EUR-Lex - 32003G1205(04) - EN Avis juridique important | 32003G1205(04) Council resolution of 25 November 2003 on common objectives for participation by and information for young people Official Journal C 295 , 05/12/2003 P. 0006 - 0008 Council resolutionof 25 November 2003on common objectives for participation by and information for young people(2003/C 295/04)THE COUNCIL OF THE EUROPEAN UNION AND THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES, MEETING WITHIN THE COUNCIL,Whereas:(1) The Commission White Paper entitled "A new impetus for European youth" presented on 21 November 2001 sets out a new framework for European cooperation on youth affairs.(2) In its conclusions of 14 February 2002 the Council (Education and Youth) recognised the White Paper as the starting point for the establishment of a framework for European cooperation on youth affairs.(3) When it established a new framework for cooperation in the youth field, in its Resolution of 27 June 2002, the Council adopted the open method of coordination, calling in particular on the Council to establish, taking into account a Commission draft, the common objectives and a timetable for follow-up reports from the Member States for each priority, as appropriate. It also stressed that those policies and initiatives that affect the young people both at national and at European level take into consideration matters such as the needs, the situation, the living conditions and the expectations of youth.(4) Further to the consultations carried out under the open method of coordination, the Commission communication [COM(2003) 184 final] of 11 April 2003 proposed a set of common objectives for participation by and information for young people,NOTE that the Council of 5 May 2003 confirmed the importance of the priorities of participation by and information for young people,AGREE the following common objectives for developing these priorities,CONCERNING PARTICIPATION to develop participation by young people, by introducing and supporting action to encourage them to exercise their citizenship actively and by enhancing their effective participation in democratic life:1. increase the participation by young people in the civic life of their community;2. increase participation by young people in the system of representative democracy;3. greater support for various forms of learning to participate,CONCERNING INFORMATION to develop information for young people, by improving access for young people to information in order to increase their participation in public life and facilitate the realisation of their potential as active, responsible citizens:1. improve access for young people to information services;2. increase provision of quality information;3. increase participation by young people in youth information, for example, in the preparation and dissemination of information.A non-exhaustive list of the possible lines of action for the above common objectives is set out in the annex hereto,THE IMPLEMENTATION AND FOLLOW-UP OF THE COMMON OBJECTIVES:RECALL that implementation must be flexible, incremental and appropriate for the youth field, must respect the powers of the Member States and the principle of subsidiarity,INVITE THE MEMBER STATES TO- specify implementing and follow-up measures, in the light of their particular circumstances and their national priorities with regard to those common objectives,- submit reports on the national contributions to the implementation of both priorities, participation and information, by the end of 2005, after consulting young people, their associations and, if appropriate, national and regional youth councils via the channels they consider appropriate,NOTE THAT THE COMMISSION INTENDS TO:- prepare, on the basis of the reports on national contributions to the implementation of the common objectives, a progress report for submission to the Council in order to encourage mutual exchange of information and good practice concerning those two priorities, after consultation of the European Youth Forum, while not excluding other forms of consultation, and propose, if appropriate, amendments to the common objectives for participation and information,- suitably inform the European Parliament, the Economic and Social Committee and the Committee of the Regions,INVITE THE COMMISSION TO: convene, when appropriate representatives of the national Administrations dealing with the youth field, in order to promote the exchange of information on the progress made and on best practice,TAKE NOTE OF THE FOLLOWING PROCEDURE:The Council and the Representatives of the Governments of the Member States, meeting within the Council will adapt or amend the common objectives, on the basis of the progress report and the amended drafts submitted by the Commission, and when appropriate take the necessary initiatives within the framework of the common objectives, in order to facilitate their implementation.ANNEXMEASURES FOR ACHIEVING THE COMMON OBJECTIVES FOR PARTICIPATION BY AND INFORMATION FOR YOUNG PEOPLEIn the light of the actual circumstances and the priorities of each Member State, the following non-exhaustive list of lines of action may be pursued:PARTICIPATION1. Participation by young people in civic life(a) promote the involvement of young people in participatory structures, for example NGOs, associations, voluntary work, local youth councils, and encourage the activities of youth NGOs, while respecting their independence and autonomy;(b) encourage the development of activities, initiatives and projects intended to involve young people directly at regional and local level;(c) publicise and show greater recognition of the outreach work done by parents, youth workers and other persons;(d) identify more clearly the obstacles in the way of participation by specific groups and by disadvantaged young people and encourage measures and mechanisms capable of overcoming those obstacles, in particular by making allowance for their diversities and priorities (cultural or ethnic background, disabilities, socio-economic factors, gender, etc.);(e) examine qualitative evaluation methods of participation for young people.2. Greater participation by young people in the system of representative democracy(a) encourage and develop, [...] at all appropriate levels, a regular, structured dialogue between the public and/or government authorities and young people and their representative structures (national, regional and local youth councils, youth organisations, the European Youth Forum, etc.);(b) ensure that such dialogue can also include young people who are not members of organisations and that their concerns are taken into account;(c) promote and develop this dialogue, so that young people can be more involved in public life;(d) identify more clearly and study the obstacles in the way of participation by young people in the system of representative democracy and encourage measures and mechanisms conducive to the inclusion of all young people in all their diversities (cultural or ethnic background, disabilities, gender, socio-economic factors, etc.).3. Support for various forms of learning to participate(a) further develop and extend training for participation within formal education systems (in conjunction with the objectives approved under the open method of coordination as applied to education);(b) encourage the development of activities in the field of non-formal and informal education that promote the active participation of young people;(c) further develop interaction between formal, non-formal and informal education;(d) foster the development of experience of participation where young people live their lives: in particular within the family, at school, in youth organisations, at university, at other places of education or training and at work, in sporting and leisure time contexts;(e) recognise the important role of persons working with young people and facilitating their learning to participate and develop training actions in this field;(f) promote and increase awareness of the benefits to all of the participation of committed young people and combat prejudices against young people which prevent them from playing an effective part;(g) analyse more carefully the phenomena which lead to the civic exclusion of certain groups and encourage approaches focused on prevention.INFORMATION1. Access for young people to information services(a) promote, at the appropriate levels, the development in Member States of comprehensive, coherent and coordinated information services which take account of the specific needs of young people and are as youth friendly and economically accessible as possible;(b) facilitate equal access of all young people to information, while avoiding any form of discrimination or exclusion based on economic, social, gender, cultural or geographical grounds;(c) encourage the development of national, regional and local youth portals linked to the European Youth Portal.2. Quality information(a) monitor the quality of youth information, taking existing instruments into account (e.g. good practices and the ERYICA's European Youth Information Charter);(b) improve the education and training of those working in the field of youth information;(c) improve the link between information and counselling, with the aim of encouraging a learning and capacity-building process among young people on how to obtain, select and evaluate information in order to become informed users of information;(d) promote the dissemination of specific information for young people through all information channels, particularly those most frequently used by young people, such as the Internet, mobile phones, video films and cinema.3. Participation by young people in information(a) promote the participation of youth organisations and people working in the area of youth information at European, national, regional and local level in the preparation and implementation of youth information strategies;(b) promote involvement by young people in the preparation of understandable, user-friendly, targeted information products, so as to improve the quality of the information and access for all young people;(c) encourage greater involvement by young people in the dissemination of information and advice (particularly in youth information centres, schools, youth organisations and the media), in order to help all young people to access information.

