### in order to ensure uniform conditions for the implementation of this regulation implementing powers should be conferred on the commission in respect of the functioning of the odr platform , the modalities for the submission of a complaint and co - operation within the odr facilitators ' network . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by member states of the commission ' s exercise of implementing powers . the advisory procedure should be used for the adoption of implementing acts relating to the electronic complaint form given its purely technical nature . the examination procedure should be used for the adoption of the rules concerning the modalities of cooperation between the odr facilitators of the network of online dispute resolution facilitators . ### in order to ensure uniform conditions for the implementation of this regulation implementing powers should be conferred on the commission in respect of the functioning of the online signposting platform . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by member states of the commission ' s exercise of implementing powers . the examination procedure should be used for the adoption of the rules concerning the modalities for the exercise of the functions of the online signposting platform .


### if , following the notification of the dispute to the parties , the parties agree to institute proceedings before the entity , accomplish the conclusion of the dispute resolution procedure within 30 days from when the proceedings have been instituted . in the case of complex disputes , the adr entity may extend this time limit ; ### if , following the notification of the dispute to the parties , the parties agree to institute proceedings before the entity , accomplish the conclusion of the dispute resolution procedure within 90 days from when the proceedings have been instituted . in the case of complex disputes , the adr entity may extend this time limit for a further period of 90 days ;


### the commission shall lay down the modalities of the electronic complaint form by means of implementing acts . those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 15 . ### the commission shall be empowered to adopt delegated acts in accordance with article 16 to lay down the modalities of the electronic complaint form , taking into account technical progress .


### traders should inform consumers on their websites about the odr platform and provide an electronic link to its homepage . they should also provide such information when a consumer submits a complaint to the trader , a consumer complaint handling system operated by the trader or a company ombudsman . this obligation should be without prejudice to article 10 - of directive . … / … / eu [ office of publications insert reference number ] concerning the information of consumers by traders about the adr procedures by which those traders are covered and about whether or not they commit to use alternative dispute resolution procedures to resolve disputes with consumers . furthermore , this obligation should be without prejudice to articles 6 and 8 of directive 2011 / 83 / eu of the european parliament and of the council of 25 october 2011 on consumer rights . article 6 of directive 2011 / 83 / eu stipulates for consumer contracts concluded at a distance or off premises that the trader has to inform the consumer about the possibility of having recourse to an out - of - court complaint and redress mechanism to which the trader is subject , and the methods for having access to it , before the consumer is bound by the contract . ### traders should inform consumers on their websites about the online signposting platform and provide an electronic link to its homepage . they should also provide such information when a consumer submits a complaint to the trader , a consumer complaint handling system operated by the trader or a company ombudsman . this obligation should be without prejudice to article 10 - of directive . … / … / eu [ office of publications insert reference number ] . furthermore , this obligation should be without prejudice to articles 6 and 8 of directive 2011 / 83 / eu of the european parliament and of the council of 25 october 2011 on consumer rights . article 6 of directive 2011 / 83 / eu stipulates for consumer contracts concluded at a distance or off premises that the trader has to inform the consumer about the possibility of having recourse to an out - of - court complaint and redress mechanism to which the trader is subject , and the methods for having access to it , before the consumer is bound by the contract . the obligation to inform consumers of the existence of the online signposting platform should not create excessive administrative burdens for smes within the meaning of commission recommendation 2003 / 361 of 6 may 2003 concerning the definition of micro , small and medium - sized enterprises1 . smes should transmit to consumers all relevant information when they are confronted to a particular problem . ___________ 1 oj l 124 , 20 . 5 . 2003 , p . 36 .


### the provisions in paragraph 1 are without prejudice to the provisions in article 10 of directive … . / … / eu [ office of publications please insert number of directive of the european parliament and of the council on alternative dispute resolution for consumer disputes and amending regulation no 2006 / 2004 and directive 2009 / 22 / ec ] concerning the information of consumers by traders about the adr procedures by which those traders are covered and about whether or not those traders commit to use alternative dispute resolution procedures to resolve disputes with consumers . ### the provisions in paragraph 1 are without prejudice to the provisions in article 10 of directive … . / … / eu [ office of publications please insert number of directive of the european parliament and of the council on alternative dispute resolution for consumer disputes and amending regulation no 2006 / 2004 and directive 2009 / 22 / ec ] .


### the co - financing rate for grants awarded under the programme shall not exceed 80 % of the eligible costs . in exceptional and duly justified cases , defined in the annual work programme referred to in article 10 , the co - financing rate shall not exceed 90 % of the eligible costs . ### the co - financing rate for grants awarded under the programme shall not exceed 50 % of the eligible costs . in exceptional and duly justified cases , defined in the annual work programme referred to in article 10 , the co - financing rate shall not exceed 90 % of the eligible costs .


### in order to implement the programme the commission shall adopt annual work programmes . they shall set out the objectives pursued , the expected results , the method of implementation and their total amount . they shall also contain a description of the actions to be financed , an indication of the amount allocated to each action and an indicative implementation timetable . they shall include for grants the priorities , the essential evaluation criteria and the maximum rate of co - financing . ### in order to implement the programme the commission shall adopt annual work programmes . they shall set out the objectives pursued , the expected results , the method of implementation and their total amount . they shall also contain a description of the actions to be financed , an indication of the amount allocated to each action and an indicative implementation timetable . they shall include for grants the priorities , the essential evaluation criteria and the maximum rate of co - financing . after completion , these annual work programmes shall be sent to european parliament and council .


### an evaluation of the programme shall be carried out by the commission . no later than by 31 december 2017 , an evaluation report shall be established by the commission on the achievement of the objectives of all the measures , results and impacts , the efficiency of the use of resources and its european added value , in view of a decision on the renewal , modification or suspension of the measures . the evaluation shall additionally address the scope for simplification , its internal and external coherence , the continued relevance of all objectives , as well as the contribution of the measures to the union priorities of smart , sustainable and inclusive growth . it shall take into account evaluation results on the long - term impact of the predecessor measures . ### an independent and thorough evaluation of the programme shall be carried out by the commission . no later than by 31 december 2017 , an evaluation report shall be established by the commission on the achievement of the objectives of all the measures , results and impacts , the efficiency of the use of resources and its european added value , in view of a decision on the renewal , modification or suspension of the measures . the evaluation shall additionally address the scope for simplification , its internal and external coherence , the continued relevance of all objectives , as well as the contribution of the measures to the union priorities of smart , sustainable and inclusive growth . it shall take into account the evaluation results on the achievements of the objectives of the hercule ii programme to be presented by the commission by 31 december 2014 .


### the commission shall be empowered to adopt delegated acts in accordance with article 22 to adapt the maximum yields laid down in paragraph 1 , taking into account scientific development and internationally agreed standards . ### the commission shall be empowered to adopt delegated acts in accordance with article 22 to adapt the maximum yields laid down in paragraph 1 , based on sound and undisputed scientific evidence and internationally agreed standards . the commission shall provide appropriate consultation in respect of the delegation of powers with due consideration given to the opinion expressed by the european parliament and the european council .


### member states shall oblige retail outlets intending to engage in cross - border distance sales to consumers located in the union to register with the competent authorities in the member state where the retail outlet is established and in the member state where the actual or potential consumer is located . retail outlets established outside the union have to register with the competent authorities in the member state where the actual or potential consumer is located . all retail outlets intending to engage in cross - border distance sales shall submit at least the following information to the competent authorities : name or corporate name and permanent address of the place of activity from where the tobacco products are supplied ; b ) the starting date of the activity of offering tobacco products for cross - border distance sales to the public by means of information society services ; c ) the address of the website / - s used for that purpose and all relevant information necessary to identify the website . 2 . the competent authorities of the member states shall publish the complete list of all retail outlets registered with them in accordance with the rules and safeguards laid down in directive 95 / 46 / ec retail outlets may only start placing tobacco products on the market in form of distance sales as of the moment the name of the retail outlet is published in the relevant member states . 3 . if it is necessary in order to ensure compliance and facilitate enforcement , member states of destination may require that the retail outlet nominates a natural person who is responsible for verifying the tobacco products before reaching the consumer comply with the national provisions adopted pursuant to this directive in the member state of destination 4 . retail outlets engaged in distance sales shall be equipped with an age verification system , which verifies at the time of sale , that the purchasing consumer respects the minimum age foreseen under the national legislation of the member state of destination . the retailer or nominated natural person shall report to the competent authorities a description of the details and functioning of the age verification system . 5 . personal data of the consumer shall only be processed in accordance with directive 95 / 46 / ec and not be disclosed to the manufacturer of tobacco products or companies forming part of the same group of companies or to any other third parties . personal data shall not be used or transferred beyond the purpose of this actual purchase . this also applies if the retail outlet forms part of a manufacturer of tobacco products . ### member states shall prohibit the sale of tobacco products over the internet in their territory .


