### there is still a lack of sufficiently detailed and comparable data at union level to determine the trends and identify possible risk factors that could lead to the development of measures to limit the risk from antimicrobial resistance and to monitor the effect of measures already introduced . therefore it is important to collect data on the sales and use of antimicrobials in animals , data on the use of antimicrobials in humans and data on antimicrobial resistant organisms found in animals , humans and food . to ensure that the information collected can be used effectively , appropriate rules should be laid down concerning the collection and the exchange of data . the member states should be responsible for collecting data on the use of antimicrobials under the coordination of the agency . ### there is still a lack of sufficiently detailed and comparable data at union level to determine the trends and identify possible risk factors that could lead to the development of measures to limit the risk from antimicrobial resistance and to monitor the effect of measures already introduced . therefore it is important to collect data on the sales and use of antimicrobials in animals , data on the use of antimicrobials in humans and data on antimicrobial resistant organisms found in animals , humans and food . better data is needed on how , when , where and why antimicrobials are being used . therefore , the data collected should be broken down by type of antimicrobial , species , disease or infection treated . to ensure that the information collected can be used effectively , appropriate rules should be laid down concerning the collection and the exchange of data . the member states should be responsible for collecting data on the use of antimicrobials under the coordination of the agency .


### by way of derogation from article 111 , where there is no authorised veterinary medicinal product in a member state for a condition affecting a food - producing aquatic species , the veterinarian responsible may , under his direct personal responsibility and in particular to avoid causing unacceptable suffering , treat the animals concerned with any of the following medicinal products : veterinary medicinal products authorised under this regulation in the member state concerned for use with another food - producing aquatic species , or for another condition in the same aquatic species ; b . veterinary medicinal products authorised under this regulation in another member state for use in the same aquatic species or in another food - producing aquatic species for the condition in question or for another condition . ### if there is no product as referred to in paragraph 1 , a medicinal product for human use authorised in the member state concerned in accordance with directive 2001 / 83 / ec or under regulation no 726 / 2004 , or a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription by a person authorised to do so under national law , may be used to treat the animal concerned . antimicrobial medicinal products for human use may be employed , subject to the issuing of a prescription by a veterinarian and approval by the veterinary authority responsible for monitoring the work of the veterinarian in question , only if treatment with a veterinary medicinal product as referred to in paragraph 1 is not possible .


### the commission may , by means of implementing acts , establish a list of veterinary medicinal products authorised in the union for use in terrestrial animals which can be used for treatment of food - producing animals of an aquatic species in accordance with paragraph 1 . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 145 . ### the commission may , by means of implementing acts , establish a list of veterinary medicinal products authorised in the union for use in terrestrial animals which can be used for treatment of food - producing animals of an aquatic species in accordance with paragraph 1 . this provision is strictly limited to closed aquatic systems with specific wastewater treatment facilities . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 145 .


### a requirement to conduct post - authorisation studies . ### a requirement to provide further data based on either post - authorisation studies or on data collected on the performance of the product in the field , where data from the field is identified as more appropriate based on benefit - risk assessment .


### a pharmacovigilance database at union level should be established to record and integrate information of adverse events for all veterinary medicinal products authorised in the union . that database should improve detection of adverse events and should allow and facilitate the pharmacovigilance surveillance and work - sharing between the competent authorities . ### a pharmacovigilance database at union level should be established to record and integrate information of adverse events for all veterinary medicinal products authorised in the union . that database should improve detection of adverse events and should allow and facilitate the pharmacovigilance surveillance and work - sharing between the competent authorities and other concerned authorities such as environmental protection agencies and food safety authorities both on national and union level .


### upon request from the coordination group or the agency , holders of the marketing authorisations for products included in a group of similar products identified for a harmonisation of the summaries of the product characteristics shall submit information concerning their products . ### upon request from the coordination group or the agency , holders of the marketing authorisations for products included in a group of essentially similar products identified for a harmonisation of the summaries of the product characteristics , or individual holders of marketing authorisations for the same product identified for harmonisation of marketing authorisations shall submit information concerning their products , including a proposal for the harmonisation of the summaries of the product characteristics for their medicines belonging to that group .


### member states shall send data on the volume of sales and the use of veterinary antimicrobial medicinal products to the agency . the agency shall analyse the data and publish an annual report . ### member states shall send to the agency data on the volume of sales and the use of veterinary antimicrobial medicinal products to the agency . the agency shall analyse the data and publish an annual report which shall contain guidelines and recommendations as appropriate .


### veterinary prescriptions shall be recognised throughout the union . a veterinary medicinal product prescribed shall be supplied in accordance with applicable national law . ### veterinary prescriptions issued by a veterinarian shall be recognised throughout the union . a veterinary medicinal product prescribed shall be supplied in accordance with applicable national law .


### information about risk mitigation measures to limit antimicrobial resistance development related to the use of veterinary medicinal product . ### information about risk mitigation measures to limit antimicrobial resistance development related to the use of veterinary medicinal product , including specifications that the product is not to be used as a routine prophylactic or metaphylactic measure in food - producing animals , and is not to be used in prophylactic group treatments where there has been no diagnosis of disease .


### ‘ veterinary prescription ‘ means any prescription for a veterinary medicinal product issued by a professional person qualified to do so in accordance with applicable national law ; ### ‘ veterinary prescription ‘ means any prescription for a veterinary medicinal product issued by a veterinarian or another professional person qualified to do so in accordance with applicable national law ;


### only manufacturers , wholesale distributors and retailers authorised specifically to do so in accordance with applicable national law shall be allowed to supply and purchase veterinary medicinal products which have anabolic , anti - infectious , anti - parasitic , anti - inflammatory , hormonal or psychotropic properties or substances which may be used as veterinary medicinal products having those properties . ### only manufacturers , wholesale distributors and retailers authorised specifically to do so in accordance with applicable national law shall be allowed to supply and purchase prescription only veterinary medicinal products which have anabolic , anti - infectious , anti - parasitic , anti - inflammatory , hormonal or psychotropic properties or substances which may be used as veterinary medicinal products having those properties


### by way of derogation from article 111 , where there is no authorised veterinary medicinal product in a member state for a condition affecting a food - producing animal of a non - aquatic species , the veterinarian responsible may , under his direct personal responsibility and in particular to avoid causing unacceptable suffering , exceptionally treat the animal concerned with any of the following : ### by way of derogation from article 111 , where there is no authorised veterinary medicinal product in a member state for a condition affecting an animal of a certain species , the veterinarian responsible may , under his direct personal responsibility and in particular to avoid causing unacceptable suffering , exceptionally treat the animal concerned with any other veterinary medicinal product authorised under this regulation , with the exception of antimicrobial products used prophylactically in an individual or a group where there is no diagnosis of disease in any of the animals :


### a harmonised summary of product characteristics shall be prepared in accordance with the procedure laid down in article 69 for veterinary medicinal products , other than homeopathic veterinary medicinal products , which have the same qualitative and quantitative composition of their active substances and the same pharmaceutical form and for which national marketing authorisations have been granted in different member states before 1 january 2004 . ### a harmonised summary of product characteristics shall be prepared in accordance with the procedure laid down in article 69 for veterinary medicinal products , other than homeopathic veterinary medicinal products , which have the same qualitative and quantitative composition of their active substances , the same pharmaceutical form , and have been shown to be bioequivalent and for which national marketing authorisations have been granted in different member states and for which nationally approved summaries of product characteristics show an unacceptable divergence .


### by way of derogation from article 111 , where there is no authorised veterinary medicinal product in a member state for a condition affecting a non - food producing animal , the veterinarian responsible may , under his / her direct personal responsibility and in particular to avoid causing unacceptable suffering , exceptionally treat the animal concerned with the following : ### by way of derogation from article 111 , where there is no authorised veterinary medicinal product in a member state for a condition affecting a non - food producing animal , the veterinarian responsible may , under his / her direct personal responsibility and in the interest of animal health and welfare , exceptionally treat the animal concerned with the following , with the exception of anticrobial products used as routine prophylactic measure , unless specifically authorised by the committee for medicinal products for veterinary use :


### competent authorities and the agency shall provide the general public , veterinarians and other healthcare professionals with all important information on adverse events relating to the use of a veterinary medicinal product in a timely manner electronically or through other publicly available means of communication . ### competent authorities and the agency shall make public all important information on adverse events relating to the use of a veterinary medicinal product in a timely manner electronically or through other publicly available means of communication .


