### it is necessary to ensure that external - cost charges continue to reflect the cost of air pollution and noise generated by heavy duty vehicles as accurately as possible without rendering the charging scheme excessively complex , to incentivise the use of the most fuel - efficient vehicles , and to keep the incentives effective and the differentiation of road charges up - to - date . therefore , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission for the purpose of adapting the reference values for external cost charging to scientific progress , defining the modalities for the revenue - neutral variation of infrastructure charges according to the co2 emissions from heavy duty vehicles , and adapting the modalities of the variation of infrastructure charges for light duty vehicles to technical progress . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement on better law - making of 13 april 201621 . in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents at the same time as member states’ experts , and their experts systematically have access to meetings of commission expert groups dealing with the preparation of delegated acts . _________________ 21 oj l 123 , 12 . 5 . 2016 , p . 1 . ### it is necessary to ensure that external - cost charges continue to reflect the cost of air pollution and noise generated by heavy duty vehicles as accurately as possible without rendering the charging scheme excessively complex , to incentivise the use of the most fuel - efficient vehicles and clean vehicles , and to keep the incentives effective and the differentiation of road charges up - to - date . therefore , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission for the purpose of adapting the reference values for external cost charging to scientific progress , defining the modalities for the revenue - neutral variation of infrastructure charges according to the co2 emissions from heavy duty vehicles , and adapting the modalities of the variation of infrastructure charges for light duty vehicles to technical progress . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement on better law - making of 13 april 201621 . in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents at the same time as member states’ experts , and their experts systematically have access to meetings of commission expert groups dealing with the preparation of delegated acts . _________________ 21 oj l 123 , 12 . 5 . 2016 , p . 1 .


### new infrastructure or new infrastructure improvements , including significant structural repairs ; ### new infrastructure , new alternative transport infrastructure for modal shifting or new infrastructure improvements , including significant structural repairs ;


### ‘ toll’ means a specified amount based on the distance travelled on a given infrastructure and on the type of the vehicle , the payment of which confers the right for a vehicle to use the infrastructures , comprising an infrastructure charge , and as the case may be a congestion charge or an external - cost charge or both ; ### ‘ toll’ means a specified amount based on the distance travelled on a given infrastructure and on the type of the vehicle , the payment of which confers the right for a vehicle to use the infrastructures , comprising an infrastructure charge , an external - cost charge and as the case may be a congestion charge ;


### ‘ infrastructure charge’ means a charge levied for the purpose of recovering the construction , the maintenance , the operation and the development costs related to infrastructure incurred in a member state ; ### ‘ infrastructure charge’ means a charge levied for the purpose of recovering the construction , the maintenance , the operation and the development costs related to infrastructure incurred in a member state and of cross - financing new , alternative transport infrastructure projects there ;


### ‘ cost of traffic - based air pollution’ means the cost of the damage caused by the release of particulate matter and of ozone precursors , such as nitrogen oxide and volatile organic compounds , in the course of the operation of a vehicle ; ### ‘ cost of traffic - based air pollution’ means the cost of the harm to human health and of the damage caused to the environment by the release of particulate matter and of ozone precursors , such as nitrogen oxide and volatile organic compounds , in the course of the operation of a vehicle ;


### ‘ cost of traffic - based noise pollution’ means the cost of the damage caused by the noise emitted by the vehicles or created by their interaction with the road surface ; ### ‘ cost of traffic - based noise pollution’ means the cost of the harm to human health and of the damage caused to the environment by the noise emitted by the vehicles or created by their interaction with the road surface ;


### costs of infrastructure or infrastructure improvements may include any specific expenditure on infrastructure designed to reduce nuisance related to noise or to improve road safety and actual payments made by the infrastructure operator corresponding to objective environmental elements such as protection against soil contamination . ### costs of infrastructure or infrastructure improvements may include any specific expenditure on infrastructure designed to reduce nuisance related to noise or air pollution or to improve road safety and actual payments made by the infrastructure operator corresponding to objective environmental elements such as protection against soil contamination .


### member states may maintain or introduce an external - cost charge , related to the cost of traffic - based air or noise pollution or both . ### member states shall maintain or introduce an external - cost charge , related to the cost of traffic - based air or noise pollution or both .


### after informing the commission , a member state may add a mark - up to the infrastructure charge levied on specific road sections which are regularly congested , or the use of which by vehicles causes significant environmental damage , where the following conditions are met : ### after informing the commission , a member state or a competent region may add a mark - up to the infrastructure charge levied on specific road sections which are regularly congested , or the use of which by vehicles causes significant environmental damage , where the following conditions are met :


### from 1 january 2022 member states shall vary tolls and , in the case of user charges , at least annual charges , according to the co2 and pollutant emissions of vehicles in accordance with the rules set out in annex vii . ### member states may vary tolls and , in the case of user charges , at least annual charges , according to the co2 and pollutant emissions of vehicles in accordance with the rules set out in annex vii .


### by providing for a period of supplementary protection of up to five years , regulation no 469 / 2009 seeks to promote , within the union , the research and innovation that is necessary to develop medicinal products , and to contribute to preventing the relocation of pharmaceutical research outside the union to countries that may offer greater protection . ### regulation no 469 / 2009 provided a uniform solution at community level to prevent a heterogeneous evolution of national legislation creating new disparities , which could hinder the free movement of medicines within the community and thus directly affect the functioning of the internal market . however , the medicines system in the eu has evolved in recent decades with the introduction of generic and biosimilar medicines which improve competitiveness , the sustainability of health systems and european citizens’ access to medicines , while the exception intended by the proposed amendment of this regulation provides an opportunity to improve the parameters referred to above , which are now under threat .


### 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 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 . 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 these specific and limited circumstances , it is appropriate to eliminate the aforementioned , unintended side effects of the supplementary protection certificate so as to enable a level - playing field between union - based manufacturers and those in third countries . this would enable making exclusively for : export to third countries , and entry onto the union market immediately after expiry of the relevant supplementary protection certificate , as well as any related acts strictly necessary for that making or for the actual export itself or that entry onto the union market .


### that exception should cover the making of the product , including the product which corresponds to the medicinal product protected by a supplementary protection certificate in the territory of a member state , for the exclusive purpose of export to third countries , as well as any upstream or downstream acts by the maker or by third parties in a contractual relationship with the maker , where such acts would otherwise require the consent of the certificate - holder , and are strictly necessary for making for the purpose of export or for the actual export itself . for instance , such acts may include the supply and import of active ingredients for the purpose of making the medicinal product to which the product covered by the certificate corresponds , or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations . ### that exception should cover the making of the product protected by a supplementary protection certificate , including the making of the corresponding medicinal product , in the territory of a member state , for the exclusive purpose of export to countries where no supplementary protection certificate is in place and to prepare for the entry in the union ' s market on the first day after patent expiration , as well as any upstream or downstream acts , where such acts would otherwise require the consent of the certificate - holder , and are necessary for making for the purpose of export , for the actual export itself or for the entry in the union ' s market on the first day after patent expiration . for instance , such acts may include the supply and import of active ingredients for the purpose of making the corresponding medicinal product , temporary storage of the product or medicinal product , advertising or other activities necessary for the purpose of actually exporting to country destinations where no supplementary protection certificate is in place or the entry in the union ' s market on the first day after patent expiration .


