### the member states shall put in place measures ensuring that the members of the scientific panels act independently and remain free from conflict of interests as provided for in article 37 and the authority’s internal measures . member states shall ensure that the members of the scientific panels have the means to dedicate the necessary time and effort to contribute to the work of the authority . member states shall ensure that the members of the scientific panels do not receive any instruction at any national level and that their independent scientific contribution to the risk assessment system at union level is recognised as a priority task for the protection of the safety of the food chain . ### members of the scientific panels shall act independently and remain free from conflict of interests as provided for in article 37 and the authority’s internal measures . they shall have the means to dedicate the necessary time and effort to contribute to the work of the authority , shall not receive any instruction at any national level , and their independent scientific contribution to the risk assessment system at union level shall be recognised as a priority task for the protection of the safety of the food chain .


### transparency of the risk assessment process contributes to the authority acquiring greater legitimacy in the eyes of the consumers and general public in pursuing its mission , increases their confidence in its work and ensures that the authority is more accountable to the union citizens in a democratic system . it is therefore essential to maintain the confidence of the general public and other interested parties in the risk analysis process underpinning union food law and in particular in the risk assessment , including the organisation and independence of the authority and transparency . ### the lack of transparency of the risk assessment process has contributed to the authority losing legitimacy in the eyes of the consumers and general public in pursuing its mission , eroded their confidence in its work and failed to make the authority more accountable to the union citizens in a democratic system . it is therefore essential to rebuild the confidence of the general public and other interested parties in the risk analysis process underpinning union food law and in particular in the risk assessment , including the functioning and independence of the authority and transparency .


### identify the appropriate main tools and channels to be used for risk communication purposes , taking into account the needs of relevant target audience groups ; and , ### identify the appropriate main tools and channels to be used for risk communication purposes , taking into account the need to ensure the balanced involvements of all interested parties including economic operators of the food chain , consumer and other civil society organisations ;


### to determine what level of disclosure strikes the appropriate balance , the relevant rights of the public to transparency in the risk assessment process , should be weighted up against the rights of commercial applicants , taking into account the objectives of regulation no 178 / 2002 . ### to determine what level of proactive disclosure strikes the appropriate balance , the need to ensure transparency in the risk assessment process , should be weighted up against the rights of commercial applicants , taking into account the objectives of regulation no 178 / 2002 .


### to preserve the independence of the risk assessment from risk management and from other interests at union level , it is appropriate that the nomination of the members of the scientific panels by the member states , their selection by the executive director of the authority and their appointment by the management board of the authority are based on strict criteria ensuring the excellence and independence of the experts while ensuring the required multidisciplinary expertise for each panel . it is also essential to this end that the executive director whose function is to defend efsa’s interests and in particular the independence of its expertise has a role in the selection and appointment of those scientific experts . further measures should also be put in place to ensure that scientific experts have the means to act independently . ### to preserve the independence of the risk assessment from risk management and from other interests at union level , it is appropriate that the selection of the members of the scientific panels by the executive director of the authority and their appointment by the management board of the authority are based on strict criteria ensuring the excellence and independence of the experts while ensuring the required multidisciplinary expertise for each panel . it is also essential to this end that the executive director whose function is to defend efsa’s interests and in particular the independence of its expertise has a role in the selection and appointment of those scientific experts . further measures should also be put in place to ensure that scientific experts have the means to act independently and to dedicate sufficient time to their risk assessment work for the authority .


### the following paragraphs 5a to 5g are inserted : “5a . the members of the scientific panels shall be appointed by the management board for a renewable five year term of office in accordance with the following procedure : the executive director , after consulting the management board , shall send to the member states the request for the specific multidisciplinary expertise needed in each scientific panel and shall indicate the number of experts to be nominated by the member states . the executive director shall notify the member states of the authority ' s independence policy and implementing rules applicable to scientific panels ' members . member states shall launch a call for interest as a basis for their nominations . the executive director shall inform the management board of the requests sent to the member states . member states shall nominate experts with a view to collectively reach the number indicated by the executive director . each member state shall nominate at least 12 scientific experts . member states may nominate nationals of other member states . on the basis of the nominations made by member states , the executive director shall draw for each scientific panel a list of experts larger than the number of members to be appointed . the executive director may not draw up such a list where he / she can justify that the nominations received do not allow him , given the criteria for selection set up in point d ) of this paragraph , to draw up a larger list . the executive director shall submit the list to the management board for appointment . the nominations by the member states , the selection by the executive director and the appointments by the management board shall be made on the basis of the following criteria : a high level of scientific expertise ; independence and absence of conflict of interests in accordance with article 37 and the authority’s independence policy and implementing rules on the independence of the scientific panels’ members ; meeting the needs for the specific multi - disciplinary expertise of the panel to which they will be appointed and the applicable language regime . the management board shall ensure that the broadest possible geographical distribution is achieved in the final appointments . 5b . when the authority identifies that specific expertise is missing in a panel or several panels , the executive director shall propose additional members of the panel for appointment to the management board in accordance with the procedure laid down in paragraph 5 . 5c . the management board shall adopt , on the basis of a proposal of the executive director , rules on the detailed organisation and timing of the procedures set up in paragraphs 5a and 5b of the present article . 5d . the member states shall put in place measures ensuring that the members of the scientific panels act independently and remain free from conflict of interests as provided for in article 37 and the authority’s internal measures . member states shall ensure that the members of the scientific panels have the means to dedicate the necessary time and effort to contribute to the work of the authority . member states shall ensure that the members of the scientific panels do not receive any instruction at any national level and that their independent scientific contribution to the risk assessment system at union level is recognised as a priority task for the protection of the safety of the food chain . 5e . member states shall ensure that the public bodies employing those scientific experts and those having responsibility for the setting of priorities of the scientific bodies employing those experts implement the measures provided for in paragraph 5d . 5f . the authority shall support the tasks of the panels by organising their work , in particular the preparatory work to be undertaken by the authority’s staff or by designated national scientific organisations referred to in the article 36 including by organising the possibility for preparing scientific opinions to be peer - reviewed by the panels before they adopt them . 5g . each panel shall include a maximum of 21 members . ” , ### the following paragraphs 5a to 5f are inserted : ' 5a . when the authority identifies that specific expertise is missing in a panel or several panels , the executive director shall propose additional members of the panel for appointment to the management board in accordance with the procedure laid down in paragraphs . 5b . the management board shall adopt , on the basis of a proposal of the executive director , rules on the detailed organisation and timing of the procedures setup in paragraphs 5a and 5a of the present article . 5c . members of the scientific panels shall act independently and remain free from conflict of interests as provided for in article 37 and the authority’s internal measures . they shall have the means to dedicate the necessary time and effort to contribute to the work of the authority , shall not receive any instruction at any national level , and their independent scientific contribution to the risk assessment system at union level is shall be recognised as a priority task for the protection of the safety of the food chain . 5d . as appropriate , member states shall ensure that the public bodies employing those scientific experts and those having responsibility for the setting of priorities of the scientific bodies employing those experts implement the measures which are necessary to ensure that the conditions referred to in paragraph 5c are met . 5e . the authority shall support the tasks of the panels by organising their work , in particular the preparatory work to be undertaken by the authority’s staff or by designated national scientific organisations referred to in the article 36 including by organising the possibility for preparing scientific opinions to be peer - reviewed by the panels before they adopt them . 5f . each panel shall include a maximum of 21 members . ” ,


