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


### financial contributions to mutual funds , including the administrative cost of setting up ; ### a list of measures relating to preventing risk and increasing ecological resilience ;


### member states should be allowed to use part of their financial ceiling available for direct payments for coupled income support in order to improve competitiveness , sustainability , and / or quality in certain sectors and productions that are particularly important for social , economic or environmental reasons and undergo certain difficulties . furthermore , member states should also be allowed to use an additional part of their financial ceiling available for direct payments to grant coupled income support specifically for the support of protein crop production in order to reduce the union ' s deficit in this regard . ### member states should be allowed to use part of their financial ceiling available for direct payments for coupled income support in order to improve competitiveness , sustainability , and / or quality in certain sectors and productions that are particularly important for social , economic , environmental or reasons that affect animal welfare and undergo certain difficulties . furthermore , member states should also be allowed to use an additional part of their financial ceiling available for direct payments to grant coupled income support specifically for the support of protein crop production in order to reduce the union ' s deficit in this regard .


### during the negotiations the commission should have the possibility to advice on how to avoid incompatibility with union law . in particular , the commission could develop , together with member states , optional model clauses or guidelines . the commission should have the possibility to draw attention to the union’s energy policy objectives and the principle of solidarity between member states and union policy positions adopted in council or european council conclusions . ### during the negotiations the commission should have the possibility to advise on how to avoid incompatibility with union law . in particular , the commission should develop , together with member states , optional model clauses or guidelines . the commission should have the possibility to draw attention to the union’s energy policy objectives and the principle of solidarity between member states and union policy positions adopted in council or european council conclusions .


### upon adopting a non - binding instrument or an amendment to a non - binding instrument , the member state concerned shall notify the non - binding instrument or the amendment , including any annexes thereto , to the commission . ### before adopting a non - binding instrument or an amendment to a non - binding instrument , the member state concerned shall promptly notify the non - binding instrument or the amendment , including any annexes thereto , to the commission .


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


### this decision should only apply to intergovernmental agreements that have an impact on the internal energy market or the security of energy supply in the union . in case of doubt , member states should consult the commission . in principle , agreements that are no longer in force or are no longer applied do not have an impact on the internal energy market or on the security of energy supply in the union and should therefore not be covered by this decision . ### this decision should only apply to intergovernmental agreements that have an impact on the internal energy market or the security of energy supply in the union and in transiting countries . in case of doubt , member states should consult the commission . in principle , agreements that are no longer in force or are no longer applied do not have an impact on the internal energy market or on the security of energy supply in the union and should therefore not be covered by this decision .


### when signing , ratifying or agreeing to an intergovernmental agreement or amendment , the member state concerned shall take utmost account of the commission ' s opinion referred to in paragraph 2 . ### before signing , ratifying or agreeing to an intergovernmental agreement or amendment , the member state concerned shall fully take account of the commission ' s opinion referred to in paragraph 2 .


### 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 and the objectives of the energy union strategy , 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 which may jeopardise conclusion of the agreement . 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 within the time limits indicated . the member states should take all necessary steps to find a suitable solution to eliminate the incompatibility identified .


### on the basis of best practices and in consultation with member states , developing optional model clauses , which , if applied , would significantly improve compliance of future intergovernmental agreements and non - binding instruments with union law ; ### on the basis of best practices and in consultation with member states , developing optional model clauses and guidelines , which , if applied , would significantly improve compliance of future intergovernmental agreements and non - binding instruments with union law ;


### at the request of the member state concerned , or at the request of the commission and with the written approval of the member state concerned , the commission may participate in the negotiations as an observer . ### the commission may participate in the negotiations as an observer at the request of the member state or on its own initiative .


### where the commission participates in the negotiations as an observer , it may provide the member state concerned with advice on how to avoid the incompatibility of the intergovernmental agreement or amendment under negotiation with union law . ### where the commission participates in the negotiations as an observer , it may provide the member state concerned with advice and guidelines on how to avoid the incompatibility of the intergovernmental agreement or amendment under negotiation with union law and the union ' s energy security objectives .


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


### 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 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 and provide wide and non - discriminatory access to information , the advice of the authority should be made public .


