### prior to initiating the collection of statements of support from signatories for a proposed citizens ' initiative , the organiser shall be required to register it with the commission , providing the information set out in annex ii , in particular on the subject - matter and objectives as well as on the sources of funding and support for the proposed citizens ' initiative . this information shall be provided in one of the official languages of the union , in an online register made available for that purpose by the commission . ### prior to initiating the collection of statements of support from signatories for a proposed citizens ' initiative , the organisers shall be required to register it with the commission , providing the information set out in annex ii , in particular on the subject - matter and objectives of the proposed citizens ' initiative . the organisers shall provide , for the register defined in the third subparagraph and where appropriate on their website , regularly updated information on all sources of support and funding for the initiative . funding by political parties and european political groups shall not be permitted . this information shall be provided in one or more official languages of the union , in an online register made available for that purpose by the commission . information in an official language other the language in which it was originally provided may be provided subsequently for entry in the register . the translation of the initiative into other official languages of the union shall be the responsibility of the organisers .


### 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 : – technical specifications for online collection systems pursuant to article 6 ; – amendments to the annexes to this regulation .


### five years after the entry into force of this regulation , the commission shall present a report to the european parliament and the council on the implementation of this regulation . ### three years after the entry into force of this regulation , and every three years thereafter , the commission shall present a report to the european parliament and the council on the implementation of this regulation , with special emphasis on online collection systems and the application of transparency requirements concerning support and funding of initiatives , together , if appropriate , with a legislative proposal for amendment of this regulation .


### this regulation shall enter into force on the twentieth day following that of its publication in the official journal of the european union . ### this regulation shall enter into force on the first day of the month following its publication in the official journal of the european union . it shall start to apply 12 months after its entry into force .


### required information for registering a proposed citizens’ initiative the following information shall be provided in order to register a proposed citizens’ initiative on the commission ' s register : the title of proposed citizens ' initiative in no more than 100 characters ; 2 . the subject - matter , in no more than 200 characters ; 3 . the description of the objectives of the proposal on which the commission is invited to act , in no more than 500 characters ; 4 . the legal base of the treaties which would allow the commission to act ; 5 . the full name , postal address and e - mail address of the organiser or , in the case of a legal entity or organisation , its legal representative ; 7 . all sources of funding and support for the proposed initiative at the time of registration . organisers may provide more detailed information on the subject , objectives and background to the proposed citizens ' initiative in an annex . they may also , if they wish , submit a draft legislative text . ### required information for a proposed citizens’ initiative the following information shall be provided for the commission ' s register : the title of the proposed citizens ' initiative in no more than 100 characters ; 2 . the subject - matter , in no more than 500 characters ; 3 . the description of the objectives of the proposal on which the commission is invited to act , in no more than 1000 characters ; 4 . the treaty provision considered relevant by the organisers for the proposed action ; 5 . the full name , postal address and e - mail address of the organisers and the contact persons ; 6 . all sources of support and funding for the proposed initiative at the time of registration organisers may provide more detailed information on the subject , objectives , and background to the proposed citizens ' initiative in an annex . they may also , if they wish , submit a draft legislative text .


### 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 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 . the scope of the criteria could be further expanded to include fiscal stability and the enhanced union focus on economic governance .


### 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 the accession 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 , good governance , 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 , and most importantly , the obligations under the treaties .


### the accession process is based on objective criteria and the application of the principle of equal treatment of all applicant countries . progression towards accession depends on the capacity of the applicant country to undertake the necessary reforms to align its political , institutional , legal , administrative and economic systems with the rules , standards , policies and practices in the union . ### the accession process is based on objective criteria and the application of the principle of equal treatment of all applicant countries . progression towards accession depends on the determination and capacity of the applicant country to undertake the necessary reforms to align its political , institutional , legal , administrative and economic systems with the rules , standards , policies and practices in the union , as well as on the respect for the integration capacity of the union .


### the european council has granted the status of candidate country to iceland , montenegro , the former yugoslav republic of macedonia and turkey . it has confirmed the european perspective for albania , bosnia and herzegovina , serbia as well as kosovo , which are considered potential candidates . ### the european council has granted the status of candidate country to iceland , montenegro , the former yugoslav republic of macedonia , turkey and serbia . it has confirmed the european perspective for albania , bosnia and herzegovina as well as kosovo , which are considered potential candidates to the sole purpose of this regulation and without prejudice to positions of member states on status .


### assistance under this regulation should be provided in accordance with the enlargement policy framework defined by the union for each beneficiary country reflected in the annual enlargement package of the commission , which includes the progress reports and the enlargement strategy , in the stabilisation and association agreements and in the european or accession partnerships . assistance should mainly focus on a limited number of policy areas that will help beneficiary countries strengthen democratic institutions and the rule of law , reform the judiciary and public administration , respect fundamental rights and promote gender equality and non - discrimination . it should also enhance their economic and social development , underpinning a smart , sustainable and inclusive growth agenda in line with the europe 2020 strategy and to align progressively with the copenhagen criteria . the coherence between the financial assistance and the overall progress made in the implementation of the pre - accession strategy should be strengthened . ### assistance under this regulation should be provided in accordance with the enlargement policy framework defined by the union for each beneficiary country reflected in the annual enlargement package of the commission , which includes the progress reports and the enlargement strategy , in the stabilisation and association agreements and in the european or accession partnerships , and corresponding to the actions envisaged in the common strategic framework and the strategy reports . assistance should mainly focus on a comprehensive number of policy areas that will help beneficiary countries strengthen their administrative and institutional capacity , build democratic institutions and the rule of law , strengthen the judiciary and public administration , respect fundamental rights and promote gender equality and non - discrimination . it should also enhance their economic and social development , underpinning a smart , sustainable and inclusive growth agenda in line with the europe 2020 strategy and to align progressively with the copenhagen criteria . the coherence between the financial assistance and the overall progress made in the implementation of the pre - accession strategy should be strengthened and made conditional on compliance with clear , specific and transparent performance indicators .


### assistance under this regulation should be provided in accordance with the enlargement policy framework defined by the union for each beneficiary country reflected in the annual enlargement package of the commission , which includes the progress reports and the enlargement strategy , in the stabilisation and association agreements and in the european or accession partnerships . assistance should mainly focus on a limited number of policy areas that will help beneficiary countries strengthen democratic institutions and the rule of law , reform the judiciary and public administration , respect fundamental rights and promote gender equality and non - discrimination . it should also enhance their economic and social development , underpinning a smart , sustainable and inclusive growth agenda in line with the europe 2020 strategy and to align progressively with the copenhagen criteria . the coherence between the financial assistance and the overall progress made in the implementation of the pre - accession strategy should be strengthened . ### assistance under this regulation should be provided in accordance with the enlargement policy framework defined by the union for each beneficiary country reflected in the annual enlargement package of the commission , which includes the progress reports and the enlargement strategy , in the stabilisation and association agreements and in the european or accession partnerships . assistance should mainly focus on a limited number of policy areas that will help beneficiary countries strengthen democratic institutions and the rule of law , reform the judiciary and public administration , respect fundamental rights and promote gender equality and non - discrimination . it should also enhance their economic and social development , underpinning a smart , sustainable and inclusive growth agenda in line with the europe 2020 strategy and to align fully with the copenhagen criteria . the coherence between the financial assistance and the overall progress made in the implementation of the pre - accession strategy should be strengthened .


### it is in the union ' s interest to assist beneficiary countries in their efforts to reform their systems in order to align them to those of the union . since the objective of this regulation cannot be sufficiently achieved by the member states and can be better achieved at union ' s level , the union may adopt measures in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality as set out in that article , this regulation does not go beyond what is necessary in order to achieve this objective . ### reforms of the political , legal and socio - economic systems of the beneficiary countries are in the interest of the union and the beneficiary countries in order to bring them to the same level of standards as the union ' s . since the objective of this regulation cannot be sufficiently achieved by the member states and can be better achieved at union ' s level , the union may adopt measures in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality as set out in that article , this regulation does not go beyond what is necessary in order to achieve this objective .


