### 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 . ” ,


### to ensure that sectoral specificities with respect to confidential information are taken into account , it is necessary to weigh up the relevant rights of the public to transparency in the risk assessment process , including those flowing from the aarhus convention35 , against the rights of commercial applicants , taking into account the specific objectives of sectoral union legislation as well as experienced gained . accordingly , it is necessary to amend directive 2001 / 18 / ec , regulation no 1829 / 2003 , regulation no 1831 / 2003 , regulation no 1935 / 2004 and regulation no 1107 / 2009 to provide for additional confidential items to those set out in regulation no 178 / 2002 . __________________ 35 regulation no 1367 / 2006 of the european parliament and of the council of 6 september 2006 on the application of the provisions of the aarhus convention on access to information , public participation in decision - making and access to justice in environmental matters to community institutions and bodies . ### to ensure that sectoral specificities with respect to confidential information are taken into account , it is necessary to weigh up right of the public to benefit from proactive disclosure of information related to the risk assessment process against the rights of commercial applicants , taking into account the specific objectives of sectoral union legislation as well as experienced gained . accordingly , it is necessary to amend directive 2001 / 18 / ec , regulation no 1829 / 2003 , regulation no 1831 / 2003 , regulation no 1935 / 2004 and regulation no 1107 / 2009 to provide for additional exhaustive list of confidential items to those set out in regulation no 178 / 2002 . the new provisions on active dissemination laid down in this regulation and the assessment of confidentiality request by the authority shall not in any manner limit the scope of the rights given by regulations 1049 / 2001 and 1367 / 2006 . __________________ 35 regulation no 1367 / 2006 of the european parliament and of the council of 6 september 2006 on the application of the provisions of the aarhus convention on access to information , public participation in decision - making and access to justice in environmental matters to community institutions and bodies .


### promote consistency and transparency in formulating risk management recommendations ; ### promote a high level of health and environmental protection , and transparency in formulating risk management recommendations ;


### 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 .


### the commission experts shall perform controls , including audits , to obtain assurance that testing facilities comply with relevant standards for carrying out tests and studies submitted to the authority as part of an application for an authorisation under union food law . these controls shall be organised in cooperation with the competent authorities of the member states . ### the commission ' s food and veterinary office experts shall perform controls , including audits , to obtain assurance that testing facilities in the union and in third countries comply with relevant standards for carrying out tests and studies submitted to the authority as part of an application for an authorisation under union food law . these controls shall be organised in cooperation with the competent authorities of the member states or of the third countries concerned .


### 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 .


### a union register of studies commissioned by business operators to obtain an authorisation under union food law is hereby established . business operators shall notify , without delay , to the authority the subject matter of any study commissioned to support a future application for an authorisation under union food law . the register shall be managed by the authority . ### a union register of studies commissioned by business operators seeking to obtain an authorisation or renewal under union food law is hereby established . business operators shall notify , without delay , to the authority the subject matter of any study commissioned within the eu and beyond to support a future application for an authorisation or renewal under union food law . the register shall be managed by the authority .


### 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 , transparent , independent and continuous risk communication process throughout risk analysis , involving union and national risk assessors and risk managers . that process should be capable of contributing to a participatory and open dialogue between all interested parties to ensure prevalence of public interest only , accuracy , comprehensiveness , transparency and consistency of the risk analysis process .


### to ensure that sectoral specificities with respect to confidential information are taken into account , it is necessary to weigh up the relevant rights of the public to transparency in the risk assessment process , including those flowing from the aarhus convention35 , against the rights of commercial applicants , taking into account the specific objectives of sectoral union legislation as well as experienced gained . accordingly , it is necessary to amend directive 2001 / 18 / ec , regulation no 1829 / 2003 , regulation no 1831 / 2003 , regulation no 1935 / 2004 and regulation no 1107 / 2009 to provide for additional confidential items to those set out in regulation no 178 / 2002 . __________________ 35 regulation no 1367 / 2006 of the european parliament and of the council of 6 september 2006 on the application of the provisions of the aarhus convention on access to information , public participation in decision - making and access to justice in environmental matters to community institutions and bodies . ### to ensure that sectoral specificities with respect to confidential information are taken into account , it is necessary to weigh up the rights of the public to transparency , including , the right to benefit from proactive information related to the risk assessment process , against the rights of commercial applicants , taking into account the specific objectives of sectoral union legislation as well as experienced gained . accordingly , it is necessary to amend directive 2001 / 18 / ec , regulation no 1829 / 2003 , regulation no 1831 / 2003 , regulation no 1935 / 2004 and regulation no 1107 / 2009 to provide for additional confidential items to those set out in regulation no 178 / 2002 . under no circumstances , the new provisions on active dissemination should limit the rights given by regulations 1049 / 2001 and 1367 / 2006 to obtain information upon request . __________________ 35 regulation no 1367 / 2006 of the european parliament and of the council of 6 september 2006 on the application of the provisions of the aarhus convention on access to information , public participation in decision - making and access to justice in environmental matters to community institutions and bodies .


