### the issuing authority should be notified without delay of the impossibility to execute an order . such impossibility might arise from the reason that the property has already been confiscated , has disappeared , cannot be found in the location indicated by the issuing authority or the location of the property has not been indicated in a sufficiently precise manner . ### the issuing authority should be notified without undue delay of the reasons for which the execution of an order is impossible . such impossibility might arise from the fact that the property has already been confiscated , has disappeared , cannot be found in the location indicated by the issuing authority or the location of the property has not been indicated in a sufficiently precise manner .


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


### the victims ' rights to compensation and restitution should not be prejudiced in cross - border cases . rules for disposal of the confiscated property should give priority to the compensation and restitution of property to the victims . member states should also take into account their obligations to assist in the recovery of tax claims from other member states in accordance with directive 2010 / 24 / eu36 . _________________ 36 council directive 2010 / 24 / eu of 16 march 2010 concerning mutual assistance for the recovery of claims relating to taxes , duties and other measures . ### the victims ' rights to compensation and restitution should not be prejudiced in cross - border cases . rules for disposal of the confiscated property should give priority to the compensation and restitution of property to the victims , thoroughly taking into account the fact that in cases of corruption , massive tax evasion , tax fraud or money laundering , for example , the victims are large communities and even entire countries . member states should also take into account their obligations to assist in the recovery of tax claims from other member states in accordance with directive 2010 / 24 / eu36 . _________________ 36 council directive 2010 / 24 / eu of 16 march 2010 concerning mutual assistance for the recovery of claims relating to taxes , duties and other measures .


### this regulation lays down the rules under which a member state shall recognise and execute in its territory a freezing or a confiscation order issued by another member state within the framework of criminal proceedings . ### this regulation lays down the rules under which a member state shall recognise and execute in its territory a freezing or a confiscation order issued by another member state within the framework of criminal , civil or administrative proceedings . this regulation&#160 ; lays down rules&#160 ; for mutual recognition of freezing and confiscation orders pertaining to main types of&#160 ; confiscation&#160 ; existing in member states : &#160 ; ordinary confiscation , extended confiscation , third party confiscation , value - based confiscation , non - conviction based confiscation .


### this regulation lays down the rules under which a member state shall recognise and execute in its territory a freezing or a confiscation order issued by another member state within the framework of criminal proceedings . ### this regulation lays down the rules and conditions under which a member state shall recognise and execute in its territory a freezing or a confiscation order issued by another member state within the framework of criminal proceedings .


### this regulation shall not have the effect of amending the obligation to respect the fundamental rights and legal principles as enshrined in article 6 teu . ### this regulation is without prejudice to the obligation to respect the fundamental rights and fundamental legal principles as enshrined in article 6 teu and in the charter of fundamental rights of the european union . any non - conviction based confiscation shall be consistent with the procedural safeguards contained in article 6 of the european convention on human rights and article 8 of directive 2014 / 42 / eu .


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


### ‘ property’ means property of any description , whether corporeal or incorporeal , movable or immovable , and legal documents or instruments evidencing title or interest in such property , which the issuing authority considers to be : ### ‘ property’ means money or assets of any kind , whether corporeal or incorporeal , movable or immovable , as well as limited property rights and legal documents or instruments , in any form including electronic or digital , evidencing ownership or other title or interest in such assets , which the issuing authority considers to be :


### ' property’ means property of any description , whether corporeal or incorporeal , movable or immovable , and legal documents or instruments evidencing title or interest in such property , which the issuing authority considers to be : ### ' property ' means money or assets of any kind , whether corporeal or incorporeal , movable or immovable , as well as limited property rights , and legal documents or instruments , in any form , including electronic or digital , evidencing ownership or other title or interest in such assets , which the issuing authority considers to be :


### a freezing order or confiscation order shall give rise to execution without verification of the double criminality of the acts if the acts giving rise to the freezing or confiscation order constitute one or more of the following offences , as defined by the law of the issuing state , and are punishable in the issuing state by a custodial sentence of a maximum of at least three years : ### a freezing order or confiscation order shall give rise to execution without verification of the double criminality of the acts if the acts &#8211 ; including acts of complicity and preparation as well as attempted acts &#8211 ; giving rise to the freezing or confiscation order constitute one or more of the following offences , as defined by the law of the issuing state , and are punishable in the issuing state by a custodial sentence of a maximum of at least three years :


### a confiscation order , or a certified copy of it , shall be transmitted together with the certificate provided for in article&#160 ; 7 by the issuing authority directly to the executing authority or , where applicable , to the central authority referred to in article&#160 ; 27 by any means capable of producing a written record under conditions allowing the executing authority to establish authenticity . ### a confiscation order , or a certified copy of it , shall be transmitted together with the certificate provided for in article&#160 ; 7 by the issuing authority directly to the executing authority or , where applicable , to the central authority referred to in article&#160 ; 27 by any means capable of producing a written record under conditions allowing the executing authority to establish its authenticity .


### a confiscation order , or a certified copy of it , shall be transmitted together with the certificate provided for in article 7 by the issuing authority directly to the executing authority or , where applicable , to the central authority referred to in article 27 by any means capable of producing a written record under conditions allowing the executing authority to establish authenticity . ### a confiscation order , or a certified copy of it , shall be transmitted together with the certificate provided for in article 7 by the issuing authority directly to the executing authority or , where applicable , to the central authority referred to in article 27 by any means capable of producing a written record under conditions allowing the executing authority to establish its authenticity .


### where a confiscation order concerning an amount of money is transmitted to one or more executing states , the total value derived from its execution may not exceed the maximum amount specified in the confiscation order . ### where a confiscation order concerning an amount of money is transmitted to one or more executing states , the total value derived from its execution may not exceed the maximum amount specified in the confiscation order . in cases where the confiscation has already been executed fully or in part , such amount shall be deducted in full from the amount confiscated in the executing state .


