### feedback should , where practicable , be made available to obliged entities on the usefulness and follow - up of the suspicious transactions reports they present . to make this possible , and to be able to review the effectiveness of their systems to combat money laundering and terrorist financing member states should keep and improve the relevant statistics . to further enhance the quality and consistency of the statistical data collected at union level , the commission should keep track of the eu - wide situation with respect to the fight against money laundering and terrorist financing and publish regular overviews . ### feedback should , where practicable , be made available to obliged entities on the usefulness and follow - up of the suspicious transactions reports they present . to make this possible , and to be able to review the effectiveness of their systems to combat money laundering and terrorist financing member states should keep and improve the relevant statistics . to further enhance the quality and consistency of the statistical data collected at union level , the commission should keep track of the eu - wide situation with respect to the fight against money laundering and terrorist financing and publish regular overviews . the commission should also include in its overviews a survey of national risk assessments . the first survey by the commission should be carried out within one year from the date of entry into force of this directive .


### all offences , including tax crimes related to direct taxes and indirect taxes , which are punishable by deprivation of liberty or a detention order for a maximum of more than one year or , as regards those states which have a minimum threshold for offences in their legal system , all offences punishable by deprivation of liberty or a detention order for a minimum of more than six months ; ### all offences , including tax crimes related to direct taxes and indirect taxes , which are punishable by deprivation of liberty or a detention order for a maximum of one year or more , as regards those states which have a minimum threshold for offences in their legal system , all offences punishable by deprivation of liberty or a detention order for a minimum of six months or more ;


### the member states may adopt or retain in force stricter provisions in the field covered by this directive to prevent money laundering and terrorist financing . ### member states may adopt or retain in force stricter provisions in the field covered by this directive to prevent money laundering and terrorist financing providing that such provisions do not unduly prevent consumers from accessing financial services and do not constitute an obstacle to the functioning of the single market .


### identifying the customer and verifying the customer ' s identity on the basis of documents , data or information obtained from a reliable and independent source ; ### identifying the customer and verifying the customer ' s identity on the basis of documents , data or information obtained from a reliable and independent source ; it shall however be strictly forbidden to require the customer to reside or to have proven links in the country where the business relationship is to be established or the transaction carried - out ;


### member states shall require obliged entities to examine , as far as reasonably possible , the background and purpose of all complex , unusual large transactions , and all unusual patterns of transactions , which have no apparent economic or lawful purpose . in particular , they shall increase the degree and nature of monitoring of the business relationship , in order to determine whether those transactions or activities appear unusual or suspicious . ### member states shall require obliged entities to examine the background and purpose of all complex , unusual large transactions , and all unusual patterns of transactions , which have no apparent economic or lawful purpose . in particular , they shall increase the degree and nature of monitoring of the business relationship , in order to determine whether those transactions or activities appear unusual or suspicious .


### the unprecedented global financial crisis and economic downturn have seriously damaged economic growth and financial stability and provoked a strong deterioration in financial and economic conditions in several member states . in particular , certain member states are experiencing serious difficulties or are threatened with such difficulties , notably with problems in their economic growth and financial stability and with a deterioration in their deficit and debt position , also as a result of the international economic and financial environment . ### the unprecedented global financial crisis and economic downturn have seriously increased social disparities in the union and damaged economic growth and financial stability , provoking a strong deterioration in social , financial and economic conditions in several member states . in particular , certain member states are experiencing dramatic difficulties or are threatened with such difficulties , notably with unemployment , poverty , social exclusion , income inequalities , problems in their sustainable economic growth and financial stability , a serious deterioration in their deficit and debt position , also as a result of the current union policies and the international economic and financial environment .


### whilst important actions to counterbalance the negative effects of the crisis have already been taken , including amendments of the legislative framework , the impact of the financial crisis on the real economy , the labour market and citizens is being widely felt . pressure on national financial resources is increasing and further steps should be taken to alleviate that pressure through the maximum and optimal use of the funding from the structural funds and the cohesion fund . in view of the persisting financial difficulties , it is necessary to extend the application of the measures adopted by amending regulation no 1311 / 2011 of the european parliament and of the council . these measures were adopted pursuant to to articles 122 , 136 and 143 of the treaty on the functioning of the european union . ### the impact of the financial crisis on the real economy , the labour market and citizens is being widely felt . a new strategy is needed to secure an adequate level of resources with particular emphasis on the programs and projects aimed at boosting growth and decent employment , eradicating poverty , investing in smart , sustainable green development . it is fundamental to increase support to member states , especially those already facing economic recession , for investment in infrastructure , social facilities , research , innovation and development . pressure on national financial resources is increasing and further steps should be taken to alleviate that pressure through the maximum and optimal use of the funding from the structural funds and the cohesion fund . in view of the persisting financial difficulties , it is necessary to extend the application of the measures adopted by amending regulation no 1311 / 2011 of the european parliament and of the council . these measures were adopted pursuant to to articles 122 , 136 and 143 of the treaty on the functioning of the european union .


### in order to further improve road safety , the communication ‘ ecall : time for deployment’6 proposes new measures to accelerate the deployment of an in - vehicle emergency call service in the union . one of the suggested measures is to make mandatory the fitting of ecall in - vehicle systems in all new vehicles starting with m1 and n1 vehicle categories as defined in annex ii to directive 2007 / 46 / ec . __________________ 6 com 434 final . ### in order to further improve road safety , the communication ‘ ecall : time for deployment’6 proposes new measures to accelerate the deployment of an in - vehicle emergency call service in the union . __________________ 6 com 434 final .


### the union ecall system is expected to reduce the number of fatalities in the union as well as the severity of injuries caused by road accidents . the mandatory introduction of the ecall system would make the service available to all citizens and thus contribute to reduce human suffering and healthcare and other costs . ### the union ecall system is expected to reduce the number of fatalities in the union as well as the severity of injuries caused by road accidents . the optional introduction of the ecall system would make the service available to all citizens and thus contribute to reduce human suffering and healthcare and other costs .


### the mandatory equipping of vehicles with the ecall in - vehicle system should be without prejudice to the right of all stakeholders such as car manufacturers and independent operators to offer additional emergency and / or added value services , in parallel with or building on the 112 - based ecall in - vehicle system . however , these additional services should be designed not to increase driver distraction . ### the optional equipping of vehicles with the ecall in - vehicle system should be without prejudice to the right of all stakeholders such as car manufacturers and independent operators to offer additional emergency and / or added value services , in parallel with or building on the 112 - based ecall in - vehicle system . however , these additional services should be designed not to increase driver distraction .


### manufacturers shall demonstrate that all new types of vehicles referred to in article 2 are equipped with an ecall in - vehicle system , in accordance with this regulation and the delegated acts adopted pursuant to this regulation . ### manufacturers shall demonstrate that all new types of vehicles referred to in article 2 can be equipped with an ecall in - vehicle system , in accordance with this regulation and the delegated acts adopted pursuant to this regulation .


### manufacturers shall demonstrate that new vehicles are constructed as to ensure that an ecall to the single european emergency number 112 can also be triggered manually . ### manufacturers shall demonstrate that these new vehicles are constructed as to ensure that an ecall to the single european emergency number 112 can also be triggered manually .


### the aim of the programme is to support the policy objective of placing the empowered consumer at the centre of the internal market . the programme will do so by contributing to protecting the health , safety and economic interests of consumers , as well as to promoting their right to information , education and to organise themselves in order to safeguard their interests . the programme will complement , support and monitor the policies of member states . ### the aim of the programme is to support a new policy objective of placing the empowered consumer at the centre of the internal market , noting that liberalisation in the internal market has led to increased prices , lower quality and fewer services . the programme will do so by contributing to citizens ' welfare , by promoting economically , socially and environmentally sound sustainable development throughout the union , by furthering social justice , sustainability and solidarity based on mutually supportive economic , social and environmental pillars steered by a democratic and participatory process of socio - economic governance , and by a focus on benefits to citizens and consumer protection , in particular by protecting the health , safety and economic interests of consumers , as well as promoting their right to information , education and to organise themselves in order to safeguard their interests . the programme will complement and support the policies of member states .


### the stability and growth pact is based on the objective of sound government finances as a means of strengthening the conditions for price stability and for strong sustainable growth underpinned by financial stability and conducive to employment creation . ### in the name of sound public finances and controlling inflation , the stability and growth pact condemned the european union to years of mediocre development , high levels of unemployment and a worsening of its internal imbalances .