### 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 , enhanced respect for minority rights , promotion of gender equality and religious freedom , non - discrimination and freedom of the press , the media and the internet and promotion of good neighbourly relations ;


### economic reforms necessary to cope with competitive pressure and market forces within the union , while pursuing economic , social and environmental goals ; ### the implementation of economic reforms necessary to cope with competitive pressure and market forces within the union , while achieving economic , social and environmental progress ;


### fostering employment and developing human capital ; ### combating unemployment , fostering employment and developing human capital ;


### development of physical capital , the improvement of connections with union and regional networks . ### the development of physical capital , the improvement of connections with union infrastructures and regional networks .


### – progress in economic reforms ; the soundness and effectiveness of social and economic development strategies , progress towards smart , sustainable and inclusive growth , including through public investments supported by ipa ; ### – progress in economic reforms ; the soundness and effectiveness of social and economic development strategies , progress towards smart , sustainable and inclusive growth , including through public investments supported by ipa ; progress towards creating a favourable business environment ;


### the types of actions which can be financed by the ipa ; ### the types of actions which can be financed by the ipa and their expected results ;


### evaluation of the current ten - e framework has clearly shown that this policy , while making a positive contribution to selected projects by giving them political visibility , lacks vision , focus , and flexibility to fill identified infrastructure gaps . ### evaluation of the current ten - e framework has clearly shown that this policy , while making a positive contribution to selected projects by giving them political visibility , lacks vision , focus , and flexibility to fill identified infrastructure gaps ; highlights in this context the importance of identifying potential future gaps in energy demand and supply .


### concerning oil transport projects falling under the categories set out in point 3 of annex ii , the project shall contribute significantly to the following three specific criteria : – security of supply reducing single supply source or route dependency ; – efficient and sustainable use of resources through mitigation of environmental risks ; – interoperability ; ### concerning oil transport projects falling under the categories set out in point 3 of annex ii , the project shall contribute significantly to the following three specific criteria : – security of supply reducing single supply source or route dependency and achieving increased connectivity ; – efficient and sustainable use of resources through mitigation of environmental risks , notably by reducing the use of risk - prone means for transporting oil , such as tankers ; – interoperability ;


### efficient and sustainable use of resources shall be evaluated by assessing the extent to which the project makes use of already existing infrastructure and contributes to minimising environmental and climate change burden and risks . ### efficient and sustainable use of resources shall be evaluated by assessing the extent to which the project makes use of already existing infrastructure and contributes to minimising environmental and climate change burden and risks , for example by substituting risk - prone means of transportation such as tankers by less risky modes of transportation .


### assisting producers , by means of the operation of quality schemes , to be rewarded for their efforts to produce a diversity of quality products , can benefit the rural economy . this is particularly the case in less favoured areas , where the farming sector accounts for a significant part of the economy . in this way quality schemes contribute to and complement rural development policy as well as market and income support policies of the common agricultural policy . ### assisting producers , by means of the operation of quality schemes , to be rewarded for their efforts to produce a diversity of quality products , can benefit the rural economy . this is particularly the case in less favoured areas and mountain areas , where the farming sector accounts for a significant part of the economy and production costs are high . in this way quality schemes contribute to and complement rural development policy as well as market and income support policies of the common agricultural policy .


### assisting producers , by means of the operation of quality schemes , to be rewarded for their efforts to produce a diversity of quality products , can benefit the rural economy . this is particularly the case in less favoured areas , where the farming sector accounts for a significant part of the economy . in this way quality schemes contribute to and complement rural development policy as well as market and income support policies of the common agricultural policy . ### assisting producers , by means of the operation of quality schemes , to be rewarded for their efforts to produce a diversity of quality products , can benefit the rural economy . this is particularly the case in less favoured areas , and in particular in the most remote regions , where the farming sector accounts for a significant part of the economy . in this way quality schemes contribute to and complement rural development policy as well as market and income support policies of the common agricultural policy .


### the specific objectives of protecting designations of origin and geographical indications are for farmers and producers to secure fair return for the qualities of product and provide clear information on products with specific characteristics linked to geographical origin , enabling consumers to make more informed purchasing choices . ### the specific objectives of protecting designations of origin and geographical indications are for farmers and producers to secure fair return for the qualities and characteristics of a given product or of its mode of production , provide clear information on products with specific characteristics linked to geographical origin , enabling consumers to make more informed purchasing choices .


### ensuring uniform respect throughout the union of the intellectual property rights related to names protected in the union is also an objective that can be achieved more effectively at union level . ### ensuring uniform respect throughout the union of the intellectual property rights related to names protected in the union is a priority objective that can be achieved more effectively at union level .


### a union framework for protection of designations of origin and geographical indications , with their inclusion into a register , permits their development since , by providing a more uniform approach , such a framework ensures fair competition between the producers of products bearing such indications and enhances the credibility of the products in the consumer ' s eyes . provision should be made for the development of designations of origin and geographical indications at union level . ### a union framework for protection of designations of origin and geographical indications , with their inclusion into a register , permits their development since , by providing a more uniform approach , such a framework ensures fair competition between the producers of products bearing such indications and enhances the credibility of the products in the consumer ' s eyes . provision should be made for the development of designations of origin and geographical indications at union level and the creation of mechanisms for their external protection in the framework of the wto , within which it is important to secure the recognition , as a factor of value added , of the quality of products and of their model of production .


### in view of their specific nature , special provisions as to labelling should be adopted for protected designations of origin and protected geographical indications , requiring producers to use the appropriate union symbols or indications on packaging . the use of such symbols or indications should be made obligatory in the case of union names , on the one hand , to make this category of products and the guarantees attached to them better known to consumers and , on the other , to permit easier identification of these products on the market so as to facilitate checks . taking into account the requirements of the world trade organization , the use of such symbols or indications should be made voluntary for geographical indications and designations of origin originating in a third country . ### in view of their specific nature , special provisions as to labelling should be adopted for protected designations of origin and protected geographical indications , requiring producers to use the appropriate union symbols or indications on packaging . the use of such symbols or indications should be made obligatory in the case of union names , on the one hand , to make this category of products and the guarantees attached to them better known to consumers and , on the other , to permit easier identification of these products on the market so as to facilitate checks . taking into account the requirements of the world trade organization , the use of a specific symbol different from the european logo should be authorised only in the case of third - country products complying with the conditions of registration and the other legal requirements applying to european products with protected designations of origin or protected geographical indications .


### the role of groups should be clarified and recognised . groups play an essential role in the application process for the registration of names of designations of origin and geographical indications and traditional specialities guaranteed , including amendments of specifications and cancellation requests . the group can also develop activities related to the surveillance of the enforcement of the protection of the registered names , the compliance of the production with the product specification , the information and promotion of the registered name as well as in general any activity aiming to improve the value of the registered names and effectiveness of the quality schemes . nevertheless , these activities should not facilitate nor lead to anti - competitive conduct incompatible with articles 101 and 102 of the treaty . ### the role of groups and inter - sectoral organisations should be clarified and recognised . these play an essential role in the application process for the registration of names of designations of origin and geographical indications and traditional specialities guaranteed , including amendments of specifications and cancellation requests . the group and / or inter - sectoral organisation can also develop activities related to the surveillance of the enforcement of the protection of the registered names , the compliance of the production with the product specification , the information and promotion of the registered name as well as in general any activity aiming to improve the value of the registered names and effectiveness of the quality schemes . groups and inter - sectoral organisations should be able to implement supply regulating measures . nevertheless , these activities should not facilitate nor lead to anti - competitive conduct incompatible with articles 101 and 102 of the treaty , nor should they infringe on the rights of small producers and new entrants on the market .