### the confiscation order is based on a criminal offence committed outside the territory of the issuing state and wholly or partially on the territory of the executing state and the conduct in connection with which the confiscation order is issued is not an offence in the executing state ; ### the confiscation order is based on a criminal , civil or administrative offence committed outside the territory of the issuing state and wholly or partially on the territory of the executing state and the conduct in connection with which the confiscation order is issued is not an offence in the executing state ;


### where it is not possible in a specific case to meet the time limits set out in paragraphs 2 or 4 , the executing authority shall , without delay , inform the issuing authority by any means , giving the reasons for the delay and shall consult with the issuing authority on the appropriate timing to carry out the confiscation . in such a case , the time limit laid down in paragraphs 2 or 4 , may be extended by a maximum of 30 days . ### where it is not possible in a specific case to meet the time limits set out in paragraphs 2 or 4 , the executing authority shall , without delay , inform the issuing authority by any means capable of producing a written record , giving the reasons for the delay and shall consult with the issuing authority on the appropriate timing to carry out the confiscation . in such a case , the time limit laid down in paragraphs 2 or 4 , may be extended by a maximum of 30 days .


### where it is not possible in a specific case to meet the time limits set out in paragraphs 2 or 4 , the executing authority shall , without delay , inform the issuing authority by any means , giving the reasons for the delay and shall consult with the issuing authority on the appropriate timing to carry out the confiscation . in such a case , the time limit laid down in paragraphs 2 or 4 , may be extended by a maximum of 30 days . ### where it is not possible in a specific case to meet the time limits set out in paragraphs 2 or 4 , the executing authority shall , without delay , inform the issuing authority by any means , giving the reasons for the delay and shall consult with the issuing authority on the appropriate timing to carry out the confiscation . in such a case , the time limit laid down in paragraphs 2 or 4 , may be extended to a maximum of 30 days .


### 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 . ### the executing authority shall without delay make a 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 . in the event of a postponement under the provisions of subparagraph , the issuing authority shall , in cases of execution of a confiscation order in more than one member state , issue fresh instructions as to the exact amount of money subject to confiscation .


### the executing authority shall without delay make a 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 . ### the executing authority shall without delay make a 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 . in the event of a postponement under point of paragraph 1 , the issuing authority shall , where a confiscation order is simultaneously executed in more than one member state , issue fresh instructions as to the exact amount of money subject to confiscation .


### the executing authority may decide to lift the freezing order if , during the execution , it becomes aware that one of the grounds for non - recognition and non - execution applies . ### the executing authority may decide to lift the freezing order if , during the execution , it becomes aware that one of the grounds for non - recognition and non - execution applies . the executing authority shall communicate to the issuing authority , by any means capable of producing a written record , the reasons for the decision to revoke the freezing order .


### where the issuing authority has indicated in the freezing order that there are legitimate grounds to believe that the property in question will imminently be moved or destroyed and that immediate freezing is necessary , or if the issuing authority has indicated in the freezing order that the freezing measure has to be carried out on a specific date , the executing authority shall take full account of this requirement . ### where the issuing authority has indicated in the freezing order that there are legitimate grounds to believe that the property in question will imminently be moved or destroyed and that immediate freezing is necessary , or if the issuing authority has indicated in the freezing order that the freezing measure has to be carried out on a specific date , the executing authority shall , in so far as possible , take full account of this requirement .


### where it is not possible in a specific case to meet the time limits set out in paragraphs 3 or 6 , the executing authority shall immediately inform the issuing authority by any means , giving the reasons for the delay and shall consult with the issuing authority on the appropriate timing to carry out the freezing . ### where it is not possible in a specific case to meet the time limits set out in paragraphs 3 or 6 , the executing authority shall immediately inform the issuing authority by any means capable of producing a written record , giving the reasons for the delay and shall consult with the issuing authority on the appropriate timing to carry out the freezing .


### for the purpose of safeguarding ongoing investigations , the issuing authority may request the executing authority to keep the execution of the freezing order confidential for a limited period of time . ### for the purpose of safeguarding ongoing investigations , the issuing authority may request the executing authority to keep the execution of the freezing order confidential for a limited period of time . the issuing authority shall inform the executing authority when the reasons for keeping the freezing order confidential no longer apply .


### after consulting the issuing authority , the executing authority , taking into account the circumstances of the case , may make a reasoned request to the issuing authority to limit the period for which the property shall be frozen . if the issuing authority does not agree to such a limitation , it shall inform the executing authority thereof , stating its reasons . if the issuing authority does not do so within six weeks of receiving the request , the executing authority may lift the freezing order . ### after consulting the issuing authority , the executing authority , taking into account the circumstances of the case , may make a reasoned request to the issuing authority to limit the period for which the property shall be frozen . if the issuing authority does not agree to such a limitation , it shall inform the executing authority thereof by any means capable of producing a written record , stating its reasons . if the issuing authority does not do so within six weeks of receiving the request , the executing authority may lift the freezing order .


### after consulting the issuing authority , the executing authority , taking into account the circumstances of the case , may make a reasoned request to the issuing authority to limit the period for which the property shall be frozen . if the issuing authority does not agree to such a limitation , it shall inform the executing authority thereof , stating its reasons . if the issuing authority does not do so within six weeks of receiving the request , the executing authority may lift the freezing order . ### after consulting the issuing authority , the executing authority , taking into account the circumstances of the case , may make a reasoned request , accompanied by evidence related to these circumstances , to the issuing authority to limit the period for which the property shall be frozen . if the issuing authority does not agree to such a limitation , it shall inform the executing authority thereof , stating its reasons . if the issuing authority does not do so within six weeks of receiving the request , the executing authority may lift the freezing order .