### the content of the stability and convergence programmes as well as the criteria for their examination should further be adapted in the light of the experience gained with the implementation of the stability and growth pact . ### the creation of a sustainable growth and employment pact entails the drawing - up of economic and social convergence programmes in each member state .


### adherence to the medium - term budgetary objective of budgetary positions should allow member states to have a safety margin with respect to the 3% of gdp reference value in order to ensure rapid progress towards sustainability and to have room for budgetary manoeuvre , in particular taking into account the needs of public investment . ### adherence to the medium - term budgetary objective of budgetary positions should allow member states to ensure sustainable public finances or clear progress in this direction . this objective should ensure room for budgetary manoeuvre to take into account the needs of public investment . the setting of prudent medium - term budgetary objectives should not prevent the adoption of an active budgetary policy where this may be necessary to combat a recession .


### in the event of a significant deviation from prudent fiscal - policy a warning should be addressed to the member state concerned and in case the significant deviation persists or is particularly serious , a recommendation should be addressed to the member state concerned to take the necessary corrective measures . ### in the event of a significant deviation from prudent fiscal - policy a warning should be addressed to the member state concerned . where this deviation persists and can be explained by causes directly attributable to governance , a recommendation should be addressed to the member state concerned to take action . the european parliament may invite the member state concerned to explain its decisions and policies in this respect before its competent committee .


### in order to ensure compliance with the fiscal surveillance framework of the union for participating member states , a specific enforcement mechanism should be established on the basis of article 136 of the treaty for cases where a persistent and significant deviation from prudent fiscal policy making prevails . ### in order to ensure compliance with the fiscal surveillance framework of the union for participating member states , a specific enforcement mechanism should be established on the basis of article 136 of the treaty for cases where a persistent and significant deviation from prudent fiscal policy making prevails . nevertheless , its application should take account of the current economic situation in the member state concerned and all other relevant factors .


### each participating member state shall submit to the council and commission information necessary for the purpose of multilateral surveillance at regular intervals under article 121 of the treaty in the form of a stability programme , which provides an essential basis for price stability and for strong sustainable growth conducive to employment creation . ' ### each participating member state shall submit to the council and commission information necessary for the purpose of multilateral surveillance at regular intervals under article 121 of the treaty in the form of an economic and social convergence programme , which defines measures geared to the objectives of sustainable growth and employment creation . '


### each member state with a derogation shall submit to the council and the commission information necessary for the purpose of multilateral surveillance of regular intervals under article 121 of the treaty in the form of a convergence programme , which provides an essential basis for price stability and for strong sustainable growth conducive to employment creation . ' ### each member state with a derogation shall submit to the council and the commission information necessary for the purpose of multilateral surveillance of regular intervals under article 121 of the treaty in the form of a convergence programme , which will implement the measures aimed at achieving the objectives of sustainable growth and employment creation .


### the information about the paths for the general government balance and debt ratio , the growth of government expenditure , the planned growth path of government revenue at unchanged policy , the planned discretionary revenue measures and the main economic assumptions referred to in paragraph 2 and shall be on an annual basis and shall cover , the preceding year , the current year and at least the following three years . ' ### the information about the paths for the general government balance and debt ratio , the growth of government expenditure , the planned growth path of government revenue at unchanged policy , the planned discretionary revenue measures , the growth path and the main economic assumptions referred to in paragraph 2 and shall be on an annual basis and shall cover , the preceding year , the current year and at least the following three years . '


### the information about the paths for the general government balance and debt ratio , the growth of government expenditure , the planned growth path of government revenue at unchanged policy , the planned discretionary revenue measures and the main economic assumptions referred to in paragraph 2 and shall be on an annual basis and shall cover the preceding year , the current year and at least the following three years . ### the information about the paths for the general government balance and debt ratio , the growth of government expenditure , the planned growth path of government revenue at unchanged policy , the planned discretionary revenue measures , the growth path and the main economic assumptions referred to in paragraph 2 and shall be on an annual basis and shall cover the preceding year , the current year and at least the following three years .


### the council , when assessing the adjustment path toward the medium - term budgetary objective , shall examine if the member state concerned pursues an appropriate annual improvement of its cyclically - adjusted budget balance , net of one - off and other temporary measures , required to meet its medium - term budgetary objective , with 0 . 5% of gdp as a benchmark . for member states with a high level of debt or excessive macroeconomic imbalances or both , the council shall examine whether the annual improvement of the cyclically - adjusted budget balance , net of one - off and other temporary measures is higher than 0 . 5% of gdp . the council shall take into account whether a higher adjustment effort is made in economic good times , whereas the effort may be more limited in economic bad times . ### the council , when assessing the adjustment path toward the medium - term budgetary objective , shall examine if the member state concerned pursues an appropriate annual improvement of its cyclically - adjusted primary balance , net of one - off and other temporary measures , required to meet its medium - term budgetary objective . for member states with a high level of debt or excessive macroeconomic imbalances or both , the council shall examine whether the annual improvement of the cyclically - adjusted primary balance , net of one - off and other temporary measures is higher than 0 . 5% of gdp . the council shall take into account whether a higher adjustment effort is made in economic good times , whereas the effort may be more limited in economic bad times .


### the council , when assessing the adjustment path toward the medium - term budgetary objective , shall take into account whether a higher adjustment effort is made in economic good times , whereas the effort may be more limited in economic bad times . for member states with a high level of debt or excessive macroeconomic imbalances or both , the council shall examine whether the annual improvement of the cyclically - adjusted budget balance , net of one - off and other temporary measures is higher than 0 . 5% of gdp . for erm2 member states , the council shall examine if the member state concerned pursues an appropriate annual improvement of its cyclically adjusted balance , net of one - off and other temporary measures , required to meet its medium - term budgetary objective , with 0 . 5% of gdp as a benchmark . ### the council , when assessing the adjustment path toward the medium - term budgetary objective , shall examine whether the member state concerned is pursuing an appropriate annual improvement of its cyclically adjusted balance , net of one - off and other temporary measures , required to meet its medium - term budgetary objective . for member states with a high level of debt or excessive macroeconomic imbalances or both , the council shall examine whether the annual improvement of the cyclically - adjusted primary balance , net of one - off and other temporary measures is higher than 0 . 5% of gdp . the council shall take into account whether a higher adjustment effort is made in economic good times , whereas the effort may be more limited in economic bad times .


### fiscal - policy making shall be considered prudent and thereby conducive to the achievement of the medium - term budgetary objective and its maintenance over time if the following conditions are satisfied : ### fiscal - policy making shall be considered prudent and thereby conducive to the achievement of the medium - term budgetary objective and its maintenance over time , without prejudice to the adoption of an active budgetary policy when necessary , if the following conditions are satisfied :


### the council shall furthermore examine whether the contents of the stability programme facilitate the achievement of sustained convergence within the euro area , closer coordination of economic policies and whether the economic policies of the member state concerned are consistent with the broad guidelines of economic policies of the member states and of the union . ### the council shall furthermore examine whether the contents of the economic and social convergence programme facilitates the objectives of convergence within the euro area and whether the economic policies of the member states concerned match the broad guidelines of the economic policies of the union .


### in the event that the significant deviation from prudent fiscal - policy making persists or is particularly serious , the council , on a recommendation from the commission , shall address a recommendation to the member state concerned to take the necessary adjustment measures . the council , on a proposal from the commission , shall make the recommendation public . ### in the event that the significant deviation from prudent fiscal - policy making persists or is particularly serious , the council , on a recommendation from the commission , shall address a fresh recommendation to the member state concerned to take the necessary measures . the council , on a proposal from the commission , shall make the recommendation public and the european parliament may ask the member state concerned to appear before the appropriate parliamentary committee to explain the decisions and policies adopted .


### on the basis of a report of the commission accompanied , if appropriate , by a legislative proposal , the european parliament and the council shall , by …* , re - examine the collection rate of 45 % and the related deadline referred to in paragraph 1 with a view inter alia to possibly setting individual collection rates for one or more categories set out in annex iii , particularly for temperature exchange equipment and for lamps containing mercury . _________ * oj : please insert the date - 3 years from the date of entry into force of this directive . ### on the basis of a report of the commission accompanied , if appropriate , by a legislative proposal , the european parliament and the council shall , by 31 december 2012 , re - examine the collection rate and the deadlines referred to in paragraph 1 with a view inter alia to setting individual collection rates for one or more categories set out in annex iii , particularly for photovoltaic panels , temperature exchange equipment , lamps , including light bulbs , and small appliances , including small it and telecommunications devices .


