### within the limits of the protection conferred by the basic patent , the protection conferred by a certificate shall extend only to the product covered by the authorisation to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorised before the expiry of the certificate . ### subject to the provisions of article 4 , the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations .


### the certificate referred to in paragraph 1 shall not confer protection against a particular act against which the basic patent conferred protection if , with respect to that particular act , the following conditions are met : ### by way of derogation from paragraph 1 , the certificate shall not confer protection against a particular act which would otherwise require the consent of the holder of the certificate referred to in article 11 if the following conditions are met :


### making for the exclusive purpose of export to third countries ; or ### an act of making for the exclusive purpose of export to third countries where protection for the product or medicinal product does not exist or has expired ; or


### the authority referred to in article 9 of the member state where that making is to take place is notified by the person doing the making of the information listed in paragraph 3 no later than 28 days before the intended start date of making in that member state ; ### the authority referred to in article 9 of the member state where each making is to take place and the certificate - holder at its address for service in the relevant member state are notified by each person doing the making of the information listed in paragraph 3 no later than 3 months before the earliest start date of making or any related act that is strictly necessary for that making in that member state ;


### the authority referred to in article 9 of the member state where that making is to take place is notified by the person doing the making of the information listed in paragraph 3 no later than 28 days before the intended start date of making in that member state ; ### the authority referred to in article 9 of the member state where that making is to take place is notified by the person responsible for the making , or any person acting on its behalf , of the information listed in paragraph 3 no later than 28 days before the intended start date of making


### the authority referred to in article 9 of the member state where that making is to take place is notified by the person doing the making of the information listed in paragraph 3 no later than 28 days before the intended start date of making in that member state ; ### the authority referred to in article 9 of the member state where that making is to take place is notified by the person doing the making of the information listed in points and of paragraph 3 no later than 28 days before the start date of making in that member state ;


### annex logo ### annex - i standard form to be used by makers for notifications under point of article 4 name and address of the maker b . address of the premises where the making is to take place in the relevant member state c . number of the certificate granted in the relevant member state , and identification of the product , by reference to its international non - proprietary name , if available ; d . earliest intended start date of making in the relevant member state e . indicative list of the intended third country or third countries to which the product is to be exported


### at european level undeclared work is defined as ‘ any paid activities that are lawful as regards their nature but not declared to public authorities , taking into account differences in the regulatory systems of the member states’ , thus excluding all illegal activities . __________________ 28 communication from the commission ‘ stepping up the fight against undeclared work’ com 628 of 24 october 2007 http : / / eur - lex . europa . eu / lexuriserv / lexuriserv . do ? uri=celex : 52007dc0628 : en : html ### at european level undeclared work is defined as ‘ any paid activities that are lawful as regards their nature but not declared to public authorities , taking account differences in the regulatory systems of the member states’28 , thus excluding all illegal activities . it should be noted that definitions vary between the member states and that undeclared work exists in many different forms . __________________ 28 communication from the commission ‘ stepping up the fight against undeclared work’ com 628 of 24 october 2007 http : / / eur - lex . europa . eu / lexuriserv / lexuriserv . do ? uri=celex : 52007dc0628 : en : html


### in order to address undeclared work comprehensively and successfully , a policy mix is to be implemented in the member states , that is facilitated by structured cooperation between relevant authorities . the cooperation should include all national authorities which are leading and / or active in the prevention and / or deterrence of undeclared work . ### in order to address undeclared work comprehensively and successfully , and while respecting the freedom to provide services , the free movement of workers and the principle of non - discrimination , a policy mix is to be implemented in the member states that is facilitated by structured cooperation between relevant authorities . the cooperation should include all national authorities which are leading and / or active in the prevention and / or deterrence of undeclared work .


### to achieve its objectives , the platform should be supported by a ‘ single point of contact’ in each member state who should have the necessary authority to liaise with national authorities dealing with the multifaceted aspects of undeclared work . ### to achieve its objectives , the platform requires the participation of all member states and should be supported by a ‘ single point of contact’ in each member state who should have the necessary authority to liaise with national authorities dealing with the multifaceted aspects of undeclared work .


### the platform should involve the social partners at eu level , both cross - industry and in those sectors more severely affected by undeclared work , and cooperate with relevant international organisations , such as the international labour organisation , and union decentralised agencies , in particular eurofound and european agency for safety and health at work . the involvement of eurofound and european agency for safety and health at work in the work of the platform as observers will not extend their existing mandates . ### the platform should involve the social partners at eu level , both cross - industry and in those sectors more severely affected by undeclared work , and cooperate with relevant international organisations , such as the international labour organisation and the organisation for economic cooperation and development , and union decentralised agencies , in particular eurofound and european agency for safety and health at work . the involvement of eurofound and european agency for safety and health at work in the work of the platform as observers will not extend their existing mandates .


### the platform should involve the social partners at eu level , both cross - industry and in those sectors more severely affected by undeclared work , and cooperate with relevant international organisations , such as the international labour organisation , and union decentralised agencies , in particular eurofound and european agency for safety and health at work . the involvement of eurofound and european agency for safety and health at work in the work of the platform as observers will not extend their existing mandates . ### the platform should involve the european parliament , the social partners at eu level , both cross - industry and in those sectors more severely affected by undeclared work , and cooperate with relevant international organisations , such as the international labour organisation , and union decentralised agencies , in particular eurofound and european agency for safety and health at work . the involvement of eurofound and european agency for safety and health at work in the work of the platform as observers will not extend their existing mandates . the representative from the european parliament should have observer status in the platform .