### if an antimicrobial is administered and used incorrectly , this presents a risk to public or animal health . therefore antimicrobial veterinary medicinal products should only be available on veterinary prescription . persons having the right to prescribe have a key role in ensuring prudent use of antimicrobials and consequently they should not be influenced , directly or indirectly , by economic incentives when prescribing those products . therefore the supply of veterinary antimicrobials by those health professionals should be restricted to the amount required for treatment of the animals under their care . ### if an antimicrobial is administered and used incorrectly , this presents a risk to public or animal health . therefore antimicrobial veterinary medicinal products should only be available on veterinary prescription . persons having the right to prescribe have a key role in ensuring prudent use of antimicrobials . veterinarians have a legal obligation , which is part of their professional code of conduct , to ensure responsible use of veterinary medicinal products . they should not be influenced , directly or indirectly , by economic incentives when prescribing those products . the animal health industry and the veterinarians should together promote responsible use . therefore the supply of veterinary antimicrobials by those health professionals should be restricted to the amount required for treatment of the animals under their care .


### member states should be able to allow exceptional use of veterinary medicinal products without a marketing authorisation where it is necessary to respond to union listed diseases and where the health situation in a member state so requires . ### member states should be able to allow exceptional use of veterinary medicinal products without a marketing authorisation where it is necessary to respond to union listed diseases or new diseases and where the health situation in a member state so requires .


### the package leaflet shall be written and designed to be clear and understandable , in terms that are comprehensible to the general public . ### the package leaflet shall be written and designed to be clear , readable and understandable , in terms that are comprehensible to the general public .


### by way of derogation from article 111 , where there is no authorised veterinary medicinal product in a member state for a condition affecting a food - producing aquatic species , the veterinarian responsible may , under his direct personal responsibility and in particular to avoid causing unacceptable suffering , treat the animals concerned with any of the following medicinal products : veterinary medicinal products authorised under this regulation in the member state concerned for use with another food - producing aquatic species , or for another condition in the same aquatic species ; b . veterinary medicinal products authorised under this regulation in another member state for use in the same aquatic species or in another food - producing aquatic species for the condition in question or for another condition . ### if there is no product as referred to in paragraph 1 , a medicinal product for human use authorised in the member state concerned in accordance with directive 2001 / 83 / ec or under regulation no 726 / 2004 , or a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription by a person authorised to do so under national law , may be used to treat the animal concerned . antimicrobial medicinal products for human use may be employed , subject to the issuing of a prescription by a veterinarian and approval by the veterinary authority responsible for monitoring the work of the veterinarian in question , only if treatment with a veterinary medicinal product as referred to in paragraph 1 is not possible .


### any observation of a lack of efficacy of a veterinary medicinal product following administration to an animal in accordance with the summary of product characteristics ; ### any observation of a lack of efficacy of a veterinary medicinal product , including signs of antimicrobial resistance , following administration to an animal in accordance with the summary of product characteristics ;


### the coordination group shall establish groups of similar products . for each of the groups of similar products , the coordination group shall appoint one member to act as a rapporteur . ### the coordination group shall establish groups of essentially similar products according to article 68 where they consider there are unacceptable differences in smpcs . for each of these groups of essentially similar products , the coordination group shall appoint one member to act as a rapporteur .


### within 120 days of his appointment , the rapporteur shall present the coordination group a report regarding possible harmonisation of summaries of product characteristics for the similar veterinary medicinal products in the group and propose a harmonised summary of products characteristics . ### within 120 days of his appointment , the rapporteur shall present the coordination group a report proposing harmonisation of the conditions governing the use of the group of similar veterinary medicinal products .


### in the event of an opinion in favour of adopting a harmonised summary of the product characteristics , each member state shall vary a marketing authorisation in conformity with the agreement within 30 days of receipt of the information regarding the agreement from the rapporteur . ### in the event of an opinion in favour of adopting a harmonisation of the conditions of use and of harmonising a marketing authorisation , each member state shall vary the marketing authorisation or authorisations of the products in their territory so that the elements listed in paragraph 4 , where they are already included in the summaries of characteristics for a product belonging to that group , are in conformity with the agreement within 30 days of receipt of the information regarding the agreement from the rapporteur . those marketing authorisations for the same product shall , henceforth be considered to be mutual recognition marketing authorisations granted under this regulation .


### in the event of an opinion in favour of adopting a harmonised summary of the product characteristics , each member state shall vary a marketing authorisation in conformity with the agreement within 30 days of receipt of the information regarding the agreement from the rapporteur . ### in the event of an opinion in favour of adopting a harmonisation of conditions of use or of harmonising a marketing authorisation , each member state shall vary the marketing authorisation or authorisations of the products in their territory so that the elements listed in paragraph 4 , where they are already included in the summaries of characteristics for a product belonging to that group , are in conformity with the agreement within 30 days of receipt of the information regarding the agreement from the rapporteur . those marketing authorisations for the same product shall , be eligible to be considered to be mutual recognition marketing authorisations granted under this regulation .


### all therapeutic indications mentioned in the marketing authorisations granted by member states in respect of the similar products in the group ; ### all therapeutic indications and dosages mentioned in the marketing authorisations granted by member states in respect of the essentially similar products in the group ,


### all species mentioned in the marketing authorisations granted by member states in respect of the similar products in the group ; ### all species mentioned in the marketing authorisations granted by member states in respect of the essentially similar products in the group ;


### harmonised summaries of product characteristics for veterinary medicinal products shall contain all of the following information : ### harmonised conditions of use shall contain at least the following information :


### the shortest withdrawal period of those stated in the summaries of the product characteristics . ### a withdrawal period which ensures that consumers are adequately protected .


### by [ 12 months after the date of application of this regulation for op to insert the actual date ] competent authorities shall provide the coordination group with lists of all products for which national marketing authorisations have been granted before 1 january 2004 . ### by [ 12 months after the date of application of this regulation for op to insert the actual date ] competent authorities shall provide the coordination group with lists of all products for which national marketing authorisations have been granted .


### to ensure the quality , and , in particular , the comparability , of data provided by the member states , and for reliable overviews to be drawn up at union level , the data used should be based on the same concepts , and should refer to the same reference date or period . ### to ensure the quality , and , in particular , the comparability , of data provided by the member states , and for reliable overviews to be drawn up at union level , the data used should be based on the same concepts , and should refer to the same reference date or period . such data should be disaggregated by gender and age and include information on regular and irregular flows , the economic impacts of migration and refugee movements , human trafficking , the needs of refugees , migrants and host communities and other issues . 1a _________________ 1a http : / / www . un . org / en / ga / search / view_doc . asp ? symbol=a / res / 71 / 1


### children should be judged in the absence of the public in order to protect their privacy and to facilitate their re - integration into society . in exceptional cases the court may decide that a hearing should be held publicly after it has taken due account of the best interests of the child . ### children should be judged in the absence of the public in order to protect their privacy and to facilitate their re - integration into society . only in exceptional cases should the court be allowed , taking into account the best interests of the child , to hold a hearing in public . member states should seek to protect the privacy of children in connection with criminal proceedings and their outcome , having regard also to breaches that might be committed through the media , including the internet , and to facilitate the re - integration into society of children involved in criminal proceedings , to that end taking steps to prevent discrimination and marginalisation .


### right of children to appear in person at the trial aiming at assessing the question of their guilt ### right of children to appear in person at , and take part in , the trial aiming at assessing the question of their guilt


### when , at the time a person becomes a suspect or accused person in criminal proceedings , that person is above the age of 18 , member states are encouraged to apply the procedural safeguards foreseen by this directive until this person reaches the age of 21 . ### when a person over the age of 18 becomes a suspect or accused person in criminal proceedings for an offence committed while under the age of 18 , this directive should apply until this person reaches the age of 21 .