Summary: Common objectives for participation by and information for young people Common objectives for participation by and information for young people This Resolution sets common objectives to develop and improve young Europeans' effective participation in democratic life and their access to information. ACT Council Resolution of 25 November 2003 on common objectives for participation by and information for young people [Official Journal C 295 of 05.12.2003] SUMMARY In this Resolution the Council approves the common objectives with a view to encouraging active citizenship among young people, promoting their access to information and their involvement in the implementation of strategies in this field. The new framework for cooperation in the field of youth has identified participation by and information for young people as priority issues. This Resolution sets out a non-exhaustive list of possible areas for action to achieve the common objectives in both fields. It focuses on the inclusion of disadvantaged young people in order to avoid all forms of discrimination or exclusion (cultural or ethnic background, disabilities, socio-economic factors, gender, etc.). Increasing participation With regard to participation, the Council proposes to promote the introduction of, and support for, measures to encourage young people to exercise their citizenship actively and to participate effectively in democratic life, and in particular to: increase participation by young people in the civic life of their community; increase participation by young people in the system of representative democracy; provide greater support for various forms of learning to participate. Encouraging information The Council proposes to promote access for young people to information in order to increase their participation in public life and help them realise their potential as active, responsible citizens, in particular by: improving access for young people to information services; increasing the provision of quality information; increasing participation by young people in youth information, for example in the preparation and dissemination of information. The Council calls on the Member States to specify their priorities with regard to these common objectives and to submit their national contributions to the implementation of the objectives by the end of 2005. On the basis of these national contributions, the Commission will prepare a progress report and will convene, when appropriate, representatives of the national administrations dealing with the field of youth, in order to promote the exchange of information and best practice. RELATED ACTS Resolution of the Council and of the Representatives of the Governments of the Member States of 24 May 2005 meeting within the Council on implementing the common objective "to increase participation by young people in the system of representative democracy" [Official Journal C 141/02 of 10 June 2005] The Council notes that young people are not automatically interested in participating in the institutions of democracy and that their participation is tending to decline in some Member States. Against this background it calls on the Member States to: encourage political parties' awareness of the importance of increasing their youth membership and the number of young people on their lists of candidates; mobilise the support of regional and local authorities for young people's participation; make young people aware of the importance of voting in elections; The Council invites the Commission and Member States to draw up an inventory of existing knowledge of obstacles to young people's active participation in representative democracy; exchange information on measures already taken and examples of good practice; strengthen dialogue between young people and political leaders; meet in 2006 to review progress on this objective. Resolution of the Council and of the Representatives of the Governments of the Member States of 24 May 2005 meeting within the Council on implementing the common objectives for youth information [Official Journal C 141/03 of 10 June 2005] The Council agreed that special attention should be focused on: stepping up networking among youth-oriented information structures in various sectors at local, national and European level; continuing training for those involved in youth information. The authors of the resolution call on the Commission and Member States to: propose guiding principles in order to enable youth information structures to develop quality assessment; raise the profile of quality youth information in Europe; promote and develop cooperation, networking and the exchange of good practice between national youth information sites and portals across Europe, together with analyses of the use of such sites and portals. In connection with youth information, the Member States are invited to use European programmes to develop: a greater insight into young people's information needs; the exchange of experience among youth information experts at various levels, through European seminars and training sessions; a regularly updated database, with particular reference to networking among youth information structures in various sectors. Communication from the Commission to the Council - Follow-up to the White Paper "A New Impetus for European Youth" - Proposed common objectives for the participation and information of young people, in response to the Council Resolution of 27 June 2002 regarding the framework of European cooperation in the youth field [COM(2003) 184 final - not published in the Official Journal]. Analysis of Member States' replies to the Commission questionnaires on youth participation and information [SEC(2003) 465 - not published in the Official Journal]. In accordance with the mandate given to it by the Council Resolution of 27 June 2002 and in application of the open method of coordination (OMC), the Commission drew up two detailed questionnaires in consultation with the Member States for each of the priorities identified in the White Paper on youth, namely participation of young people in public life and information for young people. These questionnaires were forwarded to the Member States and the candidate countries in order to gather basic information on the legislation in force in each country and then to present an outline of current policy with examples of best practice and, finally, details of expectations at European level. In an enlarged Europe of 27 Member States there are 75 million 15-25 year-olds, i.e. between 11% and 19% of the national population of each country. Depending on the country, young people represent between 10.5% and 17.5% of the electorate. Participation systems are many and diverse. The most common are: at national level: youth councils, youth parliaments and youth associations; at municipal level: councils or committees open to participation by young people; at school level: pupil or student councils. Wishing to establish the opinions and needs of young people, many countries use forms of consultation such as surveys, forums, round table conferences, debates, etc. However, there are no statistics enabling an overall picture to be gained. The best way to make young people's involvement in the decision-making process more effective is to take more account of their specific needs and personal development and by developing co-responsibility and co-decision structures. The Member States and the candidate countries agree on the main priorities to be implemented, namely increasing participation by young people in Community life, the mechanisms of representative democracy and the educational environment. As regards information, only a few Member States have a clearly identifiable youth information strategy which is implemented by national youth information networks, ensuring coordination between the national, regional and local levels. The majority of Member States and candidate countries do not, however, have a genuine, funded, systematic, coherent and integrated youth information policy or any all-embracing youth information strategy. In order to offer all young people equal and non-discriminatory access to information and advisory services, the report proposes extending the use of the Internet as a major channel for informing young people. The Member States and candidate countries agree on the common priorities to be implemented, namely access of young people to information, improvement of the quality of information and participation of young people in the production and dissemination of information. The OMC provides for common objectives to be defined and monitored. This monitoring is carried out by the Commission at European level. See also Resolution of the Council and of the representatives of the Governments of the Member States, meeting within the Council of 27 June 2002, regarding the framework of European cooperation in the youth field [Official Journal C 168 of 13.07.2002]. Commission White Paper of 21 November 2001 - " A new impetus for European youth " [COM(2001) 681 final - Not published in Official Journal]. Resolution of the Council and the Ministers of Youth meeting within the Council of 8 February 1999 on youth participation [Official Journal C 42 of 17.02.1999]. Last updated: 01.10.2005


