, as laid down in this Regulation, the possible application of the technical rule to a product lawfully marketed in another Member State.

(22)

In accordance with the principle of mutual recognition, the procedure laid down in this Regulation should provide for the competent authorities to communicate in each case to the economic operator, on the basis of the relevant technical or scientific elements available, that there are overriding reasons of public interest for imposing national technical rules on the product or type of product in question and that less restrictive measures cannot be used. The written notice should allow the economic operator to comment on all relevant aspects of the intended decision restricting access to the market. Nothing prevents the competent authority from taking action after the deadline for the receipt of those comments in the absence of a reply from the economic operator.

(23)

The concept of overriding reasons of public interest to which reference is made in certain provisions of this Regulation is an evolving concept developed by the Court of Justice in its case law in relation to Articles 28 and 30 of the Treaty. This concept covers, inter alia, the effectiveness of fiscal supervision, the fairness of commercial transactions, the protection of consumers, the protection of the environment, the maintenance of press diversity and the risk of seriously undermining the financial balance of the social security system. Such overriding reasons may justify the application of technical rules by the competent authorities. However, no such application should constitute a means of arbitrary discrimination or a disguised restriction of trade between Member States. Furthermore, the principle of proportionality should always be respected, regard being had to whether the competent authority has in fact made use of the least restrictive measure.

(24)

While applying the procedure laid down in this Regulation, the competent authority of a Member State should not withdraw or restrict the placing on its market of a product or type of product lawfully marketed in another Member State. However, it is appropriate that a competent authority be able to adopt provisional measures where rapid intervention is required to prevent harm to safety and health of users. Such provisional measures may also be adopted by a competent authority to prevent the placing on its market of a product the marketing of which is generally prohibited on grounds of public morality or public security, including the prevention of crime. Therefore, Member States should be allowed, at any stage of the procedure laid down in this Regulation, to suspend temporarily the marketing on their territories of products or types of product under those circumstances.

(25)

Any decision to which this Regulation applies should specify the remedies available so that an economic operator can bring proceedings before the competent national court or tribunal.

(26)

It is appropriate that the economic operator also be informed of the availability of non-judicial problem-solving mechanisms, such as the SOLVIT system, in order to prevent legal uncertainty and legal costs.

(27)

Once a competent authority has taken a decision to exclude a product on the basis of a technical rule in accordance with the procedural requirements of this Regulation, no further action taken in relation to that product which is based on that decision and on the same technical rule should be subject to the requirements of this Regulation.

(28)

It is important for the internal market in goods that the accessibility of national technical rules be ensured, so that enterprises, and in particular SMEs, can gather reliable and precise information concerning the law in force.

(29)

It is therefore necessary to implement principles of administrative simplification, inter alia, through the establishment of a system of Product Contact Points. This should be designed to ensure that enterprises can gain access to information in a transparent and correct manner, so that the delays, costs and dissuasive effects which result from national technical rules can be prevented.

(30)

In order to facilitate the free movement of goods, Product Contact Points should provide, free of charge, information concerning their national technical rules and the application of the principle of mutual recognition as regards products. Product Contact Points should be adequately equipped and resourced and encouraged also to make the information available through a website and in other Community languages. Product Contact Points could also provide economic operators with additional information or observations during the procedure laid down in this Regulation. For additional information, Product Contact Points may charge fees that are proportionate to the costs of this information.

(31)

Since the creation of Product Contact Points should not interfere with the allocation of functions among competent authorities within the regulatory systems of the Member States, it should be possible for Member States to set up Product Contact Points according to regional or local competences. Member States should be able to entrust the role of Product Contact Points to existing contact points established in accordance with other Community instruments, in order to prevent the unnecessary proliferation of contact points and to simplify administrative procedures. Member States should also be able to entrust the role of Product Contact Points not only to existing services within the public administration, but also to national SOLVIT centres, chambers of commerce, professional organisations and private bodies, in order not to increase administrative costs for enterprises and competent authorities.

(32)

Member States and the Commission should be encouraged to work closely together to facilitate the training of staff employed in Product Contact Points.

(33)

In view of the development and establishment of a pan-European eGovernment service and the underlying interoperable telematic networks, the possibility of establishing an electronic system for the exchange of information between Product Contact Points should be envisaged, in accordance with Decision 2004/387/EC of the European Parliament and of the Council of 21 April 2004 on the interoperable delivery of pan-European eGovernment services to public administrations, businesses and citizens (IDABC) (12).

(34)

Reliable and efficient monitoring and evaluation mechanisms should be established in order to provide information on the application of this Regulation so as to enhance knowledge concerning the functioning of the internal market in goods in sectors not subject to harmonisation and to ensure that the principle of mutual recognition is duly applied by the competent authorities of the Member States. Such mechanisms should not go beyond what is necessary to achieve those objectives.

(35)

This Regulation applies only to products or particular features of products which are not subject to Community harmonisation measures intended to eliminate obstacles to trade between Member States resulting from the existence of divergent national technical rules. The provisions of such harmonisation measures are often exhaustive, in which case Member States may not prohibit, restrict or impede the placing on the market in their territories of products complying with those measures. Some Community harmonisation measures, however, permit Member States to impose additional technical conditions on the placing of a product on their market. Such additional conditions should be subject to Articles 28 and 30 of the Treaty and to the provisions of this Regulation. It is therefore appropriate, with a view to the efficient application of this Regulation, that the Commission should establish an indicative and non-exhaustive list of products which are not subject to harmonisation at Community level.

(36)

The monitoring scheme established by Decision No 3052/95/EC of the European Parliament and of the Council of 13 December 1995 establishing a procedure for the exchange of information on national measures derogating from the principle of the free movement of goods within the Community (13) has proved largely unsuccessful in that its implementation has not provided the Commission with sufficient information to identify sectors where harmonisation might be appropriate. Nor has it brought about a rapid resolution of certain free-movement problems. Decision No 3052/95/EC should therefore be repealed.

(37)

It is appropriate to introduce a transitional period for the application of this Regulation, in order to enable the competent authorities to adapt to the requirements laid down herein.

(38)

Since the objective of this Regulation, namely the elimination of technical obstacles to the free movement of goods between Member States, cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale and effects, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. 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.