### the commission shall evaluate , as a matter of priority , whether the entries regarding printed circuit boards for mobile phones and liquid crystal displays need to be amended . ### the commission shall evaluate , as a matter of priority , whether the entries regarding printed circuit boards for mobile phones and liquid crystal displays need to be amended . the commission shall evaluate whether amendments to annex vii are necessary to address relevant nanomaterials .


### member states shall ensure that shipments of used eee suspected to be weee are carried out in accordance with the minimum requirements in annex vi and shall monitor such shipments accordingly . ### member states shall ensure that shipments of used eee are carried out in accordance with the minimum requirements in annex vi and shall monitor such shipments accordingly .


### preserving peace , preventing conflicts , strengthening international security and assisting populations , countries and regions confronting natural or man - made disasters are among the prime objectives of the union ' s external action as defined in article 21 of the treaty on european union . crises and conflicts affecting countries world - wide and other factors such as terrorism , organised crime , climate change , cyber security challenges and threats and natural disasters pose a risk to world stability and security . in order to address these issues in an effective and timely manner , specific financial resources and financing instruments are required that can work in a manner complementary to humanitarian aid and long - term cooperation instruments . ### preserving peace , preventing conflicts , promoting multilateral solutions to common problems , in particular in the framework of the united nations , strengthening international security , civil assistance for populations , countries and regions confronting natural catastrophes , the principles of equality , solidarity and respect for the principles of the united nations charter and international law , the universality and indivisibility of human rights and fundamental freedoms , the respect for human dignity , the principle for democracy and the rule of law are among the prime objectives of the union ' s external action as defined in article 21 of the treaty on european union . in order to address these objectives in an effective and timely manner , specific financial resources and financing instruments are required that can work in a manner complementary to humanitarian aid and long - term cooperation instruments , guided by the principle of the strict commitment to a purely civilian and peaceful approach in particular regarding conflict resolution .


### regulation no 1717 / 2006 was adopted with the objective of enabling the union to provide a consistent and integrated response to situations of crisis and emerging crisis , to address specific trans - regional security threats and to enhance crisis preparedness . this regulation aims at introducing a revised instrument , building on the experience of the previous one , in order to increase the efficiency and coherence of the union ' s actions in the areas of conflict prevention and crisis response , crisis preparedness and peace - building and in addressing security threats , including climate security . ### regulation no 1717 / 2006 was adopted with the objective of enabling the union to provide a consistent and integrated response to critical situations and emerging conflicts and to enhance crisis preparedness . this regulation aims at introducing a revised instrument , building on the experience of the previous one , in order to henceforth focus on purely civilian conflict prevention and response to an emerging or existing critical situation , consolidating peace and peace - building , including socio - economic consequences of climate change and on climate protection .


### to prevent conflicts , ensure preparedness to address pre - and post - crisis situations and build peace ; ### to prevent conflicts , ensure preparedness to address pre - and post - crisis situations and consolidate peace , guided by the principle of a strict commitment to a purely civilian and non military approach ;


### thematic strategy papers shall constitute the general basis for the implementation of assistance under article 4 and 5 . thematic strategy papers shall provide a framework for cooperation between the union and the partner country or regions concerned , consistent with the overall purpose and scope , objectives , principles and policy of the union . ### thematic strategy papers define the objectives , priorities , expected results and financial allocations in broad terms and shall constitute the general basis for the programming and implementation of assistance under article 4 and 5 . thematic strategy papers shall provide a framework for cooperation between the union and the partner country or regions concerned , consistent with the overall purpose and scope , objectives , principles and policy of the union . for the purposes of full democratic control , transparency and participation in the process of development , adoption and revision of those documents , co - decision in form of ordinary legislative procedure shall be introduced according to article 9 . in order guarantee quick and swift response and to avoid any delay of necessary measures in exceptional circumstances or emergency situations , an urgency procedure provided for in article 10 shall apply .


### the preparation and implementation of thematic strategy papers shall implement the principles of aid effectiveness : partnership , coordination , and harmonisation . to that end , thematic strategy papers shall be consistent with , and avoid duplication of programming documents approved or adopted under other union instruments for external assistance . thematic strategy papers shall , in principle , be based on a dialogue of the eu and , where appropriate , the relevant member states , with the partner country or regions concerned involving civil society and regional and local authorities , so as to ensure that the country or regions concerned takes sufficient ownership of the process . the union and its member states shall consult each other at an early stage of the programming process in order to promote consistency and complementarity among their cooperation activities . ### the preparation and implementation of thematic strategy papers shall implement the principles of aid effectiveness : partnership , coordination , and harmonisation . to that end , thematic strategy papers shall be consistent with , and avoid duplication of programming documents approved or adopted under other union instruments for external assistance . gender mainstreaming shall be ensured in the thematic strategy papers . these thematic strategy papers shall , in principle , be based on a dialogue of the eu and , where appropriate , the relevant member states , with the partner country or regions concerned involving civil society and regional and local authorities , so as to ensure that the country or regions concerned takes sufficient ownership of the process . the union and its member states shall consult each other at an early stage of the programming process in order to promote consistency and complementarity among their cooperation activities .


### technical and financial assistance referred to in article 4 may cover support for measures aimed at building and strengthening the capacity of the eu and its partners to prevent conflict , build peace and address pre - and post - crisis needs in close coordination with international , regional and sub - regional organisations , state and non - state actors in relation to their efforts in : ### technical and financial assistance referred to in article 4 may cover support for measures aimed at building and strengthening the capacity of the eu and its partners to prevent conflict , build peace and address pre - and post - crisis needs as well as harms to the safety of individuals and to public health in close coordination with international , regional and sub - regional organisations , state and non - state actors in relation to their efforts in :


### ' signatories ' means citizens of the union that have supported a given citizens ' initiative by completing a statement of support for that initiative ; ### ' signatories ' means citizens or residents of the union that have supported a given citizens ' initiative by completing a statement of support for that initiative ;


### where the organiser is a natural person , that person shall be a citizen of the union and be of the age to be entitled to vote in the european elections . ### where the organiser is a natural person , that person shall be a citizen of the union and be at least 16 years of age .


### in order to be eligible to support a proposed citizens ' initiative , signatories shall be citizens of the union and shall be of the age to be entitled to vote in the european elections . ### in order to be eligible to support a proposed citizens ' initiative , signatories shall be citizens of or resident in the union .


### the commission may adopt , by means of delegated acts in accordance with articles 16 , 17 and 18 , amendments to the annexes of this regulation . ### the commission may adopt , by means of delegated acts in accordance with articles 16 , 17 and 18 , amendments to the annexes to this regulation , with the exception of annexes i , ii and iii .


### a european state which has applied to join the union can become a member only when it has been confirmed that it meets the membership criteria agreed at the copenhagen european council in june 1993 and provided that the accession does not overstretch the capacity of the union to integrate the new member . these criteria relate to the stability of institutions guaranteeing democracy , the rule of law , respect of human rights and respect for , and protection of , minorities , the development of the economy that must be sufficient to withstand the competitive pressure in the internal market , and the ability to assume not only the rights but also the obligations under the treaties . ### a european state which has applied to join the union can become a member only when it has been confirmed that it meets fully the membership criteria agreed at the copenhagen european council in june 1993 and provided that the accession does not overstretch the capacity of the union to integrate the new member . these criteria relate to the stability of institutions guaranteeing democracy , the rule of law , respect of human rights and respect for , and protection of , minorities , the development of the economy that must be sufficient to withstand the competitive pressure in the internal market , and the ability to assume not only the rights but also the obligations under the treaties .


### . promotion and protection of human rights and fundamental freedoms , enhanced respect for minority rights , promotion of gender equality , non - discrimination and freedom of the press , and promotion of good neighbourly relations ; ### . promotion and protection of human rights and fundamental freedoms , trade union rights , enhanced respect for minority rights , promotion of gender equality , non - discrimination and freedom of the press , and promotion of good neighbourly relations and fostering stability and security ;


### strengthening of the ability of beneficiary countries to fulfil the obligations stemming from membership by supporting progressive alignment with and adoption , implementation and enforcement of the acquis communautaire , structural , cohesion , agricultural and rural development funds and policies of the union . ### strengthening of the ability of beneficiary countries to fulfil the obligations stemming from membership including contractual obligations by supporting progressive alignment with and adoption , implementation and enforcement of the acquis communautaire , structural , cohesion , agricultural and rural development funds and policies of the union .