### that exception should cover the making of the product , including the product which corresponds to the medicinal product protected by a supplementary protection certificate in the territory of a member state , for the exclusive purpose of export to third countries , as well as any upstream or downstream acts by the maker or by third parties in a contractual relationship with the maker , where such acts would otherwise require the consent of the certificate - holder , and are strictly necessary for making for the purpose of export or for the actual export itself . for instance , such acts may include the supply and import of active ingredients for the purpose of making the medicinal product to which the product covered by the certificate corresponds , or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations . ### that exception should cover the making of the product protected by a supplementary protection certificate , including the making of the corresponding medicinal product , in the territory of a member state , for the exclusive purpose of export to third countries or countries where no supplementary protection certificate is in place and to prepare for day - 1 entry on the union’s market , as well as any upstream or downstream acts , where such acts would otherwise require the consent of the certificate - holder , and are necessary for making for the purpose of export , for the actual export itself and for day - 1 entry . for instance , such acts may include the supply and import of active ingredient for the purpose of making the corresponding medicinal product , temporary storage of the product or medicinal product , advertising or other activities necessary for the purpose of actually exporting to third country destinations or day - 1 entry .


### that exception should cover the making of the product , including the product which corresponds to the medicinal product protected by a supplementary protection certificate in the territory of a member state , for the exclusive purpose of export to third countries , as well as any upstream or downstream acts by the maker or by third parties in a contractual relationship with the maker , where such acts would otherwise require the consent of the certificate - holder , and are strictly necessary for making for the purpose of export or for the actual export itself . for instance , such acts may include the supply and import of active ingredients for the purpose of making the medicinal product to which the product covered by the certificate corresponds , or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations . ### that exception should cover the making of the product , protected by a supplementary protection certificate , including the making of the corresponding medicinal product , in the territory of a member state , for the exclusive purpose of export to third countries or countries where no supplementary protection certificate is in place and to prepare for day - 1 entry on the union ' s market , as well as any upstream or downstream acts , where such acts would otherwise require the consent of the certificate - holder , and are necessary for making for the purpose of export or for the actual export itself and for day - 1 entry . for instance , such acts may include the supply and import of active ingredients for the purpose of making the corresponding medicinal product , temporary storage of the product or medicinal product , advertising or other activities necessary for the purpose of actually exporting to third country destinations or day - 1 entry .


### that exception should cover the making of the product , including the product which corresponds to the medicinal product protected by a supplementary protection certificate in the territory of a member state , for the exclusive purpose of export to third countries , as well as any upstream or downstream acts by the maker or by third parties in a contractual relationship with the maker , where such acts would otherwise require the consent of the certificate - holder , and are strictly necessary for making for the purpose of export or for the actual export itself . for instance , such acts may include the supply and import of active ingredients for the purpose of making the medicinal product to which the product covered by the certificate corresponds , or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations . ### that exception should cover the making of the product protected by a supplementary protection certificate , including the making of the corresponding medicinal product , in the territory of a member state , for the exclusive purpose of export to third countries or countries where no supplementary protection certificate is in place and to prepare for day - 1 entry on the union’s market , as well as any upstream or downstream acts , where such acts would otherwise require the consent of the certificate - holder , and are necessary for making for the purpose of export or for the actual export itself and for day - 1 entry . for instance , such acts may include the supply and import of active ingredients for the purpose of making the corresponding medicinal product , temporary storage of the product or medicinal product , advertising or other activities necessary for the purpose of actually exporting to third country destinations or day - 1 entry .


### that exception should cover the making of the product , including the product which corresponds to the medicinal product protected by a supplementary protection certificate in the territory of a member state , for the exclusive purpose of export to third countries , as well as any upstream or downstream acts by the maker or by third parties in a contractual relationship with the maker , where such acts would otherwise require the consent of the certificate - holder , and are strictly necessary for making for the purpose of export or for the actual export itself . for instance , such acts may include the supply and import of active ingredients for the purpose of making the medicinal product to which the product covered by the certificate corresponds , or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations . ### that exception should cover the making of the product , including the product which corresponds to the medicinal product protected by a supplementary protection certificate in the territory of a member state , for the exclusive purpose of export to third countries or day - 1 entry , as well as any upstream or downstream acts by the maker or by third parties in a contractual relationship with the maker , where such acts would otherwise require the consent of the certificate - holder , and are strictly necessary for making for the purpose of export , for the actual export itself or for day - 1 entry . for instance , such acts may include the supply and import of active ingredients for the purpose of making the medicinal product to which the product covered by the certificate corresponds , or temporary storage of the product or advertising for the purpose of export to third country destinations or day - 1 entry .


### 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 a medicinal product made for the exclusive purpose of export or for the entry in the union ' s market on the first day after patent expiration in the member state where a supplementary protection certificate is in force , nor should it cover re - importation of the medicinal 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 .


### to this end , this regulation should impose a once - off duty on the person making the product for the exclusive purpose of export , requiring that person to provide certain information to the authority which granted the supplementary protection certificate in the member state where the making is to take place . the information should be provided before the making is intended to start for the first time in that member state . the making and related acts , including those performed in member states other than the one of making in cases where the product is protected by a certificate in those other member states too , should only fall within the scope of the exception where the maker has sent this notification to the competent industrial property authority of the member state of making . the once - off duty to provide information to the authority should apply in each member state where making is to take place , both as regards the making in that member state , and as regards related acts , whether performed in that or another member state , related to that making . the authority should be required to publish that information , in the interests of transparency and for the purpose of informing the holder of the certificate of the maker’s intention . ### to this end , and to the extent it intends to rely on the exception , the person responsible for the making , or any person acting on its behalf , should provide certain information to the registered holder of the certificate , at its registered address on a confidentiality basis . the information should be provided before the making is intended to start for the first time . the making and related acts , including those performed in member states other than the one of making in cases where the product is protected by a certificate in those other member states too , would altogether fall within the scope of the exception , provided that the maker has sent this notification to the holder of the certificate .


### to this end , this regulation should impose a once - off duty on the person making the product for the exclusive purpose of export , requiring that person to provide certain information to the authority which granted the supplementary protection certificate in the member state where the making is to take place . the information should be provided before the making is intended to start for the first time in that member state . the making and related acts , including those performed in member states other than the one of making in cases where the product is protected by a certificate in those other member states too , should only fall within the scope of the exception where the maker has sent this notification to the competent industrial property authority of the member state of making . the once - off duty to provide information to the authority should apply in each member state where making is to take place , both as regards the making in that member state , and as regards related acts , whether performed in that or another member state , related to that making . the authority should be required to publish that information , in the interests of transparency and for the purpose of informing the holder of the certificate of the maker’s intention . ### to this end , this regulation should impose a duty on the person making the product for the exclusive purpose of export , requiring that person to provide certain information to the authority which granted the supplementary protection certificate in the member state , where each making is to take place , and to the certificate holder in the relevant member state , no later than three months before the start date of making in that member state . the information should be provided before the making is to start at the earliest for the first time in that member state and in advance of any related act prior to that making that would otherwise be prohibited by the protection conferred by a certificate . the making and related acts , including those performed in member states other than the one of making in cases where the product is protected by a certificate in those other member states too , should only fall within the scope of the exception where the maker has sent this notification to the competent industrial property authority of the member state of making and to the certificate holder . the duty to provide information to the authority should apply in each member state where making is to take place , both as regards the making in that member state , and as regards related acts , whether performed in that or another member state . the authority should be required to publish that information , in the interests of transparency and for the purpose of informing the holder of the certificate of the maker’s intention .


