### the following paragraph 3 is added ### the following paragraphs 3 and 4 are added : ' 4 . the public may institute a legal challenge , including make an application for injunctive relief , in respect of the development consent decision by initiating legal proceedings within three months of the issue of the formal decision by the competent authority . '


### if the competent authority decides to grant development consent , it shall ensure that the development consent includes measures to monitor the significant adverse environmental effects , in order to assess the implementation and the expected effectiveness of mitigation and compensation measures , and to identify any unforeseeable adverse effects . ### if the competent authority decides to grant development consent , it shall ensure that the development consent includes measures to monitor the significant adverse environmental effects of both construction and operational phases , in order to assess the implementation and the expected effectiveness of mitigation and compensation measures , to identify any unforeseeable adverse effects , and / or net biodiversity loss and to facilitate corrective action .


### the use of natural resources , in particular soil , land , water , and biodiversity , including hydromorphological changes . ### the use of natural resources , in particular soil , land , water , air and biodiversity , including hydromorphological changes .


### the use of natural resources , in particular land , soil , water , and biodiversity , including hydromorphological changes . ### the use of natural resources , in particular land , soil , water , air and biodiversity , including hydromorphological changes .


### coastal zones ; ### coastal zones and marine environment ;


### a description of the physical characteristics of the whole project , including , where relevant , its subsurface , and the water use and land - use requirements during the construction and operational phases ; ### a description of the physical characteristics of the whole project , including , where relevant , its subsurface , and the water use , energy and land - use requirements during the construction and operational phases ;


### the emission of pollutants , noise , vibration , light , heat and radiation , the creation of nuisances , and the elimination of waste ; ### the emission of pollutants , noise , vibration , light , heat and radiation , the creation of nuisances , and the elimination and recovery of waste ;


### the greenhouse gas emissions , including from land use , land use change and forestry ; ### the greenhouse gas emissions , including from land use , land use change , forestry and the energy demand of the project ;


### a description of the measures envisaged to prevent , reduce and , where possible , offset any significant adverse effects on the environment referred to in point 5 and , where appropriate , of any proposed monitoring arrangements , including the preparation of a post - project analysis of the adverse effects on the environment . this description should explain the extent to which significant adverse effects are reduced or offset and should cover both the construction and operational phases . ### a description of the measures envisaged firstly to prevent , then to reduce and , where possible and as a last resort , offset any significant adverse effects on the environment referred to in point 5 and , where appropriate , of any proposed monitoring arrangements , including the preparation of a post - project analysis of the adverse effects on the environment . this description should explain the extent to which significant adverse effects are reduced or offset and should cover both the construction and operational phases .


### the establishment of a european border surveillance system is necessary in order to strengthen the information exchange and operational cooperation between national authorities of member states as well as with the european agency for the management of operational cooperation at the external borders of the member states of the european union established by council regulation no 2007 / 2004 of 26 october 20046 , hereinafter referred to as ' the agency ' . eurosur should provide these authorities and the agency with the infrastructure and tools needed to improve their situational awareness and reaction capability when detecting and preventing irregular migration and cross - border crime as well as protecting and saving lives of migrants at the external borders of the member states of the union . ### the establishment of a european border surveillance system serves to strengthen the information exchange and operational cooperation between national authorities of member states as well as with the european agency for the management of operational cooperation at the external borders of the member states of the european union established by council regulation no 2007 / 2004 of 26 october 2004 , hereinafter referred to as ' the agency ' . eurosur should provide these authorities and the agency with the infrastructure and tools needed to improve their situational awareness and reaction capability when detecting and preventing cross - border crime as well as protecting and saving lives of migrants at the external borders of the member states of the union .


### in order to increase their weight and legitimacy , such warnings and recommendations should be transmitted through the council and , where appropriate , the european banking authority established by regulation no … / … the european parliament and of the council , the european securities and markets authority established by regulation no … / … of the european parliament and of the council , and the european insurance or the occupational pension authority established by regulation no … / …of the european parliament and of the council . ### in order to increase their weight and legitimacy , such warnings and legally binding recommendations should be transmitted through the council and , where appropriate , the european banking authority established by regulation no … / … the european parliament and of the council8 , the european securities and markets authority established by regulation no … / … of the european parliament and of the council9 , and the european insurance or the occupational pension authority established by regulation no … / …of the european parliament and of the council .


### in performing its tasks , the esrb shall seek , where appropriate , the advice of relevant private sector stakeholders . ### in performing its tasks , the esrb shall seek the advice of relevant private - sector stakeholders including trade unions , civil society organisations and consumer associations .


### increasingly , as investors also pursue social goals and are not only seeking financial returns , a social investment market has been emerging in the union , comprised in part by investment funds targeting social undertakings . such investment funds provide funding to social undertakings which are acting as drivers of social change by offering innovative solutions to social problems and making a valuable contribution to meeting the objectives of the europe 2020 strategy . ### increasingly , as investors also pursue social goals and are not only seeking financial returns , a social investment market has been emerging in the union , comprised in part by investment funds targeting social undertakings . such investment funds help fund social undertakings which are acting as drivers of social change by offering innovative solutions to social problems and making a valuable contribution to meeting the objectives of the europe 2020 strategy .


### ‘ rights revenue’ means income collected by a collecting society on behalf of rightholders , whether from an exclusive right , a right to remuneration or a right to compensation ; ### ‘ rights revenue’ means income collected by a collective management organisation on behalf of its members , whether from an exclusive right or a right to remuneration and including any income derived from the investments of rights revenue ;


### rightholders shall have the right to authorise a collecting society of their choice to manage the rights , categories of rights or types of works and other subject matter of their choice , for the member states of their choice , irrespective of the member state of residence or of establishment or the nationality of either the collecting society or the rightholder . ### rightholders shall have the right to authorise a collective management organisation of their choice established in the union to manage the rights , categories of rights , types of works and other subject matter of their choice , for the member states of their choice , irrespective of the rightholder’s residence , establishment or nationality .


### a collecting society which grants multi - territorial licences for online rights in musical works shall have procedures in place to enable rightholders and other collecting societies to object to the contents of the data referred to in article 22 or to information provided under article 23 , where such rightholders and collecting societies , on the basis of reasonable evidence , believe that the data or the information are inaccurate in respect of their online rights in musical works . where the claims are sufficiently substantiated , the collecting society shall ensure that the data or the information are corrected without undue delay . ### a collecting society which grants multi - territorial licences for online rights in musical works shall have procedures in place to enable rightholders and other collecting societies to object to the contents of the data referred to in article 22 and rightholders , other collecting societies and online music service providers to object to information provided under article 23 , where such rightholders , collecting societies and online music service providers on the basis of reasonable evidence , believe that the data or the information are inaccurate in respect of their online rights or licences in musical works . where the claims are sufficiently substantiated , the collecting society shall ensure that the data or the information are corrected without undue delay .


### – having regard to the treaty on the functioning of the european union , and in particular the first paragraph of article 42 and article 43 thereof , ### – having regard to the treaty on the functioning of the european union , and in particular article 349 , the first subparagraph of article 42 and article 43 thereof ,


### in order to achieve the objectives of the scheme promoting the union’s outermost regions more effectively , the posei programmes must include measures which ensure the supply of agricultural products and the preservation and development of local agricultural production . the level of programming for the regions concerned needs to be harmonised and the policy of partnership between the commission and the member states needs to become more systematic . ### in order to achieve the objectives of the scheme promoting the union’s outermost regions more effectively , the posei programmes must include measures which ensure the supply of agricultural products and the preservation and development of high - quality local agricultural production , taking imperatives linked to the fight against climate change into account . the level of programming for the regions concerned needs to be harmonised and the policy of partnership between the commission , the member states and the elected departmental or regional authorities in the outermost regions needs to become more systematic .


### in order to ensure the supply of essential agricultural products to the outermost regions and to compensate for the additional costs caused by their extreme remoteness , it is appropriate to introduce a specific supply arrangement . in fact , the exceptional geographical situation of the outermost regions imposes additional transport costs in supplying products which are essential for human consumption , for processing or as agricultural inputs . in addition , other objective factors linked to these regions’ extreme remoteness , namely their insularity and small surface areas , lead to further constraints on economic operators and producers in the outermost regions that severely handicap their activities . these handicaps can be alleviated by lowering the price of these essential products . ### without prejudicing local production and its development , it is appropriate to introduce a specific supply arrangement in order to ensure the supply of essential agricultural products to the outermost regions and to compensate for the additional costs caused by their extreme remoteness . in fact , the exceptional geographical situation of the outermost regions imposes additional transport costs in supplying products which are essential for human consumption , for processing or as agricultural inputs . in addition , other objective factors linked to these regions’ extreme remoteness , namely their insularity and small surface areas , lead to further constraints on economic operators and producers in the outermost regions that severely handicap their activities . these handicaps can be alleviated by lowering the price of these essential products .