### where necessary , the issuing authority and the executing authority shall consult each other , by any appropriate means , in order to ensure the efficient application of this regulation . ### where necessary , the issuing authority and the executing authority shall rapidly consult each other , by any appropriate means , in order to ensure the efficient application of this regulation .


### where necessary , the issuing authority and the executing authority shall consult each other , by any appropriate means , in order to ensure the efficient application of this regulation . ### where necessary , the issuing authority and the executing authority shall consult each other , by any appropriate means , including by modern communication technologies , in order to ensure the efficient application of this regulation .


### the executing state shall terminate the execution of the order as soon as it is informed by the issuing authority of that decision or measure . ### the executing state shall terminate the execution of the order as soon as it is informed by the issuing authority of that decision or measure and shall confirm this to the issuing country without delay by any means capable of producing a written record .


### where a judicial authority of the issuing state has issued a decision to compensate or restitute the victim , the corresponding sum , in so far as it is does not exceed the confiscated sum , shall accrue to the issuing state for the purposes of compensation or restitution of the victim . any remaining property is to be disposed of in accordance with paragraph 2 . ### where a judicial authority of the issuing state has issued a decision to compensate or restitute the victim , the corresponding sum , in so far as it is does not exceed the confiscated sum , shall accrue to the issuing state for the purposes of compensation or restitution of the victim . each state insures the effectiveness of exercising the right to ask for compensation in cases where the government or other officials were involved in the commission of the offence . the right to restitution should be exercised in the jurisdiction where the spoliated funds where transferred . if the authorities entitled to intervene as a civil party took advantage from the commission of the offence , the rights for restitution should be exercised in the name of the victims by a designated association or non - governmental organization . any remaining property is to be disposed of in accordance with paragraph 2 .


### where a judicial authority of the issuing state has issued a decision to compensate or restitute the victim , the corresponding sum , in so far as it is does not exceed the confiscated sum , shall accrue to the issuing state for the purposes of compensation or restitution of the victim . any remaining property is to be disposed of in accordance with paragraph 2 . ### where a judicial authority of the issuing state has issued a decision to compensate or restitute the victim , the corresponding sum , in so far as it is does not exceed the confiscated sum , shall accrue to the issuing state , solely for the purposes of compensation or restitution of the victim . any remaining property is to be disposed of in accordance with paragraph 2 .


### the issuing authority shall communicate the decision referred to in paragraph 3 and 4 to the executing authority . if a procedure to compensate or restitute the victim is pending in the issuing state , the executing state shall withhold the disposition of the confiscated property until the decision is communicated to the executing authority . ### the issuing authority shall communicate the decision referred to in paragraph 3 and 4 to the executing authority by any means capable of producing a written record . if a procedure to compensate or restitute the victim is pending in the issuing state , the executing state shall withhold the disposition of the confiscated property until the decision is communicated to the executing authority .


### where the executing state has had costs which it considers large or exceptional , the executing authority may propose to the issuing authority that the costs be shared . the issuing authority shall take into account such a proposal on the basis of detailed specifications given by the executing authority . ### where the executing state has had costs which it considers large or exceptional , the executing authority may propose to the issuing authority that the costs be shared . the issuing authority shall take into account such a proposal on the basis of detailed specifications given by the executing authority and inform the executing authority of its conclusions by any means capable of producing a written record .


### any interested party , including bona fide third parties , shall have legal remedies , including those provided for in article 8 of directive 2014 / 42 / eu , against the recognition and execution of an order pursuant to article 8 and 17 , in order to preserve their rights . the legal remedy shall be brought before a court in the executing state in accordance with its national law . the action may have suspensive effect under the law of the executing state . ### any interested party , including bona fide third parties , shall have legal remedies , including those provided for in article 8 of directive 2014 / 42 / eu , against the recognition and execution of an order pursuant to article 8 and 17 , in order to preserve their rights . the legal remedy against the recognition and the execution of a freezing / confiscation order&#160 ; shall be brought before a court in the executing state in accordance with its national law .


### medicated feed should be manufactured only with authorised veterinary medicinal products and the compatibility of all compounds used should be ensured for the purpose of safety and efficacy of the product . additional specific requirements or instructions for the inclusion of the veterinary medicinal products into feed should be foreseen to ensure a safe and efficient treatment of the animals . ### medicated feed should be manufactured only with authorised veterinary medicinal products and the compatibility of all compounds used should be ensured for the purpose of safety and efficacy of the product . additional specific requirements or instructions for the inclusion of the veterinary medicinal products into feed should be foreseen to ensure a safe and efficient treatment of the animals . the inclusion rates set should as a matter of principle be geared to a farm’s average needs . to take account of the specific features of the small - scale farming sector , and in particular to enable small or remote farms to optimise livestock care , it should be permissible to retain established control systems provided it is ensured that the prescription , production and use of medicated feed take place under the instructions and supervision of a veterinarian and are subject to an external process control .


### medicated feed should be manufactured only with authorised veterinary medicinal products and the compatibility of all compounds used should be ensured for the purpose of safety and efficacy of the product . additional specific requirements or instructions for the inclusion of the veterinary medicinal products into feed should be foreseen to ensure a safe and efficient treatment of the animals . ### medicated feed should be manufactured only with authorised veterinary medicinal products and the compatibility of all compounds used should be ensured for the purpose of safety and efficacy of the product . the holder of the authorisation of the veterinary medicinal products is responsible for compatibility assessment . additional specific requirements or instructions for the inclusion of the veterinary medicinal products into feed should be foreseen to ensure a safe and efficient treatment of the animals .