### the commission shall establish an infrastructure transparency platform easily accessible to the general public . this platform shall contain the following information : ### the commission shall establish an infrastructure transparency platform in the internet in the eu official languages easily accessible to the general public . this platform shall contain the following information :


### community rules should apply only to undertakings , the concept of which implies a certain continuity of activities and a certain degree of organisation . operations such as the occasional handling , serving and selling of food by private persons at events such as charities , or local community fairs and meetings are not covered by the scope of this regulation . ### community rules should apply only to undertakings , the concept of which implies a certain continuity of activities and a certain degree of organisation . operations such as the occasional delivery of food to third parties , serving and selling of food by private persons , for example at charity events or local community fairs and meetings , and the sale of food in the various forms of direct marketing by farmers , are not covered by the scope of this regulation . in order to avoid over - stretching small and medium - sized enterprises in the traditional food production sector in particular , products which are not prepacked should be excluded from the labelling requirements .


### in order to prevent a fragmentation of the rules concerning the responsibility of food business operators with respect to food information it is appropriate to clarify the responsibilities of food business operators in this area . ### in order to prevent a fragmentation of the rules concerning the responsibility of food business operators with respect to food information it is appropriate to clarify the responsibilities of food business operators in this area . without prejudice to article 19 of regulation no 178 / 2002 , food business operators responsible for retail or distribution activities which do not affect food information should act promptly when they learn that such information does not comply with the provisions of this regulation .


### to avoid unnecessary burdens on the industry , it is appropriate to exempt certain categories of foods that are unprocessed or for which nutrition information is not a determining factor for consumer choice from the mandatory inclusion of nutrition declaration , unless the obligation to provide such information is provided under other community legislation . ### to avoid unnecessary burdens on food manufacturers and traders , it is appropriate to exempt certain categories of foods that are unprocessed , for which nutrition information is not a determining factor for consumer choice or the outer packaging or label of which is too small to permit the mandatory labelling to be performed from the mandatory inclusion of nutrition declaration , unless the obligation to provide such information is provided under other community legislation .


### food business operators placing on the market for the first time a food intended for supply to the final consumer or mass caterer shall ensure the presence and accuracy of the food information in accordance with the applicable food information law . ### food business operators placing on the community market for the first time a food intended for supply to the final consumer or mass caterer shall ensure the presence and accuracy of the food information in accordance with the applicable food information law .


### the name or business name and address of the manufacturer or packager , or of a seller established within the community ; ### the name or business name and address within the community of the manufacturer or packager , of the seller , of the importer or , where appropriate , of the food business operator under whose name or business name the food is marketed ;


### the appropriate date shall be expressed in accordance with annex ix . ### the appropriate date shall be easy to find and shall not be hidden . it shall be expressed as follows : date of minimum durability : the date shall be preceded by the words : - ‘ best before [ date ] ’ where the date includes an indication of the day , - ‘ best before end [ month ] ’ in all other cases .


### the commission adopted the communication &#8220 ; europe 2020 - a strategy for smart , sustainable and inclusive growth&#8221 ; in march 2010 . the communication was endorsed by the european council of june 2010 . the europe 2020 strategy responds to the economic crisis and is intended to prepare europe for the next decade . it sets five ambitious objectives on climate and energy , employment , innovation , education and social inclusion to be reached by 2020 and identifies key drivers for growth , which aim at making europe more dynamic and competitive . it also emphasises the importance of reinforcing the growth of the european economy while delivering high levels of employment , a low carbon , resource and energy - efficient economy and social cohesion . ### the europe 2020 strategy adopted by the commission in march 2010 through the communication ' a strategy for smart , sustainable and inclusive growth ' , with clear support from the main european business confederations , has been the european union ' s main tool for promoting the liberalisation and privatisation of public services , more flexible and adaptable labour markets , wage restraint and the opening - up of the majority of social security systems , including pensions and national health systems , to private interests .


### in order to contribute to the reinforcement of competitiveness and sustainability of union enterprises , in particular smes , the advancement of the knowledge society , and development based on balanced economic growth , a programme for the competitiveness of enterprises and smes should be established . ### in order to establish an economic and social balance between enterprises of different sizes in the union , promoting , in particular , the creation , robust growth and long - lasting development of micro , small and medium - sized enterprises , as well as the advancement of the knowledge society , and development based on balanced economic growth , a programme for economic balance in the business environment : the development of micro , small and medium - sized enterprises should be established .


### the competitiveness policy of the union is intended to put into place the institutional and policy arrangements that create conditions under which enterprises can grow in a sustainable way . improved productivity is the dominant source of sustainable income growth , which in turn contributes to improvements in living standards . competitiveness also depends on companies’ ability to take full advantage of opportunities such as the european single market . this is especially important for smes , which account for 99% of the enterprises in the union , provide two out of three existing jobs in the private sector , and 80 % of newly - created jobs , and contribute with more than half of the total value - added created by enterprises in the union . smes are a key driver for economic growth , employment and social integration . ### the competitiveness policy of the union is intended to put into place the institutional and policy arrangements that create conditions under which enterprises can grow in a sustainable way . this objective has not been achieved , and on the contrary growth , autonomy and sustainable development have been hindered , in particular for micro , small and medium - sized enterprises . improved productivity is the dominant source of sustainable income growth , which in turn contributes to improvements in living standards . competitiveness also depends on companies’ ability to take full advantage of opportunities created by an economically balanced framework for the european industrial fabric . this is especially important for msmes , which account for more than 99% of the enterprises in the union , provide two out of three existing jobs in the private sector , and more than 80 % of newly - created jobs , and contribute with more than half of the total value - added created by enterprises in the union . msmes are a key driver for economic growth , employment and social integration .


### competitiveness has been put under the spotlight of union policy - making in recent years because of the market , policy and institutional failures that are undermining the competitiveness of union enterprises , particularly smes . ### competitiveness has been put under the spotlight of union policy - making in recent years because of the failures of the market and institutional policies that are undermining the competitiveness of union enterprises , particularly micro , small and medium - sized enterprises , which are confronted by the market domination of large enterprises and economic groups on a daily basis .


### percentage of growth of the union ' s industrial sector in relation to total gross domestic product growth , ### percentage of growth of each member state ' s and the union ' s industrial sector in relation to total gross domestic product growth ,


### sme growth in terms of added - value and number of employees , ### msme growth in terms of added - value , number of employees and permanent employment contracts ,


### the programme shall support the implementation of the europe 2020 strategy and shall contribute to achieving the objective of “smart , sustainable and inclusive growth” . in particular , the programme shall contribute to the headline target concerning employment . ### the programme shall support the balanced development of industrial sectors in the member states and shall contribute to the economic and social balance between enterprises of different sizes , encouraging the creation of msmes and safeguarding the financing conditions , competitiveness and sustainability that are necessary for their smart and robust growth and long - lasting development , guaranteeing full access and financing for msmes to set up and upgrade , generating a significant contribution in terms of employment .


### measures to improve the design , implementation and evaluation of policies affecting the competitiveness and sustainability of enterprises , including disaster resilience , and to secure the development of appropriate infrastructures , world class clusters and business networks , framework conditions and development of sustainable products , services and processes ; ### measures to redress the design , implementation and evaluation of policies affecting the growth and sustainable development of msmes , as well as their difficult access to markets , competitiveness , and unfair competition owing to the weight in the market held by large economic groups , jeopardising the sustainability and survival of msmes , including disaster resilience , and to secure the development of appropriate infrastructures , world class clusters and business networks , framework conditions and development of sustainable products , services and processes ;


### the commission may support initiatives accelerating the emergence of competitive industries based on cross - sectoral activities in areas characterised by a high proportion of smes and with a high contribution to the union ' s gdp . such initiatives shall stimulate development of new markets and the supply of goods and services based on the most competitive business models or on modified value - chains . they shall include initiatives to enhance productivity , resource efficiency , sustainability and corporate social responsibility . ### the commission may support initiatives accelerating the emergence of competitive industries based on cross - sectoral activities in areas characterised by a high proportion of msmes and with a high contribution to the member states ' and the union ' s gdp . such initiatives shall stimulate development of national production and enhance productivity , resource efficiency , sustainability and corporate social responsibility , allowing the economic growth that is of crucial importance in order to deal with the social problems arising from the systemic crisis , particularly for countries with weaker economies .