### the platform can establish working groups to examine specific issues and should be able to rely on the expertise of professionals with specific competences . ### the platform can establish working groups to examine specific issues and should be able to rely on the expertise of professionals with specific competences . these will include a working group on identifying optimum taxation practices for encouraging a regularisation of jobs and the early and effective deterrence of undeclared work .


### national enforcement authorities as nominated by all the member states , ### national enforcement authorities as nominated by all the member states , which shall include representatives of workers ' and employers ' associations based on an equitable distribution ,


### the following may attend the meetings of the platform as observers under the conditions set in its rules of procedure : ### the following shall be actively involved in the meetings of the platform as observers and their contributions shall be taken into due consideration , under the conditions set in its rules of procedure :


### the platform , as set out in article 1 , shall contribute to better enforcement of eu and national law , to the reduction of undeclared work and the emergence of formal jobs , hence avoiding the deterioration of quality of work , and to promote integration in the labour market and social inclusion by : ### the platform , fully respecting national competences and procedures , as set out in article 1 , shall contribute to exchange of best practices on enforcement of eu and national law , to the reduction of undeclared work and the emergence of formal jobs , on the deterioration of quality of work , and integration in the labour market and social inclusion by :


### for the execution of its mission , the platform shall in particular carry out the following tasks : ### for the execution of its mission , the platform shall in particular , all the while respecting and safeguarding national competencies , carry out the following tasks :


### in appointing their representatives , member states should involve all public authorities having a role in the prevention and / or deterrence of undeclared work , such as labour inspectorates , social security authorities , tax authorities , employment services and migration authorities , hereinafter referred to as ' enforcement authorities ' . they may also , in accordance with national law and / or practice , involve the social partners . ### in appointing their representatives , member states should involve all public authorities having , in their view , a role in the prevention and / or deterrence of undeclared work , such as labour inspectorates , social security authorities , tax authorities , employment services and migration authorities , hereinafter referred to as ' enforcement authorities ' . they may also , in accordance with national law and / or practice , involve the social partners .


### a maximum of 10 observers representing social partners in sectors with a high incidence of undeclared work . ### a maximum of 10 observers representing social partners in sectors with either a high incidence of undeclared work or a particular role in the prevention and deterrence of undeclared work .


### the commission shall inform regularly the european parliament and the council about the activities of the platform . ### the commission shall , on a twice - yearly basis , inform the european parliament , represented by its committee on employment and social affairs , and the council about the activities of the platform . parliament and the council shall be required to communicate any comments they may have .


### the platform shall work , as appropriate , in cooperation with other relevant union level expert groups and committees , whose work has a link with undeclared work , in particular the senior labour inspectors committee , the expert committee on posting of workers , the administrative commission for social security coordination , the employment committee , the social protection committee and the working group on administrative cooperation in the field of taxation . joint meetings may also be organised . ### the platform shall work , as appropriate , in cooperation with other relevant union level expert groups and committees , whose work has a link with undeclared work , in particular the senior labour inspectors committee , the expert committee on posting of workers , the administrative commission for social security coordination , the employment committee , the social protection committee and the working group on administrative cooperation in the field of taxation . in the interests of more efficient working and enhanced impact , joint meetings shall be organised , the minutes of which shall be forwarded to the european parliament and the council within a reasonable time .


### four years after its entry into force , the commission shall submit a report on the application of this decision to the european parliament , the council , the european economic and social committee and the committee of the regions . the report shall in particular assess to what extent the platform has contributed to the achievement of the objectives set out in article 2 and fulfilled the tasks as set out in article 3 and in work programmes of the platform . ### the commission shall determine , in a report to be produced after four years and following consultation with members of the platform , whether the objectives set out in article 2 , the mission described in article 3 and the tasks laid out in article 4 have been achieved and whether the platform’s work should continue . the report shall , where necessary , propose changes to the work of the platform or recommend that it cease its activities . the report will be submitted to the european parliament , the council , the european economic and social committee and the committee of the regions .


### four years after its entry into force , the commission shall submit a report on the application of this decision to the european parliament , the council , the european economic and social committee and the committee of the regions . the report shall in particular assess to what extent the platform has contributed to the achievement of the objectives set out in article 2 and fulfilled the tasks as set out in article 3 and in work programmes of the platform . ### four years after its entry into force , the commission shall submit a report on the application and the added value of this decision to the european parliament , the council , the european economic and social committee and the committee of the region , and propose , where appropriate , necessary amendments and modifications or withdrawal of this decision . the report shall in particular assess to what extent the platform has contributed to the achievement of the objectives set out in article 2 and carried out the initiatives as set out in article 4 and addressed the priorities as set out in its work programmes .


### the programme should maintain a balanced approach between bottom - up and top - down funding , according to the nature of the research and innovation communities that are engaged , the types and purpose of the activities carried out and the impacts that are sought . the mix of these factors should determine the choice of approach for the respective parts of the programme , all of which contribute to all of the programme’s general and specific objectives . ### the programme should maintain a balanced approach between bottom - up , top - down and territorially balanced funding , according to the nature of the research and innovation communities that are engaged , the types and purpose of the activities carried out and the impacts that are sought . the mix of these factors should determine the choice of approach for the respective parts of the programme , all of which contribute to all of the programme’s general and specific objectives .