### medicated feed should be manufactured only with authorised veterinary medicinal products and the compatibility of all compounds used should be ensured for the purpose of safety and efficacy of the product . additional specific requirements or instructions for the inclusion of the veterinary medicinal products into feed should be foreseen to ensure a safe and efficient treatment of the animals . ### medicated feed should be manufactured only with authorised veterinary medicinal products and the compatibility of all compounds used should be ensured for the purpose of safety and efficacy of the product . additional specific requirements or instructions for the inclusion of the veterinary medicinal products into feed should be foreseen to ensure a safe and efficient treatment of the animals . the inclusion rates set should as a matter of principle be geared to a farm’s average needs . to take account of the specific features of the small - scale farming sector , and in particular to enable small or remote farms to optimise livestock care , it should be permissible to retain established control systems provided it is ensured that the prescription , production and use of medicated feed take place under the instructions and supervision of a veterinarian , or another professional person qualified to do so in accordance with applicable national law , and are subject to an external process control .


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


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


### this regulation shall apply to : the manufacture , storage and transport of medicated feed and intermediate products ; the placing on the market , including import , and use of medicated feed and intermediate products ; the export to third countries of medicated feed and intermediate products . however , articles 9 , 15 , 16 and 17 shall not apply to medicated feed and intermediate products whose label indicates that they are intended for export to third countries . ### this regulation shall apply to the manufacture , storage , transport , placing on the market , including import and export to third countries , and use of medicated feed and intermediate products for both food - producing and non - food producing animals . however , the following articles shall not apply to medicated feed and intermediate products whose label indicates that they are intended for export to third countries : - article 9 , except as provided for in annex iii , point 1 , and - articles 15 , 16 and 17 . 2 . this regulation shall not apply to finished veterinary medicinal products to be orally administered that have been approved for use via feed or drinking water .


### the definitions of ' veterinary medicinal product ' , ' withdrawal period ' , ' strength ' and ' veterinary prescription ' as laid down in article 1 of directive 2001 / 82 / ec . ### the definitions of ' veterinary medicinal product ' , ' withdrawal period ' , ' strength´ , ' veterinary prescription ' and ´premix for medicated feedingstuffs´ as laid down in article 1 of directive 2001 / 82 / ec .


### the veterinary medicinal product is incorporated into the feed in accordance with annex ii ; ### the medicated premix or intermediate product is incorporated into the feed in accordance with the conditions as established in prescription of the attending veterinarian .


### 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 . ### coccidiostats or histomonostats are not present in the feed used for the production of medicated feed if they are also present as active substance in the veterinary medicinal product . for other feed additives , the manufacturer , when formulating the medicated feed , shall ask for the advice the veterinarian from the perspective of compatibilities , possible impacts on safety and efficacy profile of the final medicated feed and take into account their eventual presence in the feed used for the production of medicated feed , especially for those cases when they are also present as active substance in the medicated premix .


### feed business operators manufacturing medicated feed shall ensure the homogeneous incorporation of the veterinary medicinal product or the intermediate product into the feed . ### medicated feed business operators manufacturing medicated feed shall ensure the homogeneous incorporation of the veterinary medicinal product or the intermediate product into the feed . medicated feed business operators manufacturing intermediate products shall ensure the homogeneous incorporation of the veterinary medicinal product into the feed .


### feed business operators manufacturing , storing , transporting and placing on the market medicated feed and intermediate products shall apply measures in accordance with article 3 and 4 to avoid carry - over . ### feed business operators manufacturing , storing , transporting and placing on the market medicated feed and intermediate products shall apply measures in accordance with article 3 and 4 to avoid carry - over in accordance with the alara principle , in order to avoid risk for animal health , human health or the environment .


### where containers are used instead of packaging material , they shall be accompanied by documents complying with paragraph 1 . ### where containers are used instead of packages , they shall be accompanied a document complying with paragraph 1 .


### medicated feed and intermediate products shall be placed on the market only in sealed packages or containers . packages or containers shall be sealed in such a way that , when the package or container is opened , the seal is damaged and cannot be reused . ### medicated feed and intermediate products shall be placed on the market only in sealed packages or containers . packages or containers shall be sealed in such a way that , when the package or container is opened , the seal is damaged and cannot be reused . appropriate derogations should be provided for those instances where the application of this requirement is not necessary to protect human or animal health or consumer interests , and would represent an excessive administrative and technical burden .


### medicated feed and intermediate products shall be placed on the market only in sealed packages or containers . packages or containers shall be sealed in such a way that , when the package or container is opened , the seal is damaged and cannot be reused . ### medicated feed and intermediate products shall be placed on the market only in sealed packages – including sack packaging – or containers . packages or containers shall be sealed in such a way that , when the package or container is opened , the seal is damaged and cannot be reused .


### feed business operators manufacturing , storing , transporting or placing on the market medicated feed or intermediate products shall ensure that establishments under their control are approved by the competent authority . ### medicated feed business operators manufacturing , storing or placing on the market medicated feed or intermediate products shall ensure that establishments under their control are approved by the competent authority . medicated feed business operators transporting medicated feed or intermediate products shall ensure that establishments under their control are registered with the competent authority . the first subparagraph shall not apply to medicated feed business operators authorised to deliver veterinary medicinal products to be retailed , or to holders of animals who store or use medicated feed for their own animals .