EUR-Lex - 32003R1059 - EN Avis juridique important | 32003R1059 Regulation (EC) No 1059/2003 of the European Parliament and of the Council of 26 May 2003 on the establishment of a common classification of territorial units for statistics (NUTS) Official Journal L 154 , 21/06/2003 P. 0001 - 0041 Regulation (EC) No 1059/2003 of the European Parliament and of the Councilof 26 May 2003on the establishment of a common classification of territorial units for statistics (NUTS)THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 285 thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the European Economic and Social Committee(2),Having regard to the opinion of the Committee of the Regions(3),Acting in accordance with the procedure laid down in Article 251 of the Treaty(4),Whereas:(1) Users of statistics express an increasing need for harmonisation in order to have comparable data across the European Union. In order to function, the internal market requires statistical standards applicable to the collection, transmission and publication of national and Community statistics so that all operators in the single market can be provided with comparable statistical data. In this context, classifications are an important tool for the collection, compilation and dissemination of comparable statistics.(2) Regional statistics are a cornerstone of the European Statistical System. They are used for a wide range of purposes. For many years European regional statistics have been collected, compiled and disseminated on the basis of a common regional classification, called "Nomenclature of territorial units for statistics" (hereinafter referred to as NUTS). It is now appropriate to fix this regional classification in a legal framework and to institute clear rules for future amendments of this classification. The NUTS classification should not preclude the existence of other subdivisions and classifications.(3) Accordingly, all Member States' statistics transmitted to the Commission, which are broken down by territorial units, should use the NUTS classification, where applicable.(4) In its analysis and dissemination, the Commission should use the NUTS classification for all statistics classified by territorial units, where applicable.(5) Different levels are needed for regional statistics depending on the purpose of these statistics at national and European level. It is appropriate to have at least three hierarchical levels of detail in the European regional NUTS classification. Member States could have further levels of NUTS details, where they consider it necessary.(6) Information on the current territorial composition of NUTS level 3 regions is necessary for the proper administration of the NUTS classification and should therefore be transmitted regularly to the Commission.(7) Objective criteria for the definition of regions are necessary in order to ensure impartiality when regional statistics are compiled and used.(8) Users of regional statistics need stability of the nomenclature over time. The NUTS classification should hence not be amended too frequently. This Regulation will ensure a greater stability of rules over time.(9) Comparability of regional statistics requires that the regions be of a comparable size in terms of population. In order to achieve this goal, amendments of the NUTS classification should render the regional structure more homogeneous in terms of population size.(10) The actual political, administrative and institutional situation must also be respected. Non-administrative units must reflect economic, social, historical, cultural, geographical or environmental circumstances.(11) Reference should be made to the definition of the "population" on which the classification is based.(12) The NUTS classification is restricted to the economic territory of the Member States and does not provide complete coverage of the territory to which the Treaty establishing the European Community applies. Its use for Community purposes will therefore need to be assessed on a case-by-case basis. The economic territory of each country, as defined in Commission Decision 91/450/EEC(5),also includes extraregio territory, made up of parts of the economic territory that cannot be attached to a certain region (air-space, territorial waters and the continental shelf, territorial enclaves, in particular embassies, consulates and military bases, and deposits of oil, natural gas, etc. in international waters, outside the continental shelf, worked by resident units). The NUTS classification must also provide the possibility of statistics for this extraregio territory.(13) Amendments to the NUTS classification will require close consultations with the Member States.(14) Since the objective of the proposed action, namely the harmonisation of regional statistics, cannot be sufficiently achieved by the Member States and can therefore 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.(15) The NUTS classification laid down in this Regulation should replace the "Nomenclature of territorial units for statistics (NUTS)" established to date by the Statistical Office of the European Communities in cooperation with the national statistical institutes. As a consequence, all references in Community acts to the "Nomenclature of territorial units for statistics (NUTS)" should now be understood as referring to the NUTS classification laid down in this Regulation.(16) Council Regulation (EC) No 322/97 of 17 February 1997 on Community Statistics(6) constitutes the reference framework for the provisions of this Regulation.(17) 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(7).(18) The Statistical Programme Committee established by Council Decision 89/382/EEC, Euratom(8) has been consulted in accordance with Article 3 thereof,HAVE ADOPTED THIS REGULATION:Article 1Subject matter1. The purpose of this Regulation is to establish a common statistical classification of territorial units, hereinafter referred to as "NUTS", in order to enable the collection, compilation and dissemination of harmonised regional statistics in the Community.2. The NUTS classification laid down in Annex I shall replace the "Nomenclature of territorial units for statistics (NUTS)" established by the Statistical Office of the European Communities in cooperation with the national statistical institutes of the Member States.Article 2Structure1. The NUTS classification subdivides the economic territory of the Member States, as defined in Decision 91/450/EEC, into territorial units. It ascribes to each territorial unit a specific code and name.2. The NUTS classification is hierarchical. It subdivides each Member State into NUTS level 1 territorial units, each of which is subdivided into NUTS level 2 territorial units, these in turn each being subdivided into NUTS level 3 territorial units.3. However, a particular territorial unit may be classified at several NUTS levels.4. At the same NUTS level, two different territorial units in the same Member State may not be identified by the same name. If two territorial units in different Member States have the same name, the country identifier is added to the territorial units' names.5. In each Member State, there can be further hierarchical levels of detail, decided by the Member State, whereby NUTS level 3 is subdivided. Within two years from the entry into force of this Regulation, the Commission, after consulting the Member States, shall submit a communication to the European Parliament and the Council on the appropriateness of establishing rules on a Europe-wide basis for more detailed levels in the NUTS classification.Article 3Classification criteria1. Existing administrative units within the Member States shall constitute the first criterion used for the definition of territorial units.To this end, "administrative unit" shall mean a geographical area with an administrative authority that has the power to take administrative or policy decisions for that area within the legal and institutional framework of the Member State.2. In order to establish the relevant NUTS level in which a given class of administrative units in a Member State is to be classified, the average size of this class of administrative units in the Member State shall lie within the following population thresholds:>TABLE>If the population of a whole Member State is below the minimum threshold for a given NUTS level, the whole Member State shall be one NUTS territorial unit for this level.3. For the purpose of this Regulation, the population of a territorial unit shall consist of those persons who have their usual place of residence in this area.4. The existing administrative units that are used for the NUTS classification are laid down in Annex II. Amendments to Annex II shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).5. If for a given level of NUTS no administrative units of a suitable scale exist in a Member State, in accordance with the criteria referred to in paragraph 2, this NUTS level shall be constituted by aggregating an appropriate number of existing smaller contiguous administrative units. This aggregation shall take into consideration such relevant criteria as geographical, socio-economic, historical, cultural or environmental circumstances.The resulting aggregated units shall hereinafter be referred to as "non-administrative units". The size of the non-administrative units in a Member State for a given NUTS level shall lie within the population thresholds referred to in paragraph 2.In accordance with the regulatory procedure referred to in Article 7(2), individual non-administrative units may however deviate from these thresholds because of particular geographical, socio-economic, historical, cultural or environmental circumstances, especially in the islands and the outermost regions.Article 4Components of NUTS1. Within six months after the entry into force of this Regulation, the Commission shall publish the components of each NUTS level 3 territorial unit in terms of the smaller administrative units as laid down in Annex III, as transmitted to it by the Member States.Amendments to Annex III shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).2. Within the first six months of each year, Member States shall transmit to the Commission all changes of the components for the previous year that may affect the