### full engagement of industry in the programme , at all levels from the individual entrepreneur and small and medium - sized enterprises to large scale enterprises , should constitute one of the main channels through which the programme ' s objectives are to be realised , specifically towards the creation of sustainable jobs and growth . industry should contribute to the perspectives and priorities established through the strategic planning process which should support the development of work programmes . such engagement by industry should see its participation in the actions supported at levels at least commensurate with those under the previous framework programme horizon 2020 established by regulation no 1291 / 2013 of the european parliament and the council ### full engagement of industry in the programme , at all levels from the individual entrepreneur and small and medium - sized enterprises to large scale enterprises and producer groups , should constitute one of the main channels through which the programme ' s objectives are to be realised , specifically towards the creation of sustainable jobs and growth . industry should contribute to the perspectives and priorities established through the strategic planning process which should support the development of work programmes . such engagement by industry should see its participation in the actions supported at levels at least commensurate with those under the previous framework programme horizon 2020 established by regulation no 1291 / 2013 of the european parliament and the council13 .


### the eit , primarily through its knowledge and innovation communities , should aim at strengthening innovation ecosystems that tackle global challenges , by fostering the integration of business , research , higher education and entrepreneurship . the eit should foster innovation in its activities and should support the integration of higher education within the innovation ecosystem , in particular by : stimulating entrepreneurial education , fostering strong non - disciplinary collaborations between industry and academia ; and identifying prospective skills for future innovators to address global challenges , which includes advanced digital and innovation skills . support schemes provided by the eit should benefit to eic beneficiaries , while start - ups emerging from eit kics should have access to eic actions . while the eit’s focus on innovation ecosystems should make it naturally fit within the pillar ' open innovation ' , the planning of its kics should be aligned through the strategic planning process with the pillar ' global challenges and industrial competitiveness ' . ### the eit , primarily through its knowledge and innovation communities , should aim at strengthening innovation ecosystems that tackle global challenges , by fostering the integration of business , research , higher education and entrepreneurship . the eit should foster innovation in its activities , facilitate access to research and innovation and support the integration of higher education within the innovation ecosystem , in particular by : stimulating entrepreneurial education , fostering strong non - disciplinary collaborations between industry and academia ; and identifying prospective skills for future innovators to address global challenges , which includes advanced digital and innovation skills . support schemes provided by the eit should benefit to eic beneficiaries , while start - ups emerging from eit kics should have access to eic actions . while the eit’s focus on innovation ecosystems should make it naturally fit within the pillar ' open innovation ' , the planning of its kics should be aligned through the strategic planning process with the pillar ' global challenges and industrial competitiveness ' .


### the commission shall raise public awareness about the existence of the european citizens ' initiative through communication activities and information campaigns , thereby contributing to promoting the active participation of citizens in the political life of the union . ### the commission shall raise public awareness about the existence of the european citizens ' initiative through communication activities and information campaigns also using digital platforms and technologies&#160 ; to reach out and&#160 ; engage community , thereby contributing to promoting the active participation of citizens in the political life of the union .


### a wide variety of indices is currently grouped together as low carbon indices . those low carbon indices are used as benchmarks for investment portfolios and products that are sold across borders . the quality and integrity of low carbon benchmarks affect the effective functioning of the internal market in a wide variety of individual and collective investment portfolios . many low carbon indices used as performance measures for investment portfolios , in particular for segregated investment accounts and collective investment schemes , are provided in one member state but used by portfolio and asset managers in other member states . in addition , portfolio and asset managers often hedge their carbon exposure risks by using benchmarks produced in other member states . ### a wide variety of indices are currently grouped together as low carbon or sustainability indices . those indices are used as benchmarks for investment portfolios and products that are sold across borders . the quality and integrity of benchmarks affect the effective functioning of the internal market in a wide variety of individual and collective investment portfolios . many low carbon and sustainability indices used as performance measures for investment portfolios , in particular for segregated investment accounts and collective investment schemes , are provided in one member state but used by portfolio and asset managers in other member states . in addition , portfolio and asset managers often hedge their carbon exposure and environmental risks by using benchmarks produced in other member states .


### in the absence of a harmonised framework to ensure the accuracy and integrity of the main categories of low carbon benchmarks used in individual or collective investment portfolios , it is likely that differences in member states ' approaches will create obstacles to the smooth functioning of the internal market . ### in the absence of a harmonised framework to ensure the accuracy and integrity of the benchmarks used in individual or collective investment portfolios , it is likely that differences in member states ' approaches will create obstacles to the smooth functioning of the internal market .


### in the absence of a harmonised framework to ensure the accuracy and integrity of the main categories of low carbon benchmarks used in individual or collective investment portfolios , it is likely that differences in member states ' approaches will create obstacles to the smooth functioning of the internal market . ### in the absence of a harmonised framework to ensure the accuracy and integrity of benchmarks used in individual or collective investment portfolios , it is likely that differences in member states ' approaches will create obstacles to the smooth functioning of the internal market .


### it is furthermore necessary to introduce a clear distinction between low - carbon and positive carbon impact benchmarks . while the underlying assets in a low - carbon benchmark should be selected with the aim of reducing carbon emissions of the index portfolio when compared to the parent index , a positive carbon impact index should only comprise components whose emissions savings exceed their carbon emissions . ### while it is necessary to integrate circular economy indicators in all benchmark methodologies , a category of positive environmental impact benchmark could be introduced . the underlying assets in a positive environmental impact benchmark should only comprise components whose net impact , based on harmonised circular economy indicators , is positive .