### the prescription shall contain the information set out in annex v . the original prescription shall be kept by the manufacturer or , where appropriate , the distributor . the person issuing the prescription and the animal holder shall keep a copy of the prescription . the original and copies shall be kept for three years from the date of issuance . ### the prescription shall contain the information set out in annex v , based on article 110 of the regulation on veterinary medicinal products1 a . the original prescription shall be kept by the manufacturer or , where appropriate , the distributor . the person issuing the prescription and the animal holder shall keep a copy of the prescription . the original and copies shall be kept for three years from the date of issuance . __________________ 1 a commission proposal com 558 final


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


### the prescribed medicated feed may be used only for animals examined by the person who issued the prescription and only for a diagnosed disease . the person who issued the prescription shall verify that this medication is justified for the target animals on veterinary grounds . furthermore he shall ensure that the administration of the veterinary medicinal product concerned is not incompatible with another treatment or use and that there is no contra - indication or interaction where several medicinal products are used . ### the prescribed medicated feed may be used only for animals examined by the person who issued the prescription and only for a diagnosed disease . the person who issued the prescription shall verify that this medication is justified for the target animals on veterinary grounds and after having knowledge of the feeding systems , the possibilities of mixing and other relevant farm specificities . furthermore he shall ensure that the administration of the veterinary medicinal product concerned is not incompatible with another treatment or use and that there is no contra - indication or interaction where several medicinal products are used .


### the prescribed medicated feed may be used only for animals examined by the person who issued the prescription and only for a diagnosed disease . the person who issued the prescription shall verify that this medication is justified for the target animals on veterinary grounds . furthermore he shall ensure that the administration of the veterinary medicinal product concerned is not incompatible with another treatment or use and that there is no contra - indication or interaction where several medicinal products are used . ### the prescribed medicated feed may be used only for animals examined by the veterinarian or another professional person qualified to do so in accordance with applicable national law who issued the prescription and only for a diagnosed disease . the veterinarian or another professional person qualified to do so in accordance with applicable national law who issued the prescription shall verify , based on the knowledge of the feeding systems in use , the possibilities of mixing and other relevant farm specificities , 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 .


### feed business operators supplying medicated feed to the holder of food - producing animals , or on - farm mixers of medicated feed for food - producing animals shall ensure that the quantities supplied or mixed do not exceed : ### feed business operators supplying medicated feed to the holders of food - producing and non - food producing animals , or on - farm mixers of medicated feed for food - producing animals shall ensure that the quantities supplied or mixed do not exceed :


### 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 . ### feed business operators shall ensure that appropriate collection systems are in place for medicated feed and intermediate products that have 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 .


### a qualified person responsible for the manufacture of medicated feed and intermediate products and a qualified person responsible for quality control shall be delegated . ### the qualified people responsible for the manufacture and quality control operations must have qualifications or specific skills in the field of veterinary medicine . the qualified people responsible for the manufacture and quality control operations may not prescribe medicated feed intended to be manufactured or inspected in the establishments in which they work .


### the products used for the manufacture and unprocessed feed shall be stored separately from medicated feed and intermediate products in order to avoid any cross - contamination . ### the products used for the manufacture and unprocessed feed shall be stored separately from medicated feed and intermediate products in order to avoid or strictly minimise any carry - over .


### the label of medicated feed and intermediary products shall include the following particulars : ### the label of medicated feed and intermediary products shall include , in accordance with the requirements of this annex and of regulation no 767 / 2009 the following particulars , in a simple , clear and easily understandable manner for the end users :


### 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 , strength , added amount preceded by the heading ' medication ' ;


### a recommendation to read the package leaflet of the veterinary medicinal products , including a hyperlink where it can be found , a warning that the product is only for the treatment of animals , as well as another warning that the product must be kept out of the sight and reach of children ; ### a recommendation to read the package leaflet of the veterinary medicinal products , including a hyperlink where it can be found , a warning that the product is only for the treatment of animals , a warning that the product must be kept out of the sight and reach of children , as well as another warning that people in the proximity of animals treated with medicated feed may be contaminated .


### 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 .


### surname , forename , address and professional membership number of the person allowed to prescribe a veterinary medicinal product . ### surname , forename , address and professional membership number of the veterinarian or another professional person qualified to prescribe a veterinary medicinal product in accordance with applicable national law .


### issue date and signature or electronic identification of the person allowed to prescribe a veterinary medicinal product . ### issue date and signature or electronic identification of the veterinarian or another professional person qualified to prescribe a veterinary medicinal product in accordance with applicable national law .


### 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 amount referred to in paragraph 1 includes a financial envelope of eur 294 200 00033 in current prices supplemented by contributions from : _________________ 33 this financial envelope constitutes 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 management . ### the amount referred to in paragraph 1 includes a financial envelope of eur 197 700 000 in current prices , which corresponds to the amount originally earmarked to finance the intra - union european voluntary service activities under the erasmus + programme . the remaining amount of eur 143 800 000 for the financing of the european solidarity corps shall be drawn exclusively from unallocated margins under the multiannual financial framework ceilings .


### up to 1 , 5 % to the student loan guarantee facility ; ### 3 , 5 % of the student loan guarantee facility ;


### motion for a resolution ### 2 a . calls on the commission to refrain from using redeployments for financing new policy priorities that are added in the course of an ongoing multiannual financial framework , as this will inevitably have a negative impact on the implementation of other key union activities .


### motion for a resolution ### 2 b . calls on the commission to provide for sufficient financing for the union civil protection mechanism under the next multiannual financial framework starting in 2021 , building on the present overhaul .


### the union should be able to support member states where available capacities are insufficient to allow for an effective response to disasters by contributing to the financing of leasing or rental arrangements for ensuring rapid access to such capacities or by financing their acquisition . this would substantially increase the effectiveness of the union mechanism , by ensuring availability of capacities in cases where an effective response to disasters would otherwise not be ensured , particularly for disasters with wide ranging impacts affecting a significant number of member states . union procurement of capacities should allow for economies of scale and better coordination when responding to disasters . ### the union should be able to support member states where available capacities are insufficient to allow for an effective response to disasters by contributing to the financing of leasing or rental arrangements for ensuring rapid access to such capacities or by financing their acquisition . this would substantially increase the effectiveness and deployability of the union mechanism , by ensuring the speedy availability of capacities in cases where an effective response to disasters would otherwise not be ensured , particularly for disasters with wide ranging impacts affecting a significant number of member states . union procurement of capacities should allow for economies of scale and better coordination when responding to disasters . optimal and transparent use of financial resources should be ensured .