### to this end , this regulation should impose a once - off duty on the person making the product for the exclusive purpose of export , requiring that person to provide certain information to the authority which granted the supplementary protection certificate in the member state where the making is to take place . the information should be provided before the making is intended to start for the first time in that member state . the making and related acts , including those performed in member states other than the one of making in cases where the product is protected by a certificate in those other member states too , should only fall within the scope of the exception where the maker has sent this notification to the competent industrial property authority of the member state of making . the once - off duty to provide information to the authority should apply in each member state where making is to take place , both as regards the making in that member state , and as regards related acts , whether performed in that or another member state , related to that making . the authority should be required to publish that information , in the interests of transparency and for the purpose of informing the holder of the certificate of the maker’s intention . ### to this end , and to the extent it intends to rely on the exception , the person responsible for the making , or any person acting on its behalf , should provide certain information to the registered holder of the certificate , at its registered address on a confidentiality basis . the information should be provided before the making is intended to start for the first time . the making and related acts , including those performed in member states other than the one of making in cases where the product is protected by a certificate in those other member states too , would altogether fall within the scope of the exception , provided that the maker has sent this notification to the holder of the certificate . the notification should be without prejudice to any defences otherwise available to the maker and any other persons conducting the related acts referred to in recital 9 against a claim from the holder of the certificate in relation to an alleged infringement or threat of infringement of the certificate , and should not be construed as an acknowledgment by the maker that the certificate or the basic patent is valid and / or that the making or any of the related acts referred to in recital 9 would otherwise infringe the certificate and / or the basic patent .


### it is necessary and appropriate for the achievement of the basic objective , of providing a level playing field for generic and biosimilar manufacturers with their competitors in third country markets where protection does not exist or has expired , to lay down rules restricting the exclusive right of a supplementary protection certificate holder to make the product in question during the term of the certificate , and also to impose certain information and labelling obligations on makers wishing to take advantage of those rules . this regulation complies with the principle of proportionality , and does not go beyond what is necessary in order to achieve the objectives pursued , in accordance with article 5 of the treaty on european union . ### it is necessary and appropriate for the achievement of the basic objective of providing a level playing field for generic and biosimilar manufacturers with their competitors in third country markets where protection does not exist or has expired , to lay down rules enabling the making of the product in question during the term of the certificate . this regulation complies with the principle of proportionality , and does not go beyond what is necessary in order to achieve the objectives pursued , in accordance with article 5 of the treaty on european union .


### it is important to be able to reinforce the deterrent effect achieved by the exclusion and the financial penalty . in that regard , the deterrent effect should be reinforced by the possibility to publish the information related to the exclusion and / or to the financial penalty , with full respect for the data protection requirements set out in regulation no 45 / 2001 of the european parliament and of the council and in directive 95 / 46 / ec of the european parliament and of the council . this should contribute to ensuring that the same conduct is not repeated . for reasons of legal certainty and in accordance with the principle of proportionality it should be specified in which situations a publication should not take place . in its assessment , the authorising officer responsible should have regard to any recommendation of the panel . as far as natural persons are concerned , personal data should only be published in exceptional cases justified by the seriousness of the conduct or its impact on the union ' s financial interests . ### it is important to be able to reinforce the deterrent effect achieved by the exclusion and the financial penalty . in that regard , the deterrent effect should be reinforced by the possibility to publish the information related to the exclusion and / or to the financial penalty , with full respect for the data protection requirements set out in regulation no 45 / 2001 of the european parliament and of the council and in regulation 2016 / 679 of the european parliament and of the council . this should contribute to ensuring that the same conduct is not repeated . for reasons of legal certainty and in accordance with the principle of proportionality it should be specified in which situations a publication should not take place . in its assessment , the authorising officer responsible should have regard to any recommendation of the panel . as far as natural persons are concerned , personal data should only be published in exceptional cases justified by the seriousness of the conduct or its impact on the union ' s financial interests .


### 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 .


### personal data collected pursuant to this regulation shall be processed in accordance with directive 95 / 46 / ec and regulation no 45 / 2001 . a candidate or tenderer in a procurement procedure , an applicant in a grant award procedure , an expert in a procedure for the selection of experts , an applicant in a contest for prizes or an entity or person participating in a procedure for implementing union funds in accordance with point of article 61as well as a beneficiary , a contractor , a remunerated external expert or any person or entity that receives prizes or implements union funds pursuant to point of article 61 shall be informed accordingly . _________________ 28 oj l 281 , 23 . 11 . 1995 , p . 31 . ### personal data collected pursuant to this regulation shall be processed in accordance with regulation 2016 / 679 of the european parliament and of the council and regulation no 45 / 2001 . a candidate or tenderer in a procurement procedure , an applicant in a grant award procedure , an expert in a procedure for the selection of experts , an applicant in a contest for prizes or an entity or person participating in a procedure for implementing union funds in accordance with point of article 61as well as a beneficiary , a contractor , a remunerated external expert or any person or entity that receives prizes or implements union funds pursuant to point of article 61 shall be informed accordingly .


### 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 .


### for emergency , post - emergency or thematic actions , the commission may create , after informing the european parliament and the council , trust funds under an agreement concluded with other donors . the constitutive act of each trust fund shall define the objectives of the trust fund . the commission decision establishing the trust fund shall include a description of the fund ' s objectives , the justification for its creation in accordance with paragraph 3 , an indication of its duration and the preliminary agreements with other donors . ### for emergency , post - emergency or thematic external actions , the commission may create , after informing the european parliament and the council , trust funds under an agreement concluded with other donors . the constitutive act of each trust fund shall define the objectives of the trust fund . the commission decision establishing the trust fund shall include a description of the fund ' s objectives , the justification for its creation in accordance with paragraph 3 , an indication of its duration and the preliminary agreements with other donors .


### the commission shall submit its draft decisions concerning the establishment , the extension and the liquidation of a union trust fund to the competent committee where provided for in the basic act under which the union contribution to the union trust fund is provided . ### the commission shall consult the parliament by establishing the fund and later submit its draft decisions concerning the establishment , the extension and the liquidation of a union trust fund to the competent committee where provided for in the basic act under which the union contribution to the union trust fund is provided .


### this directive covers rules applicable to the online and other distance sales of goods only in relation to key contract elements needed to overcome contract - law related barriers in the digital single market . for this purpose , rules on conformity requirements , remedies available to consumers for lack of conformity of the goods with the contract and modalities for their exercise should be fully harmonised and the level of consumer protection as compared to directive 1999 / 44 / ec , should be increased . ### this directive covers rules applicable to the sale of goods , including online and other distance sales , only in relation to key contract elements needed to overcome contract - law related barriers in the single market and the digital single market . for this purpose , rules on conformity requirements , remedies available to consumers for lack of conformity of the goods with the contract and modalities for their exercise should be fully harmonised in such a way as to afford a high level of consumer protection .


