### subject to that assessment , member states or , where a member state has so provided , the designed competent authority , shall prepare a timetable with a target of up to 10 years for the deployment of smart metering systems . where roll - out of smart meters is assessed positively , at least 80 % of final customers shall be equipped with smart metering systems within 8 years from the date of their positive assessment or by 2020 for those member states that have initiated deployment before entering into force of this directive . ### subject to that assessment , member states or , where a member state has so provided , the designed competent authority , shall prepare a timetable with a target of up to 10 years for the deployment of smart metering systems . where roll - out of smart meters is assessed positively , at least 80 % of final customers shall be equipped with smart metering systems within 8 years from the date of their positive assessment and adopting a legal framework on deployment .


### to improve the functioning of the internal market , and especially to protect and empower citizens , consumers and businesses , in particular micro , small and medium - sized enterprises , by enforcement of union law , facilitation of market access , standard setting , and by promoting human , animal and plant health and animal welfare ; as well as to enhance cooperation between the competent authorities of member states and between the competent authorities of member states and the commission and the decentralised union agencies ; ### to improve the functioning of the internal market , and especially to protect and empower citizens , consumers and businesses , in particular micro , small and medium - sized enterprises , by enforcement of union law , facilitation of market access , standard setting , and by promoting human , animal and plant health and animal welfare ; as well as to enhance cooperation between the competent authorities of member states , between the competent authorities of member states and the commission and the decentralised union agencies and between the commission and third countries and international organisations ;


### addressing market barriers , administrative burden and creating a favourable business environment to empower smes to benefit from the internal market ; ### reducing market barriers , administrative burden and creating a favourable business environment to empower smes to benefit from the internal market ;


### it is a key union priority to establish a resilient energy union to provide secure , sustainable , competitive and affordable energy to its citizens . achieving this requires continuation of ambitious climate action with the eu ets as the cornerstone of europe’s climate policy , and progress on the other aspects of energy union17 . implementing the ambition decided in the 2030 framework contributes to delivering a meaningful carbon price and continuing to stimulate cost - efficient greenhouse gas emission reductions . __________________ 17 com80 , establishing a framework strategy for a resilient energy union with a forward - looking climate change policy ### it is a key union priority to establish a resilient energy union to provide secure , sustainable , competitive and affordable energy to its citizens and industries in view of the 20% re - industrialisation target of industry ' s share in the eu ' s gdp by 2020 and risks of job and investment leakage . achieving this requires continuation of ambitious climate action with the eu ets as the cornerstone of europe’s climate policy , and progress on the other aspects of energy union17 . implementing the ambition decided in the 2030 framework contributes to delivering a meaningful carbon price and continuing to stimulate cost - efficient greenhouse gas emission reductions . __________________ 17 com80 , establishing a framework strategy for a resilient energy union with a forward - looking climate change policy


### a modernisation fund should be established from 2% of the total eu ets allowances , and auctioned in accordance with the rules and modalities for auctions taking place on the common auction platform set out in regulation 1031 / 2010 . member states who in 2013 had a gdp per capita at market exchange rates of below 60% below the union average should be eligible for funding from the modernisation fund and derogate up to 2030 from the principle of full auctioning for electricity generation by using the option of free allocation in order to transparently promote real investments modernising their energy sector while avoiding distortions of the internal energy market . the rules for governing the modernisation fund should provide a coherent , comprehensive and transparent framework to ensure the most efficient implementation possible , taking into account the need for easy access by all participants . the function of the governance structure should be commensurate with the purpose of ensuring the appropriate use of the funds . that governance structure should be composed of an investment board and a management committee and due account should be taken of the expertise of the eib in the decision - making process unless support is provided to small projects through loans from a national promotional banks or through grants via a national programme sharing the objectives of the modernisation fund . investments financed from the fund should be proposed by the member states . to ensure that the investment needs in low income member states are adequately addressed , the distribution of funds will take into account in equal shares verified emissions and gdp criteria . the financial assistance from the modernisation fund could be provided through different forms . ### a modernisation fund should be established from 2% of the total eu ets allowances , and auctioned in accordance with the rules and modalities for auctions taking place on the common auction platform set out in regulation 1031 / 2010 . member states who in 2013 had a gdp per capita at market exchange rates of below 60% below the union average should be eligible for funding from the modernisation fund and derogate up to 2030 from the principle of full auctioning for electricity generation by using the option of free allocation in order to transparently promote real investments modernising their energy sector while avoiding distortions of the internal energy market . the rules for governing the modernisation fund should provide a coherent , comprehensive and transparent framework to ensure the most efficient implementation possible in line with the needs of beneficiary member states . the function of the governance structure should be commensurate with the purpose of ensuring the appropriate use of the funds . each of the beneficiary member states shall be responsible for the governance of its own allocation share and should be assisted by an advisory board composed of representatives from the beneficiary member states and the eib . investments financed from the fund should be proposed by the beneficiary member states . to ensure that the investment needs in low income member states are adequately addressed , the distribution of funds will take into account in equal shares verified emissions and gdp criteria . the financial assistance from the modernisation fund could be provided through different forms .


### the existing provisions which are in place for small installations to be excluded from the eu ets allow the installations which are excluded to remain so , and it should be made possible for member states to update their list of excluded installations and for member states currently not making use of this option to do so at the beginning of each trading period . ### the existing provisions which are in place for small installations to be excluded from the eu ets should be extended to cover small emitters emitting less than 50 , 000 tonnes of co2 equivalent in each of the three years preceding the year of application for exclusion . it should be made possible for member states to update their list of excluded installations and for member states currently not making use of this option to do so at the beginning of each trading period . at the beginning of each trading period , it should also be possible for small emitters to be excluded from the eu ets subject to revision every five years .


### the existing provisions which are in place for small installations to be excluded from the eu ets allow the installations which are excluded to remain so , and it should be made possible for member states to update their list of excluded installations and for member states currently not making use of this option to do so at the beginning of each trading period . ### the existing provisions which are in place for small installations below 50 . 000 tonnes of co2 emissions per year to be excluded from the eu ets allow the installations which are excluded to remain so , and it should be made possible for member states to update their list of excluded installations and for member states currently not making use of this option to do so at the beginning of each trading period .


### the total remaining quantity of allowances to be auctioned by member states shall be distributed in accordance with paragraph 2 . ### the total remaining quantity of allowances to be auctioned by member states , after deducting half of the quantity of allowances referred to in the first subparagraph of article 10a shall be distributed in accordance with paragraph 2 .


### in order to respect the auctioning share set out in article 10 , the sum of free allocations in every year where the sum of free allocations does not reach the maximum level that respects the member state auctioning share , the remaining allowances up to that level shall be used to prevent or limit reduction of free allocations to respect the member state auctioning share in later years . where , nonetheless , the maximum level is reached , free allocations shall be adjusted accordingly . any such adjustment shall be done in a uniform manner . ### in order to respect the auctioning share set out in article 10 , the sum of free allocations in every year where the sum of free allocations does not reach the maximum level that respects the member state auctioning share , the remaining allowances up to that level shall be added to the new entrant reserve that will be used to prevent or limit reduction of free allocations to respect the member state auctioning share in later years . where , nonetheless , the maximum level is reached , free allocations shall be adjusted accordingly .


### allowances from the maximum amount referred to article 10a of this directive which were not allocated for free up to 2020 shall be set aside for new entrants and significant production increases , together with 250 million allowances placed in the market stability reserve pursuant to article 1 of decision 2015 / … of the european parliament and of the council . ### allowances from the maximum amount referred to article 10a of this directive which were not allocated for free up to 2020 , shall be added to the new entrant reserve and used for new entrants , significant production increases and to prevent or limit reduction of free allocations to respect the member states auctioning share in later years , together with 250 million allowances placed in the market stability reserve by 2021 pursuant to article 1 of decision 2015 / 1814 of the european parliament and of the council .


### from 2021 , allowances not allocated to installations because of the application of paragraphs 19 and 20 shall be added to the reserve . ### from 2021 , allowances not allocated to installations because of the application of paragraphs 19 and 20 shall be added to the reserve . this shall not apply to removal units


### pursuant to articles 9 and 10 of regulation no 1380 / 2013 , multi - annual plans are to be based on scientific , technical and economic advice and contain objectives , quantifiable targets with clear timeframes , conservation reference points and safeguards . ### pursuant to articles 9 and 10 of regulation no 1380 / 2013 , multi - annual plans are to be based on scientific , technical and economic advice and contain objectives , quantifiable targets with clear timeframes , conservation reference points , objectives and safeguards , technical measures to be taken to achieve the targets laid down in article 15 of regulation no 1380 / 2013 , and measures to avoid and minimise unwanted catches as far as possible .