### support for the production of cow’s milk in madeira and réunion has not been sufficient to maintain the balance between domestic and external supply , chiefly because of the serious structural difficulties affecting the sector and its poor capacity to adapt to new economic environments . consequently , authorisation to produce uht milk reconstituted from milk powder of eu origin should continue , in order to cover local consumption more fully . in order to inform the consumer correctly , it should be made compulsory to indicate the method by which uht milk is reconstituted using milk powder on the sales labelling . ### support for the production of cow’s milk in madeira and réunion has not been sufficient to maintain the balance between domestic and external supply , chiefly because of the serious structural difficulties affecting the sector and its problems in adapting to new economic environments . consequently , authorisation to produce uht milk reconstituted from milk powder of eu origin should continue , in order to cover local consumption more fully , provided that this does not pose an obstacle to the collection and marketing of all locally produced milk , or hamper efforts to promote the expansion of local production , the medium - term aim being to secure , for réunion , self - sufficiency in milk production . in order to inform the consumer correctly , it should be made compulsory to indicate the method by which uht milk is reconstituted using milk powder on the sales labelling . this provision should also be applicable in martinique , french guiana and guadeloupe , should france make such a request citing the wish of local stakeholders to be covered by it and their ability to develop the milk sector .


### support for the production of cow’s milk in madeira and réunion has not been sufficient to maintain the balance between domestic and external supply , chiefly because of the serious structural difficulties affecting the sector and its poor capacity to adapt to new economic environments . consequently , authorisation to produce uht milk reconstituted from milk powder of eu origin should continue , in order to cover local consumption more fully . in order to inform the consumer correctly , it should be made compulsory to indicate the method by which uht milk is reconstituted using milk powder on the sales labelling . ### support for the production of cow’s milk in madeira and réunion has not been sufficient to maintain the balance between domestic and external supply , chiefly because of the serious structural difficulties affecting the sector and its problems in adapting to new economic environments . consequently , authorisation to produce uht milk reconstituted from milk powder of eu origin should continue , in order to cover local consumption more fully , provided that this does not pose an obstacle to the collection and marketing of all locally produced milk , or hamper the efforts to promote the expansion of local production , the medium - term aim being to secure , for réunion , self - sufficiency in milk . in order to inform the consumer correctly , it should be made compulsory to indicate the method by which uht milk is reconstituted using milk powder on the sales labelling . this provision should also be applicable in martinique , french guiana and guadeloupe , should france make such a request citing the wish of local stakeholders to be covered by it and their ability to develop the milk sector .


### implementation of this regulation must not jeopardise the level of special support from which the outermost regions have benefited up to now . for that reason , so that they can implement the appropriate measures , the member states should have at their disposal sums equivalent to the support already granted by the community under regulation no 247 / 2006 . ### in order to ensure that the objectives of this regulation , in particular the safeguarding and development of agricultural activities in the outermost regions , are met , the sums equivalent to the support already granted by the union to the outermost regions under regulation no 247 / 2006 should be reviewed .


### specific measures to assist local agricultural production as provided for in chapter iv . ### specific measures to assist local agricultural production , as referred to in chapter iv and in accordance with the objectives set out in article 2 .


### measures taken under posei programmes must comply with european union law and be consistent with other eu policies and with the measures taken under such policies . ### measures taken under posei programmes must comply with european union law and be consistent with other eu policies and with the measures taken under such policies , without prejudice to article&#160 ; 349 of the treaty on the functioning of the european union , which grants the outermost regions special status with a view to fostering their development and their integration on a fair basis into the union through the implementation of specific programmes and instruments tailored to their situation .


### measures taken under posei programmes must comply with european union law and be consistent with other eu policies and with the measures taken under such policies . ### measures taken under posei programmes must comply with european union law and be consistent with other eu policies and with the measures taken under such policies , without prejudice to article 349 of the treaty on the functioning of the european union , which grants the outermost regions special status with a view to fostering their development and their integration on a fair basis into the union through the implementation of specific programmes and instruments tailored to their situation .


### the part of the programme which includes measures to assist local agricultural production shall comprise at least the following elements : ### the parts of the programme which include measures to assist local agricultural production and which correspond to the objectives set out in article 2 shall comprise at least the following elements :


### a description of the strategy proposed , the priorities selected , its quantified general and operational objectives , and an appraisal showing the expected economic , environmental and social impact , including employment effects ; ### a description of the strategy proposed , the priorities selected , its quantified general and operational objectives , and an appraisal showing the expected economic , environmental and social impact , including employment effects and the effects on the quality of local products ;


### notwithstanding article 114 of regulation no 1234 / 2007 , the production in madeira and in the french overseas department of réunion of uht milk reconstituted from milk powder originating in the union shall be authorised within the limits of local consumption requirements , in so far as this measure does not hinder that locally produced milk is collected and finds outlets . this product shall be used for local consumption only . ### notwithstanding article 114 of regulation no 1234 / 2007 , the production in madeira and in the french overseas department of réunion of uht milk reconstituted from milk powder originating in the union shall be authorised within the limits of local consumption requirements , in so far as this measure does not hinder that locally produced milk is collected and finds outlets . should the member state in question demonstrate the expediency of such a measure for the french overseas departments of martinique and guadeloupe , the commission shall be empowered , in accordance with article 33 , to adopt the necessary delegated acts in order to extend this measure to the aforementioned departments . this product shall be used for local consumption only .


### in order to ensure a reasonable and proportional allocation of the finance measures with regard to studies , demonstration projects , training and technical assistance measures , the commission shall establish by delegated act an annual maximum amount which may be allocated to these measures . ### in order to ensure a reasonable and proportional allocation of the finance measures with regard to studies , research and innovation programmes , demonstration projects , training and technical assistance measures , the commission shall establish by delegated act an annual maximum amount which may be allocated to these measures .


### not later than 30 june 2015 , and thereafter every five years , the commission shall submit a general report to the european parliament and the council showing the impact of the action taken under this regulation , including in the banana sector , accompanied if applicable by appropriate proposals . ### not later than 30 june 2015 , and thereafter every five years , the commission shall submit a general report to the european parliament and the council showing the impact of the action taken under this regulation , including in the banana and milk sectors , and the impact as regards the achievement of the objectives laid down in article 2 , accompanied if applicable by appropriate proposals . once they have been carried out , these assessments shall be translated without delay into spanish , french and portuguese and forwarded to the elected departmental or regional authorities of the outermost regions .


### where the payment service provider may impose charges for information in accordance with paragraph 2 , they shall be appropriate and in line with the payment service provider’s actual costs . ### where the payment service provider may impose charges for information in accordance with paragraph 2 , they shall be reasonable and in line with the payment service provider’s actual costs .


### a framework contract may include a condition that the information referred to in paragraph 1 is to be provided or made available periodically at least once a month and in an agreed manner which allows the payer to store and reproduce information unchanged . ### a framework contract shall include a condition that the information referred to in paragraph 1 is to be provided or made available periodically at least once a month , free of charge and in an agreed manner which allows the payer to store and reproduce information unchanged .


### the reference enabling the payee to identify the payment transaction and , where appropriate , the payer , and any information transferred with the payment transaction ; ### the reference enabling the payee to identify the payment transaction and the payer , and any information transferred with the payment transaction ;


### by way of derogation from article 65 the payer may be obliged to bear the losses relating to any unauthorised payment transactions , up to a maximum of eur 50 , resulting from the use of a lost or stolen payment instrument or from the misappropriation of a payment instrument . ### by way of derogation from article 65 the payer may be obliged to bear the losses relating to any unauthorised payment transactions , up to a maximum of eur 50 , resulting from the use of a lost or stolen payment instrument or from the misappropriation of a payment instrument . this will not apply if the loss , theft or misappropriation of a payment instrument was not detectable to the payer prior to the enactment of a payment .