### cross - border distance sales of tobacco products ### internet sales of tobacco products


### in relation to the fixing of maximum yields , it might be necessary and appropriate at a later date to adapt the yields fixed or to fix maximum thresholds for emissions , taking into consideration their toxicity or addictiveness . ### in relation to the fixing of maximum yields , it might be necessary and appropriate at a later date to adapt the yields fixed or to fix maximum thresholds for emissions , taking into consideration scientific progress and internationally agreed standards in order to evaluate their toxicity or addictiveness .


### member states shall notify the commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes . taking into account internationally agreed standards , where available , and based on scientific evidence and on the yields notified by member states , the commission shall be empowered to adopt delegated acts in accordance with article 22 to adopt and adapt maximum yields for other emissions of cigarettes and for emissions of tobacco products other than cigarettes that increase in an appreciable manner the toxic or addictive effect of tobacco products beyond the threshold of toxicity and addictiveness stemming from the yields of tar , nicotine and carbon monoxide fixed in paragraph 1 . ### member states shall notify the commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes . taking into account internationally agreed standards based on sound and undisputed scientific evidence and on the yields notified by member states , the commission shall be empowered to adopt delegated acts in accordance with article 22 to adopt and adapt maximum yields for other emissions of cigarettes and for emissions of tobacco products other than cigarettes that increase in an appreciable manner the toxic or addictive effect of tobacco products beyond the threshold of toxicity and addictiveness stemming from the yields of tar , nicotine and carbon monoxide fixed in paragraph 1 . the commission shall provide appropriate consultation in respect of the delegation of powers with due consideration given to the opinion expressed by the european parliament and the european council .


### ‘ ingredient’ means an additive , tobacco , as well as any substance present in a finished tobacco product including paper , filter , inks , capsules and adhesives ; ### ‘ ingredient’ means an additive , as well as any substance present in a finished tobacco product including paper , filter , inks , capsules and adhesives ;


### the following nicotine - containing products may only be placed on the market if they were authorised pursuant to directive 2001 / 83 / ec : products with a nicotine level exceeding 2 mg per unit , or products with a nicotine concentration exceeding 4 mg per ml or products whose intended use results in a mean maximum peak plasma concentration exceeding 4 ng of nicotine per ml . 2 . the commission shall be empowered to adopt delegated acts in accordance with article 22 to update the nicotine quantities set out in paragraph 1 taking into account scientific developments and marketing authorisations granted to nicotine - containing products pursuant to directive 2001 / 83 / ec . 3 . each unit packet and any outside packaging of nicotine - containing products below the thresholds set out in paragraph 1 shall carry the following health warning : this product contains nicotine and can damage your health . 4 . the health warning referred to in paragraph 3 shall comply with the requirements specified in article 10 . in addition , it shall : be printed on the two largest surfaces of the unit packet and any outside packaging ; cover 30 % of the external area of the corresponding surface of the unit packet and any outside packaging . that proportion shall be increased to 32 % for member states with two official languages and 35 % for member states with three official languages . 5 . the commission shall be empowered to adopt delegated acts in accordance with article 22 to adapt the requirements in paragraphs 3 and 4 taking into account scientific and market developments and to adopt and adapt the position , format , layout , design and rotation of the health warnings . ### nicotine - containing products may only be placed on the market if they were authorised pursuant to directive 2001 / 83 / ec .


### ' ingredient ' means an additive , tobacco , as well as any substance present in a finished tobacco product including paper , filter , inks , capsules and adhesives ; ### ‘ ingredient’ means an additive , as well as any substance present in a finished tobacco product including paper , filter , inks , capsules and adhesives ;


### member states shall prohibit the placing on the market of tobacco products with a characterising flavour . ### member states shall prohibit the placing on the market of tobacco products with a characterising flavour in accordance with paragraph - 1 .


### all tobacco products have the potential to cause mortality , morbidity and disability and their consumption should be contained . it is therefore important to monitor developments as regards novel tobacco products . a notification obligation for novel tobacco products should be put on manufacturers and importers , without prejudice to the power of the member states to ban or to authorise them . the commission should monitor the development and submit a report 5 years after the transposition deadline of this directive , in order to assess whether amendments to this directive are necessary . ### all tobacco products have the potential to cause mortality , morbidity and disability and their consumption should be contained by means of education and prevention from taking up the habit of smoking . it is therefore important to monitor developments as regards novel tobacco products . a notification obligation for novel tobacco products should be put on manufacturers and importers , without prejudice to the power of the member states to ban or to authorise them . the commission should monitor the development and submit a report 5 years after the transposition deadline of this directive , in order to assess whether amendments to this directive are necessary .


### ‘ flavouring’ means an additive that imparts aroma and / or taste ; ### ‘ flavouring’ means an additive that imparts aroma and / or taste but is not essential to the process of manufacturing the tobacco product ;


### the food and the goods for homeless persons or for children may be purchased by the partner organisations themselves . ### the food and the goods for the end recipients may be purchased by the partner organisations themselves .


### where a public body purchases the food or basic consumer goods for personal use of homeless persons or of children and provide them to partner organisations , the costs of transporting of food or goods to the storage depots of the partner organisations at a flat rate of 1 % of the costs referred to in point ; ### where a public body purchases the food or basic consumer goods for personal use of end recipients and provides them to partner organisations , the costs of transporting of food or goods to the storage depots of the partner organisations at a flat rate of 1 % of the costs referred to in point ;


### the operational programme of each member state should identify and justify the forms of material deprivation to be addressed , and describe the objectives and features of the assistance to the most deprived persons that will be provided through the support of national schemes . it should also include elements necessary to ensure effective and efficient implementation of the operational programme . ### amendement the operational programme of each member state should identify and justify the forms of material deprivation to be addressed , and describe the objectives and features of the assistance to the most deprived persons that will be provided through the support of national schemes . access to food should be the first deprivation to be addressed by the member states . the programme should also include elements necessary to ensure its effective and efficient implementation .


### 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 eur 3&#160 ; 500&#160 ; 000&#160 ; 000 at 2011 prices , in accordance with the annual breakdown set out in annex ii .


### the costs of purchasing food and basic consumer goods for personal use of homeless persons or of children ; ### the costs of purchasing food and basic consumer goods for personal use of end recipients ;


### it is necessary to establish a maximum level of co - financing from the fund to the operational programmes to provide for a multiplier effect of union resources , while the situation of member states facing temporary budget difficulties should be addressed . ### the member states most in need of the fund are least likely to be able to afford to co - finance the measures , therefore the fund should be 100% funded by the union in order to ensure the highest possible uptake of the fund .


### the co - financing rate at the level of the operational programme shall not be higher than 85% of the public eligible expenditure . ### the co - financing rate at the level of the operational programme shall not be higher than 95% of the public eligible expenditure .


### it is necessary to establish a maximum level of co - financing from the fund to the operational programmes to provide for a multiplier effect of union resources , while the situation of member states facing temporary budget difficulties should be addressed . ### it is necessary to establish a maximum level of co - financing from the fund to the operational programmes to provide for a multiplier effect of union resources , while the situation of member states currently receiving macrofinancial assistance should be addressed and an exception clause laid down , departing from the co - financing arrangements .


### the co - financing rate at the level of the operational programme shall not be higher than 85% of the public eligible expenditure . ### the financing rate at the level of the operational programme shall be set at 100% of the public eligible expenditure .


### in order to set out an appropriate financial framework , the commission should establish , by means of implementing acts , an annual breakdown of global resources by member state using an objective and transparent method reflecting disparities in terms of poverty and material deprivation . ### in order to set out an appropriate financial framework , the commission should establish , by means of implementing acts , an annual breakdown of global resources by member state using an objective and transparent method reflecting disparities in terms of poverty and material deprivation , such as the relative poverty threshold .