### 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 ;


### 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 . ### when the management board 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 .


### it is essential to ensure the efficient operation of the authority and to improve the sustainability of its expertise . it is therefore necessary to strengthen the support provided by the authority and the member states to the work of the authority’s scientific panels . in particular , the authority should organise the preparatory work supporting the panels’ tasks , including by requesting the authority’s staff or national scientific organisations networking with the authority to draft preparatory scientific opinions to be peer - reviewed and adopted by the panels . ### it is essential to ensure the efficient operation of the authority and to improve the sustainability of its expertise . it is therefore necessary to strengthen the support provided by the authority and the member states to the work of the authority’s scientific panels . in particular , the authority should organise the preparatory work supporting the panels’ tasks , including by requesting the authority’s staff or national scientific organisations networking with the authority to draft preparatory scientific opinions to be peer - reviewed and adopted by the panels . this should be without prejudice to the independence of the authority’s scientific assessments .


### 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 .


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


### 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 .


### four members with the right to vote representing civil society and food chain interests namely , one from consumers organisations , one from environmental non - governmental organisations , one from farmers organisations and one from industry organisations . those members shall be appointed by the council in consultation with the european parliament on the basis of a list drawn up by the commission which includes more names than there are posts to be filled . the list drawn up by the commission shall be forwarded to the european parliament , together with the relevant background documents . as quickly as possible and within three months of notification , the european parliament may submit its views for consideration to the council , which shall then appoint those members . ### five members with the right to vote representing civil society and food chain workers interests namely , one from medical / health organisations , one from consumers organisations , one from environmental non - governmental organisations , one from farmers organisations and one from agrochemical or food industry organisations . those members shall be appointed by the council in consultation with the european parliament on the basis of a list drawn up by the commission which includes more names than there are posts to be filled . the list drawn up by the commission shall be forwarded to the european parliament , together with the relevant background documents . as quickly as possible and within three months of notification , the european parliament may submit its views for consideration to the council , which shall then appoint those members .


### provide a sound basis for understanding risk management decisions ; ### provide a scientific basis for understanding risk management decisions , including information on :


### establish appropriate mechanisms in order to strengthen coherence of risk communication amongst risk assessors and risk managers and ensure an open dialogue amongst all interested parties . ### establish appropriate mechanisms in order to strengthen coherence of risk communication amongst risk assessors and risk managers and ensure an open dialogue and constant interaction amongst all interested parties , while acknowledging scientific divergent opinions where they exist .


### the members of the scientific committee who are not members of scientific panels and the additional members referred to in paragraph 5b shall be appointed by the management board , acting upon a proposal from the executive director , for a five year term of office , which may be renewable , following publication in the official journal of the european union , in relevant leading scientific publications and on the authority’s website of a call for expressions of interest . ” , ### the members of the scientific committee who are not members of the scientific panels , the members of the scientific panels and the additional members referred to in paragraph 5a shall be appointed by the management board for a renewable five year term of office in accordance with the following procedure : a call for expressions of interest shall be published in the official journal of the european union , in relevant leading scientific publications and on the authority ' s website ; member states shall ensure the broad dissemination of the call for expressions of interest across the scientific community ; on the basis of the applications received and in accordance with the authority’s independence policy and implementing rules applicable to scientific panels’ members , 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 applications 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 .