### where necessary , preventive measures regarding other diseases were carried out on the animal in question . ' ### where necessary , preventive health measures regarding other diseases were carried out on the animal in question . '


### in article 5 the following subparagraph shall be added : ' the preventive measures referred to in point may be laid down by the commission . those measures , designed to amend non - essential elements of this regulation by supplementing it , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 24 . ' ### in article 5 the following subparagraph shall be added : ' the preventive health measures referred to in point may be laid down by the commission . those measures , designed to amend non - essential elements of this regulation by supplementing it , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 24 . '


### ' until 31 december 2011 , one of the member states listed in part a of annex ii , either immediately or after transit through one of the territories listed in part b of annex ii , be placed in quarantine . ' ### ' until 31 december 2011 , one of the member states listed in part a of annex ii , either immediately or after transit through one of the territories listed in part b of annex ii , be placed in quarantine unless they have been brought into conformity with the requirements of article 6 after their entry into the community . '


### in view of the significant increase in the numbers and severity of natural and man - made disasters in recent years and in a situation where future disasters are likely to be more extreme and more complex with far reaching and longer - term consequences , resulting , in particular , from climate change and potential interaction between several natural and technological hazards , an integrated approach to disaster management is increasingly important . the union should support , coordinate and supplement actions of member states in the field of civil protection with a view to improving the effectiveness of systems for preventing , preparing for and responding to natural and man - made disasters . ### in view of the significant increase in the numbers and severity of natural and man - made disasters in recent years and in a situation where future disasters are likely to be more extreme and more complex with far reaching and longer - term consequences , resulting , in particular , from climate change and potential interaction between several natural and technological hazards , an integrated approach to disaster management is increasingly important . the union should support , coordinate and supplement actions of member states in the field of civil protection with a view to improving the effectiveness of systems for preventing , preparing for and responding to natural and man - made disasters . an integrated approach for each sea basin might prove necessary .


### the protection to be ensured under the union civil protection mechanism should cover primarily people , but also the environment and property , including cultural heritage , against all natural and man - made disasters , including acts of terrorism and technological , radiological and environmental accidents , marine pollution and acute health emergencies , occurring inside or outside the union . civil protection and other emergency assistance may be required in all of these disasters to complement the response capabilities of the affected country . ### the protection to be ensured under the union civil protection mechanism should cover primarily people , but also the environment and property , including cultural heritage , against all natural and man - made disasters , including technological , radiological , industrial and environmental accidents , marine pollution , epidemics and acute health emergencies , occurring inside or outside the union . civil protection and other emergency assistance may be required in all of these disasters to complement the response capabilities of the affected country .


### the protection to be ensured by the mechanism shall cover primarily people , but also the environment and property , including cultural heritage , against all natural and man - made disasters , including acts of terrorism , technological , radiological or environmental accidents , marine pollution and acute health emergencies , occurring inside or outside the union . ### the protection to be ensured by the mechanism shall cover primarily people , but also the environment and property , including cultural heritage , against all natural and man - made disasters , including technological , radiological , industrial or environmental accidents , marine pollution , epidemics and acute health emergencies , occurring inside or outside the union .


### this decision shall take into account the special needs of isolated , outermost and other regions or islands of the union in the case of a disaster . ### this decision shall take into account the special needs of isolated , outermost , cross - border and other regions or islands of the union in the case of a disaster . an integrated approach for each sea basin might prove necessary in these regions if the best possible synergies are to be ensured .


### establish and manage the emergency response centre , ensuring 24 / 7 operational capacity , and serving the member states and the commission for the purposes of the mechanism ; ### establish and manage the emergency response centre in coordination with the existing national and regional bodies , ensuring 24 / 7 operational capacity , and serving the member states and the commission for the purposes of the mechanism ;


### prudent fiscal policy - making implies that the growth rate of government expenditure does normally not exceed a prudent medium - term growth rate of gdp , increases in excess of that norm are matched by discretionary increases in government revenues and discretionary revenue reductions are compensated by reductions in expenditure . ### sound fiscal policy making implies that public finances ; over the medium term , adhere to a set of expenditure and revenue indicative guidelines . growth in tax revenue should normally not fall behind the medium term growth rate o f gdp . growth in government expenditure should normally not exceed a prudent medium term growth rate of gdp . discretionary increases in expenditure or discretionary reductions in tax revenue are to be offset by accompanying other discretionary measures , either on the side of expenditure or / and on the side of tax revenues .


### with a view to ensuring that the medium - term budgetary objective is effectively achieved and maintained , the council shall verify that the growth path of government expenditure , taken in conjunction with the effect of measures being taken or planned on the revenue side , is consistent with prudent fiscal policy - making . ### with a view to ensuring that the medium - term budgetary objective is effectively achieved and maintained , the council shall verify that the growth path of government expenditure and the growth path of tax revenue , taking into account the possible compensating effects of offsetting discretionary measures , are consistent with sound fiscal policy - making .


### for member states that have not yet reached their medium - term budgetary objective , annual expenditure growth does not exceed a rate below a prudent medium - term rate of gdp growth , unless the excess is matched by discretionary revenue measures . the size of the shortfall of the growth rate of government expenditure compared to a prudent medium - term rate of gdp growth is set in such a way as to ensure an appropriate adjustment towards the medium - term budgetary objective ; ### for member states that have not yet reached their medium - term budgetary objective , annual growth in tax revenue should exceed the medium term rate of growth of gdp , whereas annual medium term expenditure growth should not exceed a rate below a prudent medium - term rate of gdp growth . the impact of unemployment benefits and other social expenditure related to the business cycle is not to be taken into account when in the calculation and assessment of the growth path of government expenditure . deviations from these indicative expenditure and growth paths shall not be seen as a problem in case these deviations are matched by discretionary measures , either on the expenditure side or the revenue side or both . the size of the shortfall of the growth rate of government expenditure compared to a prudent medium - term rate of gdp growth , and the size of the excess of growth rate of tax revenue compared to medium term gdp growth are both set in such a way as to ensure an appropriate adjustment towards the medium - term budgetary objective ;


### in periods of severe economic downturn of a general nature member states may be allowed to temporarily depart from the adjustment path implied by prudent fiscal - policy making referred to in the fourth subparagraph . ### in periods of severe economic downturn , including its aftermath and the period in which the economy is still operating below potential member states shall be allowed to temporarily depart from the adjustment path implied by fiscal - policy making referred to in the fourth subparagraph .


### some of the species that are invasive in the union may be native in some of the union ' s outermost regions and vice versa . in the communication from the commission on ‘ the outermost regions : an asset for europe’18 it was recognised that the remarkable biodiversity of the outermost regions calls for the development and implementation of measures to prevent and manage invasive alien species in those regions as defined by the treaty on the functioning of the european union taking into account european council decisions 2010 / 718 / eu of 29 october 2010 amending the status with regard to the european union of the island of saint - barthélemy19 and 2012 / 419 / eu of 11 july 2012 amending the status of mayotte with regard to the european union20 . therefore all the provisions of these new rules should apply to the union ' s outermost regions except for provisions relating to invasive alien species of union concern which are native to those regions . in addition , to allow for the necessary protection of the biodiversity in such regions , it is necessary that the concerned member states draw up , as a complement to the list of invasive alien species of union concern , specific lists of invasive alien species for their outermost regions to which these new rules should also apply . __________________ 18 com 642 final . 19 oj l 325 , 9 . 12 . 2010 , p . 4 . 20 oj l 204 , 31 . 7 . 2012 , p . 131 . ### some of the species that are invasive in the union may be native in some of the union ' s outermost regions and vice versa . in the communication from the commission on ' the outermost regions : an asset for europe ' it was recognised that the remarkable biodiversity of the outermost regions calls for the development and implementation of measures to prevent and manage invasive alien species in those regions as defined by the treaty on the functioning of the european union taking into account european council decisions 2010 / 718 / eu of 29 october 2010 amending the status with regard to the european union of the island of saint - barthélemy and 2012 / 419 / eu of 11 july 2012 amending the status of mayotte with regard to the european union . therefore all the provisions of these new rules should apply to the union ' s outermost regions except for provisions relating to invasive alien species of union concern which are native to those regions . in addition , to allow for the necessary protection of the biodiversity in such regions , it is necessary that the concerned member states draw up , as a complement to the list of invasive alien species of union concern , specific lists of invasive alien species for their outermost regions to which these new rules should also apply . those lists shall be open and constantly revised and kept up - to - date , as novel invasive alien species are identified and are considered to be a risk . __________________ 18 com 642 final . 19 oj l 325 , 9 . 12 . 2010 , p . 4 . 20 oj l 204 , 31 . 7 . 2012 , p . 131 .