### the european food safety authority has confirmed that surrogate dams used in cloning suffer in particular from placenta dysfunctions contributing to increased levels of miscarriages21 . this contributes , amongst other things , to the low efficiency of the technique , 6 to 15 % for bovine and 6 % for porcine species , and the need to implant embryo clones into several dams to obtain one clone . in addition , clone abnormalities and unusually large offspring result in difficult births and neonatal deaths . __________________ 21 scientific opinion of the scientific committee on food safety , animal health and welfare and environmental impact of animals derived from cloning by somatic cell nucleus transfer and their offspring and products obtained from those animals http : / / www . efsa . europa . eu / en / topics / topic / cloning . htm ? wtrl=01 . ### the european food safety authority has confirmed that surrogate dams used in cloning suffer in particular from placenta dysfunctions contributing to increased levels of miscarriages21 . this contributes , amongst other things , to the low efficiency of the technique , 6 to 15 % for bovine and 6 % for porcine species , and the need to implant embryo clones into several dams to obtain one clone . clone abnormalities and unusually large offspring result in difficult births and neonatal death . that is why the cloning technique is associated with a high mortality rate . in addition , cloning adversely affects biodiversity and genetic inheritance and creates problems related to resistance to emerging risk factors and new zoonotic agents entering europe . __________________ 21scientific opinion of the scientific committee on food safety , animal health and welfare and environmental impact of animals derived from cloning by somatic cell nucleus transfer and their offspring and products obtained from those animals http : / / www . efsa . europa . eu / en / topics / topic / cloning . htm ? wtrl=01 .


### proposal for a directive of the european parliament and the council on the cloning of animals of the bovine , porcine , ovine , caprine and equine species kept and reproduced for farming purposes ### proposal for a regulation of the european parliament and the council on the cloning of animals kept and reproduced for farming purposes


### taking into account the objectives of the union ' s agricultural policy , the results of the recent scientific assessments of efsa and the animal welfare requirement provided in article 13 of the treaty , it is prudent to provisionally prohibit the use of cloning in animal production for farm purposes of certain species . ### taking into account the objectives of the union ' s agricultural policy , the results of the continuously confirmed scientific assessments of efsa and the animal welfare requirement provided in article 13 of the treaty , it is prudent to provisionally prohibit the use of cloning in animal production for farm purposes .


### member states shall adopt and publish , by 1 april 2019 at the latest , the laws , regulations and administrative provisions necessary to comply with this directive . they shall forthwith communicate to the commission the text of those provisions . ### member states shall adopt and publish , by 1 april 2020 at the latest , the laws , regulations and administrative provisions necessary to comply with this directive . they shall forthwith communicate to the commission the text of those provisions .


### they shall apply those provisions from 1 april 2019 . ### they shall apply those provisions from 1 april 2020 .


### directive 2000 / 84 / ec is repealed with effect from 1 april 2019 . ### directive 2000 / 84 / ec is repealed with effect from 1 april 2020 .


### this directive should not prejudice the right of each member state to decide on the standard time or times for the territories under its jurisdiction and falling under the territorial scope of the treaties , and on further changes thereto . however , in order to ensure that the application of summer - time arrangements by some member states only does not disrupt the functioning of the internal market , member states should refrain from changing the standard time in any given territory under their jurisdiction for reasons related to seasonal changes , be such change presented as a change of time zone . moreover , in order to minimise disruptions , inter alia , to transport , communications and other concerned sectors , they should notify the commission in due time of their intention to change their standard time and subsequently apply the notified changes . the commission should , on the basis of that notification , inform all other member states so that they can take all necessary measures . it should also inform the general public and stakeholders by publishing this information . ### this directive should not prejudice the right of each member state to decide on the standard time or times for the territories under its jurisdiction and falling under the territorial scope of the treaties , and on further changes thereto . however , in order to ensure that the application of summer - time arrangements by some member states only does not disrupt the functioning of the internal market and ensure a coordinated approach , member states should refrain from changing the standard time in any given territory under their jurisdiction for reasons related to seasonal changes , be such change presented as a change of time zone . moreover , in order to minimise disruptions , inter alia , to transport , communications and other concerned sectors , they should notify the commission in due time of their intention to change their standard time . the commission should then assess the potential negative impact of such change on the functioning of the internal market . only after such exchange and proper analysis could a member state apply the notified changes . the commission should , on the basis of that notification , inform all other member states so that they can inform the commission if they have reasons to believe that the change would impact them , if the change is confirmed and take all necessary measures . it should also inform the general public and stakeholders by publishing this information .


### notwithstanding paragraph 1 , member states may still apply a seasonal change of their standard time or times in 2019 , provided that they do so at 1 . 00 a . m . , coordinated universal time , on 27 october 2019 . the member states shall notify this decision in accordance with article 2 . ### notwithstanding paragraph 1 , member states may still apply a seasonal change of their standard time or times in 2020 , provided that they do so at 1 . 00 a . m . , coordinated universal time , on 01 november 2020 . the member states shall notify this decision in accordance with article 2 .


### notwithstanding paragraph 1 , member states may still apply a seasonal change of their standard time or times in 2019 , provided that they do so at 1 . 00 a . m . , coordinated universal time , on 27 october 2019 . the member states shall notify this decision in accordance with article 2 . ### notwithstanding paragraph 1 , member states may still apply a seasonal change of their standard time or times in 2020 , provided that they do so at 1 . 00 a . m . , coordinated universal time , on 27 october 2020 . the member states shall notify this decision in accordance with article 2 .


### within 1 month of the notification , the commission shall inform the other member states thereof and publish that information in the official journal of the european union . ### within 1 month of the notification , the commission shall inform the other member states thereof . the other member states shall inform the commission without undue delay of potential disruptions or negative impact that the proposed notified change might bring . within 3 months of the notification , the commission shall publish an impact assessment of the planned change of standard time or times on possible negative impacts on for example the functioning of the internal market .


### this directive should not prejudice the right of each member state to decide on the standard time or times for the territories under its jurisdiction and falling under the territorial scope of the treaties , and on further changes thereto . however , in order to ensure that the application of summer - time arrangements by some member states only does not disrupt the functioning of the internal market , member states should refrain from changing the standard time in any given territory under their jurisdiction for reasons related to seasonal changes , be such change presented as a change of time zone . moreover , in order to minimise disruptions , inter alia , to transport , communications and other concerned sectors , they should notify the commission in due time of their intention to change their standard time and subsequently apply the notified changes . the commission should , on the basis of that notification , inform all other member states so that they can take all necessary measures . it should also inform the general public and stakeholders by publishing this information . ### this directive should not prejudice the right of each member state to decide on the standard time or times for the territories under its jurisdiction and falling under the territorial scope of the treaties , and on further changes thereto . however , in order to ensure that the application of summer - time arrangements by some member states only does not disrupt the functioning of the internal market and ensure a coordinated approach , member states should refrain from changing the standard time in any given territory under their jurisdiction for reasons related to seasonal changes , be such change presented as a change of time zone . moreover , in order to minimise disruptions , inter alia , to transport , communications and other concerned sectors , they should notify the commission in due time of their intention to change their standard time . the commission should then assess the potential negative impact of such change on the functioning of the internal market . only after such exchange and proper analysis and only if no significant negative impact on the internal market would be identified , could a member state apply the notified changes . the commission should , on the basis of that notification , inform all other member states so that they can inform the commission if they have reasons to believe that the change would impact the internal market and / or them , if the change is confirmed and take all necessary measures . it should also inform the general public and stakeholders by publishing this information .


### this directive should apply from 1 april 2019 , so that the last summer - time period subject to the rules of directive 2000 / 84 / ec should start , in every member state , at 1 . 00 a . m . , coordinated universal time , on 31 march 2019 . member states that , after that summer - time period , intend to adopt a standard time corresponding to the time applied during the winter season in accordance with directive 2000 / 84 / ec should change their standard time at 1 . 00 a . m . , coordinated universal time , on 27 october 2019 , so that similar and lasting changes occurring in different member states take place simultaneously . it is desirable that member states take the decisions on the standard time that each of them will apply as from 2019 in a concerted manner . ### this directive should apply from 1 april 2020 , so that the last summer - time period subject to the rules of directive 2000 / 84 / ec should start , in every member state , at 1 . 00 a . m . , coordinated universal time , on 29 march 2020 . member states that , after that summer - time period , intend to adopt a standard time corresponding to the time applied during the winter season in accordance with directive 2000 / 84 / ec should change their standard time at 1 . 00 a . m . , coordinated universal time , on 01 november 2020 , so that similar and lasting changes occurring in different member states take place simultaneously . it is a prerequisite for the implementation of this scheme that member states take the decisions on the standard time that each of them will apply as from 2020 in a concerted and consensual manner , taking account of their need to remain in their current time zone .