### the role of groups should be clarified and recognised . groups play an essential role in the application process for the registration of names of designations of origin and geographical indications and traditional specialities guaranteed , including amendments of specifications and cancellation requests . the group can also develop activities related to the surveillance of the enforcement of the protection of the registered names , the compliance of the production with the product specification , the information and promotion of the registered name as well as in general any activity aiming to improve the value of the registered names and effectiveness of the quality schemes . nevertheless , these activities should not facilitate nor lead to anti - competitive conduct incompatible with articles 101 and 102 of the treaty . ### the role of groups should be clarified and recognised . groups play an essential role in the application process for the registration of names of designations of origin and geographical indications and traditional specialities guaranteed , including amendments of specifications and cancellation requests . the group can also develop activities related to the surveillance of the enforcement of the protection of the registered names , the compliance of the production with the product specification , the information and promotion of the registered name as well as in general any activity aiming to improve the value of the registered names and effectiveness of the quality schemes , as well as to monitor the position of the products on the market and to regulate this position within prescribed rules . nevertheless , these activities should not facilitate nor lead to anti - competitive conduct incompatible with articles 101 and 102 of the treaty .


### the measures herein are intended to foster agricultural and processing activities and farming systems associated with high quality products thus contributing to the achievement of rural development policy . ### the measures herein are intended to foster agricultural and processing activities and farming systems associated with high quality products thus contributing to the achievement of rural development policy , with a special focus on areas in which the farming sector is of greater economic importance and , in particular , disadvantaged areas .


### ‘ group’ means any association , irrespective of its legal form , mainly composed of producers or processors working with the same product ; ### group : ‘ group’ means any association , irrespective of its legal form , mainly composed of operators who produce , process or produce and process the product ;


### the production steps of which all take place in the same defined geographical area ; ### the production steps of which all take place in a single defined geographical area ;


### the production steps of which all take place in the same defined geographical area ; ### the production , processing and preparation of which all take place in the same defined geographical area ; both the production of the raw materials and the production and processing of the product take place entirely in the defined geographical area ;


### at least one of the production steps of which take place in the defined geographical area . ### at least one of the production steps of which , that are critical for fulfilling the conditions set out under , takes place in the defined geographical area .


### at least one of the production steps of which take place in the defined geographical area . ### at least one of the essential production steps of which take place in the defined geographical area .


### in order to take into account the specificities related to certain sectors or areas , the commission may , by means of delegated acts , adopt restrictions and derogations regarding the steps of production which shall take place in the defined geographical area or regarding the sourcing of raw materials . ### in order to take into account the specificities related to certain sectors or areas , the commission may , on a proposal from the applicant group and by means of delegated acts , adopt derogations regarding the steps of production which shall take place in the defined geographical area or regarding the sourcing of raw materials .


### in order to take into account the specificities related to certain sectors or areas , the commission may , by means of delegated acts , adopt restrictions and derogations regarding the steps of production which shall take place in the defined geographical area or regarding the sourcing of raw materials . ### in order to take into account the specificities related to certain sectors or areas , the commission may , by means of delegated acts , adopt restrictions and derogations regarding : – specific steps in production that must take place in the defined geographical area , or – the localisation of certain steps in production in the defined geographical area , or – the sourcing of raw materials ; these restrictions and derogations shall , on the basis of objective criteria , take into account quality , usage and recognised know - how , specific natural factors and the development of disadvantaged areas .


### names that have become generic may not be registered as protected designations of origin or protected geographical indications . ### names that have become generic may not be registered as protected designations of origin or protected geographical indications . in establishing whether or not a name has become generic , the translation of the name into each of the official languages of the union shall be taken into account .


### evidence that the product originates in the defined geographical area referred to in point or of article 5 ; ### evidence that the product originates in the defined geographical area referred to in point or of article 5 and 5 ;


### a description of the method of obtaining the product and the authentic and unvarying local methods and , where applicable , information concerning packaging , if the applicant group so determines and gives reasons why the packaging must take place in the defined geographical area to safeguard quality or ensure the origin or ensure control ; ### a description of the method of obtaining the product and the authentic and unvarying local methods and , where applicable , information concerning packaging , if the applicant group so determines and gives reasons why the packaging must take place in the defined geographical area to safeguard quality or ensure the origin or ensure control . as a product - specific restriction on the free movement of goods and the free movement of services , justification and detailed reasons shall be provided for specifying that packaging must take place in the area ;


### gives details from which it can be concluded that the name for which registration is requested is generic . ### gives details from which it can be concluded that the name for which registration is requested or its translation into an official language of the union is generic .


### the commission may , by means of implementing acts without the assistance of the committee referred to in article 54 , lay down the form and content of the register . ### the commission may , by means of implementing acts without the assistance of the committee referred to in article 54 , lay down the form and content of the register . the register shall contain , at a minimum , the single document , the product specification and the commission acts of approval .


### protected designations of origin and protected geographical indications may be used by any operator marketing a product conforming to the corresponding specification . ### protected designations of origin and protected geographical indications may be used by any operator marketing a product conforming to the corresponding specification and control plan .


### in the case of products originating in the union , marketed under a protected designation of origin or a protected geographical indication registered in accordance with the procedures laid down in this regulation , the indications ‘ protected designation of origin’ or ‘ protected geographical indication’ or the union symbols associated with them shall appear on the labelling . in addition , the corresponding abbreviations ' pdo ' or ' pgi ' may appear on the labelling . ### in the case of products originating in the union , marketed under a protected designation of origin or a protected geographical indication registered in accordance with the procedures laid down in this regulation , the indications ‘ protected designation of origin’ or ‘ protected geographical indication’ or the union symbols associated with them shall appear on the labelling . in addition , the corresponding abbreviations ' pdo ' or ' pgi ' may appear on the labelling , together with depictions of the geographical area of origin as referred to in article 5 and text , graphics or symbols referring to the member state and / or region is which that geographical area of origin is located .


### in the case of products originating in the union , marketed under a protected designation of origin or a protected geographical indication registered in accordance with the procedures laid down in this regulation , the indications ‘ protected designation of origin’ or ‘ protected geographical indication’ or the union symbols associated with them shall appear on the labelling . in addition , the corresponding abbreviations ' pdo ' or ' pgi ' may appear on the labelling . ### in the case of products originating in the union , marketed under a protected designation of origin or a protected geographical indication registered in accordance with the procedures laid down in this regulation , the indications ‘ protected designation of origin’ or ‘ protected geographical indication’ or the union symbols associated with them shall appear on the labelling . in addition , the corresponding abbreviations ' pdo ' or ' pgi ' may appear on the labelling . the name or business name or registered trade mark of the producer or at least one of the persons subject to official controls shall also appear on the labelling .


### in the case of products originating in third countries marketed under a name entered in the register , the indications referred to in paragraph 3 or the union symbols associated with them may appear on the labelling . ### in the case of products originating in third countries marketed under a name entered in the register , it should only be possible to authorise use of a dedicated logo that is different from the union logo where those products comply with the same conditions of registration and other legal criteria as those required of european products with protected designations of origin or protected geographical indications . following verification of reciprocity of conditions and respect for the indications referred to in paragraph 3 , quality symbols for third - country products may appear on the labelling , provided they are different from the european logo .


### where a designation of origin or a geographical indication is registered under this regulation , the registration of a trade mark the use of which would contravene article 13 and which relates to a same type of product shall be refused if the application for registration of the trade mark is submitted after the date of submission of the registration application to the commission . ### where a designation of origin or a geographical indication is registered under this regulation , the application to register a trade mark the use of which would contravene article 13 shall be refused if that application is submitted after the date of submission of the registration application to the member state concerned .


### without prejudice to article 6 , a trade mark the use of which contravenes article 13 which has been applied for , registered , or established by use , if that possibility is provided for by the legislation concerned , in good faith within the territory of the european union , before the date on which the application for protection of the designation of origin or geographical indication is submitted to the commission , may continue to be used and renewed for that product notwithstanding the registration of a designation of origin or geographical indication , provided that no grounds for its invalidity or revocation exist under council regulation no 207 / 2009 of 26 february 2009 on the community trade mark or under directive 2008 / 95 / ec . in such cases , the use of the protected designation of origin or protected geographical indication shall be permitted as well as use of the relevant trade marks . ### without prejudice to article 6 , a trade mark the use of which contravenes article 13 which has been applied for , registered , or established by use , if that possibility is provided for by the legislation concerned , in good faith within the territory of the european union , before the date on which the application for protection of the designation of origin or geographical indication is submitted to the member state concerned , may continue to be used and renewed for that product notwithstanding the registration of a designation of origin or geographical indication , provided that no grounds for its invalidity or revocation exist under council regulation no 207 / 2009 of 26 february 2009 on the community trade mark or under directive 2008 / 95 / ec . in such cases , the use of the protected designation of origin or protected geographical indication shall be permitted as well as use of the relevant trade marks .


