### feed business operators manufacturing , whether they operate in a feed mill , with a specially equipped lorry or on - farm , storing , transporting or placing on the market medicated feed and intermediate products , should be approved by the competent authority , in line with the approval system laid down in regulation no 183 / 2005 , in order to ensure both feed safety and product traceability . provision should be made for a transition procedure concerning establishments already approved under directive 90 / 167 / eec . ### feed business operators manufacturing , whether they operate in a feed mill , with a specially equipped lorry or on - farm , storing , transporting or placing on the market medicated feed and intermediate products , should be approved by the competent authority , in line with the approval system laid down in regulation no 183 / 2005 , in order to ensure both feed safety and product traceability . provision should be made for a transition procedure concerning establishments already approved under directive 90 / 167 / eec . the approval and registration procedure under regulation no 183 / 2005 should take account of the specific features of primary production with a view to ensuring that in particular small or remote farms can optimise livestock care through the use of medicated feed .


### in addition to article 11 , articles 12 and 14 of regulation no 767 / 2009 , the labelling of medicated feed and intermediate products shall comply with annex iii to this regulation . ### in addition to article 11 and articles 12 , 14 , 15 and 17 of regulation no&#160 ; 767 / 2009 , the labelling of medicated feed and intermediate products shall comply with annex iii to this regulation .


### use in food - producing animals ### use


### 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 .


### feed business operators manufacturing , storing , transporting and placing on the market medicated feed and intermediate products shall put in place , implement and maintain a permanent written procedure or procedures based on the hazard analysis and critical control points system as provided for in regulation no 183 / 2005 . ### feed business operators manufacturing , storing , transporting and placing on the market medicated feed and intermediate products shall put in place , implement and maintain a permanent written procedure or procedures based on the hazard analysis and critical control points system as provided for in regulation no 183 / 2005 . established control systems for on - farm mixers may be retained , provided it is ensured that the principles of the haccp are complied with .


### in addition to article 11 , articles 12 and 14 of regulation no 767 / 2009 , the labelling of medicated feed and intermediate products shall comply with annex iii to this regulation . ### in addition to article 11 , articles 12 and 14 of regulation no&#160 ; 767 / 2009 , the labelling of medicated feed and intermediate products , where these are not fed directly to livestock , shall comply with annex iii to this regulation .


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


### information on the person who has issued the prescription , including at least his name and address . ### information on the veterinarian or another professional person qualified to do so in accordance with applicable national law who has issued the prescription , including at least his name and address .


### medicated feed should be marketed in sealed containers for safety reasons and to protect user ' s interest . ### medicated feed should be marketed in sealed containers for safety reasons and to protect user ' s interest . however , appropriate derogations should be provided for 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 .


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


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


### ' distributor ' : any feed business operator that supplies medicated feed , packaged and ready for use , to the animal holder ; ### ' distributor ' : any feed business operator that supplies medicated feed , packaged and ready for use , to other distributors and directly to the animal holder ;


### 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 . the original prescription shall be kept by the manufacturer or , where appropriate , the distributor . the veterinarian or another professional person qualified to do so in accordance with applicable national law 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 .


### medicated feed and intermediate products may be manufactured and stored before the prescription referred to in article 15 is issued . this provision shall not apply to on - farm mixers or in case of manufacture of medicated feed or intermediate products from veterinary medicinal products in accordance with articles 10 or 11 of directive 2001 / 82 / ec . ### medicated feed and intermediate products may be manufactured and stored for production - related reasons before the prescription referred to in article 15 is issued . in such cases the nature and quantity of the medicated feed which is manufactured or stored must be notified to the competent authority . this provision shall not apply to on - farm mixers or mobile mixers or in case of manufacture of medicated feed or intermediate products from veterinary medicinal products in accordance with articles 10 or 11 of directive 2001 / 82 / ec .


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


### 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 . ### 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 . this shall not apply to agricultural establishments which feed on - farm - manufactured medicated feed to their own animals .


### 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 :


### the placing on the market , including import , and use of medicated feed and intermediate products ; ### the placing on the market , including import , and use of medicated feed and intermediate products intended for both non - food and food - producing animals ;


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


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


### 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 .


### taking into account the serious public health risk posed by resistance to antimicrobials , it is appropriate to limit the use of medicated feed containing antimicrobials for food - producing animals . preventive use or use to enhance the performance of food - producing animals should in particular not be allowed . ### taking into account the serious public health risk posed by resistance to antimicrobials , it is appropriate to limit the use of medicated feed containing antimicrobials . prophylactic use of antibiotics should in particular not be allowed .