### information which forms part of conclusions of scientific outputs , including scientific opinions , delivered by the authority and which relate to foreseeable health effects . ; ### information which forms part of conclusions of scientific outputs , including scientific opinions , delivered by the authority which indicate risks of possible effects on and threats to public and animal health or the environment . ;


### promote consistency and transparency in formulating risk management recommendations ; ### promote consistency , maximum reliability and transparency in formulating risk management recommendations ;


### 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 .


### 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 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 players in 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 .


### provide a sound basis for understanding risk management decisions ; ### provide a sound basis for identifying the best decisions on risk management ;


### 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 .


### 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 .


### the fitness check of the general food law demonstrated that although the authority has made considerable progress in terms of transparency , the risk assessment process , especially in the context of authorisation procedures covering the agri - food chain , is not always perceived as fully transparent . this is also partly due to the different transparency and confidentiality rules that are laid down not only in regulation no 178 / 2002 but also in other union legislative acts covering the agri - food chain . their interplay can impact on the acceptability of the risk assessment by the general public . ### the fitness check of the general food law demonstrated that although the authority has made considerable progress in terms of transparency , the risk assessment process , especially in the context of authorisation procedures covering the agri - food chain , is not yet fully transparent .


### 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 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 assessing and managing risks and problems .


### adopt a reasoned decision on the confidentiality request taking into account the observations of the applicant within ten weeks from the date of receipt of the confidentiality request with respect to applications for authorisation and without undue delay in the case of supplementary data and information and notify the applicant and inform the commission and the member states , as appropriate , of its decision ; and , ### adopt a reasoned decision on the confidentiality request taking into account the observations of the applicant within ten weeks from the date of receipt of the confidentiality request with respect to applications for authorisation and without undue delay in the case of supplementary data and information and notify the applicant and inform the commission and the member states , in every case , of its decision ; and ,


### without prejudice to the obligation of applicants for authorisations under food law to demonstrate the safety of a subject matter submitted to a system of authorisation , the commission , in exceptional circumstances , may request the authority to commission scientific studies with the objective of verifying evidence used in its risk assessment process . the studies commissioned may have a wider scope than the evidence subject to verification . ; ### without prejudice to the obligation of applicants for authorisations under food law to demonstrate the safety of a subject matter submitted to a system of authorisation , the commission , in exceptional circumstances , may request the authority to commission scientific studies with the objective of verifying evidence used in its risk assessment process , with the aim of obtaining greater assurance about food or feed safety . the studies commissioned may have a wider scope than the evidence subject to verification . ;


### 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 .


### to ensure that sectoral specificities with respect to confidential information are taken into account , it is necessary to weigh up the relevant rights of the public to transparency in the risk assessment process , including those flowing from the aarhus convention35 , against the rights of commercial applicants , taking into account the specific objectives of sectoral union legislation as well as experienced gained . accordingly , it is necessary to amend directive 2001 / 18 / ec , regulation no 1829 / 2003 , regulation no 1831 / 2003 , regulation no 1935 / 2004 and regulation no 1107 / 2009 to provide for additional confidential items to those set out in regulation no 178 / 2002 . _________________ 35 regulation no 1367 / 2006 of the european parliament and of the council of 6 september 2006 on the application of the provisions of the aarhus convention on access to information , public participation in decision - making and access to justice in environmental matters to community institutions and bodies . ### to ensure that sectoral specificities with respect to confidential information are taken into account , it is necessary to weigh up the relevant rights of the public to transparency in the risk assessment process , including those flowing from the aarhus convention35 , against the rights of commercial applicants , taking into account the specific objectives of sectoral union legislation as well as experienced gained , always , however , bearing in mind that , where there are specific grounds for concern about public welfare and public health , the public interest must prevail over commercial interests . accordingly , it is necessary to amend directive 2001 / 18 / ec , regulation no 1829 / 2003 , regulation no 1831 / 2003 , regulation no 1935 / 2004 and regulation no 1107 / 2009 to provide for additional confidential items to those set out in regulation no 178 / 2002 . _________________ 35 regulation no 1367 / 2006 of the european parliament and of the council of 6 september 2006 on the application of the provisions of the aarhus convention on access to information , public participation in decision - making and access to justice in environmental matters to community institutions and bodies .