### 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 .


### 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 ,


### promote awareness and understanding of the specific issues under consideration during the entire risk analysis process ; ### promote transparency , clarity , awareness and understanding of the specific issues under consideration during the entire risk analysis and management processes ;


### 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 . ” ,


### authorisations procedures are based on the principle that it is for the applicant to prove that the subject matter of an authorisation procedure complies with union safety requirements given the scientific knowledge in its possession . this principle is based on the premise that public health is better protected when the burden of proof is on the applicant since it has to prove that a particular subject matter is safe prior to its placing on the market , instead of the public authorities having to prove that a subject matter is unsafe in order to be able to ban it from the market . moreover , public money should not be used to commission costly studies that will in the end help the industry to place a product on the market . according to this principle and in accordance with applicable regulatory requirements , in support of applications for an authorisation under union sectoral food law applicants are required to submit relevant studies , including tests , to demonstrate the safety and in some cases the efficacy of a subject matter . ### authorisations procedures are based on the principle that it is for the applicant to prove that the subject matter of an authorisation procedure complies with union safety requirements given the scientific knowledge in its possession . this principle is based on the premise that public health and the environment are better protected when the burden of proof is on the applicant since it has to prove that a particular subject matter is safe prior to its placing on the market , instead of the public authorities having to prove that a subject matter unsafe in order to be able to ban it from the market . moreover , public money should not be used to commission costly studies that will in the end help the industry to place a product on the market . according to this principle and in accordance with applicable regulatory requirements , in support of applications for an authorisation under union sectoral food law applicants are required to submit relevant studies , including tests , to demonstrate the safety and in some cases the efficacy of a subject matter .


### 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 .


### 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 .


### 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 .


### each year the institution shall forward a report to the european parliament and the council containing a summary of the number and type of internal audits carried out , the recommendations made and the action taken on those recommendations . ### article 99 is replaced by the following : ' 5 . each year the institution shall report to the european parliament and the council on internal audits carried out , the recommendations made and the action taken on those recommendations . '


### for the purposes of this article , the gross national income ratio means the ratio between the gross national income per capita of a member state , measured in purchasing power standards and calculated on the basis of union figures for the period from 2014 to 2016 , and the average gross national income per capita in purchasing power standards of the 27 member states for that same reference period . ### for the purposes of this article , the classification of a region in one of the three categories of regions shall be determined on the basis of the ratio of the gdp per capita of each region , measured in purchasing power parities and calculated on the basis of union data for the period 2014 to 2016 , and the average gdp of the eu - 27 for the same reference period .


### member states of group 2 shall allocate at least 45 % of their total erdf resources under priorities other than for technical assistance to po 1 , and at least 30 % to po 2 ; ### for the category of transition regions : at least 45 % of their totalled resources under priorities other than for technical assistance to po 1 , and at least 30 % to po 2 ;


### for the purposes of this article , the gross national income ratio means the ratio between the gross national income per capita of a member state , measured in purchasing power standards and calculated on the basis of union figures for the period from 2014 to 2016 , and the average gross national income per capita in purchasing power standards of the 27 member states for that same reference period . ### for the purposes of this article , the classification of a region under one of the three categories of regions shall be determined on the basis of the ratio between the gross domestic product per capita of each region , measured in purchasing power parity and calculated on the basis of union figures for the period from 2014 to 2016 , and the average gdp of the eu27 for that same reference period .


### those with a gross national income ratio equal to or above 100 % of the eu average ; ### those with a gross national income ratio equal to or above 105% of the eu average ;


### those with a gross national income ratio equal to or above 100 % of the eu average ; ### more developed regions , whose per capita gross domestic product is above 100 % of the eu27 average .


### member states shall be classified , in terms of their gross national income ratio , as follows : ### regions shall be classified , in terms of their gross domestic product ratio , as follows :


### those with a gross national income ratio below 75 % of the eu average . ### less developed regions whose gdp per capita is less than 75% of the average gdp of the eu - 27 ;


### the erdf should help to redress the main regional imbalances in the union and to reduce disparities between the levels of development of the various regions and the backwardness of the least favoured regions including those facing challenges due to the decarbonisation commitments . erdf support under the investment for jobs and growth goal should therefore be concentrated on key union priorities in line with policy objectives laid down in regulation 2018 / xxx [ new cpr ] . therefore support from the erdf should be concentrated on the policy objectives of ' a smarter europe by promoting innovative and smart economic transformation ' and ' a greener , low - carbon europe by promoting clean and fair energy transition , green and blue investment , the circular economy , climate adaptation and risk prevention and management ' . that thematic concentration should be attained at national level while allowing for flexibility at the level of individual programmes and between the three groups of member states formed according to respective gross national income . in addition , the methodology to classify member states should be set out in detail taking into account the specific situation of the outermost regions . ### the erdf should help to redress the main regional imbalances in the union and to reduce disparities between the levels of development of the various regions and the backwardness of the least favoured regions including those facing challenges due to the decarbonisation commitments . erdf support under the investment for jobs and growth goal should therefore be concentrated on key union priorities in line with policy objectives laid down in regulation 2018 / xxx [ new cpr ] . therefore support from the erdf should be concentrated on the policy objectives of ' a smarter europe by promoting innovative and smart economic transformation ' and ' a greener , low - carbon europe by promoting clean and fair energy transition , green and blue investment , the circular economy , climate adaptation and risk prevention and management ' . said thematic concentration should be attained at national level , allowing margins for flexibility at the level of individual programmes and between various categories of regions , taking account too of different levels of development . in addition , the methodology to classify the regions should be set out in detail taking into account the specific situation of the outermost regions .