### this directive covers rules applicable to the online and other distance sales of goods only in relation to key contract elements needed to overcome contract - law related barriers in the digital single market . for this purpose , rules on conformity requirements , remedies available to consumers for lack of conformity of the goods with the contract and modalities for their exercise should be fully harmonised and the level of consumer protection as compared to directive 1999 / 44 / ec , should be increased . ### this directive covers rules applicable to the sale of goods , including online and other distance sales , only in relation to key contract elements needed to overcome contract - law related barriers in the single market and the digital single market . for this purpose , rules on conformity requirements , remedies available to consumers for lack of conformity of the goods with the contract and modalities for their exercise should be fully harmonised in such a way as to ensure a high level of consumer protection . this directive should not affect national laws regulating the conditions under which the seller is liable for the sold goods ' hidden defects that already existed before the consumer acquired possession of the goods , but only became apparent after such acquisition , and which render the goods unfit for the use for which they were intended , or which diminish their use to such an extent that the consumer would not have bought the goods or would only have paid a lower price for them if the defect had been known .


### this directive covers rules applicable to the online and other distance sales of goods only in relation to key contract elements needed to overcome contract - law related barriers in the digital single market . for this purpose , rules on conformity requirements , remedies available to consumers for lack of conformity of the goods with the contract and modalities for their exercise should be fully harmonised and the level of consumer protection as compared to directive 1999 / 44 / ec , should be increased . ### this directive covers rules applicable to all sales of goods , including online and other distance sales of goods only in relation to key contract elements needed to overcome contract - law related barriers in the digital single market . for this purpose , rules on conformity requirements , remedies available to consumers for lack of conformity of the goods with the contract and modalities for their exercise should be fully harmonised and the level of consumer protection should be increased .


### 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 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 the observance of third - party rights in respect of the goods .


### the consumer ' s choice between repair and replacement should only be limited where the option chosen would be disproportionate compared to the other option available , impossible or unlawful . for instance , it might be disproportionate to request the replacement of goods because of a minor scratch where this replacement would create significant costs while , at the same time , the scratch could easily be repaired . ### the consumer ' s choice between repair or replacement should only be limited where the remedy chosen would be disproportionate compared to the alternative remedy available , impossible or unlawful . for instance , it might be disproportionate to request the replacement of goods because of a minor scratch where this replacement would create significant costs while , at the same time , the scratch could easily be repaired . where , however , only one remedy is available and that remedy imposes costs on the seller that are disproportionate with regard to the value the goods would have if there were no lack of conformity and to the significance of the lack of conformity , it should be possible to limit the consumer ' s right to reimbursement of the cost of removing the non - conforming goods and of installing the replacement goods to a payment by the seller of a proportionate amount .


### this directive lays down certain requirements concerning distance sales contracts concluded between the seller and the consumer , in particular rules on conformity of goods , remedies in case of non - conformity and the modalities for the exercise of these remedies . ### the purpose of this directive is , through the achievement of a high level of consumer protection , to contribute to the proper functioning of the internal market by laying down certain requirements concerning sales contracts concluded between the seller and the consumer , in particular rules on conformity of goods with the contract , remedies in cases of non - conformity and the modalities for the exercise of these remedies .


### ' sales contract ' means any contract under which the seller transfers or undertakes to transfer the ownership of goods , including goods which are to be manufactured or produced , to the consumer and the consumer pays or undertakes to pay the price thereof . ### ' sales contract ' means any contract under which the seller transfers or undertakes to transfer the ownership of goods , including goods which are to be manufactured or produced , to the consumer and the consumer pays or undertakes to pay the price thereof , including any contract having as its object both goods and services .


### conformity with the contract ### subjective requirements for conformity with the contract


### the seller shall ensure that , in order to conform with the contract , the goods shall , where relevant : ### in order to conform with the contract , the goods shall , where applicable :


### requirements for conformity of the goods ### objective requirements for conformity with the contract


### a repair or replacement shall be completed within a reasonable time and without any significant inconvenience to the consumer , taking account of the nature of the goods and the purpose for which the consumer required the goods . ### a repair or replacement shall be completed within a reasonable time and without any significant inconvenience to the consumer , taking account of the nature of the goods and the purpose for which the consumer required the goods . the seller shall bear the risk of coincidental destruction or coincidental deterioration in the goods for the duration of the subsequent performance .


### a repair or replacement are impossible or unlawful ; ### a repair or replacement is impossible or unlawful ;


### a repair or replacement are impossible or unlawful ; ### both&#160 ; repair&#160 ; and replacement are impossible , unlawful or disproportionate in accordance with article 11 ;


### the seller has not completed repair or replacement within a reasonable time ; ### the seller has not completed repair or replacement in accordance with paragraph 1 within a reasonable time ;


### the seller has declared , or it is equally clear from the circumstances , that the seller will not bring the goods in conformity with the contract within a reasonable time . ### the seller has declared , or it follows from the circumstances , that the seller will not bring the goods in conformity with the contract within a reasonable time .


### the consumer shall be entitled to withhold the payment of any outstanding part of the price , until the seller has brought the goods into conformity with the contract . ### the consumer shall be entitled to withhold the payment of the outstanding price , or in the case of a minor lack of conformity an appropriate part of the price , until the seller has brought the goods into conformity with the contract .


### the consumer shall be entitled to withhold the payment of any outstanding part of the price , until the seller has brought the goods into conformity with the contract . ### if the goods are not in conformity with the contract and the degree of non - conformity is other than insignificant , the consumer shall be entitled to withhold the payment of any outstanding part of the price , until the seller has brought the goods into conformity with the contract .


### where the seller remedies the lack of conformity with the contract by replacement , the seller shall take back the replaced goods at the seller ' s expense unless the parties have agreed otherwise after the lack of conformity with the contract has been brought to the seller ' s attention by the consumer . ### where the seller remedies the lack of conformity with the contract by replacement at the place where the goods are situated , the seller shall take back the replaced goods at the seller ' s expense unless the parties have agreed otherwise after the lack of conformity with the contract has been brought to the seller ' s attention by the consumer .


### where the lack of conformity with the contract relates to only some of the goods delivered under the contract and there is a ground for termination of a contract pursuant to article 9 , the consumer may terminate the contract only in relation to those goods and any other goods , which the consumer acquired as an accessory to the non - conforming goods . ### where the lack of conformity with the contract relates to only some of the goods delivered under the contract which are separable from the other goods and there is a ground for termination of a contract pursuant to article 9 in relation to those non - conforming goods , the consumer may terminate the contract only in relation to those separable goods and any other goods which the consumer acquired as an accessory to the non - conforming goods , unless the consumer cannot be expected to accept performance of the part of the contract in relation to the goods which are in conformity .


### the guarantee statement shall be made available on a durable medium and drafted in plain , intelligible language . it shall include the following : ### the guarantee statement shall be drafted in plain , intelligible language and shall be made available to the consumer upon request . it shall include the following :


### a clear statement of the legal rights of the consumer as provided for in this directive and a clear statement that those rights are not affected by the commercial guarantee ; and ### a clear statement of the legal rights of the consumer as provided for in this directive and a clear statement that those rights are to be fulfilled without further conditions and are not affected by the commercial guarantee ; and


### where the seller is liable to the consumer because of a lack of conformity with the contract resulting from an act or omission by a person in earlier links of the chain of transactions , the seller shall be entitled to pursue remedies against the person or persons liable in the chain of transactions . the person against whom the seller may pursue remedies and the relevant actions and conditions of exercise , shall be determined by national law . ### where the seller is liable to the consumer because of a lack of conformity with the contract resulting from an act or omission having its origin in previous links of the chain of transactions , the seller shall be entitled to pursue remedies against the person or persons liable in the chain of transactions . the person against whom the seller may pursue remedies and the relevant actions and conditions of exercise thereof , shall be adequately determined by national law .