### ' partner organisations ' means public bodies or non - for - profit organisations that deliver the food or goods directly or through other partner organisations to the most deprived persons , and whose operations have been selected by the managing authority in accordance with article 29 ; ### ' partner organisations ' means public bodies or non - for - profit organisations that deliver the food and goods directly or through other partner organisations to the most deprived persons , and whose operations have been selected by the managing authority in accordance with article 29 ;


### ' a worker ' means owner - managers of micro , small and medium - sized enterprises and self - employed workers and all members of the household active in the business , provided that , if farmers , they were already producing the output affected by the relevant trade agreement before the measures concerning the specific sector were implemented . ### ' a worker ' means owner - managers of micro , small and medium - sized enterprises and self - employed workers and all members of the household active in the business , provided that they were already engaged in the activity directly affected by the deterioration of the local , regional or national economic climate .


### in order to maintain the european nature of the egf , an application for support should be triggered when the number of redundancies reaches a minimum threshold . in small labour markets , such as small member states or remote regions , and in exceptional circumstances , applications may be submitted for a lower number of redundancies . as regards farmers , the necessary criteria should be determined by the commission in relation to the consequences of each trade agreement . ### in order to maintain the european nature of the egf , an application for support should be triggered when the number of redundancies reaches a minimum threshold . in small labour markets , such as small member states or remote regions , and in exceptional circumstances , applications may be submitted for a lower number of redundancies .


### redundant workers should have equal access to the egf independently of their type of employment contract or employment relationship . therefore , workers with fixed term contracts and temporary agency workers made redundant as well as owner - managers of micro , small and medium - sized enterprises and self - employed workers who cease their activities and farmers who change or adjust their activities to a new market situation following trade agreements , should be regarded as redundant workers for the purposes of this regulation . ### redundant workers should have equal access to the egf independently of their type of employment contract or employment relationship . therefore , workers with fixed term contracts and temporary agency workers made redundant as well as owner - managers of micro , small and medium - sized enterprises and self - employed workers who cease their activities , should be regarded as redundant workers for the purposes of this regulation .


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


### a financial contribution may be made for active labour market measures that form part of a coordinated package of personalised services , designed to facilitate the re - integration of the targeted redundant workers into employment or self - employment or , in the case of farmers , to change or adjust their previous activities . the coordinated package of personalised services may include in particular : ### a financial contribution may be made for active labour market measures that form part of a coordinated package of personalised services , designed to facilitate the re - integration of the targeted redundant workers into employment or self - employment or to change or adjust their previous activities . the coordinated package of personalised services may include in particular :


### the cost of investments in physical assets for self - employment and business start - up or for changing or adjusting activity may not exceed eur 35 000 . ### the cost of investments in physical assets for self - employment and business start - up or for changing or adjusting activity may not , in general terms , exceed eur 35 000 . in the agricultural sector , the commission may raise these limits by means of a delegated act adopted pursuant to article 24 .


### a reasoned analysis of the link between the redundancies and the major structural changes in world trade patterns , or the serious disruption of the local , regional or national economy caused by an unexpected crisis , or the new market situation in the agricultural sector in the member state and resulting from the effects of a trade agreement initialled by the european union in accordance with article xxiv of the gatt or a multilateral agreement initialled within the world trade organisation as per article 2 . this analysis shall be based on statistical and other information at the most appropriate level to demonstrate the fulfilment of the intervention criteria set out in article 4 ; ### a reasoned analysis of the link between the redundancies and the major structural changes in world trade patterns , or the serious disruption of the local , regional or national economy caused by an unexpected crisis . this analysis shall be based on statistical and other information at the most appropriate level to demonstrate the fulfilment of the intervention criteria set out in article 4 ;


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


### in order to cover the needs arising during the final months of each year , it is necessary to ensure that at least one quarter of the annual maximum amount of the egf remains available on 1 september . financial contributions made during the remainder of the year should be allocated taking into account the overall ceiling laid down for support to farmers in the multiannual financial framework . ### in order to cover the needs arising during the final months of each year , it is necessary to ensure that at least one quarter of the annual maximum amount of the egf remains available on 1 september .


### for owner - managers of micro , small and medium - sized enterprises and self - employed workers , the redundancy shall be counted either from the date of cessation of the activities caused by any of the conditions set out in article 2 , and determined in accordance with national law or administrative provisions , or from the date specified by the commission in the delegated act adopted in accordance with the article 4 . ### for owner - managers of micro , small and medium - sized enterprises and self - employed workers , the redundancy shall be counted either from the date of cessation of the activities caused by any of the conditions set out in article 2 , and determined in accordance with national law or administrative provisions .


### expenditure shall be eligible for a financial contribution from the dates set out in article 8 on which the member state starts the personalised services to the targeted workers or the administrative expenditure to implement the egf in accordance with article 7 and respectively . in the case of farmers , expenditure shall be eligible for a contribution from the date set in the delegated act taken in accordance with article 4 . ### expenditure shall be eligible for a financial contribution from the dates set out in article 8 on which the member state starts the personalised services to the targeted workers or the administrative expenditure to implement the egf in accordance with article 7 and respectively .


### redundant workers should have equal access to the egf independently of their type of employment contract or employment relationship . therefore , workers with fixed term contracts and temporary agency workers made redundant as well as owner - managers of micro , small and medium - sized enterprises and self - employed workers who cease their activities and farmers who change or adjust their activities to a new market situation following trade agreements , should be regarded as redundant workers for the purposes of this regulation . ### redundant workers should have equal access to the egf independently of their type of employment contract or employment relationship . therefore , workers with fixed term contracts and temporary agency workers made redundant as well as owner - managers of micro , small and medium - sized enterprises and self - employed workers , including farmers who cease or profoundly change their activities , should be regarded as redundant workers for the purposes of this regulation .


### where owner - managers of micro , small and medium - sized enterprises and self - employed workers change or , in the case of farmers , adjust their previous activities , such situations shall be considered as redundancies for the purposes of this regulation . ### where owner - managers of micro , small and medium - sized enterprises and self - employed workers change or adjust their previous activities such situations shall be considered as redundancies for the purposes of this regulation .


### the member state shall submit a complete application to the commission within a period of 12 weeks from the date on which the criteria set in article 4 or are met or , where applicable , before the deadline set by the commission in accordance with article 4 . in exceptional and duly justified circumstances the application may be supplemented with additional information by the applicant member state within six months from the date of application , following which the commission shall assess the application on the basis of the available information . the commission shall complete its assessment of the application within twelve weeks of the date of receipt of a complete application or six months after the date of the initial application , whichever is the earlier . ### the member state shall submit a complete application to the commission within a period of 12 weeks from the date on which the criteria set in article 4 or are met . in exceptional and duly justified circumstances the application may be supplemented with additional information by the applicant member state within six months from the date of application , following which the commission shall assess the application on the basis of the available information . the commission shall complete its assessment of the application within twelve weeks of the date of receipt of a complete application or six months after the date of the initial application , whichever is the earlier .


### the applicant member state may provide personalised services co - financed by the egf to affected workers , who may include : all workers being made redundant in accordance with article 5 , within the period provided for in article 4 , or , workers being made redundant before or after the period provided for in article 4 or , in cases where an application under article 4 derogates from the criteria set out in article 4 , farmers changing or adjusting their previous agricultural activities following the initialling by the union of a trade agreement referred to in the delegated act taken in accordance with article 4 . ### the applicant member state may provide personalised services co - financed by the egf to affected workers , who may include : all workers being made redundant in accordance with article 5 , within the period provided for in article 4 or , workers being made redundant before or after the period provided for in article 4 or , in cases where an application under article 4 derogates from the criteria set out in article 4 .


### candidate countries and potential candidates need to be better prepared to withstand global challenges , such as sustainable development and climate change , and align with the union ' s efforts to address these issues . union assistance under this regulation should also contribute to the goal of raising the climate - related proportion of the union budget to at least 20 % . ### candidate countries and potential candidates need to be better prepared to withstand global challenges , such as sustainable development and climate change , and align with the union ' s efforts to address these issues . investment in human resources to provide new skills and competences shall be made . union assistance under this regulation should also contribute to the goal of raising the climate - related proportion of the union budget to at least 20 % .


