### in order to ensure compliance with union law , member states should notify the draft intergovernmental agreement to the commission before it becomes legally binding for the parties . in a spirit of cooperation , the commission should support the member state in identifying compliance issues of the draft intergovernmental agreement or amendment . the respective member state would then be better prepared to conclude a union law compliant agreement . the commission should have sufficient time for such an assessment in order to provide for as much legal certainty as possible while avoiding undue delays . in order to fully benefit from the commission ' s support member states should refrain from concluding an intergovernmental agreement until the commission has informed the member state of its assessment . the member states should take all necessary steps to find a suitable solution to eliminate the incompatibility identified . ### in order to ensure compliance with union law , member states should notify the draft intergovernmental agreement to the commission before it becomes legally binding for the parties . in a spirit of cooperation , the commission should support the member state , following their request , in identifying compliance issues of the draft intergovernmental agreement or amendment . the respective member state would then be better prepared to conclude a union law compliant agreement . the commission should have sufficient time for such an assessment in order to provide for as much legal certainty as possible while avoiding undue delays . in order to fully benefit from the commission ' s support member states could , on a voluntary basis , refrain from concluding an intergovernmental agreement until the commission has informed the member state of its assessment . the member states should take all necessary steps to find a suitable solution to eliminate the incompatibility identified .


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


### where the commission informs the member state concerned pursuant to paragraph 1 that it has doubts , it shall inform the member state concerned of its opinion on the compatibility with union law , in particular with internal energy market legislation and union competition law , of the draft intergovernmental agreement or amendment concerned within 12 weeks of the date of notification referred to in paragraph 1 . in the absence of an opinion from the commission within that period , the commission shall be deemed not to have raised any objections . ### where the commission informs the member state concerned pursuant to paragraph 1 that it has doubts , it shall inform the member state concerned of its opinion on the compatibility with union law , in particular with internal energy market legislation and union competition law , of the draft intergovernmental agreement or amendment concerned within four weeks of the date of notification referred to in paragraph 1 . in the absence of an opinion from the commission within that period , the commission shall be deemed not to have raised any objections .


### particular emphasis should be placed on explaining in a coherent , appropriate and timely manner not only risk assessment findings themselves but also how these are utilized to help inform risk management decisions along with other legitimate factors , where relevant . ### particular emphasis should be placed on explaining in accurate , clear and timely manner not only risk assessment findings themselves but also how these are utilized to help inform risk management decisions along with other legitimate factors , where relevant .


### the general plan should identify the key factors to be taken into account when risk communications’ activities are considered , such as the different levels of risk , the nature of the risk and its potential public health impact , who and what are directly or indirectly affected by the risk , the levels of risk exposure , the ability to control risk and other factors that influence risk perception including the level of urgency as well as the applicable legislative framework and relevant market context . the general plan should also identify the tools and channels to be used and should establish appropriate mechanisms to ensure coherent risk communication . ### the general plan should identify the key factors to be taken into account when risk communications’ activities are considered , such as the different levels of hazard and risk , the nature of the hazard and its potential public health and environmental impacts , what groups of the population can directly or indirectly be affected by the risk , the levels of risk exposure , the ability to control exposure and risk and other factors that influence risk understanding including the level of urgency as well as the applicable legislative framework . the general plan should also identify the tools and channels to be used and should establish appropriate mechanisms to ensure accurate risk communication .


### experience shows that the role of the management board of the authority is focussed on administrative and financial aspects and does not impact on the independence of the scientific work performed by the authority . it is thus appropriate to include representatives of all member states in the management board of the authority , while providing that those representatives should have experience in particular on risk assessment . ### experience shows that the level of independence of the management board of the authority from industry applicants is key to ensure public confidence in the work conducted by the agency . it is thus appropriate to exclude representatives of member states in the management board of the authority who cannot demonstrate the absence of conflict of interest with the applicants .


### the management board should be selected in such a way as to secure the highest standards of competence and a broad range of relevant experience available amongst the representatives of the member states , the european parliament and the commission . ### the management board should be selected in such a way as to secure the highest standards of competence and commitment to health and environment protection and a broad range of relevant experience available amongst the representatives of the member states , the european parliament and the commission .


### 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 vested private 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 safeguard efsa’s accountability , and in particular the independence of its expertise , has a role in excluding scientific experts who oppose the publication of their name or who have conflicts of interest , from risk assessment . adequate budgetary measures should be put in place to ensure that scientific experts have the means to act independently .


### 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 never be used to cover the costs of studies that will in the end help the private entities 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 - and cover all the costs relating to - relevant studies , including tests , to demonstrate the safety and the efficacy of a subject matter where relevant .


### provisions exist on the content of applications for authorisations . it is essential that the application for authorisation submitted to the authority for its risk assessment meets the applicable specifications to ensure the best quality scientific assessment by the authority . applicants and in particular small - and medium - sized enterprises do not always have a clear understanding of these specifications . it should be thus appropriate that the authority provides advice to a potential applicant , upon request , on the applicable rules and the required content of an application for authorisation , before an application is formally submitted , while not entering into the design of the studies to be submitted that remain the applicant’s responsibility . to ensure the transparency of this process , the advice of the authority should be made public . ### provisions exist on the content of applications for authorisations . it is essential that the application for authorisation submitted to the authority for its risk assessment meets the applicable specifications to ensure the best quality scientific assessment by the authority . applicants and in particular small - and medium - sized enterprises do not always have a clear understanding of these specifications . it should be thus appropriate that the authority provides clear guidelines on its website on the applicable rules and the required content of an application for authorisation .