### this directive should apply from 1 april 2019 , so that the last summer - time period subject to the rules of directive 2000 / 84 / ec should start , in every member state , at 1 . 00 a . m . , coordinated universal time , on 31 march 2019 . member states that , after that summer - time period , intend to adopt a standard time corresponding to the time applied during the winter season in accordance with directive 2000 / 84 / ec should change their standard time at 1 . 00 a . m . , coordinated universal time , on 27 october 2019 , so that similar and lasting changes occurring in different member states take place simultaneously . it is desirable that member states take the decisions on the standard time that each of them will apply as from 2019 in a concerted manner . ### this directive should apply from 1 april 2020 , so that the last summer - time period subject to the rules of directive 2000 / 84 / ec should start , in every member state , at 1 . 00 a . m . , coordinated universal time , on 31 march 2020 . member states that , after that summer - time period , intend to adopt a standard time corresponding to the time applied during the winter season in accordance with directive 2000 / 84 / ec should change their standard time at 1 . 00 a . m . , coordinated universal time , on 27 october 2020 , so that similar and lasting changes occurring in different member states take place simultaneously . it is desirable that member states take the decisions on the standard time that each of them will apply as from 2020 in a concerted manner .


### within two months after finalising this assessment of the technical service , the member states shall report to the commission and to the other member states on those monitoring activities . the reports shall contain a summary of the assessment which shall be made publicly available . ### within two months after finalising this assessment of the technical service , the member states shall report to the european agency and to the other member states on those monitoring activities . the reports shall contain a summary of the assessment which shall be made publicly available .


### the member states shall periodically review and assess the functioning of their surveillance activities . such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other member states and the commission . the member state concerned shall make a summary of the results accessible to the public . ### the member states shall periodically review and assess the functioning of their surveillance activities . such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other member states and to the european agency . the member state concerned shall make a summary of the results accessible to the public .


### member states shall establish or appoint the approval authorities and the market surveillance authorities . member states shall notify the commission of the establishment and appointment of such authorities . ### member states shall establish or appoint the approval authorities and the market surveillance authorities . member states shall notify the european agency of the establishment and appointment of such authorities .


### the commission may adopt implementing acts to lay down the criteria for setting out the scale , scope and frequency with which the compliance verification checks of samples taken referred to in paragraph 1 have to be performed . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 87 . ### the european agency shall lay down the criteria for setting out the scale , scope and frequency with which the compliance verification checks of samples taken referred to in paragraph 1 have to be performed .


### the administrative fines imposed by the commission shall not be in addition to the penalties imposed by the member states in accordance with article 89 for the same infringement and shall not exceed eur 30 000 per non - compliant vehicle , system , component or separate technical unit . ### the administrative fines imposed by the european agency shall not be in addition to the penalties imposed by the member states in accordance with article 89 for the same infringement and shall not exceed eur 30 000 per non - compliant vehicle , system , component or separate technical unit .


### the peer - review shall include an on - site visit to a technical service under the responsibility of the reviewed authority . the commission may participate in the review and decide on its participation on the basis of a risk assessment analysis . ### the review by the european agency shall include an on - site visit to a technical service under the responsibility of the reviewed authority .


### where the commission establishes that the vehicles tested or inspected do not comply with the type - approval requirements laid down in this regulation or any of the regulatory acts listed in annex iv or that the type approval has been granted on the basis of incorrect data , it shall require in accordance with article 54 without delay the economic operator concerned to take all appropriate corrective measures to bring the vehicles in compliance with those requirements , or it shall take restrictive measures , either by requiring the economic operator to withdraw the vehicles concerned from the market , or to recall them within a reasonable period of time , depending on the seriousness of the established non - compliance . ### where the european agency establishes that the vehicles tested or inspected do not comply with the type - approval requirements laid down in this regulation or any of the regulatory acts listed in annex iv or that the type approval has been granted on the basis of incorrect data , it shall require in accordance with article 54 without delay the economic operator concerned to take all appropriate corrective measures to bring the vehicles in compliance with those requirements , or it shall take restrictive measures , either by requiring the economic operator to withdraw the vehicles concerned from the market , or to recall them within a reasonable period of time , depending on the seriousness of the established non - compliance .


### the commission shall publish a report of its findings following any compliance verification testing it has carried out . ### the european agency shall publish a report of its findings following any compliance verification testing it has carried out .


### the commission may adopt implementing acts to lay down the common criteria to appoint , review and assess the approval authorities at national level . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 87 . 87 . ### the european agency shall lay down the common criteria to appoint , review and assess the approval authorities at national level .


### the commission shall consult the type - approval authority of the member state where the technical service is established as part of the investigation referred to in paragraph 1 . the type - approval authority of that member state shall provide the commission , upon request , with all relevant information relating to the performance and the compliance with the requirements concerning independence and competence of the technical service concerned . ### the european agency shall consult the type - approval authority of the member state where the technical service is established as part of the investigation referred to in paragraph 1 . the type - approval authority of that member state shall provide the european agency , upon request , with all relevant information relating to the performance and the compliance with the requirements concerning independence and competence of the technical service concerned .


### the member states shall draw up the annual plan for the peer - review , ensuring an appropriate rotation in respect of reviewing and reviewed type - approval authorities , and submit it to the commission . ### the european agency shall draw up its annual review plan for type - approval authorities and shall forward it to the member states .


### the market surveillance authorities of different member states shall coordinate their market surveillance activities , cooperate with each other and share with each other and with the commission the results thereof . where appropriate , the market surveillance authorities shall agree on work - sharing and specialisation . ### the market surveillance authorities of different member states shall coordinate their market surveillance activities , cooperate with each other and share with each other and with the european agency the results thereof . where appropriate , the market surveillance authorities shall agree on work - sharing and specialisation .


### where requested by an approval authority of another member state or the commission , the approval authority that has issued an eu type - approval shall , within one month of receiving that request , send to the requesting approval authority a copy of the eu type - approval certificate , together with the attachments , by means of a common secure electronic exchange system or in the form of a secure electronic file . ### where requested by an approval authority of another member state or the european agency , the approval authority that has issued an eu type - approval shall , within one month of receiving that request , send to the requesting approval authority a copy of the eu type - approval certificate , together with the attachments , by means of a common secure electronic exchange system or in the form of a secure electronic file .


### the approval authority shall without delay inform the approval authorities of the other member states and the commission of its refusal or withdrawal of any eu type - approval , stating the reasons for its decision . ### the approval authority shall without delay inform the approval authorities of the other member states and the european agency of its refusal or withdrawal of any eu type - approval , stating the reasons for its decision .


### the commission shall establish and chair a forum for exchange of information on enforcement . ### the european agency shall establish and chair a forum for exchange of information on enforcement .


### the commission shall organise and carry out , or require to be carried out , on an adequate scale , tests and inspections of vehicles , systems , components and separate technical units already made available on the market , with a view to verifying that those vehicles , systems , components and separate technical units conform to the type approvals and to applicable legislation as well as to ensure the correctness of the type approvals . ### the european agency shall organise and carry out , or require to be carried out , on an adequate scale , tests and inspections of vehicles , systems , components and separate technical units already made available on the market , with a view to verifying that those vehicles , systems , components and separate technical units conform to the type approvals and to applicable legislation as well as to ensure the correctness of the type approvals .


### in order to ensure the functioning of any licensing agreement , information society service providers storing and providing access to the public to large amounts of copyright protected works or other subject - matter uploaded by their users should take appropriate and proportionate measures to ensure protection of works or other subject - matter , such as implementing effective technologies . this obligation should also apply when the information society service providers are eligible for the liability exemption provided in article 14 of directive 2000 / 31 / ec . ### in order to ensure the functioning of any licensing agreement , information society service providers actively and directly involved in allowing users to upload , making works available and promoting works to the public should take appropriate and proportionate measures to ensure protection of works or other subject - matter . such measures should respect the charter of fundamental rights of the european union and should not impose a general obligation on information society service providers to monitor the information which they transmit or store as referred to in article 15 of directive 2000 / 31 / ec .


### member states shall ensure that the service providers referred to in paragraph 1 put in place complaints and redress mechanisms that are available to users in case of disputes over the application of the measures referred to in paragraph 1 . ### member states shall ensure that the service providers referred to in paragraph 1 put in place , in cooperation with rightholders , complaints and redress mechanisms that are available to users in case of disputes over the application of the measures taken for the purpose of ensuring the proper functioning of the licensing agreements referred to in paragraph 1 .