### member states of group 1 shall allocate at least 85 % of their total erdf resources under priorities other than for technical assistance to po 1 and po 2 , and at least 60 % to po 1 ; ### member states of group 1 shall allocate at least 85 % of their total erdf resources under priorities other than for technical assistance to po 1 and po 2 , and at least 30 % to po 2 ;


### member states of group 3 shall allocate at least 35 % of their total erdf resources under priorities other than for technical assistance to po 1 , and at least 30 % to po 2 . ### member states of group 2 shall allocate at least 30 % of their total erdf resources under priorities other than for technical assistance to po 1 , and at least 30 % to po 2 .


### those with a gross national income ratio below 75 % of the eu average . ### less developed regions , whose per capita gross domestic product is below 75% of the eu27 average ;


### member states of group 1 shall allocate at least 85 % of their total erdf resources under priorities other than for technical assistance to po 1 and po 2 , and at least 60 % to po 1 ; ### member states of group 1 shall allocate at least 75 % of their total erdf resources under priorities other than for technical assistance to po 1 and po 2 , and at least 50 % to po 1 ;


### in case of urgency , such as in situations where there is a risk of immediate and irreversible injury to union air carrier , the proceedings may be shortened to one year . ### in case of urgency , such as in situations where there is a risk of immediate and irreversible injury to union air carrier , the proceedings may be shortened to a maximum period of six months .


### the commission may decide not to initiate an investigation where the adoption of measures in accordance with articles 10 or 13 would be against the union interest or where the commission considers that the facts put forward in the complaint neither raise a systemic issue , nor have a significant impact on one or more union air carriers . ### the commission may decide not to initiate an investigation where it considers that the facts put forward in the complaint neither raise a systemic issue , nor have a significant impact on one or more union air carriers .


### the proceedings shall be concluded within two years . that period may be prolonged in duly justified cases . ### the proceedings shall be concluded within an 18 month period following the initiation of an investigation . that period may be prolonged within a set timeline in duly justified cases .


### the report shall present the information referred to in paragraph 2 separately for each member state . where a member state comprises several tax jurisdictions , the information shall be combined at member state level . ### the report shall present the information referred to in paragraph 2 separately for each member state . where a member state comprises several tax jurisdictions , the information shall be listed separately for each tax jurisdiction .


### the report on income tax information shall be made accessible to the public on the date of its publication on the website of the branch or on the website of an affiliated undertaking . ### the report on income tax information shall be published in a common template available in an open data format and made accessible to the public on the date of its publication on the website of the branch or on the website of an affiliated undertaking in at least one of the official languages of the union . on the date of publication of the report on income tax information , the undertaking shall also file the report in a public registry managed by the commission .


### member states shall apply the rules set out in paragraph 4 only to a branch where the following criteria are met : the undertaking which opened the branch is either an affiliated undertaking of a group which is controlled by an ultimate parent undertaking not governed by the law of a member state and which has a consolidated net turnover exceeding eur 750 000 000 or an undertaking that is not an affiliated and which has a net turnover exceeding eur 750 000 000 ; the ultimate parent undertaking referred to in point does not have a medium - sized or large subsidiary undertaking as referred to in paragraph 3 . ### member states shall apply the rules set out in paragraph 4 only to a branch where the undertaking which opened the branch is either an affiliated undertaking of a group which is controlled by an ultimate parent undertaking not governed by the law of a member state and which has a consolidated net turnover exceeding eur 40 000 000 or an undertaking that is not an affiliated and which has a net turnover exceeding eur 40 000 000 .