NUTS level 3 boundaries and in so doing shall respect the electronic data format requested by the Commission.Article 5Amendments to NUTS1. The Member States shall inform the Commission of:(a) all changes that have occurred in administrative units, in so far as they may affect the NUTS classification, as laid down in Annex I, or the contents of Annexes II and III;(b) all other changes at the national level that may affect the NUTS classification, in accordance with the classification criteria laid down in Article 3.2. Changes to NUTS level 3 boundaries due to changes of smaller administrative units as laid down in Annex III:(a) shall not be considered as amendments of NUTS if they involve a population transfer equal to or less than one percent of the NUTS 3 territorial units concerned;(b) shall be considered as amendments of NUTS, in accordance with paragraph 3 of this Article, if they involve a population transfer of more than one percent of the NUTS 3 territorial units concerned.3. Amendments to the NUTS for the non-administrative units in a Member State, as referred to in Article 3(5), may be made if, at the NUTS level in question, the amendment reduces the standard deviation of the size in terms of population of all EU territorial units.4. Amendments to the NUTS classification shall be adopted in the second half of the calendar year in accordance with the regulatory procedure referred to in Article 7(2), not more frequently than every three years, on the basis of the criteria laid down in Article 3. Nevertheless, in the case of a substantial reorganisation of the relevant administrative structure of a Member State, the amendments to the NUTS classification may be adopted at intervals of less than three years.The Commission implementing measures referred to in the first subparagraph shall enter into force, with regard to the transmission of the data to the Commission, on 1 January of the second year after their adoption.5. When an amendment is made to the NUTS classification, the Member State concerned shall transmit to the Commission the time series for the new regional breakdown, to replace data already transmitted. The list of the time series and their length will be specified in accordance with the regulatory procedure referred to in Article 7(2) taking into account the feasibility of providing them. These time series are to be supplied within two years of the amendment to the NUTS classification.Article 6ManagementThe Commission shall take the necessary measures to ensure the consistent management of the NUTS classification. In particular, such measures may include:(a) drafting and updating of explanatory notes on NUTS;(b) examination of problems arising from the implementation of NUTS in the Member States' classifications of territorial units.Article 7Procedure1. The Commission shall be assisted by the Statistical Programme Committee, established by Article 1 of Decision 89/382/EEC, Euratom (hereinafter referred to as the Committee).2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.3. The Committee shall adopt its rules of procedure.Article 8ReportingThree years after the entry into force of this Regulation, the Commission shall submit a report on its implementation to the European Parliament and the Council.Article 9Entry into forceThis Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 26 May 2003.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentG. Drys(1) OJ C 180 E, 26.6.2001, p. 108.(2) OJ C 260, 17.9.2001, p. 57.(3) OJ C 107, 3.5.2002, p. 54.(4) Opinion of the European Parliament of 24 October 2001 (OJ C 112 E, 9.5.2002, p. 146), Council Common Position of 9 December 2002 (OJ C 32 E, 11.2.2003, p. 26) and Decision of the European Parliament of 8 April 2003 (not yet published in the Official Journal).(5) OJ L 240, 29.8.1991, p. 36.(6) OJ L 52, 22.2.1997, p. 1.(7) OJ L 184, 17.7.1999, p. 23.(8) OJ L 181, 28.6.1989, p. 47.ANNEX IThe NUTS classification (code - name)>TABLE>ANNEX IIExisting administrative unitsAt NUTS level 1 for Belgium "Gewesten/Régions", for Germany "Länder", for Portugal "Continente", Região dos Açores and Região da Madeira, and for United Kingdom Scotland, Wales, Northern Ireland and the Government Office Regions of England.At NUTS level 2 for Belgium "Provincies/Provinces", for Germany "Regierungsbezirke", for Greece "periferies", for Spain "comunidades y ciudades autónomas", for France "régions", for Ireland "regions", for Italy "regioni", for the Netherlands "provincies" and for Austria "Länder".At NUTS level 3 for Belgium "arrondissementen/arrondissements", for Denmark "Amtskommuner", for Germany "Kreise/kreisfreie Städte", for Greece "nomoi", for Spain "provincias", for France "départements", for Ireland "regional authority regions", for Italy "provincie", for Sweden "län" and for Finland "maakunnat/landskapen".ANNEX IIISmaller administrative unitsFor Belgium "Gemeenten/Communes", for Denmark "Kommuner", for Germany "Gemeinden", for Greece "Demoi/Koinotites", for Spain "Municipios", for France "Communes", for Ireland "counties or county boroughs", for Italy "Comuni", for Luxembourg "Communes", for the Netherlands "Gemeenten", for Austria "Gemeinden", for Portugal "Freguesias", for Finland "Kunnat/Kommuner", for Sweden "Kommuner" and for the United Kingdom "Wards".

Summary: Common classification of territorial units for statistical purposes (NUTS) Common classification of territorial units for statistical purposes (NUTS) SUMMARY OF: Regulation (EC) No 1059/2003 establishing a common classification of territorial units for statistics (NUTS) WHAT IS THE AIM OF THE REGULATION? Regulation (EC) No 1059/2003 sets out the rules for the management of the nomenclature of territorial units for statistics (NUTS), a hierarchical system for dividing up the economic territory of the European Union (EU) for the purpose of collecting, developing and harmonising European regional statistics, assessing levels of eligibility for EU Structural Funds and framing of EU regional policies. It also contains rules for future amendments to the classification. This is to ensure that data refer to the same regional unit for a certain period of time. This is important especially for statistical time series. It has been amended several times, including by: Regulations (EC) No 1888/2005, (EC) No 176/2008 and (EU) No 517/2013 to take account of the accession of new EU Member States;Regulations (EC) No 105/2007, (EU) No 31/2011, (EU) No 1319/2013, (EU) No 868/2014, (EU) 2016/2066 and 2019/1755 which amend the annexes to take account of amendments to the classification;amending Regulation (EU) 2017/2391 introducing legal status to territorial typologies linked to the NUTS classification — see below. KEY POINTS The NUTS hierarchy For each Member State, there is a three-level hierarchy of regional subdivisions which are based on minimum and maximum population thresholds, as shown below. NUTS 1. Major socioeconomic regions, e.g. German Länder, Belgian Gewesten/Régions, Polish or Romanian macroregions. NUTS 2. Basic regions for the application of regional policies, e.g. Belgian or Dutch provinces, Austrian Bundesländer, Czech regions (oblasti). NUTS 3. Small regions for specific diagnoses, e.g. French départements, Bulgarian provinces (oblasti), Italian provinces. The third level is a subdivision of the second level, the second level is a subdivision of the first level and the first level is a subdivision of the countries. NUTS does not cover the local (municipality) level. Where the population of a Member State as a whole is below the minimum threshold for a given NUTS level, the country itself constitutes a NUTS territorial unit of that level. Classification criteria The existing administrative units in the Member States have to be taken into account in NUTS. The NUTS level to which an existing administrative level corresponds is determined on the basis of the average population size of its administrative units as follows: Level Minimum population Maximum population NUTS 1 3 million 7 million NUTS 2 800,000 3 million NUTS 3 150,000 800,000 If, for a given level in the classification, there is no existing administrative level of an adequate size in a Member State, that level is to be established by aggregating an adequate number of smaller neighbouring administrative units. The resulting aggregated units form a ‘non-administrative level’ at which each non-administrative unit has to respect the population thresholds shown above. Deviations occur under particular geographical, socioeconomic, historical, cultural or environmental circumstances, especially in the islands and the outermost regions. Territorial typologies (Tercet) Amending Regulation (EU) 2017/2391 establishes a legal recognition of territorial typologies for the purpose of EU statistics. This makes it possible for thematic statistics regulations and policy initiatives to refer to these typologies for the purposes of collecting EU statistics and/or to target specific territories such as cities, urban, rural or coastal areas and regions in policy. The regulation covers existing territorial typologies based on either NUTS level 3 (e.g. urban-rural typology, metropolitan regions) or the local administrative units (e.g. degree of urbanisation, cities, coastal areas). The regulation also covers the 1 km2 grid level required to calculate the typologies, which are based on population distribution and density in the grid cells. It also lays down the conditions for the adoption of delegated acts by the European Commission, where appropriate. The current NUTS classification, valid from 1 January 2021, lists 92 regions at NUTS 1 level, 242 regions at NUTS 2 level and 1,166 regions at NUTS 3 level. Under the implementing act, Regulation (EC) No 11/2008, when an amendment is made to the NUTS classification, the