(39)

The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (14),

(a)

the prohibition of the placing on the market of that product or type of product;

(b)

the modification or additional testing of that product or type of product before it can be placed or kept on the market;

(c)

the withdrawal of that product or type of product from the market.

(a)

which is not the subject of harmonisation at Community level; and

(b)

which prohibits the marketing of a product or type of product in the territory of that Member State or compliance with which is compulsory when a product or type of product is marketed in the territory of that Member State, and which lays down either:

(a)

decisions of a judicial nature taken by national courts or tribunals;

(b)

decisions of a judicial nature taken by law enforcement authorities in the course of the investigation or prosecution of a criminal offence as regards the terminology, symbols or any material reference to unconstitutional or criminal organisations or offences of a racist or xenophobic nature.

(a)

Article 8(1)(d) to (f) and Article 8(3) of Directive 2001/95/EC;

(b)

Article 50(3)(a) and Article 54 of Regulation (EC) No 178/2002;

(c)

Article 54 of Regulation (EC) No 882/2004;

(d)

Article 14 of Directive 2004/49/EC.

(a)

relevant information concerning the characteristics of the product or type of product in question;

(b)

relevant and readily available information on the lawful marketing of the product in another Member State.

(a)

the intended decision is justified on one of the grounds of public interest set out in Article 30 of the Treaty or by reference to other overriding reasons of public interest; and

(b)

the intended decision is appropriate for the purpose of achieving the objective pursued and does not go beyond what is necessary in order to attain that objective.

(a)

under normal or reasonably foreseeable conditions of use, the product or type of product in question poses a serious risk to the safety and health of the users; or

(b)

the marketing of the product or type of product in question is generally prohibited in a Member State on grounds of public morality or public security.

(a)

to the manufacturer of the product, if established in the Community, or the person who has placed the product on the market or requests to the competent authority that the product be placed on the market;

(b)

where the competent authority cannot establish the identity and contact details of any of the economic operators referred to in point (a), to the manufacturer's representative, when the manufacturer is not established in the Community or, if there is no representative established in the Community, to the importer of the product;

(c)

where the competent authority cannot establish the identity and contact details of any of the economic operators referred to in points (a) and (b), to any professional in the supply chain whose activity may affect any property of the product regulated by the technical rule which is being applied to it;

(d)

where the competent authority cannot establish the identity and contact details of any of the economic operators referred to in points (a), (b) and (c), to any professional in the supply chain whose activity does not affect any property of the product regulated by the technical rule which is being applied to it.

(a)

the technical rules applicable to a specific type of product in the territory in which those Product Contact Points are established and information as to whether that type of product is subject to a requirement for prior authorisation under the laws of their Member State, together with information concerning the principle of mutual recognition and the application of this Regulation in the territory of that Member State;

(b)

the contact details of the competent authorities within that Member State by means of which they may be contacted directly, including the particulars of the authorities responsible for supervising the implementation of the technical rules in question in the territory of that Member State;

(c)

the remedies generally available in the territory of that Member State in the event of a dispute between the competent authorities and an economic operator.

(a)

the number of written notices sent pursuant to Article 6(1) and the type of products concerned;

(b)

sufficient information concerning any decisions taken pursuant to Article 6(2), including the grounds on which those decisions were based and the type of products concerned;

(c)

the number of decisions taken pursuant to Article 6(3) and the type of products concerned.

13.8.2008   

EN

Official Journal of the European Union

L 218/30

(1)

It is necessary to ensure that products benefiting from the free movement of goods within the Community fulfil requirements providing a high level of protection of public interests such as health and safety in general, health and safety at the workplace, protection of consumers, protection of the environment and security, while ensuring that the free movement of products is not restricted to any extent greater than that which is allowed under Community harmonisation legislation or any other relevant Community rules. Provision should, therefore, be made for rules on accreditation, market surveillance, controls of products from third countries and the CE marking.

(2)

It is necessary to establish an overall framework of rules and principles in relation to accreditation and market surveillance. That framework should not affect the substantive rules of existing legislation setting out the provisions to be observed for the purpose of protecting public interests such as health, safety and protection of consumers and of the environment, but should aim at enhancing their operation.

(3)

This Regulation should be seen as complementary to 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 (3).

(4)

It is very difficult to adopt Community legislation for every product which exists or which may be developed; there is a need for a broad-based, legislative framework of a horizontal nature to deal with such products, to cover lacunae, in particular pending revision of existing specific legislation, and to complement provisions in existing or future specific legislation, in particular with a view to ensuring a high level of protection of health, safety, the environment and consumers, as required by Article 95 of the Treaty.

(5)

The framework for market surveillance established by this Regulation should complement and strengthen existing provisions in Community harmonisation legislation relating to market surveillance and the enforcement of such provisions. However, in accordance with the principle of lex specialis, this Regulation should apply only in so far as there are no specific provisions with the same objective, nature or effect in other existing or future rules of Community harmonisation legislation. Examples can be found in the following sectors: drug precursors, medical devices, medicinal products for human and veterinary use, motor vehicles and aviation. The corresponding provisions of this Regulation should not therefore apply in the areas covered by such specific provisions.

(6)

Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (4) established rules to ensure the safety of consumer products. Market surveillance authorities should have the possibility of taking the more specific measures available to them under that Directive.

(7)

However, in order to achieve a higher level of safety for consumer products, the market surveillance mechanisms provided for in Directive 2001/95/EC should be reinforced as regards products presenting a serious risk, in accordance with the principles established by this Regulation. Directive 2001/95/EC should therefore be amended accordingly.

(8)

Accreditation is part of an overall system, including conformity assessment and market surveillance, designed to assess and ensure conformity with the applicable requirements.

(9)

The particular value of accreditation lies in the fact that it provides an authoritative statement of the technical competence of bodies whose task is to ensure conformity with the applicable requirements.

(10)

Accreditation, though so far not regulated at Community level, is carried out in all Member States. The lack of common rules for that activity has resulted in different approaches and differing systems throughout the Community, with the result that the degree of rigour applied in the performance of accreditation has varied between Member States. It is therefore necessary to develop a comprehensive framework for accreditation and to lay down at Community level the principles for its operation and organisation.