### the authority should have knowledge of the subject matter of all studies performed by an applicant with a view to a future application for an authorisation under union food law . to this end , it is necessary and appropriate that business operators commissioning the studies and laboratories carrying them out notify those studies to the authority when commissioned . information about the notified studies should be made public only once a corresponding application for authorisation has been made public in accordance with the applicable rules on transparency . ### the authority should have knowledge of the subject matter of all studies performed by an applicant with a view to a future application for an authorisation under union food law . to this end , it is necessary and appropriate that business operators commissioning the studies and laboratories carrying them out notify those studies to the authority when commissioned . information about the notified studies should be made public only once a corresponding application for authorisation or renewal has been made public in accordance with the applicable rules on transparency .


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


### studies , including tests , submitted by business operators in support of applications for authorisations under union sectoral food law usually comply with internationally recognised principles , which provide a uniform basis for their quality in particular in terms of reproducibility of results . however , issues of compliance with the applicable standards may arise in some cases and this is why national systems are in place to verify such compliance . it is appropriate to provide an additional level of guarantees to reassure the general public on the quality of studies and to lay down an enhanced auditing system whereby member state controls on the implementation of those principles by the laboratories carrying out such studies and tests would be verified by the commission . ### studies , including tests , submitted by business operators in support of applications for authorisations under union sectoral food law usually refer to internationally recognised principles , which provide a uniform basis for their quality in particular in terms of reproducibility of results . however , non - compliance with the applicable standards may arise and this is why national systems are in place to verify such compliance . in order to ensure the quality of studies it is appropriate to enhance the auditing system whereby member states control and ensure the implementation of those principles by the laboratories carrying out such studies and tests and whereby member states’ controls would be verified by the commission .


### the european citizens’ initiative “ban glyphosate and protect people and the environment from toxic pesticides” further confirmed concerns regarding transparency with respect to studies commissioned by the industry and submitted in authorisation application23 . __________________ 23 communication from the commission on the eci “ban glyphosate and protect people and the environment from toxic pesticides” , c 8414 final . ### as a party to the aarhus convention , the eu has recognized that , in the field of the environment , improved access to information and public participation in decision - making enhance the quality and the implementation of decisions , contribute to public awareness of environmental issues , give the public the opportunity to express its concerns and enable public authorities to take due account of such concerns . the european citizens’ initiative “ban glyphosate and protect people and the environment from toxic pesticides” further confirmed concerns regarding transparency with respect to studies commissioned by the industry and submitted in authorisation application23 . __________________ 23 communication from the commission on the eci “ban glyphosate and protect people and the environment from toxic pesticides” , c 8414 final .


### it is therefore necessary to strengthen the transparency of the risk assessment process in a proactive manner . public access to all scientific data and information supporting requests for authorisations under union food law as well as other requests for scientific output should be ensured , as early as possible in the risk assessment process . however , this process should be without prejudice to existing intellectual property rights or to any provisions of union food law protecting the investment made by innovators in gathering the information and data supporting relevant applications for authorisations . ### to further the accountability and to regain public support for decisions of the authority , it is therefore necessary to strengthen the transparency and clarity of the risk assessment process in a proactive manner . in order to ensure public scrutiny , public access to all scientific data and information supporting requests for authorisations under union food law as well as other requests for scientific output should be ensured , as early as possible in the risk assessment process .


### 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 . ### the present regulation is intended to give the fullest possible effect to the right of public access to documents of the authority and must be read in conjunction with regulation no 1049 / 2001 and 1367 / 2006 .


### accordingly and with respect to the procedures governing requests for authorisation procedures provided in union food law , experience gained so far has shown that certain information items are generally considered sensitive and should remain confidential across the different sectoral authorisation procedures . it is appropriate to lay down in regulation no 178 / 2002 a horizontal list of information items whose disclosure may be considered to significantly harm the commercial interests concerned and should not therefore be disclosed to the public , . only in very limited and exceptional circumstances relating to foreseeable health effects and urgent needs to protect human health , animal health or the environment , such information should be disclosed . ### any information relating to impacts on health or the environment must therefore always be made public . it is appropriate to lay down in regulation no 178 / 2002 a horizontal exhaustive list of information items which could be kept confidential on the ground that they would significantly undermine the protection of commercial interest . however , this information can only be kept secret if the company opposing its dissemination proves , with verifiable justifications , that the dissemination would significantly undermine its commercial interests . the exceptions to the principle of transparency must be interpreted strictly . in any event , even in a case the disclosure of the information is considered to undermine the commercial interests of an economic operator , if there is an overriding public interest in the disclosure , the information cannot be kept secret . it is appropriate to lay down in regulation no178 / 2002 a horizontal non - exhaustive list of information items which can never be kept secret , an overriding public interest in their disclosure being deemed .