### the report on income tax information shall be made accessible to the public on the date of its publication on the website of the subsidiary undertaking or on the website of an affiliated undertaking . ### the report on income tax information shall be published in a common template available in an open data format and made accessible to the public on the date of its publication on the website of the subsidiary undertaking or on the website of an affiliated undertaking in at least one of the official languages of the union . on the date of publication of the report on income tax information , the undertaking shall also file the report in a public registry managed by the commission .


### the public should be able to scrutinise all the activities of a group when the group has certain establishments within the union . for groups which carry out activities within the union only through subsidiary undertakings or branches , subsidiaries and branches should publish and make accessible the report of the ultimate parent undertaking . however for reasons of proportionality and effectiveness , the obligation to publish and make accessible the report should be limited to medium - sized or large subsidiaries established in the union , or branches of a comparable size opened in a member state . the scope of directive 2013 / 34 / eu should therefore be extended accordingly to branches opened in a member state by an undertaking which is established outside the union . ### the public should be able to scrutinise all the activities of a group when the group has certain establishments within and outside the union . multinational undertakings are operating worldwide and their corporate behaviour has a substantial impact on developing countries . providing their citizens access to corporate country - by - country information would allow them and tax administrations in their countries to monitor , assess and / or hold those companies to account . by making the information public for each tax jurisdiction where the multinational undertaking has operations , the union would increase its policy coherence for development and limit potential tax avoidance schemes in countries where domestic resources mobilization has been identified as a key component of the development policy of the union .


### the number of employees ; ### the number of employees on a full - time equivalent basis ;


### member states shall require ultimate parent undertakings governed by their national laws and having a consolidated net turnover exceeding eur 750 000 000 as well as undertakings governed by their national laws that are not affiliated undertakings and having a net turnover exceeding eur 750 000 000 to draw up and publish a report on income tax information on an annual basis . ### member states shall require ultimate parent undertakings of large groups as defined in article 3 , governed by their national laws , and of large undertakings as defined in article 3 , governed by their national laws that are not affiliated undertakings to draw up and publish a report on income tax information on an annual basis .


### member states shall require the medium - sized and large subsidiary undertakings referred to in article 3 and which are governed by their national laws and controlled by an ultimate parent undertaking which has a consolidated net turnover exceeding eur 750 000 000 and which is not governed by the law of a member state , to publish the report on income tax information of that ultimate parent undertaking on an annual basis . ### member states shall require subsidiary undertakings which are governed by their national laws and controlled by an ultimate parent undertaking which has a consolidated net turnover exceeding eur 40 000 000 and which is not governed by the law of a member state , to publish the report on income tax information of that ultimate parent undertaking on an annual basis .


### in order to ensure a level of detail that enables citizens to better assess the contribution of multinational undertakings to welfare in each member state , the information should be broken down by member state . moreover , information concerning the operations of multinational enterprises should also be shown with a high level of detail as regards certain tax jurisdictions which pose particular challenges . for all other third country operations , the information should be given in an aggregate number . ### in order to ensure a level of detail that enables citizens to better assess the contribution of multinational undertakings to welfare in each jurisdiction in which they operate , both within and outside the union , the information should be broken down by jurisdiction .


### the performance of the programme shall be assessed against the objective laid out in article 1 and the actions of the rolling work programme . the objective shall be measured in particular through the number of key interoperability enablers and through the number of supporting instruments for public administrations delivered to and used by european public administrations . indicators for measuring the result and impact of the programme shall be defined in the rolling work programme . ### the performance of the isa2 programme shall be assessed against the objective laid out in article 1 and the eligibility and selection criteria set out in article 4 . the achievement of the objective shall be measured in particular in terms of the number of key interoperability enablers and supporting instruments for public administrations delivered to and used by european public administrations .


### national administrations can be supported in their endeavours through specific instruments under the european structural and investment funds . close cooperation under the isa2 programme should maximise the benefits expected from such instruments by ensuring that funded projects are aligned with the union - wide interoperability frameworks and specifications such as the eif . ### national , regional and local administrations can be supported in their endeavours through specific instruments under the european structural and investment funds . close cooperation under the isa2 programme should maximise the benefits expected from such instruments by ensuring that funded projects are aligned with the union - wide interoperability frameworks and specifications such as the eif .