### the fitness check of the general food law identified certain shortcomings in the long - term capability of the authority to maintain its high - level expertise . in particular , there has been a decrease in the number of candidates applying to be members of the scientific panels . the system has thus to be strengthened and member states should take a more active role to ensure that a sufficient pool of experts is available to meet the needs of the union risk assessment system in terms of high level of scientific expertise , independence and multidisciplinary expertise . ### the fitness check of the general food law identified certain shortcomings in the long - term capacity of the authority to maintain its high - level expertise . in particular , there has been a decrease in the number of candidates applying to be members of the scientific panels . member states should support the dissemination of the authority’s calls for expressions of interest for membership of the scientific panels and scientific committee , to ensure that a sufficient pool of experts is available to meet the needs of the union risk assessment system in terms of high level of scientific expertise , independence and multidisciplinary expertise .


### to preserve the independence of the risk assessment from risk management and from other interests at union level , it is appropriate that the nomination of the members of the scientific panels by the member states , their selection by the executive director of the authority and their appointment by the management board of the authority are based on strict criteria ensuring the excellence and independence of the experts while ensuring the required multidisciplinary expertise for each panel . it is also essential to this end that the executive director whose function is to defend efsa’s interests and in particular the independence of its expertise has a role in the selection and appointment of those scientific experts . further measures should also be put in place to ensure that scientific experts have the means to act independently . ### to preserve the independence of the risk assessment from risk management and from other interests at union level , it is appropriate that the selection of the members of the scientific panels by the executive director of the authority and their appointment by the management board of the authority are based on strict criteria , such as the absence of any links to industry , ensuring the excellence and independence of the experts while ensuring the required multidisciplinary expertise for each panel . it is also essential to this end that the executive director whose function is to defend efsa’s interests and in particular the independence of its expertise has a role in the selection and appointment of those scientific experts . measures , including proper financial compensation , should be put in place to ensure that scientific experts have the means to act independently and to dedicate sufficient time to their risk assessment work for the authority .


### food safety is a sensitive matter of prime interest for all union citizens . while maintaining the principle that the burden is on the industry to prove compliance with union requirements , it is important to establish an additional verification tool to address specific cases of high societal importance where there is a controversy on safety issues , namely the commissioning of additional studies with the objective of verifying evidence used in the context of risk assessment . considering that it would be financed by the union budget and that the use of this exceptional verification tool should remain proportionate , the commission should be responsible for triggering the commissioning of such verification studies . account should be taken of the fact that in some specific cases the studies commissioned may need to have a wider scope than the evidence at stake . ### food safety is a sensitive matter of prime interest for all union citizens . while maintaining the principle that the burden is on the industry to prove compliance with union requirements , it is important to establish an additional verification tool to address specific cases of high societal importance where there is a controversy on safety issues , namely the commissioning of additional studies with the objective of verifying evidence used in the context of risk assessment . this exceptional verification tool should remain proportionate and should not replace the application of the precautionary principle in the presence of scientific uncertainty . the commission , the member states and the european parliament should have the possibility to ask the authority to commission such verification studies . account should be taken of the fact that in some specific cases the studies commissioned may need to have a wider scope than the evidence at stake .


### there are certain public concerns about the authority’s assessment in the area of authorisation being primarily based on industry studies . the authority already makes searches in scientific literature to be able to consider other data and studies existing on the subject matter submitted to its assessment . in order to provide an additional level of guarantee ensuring that the authority can have access to all relevant scientific data and studies available on a subject matter of an authorisation procedure , it is appropriate to provide for a consultation of third parties in order to identify whether other relevant scientific data or studies are available . to increase the effectiveness of the consultation , the consultation should take place when the studies submitted by industry included in an application for authorisation are made public , under the transparency rules of this regulation . ### there are certain public concerns about the authority’s assessment in the area of authorisation being primarily based on industry studies . if there is a new application , the authority shall always conduct searches in scientific literature to be able to consider other data and studies existing on the subject matter submitted to its assessment , and demand additional studies if needed . in order to provide an additional level of guarantee ensuring that the authority can have access to all relevant scientific data and studies available on a subject matter of an authorisation procedure , it is appropriate to provide for a consultation of third parties in order to identify whether other relevant scientific data or studies are available . to increase the effectiveness of the consultation , the consultation should take place immediately after the studies submitted by industry included in an application for authorisation have been made public , under the transparency rules of this regulation .


### at the request of a potential applicant for a food law authorisation , the staff of the authority shall advise on the relevant provisions and the required content of the application for authorisation . the advice provided by the staff of the authority shall be without prejudice and non - committal as to the subsequent assessment of applications for authorisation by the scientific panels . ### at the request of a potential applicant for a food law authorisation , the staff of the authority may , in written form , advise on the relevant provisions and the required content of the application for authorisation . the staff of the authority providing the advice referred to in paragraph 1 shall not be involved in any scientific work , including within the meaning of article 28 , that is directly or indirectly relevant to the application that is the subject of the advice . the advice provided by the staff of the authority shall be documented and be published on the authority’s website immediately after it has been provided . it shall contribute to the development of a frequently asked questions document , in order to develop more comprehensive guidelines for applicants and reduce the need for individual correspondence . the advice provided shall be without prejudice and non - committal as to the subsequent assessment of applications for authorisation by the scientific panels . within [ 36 months after the entry into force of this regulation ] , the commission shall assess the impact of this article on the functioning of the authority . particular attention shall be paid to the additional workload and mobilisation of staff , and whether it has led to any shift in the allocation of the authority’s resources , at the expense of activities of public interest .