### in order to achieve the functioning of the resceu capacity , additional financial appropriations should made available to finance actions under the union mechanism . ### in order to achieve the functioning of the resceu capacity , additional financial appropriations should be made available to finance actions under the union mechanism , but not at the expense of the financial envelopes allocated to other key union policies such as those promoting rights , equality and citizenship , justice or human development worldwide .


### the commission shall inform the european parliament and the council of operations and progress made under articles 11 and 12 every two years . ' ### the commission shall inform the european parliament and the council of operations and progress made under articles 11 and 12 every year .


### union support in the fields of the protection of the financial interests of the union , of irregularity reporting , and of mutual administrative assistance and cooperation in customs and agricultural matters should be streamlined under a single programme , the eu anti - fraud programme , with a view to increasing synergies and budgetary flexibility , and to simplifying management . ### union support in the fields of the protection of the financial interests of the union , of irregularity reporting , and of mutual administrative assistance and cooperation in customs and agricultural matters should be streamlined under a single programme , the eu anti - fraud programme , with a view to increasing synergies and budgetary flexibility , and to simplifying management without prejudice to an effective control by the co - legislators of the programme implementation .


### the programme should be open to participation by countries of the european free trade association which are members in the european economic area . it should also be open to participation by acceding countries , candidate countries and potential candidates , as well as countries covered by the european neighbourhood policy , in accordance with the general principles and general terms and conditions for the participation of those countries in union programmes established in the respective framework agreements and association council decisions , or similar agreements . the programme should also be open to other third countries provided that they enter into a specific agreement covering their participation to union programmes . ### the programme should be open to participation by countries of the european free trade association which are members in the european economic area . it should also be open to participation by acceding countries , candidate and potential candidate countries , as well as countries covered by the european neighbourhood policy , in accordance with the general principles and general terms and conditions for the participation of those countries in union programmes established in the respective framework agreements and association council decisions , or similar agreements . the programme should also be open to other third countries provided that they have an association agreement or enter into a specific agreement covering their participation to union programmes .


### pursuant to paragraph 22 and 23 of the inter - institutional agreement for better law - making of 13 april 201635 , there is a need to evaluate this programme on the basis of information collected through specific monitoring requirements , while avoiding overregulation and administrative burdens , in particular on member states . these requirements , where appropriate , can include measurable indicators , as a basis for evaluating the effects of the programme on the ground . __________________ 35 interinstitutional agreement between the european parliament , the council of the european union and the european commission on better law - making of 13 april 2016 . ### pursuant to paragraph 22 and 23 of the inter - institutional agreement for better law - making of 13 april 201635 , there is a need to evaluate this programme on the basis of information collected through reporting , namely on performance , monitoring and evaluation requirements , while avoiding overregulation and administrative burdens , in particular on member states . these requirements , where appropriate , can include measurable indicators , as a basis for evaluating the effects of the programme on the ground . an independent evaluator should carry out the evaluation . __________________ 35 interinstitutional agreement between the european parliament , the council of the european union and the european commission on better law - making of 13 april 2016 .


### 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 to develop the provisions for a monitoring and evaluations framework of the programme . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement on better law - making of 13 april 2016 . in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents at the same time as member states ' experts , and their experts systematically have access to meetings of commission expert groups dealing with the preparation of delegated acts . ### in order to supplement 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 to adopt the work programmes . in addition , in order to amend 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 in respect of the indicators set out in annex ii to this regulation . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement on better law - making of 13 april 2016 . in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents at the same time as member states ' experts , and their experts systematically have access to meetings of commission expert groups dealing with the preparation of delegated acts .


### the financial envelope for the implementation of the programme for the period 2021 &#8211 ; 2027 shall be eur 181 . 207 million in current prices . ### the financial envelope for the implementation of the programme for the period 2021 &#8211 ; 2027 shall be eur 321&#160 ; 314&#160 ; 000 in 2018 prices .


### eur 114 . 207 million for the objective referred to in article 2 ; ### eur 202&#160 ; 512&#160 ; 000 in 2018 prices for the objective referred to in article 2 ;


### eur 7 million for the objective referred to in article 2 ; ### eur 12 412 000 in 2018 prices for the objective referred to in article 2 ;


### eur 60 million for the objective referred to in article 2 . ### eur 106 390 000 in 2018 prices for the objective referred to in article 2 .


### the programme may provide funding in any of the forms laid down in the financial regulation , in particular grants and procurement , as well as the reimbursement of travel and subsistence expenses as provided for by article 238 of the financial regulation . ### the programme may provide funding in any of the forms laid down in the financial regulation , in particular grants in accordance with title viii and procurement in accordance with title vii , as well as the reimbursement of travel and subsistence expenses as provided for by article 238 of the financial regulation .


### grants under the programme shall be awarded and managed in accordance with title viii of the financial regulation . ### the co - financing rate for grants awarded under the programme shall not exceed 80% of the eligible costs .


### only actions implementing the objectives referred to in article 2 shall be eligible for funding . ### the following actions implementing the objectives referred to in article 2 shall be eligible for funding :


### any legal entity created under union law or any international organisation . ### any legal entity created under union law or any international organisation , as defined in article 156 of the financial regulation .


### to ensure effective assessment of progress of the programme towards the achievement of its objectives , the commission is empowered to adopt delegated acts , in accordance with article 14 , to amend annex ii to review or complement the indicators where considered necessary and to supplement this regulation with provisions on the establishment of a monitoring and evaluation framework . ### to ensure effective assessment of progress of the programme towards the achievement of its objectives , the commission is empowered to adopt delegated acts , in accordance with article 14 , to amend annex ii to review or complement the indicators where considered necessary .