### economic reforms necessary to cope with competitive pressure and market forces within the union , while pursuing economic , social and environmental goals ; ### economic reforms necessary to cope with competitive pressure and market forces within the union , while pursuing economic , social and environmental goals and fostering job creation with particular reference to smes ;


### the financial reference amount for the implementation of this regulation for the period from 2014 to 2020 shall be eur&#160 ; 14&#160 ; 110&#160 ; 100&#160 ; 000 . up to 3% of the financial reference amount shall be allocated to cross - border cooperation programmes between beneficiary countries and eu member states . ### the financial reference amount for the implementation of this regulation for the period from 2014 to 2020 shall be eur&#160 ; 14&#160 ; 110&#160 ; 100&#160 ; 000 . up to 3% of the financial reference amount shall be allocated to cross - border cooperation programmes between beneficiary countries and eu member states and 1 , 5% of the financial reference shall be reserved for civil society and social partner organizations .


### – progress in economic reforms ; the soundness and effectiveness of social and economic development strategies , progress towards smart , sustainable and inclusive growth , including through public investments supported by ipa ; ### – progress in socio - economic reforms ; the soundness and effectiveness of social and economic development strategies , progress towards smart , sustainable and inclusive growth and the creation of quality education , training and employment , including through public investments supported by ipa ;


### – progress in the areas of democracy , the rule of law , the respect of human rights and fundamental freedoms , the justice system and the level of administrative capacity ; ### – progress in the areas of democracy , the rule of law , the respect of human rights and fundamental freedoms , the justice system and the level of administrative capacity and the quality of civil dialogue and social dialogue between employers ' organizations and trade unions ;


### where goods other than those covered by articles 23 and 24 are suspected of infringing an intellectual property right , the holder of the decision granting the application shall initiate proceedings to determine whether an intellectual property right has been infringed within 10 working days of dispatch of the decision to suspend the release of the goods or to detain them . ### where goods other than those covered by articles 23 and 24 are suspected of infringing an intellectual property right , the holder of the decision granting the application shall initiate proceedings to determine whether an intellectual property right has been infringed within 10 working days of receipt of the decision to suspend the release of the goods or to detain them .


### regulation no 1383 / 2003 does not cover certain intellectual property rights and excludes certain infringements . in order to strengthen the enforcement of intellectual property rights , customs control should therefore be extended to other types of infringements , such as infringements resulting from parallel trade , as well as other infringements of rights already enforced by customs authorities but not covered by regulation no 1383 / 2003 . for the same purpose it is appropriate to include in the scope of this regulation , in addition to the rights already covered by regulation no 1383 / 2003 , trade names in so far as they are protected as exclusive property rights under national law , topographies of semiconductor products , utility models and devices to circumvent technological measures , as well as any exclusive intellectual property right established by union legislation . ### regulation no 1383 / 2003 does not cover certain intellectual property rights and excludes certain infringements . in order to strengthen the enforcement of intellectual property rights , customs control should therefore be extended to other types of infringements not covered by regulation no 1383 / 2003 . for this purpose it is appropriate to include in the scope of this regulation , in addition to the rights already covered by regulation no 1383 / 2003 , trade names in so far as they are protected as exclusive property rights under national law , topographies of semiconductor products , utility models and devices to circumvent technological measures .


### goods which are subject of an action infringing an intellectual property right under the law of the union or of that member state ; ### goods which are subject of an action infringing an intellectual property right in the member state where the goods are found ;


### administrative sanctions ### sanctions


### taking into account the provisional and preventive character of the measures adopted by the customs authorities in this field and the conflicting interests of the parties affected by the measures , some aspects of the procedures should be adapted to ensure a smooth application of the regulation , whilst respecting the rights of the concerned parties . thus , with respect to the various notifications envisaged by this regulation , the customs authorities should notify the most appropriate person , on the basis of the documents concerning the customs treatment or of the situation in which the goods are placed . the periods laid down in this regulation for the required notifications should be counted from the time those are sent by the customs authorities in order to align all periods of notifications sent to the concerned parties . the period allowing for a right to be heard before an adverse decision is taken should be three working days , given that the holders of decisions granting applications for action have voluntarily requested the customs authorities to take action and that the declarants or holders of the goods must be aware of the particular situation of their goods when placed under customs supervision . in the case of the specific procedure for small consignments , where consumers are likely to be directly concerned and cannot be expected to have the same level of diligence as other economic operators usually involved in the accomplishment of customs formalities , that period should be significantly extended . ### taking into account the provisional and preventive character of the measures adopted by the customs authorities in this field and the conflicting interests of the parties affected by the measures , some aspects of the procedures should be adapted to ensure a smooth application of the regulation , whilst respecting the rights of the concerned parties . thus , with respect to the various notifications envisaged by this regulation , the customs authorities should notify the most appropriate person , on the basis of the documents concerning the customs treatment or of the situation in which the goods are placed . the periods laid down in this regulation for the required notifications should be counted from the time those have been received . the period allowing for a right to be heard before an adverse decision is taken should be three working days after receipt , given that the holders of decisions granting applications for action have voluntarily requested the customs authorities to take action and that the declarants or holders of the goods must be aware of the particular situation of their goods when placed under customs supervision . in the case of the specific procedure for small consignments , where consumers are likely to be directly concerned and cannot be expected to have the same level of diligence as other economic operators usually involved in the accomplishment of customs formalities , that period should be significantly extended .


### a utility model as provided for by the legislation of a member state ; ### a utility model insofar as it is protected as an exclusive intellectual property right by the legislation of a member state ,


### before adopting a decision to suspend the release of the goods or to detain them , the customs authorities shall communicate their intention to the declarant or , in cases where goods are to be detained , to the holder of the goods . the declarant or the holder of the goods shall be given the opportunity to express his / her views within three working days of dispatch of that communication . ### before adopting a decision to suspend the release of the goods or to detain them , the customs authorities shall communicate their intention to the declarant or , in cases where goods are to be detained , to the holder of the goods . the declarant or the holder of the goods shall be given the opportunity to express his / her views within three working days of receipt of that communication .


### goods which are subject of an action infringing an intellectual property right under the law of the union or of that member state ; ### goods which are the subject of an action infringing an intellectual property right under the law of the union or of that member state or goods for which it cannot be ruled out that they are the subject of such an action , and which at the same time pose a clear threat to the health or safety of consumers ;


### the customs authorities shall , upon request and if known , provide the holder of the decision granting the application with the names and addresses of the consignee , the consignor , the declarant or the holder of the goods , the customs procedure and the origin , provenance and destination of goods suspected of infringing an intellectual property right . ### the customs authorities shall , upon request and if known , provide the holder of the decision granting the application with the names and addresses of the consignee , the consignor , the declarant or the holder of the goods , the customs procedure and the origin , provenance and destination of goods suspected of infringing an intellectual property right . for goods in transit that are suspected of infringing an intellectual property right in the country of destination , the customs authorities may communicate this information to the customs authorities in the destination country using inter alia the world customs organisation safe framework .


### is impartial and free from any conflict of interest as regards the exercise of the specific official control tasks delegated to it ; ### is impartial , independent , not directly nor indirectly employed by the operator on which it is performing control activities , and otherwise free from any conflict of interest as regards the exercise of the specific official control tasks delegated to it ;


### is impartial and free from any conflict of interest as regards the exercise of the specific official control tasks delegated to it ; ### is independent and free from any conflict of interest as regards the exercise of the specific official control tasks delegated to it ;


### samples shall be taken , handled and labelled in such a way as to guarantee their legal , scientific and technical validity . ### samples shall be taken , handled and labelled in such a way as to guarantee their legal , scientific and technical validity . the size of the sample taken must be such as to enable a second expert opinion to be given , where necessary , should an operator so request under article 34 .


### where such checks are performed on animals they shall be carried out by an official veterinarian or under his supervision . ### where such checks are performed on animals or on products of animal origin , they shall be carried out by an official veterinarian or under his supervision .


### on operators and the activities and operations under their control , on their premises and processes , on the storage , transport , and the use of goods and the keeping of animals . ### on operators and the activities and operations under their control , on their premises , land , crops and processes , on the storage , transport and the use of goods and on the keeping of animals .