### in the european defence action plan , adopted on 30 november 2016 , the commission committed to complement , leverage and consolidate collaborative efforts by member states in developing defence capabilities to respond to security challenges , as well as to foster a competitive and innovative european defence industry . it proposed in particular to launch a european defence fund to support investment in joint research and the joint development of defence equipment and technologies . the fund would support cooperation during the whole cycle of defence product and technology development . ### in the european defence action plan , adopted on 30 november 2016 , the commission committed to complement , leverage and consolidate collaborative efforts by member states in developing defence capabilities to respond to security challenges , as well as to foster a competitive and innovative european defence industry . it proposed in particular to launch a european defence fund to support investment in joint research and the joint development of defence equipment and technologies . the fund would support cooperation during the whole cycle of defence product and technology development . complementary to national programmes , it should enable the union to introduce a significant leverage effect&#160 ; for national investments to boost cooperation between member states and between their industries .


### in order to contribute to the enhancement of the competitiveness and innovation capacity of the union ' s defence industry , a european defence industrial development programme should be established . the programme should aim at enhancing the competitiveness of the union ' s defence industry inter alia cyber defence by supporting the cooperation between undertakings in the development phase of defence products and technologies . the development phase , which follows the research and technology phase , entails significant risks and costs that hamper the further exploitation of the results of research and adversely impact the competitiveness of the union ' s defence industry . by supporting the development phase , the programme would contribute to a better exploitation of the results of defence research and it would help to cover the gap between research and production as well as to promote all forms of innovation . the programme should complement activities carried out in accordance with article 182 tfeu and it does not cover the production of defence products and technologies . ### in order to contribute to the enhancement of the competitiveness and innovation capacity of the union ' s defence industry , with a view to the european union’s strategic and technological autonomy , a european defence industrial development programme should be established . this programme is intended to develop the modern capabilities necessary for the armed forces of the member states . in addition , this programme should aim at enhancing the competitiveness of the union ' s defence industry inter alia cyber defence by supporting the cooperation between undertakings in the development phase of defence products and technologies . the development phase , which follows the research and technology phase , entails significant risks and costs that hamper the further exploitation of the results of research and adversely impact the competitiveness of the union ' s defence industry . by supporting the development phase , the programme would contribute to a better exploitation of the results of defence research and it would help to cover the gap between research and production as well as to promote all forms of innovation . the programme should complement activities carried out in accordance with article 182 tfeu and it does not cover the production of defence products and technologies .


### in order to contribute to the enhancement of the competitiveness and innovation capacity of the union ' s defence industry , a european defence industrial development programme should be established . the programme should aim at enhancing the competitiveness of the union ' s defence industry inter alia cyber defence by supporting the cooperation between undertakings in the development phase of defence products and technologies . the development phase , which follows the research and technology phase , entails significant risks and costs that hamper the further exploitation of the results of research and adversely impact the competitiveness of the union ' s defence industry . by supporting the development phase , the programme would contribute to a better exploitation of the results of defence research and it would help to cover the gap between research and production as well as to promote all forms of innovation . the programme should complement activities carried out in accordance with article 182 tfeu and it does not cover the production of defence products and technologies . ### in order to contribute to the enhancement of the competitiveness and innovation capacity of the union ' s defence industry and to consolidate the union’s strategic defence autonomy , a european defence industrial development programme should be established . the programme should aim at enhancing the competitiveness of the union ' s defence industry inter alia cyber defence by supporting the cooperation between undertakings in the development phase of defence products and technologies . the development phase , which follows the research and technology phase , entails significant risks and costs that hamper the further exploitation of the results of research and adversely impact the competitiveness of the union ' s defence industry . by supporting the development phase , the programme would contribute to a better exploitation of the results of defence research and it would help to cover the gap between research and production as well as to promote all forms of innovation . the programme should complement activities carried out in accordance with article 182 tfeu and it does not cover the production of defence products and technologies .


### in order to contribute to the enhancement of the competitiveness and innovation capacity of the union ' s defence industry , a european defence industrial development programme should be established . the programme should aim at enhancing the competitiveness of the union ' s defence industry inter alia cyber defence by supporting the cooperation between undertakings in the development phase of defence products and technologies . the development phase , which follows the research and technology phase , entails significant risks and costs that hamper the further exploitation of the results of research and adversely impact the competitiveness of the union ' s defence industry . by supporting the development phase , the programme would contribute to a better exploitation of the results of defence research and it would help to cover the gap between research and production as well as to promote all forms of innovation . the programme should complement activities carried out in accordance with article 182 tfeu and it does not cover the production of defence products and technologies . ### in order to contribute to the enhancement of the competitiveness and innovation capacity of the union ' s defence industry , a european defence industrial development programme should be established . the programme should aim at enhancing the competitiveness of the union ' s defence industry inter alia cyber defence by supporting the cooperation between undertakings in the development phase of defence products and technologies . the development phase , which follows the research and technology phase , entails significant risks and costs that hamper the further exploitation of the results of research and adversely impact the competitiveness of the union ' s defence industry . by supporting the development phase , the programme would contribute to a better exploitation of the results of defence research and it would help to cover the gap between research and production as well as to promote all forms of innovation . the programme and any form of its potential continuation after 2020 , should complement activities carried out in accordance with article 182 tfeu and it does not cover the production of defence products and technologies .


### to better exploit economies of scale in the defence industry , the programme should support the cooperation between undertakings in the development of defence products and technologies . ### to better exploit economies of scale in the defence industry , the programme should support the cooperation between undertakings in the development of defence products and technologies , promoting a more integrated market , making investment profitable and avoiding duplication of capacities and spending .


### in view of the specificities of the sector , in practice no collaborative project between undertakings will be launched if the member states have not first agreed to support such projects . after having defined common defence capability priorities at union - level and also taking into account where appropriate collaborative initiatives on a regional basis , member states identify and consolidate military requirements and define the technical specifications of the project . they may also appoint a project manager in charge of leading the work related to the development of a collaborative project . ### in view of the specificities of the sector , in practice no collaborative project between undertakings will be launched if the member states have not first agreed to support such projects . after having defined common defence capability priorities at union - level and also taking into account where appropriate collaborative initiatives on a regional basis , member states identify and consolidate defence requirements and define the technical specifications of the project . they should also appoint a project manager in charge of leading the work related to the development of a collaborative project .


### as the objective of the programme is to support the competitiveness of the union defence industry by de - risking the development phase of cooperative projects , actions related to the development of a defence product or technology , namely definition of common technical specifications , design , prototyping , testing , qualification , certification as well feasibility studies and other supporting measures , should be eligible to benefit from it . this will also apply to the upgrade of existing defence products and technologies . ### as the objective of the programme is to support the competitiveness of the union defence industry by de - risking the development phase of cooperative projects , actions related to the development of a defence product or technology , namely definition of common technical specifications , design , prototyping , testing , qualification , certification as well feasibility studies and other supporting measures , should be eligible to benefit from it . this will also apply to the upgrade of existing defence products and technologies developed in the union by member states .