### there may be cases where alien species not yet recognised as invasive alien species of union concern appear at the union borders or are detected in the union territory . member states should therefore be granted the possibility to adopt on the basis of available scientific evidence certain emergency measures . such emergency measures would allow immediate reaction against species which may pose risks related to their introduction , establishment and spread in those countries , while member states assess the effective risks posed by them , in line with the applicable provisions of the agreements of the world trade organisation , in particular with a view to having those species recognised as invasive alien species of union concern . there is a need to couple national emergency measures with the possibility of adopting emergency measures at union level in order to comply with the provisions of the agreements of the world trade organisation . furthermore , union level emergency measures would equip the union with a mechanism to act swiftly in case of presence or imminent danger of entry of a new invasive alien species in accordance with the precautionary principle . ### there may be cases where alien species not yet recognised as invasive alien species of union concern appear at the union borders or are detected in the union territory . member states should therefore be granted the possibility to adopt on the basis of available scientific evidence certain emergency measures . such emergency measures would allow immediate reaction against species which may pose risks related to their introduction , establishment and spread in those countries , while member states assess the effective risks posed by them , in line with the applicable provisions of the agreements of the world trade organisation , in particular with a view to having those species recognised as invasive alien species of union concern . there is a need to couple national emergency measures with the possibility of adopting emergency measures at union level in order to comply with the provisions of the agreements of the world trade organisation . furthermore , union level emergency measures would equip the union with a mechanism to act swiftly in case of presence or imminent danger of entry of a new invasive alien species in accordance with the precautionary principle . in case emergency measures require eradication , control or containment , the welfare of targeted and non - targeted animals should be taken into account . the competent authorities should take the necessary measures to avoid pain , distress and suffering of animals during the process , based insofar as possible on best practices in the field .


### eradicating and managing some invasive alien species , while necessary , may induce pain , distress , fear or other forms of suffering to the animals even when using the best available technical means . for that reason , member states and any operator involved in the eradication , control or containment of invasive alien species should take the necessary measures to minimise pain , distress and suffering of animals during the process , taking into account in so far as possible the best practices in the field , for example the guiding principles on animal welfare developed by the world organisation for animal health . ### eradicating and managing some invasive alien species , if deemed to be necessary , may induce pain , distress , fear or other forms of suffering to the animals even when using the best available technical means . for that reason , member states and any operator involved in the eradication , control or containment of invasive alien species should take the necessary measures to avoid pain , distress and suffering of animals during the process , taking into account in so far as possible the best practices in the field , for example the guiding principles on animal welfare developed by the world organisation for animal health . if eradication or management is considered , humane and scientifically tested methods should be used and member states should engage with all relevant stakeholders and scientific experts in the decision making process . non - lethal methods should be considered and any actions taken should minimise impact on non - target species .


### in order to guarantee compliance with this regulation , it is important that member states impose dissuasive , effective and proportionate sanctions for infringements taking into account the nature and gravity of the infringement . ### in order to guarantee compliance with this regulation , it is important that member states impose dissuasive , effective and proportionate sanctions for infringements taking into account the nature and gravity of the infringement . sanctions should take into account the polluter pays principle and apply to all persons responsible for introducing non - native species whether intentionally or unintentionally .


### a list of invasive alien species of union concern shall be adopted , and updated , by the commission by means of implementing acts on the basis of the criteria in paragraph 2 . the implementing acts shall be adopted in accordance with the examination procedure referred to in article 22 . ### a list comprising invasive alien species and taxonomic groups of species of union concern shall be adopted , and updated , by the commission by means of implementing acts on the basis of the criteria in paragraph 2 . the implementing acts shall be adopted in accordance with the examination procedure referred to in article 22 .


### invasive alien species shall only be included on the list referred to in paragraph 1 if they meet all of the following criteria : ### invasive alien species or taxonomic groups of species shall only be included on the list referred to in paragraph 1 if they meet all of the following criteria :


### a continuous surveillance and a contingency plan to cater for possible escape or spread is drawn up , including an eradication plan . ### a continuous surveillance and a contingency plan to cater for possible escape or spread is drawn up , including an eradication plan . such plans should follow a process that ensures they are last , not first , resorts and that methods suggested are humane and cause no pain , distress or suffering to any animals , both target and non - target .


### when applying for a permit , the establishment shall provide all necessary evidence to allow the competent authority to assess whether the conditions referred to in paragraphs 2 and 3 are fulfilled . ### when applying for a permit , the establishment shall provide all necessary evidence to allow the competent authority to assess whether the conditions referred to in paragraphs 2 and 3 are fulfilled . the establishment shall be subject to regular inspections by the member state competent authority .


### when applying eradication measures , member states shall ensure that the methods used are effective in achieving the complete and permanent removal of the population of the invasive alien species concerned , with due regard to human health and the environment , and ensuring that targeted animals are spared any avoidable pain , distress or suffering . ### when applying eradication measures , member states shall ensure that the methods used are effective in achieving the complete and permanent removal of the population of the invasive alien species concerned , with due regard to human health and the environment , and ensuring that targeted and non - targeted animals are spared any avoidable pain , distress or suffering .


### by 12 months of an invasive alien species being included on the list referred to in article 4 at the latest , member states shall have in place management measures for those invasive alien species of union concern which the member states have found to be widely spread on their territory , so that their impacts on biodiversity and ecosystem services , human health and the economy are minimised . those management measures shall be based on an analysis of costs and benefits and also include the restoration measures referred to in article 18 . ### by 12 months of an invasive alien species being included on the list referred to in article 4 at the latest , member states shall have in place management measures for those invasive alien species of union concern which the member states have found to be widely spread on their territory , so that their impacts on biodiversity and ecosystem services , human health and the economy are minimised . those management measures shall include an analysis of costs and benefits and also the restoration measures referred to in article 18 .


### the surveillance system provided for in article 12 shall be designed and used to monitor how effective eradication , population control or containment measures are in minimising the impacts on biodiversity and ecosystems services , human health or the economy . ### the surveillance system provided for in article 12 shall be designed and used to monitor how effective eradication , population control or containment measures are in minimising the impacts on biodiversity and ecosystems services , human health or the economy . monitoring should also assess the impact on non - targeted species and the welfare impact on targeted species .


### where there is a significant risk that an invasive alien species of union concern will spread to a neighbouring member state , the member states in which the species is widely spread shall immediately notify the neighbouring member states and the commission . where appropriate , the member states concerned shall establish jointly agreed management measures . in the cases where third countries may also be affected by the spread , the member state affected shall consider the need to inform the concerned third countries . ### where there is a significant risk that an invasive alien species of union concern will spread to a neighbouring member state , the member states in which the species is widely spread shall immediately notify the neighbouring member states and the commission . where appropriate , the member states concerned shall establish jointly agreed management measures . in the cases where third countries may also be affected by the spread , the member state affected shall inform the concerned third countries .


### member states shall lay down the rules on administrative measures and sanctions applicable to breaches of this regulation . member states shall take all necessary measures to ensure that they are enforced . the measures and sanctions provided for must be effective , proportionate and dissuasive . ### member states shall lay down the rules on administrative measures and sanctions applicable to breaches of this regulation . member states shall take all necessary measures to ensure that they are enforced . the measures and sanctions provided for must be effective , proportionate and dissuasive . member states should apply the ' polluter pays ' principle where appropriate .


### the vehicle manufacturer shall not intentionally alter , adjust , or introduce any mechanical , electrical , thermal , or other device or procedure solely for the purpose of fulfilling the noise emission requirements under this regulation which is not operational during typical on - road operation under conditions applicable to asep . ### the vehicle manufacturer shall not intentionally alter , adjust , or introduce any mechanical , electrical , thermal , or other device or procedure solely for the purpose of fulfilling the noise emission requirements under this regulation which is not operational during typical on - road operation under conditions applicable to asep . these measures are typically referred to as ' cycle beating ' .