### this regulation establishes a multi - annual plan for the demersal stocks in waters of union waters of ices zones iia , iiia and iv and the fisheries exploiting those stocks . ### this regulation establishes a multi - annual plan for the following demersal stocks in waters of union waters of ices zones iia , iiia and iv the north sea and its adjacent waters and the fisheries exploiting the stocks concerned : cod in subarea iv and divisions viid and iiia west , hereinafter referred to as north sea cod ; haddock in subarea iv and divisions via and iiia west hereinafter referred to as haddock ; plaice in subarea iv and division iiia , hereinafter referred to as north sea plaice ; saithe in subareas iv and vi and division iiia , hereinafter referred to as saithe ; sole in subarea iv , hereinafter referred to as north sea sole ; sole in division iiia and subdivisions 22&#8211 ; 24 , hereinafter referred to as kattegat sole ; whiting in subarea iv and division viid , hereinafter referred to as north sea whiting ; anglerfish in division iiia and subareas iv and vi ; northern prawn in divisions iva east and iiia ; nephrops in division iiia ;


### &#8220 ; demersal stocks&#8221 ; means those roundfish and flatfish species and norway lobster that live at or near the bottom of the water column . ### &#8220 ; demersal stocks&#8221 ; means those roundfish and flatfish species , norway lobster and northern prawn that live at or near the bottom of the water column .


### “group 2” means norway lobster functional units for which targets as fmsy ranges and safeguards linked to abundance are established in this plan consisting of : ### “group 2” means norway lobster by functional units :


### the plan shall contribute to the achievement of the objectives of the common fisheries policy listed in article 2 of regulation no 1380 / 2013 , in particular by applying the precautionary approach to fisheries management , and shall aim to ensure that exploitation of living marine biological resources restores and maintains populations of harvested species above levels which can produce the maximum sustainable yield . ### the plan shall contribute to the achievement of the objectives of the common fisheries policy listed in article 2 of regulation no 1380 / 2013 , in particular by applying the precautionary approach to fisheries management , and shall aim to ensure that exploitation of living marine biological resources restores and maintains populations of harvested species above levels which can produce the maximum sustainable yield by 2020 at the latest .


### in accordance with article 16 of regulation no 1380 / 2013 , fishing opportunities shall comply with the target fishing mortality ranges set out in annex i , column a to this regulation . ### in accordance with article 16 of regulation no 1380 / 2013 , fishing opportunities shall be set in accordance with the objectives and targets of the plan and shall accord with the target fishing mortality ranges set out in annex i , column a to this regulation .


### without prejudice to article 8 , the tac for the stock of norway lobster in ices zones iia and iv shall be the sum of the catch limits of the functional units and of the statistical rectangles outside the functional units . ### without prejudice to article 8 , the tac for the stock of norway lobster in ices zones in union waters of iia and iv may be the sum of the catch limits of the functional units and of the statistical rectangles outside the functional units .


### by way of derogation from article 14 of regulation no 1224 / 2009 , masters of union fishing vessels of an overall length of eight metres or more engaged in fishing for demersal stocks shall keep a logbook of their operations in accordance with article 14 of that regulation . ### in accordance with article 14 of regulation no 1224 / 2009 , masters of union fishing vessels of an overall length of ten metres or more engaged in fishing for demersal stocks shall keep a logbook of their operations in accordance with article 14 of that regulation .


### member states may exempt new medium combustion plants which do not operate more than 500 operating hours per year from compliance with the emission limit values set out in part 2 of annex ii . in that case , for plants firing solid fuels , an emission limit value for particulate matter of 100 mg / nm³ shall apply . ### member states may exempt new medium combustion plants which do not operate more than 1000 operating hours per year as a rolling average over a period of five years from compliance with the emission limit values set out in part 2 of annex ii . in that case , for plants firing solid fuels , an emission limit value for particulate matter of 100 mg / nm³ shall apply .


### the first measurements shall be carried out within three months following the registration of the plant . ### the first measurements shall be carried out within six months following the permit or registration of the plant or the date of start of the operation , whichever is the latest .


### sampling and analysis of polluting substances and measurements of process parameters as well as any alternatives used as referred to under point 4 , shall be carried out in accordance with cen standards . if cen standards are not available , iso , national or other international standards which ensure the provision of data of an equivalent scientific quality shall apply . ### sampling and analysis of polluting substances and measurements of process parameters as well as any alternatives used as referred to under point 4 , shall be carried out in accordance with cen standards . during the sampling the plant shall be operating under stable conditions at a representative even load , start - up and close - down periods should be excluded . if cen standards are not available , iso , national or other international standards which ensure the provision of data of an equivalent scientific quality shall apply .


### a legislative framework for a pepp will lay the foundations for a successful market in affordable and voluntary retirement - related investments that can be managed on a pan - european scale . by complementing the existing pension products and schemes , it will contribute to meeting the needs of people wishing to enhance the adequacy of their retirement savings , addressing the demographical challenge and providing a powerful new source of private capital for long - term investment . this framework will not replace or harmonise existing national personal pension schemes . ### a legislative framework for a pepp will lay the foundations for a successful market in affordable and voluntary retirement - related investments that can be managed on a pan - european scale . by complementing the existing statutory and occupational pension schemes and products , it will contribute to meeting the needs of people wishing to enhance the adequacy of their retirement savings , addressing the demographic challenge and providing a powerful new source of private capital for long - term investment . this framework will not replace or harmonise existing national personal pension schemes , nor will it affect existing national statutory and occupational pension schemes and products . the pepp will neither directly nor indirectly be linked to the occupation or the employment status of the pepp saver .


### prior to the conclusion of a pepp - related contract , the pepp provider or distributor referred to in article 19 of this regulation shall specify , on the basis of information obtained from the pepp saver , the retirement - related demands and the needs of that pepp saver and shall provide the pepp saver with objective information about the pepp in a comprehensible form to allow that pepp saver to make an informed decision . ### pepp providers and distributors may provide advice . potential pepp savers may opt for a contract without advice . pepp providers and distributors shall ensure that the costs of advice are borne by those who seek advice . where advice is provided prior to the conclusion of a pepp - related contract , the pepp provider or distributor shall specify , on the basis of information obtained from the pepp saver , the retirement - related demands and the needs of that pepp saver and shall provide the pepp saver with objective information about the pepp in a comprehensible form to allow that pepp saver to make an informed decision .


### this regulation should cover products that are subject to the union harmonisation legislation listed in the annex . the legislation listed in the annex should cover all union harmonisation legislation concerning manufactured products other than food , feed , medicinal products for human and veterinary use , living plants and animals , products of human origin and products of plants and animals relating directly to their future reproduction . this will ensure a uniform framework for market surveillance of those products at union level . several instruments of union harmonisation legislation on products need to be amended in consequence , in particular to remove references to certain provisions of regulation no 765 / 2008 . if new union harmonisation legislation is adopted in the future , it will be for that legislation to provide whether this regulation is also to apply to that legislation . ### this regulation should cover products that are subject to the directive 2001 / 95 / ec or the union harmonisation legislation listed in the annex . the legislation listed in the annex should cover all union harmonisation legislation concerning manufactured products other than food , feed , medicinal products for human and veterinary use , living plants and animals , products of human origin and products of plants and animals relating directly to their future reproduction . this will ensure a uniform framework for market surveillance of those products at union level . several instruments of union harmonisation legislation on products need to be amended in consequence , in particular to remove references to certain provisions of regulation no 765 / 2008 . if new union harmonisation legislation is adopted in the future , it will be for that legislation to provide whether this regulation is also to apply to that legislation .