### it is furthermore necessary to introduce a clear distinction between low - carbon and positive carbon impact benchmarks . while the underlying assets in a low - carbon benchmark should be selected with the aim of reducing carbon emissions of the index portfolio when compared to the parent index , a positive carbon impact index should only comprise components whose emissions savings exceed their carbon emissions . ### while it is necessary to integrate circular economy indicators to all benchmark methodologies , a category of positive impact benchmarks should be introduced . the underlying assets in a positive impact benchmark should only comprise components whose net impact based on harmonised circular economy indicators is positive .


### for the same reasons , administrators of low - carbon and of positive carbon impact benchmarks should equally publish their methodology used for their calculation . that information should describe how the underlying assets were selected and weighted and which assets were excluded and for what reason . the benchmark administrators should also specify how the low carbon benchmarks differ from the underlying parent index , notably in terms of the applicable weights , market capitalisation and financial performance of the underlying assets . to assess how the benchmark contributes to the environmental objectives , the benchmark administrator should disclose how the carbon footprint and carbon savings of the underlying assets were measured , their respective values , including the total carbon footprint of the benchmark , and the type and source of the data used . to enable asset managers to choose the most appropriate benchmark for their investment strategy , benchmark administrators should explain the rationale behind the parameters of their methodology and explain how the benchmark contributes to the environmental objectives , including its impact on climate - change mitigation . the published information should also include details on the frequency of reviews and the procedure followed . ### for the same reasons , benchmark administrators of positive impact benchmarks should equally publish their methodology used for their calculation . that information should describe how the underlying assets were selected and weighted and which assets were excluded and for what reason . the benchmark administrators should also specify how the positive impact benchmarks differ from the underlying parent index , notably in terms of the applicable weights , market capitalisation and financial performance of the underlying assets . to assess how the benchmark contributes to the environmental objectives , the benchmark administrator should disclose how the environmental impact and risks of the underlying assets were measured , their respective values , including the total environmental footprint of the benchmark , and the type and source of the data used . to enable asset managers to choose the most appropriate benchmark for their investment strategy , benchmark administrators should explain the rationale behind the parameters of their methodology and explain how the benchmark contributes to the environmental objectives . the published information should also include details on the frequency of reviews and the procedure followed .


### to ensure continued adherence to the selected climate - change mitigation objective , administrators of low - carbon and positive carbon impact benchmarks should regularly review their methodologies and inform users of the applicable procedures for any material change . when introducing a material change , benchmark administrators should disclose the reasons for that change and explain how the change is consistent with the benchmarks’ initial objectives . ### to ensure the accuracy of information to investors , administrators of positive environmental impact benchmarks should regularly review their methodologies and inform users of the applicable procedures for any material change . when introducing a material change , benchmark administrators should disclose the reasons for that change and explain how the change is consistent with the benchmarks’ initial objectives .


### to ensure continued adherence to the selected climate - change mitigation objective , administrators of low - carbon and positive carbon impact benchmarks should regularly review their methodologies and inform users of the applicable procedures for any material change . when introducing a material change , benchmark administrators should disclose the reasons for that change and explain how the change is consistent with the benchmarks’ initial objectives . ### to ensure accuracy of information to investors , administrators of positive impact benchmarks should regularly review their methodologies and inform users of the applicable procedures for any material change . when introducing a material change , benchmark administrators should disclose the reasons for that change and explain how the change is consistent with the benchmarks’ initial objectives .


### ‘ low - carbon benchmark’ means a benchmark where the underlying assets , for the purposes of point 1 of this paragraph , are selected so that the resulting benchmark portfolio has less carbon emissions when compared to the assets that comprise a standard capital - weighted benchmark and which is constructed in accordance with the standards laid down in the delegated acts referred to in article 19a ; ### ‘ low - carbon benchmark’ means a benchmark where the underlying assets , for the purposes of point 1 of this paragraph , are selected so that the resulting benchmark portfolio has fewer carbon emissions when compared to the benchmarks using the same methodology , but not taking carbon emissions into account and which is constructed in accordance with the minimum standards laid down in the delegated acts referred to in article 19a or with the benchmarks marketed as such ;


### ‘ positive carbon impact benchmark’ means a benchmark where the underlying assets , for the purposes of point 1 of this paragraph , are selected on the basis that their carbon emissions savings exceed the asset’s carbon footprint and which is constructed in accordance with the standards laid down in the delegated acts referred to in article 19a . ### ‘ positive carbon impact benchmark’ means a benchmark where the underlying assets , for the purposes of point 1 of this paragraph , are selected on the basis that their carbon emissions savings exceed the asset’s carbon footprint and which is constructed in accordance with the minimum standards laid down in the delegated acts referred to in article 19a .


### the commission shall be empowered to adopt delegated acts in accordance with article 49 to specify further the minimum content of the explanation referred to in point of paragraph 1 . ; ### after having consulted esma , the commission shall be empowered to adopt delegated acts in accordance with article 49 to specify further the minimum content of the explanation referred to in point of paragraph 1 . the delegated acts shall not force benchmark administrators to disclose any information that is proprietary or confidential in nature .


### the method for the calculation of carbon emissions and carbon savings associated with the underlying assets . ; ### the method for the calculation of carbon emissions , other emissions , impact on biodiversity , production of waste and the use of energy , renewable energy , raw materials , water , and direct and indirect land use , associated with the underlying assets . ;


### the method for the calculation of carbon emissions and carbon savings associated with the underlying assets . ### the method for the calculation of carbon emissions , other emissions , impact on biodiversity , production of waste and the use of energy , renewable energy , raw materials , water , and land , associated with the underlying assets .