### given that the programme aims particularly at enhancing cooperation between undertakings across member states , an action should be eligible for funding under the programme only if it is undertaken by a cooperation of at least three undertakings based in at least two different member states . ### given that the programme aims particularly at enhancing cooperation between undertakings across member states , an action should be eligible for funding under the programme only if it is undertaken by a cooperation of at least three undertakings based in at least three different member states and remains open for expanding by undertakings based in other member states .


### cross - border collaboration in the development of defence products and technologies has often been hampered by the difficulty to agree on common technical specifications . the absence or limited level of common technical specifications have led to increased complexity , delays and inflated costs in the development phase . the agreement on common technical specifications should be a condition in order to benefit from the union ' s support under this programme . actions aiming at supporting the creation of a common definition of technical specifications should also be eligible for support under the programme . ### cross - border collaboration in the development of defence products and technologies has often been hampered by the difficulty to agree on common technical specifications that promote interoperability . the absence or limited level of common technical specifications have led to increased complexity , delays and inflated costs in the development phase . the agreement on common technical specifications should be a condition in order to benefit from the union ' s support under this programme . actions aiming at supporting the creation of a common definition of technical specifications should also be eligible for support under the programme .


### eligible actions developed in the context of permanent structured cooperation in the institutional framework of the union would ensure enhanced cooperation between undertakings in the different member states on a continuous basis and thus directly contribute to the aims of the programme . such projects should thus be eligible for an increased funding rate . ### eligible actions developed in the context of the permanent structured cooperation in the institutional framework of the union that was agreed and signed by the foreign ministers and defence ministers of 23 member states on 13 november 2017 would ensure enhanced cooperation between undertakings in the different member states on a continuous basis and thus directly contribute to the aims of the programme . such projects should thus be eligible for an increased funding rate .


### the promotion of innovation and technological development in the union defence industry should take place in a manner coherent with the security interests of the union . accordingly , the action ' s contribution to those interests and to the defence capability priorities commonly agreed by member states should serve as an award criterion . within the union , common defence capability priorities are identified notably through the capability development plan . other union processes such as the coordinated annual review on defence and the permanent structured cooperation will support the implementation of relevant priorities through enhanced cooperation . where appropriate regional or international cooperative initiatives , such as in the nato context , and serving the union security and defence interest , may also be taken into account . ### the promotion of innovation and technological development in the union defence industry should take place in a manner coherent with the security interests of the union . accordingly , the action ' s contribution to those interests and to the defence capability priorities commonly agreed by member states should serve as an award criterion . within the union , common defence capability priorities are identified notably through the capability development plan . the european defence action plan published by the commission on 30 november 2016 emphasised the need to maximise synergies between the civil and military spheres , including in areas such as space policy , cyber security , cyber defence and maritime security . other union processes such as the coordinated annual review on defence and the permanent structured cooperation will support the implementation of relevant priorities through enhanced cooperation . where appropriate regional or international cooperative initiatives , such as in the nato context , and serving the union security and defence interest , may also be taken into account .


### as the union support aims at enhancing the competitiveness of the sector and concerns only the specific development phase , the commission should not have ownership or intellectual property rights over the products or technologies resulting from the funded actions . the applicable intellectual property rights regime will be defined contractually by the beneficiaries . ### as the union support aims at enhancing the competitiveness of the sector and concerns only the specific development phase , the union should not have ownership or intellectual property rights over the products or technologies resulting from the funded actions . the applicable intellectual property rights regime will be defined contractually by the beneficiaries . the results of actions which receive funding under the programme should not be subject to any control or restriction by a third country or a non - eu entity .


### the commission should establish a multiannual work programme in line with the objectives of the programme . the commission should be assisted in the establishment of the work programme by a committee of member states . in light of the union policy on small and medium enterprises as key to ensuring economic growth , innovation , job creation , and social integration in the union and the fact that the supported actions will typically require trans - national collaboration , it is of importance that the work programme will reflect and enable such cross - border participation of smes and that therefore a proportion of the overall budget will benefit such action . ### the commission should establish a multiannual work programme in line with the objectives of the programme , especially that of competitiveness . the commission should be assisted in the establishment of the work programme by a committee of member states . in light of the union policy on small and medium enterprises as key to ensuring economic growth , innovation , job creation , and social integration in the union and the fact that the supported actions will typically require trans - national collaboration , it is of importance that the work programme will reflect and enable such cross - border participation of smes and that therefore a proportion of the overall budget will benefit such action .


### to foster the competitiveness and innovation capacity of the union defence industry by supporting actions in their development phase ; ### in an effort to progressivly framing the common defence policy in accordance with artile 2 . 4 tfeu to foster the competitiveness and innovation capacity of the union defence industry by supporting actions in their development phase ;


### to support and leverage the cooperation between undertakings , including small and medium - sized enterprises , in the development of technologies or products in line with defence capability priorities commonly agreed by member states within the union ; ### to support , level and leverage the cooperation between undertakings , including and promoting the participation of small and medium - sized enterprises , in the development of technologies or products in line with defence capability priorities commonly agreed by member states within the union ;


### the union ' s financial assistance shall be implemented by the commission as provided for by regulation no 966 / 2012 directly or indirectly by entrusting budget implementation tasks to the entities listed in article 58 of that regulation . ### the union ' s financial assistance shall be implemented by the commission as provided for in article 58 of regulation no 966 / 2012 .


### in case a project manager is appointed by member states , the commission shall execute the payment to the eligible beneficiaries after informing the project manager . ### member states shall appoint a project manager who shall follow the contract on their behalf and inform the commission when the payment to the eligible beneficiaries is to be executed . the eligible beneficiaries , in the consortium , shall have their project manager who shall cooperate with the project manager appointed by the member states .


### beneficiaries shall be undertakings established in the union , in which member states and / or nationals of member states own more than 50% of the undertaking and effectively control it within the meaning of article 6 , whether directly or indirectly through one or more intermediate undertakings . in addition , all infrastructure , facilities , assets and resources used by the participants , including subcontractors and other third parties , in actions funded under the programme shall not be located on the territory of non - member states during the entire duration of the action . ### beneficiaries and their subcontractors shall be undertakings established in the union which are effectively controlled by member states and / or nationals of member states within the meaning of article 6 , whether directly or indirectly through one or more intermediate undertakings . in addition , all infrastructure , facilities , assets and resources used by the participants , including subcontractors and other third parties , in actions funded under the programme shall not be located on the territory of non - member states during the entire duration of the action . the use of such infrastructure , facilities , assets and resources shall not be subject to any control or restriction by a third country or a non - eu entity .


### each applicant shall declare , by written statement , that it is fully aware of and compliant with applicable national and union legislation and regulations relating to activities in the domain of defence . ### each member of a consortium wishing to participate in an action shall declare , by written statement , that it is fully aware of and compliant with applicable national and union legislation and regulations relating to activities in the domain of defence .


### the members of a consortium participating in an action shall conclude an internal agreement establishing their rights and obligations with respect to the implementation of the action , except in duly justified cases provided for in the work programme or call for proposals . ### the members of a consortium participating in an action shall conclude an internal agreement establishing their rights and obligations with respect to the implementation of the action , including the issue of the intellectual property rights connected to the new products , , except in duly justified cases provided for in the work programme or call for proposals .