### evaluations shall be carried out in a timely manner to feed into the decision - making process . ### evaluations shall be carried out in a timely manner by an independent evaluator to feed into the decision - making process .


### at the end of the implementation of the programme , but no later than four years after the end of the period specified in article 1 , a final evaluation of the programme shall be carried out by the commission . ### at the end of the implementation of the programme , but no later than three years after the end of the period specified in article 1 , a final evaluation of the programme shall be carried out by the commission .


### consequently , customs infringements and sanctions follow 28 different sets of legal rules . as a result of that , a breach of union customs legislation is not treated the same way throughout the union and the sanctions that may be imposed in each case differ in nature and severity depending on the member state that is imposing the sanction . ### consequently , customs infringements and sanctions follow 28 different sets of legal rules . as a result of that , a breach of union customs legislation is not treated the same way throughout the union and the sanctions that may be imposed in each case differ in nature and severity depending on the member state that is imposing the sanction , leading to possible losses of revenue for the member states and trade distortions .


### that disparity of member states ' legal systems affects not only the optimal management of the customs union , but also prevents that a level playing field is achieved for economic operators in the customs union because it has an impact on their access to customs simplifications and facilitations . ### that disparity of member states ' legal systems not only affects the optimal management of the customs union , but also hinders the achievement of a level playing field for economic operators in the customs union as it has an impact on their access to customs simplifications and facilitations . uniformity of the principles governing the way in which customs infringements should be handled by the different customs authorities is needed in order to ensure the proper functioning of the internal market .


### a suspension of administrative proceedings concerning customs infringements should be provided for where criminal proceedings have been initiated against the same person in connection with the same facts . the continuation of the administrative proceedings after the completion of the criminal proceedings should be possible only in strict conformity with the ne bis in idem principle . ### a suspension of administrative proceedings concerning customs infringements should be provided for where criminal proceedings have been initiated against the same person in connection with the same facts . the continuation of the administrative proceedings after the completion of the criminal proceedings should be possible only in strict conformity with the ne bis in idem principle , meaning that the same offence must not be penalised twice .


### failure of a person bringing goods into the customs territory of the union to comply with the obligations relating to the conveyance of the goods in the appropriate place in accordance with article 135 of the code , or to inform customs authorities when the obligations cannot be complied with in accordance with article 137 and of the code ; ### failure of a person bringing goods into the customs territory of the union to comply with the obligations relating to the conveyance of the goods in the appropriate place in accordance with article 135 of the code , or to inform customs authorities immediately when the obligations cannot be complied with in accordance with article 137 and of the code and of the whereabouts of the goods ;


### failure of the economic operator responsible for non - union goods which are in temporary storage to place those goods under a customs procedure or to re - export them within the time limit in accordance with article 149 of the code ; ### failure of the person keeping the goods in its approved storage facility or in other places designated or approved by the customs authorities responsible for non - union goods which are in temporary storage to place those goods under a customs procedure or to re - export them within the time limit in accordance with article 149 of the code ;


### construction of a building in a free zone without the approval of the customs authorities in accordance with article 244 of the code ; ### construction of a building in a free zone without the prior approval of the customs authorities in accordance with article 244 of the code ;


### where the customs infringement relates to specific goods , a pecuniary fine up to 15 % of the value of the goods ; ### where the customs infringement relates to specific goods , a pecuniary fine of between 5% and 15 % of the value of the goods or of the duties evaded ;


### member states shall ensure that the limitation period is interrupted by any act of the competent authority , notified to the person in question , relating to an investigation or legal proceedings concerning the same customs infringement . the limitation period shall start to run on the day of the interrupting act . ### member states shall ensure that the limitation period is interrupted by any act on the part of the person responsible for the infringement relating to an investigation or legal proceedings concerning the same customs infringement . the limitation period shall continue to run on the day on which the interrupting act comes to an end .


### member states shall co - operate and exchange any information necessary for the proceedings concerning an act or omission constituting a customs infringement referred to in articles 3 to 6 , in particular in case more than one member state has started proceedings against the same person in connection with the same facts . ### member states shall co - operate and exchange any information necessary for the proceedings concerning an act or omission constituting a customs infringement referred to in articles 3 to 6 , in particular in cases where more than one member state has started proceedings against the same person in connection with the same facts . the objective of cooperation between member states shall be to increase the effectiveness of customs checks on goods and to harmonise procedures within the union .


### to this effect , it is necessary to establish general objectives and principles of risk communication , taking into account the respective roles of risk assessors and managers . ### to this effect , it is necessary to establish general objectives and principles of risk communication . in this connection , the respective roles of risk assessors and managers should be taken into account and their mutual independence guaranteed .


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


### it is appropriate to align the composition of the management board of the authority to the common approach on decentralised agencies , in accordance with the joint statement of the european parliament , the council of the european union and the european commission on decentralised agencies of 201222 . _________________ 22 https : / / europa . eu / european - union / sites / europaeu / files / docs / body / joint_statement_and_common_approach_2012_en . pdf . ### it is appropriate to align the composition of the management board of the authority to the common approach on decentralised agencies , in accordance with the joint statement of the european parliament , the council of the european union and the european commission on decentralised agencies of 201222 , while also taking into account the withdrawal of the united kingdom from the eu and the legal effects resulting therefrom . _________________ 22 https : / / europa . eu / european - union / sites / europaeu / files / docs / body / joint_statement_and_common_approach_2012_en . pdf .