### a fairer single market should ensure equal conditions for competition to all economic operators and protection against unfair competition . to this purpose , strengthened enforcement of union harmonisation legislation on products is necessary . good cooperation between manufacturers and the market surveillance authorities is a key element allowing immediate intervention and corrective action in relation to the product . it is important that there should be a contact person established in the union so that market surveillance authorities have someone to whom questions can be addressed regarding a product’s compliance with union harmonisation legislation . the person responsible for providing such compliance information should be the manufacturer , or the importer , or another person designated by the manufacturer for this purpose , for example another economic operator . the role of a person responsible for compliance information established in the union is essential for providing market surveillance authorities with an interlocutor established in the union , and for performing specific tasks in a timely manner to ensure that the products comply with the requirements of union harmonisation legislation , for the benefit of consumers , workers and businesses within the union . the provisions in this regulation requiring there to be a person established in the union responsible for compliance information should not apply where specific requirements set out in certain legal instruments on products achieve the same result in effect , namely article 4 of regulation no 1223 / 2009 , article 15 of regulation 2017 / 745 and article 15 of regulation 2017 / 746 . ### a fairer single market should ensure equal conditions for competition to all economic operators and protection against unfair competition . to this purpose , strengthened enforcement of union harmonisation legislation on products is necessary . good cooperation between manufacturers , wholesalers , retailers and the market surveillance authorities is a key element allowing immediate intervention and corrective action in relation to the product . it is important that there should be a contact person established in the union so that market surveillance authorities have someone to whom questions can be addressed regarding a product’s compliance with union harmonisation legislation . the person responsible for providing such compliance information should be the manufacturer , or the authorised representative , an importer when the manufacturer is not established in the union and there is no other authorised representative , or - in the case there is no manufacturers or importer established in the union - another person designated by the manufacturer for this purpose , for example another economic operator . the role of a person responsible for compliance information established in the union is essential for providing market surveillance authorities with an interlocutor established in the union , and for performing specific tasks in a timely manner to ensure that the products comply with the requirements of union harmonisation legislation , for the benefit of consumers , workers and businesses within the union . the provisions in this regulation requiring there to be a person established in the union responsible for compliance information should not apply where specific requirements set out in certain legal instruments on products achieve the same result in effect , namely article 4 of regulation no 1223 / 2009 , article 15 of regulation 2017 / 745 and article 15 of regulation 2017 / 746 .


### each member state shall draw up a national market surveillance strategy , as a minimum , every 3 years . the strategy shall promote a consistent , comprehensive and integrated approach to market surveillance and enforcement of union harmonisation legislation within the territory of the member state and shall include all sectors and stages of the product supply chain , including imports and digital supply chains . ### each member state shall draw up a national market surveillance strategy , as a minimum , every 3 years . the strategy shall promote a consistent , comprehensive and integrated approach to market surveillance and enforcement of union harmonisation legislation within the territory of the member state and shall include all sectors and stages of the product supply chain , including imports and digital supply chains . in establishing their national market surveillance strategies , the member states shall consult stakeholders and make their comments available to the general public .


### member states shall communicate their national market surveillance strategy through the system referred to under article 34 . ### member states shall communicate their national market surveillance strategy through the system referred to under article 34 , and shall make it available to the general public .


### within one year after official co2 emission data are published by the commission pursuant to regulation … / …***** , the commission shall adopt a delegated act , in accordance with article 9e , to define the reference values of co2 emissions , together with an appropriate categorisation of the heavy duty vehicles concerned . ### within two year after official co2 emission data are published by the commission pursuant to regulation … / …***** , the commission shall adopt a implementing act , in accordance with article 9e , to define the reference values of co2 emissions , together with an appropriate categorisation of the heavy duty vehicles concerned .


### within one year from the entry into force of the delegated act , member states shall vary the infrastructure charge taking into account the reference co2 emission values and the relevant vehicle categorisation . charges shall be varied in such a way that no infrastructure charge is more than 100% above the same charge for equivalent vehicles having the lowest , but not zero , co2 emissions . zero - emission vehicles shall benefit from infrastructure charges reduced by 75% compared to the highest rate . ### within two year from the entry into force of the implementing act , member states shall vary the infrastructure charge taking into account the reference co2 emission values and the relevant vehicle categorisation . charges shall be varied in such a way that no infrastructure charge is more than 100% above the same charge for equivalent vehicles having the lowest , but not zero , co2 emissions .


### the trans - european transport network guidelines as laid down in regulation no 1315 / 2013 of the european parliament and of the council4 identify the infrastructure of the ten - t , specify the requirements to be fulfilled by it and provide for measures for their implementation . those guidelines envisage , in particular , the completion of the core network by 2030 through the creation of new infrastructure as well as the substantial upgrading and rehabilitation of existing infrastructure . __________________ 4 regulation no 1315 / 2013 of the european parliament and of the council of 11 december 2013 on union guidelines for the development of the trans - european transport network and repealing decision no 661 / 2010 / eu . ### the trans - european transport network guidelines as laid down in regulation no 1315 / 2013 of the european parliament and of the council4 identify the infrastructure of the ten - t , specify the requirements to be fulfilled by it and provide for measures for their implementation . those guidelines envisage , in particular , the completion of the core network by 2030 through the creation of new infrastructure as well as the substantial upgrading and rehabilitation of existing infrastructure . account will also be taken of military mobility requirements in this process , with due consultation with nato . __________________ 4 regulation no 1315 / 2013 of the european parliament and of the council of 11 december 2013 on union guidelines for the development of the trans - european transport network and repealing decision no 661 / 2010 / eu .


### it is necessary to promote investments in favour of smart , sustainable , inclusive , safe and secure mobility throughout the union . in 2017 , the commission presented5 ' europe on the move ' , a wide - ranging set of initiatives to make traffic safer , encourage smart road charging , reduce co2 emissions , air pollution and congestion , promote connected and autonomous mobility and ensure proper conditions and rest times for workers . these initiatives should be accompanied by union financial support , where relevant through this programme . __________________ 5 commission communication ' europe on the move : an agenda for a socially fair transition towards clean , competitive and connected mobility for all ' – com 283 ### it is necessary to promote investments in favour of smart , sustainable , inclusive , safe and secure mobility throughout the union . in 2017 , the commission presented5 ' europe on the move ' , a wide - ranging set of initiatives to make traffic safer , encourage smart road charging , reduce co2 emissions , air pollution and congestion , promote connected and autonomous mobility and ensure proper conditions and rest times for workers . at the same time due consideration must be given for military mobility factors . these initiatives should be accompanied by union financial support , where relevant through this programme . __________________ 5 commission communication ' europe on the move : an agenda for a socially fair transition towards clean , competitive and connected mobility for all ' – com 283


### following the joint communication on improving military mobility in the european union of november 20179 , the action plan on military mobility adopted on 28 march 2018 by the commission and the high representative of the union for foreign affairs and security policy10 highlighted that transport infrastructure policy offers a clear opportunity to increase synergies between defence needs and ten - t . the action plan indicates that by mid - 2018 , the council is invited to consider and validate the military requirements in relation to transport infrastructure and that , by 2019 the commission services will identify the parts of the trans - european transport network suitable for military transport , including necessary upgrades of existing infrastructure . union funding for the implementation of the dual - use projects should be implemented through the programme on the basis of specific work programmes specifying the applicable requirements as defined in the context of the action plan . __________________ 9 join 41 10 join 5 ### following the joint communication on improving military mobility in the european union of november 20179 , the action plan on military mobility adopted on 28 march 2018 by the commission and the high representative of the union for foreign affairs and security policy10 highlighted that transport infrastructure policy offers a clear opportunity to increase synergies between defence needs and ten - t . the action plan indicates that by mid - 2018 , the council is invited to consider and validate the military requirements in relation to transport infrastructure and that , by 2019 the commission and nato will have identified the parts of the trans - european transport network suitable for military transport , including necessary upgrades of existing infrastructure . union funding for the implementation of the dual - use projects should be implemented through the programme on the basis of specific work programmes specifying the applicable requirements as defined in the context of the action plan . __________________ 9 join 41 10 join 5


### organise and coordinate appropriate nominations of participants for activities at the national level in a timely manner ; ### organise and coordinate appropriate nominations of participants for activities at the national level in a transparent manner ;


### a participating dgs shall not be covered by edis in the reinsurance , co - insurance or full insurance phase , if the commission , acting on its own initiative or upon a request of the board or a participating member state , decides and informs the board accordingly that at least one of the following disqualifying conditions is met : ### a participating dgs shall not be covered by edis , if the commission , acting on its own initiative or upon a request of the board or a participating member state , decides and informs the board , the dgs , the designated authority of the participating member state within the meaning of point 18 of article 2 of directive 2014 / 49 / eu , and the national competent authority or authorities accordingly , that at least one of the following disqualifying conditions is met :


### the participating dgs has failed to comply with the obligations under this regulation or articles 4 , 6 , 7 or 10 of directive 2014 / 49 / eu ; ### the participating dgs has failed to comply with the obligations under this regulation or under articles 4 , 5 , 6 , 7 , 8 or 10 of directive 2014 / 49 / eu ;


### when funding has already been obtained by a participating dgs and at least one of the disqualifying conditions referred to in paragraph 1 is met in relation to a payout event or a use in resolution , the commission may order full or partial repayment of the funding to the dif . ### when funding has already been obtained by a participating dgs and at least one of the disqualifying conditions referred to in paragraph 1 is met in relation to a payout event or a use in resolution , the commission shall order full repayment of the funding to the dif .