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


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


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


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


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


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


### taking into account the likely evolution of the workload of the general court , the number of judges should be fixed at 56 at the end of a three - stage process , it being understood that at no point of time can there be more than two judges sitting at the general court appointed upon a proposal by the same member state . ### taking into account the evolution of the workload of the general court , the number of judges should be fixed at 56 at the end of a three - stage process , two judges each being appointed upon a proposal by each of the member states , it being understood that at no point of time can there be more than two judges sitting at the general court appointed upon proposal by the same member state .


### a list of behaviour which should be considered as infringing union customs legislation and give rise to sanctions should be established . those customs infringements should be fully based on the obligations stemming from the customs legislation with direct references to the code . this directive does not determine whether member states should apply administrative or criminal law sanctions in respect of those customs infringements . ### a list of behaviour which should be considered as infringing union customs legislation and give rise to sanctions should be established . those customs infringements should be fully based on the obligations stemming from the customs legislation with direct references to the code . this directive provides that member states should apply administrative sanctions in respect of those customs infringements . however , it should also be possible for member states to apply criminal sanctions where a customs infringement is committed intentionally and where the financial consequences of the infringement exceed eur 10 000 in duties evaded . this clarification is needed in order to ensure that criminal sanctions can only be used to combat unlawful trade .


### 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 start to run again on the day on which the interrupting act comes to an end .


### member states shall ensure that when determining the type and the level of sanctions for the customs infringements referred to in articles 3 to 6 , the competent authorities shall take into account all relevant circumstances , including , where appropriate : ### member states shall ensure that , when determining the type and the level of sanctions for the customs infringements referred to in articles 3 to 6 , the competent authorities take into account the mitigating and aggravating circumstances as follows , resulting in the sanction being decreased or increased within the limits set in articles 9 and 11 . aggravating circumstances : the basic amount of the sanction may be increased where the competent authorities find that there are aggravating circumstances , as follows :


### member states shall ensure that effective , proportionate and dissuasive sanctions are imposed for the customs infringements referred to in article 3 within the following limits : ### member states shall ensure that effective , proportionate , dissuasive and non - criminal sanctions are imposed for the customs infringements referred to in article 3 , within the following limits :


### 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 and the transparency necessary to ensure the proper functioning of the internal market as regards ways in which infringements are handled by the different customs authorities , but also prevents the achievement of a level playing field for economic operators in the customs union because it has an impact on their access to customs simplifications and facilitations .


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


### a list of behaviour which should be considered as infringing union customs legislation and give rise to sanctions should be established . those customs infringements should be fully based on the obligations stemming from the customs legislation with direct references to the code . this directive does not determine whether member states should apply administrative or criminal law sanctions in respect of those customs infringements . ### a list of behaviour which should be considered as infringing union customs legislation and give rise to sanctions should be established . those customs infringements should be fully based on the obligations stemming from the customs legislation with direct references to the code . this directive does not determine whether member states should apply administrative or criminal law sanctions in respect of those customs infringements . this directive provides that member states should apply administrative sanctions in respect of those customs infringements .


### member states shall ensure that effective , proportionate and dissuasive sanctions are imposed for the customs infringements referred to in articles 5 and 6 within the following limits : ### member states shall ensure that effective , proportionate , dissuasive and non - criminal sanctions are imposed for the customs infringements referred to in articles 5 and 6 , within the following limits :


### member states shall ensure that when determining the type and the level of sanctions for the customs infringements referred to in articles 3 to 6 , the competent authorities shall take into account all relevant circumstances , including , where appropriate : ### member states shall ensure that , when determining the type and the level of sanctions for the customs infringements referred to in articles 3 to 6 , the competent authorities take into account the following aggravating circumstances , resulting in the sanction being increased within the limits laid down in articles 9 and 11 . aggravating circumstances shall also be taken into consideration from the very beginning of the process , that is to say , during the determination of whether a customs infringement has been committed and taking into account the principle of proportionality and the appropriateness of the sanctions . the classification of the customs infringement in terms of its gravity and the amount of the sanction to be imposed shall be increased within the limits laid down in this directive where the competent authorities find that there are aggravating circumstances , such as :


### 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 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 , who are already subject to different sets of rules across the union \ , because it has an impact on their access to customs simplifications and facilitations .