(11)

The establishment of a uniform national accreditation body should be without prejudice to the allocation of functions within Member States.

(12)

Where Community harmonisation legislation provides for the selection of conformity assessment bodies for its implementation, transparent accreditation, as provided for in this Regulation, ensuring the necessary level of confidence in conformity certificates, should be considered by the national public authorities throughout the Community the preferred means of demonstrating the technical competence of those bodies. However, national authorities may consider that they possess the appropriate means of carrying out this evaluation themselves. In such cases, in order to ensure the appropriate level of credibility of evaluations carried out by other national authorities, they should provide the Commission and the other Member States with the necessary documentary evidence demonstrating the compliance of the conformity assessment bodies evaluated with the relevant regulatory requirements.

(13)

A system of accreditation which functions by reference to binding rules helps to strengthen mutual confidence between Member States as regards the competence of conformity assessment bodies and consequently the certificates and test reports issued by them. It thereby enhances the principle of mutual recognition and therefore the provisions of this Regulation on accreditation should apply in relation to bodies carrying out conformity assessments in both the regulated and the non-regulated areas. The issue at stake is the quality of certificates and test reports irrespective of whether they fall within the regulated or the non-regulated area, and no distinction should therefore be made between those areas.

(14)

For the purposes of this Regulation, not-for-profit operation by a national accreditation body should be understood as an activity that is not intended to add any gain to the resources of the body's owners or members. While national accreditation bodies do not have the objective of maximising or distributing profits, they may provide services in return for payment, or receive income. Any excess revenue that results from such services may be used for investment to develop their activities further, as long as it is in line with their main activities. It should accordingly be emphasised that the primary objective of national accreditation bodies should be to support or engage actively in activities that are not intended to produce any gain.

(15)

Since the purpose of accreditation is to provide an authoritative statement of the competence of a body to perform conformity assessment activities, Member States should not maintain more than one national accreditation body and should ensure that that body is organised in such a way as to safeguard the objectivity and impartiality of its activities. Such national accreditation bodies should operate independently of commercial conformity assessment activities. It is therefore appropriate to provide that Member States ensure that, in the performance of their tasks, national accreditation bodies are deemed to exercise public authority, irrespective of their legal status.

(16)

For the assessment and continued monitoring of the competence of a conformity assessment body, it is essential to determine its technological knowledge and experience and its ability to carry out assessment. It is therefore necessary that the national accreditation body possess the relevant knowledge, competence and means for the proper performance of its tasks.

(17)

Accreditation should in principle be operated as a self-supporting activity. Member States should ensure that financial support exists for the fulfilment of special tasks.

(18)

In those cases where it is not economically meaningful or sustainable for a Member State to establish a national accreditation body, that Member State should have recourse to the national accreditation body of another Member State and should be encouraged to have such recourse to the fullest extent possible.

(19)

Competition between national accreditation bodies could lead to the commercialisation of their activity, which would be incompatible with their role as the last level of control in the conformity assessment chain. The objective of this Regulation is to ensure that, within the European Union, one accreditation certificate is sufficient for the whole territory of the Union, and to avoid multiple accreditation, which is added cost without added value. National accreditation bodies may find themselves in competition on the markets of third countries, but that must have no effect on their activities inside the Community, or on the cooperation and peer evaluation activities organised by the body recognised under this Regulation.

(20)

In order to avoid multiple accreditation, to enhance acceptance and recognition of accreditation certificates and to carry out effective monitoring of accredited conformity assessment bodies, conformity assessment bodies should request accreditation by the national accreditation body of the Member State in which they are established. Nevertheless, it is necessary to ensure that a conformity assessment body is able to request accreditation in another Member State in the event that there is no national accreditation body in its own Member State or where the national accreditation body is not competent to provide the accreditation services requested. In such cases, appropriate cooperation and exchange of information between national accreditation bodies should be established.

(21)

In order to ensure that national accreditation bodies fulfil the requirements and obligations provided for in this Regulation, it is important that Member States support the proper functioning of the accreditation system, monitor their national accreditation bodies regularly and take appropriate corrective measures within a reasonable timeframe where necessary.

(22)

In order to ensure the equivalence of the level of competence of conformity assessment bodies, to facilitate mutual recognition and to promote the overall acceptance of accreditation certificates and conformity assessment results issued by accredited bodies, it is necessary that national accreditation bodies operate a rigorous and transparent peer evaluation system and regularly undergo such evaluation.

(23)

This Regulation should provide for the recognition of a single organisation at European level in respect of certain functions in the field of accreditation. The European cooperation for Accreditation (the EA), whose main mission is to promote a transparent and quality-led system for the evaluation of the competence of conformity assessment bodies throughout Europe, manages a peer evaluation system among national accreditation bodies from the Member States and other European countries. That system has proved to be efficient and to provide mutual confidence. The EA should, therefore, be the first body recognised under this Regulation and Member States should ensure that their national accreditation bodies seek and maintain membership of the EA for as long as it is so recognised. At the same time, the possibility of changing the relevant body recognised under this Regulation should be provided for, in case there is a need for it in the future.

(24)

Effective cooperation among national accreditation bodies is essential for the proper implementation of peer evaluation and with regard to cross-border accreditation. In the interests of transparency, it is, therefore, necessary to provide for an obligation on national accreditation bodies to exchange information among themselves and to provide the national authorities and the Commission with relevant information. Updated and accurate information concerning the availability of accreditation activities operated by national accreditation bodies should also be made public and, therefore, accessible, in particular to conformity assessment bodies.

(25)

Sectoral accreditation schemes should cover the fields of activity where general requirements for the competence of conformity assessment bodies are not sufficient to ensure the necessary level of protection where specific detailed technology or health and safety-related requirements are imposed. Given the fact that the EA has at its disposal a broad range of technical expertise, it should be requested to develop such schemes, especially for areas covered by Community legislation.

(26)

For the purpose of ensuring the equivalent and consistent enforcement of Community harmonisation legislation, this Regulation introduces a Community 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.

(27)

In the case of economic operators in possession of test reports or certificates attesting conformity issued by an accredited conformity assessment body, where the relevant Community harmonisation legislation does not require such reports or certificates, market surveillance authorities should take due account of them when performing checks on product characteristics.