### for each requirement in paragraph 2 , a benchmark statement shall contain an explanation of how environmental , social and governance factors are reflected for each benchmark or family of benchmarks provided and published which pursue or take into account esg objectives . ### for the requirements laid down in paragraph 2 , and , a benchmark statement shall contain an explanation of how environmental , social and governance factors are reflected for each benchmark or family of benchmarks provided and published which pursue or take into account esg objectives .


### the positive reweighting of low - carbon assets in the low carbon benchmark versus the parent index and the explanation of why this reweighting is necessary to reflect the chosen objectives of the low carbon benchmark ; ### the positive reweighting of assets with environmentally positive impact in the benchmark versus the parent index and the explanation of why this reweighting is necessary to reflect the chosen objectives of the positive impact benchmark ;


### the rationale for adopting a particular low - carbon methodology strategy or objective and an explanation of why the methodology is appropriate for the calculation of the low - carbon objectives of the benchmark ; ### the rationale for adopting a particular methodology , and where relevant , a sustainability strategy or objective , and an explanation of why the methodology is appropriate for the calculation of the environmental impact , and where relevant , sustainability strategies or objectives of the benchmark ;


### the rationale for adopting a particular low - carbon methodology strategy or objective and an explanation of why the methodology is appropriate for the calculation of the low - carbon objectives of the benchmark ; ### the rationale for adopting a particular environmental methodology strategy or sustainability objective and an explanation of why the methodology is appropriate for the calculation of the environmental impact and sustainability objectives of the benchmark ;


### the conditions for making fertilisers available on the internal market have been partially harmonised through regulation no 2003 / 2003 of the european parliament and of the council15 , which almost exclusively covers fertilisers from mined or chemically produced , inorganic materials . there is also a need to make use of recycled or organic materials for fertilising purposes . harmonised conditions for making fertilisers made from such recycled or organic materials available on the entire internal market should be established in order to provide an important incentive for their further use . the scope of the harmonisation should therefore be extended in order to include recycled and organic materials . __________________ 15 regulation no 2003 / 2003 of the european parliament and of the council of 13 october 2003 relating to fertilisers . ### the regulation must foster the goals of the circular economy , provided it ensures at the same time that farmers have a secure supply of highly efficient fertilisers . the european commission must present the european parliament and the council with a report taking stock of the application of this regulation five years after its entry into force . __________________ deleted


### the end point in the manufacturing chain should be determined for each relevant component material containing animal by - products in accordance with the procedures laid down in regulation no 1069 / 2009 . where a manufacturing process regulated under this regulation starts already before that end point has been reached , the process requirements of both regulation no 1069 / 2009 and this regulation should apply cumulatively to ce marked fertilising products , which means application of the stricter requirement in case both regulations regulate the same parameter . ### the end point in the manufacturing chain should be determined for each relevant component material containing animal by - products in accordance with the procedures laid down in regulation no 1069 / 2009 . the setting of processing methods and recovery rules for animal by - products for which an end point in the manufacturing chain has been determined should start immediately after the entry into force of this regulation . accordingly , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of expanding or adding , without any unnecessary delay , certain animal by - products to the specific component material categories in order to increase opportunities and provide more legal certainty for producers and users by unlocking the circular potential of increased use of nutrients from animal by - products such as animal manure . where a manufacturing process regulated under this regulation starts already before that end point has been reached , the process requirements of both regulation no 1069 / 2009 and this regulation should apply cumulatively to ce marked fertilising products , which means application of the stricter requirement in case both regulations regulate the same parameter .


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


### certain substances and mixtures , commonly referred to as agronomic additives , improve the nutrient release pattern of a nutrient in a fertiliser . substances and mixtures made available on the market with the intention of them being added to ce marked fertilising products for that purpose should fulfil certain efficacy criteria at the responsibility of the manufacturer of those substances or mixtures , and should therefore as such be considered as ce marked fertilising products under this regulation . furthermore , ce marked fertilising products containing such substances or mixtures should be subject to certain efficacy and safety criteria . such substances and mixtures should therefore also be regulated as component materials for ce marked fertilising products . ### certain substances and mixtures , commonly referred to as agronomic additives , improve the nutrient release pattern of a nutrient in a fertiliser . substances and mixtures made available on the market with the intention of them being added to ce marked fertilising or organic farm based fertilising products for that purpose or intended to be used in separate application but with the same aim should fulfil certain efficacy criteria at the responsibility of the manufacturer of those substances or mixtures , and should therefore as such be considered as ce marked fertilising products under this regulation . furthermore , ce marked fertilising products containing such substances or mixtures should be subject to certain efficacy and safety criteria . such substances and mixtures should therefore also be regulated as component materials for ce marked fertilising products .


### products with one or more functions , one of which is covered by the scope of regulation no 1107 / 2009 , should remain under the control tailored for such products and provided for by that regulation . where such products also have the function of a fertilising product , it would be misleading to provide for their ce marking under this regulation , since the making available on the market of a plant protection product is contingent on a product authorisation valid in the member state in question . therefore , such products should be excluded from the scope of this regulation . ### products with one or more functions , one of which is covered by the scope of regulation no 1107 / 2009 , should remain under the control tailored for such products and provided for by that regulation . where such products also have the function of a fertilising product , it would be misleading to provide for their ce marking under this regulation , since the making available on the market of a plant protection product is contingent on a product authorisation valid in the member state in question . therefore , such products should be excluded from the scope of this regulation . products containing components registered under regulation no 1107 / 2009 can have one or more fertilising functions and therefore be covered by the scope of this regulation .


