### where the taking - up and pursuit of certain employed or self - employed activities are conditional on complying with certain provisions relating to specific professional qualifications , laid down directly or indirectly by the member states , it is necessary to ensure that such provisions are justified by public interest objectives , such as those within the meaning of the treaty , namely public policy , public security and public health or by overriding reasons of general interest , recognised as such in the case - law of the court of justice . it is important to ensure that public interest objectives are adequately identified in order to determine the intensity of the regulation . for example , in order to ensure a high level of protection of public health , member states should enjoy a margin of discretion to decide on the degree of protection which they wish to afford to public health and on the way in which that protection is to be achieved . it is also necessary to clarify that among the overriding reasons of general interest , recognised by the court of justice , are preserving the financial equilibrium of the social security system ; the protection of consumers , recipients of services and workers ; the safeguarding of the proper administration of justice ; fairness of trade transactions ; combating fraud and prevention of tax evasion and avoidance ; road safety ; the protection of the environment and the urban environment ; the health of animals ; intellectual property ; the safeguarding and conservation of the national historic and artistic heritage , social policy objectives and cultural policy objectives . according to settled case - law , purely economic reasons , having essentially protectionist aims , as well as purely administrative reasons , such as carrying out controls or gathering statistics cannot constitute an overriding reason of general interest . ### where the taking - up and pursuit of certain employed or self - employed activities are conditional on complying with certain provisions relating to specific professional qualifications , laid down directly or indirectly by the member states , it is necessary to ensure that such provisions are justified by public interest objectives , such as those within the meaning of the treaty , namely public policy , public security and public health or by overriding reasons of general interest . it is important to ensure that public interest objectives are adequately identified in order to determine the intensity of the regulation . it is also useful to provide certain examples of overriding reasons of general interest which have been recognised by the european court of justice , whose case - law may continue to evolve . such examples include : preserving the financial equilibrium of the social security system ; the protection of consumers , recipients of services and workers ; ensuring safe , healthy and secure working conditions ; the safeguarding of the proper administration of justice ; fairness of trade transactions ; combating fraud , prevention of tax evasion and avoidance and effectiveness of fiscal supervision ; transport safety ; guaranteeing the quality of products and services ; promotion of research and development ; ensuring high standards of education ; the protection of the environment and the urban environment ; the health of animals ; intellectual property ; the safeguarding and conservation of the national historic and artistic heritage , social policy objectives , including the encouragement of employment and recruitment and the maintenance of employment , and cultural policy objectives . according to settled case - law , purely economic reasons , having essentially protectionist aims , as well as purely administrative reasons , such as carrying out controls or gathering statistics cannot constitute an overriding reason of general interest . control measures should be considered justified if they are needed in order to ensure compliance with provisions justified by public interest objectives .


### “4a . the information held in the register referred to in paragraph 3a of this article with respect to any other trusts than those referred to in article 7b of directive 2009 / 101 shall be accessible to any person or organisation that can demonstrate a legitimate interest . the information accessible to persons and organisations that can demonstrate a legitimate interest shall consist of the name , the month and year of birth , the nationality and the country of residence of the beneficial owner as defined in article 3 . ### “4a . the information held in the register referred to in paragraph 3a of this article shall be accessible to the public in an open data format . the information accessible to the public shall consist of the name , the date of birth , the nationality and the country of residence of the beneficial owner as defined in article 3 , as well as the nature and extent of the beneficial interest held . member states shall ensure that , in exceptional circumstances and under specific terms to be laid down in national law , a settlor and / or a trustee may request national authorities not to make that information about the trust or legal arrangement in question publicly accessible , for the purpose of protecting the privacy of vulnerable beneficiaries . where the national authority agrees to that request , a statement shall be inserted in the public register stating that the available information on the trust or legal arrangement is incomplete . it shall always be possible to challenge such decisions .


### in the case of corporate entities : the natural person who ultimately owns or controls a legal entity through direct or indirect ownership of a sufficient percentage of the shares or voting rights or ownership interest in that entity , including through bearer shareholdings , or through control via other means , other than a company listed on a regulated market that is subject to disclosure requirements consistent with union law or subject to equivalent international standards which ensure adequate transparency of ownership information . a shareholding of 25 % plus one share or an ownership interest of more than 25 % in the customer held by a natural person shall be an indication of direct ownership . a shareholding of 25 % plus one share or an ownership interest of more than 25 % in the customer held by a corporate entity , which is under the control of a natural person , or by multiple corporate entities , which are under the control of the same natural person , shall be an indication of indirect ownership . this applies without prejudice to the right of member states to decide that a lower percentage may be an indication of ownership or control . control through other means may be determined , inter alia , in accordance with the criteria in article 22 to of directive 2013 / 34 / eu of the european parliament and of the council ; if , after having exhausted all possible means and provided there are no grounds for suspicion , no person under point is identified , or if there is any doubt that the person identified are the beneficial owner , the natural person who hold the position of senior managing official , the obliged entities shall keep records of the actions taken in order to identify the beneficial ownership under point and this point ; ' _________________ directive 2013 / 34 / eu of the european parliament and of the council of 26 june 2013 on the annual financial statements , consolidated financial statements and related reports of certain types of undertakings , amending directive 2006 / 43 / ec of the european parliament and of the council and repealing council directives 78 / 660 / eec and 83 / 349 / eec . ### in point , point is replaced by the following : ‘ in the case of corporate entities : all the natural persons who ultimately own or control a legal entity through direct or indirect ownership of a sufficient percentage of the shares or voting rights or ownership interest in that entity , including through bearer shareholdings , or through control via other means , other than a company listed on a regulated market that is subject to disclosure requirements consistent with union law or subject to equivalent international standards which ensure adequate transparency of ownership information . a shareholding of 5 % plus one share or an ownership interest of more than 5 % in the customer held by a natural person shall be an indication of direct ownership . a shareholding of 5 % plus one share or an ownership interest of more than 5 % in the customer held by a corporate entity , which is under the control of a natural person , or by multiple corporate entities , which are under the control of the same natural person , shall be an indication of indirect ownership . this applies without prejudice to the right of member states to decide that a lower percentage may be an indication of ownership or control . control through other means may be determined , inter alia , in accordance with the criteria in article 22 to of directive 2013 / 34 / eu of the european parliament and of the council ; if the entity fails to provide the identity of any natural person that meets the criteria under point , or if there is any doubt that the person identified are the beneficial owner , the obliged entities shall record that no beneficial owner exists and keep records of the actions taken in order to identify the beneficial ownership under point . in addition , the obliged entities should identify and verify the identity of the relevant natural person who holds the position of senior managing official , who should be identified as ' senior manager ' , and record details of all legal owners of the entity ; _________________ directive 2013 / 34 / eu of the european parliament and of the council of 26 june 2013 on the annual financial statements , consolidated financial statements and related reports of certain types of undertakings , amending directive 2006 / 43 / ec of the european parliament and of the council and repealing council directives 78 / 660 / eec and 83 / 349 / eec . ’


### the specific factor determining the member state responsible for the monitoring and registration of beneficial ownership information of trusts and similar legal arrangements should be clarified . in order to avoid that , due to differences in the legal systems of member states , certain trusts are not monitored or registered anywhere in the union , all trusts and similar legal arrangements should be registered where they are administered . in order to ensure the effective monitoring and registration of information on the beneficial ownership of trusts , cooperation among member states is also necessary . ### the specific factor determining the member state responsible for the monitoring and registration of beneficial ownership information of trusts and similar legal arrangements should be clarified . in order to avoid that , due to differences in the legal systems of member states , certain trusts are not monitored or registered anywhere in the union , all trusts and similar legal arrangements should be registered where they are created , administered or operated . in order to ensure the effective monitoring and registration of information on the beneficial ownership of trusts , cooperation among member states is also necessary .


### member states shall ensure that the beneficial ownership information referred to in paragraph 1 of this article shall also be made publicly available through the system of interconnection of registers referred to in article 4a . ### member states shall ensure that the beneficial ownership information referred to in paragraph 1 of this article shall also be made publicly available through the system of interconnection of registers referred to in article 4a , in accordance with both data protection rules and open data standards , and subject to online registration .