### 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 .


### 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 . moreover , there has been a decrease in the number of candidates applying to be members of the scientific panels . six member states provide two thirds of the experts on the scientific panels . as the united kingdom currently provides approximately 20% of the national experts , the problem will be further exacerbated with the withdrawal of the united kingdome from the eu . the system has thus to be strengthened to ensure that a sufficient pool of experts is available to meet the needs of the union risk assessment system in terms of high level of scientific expertise , independence and multidisciplinary expertise .


### the fitness check of the general food law identified certain shortcomings in the long - term capability of the authority to maintain its high - level expertise . in particular , there has been a decrease in the number of candidates applying to be members of the scientific panels . the system has thus to be strengthened and member states should take a more active role to ensure that a sufficient pool of 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 through expert personnel . in particular , there has been a decrease in the number of candidates applying to be members of the scientific panels and the reason for this decline should be examined . the system must encourage candidates to apply 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 .


### 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 .


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


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


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


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


### studies , including tests , submitted by business operators in support of applications for authorisations under union sectoral food law usually comply with internationally recognised principles , which provide a uniform basis for their quality in particular in terms of reproducibility of results . however , issues of compliance with the applicable standards may arise in some cases and this is why national systems are in place to verify such compliance . it is appropriate to provide an additional level of guarantees to reassure the general public on the quality of studies and to lay down an enhanced auditing system whereby member state controls on the implementation of those principles by the laboratories carrying out such studies and tests would be verified by the commission . ### studies , including tests , submitted pursuant to directive 2004 / 10 / ec 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 enhanced auditing system whereby the laboratories carrying out such studies and tests would be verified by the food and veterinary office of the commission .


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


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


### for the purposes of increased transparency and in order to ensure that requests for scientific outputs received by the authority are processed in an effective manner , standard data formats and software packages should be developed . in order to ensure uniform conditions for the implementation of regulation no 178 / 2002 with regard to the adoption of standard data formats and software packages , implementing powers should be conferred on the commission . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council26 . _________________ 26 regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by member states of the commission’s exercise of implementing powers . ### for the purposes of increased transparency and in order to ensure that requests for scientific outputs received by the authority are processed in an effective manner , standard data formats and software packages should be developed . in order to ensure uniform and harmonised conditions for the implementation of regulation no 178 / 2002 with regard to the adoption of standard data formats and software packages , implementing powers should be conferred on the commission . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council26 . _________________ 26 regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by member states of the commission’s exercise of implementing powers .


### for the purposes of ensuring transparency of the risk assessment process , it is also necessary to extend the scope of regulation no 178 / 2002 , currently limited to food law , to also cover applications for authorisations in the context of regulation no 1831 / 2003 as regards feed additives , regulation no 1935 / 2004 as regards food contact materials and regulation no 1107 / 2009 as regards plant protection products . ### for the purposes of ensuring the transparency and independence of the risk assessment process , it is also necessary to extend the scope of regulation no 178 / 2002 , currently limited to food law , to also cover applications for authorisations in the context of regulation no 1831 / 2003 as regards feed additives , regulation no 1935 / 2004 as regards food contact materials and regulation no 1107 / 2009 as regards plant protection products .


### ensure appropriate exchange of information with interested parties in relation to risks associated with the agri - food chain . ### ensure appropriate exchange of information with interested parties in relation to risks associated with the agri - food chain and strategies to avoid them .


### facilitate understanding and dialogue amongst all interested parties ; and , ### facilitate understanding , dialogue and cooperation amongst all interested parties , such as consumers and consumer associations , environmental groups , animal welfare organisations , health organisations , citizens’ associations , scientific research centres , trade unions and also cooperatives , associations of producers and farmers , representatives of small and medium - sized enterprises , and the research and innovation sectors ; and ,


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


### one member appointed by the european parliament , with the right to vote . ### two members and the alternate members appointed by the european parliament and representing the european parliament , with the right to vote .


### at the request of a potential applicant for a food law authorisation , the staff of the authority shall advise on the relevant provisions and the required content of the application for authorisation . the advice provided by the staff of the authority shall be without prejudice and non - committal as to the subsequent assessment of applications for authorisation by the scientific panels . ### the authority shall publish a guidance document including a list of questions and answers regarding the administrative and scientific requirements of an application for authorisation . at the request of a potential applicant for a food law authorisation , the authority shall also offer consultation sessions to explain what information is required and how the various tests and studies necessary to prove the quality , safety and efficacy of the planned product are to be carried out . the advice provided by the authority shall be without prejudice and non - committal as to the subsequent assessment of applications for authorisation by the scientific panels .


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


### the authority shall carry out its activities with a high level of transparency . it shall in particular make public without delay : ### the authority shall ensure a high level of transparency , in line with the aarhus convention and regulation no 1367 / 2006 , without prejudice to regulation no 1049 / 2001 , as well as in line with with directive 2003 / 4 / ec , providing for an active and systematic dissemination to the public of environmental information . it shall in particular make public without delay :


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


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


### commercial information revealing sourcing , market shares or business strategy of the applicant ; and ### commercial information revealing sourcing , innovative ideas for the product / substance , market shares or business strategy of the applicant ;


### commercial information revealing sourcing , market shares or business strategy of the applicant ; and , ### commercial information revealing sourcing , market shares , innovative product ideas or business strategy of the applicant ; and ,


### 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 . ;


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


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


### make public any additional data and information for which the confidentiality request has not been accepted as justified not earlier than two weeks after the notification of its decision to the applicant has taken place , pursuant to point . ### publish non - confidential data and information relating to the application only once a final decision has been taken in respect of the confidentiality request pursuant to this article and the authority has published its scientific opinion . where an applicant withdraws the application pursuant to article 39 because the applicant deems the publication of the information planned by the authority to be too comprehensive , the authority , the commission and the member states shall refrain from publishing any information on the application for authorisation .