### a ce marked fertilising product that has undergone a recovery operation and complies with the requirements laid down in this regulation shall be considered to comply with the conditions laid down in article 6 of directive 2008 / 98 / ec and shall , therefore , be considered as having ceased to be waste . ### a material that has undergone a recovery operation and complies with the requirements laid down in this regulation shall be considered to be a component material of a ce marked fertilising product that complies with the conditions laid down in article 6 of directive 2008 / 98 / ec and shall , therefore , be considered to have ceased being waste . this component material may fall under the scope of this regulation if it demonstrates an agronomic efficacy and if it meets the requirements laid down in the annexes to this regulation .


### the commission shall be empowered to adopt delegated acts in accordance with article 43 to amend annexes i to iv for the purposes of adapting them to technical progress and facilitating internal market access and free movement for ce marked fertilising products ### the commission shall be empowered to adopt delegated acts in accordance with article 43 and taking into account the results of the report mentioned in para . 1a to amend annexes i to iv for the purposes of adapting them to technical progress and facilitating internal market access and free movement for ce marked fertilising products .


### member states shall not impede the making available on the market of products which were placed on the market as fertilisers designated ' ec fertiliser ' in conformity with regulation no 2003 / 2003 before [ publications office , please insert the date of application of this regulation ] . however , chapter 5 shall apply mutatis mutandis to such products . ### member states shall not impede the making available on the market of products which were placed on the market as fertilisers designated ' ec fertiliser ' in conformity with regulation no 2003 / 2003 before [ publications office , please insert the date : twelve months after the date of application of this regulation ] . however , chapter 5 shall apply mutatis mutandis to such products .


### an organic soil improver shall consist exclusively of material of solely biological origin , excluding material which is fossilized or embedded in geological formations . ### an organic soil improver shall contain material of biological origin .


### the ce marked fertilising product shall contain at least one of the following declared nutrients in the minimum quantities stated : ### the ce marked fertilising product shall contain at least one of the following declared primary nutrients in the minimum quantities stated :


### the ce marked fertilising product shall contain more than one of the following declared nutrients in the minimum quantities stated : ### the ce marked fertilising product shall contain more than one of the primary declared nutrients in the minimum quantities stated :


### the ce marked fertilising product shall contain one of the following declared nutrients in the minimum quantity stated : ### the ce marked fertilising product shall contain one of the primary declared nutrients in the minimum quantity stated :


### - 1 , 5% by mass of total nitrogen , ### - 3% by mass of total nitrogen , or


### - 1 , 5% by mass of total potassium oxide , ### - 3% by mass of total potassium oxide , or


### - 1 , 5% by mass of total phosphorus pentoxide , ### - 3% by mass of total phosphorus pentoxide , or


### in the ce marked fertilising product , each unit shall contain the organic matter and the nutrients in their declared content . ### in the ce marked fertilising product , each unit shall contain organic carbon and all the nutrients in their declared content . a unit refers to one of the component pieces of product such as granules , pellets , etc .


### a straight solid inorganic macronutrient fertiliser shall have a declared content of not more than one nutrient . ### a straight solid inorganic macronutrient fertiliser shall have a declared content of not more than one primary or secondary nutrient . straight solid mineral primary nutrients can have also secondary nutrients .


### a straight liquid inorganic macronutrient fertiliser shall have a declared content of not more than one nutrient . ### a straight liquid inorganic macronutrient fertiliser shall have a declared content of not more than one primary or secondary nutrient . straight liquid mineral primary nutrients can have also secondary nutrients .


### a compound liquid inorganic macronutrient fertiliser shall have a declared content of more than one nutrient . ### a compound liquid inorganic macronutrient fertiliser shall have a declared content of more than one primary nutrient .


### - 0 , 75% by mass of total magnesium oxide , ### - 1 , 5% by mass of total magnesium oxide , or


### - 0 , 75% by mass of total calcium oxide , ### - 1 , 5% by mass of total calcium oxide , or


### - 1 , 5% by mass of total sulphur trioxide , or ### - 5% by mass of total sulphur trioxide ,


### - 5% by mass of total sulphur trioxide , or ### - 5% by mass of total sulphur trioxide ,


### a soil improver shall be a ce marked fertilising product aimed at being added to the soil for the purpose of maintaining , improving or protecting the physical or chemical properties , the structure or the biological activity of soil . ### a soil improver shall be a material added to soil in situ primarily to maintain or improve its physical properties , and which may improve its chemical and / or biological properties or activity .


### a soil improver shall be a ce marked fertilising product aimed at being added to the soil for the purpose of maintaining , improving or protecting the physical or chemical properties , the structure or the biological activity of soil . ### a soil improver shall be a ce marked fertilising product aimed at being added to the soil for the purpose of maintaining , improving or protecting the physical or chemical properties , the structure or the biological activity of soil . a soil improver can also be a material added to soil in situ in order to maintain or improve its physical properties , and which may improve its chemical and / or biological properties or activity .


### an agronomic additive shall be a ce marked fertilising product intended to be added to a product providing plants with nutrient , with the intention to improve that product ' s nutrient release patterns . ### an agronomic additive shall be a ce marked fertilising product intended to be added to a product , which has a proven effect on the transformation and / or plant - availability of different forms of mineral or mineralized nutrients , or to be added to the soil with the intention to improve that nutrient uptake by plants or to reduce nutrient losses .