### in order to further strengthen the link between risk assessors and risk managers at union and national levels as well as the coherence and consistency of risk communication , the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission to adopt a general plan on risk communication on matters covering the agri - food chain . it is of particular importance that the commission carries 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 2016 . 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 . ### in order to further strengthen the link between risk assessors and risk managers at union and national levels , as well as with other stakeholders in the food chain such as economic operators , consumer and other civil society organisations , the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission to adopt a general plan on risk communication on matters covering the agri - food chain . the general plan on risk communication shall lay down the practical arrangements for making available to the public the necessary information to achieve a high level of transparency of the risk management process . therefore , it is of particular importance that the commission carries 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 2016 . 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 .


### promote appropriate involvement of all interested parties ; and , ### promote the balanced involvement of all interested parties , including economic operators of the food chain , consumer and other civil society organisations ; and ,


### it is therefore necessary to ensure a comprehensive and continuous risk communication process throughout risk analysis , involving union and national risk assessors and risk managers . that process should be combined with an open dialogue between all interested parties to ensure the coherence and consistency within the risk analysis process . ### it is therefore necessary to ensure a comprehensive , continuous and inclusive risk communication process throughout risk analysis , involving union and national risk assessors and risk managers . that process should be combined with an open dialogue between all interested parties to ensure the prevalence of public interest , accuracy and consistency within the risk analysis process .


### promote consistency and transparency in formulating risk management recommendations ; ### promote transparency and clarity in formulating risk management options and recommendations ;


### ensure appropriate exchange of information with interested parties in relation to risks associated with the agri - food chain . ### ensure transparent and equitable exchange of information with these interested parties in relation to risks associated with the agri - food chain .


### all actions and interoperability solutions funded under the isa2 programme shall be encouraged , where appropriate , to re - use available interoperability solutions . ### all actions and interoperability solutions funded under the isa2 programme shall be encouraged to re - use available interoperability solutions .


### involvement of the largest possible number of member states in a project shall be encouraged . member states shall be able , and encouraged , to join a project at any stage . ### involvement of the largest possible number of member states in a project shall be a selection priority . member states shall be able , and encouraged , to join a project at any stage . involvement of private companies and other organisations shall be encouraged .


### solutions established or operated under the present isa2 programme should , as far as possible , form part of a consistent environment of services facilitating interaction between european public administrations , enterprises and citizens , and ensuring , facilitating and enabling cross - border or cross - sector interoperability . ### solutions established or operated under the present isa2 programme should form part of a consistent environment of services facilitating interaction between european public administrations , enterprises and citizens , and ensuring , facilitating and enabling cross - border or cross - sector interoperability .


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


### the inclusion of actions in the rolling work programme shall be subject to compliance with a set of rules and admission criteria before being included in the rolling work programme . those rules and criteria and any amendments thereof shall be an integral part of the rolling work programme . ### the inclusion of actions in the rolling work programme shall be subject to compliance with a set of administrative procedures defining the applicable objectives , rules and admission criteria before being included in the rolling work programme . those administrative procedures and any amendments thereof shall be an integral part of the rolling work programme .


### – monitoring and control . ### – – monitoring , control and ex - post impact evaluation ,


### with decision no 922 / 2009 / ec ceasing to apply on 31 december 2015 , a new union programme on interoperability solutions for european public administrations , businesses and citizens is needed in order to map and analyse the overall interoperability landscape in europe and avoid its fragmentation . the programme will enable , support and promote a holistic approach to the collection , assessment , development , establishment , industrialisation , operation , improvement and maintenance of interoperability solutions , including solutions that facilitate the re - use of data as well as its exchange , in support of european public administrations’ cross - border or cross - sector interactions with each other and with enterprises and citizens . finally , the programme will promote the re - usability , integration and convergence of existing solutions , including those derived from other union policy areas . ### with decision no 922 / 2009 / ec ceasing to apply on 31 december 2015 , a new union programme on interoperability solutions for european public administrations , businesses and citizens is needed in order to map and analyse the overall interoperability landscape in europe and avoid electronic barriers , public service incompatibilities and fragmentation . the programme will enable , support and promote a holistic approach to the collection , assessment , development , establishment , industrialisation , operation , improvement and maintenance of interoperability solutions , including solutions that facilitate the re - use of data as well as its exchange , in support of european public administrations ' cross - border or cross - sector interactions with each other and with enterprises and citizens . finally , the programme will promote the re - usability , integration and convergence of existing solutions , including those derived from other union policy areas . the isa2 programme should build upon the experience gained with the ida , idabc and isa programmes , and the progress of the digital agenda for europe , in particular the advances for interoperability reached by the bundling of large scale pilots . as the scope of the isa2 programme is expanded to include interactions of public administration with businesses and citizens , high levels of security and privacy guarantees should be assured .


### interoperability solutions and their updates shall be included in the eic and made available , where appropriate , for re - use by european public administrations . ### interoperability solutions and their updates shall be included in the eic and made available for re - use under an open licence .


### promoting sustainable multimodal urban mobility ; ### promoting sustainable multimodal urban mobility , with a focus on walking , cycling , public transport and shared mobility ;


### developing sustainable , climate resilient , intelligent and intermodal national , regional and local mobility , including improved access to ten - t and cross - border mobility ; ### developing sustainable , climate resilient , intelligent , safe and intermodal national , regional and local mobility , including improved access to ten - t and cross - border mobility ;


### ' conflict - affected and high - risk areas ' means areas in a state of armed conflict , fragile post - conflict as well as areas witnessing weak or non - existent governance and security , such as failed states , and widespread and systematic violations of international law , including human rights abuses ; ### ‘ conflict - affected and high - risk areas’ means areas identified by the presence of armed conflict , widespread violence or other risks of harm to people and , for these purposes , it is recognized that : armed conflict may take a variety of forms , such as a conflict of international or non - international character , which may involve two or more states , or may consist of wars of liberation , or insurgencies , civil wars ; and high - - risk areas may include areas of political instability or repression , institutional weakness , insecurity , collapse of civil infrastructure and widespread violence , both of which areas are often characterized by widespread human rights abuses and violations of national or international law ;


### adopt and clearly communicate to suppliers and the public its supply chain policy for the minerals and metals potentially originating from conflict - affected and high - risk areas , ### adopt and clearly and systematically communicate to suppliers and the public its supply chain policy for the minerals and metals potentially originating from conflict - affected and high - risk areas ,


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


### the commission should report regularly to the council and the european parliament on the effects of the scheme . no later than three years after entering into force and every six years thereafter , the commission should review the functioning and the effectiveness of this regulation , including as regards the promotion of responsible sourcing of the minerals within its scope from conflict - affected and high - risk areas . the reports may be accompanied , if necessary , by appropriate legislative proposals , which may include mandatory measures , ### the commission should report regularly to the council and the european parliament on the effects of the scheme . no later than three years after entering into force and every six years thereafter , the commission should review the functioning and the effectiveness of this regulation ,