(28)

Cooperation between competent authorities at national level and across borders in exchanging information, investigating infringements and taking action to bring about their cessation, even before the placing on the market of dangerous products, by reinforcing measures to identify them, mainly in seaports, is essential to the protection of health and safety and to guaranteeing the smooth functioning of the internal market. National consumer protection authorities should cooperate, at national level, with national market surveillance authorities and should exchange information with them relating to products which they suspect present a risk.

(29)

Risk assessment should take all relevant data into account, including, where available, data on risks that have materialised 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.

(30)

Situations of serious risk posed by a product require rapid intervention, which may entail the withdrawal of the product, its recall or the prohibition of its being made available on the market. In those situations it is necessary to have access to a system of rapid exchange of information between Member States and the Commission. The system provided for in Article 12 of Directive 2001/95/EC has proved its effectiveness and efficiency in the field of consumer products. To avoid unnecessary duplication, that system should be used for the purposes of this Regulation. Moreover, coherent market surveillance throughout the Community requires a comprehensive exchange of information on national activities in this context which goes beyond this system.

(31)

Information exchanged between competent authorities should be subject to the strictest guarantees of confidentiality and professional secrecy and be handled in accordance with rules on confidentiality pursuant to the 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 (5), in order to ensure that investigations are not compromised and that the reputations of economic operators are not prejudiced. 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 (6) 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 (7) apply in the context of this Regulation.

(32)

Community harmonisation legislation provides for specific procedures establishing whether or not a national measure restricting the free movement of a product is justified (safeguard clause procedures). Those procedures apply following a rapid exchange of information on products presenting a serious risk.

(33)

Points of entry at the external borders are well placed to detect unsafe non-conforming products or products to which the CE marking has been affixed falsely or in a misleading manner even before they are placed on the market. An obligation on authorities in charge of the control of products entering the Community market to execute checks on an adequate scale can therefore contribute to a safer market place. In order to increase the effectiveness of such checks, those authorities should receive all the necessary information concerning dangerous non-conforming products from the market surveillance authorities well in advance.

(34)

Council Regulation (EEC) No 339/93 of 8 February 1993 on checks for conformity with the rules on product safety in the case of products imported from third countries (8) lays down rules regarding the suspension of the release of products by customs authorities and provides for further measures including the involvement of market surveillance authorities. It is therefore appropriate that those provisions, including the involvement of market surveillance authorities, be incorporated in this Regulation.

(35)

Experience has shown that products which are not released are often re-exported and subsequently enter the Community market at other points of entry, thus undermining the customs authorities' efforts. Market surveillance authorities should therefore be given the means of proceeding with the destruction of products if they deem it appropriate.

(36)

Within one year of the publication of this Regulation in the Official Journal of the European Union, the Commission should present an in-depth analysis in the realm of consumer safety markings, followed by legislative proposals where necessary.

(37)

The CE marking, indicating the conformity of a product, is the visible consequence of a whole process comprising conformity assessment in a broad sense. General principles governing the CE marking should be set out in this Regulation so as to make them immediately applicable and to simplify future legislation.

(38)

The CE marking should be the only marking of conformity indicating that a product is in conformity with Community harmonisation legislation. However, other markings may be used as long as they contribute to the improvement of consumer protection and are not covered by Community harmonisation legislation.

(39)

It is necessary for Member States to provide for appropriate means of redress in the competent courts and tribunals in respect of measures taken by the competent authorities which restrict the placing on the market of a product or which require its withdrawal or recall.

(40)

Member States may find it useful to establish cooperation with the stakeholders concerned, including sectoral professional organisations and consumer organisations, in order to take advantage of available market intelligence when establishing, implementing and updating market surveillance programmes.

(41)

The Member States should lay down rules on penalties applicable to infringements of the provisions of this Regulation and ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive and could be increased if the relevant economic operator has previously committed a similar infringement of the provisions of this Regulation.

(42)

In order to achieve the objectives of this Regulation, it is necessary for the Community to contribute to the financing of activities required to implement policies in the field of accreditation and market surveillance. Financing should be provided in the form of grants to the body recognised under this Regulation without a call for proposals, in the form of grants after a call for proposals, or by the award of contracts to that or to other bodies, depending on the nature of the activity to be financed and in accordance with Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (9) (the Financial Regulation).

(43)

For some specialised tasks, such as the production and revision of sectoral accreditation schemes, and for other tasks related to the verification of the technical competence and the facilities of laboratories and certification or inspection bodies, the EA should initially be eligible for Community financing, since it is well adapted to providing the necessary technical expertise in this respect.

(44)

Given the role of the body recognised under this Regulation in the peer evaluation of accreditation bodies and its ability to assist the Member States with the management of that peer evaluation, the Commission should be in a position to provide grants for the functioning of the secretariat of the body recognised under this Regulation, which should provide ongoing support for accreditation activities at Community level.

(45)

A partnership agreement should be signed, in accordance with the provisions of the Financial Regulation, between the Commission and the body recognised under this Regulation in order to fix the administrative and financial rules on the financing of accreditation activities.

(46)

In addition, financing should also be available to bodies other than the body recognised under this Regulation for other activities in the field of conformity assessment, metrology, accreditation and market surveillance, such as the drawing-up and updating of guidelines, inter-comparison activities linked to the operation of safeguard clauses, preliminary or ancillary activities in connection with the implementation of Community legislation in those areas and programmes of technical assistance and cooperation with third countries as well as the enhancement of policies in those areas at Community and international level.

(47)

This Regulation respects the fundamental rights and observes the principles reflected in the Charter of Fundamental Rights of the European Union.

(48)

Since the objective of this Regulation, namely to ensure that products on the market covered by Community legislation fulfil 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 accreditation and market surveillance, cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale and effects, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. 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,

1.

‘making available on the market’ shall mean any supply of a product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge;

2.

‘placing on the market’ shall mean the first making available of a product on the Community market;

3.

‘manufacturer’ shall mean any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark;

4.

‘authorised representative’ shall mean any natural or legal person established within the Community who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks with regard to the latter's obligations under the relevant Community legislation;

5.