### without prejudice to article 6 , a trade mark the use of which contravenes article 13 which has been applied for , registered , or established by use , if that possibility is provided for by the legislation concerned , in good faith within the territory of the european union , before the date on which the application for protection of the designation of origin or geographical indication is submitted to the commission , may continue to be used and renewed for that product notwithstanding the registration of a designation of origin or geographical indication , provided that no grounds for its invalidity or revocation exist under council regulation no 207 / 2009 of 26 february 2009 on the community trade mark or under directive 2008 / 95 / ec . in such cases , the use of the protected designation of origin or protected geographical indication shall be permitted as well as use of the relevant trade marks . ### without prejudice to article 6 , a trade mark the use of which contravenes article 13 which has been applied for , registered , or established by use , if that possibility is provided for by the legislation concerned , in good faith within the territory of the european union , before the date on which the application for protection of the designation of origin or geographical indication is submitted to the commission , may continue to be used and renewed for that product notwithstanding the registration of a designation of origin or geographical indication , provided that no grounds for its invalidity or revocation exist under council regulation no 207 / 2009 of 26 february 2009 on the community trade mark or under directive 2008 / 95 / ec . in such cases , the use of the protected designation of origin or protected geographical indication shall be permitted as well as use of the relevant trade marks if the product bearing the trade mark which would contravene article 13 is produced in accordance with the specification and is covered by the system of controls .


### without prejudice to article&#160 ; 14 , products originating in a member state or a third country other than the one of the applicant the designation of which comprises or contains a name that contravenes article 13 may continue to use the protected name for a transitional period of up to five years , solely where an admissible statement of opposition under article&#160 ; 48 shows that : ### without prejudice to article 14 , products originating in a member state or a third country other than the one of the applicant the designation of which comprises or contains a name that contravenes article 13 may continue to use the name under which it was marketed for a transitional period of up to five years , solely where an admissible statement of opposition under article 48 shows that :


### a name shall be eligible for registration as a traditional speciality guaranteed where it describes a specific processed product that : ### a name shall be eligible for registration as a traditional speciality guaranteed where it describes a specific product that results from a mode of production and composition corresponding to traditional practice for that product . a name shall also be eligible for registration as a traditional speciality guaranteed where it describes a specific processed product that :


### a name registered as a traditional speciality guaranteed may be used by any operator marketing a product conforming to the corresponding specification . ### a name registered as a traditional speciality guaranteed may be used by any operator marketing a product conforming to the corresponding specification and its control plan .


### in the case of the products originating in the union marketed under a traditional speciality guaranteed registered in accordance with this regulation the symbol referred to in paragraph 2 shall , without prejudice to paragraph 4 , appear on the labelling . ### the labelling of products originating in the union marketed as a traditional speciality guaranteed , in accordance with the procedures laid down in this regulation , must bear the wording ' traditional speciality guaranteed ' immediately after the designation of origin . the associated union symbols and / or the relevant tsg abbreviation may , without prejudice to paragraph 4 , appear on the labelling .


### in the case of the products originating in the union marketed under a traditional speciality guaranteed registered in accordance with this regulation the symbol referred to in paragraph 2 shall , without prejudice to paragraph 4 , appear on the labelling . ### in the case of the products originating in the union marketed under a traditional speciality guaranteed registered in accordance with this regulation the symbol referred to in paragraph 2 shall , without prejudice to paragraph 4 , appear on the labelling . in addition , ‘ traditional speciality guaranteed’ , or the corresponding abbreviation ‘ tsg’ , may also appear on the labelling .


### the costs of such verification of compliance with the specifications may be borne by the operators subject to those controls . ### the costs of such verification of compliance with the specifications shall be borne by the operators subject to those controls . the member states may also contribute to the costs .


### without prejudice to article 13 , this regulation shall not affect the use of terms that are generic in the union , even if the generic term is part of a name that is protected under a quality scheme . ### without prejudice to article 13 , this regulation shall not affect the use of terms that are generic in one or more member states , even if the generic term is part of a name that is protected under a quality scheme .


### the existing situation in the member states and in areas of consumption ; ### the existing situation in areas of consumption ;


### indications , abbreviations and symbols referring to the quality schemes may only be used in the labelling of product produced in conformity with the rules of the quality scheme to which they apply . this applies in particular to the following indications , abbreviations and symbols : ### indications , abbreviations and symbols referring to the quality schemes may only be used to identify products produced in conformity with the rules of the quality scheme to which they apply . this applies in particular to the following indications , abbreviations and symbols :


### the commission shall adopt , by means of implementing acts , rules for the uniform protection of the indications , abbreviations and symbols referred to in paragraph 1 . ### the commission shall adopt , by means of delegated acts , rules for the uniform protection of the indications , abbreviations and symbols referred to in paragraph 1 .


### without prejudice to regulation no 882 / 2004 and in particular the provisions of chapter vi of title ii thereof , member states may charge a fee to cover their costs of managing the quality schemes , including those incurred in processing applications , statements of opposition , applications for amendments and requests for cancellations provided for in this regulation . ### without prejudice to regulation no 882 / 2004 and in particular the provisions of chapter vi of title ii thereof , member states may charge a reasonable fee to cover their costs of managing the quality schemes , including those incurred in processing applications , statements of opposition , applications for amendments and requests for cancellations provided for in this regulation .


### the commission shall scrutinise by appropriate means an application received pursuant to article 46 , to check that it is justified and meets the conditions of the respective scheme . this scrutiny should not exceed a period of six months . ### the commission shall scrutinise by appropriate means an application received pursuant to article 46 , to check that it is justified and meets the conditions of the respective scheme . this scrutiny must not exceed a period of six months . this period shall be suspended , generally not more than once , should the commission request any further information . the period shall resume once the commission has received the information .


### within two months from the date of publication in the official journal of the european union , a statement of opposition may be lodged to the commission by the authorities of a member state or of a third country , or a natural or legal person having a legitimate interest and established in a third country . ### within four months from the date of publication in the official journal of the european union , a notice of opposition may be lodged to the commission by the authorities of a member state or of a third country , or a natural or legal person having a legitimate interest and established in a third country . if a notice of opposition has been submitted to the commission , it must be followed within two months by a reasoned statement of opposition .


### where statement of opposition is admissible , the commission shall invite the authority or person that lodged the opposition and the authority or body that lodged the application to engage in appropriate consultations for a reasonable period that shall not exceed three months . ### where a reasoned statement of opposition is admissible , the commission shall , within two months after the time period mentioned in paragraph 1 , subparagraph 2 , invite the authority or person that lodged the opposition and the authority or body that lodged the application to engage in appropriate consultations for a reasonable period that shall not exceed three months .


### where the amendment involves one or more amendments to the specification that are not minor , the amendment application shall follow the procedure laid down in articles 46 , 47 , 48 and 49 . ### where the amendment involves one or more amendments to the specification that are not minor , the amendment application shall follow the procedure laid down in articles 46 , 47 , 48 and 49 . the scrutiny of the application shall focus exclusively on the proposed amendment .


### the powers to adopt the delegated acts referred to in this regulation shall be conferred on the commission for an indeterminate period of time . ### the powers to adopt the delegated acts referred to in this regulation shall be conferred on the commission for an indeterminate period of time . before initiating any procedure for adoption of a delegated act pursuant to this regulation , the commission shall first inform the representatives of the sectors concerned .


### as soon as it adopts a delegated act , the commission shall notify it simultaneously to the european parliament and to the council . ### as soon as it adopts a delegated act , the commission shall notify it simultaneously to the european parliament , to the council and to the representatives of the sectors concerned .