### the commission , after consulting the board , may approve a derogation from the requirements set out in paragraph 1 for duly justified reasons linked to the business cycle in the respective member state , the impact pro - cyclical contributions may have , or to a payout event which occurred at national level . those derogations must be temporary and may be subject to the fulfilment of certain conditions . ### the commission , after consulting the board , may approve a derogation from the requirements set out in paragraph 1 only where , at national level , a participating dgs has encountered a payout event or has been used in resolution in accordance with article 109 of directive 2014 / 59 / eu or article 79 of this regulation . this derogation should last no longer than 5 years and may be subject to the fulfilment of certain conditions .


### a progressive reduction of landfilling is necessary to prevent detrimental impacts on human health and the environment and to ensure that economically valuable waste materials are gradually and effectively recovered through proper waste management and in line with the waste hierarchy . this reduction should avoid the development of excessive capacity for the treatment of residual waste facilities , such as through energy recovery or low grade mechanical biological treatment of untreated municipal waste , as this could result in undermining the achievement of the union ' s long - term preparation for reuse and recycling targets for municipal waste as laid down in article 11 of directive 2008 / 98 / ec . similarly , and to prevent detrimental impacts on human health and the environment , while member states should take all necessary measures to ensure that only waste that has been subject to treatment is landfilled , compliance with such obligation should not lead to the creation of overcapacities for the treatment of residual municipal waste . in addition , in order to ensure consistency between the targets laid down in article 11 of directive 2008 / 98 / ec and the landfill reduction target defined in article 5 of this directive and to ensure a coordinated planning of the infrastructures and investments needed to meet those targets , member states which may obtain additional time for the attainment of the municipal waste recycling targets should also be given additional time to attain the landfill reduction target for 2030 as laid down in this directive . ### a progressive reduction of landfilling is necessary to prevent detrimental impacts on human health and the environment and to ensure that economically valuable waste materials are gradually and effectively recovered through proper waste management and in line with the waste hierarchy . this reduction should avoid the development of excessive capacity for the treatment of residual waste facilities , such as through energy recovery or low grade mechanical biological treatment of untreated municipal waste , as this could result in undermining the achievement of the union ' s long - term preparation for reuse and recycling targets for municipal waste as laid down in article 11 of directive 2008 / 98 / ec . similarly , and to prevent detrimental impacts on human health and the environment , while member states should take all necessary measures to ensure that only waste that has been subject to treatment is landfilled , compliance with such obligation should not lead to the creation of overcapacities for the treatment of residual municipal waste . due attention must be paid to ensuring consistency between the targets laid down in article 11 of directive 2008 / 98 / ec and the need to reduce the volume of landfill in accordance with article 5 of this directive and to ensuring a coordinated planning of the infrastructures and investments needed to meet those targets .


### ' waste that has been separately collected pursuant to article 11 and 22 of directive 2008 / 98 / ec . ' ; ### ' waste that has been separately collected pursuant to article 11 and article 22 of directive 2008 / 98 / ec . ' ;


### member states shall ensure that measures taken in accordance with this point do not compromise the achievement of the objectives of directive 2008 / 98 / ec , notably on the increase of preparing for re - use and recycling as set out in article 11 of that directive . ### member states shall ensure that measures taken in accordance with this point do not compromise the achievement of the objectives of directive 2008 / 98 / ec , notably on the waste hierarchy and on the increase of reuse and recycling .


### many small and medium enterprises , as well as mid - cap companies , across the union require assistance to attract market financing , especially as regards investments that carry a greater degree of risk . the efsi should help these businesses to overcome capital shortages by allowing the eib and the european investment fund to provide direct and indirect equity injections , as well as to provide guarantees for high - quality securitisation of loans , and other products that are granted in pursuit of the aims of the efsi . ### many small and medium enterprises , as well as mid - cap companies , across the union require assistance to attract market financing , especially as regards investments that carry a greater degree of risk . the efsi should help these businesses to overcome capital shortages by allowing the eib and the european investment fund to provide direct and indirect equity injections , as well as to provide guarantees for high - quality securitisation of loans , and other products that are granted in pursuit of the aims of the efsi . it is important that the efsi takes into account the specific investment conditions in countries with less developed financial markets .


### the efsi should be established within the eib in order to benefit from its experience and proven track record and in order for its operations to start to have a positive impact as quickly as possible . the work of the efsi on providing finance to small and medium enterprises and small mid - cap companies should be channelled through the european investment fund to benefit from its experience in these activities . ### the efsi should be established within the eib in order to benefit from its experience and proven track record and in order for its operations to start to have a positive impact as quickly as possible . in connection with the increased responsibility of the eib and the need to take into account the specific circumstances of the member states , the bank’s management committee should be expanded . the work of the efsi on providing finance to small and medium enterprises and small mid - cap companies should be channelled through the european investment fund to benefit from its experience in these activities .


### decisions on the use of the efsi support for infrastructure and large mid - cap projects should be made by an investment committee . the investment committee should be composed of independent experts who are knowledgeable and experienced in the areas of investment projects . the investment committee should be accountable to a steering board of the efsi , who should supervise the fulfilment of the efsi ' s objectives . to effectively benefit from the experience of the eif , the efsi should support funding to the eif to allow the eif to undertake individual projects in the areas of small and medium enterprises and small mid - cap companies . ### decisions on the use of the efsi support for infrastructure and large mid - cap projects should be made by an investment committee . the investment committee should be composed of experts who are knowledgeable and experienced in the areas of investment projects and who are also aware of the specific circumstances of member states , particularly those that are affected by the crisis . the investment committee should be accountable to a steering board of the efsi and to the european parliament , who should supervise the fulfilment of the efsi ' s objectives . the work of the investment committee should be monitored by the european parliament . to effectively benefit from the experience of the eif , the efsi should support funding to the eif to allow the eif to undertake individual projects in the areas of small and medium enterprises and small mid - cap companies .


### provided that all relevant eligibility criteria are fulfilled , member states may use european structural investment funds to contribute to the financing of eligible projects that are supported by the eu guarantee . the flexibility of this approach should maximise the potential to attract investors to the areas of investment targeted by the efsi . ### provided that all relevant eligibility criteria are fulfilled , member states may , where appropriate , use european structural investment funds to contribute to the financing of eligible projects that are supported by the eu guarantee . the flexibility of this approach should maximise the potential to attract investors to the areas of investment targeted by the efsi . the efsi may not be used for co - financing projects eligible under european structural and investment funds .


### provided that all relevant eligibility criteria are fulfilled , member states may use european structural and investment funds to contribute to the financing of eligible projects in which the eib is investing with the support of the eu guarantee . ### provided that all relevant eligibility criteria are fulfilled , member states may use european structural and investment funds to contribute to the financing of eligible projects in which the eib is investing with the support of the eu guarantee . the efsi may not be used for co - financing projects eligible for european structural and investment funds .


### the commission should report on the implementation of this regulation after three years after its date of application , including on the appropriateness of the level of security . in accordance with paragraphs 22 and 23 of the interinstitutional agreement on better law - making41 the commission should carry out an evaluation of this regulation on the basis of information collected through specific monitoring arrangements in order to assess the actual effects of the regulation and the need for any further action . _________________ 41 interinstitutional agreement between the european parliament , the council of the european union and the european commission on better law - making of 13 april 2016 ; oj l 123 , 12 . 5 . 2016 , p . 1–14 . ### the commission should report on the implementation of this regulation after four years after its date of application , including on the appropriateness of the level of security . in accordance with paragraphs 22 and 23 of the interinstitutional agreement on better law - making41 the commission should carry out an evaluation of this regulation on the basis of information collected through specific monitoring arrangements in order to assess the actual effects of the regulation and the need for any further action , including the use of more advanced and higher accuracy biometric technologies against new types of fraud such as the iris - recognition technology proposed in the european court of justice´s case law41a which puts the technology forward as the only real alternative to taking fingerprints and less intervening on the rights recognised by articles 7 and 8 of the charter . _________________ 41 interinstitutional agreement between the european parliament , the council of the european union and the european commission on better law - making of 13 april 2016 ; oj l 123 , 12 . 5 . 2016 , p . 1–14 . 41a judgment of the court of justice of 17 october 2013 , schwarz v stadt bochum , c - 291 / 12 , ecli : eu : c : 2013 : 670 .


### the office may request oral information , including through interviews , and written information from officials , other servants , members of institutions or bodies , heads of offices or agencies , or staff members . ### the office may request oral information , including through interviews , and written information from officials , other servants , members of institutions or bodies , heads of offices or agencies , or staff members , thoroughly documented according to regular confidentiality and union data protection standards .