### information society service providers that store and provide to the public access to large amounts of works or other subject - matter uploaded by their users shall , in cooperation with rightholders , take measures to ensure the functioning of agreements concluded with rightholders for the use of their works or other subject - matter or to prevent the availability on their services of works or other subject - matter identified by rightholders through the cooperation with the service providers . those measures , such as the use of effective content recognition technologies , shall be appropriate and proportionate . the service providers shall provide rightholders with adequate information on the functioning and the deployment of the measures , as well as , when relevant , adequate reporting on the recognition and use of the works and other subject - matter . ### where information society service providers offer users content storage services and provide the public with access to content and where such activity is not eligible for the liability exemptions provided for in directive 2000 / 31 / ec , they shall take appropriate and proportionate measures to ensure the functioning of licensing agreements concluded with rightholders . the implementation of such agreements shall respect the fundamental rights of users and shall not impose a general obligation on information society service providers to monitor the information which they transmit or store , in accordance with article 15 of directive 2000 / 31 / ec .


### member states shall facilitate , where appropriate , the cooperation between the information society service providers and rightholders through stakeholder dialogues to define best practices , such as appropriate and proportionate content recognition technologies , taking into account , among others , the nature of the services , the availability of the technologies and their effectiveness in light of technological developments . ### member states shall facilitate , where appropriate , the cooperation between the information society service providers and rightholders referred to in paragraph 1 and collective rights management organisations through stakeholder dialogues to define best practices as regards the measures used for the purposes of paragraph 1 . these measures shall be appropriate and proportionate and take into account , among others , the nature of the services , the availability of the technologies and their effectiveness in light of technological developments .


### the objective of the plan provided for in this regulation should be to contribute to the achievement of the cfp , and in particular , reaching and maintaining msy for the target stocks , implementing the landing obligation for demersal stocks subject to minimum conservation reference size , and promoting a fair standard of living for those who depend on fishing activities , bearing in mind coastal fisheries and socio - economic aspects . it should also implement the ecosystem - based approach to fisheries management in order to minimise negative impacts of fishing activities on the marine ecosystem . it should be coherent with the union’s environmental legislation , in particular the objective of achieving good environmental status by 2020 and the objectives of directive 2009 / 147 / ec29 and council directive 92 / 43 / eec30 . _________________ 28 directive 2008 / 56 / ec of the european parliament and of the council of 17 june 2008 establishing a framework for community action in the field of marine environmental policy 29 directive 2009 / 147 / ec of the european parliament and of the council of 30 november 2009 on the conservation of wild birds . 30 council directive 92 / 43 / eec of 21 may 1992 on the conservation of natural habitats and of wild fauna and flora . ### the objective of the plan provided for in this regulation should be to contribute to the achievement of the cfp , and in particular , restoring and maintaining fish stocks above levels of biomass capable of producing msy for the target stocks , implementing the landing obligation for demersal stocks subject to minimum conservation reference size , and promoting a fair standard of living for those who depend on fishing activities , bearing in mind coastal fisheries and socio - economic aspects . it should also implement the ecosystem - based approach to fisheries management by reducing , and when possible eliminating , the negative effects of fishing activities in the marine environment . that plan should also contribute to the achievement of good environmental status , as laid down in directive 2008 / 56 / ec28 and to the achievement of favourable conservation status for habitats and species as required by directive 2009 / 147 / ec of the european parliament and of the council29 and the council directive 92 / 43 / ec30 respectively . _________________ 28 directive 2008 / 56 / ec of the european parliament and of the council of 17 june 2008 establishing a framework for community action in the field of marine environmental policy 29 directive 2009 / 147 / ec of the european parliament and of the council of 30 november 2009 on the conservation of wild birds . 30 council directive 92 / 43 / eec of 21 may 1992 on the conservation of natural habitats and of wild fauna and flora .


### pursuant to articles 9 and 10 of regulation no 1380 / 2013 , multi - annual plans are to be based on scientific , technical and economic advice . in accordance with those provisions , the multi - annual plan provided for in this regulation should contain objectives , quantifiable targets with clear timeframes , conservation reference points , safeguards and technical measures designed to avoid and reduce unwanted catches . ### pursuant to articles 9 and 10 of regulation no 1380 / 2013 , multi - annual plans are to be based on scientific , technical and economic advice . in accordance with those provisions , the multi - annual plan provided for in this regulation should contain objectives , quantifiable targets with clear timeframes , conservation reference points , safeguards and technical measures designed to avoid and reduce unwanted catches and minimise the impact on the marine environment .


### in order to ensure that holders of supplementary protection certificates already in force are not deprived of their acquired rights , the exception provided for in this regulation should only apply to certificates that are granted on or after a specified date after entry into force , irrespective of when the application for the certificate was first lodged . the date specified should allow a reasonable time for applicants and other relevant market players to adjust to the changed legal context and to make appropriate investment and manufacturing location decisions in a timely way . the date should also allow sufficient time for public authorities to put in place appropriate arrangements to receive and publish notifications of the intention to make , and should take due account of pending applications for certificates . ### in order to ensure that holders of supplementary protection certificates already in force are not deprived of their acquired rights , the exception provided for in this regulation should not apply to certificates that are granted on or applied for before entry into force of this regulation . the date specified should allow a reasonable time for applicants and other relevant market players to adjust to the changed legal context and to make appropriate investment and manufacturing location decisions in a timely way . the date should also allow sufficient time for public authorities to put in place appropriate arrangements to receive and publish notifications of the intention to make , and should take due account of pending applications for certificates .


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


### to this end , this regulation should impose a once - off duty on the person making the product for the exclusive purpose of export , requiring that person to provide certain information to the authority which granted the supplementary protection certificate in the member state where the making is to take place . the information should be provided before the making is intended to start for the first time in that member state . the making and related acts , including those performed in member states other than the one of making in cases where the product is protected by a certificate in those other member states too , should only fall within the scope of the exception where the maker has sent this notification to the competent industrial property authority of the member state of making . the once - off duty to provide information to the authority should apply in each member state where making is to take place , both as regards the making in that member state , and as regards related acts , whether performed in that or another member state , related to that making . the authority should be required to publish that information , in the interests of transparency and for the purpose of informing the holder of the certificate of the maker’s intention . ### to this end , this regulation should impose a once - off duty on the person making the product for the exclusive purpose of export , requiring that person to provide certain information to the authority which granted the supplementary protection certificate in the member state where the making is to take place . the information should be provided before the starts for the first time in that member state . the making should only fall within the scope of the exception where the maker has sent this notification to the competent industrial property authority of the member state of making and where the supplementary protection certificate holder has been duly informed about the name and address of the maker , the certificate number and the intended starting date of the making . on the one hand , this limited information should be sufficient for the certificate holder to assess whether there is or will be an infringement of his certificate , and on the other hand , prevents the disclosure of business sensitive information to the certificate holder . the once - off duty to provide information to the authority should apply in each member state where making is to take place . the authority should be required to publish the information provided by the maker , in the interests of transparency in a timely manner whereby business sensitive information provided to the competent authority should not be published .


### by limiting the scope of the exception to making for the purpose of export outside the union and acts strictly necessary for such making or for the actual export itself , the exception introduced by this regulation will not unreasonably conflict with normal exploitation of the product in the member state where the certificate is in force , nor unreasonably prejudice the legitimate interests of the certificate - holder , taking account of the legitimate interests of third parties . ### by limiting the scope of the exception to making for the purpose of export outside the union , the exception introduced by this regulation should not unreasonably conflict with normal exploitation of the product in the member state where the certificate is in force , nor unreasonably prejudice the legitimate interests of the certificate - holder .


### an indicative list of the intended third country or third countries to which the product is to be exported . ### the third country or third countries to which the product is intended to be exported .


### in those specific and limited circumstances , and in order to create a level playing field between union - based manufacturers and third country manufacturers , it is appropriate to restrict the protection conferred by a supplementary protection certificate so as to allow making for the exclusive purpose of export to third countries and any related acts strictly necessary for making or for the actual export itself . ### in those specific cases , in order to create a level playing field between union - based manufacturers and third country manufacturers , it is appropriate to restrict the protection conferred by a supplementary protection certificate , so as to allow making of generic products , biosimilars and active ingredients for the exclusive purpose of export to third countries .