### where a medicinal product is authorized subject to the requirement to conduct a post - authorisation safety study or where there are conditions or restrictions with regard to the safe and effective use of the medicinal product , the medicinal product should be intensively monitored on the market . patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products , and a publicly available list of such medicinal products should be maintained up to date by the european medicines agency established by regulation no 726 / 2004 of the european parliament and of the council of 31 march 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency . ### where a medicinal product is authorized subject to the requirement to conduct a post - authorisation safety study or where there are conditions or restrictions with regard to the safe and effective use of the medicinal product , the medicinal product should be continuously monitored on the market . as with all medicines , patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products , and a publicly available list of such medicinal products should be maintained up to date by the european medicines agency established by regulation no 726 / 2004 of the european parliament and of the council of 31 march 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency .


### with a view to ensuring that the same level of scientific expertise in the area of pharmacovigilance decision - making at both community and national level , when fulfilling pharmacovigilance tasks the coordination group should be able to rely on the advice of the pharmacovigilance risk assessment advisory committee of the agency . ### with a view to ensuring the same level of scientific expertise in the area of pharmacovigilance decision - making at both community and national level , when fulfilling pharmacovigilance tasks the coordination group should be able to rely on the advice of the agency’s pharmacovigilance risk - benefit balance assessment advisory committee .


### requirements for periodic safety update reports should be proportional to the risks posed by medicinal products . periodic safety update reporting should therefore be linked to the risk management system for newly authorised medicinal products and routine reporting should not be necessary for generic , well - established use , informed consent , homeopathic , or traditional use registered herbal medicinal products . however , in the interest of public health the authorities should require periodic safety update reports for such products when there is a need to assess their risk or review the adequacy of product information . ### requirements for periodic safety update reports should be proportional to the risks posed by medicinal products . periodic safety update reporting should therefore be linked to the risk management system for newly authorised medicinal products and the intervals between reports should be extended for generic , well - established use , informed consent , homeopathic , or traditional use registered herbal medicinal products . however , in the interest of public health the authorities should require safety update reports for such products at specific intervals when there is a need to assess their risk or review the adequacy of product information .


### “for the purpose of point of the first subparagraph , for medicinal products included on the list referred to in article 23 of regulation no . 726 / 2004 , the summary shall include the statement : “this medicinal product is under intensive monitoring . all suspected adverse reactions should be reported to &#8220 ; ### “for the purpose of point of the first subparagraph , for medicinal products included on the list referred to in article 23 of regulation no . 726 / 2004 , the summary shall include the statement : “this medicinal product has been proven to be of benefit for patients with your condition . as with all medicines it is subject to safety monitoring . all suspected adverse reactions should be reported to &#8220 ;


### a marketing authorisation may be granted subject to one or more of the following conditions : ### in addition to the provisions of article 19 , marketing authorisation may be granted subject to one or more of the following conditions :


### for the fulfilment of its pharmacovigilance tasks , the coordination group shall be assisted by the pharmacovigilance risk assessment advisory committee referred to in article 56 of regulation no 726 / 2004 . ” ### for the fulfilment of its pharmacovigilance tasks , the coordination group shall be assisted by the agency’s advisory committee to assess the risk - benefit balance as regards pharmacovigilance referred to in article 56 of regulation no 726 / 2004 . ”


### for medicinal products included on the list referred to in article 23 of regulation no . 726 / 2004 , the following additional statement shall be included “this medicinal product is under intensive monitoring . all suspected adverse reactions should be reported to &#8220 ; . ### for medicinal products included on the list referred to in article 23 of regulation no . 726 / 2004 , the following additional statement shall be included “this medicinal product has been proven to be of benefit for patients with your condition . as with all medicines , it is subject to safety monitoring . . all suspected adverse reactions should be reported to your healthcare professional or to &#8220 ; .


### take all appropriate measures to encourage doctors , pharmacists and other health - care professionals to report suspected adverse reactions to the national competent authority or the marketing authorisation holder ; ### take all appropriate measures to encourage doctors , pharmacists , other health - care professionals and patients to report suspected adverse reactions to the national competent authority ;


### marketing authorisation holders shall be required to record all suspected adverse reactions in the community or in third countries which are brought to their attention , whether reported spontaneously by patients or healthcare professionals or occurring in the context of a post - authorisation safety study . ### marketing authorisation holders shall be required to record all suspected adverse reactions in the community or in third countries which are brought to their attention , stating that they have occurred at doses normally used in humans for prophylaxis , diagnosis or treatment of a disease or for restoring , correcting or modifying a physiological function ; following a medication error ; or following use not consistent with the authorised summary of product characteristics , &#160 ; whether reported spontaneously by patients or healthcare professionals or occurring in the context of a post - authorisation safety study .


### the marketing authorisation holder may not refuse reports of suspected adverse reactions received electronically from patients and health - care professionals . ### the marketing authorisation holder may not refuse reports of suspected adverse reactions received electronically or by any other suitable means from patients and health - care professionals .


### marketing authorisation holders shall be required to submit electronically to the database and data - processing network referred to in article 24 of regulation no 726 / 2004 information on all serious suspected adverse reactions that occur in the community and in third countries within 15 days following the receipt of the report or , in the absence of a report , following the day on which the holder concerned gained knowledge of the event . marketing authorisation holders shall be required to submit electronically to the eudravigilance database information on all non - serious suspected adverse reactions that occur in the community , within 90 days following the receipt of the report or , in the absence of a report , following the day on which the holder concerned gained knowledge of the event . ### marketing authorisation holders shall be required to submit electronically to the database and data - processing network referred to in article 24 of regulation no 726 / 2004 information on all serious suspected adverse reactions that occur in the community and in third countries , stating whether they have occurred at doses normally used in humans for prophylaxis , diagnosis or treatment of a disease or for restoring , correcting or modifying a physiological function ; following a medication error ; or following use not consistent with the authorised summary of product characteristics , within 15 days following the receipt of the report or , in the absence of a report , within 15 days of the date on which the holder concerned gained knowledge of the event . marketing authorisation holders shall be required to submit electronically to the eudravigilance database information on all non - serious suspected adverse reactions that occur in the community , stating whether they have occurred at doses normally used in humans for prophylaxis , diagnosis or treatment of a disease or for restoring , correcting or modifying a physiological function ; following a medication error ; or following use not consistent with the authorised summary of product characteristics , within 90 days following the receipt of the report or , in the absence of a report , following the day on which the holder concerned gained knowledge of the event .


### member states shall , within 15 days following the receipt of the reports referred to in paragraph 1 , submit the reports electronically to the eudravigilance database . ### member states shall , within 15 days following the receipt of the reports referred to in paragraph 1 , submit the reports electronically to the eudravigilance database , stating whether they have occurred at doses normally used in humans for prophylaxis , diagnosis or treatment of a disease or for restoring , correcting or modifying a physiological function ; following a medication error ; or following use not consistent with the authorised summary of product characteristics .


### by way of derogation from paragraph 1 of this article , holders of marketing authorisations for medicinal products referred to in articles 10 , 10a or 10c , and holders of registrations for medicinal products referred to in articles 14 or 16a , shall be required to submit periodic safety update reports for such products only in the following cases : ### by way of derogation from paragraph 1 of this article , holders of marketing authorisations for medicinal products referred to in articles 10 , 10a or 10c , and holders of registrations for medicinal products referred to in articles 14 or 16a , shall be required to submit periodic safety update reports for such products only every three years , save in the following cases :


### the pharmacovigilance risk assessment advisory committee shall assess the matter which has been submitted . for the purposes of that assessment , it may hold a public hearing . ### the pharmacovigilance risk - benefit balance assessment advisory committee shall consider the situation concerned . it may hold a public hearing for that purpose in connection with a risk - benefit analysis .