### it is therefore necessary to ensure a comprehensive and continuous risk communication process throughout risk analysis , involving union and national risk assessors and risk managers . that process should be combined with an open dialogue between all interested parties to ensure the coherence and consistency within the risk analysis process . ### it is therefore necessary to ensure a comprehensive , transparent , independent and continuous risk communication process throughout risk analysis , involving union and national risk assessors and risk managers . that process should be capable of contributing to a participatory and open dialogue between all interested parties to ensure the coherence , comprehensiveness and consistency of the risk analysis process .


### the substantive reasons for issuing the freezing or confiscation order shall not be challenged before a court in the executing state . ### the substantive reasons for issuing the freezing or confiscation order may be challenged only in an action brought in the issuing state , without prejudice to the guarantees of fundamental rights in the executing state .


### in order to amend the certificate and the form set out in annexes i and ii to this regulation , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carry out appropriate consultations during its preparatory work for delegated acts , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure the simultaneous , timely and appropriate transmission of relevant documents to the european parliament and the council . ### in order to amend the certificate and the form set out in annexes i and ii to this regulation , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carry out appropriate consultations during its preparatory work for delegated acts with specialised authorities in the member states and the corresponding european agencies , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure the simultaneous , timely and appropriate transmission of relevant documents to the european parliament and the council .


### unless grounds for postponement pursuant to article 11 exist , the executing authority shall carry out the confiscation without delay and without prejudice to paragraph 5 of this article , not later than 30 days following the taking of the decision referred to in paragraph 2 of this article . ### unless grounds for postponement pursuant to article 11 exist , the executing authority shall carry out the confiscation without delay and without prejudice to paragraph 5 of this article , not later than 15 days following the taking of the decision referred to in paragraph 2 of this article .


### where it is impossible to execute the confiscation order because the property to be confiscated has already been confiscated , has disappeared , has been destroyed , or cannot be found in the location indicated in the certificate or because the location of the property has not been indicated in a sufficiently precise manner , even after consultation with the issuing authority , the issuing authority shall be notified without delay . where possible , the order may be executed on other property in accordance with article 8 or . ### where it is impossible to execute the confiscation order because the property to be confiscated has already been confiscated , has disappeared , has been destroyed , or cannot be found in the location indicated in the certificate or because the location of the property has not been indicated in a sufficiently precise manner , even after consultation with the issuing authority , the issuing authority shall be notified within 3 working days at the latest . where possible , the order may be executed on other property in accordance with article 8 or .


### it is important to facilitate the mutual recognition and execution of orders to freeze and to confiscate property by establishing rules obliging a member state to recognise and execute in its territory freezing and confiscation orders issued by another member state within the framework of criminal proceedings . ### it is important to facilitate the mutual recognition and execution of orders to freeze and to confiscate property by establishing rules obliging a member state to recognise and execute in its territory freezing and confiscation orders issued by another member state within the framework of criminal , civil and administrative proceedings .


### where the authority in the executing state which receives a confiscation order has no competence to recognise it and to take the necessary measures for its execution , it shall immediately transmit the confiscation order to the competent executing authority in its member state and shall inform the issuing authority accordingly . ### where the authority in the executing state which receives a confiscation order has no competence to recognise it and to take the necessary measures for its execution , it shall immediately or within 3 working days at the latest , transmit the confiscation order to the competent executing authority in its member state and shall inform the issuing authority accordingly .


### the executing authority shall immediately report to the issuing authority by any means capable of producing a written record on the postponement of the execution of the order , including the grounds for the postponement and , if possible , the expected duration of the postponement . as soon as the ground for postponement has ceased to exist , the executing authority shall immediately take the necessary measures for the execution of the order and inform the issuing authority thereof by any means capable of producing a written record . ### the executing authority shall immediately or within 3 working days at the latest , report to the issuing authority by any means capable of producing a written record on the postponement of the execution of the order , including the grounds for the postponement and , if possible , the expected duration of the postponement . as soon as the ground for postponement has ceased to exist , the executing authority shall immediately take the necessary measures for the execution of the order and inform the issuing authority thereof by any means capable of producing a written record .