### interoperability solutions and their updates shall be included in the eic and made available , where appropriate , for re - use by european public administrations . 8 . the commission shall monitor periodically the implementation and re - use of interoperability solutions across the union , as part of the rolling work programme established pursuant to article 7 . 9 . in order to maximise synergies and ensure complementary and combined efforts , actions shall , where appropriate , be coordinated with other relevant union initiatives . 10 . all actions and interoperability solutions funded under the isa2 programme shall be encouraged , where appropriate , to re - use available interoperability solutions . ### interoperability solutions and their updates shall be included in the eic and made available , where appropriate , for re - use by european public administrations and , where applicable , by citizens and businesses . 9 . in order to maximise synergies , ensure complementary and combined efforts and avoid duplication , actions shall , where appropriate , be coordinated with other relevant union initiatives . 10 . all actions and interoperability solutions funded under the isa2 programme shall , where appropriate , re - use available interoperability solutions .


### in the implementation of the isa2 programme , due consideration shall be given to the european interoperability strategy , the european interoperability framework and their future updates . ### eligibility criteria : in order to ensure interoperability between national and union information systems , interoperability solutions shall be specified with reference to existing and new european standards or publicly available or open specifications for information exchange and service integration . in order to avoid duplication and to speed up the establishing of interoperability solutions , results achieved by other relevant union and member state initiatives shall be taken into account where appropriate . duplicating solutions shall not be eligible .


### the evaluations shall examine issues such as the relevance , effectiveness , efficiency , utility , sustainability and coherence of programme actions . the final evaluation shall , in addition , examine the extent to which the programme has achieved its objective . ### the evaluations shall examine issues such as the relevance , added value , effectiveness , efficiency , utility , the satisfaction of citizens and businesses , sustainability and coherence of isa2 programme actions , as well as their coordination with other relevant union initiatives . the final evaluation shall , in addition , examine the extent to which the isa2 programme has achieved its objective .


### 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 .


### the objectives of this decision are to facilitate efficient and effective electronic cross - border or cross - sector interaction between european public administrations and between them and citizens and businesses , to enable the delivery of electronic public services supporting the implementation of union policies and activities . since this cannot be sufficiently achieved by the member states acting alone because the coordination function at the european level would be difficult and costly to set up at the level of the member states by member states themselves and can therefore , by reason of the scale and effects of the proposed action , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in that article l , this decision does not go beyond what is necessary in order to achieve those objectives , ### the objectives of this decision are to facilitate efficient and effective electronic cross - border or cross - sector interaction between european public administrations and between them and citizens and businesses , to enable the delivery of electronic public services supporting the implementation of union policies and activities . these electronic public services require an inclusive approach that will reduce disparities in the use of ict solutions , promote the use of ict to combat exclusion – but also to combat the digital divide created in those areas that have been the most adversely affected by processes relating to the ageing population and depopulation – and contribute to economic growth , in order to generate job opportunities , improve quality of life and encourage social participation and cohesion . since this cannot be sufficiently achieved by the member states acting alone because the coordination function at the european level would be difficult and costly to set up at the level of the member states by member states themselves and can therefore , by reason of the scale and effects of the proposed action , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in that article l , this decision does not go beyond what is necessary in order to achieve those objectives ,


### in order to ensure interoperability between national and union information systems , interoperability solutions shall be specified with reference to existing and new european standards or publicly available or open specifications for information exchange and service integration . ### implementation rules : in the implementation of the isa2 programme , due consideration shall be given to the european interoperability strategy , the european interoperability framework and their future updates . the establishment or improvement of interoperability solutions shall , where appropriate , build on or be accompanied by the sharing of experience and the exchange and promotion of good practices . the sharing of experience and good practices between all stakeholders and relevant public consultations shall be encouraged and facilitated by adequate means , e . g . a virtual repository . the implementation of interoperability solutions under the isa2 programme shall , where appropriate , be guided by the eira . interoperability solutions and their updates shall be included in the eic and made available , where appropriate , for re - use by european public administrations . in duly justified cases , the management interoperability solutions can be shared with non - profit associations or entities , under the commission ' s control . the commission shall monitor annually the implementation and re - use of interoperability solutions across the union , as part of the rolling work programme established pursuant to article 7 . in order to maximise synergies and ensure complementary and combined efforts , actions shall , where appropriate , be coordinated with other relevant union initiatives .