### member states should set farm advisory services for the purpose of improving the sustainable management and overall performance of agricultural holdings and rural businesses , covering economic , environmental and social dimensions , and to identify the necessary improvements as regards all measures at farm level provided for in the cap strategic plans . these farm advisory services should help farmers and other beneficiaries of cap support to become more aware of the relationship between farm management and land management on the one hand , and certain standards , requirements and information , including environmental and climate ones , on the other hand . the list of the latter includes standards applying to or necessary for farmers and other cap beneficiaries and set in the cap strategic plan , as well as those stemming from the legislation on water , on the sustainable use of pesticides , as well as the initiatives to combat antimicrobial resistance and the management of risks . in order to enhance the quality and effectiveness of the advice , member states should integrate advisors within the agricultural knowledge and innovation systems , in order to be able to deliver up - to - date technological and scientific information developed by research and innovation . ### member states should set farm advisory services for the purpose of improving the sustainable management and overall performance of agricultural holdings and rural businesses , covering economic , environmental and social dimensions , and to identify the necessary improvements as regards all measures at farm level provided for in the cap strategic plans . these farm advisory services should help farmers and other beneficiaries of cap support to become more aware of the relationship between farm management and land management on the one hand , and certain standards , requirements and information , including animal welfare , environmental and climate ones , on the other hand . the list of the latter includes standards applying to or necessary for farmers and other cap beneficiaries and set in the cap strategic plan , as well as those stemming from the legislation on water , on the sustainable use of pesticides , as well as the initiatives to combat antimicrobial resistance and the management of risks . in order to enhance the quality and effectiveness of the advice , member states should integrate advisors within the agricultural knowledge and innovation systems , in order to be able to deliver up - to - date technological and scientific information developed by research and innovation .


### the cap should ensure that member states increase the environmental delivery by respecting local needs and farmers ' actual circumstances . member states should under direct payments in the cap strategic plan set up eco - schemes voluntary for farmers , which should be fully coordinated with the other relevant interventions . they should be defined by the member states as a payment granted either for incentivising and remunerating the provision of public goods by agricultural practices beneficial to the environment and climate or as a compensation for the introduction of these practices . in both cases they should aim at enhancing the environmental and climate performance of the cap and should consequently be conceived to go beyond the mandatory requirements already prescribed by the system of conditionality . member states may decide to set up eco - schemes for agricultural practices such as the enhanced management of permanent pastures and landscape features , and organic farming . these schemes may also include ‘ entry - level schemes’ which may be a condition for taking up more ambitious rural development commitments . ### the cap should ensure that member states increase the environmental delivery by respecting local needs and farmers ' actual circumstances . member states may under direct payments in the cap strategic plan set up eco - schemes voluntary for farmers , which should be fully coordinated with the other relevant interventions . they should be defined by the member states as a payment granted either for incentivising and remunerating the provision of public goods by agricultural practices beneficial to the environment and climate or as a compensation for the introduction of these practices . in both cases they should aim at enhancing the environmental and climate performance of the cap and should consequently be conceived to go beyond the mandatory requirements already prescribed by the system of conditionality . member states may decide to set up eco - schemes for agricultural practices such as the enhanced management of permanent pastures and landscape features , and organic farming . these schemes may also include ‘ entry - level schemes’ which may be a condition for taking up more ambitious rural development commitments .


### support for management commitments may include organic farming premia for the maintenance of and the conversion to organic land ; payments for other types of interventions supporting environmentally friendly production systems such as agro - ecology , conservation agriculture and integrated production ; forest environmental and climate services and forest conservation ; premia for forests and establishment of agroforestry systems ; animal welfare ; conservation , sustainable use and development of genetic resources . member states may develop other schemes under this type of interventions on the basis of their needs . this type of payments should cover additional costs and income foregone only resulting from commitments going beyond the baseline of mandatory standards and requirements established in union and national law , as well as conditionality , as laid down in the cap strategic plan . commitments related to this type of interventions may be undertaken for a pre - established annual or pluri - annual period and might go beyond seven years where duly justified . ### support for management commitments may include organic farming premia for the maintenance of and the conversion to organic land ; payments for other types of interventions supporting environmentally friendly production systems such as agro - ecology , conservation agriculture and integrated production ; forest environmental and climate services and forest conservation ; premia for forests and establishment of agroforestry systems ; animal welfare ; conservation , sustainable use and development of genetic resources . member states may develop other schemes under this type of interventions on the basis of their needs . this type of payments should be determined solely based on additional costs and income losses only resulting from commitments going beyond the baseline of mandatory standards and requirements established in union and national law , as well as conditionality , as laid down in the cap strategic plan . commitments related to this type of interventions may be undertaken for a pre - established annual or pluri - annual period and might go beyond seven years where duly justified .


### member states shall ensure that all agricultural areas including land which is no longer used for production purposes , is maintained in good agricultural and environmental condition . member states shall define , at national or regional level , minimum standards for beneficiaries for good agricultural and environmental condition of land in line with the main objective of the standards as referred to in annex iii , taking into account the specific characteristics of the areas concerned , including soil and climatic condition , existing farming systems , land use , crop rotation , farming practices , and farm structures . ### member states shall ensure that all agricultural areas including land which is no longer used for production purposes , is maintained in good agricultural and environmental condition . member states shall define , at national or regional level , minimum standards for beneficiaries holding more than [ x ] ha , as defined by member states , for good agricultural and environmental condition of land in line with the main objective of the standards as referred to in annex iii , farm structure , taking into account the specific characteristics of the areas concerned , including soil and climatic condition , existing farming systems , land use and cultivation methods .


### commitments shall be undertaken for a period of five to seven years . however , where necessary in order to achieve or maintain certain environmental benefits sought , member states may determine a longer period in the cap strategic plan for particular types of commitments , including by means of providing for their annual extension after the termination of the initial period . in exceptional and duly justified cases , and for new commitments directly following the commitment performed in the initial period , member states may determine a shorter period in their cap strategic plans . ### commitments shall be undertaken for a period of one to seven years . however , where necessary in order to achieve or maintain certain environmental benefits sought , member states may determine a longer period in the cap strategic plan for particular types of commitments , including by means of providing for their annual extension after the termination of the initial period .


### member states shall aim to make , through their cap strategic plans and in particular through the elements of the intervention strategy referred to in point of article 97 , a greater overall contribution to the achievement of the specific environmental - and climate - related objectives set out in points , and of article 6 in comparison to the overall contribution made to the achievement of the objective laid down in point of the first subparagraph of article 110 of regulation no 1306 / 2013 through support under the eagf and the eafrd in the period 2014 to 2020 . ### member states shall aim to make , through their cap strategic plans and in particular through the elements of the intervention strategy referred to in point of article 97 , a greater overall contribution to the achievement of the specific environmental - , climate - and animal welfare - related objectives set out in points , , and of article 6 in comparison to the overall contribution made to the achievement of the objective laid down in point of the first subparagraph of article 110 of regulation no 1306 / 2013 through support under the eagf and the eafrd in the period 2014 to 2020 .


### this decision should not create obligations as regards agreements between undertakings . however , member states should be free to communicate to the commission , on a voluntary basis , such agreements that are referred to explicitly in intergovernmental agreements or non - binding instruments . ### this decision should not create obligations as regards agreements between undertakings which are subject to notification under regulation 2016 / … of the european parliament and of the council 1a . member states should be free to communicate to the commission , on a voluntary basis , other agreements that are referred to explicitly in intergovernmental agreements or non - binding instruments . __________________ 1a regulation 2016 / … of the european parliament and of the council of … concerning measures to safeguard the security of gas supply and repealing regulation no 994 / 2010 [ cod 2016 / 0052 - sos regulation ] .


### the commission shall , within six weeks of the date of notification of the complete draft intergovernmental agreement or amendment , including annexes thereto , pursuant to article 3 , inform the member state concerned of any doubts it may have as to the compatibility of the draft intergovernmental agreement or amendment with union law , in particular with internal energy market legislation and union competition law . in the absence of a response from the commission within that period , the commission shall be deemed not to have any such doubts . ### the commission shall , within six weeks of the date of notification of the complete draft intergovernmental agreement or amendment , including annexes thereto , pursuant to article 3 , inform the member state concerned of any doubts it may have as to the compatibility of the draft intergovernmental agreement or amendment , or other text to which it explicitly refers with union law , in particular with internal energy market legislation , union competition law , public procurement rules , environmental rules and the union ' s energy security objectives . in the absence of a response from the commission within that period , the commission shall be deemed not to have any such doubts .