### making for the exclusive purpose of export to third countries ; or ### making of a medicinal product for the exclusive purpose of export to third countries , including the supply and the import of active ingredients for the purpose of making the medicinal product ;


### that exception should cover the making of the product , including the product which corresponds to the medicinal product protected by a supplementary protection certificate in the territory of a member state , for the exclusive purpose of export to third countries , as well as any upstream or downstream acts by the maker or by third parties in a contractual relationship with the maker , where such acts would otherwise require the consent of the certificate - holder , and are strictly necessary for making for the purpose of export or for the actual export itself . for instance , such acts may include the supply and import of active ingredients for the purpose of making the medicinal product to which the product covered by the certificate corresponds , or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations . ### that exception should cover the making of the product , including the product which corresponds to the medicinal product protected by a supplementary protection certificate in the territory of a member state , for the exclusive purpose of export to third countries .


### the notification sent to an authority as referred to in article 4 shall be published by that authority within 15 days of receipt of the notification . ; ### the authority as referred to in article 9 shall publish the information listed in article 4 , paragraph 3 , points , and as well as any changes thereof without undue


### by limiting the scope of the exception to making for the purpose of export outside the union and acts strictly necessary for such making or for the actual export itself , the exception introduced by this regulation will not unreasonably conflict with normal exploitation of the product in the member state where the certificate is in force , nor unreasonably prejudice the legitimate interests of the certificate - holder , taking account of the legitimate interests of third parties . ### by limiting the scope of the exception to making for the purpose of export outside the union and acts strictly necessary for such making or for the actual export itself , the exception introduced by this regulation should not unreasonably conflict with normal exploitation of the product in the member state where the certificate is in force , nor unreasonably prejudice the legitimate interests of the certificate - holder , taking account of the legitimate interests of third parties .


### the aim of this regulation is to ensure that manufacturers established in the union are able to compete effectively in those third country markets where supplementary protection does not exist or has expired . it is intended to complement the efforts of the union’s trade policy to ensure open markets for union - based manufacturers of medicinal products . indirectly , it is also intended to put those manufacturers in a better position to enter the union market immediately after expiry of the relevant supplementary protection certificate . it would also help to serve the aim of fostering access to medicines in the union by helping to ensure a swifter entry of generic and biosimilar medicines onto the market after expiry of the relevant certificate . ### the aim of this regulation is to ensure that manufacturers established in the union are able to compete effectively in those third country markets where supplementary protection does not exist or has expired . it should thereby complement the efforts of the union’s trade policy to ensure open markets for union - based manufacturers of medicinal products .


### the strengthening of cooperation among member states at eu level is necessary to help member states to prevent and deter undeclared work more efficiently and effectively . ### the strengthening of cooperation among member states at eu level is necessary to help member states to prevent and deter undeclared work more efficiently and effectively . the goal of the strengthened cooperation must be to encourage declared work by making declared work associated with less bureaucracy and administration thereby making sure that undeclared work is the less attractive option .


### organise peer reviews to follow member states progress when fighting undeclared work , including support for the implementation of country - specific recommendations related to fight or prevent undeclared work issued by the council . ### organise peer reviews to follow member states progress when fighting undeclared work .


### a maximum of 8 observers representing social partners at cross - industry level , ### a maximum of 8 observers ensuring balanced representation of social partners at cross - industry level ,


### the commission shall inform regularly the european parliament and the council about the activities of the platform . ### the commission shall inform the european parliament and the council about the activities of the platform annually and whenever needed as well , upon request .


### improving cooperation between member states ' different enforcement authorities at eu level to prevent and deter undeclared work , including bogus self - employment , more efficiently and effectively , ### improving cooperation between member states ' different enforcement authorities at eu level to prevent and deter undeclared work , more efficiently and effectively ,


### cluster ' food and natural resources ' ; ### cluster ' agriculture , food and natural resources ' ;


### eur 10 000 000 000 for cluster ' food and natural resources ' ; ### eur 10 000 000 000 for cluster ' agriculture , food and natural resources ' ;


### the commission shall be empowered to adopt delegated acts in accordance with article 49 to specify further the minimum standards for low - carbon and positive carbon impact benchmarks , including : ### the administrator of a climate transition benchmark or a negative carbon benchmark shall formalise , document and make public any methodology used for the calculation of these benchmarks , including :


### the commission shall be empowered to adopt delegated acts in accordance with article 49 to specify further the minimum standards for low - carbon and positive carbon impact benchmarks , including : ### the commission shall be empowered to adopt delegated acts in accordance with article 49 to specify further the minimum standards for positive environmental impact benchmarks in line with the paris agreement commitments as implemented in union law , including :


### as of [ publications office , please insert the date occurring three years after the date of application of this regulation ] , the following criterion shall be complied with : the polymer shall be capable of undergoing physical , biological decomposition , such that most of it ultimately decomposes into carbon dioxide , biomass and water . it shall have at least 90 % of the organic carbon converted into co2 in maximum 24 months , in a biodegradability test as specified points - below . ### as of [ publications office , please insert the date occurring five years after the date of application of this regulation ] , the commission shall adopt delegated acts , pursuant to article 42 of this regulation , introducing a standard for the biodegradability by setting a timeframe in which at least 90% of the organic carbon is converted into co2 , after the claimed release time of the polymer has been fulfilled , and a biodegradability test that complies with the following criterion : the polymer is capable of undergoing physical , biological decomposition , such that most of it ultimately decomposes into carbon dioxide , biomass and water .


### a ce marked fertilising product may contain plants , plant parts or plant extracts having undergone no other processing than cutting , grinding , centrifugation , pressing , drying , freeze - drying or extraction with water . ### a ce marked fertilising product may contain plants , plant parts or plant extracts having undergone no other processing than cutting , grinding , centrifugation , sieving , milling , centrifugation , pressing , drying , freeze - drying , buffering , extrusion , frost - treatment , radiation , sanitation by using heat , or extraction with water .


### for certain recovered wastes within the meaning of directive 2008 / 98 / ec of the european parliament and of the council20 , a market demand for their use as fertilising products has been identified . furthermore , certain requirements are necessary for the waste used as input in the recovery operation and for the treatment processes and techniques , as well as for fertilising products resulting from the recovery operation , in order to ensure that the use of those products does not lead to overall adverse environmental or human health impacts . for ce marked fertilising products , those requirements should be laid down in this regulation . therefore , as of the moment of compliance with all the requirements of this regulation , such products should cease to be regarded as waste within the meaning of directive 2008 / 98 / ec . __________________ 20 directive 2008 / 98 / ec of the european parliament and of the council on waste and repealing certain directives . ### for certain recovered wastes such as struvite , biochar and ash - based products within the meaning of directive 2008 / 98 / ec of the european parliament and of the council20 , a market demand for their use as fertilising products has been identified . furthermore , certain requirements are necessary for the waste used as input in the recovery operation and for the treatment processes and techniques , as well as for fertilising products resulting from the recovery operation , in order to ensure that the use of those products does not lead to overall adverse environmental or human health impacts . for ce marked fertilising products , those requirements should be laid down in this regulation . therefore , as of the moment of compliance with all the requirements of this regulation , such products should cease to be regarded as waste , within the meaning of directive 2008 / 98 / ec , and accordingly it should be possible for products containing or consisting of such recovered waste materials to access the internal market . to ensure legal clarity and to further stimulate the incentive among producers to make more use of valuable waste streams , the scientific analyses and the setting of process requirements on union level for such products should start immediately after the entry into force of this regulation . accordingly , the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission in respect of defining , without unnecessary delay , larger or additional categories of component materials eligible for the use in the production of ce marked fertilising products such as struvite , biochar and ash - based products . __________________ 20 directive 2008 / 98 / ec of the european parliament and of the council on waste and repealing certain directives .


### organic carbon shall be present in the ce marked fertilising product by at least 3 % by mass . ### organic carbon shall be present in the ce marked fertilising product by at least 1 % by mass .


### an organic soil improver shall consist exclusively of material of solely biological origin , excluding material which is fossilized or embedded in geological formations . ### an organic soil improver shall consist exclusively of material of solely biological origin , excluding material which is fossilized or embedded in geological formations , with the exemption of leonardite , lignite and peat .