### each substance shall have been registered pursuant to regulation no 1907 / 2006 , 36 in a dossier containing __________________ 36 in the case of an additive recovered in the european union , this condition is fulfilled if the additive is the same , within the meaning of article 2 of regulation no 1907 / 2006 , as a substance registered in a dossier containing the information here indicated , and if information is available to the fertilising product manufacturer within the meaning of article 2 of regulation no 1907 / 2006 . ### each substance shall have been registered pursuant to regulation no 1907 / 2006 , 36 unless explicitly covered by one of the registration obligation exemptions provided for in article 6 of that regulation or in annex iv or annex v thereto . __________________ 36 in the case of an additive recovered in the european union , this condition is fulfilled if the additive is the same , within the meaning of article 2 of regulation no 1907 / 2006 , as a substance registered in a dossier containing the information here indicated , and if information is available to the fertilising product manufacturer within the meaning of article 2 of regulation no 1907 / 2006 .


### the substance shall have been registered pursuant to regulation no 1907 / 200647 , in a dossier containing __________________ 47 in the case of a substance recovered in the european union , this condition is fulfilled if the substance is the same , within the meaning of article 2 of regulation no 1907 / 2006 , as a substance registered in a dossier containing the information here indicated , and if information is available to the fertilising product manufacturer within the meaning of article 2 of regulation no 1907 / 2006 . ### the substance shall have been registered pursuant to regulation no 1907 / 200647 , unless explicitly covered by one of the registration obligation exemptions provided for in article 6 of that regulation or in annex iv or annex v thereto . __________________ 47 in the case of a substance recovered in the european union , this condition is fulfilled if the substance is the same , within the meaning of article 2 of regulation no 1907 / 2006 , as a substance registered in a dossier containing the information here indicated , and if information is available to the fertilising product manufacturer within the meaning of article 2 of regulation no 1907 / 2006 .


### the substance shall have been registered pursuant to regulation no 1907 / 2006 , 37 in a dossier containing __________________ 37 in the case of an additive recovered in the european union , this condition is fulfilled if the additive is the same , within the meaning of article 2 of regulation no 1907 / 2006 , as a substance registered in a dossier containing the information here indicated , and if information is available to the fertilising product manufacturer within the meaning of article 2 of regulation no 1907 / 2006 . ### the substance shall have been registered pursuant to regulation no 1907 / 2006 , 37 unless explicitly covered by one of the registration obligation exemptions provided for in article 6 of that regulation or in annex iv or annex v thereto . __________________ 37 in the case of an additive recovered in the european union , this condition is fulfilled if the additive is the same , within the meaning of article 2 of regulation no 1907 / 2006 , as a substance registered in a dossier containing the information here indicated , and if information is available to the fertilising product manufacturer within the meaning of article 2 of regulation no 1907 / 2006 .


### the substance shall have been registered pursuant to regulation no 1907 / 2006 , 38 in a dossier containing __________________ 38 in the case of an additive recovered in the european union , this condition is fulfilled if the additive is the same , within the meaning of article 2 of regulation no 1907 / 2006 , as a substance registered in a dossier containing the information here indicated , and if information is available to the fertilising product manufacturer within the meaning of article 2 of regulation no 1907 / 2006 . ### the substance shall have been registered pursuant to regulation no 1907 / 2006 , 38 unless explicitly covered by one of the registration obligation exemptions provided for in article 6 of that regulation or in annex iv or annex v thereto . __________________ 38 in the case of an additive recovered in the european union , this condition is fulfilled if the additive is the same , within the meaning of article 2 of regulation no 1907 / 2006 , as a substance registered in a dossier containing the information here indicated , and if information is available to the fertilising product manufacturer within the meaning of article 2 of regulation no 1907 / 2006 .


### the plant biostimulant shall have the effects that are claimed on the label for the crops specified thereon . ### the plant biostimulant shall have the effects that are claimed on the label for the crops specified thereon . where the plant biostimulant contains one or more ingredients that have been approved under regulation no 1107 / 2009 , the information provided during conformity assessment will provide compelling empirical evidence of the biostimulant effect , taking into account relevant parameters , e . g . relative concentrations of components , application rate , timing , plant growth stage , target crop , etc .


### a microbial plant biostimulant shall consist solely of a micro - organism or a consortium of micro - organisms referred to in component material category 7 of annex ii . ### a microbial plant biostimulant shall consist :


### the blending shall not change the nature of each component fertilising product ### the blending shall not change the function of each component fertilising product and shall not have an adverse effect on human , animal or plant health , on safety , or on the environment , under reasonably foreseeable conditions of storage or use of the ce marked fertilising product blend .


### polymers , or ### polymers with the exception of those used in growing media not in contact with the soil , or


### all the substances incorporated into the ce marked fertilising product , in their own or in a mixture , shall have been registered pursuant to regulation no 1907 / 2006 , in a dossier containing ### all the substances incorporated into the ce marked fertilising product , in their own or in a mixture , shall have been registered pursuant to regulation no 1907 / 2006 , unless explicitly covered by one of the registration obligation exemptions provided for in article 6 of that regulation or in annex iv or annex v to it .


### a ce marked fertilising product may contain plants , plant parts or plant extracts having undergone no other processing than cutting , grinding , centrifugation , pressing , drying , freeze - drying or extraction with water . ### a ce marked fertilising product may contain plants , plant parts or plant extracts having undergone only physical , mechanical or biochemical processing such as cutting , grinding , centrifugation , pressing , drying , freeze - drying , granulating , chopping , extrusion , frost - treatment , phytosanitary heat treatment , milling , or sieving , nutrient balancing or extraction with water .