### it is also necessary to set out specific requirements with respect to the protection of personal data for the purposes of the transparency of the risk assessment process taking into account regulation no 45 / 2001 of the european parliament and of the council24 and regulation 2016 / 679 of the european parliament and of the council25 . accordingly , no personal data should be made publicly available under this regulation , unless it is necessary and proportionate for the purposes of ensuring the transparency , independence and the reliability of the risk assessment process , while preventing conflicts of interests . __________________ 24 regulation no 45 / 2001 of the european parliament and of the council of 18 december 2000 on the protection of individuals with regard to the processing of personal data by the community institutions and bodies and on the free movement of such data . 25 regulation 2016 / 679 of the european parliament and of the council of 27 april 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data , and repealing directive 95 / 46 / ec . ### it is also necessary to refer to the protection of personal data for the purposes of the transparency of the risk assessment process to regulation no 45 / 2001 of the european parliament and of the council24 and regulation 2016 / 679 of the european parliament and of the council25 . accordingly , no personal data should be made publicly available under this regulation , unless it is necessary and proportionate for the purposes of ensuring the transparency , independence and the reliability of the risk assessment process , while preventing conflicts of interests . this regulation considers necessary and proportionate for the purpose of ensuring the transparency , independence and reliability of the risk assessment process , in particular to avoid conflicts of interest , to publish the names of any individual designated by the authority to contribute to the authority’s decision making process , including in the context of the adoption of guidance documents . __________________ 24 regulation no 45 / 2001 of the european parliament and of the council of 18 december 2000 on the protection of individuals with regard to the processing of personal data by the community institutions and bodies and on the free movement of such data . 25 regulation 2016 / 679 of the european parliament and of the council of 27 april 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data , and repealing directive 95 / 46 / ec .


### 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 safeguard the independence of the risk assessment and risk management stages at union and national levels as well as the accuracy 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 .


### 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 ;


### provide a sound basis for understanding risk management decisions ; ### provide a scientific basis for risk management decisions ;


### foster public understanding of the risk analysis process so as to enhance confidence in its outcome ; ### foster public understanding of the risk analysis process so as to enhance accountability in its outcome ;


### confidentiality ### limitations to transparency


### where an applicant submits a request for confidentiality , it shall provide a non - confidential version and a confidential version of the information submitted in accordance with standard data formats , where they exist , pursuant to article 39f . the non - confidential version shall be without the information the applicant deems confidential in accordance with paragraphs 2 and 3 of article 39 . the confidential version shall contain all information submitted , including information the applicant deems confidential . information requested to be treated as confidential in the confidential version shall be clearly marked . the applicant shall clearly indicate the grounds on the basis of which confidentiality is requested for the different pieces of information . ### where an applicant submits a request for confidentiality , it shall provide a non - confidential version and a confidential version of the information submitted in accordance with standard data formats , where they exist , pursuant to article 39f . the non - confidential version shall redact with black bars the information the applicant requests the confidential treatment of in accordance with paragraphs 2 and 3 of article39 . the confidential version shall contain all information submitted , including in formation the applicant considers confidential . information requested to be treated as confidential in the confidential version shall be clearly marked . the applicant shall clearly indicate the verifiable justifications on the basis of which confidentiality is requested for each of the different pieces of information .


### inform the applicant in writing of its intention to disclose information and the reasons for it , before the authority formally takes a decision on the confidentiality request . if the applicant disagrees with the assessment of the authority it may state its views or withdraw its application within two weeks from the date on which it was notified of the authority’s position . ### inform the applicant in writing of its intention to disclose information and the reasons for it , before the authority formally takes a decision on the confidentiality request . if the applicant objects to the assessment of the authority it may state its views or withdraw its application within two weeks from the date on which it was notified of the authority’s position .


### the general plan for risk communication shall promote an integrated risk communication framework to be followed both by the risk assessors and the risk managers in a coherent and systematic manner both at union and national level . it shall : ### the general plan for risk communication shall promote an integrated risk communication framework to be followed both by the risk assessors and the risk managers in a accurate and systematic manner both at union and national level , while acknowledging scientific divergent opinions where they exist . it shall :


### identify the key factors that need to be taken into account when considering the type and level of risk communications ' activities needed ; ### identify the factors that need to be taken into account when considering the type and level of risk communications ' activities needed ;


### 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 amongst all interested parties , while acknowledging scientific divergent opinions where they exist .


### 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 health organisations , 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 .


### 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 . ### 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 her / 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 authority shall consult stakeholders and the public regarding the studies supporting applications for authorisation once they are made public by the authority in accordance with article 38 and articles 39 to 39f in order to identify whether other relevant scientific data or studies are available on the subject matter concerned by the application for authorisation . this provision does not apply to the submission of any supplementary information by the applicants during the risk assessment process . ### the authority shall consult stakeholders and the public regarding the studies supporting applications for authorisation once they are made public by the authority in accordance with article 38 and articles 39 to 39f in order to identify whether other relevant scientific data or studies are available on the subject matter concerned by the application for authorisation .


### agendas and minutes of the scientific committee and the scientific panels and their working groups ; ### agendas , participants lists , and minutes of the scientific committee and the scientific panels and their working groups ;


### the disclosure to the public of the information mentioned in paragraph shall not be considered as an explicit or implicit permission or license for the relevant data and information and their content to be used , reproduced , or otherwise exploited and its use by third parties shall not engage the responsibility of the european union . ### the disclosure to the public of the information mentioned in paragraph shall not be considered as an explicit or implicit permission or license for the relevant data and information and their content to be commercially used , reproduced , or otherwise exploited for commercial purposes . for the avoidance of doubt , the information published can be used for the purpose of public scrutiny of the results , including abetter understanding of the potential adverse effects on health and the environment and its use by third parties for that purpose shall not engage the responsibility of the european union . ”


### by way of derogation from article 38 , the authority shall not make public information for which confidential treatment has been requested under the conditions laid down in this article . ### by way of derogation from article 38 and without prejudice to regulation 1049 / 2001 and directive 2003 / 4 , the authority shall not make public information for which confidential treatment has been requested and granted in application of the conditions laid down in this article .