### when drawing up the coordinated package of active labour market policy measures , member states should favour measures that will significantly contribute to the employability of the redundant workers . member states should strive towards the reintegration into employment or new activities of at least 50 % of the targeted workers within 12 months of the date of application . ### when drawing up the coordinated package of active labour market policy measures , member states should favour measures that will significantly contribute to the employability of the redundant workers . member states should strive towards the reintegration into employment or new activities of at least 50 % of the targeted workers within 12 months of the resources being allocated .


### the aim of the egf shall be to contribute to economic growth and employment in the union by enabling the union to show solidarity towards workers made redundant as a result of major structural changes in world trade patterns due to globalisation , trade agreements affecting agriculture , or an unexpected crisis , and to provide financial support for their rapid reintegration into employment , or for changing or adjusting their agricultural activities . ### the aim of the egf shall be to contribute to economic growth and employment in the union by enabling the union to show solidarity towards workers made redundant as a result of major structural changes in world trade patterns due to globalisation or an unexpected crisis , and to provide financial support for their rapid reintegration into employment .


### the procedures followed for consulting the social partners or other relevant organisations as applicable ; ### the procedures followed for consulting the workers concerned or their representatives , the social partners , local and regional authorities or other relevant organisations as applicable ;


### the commission ' s technical assistance shall include the provision of information and guidance to the member states for using , monitoring and evaluating the egf . the commission may also provide information on using the egf to the european and national social partners . ### the commission ' s technical assistance shall include the provision of information and guidance to the member states for using , monitoring and evaluating the egf . the commission shall also provide clear guidelines on using the egf to the european and national social partners and local and regional authorities .


### in the case of glass bottles intended for reuse which are indelibly marked and which therefore bear no label , ring or collar only the particulars listed in article 9 , , and shall be mandatory . ### in the case of glass bottles intended for reuse which are indelibly marked and which therefore bear no label , ring or collar only the particulars listed in article 9 , , , , , and shall be mandatory .


### without prejudice to labelling in accordance with specific community legislation , paragraphs 3 and 4 shall apply where the country of origin or the place of provenance of a food is voluntary indicated to inform consumers that a food originates or comes from the european community or a given country of place . ### without prejudice to labelling in accordance with specific community legislation and in addition to the requirements of article 9 , paragraphs 3 and 4 shall apply where information on the country of origin or the place of provenance of a food is voluntary indicated to inform consumers that a food originates or comes from the european community or a given country of place .


### the creation of an area in which the free movement of persons across internal borders is ensured is one of the main achievements of the european union . in such an area without controls at internal borders , it is necessary to have a common response to situations seriously affecting the public policy or internal security of the european union or of one or more member states by allowing for the reintroduction of border control at internal borders in exceptional circumstances , but without jeopardising the principle of the free movement of persons . a common union response is therefore needed , given the impact that such measures of last resort may have on all persons having the right to circulate within this area without border control at internal borders . ### the creation of an area in which the free movement of persons across internal borders is ensured is one of the main achievements of the european union . in such an area without controls at internal borders , it is necessary to have a common response to situations seriously affecting the public policy or internal security of the european union or of one or more member states , but without jeopardising the principle of the free movement of persons .


### where in the area without border control at internal borders there is a serious threat to public policy or internal security at the union or national level , border control at internal borders may exceptionally be reintroduced at all or specific parts of the internal borders of one or several member states for a limited period of no more than 30 days or for the foreseeable duration of the serious threat if its duration exceeds the period of 30 days . the scope and duration of the temporary reintroduction of border control at internal borders shall not exceed what is strictly necessary to respond to the serious threat . ### where in the area without border control at internal borders there is a concrete serious threat to public policy or internal security at the union or national level , border control at internal borders may exceptionally be reintroduced at all or specific parts of the internal borders of one or several member states for a limited period of no more than 30 days or for the foreseeable duration of the serious threat if its duration exceeds the period of 30 days . the scope and duration of the temporary reintroduction of border control at internal borders shall not exceed what is strictly necessary to respond to the serious threat .


### the common fisheries policy should ensure that fishing and aquaculture activities contribute to long - term sustainable environmental , economic , and social conditions . it should contribute moreover to increased productivity , a fair standard of living for the fisheries sector , stable markets , ensure the availability of resources and that supplies reach consumers at reasonable prices . ### the common fisheries policy should ensure that fishing and aquaculture activities contribute to long - term sustainable environmental , economic , and social conditions . it should contribute moreover to increased productivity , a fair standard of living for the fisheries sector , a decent income for fishermen , stable markets , the availability of resources and ensuring that supplies reach consumers at reasonable prices .


### fisheries targets were laid down in the decision by the conference of the parties to the convention on biological diversity on the strategic plan for biodiversity 2011 – 2020 , the common fisheries policy should ensure coherence with the biodiversity targets adopted by the european council , and the targets of commission communication ' our life insurance , our natural capital : an eu biodiversity strategy to 2020 ' , in particular to achieve maximum sustainable yield by 2015 . ### fisheries targets were laid down in the decision by the conference of the parties to the convention on biological diversity on the strategic plan for biodiversity 2011–2020 , and the common fisheries policy should ensure coherence with the biodiversity targets adopted by the european council and the targets of commission communication ‘ our life insurance , our natural capital : an eu biodiversity strategy to 2020’ , in particular to achieve maximum sustainable yield .


### implementation of the common fisheries policy should take into account interactions with other maritime affairs as addressed by the integrated maritime policy , recognizing that all matters related to europe ' s oceans and seas are interlinked , including maritime spatial planning . coherence and integration should be ensured in the management of different sectoral policies within the baltic sea , north sea , celtic seas , bay of biscay and the iberian coast , mediterranean and black sea sea basins . ### implementation of the common fisheries policy should take into account interactions with other maritime affairs as addressed by the integrated maritime policy , recognizing that all matters related to the seas and oceans which border european territory are interlinked , including maritime spatial planning . coherence and integration should be ensured in the management of different sectoral policies within the atlantic ocean , indian ocean , baltic sea , north sea , celtic seas , bay of biscay and the iberian coast , mediterranean and black sea basins .


### in view of the precarious economic state of the fishing industry and the dependence of certain coastal communities on fishing activities , it is necessary to ensure the relative stability of fishing activities by allocating fishing opportunities among member states , based on a predictable share of stocks for each member state . ### in view of the precarious economic state of the fishing industry and the dependence of many coastal and island communities on fishing activities , it is necessary to revise the concept of relative stability and to ensure the stability of fishing activities and the socio - economic viability of the sector and the regions that are dependent on it by allocating fishing opportunities among member states , based on a predictable share of stocks for each member state and the fishing capacity that they have .


### policy - oriented fisheries science should be reinforced by means of nationally - adopted fisheries scientific data collection , research and innovation programs in coordination with other member states as well as by union research and innovation framework tools . ### fisheries science should be reinforced by means of nationally - adopted fisheries scientific data collection , research and innovation programs in coordination with other member states as well as by research and innovation framework tools and increasing human resources , expertise and union financial assistance .


### the union should promote the objectives of the common fisheries policy internationally . to this end , the union should strive to improve the performance of regional and international organisations in conservation and management of international fish stocks , by promoting decision - making based on science and improved compliance , increased transparency and stakeholder participation , and by combating illegal , unreported and unregulated fishing activities . ### the union should promote the objectives of the common fisheries policy internationally . to this end , the union should strive to improve the performance of regional and international organisations in conservation and management of international fish stocks , by promoting decision - making based on science , improved compliance , increased transparency , ensuring effective stakeholder participation , and by combating illegal , unreported and unregulated fishing activities .


### sustainable fisheries agreements concluded with third countries should ensure that union fishing activities in third country waters are based on the best available scientific advice , ensuring a sustainable exploitation of the marine biological resources . those agreements , which provide for access rights in exchange for a financial contribution from the union , should contribute to the establishment of a high quality governance framework to ensure in particular efficient monitoring , control and surveillance measures . ### sustainable fisheries agreements concluded with third countries should ensure that union fishing activities in third country waters are based on the best available scientific advice , ensuring a sustainable exploitation of the marine biological resources . those agreements , which provide for access rights in exchange for a financial contribution from the union , should contribute to the establishment of a high quality governance framework to ensure in particular efficient monitoring , control and surveillance measures . the fishing activities of union vessels in the context of these agreements should not lead to a reduction in fishing activity carried out by fishermen from the countries with which the agreements are concluded , nor to their impoverishment .