### decisions on consignments of animals shall be taken by an official veterinarian or under his supervision . ### decisions on consignments of animals shall be taken by an official veterinarian , who may be assisted by specially trained support staff whilst retaining responsibility for the checks carried out .


### competent authorities shall be entitled to publish or make otherwise available to the public information about the rating of individual operators based on the outcome of official controls , provided that the following conditions are met : ### competent authorities shall publish or make otherwise available to the public information about the rating of individual operators through the use of food hygiene rating schemes . this shall be based on the outcome of official controls , provided that the following conditions are met :


### developing or coordinating the development of methods for the assessment of the level of welfare of animals and of methods for the improvement of the welfare of animals ; ### helping to develop and coordinate methods for the assessment of the level of welfare of animals and methods for the improvement of the welfare of animals ;


### paragraphs 1 and 2 shall not prevent the competent authorities from publishing or making otherwise available to the public information about the outcome of official controls regarding individual operators , provided that the following conditions are met : ### competent authorities shall publish or make otherwise available to the public information about the outcome of official controls regarding individual operators , provided that the following conditions are met :


### ' delegated body ' means a third party , to which the competent authorities have delegated specific official control tasks ; ### ‘ delegated body’ means a third party , to which the competent authorities have delegated specific tasks relating to official controls and other official activities ;


### ' control authority for organic products ' means a public administrative organisation of a member state to which the competent authorities have conferred , in whole or in part , their competences in relation to the application of regulation no 834 / 2007 , including , where appropriate , the corresponding authority of a third country or operating in a third country ; ### ‘ control authority for organic production’ means a public administrative organisation of a member state to which the competent authorities have conferred , in whole or in part , their competences for inspections and certification in the organic production sector , in relation to the provisions of regulation no 834 / 2007 , including , where appropriate , the corresponding authority of a third country or operating in a third country ;


### designate a single authority responsible to coordinate the cooperation and the contacts with the commission and other member states in relation to the official controls and other official activities performed in that area . ### designate a single authority responsible to coordinate the cooperation and the contacts with the commission and other member states in relation to the official controls and other official activities performed in each of the sectors defined by the member state , in such a way as to cover all the areas referred to in article 1 .


### official controls shall be performed as much as possible in a manner that minimises the burden on the operators . ### official controls shall be performed as much as possible in a manner that minimises the burden on the operators ; to that end , where the same operator is subject to various official controls over the same period , the competent authority shall aggregate them .


### for the purpose of ensuring that competent authorities are provided with adequate resources for the performance of official controls , the competent authorities shall collect fees to recover the costs they incur in relation to : ### for the purpose of ensuring that competent authorities are provided with adequate resources for the performance of official controls , the competent authorities may collect fees to recover , some or all of the costs they incur in relation to :


### each competent authority shall make available to the public the following information for each reference period : ### each competent authority shall at regular intervals , and at the minimum at the time of publication pursuant to article 79a , make available to the public the following information :


### mandatory fees ### fees or contributions to costs


### have , or have access to , a sufficient number of suitably qualified and experienced staff so that official controls and other official activities can be performed efficiently and effectively ; ### have , or have access to , a sufficient number of independent , suitably qualified and experienced staff so that official controls and other official activities can be performed efficiently and effectively ;


### their documents and any other relevant information . ### their documents and any other information that is relevant for the purpose of performing such controls or activities .


### to the extent that this is necessary for the performance of official controls or of other official activities , operators shall , where required by the competent authorities , give staff of the competent authorities access to : ### to the extent that this is necessary for the performance of official controls or of other official activities , operators shall , where required by the competent authorities , give staff of the competent authorities and staff of the delegated bodies , where specific official control tasks have been delegated in accordance with the provisions of article 25 , access to :


### the commission may , by means of implementing acts , designate european union reference centres that shall support the activities of the commission and of the member states in relation to the application of the rules referred to in point of article 1 . ### the commission shall , by means of implementing acts , designate european union reference centres that shall support the activities of the commission and of the member states in relation to the application of the rules referred to in point of article 1 .


### the amount of the fees provided for in article 77 applied to each category of operators , and for each category of official controls ; ### the amount of the fees provided for in article 77 applied to each category of operators , and for official controls ;


### articles 15 , 18 , 45 to 62 and 76 to 84 , point of article 150 , point of article 152 , point of article 154 , point of article 155 and point of article 156 shall apply from [ office of publications , please insert date of entry into force this regulation + 3 years ] . ### articles 15 , 18 , 45 to 62 and 76 to 84 , point of article 152 , point of article 154 and point of article 155 shall apply from [ office of publications , please insert date of entry into force this regulation + 3 years ] . point of article 150 and point of article 156 shall not apply until the delegated acts that replace them are in force .


### ' plant protection products ' means plant protection products as referred to in article 2 of regulation no 1107 / 2009 ; ### ' plant protection products ' means plant protection products as referred to in article 2 of regulation no 1107 / 2009 ; for the purposes of this regulation , ‘ plant protection products’ also refers to the active substances referred to in article 2 of regulation no 1107 / 2009 and other substances or preparations referred to in article 2 of that regulation ;


### during official controls and other official activities , operators shall assist the staff of the competent authorities in the accomplishment of their tasks . ### during official controls and other official activities , operators shall assist the staff of the competent authorities in the accomplishment of their control tasks .


### competent authorities shall perform official controls with a high level of transparency and make available to the public relevant information concerning the organisation and the performance of official controls . ### competent authorities shall perform official controls with a high level of transparency and make available to the public relevant information concerning the results of the controls and the conformity of the production and products with the requirements of this regulation . where a threat to public health is detected , special measures shall be taken to inform the public of this .


### that a sufficient number of other samples be taken for a second expert opinion ; or , ### that a sufficient number of samples be taken for a second expert opinion ; or


### for the purpose of ensuring that competent authorities are provided with adequate resources for the performance of official controls , the competent authorities shall collect fees to recover the costs they incur in relation to : ### for the purpose of ensuring that competent authorities are provided with adequate resources for the performance of official controls , the competent authorities may collect fees or contributions to costs to recover the costs they incur in relation to :


### the type , number and outcome of official controls ; ### the type , number and final outcome of official controls ;


### articles 14 , 15 , 16 , 21 , 22 , 23 , 24 and 26 are deleted ; ### articles 14 , 15 , 16 , 21 , 23 , 24 and 26 are deleted ;


### the rules laid down in regulation no 1234 / 2007 ; ### the rules laid down in regulation no 1234 / 2007 in areas other than those under part ii , title ii , chapter i of that regulation ;


### competent authorities responsible for the verification of compliance with the rules referred to in point of article 1 may confer specific official control tasks to one or more control authorities for organic products . in such cases , they shall attribute a code number to each of them . ### competent authorities responsible for the verification of compliance with the rules referred to in point of article 1 may confer specific official control tasks to one or more control authorities for organic production . in such cases , they shall attribute a code number to each of them .


### the competent authorities shall collect fees in accordance with article 77 to recover the following costs : ### the competent authorities shall be entitled , when calculating fees or contributions to costs in accordance with article 77 , to take the following criteria into account :


### have arrangements in place to ensure the impartiality , quality and consistency of official controls and other official activities at all levels ; ### have arrangements in place to ensure the independence , quality and consistency of official controls and other official activities at all levels ;


### uniform specific requirements for the performance of official controls and uniform minimum frequency of such official controls , concerning the manufacture , placing on the market , entry into the union , labelling , packaging , transport , storage and use of plant protection products , having regard , in addition to the criteria referred to in article 8 , to the need to ensure the safe and sustainable use of plant protection products and to combat illegal trade of such products ; ### uniform specific requirements for the performance of official controls and uniform minimum frequency of such official controls , concerning the manufacture , placing on the market , entry into the union , labelling , packaging , transport , storage , parallel trade and use of plant protection products , having regard , in addition to the criteria referred to in article 8 , to the need to ensure the safe and sustainable use of plant protection products and to combat illegal trade of such products ;


### for the purpose of ensuring that competent authorities are provided with adequate resources for the performance of official controls , the competent authorities shall collect fees to recover the costs they incur in relation to : ### for the purpose of ensuring that competent authorities are provided with adequate resources for the performance of official controls and other official activities , the competent authorities shall collect fees to recover the costs they incur in relation to :


### order the unloading , transfer to another means of transport , holding and care of animals , quarantine periods , the postponement of the slaughter of animals ; ### order the unloading , transfer to another means of transport , holding in suitable accommodation with appropriate care of animals , quarantine periods , the postponement of the slaughter of animals ;


### governing the deliberate release into the environment and the contained use of gmos ; ### governing the deliberate release into the environment of gmos ;


### where such checks are performed on animals they shall be carried out by an official veterinarian or under his supervision . ### where such checks are performed on animals they shall be carried out by an official veterinarian , who may be assisted by specially trained support staff whilst retaining responsibility for the checks carried out .