### proposal for a regulation of the european parliament and of the council laying down rules on the making available on the market of ce marked fertilising products and amending regulations no 1069 / 2009 and no 1107 / 2009 ### proposal for a regulation of the european parliament and of the council laying down rules on the making available on the market of ce marked fertilising products and amending regulations no 1069 / 2009 , no 1107 / 2009 , directive 91 / 676 / eec and regulation no 1907 / 2006 ,


### the conditions for making fertilisers available on the internal market have been partially harmonised through regulation no 2003 / 2003 of the european parliament and of the council15 , which almost exclusively covers fertilisers from mined or chemically produced , inorganic materials . there is also a need to make use of recycled or organic materials for fertilising purposes . harmonised conditions for making fertilisers made from such recycled or organic materials available on the entire internal market should be established in order to provide an important incentive for their further use . the scope of the harmonisation should therefore be extended in order to include recycled and organic materials . __________________ 15 regulation no 2003 / 2003 of the european parliament and of the council of 13 october 2003 relating to fertilisers . ### the conditions for making fertilisers available on the internal market have been partially harmonised through regulation no 2003 / 2003 of the european parliament and of the council15 , which almost exclusively covers fertilisers from mined or chemically produced , inorganic materials . there is also a need to make use of recycled or organic materials for fertilising purposes . harmonised conditions for making fertilisers made from such recycled or organic materials available on the entire internal market should be established in order to provide an important incentive to promote their further use . this is vital in order to decrease the dependence of the union on imports of nutrients from third countries and contribute to the circular economy . the scope of the harmonisation should therefore be extended in order to include recycled and organic materials . __________________ 15 regulation no 2003 / 2003 of the european parliament and of the council of 13 october 2003 relating to fertilisers .


### a ce marked fertilising product that has undergone a recovery operation and complies with the requirements laid down in this regulation shall be considered to comply with the conditions laid down in article 6 of directive 2008 / 98 / ec and shall , therefore , be considered as having ceased to be waste . ### where a material that was waste has undergone a recovery operation in accordance with this regulation and a compliant ce marked fertilising product contains or consists of that material , the material shall be considered to comply with the conditions laid down in article 6 of directive 2008 / 98 / ec and shall , therefore , be considered as having ceased to be waste from the moment the eu declaration of conformity is drawn up .


### of solely biological origin , excluding material which is fossilized or embedded in geological formations . ### of solely biological origin , excluding material which is fossilized or embedded in geological formations , with the exemption of leonardite , lignite and peat .


### forms for the declared nutrient and other declared quality criteria electric conductivity ph quantity by volume quantity determination of materials with particle size greater than 60 mm quantity determination of pre - shaped gm water - soluble nitrogen water - soluble phosphorus pentoxide water - soluble potassium oxide forms for the declared nutrient and other declared quality criteria electric conductivity ph quantity by volume quantity determination of materials with particle size greater than 60 mm quantity determination of pre - shaped gm water - soluble nitrogen water - soluble phosphorus pentoxide water - soluble potassium oxide ### permissible tolerances for the declared parameter ± 50% relative deviation at the time of manufacture ± 75% relative deviation at any time in the distribution chain ± 0 , 7 at the time of manufacture ± 1 , 0 at any time in the distribution chain - 5% relative deviation at the time of manufacture - 25% relative deviation at any time in the distribution chain - 5% relative deviation at the time of manufacture - 25% relative deviation at any time in the distribution chain - 5% relative deviation at the time of manufacture - 25% relative deviation at any time in the distribution chain ± 50% relative deviation at the time of manufacture ± 75% relative deviation at any time in the distribution chain ± 50% relative deviation at the time of manufacture ± 75% relative deviation at any time in the distribution chain ± 50% relative deviation at the time of manufacture ± 75% relative deviation at any time in the distribution chain permissible tolerances for the declared parameter ± 50% relative deviation at the time of manufacture ± 75% relative deviation at any time in the manufacturing chain ± 0 , 7 at the time of manufacture ± 1 , 0 at any time in the manufacturing chain - 5% relative deviation at the time of manufacture - 25% relative deviation at any time in the manufacturing chain - 5% relative deviation at the time of manufacture - 25% relative deviation at any time in the manufacturing chain - 5% relative deviation at the time of manufacture - 25% relative deviation at any time in the manufacturing chain ± 50% relative deviation at the time of manufacture ± 75% relative deviation at any time in the manufacturing chain ± 50% relative deviation at the time of manufacture ± 75% relative deviation at any time in the manufacturing chain ± 50% relative deviation at the time of manufacture ± 75% relative deviation at any time in the manufacturing chain


### name of the micro - organism ; ### name of the micro - organism by strain level ;


### - 2 % by mass of total nitrogen , out of which 0 , 5 % by mass of the ce marked fertilising product shall be organic nitrogen , or ### - 1 % by mass of total nitrogen , out of which 0 , 5 % by mass of the ce marked fertilising product shall be organic nitrogen , or


### member states should determine how relevant country - specific recommendations adopted in accordance with article 121 of the tfeu and relevant council recommendations adopted in accordance with article 148 of the tfeu are taken into account in the preparation of programming documents . during the 2021–2027 programming period , member states should regularly present to the monitoring committee and to the commission the progress in implementing the programmes in support of the csrs . during a mid - term review , member states should , among other elements , consider the need for programme modifications to accommodate relevant csrs adopted or modified since the start of the programming period . ### member states should take into account country - specific recommendations adopted in accordance with article 121 of the tfeu and council recommendations adopted in accordance with article 148of the tfeu in the preparation of programming documents . during the2021–2027 programming period , member states should regularly present to the monitoring committee and to the commission the progress in implementing the programmes in support of the csrs . during a mid - term review , member states should , among other elements , consider the need for programme modifications to accommodate relevant csrs adopted or modified since the start of the programming period .


### a greener , low - carbon europe by promoting clean and fair energy transition , green and blue investment , the circular economy , climate adaptation and risk prevention and management ; ### low - carbon and circular europe economy by promoting zero emission energy transition , low carbon and blue investment , the circular economy , climate adaptation and risk prevention and management ;


### 2023 : 0 . 5 % ; ### 2023 : 1 % ;


### 2026 : 0 . 5 ### 2026 : 2 %


### 2025 : 0 . 5 % ; ### 2025 : 2 % ;


### market failures , investment needs and complementarity with other forms of support ; ### market failures , investment needs at national regional and local level , and complementarity with other forms of support ;


### the commission shall adopt a decision by means of an implementing act approving the programme no later than six months after the date of submission of the programme by the member state . ### the commission shall adopt a decision by means of an implementing act approving the programme no later than three months after the date of submission of the programme by the member state .


### the co - financing rate for the cohesion fund at the level of each priority shall not be higher than 70 % . ### the co - financing rate for the cohesion fund at the level of each priority shall not be higher than 85 % .


### the commission shall assess the programme and its compliance with this regulation and with the fund - specific regulations , as well as its consistency with the partnership agreement . in its assessment , the commission shall , in particular , take into account relevant country - specific recommendations . ### the commission shall assess the compliance of the programme with the investment needs at national , regional and local level , its compliance with this regulation and with the fund - specific regulations , as well as its consistency with the investment strategy and the simplification measures proposed . in its assessment , the commission shall also take into account relevant country - specific recommendations .


### 40 % for the more developed regions . ### 50 % for the more developed regions .


### the commission shall approve the amendment of a programme no later than six months after its submission by the member state . ### the commission shall approve the amendment of a programme as soon as possible but no later than three months after its submission by the member state .