### effective application of sanctions and exercise of powers to impose sanctions by competent authorities ### aggravating circumstances


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


### at the request of a potential applicant for a food law authorisation , the staff of the authority shall advise on the relevant provisions and the required content of the application for authorisation . the advice provided by the staff of the authority shall be without prejudice and non - committal as to the subsequent assessment of applications for authorisation by the scientific panels . ### at the request of a potential applicant for a food law authorisation , the staff of the authority may , in written form , advise on the relevant provisions and the required content of the application for authorisation . the staff of the authority providing the advice referred to in the first sentence shall not be involved in any scientific work , including within the meaning of paragraph 5f of article 28 , that is directly or indirectly relevant to the application which is the subject of the advice . the advice provided by the staff of the authority shall immediately be documented and published on the authority’s website . it shall contribute to the development of a frequently asked questions document with the purpose of developing more comprehensive guidelines for applicants and reducing the need for individual correspondence . the advice provided shall be without prejudice and non - committal as to the subsequent assessment of applications for authorisation by the scientific panels . within [ 36 months after the entry into force of this regulation ] , the commission shall assess the impact of this article on the functioning of the authority . particular attention shall be paid to the additional workload and mobilisation of staff , and whether it has led to any shift in the allocation of the autority’s resources at the expense of activities of public interest .


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


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


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


### the 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 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 , risk mitigation measures 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 .


### 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 .


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


### 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 .


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


### food safety is a sensitive matter of prime interest for all union citizens . while maintaining the principle that the burden is on the industry to prove compliance with union requirements , it is important to establish an additional verification tool to address specific cases of high societal importance where there is a controversy on safety issues , namely the commissioning of additional studies with the objective of verifying evidence used in the context of risk assessment . considering that it would be financed by the union budget and that the use of this exceptional verification tool should remain proportionate , the commission should be responsible for triggering the commissioning of such verification studies . account should be taken of the fact that in some specific cases the studies commissioned may need to have a wider scope than the evidence at stake . ### food safety is a sensitive matter of prime interest for all union citizens . while maintaining the principle that the burden is on the industry to prove compliance with union requirements , it is important to establish an additional verification tool to address specific cases of high societal importance where there is a controversy on safety issues , namely the commissioning of additional studies with the objective of verifying evidence used in the context of risk assessment . considering that it would be financed by the union budget and that the use of this exceptional verification tool should remain proportionate , the authority should be responsible for triggering the commissioning of such verification studies . account should be taken of the fact that in some specific cases the studies commissioned may need to have a wider scope than the evidence at stake .


### not later than five years after the date referred to in article [ entry into force of the regulation amending the gfl ] , and every five years thereafter , the commission shall assess the authority’s performance in relation to its objectives , mandate , tasks , procedures and location , in accordance with commission guidelines . the evaluation shall address the possible need to modify the mandate of the authority , and the financial implications of any such modification . ### not later than five years after the date referred to in article [ entry into force of the regulation amending the gfl ] , and every five years thereafter , the authority jointly with the commission shall commission an independent evaluation of their performance in relation to their objectives , mandates , tasks , procedures and locations . the evaluation shall address the possible need to modify the mandate of the authority , and the financial implications of any such modification . the evaluation shall take into account the views of the stakeholders , at both community and national level .


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


### 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 make public the application for authorisation , relevant supporting information and any supplementary information supplied by the applicant , as well as its scientific opinions and opinions from the competent authorities referred to in article 4 of directive 2001 / 18 / ec , in accordance with article 38 , articles 39 to 39f and article 40 of regulation no 178 / 2002 and taking into account article 30 of this regulation . ### the authority shall make public the application for authorisation , relevant supporting information and any supplementary information supplied by the applicant , at the same time as its scientific opinion and opinions from the competent authorities referred to in article 4 of directive 2001 / 18 / ec , in accordance with article 38 , articles 39 to 39f and article 40 of regulation no 178 / 2002 and taking into account article 30 of this regulation . .


### foster public understanding of the risk analysis process so as to enhance confidence in its outcome ; ### foster public understanding of the risk analysis process so as to enhance confidence in its outcome , including the provision of clear and consistent information regarding the respective tasks , powers and responsibilities of risk assessors and risk managers ;


### when the authority identifies that specific expertise is missing in a panel or several panels , the executive director shall propose additional members of the panel for appointment to the management board in accordance with the procedure laid down in paragraph 5 . ### when the management board identifies that specific expertise is missing in a panel or several panels , the executive director shall propose additional members of the panel for appointment to the management board in accordance with the procedure laid down in paragraph 5 .