### independent third - party audits regarding each of the responsible smelters or refiners in its supply chain carried out in accordance with the scope , objective and principles set out in article 6 of the regulation , ### independent third - party audits carried out in accordance with article 6 of this regulation ; and


### smelters and refiners are an important point in global mineral supply chains as they are typically the last stage in which due diligence can effectively be assured by collecting , disclosing and verifying information on the mineral ' s origin and chain of custody . after this stage of transformation it is often considered unfeasible to trace back the origins of minerals . a union list of responsible smelters and refiners could therefore provide transparency and certainty to downstream companies as regards supply chain due diligence practices . ### smelters and refiners are recognised choke points in their respective supply chains with substantial influence over the due diligence that is conducted along the supply chain in the sourcing countries . a union list of responsible choke - point actors could therefore provide transparency and certainty to companies in the downstream with a view to carrying out supply chain due diligence practices . consistently with the oecd due diligence guidance , choke - point actors should undergo independent third - party audit of their supply chain due diligence practices , also with a view to being included in the list of responsible actors . choke point actors based outside the european union should also have a possibility for being included in the list to ensure its global scope .


### the commission shall update the information included in the list in a timely manner . the commission shall remove from the list the names of the smelters and refiners that are no longer recognised as responsible importers by member states in accordance with article 14 , or the names of the smelters and refiners in the supply chain of the no longer recognised responsible importers . ### the commission shall update the information included in the list in a timely manner but no later than every six months . the commission shall remove from the list the names of upstream actors that are no longer recognised as responsible upstream actors by member states in accordance with article 14 .


### union companies have expressed their interest through the public consultation in the responsible sourcing of minerals and reported on current industry schemes designed to pursue their corporate social responsibility objectives , customer requests , or the security of their supplies . however , union companies have also reported countless difficulties in the exercise of supply chain due diligence because of lengthy and complex global supply chains involving a high number of operators that are often insufficiently aware or ethically unconcerned . the cost of responsible sourcing and their potential impact on competitiveness notably on smes should be monitored by the commission . ### union companies have expressed their interest through the public consultation in the responsible sourcing of minerals and reported on current industry schemes designed to pursue their corporate social responsibility objectives , customer requests , or the security of their supplies . in accordance with the oecd due diligence guidance it is recognized that due diligence in conflict - affected and high - risk areas presents practical challenges and that flexibility is therefore needed in the application thereof . the nature and extent of due diligence that is appropriate for an undertakings´ individual circumstances depend on a number of factors , including its size and position in the supply chain , fully taking account of the challenges faced by smes .


### in the context of this regulation , supply chain due diligence is an on - going , proactive and reactive process through which business operators monitor and administer their purchases and sales with a view to ensuring that they do not contribute to conflict and adverse impacts thereof . ### in the context of this regulation , and in accordance with the oecd due diligence guidance , supply chain due diligence is an on - going , proactive and reactive process through which business operators monitor and administer their purchases and sales upstream and downstream of the supply chain with a view to ensuring that they respect human rights and do not contribute to conflict and adverse impacts thereof , both directly in the mining sector and indirectly in the wider communities .


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


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


### the commission shall update the information included in the list in a timely manner . the commission shall remove from the list the names of the smelters and refiners that are no longer recognised as responsible importers by member states in accordance with article 14 , or the names of the smelters and refiners in the supply chain of the no longer recognised responsible importers . ### the commission shall update the information included in the list in a timely manner but no later than every six months . the commission shall remove from the list the names of annex ia actors that are no longer recognised as responsible annex ia actors by member states in accordance with article 14 .


### union citizens and civil society actors have raised awareness with respect to companies operating under the union ' s jurisdiction for not being held accountable for their potential connection to the illicit extraction and trade of minerals from conflict regions . the consequence is that such minerals , potentially present in consumer products , link consumers to conflicts outside the union . to this end , citizens have requested , notably through petitions , that legislation be proposed to the european parliament and the council holding companies accountable under the guidelines as established by the un and oecd . ### union citizens and civil society actors have raised awareness with respect to companies operating under the union ' s jurisdiction for not being held accountable for their potential connection to the illicit extraction and trade of natural resources from conflict regions . the consequence is that such natural resources , potentially present in consumer products , link consumers to conflicts outside the union . as such , consumers are indirectly linked to conflicts that have severe impacts on human rights , notably the rights of women as armed groups often use mass rape as a deliberate strategy to intimidate and control local populations in order to protect their interests . to this end , citizens have requested , notably through petitions , that legislation be proposed to the european parliament and the council holding companies accountable under the guidelines as established by the un and oecd .


### three years after the entry into force of this regulation and every six years thereafter , the commission shall review the functioning and effectiveness of this regulation , including on the promotion and cost of responsible sourcing of the minerals within its scope from conflict - affected and high - risk areas . the commission shall submit a review report to the european parliament and to the council . ### three years after the entry into force of this regulation and every six years thereafter , the commission shall review the functioning and effectiveness of this regulation , including on the promotion and cost of responsible sourcing of the resources within its scope from conflict - affected and high - risk areas . the commission shall submit a review report to the european parliament and to the council .


### union companies have expressed their interest through the public consultation in the responsible sourcing of minerals and reported on current industry schemes designed to pursue their corporate social responsibility objectives , customer requests , or the security of their supplies . however , union companies have also reported countless difficulties in the exercise of supply chain due diligence because of lengthy and complex global supply chains involving a high number of operators that are often insufficiently aware or ethically unconcerned . the cost of responsible sourcing and their potential impact on competitiveness notably on smes should be monitored by the commission . ### union companies have expressed their interest through the public consultation in the responsible sourcing of minerals and reported on current industry schemes designed to pursue their corporate social responsibility objectives , customer requests , or the security of their supplies . in accordance with the oecd due diligence guidance it is recognized that due diligence in conflict - affected and high - risk areas presents practical challenges and that flexibility is therefore needed in the application thereof . the nature and extent of due diligence that is appropriate for an enterprises ' individual circumstances depend on a number of factors , including its size and position in the supply chain , fully taking account of the challenges faced by smes .


### the commission shall update the information included in the list in a timely manner . the commission shall remove from the list the names of the smelters and refiners that are no longer recognised as responsible importers by member states in accordance with article 14 , or the names of the smelters and refiners in the supply chain of the no longer recognised responsible importers . ### the commission shall update the information included in the list in a timely manner but no later than every six months . the commission shall remove from the list the names of annex ii actors that are no longer recognised as responsible annex ii actors by member states in accordance with article 14 .