### 55 % for the transition regions ; ### 65 % for the transition regions ;


### the related types of actions , including a list of planned operations of strategic importance , and their expected contribution to those specific objectives and to macro - regional strategies and sea - basin strategies , where appropriate ; ### a list of planned operations and their expected contribution to the specific objectives and to macro - regional strategies and sea - basin strategies , where appropriate ;


### for point of paragraph 1 , management fees shall be performance based . where bodies implementing a holding fund and / or specific funds , pursuant to article 53 , are selected through a direct award of contract , the amount of management cost and fees paid to those bodies that can be declared as eligible expenditure shall be subject to a threshold of up to 5 % of the total amount of programme contributions disbursed to final recipients in loans , equity or quasi - equity investments or set aside as agreed in guarantee contracts . ### for point of paragraph 1 , management fees shall include a performance element disbursed to final recipients in loans , equity or quasi - equity investments or set aside as agreed in guarantee contracts committed to such bodies . where bodies implementing a holding fund and / or specific funds , pursuant to article 53 , are selected through a direct award of contract , the amount of management cost and fees paid to each of those bodies that can be declared as eligible expenditure shall be determined as follows : –in recognition of the fact that setting up financial instruments implies costs not linked to disbursements to final recipients , a base fee subject to a threshold of up to 1 % per annum of the total amount of programme contributions paid to the holding fund and / or specific funds ; plus –with a view to incentivising performance of the financial instruments , a performance fee to be determined between the parties , subject to an overall threshold of up to 6 % of the total amount of programme contributions disbursed to final recipients in loans , equity or quasi - equity investments or set aside as agreed in guarantee contracts . that threshold is not mandatory : where the selection of bodies implementing financial instruments is made through a competitive selection process in accordance with the applicable law and the competitive process establishes the need for a higher level of management costs and fees ; and where the management cost or fee is paid in relation to the use of resources paid back before the end of the eligibility period under article 56 .


### interest and other gains attributable to support from the funds paid to financial instruments shall be used under the same objective or objectives as the initial support from the funds , either within the same financial instrument ; or , following the winding up of the financial instrument , in other financial instruments or other forms of support , until the end of the eligibility period . ### interest and other gains attributable to support from the funds paid to financial instruments supported by the fund shall be used under the same objective or objectives , including the reimbursement of management costs and payment of fees , as the initial support from the funds , either within the same financial instrument ; or , where this is not practicable , in other financial instruments or other forms of support , until the end of the eligibility period .


### the member state may transfer during the programming period an amount of up to 5 % of the initial allocation of a priority and no more than 3 % of the programme budget to another priority of the same fund of the same programme . for the programmes supported by the erdf and esf + , the transfer shall only concern allocations for the same category of region . ### the member state may transfer during the programming period an amount of up to 7 % of the initial allocation of a priority and no more than 5 % of the programme budget to another priority of the same fund of the same programme . for the programmes supported by the erdf and esf + , the transfer shall only concern allocations for the same category of region .


### the selected policy objectives indicating by which of the funds and programmes they will be pursued and a justification thereto , and where relevant , a justification for using the delivery mode of the investeu , taking into account relevant country - specific recommendations ; ### the list of investment needs at national , regional and local level specifying the link with the funds objectives , invest eu or other centralised managed funds as well as other sources of financing for those outside finance outside cohesion policy . the link with country - specific recommendations should be mentioned where relevant .


### where an urban , local or other territorial authority or body carries out tasks falling under the responsibility of the managing authority other than the selection of operations , the authority shall be identified by the managing authority as an intermediate body . ### the urban , local or other territorial authority or body which implements the territorial strategy shall be identified as a managing authority and implement all operations related to this function .


### challenges in administrative capacity and governance ; ### challenges in administrative capacity and governance and simplification measures ;


### 70 % for the less developed regions ; ### 85 % for the less developed regions ;


### the principle of partnership is a key feature in the implementation of the funds , building on the multi - level governance approach and ensuring the involvement of civil society and social partners . in order to provide continuity in the organisation of partnership , commission delegated regulation no 240 / 201413should continue to apply . _________________ 13 commission delegated regulation no 240 / 2014 of 7 january 2014 on the european code of conduct on partnership in the framework of the european structural and investment funds . ### the principle of partnership is a key feature in the implementation of the funds , building on the multi - level governance approach and ensuring the involvement of civil society and social partners , as well as local and regional levels of government . in order to provide continuity in the organisation of partnership , commission delegated regulation no 240 / 201413 should continue to apply . _________________ 13 commission delegated regulation no 240 / 2014 of 7 january 2014 on the european code of conduct on partnership in the framework of the european structural and investment funds .


### the erdf , the esf + and the emff may support community - led local development . ### the erdf , the esf + and the emff shall support community - led local development .


### financial instruments shall provide support to final recipients only for new investments expected to be financially viable , such as generating revenues or savings , and which do not find sufficient funding from market sources . ### financial instruments shall provide support to final recipients and their investments expected to be financially viable , such as generating revenues or savings , and which do not find sufficient funding from market sources . such support may target investments in both tangible and intangible assets as well as working capital , in compliance with applicable union state aid rules . investments to be supported through financial instruments are those not physically completed or fully implemented at the date of the investment decision .


### resources for the european territorial cooperation goal shall amount to 2 . 5 % of the global resources available for budgetary commitment from the funds for the period 2021 - 2027 . ### resources for the european territorial cooperation goal shall amount to 3 % of the global resources available for budgetary commitment from the funds for the period 2021 - 2027 .


### the member state may transfer during the programming period an amount of up to 5 % of the initial allocation of a priority and no more than 3 % of the programme budget to another priority of the same fund of the same programme . for the programmes supported by the erdf and esf + , the transfer shall only concern allocations for the same category of region . ### without commission approval , the member state may transfer during the programming period an amount of up to 30% of the initial allocation of a priority and no more than 30 % of the programme budget to another priority of the same fund of the same programme .


### led by local action groups composed of representatives of public and private local socio - economic interests , in which no single interest group controls the decision - making ; ### led by local action groups composed of representatives of public and private local socio - economic interests , without the participation of local authorities in which no single interest group controls the decision - making ;


### however , the commission shall implement the amount of support from the cohesion fund transferred to the connecting europe facility , the european urban initiative , interregional innovative investments , the amount of support transferred from the esf + to transnational cooperation , the amounts contributed to investeu37 and technical assistance at the initiative of the commission under direct or indirect management in accordance with [ points and of article 62 ] of the financial regulation . _________________ 37 [ regulation no [ … ] on [ … ] ] . ### however , the commission shall implement the amount of support from the cohesion fund transferred to the connecting europe facility , the amount of support transferred from the esf + to transnational cooperation , the amounts contributed to investeu37 and technical assistance at the initiative of the commission under direct or indirect management in accordance with [ points and of article 62 ] of the financial regulation . _________________ 37 [ regulation no [ … ] on [ … ] ] .


### another territorial tool supporting initiatives designed by the member state for investments programmed for the erdf under the policy objective referred in article 4 . ### another territorial tool supporting initiatives designed by the member state for investments programmed for the erdf under the policy objectives referred to in article 4 .


### member states should determine how relevant country - specific recommendations adopted in accordance with article 121 of the tfeu and relevant council recommendations adopted in accordance with article 148 of the tfeu are taken into account in the preparation of programming documents . during the 2021–2027 programming period , member states should regularly present to the monitoring committee and to the commission the progress in implementing the programmes in support of the csrs . during a mid - term review , member states should , among other elements , consider the need for programme modifications to accommodate relevant csrs adopted or modified since the start of the programming period . ### member states should take into account country - specific recommendations adopted in accordance with article 121 of the tfeu and council recommendations adopted in accordance with article 148of the tfeu in the preparation of programming documents . during the2021–2027 programming period , member states should regularly present to the monitoring committee and to the commission the progress in implementing the programmes in support of the csrs . during a mid - term review , member states should , among other elements , consider the need for programme modifications to accommodate relevant csrs adopted or modified since the start of the programming period .


### the co - financing rate for interreg programmes shall be no higher than 70 % . ### the co - financing rate for interreg programmes shall be no higher than 85 % .


### the member state shall review the programme taking into account the observations made by the commission . ### the member state shall review the programme within one month , taking into account the observations made by the commission .


### the audit authority shall carry out system audits and audits of operations in accordance with articles 71 , 73 or 77 at the level of bodies implementing the financial instrument and , in the context of guarantee funds , at the level of bodies delivering the underlying new loans . ### the audit authority shall carry out system audits and audits of operations in accordance with articles 71 , 73 or 77 at the level of bodies implementing the financial instrument and , in the context of guarantee funds , at the level of bodies delivering the underlying new loans or other risk - sharing instruments .


### reflecting the importance of tackling climate change in line with the union ' s commitments to implement the paris agreement and the united nations sustainable development goals , the funds will contribute to mainstream climate actions and to the achievement of an overall target of 25 % of the eu budget expenditure supporting climate objectives . ### reflecting the importance of tackling climate change in line with the union ' s commitments to implement the paris agreement and the united nations sustainable development goals , the funds will contribute to mainstream climate actions and to the achievement of an overall target of 30 % of the eu budget expenditure supporting climate objectives .