### member states shall ensure that this article applies to trusts and other types of legal arrangements having a structure or functions similar to trusts , such as , inter alia , fiducie , treuhand or fideicomiso . ### member states shall ensure that this article applies to trusts and other types of legal instrument or legal arrangements having a structure or functions similar to trusts , such as , inter alia , fiducie , treuhand , waqf or fideicomiso , and all existing or future legal arrangements , which are similar in terms of structure or function .


### in the case of trusts : the settlor ; the trustee ; the protector , if any ; the beneficiaries , or where the individuals benefiting from the legal arrangement or entity have yet to be determined , the class of persons in whose main interest the legal arrangement or entity is set up or operates ; any other natural person exercising ultimate control over the trust by means of direct or indirect ownership or by other means ; ### in point 6 , point is replaced by the following : ‘ in the case of trusts : the settlor ; the trustee ; the protector if any ; the beneficiaries , or where the individuals benefiting from the legal arrangement or entity have yet to be determined , the class of persons in whose main interest the legal arrangement or entity is set up or operates ; any other natural person exercising ultimate control over the trust by means of direct or indirect ownership or by other means . with regard to trusts that are designated by characteristics or by class , the trust deed or related document should provide sufficient information concerning the beneficiary so that any person would be able to establish the identity of the beneficiary at the time of the distribution or when the beneficiary intends to exercise vested rights . ’


### member states shall ensure that the information on the beneficial ownership is accessible in all cases to : competent authorities and fius , without any restriction ; obliged entities , within the framework of customer due diligence in accordance with chapter ii ; any person or organisation that can demonstrate a legitimate interest ; the persons or organisations referred to in point shall access at least the name , the month and year of birth , the nationality and the country of residence of the beneficial owner as well as the nature and extent of the beneficial interest held . for the purposes of this paragraph , access to the information on beneficial ownership shall be in accordance with data protection rules and may be subject to online registration and to the payment of a fee . the fees charged for obtaining the information shall not exceed the administrative costs thereof . ### paragraph 5 is replaced by the following : ‘ 5 . member states shall ensure that the information on the beneficial ownership is accessible in all cases to : competent authorities and fius , without any restriction ; obliged entities , within the framework of customer due diligence in accordance with chapter ii ; the public the information accessible to the public shall consist of at least the name , the date of birth , the nationality , a business or service address and the country of residence of the beneficial owner as well as the nature and extent of the beneficial interest held . for the purposes of this paragraph , access to the information on beneficial ownership shall be in accordance with both data protection rules and open data standards . ’ ;


### “1 . member states shall ensure that this article applies to trusts and other types of legal arrangements having a structure or functions similar to trusts , such as , inter alia , fiducie , treuhand or fideicomiso . each member state shall require that trustees of any express trust administered in that member state obtain and hold adequate , accurate and up - to - date information on beneficial ownership regarding the trust . that information shall include the identity of : the settlor ; the trustee ; the protector ; the beneficiaries or class of beneficiaries ; any other natural person exercising effective control of the trust . ' ; ### “1 . member states shall ensure that this article applies to trusts and other types of legal arrangements having a structure or functions similar to trusts , such as , inter alia , fiducie , treuhand , waqf or fideicomiso , and all other similar , in terms of structure or function , existing or future legal arrangements . member states shall require that trustees of any express trust created , administered and / or operating in that member state obtain and hold adequate , accurate and up - to - date information on beneficial ownership regarding the trust . that information shall include the identity of : the settlor ; the trustee ; the protector ; the beneficiaries or class of beneficiaries ; and any other natural person exercising effective control over the trust . ” ;


### “10 . for the purposes of this article , a trust is considered to be administered in each member state where the trustees are established” ; ### “10 . for the purposes of this article , a trust is considered to be created , administered or to operate in a member state when it : is created according to , or governed by , the law of that member state or has its ultimate court of appeal in the jurisdiction of that member state ; or is connected to that member state by : having one or more of the beneficial owners of the trust , as defined in article 3 , resident in that member state ; holding real estate in that member state ; holding shares or voting rights or ownership interest in a legal entity incorporated in that member state ; or holding a bank or payment account in a credit institution operating in that member state . ” ;


### the information referred to in paragraph 1 shall be held in a central register set up by the member state where the trust is administered ; ### the information referred to in paragraph 1 shall be held in a central register set up by the member state where the trust is created , administered or operated ;


### the specific factor determining the member state responsible for the monitoring and registration of beneficial ownership information of trusts and similar legal arrangements should be clarified . in order to avoid that , due to differences in the legal systems of member states , certain trusts are not monitored or registered anywhere in the union , all trusts and similar legal arrangements should be registered where they are administered . in order to ensure the effective monitoring and registration of information on the beneficial ownership of trusts , cooperation among member states is also necessary . ### the specific factor determining the member state responsible for the monitoring and registration of beneficial ownership information of trusts and similar legal arrangements should be clarified . in order to avoid that , due to differences in the legal systems of member states , certain trusts are not monitored or registered anywhere in the union , and to avoid distorting the internal market , all trusts and similar legal arrangements should be registered where they are administered . in order to ensure the effective monitoring and registration of information on the beneficial ownership of trusts , cooperation among member states is also necessary .


### if , after having exhausted all possible means and provided there are no grounds for suspicion , no person under point is identified , or if there is any doubt that the person identified are the beneficial owner , the natural person who hold the position of senior managing official , the obliged entities shall keep records of the actions taken in order to identify the beneficial ownership under point and this point ; ### in point , point is replaced by the following : “if , after having exhausted all possible means , the entity fails to provide the identity of any natural person who meets the criteria set out in point , the obliged entities shall record that no beneficial owner exists and keep records of the actions taken in order to identify the beneficial ownership under point . where there is any doubt that the person identified are the beneficial owner , a record of that doubt shall be made . in addition , obliged entities shall identify and verify the identity of the relevant natural person who holds the position of senior managing official , who shall be identified as the ' senior manager ' , and record details of all legal owners of the entity ; ”


### the information shall consist of the name , the month and year of birth , the nationality and the country of residence of the beneficial owner as well as the nature and extent of the beneficial interest held . ### the information shall consist of the name , date of birth , the nationality , the country of residence and contact details of the beneficial owner as well as the nature and extent of the beneficial interest held .


### in exceptional circumstances laid down in national law , where the access to the information set out in paragraph 1 would expose the beneficial owner to the risk of fraud , kidnapping , blackmail , violence or intimidation , or where the beneficial owner is a minor or otherwise incapable , member states may provide for an exemption from the compulsory disclosure of to all or part of the information on the beneficial ownership on a case - by - case basis . ### in exceptional circumstances laid down in national law , where the access to the information set out in paragraph 1 would expose the beneficial owner to the risk of kidnapping , blackmail , violence or intimidation , or where the beneficial owner is a minor or otherwise incapable , member states may provide for an exemption from the compulsory disclosure of to all or part of the information on the beneficial ownership on a case - by - case basis . exemptions shall never be indefinite and shall be reassessed at regular intervals to avoid abuse . when an exemption is granted , this shall be clearly noted in the register accessible to entities referred to in points and of article 30 of directive 2015 / 849 .


### the information accessible to persons and organisations that can demonstrate a legitimate interest shall consist of the name , the month and year of birth , the nationality and the country of residence of the beneficial owner as defined in article 3 . ### the information publicly accessible shall consist of at least the name , the date of birth , the nationality , the country of residence , contact details , the nature and extent of the beneficial interest held of the beneficial owner as defined in point of article 3 .