### ' confiscation order ' means a final penalty or measure imposed by a court following proceedings in relation to a criminal offence , resulting in the final deprivation of property from a natural or legal person ; ### ' confiscation order ' means a measure imposed by a court following proceedings in relation to a criminal offence , resulting in the final deprivation of property from a natural or legal person ;


### the reason or reasons for the order are properly indicated , at least briefly . ### the reason or reasons for the order are properly indicated .


### medicated feed containing antimicrobial veterinary medicinal products shall not be used to prevent diseases in food - producing animals or to enhance their performance . ### medicated feed containing antibiotic veterinary medicinal products shall not be used to prevent diseases in food - producing animals unless such use is permitted under regulation 2015 / . . . .


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


### 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 minimise carry - over .


### the commission shall be empowered to adopt delegated acts in accordance with article 19 concerning the establishment of specific carry - over limits for active substances . ### the commission shall be empowered to adopt delegated acts in accordance with article 19 concerning the establishment of specific carry - over limits for active substances to avoid risk for animal and human health or for the environment .


### technical or organisational measures shall be taken to avoid any cross - contamination and errors , to carry out checks in the course of manufacture and to ensure effective tracing of the products used for the manufacture of medicated feed and intermediate products . ### technical or organisational measures shall be taken to minimise any cross - contamination and errors , to carry out checks in the course of manufacture and to ensure effective tracing of the products used for the manufacture of medicated feed and intermediate products .


### therapeutic indications of the veterinary medicinal products , any contra - indications and adverse events in so far as these particulars are necessary for the use ; ### any contra - indications and adverse events in so far as these particulars are necessary for the use ;


### ‘ mobile mixer’ : a feed business operator with a feed establishment consisting of a specifically equipped lorry for the manufacture of medicated feed ; ### ‘ mobile mixer’ : a feed business operator with a feed establishment consisting of a mobile infrastructure specifically equipped for the manufacture of medicated feed which moves from farm to farm for the purpose of providing its services ;


### ‘ intermediate product’ : a mixture of one or more veterinary medicinal products with one or more feeds , intended to be used for the manufacture of medicated feed ; ### ‘ intermediate medicated feed’ : a mixture of one or more veterinary medicinal products with one or more feeds , intended to be used for the manufacture of medicated feed ;


### the prescription shall , in line with the summary of the product characteristics of the veterinary medicinal product , indicate the inclusion rate of the veterinary medicinal product calculated on the basis of the relevant parameters . ### the prescription shall , in line with the summary of the product characteristics of the veterinary medicinal product , indicate the inclusion rate of the active substance of the veterinary medicinal product per kilogram of medicated feed .


### ' medicated feed ' : a mixture of one or more veterinary medicinal products or intermediate products with one or more feeds which is ready to be directly fed to animals without further processing ; ### ' medicated feed ' : a mixture of one veterinary medicinal product or one intermediate product with one or more feeds which is ready to be directly fed to animals without further processing , owing to the properties brought by the medicinal part of the mixture for treating or preventing disease and owing to the properties brought by the feed part of the mixture for providing nutrition ;


### collection systems of unused or expired products ### collection systems of expired products


### ' medicated feed ' : a mixture of one or more veterinary medicinal products or intermediate products with one or more feeds which is ready to be directly fed to animals without further processing ; ### ' medicated feed ' : feed resulting from the manufacture of one or more veterinary medicinal products authorised for this purpose or intermediate products with one or more feeds which is ready to be directly fed to animals without further processing ;


### 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 ensure that appropriate collection systems are in place for medicated feed and intermediate products that are expired . the collected material should be disposed of in accordance with existing regulations .


### feed business operators shall manufacture , store , transport and place on the market medicated feed and intermediate products in compliance with annex i . ### feed business operators shall manufacture , store , transport and place on the market medicated feed and intermediate products in compliance with the requirements of regulation no 183 / 2005 and regulation no 767 / 2009 and additional requirements established in annex i and iii to this regulation .