### the common market organisation should be implemented in compliance with international commitments of the union , in particular with regard to the provisions of the world trade organisation . the success of the common fisheries policy requires an effective system of control , inspection and enforcement , including the fight against iuu fishing activities . a union system for control , inspection , and enforcement should be established so as to ensure compliance with the common fisheries policy ' s rules . ### the success of the common fisheries policy requires an effective system of control , inspection and enforcement , including the fight against iuu fishing activities . a union system for control , inspection , and enforcement should be established so as to ensure compliance with the common fisheries policy ' s rules .


### to achieve the basic objective of the common fisheries policy , namely to provide long - term sustainable environmental , economic and social conditions for the fishing and aquaculture sectors , and to contribute to the availability of food supplies , it is necessary and appropriate to lay down rules on the conservation and exploitation of marine biological resources . ### to achieve the basic objective of the common fisheries policy , namely to provide long - term sustainable environmental , economic and social conditions for the fishing and aquaculture sectors , and to contribute to the availability of food supplies , it is necessary to provide sufficient funding as and where appropriate , in addition to laying down rules on the conservation and exploitation of marine biological resources .


### a member state may take non - discriminatory measures for the conservation and management of fish stocks and to minimise the effect of fishing on the conservation of marine eco - systems within 12 nautical miles of its baselines provided that the union has not adopted measures addressing conservation and management specifically for that area . the member state measures shall be compatible with the objectives set out in articles 2 and 3 and no less stringent than those in existing union legislation . ### a member state may take non - discriminatory measures for the conservation and management of fish stocks and to minimise the effect of fishing on the conservation of marine eco - systems within 12 nautical miles of its baselines and within the 100 nautical mile zone around the outermost regions within the limit of their exclusive economic zone , provided that the union has not adopted measures addressing conservation and management specifically for that area . the member state measures shall be compatible with the objectives set out in articles 2 and 3 and no less stringent than those in existing union legislation .


### member states shall ensure the national coordination of the collection and management of scientific data for fisheries management . to this end , they shall designate a national correspondent and organize an annual national coordination meeting . the commission shall be informed of the national coordination activities and be invited to the coordination meetings . ### member states shall ensure the national coordination of the collection and management of scientific data for fisheries management . to this end , they shall designate a national correspondent and organize an annual national coordination meeting . the commission shall be informed of the national coordination activities and may be invited to the coordination meetings .


### an advisory council on aquaculture shall be established in accordance with article 53 . ### advisory councils on aquaculture may be established in accordance with article 53 .


### improve the transparency of the markets , in particular as regards economic knowledge and understanding of the union markets for fishery and aquaculture products along the supply chain and consumer awareness ; ### improve the transparency and stability of the markets , in particular as regards economic knowledge and understanding of the union markets for fishery and aquaculture products along the supply chain , fair distribution of added value along the sector’s value chain and consumer awareness ;


### union financial assistance may be granted to contribute to the achievement of the objectives set out in articles 2 and 3 . ### the union shall take responsibility for the financing of the cost of the common fisheries policy and may grant financial assistance to contribute to the achievement of the objectives set out in articles 2 and 3 .


### advisory councils may apply for union financial assistance as bodies pursuing an aim of general european interest . ### advisory councils may , for the purposes of their establishment and operation , apply for union financial assistance as bodies pursuing an aim of general european interest .


### 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 , as well as to their social and economic interests . differences between national laws , regulations and administrative provisions concerning the safety assessment and authorisation of novel foods may hinder their free movement , thereby creating unfair competition conditions . ### in implementing union policy and having regard to the treaty on the functioning of the european union , a high level of protection of human health and consumer protection should be guaranteed and also a high level of animal welfare and environmental protection . at all times , moreover , the precautionary principle as laid down in regulation 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 safety1 , should be applied . 1 oj l 31 , 1 . 2 . 2002 , p . 1 .


### a high level of protection of human health should be assured in the pursuit of union policies . due attention should be given , where appropriate , to the protection of the environment and to animal welfare . ### a high level of human health protection should be assured in the pursuit of union policies and should be given priority over the functioning of the internal market .


### the union ' s rules on novel foods were established by regulation no 258 / 97 of the european parliament and of the council of 27 january 1997 concerning novel foods and novel food ingredients and by commission regulation no 1852 / 2001 of 20 september 2001 laying down detailed rules for making certain information available to the public and for the protection of information submitted pursuant to european parliament and council regulation no 258 / 97 . for the sake of clarity , regulation no 258 / 97 and regulation no 1852 / 2001 should be repealed and regulation no 258 / 97 should be replaced by this regulation . commission recommendation 97 / 618 / ec of 29 july 1997 concerning the scientific aspects and the presentation of information necessary to support applications for the placing on the market of novel foods and novel food ingredients and the preparation of initial assessment reports under regulation no 258 / 97 of the european parliament and of the council should therefore become obsolete as regards novel foods . ### the union ' s rules on novel foods were established by regulation no 258 / 97 of the european parliament and of the council of 27 january 1997 concerning novel foods and novel food ingredients1 and by commission regulation no 1852 / 2001 of 20 september 2001 laying down detailed rules for making certain information available to the public and for the protection of information submitted pursuant to european parliament and council regulation no 258 / 972 . for the sake of clarity , regulation no 258 / 97 should be repealed and replaced by this regulation . the present regulation should include measures currently governed by regulation no 1852 / 2001 .


### regulation 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 applies . the existing definition of novel food should be clarified and updated by replacing the existing categories with a reference to the general definition of food in that regulation . ### the existing definition of novel food should be clarified , with an explanation of the criteria for novelty , and updated by replacing the existing categories with a reference to the general definition of food in regulation no 178 / 2002 .


### it should also be clarified that a food is to be considered as novel when a production technology which was not previously used for food production in the union is applied to that food . in particular , emerging technologies in breeding and food production processes which have an impact on food , and thus might have an impact on food safety , should be covered by this regulation . novel food should therefore include foods derived from animals produced by non - traditional breeding techniques and from their offspring , foods derived from plants produced by non - traditional breeding techniques , foods produced by new production processes which might have an impact on food , and foods containing or consisting of engineered nanomaterials . foods derived from new plant varieties or animal breeds produced by traditional breeding techniques should not be considered as novel foods . furthermore , it should be clarified that foods from third countries which are novel in the union can be considered as traditional only when they are derived from primary production as defined in regulation no 178 / 2002 , whether they are processed or unprocessed . however , foods thus obtained should neither include foods produced from animals or plants to which a non - traditional breeding technique was applied or foods produced from the offspring of such animals , nor foods to which a new production process is applied . ### it should also be clarified that a food should be considered as novel when it is applied to a production technology which was not previously used . in particular , emerging technologies in breeding and food production processes , which have an impact on food and thus might have an impact on food safety , should be covered by this regulation . novel food should therefore include foods derived from plants and animals , produced by non - traditional breeding techniques , and foods modified by new production processes , such as nanotechnology and nanoscience , which might have an impact on food . foods derived from new plant varieties , or animal breeds produced by traditional breeding techniques , should not be considered as novel foods .


### however , in the light of the opinion of the european group on ethics in science and new technologies , established by commission decision of 16 december 1997 , issued on 16 january 2008 and of the opinion of the european food safety authority adopted on 15 july 2008 , techniques for the cloning of animals , such as somatic cell nuclear transfer , have specific characteristics such that this regulation cannot address all the issues of cloning . therefore , food produced from animals obtained by using a cloning technique and from the offspring thereof should be subject to a report submitted by the commission to the european parliament and the council , followed , if appropriate , by a legislative proposal . if specific legislation is adopted , the scope of this regulation should be adapted accordingly . ### the european group on ethics in science and new technologies stated in its opinion of 16 january 2008 on ethical aspects of animal cloning for food supply that it ‘ does not see convincing arguments to justify the production of food from clones and their offspring’ . the scientific committee of the european food safety authority concluded in its opinion of 15 july 2008 on animal cloning1 that ‘ the health and welfare of a significant proportion of clones … have been found to be adversely affected , often severely and with a fatal outcome’ . 1 the efsa journal 767 , p . 32 .