### the definitions of ' food ' and ' placing on the market ' set out in articles 2 and 3 of regulation no 178 / 2002 ; ### the definitions of ' food ' , ' retail ' and ' placing on the market ' set out in articles 2 and 3 and 3 of regulation no 178 / 2002 ;


### a systematic review of the scientific data and appropriate studies performed following generally accepted expert guidance on the design and conduct of such studies ; ### a systematic review of the scientific data and appropriate peer - reviewed studies performed following generally accepted expert guidance on the design and conduct of such studies ;


### scientific evidence demonstrating that the substance is available for use by the human body ; ### scientific evidence demonstrating that the substance is available for use by the human body and has a nutritional or physiological effect ;


### where appropriate , the authority should consult interested parties on technical standards , guidelines and recommendations and provide them with a reasonable opportunity to comment on proposed measures . for reasons of efficiency , a banking stakeholder group should be established for that purpose , representing in balanced proportions community credit and investment institutions , their employees , and consumers and other retail users of banking services , including smes . the banking stakeholder group should actively work as an interface with other user groups in the financial services area established by the commission or community legislation . ### the authority shall allow interested parties on to be consulted on all work undertaken by the authority and provide them with a reasonable opportunity to comment on proposed measures . for reasons of efficiency , a banking stakeholder group should be established for that purpose , representing in balanced proportions community credit and investment institutions , their employees , and consumers and other retail users of banking services , including smes . the banking stakeholder group should actively work as an interface with other user groups in the financial services area established by the commission or community legislation .


### contribute to developing high quality and uniform supervisory standards , including reporting standards ; ### contribute to developing high quality uniform supervisory standards , including reporting and accounting standards ;


### the union also aims to ensure coherence with other areas of its external action . this should be ensured when formulating the union ' s development cooperation policy and its strategic planning programming and implementation of measures . ### the union is fully committed to advance policy coherence for development and to ensure consistency between the different areas of its external action and between these and its other policies . union development cooperation policy has as its primary objective the reduction and eradication of poverty . its external policy fosters the sustainable economic , social and environmental development of developing countries . this includes the advancement of human rights , social justice , labour standards , fair trade relations , and environmental and climate - relevant practices . development programmes aiming to improve , expand , train or facilitate trade relations will follow the same principles . this should be ensured when formulating strategic planning programming and implementation of measures . the union aims to use the available resources efficiently so as to optimise their impact .


### union assistance should focus where it has more impact , having regard to its capacity to act on a global scale and respond to global challenges such as poverty eradication , sustainable and inclusive development and worldwide promotion of democracy , good governance , human rights and the rule of law , its long - term and predictable commitment to development assistance and its role in coordinating with its member states . to ensure such impact , the principle of differentiation should be applied not only at the level of funds allocation , but also at the level of programming , to ensure that bilateral development cooperation targets partner countries most in need , including fragile states and states with high vulnerability , and with limited capacity to have access to other sources of financing for supporting their own development , having regard to the potential impact of the union assistance in partner countries . as a consequence , bilateral programming would target such countries , pursuant to the application of objective criteria based on the needs and capacities of these countries , as well as the impact of eu assistance . ### union assistance should focus where it has more impact , having regard to its capacity to act on a global scale and respond to global challenges such as poverty eradication , sustainable and inclusive development through open and fair trade , and worldwide promotion of democracy , good governance , human rights , international labour standards , and the rule of law , its long - term and predictable commitment to development assistance and its role in coordinating with its member states . to ensure such impact , the principle of differentiation should be applied not only at the level of funds allocation , but also at the level of programming , to ensure that bilateral development cooperation benefits strongest those partner countries most in need , including fragile states and states with high vulnerability , and with limited capacity to have access to other sources of financing for supporting their own development , having regard to the potential impact of the union assistance in partner countries . as a consequence , bilateral programming should focus on such countries , pursuant to the application of objective criteria based on the needs and capacities of these countries , as well as the impact of eu assistance . for countries no longer eligible for country - specific geographical programmes , provision should be made for phasing out assistance through a gradual approach , paying special attention to the needs of particularly vulnerable population groups and bearing in mind that some of those countries will also cease to enjoy the commercial advantages of the generalised system of preferences , meaning they will be negatively affected twice .


### the lists of partner countries under this regulation should be adapted on the basis of possible changes to their status as established by the development assistance committee of the organization for economic cooperation and development , as well as important changes in human development , aid dependency , crisis situations , vulnerability and other aspects including the dynamics of the development process . such updates , reviews of the partner countries eligible for bilateral development cooperation and modifications in the definitions of detailed areas of cooperation and activities , and adjustments of the indicative financial allocation per programme , constitute non - essential elements of this regulation . consequently , in order to adapt its scope to the rapidly evolving reality in third countries , the power to adopt acts in accordance with article 290 of the treaty of the functioning of the european union should be delegated to the commission for updating the annexes of this regulation which includes the list of partner countries and regions eligible for union financing , the definition of detailed areas of cooperation under geographic and thematic programmes and the indicative allocations per programme . it is of particular importance that the commission should carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should further ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . ### the lists of partner countries under this regulation should be adapted on the basis of possible changes to their status as established by the development assistance committee of the organization for economic cooperation and development , as well as important changes in human development , aid dependency , crisis situations , vulnerability and other aspects including the dynamics of the development process . updates and reviews of the partner countries eligible for bilateral development cooperation and modifications in the definitions of areas of cooperation and activities , as well as adjustments of the indicative financial allocation per programme , should be submitted by the commission as legislative proposals introducing the necessary modifications to annexes i , iii , iv , v , vi and vii of this regulation .


### promoting democracy , the rule of law , good governance and respect for human rights . ### promoting , consolidating and advancing democracy , including through fair and transparent elections , strengthening respect for human rights , social justice , and international labour standards , fostering the rule of law , good governance in both the public and private sector , fair trade relations , and promoting respect for international conventions and the principles of international law regarding social and environmental standards .


### the following cross - cutting issues shall be mainstreamed in all programmes : the promotion of human rights , gender equality , women empowerment , non - discrimination , democracy , good governance , the rights of the child and indigenous peoples ' rights , social inclusion and the rights of persons with disabilities , environmental sustainability including addressing climate change and combating hiv / aids . ### the following cross - cutting issues shall be mainstreamed in all programmes : the promotion of human rights , gender equality , women empowerment , non - discrimination , democracy , good governance , the rights of the child and indigenous peoples ' rights , social inclusion , decent work , and the rights of persons with disabilities , environmental sustainability including addressing climate change and combating hiv / aids .


### inclusive and participatory approaches to development and a broad involvement of all segments of society in the development process and in national and regional dialogue , including political dialogue ; ### inclusive and participatory approaches to development and a broad involvement of all segments of society in the development process and in national and regional dialogue , including political dialogue and national and regional parliaments in the partner countries and regions ;


### multiannual indicative programmes shall be drawn up for each of the countries or regions receiving an indicative allocation of union funds under this regulation except for countries or regions mentioned in paragraph 4 , these documents shall be drawn up on the basis of the strategy papers or similar documents referred to in this article . ### multiannual indicative programmes shall be drawn up for each of the countries or regions receiving an indicative allocation of union funds under this regulation . these documents shall be drawn up on the basis of the strategy papers or similar documents referred to in this article .


### sustainable agriculture and energy . ### sustainable , in particular small - scale agriculture and renewable energy .


### data shall be stored in a central database and made available to competent authorities , aircraft operators , air navigation service providers and airport operators for operational purposes . ### data shall be stored in a central database and made available to competent authorities , aircraft operators , air navigation service providers , airport operators for operational purposes and to the public in an easily accessible electronic format .


### at the same time , it is crucial to support the development and competitiveness of european small and medium - sized enterprises and to ensure that people can adapt , through acquiring appropriate skills and through lifelong learning opportunities , to new challenges such as the shift to a knowledge - based economy , the digital agenda , and the transition to a low - carbon and more energy - efficient economy . by pursuing its primary thematic objectives , the esf should contribute to addressing these challenges . in this context , the esf should support the labour force transition towards greener skills and jobs , in particular in the energy efficiency , renewable energy and sustainable transport sectors , taking into account the union ' s intention to increase the proportion of the eu budget that is related to climate mainstreaming to at least 20% , with contributions from different policy fields . ### at the same time , it is crucial to support the sustainable development of micro - enterprises and smes , including cultural and creative enterprises , and to ensure that , through acquiring appropriate skills and through lifelong learning opportunities , people can meet new challenges such as the shift to a knowledge - based economy , the digital agenda , and the transition to a low - carbon and more energy - efficient economy . by pursuing its primary thematic objectives , the esf should contribute to addressing these challenges . in this context , the esf should include the contribution of cultural and creative skills , which facilitate access to decent work , and support training possibilities for workers and job - seekers geared towards greener skills and jobs , in particular in the energy efficiency , renewable energy and sustainable transport sectors , taking into account the union ' s intention to increase the proportion of the eu budget that is related to climate mainstreaming to at least 20% , with contributions from different policy fields .