### in accordance with article 168 of the treaty on the functioning of the european union , the member states remain responsible for the organisation and delivery of their healthcare . as such , it is appropriate to limit the scope of union rules to those aspects of hta that relate to the clinical assessment of a health technology , and in particular , to ensure that the assessment conclusions are confined to findings relating to the comparative effectiveness of a health technology . the outcome of such assessments should not therefore affect the discretion of member states in relation to subsequent decisions on pricing and reimbursement of health technologies , including the fixing of criteria for such pricing and reimbursement which may depend on both clinical and non - clinical considerations , and which remain solely a matter of national competence . ### in accordance with article 168 of the treaty on the functioning of the european union , the member states remain responsible for the organisation and delivery of their healthcare . as such , it is appropriate to limit the scope of union rules to those aspects of hta that relate to the clinical assessment of a health technology . in this connection , the joint clinical assessment provided for by the regulation , which will be mandatory for members states , constitutes a scientific analyses of the relatives effects of healthy technology on clinical outcomes , evaluated in relation to the chosen comparative indicators and chosen groups or subgroups of paints , taking into account the hta core model criteria . this will include consideration of the degree of certainty on the relative outcomes , based on the available evidence . the outcome of such joint clinical assessments should not therefore affect the discretion of member states in relation to subsequent decisions on pricing and reimbursement of health technologies , including the fixing of criteria for such pricing and reimbursement which may depend on both clinical and non - clinical considerations , and which remain solely a matter of national competence .


### in order to ensure a uniform approach to the joint work provided for in this regulation , implementing powers should be conferred on the commission to establish a common procedural and methodological framework for clinical assessments , procedures for joint clinical assessments and procedures for joint scientific consultations . where appropriate , distinct rules should be developed for medicinal products and medical devices . in the development of such rules , the commission should take into account the results of the work already undertaken in the eunethta joint actions . it should also take into account initiatives on hta funded through the horizon 2020 research programme , as well as regional initiatives on hta such as the beneluxa and valletta declaration initiatives . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council . 13 _________________ 13 regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission ' s exercise of implementing powers . ### in order to ensure a uniform approach to the joint work provided for in this regulation , implementing powers should be conferred on the commission to establish a common procedural and methodological framework for clinical assessments , procedures for joint clinical assessments and procedures for joint scientific consultations . where appropriate , distinct rules should be developed for medicinal products and medical devices . in the development of such rules , the commission should take into account the results of the work already undertaken in the eunethta joint actions and in particular the methodological guidelines and evidence submission template . it should also take into account initiatives on hta funded through the horizon 2020 research programme , as well as regional initiatives on hta . the procedural and methodological framework are updated at the frequency deemed necessary by the commission to ensure that they should be adapted to the evolution of science . in developing the methodological framework , the commission should consider the specificity and corresponding challenges of certain types of health technologies , advanced therapies or life - prolonging therapies where innovative clinical study designs may be required . these may result in evidential uncertainty at the time of the marketing authorization . as such innovative clinical study designs are often accepted for the purposes of regulatory assessments , the methodology for joint clinical assessments should not prevent these health technologies from reaching patients . the commission should therefore ensure that the methodology provides for a sufficient level of flexibility to enable an adequate assessment of such health technologies . such flexibility should include the acceptance of the best available scientific evidence at the time of the submission , including , for instance , data from case control studies , real world evidence , as well as the acceptance of indirect treatment comparators . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council . 13 _________________ 13 regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission ' s exercise of implementing powers .


### the commission shall adopt implementing acts concerning : ### the commission shall adopt delegated acts concerning :


### in order to ensure a uniform approach to the joint work provided for in this regulation , implementing powers should be conferred on the commission to establish a common procedural and methodological framework for clinical assessments , procedures for joint clinical assessments and procedures for joint scientific consultations . where appropriate , distinct rules should be developed for medicinal products and medical devices . in the development of such rules , the commission should take into account the results of the work already undertaken in the eunethta joint actions . it should also take into account initiatives on hta funded through the horizon 2020 research programme , as well as regional initiatives on hta such as the beneluxa and valletta declaration initiatives . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council . 13 _________________ 13 regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission ' s exercise of implementing powers . ### in order to ensure a uniform approach to the joint work provided for in this regulation , the commission should establish , by means of implementing acts , a common procedural framework for joint clinical assessments and joint scientific consultations , while the coordination group should establish a common methodological framework . where appropriate , and in justified cases , distinct rules must be developed for medicinal products and medical devices . in the development of such rules , the results of the work already undertaken in the eunethta joint actions , initiatives on hta funded through the horizon 2020 research programme , as well as regional initiatives on hta such as the beneluxa and valletta declaration initiatives may be taken into account . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council . 13 _________________ 13 regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission ' s exercise of implementing powers .


### when preparing those implementing and delegated acts , the commission shall take into account the distinctive characteristics of the medicinal product and medical device sectors . ### when preparing those implementing and delegated acts , the commission shall take into account the distinctive characteristics of the medicinal product and medical device sectors and shall consider the work already undertaken in the eunethta joint actions .


### in accordance with article 168 of the treaty on the functioning of the european union , the member states remain responsible for the organisation and delivery of their healthcare . as such , it is appropriate to limit the scope of union rules to those aspects of hta that relate to the clinical assessment of a health technology , and in particular , to ensure that the assessment conclusions are confined to findings relating to the comparative effectiveness of a health technology . the outcome of such assessments should not therefore affect the discretion of member states in relation to subsequent decisions on pricing and reimbursement of health technologies , including the fixing of criteria for such pricing and reimbursement which may depend on both clinical and non - clinical considerations , and which remain solely a matter of national competence . ### in accordance with article 168 of the treaty on the functioning of the european union , the member states remain responsible for the organisation and delivery of their healthcare . as such , it is appropriate to limit the scope of union rules to those aspects of hta that relate to the clinical assessment of a health technology . in this connection , the joint clinical assessment provided for by this regulation , which will be mandatory for member states , constitutes a scientific analysis of the relative effects of health technology on clinical outcomes , evaluated in relation to the chosen comparative indicators and chosen groups or subgroups of patients , taking into account the hta core model criteria . this will include consideration of the degree of certainty on the relative outcomes , based on the available evidence . the outcome of such joint clinical assessments should not therefore affect the discretion of member states in relation to subsequent decisions on pricing and reimbursement of health technologies , including the fixing of criteria for such pricing and reimbursement which may depend on both clinical and non - clinical considerations , and which remain solely a matter of national competence . the assessment conducted by each member state as part of its national appraisal therefore falls outside the scope of this regulation . such appraisals must include : the joint clinical assessment ; the data specific to each member state ; the medical need within their health system ; information on a national early - access programme , if available ; the target group , therapeutic strategy , clinical use ) ; context - specific analyses ; additional context - specific considerations for each member state .


### in order to ensure a wide application of harmonised rules on clinical aspects of hta and enable pooling of expertise and resources across hta bodies , it is appropriate to require joint clinical assessments to be carried out for all medicinal products undergoing the central marketing authorisation procedure provided for under regulation no 726 / 2004 of the european parliament and of the council , 11 which incorporate a new active substance , and where those medicinal products are subsequently authorised for a new therapeutic indication . joint clinical assessments should also be carried out on certain medical devices within the meaning of regulation 2017 / 745 of the european parliament and of the council12 which are in the highest risk classes and for which the relevant expert panels have provided their opinions or views . a selection of medical devices for joint clinical assessment should be made based on specific criteria . __________________ 11 regulation no 726 / 2004 of the european parliament and of the council of 31 march 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency . 12 regulation 2017 / 745 of the european parliament and of the council of 5 april 2017 on medical devices , amending directive 2001 / 83 / ec , regulation no 178 / 2002 and regulation no 1223 / 2009 and repealing council directives 90 / 385 / eec and 93 / 42 / eec . ### in order to ensure a wide application of harmonised rules on clinical aspects of hta and enable pooling of expertise and resources across hta bodies , it is appropriate to require joint clinical assessments to be carried out for all medicinal products undergoing the central marketing authorisation procedure provided for under regulation no 726 / 2004 of the european parliament and of the council , 11 which incorporate a new active substance , and where those medicinal products are subsequently authorised for a new therapeutic indication . __________________ 11 regulation no 726 / 2004 of the european parliament and of the council of 31 march 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency .


### in order to ensure a uniform approach to the joint work provided for in this regulation , implementing powers should be conferred on the commission to establish a common procedural and methodological framework for clinical assessments , procedures for joint clinical assessments and procedures for joint scientific consultations . where appropriate , distinct rules should be developed for medicinal products and medical devices . in the development of such rules , the commission should take into account the results of the work already undertaken in the eunethta joint actions . it should also take into account initiatives on hta funded through the horizon 2020 research programme , as well as regional initiatives on hta such as the beneluxa and valletta declaration initiatives . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council . 13 _________________ 13 regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission ' s exercise of implementing powers . ### in order to ensure a uniform approach to the joint work provided for in this regulation , the coordination group together with the commission should establish a common procedural and methodological framework for clinical assessments , procedures for joint clinical assessments and procedures for joint scientific consultations . where appropriate , distinct rules should be developed for medicinal products and medical devices . in the development of such rules , the coordination group and the commission should take into account the results of the work already undertaken in the eunethta joint actions . it should also take into account initiatives on hta funded through the horizon 2020 research programme , as well as regional initiatives on hta such as the beneluxa and valletta declaration initiatives . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council . 13 _________________ 13 regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission ' s exercise of implementing powers .


### in order to ensure a wide application of harmonised rules on clinical aspects of hta and enable pooling of expertise and resources across hta bodies , it is appropriate to require joint clinical assessments to be carried out for all medicinal products undergoing the central marketing authorisation procedure provided for under regulation no 726 / 2004 of the european parliament and of the council , 11 which incorporate a new active substance , and where those medicinal products are subsequently authorised for a new therapeutic indication . joint clinical assessments should also be carried out on certain medical devices within the meaning of regulation 2017 / 745 of the european parliament and of the council12 which are in the highest risk classes and for which the relevant expert panels have provided their opinions or views . a selection of medical devices for joint clinical assessment should be made based on specific criteria . _________________ 11 regulation no 726 / 2004 of the european parliament and of the council of 31 march 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency . 12 regulation 2017 / 745 of the european parliament and of the council of 5 april 2017 on medical devices , amending directive 2001 / 83 / ec , regulation no 178 / 2002 and regulation no 1223 / 2009 and repealing council directives 90 / 385 / eec and 93 / 42 / eec . ### in order to ensure a wide application of harmonised rules on clinical aspects of hta and enable pooling of expertise and resources across hta bodies , it is appropriate to require joint clinical assessments to be carried out for all medicinal products undergoing the central marketing authorisation procedure provided for under regulation no 726 / 2004 of the european parliament and of the council , 11 which incorporate a new active substance , and where those medicinal products are subsequently authorised for a new therapeutic indication . joint clinical assessments should also be carried out on certain medical devices within the meaning of regulation 2017 / 745 of the european parliament and of the council given the need for greater clinical evidence concerning all of these new technologies . _________________ 11 regulation no 726 / 2004 of the european parliament and of the council of 31 march 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency .


### in order to ensure a uniform approach to the joint work provided for in this regulation , implementing powers should be conferred on the commission to establish a common procedural and methodological framework for clinical assessments , procedures for joint clinical assessments and procedures for joint scientific consultations . where appropriate , distinct rules should be developed for medicinal products and medical devices . in the development of such rules , the commission should take into account the results of the work already undertaken in the eunethta joint actions . it should also take into account initiatives on hta funded through the horizon 2020 research programme , as well as regional initiatives on hta such as the beneluxa and valletta declaration initiatives . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council . 13 _________________ 13 regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission ' s exercise of implementing powers . ### in order to ensure a uniform approach to the joint work provided for in this regulation , the coordination group shall establish a common procedural and methodological framework for clinical assessments , procedures for joint clinical assessments and procedures for joint scientific consultations . where appropriate , distinct rules should be developed for medicinal products and medical devices . in the development of such rules , the results of the work already undertaken in the eunethta joint actions should be taken into account . it should also take into account initiatives on hta funded through the horizon 2020 research programme , as well as regional initiatives on hta such as the beneluxa and valletta declaration initiatives .


### the amount of the guarantee fund in surplus exceeding 10% of the union ' s total outstanding capital liabilities should be paid back to the general budget of the union in order to better protect the budget against potential additional risk of default of the eib financing operations addressing root causes of migration . ### the amount of the guarantee fund in surplus exceeding 10% of the union ' s total outstanding capital liabilities should be paid back to the general budget of the union in order to better protect the budget against potential additional risk of default of the eib financing operations addressing migratory pressures stemming from poverty , underdevelopment , inequality , demographic growth , lack of employment and economic opportunities as well as from climate change .


### the financial management of the guarantee fund should be transferred from the eib to the commission , which has an established practice of managing similar investments . by taking over the asset management of the guarantee fund , the commission should be able to streamline and consolidate its asset management activities , building on existing structures and a good track record . ### the financial management of the guarantee fund should be transferred from the eib to the commission , which has an established practice of managing similar investments . by taking over the asset management of the guarantee fund , the commission should be able to further streamline and consolidate its asset management activities , building on existing structures and a good track record .


### when scientific advice indicates that the spawning stock biomass of either of the stocks concerned is below the minimum spawning stock biomass reference point set out in annex ii , column a to this regulation , all appropriate remedial measures shall be adopted to ensure the rapid return of the stock concerned to levels above those capable of producing msy . in particular , by way of derogation from article 4 and 4 of this regulation , fishing opportunities for the stocks concerned shall be fixed at a level consistent with a fishing mortality that is reduced below the range set out in annex i , column a to this regulation , taking into account the decrease in biomass of that stock . ### when scientific advice indicates that the spawning stock biomass of either of the stocks concerned is below the minimum spawning stock biomass reference point set , all appropriate remedial measures shall be adopted to ensure the rapid return of the stock concerned to levels above those capable of producing msy . in particular , by way of derogation from article 4 and 4 of this regulation , fishing opportunities for the stocks concerned shall be fixed at a level consistent with a fishing mortality that is reduced below the lower range of fmsy , taking into account the decrease in biomass of that stock .


### fishing opportunities shall comply with the target fishing mortality ranges set out in annex i , column a to this regulation . ### fishing opportunities shall comply with the lower range of fmsy available at that time for that stock .


### when scientific advice indicates that the spawning stock biomass of either of the stocks concerned is below the minimum spawning stock biomass reference point set out in annex ii , column a to this regulation , all appropriate remedial measures shall be adopted to ensure the rapid return of the stock concerned to levels above those capable of producing msy . in particular , by way of derogation from article 4 and 4 of this regulation , fishing opportunities for the stocks concerned shall be fixed at a level consistent with a fishing mortality that is reduced below the range set out in annex i , column a to this regulation , taking into account the decrease in biomass of that stock . ### if the scientific advice indicates after 31 december 2020 that the spawning stock biomass of either of the stocks concerned is below the minimum spawning stock biomass reference point set out in annex ii , column a to this regulation , all appropriate remedial measures shall be adopted to ensure the rapid return of the stock concerned to levels above those capable of producing msy . in particular , by way of derogation from article 4 and 4 of this regulation , fishing opportunities for the stocks concerned shall be fixed at a level consistent with a fishing mortality that is reduced below the range set out in annex i , column a to this regulation , taking into account the decrease in biomass of that stock .


### when scientific advice indicates that the spawning stock biomass of either of the stocks concerned is below the limit spawning stock biomass reference point as set out in annex ii , column b to this regulation , further remedial measures shall be taken to ensure the rapid return of the stock concerned to levels above the level capable of producing msy . in particular , those remedial measures may include , by way of derogation from article 4 , paragraphs 2 and 4 , suspending the targeted fishery for the stock concerned and the adequate reduction of fishing opportunities . ### when the best available scientific advice indicates that the spawning stock biomass of either of the stocks concerned is below the limit spawning stock biomass reference point , further remedial measures shall be taken to ensure the rapid return of the stock concerned to levels above the level capable of producing msy . in particular , those remedial measures may include , by way of derogation from article 4 , paragraphs 2 and 4 , suspending the targeted fishery for the stock concerned and the adequate reduction of fishing opportunities .


### 2000 kg of sardine . ### 2 tonnes of sardine .


### the objective of the multiannual plan should be to contribute to achieving the objectives of the cfp , and especially reaching and maintaining msy for the stocks concerned , achieving a sustainable fisheries sector and providing an effective management framework . ### the objective of the multiannual plan should be to contribute to achieving the objectives of the cfp , and especially gradually expanding fish populations again by 2020 and keeping them above the biomass level for maximum sustainable yield , achieving a sustainable fisheries sector and providing an effective management framework .