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


### experience shows that the role of the management board of the authority is focussed on administrative and financial aspects and does not impact on the independence of the scientific work performed by the authority . it is thus appropriate to include representatives of all member states in the management board of the authority , while providing that those representatives should have experience in particular on risk assessment . ### experience shows that the role of the management board of the authority is focussed on administrative and financial aspects and does not impact on the independence of the scientific work performed by the authority . it is thus appropriate to include representatives of all member states , including representatives of civil society and industry , in the management board of the authority , while providing that those representatives should have experience in particular in assessing and managing risks and problems and that they have no conflict of interest with the applicants .


### be accessible , including to those not directly involved in the process , while taking into account confidentiality and protection of personal data . ### be accessible , including to those not directly involved in the process , while taking into account confidentiality of data and intellectual property and protection of personal data .


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


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


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


### the authority shall make public the application for authorisation , relevant supporting information and any supplementary information supplied by the applicant , as well as its scientific opinions and opinions from the competent authorities referred to in article 4 of directive 2001 / 18 / ec , in accordance with article 38 , articles 39 to 39f and article 40 of regulation no 178 / 2002 and taking into account article 30 of this regulation . ### the authority shall make public the application for authorisation , relevant supporting information and any supplementary information supplied by the applicant and the opinions from the competent authorities referred to in article 4 of directive 2001 / 18 / ec , at the same time as its scientific opinion , in accordance with article 38 , articles 39 to 39f and article 40 of regulation no 178 / 2002 and taking into account article 30 of this regulation .


### 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 commission and the member states shall take the necessary measures so that information received by them under union food law for which confidential treatment has been requested is not made public until a decision on the confidentiality request has been taken by the authority and has become definitive . the commission and the member states shall also take the necessary measures so that information for which confidential treatment has been accepted by the authority is not made public . ### the commission and the member states shall take the necessary measures so that information received by them under union food law for which confidential treatment has been requested is not made public until a decision on the confidentiality request has been taken by the authority and its scientific opinion has been published . the commission and the member states shall also take the necessary measures so that information for which confidential treatment has been accepted by the authority is not made public .


### 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 .


### if an applicant in the context of an authorisation procedure withdraws or has withdrawn an application , the authority , the commission and the member states shall respect the confidentiality of commercial and industrial information as accepted by the authority in accordance with articles 39to 39f . the application shall be considered withdrawn as of the moment the written request is received by the competent body that had received the original application . where the withdrawal of the application takes place before the authority has decided on the relevant confidentiality request , the authority , the commission and the member states shall not make public the information for which confidentiality has been requested . ### if an applicant in the context of an authorisation procedure withdraws or has withdrawn an application , the authority , the commission and the member states shall respect the confidentiality of commercial and industrial information as accepted by the authority in accordance with articles 39to 39f . the application shall be considered withdrawn as of the moment the written request is received by the competent body that had received the original application . where the withdrawal of the application takes place before the authority has decided on the relevant confidentiality request , the authority , the commission and the member states shall not make public any information relating to the planned application .


### 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 .


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


### the court of auditors shall transmit to the commission and the institutions concerned by 30 june , any observations which are , in its opinion , such that they should appear in the annual report . those observations shall remain confidential and shall be subject to an adversarial procedure . each institution shall address its reply to the court of auditors by 15 october . the replies of institutions other than the commission shall be sent to the commission at the same time . ### article 162 is replaced by the following : ' 1 . the court of auditors shall transmit to the commission and the institutions concerned by 30 june , any observations which are , in its opinion , such that they should appear in the annual report . those observations shall remain confidential and shall be subject to an adversarial procedure . each institution shall address its reply to the court of auditors by 15 october . the replies of institutions other than the commission shall be sent to the commission at the same time . they shall nevertheless be published in the end of the adversarial procedure . '


### for the situations referred to in points , , and of article 106 , a panel shall be set up by the commission at the request of an authorising officer of the commission or of an executive agency or a joint panel at the request of another institution , body or european office . the panel , on behalf of the commission and its executive agencies , other institutions , bodies or european offices , shall apply the following procedure : ### for the situations referred to in points , , and of article 106 , a panel shall be set up by the commission at the request of an authorising officer of the commission or of an executive agency or a joint panel at the request of another institution , body or european office . the panel shall be a high - level body composed of members with technical and legal competences . the commission shall ensure that it can work independently . the panel , on behalf of the commission and its executive agencies , other institutions , bodies or european offices , shall apply the following procedure :