Member State concerned must send to the Commission the time series for the new regional classification to replace data already sent. FROM WHEN DOES THE REGULATION APPLY? It has applied since 11 July 2003. BACKGROUND Since the 1970s, to produce regional statistics and assess levels of eligibility for EU Structural Funds on the basis of objective, quantitative criteria, the EU has developed the NUTS classification as a single, coherent system for dividing up its territory geographically. All Member States have their own systems of government and administrative structure, with some more centralised than others. They also vary enormously in terms of population, surface area and levels of development. NUTS has been developed by Eurostat specifically with this diversity of circumstances in mind. For more information, see: NUTS — Nomenclature of territorial units for statistics (Eurostat). MAIN DOCUMENT Regulation (EC) No 1059/2003 of the European Parliament and of the Council of 26 May 2003 on the establishment of a common classification of territorial units for statistics (NUTS) (OJ L 154, 21.6.2003, pp. 1-41) Successive amendments to Regulation (EC) No 1059/2003 have been incorporated in the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Regulation (EU) 2021/690 of the European Parliament and of the Council of 28 April 2021 establishing a programme for the internal market, competitiveness of enterprises, including small and medium-sized enterprises, the area of plants, animals, food and feed, and European statistics (Single Market Programme) and repealing Regulations (EU) No 99/2013, (EU) No 1287/2013, (EU) No 254/2014 and (EU) No 652/2014 (OJ L 153, 3.5.2021, pp. 1-47) Commission Implementing Decision (EU) 2021/1130 of 5 July 2021 setting out the list of regions eligible for funding from the European Regional Development Fund and the European Social Fund Plus and of Member States eligible for funding from the Cohesion Fund for the period 2021-2027 (notified under document C(2021) 4894) (OJ L 244, 9.7.2021, pp. 10-20) last update 14.07.2021


EUR-Lex - 32003R2065 - EN Avis juridique important | 32003R2065 Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods Official Journal L 309 , 26/11/2003 P. 0001 - 0008 Regulation (EC) No 2065/2003 of the European Parliament and of the Councilof 10 November 2003on smoke flavourings used or intended for use in or on foodsTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the European Economic and Social Committee(2),Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),Whereas:(1) Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production(4), and in particular Article 5(1), seventh indent thereof, provides for the adoption of appropriate provisions concerning source materials used for the production of smoke flavourings and reaction conditions under which they are prepared.(2) The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, and to their social and economic interests.(3) A high level of protection of human life and health should be assured in the pursuit of Community policies.(4) In order to protect human health, smoke flavourings should undergo a safety assessment through a Community procedure before being placed on the market or used in or on foods within the Community.(5) Differences between national laws, regulations and administrative provisions concerning the assessment and authorisation of smoke flavourings may hinder their free movement, creating conditions of unequal and unfair competition. An authorisation procedure should therefore be established at Community level.(6) The chemical composition of smoke is complex and depends among other things on the types of wood used, the method used for developing smoke, the water content of the wood and the temperature and oxygen concentration during smoke generation. Smoked foods in general give rise to health concerns, especially with respect to the possible presence of polycyclic aromatic hydrocarbons. Because smoke flavourings are produced from smoke which is subjected to fractionation and purification processes, the use of smoke flavourings is generally considered to be of less health concern than the traditional smoking process. However, the possibility of wider applications of smoke flavourings in comparison to conventional smoking has to be taken into account in safety assessments.(7) This Regulation covers smoke flavourings as defined in Directive 88/388/EEC. The production of these smoke flavourings starts with the condensation of smoke. The condensed smoke is normally separated by physical processes into a water-based primary smoke condensate, a water-insoluble high-density tar phase and a water-insoluble oily phase. The water-insoluble oily phase is a by-product and unsuitable for the production of smoke flavourings. The primary smoke condensates and fractions of the water-insoluble high-density tar phase, the "primary tar fractions", are purified to remove components of smoke which are most harmful to human health. They may then be suitable for use as such in or on foods or for the production of derived smoke flavourings made by further appropriate physical processing such as extraction procedures, distillation, concentration by evaporation, absorption or membrane separation and the addition of food ingredients, other flavourings, food additives or solvents, without prejudice to more specific Community legislation.(8) The Scientific Committee on Food concluded that because of the wide physical and chemical differences in smoke flavourings used for flavouring food, it is not possible to design a common approach to their safety assessment and, accordingly, toxicological evaluation should focus on the safety of individual smoke condensates. Following this advice, this Regulation should provide for the scientific evaluation of primary smoke condensates and primary tar fractions, hereinafter referred to as "primary products", in terms of the safety of their use as such and/or for the production of derived smoke flavourings intended for use in or on foods.(9) As regards conditions of production, this Regulation reflects the findings set out by the Scientific Committee on Food in its report on smoke flavourings of 25 June 1993(5), in which it specified various production conditions and the information necessary to evaluate smoke flavourings used or intended for use in or on foods. That report was based, in turn, on the report of the Council of Europe on health aspects of using smoke flavours as food ingredients(6). It also contains a non-exhaustive list of types of wood which may be regarded as an indicative list of woods suitable for the production of smoke flavourings.(10) Provision should be made for the establishment, on the basis of the safety assessment, of a list of primary products authorised for use as such in or on foods and/or for the production of smoke flavourings for use in or on foods within the Community. That list should clearly describe the primary products, specifying conditions of their uses and the dates from which the authorisations are valid.(11) In order to ensure harmonisation, safety assessments should be carried out by the European Food Safety Authority ("the Authority"), established by 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(7).(12) The safety assessment of a specific primary product should be followed by a risk-management decision as to whether the product should be entered on the Community list of authorised primary products. That decision should be adopted in accordance with the regulatory procedure so as to ensure close cooperation between the Commission and the Member States.(13) It is appropriate that the person ("the applicant") who intends to place on the market primary products or derived smoke flavourings should submit all the information necessary for the safety assessment. The applicant should also propose a validated method of sampling and detection for the primary products to be used for control of compliance with the provisions of this Regulation. If necessary, the Commission should adopt quality criteria for those analytical methods after having consulted the Authority for scientific and technical assistance.(14) Since many smoke flavourings are already on the market in the Member States, provision should be made to ensure that the transition to a Community authorisation procedure is smooth and does not disturb the existing smoke flavourings market. Sufficient time should be allowed for the applicant to make available to the Authority the information necessary for the safety assessment of these products. Therefore, a certain time period, hereinafter referred to as the "first phase", should be fixed during which the information for existing primary products should be submitted by the applicant to the Authority. Applications for authorisation of new primary products may also be submitted during the first phase. The Authority should evaluate without delay all applications for existing as well as new primary products for which sufficient information has been submitted during the first phase.(15) The Community positive list should be established by the Commission after the completion of the safety assessment of all primary products for which sufficient information was submitted during the first phase. In order to ensure fair and equal conditions for all applicants, this initial establishment of the list should be done in a single step. After the initial establishment of the list of authorised primary products, it should be possible for additional primary products to be added thereto by decision of the Commission, following the safety assessment by the Authority.(16) Whenever the evaluation by the Authority indicates that an existing smoke flavouring already on the market in the Member States constitutes a serious risk to human health, this product should be removed from the market without delay.