### the target fishing mortality shall be achieved as soon as possible and on a progressive , incremental basis , by 2020 for the stocks concerned , and it shall be maintained thereafter within the ranges set out in annex i and in line with the objectives laid down in article 3 . ### the target fishing mortality shall be achieved as soon as possible and on a progressive , incremental basis , by 2020 for the stocks concerned , and it shall be maintained thereafter within the ranges&#160 ; of fmsy , in accordance with this article , &#160 ; and in line with the objectives laid down in article 3 .


### the conservation reference points expressed as minimum and limit spawning stock biomass levels to be applied in order to safeguard the full reproductive capacity of the stocks concerned are set out in annex ii . ### the conservation reference points expressed as minimum and limit spawning stock biomass levels&#160 ; shall be applied in order to safeguard the full reproductive capacity of the stocks concerned .


### pursuant to articles 9 and 10 of regulation no 1380 / 2013 , multiannual plans are to be based on scientific , technical and economic advice and contain objectives , quantifiable targets with clear timeframes , conservation reference points and safeguards . ### pursuant to articles 9 and 10 of regulation no 1380 / 2013 , multiannual plans are to be based on scientific , technical and economic advice and contain objectives , quantifiable targets with clear timeframes , conservation reference points , objectives and safeguards , goals for stock conservation and technical measures to be taken to achieve the targets for the maximum possible avoidance of and reduction of unwanted catches as set out in article 15 thereof .


### the multiannual plan shall implement the ecosystem - based approach to fisheries management in order to ensure that negative impacts of fishing activities on the marine ecosystem are minimised . it shall be coherent with union environmental legislation , in particular with the objective of achieving good environmental status by 2020 as set out in article 1 of directive 2008 / 56 / ec . ### the multiannual plan shall implement the ecosystem - based approach to fisheries management in order to ensure that negative impacts of fishing activities on the marine ecosystem , particularly threatened habitats and protected species including marine mammals , seabirds and reptiles , are minimised , and where possible eliminated . it shall be coherent with union environmental legislation , in particular with the objective of achieving good environmental status by 2020 as set out in article 1 of directive 2008 / 56 / ec , and with the targets and rules laid down in directives 2009 / 147 / ec and 92 / 43 / eec .


### 2000 kg of anchovy ; ### 2 tonnes of anchovy ;


### with the approval of the member state concerned , the periods referred to in paragraphs 1 and 2 may be extended . the periods referred to in paragraphs 1 and 2 shall be shortened in agreement with the commission if circumstances so warrant . ### with the approval of the member state concerned , the periods referred to in paragraphs 1 and 2 may be extended . the periods referred to in paragraphs 1 and 2 shall be shortened in agreement with the commission if circumstances so warrant , to ensure that the negotiations are concluded in due time .


### in order to ensure that additional geographical indications protected and registered in the union are registered in the international register , it is appropriate to authorise the commission , at a later stage , to file applications for the international registration of such additional geographical indications , on its own initiative or at the request of a member state or of an interested group of producers or , in exceptional cases , at the request of a single producer . ### in order to ensure that additional or future geographical indications protected and registered in the union are registered in the international register , including the possible extension of protection to geographical indications for non - agricultural products , it is appropriate to authorise the commission , at a later stage , to file applications for the international registration of such additional geographical indications , on its own initiative or , in case of non - agricultural geographical indications , at the request of a member state or of an interested group of producers or , in exceptional cases , at the request of a single producer . the accession of the union to the geneva act does not prejudice the current and future protection of geographical indications in bilateral free trade agreements . in this regard , the commission should use a regular mechanism to consult member states , trade associations and european producers in order to establish a fluid dialogue with stakeholders .


### following the accession of the union to the geneva act , the commission should as a first step file with the international bureau of the world intellectual property organization an application for registration of a list of geographical indications originating and protected in the territory of the union in their register . the criteria for the establishment of such a list should , as it is the case for some of the bilateral and regional agreements of the union regarding protection of geographical indications , take into account in particular the production value and export value , protection under other agreements as well as current or potential misuse in the third countries concerned . ### following the accession of the union to the geneva act , the commission should as a first step file with the international bureau of the world intellectual property organization an application for registration of a list of geographical indications originating and protected in the territory of the union in their register , in close cooperation with the member states , trade associations and producers concerned . that list should include , as far as possible , geographical indications already registered by the member states that were contracting parties to the special union prior to the european union ' s accession to the geneva act . moreover , the criteria for the establishment of such a list should , as it is the case for some of the bilateral and regional agreements of the union regarding protection of geographical indications , take into account in particular the production value and export value , protection under other agreements as well as current or potential misuse in the third countries concerned .


### that the geographical indication registered in the international register relates to a product in respect of which protection within the eu of geographical indications is currently not provided ; ### that the geographical indication registered in the international register relates to a product in respect of which protection within the eu of geographical indications is not provided at the moment of opposition ;


### the executive director shall also be responsible for deciding whether it is necessary for the purpose of carrying out the agency ' s tasks in an efficient and effective manner to establish one or more local offices in one or more member states . that decision requires the prior consent of the commission , the management board and the member state where the local office is to be established . that decision shall specify the scope of the activities to be carried out at that local office in a manner that avoids unnecessary costs and duplication of administrative functions of the agency . ### the executive director shall also be responsible for deciding whether it is necessary for the purpose of carrying out the agency ' s tasks in an efficient and effective manner to establish one liaison office in brussels to further the agency´s cooperation with the relevant union institutions . that decision requires the prior consent of commission , the management board and the member state where the local office is to be established . that decision shall specify the scope of the activities to be carried out that that local office in a manner that avoids unnecessary costs and duplication of administrative functions of the agency .


### where necessary , because of urgency , the executive board may take certain provisional decisions on behalf of the management board , in particular on administrative management matters , including the suspension of the delegation of the appointing authority powers and budgetary matters ### where necessary , because of urgency , the executive board may take certain provisional decisions on behalf of the management board .


### the executive director shall manage the agency . the executive director shall be accountable to the management board . ### the executive director shall be responsible for the overall management of the agency according to the strategic direction set by the management board and shall be accountable to the management board .


### the translation services required for the functioning of the agency shall be provided by the translation centre of the bodies of the european union . ### the translation services required for the functioning of the agency may be provided by the translation centre of the bodies of the european union or other translation services , that respect the union ' s environmental , labour and social criteria .


### the executive director shall be appointed by the management board , from a list of candidates proposed by the commission , following an open and transparent selection procedure . for the purpose of concluding the contract with the executive director , the agency shall be represented by the chairperson of the management board . ### the executive director shall be appointed by the management board , from a list of candidates proposed by the commission after obtaining the consent of the management board which must be involved in the process of short - listing the candidates and can act by written procedure if necessary , and following an open and transparent selection procedure . once appointed the new executive director shall attend a hearing in the european parliament . for the purpose of concluding the contract with the executive director , the agency shall be represented by the chairperson of the management board .


### in carrying out its tasks , the agency shall maintain a close dialogue particularly with specialised bodies , whether public or private , public authorities and workers ' and employers’ organisations . the agency , without prejudice to its own aims , shall ensure cooperation with other european union agencies aimed at avoiding overlaps and promoting synergy and complementarity in their activities , in particular with the european foundation for the improvement of living and working conditions , the european centre for the development of vocational training and , where relevant , with other eu agencies . ### in carrying out its tasks , the agency shall maintain a close dialogue particularly with specialised bodies , whether public or private , public authorities and workers ' and employers ' organisations . the agency , without prejudice to its own aims , shall ensure cooperation with other european union agencies aimed at avoiding overlaps and promoting synergy and complementarity in their activities , including the possibility of working jointly , in particular with the european foundation for the improvement of living and working conditions , the european centre for the development of vocational training and , where relevant , with other eu agencies .