### before deciding to apply a ground for non - recognition and non - execution , the executing authority should consult the issuing authority , in order to obtain any necessary additional information . ### before deciding to apply a ground for non - recognition and non - execution , the executing authority should consult the issuing authority without any undue delay , in order to obtain necessary additional information .


### the proper practical operation of this regulation presupposes close communication between the competent national authorities involved , in particular in cases of simultaneous execution of a confiscation order in more than one member state . the competent national authorities should therefore consult each other whenever necessary . ### the proper practical operation of this regulation presupposes close communication and optimal cooperation between the competent national authorities involved , in particular in cases of simultaneous execution of a freezing or confiscation order in more than one member state . the competent national authorities should therefore consult each other and should use modern communication technologies accepted under the procedural rules of the member states concerned .


### the victims ' rights to compensation and restitution should not be prejudiced in cross - border cases . rules for disposal of the confiscated property should give priority to the compensation and restitution of property to the victims . member states should also take into account their obligations to assist in the recovery of tax claims from other member states in accordance with directive 2010 / 24 / eu36 . _________________ 36 council directive 2010 / 24 / eu of 16 march 2010 concerning mutual assistance for the recovery of claims relating to taxes , duties and other measures . ### the victims ' rights to compensation and restitution shall not be prejudiced in cross - border cases . rules for disposal of the confiscated property shall give priority to the compensation and restitution of property to the victims . member states should also take into account their obligations to assist in the recovery of tax claims from other member states in accordance with directive 2010 / 24 / eu36 . _________________ 36 council directive 2010 / 24 / eu of 16 march 2010 concerning mutual assistance for the recovery of claims relating to taxes , duties and other measures .


### the executing authority may decide not to recognise and not to execute confiscation orders only if : ### the executing authority must decide not to recognise and not to execute confiscation orders if :


### the issuing authority shall complete the certificate set out in annex i , sign it and certify its content as being accurate and correct . ### the issuing authority shall complete without undue delay the certificate set out in annex i , sign it and certify its content as being accurate and correct .


### the executing authority shall , in accordance with its national law , guarantee the confidentiality of the facts and the substance of the freezing order , except to the extent necessary to execute it . if the executing authority cannot comply with the requirement of confidentiality , it shall notify the issuing authority immediately . ### the executing authority shall , in accordance with its national and eu law , guarantee the confidentiality of the facts and the substance of the freezing order , except to the extent necessary to execute it . if the executing authority cannot comply with the requirement of confidentiality , it shall notify the issuing authority immediately .


### the property may be used for public interest or social purposes in the executing state in accordance with its laws , subject to the agreement of the issuing state . ### the property may be used for public interest or social purposes in the executing state in accordance with its laws .


### as a type of feed , medicated feed falls within the scope of regulation no 183 / 2005 of the european parliament and of the council6 , of regulation no 767 / 2009 of the european parliament and of the council7 , of regulation no 1831 / 2003 of the european parliament and of the council8 and of directive 2002 / 32 / ec of the european parliament and of the council9 . specific provisions for medicated feed and intermediate products should be established concerning facilities and equipment , personnel , manufacture quality control , storage and transport , record - keeping , complaints and product recalls , the application of procedures based on the hazard analysis and critical control points principles and labelling . __________________ 6 regulation no 183 / 2005 of the european parliament and of the council of 12 january 2005 laying down requirements for feed hygiene . 7 regulation no 767 / 2009 of the european parliament and of the council of 13 july 2009 on the placing on the market and use of feed . 8 regulation no 1831 / 2003 of the european parliament and of the council of 22 september 2003 on additives for use in animal nutrition . 9 directive 2002 / 32 / ec of the european parliament and of the council of 7 may 2002 on undesirable substances in animal feed . ### as a type of feed , medicated feed falls within the scope of regulation no 183 / 2005 of the european parliament and of the council6 , of regulation no 767 / 2009 of the european parliament and of the council7 , of regulation no 1831 / 2003 of the european parliament and of the council8 and of directive 2002 / 32 / ec of the european parliament and of the council9 . specific provisions for medicated feed and intermediate products should be established concerning facilities and equipment , personnel , animal welfare , manufacture quality control , storage and transport , record - keeping , complaints and product recalls , the application of procedures based on the hazard analysis and critical control points principles and labelling . __________________ 6 regulation no 183 / 2005 of the european parliament and of the council of 12 january 2005 laying down requirements for feed hygiene . 7 regulation no 767 / 2009 of the european parliament and of the council of 13 july 2009 on the placing on the market and use of feed . 8 regulation no 1831 / 2003 of the european parliament and of the council of 22 september 2003 on additives for use in animal nutrition . 9 directive 2002 / 32 / ec of the european parliament and of the council of 7 may 2002 on undesirable substances in animal feed .