‘importer’ shall mean any natural or legal person established within the Community who places a product from a third country on the Community market;

6.

‘distributor’ shall mean any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market;

7.

‘economic operators’ shall mean the manufacturer, the authorised representative, the importer and the distributor;

8.

‘technical specification’ shall mean a document that prescribes technical requirements to be fulfilled by a product, process or service;

9.

‘harmonised standard’ shall mean a standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (10) on the basis of a request made by the Commission in accordance with Article 6 of that Directive;

10.

‘accreditation’ shall mean an attestation by a national accreditation body that a conformity assessment body meets the requirements set by harmonised standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a specific conformity assessment activity;

11.

‘national accreditation body’ shall mean the sole body in a Member State that performs accreditation with authority derived from the State;

12.

‘conformity assessment’ shall mean the process demonstrating whether specified requirements relating to a product, process, service, system, person or body have been fulfilled;

13.

‘conformity assessment body’ shall mean a body that performs conformity assessment activities including calibration, testing, certification and inspection;

14.

‘recall’ shall mean any measure aimed at achieving the return of a product that has already been made available to the end user;

15.

‘withdrawal’ shall mean any measure aimed at preventing a product in the supply chain from being made available on the market;

16.

‘peer evaluation’ shall mean a process for the assessment of a national accreditation body by other national accreditation bodies, carried out in accordance with the requirements of this Regulation, and, where applicable, additional sectoral technical specifications;

17.

‘market surveillance’ shall mean the activities carried out and measures taken by public authorities to ensure that products comply with the requirements set out in the relevant Community harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection;

18.

‘market surveillance authority’ shall mean an authority of a Member State responsible for carrying out market surveillance on its territory;

19.

‘release for free circulation’ shall mean the procedure laid down in Article 79 of Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (11);

20.

‘CE marking’ shall mean a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Community harmonisation legislation providing for its affixing;

21.

‘Community harmonisation legislation’ shall mean any Community legislation harmonising the conditions for the marketing of products.

(a)

where the Member State in which it is established has decided not to establish a national accreditation body and has not had recourse to the national accreditation body of another Member State in accordance with Article 4(2);

(b)

where the national accreditation bodies referred to in the first subparagraph do not perform accreditation in respect of the conformity assessment activities for which accreditation is sought;

(c)

where the national accreditation bodies referred to in the first subparagraph have not successfully undergone peer evaluation under Article 10 in respect of the conformity assessment activities for which accreditation is sought.

1.

it shall be organised in such a manner as to make it independent of the conformity assessment bodies it assesses and of commercial pressures, and to ensure that no conflicts of interest with conformity assessment bodies occur;

2.

it shall be organised and operated so as to safeguard the objectivity and impartiality of its activities;

3.

it shall ensure that each decision relating to the attestation of competence is taken by competent persons different from those who carried out the assessment;

4.

it shall have adequate arrangements to safeguard the confidentiality of the information obtained;

5.

it shall identify the conformity assessment activities for which it is competent to perform accreditation, referring, where appropriate, to relevant Community or national legislation and standards;

6.

it shall set up the procedures necessary to ensure efficient management and appropriate internal controls;

7.

it shall have a number of competent personnel at its disposal sufficient for the proper performance of its tasks;

8.

it shall document the duties, responsibilities and authorities of personnel who could affect the quality of the assessment and of the attestation of competence;

9.

it shall establish, implement and maintain procedures for monitoring the performance and competence of the personnel involved;

10.

it shall verify that conformity assessments are carried out in an appropriate manner, meaning that unnecessary burdens are not imposed on undertakings and that due account is taken of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process;

11.

it shall publish audited annual accounts prepared in accordance with generally accepted accounting principles.

(a)

request the body recognised under Article 14 to lay down evaluation criteria and procedures for peer evaluation and to develop sectoral accreditation schemes;

(b)

accept any existing scheme that already lays down evaluation criteria and procedures for peer evaluation.

(a)

follow up complaints or reports on issues relating to risks arising in connection with products subject to Community harmonisation legislation;

(b)

monitor accidents and harm to health which are suspected to have been caused by those products;

(c)

verify that corrective action has been taken; and

(d)

follow up scientific and technical knowledge concerning safety issues.

(a)

develop and organise training programmes and exchanges of national officials;

(b)

develop, organise and set up programmes for the exchange of experience, information and best practice, programmes and actions for common projects, information campaigns, joint visit programmes and the consequent sharing of resources.

(a)

the product displays characteristics which give cause to believe that the product, when properly installed, maintained and used, presents a serious risk to health, safety, the environment or any other public interest referred to in Article 1;

(b)

the product is not accompanied by the written or electronic documentation required by the relevant Community harmonisation legislation or is not marked in accordance with that legislation;

(c)

the CE marking has been affixed to the product in a false or misleading manner.

(a)

the production and revision of sectoral accreditation schemes referred to in Article 13(3);

(b)

the activities of the secretariat of the body recognised under Article 14, such as the coordination of accreditation activities, the processing of technical work linked to the operation of the peer evaluation system, the provision of interested parties with information and the participation of the body in the activities of international organisations in the field of accreditation;

(c)

the drawing up and updating of contributions to guidelines in the fields of accreditation, notification to the Commission of conformity assessment bodies, conformity assessment and market surveillance;

(d)

inter-comparison activities linked to the operation of safeguard clauses;

(e)

the making available to the Commission of technical expertise for the purpose of assisting the Commission in its implementation of market surveillance administrative cooperation, including the financing of administrative cooperation groups, market surveillance decisions and safeguard clause cases;

(f)

the performance of preliminary or ancillary work in connection with the implementation of the conformity assessment, metrology, accreditation and market surveillance activities linked to the implementation of Community legislation, such as studies, programmes, evaluations, guidelines, comparative analyses, mutual joint visits, research work, the development and maintenance of databases, training activities, laboratory work, proficiency testing, inter-laboratory tests and conformity assessment work, as well as European market surveillance campaigns and similar activities;

(g)

activities carried out under programmes of technical assistance, cooperation with third countries and the promotion and enhancement of European conformity assessment, market surveillance and accreditation policies and systems among interested parties in the Community and at international level.