### when signing , ratifying or agreeing to an intergovernmental agreement or amendment , the member state concerned shall take utmost account of the commission ' s opinion referred to in paragraph 2 . ### before signing , ratifying or agreeing to an intergovernmental agreement or amendment , the member state concerned shall demonstrate how objections expressed in the commission ' s opinion as referred to in paragraph 2 have been addressed in order to ensure full compliance with union law and the union ' s energy security objectives .


### carry - over may occur during production , processing , storage and transport of feed where the same production and processing equipment , storage facilities or means of transport are used for feed with different components . for the purposes of this regulation , the concept of ‘ carry - over ' is used specifically to designate the transfer of traces of an active substance contained in a medicated feed to a non - target feed , while the term ‘ cross - contamination ' is to be considered as a contamination resulting from a carry - over or from the transfer in feed of any unintended substance . carry - over of active substances contained in medicated feed to non - target feed should be avoided or kept as low as possible . in order to protect animal health , human health and the environment , maximum levels of carry - over for active substances contained in medicated feed should be established , based on a scientific risk assessment performed by the european food safety authority and taking into account the application of good manufacturing practice and the alara principle . general limits should be set out in this regulation , taking into account the unavoidable carry - over and the risk caused by the active substances concerned . ### carry - over may occur during production , processing , storage and transport of feed where the same production and processing equipment , storage facilities or means of transport are used for feed with different components . for the purposes of this regulation , the concept of ' carry - over ' is used specifically to designate the transfer of traces of an active substance contained in a medicated feed to a non - target feed , while the term ' cross - contamination ' is to be considered as a contamination resulting from a carry - over or from the transfer in feed of any unintended substance . carry - over of active substances contained in medicated feed to non - target feed should be avoided or kept as low as possible . in order to protect animal health , human health and the environment , maximum limits for levels of carry - over for active substances contained in non - target feed should be established , based on a scientific risk assessment performed by the european food safety authority and taking into account the application of good manufacturing practice and the alara principle . in the interim , a general maximum limit should be set out in this regulation , taking into account the unavoidable carry - over and the risk caused by the active substances concerned .


### taking into account the serious public health risk posed by resistance to antimicrobials , it is appropriate to limit the use of medicated feed containing antimicrobials for food - producing animals . preventive use or use to enhance the performance of food - producing animals should in particular not be allowed . ### taking into account the serious public health risk posed by resistance to antimicrobials , it is appropriate to take measures to reduce the overall use of antimicrobials , specifically antibiotics , in food - producing animals . the use of antimicrobials in medicated feed to enhance the performance of food - producing animals should be prohibited . the use of antimicrobials , specifically antibiotics , in medicated feed before a disease is diagnosed or clinical signs are present should only be allowed in very exceptional circumstances and under prescription on the basis of the epidemiological and clinical knowledge of the person who issued the prescription . it should never be applied routinely nor to compensate for poor hygiene or for inadequate husbandry conditions .


### medicated feed and intermediate products shall be placed on the market only in sealed packages or containers . packages or containers shall be sealed in such a way that , when the package or container is opened , the seal is damaged and cannot be reused . ### medicated feed and intermediate products shall be placed on the market only in sealed packages or containers . packages or containers shall be sealed in such a way that , when the package or container is opened , the seal is damaged and cannot be reused . appropriate derogations should be provided for those instances where the application of this requirement is not necessary to protect human or animal health or consumer interests , and would represent an excessive administrative and technical burden .


### the prescribed medicated feed may be used only for animals examined by the person who issued the prescription and only for a diagnosed disease . the person who issued the prescription shall verify that this medication is justified for the target animals on veterinary grounds . furthermore he shall ensure that the administration of the veterinary medicinal product concerned is not incompatible with another treatment or use and that there is no contra - indication or interaction where several medicinal products are used . ### the prescribed medicated feed may be used only for animals under the care of the person who issued the prescription and only for a diagnosed disease . the person who issued the prescription shall verify that this medication is justified for the target animals on veterinary grounds . furthermore he shall ensure that the administration of the veterinary medicinal product concerned is not incompatible with another treatment or use and that there is no contra - indication or interaction where several medicinal products are used .


### feed business operators supplying medicated feed to the holder of food - producing animals , or on - farm mixers of medicated feed for food - producing animals shall ensure that the quantities supplied or mixed do not exceed : ### feed business operators supplying medicated feed to the holder of food - producing animals , or on - farm mixers of medicated feed for food - producing animals shall ensure that the quantities supplied or mixed do not exceed the quantities prescribed by the person issuing the prescription .


### the instructions for use in line with the veterinary prescription and the summary of the product characteristics referred to in article 14 of directive 2001 / 82 / ec ; ### the instructions for use in line with the summary of the product characteristics referred to in article 14 of directive 2001 / 82 / ec and the veterinary prescription if available at the time of manufacture ;


### where the evidence presented is insufficient for the purposes of paragraph 1 , the commission shall inform the complainant about the insufficiency within 60 days of the date on which the complaint was lodged . the complainant shall be given 30 days to provide additional evidence . where the complainant fails to do so within that time limit , the commission may decide not to initiate the investigation . ### where the evidence presented is insufficient for the purposes of paragraph 1 , the commission shall inform the complainant about the insufficiency within 30 days of the date on which the complaint was lodged . the complainant shall be given 30 days to provide additional evidence . where the complainant fails to do so within that time limit , the commission may decide not to initiate the investigation .


### the commission shall decide on the initiation of an investigation in accordance with paragraph 1 within 6 months of the lodging of the complaint . ### the commission shall decide on the initiation of an investigation in accordance with paragraph 1 within three months of the lodging of the complaint .


### at union level , interoperability facilitates successful implementation of policies . the following policies in particular rely on interoperability for their effective and efficient implementation : ### at union level , interoperability can facilitate successful implementation of policies with a relevant cross - border dimension . the following policies in particular rely on interoperability for their effective and efficient implementation :


### interoperability is also a fundamental element of the connecting europe facility established by regulation no 1316 / 2013 of the european parliament and the council55 in the area of broadband infrastructure and services . the regulation 2014 / 283 / eu56 on guidelines for trans - european networks in the area of telecommunications infrastructure explicitly mentions that an operational priority for the cef to achieve its objectives is the interoperability , connectivity , sustainable deployment , operation and upgrading of trans - european digital service infrastructures as well as their coordination at union level . __________________ 55 regulation no 1316 / 2013 / eu of the european parliament and of the council of 11 december 2013 establishing the connecting europe facility , amending regulation no 913 / 2010 and repealing regulations no 680 / 2007 and no 67 / 2010 . oj l 348 , 20 . 12 . 2013 , p . 129 . 56 regulation no 283 / 2014 of the european parliament and of the council of 11 march 2014 on guidelines for trans - european networks in the area of telecommunications infrastructure and repealing decision no 1336 / 97 / ec . oj l 86 , 21 . 3 . 2014 , p . 14 . ### interoperability is also a fundamental element of the connecting europe facility established by regulation no 1316 / 2013 of the european parliament and the council55 in the area of broadband infrastructure and services . the regulation 2014 / 283 / eu56 on guidelines for trans - european networks in the area of telecommunications infrastructure explicitly mentions that one of the operational priorities for the cef to achieve its objectives is the interoperability , connectivity , sustainable deployment , operation and upgrading of trans - european digital service infrastructures as well as their coordination at union level . that regulation particularly provides for so - called building blocks , such as e - identification , e - delivery and automated translation , to facilitate cross - border interoperability . __________________ 55 regulation no 1316 / 2013 / eu of the european parliament and of the council of 11 december 2013 establishing the connecting europe facility , amending regulation no 913 / 2010 and repealing regulations no 680 / 2007 and no 67 / 2010 . oj l 348 , 20 . 12 . 2013 , p . 129 . 56 regulation no 283 / 2014 of the european parliament and of the council of 11 march 2014 on guidelines for trans - european networks in the area of telecommunications infrastructure and repealing decision no 1336 / 97 / ec . oj l 86 , 21 . 3 . 2014 , p . 14 .


### through the isa2 programme , the union shall identify , create and operate interoperability solutions implementing union policies . these solutions shall subsequently be provided for unlimited use to other union institutions and bodies , and to national , regional and local public administrations , thus facilitating cross - border or cross - sector interaction between them . ### through the isa2 programme , the commission , in conjunction with the member states , represented by the committee on interoperability solutions for european public administrations , businesses and citizens established under regulation no 182 / 2011 , shall identify , create and operate interoperability solutions implementing union policies . these solutions shall subsequently be provided for unlimited use to other union institutions and bodies , and to national , regional and local public administrations , thus facilitating cross - border or cross - sector interaction between them .