### the quantities provided in the prescription and ### the quantities provided in the prescription . the quantities required for a treatment shall be determined according to the summary of product characteristics included in the marketing authorisation of the veterinary medicinal product included in the prescription .


### ' on - farm mixer ' : a feed business operator manufacturing medicated feed on the farm of use . ### ' on - farm mixer ' : a feed business operator manufacturing medicated feed for exclusive use on the farm on which it is produced .


### ' on - farm mixer ' : a feed business operator manufacturing medicated feed on the farm of use . ### ' on - farm mixer ' : a feed business operator manufacturing medicated feed intended exclusively for animals on his or her farm .


### feed business operators shall manufacture , store , transport and place on the market medicated feed and intermediate products in compliance with annex i . ### medicated feed business operators shall manufacture , store , transport and place on the market medicated feed and intermediate products in compliance with annex i .


### 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 types of feed , medicated feed and intermediate products fall 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 .


### 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 . ### in addition to the tolerances listed in annex iv to regulation no 767 / 2009 , the permitted tolerances for discrepancies between the labelled active ingredient content 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 .


### the prescription shall , in line with the summary of the product characteristics of the veterinary medicinal product , indicate the inclusion rate of the veterinary medicinal product calculated on the basis of the relevant parameters . ### the prescription shall , in line with the summary of the product characteristics of the veterinary medicinal product , indicate the inclusion rate of the veterinary medicinal product calculated on the basis of the relevant parameters and the quantity of medicated feed calculated on the basis of the relevant parameters . the daily dose of the veterinary medicinal product shall be incorporated in a quantity of medicated feed that ensures the uptake of the daily dose by the target animal considering that the feed uptake of diseased animals might differ from a normal daily ration .


### the daily dose of the veterinary medicinal product shall be incorporated in a quantity of medicated feed that ensures the uptake of the daily dose by the target animal considering that the feed uptake of diseased animals might differ from a normal daily ration . ### the daily dose of the veterinary medicinal product shall be incorporated in accordance with the prescription .


### the placing on the market , including import , and use of medicated feed and intermediate products ; ### the placing on the market , including import from third countries , and use of medicated feed and intermediate products ;


### the commission may , by means of implementing acts , establish criteria for the homogenous incorporation of the veterinary medicinal product into the medicated feed or into the intermediate product , taking into account the specific properties of the veterinary medicinal products and of the mixing technology . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 20 . ### the commission may , by means of implementing acts , establish criteria for the homogenous incorporation of the veterinary medicinal product into the medicated feed or into the intermediate product , taking into account the specific properties of the veterinary medicinal products and of the manufacturing technology . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 20 .


### 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 individual animals or a group of animals examined by the veterinarian who issued the prescription and only for a diagnosed disease . the veterinarian 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 .


### in addition to article 11 , articles 12 and 14 of regulation no 767 / 2009 , the labelling of medicated feed and intermediate products shall comply with annex iii to this regulation . ### in addition to articles 11 , 11 , 12 , 14 , 15 , 15 , 15 , 15 , 17 , 17 , 17 , 17 , 17 and 17 of regulation no 767 / 2009 , the labelling of medicated feed and intermediate products should comply with annex iii to this regulation .


### a feed additive for which a maximum content is set in the respective authorisation act is not incorporated in the medicated feed if it is already used as active substance in the veterinary medicinal product . ### a feed additive authorised as coccidiostats or histomonostats for which a maximum content is set in the respective authorisation act is not incorporated in the medicated feed if it is already used as active substance in the veterinary medicinal product .


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


### in order to ensure the safe use of medicated feed , its supply and use should be subject to presentation of a valid veterinary prescription which has been issued after examination of the animals to be treated . however , the possibility to manufacture medicated feed before a prescription is presented to the manufacturer should not be excluded . ### in order to ensure the safe use of medicated feed , its supply and use should be subject to presentation of a valid written or electronic veterinary prescription issued , for a limited period of time , by a veterinarian or another professional person qualified to do so in accordance with applicable national law after examination and diagnosis of the animals to be treated . however , the possibility to manufacture medicated feed before a prescription is presented to the manufacturer should not be excluded .