### actions proposed for funding under the programme shall be evaluated on the basis of the following cumulative criteria : ### actions proposed for funding under the programme shall be evaluated in a transparent manner , based on objective and measurable parameters , taking into account the overall aim of the programme to achieve a well - functioning european defence industrial development programme , as well as the geographical balance between participating member states and on the basis of the following cumulative criteria :


### actions proposed for funding under the programme shall be evaluated on the basis of the following cumulative criteria : ### actions proposed for funding under the programme shall be evaluated on the basis of the following criteria :


### the work programme shall ensure that a credible proportion of the overall budget will benefit actions enabling the cross - border participation of smes . ### the work programme , whose objective is to promote european cooperation , shall ensure that a credible proportion of the overall budget will benefit actions enabling the cross - border participation of smes .


### this regulation establishes the format and the technical specifications of a european travel document for the return of third - country nationals . ### this regulation establishes the format and the technical specifications of a european travel document for the return of third - country nationals whose stay on the territory of the union is illegal .


### the format of the european travel document for return shall correspond to the model set in the annex . it shall contain the following information of the third - country national : ### the format of the european travel document for return shall correspond to the model set in the annex . it shall contain the following information of the third - country national illegally staying on&#160 ; the territory of the union :


### proposal for a regulation of the european parliament and of the council on the european fund for strategic investments and amending regulations no 1291 / 2013 and no 1316 / 2013 ### proposal for a regulation of the european parliament and of the council on the european fund for strategic investments


### throughout the economic and financial crisis , the union has made efforts to promote growth , in particular through initiatives set out in the europe 2020 strategy that put in place an approach for smart , sustainable and inclusive growth . the european investment bank has also strengthened its role in instigating and promoting investment within the union , partly by way of an increase in capital in january 2013 . further action is required to ensure that the investment needs of the union are addressed and that the liquidity available on the market is used efficiently and channelled towards the funding of viable investment projects . ### throughout the economic and financial crisis , the union has not made enough efforts to promote growth , despite initiatives set out in the europe 2020 strategy that put in place an approach for smart , sustainable and inclusive growth . the european investment bank strengthened its role in instigating and promoting investment within the union , partly by way of an increase in capital in january 2013 . further action is required to ensure that the investment needs of the union are addressed and that the liquidity available on the market is used efficiently and channelled towards the funding of viable investment projects .


### the purpose of the efsi should be to help resolve the difficulties in financing and implementing productive investments in the union and to ensure increased access to financing . it is intended that increased access to financing should be of particular benefit to small and medium enterprises . it is also appropriate to extend the benefit of such increased access to financing to mid - cap companies , which are companies having up to 3000 employees . overcoming europe ' s current investment difficulties should contribute to strengthening the union ' s economic , social and territorial cohesion . ### the purpose of the efsi should be to help resolve the difficulties in financing and implementing productive investments in the union and to ensure increased access to financing . it is intended that increased access to financing should be prioritized to the benefit of small and medium enterprises . it is also appropriate to extend the benefit of such increased access to financing to mid - cap companies , which are companies having up to 3000 employees . overcoming europe ' s current investment difficulties through efsi shall contribute to strengthening the union ' s economic , social and territorial cohesion .


### the purpose of the efsi should be to help resolve the difficulties in financing and implementing productive investments in the union and to ensure increased access to financing . it is intended that increased access to financing should be of particular benefit to small and medium enterprises . it is also appropriate to extend the benefit of such increased access to financing to mid - cap companies , which are companies having up to 3000 employees . overcoming europe ' s current investment difficulties should contribute to strengthening the union ' s economic , social and territorial cohesion . ### the purpose of the efsi should be to help resolve the difficulties in financing and implementing productive investments in the union and to ensure increased access to financing . it is intended that increased access to financing should be of particular benefit to small and medium enterprises and cooperative enterprises . it is also appropriate to extend the benefit of such increased access to financing to mid - cap companies , which are companies having up to 3000 employees . overcoming europe ' s current investment difficulties should contribute to strengthening the union ' s economic , social and territorial cohesion .


### the efsi should target projects delivering high societal and economic value . in particular , the efsi should target projects that promote job creation , long - term growth and competitiveness . the efsi should support a wide range of financial products , including equity , debt or guarantees , to best accommodate the needs of the individual project . this wide range of products should allow the efsi to adapt to market needs whilst encouraging private investment in the projects . the efsi should not be a substitute for private market finance but should instead catalyse private finance by addressing market failures so as to ensure the most effective and strategic use of public money . the requirement for consistency with state aid principles should contribute to such effective and strategic use . ### the efsi should target environmentally sound and socially acceptable projects delivering high societal and economic value . in particular , the efsi should target projects that promote job creation , long - term growth and competitiveness . the efsi should support a wide range of financial products , including equity , debt or guarantees , to best accommodate the needs of the individual project . this wide range of products should allow the efsi to adapt to market needs whilst encouraging private investment in the projects . the efsi should not be a substitute for private market finance but should instead catalyse private finance by addressing market failures so as to ensure the most effective and strategic use of public money . the requirement for consistency with state aid principles should contribute to such effective and strategic use .


### the efsi should target projects with a higher risk - return profile than existing eib and union instruments to ensure additionality over existing operations . the efsi should finance projects across the union , including in the countries most affected by the financial crisis . the efsi should only be used where financing is not available from other sources on reasonable terms . ### the efsi should , to ensure additionality over existing operations , finance projects across the union , including in the countries most affected by the financial crisis . the efsi should only be used where financing is not available from other sources on reasonable terms .


### the efsi should target projects with a higher risk - return profile than existing eib and union instruments to ensure additionality over existing operations . the efsi should finance projects across the union , including in the countries most affected by the financial crisis . the efsi should only be used where financing is not available from other sources on reasonable terms . ### the efsi should target projects with a higher risk - return profile than existing eib and union instruments to ensure additionality over existing operations . the efsi should finance projects across the union , including in the countries most affected by the financial crisis , and in other disadvantaged rural areas of europe . the efsi should only be used where financing is not available from other sources on reasonable terms .


### in order to allow for further increase in its resources , participation in the efsi should be open to third parties , including member states , national promotional banks or public agencies owned or controlled by member states , private sector entities and entities outside the union subject to the consent of existing contributors . third parties may contribute directly to the efsi and take part in the efsi governance structure . ### in order to allow for further increase in its resources , participation in the efsi should be open to third parties , including member states , public agencies owned or controlled by member states , private sector entities and entities outside the union subject to the consent of existing contributors . third parties may contribute directly to the efsi and take part in the efsi governance structure .


### the eib should regularly evaluate activities supported by the efsi with a view to assessing their relevance , performance and impact and to identifying aspects that could improve future activities . such evaluations should contribute to accountability and analysis of sustainability . ### the eib should regularly evaluate activities supported by the efsi with a view to assessing their relevance , performance and impact and to identifying aspects that could improve future activities . such evaluations should contribute to accountability and analysis of sustainability . impact assessment should also take into account the resource efficiency of the projects .


### the purpose of the efsi shall be to support investments in the union and to ensure increased access to financing for companies having up to 3000 employees , with a particular focus on small and medium enterprises , through the supply of risk bearing capacity to the eib . ### the purpose of the efsi shall be to support investments in the union and to ensure increased access to financing for companies , with a particular focus on small and medium - sized enterprises as defined in recommendation 2003 / 361 / ec , through the supply of risk bearing capacity to the eib , with special priority being given to businesses in rural areas and in structurally weak and disadvantaged areas .