### ' interoperability ' means the ability of disparate and diverse organisations to interact towards mutually beneficial and agreed common goals , involving the sharing of information and knowledge between the organisations , through the business processes they support , by means of the exchange of data between their respective information and communication technology systems ; ### ' interoperability ' means the ability of different organisations to interact towards mutually beneficial and agreed common goals , involving the sharing of information and knowledge between the organisations , through the business processes they support , by means of the exchange of data between their respective information and communication technology systems ;


### ’interoperability solutions’ means common frameworks , common services and generic tools facilitating cooperation between disparate and diverse organisations , either autonomously funded and developed by the isa2 programme or developed in cooperation with other union initiatives , based on identified requirements of european public administrations ; ### ’interoperability solutions’ means common frameworks , common services and functional tools facilitating cooperation between different organisations , either autonomously funded and developed by the isa2 programme or developed in cooperation with other union initiatives , based on identified requirements of european public administrations ;


### actions in the form of projects shall , where appropriate , consist of the following phases : ### where appropriate , actions in the form of projects may consist of multiple phases :


### the phases of specific projects shall be defined and specified at the time when the action is included in the rolling work programme . ### the phases of specific projects may be defined and specified at the time when the action is included in the rolling work programme . it shall be possible to terminate a project at any point if it is no longer needed or considered effective .


### the evaluations shall examine issues such as the relevance , effectiveness , efficiency , utility , sustainability and coherence of programme actions . the final evaluation shall , in addition , examine the extent to which the programme has achieved its objective . ### the evaluations shall examine issues such as the relevance , effectiveness , efficiency , utility , sustainability and coherence of programme actions . furthermore they shall examine coherence , synergies and complementarity with other union programmes , in particular the connecting europe facility . the final evaluation shall , in addition , examine the extent to which the programme has achieved its objective .


### quantifiable benefits that the interoperability solutions deliver by linking ict with users ' needs ; ### quantifiable benefits and cost savings that the interoperability solutions deliver by linking ict with users ' needs ;


### enhancing research and innovation capacities and the uptake of advanced technologies ; ### fostering research and innovation capacities and the uptake of advanced technologies ;


### reaping the benefits of digitisation for citizens , companies and governments ; ### reaping the benefits of digitisation for citizens , companies and governments and enhancing digital connectivity


### natural mineral resources in conflict - affected or high risk areas &#8722 ; although holding great potential for development &#8211 ; can be a cause of dispute where their revenues are fuelling the outbreak or continuation of violent conflict , undermining national endeavours towards development , good governance and the rule of law . in these areas , breaking the nexus between conflict and illegal exploitation of minerals is critical to peace and stability . ### natural mineral resources in conflict - affected or high risk areas &#8722 ; although holding great potential for development &#8211 ; can be a cause of dispute where their revenues are fuelling the outbreak or continuation of violent conflict , undermining endeavours towards development , good governance and the rule of law . in these areas , breaking the nexus between conflict and illegal exploitation of minerals is a critical element in guaranteeing peace , development and stability .


### the issue concerns resource - rich regions where the challenge posed by the desire to minimise the financing of armed groups and security forces has been taken up by governments and international organisations together with business operators and civil society organisations . ### the issue concerns resource - rich areas where the challenge posed by the desire to minimise the financing of armed groups and security forces has been taken up by governments and international organisations together with business operators and civil society organisations .


### union citizens and civil society actors have raised awareness with respect to companies operating under the union ' s jurisdiction for not being held accountable for their potential connection to the illicit extraction and trade of minerals from conflict regions . the consequence is that such minerals , potentially present in consumer products , link consumers to conflicts outside the union . to this end , citizens have requested , notably through petitions , that legislation be proposed to the european parliament and the council holding companies accountable under the guidelines as established by the un and oecd . ### union citizens and civil society actors have raised awareness with respect to companies operating under the union ' s jurisdiction for not being held accountable for their potential connection to the illicit extraction and trade of minerals from conflict areas . the consequence is that such minerals , potentially present in consumer products , link consumers to conflicts outside the union . to this end , citizens have requested , notably through petitions , that legislation be proposed to the european parliament and the council holding companies accountable under the guidelines as established by the un and oecd .


### in the context of this regulation , supply chain due diligence is an on - going , proactive and reactive process through which business operators monitor and administer their purchases and sales with a view to ensuring that they do not contribute to conflict and adverse impacts thereof . ### in the context of this regulation , supply chain due diligence is an on - going , proactive and reactive process through which importers may monitor and administer their supply chains with a view to ensuring that they do not contribute to conflict and adverse impacts thereof .


### the commission shall identify on the list referred to in paragraph 1 those responsible smelters and refiners that source – at least partially – from conflict - affected and high - risk areas . ### the commission shall identify on the list referred to in paragraph 1 those responsible smelters and refiners that source – at least partially – from conflict - affected and high - risk areas . this list shall be drawn up taking into account existing equivalent industry , governmental or other due diligence schemes covering the minerals and metals within the scope of this regulation as set out in annex i .


### blending operations supported by means of a cef blending facility shall be selected on the basis of maturity and shall seek sectoral diversification in accordance with articles 3 and 4 as well as geographical balance across the member states . they shall : ### blending operations supported by means of a cef blending facility shall be selected on the basis of maturity taking into account a minimum set of criteria which are to be set by the commission and shall seek sectoral diversification in accordance with articles 3 and 4 as well as geographical balance across the member states . they shall :


### the absence of any exception in regulation no 469 / 2009 to the protection conferred by a supplementary protection certificate has had the unintended consequence of preventing manufacturers of generics and biosimilars established in the union from manufacturing , even for the exclusive purpose of exporting to third country markets in which such protection does not exist or has expired . a further unintended consequence is that the protection conferred by the certificate makes it more difficult for those manufacturers to enter the union market immediately after expiry of the certificate , given that they are not in a position to build up production capacity until the protection provided by the certificate has lapsed , by contrast with manufacturers located in third countries where protection does not exist or has expired . ### the absence of any exception in regulation no 469 / 2009 to the protection conferred by a supplementary protection certificate has had the unintended consequence of preventing manufacturers of generics and biosimilars established in the union from manufacturing , even for the exclusive purpose of exporting to third country markets in which such protection does not exist or has expired . a further unintended consequence is that the protection conferred by the certificate makes it more difficult for those manufacturers to enter the union market immediately after expiry of the certificate , given that they are not in a position to build up production capacity until the protection provided by the certificate has lapsed , by contrast with manufacturers located in third countries where protection does not exist or has expired . a significant effect could be the re - export – i . e . the export , repackaging and re - import of medicinal products – both from the union and , above all , from third countries .


### this puts manufacturers of generics and biosimilars established in the union at a significant competitive disadvantage compared with manufacturers based in third countries that offer less or no protection . ### this puts manufacturers of generics and biosimilars established in the union at a significant competitive disadvantage compared with manufacturers based in third countries that offer less or no protection . it may result in the re - export of generic and biosimilar medicinal products of unknown origin , often at dumping prices .


### the aim of this regulation is to ensure that manufacturers established in the union are able to compete effectively in those third country markets where supplementary protection does not exist or has expired . it is intended to complement the efforts of the union’s trade policy to ensure open markets for union - based manufacturers of medicinal products . indirectly , it is also intended to put those manufacturers in a better position to enter the union market immediately after expiry of the relevant supplementary protection certificate . it would also help to serve the aim of fostering access to medicines in the union by helping to ensure a swifter entry of generic and biosimilar medicines onto the market after expiry of the relevant certificate . ### the aim of this regulation is to ensure that manufacturers established in the union are able to compete effectively in those third country markets where supplementary protection does not exist , has expired or where there are indications that medicinal products may be re - exported or sold at dumping prices . it is intended to complement the efforts of the union’s trade policy to ensure open markets for union - based manufacturers of medicinal products . indirectly , it is also intended to put those manufacturers in a better position to enter the union market immediately after expiry of the relevant supplementary protection certificate . it would also help to serve the aim of fostering access to medicines in the union by helping to ensure a swifter entry of generic and biosimilar medicines onto the market after expiry of the relevant certificate .


### in those specific and limited circumstances , and in order to create a level playing field between union - based manufacturers and third country manufacturers , it is appropriate to restrict the protection conferred by a supplementary protection certificate so as to allow making for the exclusive purpose of export to third countries and any related acts strictly necessary for making or for the actual export itself . ### in those specific and limited circumstances , and in order to create a level playing field between union - based manufacturers and third country manufacturers , it is appropriate to restrict the protection conferred by a supplementary protection certificate so as to allow making for the exclusive purpose of export to third countries and any related acts strictly necessary for making , for the actual export itself and also for re - export or sale of medicinal products at dumping prices .