### ' medicated feed ' : a mixture of one or more veterinary medicinal products or intermediate products with one or more feeds which is ready to be directly fed to animals without further processing ; ### ' medicated feed ' : a mixture of one veterinary medicinal product or one intermediate product with one or more feeds which is ready to be directly fed to animals without further processing , owing to the properties brought by the medicinal part of the mixture for treating or preventing disease and owing to the properties brought by the feed part of the mixture for providing nutrition ;


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


### the definitions of ' food - producing animal ' , ' feed materials ' , ' compound feed ' , ' complementary feed ' , ' mineral feed ' , labelling ' , ' label ' , ' minimum storage life ' and ' batch ' as laid down in article 3 of regulation no 767 / 2009 ; ### the definitions of ' food - producing animal ' , ' non - food producing animals ' , ' feed materials ' , ' compound feed ' , ' complementary feed ' , ' mineral feed ' , labelling ' , ' label ' , ' minimum storage life ' and ' batch ' as laid down in article 3 of regulation no 767 / 2009 ;


### 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 veterinary medicinal products with name , active substance , strength , added amount , marketing authorisation holder and marketing authorisation number , preceded by the heading ‘ medication’ ; ### the veterinary medicinal products with name , active substance , added amount of active substance , preceded by the heading ‘ medication’ ;


### taking into account the serious public health risk posed by resistance to antimicrobials , it is appropriate to limit the use of medicated feed containing antimicrobials for food - producing animals . preventive use or use to enhance the performance of food - producing animals should in particular not be allowed . ### taking into account the serious public health risk posed by resistance to antimicrobials , it is appropriate to limit the use of medicated feed containing antibiotics for food - producing animals . medicated feed containing antibiotics should not be used to prevent diseases in food - producing animals unless such use is permitted under regulation 2015 / . . . .


### the approval number of the person responsible for the labelling in accordance with article 12 ; ### the approval number of the person responsible for the labelling and of the manufacturer if different from the person responsible for labelling , in accordance with article 12 ;


### active substance per kg of medicated feed 500 mg 10 mg and ≤ 500 mg 0 , 5 mg and ≤ 10 mg 0 , 5 mg ### tolerance ± 10% ± 20% ± 30% ± 40%


### the medicated feed is manufactured in compliance with the relevant conditions laid down in the summary of the product characteristics referred to in article 14 of directive 2001 / 82 / ec , related to the veterinary medicinal products to be incorporated in the medicated feed ; ### the medicated feed is manufactured in compliance with the relevant conditions laid down in the summary of the product characteristics referred to in article 14 of directive 2001 / 82 / ec , related to the veterinary medicinal products to be incorporated in the medicated feed ; this includes , in particular , provisions relating to possible interactions between the veterinary medicinal products and the feed impairing the safety or the efficacy of the medicated feed ;


### feed business operators feeding food - producing animals with medicated feed shall keep records in accordance with article 69 of directive 2001 / 82 / ec . those records shall be kept for five years after the date of administration of medicated feed , including when the animal is slaughtered during the five - year period . ### feed business operators feeding food - producing animals with medicated feed shall keep records in accordance with article 69 of directive 2001 / 82 / ec . those records shall be kept for three years after the date of administration of medicated feed , including when the animal is slaughtered during the three - year period .


### the financial envelope of the european solidarity corps under heading 1a of the multiannual financial framework also builds on funds redeployed from the erasmus + programme . these funds should mainly come from appropriations aimed at financing european voluntary service activities that would fall under the scope of the volunteering placements supported under this regulation . in addition , some appropriations of the student loan guarantee facility , which are unlikely to be absorbed under erasmus + , should be redeployed with a view to providing adequate co - financing to the operating costs of national agencies and be brought more in line with the absorption capacity of this action . ### the financial envelope of the european solidarity corps under heading 1a of the multiannual financial framework builds on funds redeployed from the erasmus + programme . these funds should exclusively come from appropriations aimed at financing european voluntary service activities that would fall under the scope of the volunteering placements supported under this regulation .