### the indication of the country of origin or of the place of provenance of a food should be provided whenever its absence is likely to mislead consumers as to the true country of origin or place of provenance of that product . in other cases , the provision of the indication of country of origin or place of provenance is left to the appreciation of food business operators . in all cases , the indication of country of origin or place of provenance should be provided in a manner which does not deceive the consumer and on the basis of clearly defined criteria which ensure a level playing field for the industry and improve consumers ' understanding of the information related to the country of origin or place of provenance of a food . such criteria should not apply to indications related to the name or address of the food business operator . ### with a view to guaranteeing complete transparency and traceability , the indication of the country of origin or of the place of provenance of all meat should be mandatory . in all cases , the indication of country of origin or place of provenance should be provided in a manner which does not deceive the consumer and on the basis of clearly defined criteria which improve consumers’ understanding of the information related to the country of origin or place of provenance of a food . such criteria should not apply to indications related to the name or address of the food business operator .


### recent developments in the expression of the nutrition declaration , other than per 100g / 100ml / portion , by some member states and organisations in the food sector suggest that consumers like such schemes as they can help them make informed choices quickly . however , there is not evidence across all the community on how the average consumer understands and uses the alternative expression of the information . therefore , it is appropriate to allow for different schemes to be developed and to allow research on consumer understanding in different member states to continue so that , if appropriate , harmonised schemes may be introduced . ### recent developments in the expression of the nutrition declaration , other than per 100g / 100ml / portion , by some member states and organisations in the food sector suggest that consumers like such schemes as they can help them make speedy choices quickly . however , there is no scientific evidence across all the community on how the average consumer understands and uses the alternative expression of the information . to facilitate comparisons of products in differing package sizes , it is therefore appropriate to retain the mandatory stipulation that the nutrition declaration should refer to 100 g / 100 ml amounts . it is also appropriate to allow research on consumer understanding so that , if appropriate , harmonised schemes may be introduced .


### member states should retain the right , depending on local practical conditions and circumstances , to lay down rules in respect of the provision of information concerning non - prepacked foods . although in such cases the consumer demand for other information is limited , information on potential allergens is considered very important . evidence suggests that most food allergy incidents can be traced back to non - prepacked food . therefore such information should always be provided to the consumer . ### information concerning potential allergens is also very important for allergic persons in connection with food which is not pre - packed and for mass catering services . therefore such information should always be available to the consumer in the place where the food is bought or consumed .


### this regulation applies to all stages of the food chain , where the activities of food businesses concern the provision of food information to consumers . it shall apply to all foods intended for the final consumer , including foods delivered by mass caterers and foods intended for supply to mass caterers . ### this regulation applies to all stages of the food chain , where the provision of food information to the final consumer is concerned . it shall apply to all prepacked foods intended for delivery to the final consumer and foods intended for supply to mass caterers . it shall not apply to foods which are packaged directly at the place of sale before delivery to the final consumer .


### when food information law establishes new requirements , consideration shall be given to the need for a transitory period after the entry into force of the new requirements , during which foods bearing labels not complying with the new requirements can be placed on the market and for stocks of such foods that have been placed on the market before the end of the transitory period to continue to be sold until exhausted . ### when food information law establishes new requirements , appropriate transitional periods of at least three years shall be established after the entry into force of the new requirements , during which foods bearing labels not complying with the new requirements can be placed on the market . provision shall be made for stocks of such foods that have been placed on the market before the end of the transitional period to continue to be sold until exhausted , but not longer than three years after the entry into force of the new provisions . the same shall apply to stocks of labels which food business operators have in their possession before the entry into force of the new provisions .


### the name of the food ; ### the name under which the product is sold ;


### in the case of packaging or containers the largest surface of which has an area of less than 10 cm2 only the particulars listed in article 9 , , and shall be mandatory on the package or on the label . the particulars referred to in article 9 shall be provided through other means or shall be available at the request of the consumer . ### in the case of packaging or containers the largest printable surface of which has an area of less than 100 cm2 only the particulars listed in article 9 , , and and article 29 shall be mandatory on the package or on the label . the particulars referred to in article 9 shall be provided through other means or shall be available at the request of the consumer .


### the declared values shall , according to the individual case , be average values based on : the manufacturer ' s analysis of the food ; or a calculation from the known or actual average values of the ingredients used ; or a calculation from generally established and accepted data . the rules for implementing the declaration of energy and nutrients with regard to the precision of the declared values such as the differences between the declared values and those established in the course of official checks may be decided upon in accordance with the procedure laid down in article 49 . ### the declared values shall be average values at the end of the minimum durability period and shall , as appropriate , be based on : the manufacturer ' s analysis of the food ; or a calculation from the known or actual average values of the ingredients used ; or a calculation from generally established and accepted data . the rules for implementing the declaration of energy and nutrients with regard to the precision of the declared values such as the differences between the declared values and those established in the course of official checks shall be adopted , after the european food safety authority has given its opinion , in accordance with the procedure laid down in article 49 .


### in addition to the nutrition declaration per 100g or per 100ml referred to in article 31 , the information may be expressed per portion as quantified on the label , provided that the number of portions contained in the package is stated . ### in addition to the nutrition labelling per 100g or per 100ml , it may be expressed per portion , provided that the quantity contained in the portion is stated .


### the particulars referred to article&#160 ; 31 related to the mandatory nutrition declaration shall be included in the principal field of vision . they shall be presented , where appropriate , together in a clear format in the following order : energy , fat , saturates , carbohydrates with specific reference to sugars , and salt . ### the particulars referred to in article 29 shall be presented in a clear format in the following order : energy , protein , carbohydrates and fat .


### 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 voluntarily indicated to inform consumers that a food originates or comes from the european community or a given country or place . ### without prejudice to labelling in accordance with specific community legislation , and more specifically with council regulation no 509 / 2006 of 20 march 2006 on agricultural products and foodstuffs as traditional specialities guaranteed1 , council regulation no 510 / 2006 of 20 march 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs2 , council regulation no 479 / 2008 of 29 april 2008 on the common organisation of the market in wine , amending regulations no 1493 / 1999 , no 1782 / 2003 , no 1290 / 2005 , no 3 / 2008 and repealing regulations no 2392 / 86 and no 1493 / 19993 , regulation no 110 / 2008 of the european parliament and of the council of 15 january 2008 on the definition , description , presentation , labelling and the protection of geographical indications of spirit drinks and repealing council regulation no 1576 / 894 and council regulation no 1601 / 91 of 10 june 1991 laying down general rules on the definition , description and presentation of aromatized wines , aromatized wine - based drinks and aromatized wine - product cocktails5 , paragraphs 3 and 4 shall apply where the country of origin or the place of provenance of a food is voluntarily indicated to inform consumers that a food originates or comes from the european community or a given country or place . 1 oj l 93 , 31 . 3 . 2006 , p . 1 . 2 oj l 93 , 31 . 3 . 2006 , p . 12 . 3 oj l 148 , 6 . 6 . 2008 , p . 1 . 4 oj l 39 , 13 . 2 . 2008 , p . 16 . 5 oj l 149 , 14 . 6 . 1991 , p . 1 .


### where the country of origin or the place of provenance of the food is not the same as the one of its primary ingredient , the country of origin or place of provenance of those ingredient shall also be given . ### where the country of origin or the place of provenance of the food is not the same as the one of its primary ingredient , the country of origin or place of provenance of those ingredient shall also be given , except for products whose ingredients do not need to be listed , in accordance with article 20 of this regulation .


### article 14 shall apply from [ the first day of the month 3 years after the entry into force ] . articles 29 to 34 shall apply from [ the first day of the month 3 years after the entry into force ] except in the case of foods labelled by food business operators with , on the date of entry into force , less than 10 employees and whose annual turnover and / or annual balance sheet total does not exceed eur 2 million where they shall apply [ the first day of the month 5 years after the entry into force ] . article 14 shall apply from [ the first day of the month 5 years after the entry into force ] . ### articles 29 to 34 shall apply from [ the first day of the month 5 years after the entry into force ] . food labelled before the entry into force may be placed in circulation until stocks are completely exhausted . the requirements pursuant to article 17 shall apply from [ the first day of the month 15 years after the entry into force ] .