### implementing measures should be adopted to provide for criteria to facilitate the assessment of whether a food was used for human consumption to a significant degree within the union before 15 may 1997 . if , prior to that date , a food was used exclusively as , or in , a food supplement , as defined in directive 2002 / 46 / ec , it should be allowed to be placed on the market within the union after that date for the same use without being considered a novel food . however , that use as , or in , a food supplement should not be taken into account for the assessment of whether the food was used for human consumption to a significant degree within the union before 15 may 1997 . therefore , uses of the food concerned other than in , or as , a food supplement should be authorised in accordance with this regulation . ### implementing measures should be adopted to provide for further criteria in order to facilitate the assessment of whether a food has been used for human consumption to a significant degree within the union before 15 may 1997 . if a food has been used exclusively as , or in , a food supplement , as defined in directive 2002 / 46 / ec of the european parliament and of the council of 10 june 2002 on the approximation of the laws of the member states relating to food supplements1 , prior to that date , it can be placed on the market after that date for the same use without being considered as a novel food . however , that use as , or in , a food supplement should not be taken into account for the assessment of whether it has been used for human consumption to a significant degree within the union before 15 may 1997 . therefore , other uses of the food concerned , namely other than food supplement uses , have to be authorised in accordance with this regulation . 1 oj l 183 , 12 . 7 . 2002 , p . 51 .


### the use of engineered nanomaterials in food production might increase with the further development of technology . in order to ensure a high level of protection of human health , free movement of goods and legal certainty for manufacturers , it is necessary to develop a uniform definition for engineered nanomaterial at international level . the union should endeavour to reach an agreement on a definition in appropriate international fora . should such an agreement be reached , the definition of engineered nanomaterial in this regulation should be adapted accordingly ### the use of engineered nanomaterials in food production might increase with the further development of technology . in order to ensure a high level of protection of human health , it is necessary to develop a uniform definition for engineered nanomaterials .


### food products produced from food ingredients that do not fall within the scope of this regulation , in particular by changing the ingredients of the food , their composition or amount , should not be considered as novel food . however , modifications of a food ingredient , e . g . selective extracts or the use of other parts of a plant , that have so far not been used for human consumption within the union , should still fall within the scope of this regulation . ### reformulated food products produced from existing food ingredients available on the market within the union , in particular those reformulated by changing the composition or amounts of those food ingredients , should not be considered as novel food .


### foods which are intended for technological uses or which are genetically modified should not fall within the scope of this regulation . therefore , genetically modified food falling within the scope of regulation no 1829 / 2003 , food used solely as additives falling within the scope of regulation no 1333 / 2008 , flavourings falling within the scope of regulation no 1334 / 2008 , enzymes falling within the scope of regulation no 1332 / 2008 and extraction solvents falling within the scope of directive 2009 / 32 / ec should not be covered by this regulation . ### foods which are intended for technological uses or which are genetically modified should not fall within the scope of this regulation as long as these foods are covered by a safety evaluation and approval according to other union legislation . therefore , food used solely as additives falling within the scope of regulation no 1333 / 2008 of the european parliament and of the council of 16 december 2008 on food additives1 , flavourings falling within the scope of regulation 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 foods2 , extraction solvents falling within the scope of council directive 88 / 344 / eec of 13 june 1988 on the approximation of the laws of the member states on extraction solvents used in the production of foodstuffs and food ingredients3 , enzymes falling within the scope of regulation no 1332 / 2008 of the european parliament and of the council of 16 december 2008 on food enzymes4 and genetically modified food falling within the scope of regulation no 1829 / 2003 of the european parliament and of the council of 22 september 2003 on genetically modified food and feed5 should be excluded from the scope of this regulation . 1 oj l 354 , 31 . 12 . 2008 , p . 16 . 2 oj l 354 , 31 . 12 . 2008 , p . 34 . 3 oj l 157 , 24 . 6 . 1988 , p . 28 . 4 oj l 354 , 31 . 12 . 2008 , p . 7 . 5 oj l 268 , 18 . 10 . 2003 , p . 1 .


### novel foods , other than vitamins and minerals , intended for particular nutritional uses , for food fortification or as food supplements , should be assessed in conformity with this regulation . they should also remain subject to the rules provided for in directive 2002 / 46 / ec , in regulation no 1925 / 2006 , in directive 2009 / 39 / ec , and in the specific directives referred to in directive 2009 / 39 / ec and in annex i thereto . ### novel foods , other than vitamins and minerals , intended for particular nutritional uses , for food fortification or as food supplements , should be assessed in conformity with the safety criteria and requirements applicable to all novel foods . at the same time they should remain subject to the rules provided for in directive 89 / 398 / eec and in the specific directives referred to in article 4 thereof and in annex i thereof , in directive 2002 / 46 / ec and in regulation no 1925 / 2006 .


### the determination of whether a food was used for human consumption to a significant degree within the union before 15 may 1997 , should be based on information submitted by food business operators and , where appropriate , supported by other information available in the member states . when there is no or insufficient information available on human consumption before 15 may 1997 , a simple and transparent procedure , involving the commission , the member states and any parties concerned , should be established for collecting that information . ### the commission should establish a simple and transparent procedure for cases in which it does not have information on human consumption before 15 may 1997 . the member states should be involved in this procedure . the procedure should be adopted no later than six months after the entry into force of this regulation .


### novel foods should be placed on the market within the union only if they are safe and do not mislead the consumer . in addition , where the novel food is intended to replace another food , it should not differ from that food in a way that would be nutritionally disadvantageous for the consumer . ### novel foods should be placed on the market within the union only if they are safe and do not mislead the consumer . the assessment of their safety should be based on the precautionary principle as laid down in article 7 of regulation no 178 / 2002 . in addition , they should not differ from the food that they are to replace in any way that would be nutritionally disadvantageous for the consumer .


### at present , there is inadequate information on the risks associated with engineered nanomaterials . in order to better assess their safety the commission , in cooperation with the authority , should develop test methodologies which take into account specific characteristics of engineered nanomaterials . ### test methods currently available are not adequate for assessing the risks associated with nanomaterials . non - animal test methods for testing nanomaterials should be developed as a matter of urgency .


### the inclusion of a novel food in the union list of novel foods or in the list of traditional foods from third countries should be without prejudice to the possibility of evaluating the effects of the overall consumption of a substance which is added to , or used for the manufacture of that food , or of a comparable product in accordance with regulation no 1925 / 2006 . ### the inclusion of a novel food in the union list of novel foods should be without prejudice to the possibility of evaluating the effects of the overall consumption of a substance which is added to , or used for the manufacture of that food , or of a comparable product in accordance with article 8 of regulation no 1925 / 2006 .


### under specific circumstances , in order to stimulate research and development within the agri - food industry , and thus innovation , the newly developed scientific evidence and proprietary data provided in support of an application for inclusion of a novel food in the union list should be protected . that data and information should not be used to the benefit of a subsequent applicant , during a limited period of time , without the agreement of the prior applicant . the protection of scientific data provided by one applicant should not prevent other applicants from seeking the inclusion in the union list of novel foods on the basis of their own scientific data . ### under specific circumstances in order to stimulate research and development within the agri - food industry , and thus innovation , it is appropriate to protect the investment made by innovators in gathering the information and data provided in support of an application under this regulation . the newly developed scientific evidence and proprietary data provided in support of an application for inclusion of a novel food in the union list should not be used to the benefit of another applicant during a limited period of time , without the agreement of the first applicant . the protection of scientific data provided by one applicant should not prevent other applicants from seeking the inclusion in the union list of novel foods on the basis of their own scientific data . in addition , the protection of scientific data should not prevent transparency and access to information relating to the data used in the safety assessment of novel foods . intellectual property rights should , nevertheless , be respected .


### novel foods are subject to the general labelling requirements laid down in directive 2000 / 13 / ec and , where necessary , to the nutritional labelling requirements laid down in directive 90 / 496 / eec . in certain cases it might be necessary to provide for additional labelling information , in particular regarding the description of the food , its source or its conditions of use . therefore , when a novel food is included in the union list or in the list of traditional foods from third countries , specific conditions of use or labelling obligations may be imposed , which might , inter alia , relate to any specific characteristic or food property , such as composition , nutritional value or nutritional effects and intended use of the food , or to ethical considerations or implications for the health of specific groups of the population . ### novel foods are subject to the general labelling requirements laid down in directive 2000 / 13 / ec of the european parliament and of the council of 20 march 2000 on the approximation of the laws of the member states relating to labelling , presentation and advertising of foodstuffs1 . in certain cases it might be necessary to provide for additional labelling information , in particular regarding the description of the food , its source , or its conditions of use . therefore , the inclusion of a novel food in the union list may be subject to specific conditions of use or labelling obligations . 1 oj l 109 , 6 . 5 . 2000 , p . 29 .