### 25round sum payment for small farmers ### 25lump sum payment for small farmers


### at least 20% of expenditure under operational programs covers the interventions linked to the objectives referred to in points and of article 42 ; ### at least 10% of expenditure under operational programs covers the interventions linked to the objectives referred to in points , and of article 42 ;


### to calculate the amounts referred to in points a ) and b ) , member states shall use the average standard salaries linked to an agricultural activity at national or regional level multiplied by the number of annual work units declared by the farmer concerned . ### to calculate the amounts referred to in points a ) and b ) , member states shall use the actual labour costs and salaries linked to an agricultural and related activity at national or regional level multiplied by the number of annual work units declared by the farmer concerned .


### to calculate the amounts referred to in points a ) and b ) , member states shall use the average standard salaries linked to an agricultural activity at national or regional level multiplied by the number of annual work units declared by the farmer concerned . ### to calculate the amounts referred to in points a ) and b ) , member states shall use the actual salary costs or the average standard salaries linked to an agricultural activity at national or regional level multiplied by the number of annual work units declared by the farmer concerned . member states may use indicators on standard salary costs associated with various types of farm , reference data on employment generation by farm type , as well as records containing work outsourced by farms .


### financial contributions to mutual funds , including the administrative cost of setting up ; ### mutual funds to pay financial compensations to farmers , for economic losses caused by adverse climatic events or by the outbreak of an animal or plant disease or pest infestation or an environmental incident ;


### the types and coverage of eligible insurance schemes and mutual funds ; ### the types and coverage eligible insurance schemes , mutual funds and income stabilization tools ;


### the member states shall pursue one or more of the following objectives in the other sectors referred to in point of article 39 : ### when establishing operational programmes in the other sectors referred to in point of article 39 , the member states shall pursue one or more of the following objectives :


### member states shall design the interventions of their cap strategic plans in accordance with the charter of fundamental rights of the european union and the general principles of union law . ### member states shall design the interventions of their cap strategic plans in accordance with the charter of fundamental rights of the european union and the general principles of union law , with respect for the principles of gender equality and non - discrimination .


### member states shall support under this type of intervention genuine farmers who make commitments to observe , on eligible hectares , agricultural practices beneficial for the climate and the environment . ### member states shall support under this type of intervention genuine farmers who observe , on eligible hectares , practices beneficial for the climate , the environment and the maintenance of pastures and landscapes , such as particular agronomic measures , organic farming , techniques compatible with park management plans , and practices that reduce emissions or facilitate the absorption of climate - changing gases .


### member states may grant support for agricultural , forestry and rural business knowledge exchange and information under the conditions set out in this article and as further specified in their cap strategic plans . ### member states may grant support for knowledge exchange and information under the conditions set out in this article and as further specified in their cap strategic plans .


### the managing authority of the cap strategic plan or other designated intermediate bodies shall define selection criteria for interventions relating to the following types of interventions : investments , installation of young farmers and rural business start - up , cooperation , knowledge exchange and information , after consultation of the monitoring committee referred to in article 111 . selection criteria shall aim to ensure equal treatment of applicants , better use of financial resources and targeting of the support in accordance with the purpose of the interventions . ### the managing authority of the cap strategic plan , including , if applicable , the regional rural development programmes , or other designated intermediate bodies , shall define selection criteria for interventions relating to the following types of interventions : investments , installation of young farmers and rural business start - up , cooperation , knowledge exchange and information , after consultation of the monitoring committee referred to in article 111 . selection criteria shall aim to ensure equal treatment of applicants , better use of financial resources and targeting of the support in accordance with the purpose of the interventions .


### the member state shall publish the list of the members of the monitoring committee online . ### the member state , and where applicable the regions , shall publish online the list of the members of the monitoring committee .


### support viable farm income and resilience across the union to enhance food security ; ### support viable farm income and resilience across the union to enhance food security and providing secure , safe and high quality food for over 500 million of eu consumers ;


### coupled income support may only be granted to the following sectors and productions or specific types of farming therein where these are important for economic , social or environmental reasons : cereals , oilseeds , protein crops , grain legumes , flax , hemp , rice , nuts , starch potato , milk and milk products , seeds , sheepmeat and goatmeat , beef and veal , olive oil , silkworms , dried fodder , hops , sugar beet , cane and chicory , fruit and vegetables , short rotation coppice and other non - food crops , excluding trees , used for the production of products that have the potential to substitute fossil materials . ### coupled income support may only be granted to the following sectors and productions or specific types of farming therein where these are important for economic , social or environmental reasons : cereals , oilseeds , protein crops , grain legumes , pure fodder legumes or in combination with grass , grassland flax , hemp , rice , nuts , potatoes , seeds , sheepmeat and goatmeat , olive oil , silkworms , dried fodder , hops , chicory , fruit and vegetables , short rotation coppice .


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


### member states shall provide support for voluntary schemes for the climate and the environment under the conditions set out in this article and as further specified in their cap strategic plans . ### member states shall provide support for voluntary schemes for the climate , the environment and animal welfare under the conditions set out in this article and as further specified in their cap strategic plans .


### the member state shall publish the rules of procedures of the monitoring committee and all the data and information shared with the monitoring committee online . ### the member state , and where applicable the regions shall publish online the rules of procedures of the monitoring committee / s and all the data and information shared with the monitoring committee / s .


### the target plan referred to in point of article 95 shall consist of a recapitulative table showing the targets as referred to in point of article 97 , indicating the break - down in annual milestones . ### the section of the plan referred to in point of article 95 shall consist of a recapitulative table showing the targets as referred to in point of article 97 , indicating the breakdown in annual milestones , if applicable .


### contribute to the protection of biodiversity , enhance ecosystem services and preserve habitats and landscapes ; ### contribute to reversing the decline of biodiversity , including agrobiodiversity , enhance and reward the provision of environmental services and preserve habitats and landscapes ;


### up to 15% of the member state ' s allocation for eafrd in financial years 2022 – 2027 to the member state ' s allocation for direct payments set out in annex iv for calendar years 2021 to 2026 . ### up to 5% of the member state ' s allocation for eafrd in financial years 2022 – 2027 to the member state ' s allocation for direct payments set out in annex iv for calendar years 2021 to 2026 .


### the total amount of union support for types of interventions for rural development under this regulation for the period from 1 january 2021 to 31 december 2027 shall be eur 78 811 million in current prices in accordance with the multiannual financial framework for the years 2021 to 202738 . _________________ 38 proposal for a council regulation laying down the multiannual financial framework for the years 2021 - 2027 communication from the commission to the european parliament , the council , the european economic and social committee and the committee of the regions , com322 final . ### the total amount of union support for types of interventions for rural development under this regulation for the period from 1 january 2021 to 31 december 2027 shall be at least eur 78 811 million in current prices in accordance with the multiannual financial framework for the years 2021 to 202738 to properly address the important interventions for rural development , especially regarding the specific objectives in article 6 , and . _________________ 38 proposal for a council regulation laying down the multiannual financial framework for the years 2021 - 2027 communication from the commission to the european parliament , the council , the european economic and social committee and the committee of the regions , com322 final .


### the indicative financial allocations for the coupled income support interventions referred to in subsection 1 of section 2 of chapter ii of title iii , shall be limited to a maximum of 10% of the amounts set out in annex vii . ### the indicative financial allocations for the coupled income support interventions referred to in subsection 1 of section 2 of chapter ii of title iii , shall be limited to a maximum of 16% of the amounts set out in annex vii .


### in view of further improving the performance of the cap , income support should be targeted to genuine farmers . in order to ensure a common approach at union level for such a targeting of support , a framework definition for ‘ genuine farmer’ displaying the essential elements should be set out . on the basis of this framework , member states should define in their cap strategic plans which farmers are not considered genuine farmers based on conditions such as income tests , labour inputs on the farm , company object and inclusion in registers . it should also not result in precluding support to pluri - active farmers , who are actively farming but who are also engaged in non - agricultural activities outside their farm , as their multiple activities often strengthen the socio - economic fabric of rural areas . ### in view of further improving the performance of the cap , income support should be targeted to genuine farmers . in order to ensure a common approach at union level for such a targeting of support , a framework definition for ‘ genuine farmer’ displaying the common elements should be set out . on the basis of this framework , member states should define in their cap strategic plans which farmers are considered genuine farmers based on conditions such as income tests , labour inputs on the farm , company object and inclusion in registers . support to pluri - active farmers , who are actively farming but who are also engaged in non - agricultural activities outside their farm , should not be precluded , as their multiple activities often strengthen the socio - economic fabric of rural areas . the framework definition must , in any event , help to preserve the model of family farming that exists in the european union and must be based on a credible agricultural activity .