### the responsible importer of the minerals or metals within the scope of this regulation shall carry out audits via an independent third - party . ### annex ia operators shall have their due diligence practices audited by an independent third - party in accordance with the oecd due diligence guidance .


### on the basis of the information provided by the member states in their reports as referred to in article 15 , the commission shall adopt and make publicly available a decision listing the names and addresses of responsible smelters and refiners of minerals within the scope of this regulation . ### on the basis of the information provided by the member states in their reports as referred to in article 15 , the commission shall adopt and make publicly available a decision listing the names and addresses of responsible annex ia actors .


### on 7 october 2010 , the european parliament passed a resolution calling for the union to legislate along the lines of the us ' conflict minerals ' law alias section 1502 of the dodd - frank wall street reform and consumer protection act ; and the commission announced in its communications of 20119 and 201210 its intention to explore ways of improving transparency throughout the supply chain , including aspects of due diligence . in the latter communication and in line with the commitment it had made at the may 2011 oecd ministerial council , the commission also advocated greater support for and use of the oecd guidelines for multinational enterprises , and of the oecd due diligence guidance – even outside the oecd membership . __________________ 9 commodity markets and raw materials , com 25 final . 10 trade , growth and development , com 22 final . ### in its resolutions of 7 october 20108a , of 8 march 20118b , of 5 july 20118c and of 26 february 20148d , the european parliament called for the union to legislate along the lines of the us ' conflict minerals ' law alias section 1502 of the dodd - frank wall street reform and consumer protection act ; and the commission announced in its communications of 20119 and 201210 its intention to explore ways of improving transparency throughout the supply chain , including aspects of due diligence . in the latter communication and in line with the commitment it had made at the may 2011 oecd ministerial council , the commission also advocated greater support for and use of the oecd guidelines for multinational enterprises , and of the oecd due diligence guidance – even outside the oecd membership . __________________ 8a european parliament resolution of 7 october 2010 on failures in protection of human rights and justice in the democratic republic of congo . 8b european parliament resolution of 8 march 2011 on tax and development – cooperating with developing countries on promoting good governance in tax matters . 8c european parliament resolution of 5 july 2011 on increasing the impact of eu development policy . 8d european parliament resolution of 26 february 2014 on promoting development through responsible business practices , including the role of extractive industries in developing countries . 9 commodity markets and raw materials , com 25 final . 10 trade , growth and development , com 22 final .


### member states shall ensure that support measures for combined transport operations aim at reducing the road freight and encourage the use of other modes of transport such as rail , inland waterways and maritime transport , thereby reducing air pollution , greenhouse gas emissions , road traffic accidents , noise and congestion . ; ### member states shall ensure that support measures for combined transport operations aim at reducing the road freight and encourage the use of other modes of transport such as rail , inland waterways , maritime transport or low - emission vehicles , or the use of lower - emission alternative fuels such as biofuels , electricity from renewable sources , natural gas or hydrogen fuel cells , thereby reducing air pollution , greenhouse gas emissions , road traffic accidents , noise and congestion .


### reducing the negative impact of transport activities remains one of the main goals of the union ' s transport policy . council directive 92 / 106 / eec21 which establishes measures to encourage the development of combined transport , is the only legislative act of the union to directly incentivise the shift from road freight to lower emission transport modes such as inland waterways , maritime and rail . _________________ 21 council directive 92 / 106 / eec of 7 december 1992 on the establishment of common rules for certain types of combined transport of goods between member states . ### reducing the negative impact of transport activities and improving the efficiency of the transport system remains one of the main goals of the union ' s transport policy . council directive 92 / 106 / eec21 which establishes measures to encourage the development of combined transport , is the only legislative act of the union to directly incentivise the shift from road freight to lower emission transport modes such as inland waterways , maritime and rail . _________________ 21 council directive 92 / 106 / eec of 7 december 1992 on the establishment of common rules for certain types of combined transport of goods between member states .


### member states shall submit to the commission in the first instance by [ xx / xx / xxxx - 18 months after transposition of the directive ] and every two years thereafter a report providing the following information related to the combined transport operations covered by this directive on their territory : ### member states shall submit to the commission in the first instance by [ xx / xx / xxxx - 18 months after transposition of the directive ] and every year thereafter a report providing the following information related to the combined transport operations covered by this directive on their territory :


### the road leg distance limit may be exceeded for combined road / rail transport operations , when authorised by the member state or member states on whose territory the road leg takes place , in order to reach the geographically nearest transport terminal which has the necessary operational transhipment capability for loading or unloading in terms of transhipment equipment , terminal capacity and appropriate rail freight services . ### the road leg distance limit may be exceeded for combined road / rail transport operations , when authorised by the member state or member states on whose territory the road leg takes place , in order to reach the geographically nearest transport terminal or transhipment point which has the necessary operational transhipment capability for loading or unloading in terms of transhipment equipment , terminal capacity and appropriate rail freight services .


### member states shall take the measures necessary to ensure that the taxes listed in paragraph 3 which are applicable to road vehicles when routed in combined transport are reduced or reimbursed either by a standard amount , or in proportion to the journeys that such vehicles undertake by rail , within limits and in accordance with conditions and rules they fix after consultation with the commission . ### in article 6 , paragraph 1 is replaced by the following : ' 1 . member states shall take the measures necessary to ensure that the taxes listed in paragraph 3 which are applicable to road vehicles when routed in combined transport are reduced or reimbursed either by a standard amount , or in proportion to the journeys that such vehicles undertake by rail , inland waterway or maritime transport , within limits and in accordance with conditions and rules they fix after consultation with the commission . the reductions of reimbursements referred to in the first paragraph shall be granted by the member state in which the vehicles are registered , on the basis of the rail , inland waterway or maritime transport journeys effected within that state . member states may , however , grant these reductions or reimbursements on the basis of the rail , inland waterway or maritime transport journeys which take place partially or wholly outside the member state in which the vehicles are registered . '


### new psychoactive substances can pose serious cross border threats to health which makes necessary to enhance monitoring , early warning and combating of those threats . ### new psychoactive substances can pose serious cross border threats to health which makes necessary to enhance monitoring , early warning , risk reduction measures and combating of those threats .


### in those specific and limited circumstances , and in order to create a level playing field between union - based manufacturers and third country manufacturers , it is appropriate to restrict the protection conferred by a supplementary protection certificate so as to allow making for the exclusive purpose of export to third countries and any related acts strictly necessary for making or for the actual export itself . ### in those specific and limited circumstances , and in order to create a level playing field between union - based manufacturers and third country manufacturers , it is appropriate to restrict the protection conferred by a supplementary protection certificate so as to allow making for the exclusive purpose of export to third countries , and in order for producers to produce a stock to ensure day - 1 entry , and any related acts strictly necessary for making or for the actual export itself .