### the esf should contribute to the europe 2020 strategy , ensuring greater concentration of support on the priorities of the european union . the esf should in particular increase its support for the fight against social exclusion and poverty , through a minimum ring - fenced allocation . according to the level of development of the supported regions , the choice and number of investment priorities for esf support should also be limited . ### the esf should contribute to the europe 2020 strategy , in particular by increasing its support for the fight against social exclusion and poverty . the bottom - up approach to cohesion policy which allows investment priorities to be geared to the specific needs of the region concerned will be retained .


### the mobilisation of regional and local stakeholders is necessary to deliver the europe 2020 strategy and its headline targets . territorial pacts , local initiatives for employment and social inclusion , community - led local development strategies and sustainable urban development strategies may be used and supported to involve more actively regional and local authorities , cities , social partners and non - governmental organisations in the implementation of programmes . ### the mobilisation of regional and local stakeholders , in particular those operating on a cross - border basis , is necessary to achieve the cohesion policy ' s objectives , especially the esf ' s objectives , and the targets specific to the esf in the europe 2020 strategy . territorial pacts , local initiatives for employment and social inclusion , community - led local development strategies and sustainable urban development strategies may be used and supported to involve more actively regional and local authorities , cities , social partners and non - governmental organisations in the implementation of programmes .


### it shall do so by supporting member states in pursuing the priorities and headline targets of the europe 2020 strategy for smart , sustainable and inclusive growth . the esf shall support the design and implementation of policies and actions , taking account of the integrated guidelines for the economic and employment policies of member states and the council recommendations on the national reform programmes . ### it shall do so by also supporting member states in pursuing the priorities and headline targets of the europe 2020 strategy for smart , sustainable and inclusive growth , with the aim of ensuring enhanced social cohesion . the esf shall support the design and implementation of policies and actions , taking account of the integrated guidelines for the economic and employment policies of member states and the council recommendations on the national reform programmes .


### the esf shall benefit people , including disadvantaged groups such as the long - term unemployed , people with disabilities , migrants , ethnic minorities , marginalised communities and people facing social exclusion . the esf shall also provide support to enterprises , systems and structures with a view to facilitating their adaptation to new challenges and promoting good governance and the implementation of reforms , in particular in the fields of employment , education and social policies . ### the esf shall benefit people , including disadvantaged groups such as the long - term unemployed , people with disabilities , migrants , young people , children , ethnic minorities , marginalised communities and groups threatened by or facing social exclusion . the esf shall also provide support to organisations , systems and structures with a view to facilitating their adaptation to new challenges and promoting good governance , in particular in the fields of employment , education and social policies .


### access to employment for job - seekers and inactive people , including local employment initiatives and support for labour mobility ; ### access to decent work for job - seekers and inactive people , including local employment initiatives , support for guidance , mobility , retraining and acquiring skills ;


### the report to be established in accordance to article 17 of directive 89 / 391 / eec shall notably report on the effectiveness of the directive in reducing exposure to electromagnetic fields and the percentage of workplaces that required corrective action . ### the report to be established in accordance to article 17 of directive 89 / 391 / eec shall notably report on the effectiveness of the directive in reducing exposure to electromagnetic fields and the percentage of workplaces that required corrective action . the commission shall assess the scientific evidence for long - term effects of exposure to electromagnetic fields within 5 years after the publication of this directive in the official journal of the european union and submit a proposal for its review in order to include the protection of workers health and safety against such long - term effects .


### this regulation should enable natural gas undertakings and customers to rely on market mechanisms for as long as possible when coping with disruptions . it should also provide for emergency mechanisms to be used when markets are no longer able to deal adequately with a gas supply disruption . even in an emergency , market based instruments should be given priority to mitigate the effects of the supply disruption . ### this regulation should provide for emergency mechanisms to be used when markets are no longer able to deal adequately with a gas supply disruption . in an emergency , instruments based on safeguarding consumer protection should be given priority to mitigate the effects of the supply disruption .


### security of gas supply is a task of the natural gas undertakings , competent authorities of the member states , the industrial gas customers , and the commission within their respective areas of responsibility . it requires a high degree of cooperation between them . ### security of gas supply is a task primarily of the member states and the competent authorities of the member states . security of gas supply is also a task of the natural gas undertakings and the industrial gas customers within their respective areas of responsibility . it requires a high degree of cooperation between them .


### the competent authority shall ensure that conditions for supplies to protected customers are established without prejudice to the proper functioning of the internal gas market and at a price respecting the market value of the commodity . ### the competent authority shall ensure that conditions for supplies to protected customers are established without prejudice to the proper functioning of the internal gas market , without decreasing the protection of the economic interests of consumers , and at a price reflecting the fair market value of the commodity .


### member states shall submit to the commission the existing inter - governmental agreements concluded with third countries which have an impact on the development of gas infrastructures and supplies ; before concluding new inter - governmental agreements , the member states shall inform the commission to assess their compliance with the internal market legislation ; ### member states shall submit to the commission the existing inter - governmental agreements concluded with third countries which have an impact on the development of gas infrastructures and supplies ; after concluding new inter - governmental agreements , the member states shall inform the commission ;


### it is not appropriate to extend limitations of the use of phosphates and other phosphorous compounds in household laundry detergents to household automatic dishwasher detergents or to industrial and institutional detergents because suitable technically and economically feasible alternatives to the use of phosphates in those detergents are not yet available . ### efficient household automatic dishwasher detergents with a limited concentration of phosphorus are currently already available on the market . it is thus appropriate to extend limitations of the use of phosphates and other phosphorus compounds in household laundry detergents to household automatic dishwasher detergents . given that technical and economic conditions for the use of phosphates in industrial and institutional detergents differ from those for household use , longer periods of adjustment should be taken into account when introducing limit values in this area .


### by 31 december 2014 , the commission shall evaluate , submit a report to the european parliament and to the council on the use of phosphates and other phosphorous compounds in household automatic dishwasher detergents and , if justified , present a legislative proposal with a view to their gradual phase - out or restriction to specific applications . ### by 31 december 2014 , the commission shall evaluate the environmental performance of alternatives to phosphates - based household laundry and automatic dishwasher detergents , particularly in relation to their impact in waste water treatment plants and on the aquatic environment and aquatic sediments , and , if justified , present a legislative proposal with a view to the gradual phase - out of the use of phosphates and other phosphorus compounds in household laundry and automatic dishwasher detergents or their restriction to specific applications .


### risk management systems for medicinal products authorised in accordance with this regulation ; ### risk management systems for medicinal products authorised in accordance with this regulation , with an explanation of how to operate them ;


### information about how to report suspected adverse reactions to medicinal products and standard forms for their web - based reporting by patients and health - care professionals ; ### information about how to report suspected adverse reactions to medicinal products and standard forms for their reporting by patients and health - care professionals ;


### monitoring of information on prescription - only medicinal products should ensure that marketing authorisation holders only disseminate information which is in compliance with directive 2001 / 83 / ec . member states should adopt rules establishing effective monitoring mechanisms and allowing effective enforcement in cases of non - compliance . monitoring should be based on the control of information prior to its dissemination , unless the substance of the information has already been agreed by the competent authorities or if there is a different mechanism in place to ensure an equivalent level of adequate and effective monitoring . ### monitoring of information on prescription - only medicinal products should ensure that the information made available by marketing authorisation holders which is in compliance with directive 2001 / 83 / ec . member states should adopt rules establishing effective and efficient monitoring mechanisms and allowing effective enforcement in cases of non - compliance and redress mechanisms for consumers . monitoring should be based on the control of information prior to its dissemination , unless the content of the information has already been agreed by the competent authorities .


### a statement indicating that the information is disseminated by a marketing authorisation holder ; ### a statement indicating that the information is disseminated by [ name of the marketing authorisation holder ] ;


### no means of identification may be removed or replaced without the permission and without the control of the competent authority . such permission may only be granted where the removal or replacement do not compromise the traceability of the animal . ### no means of identification shall be modified , removed or replaced without the permission and without the control of the competent authority . such permission may only be granted where the modification , the removal or replacement do not compromise the traceability of the animal .