### as a type of feed , medicated feed falls within the scope of regulation no 183 / 2005 of the european parliament and of the council6 , of regulation no 767 / 2009 of the european parliament and of the council7 , of regulation no 1831 / 2003 of the european parliament and of the council8 and of directive 2002 / 32 / ec of the european parliament and of the council9 . specific provisions for medicated feed and intermediate products should be established concerning facilities and equipment , personnel , manufacture quality control , storage and transport , record - keeping , complaints and product recalls , the application of procedures based on the hazard analysis and critical control points principles and labelling . __________________ 6 regulation no 183 / 2005 of the european parliament and of the council of 12 january 2005 laying down requirements for feed hygiene . 7 regulation no 767 / 2009 of the european parliament and of the council of 13 july 2009 on the placing on the market and use of feed . 8 regulation no 1831 / 2003 of the european parliament and of the council of 22 september 2003 on additives for use in animal nutrition . 9 directive 2002 / 32 / ec of the european parliament and of the council of 7 may 2002 on undesirable substances in animal feed . ### as a type of feed , medicated feed falls within the scope of regulation no 183 / 2005 of the european parliament and of the council6 , of regulation no 767 / 2009 of the european parliament and of the council7 , of regulation no 1831 / 2003 of the european parliament and of the council8 and of directive 2002 / 32 / ec of the european parliament and of the council9 . specific provisions for medicated feed and intermediate products should be established concerning facilities and equipment , personnel , manufacture quality control , animal welfare , storage and transport , record - keeping , complaints and product recalls , the application of procedures based on the hazard analysis and critical control points principles and labelling . __________________ 6 regulation no 183 / 2005 of the european parliament and of the council of 12 january 2005 laying down requirements for feed hygiene . 7 regulation no 767 / 2009 of the european parliament and of the council of 13 july 2009 on the placing on the market and use of feed . 8 regulation no 1831 / 2003 of the european parliament and of the council of 22 september 2003 on additives for use in animal nutrition . 9 directive 2002 / 32 / ec of the european parliament and of the council of 7 may 2002 on undesirable substances in animal feed .


### in order to ensure a particularly prudent use of medicated feed for food - producing animals and therefore provide the basis for the assurance of a high level of protection of public health , specific conditions concerning the use and the validity of the prescription , compliance with the withdrawal period and record - keeping by the animal holder should be provided for . ### in order to ensure a particularly prudent use of medicated feed for food - producing animals and therefore provide the basis for the assurance of a high level of protection of animal health and public health , specific conditions concerning the use and the validity of the prescription , compliance with the withdrawal period and record - keeping by the animal holder should be provided for .


### feed business operators manufacturing , storing , transporting and placing on the market medicated feed and intermediate products shall apply measures in accordance with article 3 and 4 to avoid carry - over . ### feed business operators manufacturing , storing , transporting and placing on the market medicated feed and intermediate products shall apply measures in accordance with article 3 and 4 to avoid carry - over or restrict the levels determined by the european food safety authority .


### permitted tolerances for discrepancies between the labelled compositional values of a medicated feed or an intermediate product and the values analysed in official controls performed in accordance with regulation no 882 / 2004 are as set out in annex iv . ### discrepancies between the labelled compositional values of a medicated feed or an intermediate product and the values analysed in official controls shall not be permitted .


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


### medicated feed containing antimicrobial veterinary medicinal products shall not be used to prevent diseases in food - producing animals or to enhance their performance . ### since there is a direct link between good animal husbandry and a responsible use of veterinary medicines , medicated feed containing antimicrobial veterinary medicinal products shall not be used to prevent diseases in food - producing animals or to enhance their performance .


### member states shall ensure that appropriate collection systems are in place for medicated feed and intermediate products that are expired or in case the animal holder has received a bigger quantity of medicated feed than he actually uses for the treatment referred to in the veterinary prescription . ### member states shall develop appropriate collection systems , in cooperation with the operators of the sector for medicated feed and intermediate products that are expired or in case the animal holder has received a bigger quantity of medicated feed than he actually uses for the treatment referred to in the veterinary prescription .


### the presence of undesirable substances within the meaning of directive 2002 / 32 / ec and of other contaminants in relation to human and animal health shall be monitored , and appropriate measures to minimise this presence shall be taken . ### the presence of undesirable substances within the meaning of directive 2002 / 32 / ec and of other contaminants in relation to human and animal health shall not be permitted , and appropriate measures to avoid this presence shall be taken .


### to this effect , it is necessary to establish general objectives and principles of risk communication , taking into account the respective roles of risk assessors and managers . ### to this effect , it is necessary to establish general objectives and principles of risk communication , taking into account the expressed expectations of the citizens and the respective roles of risk assessors and managers .


### the general plan should identify the key factors to be taken into account when risk communications’ activities are considered , such as the different levels of risk , the nature of the risk and its potential public health impact , who and what are directly or indirectly affected by the risk , the levels of risk exposure , the ability to control risk and other factors that influence risk perception including the level of urgency as well as the applicable legislative framework and relevant market context . the general plan should also identify the tools and channels to be used and should establish appropriate mechanisms to ensure coherent risk communication . ### the general plan should identify the key factors to be taken into account when risk communications’ activities are considered , such as the different levels of hazard and risk , the nature of the hazard and its potential environmental and public health and environmental impacts , what groups of the population can directly or indirectly be affected by the risk , the levels of risk exposure , the ability to control exposure and risk , the ways of managing it and other factors that influence risk understanding including the level of urgency as well as the applicable legislative framework . the general plan should also identify the tools and channels to be used and should establish appropriate , exhaustive and expeditious mechanisms to ensure accurate risk communication .


### the general plan should identify the key factors to be taken into account when risk communications’ activities are considered , such as the different levels of risk , the nature of the risk and its potential public health impact , who and what are directly or indirectly affected by the risk , the levels of risk exposure , the ability to control risk and other factors that influence risk perception including the level of urgency as well as the applicable legislative framework and relevant market context . the general plan should also identify the tools and channels to be used and should establish appropriate mechanisms to ensure coherent risk communication . ### the general plan should identify the key factors to be taken into account when risk communications’ activities are considered , such as the hazard , the different levels of risk , the nature of the risk and its potential public health , animal health and environmental impact , who and what are directly or indirectly affected by the risk , the levels of risk exposure , the ability to minimise or control risk and other factors that influence risk perception including the level of urgency as well as the existing or not legislative framework . the general plan should also identify the tools and channels to be used and should establish appropriate mechanisms to ensure coherent risk communication .