### the aim of this regulation is to ensure that manufacturers established in the union are able to compete effectively in those third country markets where supplementary protection does not exist or has expired . it is intended to complement the efforts of the union’s trade policy to ensure open markets for union - based manufacturers of medicinal products . indirectly , it is also intended to put those manufacturers in a better position to enter the union market immediately after expiry of the relevant supplementary protection certificate . it would also help to serve the aim of fostering access to medicines in the union by helping to ensure a swifter entry of generic and biosimilar medicines onto the market after expiry of the relevant certificate . ### the aim of this regulation is to ensure that manufacturers established in the union are able to compete effectively in those third country markets where supplementary protection does not exist or has expired , and to ensure day - 1 entry of generic and biosimilar medicines onto the union market after the expiry of the relevant supplementary protection certificate , thus fostering access to medicines . it is intended to complement the efforts of the union’s trade policy to ensure open markets for union - based manufacturers of medicinal products .


### making for the exclusive purpose of export to third countries ; or ### making for the exclusive purposes of export to third countries or entry onto the union market immediately after expiry of the certificate ; or


### member states shall not maintain or introduce provisions diverging from those laid down in this directive including more or less stringent provisions to ensure a different level of consumer protection . ### member states may maintain or introduce provisions diverging from those laid down in this directive , including more stringent provisions to ensure a higher level of consumer protection


### 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 in any case within 30 days from the moment the seller has acquired physical posession of the goods , 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 consumer shall be entitled to a remedy for the lack of conformity with the contract of the goods where the lack of conformity becomes apparent within two years as from the relevant time for establishing conformity . if , under national legislation , the rights laid down in article 9 are subject to a limitation period , that period shall not be shorter than two years from the relevant time for establishing conformity with the contract . ### the consumer shall be entitled to a remedy for the lack of conformity with the contract of the goods where the lack of conformity becomes apparent within two years from the relevant time for establishing conformity . where the consumer can reasonably expect that the lifespan of a product is longer than two years , and the lack of conformity becomes apparent within that lifespan , the consumer shall also be entitled to a remedy for that lack of conformity . in order to determine the lifespan of a product which is reasonable for the consumer to expect , all circumstances shall be taken into account , including in particular : durability requirements laid down by product - specific legislation , or durability information indicated in any pre - contractual or public statement made by the seller , or , where relevant , by other persons in earlier links of the chain of transactions , including the producer . if , under national legislation , the rights laid down in article 9 are subject to a limitation period , that period shall not be shorter than the time limit specified in the first subparagraph of this paragraph .


### in cases where the goods were installed by the seller or under the seller’s responsibility , the time when the installation is complete shall be considered as the time when the consumer has acquired the physical possession of the goods . in a case where the goods were intended to be installed by the consumer , the time when the consumer had reasonable time for the installation but in any case not later than 30 days after the time indicated in paragraph 1 shall be considered as the time when the consumer has acquired the physical possession of the goods . ### in cases where the goods were installed by the seller or under the seller ' s responsibility , the time when the installation is complete shall be considered as the time when the consumer has acquired physical possession of the goods . in a case where the goods were intended to be installed by the consumer , the time when the consumer had reasonable time for the installation , being not later than 30 days after the time indicated in paragraph 1 , shall be considered as the time when the consumer has acquired physical possession of the goods , save where the complexity of the installation requires a longer time .


### any contractual agreement which , to the detriment of the consumer , excludes the application of national measures transposing this directive , derogates from them or varies their effect before the lack of conformity with the contract of the goods is brought to the seller ' s attention by the consumer shall not be binding on the consumer unless parties to the contract exclude , derogate from or vary the effects of the requirements of articles 5 and 6 in accordance with article 4 . ### any contractual agreement which , to the detriment of the consumer , excludes the application of national measures transposing this directive , derogates from them or varies their effect before the lack of conformity with the contract of the goods is brought to the seller ' s attention by the consumer shall not be binding on 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 .


### ‘ consumer’ means any natural person who , in contracts covered by this directive , is acting for purposes which are outside his trade , business , craft or profession ; ### ' consumer ' means any natural person who , in contracts covered by this directive , is acting for purposes which are primarily outside his trade , business , craft or profession ;


### in cases where the goods were installed by the seller or under the seller’s responsibility , the time when the installation is complete shall be considered as the time when the consumer has acquired the physical possession of the goods . in a case where the goods were intended to be installed by the consumer , the time when the consumer had reasonable time for the installation but in any case not later than 30 days after the time indicated in paragraph 1 shall be considered as the time when the consumer has acquired the physical possession of the goods . ### in cases where the goods were installed by the seller or under the seller’s responsibility , the time when the installation is complete shall be considered as the time when the consumer has acquired physical possession of the goods . in a case where the goods were intended to be installed by the consumer , the time when the consumer had reasonable time for the installation , being not later than 30 days after the time indicated in paragraph 1 , shall be considered as the time when the consumer has acquired physical possession of the goods , save where the complexity of the installation requires a longer time .


### 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 online and other distance sales of goods only in relation to key contract elements needed to provide for a high level of consumer protection and 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 .


### in cases where the goods were installed by the seller or under the seller’s responsibility , the time when the installation is complete shall be considered as the time when the consumer has acquired the physical possession of the goods . in a case where the goods were intended to be installed by the consumer , the time when the consumer had reasonable time for the installation but in any case not later than 30 days after the time indicated in paragraph 1 shall be considered as the time when the consumer has acquired the physical possession of the goods . ### in a case governed by point of article 6 , the time when the installation is complete shall be considered as the time when the consumer has acquired physical possession of the goods . in a case governed by point of article 6 , the time when the consumer has had reasonable time for the installation but in any case not later than 30 days after the time indicated in paragraph 1 shall be considered as the time when the consumer has acquired physical possession of the goods .