### the efsi agreement shall provide that there is a clear distinction between operations carried out with the efsi support and other operations of the eib . ### the efsi agreement shall provide that there is a clear distinction between operations carried out with the efsi support and other operations of the eib . such additionality shall be ensured by the steering board on the basis of the risk profile of the efsi and on the fulfilment of the policy objectives set in art . 5 .


### member states that become parties to the efsi agreement shall be able to provide their contribution , in particular , in the form of cash or a guarantee acceptable to the eib . other third parties shall be able to provide their contribution only in cash . ### member states that become parties to the efsi agreement shall be able to provide their contribution , in particular , in the form of cash or a guarantee acceptable to the eib . other third parties shall be able to provide their contribution only in cash . member states ' contributions shall be subject to the full range of the existing rules of the stability and growth pact .


### the efsi agreement shall provide that the efsi shall be governed by a steering board , which shall determine the strategic orientation , the strategic asset allocation and operating policies and procedures , including the investment policy of projects that efsi can support and the risk profile of the efsi , in conformity with the objectives under article 5 . the steering board shall elect one of its members to be chairperson . ### the efsi agreement shall provide that the efsi shall be governed by a steering board , which shall determine the strategic orientation , the strategic asset allocation and operating policies and procedures , including the risk profile of the efsi and the investment policy of projects that efsi can support , in order to ensure additionality of the efsi compared to normal eib operations , and conformity with the objectives under article 5 and the eu treaty ' s objectives of social , economic and territorial cohesion . the steering board shall elect one of its members to be chairperson .


### the managing director and the deputy managing director shall be appointed by the steering board on a joint proposal of the commission and the eib for a renewable fixed term of three years . ### the managing director and the deputy managing director shall be appointed by the steering board on a joint proposal of the commission and the eib for a fixed term of three years renewable three times only .


### in addition , the eu guarantee shall be granted for support of dedicated investment platforms and national promotional banks , via the eib , that invest in operations meeting the requirements of this regulation . in that case , the steering board shall specify policies regarding eligible investment platforms . ### in addition , the eu guarantee shall be granted for support of dedicated investment platforms and national and regional promotional banks , via the eib , that invest in operations meeting the requirements of this regulation . in that case , the steering board shall specify policies and criteria regarding eligible investment platforms . a criterion to select future investment platforms should be the participation of regional promotional banks , which foster also transnational investment projects in the framework of institutional cooperation among european regions


### any surplus shall be paid in one transaction to a special heading in the statement of revenue in the general budget of the european union of the year n + 1 , ### any surplus shall be paid in one transaction to a special heading in the statement of revenue in the general budget of the european union of the year n + 1 , and shall be reallocated to programmes which envelopes might have been reduced to finance the guarantee fund , as referred to in paragraph 5a , in order to compensate these losses ;


### the commission and the eib , with support from the member states , shall promote the creation of a transparent pipeline of current and potential future investment projects in the union . the pipeline is without prejudice to the final projects selected for support according to article 3 . ### the commission and the eib , with support from the member states , shall promote the creation of a transparent pipeline of current and potential future investment projects , which are environmentally sound and socially acceptable , &#160 ; in the union . the pipeline is without prejudice to the final projects selected for support according to article 3 .


### the commission and the eib shall develop , update and disseminate , on a regular and structured basis , information on current and future investments which significantly contribute to achieving eu policy objectives . ### the commission and the eib shall develop , update and disseminate , on a yearly and structured basis , information on current and future investments which significantly contribute to achieving eu policy objectives .


### member states shall develop , update and disseminate , on a regular and structured basis , information on current and future investment projects in their territory . ### member states shall develop , update and disseminate , on a yearly and structured basis , information on current and future investment projects in their territory .


### an assessment of the added value , the mobilisation of private sector resources , the estimated and actual outputs , outcomes and impact of eib financing and investment operations at an aggregated basis ; ### an assessment of the economical , social and environmental added value , including indicators that measure the efficient use of resources , the mobilisation of private sector resources , the estimated and actual outputs , outcomes and impact of eib financing and investment operations at an aggregated basis ;


### in accordance with its own transparency policies on access to documents and information , the eib shall make publicly available on its website information relating to all eib financing and investment operations and how they contribute to the general objectives referred to in article 5 . ### in accordance with its own transparency policies on access to documents and information , the eib shall make publicly available on its website information relating to all eib financing and investment operations and how they contribute to the general objectives and criteria referred to in article 5 .


### the eu guarantee and the payments and recoveries under it that are attributable to the general budget of the union shall be audited by the court of auditors . ### the external audit of the activities undertaken in accordance with the efsi regulation are carried out by the european court of auditors in accordance with the article 287 tfeu .


### following the stakeholder consultation and in the light of the impact assessment30 results , the commission considered that action at union level was necessary in order to address the remaining and emerging barriers to a wide re - use of public sector and publicly - funded information across the union and to bring the legislative framework up to date with the advances in digital technologies , such as artificial intelligence and the internet of things . _________________ 30 swd 127 . ### following the stakeholder consultation and in the light of the impact assessment30 results , the commission considered that action at union level was necessary in order to address the remaining and emerging barriers to a wide re - use of public sector and publicly - funded information across the union and to bring the legislative framework up to date with the advances in digital technologies , such as artificial intelligence and the internet of things , high performance cloud computing and quantum technology . open - source data sets will contribute to rapidly progress and create a new strategy to embrace new digital technologies , especially artificial intelligence . _________________ 30 swd 127 .


### the directive lays down an obligation for member states to make all documents re - usable unless access is restricted or excluded under national rules on access to documents and subject to the other exceptions laid down in this directive . the directive builds on the existing access regimes in the member states and does not change the national rules for access to documents . it does not apply in cases in which citizens or companies can , under the relevant access regime , only obtain a document if they can prove a particular interest . at union level , articles 41 and 42 of the charter of fundamental rights of the european union recognise the right of any citizen of the union and any natural or legal person residing or having its registered office in a member state to have access to european parliament , council and commission documents . public sector bodies should be encouraged to make available for re - use any documents held by them . public sector bodies should promote and encourage re - use of documents , including official texts of a legislative and administrative nature in those cases where the public sector body has the right to authorise their re - use . ### the directive lays down an obligation for member states to make all documents re - usable unless access is restricted or excluded under national rules on access to documents , including situations in which access is restricted or excluded in order to ensure the security of the network and information systems pursuant to directive 2016 / 11481a and subject to the other exceptions laid down in this directive . the directive builds on the existing access regimes in the member states and does not change the national rules for access to documents . it does not apply in cases in which citizens or companies can , under the relevant access regime , only obtain a document if they can prove a particular interest . at union level , articles 41 and 42 of the charter of fundamental rights of the european union recognise the right of any citizen of the union and any natural or legal person residing or having its registered office in a member state to have access to european parliament , council and commission documents . public sector bodies should be encouraged to make available for re - use any documents held by them . public sector bodies should promote and encourage re - use of documents , including official texts of a legislative and administrative nature in those cases where the public sector body has the right to authorise their re - use . _________________ 1a directive 2016 / 1148 of the european parliament and of the council of 6 july 2016 concerning measures for a high common level of security of network and information systems across the union .