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


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


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


### the establishment or improvement of interoperability solutions shall , where appropriate , build on or be accompanied by the sharing of experience and the exchange and promotion of good practices . the sharing of experience and good practices between all stakeholders and relevant public consultations shall be encouraged ### the establishment or improvement of interoperability solutions shall , where appropriate , build on or be accompanied by the sharing of experience and the exchange and promotion of good practices . this shall include a due consideration of the impact of interoperability solutions on privacy and data protection . the sharing of experience and good practices between all stakeholders and relevant public consultations shall be encouraged .


### the isa2 programme should be an instrument for public - sector modernisation in the union . ### the isa2 programme is one of the many instruments for the encouragement of public - sector modernisation in the union . modernising european administrations and increasing their interoperability is a prerequisite for the completion of the digital single market , which will lead to the modernisation of traditional industry , and which has estimated gains of eur 500 billion in additional annual growth , and which can give a substantial boost to job creation in the union . member states should continue to modernise their administrations by improving business processes and ict infrastructures . this decision should be in line with the commission ' s commitment to enable european citizens fully to benefit from interoperable e - services , from e - government to e - health , prioritising the removal of obstacles such as unconnected e - services in order to make the single market freedoms of the union ' go digital ' .


### interoperability is directly connected with , and dependent on the use of , standards and common specifications . the isa2 programme should promote and , where appropriate , support the partial or full standardisation of existing interoperability solutions . this should be achieved in cooperation with other standardisation activities at union level , european standardisation organisations and other international standardisation organisations . ### the lack of interoperability often undermines the implementation of digital end - to - end services and the development of one - stop shops for businesses and citizens . interoperability is directly connected with , and dependent on the use of , open standards and common specifications . the isa2 programme should promote and , where appropriate , support the partial or full standardisation of existing interoperability solutions . this should be achieved in cooperation with other standardisation activities at union level , european standardisation organisations and other international standardisation organisations .


### the evaluations shall examine issues such as the relevance , effectiveness , efficiency , utility , sustainability and coherence of programme actions . the final evaluation shall , in addition , examine the extent to which the programme has achieved its objective . ### the findings drawn from the interim evaluation of the evaluations shall examine issues such as the relevance , effectiveness , efficiency , utility , sustainability and coherence of programme actions . the final evaluation shall , in addition , examine the extent to which the programme has achieved its objective ; particular attention should be paid to the needs expressed by the users of that programme .


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


### investment in facilities for the treatment of residual waste ; ### investment in facilities for the treatment of residual waste , except for the outermost regions ;


### member states of group 3 shall allocate at least 35 % of their total erdf resources under priorities other than for technical assistance to po 1 , and at least 30 % to po 2 . ### member states of group 3 shall allocate at least 25 % of their total erdf resources under priorities other than for technical assistance to po 1 , and at least 20 % to po 2 .


### in an increasingly interconnected world and in view of the demographic and migration dynamics , it is clear that union migration policy requires a common approach that relies on the synergies and complementarities of the different funding instruments . in order to ensure coherent , strong and consistent support for solidarity and responsibility - sharing efforts between member states in managing migration , the erdf should provide support to facilitate the long - term integration of migrants . ### in an increasingly interconnected world and in view of the demographic and migration dynamics , it is clear that union migration policy requires a common approach that relies on the synergies and complementarities of the different funding instruments . in order to ensure coherent , strong and consistent support for solidarity and responsibility - sharing efforts between member states in managing migration , the erdf and the cohesion fund should provide support to facilitate the long - term integration of migrants .


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


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


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


### smelters and refiners are an important point in global mineral supply chains as they are typically the last stage in which due diligence can effectively be assured by collecting , disclosing and verifying information on the mineral’s origin and chain of custody . after this stage of transformation it is often considered unfeasible to trace back the origins of minerals . a union list of responsible smelters and refiners could therefore provide transparency and certainty to downstream companies as regards supply chain due diligence practices . ### importers are an important point in global mineral and metals supply chains as they are typically better placed to collect , disclose and verify information on the mineral’s and metal`s origin and chain of custody . a union list of responsible importers could therefore provide transparency and certainty to downstream undertakings , which themselves must comply , depending on their position in the supply chain , with due diligence practices as defined in this regulation and the oecd due diligence guidance .