### paragraphs 2 to 14 are deleted ; ### paragraphs 3 to 6 and 8 to 14 are deleted ;


### the method used to establish the fees provided for in article 77 , including the data and estimates used for the establishment of the flat rate fees referred to in point of article 79 ; ### the method used to establish the fees provided for in article 77 ;


### for the performance of official controls aimed at verifying the correct application of union agri - food chain legislation , and of the other official activities entrusted to member state authorities by union agri - food chain legislation , member states should designate competent authorities which act in the public interest , are appropriately resourced and equipped , and offer guarantees of impartiality and professionalism . competent authorities should ensure the quality , consistency and effectiveness of official controls . ### for the performance of official controls aimed at verifying the correct application of union agri - food chain legislation , and of the other official activities entrusted to member state authorities by union agri - food chain legislation , member states should designate competent public authorities which act in the public interest and ensure the quality , consistency and effectiveness of official controls . the designated competent authority , or authorities , should be appropriately resourced and equipped , and member states should be able to guarantee their impartiality and professionalism by ensuring their independence from any operator operating within the agri - food chain .


### competent authorities shall perform official controls on all operators regularly , on a risk basis and with appropriate frequency , taking account of : ### competent authorities shall perform official controls on operators at suitable intervals , in line with the risks that may arise in relation to the area concerned , with appropriate frequency , and taking account of :


### the procedure for the application of the fines on the member states which fail to take effective measures to correct macroeconomic imbalances should be construed in such a way that the application of the fine on those member states would be the rule and not the exception . ### the procedure for the application of the fines on the member states which fail to take effective measures to correct macroeconomic imbalances should be construed in such a way that the application of the fine on those member states would be fair and efficient .


### the collected fines should be distributed between member states whose currency is the euro which are neither the subject of an excessive imbalance procedure nor have an excessive deficit . ### the collected fines should be used in support of achieving the union’s long - term investment and jobs objectives .


### fines collected in accordance with article 3 of this regulation shall constitute other revenue , as referred to in article 311 of the treaty , and shall be distributed , in proportion to their share in the total gross national income of the eligible member states , between member states whose currency is the euro and which are not the subject of an excessive imbalance procedure within the meaning of regulation no [ … / … ] and do not have an excessive deficit as determined in accordance with article 126 of the treaty . ### fines collected in accordance with article 3 of this regulation shall constitute other revenue , as referred to in article 311 tfeu , and shall be used in support of achieving the union’s long - term investment and jobs objectives .


### ‘ the competent authorities referred to in article 32 shall cooperate in view of achieving a convergence of the requirements set out in this article . they shall cooperate with the european securities and markets authority and the competent authorities referred to in article x of regulation [ xxx ] of [ xxx ] in so far as such convergence relates to the statutory audit of public - interest entities . ’ ### ‘ the competent bodies referred to in article 32 shall cooperate with a view to achieving a minimum convergence of the requirements set out in this article . they shall cooperate with esma in so far as such convergence relates to the statutory audits of public - interest entities . ’ .


### ‘ the competent authorities referred to in article 32 shall cooperate in view of achieving a convergence of the requirements set out in this article . they shall cooperate with the european securities and markets authority and the competent authorities referred to in article x of regulation [ xxx ] of [ xxx ] in so far as such convergence relates to the statutory audit of public - interest entities . ’ ### ‘ the competent authorities referred to in article 32 shall cooperate in view of achieving a convergence of the requirements set out in this article . they shall cooperate with the european group of auditors’ oversight bodies and the competent authorities referred to in article [ xxx ] regulation [ xxx ] of [ xxx ] in so far as such convergence relates to the statutory audits of public - interest entities . ’ .


### member states shall ensure that when carrying out a statutory audit , the statutory auditor and / or the audit firm and any holder of voting rights in the audit firm is independent of the audited entity and is not involved in the decision - taking of the audited entity . ### member states shall ensure that when carrying out a statutory audit , the statutory auditor and / or the audit firm and any holder of voting rights in the audit firm is independent of the audited entity and is not involved in the decision - taking of the audited entity or in the provision of any non - audit services .


### the activities referred to in paragraphs 2 and 6 shall be subject to receiving a prior favourable opinion of the commission . ### the activities referred to in paragraphs 2 , 5 , and 6 shall be subject to receiving a prior favourable opinion of the commission and to consultation of the european parliament .


### efficient management of the external borders through checks and surveillance contributes to combat illegal immigration and trafficking in human beings and to reduce the threats to the internal security , public policy , public health and international relations of the member states . ### efficient management of the external borders through checks and surveillance contributes to combating irregular immigration and trafficking in human beings and to reducing the threats to the internal security , public policy , public health and international relations of the member states .


### the tasks of the liaison officers shall include , in compliance with european union law and in accordance with fundamental rights , the establishment and maintaining of contacts with the competent authorities of the third country to which they are assigned to with a view to contribute to the prevention of and fight against illegal immigration and the return of illegal migrants . ### the tasks of the liaison officers shall include , in compliance with european union law and in accordance with fundamental rights , the establishment and maintaining of contacts with the competent authorities of the third country to which they are assigned to with a view to contribute to the prevention of and fight against irregular immigration and the return of irregular migrants .


### efficient management of the external borders through checks and surveillance contributes to combat illegal immigration and trafficking in human beings and to reduce the threats to the internal security , public policy , public health and international relations of the member states . ### efficient management of the external borders through effective checks and efficient surveillance contributes to combat irregular immigration and trafficking in human beings and to reduce the threats to the internal security , public policy , public health and international relations of the member states .


### the tasks of the liaison officers shall include , in compliance with european union law and in accordance with fundamental rights , the establishment and maintaining of contacts with the competent authorities of the third country to which they are assigned to with a view to contribute to the prevention of and fight against illegal immigration and the return of illegal migrants . ### the tasks of the liaison officers shall include , in compliance with european union law and in accordance with fundamental rights , the establishment and maintaining of contacts with the competent authorities of the third country to which they are assigned to with a view to contributing to the prevention of and fight against irregular immigration and the return of irregular migrants .


### in matters covered by its activities and to the extent required for the fulfilment of its tasks , the agency shall facilitate the operational cooperation between member states and third countries , in the framework of the european union external relations policy , including with regard to human rights . ### in matters covered by its activities and to the extent required for the fulfilment of its tasks , the agency shall facilitate the operational cooperation between member states and third countries , in the framework of the european union external relations policy , including with regard to human rights . the establishment of cooperation with third countries shall serve to promote european border management standards , also covering respect for fundamental rights and human dignity .


### the agency may cooperate with europol , the european asylum support office , the fundamental rights agency , other european union agencies and bodies , and the international organisations competent in matters covered by this regulation in the framework of working arrangements concluded with those bodies , in accordance with the relevant provisions of the treaty and the provisions on the competence of those bodies . ### the agency may cooperate with europol , the european asylum support office , the european union agency for fundamental rights , other european union agencies and bodies , and the international organisations competent in matters covered by this regulation in the framework of working arrangements concluded with those bodies , in accordance with the relevant provisions of the treaty and the provisions on the competence of those bodies . the exchanges of information to which such cooperation arrangements may give rise shall not include exchanges of personal information .