### - waters intended for human consumption , including those where the only added ingredients are carbon dioxide and / or flavourings ; - a herb , a spice or mixtures thereof ; - salt and salt substitutes ; ### - natural mineral waters or other waters intended for human consumption , including those where the only added ingredients are carbon dioxide and / or flavourings ; - herbs , spices , seasonings and mixtures thereof ; - salt and salt substitutes ; - sugar ;


### as the methods for establishing and levying the amounts due for the coverage of security costs differ across the community , the harmonisation of the basis for charging security costs at community airports where the costs of security are reflected in the security charges is necessary . at these airports the charge should be related to the cost for providing security , taking into account any public financing of security costs . ### as the methods for establishing and levying the amounts due for the coverage of security costs differ across the community , the harmonisation of the basis for charging security costs at community airports and airport networks where the costs of security are reflected in the security charges is necessary . at these airports and airport networks the charge should be related to the cost for providing security , taking into account any public financing of security costs .


### this directive applies to any airport located in a territory subject to the provisions of the treaty . ### this directive applies to any airport located in a territory subject to the provisions of the treaty in the case of passengers on commercial flights .


### this directive applies to any airport located in a territory subject to the provisions of the treaty . ### this directive applies to any airport located in a territory subject to the provisions of the treaty and open to commercial traffic whose annual traffic is over one million passenger movements .


### this directive applies to any airport located in a territory subject to the provisions of the treaty . ### this directive applies to any airport open to commercial traffic and located in a territory subject to the provisions of the treaty whose annual traffic is over five million passenger movements , and to the airport with the most passenger movements in each member state .


### this directive applies to any airport located in a territory subject to the provisions of the treaty . ### this directive shall apply to any airport located in a territory subject to the treaty and open to commercial traffic whose annual traffic is over five million passenger movements and to the airport with the highest passenger movement in each member state .


### this directive applies to any airport located in a territory subject to the provisions of the treaty . ### this directive applies to any airport , airport network and airports organised into networks located in a territory subject to the provisions of the treaty , and open to commercial traffic .


### member states shall ensure that at each airport a compulsory and regular procedure for consultation between the airport managing body and airport users is established with respect to the operation of the system of security charges and the level of such charges . that consultation shall take place at least once a year . ### member states shall ensure that a compulsory procedure for regular consultation between the competent body and airport users or the representatives or associations of airport users is established with respect to the operation of the system of security charges and the level of such charges . such consultation shall take place at least once a year , unless agreed otherwise in the last consultation round . if there is a multiannual agreement between the competent body and the airport users , the consultation shall take place as laid down in that agreement . member states shall , however , retain the right to require more frequent consultation .


### member states shall ensure that at each airport a compulsory and regular procedure for consultation between the airport managing body and airport users is established with respect to the operation of the system of security charges and the level of such charges . that consultation shall take place at least once a year . ### member states shall ensure that a compulsory procedure for regular consultation between the competent body and airport users or the representatives or associations of airport users is established with respect to the operation of the system of security charges and the level of such charges . such consultation shall take place at least once a year , unless agreed otherwise in the latest consultation . where a multi - annual agreement between the competent body and the airport users exists , the consultations shall take place as provided for in such an agreement . member states shall retain the right to request more frequent consultations .


### the programme should therefore address market failures affecting the competitiveness of the union economy on a global scale due principally to issues which undermine the capacity of enterprises to compete with their counterparts in other parts of the world . ### the programme should therefore address market failures affecting the competitiveness of the union economy on a global scale due principally to issues which undermine the capacity of enterprises to compete with their counterparts in other parts of the world . these include failures connected with the absence of reciprocity between the eu and its competitors in conditions for access to their markets .


### the programme should particularly address smes , as defined in commission recommendation 2003 / 361 / ec of 6 may 2003 concerning the definition of micro , small and medium - sized enterprises . particular attention should be paid to micro enterprises , enterprises engaged in craft activities and social enterprises . attention should also be paid to the specific characteristics and requirements of young entrepreneurs , new and potential entrepreneurs and female entrepreneurs , as well as specific target groups , such as migrants and entrepreneurs belonging to socially disadvantaged or vulnerable groups such as persons with disabilities . the programme should also encourage senior citizens to become and remain entrepreneurs and promote second chances for entrepreneurs . ### the programme should particularly address smes , as defined in commission recommendation 2003 / 361 / ec of 6 may 2003 concerning the definition of micro , small and medium - sized enterprises . particular attention should be paid to micro enterprises , enterprises engaged in craft activities and social enterprises . attention should also be paid to the specific characteristics and requirements of young entrepreneurs , self employed workers , new and potential entrepreneurs and female entrepreneurs , as well as specific target groups , such as migrants and entrepreneurs belonging to socially disadvantaged or vulnerable groups such as persons with disabilities . the programme should also encourage senior citizens to become and remain entrepreneurs and promote second chances for entrepreneurs . special attention should be paid to young entrepreneurs in particular through the establishment of the programme “erasmus for young entrepreneurs” .


### many of the union ' s competitiveness problems involve smes ' difficulties in getting access to finance because they struggle to demonstrate their credit - worthiness and have difficulties in gaining access to risk capital . this has a negative effect on the level and quality of the new enterprises created and on the growth of enterprises . the added value for the union of the proposed financial instruments lies inter alia in strengthening the single market for venture capital and in developing a pan - european sme finance market . the union’s actions should be complementary to the member states’ use of financial instruments for smes . the entities entrusted with the implementation of the actions should ensure additionality and avoid double financing through eu resources . ### many of the union ' s competitiveness problems involve smes ' difficulties in getting access to finance because they struggle to demonstrate their credit - worthiness and have difficulties in gaining access to risk capital . this has a negative effect on the level and quality of the new enterprises created and on the growth of enterprises , as well as the readiness of new entrepreneurs to take over viable companies in the context of a transfer of business / succession . eu financial instruments put in place in 2007 - 2013 , in particular smeg , have a proven added value and have brought a positive contribution to at least 120 000 smes , contributing to maintaining 851 000 jobs since the eruption of the financial crisis in 2008 . the enhanced added value for the union of the proposed financial instruments lies inter alia in strengthening the single market for venture capital and in developing a pan - european sme finance market . the union’s actions should be complementary to the member states’ use of financial instruments for smes and member states should do their utmost to increase the visibility and accessibility of such instruments on their territory . the entities entrusted with the implementation of the actions should ensure additionality and avoid double financing through eu resources .


### the enterprise europe network has proven its added value for european smes as a one - stop - shop for business support by helping enterprises to improve their competitiveness and explore business opportunities in the single market and beyond . the streamlining of methodologies and working methods and provisions of a european dimension to business support services can only be achieved at union level . in particular , the network has helped smes to find cooperation or technology transfer partners , get advice on sources of financing , and on intellectual property and on eco - innovation and sustainable production . it has also obtained feedback on union legislation and standards . its unique expertise is particularly important in overcoming information asymmetries and alleviating transaction costs associated with cross - border transactions . ### the enterprise europe network has proven its added value for european smes as a one - stop - shop for business support services by helping enterprises to improve their competitiveness and explore business opportunities in the single market and in third countries . the streamlining of methodologies and working methods and provisions of a european dimension to business support services can only be achieved at union level . in particular , the network has helped smes to find cooperation or technology transfer partners in foreign countries , get advice on sources of financing , and on intellectual property and on eco - innovation and sustainable production . it has also obtained feedback on union legislation and standards . its unique expertise is particularly important in overcoming information asymmetries and alleviating transaction costs associated with cross - border transactions . the network has also successfully encouraged the participation of smes in eu funding programmes such as seventh framework programme .