### experience shows that the role of the management board of the authority is focussed on administrative and financial aspects and does not impact on the independence of the scientific work performed by the authority . it is thus appropriate to include representatives of all member states in the management board of the authority , while providing that those representatives should have experience in particular on risk assessment . ### experience shows that the role of the management board of the authority apart from risk assessment is also focussed on administrative and financial aspects and does not impact on the independence of the scientific work performed by the authority . it is thus appropriate to include representatives of all member states , as well from the commission , the parliament in the management board of the authority , while providing that those representatives should have experience in particular on risk assessment and that the absence of any conflict of interest is avoided .


### the management board should be selected in such a way as to secure the highest standards of competence and a broad range of relevant experience available amongst the representatives of the member states , the european parliament and the commission . ### the management board should be selected in such a way as to secure the highest standards of competence , impartiality , independence , lack of conflict of interest and a broad range of relevant experience available amongst the representatives of the member states , the european parliament , the commission and the civil society .


### 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 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 independent 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 . ### preserve the independence of the risk assessment from risk management and from vested private 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 , transparent 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 safeguard efsa’s accountability , and in particular the independence of its expertise , has a role in excluding scientific experts who oppose the publication of their name or who have conflicts of interest , from risk assessment . adequate budgetary measures should be put in place to ensure that scientific experts have the means to act independently . to this effect , it is necessary to implement new and adequate budgetary measures .


### 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 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 , integrity 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 , who is the legal representative of efsa and whose function is to be responsible for the performance of the works of the authority 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 .


### 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 .


### 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 , animal health and the environment 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 and create relative advantage of those over its competitors . according to this principle and in accordance with applicable regulatory requirements , in support of applications for an authorisation under union sectorial food law applicants are required to submit relevant , verifiable and reliable studies , including tests , to demonstrate the safety and in some cases the efficacy of a subject matter .


### provisions exist on the content of applications for authorisations . it is essential that the application for authorisation submitted to the authority for its risk assessment meets the applicable specifications to ensure the best quality scientific assessment by the authority . applicants and in particular small - and medium - sized enterprises do not always have a clear understanding of these specifications . it should be thus appropriate that the authority provides advice to a potential applicant , upon request , on the applicable rules and the required content of an application for authorisation , before an application is formally submitted , while not entering into the design of the studies to be submitted that remain the applicant’s responsibility . to ensure the transparency of this process , the advice of the authority should be made public . ### provisions on the content of applications for authorisations should be scrutinised and formulated in such a way that the application for authorisation meets the highest standards regarding transparency and reliability . it is essential that the application for authorisation submitted to the authority for its risk assessment meets the applicable specifications to ensure the best quality scientific assessment by the authority . applicants and in particular small - and medium - sized enterprises do not always have a clear understanding of these specifications . it should be thus appropriate that the authority provides advice to a potential applicant , upon request , on the applicable rules and the required content of an application for authorisation , before an application is formally submitted , while not entering into the design of the studies to be submitted that remain the applicant’s responsibility . to ensure the transparency of this process , access to practical info on the application compilation that would benefit all , , the advice of the authority will be made public .


### the authority should have knowledge of the subject matter of all studies performed by an applicant with a view to a future application for an authorisation under union food law . to this end , it is necessary and appropriate that business operators commissioning the studies and laboratories carrying them out notify those studies to the authority when commissioned . information about the notified studies should be made public only once a corresponding application for authorisation has been made public in accordance with the applicable rules on transparency . ### the authority should have knowledge of the subject matter of all studies performed by an applicant with a view to a future application for an authorisation under union food law . to this end , it is necessary and appropriate that business operators commissioning the studies and laboratories carrying them out notify those studies to the authority when commissioned . information about the notified studies should be made public as soon as the corresponding application for authorisation or renewal has been made public in accordance with the applicable rules on transparency .


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


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


### studies , including tests , submitted by business operators in support of applications for authorisations under union sectoral food law usually comply with internationally recognised principles , which provide a uniform basis for their quality in particular in terms of reproducibility of results . however , issues of compliance with the applicable standards may arise in some cases and this is why national systems are in place to verify such compliance . it is appropriate to provide an additional level of guarantees to reassure the general public on the quality of studies and to lay down an enhanced auditing system whereby member state controls on the implementation of those principles by the laboratories carrying out such studies and tests would be verified by the commission . ### studies , including tests , submitted by business operators in support of applications for authorisations under union sectoral food law usually refer to internationally recognised principles , which provide a uniform basis for their quality in particular in terms of reproducibility of results . however , non - compliance with the applicable standards may arise and this is why national systems are in place to verify such compliance . in order to ensure the quality of studies it is appropriate to enhance the auditing system whereby member states control and ensure the implementation of those principles by the laboratories carrying out such studies and tests and whereby member states’ controls are to be verified by the commission .


### studies , including tests , submitted by business operators in support of applications for authorisations under union sectoral food law usually comply with internationally recognised principles , which provide a uniform basis for their quality in particular in terms of reproducibility of results . however , issues of compliance with the applicable standards may arise in some cases and this is why national systems are in place to verify such compliance . it is appropriate to provide an additional level of guarantees to reassure the general public on the quality of studies and to lay down an enhanced auditing system whereby member state controls on the implementation of those principles by the laboratories carrying out such studies and tests would be verified by the commission . ### studies , including tests , submitted by business operators in support of applications for authorisations under union sectorial food law shall comply with internationally recognised principles , which provide a uniform basis for their quality in particular in terms of reproducibility of results . however , issues of compliance with the applicable standards may arise in some cases and this is why national systems are in place to verify such compliance . it is appropriate to provide an additional level of guarantees to reassure the general public on the quality of studies and to lay down an enhanced control and auditing system whereby member state and third countries controls on the implementation of those principles by the laboratories carrying out such studies and tests would be verified by the commission .