### the agency may cooperate with europol , the european asylum support office , the fundamental rights agency , other european union agencies and bodies , and the international organisations competent in matters covered by this regulation in the framework of working arrangements concluded with those bodies , in accordance with the relevant provisions of the treaty and the provisions on the competence of those bodies . ### the agency may cooperate with europol , the european asylum support office , the european union agency for fundamental rights , other european union agencies and bodies , and the international and other organisations competent in matters covered by this regulation in the framework of working arrangements concluded with those bodies , in accordance with the relevant provisions of the treaty and the provisions on the competence of those bodies . in every case the agency shall inform the european parliament of any such arrangements without delay .


### the agency may deploy liaison officers , which should enjoy the highest possible protection to carry out their duties , in third countries . they shall form part of the local or regional cooperation networks of member states ' liaison officers set up pursuant to council regulation no 377 / 2004 . liaison officers shall only be deployed to third countries in which border management practices respect minimum human rights standards . priority for deployment should be given to those third countries , which on the basis of risk analysis constitute a country of origin or transit regarding illegal migration . on a reciprocal basis the agency may receive liaison officers posted by those third countries also , for a limited period of time . the management board shall adopt , on a proposal of the executive director , the list of priorities on a yearly basis in accordance with the provisions of article 24 . ### the agency may deploy liaison officers , which should enjoy the highest possible protection to carry out their duties , in third countries . they shall form part of the local or regional cooperation networks of member states ' liaison officers set up pursuant to council regulation no 377 / 2004 . liaison officers shall only be deployed to third countries in which border management practices respect minimum human rights standards . priority for deployment should be given to those third countries , which on the basis of risk analysis constitute a country of origin or transit regarding irregular migration . on a reciprocal basis the agency may receive liaison officers posted by those third countries also , for a limited period of time . the management board shall adopt , on a proposal of the executive director , the list of priorities on a yearly basis in accordance with the provisions of article 24 .


### the agency may also terminate joint operations and pilot projects if the conditions to conduct these initiatives are no longer fulfilled . ### the agency may also terminate joint operations and pilot projects if the conditions to conduct these initiatives are no longer fulfilled , including because of violations of fundamental rights and international protection obligations .


### the agency may benefit from union funding in accordance with the provisions of the relevant instruments supporting the union ' s external relations policy . it may launch and finance technical assistance projects in third countries regarding matters covered by this regulation . the agency may also invite representatives of third countries , other european union agencies and bodies or international organisations to participate in its activities referred to in articles 3 , 4 and 5 . these representatives shall receive the appropriate training from the agency prior to their participation . ### the agency may benefit from union funding in accordance with the provisions of the relevant instruments supporting the union ' s external relations policy . it may launch and finance technical assistance projects in third countries regarding matters covered by this regulation . the agency may also , in agreement with the host member state , invite representatives of third countries , other european union agencies and bodies or international organisations to participate in its activities referred to in articles 3 , 4 and 5 . these representatives shall receive the appropriate training from the agency prior to their participation .


### member states shall ensure that staff in charge of verifying the proper implementation of directive 2009 / 13 / ec has the training , competence , terms of reference , powers , status and independence necessary or desirable so as to enable them to carry out that verification and ensure compliance with that directive . ### a member state shall ensure that the institutions or other organisations referred to in article 3 and those members of their staff in charge of verifying the proper implementation of directive 2009 / 13 / ec have the training , competence , terms of reference , powers , status and independence necessary or desirable so as to enable them to carry out that verification and ensure compliance with that directive . the inspection or certification functions which the recognised organisations may be authorised to carry out shall come within the scope of the activities that are expressly referred to in paragraphs 1b to 1e as carried out by the member state or a recognised organisation .


### compliance monitoring ### compliance monitoring and certification


### staff in charge of compliance monitoring ### recognised organisations and their staff in charge of compliance monitoring


### in order to take account of new risk profiles , while at the same time ensuring the functioning of the internal market for medicinal products , safety features designed to ensure the identification , authentication and traceability of prescription medicinal products should be established at community level . when introducing obligatory safety features for prescription medicinal products , due account should be taken of the particularities of certain products or categories of products , such as generic medicines . this includes the risk of falsifications in view of their price and past incidences in the community and abroad , as well as the consequences of falsifications for public health in view of the specific characteristics of the products concerned or of the severity of the conditions intended to be treated . ### in order to take account of new risk profiles , while at the same time ensuring the functioning of the internal market for medicinal products , safety features designed to ensure the identification , authentication and traceability of medicinal products should be established at community level . when introducing obligatory safety features for medicinal products , due account should be taken of the particularities of certain products or categories of products , such as generic medicines , over - the - counter medicines and medicinal products sold directly by producers , without any intermediary , to clinical establishments in which the products are directly administered to the patient . this includes the risk of falsifications in view of their price and past incidences in the community and abroad , as well as the consequences of falsifications for public health in view of the specific characteristics of the products concerned or of the severity of the conditions intended to be treated .


### the measures referred to in this paragraph shall take due account of the legitimate interests to protect information of a commercially confidential nature and of the protection of industrial and commercial property rights . ’ ### the measures referred to in this paragraph shall take due account of the legitimate interests to protect information of a commercially confidential nature and of the protection of industrial and commercial property rights . member states shall ensure that the ownership and confidentiality of the data generated by using technology to combat counterfeiting of pharmaceutical products are respected . '


### ‘ safety features making it possible to ascertain identification , authenticity and traceability of medicinal products , other than radiopharmaceuticals , subject to medical prescription as defined in title vi . ’ ### ‘ safety features making it possible to ascertain identification , authenticity and traceability of medicinal products , other than radiopharmaceuticals . ’


### the operation of sst services should be based on a partnership between the union and the member states and use existing as well as future national expertise and assets , such as mathematical analysis and modelling know - how , ground - based radars or telescopes made available by participating member states . the member states retain ownership and control over their assets and remain responsible for their operations , maintenance and renewal . ### the operation of sst services should be based on a partnership between the union and the member states and use existing as well as future national and european expertise and assets , such as mathematical analysis and modelling know - how , ground - based radars or telescopes made available by participating member states and esa . the member states retain ownership and control over their assets and remain responsible for their operations , maintenance and renewal .


### the objectives of the sst support programme shall be to support actions aimed at establishing a sst capability and , in particular : ### the objectives of the sst support programme shall be to support actions aimed at mitigating the risk and consequences of space collisions by establishing a european sst capability and , in particular :


### the provision of sst services will benefit all public and private operators of space - based infrastructures , including the union in view of its responsibilities for its eu space programmes – european geostationary navigation overlay service and galileo being implemented by regulation no 683 / 2008 of the european parliament and of the council of 9 july 2008 on the further implementation of the european satellite navigation programmes 12 and copernicus / gmes established by regulation no 911 / 2010 of the european parliament and of the council of 22 september 2010 on the european earth monitoring programme and its initial operations 13 . re - entry warnings will also benefit national public authorities concerned with civil protection . __________________ 12 oj l 196 , 27 . 4 . 2008 , p . 1 . 13 oj l 276 , 20 . 10 . 2010 , p . 1 . ### the provision of sst services will benefit all public and private operators of space - based infrastructures , including the union in view of its responsibilities for its eu space programmes – european geostationary navigation overlay service and galileo being implemented by regulation no 683 / 2008 of the european parliament and of the council of 9 july 2008 on the further implementation of the european satellite navigation programmes 12 and copernicus / gmes established by regulation no 911 / 2010 of the european parliament and of the council of 22 september 2010 on the european earth monitoring programme and its initial operations 13 . re - entry warnings will also benefit national public authorities concerned with civil protection . moreover these services will aid private insurers to estimate potential liabilities resulting from collision during the life of a satellite . __________________ 12 oj l 196 , 27 . 4 . 2008 , p . 1 . 13 oj l 276 , 20 . 10 . 2010 , p . 1 .


### the sst services should be complementary to research activities related to the protection of space - based infrastructure carried out under the horizon 2020 programme established by [ reference to horizon 2020 regulation to be added once adopted ] , as well as to the european space agency ' s activities in this domain . ### the sst services should be complementary to research activities related to the protection of space - based infrastructure carried out under the horizon 2020 programme established by [ reference to horizon 2020 regulation to be added once adopted ] , as well as to the european space agency ' s existing and future activities in this domain .