### in order to provide clarity as to what a consumer can expect from the goods and what the seller would be liable for in case of failure to deliver what is expected , it is essential to fully harmonise rules for determining the conformity with the contract . applying a combination of subjective and objective criteria should safeguard legitimate interests of both parties to a sales contract . conformity with the contract should be assessed by taking into account not only requirements which have actually been set in the contract - including in pre - contractual information which forms an integral part of the contract - but also certain objective requirements which constitute the standards normally expected for goods , in particular in terms of fitness for the purpose , packaging , installation instructions and normal qualities and performance capabilities . ### in order to provide clarity as to what a consumer can expect from the goods and what the seller would be liable for in case of failure to deliver what is expected , it is essential to harmonise rules for determining the conformity with the contract . applying criteria should safeguard legitimate interests of both parties to a sales contract . conformity with the contract should be assessed by taking into account not only requirements which have actually been set in the contract - including in pre - contractual information which forms an integral part of the contract - but also certain objective requirements which constitute the standards normally expected for goods , in particular in terms of fitness for the purpose , durability , packaging , installation instructions and normal qualities and performance capabilities .


### ensuring longer durability of consumer goods is important for achieving more sustainable consumption patterns and a circular economy . similarly , keeping non - compliant products out of the union market by strengthening market surveillance and providing the right incentives to economic operators is essential to increase trust in the single market . for these purposes , product specific union legislation is the most appropriate approach to introduce durability and other product related requirements in relation to specific types or groups of products , using for this purpose adapted criteria . this directive should therefore be complementary to the objectives followed in this union sector specific legislation . in so far as specific durability information is indicated in any pre - contractual statement which forms part of the sales contract , the consumer should be able to rely on them as a part of the criteria for conformity . ### ensuring longer durability of goods is important for achieving more sustainable consumption patterns and a circular economy . therefore sellers should inform consumers of the minimum expected lifespan of a product , and clearly indicate if they guarantee that lifespan . consumers should be entitled to a remedy for the lack of conformity with the contract of the goods where the lack of conformity becomes apparent within the lifespan of the goods consumers can reasonably expect . furthermore , sellers should inform the consumer about the availability of spare parts which are essential to the use of the product .


### 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 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 . however , the seller shall be entitled to pursue remedies for at least the duration of the legal guarantee period , and the period during which a presumption exists that any lack of conformity with the contract already existed at the time indicated in article 8 and shall be no shorter than as provided for in article 8 .


### possess qualities and performance capabilities which are normal in goods of the same type and which the consumer may expect given the nature of the goods and taking into account any public statement made by or on behalf of the seller or other persons in earlier links of the chain of transactions , including the producer , unless the seller shows that : ### possess qualities , durability and performance capabilities which are normal in goods of the same type and which the consumer can expect given the nature of the goods and taking into account any public statement made by or on behalf of the seller or other persons in earlier links of the chain of transactions , including the producer , unless the seller shows that


### in order to provide clarity as to what a consumer can expect from the goods and what the seller would be liable for in case of failure to deliver what is expected , it is essential to fully harmonise rules for determining the conformity with the contract . applying a combination of subjective and objective criteria should safeguard legitimate interests of both parties to a sales contract . conformity with the contract should be assessed by taking into account not only requirements which have actually been set in the contract - including in pre - contractual information which forms an integral part of the contract - but also certain objective requirements which constitute the standards normally expected for goods , in particular in terms of fitness for the purpose , packaging , installation instructions and normal qualities and performance capabilities . ### in order to provide clarity as to what a consumer can expect from the goods and what the seller would be liable for in case of failure to deliver what is expected , it is justifiable to harmonise rules for determining the conformity with the contract . applying a combination of subjective and objective criteria should safeguard legitimate interests of both parties to a sales contract . conformity with the contract should be assessed by taking into account not only requirements which have actually been set in the contract - including in pre - contractual information which forms an integral part of the contract - but also certain objective requirements which constitute the standards normally expected for goods , in particular in terms of fitness for the purpose , durability , packaging , installation instructions and normal qualities and performance capabilities .


### contribution to the security and defence interests of the union by enhancing defence technologies which contribute to implement defence capability priorities commonly agreed by member states within the union ; and , ### contribution to the common security and defence policy by enhancing defence technologies which contribute to implement defence capability priorities commonly agreed by member states n in the context of the capability development plan ; and ,


### the action shall be undertaken in a cooperation of at least three undertakings which are established in at least two different member states . the undertakings which are beneficiaries shall not effectively be controlled , directly or indirectly , by the same entity or shall not control each other . ### the action shall be undertaken in a cooperation of at least three undertakings which are established in at least two different member states . the undertakings and their subcontractors which are participants shall not effectively be controlled , directly or indirectly , by the same entity or shall not control each other .


### 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 efficient cooperation within 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 actions supported . the applicable intellectual property rights regime will be defined contractually by the participants .


### 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 efficiency of the union ' s defence industry , a european defence industrial development cooperation programme should be established jointly by the member states and the commission . the programme should consist of a cooperation mechanism between member states , the commission , and undertakings and address the development phase of defence products and technologies which follows the research and technology phase which entails significant risks and costs that hamper the further exploitation of the results of research . by addressing 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 article182 tfeu and it does not cover the production of defence products and technologies .


### contribution to the innovation and technological development of defence industries and thus to fostering the industrial autonomy of the union in the field of defence technologies ; and , ### contribution to the innovation and technological development of defence industries and thus to fostering the industrial autonomy of the union in relation to the capability requirements under the common security and defence policy ; and ,


### as the programme aims at enhancing the competitiveness of the union ' s defence industry , only entities established in the union and effectively controlled by member states or their nationals should be eligible for support . additionally , in order to ensure the protection of essential security interests of the union and its member states , the infrastructure , facilities , assets and resources used by the beneficiaries and subcontractors in actions funded under the programme , shall not be located on the territory of non - member states . ### as the programme aims at enhancing the efficiency of the cooperation of the union ' s defence industry , only entities established in the union and effectively controlled by member states or their nationals should be eligible for support . additionally , in order to ensure the protection of essential security interests of the union and its member states , the infrastructure , facilities , assets and resources used by the participants and subcontractors in actions supported under the programme , shall not be located on the territory of non - member states and shall not be subject to control or restrictions by third - countries , undertakings or public entities in third countries .


### 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 as defined objectively within the context of the common security and defence policy . accordingly , the action ' s contribution to those interests and to the defence capability priorities commonly agreed by member states within the context of csdp 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 .


### 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 and leverage the cooperation between member states and with undertakings , including small and medium - sized enterprises , in the development of technologies or products solely in line with defence capability priorities commonly agreed by member states within the union in the context of the capability development plan of the common security and defence policy ;


### 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 increase the level of efficiency of cooperation between member states and de - risking the development phase of cooperative defence industry projects , actions related to the development of a defence product or technology , namely definition of common technical specifications , design , prototyping , testing , qualification , certification should be considered under the programme . this will also apply to the upgrade of existing defence products and technologies .