(a)

without a call for proposals, to the body recognised under Article 14 to carry out those activities referred to in Article 32(1)(a) to (g) for which grants can be awarded in accordance with the Financial Regulation;

(b)

in the form of grants after a call for proposals, or by public procurement procedures, to other bodies to carry out the activities referred to in Article 32(1)(c) to (g).

13.8.2008   

EN

Official Journal of the European Union

L 218/48

(1)

Council Regulation (EC) No 515/97 (3) improved the earlier legal mechanism, in particular by allowing information to be stored in the Community database Customs Information System (CIS).

(2)

However, experience gained since Regulation (EC) No 515/97 entered into force has shown that the use of the CIS for the sole purposes of sighting and reporting, discreet surveillance or specific checks does not make it possible to achieve fully the system's objective, which is to assist in preventing, investigating and prosecuting operations that are in breach of customs or agricultural legislation.

(3)

The changes introduced when the European Union was enlarged to include 27 Member States require a reconsideration of Community customs cooperation in a broader framework and with modernised mechanisms.

(4)

Commission Decision 1999/352/EC, ECSC, Euratom of 28 April 1999 establishing the European Anti-Fraud Office (OLAF) (4) and the Convention on the use of information technology for customs purposes (5), drawn up by Council Act of 26 July 1995 (6), modified the general framework for cooperation between the Member States and the Commission as regards preventing, investigating and prosecuting offences under Community legislation.

(5)

The results of strategic analysis should help those responsible at the highest level to determine projects, objectives and policies for combating fraud, to plan activities and to deploy the resources needed to achieve the operational objectives laid down.

(6)

The result of an operational analysis concerning the activities, resources and intentions of certain persons or businesses that do not comply or appear not to comply with customs or agricultural legislation should help the customs authorities and the Commission take the appropriate measures in specific cases to achieve the objectives laid down as regards the fight against fraud.

(7)

Under the current mechanism set out in Regulation (EC) No 515/97, personal data entered by a Member State can be copied from CIS into other data-processing systems only with the prior authorisation of the CIS partner which entered them and subject to the conditions imposed by it in accordance with Article 30(1). The amendment of the Regulation is designed to derogate from that principle of prior authorisation only where the data are to be processed by the national authorities and the Commission services responsible for risk management with a view to targeting controls on movements of goods.

(8)

The current mechanism needs to be supplemented by a legal framework establishing a customs files identification database covering past and current files. The creation of such a database follows up the intergovernmental customs cooperation initiative which led to the adoption of the Council Act of 8 May 2003 drawing up the Protocol amending, as regards the creation of a customs files identification database, the Convention on the use of information technology for customs purposes (7).

(9)

It is necessary to ensure that, in order to strengthen customs cooperation between Member States and between Member States and the Commission, and without prejudice to other provisions of Regulation (EC) No 515/97, certain data may be exchanged in pursuit of the objectives of that Regulation.

(10)

In addition, it is necessary to ensure greater complementarity with action in the context of intergovernmental customs cooperation and of cooperation with the other bodies and agencies of the European Union and other international and regional organisations. Such action follows on from the Council Resolution of 2 October 2003 concerning a strategy for customs cooperation (8) and the Council Decision of 6 December 2001 extending the mandate of Europol to the fight against the serious forms of international crime listed in the Annex to the Europol Convention (9).

(11)

In order to promote coherence between the action taken by the Commission, the other bodies and agencies of the European Union and other international and regional organisations, the Commission should be authorised to provide training and all forms of assistance other than financial assistance for the liaison officers of third countries and of European and international organisations and agencies, including the exchange of best practice with those bodies, and, for example, with Europol and the European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union (Frontex).

(12)

The conditions should be created under Regulation (EC) No 515/97 for the implementation of joint customs operations in the Community context. The Committee provided for by Article 43 of Regulation (EC) No 515/97 should be empowered to determine the mandate for Community joint customs operations.

(13)

A permanent infrastructure must be created within the Commission so that joint customs operations can be coordinated throughout the calendar year and representatives of the Member States and, if necessary, liaison officers from third countries or European or international organisations and agencies, in particular Europol and the World Customs Organisation (WCO) and Interpol, can be hosted for the time needed to carry out one or more individual operations.

(14)

In order to address CIS-related supervision issues, the European Data Protection Supervisor should convene a meeting with national data protection supervisory authorities at least once a year.

(15)

The Member States must have the possibility of reusing that infrastructure for joint customs operations organised by way of customs cooperation as provided for in Articles 29 and 30 of the Treaty on European Union, without prejudice to the role of Europol. In that event, joint customs operations should be conducted under the mandate determined by the relevant Council working party as regards customs cooperation under Title VI of the Treaty on European Union.

(16)

In addition, the development of new markets, the increasing internationalisation of trade and the rapid expansion thereof, combined with the increase in the speed of the carriage of goods, require customs administrations to keep up with movement so as not to harm the development of Europe's economy.

(17)

The ultimate objectives are that all operators should be able to provide all necessary documentation in advance and fully computerise their connections with the customs authorities. Meanwhile, the current situation will continue to exist, with various levels of development of national computer systems, and anti-fraud mechanisms must be improved since deflections of trade can still occur.

(18)

For the purpose of the fight against fraud, it is therefore necessary, together with the reform and modernisation of customs systems, to seek information at the furthest possible point upstream. In addition, in order to help the competent authorities of the Member States to detect movements of goods that are the object of operations in potential breach of customs or agricultural legislation and means of transport, including containers, used for that purpose, data from the principal service suppliers worldwide, public or private, that are active in the international supply chain should be pooled in a European central data directory.

(19)

The protection of natural persons in the processing of personal data is governed by 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 (10) and by Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (11), which are fully applicable to information society services. Those Directives already establish a Community legal framework in the field of personal data and therefore it is not necessary to cover the issue in this Regulation in order to ensure the smooth functioning of the internal market, in particular the free movement of personal data between Member States. This Regulation must be implemented and applied in accordance with the rules on the protection of personal data, in particular as regards the exchange and storage of information in support of action to prevent and detect fraud.

(20)

The exchange of personal data with third countries should be subject to prior verification that data protection rules in the receiving country offer a degree of protection equivalent to that provided by Community law.