### at union level , interoperability facilitates successful implementation of policies . the following policies in particular rely on interoperability for their effective and efficient implementation : ### at union level , interoperability facilitates successful implementation of policies and offers great potential with a view to avoiding cross - border electronic barriers . the following policies in particular rely on interoperability for their effective and efficient implementation :


### through the isa2 programme , the union shall identify , create and operate interoperability solutions implementing union policies . these solutions shall subsequently be provided for unlimited use to other union institutions and bodies , and to national , regional and local public administrations , thus facilitating cross - border or cross - sector interaction between them . ### through the isa2 programme , the union shall support and promote the identification , creation and operation of interoperability solutions implementing union policies . these solutions shall subsequently be provided for unlimited use to other union institutions and bodies , and to national , regional and local public administrations , thus facilitating cross - border or cross - sector interaction between them .


### be based on utility and driven by identified needs ; ### be selected on the basis of utility and priorities and driven by identified needs ;


### the identification of legislation gaps that hamper interoperability between european public administrations ; ### the identification of legislation gaps , at union and national level , that hamper interoperability between european public administrations ;


### in the implementation of the isa2 programme , due consideration shall be given to the european interoperability strategy , the european interoperability framework and their future updates . ### in the implementation of the isa2 programme , solutions shall contribute to the implementation of , and only be developed if they are fully in line with , the european interoperability strategy , the european interoperability framework , the commission ' s digital single market strategy , and their future updates .


### at political level , the council has repeatedly called for even greater interoperability in europe and for continued efforts to modernise european public administrations . in particular , on 24 and 25 october 2013 , the european council adopted conclusions stressing that the modernisation of public administrations should continue through the swift implementation of services such as e - government , e - health , e - invoicing and e - procurement , which rely on interoperability . ### at political level , the council has repeatedly called for even greater interoperability in europe and for continued efforts to modernise european public administrations . in particular , on 24 and 25 october 2013 , the european council adopted conclusions stressing that the modernisation of public administrations should continue through the swift implementation of services such as e - government , e - health , e - invoicing and e - procurement , which rely on interoperability . the commitment of member states is essential to ensure the rapid deployment of an interoperable e - society in the union and the involvement of public administrations in encouraging the use of online procedures . additionally , in order to establish a more effective , simplified and user - friendly e - administration , a meaningful change in european public administrations , with support and a higher level of commitment from member states , is necessary . efficient online public services are crucial for fostering the trust of businesses and citizens in digital services .


### 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 constitute a priority for selection . member states shall be able , and encouraged , to join a project at any stage .


### interoperability of european public administrations concerns all levels of administration : european , local , regional and national . it is therefore important that solutions take into account their respective needs , as well as those of citizens and enterprises where relevant . ### interoperability of european public administrations concerns all levels of administration : european , local , regional and national . it is therefore important that solutions take into account their respective needs , including those of citizens , enterprises and other stakeholders , and in particular small and medium - sized enterprises , given their valuable contribution to the union economy .


### 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 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 be based on the experience gained from the ida , idabc and isa programmes .


### national administrations can be supported in their endeavours through specific instruments under the european structural and investment funds . close cooperation under the isa2 programme should maximise the benefits expected from such instruments by ensuring that funded projects are aligned with the union - wide interoperability frameworks and specifications such as the eif . ### national administrations can be supported in their endeavours through specific instruments under the european structural and investment funds and encouraged jointly to develop solutions involving two or more states . in this regard , the efforts made by the european grouping of territorial cooperation must merit special attention . close cooperation under the isa2 programme should maximise the benefits expected from such instruments by ensuring that funded projects are aligned with the union - wide interoperability frameworks and specifications such as the eif .


### regulation no 1303 / 2013 includes a thematic objective of ‘ enhancing institutional capacity of public authorities and stakeholders and an efficient public administration’ . in this context , the isa2 programme should tie in with programmes and initiatives contributing to the modernisation of public administrations like e . g . the dae , and related networks like e . g . the european public administration network and seek synergies with them . ### regulation no 1303 / 2013 includes a thematic objective of ‘ enhancing institutional capacity of public authorities and stakeholders and an efficient public administration’ . in this context , the isa2 programme should tie in with programmes and initiatives contributing to the modernisation of public administrations like e . g . the dae , and related networks like e . g . the european public administration network and seek synergies with them and should help to optimise human capital in public administration .


### the rolling work programme shall identify , prioritise , document , select , design , implement and evaluate the actions referred to in article 5 , as well as promote their results . ### the rolling work programme shall identify , prioritise , document , select , design , implement and evaluate the actions referred to in article 5 , in accordance with the criteria set out in article 7 , as well as promoting their results and making them known to the european parliament through its appropriate committee .