### the limited internationalisation of smes both within and outside europe affects competitiveness . according to some estimates currently 25% of the smes in the union export or have exported at some point over the last three years , of which only 13% export outside the union on a regular basis and only 2 % have invested beyond their home country . in line with the small business act , which called on the union and the member states to support and encourage smes to benefit from the growth of markets outside the union , the eu supports a network of european business organisations in more than 20 markets abroad . it provides financial assistance to the eu - japan centre for industrial cooperation , business bodies in hong kong , malaysia and singapore as well as the european business and technology centre in india , eu sme centres in china and in thailand and the china intellectual property rights sme helpdesk . european added value is created by bundling national efforts in this domain , avoiding duplication , promoting cooperation and by offering services that would lack critical mass if provided at national level . ### the limited internationalisation of smes both within and outside europe affects competitiveness . according to some estimates currently 25% of the smes in the union export or have exported at some point over the last three years , of which only 13% export outside the union on a regular basis and only 2% have invested beyond their home country . in line with the small business act , which called on the union and the member states to support and encourage smes to benefit from the growth of markets outside the union , the eu supports a network of european business organisations in more than 20 markets abroad . it provides financial assistance to the eu - japan centre for industrial cooperation , business bodies in hong kong , malaysia and singapore as well as the european business and technology centre in india , eu sme centres in china and in thailand and the china intellectual property rights sme helpdesk . european added value is created by bundling national efforts in this domain , avoiding duplication , promoting cooperation and by offering services that would lack critical mass if provided at national level . where these support and assistance measures fall down , especially as a result of excessive barriers indiscriminately put in the way of foreign businesses , this network will inform the national and european authorities of the relevant problems so that appropriate measures can be considered .


### the financial envelope for implementing the programme shall be eur 2 . 522 billion , of which approximately eur 1 . 4 billion shall be allocated to financial instruments . ### within the meaning of point [ 17 ] of the interinstitutional agreement of xxx / 201z . between the european parliament , the council and the commission on cooperation in budgetary matters and sound financial management , the financial envelope for implementing the programme for its entire duration shall be [ . . . ] of the total 2014 - 2020 mff ceilings , of which approximately 60 % shall be allocated to financial instruments . that amount shall constitute the prime reference for the budgetary authority during the annual budgetary procedure .


### the commission shall support actions to improve and strengthen the competitiveness and sustainability of union enterprises , particularly smes , so as to enhance the effectiveness , coherence and consistency of national policies promoting competitiveness , sustainability and the growth of enterprises in europe . ### the commission shall support actions to improve and strengthen the competitiveness and sustainability of union enterprises , particularly smes , so as to enhance the effectiveness , coherence and consistency of local , regional and national policies promoting competitiveness , sustainability and the growth of enterprises in europe , including in the tourism sector .


### 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 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 , to ensure cooperation between european competitiveness clusters and to improve their attractiveness , and to lay down framework conditions and development of sustainable products , services and processes , as well as support for corporate social responsibility ;


### support for sme policy development and cooperation between policy makers , particularly with a view to improving the ease - of - access to programmes and measures for smes . ### support for sme policy development in close cooperation with sme associations as the voice of smes and cooperation between policy makers , particularly with a view to improving the ease - of - access to programmes and measures for smes .


### the commission may support member states ' measures to build - up entrepreneurial education , skills and attitudes , in particular among potential and new entrepreneurs . ### the commission may support member states ' measures to build - up entrepreneurial education , skills , mindsets and attitudes , in particular in education and training as well as among potential and new entrepreneurs .


### the commission shall support actions which aim to improve access to finance for smes in their start - up and growth phases , being complementary to the member states ' use of financial instruments for smes at national and regional level . in order to ensure complementarity , these actions will be closely coordinated with those undertaken in the framework of cohesion policy and at national level . such actions shall aim to stimulate the supply of both equity and debt finance . ### the commission shall support actions which aim to improve access to finance for smes in their start - up and growth phases , being complementary to the member states ' use of financial instruments for smes at national and regional level . in order to ensure complementarity , these actions will be closely coordinated with those undertaken in the framework of cohesion policy and at national level . such actions shall aim to stimulate the supply of both equity and debt finance . the commission shall pay particular attention to the visibility of eu funding to smes so as to ensure that eu support is known and recognised .


### actions under the programme may aim to foster international industrial cooperation , including industrial and regulatory dialogues with third countries . specific measures may aim to reduce differences between the union and other countries in regulatory frameworks for industrial products , on industrial policy and the improvement of the business environment . ### actions under the programme may aim to foster international industrial cooperation , including industrial and regulatory dialogues and reciprocal actions with third countries . specific measures may aim to reduce differences between the union and other countries in regulatory frameworks for industrial products , on industrial policy and the improvement of the business environment .


### impact assessments of union measures of particular relevance for the competitiveness of enterprises , with a view to identifying areas of existing legislation that need to be simplified , or areas in which new legislative measures need to be proposed ; ### impact assessments of union measures of particular relevance for the competitiveness of enterprises with a view to identifying areas of existing legislation that need to be simplified , or areas in which new legislative measures need to be proposed , to be achieved with an sme test following the ‘ small comes first’ principle and which contains a thorough analysis of all facilitation possibilities for microenterprises ;


### the commission shall be empowered to adopt delegated acts in accordance with article 18 concerning changes to the details of the specific actions set out in annex ii to this regulation if economic market developments so require or according to the results achieved by the competitiveness and innovation framework programme loan guarantee facility and the risk sharing instrument of the 7th framework programme for risk sharing financial facility . ### with regard to financial instruments , the commission shall be empowered to adopt delegated acts in accordance with article 18 concerning changes in the share of investment from efg of the total eu investment in early stage venture capital funds and the composition of the securitised loan portfolios .


### furthermore , it is important to foster and facilitate cooperation for the common benefit of union and its partners , notably through pooling of contributions from internal and external instruments of the union budget , in particular for cross - border cooperation , infrastructure projects of union interest that will pass through neighbourhood countries and other areas of cooperation . ### furthermore , it is important to foster and facilitate cooperation for the common benefit of union and its partners , notably through the best and most effective coordination of resources provided and the pooling of contributions from internal and external instruments of the union budget , in particular for cross - border cooperation , infrastructure projects of union interest that will pass through neighbourhood countries and other areas of cooperation .


### european union external support has increasing financing needs but the economic and budgetary situation of the union limits the resources available for such support . the commission must therefore seek the most efficient use of available resources by using financial instruments with leverage effect . such effect could be increased by enabling the use and re - use of funds invested and generated by financial instruments . ### european union external support has increasing financing needs but the economic and budgetary situation of the union limits the resources available for such support . the commission must therefore seek the most efficient and transparent use of available resources by using financial instruments with leverage effect . such effect could be increased by enabling the use and re - use of funds invested and generated by financial instruments .


### the union is committed to promote in relations with its partners worldwide decent work as well as ratification and effective implementation of the internationally recognised labour standards and multilateral environment agreements , in relations with its partners worldwide . ### the union is committed to promote in relations with its partners worldwide decent work and social dialogue , as well as ratification and effective implementation of the internationally recognised labour standards and multilateral environment agreements , in relations with its partners worldwide .


### sustainable and inclusive development in all aspects , poverty reduction , including through private - sector development ; promotion of internal economic , social and territorial cohesion , rural development , climate action and disaster resilience ; ### sustainable and inclusive development in all aspects , reduction and prevention of poverty and unemployment , including through private - sector development for the creation of decent and sustainable employment ; promotion of internal economic , social and territorial cohesion , rural development , climate action and disaster resilience ;


### this regulation shall not apply to interchangeable machinery that is fully raised from the ground when the vehicle to which it is attached is in use on a road . ### this regulation shall not apply to interchangeable machinery that is fully raised from the ground or that cannot articulate around a vertical axis when the vehicle to which it is attached is in use on a road .


### this regulation shall not apply to interchangeable machinery that is fully raised from the ground when the vehicle to which it is attached is in use on a road . ### this regulation shall not apply to interchangeable machinery that is fully raised from the ground or cannot articulate around a vertical axis when the vehicle to which it is attached is in use on a road .


### ' category t ' comprises all wheeled tractors ; ### ' category t ' comprises all wheeled tractors ; each wheeled tractor category described in points 2 to 8 also includes an ' a ' or ' b ' index , according to its design speed : – ‘ a’ for wheeled tractors with a maximum design speed below or equal to 40 km / h , – ‘ b’ for wheeled tractors with a maximum design speed above 40 km / h ;