(21)

As Directive 95/46/EC has been transposed by the Member States since the adoption of Regulation (EC) No 515/97, and the Commission has established an independent authority to ensure that freedoms and fundamental rights of persons are respected by Community institutions and bodies in the processing of personal data in accordance with 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 (12), the personal data protection control measures should be aligned and the reference to the European Ombudsman should be replaced by a reference to the European Data Protection Supervisor, without prejudice to the powers of the Ombudsman.

(22)

The measures necessary for the implementation of Regulation (EC) No 515/97 should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (13).

(23)

In particular, the Commission should be empowered to decide on items to be included in the CIS and to determine operations concerning the application of agricultural legislation in respect of which information is to be entered therein. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 515/97, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(24)

The report on the implementation of Regulation (EC) No 515/97 should be integrated in the report submitted each year to the European Parliament and to the Council on the measures taken in implementation of Article 280 of the Treaty.

(25)

Regulation (EC) No 515/97 should be amended accordingly.

(26)

Since the objective of this Regulation, namely the coordination of the fight against fraud and any other illegal activity to the detriment of the Community's financial interests, cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale and effects, be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. 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.

(27)

This Regulation respects fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union (14). In particular, this Regulation aims to ensure full respect for the right to the protection of personal data (Article 8 of the Charter of Fundamental Rights of the European Union).

(28)

The European Data Protection Supervisor has been consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 and delivered an opinion on 22 February 2007 (15),

1.

in Article 2(1), the following indents shall be added:

2.

the following Article shall be inserted:

‘Article 2a

Without prejudice to other provisions of this Regulation, and in pursuit of the objectives thereof, in particular where no customs declaration or simplified declaration is presented or where it is incomplete or where there is a reason to believe that the data contained therein are false, the Commission or the competent authorities of each Member State may exchange with the competent authority of any other Member State or the Commission the following data:

This Article shall apply only to movements of goods as described in the first indent of Article 2(1).

3.

Article 15 shall be amended as follows:

4.

Article 18 shall be amended as follows:

5.

in Title III, the following Articles shall be added:

‘Article 18a

1.   Without prejudice to the competences of the Member States, with a view to assisting the authorities referred to in Article 1(1) to detect movements of goods that are the object of operations in potential breach of customs and agricultural legislation and means of transport, including containers, used for that purpose, the Commission shall establish and manage a directory of data received from public or private service providers active in the international supply chain. That directory shall be directly accessible to those authorities.

2.   In managing that directory, the Commission shall be empowered:

3.   The data referred to in this Article concern in particular movements of containers and/or means of transport and goods and persons concerned with those movements. Those shall include, where available, the following data:

4.   Within the Commission, only designated analysts shall be empowered to process personal data to which paragraphs 2(b) and 2(c) apply.

Personal data which are not necessary for the purpose of achieving the aim in question shall be deleted immediately or have any identifying factors removed. In any event, they may be stored for no more than three years.

Article 18b

1.   The Commission shall be authorised to provide training and all forms of assistance other than financial assistance for the liaison officers of third countries and of European and international organisations and agencies.

2.   The Commission may make expertise, technical or logistical assistance, training or communication activity or any other operational support available to the Member States both for the achievement of the objectives of this Regulation and in the performance of Member States’ duties in the framework of the implementation of the customs cooperation provided for by Articles 29 and 30 of the Treaty on European Union.

6.

Article 19 shall be replaced by the following:

‘Article 19

Provided that the third country concerned has legally committed itself to providing the assistance necessary to assemble all the evidence of the irregular nature of operations which appear to be in breach of customs or agricultural legislation or to determine the extent of the operations which have been found to be in breach of such legislation, information obtained pursuant to this Regulation may be communicated to it:

Such communication by a Member State shall be made in compliance with its domestic provisions applicable to the transfer of personal data to third countries.

In all cases, it shall be ensured that the rules of the third country concerned offer a degree of protection equivalent to that provided for in Article 45(1) and (2).’;

7.

in Article 20(2), point (d) shall be deleted;

8.

Article 23 shall be amended as follows:

9.

in Article 24, the following points shall be added:

10.

Article 25 shall be replaced by the following:

‘Article 25

1.   The items to be included in the CIS relating to each of the categories referred to in Article 24(a) to (h) shall be determined in accordance with the regulatory procedure with scrutiny referred to in Article 43(2) to the extent that this is necessary to achieve the aim of the System. Personal data may under no circumstances appear in the category referred to in Article 24(e).

2.   With regard to the categories referred to in Article 24(a) to (d), the items of information to be included in respect of personal data shall comprise no more than:

3.   With regard to the category referred to in Article 24(f), the items of information to be included in respect of personal data shall comprise no more than the experts’ names and forenames.

4.   With regard to the categories referred to in Article 24(g) and (h), the items of information to be included in respect of personal data shall comprise no more than:

5.   In all cases, no personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, trade union membership and data concerning the health or sex life of an individual shall be included.’;

11.

Article 27 shall be replaced by the following:

‘Article 27

1.   Personal data which are included in the categories referred to in Article 24 shall be included in the CIS solely for the purposes of the following suggested actions:

2.   Personal data which are included in the categories referred to in Article 24 may be included in the CIS only if, in particular on the basis of prior illegal activities or of information provided by way of assistance, there is a real indication that the person in question has carried out, is carrying out or is about to carry out operations in breach of customs or agricultural legislation which are of particular relevance at Community level.’;

12.

Article 34(3) shall be replaced by the following:

‘3.   To ensure the correct application of the data protection provisions of this Regulation, the Member States and the Commission shall regard the CIS as a personal data-processing system which is subject to:

13.

Article 35 shall be replaced by the following:

‘Article 35

1.   Subject to Article 30(1), CIS partners shall be prohibited from using personal data from the CIS for any purpose other than that stated in Article 23(2).

2.   Data may be duplicated only for technical purposes, provided that such duplication is required for the purpose of searches carried out by the authorities referred to in Article 29.

3.   Personal data included in CIS by a Member State or the Commission may not be copied in data-processing systems for which the Member States or the Commission are responsible, except in systems of risk management used to direct national customs controls or in an operational analysis system used to coordinate actions at Community level.