### ' serious transnational crime ' means the offences under national law referred to in article 2 of council framework decision 2002 / 584 / jha if they are punishable by a custodial sentence or a detention order for a maximum period of at least three years under the national law of a member state , and if : ### ' serious transnational crime ' means the offences under national law referred to in article 2 of council framework decision 2002 / 584 / jha if they are punishable by a custodial sentence or a detention order for a maximum period of at least five years under the national law of a member state , however , member states may exclude those minor offences for which , taking into account their respective criminal justice system , the processing of pnr data pursuant to this directive would not be in line with the principle of proportionality , and if :


### limit the ability of a person from entering into a commodity derivative . ### limit the ability of a person , class of persons or investment firm from entering into a commodity derivative .


### the measures listed in points to of paragraph 1 address a threat to the orderly functioning and integrity of financial markets including in relation to delivery arrangements for physical commodities , or the stability of the whole or part of the financial system in the union ; ### the measures listed in points to of paragraph 1 prevent market abuse , reduce or eliminate excessive speculation , address a threat to the orderly functioning and integrity of financial markets and orderly pricing including in relation to delivery arrangements for physical commodities and price discovery for the underlying commodity market , or the stability of the whole or part of the financial system ;


### does significantly address the threat to the orderly functioning and integrity of financial markets or of delivery arrangements for physical commodities , or the stability of the whole or part of the financial system in the union or significantly improve the ability of competent authorities to monitor the threat ; ### does significantly prevent market abuse , reduce or eliminate excessive speculation , address the threat to the orderly pricing , orderly functioning and integrity of financial markets or of delivery arrangements for physical commodities and price discovery for the underlying commodity market , or the stability of the whole or part of the financial system in the union or significantly improve the ability of competent authorities to monitor the threat ;


### does not have a detrimental effect on the efficiency of financial markets , including reducing liquidity in those markets or creating uncertainty for market participants , that is disproportionate to the benefits of the measure . ### does not have a detrimental effect on the efficiency of financial and underlying commodity markets , including distorting their price discovery function , that is disproportionate to the benefits of the measure .


### in the cases referred to in the first subparagraph the member state concerned shall provide to the commission a list of the establishments concerned , including the inventory of dangerous substances concerned . the member state concerned shall give reasons for the exclusion . ### in the cases referred to in the first subparagraph the member state concerned shall provide to the commission a list of the establishments concerned , including the inventory of dangerous substances concerned and the nature of the applicable specific conditions . the member state concerned shall give reasons for the exclusion .


### the safety report shall be sent to the competent authority within the following time - limits : ### the safety report shall be sent to the competent authority , after presentation to workers’ representatives , within the following time - limits :


### for new establishments , a reasonable period of time prior to the start of construction or operation ; ### for new establishments , a reasonable period of time prior to the start of construction ,


### member states shall ensure that operators of lower - tier establishments provide , at the request of the competent authority , sufficient information on the risks arising from the establishment necessary for land - use planning purposes . ### member states shall ensure that operators of lower - tier establishments provide , at the request of the competent authority , the information it deems necessary on the risks arising from the establishment necessary for land - use planning purposes .


### inform the broader public and potential beneficiaries on rural development policy ; ### inform the broader public and potential beneficiaries on rural development policy and funding opportunities ;


### where a non - financial counterparty takes positions in otc derivative contracts exceeding the clearing threshold to be determined pursuant to paragraph 3 , it shall be subject to the clearing obligation set out in article 3 with regard to all its eligible otc derivative contracts . ### where a non - financial counterparty takes positions in otc derivative contracts it shall be subject to the clearing obligation set out in article 3 with regard to all its eligible otc derivative contracts . exemptions from clearing can only be determined by esma , up to a certain threshold , and after interests of all stakeholders in society as well as all financial , economic , social and environmental negative aspects have been assessed .


### these specific objectives should be achieved by establishing interconnections and interoperability between national transport networks in a resource - efficient way . ### these specific objectives should be achieved by establishing interconnections and interoperability between national transport networks in a resource - efficient , eco - efficient and socially sustainable way .


### meet the mobility and transport needs of its users within the union and in the relations with third countries , thereby contributing to further economic growth and competitiveness ; ### meet the mobility and transport needs of all its users within the union and in the relations with third countries .


### promote the most advanced technological and operational concepts ; ### promote the most advanced technological , eco - efficient and operational concepts ,


### the comprehensive network shall be made up of all existing and planned transport infrastructures of the trans - european transport network as well as measures promoting the efficient use of such infrastructure . it shall be developed in accordance with chapter ii . ### the comprehensive network shall be made up of all existing and planned transport infrastructures of the trans - european transport network as well as measures promoting the eco - efficient use of such infrastructure . it shall be developed so as to switch from fossil - dependent and environmentally harmful transport to sustainable transport .


### demonstrate clear european added value . ### demonstrate clear european added value from a social , ecological and environmentally friendly perspective .


### – availability of alternative clean fuels . ### – availability of renewable clean fuels .


### “organiser” means a natural or legal person or organisation responsible for the preparation and submission of a citizens’ initiative to the commission . ### “organising committee” means a group of natural or legal persons responsible for the preparation and submission of a citizens’ initiative to the commission .


### an increased transnational cooperation at the union level and in particular to the effectiveness of the cross - border operations ; ### an increased transnational cooperation and coordination at the union level and in particular to the effectiveness and efficiency of the cross - border operations specifically delivering added value to already existing activities in this field in and between member states and at union level ;


### this objective shall be measured , inter alia , through the amount of recoveries following fraud cases detected by joint actions and cross border operations , the increased percentage of successful joint operations , and the increased number of cases accepted by the criminal investigative authorities . ### this specific objective shall be measured taking into account the key performance indicators , inter alia , through the amount of seizures , confiscations and recoveries following fraud cases detected by joint actions and cross border operations , the added value and effective use of technical equipment financed under this regulation , the increased percentage of successful joint operations , and the number and type of training activities , as well as their direct and indirect effects on the detection , seizure , confiscation and recovery of smuggled and counterfeit products .


### the commission shall provide annual information on the results of the programme to the european parliament and to the council . information on consistency and complementarity with other programmes and activities at union level shall be included . the commission shall continually disseminate the results of the activities supported under the programme . all participating countries shall provide the commission with all the data and information necessary to permit the monitoring and evaluation of the programme . ### the commission shall provide the european parliament and the council , on a yearly basis , with information on the annual implementation of the programme , including the objectives achieved , the results and the key performance indicators identified in the annual programme . information on consistency and complementarity with other programmes and activities at union level shall be detailed and included in the communication . the commission shall continually disseminate , including the relevant websites , the results of the funded actions and activities supported under the programme . in order to demonstrate the added value of the commission ' s activities under this regulation , the commission shall , in particular , report on measures taken to enhance co - ordination and to avoid overlap with existing , related activities in the field of the protection of the eu ' s financial interests . all participating countries and representatives referred to in article 6 shall provide the commission with all the data and information necessary to permit the monitoring and evaluation of the annual implementation of the programme , where relevant and of the overall programme .


### in line with the conclusions of the european council of 17 june 2010 , whereby the union strategy for smart , sustainable and inclusive growth was adopted , the union and the member states have set themselves the objective of having at least 20 million fewer people at risk of poverty and social exclusion by 2020 . ### the provision of foodstuffs and agricultural products and assistance for the most deprived persons is an imperative , and whereas in line with the conclusions of the european council of 17&#160 ; june 2010 , whereby the union strategy for smart , sustainable and inclusive growth was adopted , the union and the member states have set themselves the objective of having at least 20 million fewer people at risk of poverty and social exclusion by 2020 .


### the number of persons suffering from material or even severe material deprivation in the union is increasing and those persons are often too excluded to benefit from the activation measures of regulation no [ …cpr ] , and , in particular of regulation no [ …esf ] . ### the number of persons suffering from food and material or even severe food and material deprivation in the union is increasing and those persons are often too excluded to benefit from the activation measures of regulation no [ …cpr ] , and , in particular of regulation no [ …esf ] .


### the fund for european aid to the most deprived should strengthen social cohesion by contributing to the reduction of poverty in the union by supporting national schemes that provide non - financial assistance to the most deprived persons to alleviate food deprivation , homelessness and material deprivation of children . ### the fund for european aid to the most deprived should strengthen social cohesion by contributing to the reduction of poverty in the union by supporting , primarily through the provision of food supplies , national schemes that provide non - financial assistance to the most deprived persons to alleviate food deprivation , homelessness and material deprivation of children .