### the union financial support should not affect the export of products , equipment or technologies , and it should not affect the discretion of member states regarding policy on the export of defence related products . the union financial support should not affect member states ' export policies on defence related products . ### military or dual - use technology supported by this programme should only be exported to nato allies and friendly nations which fully comply with the provisions of the arms trade treaty . also any technology supported by this programme should , when exported to third countries , comply with the eight criteria of common position 944 / 2008 / cfsp . those member states involved in a particular action should all agree to the export and the commission should monitor and report back on the end - use and end - users of that particular technolgy .


### 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 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 administrative support by the commission .


### in order to ensure that the funded actions will contribute to the competitiveness of the european defence industry , they should be market - oriented and demand driven . therefore , the fact that member states have already committed to jointly produce and procure the final product or technology , possibly in a coordinated way , should be taken into account in the award criteria . ### in order to ensure that the actions will contribute to a higher level of efficiency of the european defence industry , they should be market - oriented and demand driven . therefore , the fact that member states have already committed to jointly produce and procure the final product or technology , possibly in a coordinated way , should be taken into account in the award criteria . in order to reduce market distortions in the defence sector , which often hamper efficient projects , it is of crucial importance to not subsidize the defence industry via the use of eu funds .


### 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 30november 2016 , the commission described the many structural problems in the european defence sector which hamper the efficient use of national resources for providing the defence capabilities needed for an effective common security and defence policy . the commission in particular underlines that duplications , fragmentation , and other structural problems have led to a sector which generates only 15% of capabilities compared to the same investment by the us . the highly inefficient structures and mechanism , coupled with a very low rate of collaborative projects currently lead to a loss of eur 25 - 100 billion annually . 1a this is why in the european defence action plan , 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 an efficient european defence industry . to realise these objectives it is therefore at the union level necessary to enhance the institutional framework for cooperation of member states and undertakings in the defence industrial development sector . it proposed in particular to launch efficient cooperation actions that would lead to investments by the member states in joint research and the joint development of defence equipment and technologies . _________________ 1a european commission , 30 november 2016 , annex the business case for more efficient spending on defence .


### 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 . ### participants in the actions foreseen by the programme shall be undertakings and their subcontractors established in the union , in which member states and / or nationals of member states own 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 foreseen under the programme shall not be located on the territory of non - member states during the entire duration of the action . the use of these infrastructures , facilities , assets and resources shall not be under the control of any third country or entity established outside of the union .


### the commission shall be assisted by a committee . that committee shall be a committee within the meaning of regulation no 182 / 2011 . the european defence agency shall be invited as observer . ### the commission shall be assisted by a committee . that committee shall be a committee within the meaning of regulation no 182 / 2011 . the european defence agency and representatives of the european parliament , civil society and academia shall be invited as observer .


### the programme should be implemented in full compliance with regulation no 966 / 2012 of the european parliament and of the council6 . funding may take in particular the form of grants . financial instruments or public procurement may be used where appropriate . _________________ 6 regulation no 966 / 2012 of the european parliament and of the council of 25 october 2012 on the financial rules applicable to the general budget of the union and repealing council regulation no 1605 / 2002 . ### the programme should be implemented in full compliance with regulation no 966 / 2012 of the european parliament and of the council6 . _________________ 6 regulation no 966 / 2012 of the european parliament and of the council of 25 october 2012 on the financial rules applicable to the general budget of the union and repealing council regulation no 1605 / 2002 .


### the commission should draw up an implementation report at the end of the programme , examining the financial activities in terms of financial implementation results and where possible , impact . this report should also analyse the cross border participation of smes in projects under the programme as well as the participation of smes to the global value chain . ### the commission should draw up an interim progress report by the end of the first year of implementation and an implementation report at the end of the programme , examining the financial activities in terms of financial implementation results and where possible , impact . this report should also analyse the cross border participation of smes in projects under the programme as well as the participation of smes to the global value chain .


### to foster the competitiveness and innovation capacity of the union defence industry by supporting actions in their development phase ; ### to increase efficient cooperation between member states by supporting actions on union territory in their industrial development phase ;


### the european travel document for return should help reduce the administrative and bureaucratic burden on member states ' and third countries ' administrations , including consular services , and it should contribute to reducing the length of the administrative procedures necessary for ensuring return and readmission of illegally staying third - country nationals . ### the european travel document for return should help reduce the administrative and bureaucratic burden on member states ' and third countries ' administrations , including consular services , and , without prejudice to the fundamental rights of returnees , including the right to asylum , protection in the event of removal , expulsion or extradition and the right to an effective remedy and to a fair trial , it should contribute to reducing the length of the administrative procedures necessary for ensuring return and readmission of illegally staying third - country nationals .


### the european travel document for return shall be established in the official language or languages of the member state that issues the return decision and , where appropriate , it shall be translated into english and french . ### the european travel document for return shall be established in the official language or languages of the member state that issues the return decision and it shall be translated into english and french and into an official language of the third country of return .


### 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 projects delivering high societal , environmental and economic benefits . in particular , the efsi should target projects that promote job creation , long - term and sustainable growth , the efficient use of energy 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 an effective and strategic use .


### 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 environmental , social and economic sustainability .


### 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 projects delivering high societal and economic value . in particular , the efsi should target projects that promote green job creation , sustainable growth and the green economy . 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 support strategic investments with high economic value added contributing to achieving union policy objectives . ### the efsi should support strategic investments with high environmental and economic value added contributing to achieving union policy objectives in support of the green economy .


### 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 projects delivering high societal environmental and economic benefits . in particular , the efsi should target projects that promote job creation , long - term growth , sustainability , resource and energy efficiency 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 .


### development of infrastructure , including in the areas of transport , particularly in industrial centres ; energy , in particular energy interconnections ; and digital infrastructure ; ### development of sustainable infrastructure in compliance with the eu ' s long term climate , energy and environment policy goals , including in the areas of low - emission transport , particularly sustainable modes of transport , eco - friendly solutions in industrial centres ; sustainable energy , in particular smart grids , smart meters , energy storage capacities , renewables and energy interconnections ; and digital infrastructure ;


### infrastructure projects in the environmental , natural resources , urban development and social fields ; ### sustainable infrastructure projects in the environmental , natural resources , resource efficiency , urban development and social fields ;


### 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 made efforts to promote growth , in particular through initiatives set out in the europe 2020 strategy that put in place an approach for smart , environmentally sustainable and socially 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 and environmentally sustainable investment projects .


### 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 clear environmental and societal value added to ensure additionality over existing operations . the efsi should finance sustainable 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 .


### expansion of renewable energy and energy and resource efficiency ; ### expansion of renewable energy , energy savings and efficiency and natural resources ;