### this regulation lays down a financial envelope for the period 2018 - 2020 which is to constitute the prime reference amount , within the meaning of point 17 of the interinstitutional agreement between the european parliament , the council and the commission on budgetary discipline , on cooperation in budgetary matters and on sound financial management23 , for the european parliament and the council during the annual budgetary procedure . the prime reference amount includes redeployments from the erasmus + programme and from the employment and social innovation programme for the financial years 2018 , 2019 and 2020 , and it is complemented by contributions from several union programmes under different headings , such as the european social fund , the union civil protection mechanism , the life programme and the european agricultural fund for rural development . _________________ 23 interinstitutional agreement of 2 december 2013 between the european parliament , the council and the commission on budgetary discipline , on cooperation in budgetary matters and on sound financial management , oj c 373 , 20 . 12 . 2013 , p . 1 . ### this regulation lays down a financial envelope of eur 341 , 5 million in current prices for the period 2018 - 2020 which is to constitute the prime reference amount , within the meaning of point 17 of the interinstitutional agreement between the european parliament , the council and the commission on budgetary discipline , on cooperation in budgetary matters and on sound financial management23 , for the european parliament and the council during the annual budgetary procedure . the financial envelope should include the amount of eur 197 , 7 million that was originally earmarked to finance the intra - union european voluntary service activities under the erasmus + programme for the financial years 2018 , 2019 and 2020 , given that those activities are to be transferred to the european solidarity corps programme . considering the need to avoid any negative impact on the financing of existing multiannual programmes , the remaining amount for the financing of the european solidarity corps should be drawn exclusively from unallocated margins under the multiannual financial framework ceilings . _________________ 23 interinstitutional agreement of 2 december 2013 between the european parliament , the council and the commission on budgetary discipline , on cooperation in budgetary matters and on sound financial management , oj c 373 , 20 . 12 . 2013 , p . 1 .


### the term of office of three of the seven additional judges to be appointed as from 1 september 2016 shall end on 31 august 2019 . those three judges shall be chosen by lot . the term of office of the other four judges shall end on 31 august 2022 ; ### the term of office of three of the seven additional judges to be appointed as from 1 september 2016 shall end on 31 august 2019 . those three judges shall be chosen in such a way that the governments of three member states nominate two judges for the partial replacement of the general court in 2019 . the term of office of the other four judges shall end on 31 august 2022 ;


### the term of office of four of the nine additional judges to be appointed as from 1 september 2019 shall end on 31 august 2022 . those four judges shall be chosen by lot . the term of office of the other five judges shall end on 31 august 2025 . ### the term of office of four of the nine additional judges to be appointed as from 1 september 2019 shall end on 31 august 2022 . those four judges shall be chosen in such a way that the governments of four member states nominate two judges for the partial replacement of the general court in 2022 . the term of office of the other five judges shall end on 31 august 2025 .


### member states shall ensure that the limitation period for proceedings concerning a customs infringement referred to in articles 3 to 6 is four years and starts to run on the day on which the customs infringement was committed . ### member states shall ensure that the limitation period for proceedings concerning a customs infringement referred to in articles 3 to 6 is five years and starts to run on the day on which the customs infringement was committed .


### member states shall ensure that the following acts or omissions constitute customs infringements irrespective of any element of fault : ### member states shall ensure that the following acts or omissions constitute minor customs infringements :


### having regard to the treaty on the functioning of the european union , and in particular article 33 thereof , ### having regard to the treaty on the functioning of the european union , and in particular articles 33 and 114 thereof ,


### member states shall ensure that when determining the type and the level of sanctions for the customs infringements referred to in articles 3 to 6 , the competent authorities shall take into account all relevant circumstances , including , where appropriate : ### whatever the circumstances , including in the event of discharge , the courts cannot exempt the person liable for payment from payment of the sums defrauded or unduly obtained or from seizure of goods dangerous to health or morality and public security , counterfeit goods , or goods subject to quantitative restrictions .


### member states shall lay down rules on sanctions in respect of the customs infringements set out in articles 3 to 6 . ### member states shall lay down rules on non - criminal sanctions in respect of the customs infringements set out in articles 3 to 6 , where committed by negligence or intentionally .