### the exception should not cover placing the product made for the exclusive purpose of export on the market in the member state where a supplementary protection certificate is in force , either directly or indirectly after export , nor should it cover re - importation of the product to the market of a member state in which a certificate is in force . moreover , it should not cover any act or activity for the purpose of import of medicinal products , or parts of medicinal products , into the union merely for the purposes of repackaging and re - exporting . ### the exception should not cover placing the product made for the exclusive purpose of export on the market in the member state where a supplementary protection certificate is in force , either directly or indirectly after export , nor should it cover re - importation of the product to the market of a member state in which a certificate is in force . moreover , it should not cover any act or activity for the purpose of import of medicinal products , or parts of medicinal products , into the union merely for the purposes of repackaging and re - exporting , i . e . their re - export from third countries to the union .


### the commission should carry out an evaluation of this regulation . pursuant to paragraph 22 of the interinstitutional agreement between the european parliament , the council of the european union and the european commission on better law - making of 13 april 201643 , that evaluation should be based on the five criteria of effectiveness , efficiency , relevance , coherence and added value and should provide the basis for impact assessments of possible further measures . the evaluation should take into account exports to outside the union and the ability of generics and especially biosimilars to enter markets in the union as soon as possible after a certificate lapses . in particular , this evaluation should review the effectiveness of the exception in the light of the aim to restore a global level playing field for generic and biosimilar firms in the union and a swifter entry of generic and especially biosimilar medicines onto the market after a certificate lapses . it should also study the impact of the exception on research and production of innovative medicines by holders of certificates in the union and consider the balance between the different interests at stake , including those of public health . _________________ 43 oj l 123 , 12 . 5 . 2016 , p . 1 . ### the commission should carry out an evaluation of this regulation . pursuant to paragraph 22 of the interinstitutional agreement between the european parliament , the council of the european union and the european commission on better law - making of 13 april 201643 , that evaluation should be based on the five criteria of effectiveness , efficiency , relevance , coherence and added value and should provide the basis for impact assessments of possible further measures . the evaluation should take into account exports to outside the union and the ability of generics and especially biosimilars to enter markets in the union as soon as possible after a certificate lapses . in particular , this evaluation should review the effectiveness of the exception in the light of the aim to restore a global level playing field for generic and biosimilar firms in the union and a swifter entry of generic and especially biosimilar medicines onto the market after a certificate lapses . it should also study the impact of the exception on research and production of innovative medicines by holders of certificates in the union and consider the balance between the different interests at stake , and above all those of public health . _________________ 43 oj l 123 , 12 . 5 . 2016 , p . 1 .


### the release of political prisoners on 22 august 2015 was an important step , which together with several positive initiatives undertaken by the republic of belarus over the last two years contributed to the improvement of relations between the european union and the republic of belarus . ### the release of political prisoners on 22 august 2015 was a very important step , which together with several positive initiatives undertaken by the republic of belarus over the last two years contributed to the improvement of relations between the european union and the republic of belarus .


### these positive political developments between the european union and the republic of belarus should be recognised and bilateral relations further improved . accordingly , the present regulation repeals the autonomous quotas on imports of textiles and clothing originating in the republic of belarus , provided for in annexes ii and iii of regulation 2015 / 936 . ### these positive political developments between the european union and the republic of belarus should be recognised and bilateral relations further improved .


### the limited use of the autonomous quotas on imports of textiles and clothing originating in the republic of belarus implies that the removal of those quotas will have a limited impact on eu trade . ### despite the limited use of the autonomous quotas on imports of textiles and clothing originating in the republic of belarus , the removal of those quotas will have serious consequences for employment in the eu member states .


### it is appropriate that different cases usually referred to as situations of conflict of interest be identified and treated distinctly . the notion of a ‘ conflict of interest’ should be solely used for cases where an entity or person with responsibilities for budget implementation , audit or control or an official or an agent of a union institution is in such a situation . in cases where an economic operator attempts to unduly influence a procedure or obtain confidential information , this should be treated as grave professional misconduct . in addition , economic operators may be in a situation where they should not be selected to implement a contract because of a professional conflicting interest . for instance , a company should not evaluate a project in which it has participated or an auditor should not be in a position to audit accounts it has previously certified . ### it is appropriate that different cases usually referred to as situations of conflict of interest be identified and treated distinctly . the notion of a ‘ conflict of interest’ should be used for cases where an entity or person with responsibilities for budget implementation , audit or control or an official or an agent of a union institution is in such a situation . all persons or entities potentially subject to conflict of interest should be encouraged to publish their declarations of interest , instead of a declaration of absence of conflict of interest . a self - evaluation of conflict of interest is a conflict of interest in itself . therefore , the evaluation of conflict of interest should be done by an independent third party . in cases where an economic operator attempts to unduly influence a procedure or obtain confidential information , this should be treated as grave professional misconduct . in addition , economic operators may be in a situation where they should not be selected to implement a contract because of a professional conflicting interest . for instance , a company should not evaluate a project in which it has participated or an auditor should not be in a position to audit accounts it has previously certified . a record of all cases of conflict of interest and revolving door identified in the union institutions should be published on a regular basis .


### union public procurement should ensure that union funds are used in an effective , transparent , and appropriate way . in that regard , electronic procurement should contribute to the better use of union funds and enhance access to contracts for all economic operators . ### union public procurement should ensure that union funds are used in an effective , transparent , and appropriate way . in that regard , electronic procurement should contribute to the better use of union funds and enhance access to contracts for all economic operators . all union institutions conducting public procurement should publish clear rules on their websites regarding acquisition , expenditure and monitoring , as well as all contracts awarded , including their value .


### a contracting authority should be able to cancel a procurement procedure before the contract is signed , without the candidates or tenderers being entitled to claim compensation . this should be without prejudice to situations where the contracting authority has acted in such a way that it may be held liable for damages in accordance with the general principles of union law . ### a contracting authority should be able to cancel a procurement procedure before the contract is signed , including on grounds of suspicion of conflict of interest , revolving doors or grave professional misconduct , without the candidates or tenderers being entitled to claim compensation . this should be without prejudice to situations where the contracting authority has acted in such a way that it may be held liable for damages in accordance with the general principles of union law .


### the contracting authority may , before the contract is signed , cancel the procurement procedure without the candidates or tenderers being entitled to claim any compensation . ### the contracting authority may , before the contract is signed , cancel the procurement procedure , including on grounds of suspicion of conflict of interest , revolving doors or grave professional misconduct , without the candidates or tenderers being entitled to claim any compensation .


### all grants awarded in the course of a financial year shall be published in accordance with paragraphs 1 to 4 of article 36 . ### all grants awarded in the course of a financial year shall be published in accordance with paragraphs 1 to 4 of article 36 . in addition , all union institutions conducting public procurement shall publish on their websites clear rules regarding acquisition , expenditure and monitoring , as well as all contracts awarded , including their value .


### e - commerce is the main driver for growth within the digital single market . however its growth potential is far from being fully exploited . in order to strengthen union competiveness and to boost growth , the union needs to act swiftly and encourage economic actors to unleash the full potential offered by the digital single market . the full potential of the digital single market can only be unleashed if all market participants enjoy smooth access to the online sales of goods and are able to confidently engage in e - commerce transactions . the contract law rules on the basis of which market participants conclude transactions are among the key factors shaping business’ decisions whether to offer goods online cross - border . those rules also influence consumers’ willingness to embrace and trust this type of purchase . ### e - commerce has made major inroads in the retail sector is the main driver for growth within the digital single market . however its growth potential is far from being fully exploited . in order to strengthen union competitiveness and to boost growth , the union needs to act swiftly and encourage economic actors to unleash the full potential offered by the digital single market . the full potential of the digital single market can only be unleashed if all market participants enjoy smooth access to the online sales of goods and are able to confidently engage in e - commerce transactions . the contract law rules on the basis of which market participants conclude transactions are among the key factors shaping business’ decisions whether to offer goods online cross - border . those rules also influence consumers’ willingness to embrace and trust this type of purchase .


### conformity should cover material defects as well as legal defects . third party rights and other legal defects might effectively bar the consumer from enjoying the goods in accordance with the contract when the right ' s holder rightfully compels the consumer to stop infringing those rights . therefore the seller should ensure that the goods are free from any right of a third party , which precludes the consumer from enjoying the goods in accordance with the contract . ### conformity should cover fully material defects as well as legal defects . third party rights and other legal defects might effectively bar the consumer from enjoying the goods in accordance with the contract when the rights holder rightfully compels the consumer to stop infringing those rights . therefore the seller should ensure that the goods are free from any right of a third party , which precludes the consumer from enjoying the goods in accordance with the contract .