(17) Articles 53 and 54 of Regulation (EC) No 178/2002 establish procedures for taking emergency measures in relation to food of Community origin or imported from a third country. They allow the Commission to adopt such measures in situations where food is likely to constitute a serious risk to human health, animal health or the environment and where such risk cannot be contained satisfactorily by measures taken by the Member State(s) concerned.(18) It is necessary that food business operators using primary products or derived smoke flavourings be required to establish procedures in accordance with which it is possible, at all stages of placing a primary product or derived smoke flavouring on the market, to verify whether it is authorised by this Regulation and whether the conditions of use are respected.(19) In order to ensure equal access of existing and new primary products to the market, an interim period should be established during which national measures continue to apply in the Member States.(20) Provision should be made for the Annexes to this Regulation to be adapted to scientific and technical progress.(21) 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(8),HAVE ADOPTED THIS REGULATION:Article 1Subject matter1. The purpose of this Regulation is to ensure the effective functioning of the internal market in relation to smoke flavourings used or intended for use in or on foods, whilst providing the basis for securing a high level of protection for human health and the interests of consumers.2. To this end, this Regulation lays down:(a) a Community procedure for the evaluation and authorisation of primary smoke condensates and primary tar fractions for use as such in or on foods or in the production of derived smoke flavourings for use in or on foods;(b) a Community procedure for the establishment of a list of primary smoke condensates and primary tar fractions authorised to the exclusion of all others in the Community and their conditions of use in or on foods.Article 2ScopeThis Regulation shall apply to:1. smoke flavourings used or intended for use in or on foods;2. source materials for the production of smoke flavourings;3. the conditions under which smoke flavourings are prepared;4. foods in or on which smoke flavourings are present.Article 3DefinitionsFor the purposes of this Regulation, the definitions laid down in Directive 88/388/EEC and Regulation (EC) No 178/2002 shall apply.The following definitions shall also apply:1. "primary smoke condensate" shall refer to the purified water-based part of condensed smoke and shall fall within the definition of "smoke flavourings";2. "primary tar fraction" shall refer to the purified fraction of the water-insoluble high-density tar phase of condensed smoke and shall fall within the definition of "smoke flavourings";3. "primary products" shall refer to primary smoke condensates and primary tar fractions;4. "derived smoke flavourings" shall refer to flavourings produced as a result of the further processing of primary products and which are used or intended to be used in or on foods in order to impart smoke flavour to those foods.Article 4General use and safety requirements1. The use of smoke flavourings in or on foods shall only be authorised if it is sufficiently demonstrated that- it does not present risks to human health,- it does not mislead consumers.Each authorisation may be subject to specific conditions of use.2. No person shall place on the market a smoke flavouring or any food in or on which such a smoke flavouring is present if the smoke flavouring is not a primary product authorised in accordance with Article 6, or if is not derived therefrom, and if the conditions of use laid down in the authorisation in accordance with this Regulation are not adhered to.Article 5Conditions of production1. The wood used for the production of primary products shall not have been treated, whether intentionally or unintentionally, with chemical substances during the six months immediately preceding felling or subsequent thereto, unless it can be demonstrated that the substance used for the treatment does not give rise to potentially toxic substances during combustion.The person who places on the market primary products must be able to demonstrate by appropriate certification or documentation that the requirements laid down in the first subparagraph have been met.2. The conditions for the production of primary products are laid down in Annex I. The water-insoluble oily phase which is a by-product of the process shall not be used for the production of smoke flavourings.3. Without prejudice to other Community legislation, primary products may be further processed by appropriate physical processes for the production of derived smoke flavourings. Where opinions differ as to whether a particular physical process is appropriate, a decision may be reached in accordance with the procedure referred to in Article 19(2).Article 6Community list of authorised primary products1. A list of the primary products authorised to the exclusion of all others in the Community for use as such in or on foods and/or for the production of derived smoke flavourings shall be established in accordance with the procedure referred to in Article 19(2).2. In respect of each authorised primary product, the list referred to in paragraph 1 shall give a unique code for that product, the name of the product, the name and address of the authorisation holder, a clear description and characterisation of the product, the conditions of its use in or on specific foods or food categories and the date from which the product is authorised.3. Following the establishment of the list referred to in paragraph 1, primary products may be added to that list in accordance with the procedure referred to in Article 19(2).Article 7Application for authorisation1. To obtain the inclusion of a primary product in the list referred to in Article 6(1), an application shall be submitted in accordance with the following provisions.2. (a) The application shall be sent to the competent authority of a Member State.(b) The competent authority:(i) shall acknowledge receipt of the application in writing to the applicant within 14 days of its receipt. The acknowledgement shall state the date of receipt of the application;(ii) shall inform without delay the European Food Safety Authority (hereinafter referred to as the "Authority"); and(iii) shall make the application and any supplementary information supplied by the applicant available to the Authority.(c) The Authority shall inform without delay the other Member States and the Commission of the application and shall make the application and any supplementary information supplied by the applicant available to them.3. The application shall be accompanied by the following:(a) the name and address of the applicant;(b) the information listed in Annex II;(c) a reasoned statement affirming that the product complies with Article 4(1), first indent;(d) a summary of the dossier.4. The Authority shall publish detailed guidance concerning the preparation and the submission of the application(9).Article 8Opinion of the Authority1. The Authority shall give an opinion within six months of the receipt of a valid application as to whether the product and its intended use complies with Article 4(1). The Authority may extend the said period. In such a case it shall provide an explanation for the delay to the applicant, the Commission and the Member States.2. The Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a time limit specified by the Authority which in no event shall exceed 12 months. Where the Authority requests supplementary information, the time limit laid down in paragraph 1 shall be suspended until such time that this information has been provided. Likewise, this time limit shall be suspended for the time allowed to the applicant to prepare oral or written explanations.3. In order to prepare its opinion, the Authority shall:(a) verify that the particulars and documents submitted by the applicant are in accordance with Article 7(3) in which case the application shall be regarded as valid;(b) inform the applicant, the Commission and the Member States if an application is not valid.4. In the event of an opinion in favour of authorising the evaluated product, the opinion shall include:(a) any conditions or restrictions which should be attached to the use of the evaluated primary product either as such and/or as derived smoke flavourings in or on specific foods or food categories;(b) an assessment as to whether the analytical method proposed in accordance with point 4 of Annex II is appropriate for the intended control purposes.5. The Authority shall forward its opinion to the Commission, the Member States and the applicant.6. The Authority shall make its opinion public, after deletion of any information identified as confidential in accordance with Article 15.Article 9Community authorisation1. Within three months of receiving the opinion of the Authority, the Commission shall prepare a draft of the measure to be taken in respect of the application for inclusion of a primary product in the list referred to in Article 6(1), taking into account the requirements of Article 4(1), Community law and other legitimate factors relevant to the matter under consideration. Where the draft measure is not in accordance with the opinion of the Authority, the Commission shall provide an explanation for the reasons for the differences.The measure referred to in the first subparagraph shall be(a) a draft regulation amending the list referred to in Article 6(1), by including the primary product on the list of authorised products, in accordance with the requirements