### this directive establishes a framework concerning the infringements of union customs legislation and provides for sanctions for those infringements . ### this directive seeks to contribute to the proper functioning of the internal market and to lay down the framework concerning infringements of union customs legislation , and it provides for non - criminal sanctions for those infringements by approximating the provisions laid down by law , regulation , or administrative action in member states .


### 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 purpose of this regulation is to give the fullest possible effect to the right of public access to documents of the authority , encourage proactive publication , and must be read in conjunction with regulations no 1049 / 2001 and 1367 / 2006 .


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


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


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


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


### member states shall ensure that the public bodies employing those scientific experts and those having responsibility for the setting of priorities of the scientific bodies employing those experts implement the measures provided for in paragraph 5d . ### as appropriate , member states shall ensure that the public bodies employing those scientific experts and those having responsibility for the setting of priorities of the scientific bodies employing those experts implement the measures which are necessary to ensure that the conditions referred to in paragraph 5d are met .


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


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


### 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 . in order to tackle this phenomenon more effectively , the system has thus to be strengthened and promoted , and member states should take a more active role to ensure that a sufficient pool of experts is available , by undertaking support actions and using incentives and rewards to increase the level of participation and the degree of interest in seeking to engage in it , to meet the needs of the union risk assessment system in terms of high level of scientific expertise , independence and multidisciplinary expertise .


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


### 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 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 . by 36 months after the entry into force of this regulation , the commission should evaluate the impact of these pre - submission meetings on the functioning of the authority . it should particularly evaluate their impact on the allocation of the authority’s resources and its independence .


### furthermore , in order to assess the effectiveness and efficiency of the different provisions applying to the authority , it is also appropriate to provide for a commission evaluation of the authority , in accordance with the common approach on decentralised agencies . the evaluation should , in particular , review the procedures for selecting the members of scientific committee and panels , for their degree of transparency , cost - effectiveness , and suitability to ensure independence and competence , and to prevent conflicts of interests . ### furthermore , in order to assess the effectiveness and efficiency of the different provisions applying to the authority , it is also appropriate to conduct an independent evaluation of the authority . the evaluation should , in particular , review the procedures for selecting the members of scientific committee and panels , for their degree of transparency , cost - effectiveness , and suitability to ensure independence and competence , and to prevent conflicts of interests .


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


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


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


### 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 , and restore consumer trust in the union and its institutions ;


### 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 .


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


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


### ensure that accurate , appropriate and timely information is interactively exchanged , based on the principles of transparency , openness , and responsiveness ; ### ensure that accurate , complete and timely information is interactively exchanged , including with all interested parties , based on the principles of transparency , openness , and responsiveness ;


### the members of the scientific committee who are not members of scientific panels and the additional members referred to in paragraph 5b shall be appointed by the management board , acting upon a proposal from the executive director , for a five year term of office , which may be renewable , following publication in the official journal of the european union , in relevant leading scientific publications and on the authority’s website of a call for expressions of interest . ” , ### the members of the scientific committee who are not members of the scientific panels , the members of the scientific panels and the additional members referred to in paragraph 5a shall be appointed by the management board for a renewable five year term of office in accordance with the following procedure : a call for expressions of interest shall be published in the official journal of the european union , in relevant leading scientific publications and on the authority ' s website ; member states shall ensure the broad dissemination of the call for expressions of interest across the scientific community ; on the basis of the applications received and in accordance with the authority’s independence policy and implementing rules applicable to scientific panels’ members , the executive director shall draw for each scientific panel a list of experts larger than the number of members to be appointed . the executive director may not draw up such a list where he / she can justify that the applications received do not allow him , given the criteria for selection set up in point d ) of this paragraph , to draw up a larger list . the executive director shall submit the list to the management board for appointment . the nominations by the member states , the selection by the executive director and the appointments by the management board shall be made on the basis of the following criteria : a high level of scientific expertise ; independence and absence of conflict of interests in accordance with article 37 and the authority’s independence policy and implementing rules on the independence of the scientific panels’ members ; meeting the needs for the specific multi - disciplinary expertise of the panel to which they will be appointed and the applicable language regime . the management board shall ensure that the broadest possible geographical distribution is achieved in the final appointments .


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