### regulation no 1924 / 2006 harmonises the provisions in the member states which relate to nutrition and health claims . therefore , claims regarding novel foods should only be made in accordance with that regulation . ### regulation no 1924 / 2006 of the european parliament and of the council of 20 december 2006 on nutrition and health claims made on foods2 harmonises the provisions in the member states which relate to nutrition and health claims . therefore , claims regarding novel foods should only be made in accordance with that regulation . where an applicant wishes a novel food to carry a health claim that needs to be authorised in accordance with article 17 or 18 of regulation no 1924 / 2006 and the novel food and health claim applications both include requests for the protection of proprietary data , the periods of data protection should start together and run concurrently , where the applicant so requests . 2 oj l 404 , 30 . 12 . 2006 , p . 9 .


### the european group on ethics in science and new technologies may be consulted , where appropriate , with a view to obtaining advice on ethical issues regarding the placing on the market within the union of novel foods . ### the european group on ethics in science and new technologies established by commission decision of 16 december 1997 should be consulted in specific cases with a view to obtaining advice on ethical issues regarding the use of new technologies and the placing on the market of novel foods .


### novel foods placed on the market within the union under regulation no 258 / 97 should continue to be placed on the market . novel foods authorised in accordance with regulation no 258 / 97 should be included in the union list of novel foods established by this regulation . in addition , applications submitted under regulation no 258 / 97 before the date of application of this regulation should be transformed into an application under this regulation where the initial assessment report provided for under regulation no 258 / 97 has not yet been forwarded to the commission , as well as in all cases where an additional assessment report is required in accordance with that regulation . other pending requests submitted under article 4 of regulation no 258 / 97 before the date of application of this regulation should be processed under the provisions of regulation no 258 / 97 . ### novel foods placed on the market within the union under regulation no 258 / 97 should continue to be placed on the market . novel foods authorised in accordance with regulation no 258 / 97 should be included in the union list of novel foods established by this regulation . in addition , applications submitted under regulation no 258 / 97 , in relation to which the initial assessment report provided for under article 6 of that regulation has not yet been forwarded to the commission and in relation to which an additional assessment report is required in accordance with article 6 or 6 of that regulation before the date of application of this regulation , should be considered as an application under this regulation . when required to give an opinion , the authority and the member states should take into account the outcome of the initial assessment . other requests submitted under article 4 of regulation no 258 / 97 before the date of application of this regulation should be processed under the provisions of regulation no 258 / 97 .


### regulation no 882 / 2004 lays down general rules for the performance of official controls to verify compliance with food law . the member states should be requested to carry out official controls in accordance with that regulation , in order to enforce compliance with this regulation . ### regulation 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 lays down general rules for the performance of official controls to verify compliance with food law . therefore , member states are to carry out official controls in accordance with regulation no 882 / 2004 , in order to enforce compliance with this regulation .


### in addition , the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty on the functioning of the european union in respect of the criteria according to which foods may be considered as having been used for human consumption to a significant degree within the union before 15 may 1997 . it is of particular importance that the commission consult experts in the preparatory phase in accordance with the commitment of the commission undertaken in the communication of 9 december 2009 on the implementation of article 290 of the treaty on the functioning of the european union . ### the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty on the functioning of the european union in respect of the criteria according to which foods may be considered as having been used for human consumption to a significant degree within the union before 15 may 1997 , in respect of the determination of whether a type of food falls within the scope of this regulation , the adjustment and adaptation of the definition of ' engineered nanomaterial ' to technical and scientific progress and in line with definitions subsequently agreed at international level , rules on how to proceed in cases in which the commission has no information about use of a food for human consumption before 15 may 1997 , as well as in respect of rules for the application of article 4 and the update of the union list . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level .


### this regulation lays down harmonised rules for the placing of novel foods on the market within the union with a view to ensuring a high level of protection of human health and consumers ' interests , whilst ensuring the effective functioning of the internal market , taking into account , where appropriate , the protection of the environment and animal welfare . ### this regulation lays down harmonised rules for the placing of novel foods on the market within the union with a view to ensuring a high level of protection of human life and health , animal health and welfare , the environment and the interests of consumers whilst ensuring transparency and the effective functioning of the internal market and stimulating innovation within the agri - food industry .


### this regulation shall not apply to : foods when and in so far as they are used as : food additives falling within the scope of regulation no 1333 / 2008 ; food flavourings falling within the scope of regulation no 1334 / 2008 ; extraction solvents used in the production of foodstuffs and falling within the scope of directive 2009 / 32 / ec ; food enzymes falling within scope of regulation no 1332 / 2008 ; vitamins and minerals falling within the respective scope of directive 2002 / 46 / ec , regulation no 1925 / 2006 or directive 2009 / 39 / ec , except for vitamin and mineral substances already authorised , which are obtained by production methods or using new sources that were not taken into account when they were authorised under specific legislation , where those production methods or new sources give rise to the significant changes referred to in point of article 3 of this regulation . foods falling within the scope of regulation no 1829 / 2003 ; ### this regulation shall , unless otherwise provided for , not apply to : foods when and insofar as they are used as : food additives falling within the scope of regulation no 1333 / 2008 ; food flavourings falling within the scope of regulation no 1334 / 2008 ; extraction solvents used in the production of foodstuffs and falling within the scope of directive 88 / 344 / eec ; food enzymes falling within scope of regulation no 1332 / 2008 ; vitamins and minerals falling within the scope of directive 89 / 398 / eec , directive 2002 / 46 / ec or regulation no 1925 / 2006 , except for vitamin and mineral substances already approved which are obtained by production methods or using new sources that were not taken into account when they were authorised under specific legislation , where these production methods or new sources give rise to significant changes referred to in article 3 . foods falling within the scope of regulation no 1829 / 2003 ;


### ' novel food ' means food that was not used for human consumption to a significant degree within the union before 15 may 1997 , including : food of animal origin , when a non - traditional breeding technique not used for food production within the community before 15&#160 ; may&#160 ; 1997 is applied to the animal and food derived from the offspring of these animals ; ### ' novel food ' means : food that was not used for human consumption to a significant degree within the union before 15 may 1997 ;


### food of plant origin , when a non - traditional breeding technique not used for food production within the union before 15 may 1997 is applied to the plant , if that non - traditional breeding technique applied to a plant gives rise to significant changes in the composition or structure of the food , which affect its nutritional value , how it is metabolised or the level of undesirable substances ; ### food of plant or animal origin when to the plant and animal is applied a non - traditional breeding technique not used before 15 may 1997 , with the exception of foods derived from cloned animals and their descendants ;


### ' traditional food from a third country ' means novel food , other than the novel food under sub - points to of point , derived from primary production , with a history of food use in any third country , such that the food in question has been and continues to be part of the customary diet for at least 25 years in a large part of the population of the country ; ### ' traditional food from a third country ' means a natural non - engineered novel food with a history of food use in a third country , meaning that the food in question has been , for at least 25 years before . . . * , and continues to be , part of the normal diet in a large part of the population of the country ; * six months after the date of entry into force of this regulation .


### ' history of safe food use in a third country ' means that the safety of the food in question is confirmed with compositional data and from experience of use and continued use for at least 25 years in the customary diet of a large part of the population of a country . ### ' ' history of safe food use ' ' means that the safety of the food in question is confirmed with compositional data and from experience of use and continued use for at least 30 years in the customary diet of a large part of the population of a country ;


### the commission may adopt further criteria to clarify the definitions in sub - points to of point , and in points , and of paragraph 2 of this article in accordance with the regulatory procedure referred to in article 19 . ### in view of the various definitions of nanomaterials published by different bodies at international level and the constant technical and scientific developments in the field of nanotechnologies , the commission shall adjust and adapt point of paragraph 2 to technical and scientific progress and with definitions subsequently agreed at international level . that measure , designed to amend non - essential elements of this regulation , shall be adopted in accordance with . . . . .


### procedure for determination of novel food status ### collection of information regarding the classification of a novel food


### food business operators shall verify the status of the food they intend to place on the market within the union with respect to the scope of this regulation . ### the commission shall collect information from the member states and / or from food business operators or any other interested party to determine whether a food falls within the scope of this regulation . member states , business operators and other interested parties shall transmit to the commission information on the extent a food has been used for human consumption within the union before 15 may 1997 .


### in case of doubt , food business operators shall consult the relevant competent authority for novel foods as defined in article 15 of regulation no 1331 / 2008 on the status of the food in question . on request from the relevant competent authority , food business operators shall submit information concerning the extent to which the food in question was used for human consumption within the union before 15 may 1997 . ### the commission shall publish those data and the conclusions drawn from the data collection and the non - confidential data supporting it .


### no person shall place on the union market a novel food if it does not comply with this regulation . ### novel foods shall not be placed on the market if they do not comply with the provisions of this regulation .