In that case, only the analysts designated by the national authorities of each Member State and those designated by Commission services shall be empowered to process personal data obtained from the CIS within the framework respectively of a risk management system used to direct customs controls by national authorities or an operational analysis system used to coordinate actions at Community level.

Member States shall send the Commission a list of the risk management departments whose analysts are authorised to copy and process personal data entered in the CIS. The Commission shall inform the other Member States accordingly. It shall also provide all Member States with the corresponding information regarding its own services responsible for operational analysis.

The list of designated national authorities and Commission services shall be published for information by the Commission in the Official Journal of the European Union.

Personal data copied from the CIS shall be kept only for the time necessary to achieve the purpose for which they were copied. The need for their retention shall be reviewed at least annually by the copying CIS partner. The storage period shall not exceed 10 years. Personal data which are not necessary for the continuation of the analysis shall be deleted immediately or have any identifying factors removed.’;

14.

the second subparagraph of Article 36(2) shall be replaced by the following:

‘In any event, access may be denied to any person whose data are processed during the period in which actions are carried out for the purposes of sighting and reporting or discreet surveillance and during the period in which the operational analysis of the data or administrative enquiry or criminal investigation is ongoing.’;

15.

Article 37 shall be amended as follows:

16.

in Title V, the title of Chapter 7 shall be replaced by the following: ‘Data security’;

17.

in Article 38(1), the following point shall be added:

18.

the following Title shall be inserted:

‘TITLE Va

CUSTOMS FILES IDENTIFICATION DATABASE

CHAPTER 1

Establishment of a customs files identification database

Article 41a

1.   The CIS shall also include a specific database called the “Customs files identification database” (FIDE). Subject to the provisions of this Title, all the provisions of this Regulation relating to the CIS shall also apply to the FIDE, and any reference to the CIS shall include that database.

2.   The objectives of the FIDE shall be to help to prevent operations in breach of customs legislation and of agricultural legislation applicable to goods entering or leaving the customs territory of the Community and to facilitate and accelerate their detection and prosecution.

3.   The purpose of the FIDE shall be to allow the Commission, when it opens a coordination file within the meaning of Article 18 or prepares a Community mission in a third country within the meaning of Article 20, and the competent authorities of a Member State designated as regards administrative enquiries in accordance with Article 29, when they open an investigation file or investigate one or more persons or businesses, to identify the competent authorities of the other Member States or the Commission departments which are or have been investigating the persons or businesses concerned, in order to achieve the objectives specified in paragraph 2 by means of information on the existence of investigation files.

4.   If the Member State or the Commission making a search in the FIDE needs fuller information on the registered investigation files on persons or businesses, it shall ask for the assistance of the supplier Member State.

5.   The customs authorities of the Member States may use the FIDE within the framework of customs cooperation provided for in Articles 29 and 30 of the Treaty on European Union. In such a case, the Commission shall ensure the technical management of the database.

CHAPTER 2

Operation and use of the FIDE

Article 41b

1.   The competent authorities may enter data from investigation files in the FIDE for the purposes defined in Article 41a(3) concerning cases which are in breach of customs legislation or agricultural legislation applicable to goods entering or leaving the customs territory of the Community and which are of particular relevance at Community level. The data shall cover only the following categories:

The data referred to in points (a), (b) and (c) shall be introduced separately for each person or business. The creation of links between those data shall be prohibited.

2.   The personal data referred to in paragraph 1(a) shall consist only of the following:

3.   Data shall be entered for a limited period in accordance with Article 41d.

Article 41c

1.   The introduction and consultation of data in the FIDE shall be reserved exclusively to the authorities referred to in Article 41a.

2.   Any consultation of the FIDE must specify the following personal data:

CHAPTER 3

Storage of data

Article 41d

1.   The period for which data may be stored shall depend on the laws, regulations and procedures of the Member State supplying them. The following are the maximum periods, calculated from the date of entry of the data in the investigation file, which may not be exceeded:

These periods shall not be cumulative.

2.   At all stages of an investigation file as referred to in paragraph 1(a), (b) and (c), as soon as a person to whom, or a business to which, Article 41b applies is cleared of suspicion under the laws, regulations and procedures of the supplier Member State, data concerning that person or business shall immediately be deleted.

3.   The FIDE shall delete the data automatically as soon as the maximum storage period provided for in paragraph 1 has elapsed.’;

19.

Title VI shall be replaced by the following:

‘TITLE VI

FINANCING

Article 42a

1.   This Regulation is the basic act on which the financing of all Community action provided for herein is based, including:

2.   Expenditure relating to the acquisition, study, development and maintenance of the Community components of the common communication network used for the purposes of paragraph 1(c) shall also be borne by the general budget of the European Union. The Commission shall conclude the necessary contracts on behalf of the Community to ensure the operational nature of those components.

3.   Without prejudice to the expenses relating to the operation of the CIS and the amounts provided for by way of compensation pursuant to Article 40, the Member States and the Commission shall waive all claims for the reimbursement of expenditure relating to the supply of information or of documents or to the implementation of an administrative investigation or of any other operational action pursuant to this Regulation which are carried out at the request of a Member State or the Commission, except as regards the allowances, if any, paid to experts.

20.

Article 43 shall be amended as follows:

21.

in Articles 44 and 45(2), the terms ‘in Title V on the CIS’ shall be replaced by the terms ‘in Titles V and Va’;

22.

the following Article shall be inserted:

‘Article 51a

The Commission, in cooperation with the Member States, shall report each year to the European Parliament and to the Council on the measures taken in implementation of this Regulation.’;

23.

Article 53 shall be amended as follows:

13.8.2008   

EN

Official Journal of the European Union

L 218/60

(1)

Building upon the conclusions of the Council of 20 September 2001, and the conclusions of the European Council in Laeken in December 2001, in Seville in June 2002, in Thessaloniki in June 2003 and in Brussels in March 2004, the establishment of the Visa Information System (VIS) represents one of the key initiatives within the policies of the European Union aimed at establishing an area of freedom, security and justice.

(2)

Council Decision 2004/512/EC of 8 June 2004 establishing the Visa Information System (VIS) (2) established the VIS as a system for the exchange of visa data between Member States.