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


### the commission shall make a decision to publish , including on the internet , a list of competent authorities in accordance with the template in annex iii and the regulatory procedure referred to in paragraph 2 of article 13 . the commission shall update the list regularly . ### the commission shall make a decision to publish , including on the internet , a list of competent authorities using the template in annex iii and in accordance with the advisory procedure referred to in article 13 . the commission shall update the list regularly .


### the checks referred to in paragraph 1 shall be conducted by taking a risk - based approach . in addition , checks may be conducted when a competent authority is in possession of relevant information , including on the basis of substantiated concerns provided by third parties , concerning the compliance by a responsible importer with this regulation . ### the checks referred to in paragraph 1 shall be conducted by taking a risk - based approach . in addition , checks shall be conducted when a competent authority is in possession of relevant information , including on the basis of substantiated concerns provided by third parties , concerning the compliance by a responsible operator with this regulation .


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


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


### union companies have expressed their interest through the public consultation in the responsible sourcing of minerals and reported on current industry schemes designed to pursue their corporate social responsibility objectives , customer requests , or the security of their supplies . however , union companies have also reported countless difficulties in the exercise of supply chain due diligence because of lengthy and complex global supply chains involving a high number of operators that are often insufficiently aware or ethically unconcerned . the cost of responsible sourcing and their potential impact on competitiveness notably on smes should be monitored by the commission . ### union companies have expressed their interest through the public consultation in the responsible sourcing of minerals and reported on current industry schemes designed to pursue their corporate social responsibility objectives , customer requests , or the security of their supplies . the voluntary self - certification system serves as a competitive advantage for participating union companies . however , union companies have also reported countless difficulties in the exercise of supply chain due diligence because of lengthy and complex global supply chains involving a high number of operators that are often insufficiently aware or ethically unconcerned . moreover , a mandatory system is undesirable and should be avoided if possible in future reviews of the regulation , since such a mandatory system may act as an entry barrier for new smes , which can be abused by already established union companies with the resources to manage a mandatory system . the cost of responsible sourcing and their potential impact on competitiveness notably on smes should be closely monitored by the commission .


### ' responsible smelters or refiners ' means smelters or refiners in the supply chain of the responsible importer ; ### ' responsible smelters or refiners ' means smelters or refiners in the supply chain of the responsible operator ;


### the commission shall adopt the list in accordance with the template in annex ii and the regulatory procedure referred to in article 13 . the oecd secretariat shall be consulted . ### the commission shall adopt the list using the template in annex ii and in accordance with the advisory procedure referred to in article 13 . the oecd secretariat shall be consulted .


### ' importer ' means any natural or legal person declaring minerals or metals within the scope of this regulation for release for free circulation within the meaning of article 79 of council regulation no 2913 / 199213 ; __________________ 13 council regulation no 2913 / 92 of 12 october 1992 establishing the community customs code . ### ' operator ' means any natural or legal person that places minerals or metals within the scope of this regulation on the market for the first time ; ' placing on the market ' means the supply by any means , irrespective of the selling technique used , of products for the first time on the internal market for distribution or use in the course of commercial activity whether in return for payment or free of charge , including the supply by means of distance communication as defined in directive 97 / 7 / ec ; ' placing on the market ' also includes the supply on the internal market of products derived from minerals or metals within the scope of this regulation already placed on the internal market ;


### ' importer ' means any natural or legal person declaring minerals or metals within the scope of this regulation for release for free circulation within the meaning of article 79 of council regulation no 2913 / 199213 ; __________________ 13 council regulation no 2913 / 92 of 12 october 1992 establishing the community customs code . ### ' importer ' means any natural or legal person established in the union in whose name the customs declaration is made for the physical introduction into the customs territory of the union of the minerals or metal within the scope of this regulation for release for free circulation within the meaning of article 79 of council regulation no . 2913 / 199213 ; __________________ 13 council regulation no 2913 / 92 of 12 october 1992 establishing the community customs code .


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


### smelters and refiners are an important point in global mineral supply chains as they are typically the last stage in which due diligence can effectively be assured by collecting , disclosing and verifying information on the mineral ' s origin and chain of custody . after this stage of transformation it is often considered unfeasible to trace back the origins of minerals . a union list of responsible smelters and refiners could therefore provide transparency and certainty to downstream companies as regards supply chain due diligence practices . ### smelters and refiners are an important point in global mineral supply chains as they are typically the last stage in which due diligence can effectively be assured by collecting , disclosing and verifying information on the mineral ' s origin and chain of custody . after this stage of transformation it is often considered unfeasible to trace back the origins of minerals . the same applies to recycled metals , which have undergone even further steps in the transformation process . a union list of responsible smelters and refiners could therefore provide transparency and certainty to downstream companies as regards supply chain due diligence practices .