### those provisions also ensure that the operations supported shall comply with applicable union and national laws , notably in regard to the safety of the goods that are distributed to the most deprived persons . ### those provisions also ensure that the operations supported shall comply with applicable union and national laws , notably in regard to the safety of the goods and the quality of the food products that are distributed to the most deprived persons .


### uniform and equitable rules on the eligibility period , operations and expenditures for the fund should be applied across the union . the conditions of eligibility should reflect the specific nature of the fund’s objectives and target populations , notably through adequate conditions of eligibility of the operations as well as forms of support and rules and conditions of reimbursement . ### simple , uniform and equitable rules on the eligibility period , operations and expenditures for the fund should be applied across the union . the conditions of eligibility should reflect the specific nature of the fund’s objectives and target populations , notably through adequate and simplified conditions of eligibility of the operations as well as forms of support and rules and conditions of reimbursement .


### in order to ensure that expenditure financed by the union budget in any given financial year is used in accordance with the applicable rules , an appropriate framework should be created for the annual examination and acceptance of accounts . under this framework , the designated bodies should submit to the commission , in respect of the operational programme , a management declaration accompanied by the certified annual accounts , an annual summary of the final audit reports and of controls carried out and an independent audit opinion and control report . ### in order to ensure that expenditure financed by the union budget in any given financial year is used in accordance with the applicable rules , an appropriate and simple framework should be created for the annual examination and acceptance of accounts . under this framework , the designated bodies should submit to the commission , in respect of the operational programme , a management declaration accompanied by the certified annual accounts , an annual summary of the final audit reports and of controls carried out and an independent audit opinion and control report .


### the frequency of audits on operations should be proportionate to the extent of the union ' s support from the fund . in particular , the number of audits carried out should be reduced where the total eligible expenditure for an operation does not exceed eur 100 000 . nevertheless , it should be possible to carry out audits at any time where there is evidence of an irregularity or fraud , or as part of an audit sample . in order that the level of auditing by the commission is proportionate to the risk , the commission should be able to reduce its audit work in relation to operational programmes where there are no significant deficiencies or where the audit authority can be relied on . in addition , the scope of audits should take fully into account the objective and the features of the target populations of the fund . ### the frequency of audits on operations should be proportionate to the extent of the union ' s support from the fund . in particular , the number of audits carried out should be reduced where the total eligible expenditure for an operation does not exceed eur 100 000 . nevertheless , it should be possible to carry out audits at any time where there is evidence of an irregularity or fraud , or as part of an audit sample . in order that the level of auditing by the commission is proportionate to the risk , the commission should be able to reduce its audit work in relation to operational programmes where there are no significant deficiencies or where the audit authority can be relied on . in addition , the scope of audits should take fully into account the objective and the features of the target populations of the fund , as well as the voluntary nature of the beneficiary bodies .


### this regulation respects fundamental rights and observes the principles recognised in particular by the charter of fundamental rights of the european union , including respect for human dignity and for private and family life , the right to the protection of personal data , the rights of the child , the rights of the elderly , equality between men and women , and the prohibition of discrimination . this regulation must be applied according to these rights and principles . ### this regulation respects fundamental rights and observes the principles recognised in particular by the charter of fundamental rights of the european union , including respect for human dignity and for private and family life , the right to the protection of personal data , the rights of the child , the right to social assistance and to housing , the rights of the elderly , equality between men and women , and the prohibition of discrimination . this regulation must be applied according to these rights and principles .


### ' most deprived persons ' means physical persons , whether individuals , families , households or groups composed of such persons , whose need for assistance has been established according to the objective criteria adopted by the national competent authorities , or defined by the partner organisations and which are approved by those competent authorities ; ### ' most deprived persons ' means physical persons , whether individuals , families , households or groups composed of such persons , whose need for assistance has been established according to the objective criteria defined by the national competent authorities in cooperation with the partner organisations , in particular national , regional or local organisations which are already working to hand out food to the most deprived , or which are providing assistance to homeless persons and people affected by poverty or social exclusion ;


### the fund shall support national schemes whereby food products and basic consumer goods for the personal use of homeless persons or of children are distributed to the most deprived persons through partner organisations selected by member states . ### the fund shall support national systems for distributing healthy food products to the most deprived as well as basic consumer goods for their personal use .


### the commission and the member states shall carry out their respective roles in relation to the fund with the aim of reducing the administrative burden for beneficiaries . ### the commission and the member states shall take action to guarantee the effectiveness of the fund , in particular through monitoring , reporting and evaluation . they shall also ensure that the fund is easy for the partner organisations and beneficiaries to implement .


### the global resources available for budgetary commitment from the fund for the period 2014 - 2020 shall be eur 2 500 000 000 at 2011 prices , in accordance with the annual breakdown set out in annex ii . ### the global resources available for budgetary commitment from the fund for the period 2014 - 2020 shall be at least eur&#160 ; 5&#160 ; 000&#160 ; 000&#160 ; 000 at 2011 prices , in accordance with the annual breakdown set out in annex&#160 ; ii .


### each member state shall submit to the commission one operational programme covering the period between 1 january 2014 and 31 december 2020 within three months of the entry into force of this regulation , containing the following items : ### each member state shall submit to the commission one operational programme within three months of the entry into force of this regulation that has been prepared in cooperation with the local authorities and the organisations fighting poverty and social exclusion , including organisations formerly in receipt of mdp funding . the operational programme shall cover the period between 1 january 2014 and 31 december 2020 and shall contain the following items :


### at its own initiative and in close cooperation with the member states , the commission shall carry out , with the assistance of external experts , an ex - post evaluation , to assess the effectiveness and sustainability of results obtained as well as to measure the added value of the fund . this ex post evaluation shall be completed by 31 december 2023 . ### at its own initiative and in close cooperation with the member states , the commission shall carry out , with the assistance of external experts , an ex - post evaluation , to assess the simplicity of the management system for the programmes , the effectiveness and sustainability of results obtained and the needs indicated by the partner organisations , as well as to measure the added value of the fund . this ex post evaluation shall be completed by 31 december 2023 .


### the member states shall provide information on and promote the actions supported by the fund . the information shall be addressed to the most deprived persons , the media and the wider public . it shall highlight the role of the union and ensure that the contribution from the fund is visible . ### the commission and member states shall provide information on and promote the actions supported by the fund . the information shall be addressed to the most deprived persons , the media and the wider public . it shall highlight the role of the union and ensure that the contribution from the fund , the partner organisations and their volunteers is visible .


### during the implementation of an operation , the beneficiaries and partner organisations shall inform the public about the support obtained from the fund by placing at least one poster with information about the operation , including about the financial support from the union , at a location readily visible to the public , at each place of provision of the food , goods and any accompanying measure , except if this is not possible due to the circumstances of the distribution . ### during the implementation of an operation , the beneficiaries and partner organisations shall inform the public about the support obtained from the fund by placing either at least one poster with information about the operation , including about the financial support from the union , at a location readily visible to the public , at each place of provision of the food , goods and any accompanying measure or a european flag , and in such a way as not to stigmatise end recipients , except if this is not possible due to the circumstances of the distribution .


### that material assistance shall be distributed free of charge to the most deprived persons . ### that food and / or material assistance shall as a rule be distributed free of charge to the most deprived persons . where the aims of providing such food and / or material assistance to the most deprived persons include furthering their integration or social rehabilitation , final beneficiaries may be charged a symbolic price not exceeding 10% of the market price .


### article 23 financial management of support to farmers by way of derogation from articles 21 and 22 , support for farmers shall be managed and controlled in accordance with regulation no………… on the financing , management and monitoring of the common agricultural policy . ### delete


### in order to ensure that the union’s expression of solidarity with workers is not hampered by a lack of member state co - funding resources , the co - funding rate should be modulated , with a maximum 50 % contribution to the cost of the package and its implementation as the norm , and the possibility to raise this rate to up to 65 % in the case of applications submitted by those member states on the territory of which at least one region at nuts ii level is eligible under the ' convergence ' objective of the structural funds . ### in order to ensure that the union’s expression of solidarity with workers is not hampered by a lack of member state co - funding resources , the co - funding rate should be up to 65 % .