### in the context of greater market - orientation of the cap , as outlined by the communication on ‘ the future of food and farming’ , market exposure , climate change and associated frequency and severity of extreme weather events , as well as sanitary and phytosanitary crises , may lead to risks of price volatility and increasing pressures on incomes . thus , although farmers are ultimately responsible for designing their on - farm strategies , a robust framework should be set up to ensure appropriate risk management . to this aim , member states and farmers may be able to draw on a union - level platform on risk management for capacity - building in order to provide farmers with adequate financial instruments for investments and access to working capital , training , knowledge transfer and advice . ### in the context of greater market - orientation of the cap , as outlined by the communication on ‘ the future of food and farming’ , market exposure , climate change and associated frequency and severity of extreme weather events , as well as sanitary and phytosanitary crises , may lead to risks of price volatility and increasing pressures on incomes . thus , although farmers are ultimately responsible for designing their on - farm strategies , a robust framework should be set up to ensure appropriate risk management . to this aim , member states and farmers may be able to draw on a union - level platform on risk management for capacity - building in order to provide farmers with adequate financial instruments for investments and access to working capital , training , knowledge transfer and advice . taking into account the existing gender gaps , including digital gender gap , a gender - perspective must be incorporated and member states may develop sub - programmes in the strategic plan for supporting women farmers to utilise financial instruments and to upgrade their knowledge and skills .


### member states should set farm advisory services for the purpose of improving the sustainable management and overall performance of agricultural holdings and rural businesses , covering economic , environmental and social dimensions , and to identify the necessary improvements as regards all measures at farm level provided for in the cap strategic plans . these farm advisory services should help farmers and other beneficiaries of cap support to become more aware of the relationship between farm management and land management on the one hand , and certain standards , requirements and information , including environmental and climate ones , on the other hand . the list of the latter includes standards applying to or necessary for farmers and other cap beneficiaries and set in the cap strategic plan , as well as those stemming from the legislation on water , on the sustainable use of pesticides , as well as the initiatives to combat antimicrobial resistance and the management of risks . in order to enhance the quality and effectiveness of the advice , member states should integrate advisors within the agricultural knowledge and innovation systems , in order to be able to deliver up - to - date technological and scientific information developed by research and innovation . ### member states should set up and ensure access to farm advisory services for the purpose of improving the sustainable management and overall performance of agricultural holdings and rural businesses , covering economic , environmental and social dimensions , and to identify the necessary improvements as regards all measures at farm level provided for in the cap strategic plans . these farm advisory services should help farmers and other beneficiaries of cap support to become more aware of the relationship between farm management and land management on the one hand , and certain standards , requirements and information , including environmental and climate and animal welfare ones , on the other hand . the list of the latter includes standards applying to or necessary for farmers and other cap beneficiaries and set in the cap strategic plan , as well as those stemming from the legislation on water , on the sustainable use of pesticides , as well as the initiatives to combat antimicrobial resistance , the management of risks , and to promote the sustainable management of nutrients , and input reduction . in order to enhance the quality and effectiveness of the advice , member states should integrate advisors within the agricultural knowledge and innovation systems , in order to be able to deliver up - to - date technological and scientific information developed by research and innovation .


### member states should set farm advisory services for the purpose of improving the sustainable management and overall performance of agricultural holdings and rural businesses , covering economic , environmental and social dimensions , and to identify the necessary improvements as regards all measures at farm level provided for in the cap strategic plans . these farm advisory services should help farmers and other beneficiaries of cap support to become more aware of the relationship between farm management and land management on the one hand , and certain standards , requirements and information , including environmental and climate ones , on the other hand . the list of the latter includes standards applying to or necessary for farmers and other cap beneficiaries and set in the cap strategic plan , as well as those stemming from the legislation on water , on the sustainable use of pesticides , as well as the initiatives to combat antimicrobial resistance and the management of risks . in order to enhance the quality and effectiveness of the advice , member states should integrate advisors within the agricultural knowledge and innovation systems , in order to be able to deliver up - to - date technological and scientific information developed by research and innovation . ### member states should set farm advisory services for the purpose of improving the sustainable management and overall performance of agricultural holdings and rural businesses , covering economic , environmental and social dimensions , and to identify the necessary improvements as regards all measures at farm level provided for in the cap strategic plans . these farm advisory services should help farmers and other beneficiaries of cap support to become more aware of the relationship between farm management and land management on the one hand , and certain standards , requirements and information , including animal welfare , environmental and climate ones , on the other hand . the list of the latter includes standards applying to or necessary for farmers and other cap beneficiaries and set in the cap strategic plan , as well as those stemming from the legislation on water , on the sustainable use of pesticides , as well as the initiatives to combat antimicrobial resistance and the management of risks . in order to enhance the quality and effectiveness of the advice , member states should integrate advisors within the agricultural knowledge and innovation systems , in order to be able to deliver up - to - date technological and scientific information developed by research and innovation .


### foster sustainable development and efficient management of natural resources such as water , soil and air ; ### foster environmental conservation and preservation of natural resources such as water , soil and air ; reaching the good state foreseen in the relevant legislative instruments ;


### 65% of the eligible expenditure for payments under article 66 ; ### 75% of the eligible expenditure for payments under article 66 ;


### member states shall establish an amount per hectare or different amounts for different ranges of hectares , as well as the maximum number of hectares per farmer for which the redistributive income support shall be paid . ### member states shall identify the criteria for calculating the amount to be granted for complementary redistributive income support for sustainability under the cap strategic plans . member states shall establish an amount per hectare or different amounts for different ranges of hectares , depending on the higher or lower intensity of the criteria previously identified , for each farmer receiving redistributive income support .


### member states shall reduce the amount of direct payments to be granted to a farmer pursuant to this chapter for a given calendar year exceeding eur 60 000 as follows : ### member states may reduce the amount of basic income support to be granted to a farmer pursuant to this chapter for a given calendar year exceeding a financial ceiling set by the member state


### the body of the member state responsible for drawing up the cap strategic plan shall ensure that the competent authorities for the environment and climate are effectively involved in the preparation of the environmental and climate aspects of the plan . ### the body of the member state responsible for drawing up the cap strategic plan shall ensure that the competent authorities for the environment and climate are fully involved in the preparation of the plan and are jointly responsible with regards to the environmental and climate aspects of the plan , especially in the setting of environmental targets based on the result and impact indicators and articles 28 , 65 , 66 and 67 .


### promotion and marketing of the products of the fruit and vegetables sector , whether in a fresh or processed form ; those objectives relate to the specific objectives set out in points and of article 6 ; ### promotion and marketing of the products of the fruit and vegetables sector , whether in a fresh or processed form ; those objectives relate to the specific objectives set out in points , and of article 6 ;


### where elements of the cap strategic plan are established at regional level , the member state shall ensure the coherence and the consistency with the elements of the cap strategic plan established at national level . ### where elements of the cap strategic plan are established and implemented at regional level , through the regional intervention programmes , the member state shall ensure the coherence and the consistency with the cap strategic plans .


### the indicative financial allocations for the coupled income support interventions referred to in subsection 1 of section 2 of chapter ii of title iii , shall be limited to a maximum of 10% of the amounts set out in annex vii . ### the indicative financial allocations for the coupled support interventions referred to in subsection 1 of section 2 of chapter ii of title iii shall be limited to a maximum of 13% of the amounts set out in annex vii .