### ' conflict - affected and high - risk areas ' means areas in a state of armed conflict , fragile post - conflict as well as areas witnessing weak or non - existent governance and security , such as failed states , and widespread and systematic violations of international law , including human rights abuses ; ### ' conflict - affected and high - risk areas ' means areas in a state of armed conflict , fragile post - conflict as well as areas witnessing weak or non - existent governance and security , such as failed states , and widespread and systematic violations of international law , including human rights abuses ; the commission shall decide a list of conflict - affected and high - risk areas after the consultation of a committee consisting of members states and industry representatives ;


### ' self - certification ' means the act of declaring one ' s adherence to the obligations relating to management systems , risk management , third - party audits and disclosure as set out in this regulation ; ### ' self - certification ' means the act of declaring one ' s adherence to the obligations relating to management systems , risk management , third - party conformity assessment and disclosure as set out in this regulation ;


### the checks referred to in paragraph 1 shall be conducted by taking a risk - based approach . in addition , checks may be conducted when a competent authority is in possession of relevant information , including on the basis of substantiated concerns provided by third parties , concerning the compliance by a responsible importer with this regulation . ### the checks referred to in paragraph 1 shall be conducted by taking a risk - based approach . in addition , checks shall be conducted when a competent authority is in possession of relevant information , including on the basis of substantiated concerns provided by third parties , concerning the compliance by a responsible importer with this regulation .


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


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


### independent third - party audits carried out in accordance with article 6 of this regulation . ### the certificate issued as result of the third party conformity assessment carried out in accordance with article 6 of this regulation .


### the volume of national intermodal operations constitutes 19 , 3 % of the total intermodal transport in the union . such operations currently do not benefit from the support measures provided by directive 92 / 106 / eec because of the limited scope of the definition of combined transport . however , the negative effect of national road transport operations , and notably greenhouse gas emissions and congestion , have an impact beyond the national borders . therefore it is necessary to broaden the scope of directive 92 / 106 / eec to national combined transport operations in order to support the further development of combined transport in the union , hence an increase in the modal shift from road to rail , inland waterways and short sea shipping . ### the volume of national intermodal operations constitutes 19 , 3% of the total intermodal transport in the union . such operations currently do not benefit from the support measures provided by directive 92 / 106 / eec because of the limited scope of the definition of combined transport . however , the negative effect of national road transport operations , and notably greenhouse gas emissions and congestion , have an impact beyond the national borders . therefore it is necessary to broaden the scope of directive 92 / 106 / eec to national combined transport operations in order to support the further development of combined transport in the union , hence an increase in the modal shift from road to rail , inland waterways and short sea shipping . the derogation to cabotage rules continues , however , to apply only to international combined transport operations between member states . the member states will have to carry out effective checks to ensure that those rules are observed and to promote the harmonisation of working and social conditions across the various modes of transport and the different member states .


### - the distance of the final road transport leg as the crow flies between the place of transhipment and the place where the combined transport operation ends in the union ) ; ### - the distance of the final road transport leg between the place of transhipment and the place where the combined transport operation ends in the union ;


### the negative impact of transport on air pollution , greenhouse gas emissions , accidents , noise and congestion continue to pose problems to the economy , health and well - being of european citizens . despite the fact that road transport is the main contributor of those negative effects , road freight transport is estimated to grow by 60 per cent by 2050 . ### the overall aim is to establish a resource - efficient multimodal transport network and to reduce the negative impact of transport on air pollution , greenhouse gas emissions , accidents , noise and congestion .


### the road leg distance limit may be exceeded for combined road / rail transport operations , when authorised by the member state or member states on whose territory the road leg takes place , in order to reach the geographically nearest transport terminal which has the necessary operational transhipment capability for loading or unloading in terms of transhipment equipment , terminal capacity and appropriate rail freight services . ### the road leg distance limit may be exceeded for combined transport operations , in order to reach the geographically nearest transhipment terminal – including in cases when that is in another member state – which has the necessary operational transhipment capability for loading or unloading in terms of transhipment equipment , terminal capacity , terminal opening hours and appropriate rail freight services . with a view to avoiding differences in interpretation between member states , the commission shall adopt a delegated act in accordance with article 10 , supplementing this directive , laying down the criteria under which combined transport operators may exceed the road leg distance limit for combined transport operations . the member states shall be responsible for ensuring compliance with these rules by operators and shall forward to the commission the necessary information concerning authorisations , including the justification for granting derogations and the duration thereof .