### the establishment or improvement of interoperability solutions shall , where appropriate , build on or be accompanied by the sharing of experience and the exchange and promotion of good practices . the sharing of experience and good practices between all stakeholders and relevant public consultations shall be encouraged . ### should it prove necessary to supplement the eligibility , selection and implementation rules laid down in this article , the commission shall be empowered to adopt delegated acts in accordance with article 10a modifying , clarifying or adding new ones .


### a single sector interoperability perspective is associated with the risk that the adoption of different or incompatible solutions at national or sectoral levels will throw up new e - barriers that impede the proper functioning of the internal market and the associated freedoms of movement , and undermine the openness and competitiveness of markets and the delivery of services of general interest to citizens and enterprises . in order to mitigate this risk , member states and the union should step up joint efforts to avoid market fragmentation and ensure cross - border or cross - sector interoperability in the implementation of legislation , while reducing administrative burdens and costs , and promote commonly agreed ict solutions , while ensuring appropriate governance . ### a single sector interoperability perspective is associated with the risk that the adoption of different or incompatible solutions at national or sectoral levels will throw up new e - barriers that impede the proper functioning of the internal market and the associated freedoms of movement , and undermine the openness and competitiveness of markets , particularly public procurement markets , and the delivery of services of general interest to citizens and enterprises . however , it is important to recognise that there is a need for a targeted approach to the adoption of solutions regarding interoperability , given the different challenges posed by different policy objectives .


### the performance of the programme shall be assessed against the objective laid out in article 1 and the actions of the rolling work programme . the objective shall be measured in particular through the number of key interoperability enablers and through the number of supporting instruments for public administrations delivered to and used by european public administrations . indicators for measuring the result and impact of the programme shall be defined in the rolling work programme . ### the performance of the isa2 programme shall be assessed against the objective laid out in article 1 and the eligibility and selection criteria set out in article 4 . the achievement of the objective shall be measured in particular in terms of the number of key interoperability enablers and supporting instruments for public administrations delivered to and used by european public administrations .


### in the implementation of the isa2 programme , due consideration shall be given to the european interoperability strategy , the european interoperability framework and their future updates . ### eligibility criteria : in order to ensure interoperability between national and union information systems , interoperability solutions shall be specified with reference to existing and new european standards or publicly available or open specifications for information exchange and service integration . in order to avoid duplication and to speed up the establishing of interoperability solutions , results achieved by other relevant union and member state initiatives shall be taken into account where appropriate . duplicating solutions shall not be eligible .


### member states of group 2 shall allocate at least 45 % of their total erdf resources under priorities other than for technical assistance to po 1 , and at least 30 % to po 2 ; ### member states of group 2 shall allocate at least 40 % of their total erdf resources under priorities other than for technical assistance to po 1 , and at least 25 % to po 2 and 15 % to po 4 ;


### the estimate shall be forwarded by the commission to the european parliament and the council together with the preliminary draft budget of the european union . ### upon reception the estimate shall be forwarded by the commission to the european parliament and the council .


### ' 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 .


### ' importer ' means any natural or legal person declaring minerals or metals within the scope of this regulation for release for free circulation within the meaning of article 79 of council regulation no 2913 / 199213 ; __________________ 13 council regulation no 2913 / 92 of 12 october 1992 establishing the community customs code . ### ' downstream operator ' means any natural or legal person that places any product comprising or containing covered resources for the first time on the internal market for distribution or use in the course of commercial activities ;


### 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 . women and children are disproportionately affected by these conflicts , and are the victims of systematic physical and sexual violence , recognised as an international war crime and used as a weapon of war by armed groups . in these areas , breaking the nexus between conflict and illegal exploitation of natural resources is critical to peace and stability .


### natural mineral resources in conflict - affected or high risk areas &#8722 ; although holding great potential for development &#8211 ; can be a cause of dispute where their revenues are fuelling the outbreak or continuation of violent conflict , undermining 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 .


### 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 . ### on 26 february 2014 , the european parliament passed a resolution on promoting development through responsible business practices which drew attention to the role of extractive industries in developing countries . in that resolution , parliament called on the commission to bring forward binding legislation designed to ensure that purchases of minerals do not fuel conflicts ; )


### ' responsible smelters or refiners ' means smelters or refiners in the supply chain of the responsible importer ; ### ' responsible upstream actor ' refers to any upstream actor that complies with the oecd due diligence guidance and has submitted audited reports in accordance with article 7 or 7 ;


### 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 .


### 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 .