### concentration of supply and the placing on the market of the products of the fruit and vegetables sector , including through direct marketing ; those objectives relate to the specific objectives set out in points and of article 6 ; ### concentration of supply and the placing on the market of the products of the fruit and vegetables sector , including through direct marketing ; those objectives relate to the specific objectives set out in points , and of article 6 ;


### member states shall only grant payments to farmers and other beneficiaries who undertake , on a voluntary basis , management commitments which are considered to be beneficial to achieving the specific objectives set out in article 6 . ### member states shall only grant payments to farmers , group of farmers and other land - managers who undertake , on a voluntary basis , commitments which are considered to be beneficial to achieving the specific objectives set out in article 6 , , and . priority should be given to schemes which are specifically targeted towards addressing local environmental conditions and needs , and contribute to the achievement of the objectives set out in the legislation listed in annex xi .


### where the reported value of one or more result indicators reveals a gap of more than 25% from the respective milestone for the reporting year concerned , the commission may ask the member state to submit an action plan in accordance with article 39 of regulation [ hzr ] , describing the intended remedial actions and the expected timeframe . ### where the reported value of one or more result indicators reveals a shortfall of more than 35% from the respective milestone for the reporting year concerned , member states shall submit justification for this deviation . where necessary , the commission may ask the member state to submit an action plan in accordance with article 39 of regulation [ hzr ] , describing the intended remedial actions and the expected timeframe .


### member states shall design the interventions of their cap strategic plans in accordance with the charter of fundamental rights of the european union and the general principles of union law . ### member states and , where appropriate , in collaboration with regions , shall design the interventions of their cap strategic plans in accordance with the charter of fundamental rights of the european union , the general principles of union law and the subsidiarity principle .


### member states shall ensure that all agricultural areas including land which is no longer used for production purposes , is maintained in good agricultural and environmental condition . member states shall define , at national or regional level , minimum standards for beneficiaries for good agricultural and environmental condition of land in line with the main objective of the standards as referred to in annex iii , taking into account the specific characteristics of the areas concerned , including soil and climatic condition , existing farming systems , land use , crop rotation , farming practices , and farm structures . ### member states shall ensure that all agricultural areas including land which is no longer used for production purposes , is maintained in good agricultural and environmental condition . member states shall define , at national or regional level , minimum standards for beneficiaries for good agricultural and environmental condition of land in line with the main objective of the standards as referred to in annex iii , taking into account the specific characteristics of the areas concerned , and ensures the land contributes to the specific objectives as set out in article 6 , , and .


### young farmers and new entrants still face significant barriers regarding access to land , high prices and access to credit . their businesses are more threatened by price volatility and their needs in terms of training in entrepreneurial and risk management skills are high . it is therefore essential to continue the support for the setting up of new businesses and new farms . member states should provide for a strategic approach and identify a clear and coherent set of interventions for generational renewal under the specific objective dedicated to this issue . to this aim , member states may set in their cap strategic plans preferential conditions for financial instruments for young farmers and new entrants , and should include in their cap strategic plan the ring - fencing of at least an amount corresponding to 2% of the annual direct payments ' envelope . an increase of the maximum amount of aid for the installation of young farmers and rural business start - ups , up to eur 100 . 000 , which can be accessed also through or in combination with financial instrument form of support , should be established . ### as outlined in the report from the european parliament on the implementation of cap young farmers’ tools in the eu after the 2013 reform , young farmers still face significant barriers regarding access to land , high prices and access to credit . their businesses are more threatened by price volatility and their needs in terms of training in entrepreneurial and risk management skills are high . vocational training is fundamental to help young farmers with the uptake of innovation and new technologies which will , in turn , improve their competitiveness and sustainability . it is therefore essential to continue the support for the setting up of new businesses and new farms . member states should provide for a strategic approach and identify a clear and coherent set of interventions for generational renewal under the specific objective dedicated to this issue . these interventions would only constitute a good option if there is a clear and continued direct benefit for young farmers to start or develop their business . to this aim , member states may set in their cap strategic plans preferential conditions for financial instruments for young farmers , and should include in their cap strategic plan the ring - fencing of at least an amount corresponding to 4% of the annual direct payments ' envelope . an increase of the maximum amount of aid for the installation of young farmers and rural business start - ups , up to eur 100 . 000 , which can be accessed also through or in combination with financial instrument form of support , should be established .


### the commission shall adopt implementing acts on the content of the performance framework . such acts shall include the list of context indicators , other indicators needed for the appropriate monitoring and evaluation of the policy , the methods for the calculation of indicators and the necessary provisions to guarantee accuracy and reliability of the data collected by member states . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 139 . ### the commission shall adopt , within three months of the entry into force of this regulation , delegated acts with detailed rules on the performance framework , in accordance with article 138 . such acts shall include the list of context indicators , the methods for the calculation of indicators and the necessary provisions to guarantee accuracy and reliability of the data collected by member states .


### the commission shall adopt implementing acts on the content of the performance framework . such acts shall include the list of context indicators , other indicators needed for the appropriate monitoring and evaluation of the policy , the methods for the calculation of indicators and the necessary provisions to guarantee accuracy and reliability of the data collected by member states . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 139 . ### the commission shall adopt , within three months of the entry into force of this regulation , delegated acts with detailed rules on the performance framework , in accordance with article 138 . such acts shall include the methods for the calculation of indicators and the necessary provisions to guarantee accuracy and reliability of the data collected by member states .


### the member states shall pursue at least one of the specific objectives referred to in article 6 in the apiculture sector . ### the member states shall pursue at least two of the specific objectives referred to in article 6 in the apiculture sector .


### member states shall reduce the amount of direct payments to be granted to a farmer pursuant to this chapter for a given calendar year exceeding eur 60 000 as follows : ### member states may reduce the amount of basic income support for sustainability to be granted to a farmer pursuant to this chapter for a given calendar year as further specified in their cap strategic plans :


### member states shall provide support for voluntary schemes for the climate and the environment under the conditions set out in this article and as further specified in their cap strategic plans . ### member states shall provide support for voluntary schemes for the climate and the environment under the conditions set out in this article and as further specified in their cap strategic plans and to dedicate at least 20% of their allocations for direct payments to these schemes in accordance with article 86 .


### these payments may be granted to farmers , forest holders and other land managers in respect of areas with disadvantages referred to in paragraph 1 . ### these payments may be granted to farmers , groups and / or cooperatives of farmers , forest holders and groups and / or cooperatives of forest holders . in duly justified cases they may also be granted to other land managers .


### the use of common definitions entirely set at union level has caused certain difficulties for member states to cater their own specificities at national , regional , and local level . member states should therefore be given the flexibility to specify certain definitions in their cap strategic plan . in order to ensure a common level playing field , a certain framework has , however , to be set at union level constituting the necessary essential elements to be included in those definitions . ### the use of common definitions entirely set at union level has caused certain difficulties for member states to cater their own specificities at national , regional , and local level . member states should therefore be given the flexibility to specify certain definitions in their cap strategic plan . in order to ensure a common level playing field , the framework has , however , to be set at union level constituting the necessary essential elements to be included in those definitions to prevent distortion of the single market .


### support for management commitments may include organic farming premia for the maintenance of and the conversion to organic land ; payments for other types of interventions supporting environmentally friendly production systems such as agro - ecology , conservation agriculture and integrated production ; forest environmental and climate services and forest conservation ; premia for forests and establishment of agroforestry systems ; animal welfare ; conservation , sustainable use and development of genetic resources . member states may develop other schemes under this type of interventions on the basis of their needs . this type of payments should cover additional costs and income foregone only resulting from commitments going beyond the baseline of mandatory standards and requirements established in union and national law , as well as conditionality , as laid down in the cap strategic plan . commitments related to this type of interventions may be undertaken for a pre - established annual or pluri - annual period and might go beyond seven years where duly justified . ### support for management commitments may include payments for types of interventions supporting environmentally friendly production systems such as agro - ecology , agro - forestry and integrated production ; forest environmental and climate services and forest conservation ; premia for forests and establishment of agroforestry systems ; animal welfare ; conservation , sustainable use and development of genetic resources and biodiversity . member states may develop other schemes under this type of interventions on the basis of their needs . this type of payments should cover an incentive component additional costs , income foregone only resulting from commitments going beyond the baseline of mandatory standards and requirements established in union and national law , as well as conditionality , as laid down in the cap strategic plan . commitments related to this type of interventions may be undertaken for a pre - established annual or pluri - annual period and might go beyond seven years where duly justified .