### it is also necessary to set out specific requirements with respect to the protection of personal data for the purposes of the transparency of the risk assessment process taking into account regulation no 45 / 2001 of the european parliament and of the council24 and regulation 2016 / 679 of the european parliament and of the council25 . accordingly , no personal data should be made publicly available under this regulation , unless it is necessary and proportionate for the purposes of ensuring the transparency , independence and the reliability of the risk assessment process , while preventing conflicts of interests . __________________ 24 regulation no 45 / 2001 of the european parliament and of the council of 18 december 2000 on the protection of individuals with regard to the processing of personal data by the community institutions and bodies and on the free movement of such data . 25 regulation 2016 / 679 of the european parliament and of the council of 27 april 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data , and repealing directive 95 / 46 / ec . ### it is also necessary to set out specific requirements with respect to the protection of personal data for the purposes of the transparency of the risk assessment process taking into account regulation no 45 / 2001 of the european parliament and of the council and regulation 2016 / 679 of the european parliament and of the council . accordingly , personal data should be made publicly available under this regulation whenever , it is necessary for the purposes of ensuring the transparency , independence and the reliability of the risk assessment process , and the common interest being the highest level of protection of human health , animal health and the environment . __________________ 24 regulation no 45 / 2001 of the european parliament and of the council of 18 december 2000 on the protection of individuals with regard to the processing of personal data by the community institutions and bodies and on the free movement of such data . 25 regulation 2016 / 679 of the european parliament and of the council of 27 april 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data , and repealing directive 95 / 46 / ec .


### 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 safeguard the independence of the risk assessment and risk management stages at union and national levels as well as the accuracy 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 enable the authority and the business operators to adapt to the new requirements while ensuring that the authority continues its smooth operation , it is necessary to provide for transitional measures for the application of this regulation . ### in order to enable the authority , member states , the commission and the business operators to adapt to the new requirements while ensuring that the authority continues its smooth operation , it is necessary to provide for transitional measures for the application of this regulation .


### risk communication shall pursue the following objectives , while taking into account the respective roles of risk assessors and risk managers : ### risk communication shall contribute to the achievement of the general objective of the regulation pursuing the following risk communication objectives , while taking into account the respective roles of risk assessors and risk managers :


### identify the key factors that need to be taken into account when considering the type and level of risk communications ' activities needed ; ### identify the factors that need to be taken into account when considering the type and level of risk communications ' activities needed ;


### the authority shall consult stakeholders and the public regarding the studies supporting applications for authorisation once they are made public by the authority in accordance with article 38 and articles 39 to 39f in order to identify whether other relevant scientific data or studies are available on the subject matter concerned by the application for authorisation . this provision does not apply to the submission of any supplementary information by the applicants during the risk assessment process . ### the authority shall consult stakeholders and the public regarding the studies supporting applications for authorisation once they are made public by the authority in accordance with article 38 and articles 39 to 39f in order to identify whether other relevant scientific data or studies are available on the subject matter concerned by the application for authorisation .


### agendas and minutes of the scientific committee and the scientific panels and their working groups ; ### agendas , participants lists , and minutes of the scientific committee and the scientific panels and their working groups ;


### the disclosure to the public of the information mentioned in paragraph shall not be considered as an explicit or implicit permission or license for the relevant data and information and their content to be used , reproduced , or otherwise exploited and its use by third parties shall not engage the responsibility of the european union . ### the disclosure to the public of the information mentioned in paragraph shall not be considered as an explicit or implicit permission or license for the relevant data and information and their content to be commercially used , reproduced , or otherwise exploited for commercial purposes . for the avoidance of doubt , the information published may be used for the purpose of public scrutiny of the results , including a better understanding of the potential adverse effects on health and the environment and its use by third parties for that purpose shall not engage the responsibility of the european union . ”


### by way of derogation from article 38 , the authority shall not make public information for which confidential treatment has been requested under the conditions laid down in this article . ### by way of derogation from article 38 and without prejudice to regulation no 1049 / 2001 and directive 2003 / 4 / ec and the general principle that the interests of public health always prevail over private interests , the authority shall not make public information for which confidential treatment has been requested and granted in application of the conditions laid down in this article .


### where an applicant submits a request for confidentiality , it shall provide a non - confidential version and a confidential version of the information submitted in accordance with standard data formats , where they exist , pursuant to article 39f . the non - confidential version shall be without the information the applicant deems confidential in accordance with paragraphs 2 and 3 of article 39 . the confidential version shall contain all information submitted , including information the applicant deems confidential . information requested to be treated as confidential in the confidential version shall be clearly marked . the applicant shall clearly indicate the grounds on the basis of which confidentiality is requested for the different pieces of information . ### where an applicant submits a request for confidentiality , it shall provide a non - confidential version and a confidential version of the information submitted in accordance with standard data formats , where they exist , pursuant to article 39f . the non - confidential version shall edit , with black bars , the information for which the applicant requests confidential treatment in accordance with paragraphs 2 and 3 of article 39 . the confidential version shall contain all information submitted , including information the applicant considers confidential . information requested to be treated as confidential in the confidential version shall be clearly marked . the applicant shall clearly indicate the verifiable justifications on the basis of which confidentiality is requested for each of the different pieces of information .