under Article 6(2); or(b) a draft decision, addressed to the applicant, refusing authorisation.2. The measure shall be adopted in accordance with the procedure referred to in Article 19(2). The Commission shall inform the applicant of its adoption without delay.3. Without prejudice to Article 11, the authorisation granted in accordance with the procedure laid down in this Regulation shall be valid throughout the Community for 10 years and shall be renewable in accordance with Article 12.4. After an authorisation has been issued in accordance with this Regulation, the authorisation holder or any other food business operator using the authorised primary product or derived smoke flavourings shall comply with any condition or restriction attached to such authorisation.5. The authorisation holder shall inform the Commission immediately of any new scientific or technical information which might affect the assessment of the safety of the authorised primary product or derived smoke flavourings in relation to human health. If necessary, the Authority shall then review the assessment.6. The granting of an authorisation shall not diminish the general civil and criminal liability of any food business operator in respect of the authorised primary product, derived smoke flavouring or food containing the authorised primary product or derived smoke flavouring.Article 10Initial establishment of the Community list of authorised primary products1. During the 18 months following the entry into force of this Regulation, business operators shall submit an application in accordance with Article 7 with a view to the establishment of an initial Community list of authorised primary products. Without prejudice to Article 9(1), this initial list shall be established after the Authority has issued an opinion on each primary product for which a valid application has been submitted during this period.Applications for which the Authority could not issue an opinion owing to the applicant's failure to comply with the time limits specified for submission of supplementary information in accordance with Article 8(2) shall be excluded from consideration for inclusion in the initial Community list.2. Within three months of receiving all the opinions referred to in paragraph 1, the Commission shall prepare a draft regulation for the initial establishment of the list referred to in Article 6(1), having regard to the requirements of Article 6(2).Article 11Modification, suspension and revocation of authorisations1. The authorisation holder may, in accordance with the procedure laid down in Article 7, apply for a modification of the existing authorisation.2. On its own initiative or following a request from a Member State or the Commission, the Authority shall deliver an opinion on whether an authorisation is still in accordance with this Regulation, following the procedure laid down in Article 8, where applicable.3. The Commission shall examine the opinion of the Authority without delay and prepare a draft of the decision to be taken.4. A draft measure modifying an authorisation shall specify any necessary changes in the conditions of use and, if any, in the restrictions attaching to that authorisation.5. The final measure, i.e. the modification, suspension or revocation of the authorisation, shall be adopted in accordance with the procedure referred to in Article 19(2).6. The Commission shall without delay inform the authorisation holder of the measure taken.Article 12Renewal of authorisations1. Without prejudice to Article 11, authorisations under this Regulation shall be renewable for 10-year periods on application to the Commission by the authorisation holder, at the latest 18 months before the expiry date of the authorisation.2. The application shall be accompanied by the following particulars and documents:(a) a reference to the original authorisation;(b) any available information concerning the points listed in Annex II which supplements the information already provided to the Authority in the course of the previous evaluation(s) and updates this in the light of the most recent scientific and technical developments;(c) a reasoned statement affirming that the product complies with Article 4(1), first indent.3. Articles 7 to 9 shall apply mutatis mutandis.4. Where, for reasons beyond the control of the authorisation holder, no decision is taken on the renewal of an authorisation until one month before its expiry date, the period of authorisation of the product shall automatically be extended by six months. The Commission shall inform the authorisation holder and the Member States about the delay.Article 13Traceability1. At the first stage of the placing on the market of an authorised primary product or smoke flavouring derived from the authorised products specified in the list referred to in Article 6(1), food business operators shall ensure that the following information is transmitted to the food business operator receiving the product:(a) the code of the authorised product as given in the list referred to in Article 6(1);(b) the conditions of use of the authorised product as set out in the list referred to in Article 6(1);(c) in the case of a derived smoke flavouring, the quantitative relation to the primary product; this shall be expressed in clear and easily understandable terms so that the receiving food business operator can use the derived smoke flavouring in compliance with the conditions of use set out in the list referred to in Article 6(1).2. At all subsequent stages of the placing on the market of products referred to in paragraph 1, food business operators shall ensure that the information received in accordance with paragraph 1 is transmitted to the food business operators receiving the products.3. Food business operators shall have in place systems and procedures making it possible to identify the person from whom and to whom the products mentioned in paragraph 1 have been made available.4. Paragraphs 1 to 3 shall be without prejudice to other specific requirements under Community legislation.Article 14Public access1. Applications for authorisation, supplementary information from applicants and opinions from the Authority, excluding confidential information, shall be made accessible to the public in accordance with Articles 38, 39 and 41 of Regulation (EC) No 178/2002.2. The Authority shall apply the principles of 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(10) when handling applications for access to documents held by the Authority.3. Member States shall handle applications for access to documents received under this Regulation in accordance with Article 5 of Regulation (EC) No 1049/2001.Article 15Confidentiality1. The applicant may indicate which information submitted under Article 7 should be treated as confidential because disclosure may significantly harm his or her competitive position. Verifiable justification must be given in such cases.2. Without prejudice to paragraph 3, the Commission shall determine, after consultation with the applicant, which information should be kept confidential and shall inform the applicant and the Authority of its decision.3. Without prejudice to Article 39(3) of Regulation (EC) No 178/2002, information relating to the following shall not be considered confidential:(a) the name and address of the applicant and the name of the product;(b) in the case of an opinion in favour of authorising the evaluated product, the particulars mentioned in Article 6(2);(c) information of direct relevance to the assessment of the safety of the product;(d) the analytical method referred to in point 4 of Annex II.4. Notwithstanding paragraph 2, the Authority shall on request supply the Commission and the Member States with all information in its possession.5. The Commission, the Authority and the Member States shall take the necessary measures to ensure appropriate confidentiality of the information received by them under this Regulation except for information which must be made public if circumstances so require in order to protect human health.6. If an applicant withdraws or has withdrawn an application, the Authority, the Commission and the Member States shall respect the confidentiality of the commercial and industrial information provided, including research and development information as well as information on which the Commission and the applicant disagree as to its confidentiality.Article 16Data protectionThe information in the application submitted according to Article 7 may not be used for the benefit of another applicant, unless the other applicant has agreed with the authorisation holder that such information may be used.Article 17Inspection and control measures1. Member States shall ensure that inspections and other control measures, as appropriate, are carried out to ensure compliance with this Regulation.2. Where necessary and at the request of the Commission, the Authority shall assist in developing technical guidance on sampling and testing to facilitate a coordinated approach for the implementation of paragraph 1.3. If necessary, the Commission shall, after having requested scientific and technical assistance from the Authority, adopt quality criteria for validated analytical methods proposed in accordance with point 4 of Annex II, including substances to be measured, in accordance with the procedure referred to in Article 19(2).Article 18AmendmentsAmendments to the Annexes to this Regulation and to the list referred to in Article 6(1) shall be adopted in accordance with the procedure referred to in Article 19(2), following consultation of the Authority for scientific and/or technical assistance.Article 19Committee procedure1. The Commission shall be assisted by the Committee referred to in Article 58(1) of Regulation (EC) No 