### sst services shall be provided to member states , the council , the commission , the eeas , public and private spacecraft operators , and public authorities concerned with civil protection . the sst services shall be provided in compliance with the provisions on the use and exchange of sst data and information set out in article 9 . ### sst services shall be provided to member states , the council , the commission , the eeas , public and private spacecraft operators , public authorities concerned with civil protection , and wherever appropriate insurance companies . the sst services shall be provided in compliance with the provisions on the use and exchange of sst data and information set out in article 9 .


### the commission may on its own initiative until four weeks after it has been informed of the closure of the negotiations at the latest or on request from the member state which has negotiated the intergovernmental agreement , assess the compatibility of the negotiated agreement with union law before the agreement has been signed . in case the commission or the member state concerned ask for such an ex - ante assessment of the negotiated intergovernmental agreement with union law , the negotiated but not yet signed draft intergovernmental agreement shall be submitted to the commission for examination . the member state concerned shall refrain from signing the agreement for a period of four months following the submission of the draft intergovernmental agreement . in agreement with the member state concerned , the examination period might be prolonged . when a compatibility control has been requested , in the absence of an opinion by the commission within the examination period , the commission shall be deemed not to have raised objections . ### as early as possible and not later than two weeks after closure of the negotiations the member state concerned shall inform the commission of the closure of the negotiations and shall submit the negotiated but not yet signed draft intergovernmental agreement , including its&#160 ; annexes and other texts it refers to explicitly , &#160 ; to the commission for examination . the commission shall , on its own initiative or at the request of the member state that negotiated the intergovernmental agreement , inform that member state , within two months after being informed of the closure of the negotiations , of any doubts on the compatibility of the negotiated agreement , and its annexes and other texts it refers to explicitly , with union law , in particular with eu competition law and eu internal energy market legislation . the member state concerned shall refrain from signing the agreement for a period of two months following the submission of the intergovernmental agreement . in the absence of a response from the commission within that period , the commission shall be deemed not to have raised objections . the member state shall postpone the signing of an intergovernmental agreement for another two months if it has received a response from the commission that the negotiated but not yet signed agreement , is not compatible with union law . within those two months the commission shall issue a legal opinion . 2 . where the legal opinion identifies incompatibility between the negotiated agreement and union law , the commission shall specify that incompatibility and shall make recommendations on how to eliminate the incompatibility . 3 . member states shall take due account of the commission ' s recommendations and , if necessary , renegotiate the agreement . if the recommendations are not taken into account and serious doubts persist about the compatibility of the signed intergovernmental agreement with union law , the commission shall consider launching infringement proceedings .


### the work programme shall be organised in accordance with the activity - based management principle . the work programme shall be in line with the statement of estimates of the agency ' s revenue and expenditure and the agency ' s budget for the same financial year . ### the work programme shall be organised in accordance with the activity - based management principle . this work programme shall include both the virtual and non - virtual aspects of the agency ' s operations , activities and commitments . the work programme shall be in line with the statement of estimates of the agency ' s revenue and expenditure and the agency ' s budget for the same financial year .


### the member states and the commission shall ensure that environmental protection requirements , resource efficiency , climate change mitigation and adaptation , disaster resilience and risk prevention and management are promoted in the preparation and implementation of partnership contracts and programmes . member states shall provide information on the support for climate change objectives using the methodology adopted by the commission . the commission shall adopt this methodology by means of an implementing act . the implementing act shall be adopted in accordance with the examination procedure referred to in article 143 . ### the member states and the commission shall ensure that environmental protection requirements , resource efficiency , climate change mitigation and adaptation , transport sustainability and transport efficiency , disaster resilience and risk prevention and management are promoted in the preparation and implementation of partnership contracts and programmes . member states shall provide information on the support for climate change objectives using the methodology adopted by the commission . the commission shall adopt this methodology by means of an implementing act . the implementing act shall be adopted in accordance with the examination procedure referred to in article 143 .


### the commission shall adopt a decision by implementing act setting out the amount to be transferred from each member state ' s cohesion fund allocation for the whole period . the cohesion fund allocation of each member state shall be reduced accordingly . ### the commission shall adopt a decision by implementing act setting out the amount to be transferred from each member state ' s cohesion fund allocation for the whole period . the cohesion fund allocation of each member state shall be reduced accordingly , to enable the amount to be allocated explicitly to the member state concerned , under the connecting europe facility .


### support from the cohesion fund under the connecting europe facility shall be implemented in accordance with article [ 13 ] of regulation [ … ] / 2012 on establishing the connecting europe facility35 in respect of projects listed in annex 1 to that regulation , giving greatest possible priority to projects respecting the national allocations under the cohesion fund . ### support from the cohesion fund under the connecting europe facility shall be implemented in accordance with article [ 13 ] of regulation [ … ] / 2012 on establishing the connecting europe facility35 in respect of projects listed in annex 1 to that regulation , giving priority to projects respecting the national allocations under the cohesion fund and assuring that no distortion of the national allocations is possible . the commission shall provide necessary coordination and assistance to the eligible member states in order to remove administrative and bureaucratic barriers and ensure transparent process of selection of the projects .


### the commission shall adopt a decision by implementing act setting out the amount to be transferred from each member state ' s cohesion fund allocation for the whole period . the cohesion fund allocation of each member state shall be reduced accordingly . ### the decision setting out the amount to be transferred from each member state ' s cohesion fund allocation for the whole period shall be adopted by the ordinary legislative procedure . the cohesion fund allocation of each member state shall be reduced accordingly .


### competent authorities should pay due attention to preserving informal and trusted channels of information - sharing between market operators and between the public and the private sectors . publicity of incidents reported to the competent authorities should duly balance the interest of the public in being informed about threats with possible reputational and commercial damages for the public administrations and market operators reporting incidents . in the implementation of the notification obligations , competent authorities should pay particular attention to the need to maintain information about product vulnerabilities strictly confidential prior to the release of appropriate security fixes . ### competent authorities should pay due attention to preserving informal and trusted channels of information - sharing between market operators and between the public and the private sectors . publicity of incidents reported to the competent authorities should assign precedence to the interest of the public in being informed about threats rather than to short - term economic considerations .


### the competent authorities shall consult and cooperate , whenever appropriate , with the relevant law enforcement national authorities and data protection authorities . ### the competent authorities shall consult and cooperate closely with the competent law enforcement national authorities and data protection authorities .


### the cert shall implement and manage security measures to ensure the confidentiality , integrity , availability and authenticity of information it receives and treats . ### the cert shall implement and manage security measures to ensure the confidentiality , integrity , availability and authenticity of information it receives and treats and ensure data protection .


### without prejudice to the possibility for the cooperation network to have informal international cooperation , the union may conclude international agreements with third countries or international organisations allowing and organizing their participation in some activities of the cooperation network . such agreement shall take into account the need to ensure adequate protection of the personal data circulating on the cooperation network . ### without prejudice to the scope open to the cooperation network , the union may conclude international agreements with third countries or international organisations allowing and organizing their participation in some activities of the cooperation network . such agreement must provide for a high level of protection of the personal data circulating on the cooperation network .


### any body , organisation or association referred to in article 73 shall have the right to exercise the rights referred to in articles 74 and 75 on behalf of one or more data subjects . ### any body , organisation or association referred to in article 73 shall have the right to exercise the rights referred to in articles 74 on behalf of one or more data subjects . claims according to article 77 may not be exercised by bodies , organisations or associations within the meaning of article 73 .


### where processing is based on the data subject ' s consent , the controller should have the burden of proving that the data subject has given the consent to the processing operation . in particular in the context of a written declaration on another matter , safeguards should ensure that the data subject is aware that and to what extent consent is given . ### where processing is based on the data subject ' s consent , the controller should have the burden of proving that the data subject has given the consent to the processing operation . in particular in the context of a written declaration on another matter , safeguards should ensure that the data subject is aware that and to what extent consent is given . to comply with the principle of data minimisation , this burden of proof should not be understood neither as requiring positive identification of data subjects unless necessary nor as causing more data to be processed than otherwise have been the case .


### consent shall not provide a legal basis for the processing , where there is a significant imbalance between the position of the data subject and the controller . ### consent of an employee shall not provide a legal basis for the processing of data by the employer . the lawfulness of the processing shall be assessed in accordance with points through of article 6 and paragraphs 2 through 5 . the individual consent according to point of article 6 can be replaced by collective agreements as legal basis , in particular by collective bargaining agreements or works council agreements .