### inform the applicant in writing of its intention to disclose information and the reasons for it , before the authority formally takes a decision on the confidentiality request . if the applicant disagrees with the assessment of the authority it may state its views or withdraw its application within two weeks from the date on which it was notified of the authority’s position . ### inform the applicant in writing of its intention to disclose information and the reasons for it , before the authority formally takes a decision on the confidentiality request . if the applicant objects to the assessment of the authority it may state its views or withdraw its application within two weeks from the date on which it was notified of the authority’s position .


### 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 , including information on the number and type of these audits , the recommendations made and the action taken on those recommendations . '


### except for cases provided for in point of paragraph 1 , the contracting authority may decide not to exclude the economic operator concerned where it has taken remedial measures to demonstrate its reliability . ### except for cases provided for in point of paragraph 1 , the contracting authority may decide not to exclude the economic operator concerned where it has taken remedial measures safeguarding its reliability .


### 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 good functioning 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 , the digital divide and ensure cross - border or cross - sector interoperability in the implementation of legislation , while improving efficiency , and promote commonly agreed ict solutions , while ensuring appropriate governance .


### the main infrastructure bottleneck hampering the shift from road freight to other modes of transport is at the transhipment terminal level . the current distribution and coverage of transhipment terminals in the union , at least along the existing ten - t core and comprehensive network , is insufficient yet the capacity of existing transhipment terminals is reaching its limit and will need to develop in order to cope with overall freight traffic growth . investing in transhipment terminal capacity may reduce overall transhipment costs , and hence produce a derived modal shift , as demonstrated in some member states . member states should therefore ensure , in coordination with the neighbouring member states and with the commission , that more combined transport transhipment terminals and transhipment capacity are constructed or made available to transport operators . this would incentivise the use of freight transport alternatives and increase modal shift , thus making combined transport operations more competitive than road transport alone . the increased coverage and capacity of transhipment terminals should , at the very minimum , be established along the existing ten - t core and comprehensive networks . there should be on average at least one suitable transhipment terminal for combined transport located no further than 150 km from any shipment location in the union . ### the main infrastructure bottleneck hampering the shift from road freight to other modes of transport is at the transhipment terminal level . the current distribution and coverage of transhipment terminals in the union , at least along the existing ten - t core and comprehensive network , is in some cases insufficient yet the capacity of existing transhipment terminals is reaching its limit while other terminals are not exploited according to their real capacities that could enable to cope with overall freight traffic growth . investing in transhipment terminal capacity , network optimisation and the development of new transhipment techniques may reduce overall transhipment costs , and hence produce a derived modal shift , as demonstrated in some member states .


### a combined transport operation shall be deemed to take place in the union where the operation or the part thereof taking place in the union fulfils the requirements laid down in paragraphs 2 and 3 . ### operations shall not be regarded as part of a combined transport operation if the road / non - road legs thereof or part of those legs are performed outside the territory of the union .


### the number and geographic coverage of terminals servicing combined transport operations and the yearly number of transhipments on those terminals ; ### the number and geographic location coverage of terminals servicing combined transport operations and the yearly number of transhipments on those terminals related to their respective used capacity ;


### in order to secure user acceptance of future road charging schemes , member states should be allowed to introduce adequate systems for the collection of charges as part of a wider package of mobility services . such systems should ensure a fair distribution of infrastructure costs and reflect the ‘ polluter pays’ principle . any member states introducing such a system should ensure that it complies with the provisions of directive 2004 / 52 / ec of the european parliament and of the council16 . _________________ 16 directive 2004 / 52 / ec of the european parliament and of the council of 29 april 2004 on the interoperability of electronic road toll systems in the community , oj l 166 , 30 . 4 . 2004 , p . 124–143 ### in order to secure user acceptance of future road charging schemes , member states should be allowed to introduce adequate systems for the collection of charges as part of a wider package of mobility services . such systems should ensure a fair distribution of infrastructure costs and reflect the ‘ polluter pays’ principle . such toll systems , however , should also be monitored to ensure they do not cause that which they are designed to reduce - traffic jams and back - up . any member states introducing such a system should ensure that it complies with the provisions of directive 2004 / 52 / ec of the european parliament and of the council16 . _________________ 16 directive 2004 / 52 / ec of the european parliament and of the council of 29 april 2004 on the interoperability of electronic road toll systems in the community , oj l 166 , 30 . 4 . 2004 , p . 124–143


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


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


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


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


### retrospective evaluations shall assess the performance of the programme or activity , including aspects such as effectiveness , efficiency , coherence , relevance and eu added value . they shall be undertaken periodically and in sufficient time for the findings to be taken into account in ex - ante evaluations which support the preparation of related programmes and activities . ### 3 . ongoing and retrospective evaluations shall assess the performance of the programme or activity , including aspects such as effectiveness , efficiency , coherence , relevance and eu added value . they shall be undertaken periodically and in sufficient time for the findings to be taken into account in ex - ante evaluations which support the preparation of related programmes and activities .


### citizens may be consulted on the implementation of the union budget by the commission , member states or any other entity implementing the union budget . ### citizens and civil society organisations shall be consulted on the implementation of the union budget by the commission , member states or any other entity implementing the union budget . effective partnership principles for civil society organisations shall be established , securing the involvement of such organisations in the preparation , planning , monitoring , implementation and evaluation of funding at both national and union level .


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