178/2002.2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.3. The Committee shall adopt its Rules of Procedure.Article 20Transitional measuresWithout prejudice to Article 4(2), trade in and use of the following primary products and derived smoke flavourings, as well as foods containing any of those products, already on the market on the date of entry into force of this Regulation, shall be permitted for the following periods:(a) primary products for which a valid application is submitted in accordance with Article 7 and Article 8(3) before 16 June 2005 and derived smoke flavourings: until the establishment of the list referred to in Article 10(1);(b) foods containing primary products for which a valid application is submitted in accordance with Article 7 and Article 8(3) before 16 June 2005 and/or containing derived smoke flavourings: until 12 months after the establishment of the list referred to in Article 10(1);(c) foods containing primary products for which a valid application is not submitted in accordance with Article 7 and Article 8(3) before 16 June 2005 and/or derived smoke flavourings: until 16 June 2006.Foods that have been lawfully placed on the market before the end of the periods referred to in (b) and (c) may be marketed until stocks are exhausted.Article 21Entry into forceThis Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.Article 4(2) shall apply from 16 June 2005. Until this date, national provisions in force concerning smoke flavourings and their use in and on foods continue to apply in the Member States.This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 10 November 2003.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentA. Marzano(1) OJ C 262 E, 29.10.2002, p. 523.(2) OJ C 85, 8.4.2003, p. 32.(3) Opinion of the European Parliament of 5 June 2003 (not yet published in the Official Journal) and the Council Decision of 9 October 2003.(4) OJ L 184, 15.7.1988, p. 61; Directive as amended by Commission Directive 91/71/EEC (OJ L 42, 15.2.1991, p. 25).(5) Reports of the Scientific Committee for Food, 34th series, pp. 1 to 7.(6) Council of Europe Publishing, 1992, reprinted 1998, ISBN 92-871-2189-3.(7) OJ L 31, 1.2.2002, p. 1.(8) OJ L 184, 17.7.1999, p. 23.(9) Until publication, applicants shall follow the "Guidance on submissions for food additive evaluations" by the Scientific Committee on Food, of 11 July 2001 or its latest update: http://europa.eu.int/comm/food/fs/sc/scf/out98_en.pdf(10) OJ L 145, 31.5.2001, p. 43.ANNEX IConditions for the production of primary products1. Smoke is generated from the wood referred to in Article 5(1). Herbs, spices, twigs of juniper and twigs, needles and cones of picea may be added if they are free of residues of intentional or unintentional chemical treatment or if they comply with more specific Community legislation. The source material is subjected to controlled burning, dry distillation or treatment with superheated steam in a controlled oxygen environment with a maximum temperature of 600 °C.2. The smoke is condensed. Water and/or, without prejudice to other Community legislation, solvents may be added to achieve phase separation. Physical processes may be used for isolation, fractionation and/or purification to obtain the following phases:(a) a water-based "primary smoke condensate" mainly containing carboxylic acids, carbonylic and phenolic compounds, having a maximum content of:>TABLE>(b) a water-insoluble high-density tar phase which during the phase separation will precipitate, and which cannot be used as such for the production of smoke flavourings but only after appropriate physical processing to obtain fractions from this water-insoluble tar phase which are low in polycyclic aromatic hydrocarbons, already defined as "primary tar fractions", having a maximum content of:>TABLE>(c) a "water-insoluble oily phase".If no phase separation has occurred during or after the condensation, the smoke condensate obtained must be regarded as a water-insoluble high-density tar phase, and must be processed by appropriate physical processing to obtain primary tar fractions which stay within the specified limits.ANNEX IIInformation necessary for the scientific evaluation of primary productsThe information should be compiled in accordance with the guidelines referred to in Article 7(4) and should be submitted as described therein. Without prejudice to Article 8(2), the following information should be included in the application for authorisation referred to in Article 7:1. the type of wood used for the production of the primary product;2. detailed information on the production methods of the primary products and the further processing in the production of derived smoke flavourings;3. the qualitative and quantitative chemical composition of the primary product and the characterisation of the portion which has not been identified. Of major importance are the chemical specifications of the primary product and information on the stability and the degree of variability of the chemical composition. The portions which have not been identified, i.e. the amount of substances whose chemical structure is not known, should be as small as possible and should be characterised by appropriate analytical methods, e.g. chromatographic or spectrometric methods;4. a validated analytical method for sampling, identification and characterisation of the primary product;5. information on the intended use levels in or on specific foods or food categories;6. toxicological data following the advice of the Scientific Committee on Food given in its report on smoke flavourings of 25 June 1993 or its latest update.

Summary: Smoke flavourings — safety assessment Smoke flavourings — safety assessment SUMMARY OF: Regulation (EC) No 2065/2003 — smoke flavourings for foods WHAT IS THE AIM OF THIS REGULATION? It sets EU-wide rules on authorising and using smoke flavourings in foods. KEY POINTS The regulation introduces a safety assessment and authorisation procedure for primary smoke condensates* and primary tar fractions* which can be used in and on foods and/or for the production of derived smoke flavourings*. The primary products* for which no health concern is expressed during evaluation are then included in a list of authorised products under specific conditions of use. Authorisations are granted for a period of 10 years after which they have to be renewed. This ensures that products are regularly re-assessed in the light of the latest scientific and technical knowledge and that authorised products, that are no longer used, are removed from the EU’s positive list. Applicants for the authorisation of a primary product must provide detailed information on: the type of wood used for the production of the primary product; detailed information on the production methods of the primary products and the further processing in the production of derived smoke flavourings; the intended uses in or on specific foods or food categories; chemical specifications; toxicological studies; and validated methods for sampling and detecting primary products and derived smoke flavourings. The safety evaluation of the applications is carried out by the European Food Safety Authority (EFSA) according to a specific time-frame and on the basis of transparent procedures. The application is made to EFSA, the Commission and the EU countries. If requested by the applicant, certain sensitive data may remain confidential. The EFSA assessments on smoke flavourings are available here: EU lists of flavourings – Scientific advice – 3 Smoke flavourings (primary products) Commission Regulation (EC) No 627/2006 establishes quality criteria for the validated analytical methods for sampling, identification and characterisation of primary smoke products, as referred to in Annex II of Regulation (EC) No 2065/2003. FROM WHEN DOES THE REGULATION APPLY? It has applied since 16 December 2003 apart from its Article 4(2) prohibiting the placing on the market of a smoke flavouring or food in or on which smoke flavouring is present if the flavouring has not been authorised, which has applied since 16 June 2005. BACKGROUND For more information, see: EU rules on flavourings (European Commission) EU lists of flavourings (European Commission) Smoke flavourings (European Food Safety Authority). KEY TERMS Primary smoke condensates: the purified water-based part of condensed smoke which falls within the definition of smoke flavourings. Primary tar fractions: the purified fraction of the water-insoluble high-density tar phase of condensed smoke which falls within the definition of smoke flavourings. Derived smoke flavourings: flavourings produced as a result of the further processing of primary products used in or on foods in order to impart smoke flavour to those foods. Primary products: primary smoke condensates and primary tar fractions. MAIN DOCUMENT Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods (OJ L 309, 26.11.2003, pp. 1-8) Successive amendments to Regulation (EC) No 2065/2003 have been incorporated into the original document. This consolidated version is of documentary value only. RELATED DOCUMENTS Commission Implementing Regulation (EU) No 1321/2013 of 10 December 2013 establishing the Union list of authorised smoke flavouring primary products for use as such in or on foods and/or for the production of derived smoke flavourings (OJ L 333, 12.12.2013, p. 54-67) Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (OJ L 354, 31.12.2008, pp. 34-50) See consolidated version. Commission Regulation (EC) No 627/2006 of 21 April 2006 implementing Regulation (EC) No 2065/2003 of the European Parliament and of the Council as regards quality criteria for validated analytical methods for sampling, identification and characterisation of primary smoke products (OJ L 109, 22.4.2006, pp. 3-6) last update 11.04.2018