### directive 92 / 106 / eec should be simplified and its implementation improved by reviewing the economic incentives to combined transport , with the aim of encouraging the shift of goods from road transport to modes which are more environmentally friendly , safer , more energy efficient and cause less congestion . ### directive 92 / 106 / eec should be simplified and its implementation improved by reviewing the economic incentives to combined transport , with the aim of improving the competitiveness of rail and waterborne transport in comparison to road transport .


### a description , signed by the shipper , of the combined transport operation routing including at least the following details for each leg , including for each mode of transport which constitutes the non - road leg , of the operation within the union : ### a description of the combined transport operation routing , signed by the responsible operator for the planning , including at least the following details for each leg , including for each mode of transport which constitutes the non - road leg , of the operation within the union :


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


### the road leg distance limit may be exceeded for combined road / rail transport operations , when authorised by the member state or member states on whose territory the road leg takes place , in order to reach the geographically nearest transport terminal which has the necessary operational transhipment capability for loading or unloading in terms of transhipment equipment , terminal capacity and appropriate rail freight services . ### exceeding the road leg distance limit specified in this paragraph for combined road / rail transport operations shall be allowed by the member state or member states on whose territory the road leg takes place , in order to reach the geographically nearest transhipment terminal which has the necessary operational transhipment capability for loading or unloading in terms of transhipment equipment , terminal capacity , terminal opening times and appropriate rail freight services , in the absence of a transhipment terminal fulfilling all of these conditions within the distance limit .


### - the distance of the initial road transport leg as the crow flies between the place of shipment and the first transhipment terminal ; ### - the distance of the initial road transport leg between the place of shipment and the first transhipment terminal ;


### directive 92 / 106 / eec should be simplified and its implementation improved by reviewing the economic incentives to combined transport , with the aim of encouraging the shift of goods from road transport to modes which are more environmentally friendly , safer , more energy efficient and cause less congestion ### directive 92 / 106 / eec should be simplified and its implementation improved by reviewing and enhancing the economic incentives to combined transport , with the aim of encouraging the shift of goods from road transport to less polluting modes which are more environmentally friendly , safer , more energy efficient and cause less congestion . in view of that , research on , and the sharing of , best practices on the shift from road to rail should be encouraged .


### a description , signed by the shipper , of the combined transport operation routing including at least the following details for each leg , including for each mode of transport which constitutes the non - road leg , of the operation within the union : ### a description of the combined transport operation routing , signed by the responsible operator for the planning , where the signature can mean an electronic signature , including at least the following details for each leg , including for each mode of transport which constitutes the non - road leg , of the operation within the union :


### the increase of operational efficiency in existing terminals . ### the increase of operational efficiency in existing transhipment terminals which enable the establishment of a network of terminals in the union to meet freight traffic demand , by fostering , among other things , the integration of connected systems and the automation of operations as well as investment in digital logistics , information and communications technologies and intelligent transport systems .


### support measures should also be reviewed on a regular basis by the members states to ensure their effectiveness and efficiency . ### support measures should also be reviewed on a regular basis by the members states to ensure their effectiveness and efficiency , and corrective measures should be taken as needed . the commission should provide , on the basis of information supplied by the member states , an analysis of the various measures the member states undertake and the effectiveness of those measures , and should promote the sharing of good practice .


### the evidence may be provided through a transport document fulfilling the requirements laid down in article 6 of council regulation no 11 , or through other existing transport documents such as the convention on the contract for the international carriage of goods by road transport document or the uniform rules concerning the contract of international carriage of goods by rail transport document . ### the evidence may be provided through a transport document fulfilling the requirements laid down in article 6 of council regulation no 11 , or through other existing transport documents such as the convention on the contract for the international carriage of goods by road transport document , the convention on the contract for the carriage of goods by inland waterways or the uniform rules concerning the contract of international carriage of goods by rail transport document .


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


### support measures should be coordinated , as needed , between member states and the commission . ### to ensure the avoidance of possible overlapping investments between member states in close proximity , support measures should be coordinated , as needed , between member states and the commission by means of close cooperation between the member sates’ competent authorities .