### - criterion : maximum 25 mmol o2 / kg organic matter / h ; or ### - criterion : maximum 50 mmol o2 / kg organic matter / h ; or


### –sewage sludge , industrial sludge or dredging sludge , ### –sewage sludge , industrial sludge other than those specified in point or dredging sludge , and


### thermophilic anaerobic digestion at 55&#176 ; c during at least 24h and a hydraulic retention time of at least 20 days ; ### thermophilic anaerobic digestion at 55&#176 ; c during at least 24h and a hydraulic retention time of at least 20 days , followed by an analysis to verify that the digestion process successfully destroyed the pathogens ;


### a ce marked fertilising product may contain micro - organisms , including dead or empty - cell micro - organisms and non - harmful residual elements of the media on which they were produced , which ### micro - organisms , including dead or empty - cell micro - organisms and non - harmful residual elements of the media on which they were produced may be presumed to be safe for incorporation into a ce - marked fertilizing product if they fall into one of the following three cases :


### a ce marked fertilising product may contain a compliant nitrification inhibitor , as referred to in pfc 5 of annex i , only if at least 50% of the total nitrogen content of the fertilising product consists of the nitrogen forms ammonium and urea . ### a ce marked fertilising product may contain a compliant nitrification inhibitor , as referred to in pfc 5 of annex i , only if at least 50% of the total nitrogen content of the fertilising product consists of the nitrogen forms ammonium or ammonium and urea .


### a description of all components above 5% by product weight in descending order of magnitude by dry weight , including an indication of the relevant component material categories as referred to in annex ii . ### a description of all components above 1% by product weight in descending order of magnitude by dry weight , including an indication of the relevant component material categories as referred to in annex ii and including the content as percentage by the dry matter ;


### the nitrification inhibitor content shall be expressed as a percentage by mass of the total nitrogen present as ammonium nitrogen and urea nitrogen . ### the nitrification inhibitor content shall be expressed as a percentage by mass of the total nitrogen present as ammonium nitrogen or ammonium nitrogen and urea nitrogen .


### dose , timing and frequency of application ; ### dose , timing , placement and frequency of application ) ;


### organic carbon dry matter content total nitrogen organic nitrogen total phosphorus pentoxide total potassium oxide total and water - soluble magnesium oxide , calcium oxide , sulphur trioxide or sodium oxide total copper total zinc quantity organic carbon dry matter content total nitrogen organic nitrogen total phosphorus pentoxide total potassium oxide total and water - soluble magnesium oxide , calcium oxide , sulphur trioxide or sodium oxide total copper total zinc quantity ### permissible tolerance for the declared nutrient content and other declared parameter ± 20 % relative deviation of the declared value up to a maximum of 2 , 0 percentage point in absolute terms ± 5 , 0 percentage point in absolute terms ± 50 % relative deviation of the declared value up to a maximum of 1 , 0 percentage point in absolute terms ± 50 % relative deviation of the declared value up to a maximum of 1 , 0 percentage point in absolute terms ± 50 % relative deviation of the declared value up to a maximum of 1 , 0 percentage point in absolute terms ± 50 % relative deviation of the declared value up to a maximum of 1 , 0 percentage point in absolute terms ± 25% of the declared content of those nutrients up to a maximum of 1 , 5 percentage points in absolute terms . ± 50 % relative deviation of the declared value up to a maximum of 2 , 5 percentage points in absolute terms ± 50 % relative deviation of the declared value up to a maximum of 2 , 0 percentage points in absolute terms - 5 % relative deviation of the declared value permissible tolerance for the declared nutrient content and other declared parameter ± 15 % relative deviation of the declared value up to a maximum of 2 , 0 percentage point in absolute terms ± 5 , 0 percentage point in absolute terms ± 15 % relative deviation of the declared value up to a maximum of 1 , 0 percentage point in absolute terms ± 15 % relative deviation of the declared value up to a maximum of 1 , 0 percentage point in absolute terms ± 15 % relative deviation of the declared value up to a maximum of 1 , 0 percentage point in absolute terms ± 15 % relative deviation of the declared value up to a maximum of 1 , 0 percentage point in absolute terms ± 25% of the declared content of those nutrients up to a maximum of 1 , 5 percentage points in absolute terms . ± 50 % relative deviation of the declared value up to a maximum of 2 , 5 percentage points in absolute terms ± 50 % relative deviation of the declared value up to a maximum of 2 , 0 percentage points in absolute terms - 5 % relative deviation of the declared value


### organic carbon : 20% relative deviation of the declared value up to a maximum of 2 , 0 percentage point in absolute terms ### organic carbon : 15% relative deviation of the declared value up to a maximum of 2 , 0 percentage point in absolute terms


### organic nitrogen : 50% relative deviation of the declared value up to a maximum of 1 , 0 percentage point in absolute terms ### organic nitrogen : 15% relative deviation of the declared value up to a maximum of 1 , 0 percentage point in absolute terms


### granulometry : ± 10 % relative deviation applicable to the declared percentage of material passing a specific sieve ### granulometry : ± 20 % relative deviation applicable to the declared percentage of material passing a specific sieve


### forms for the declared nutrient and other declared quality criteria electric conductivity ph quantity by volume quantity determination of materials with particle size greater than 60 mm quantity determination of pre - shaped gm water - soluble nitrogen water - soluble phosphorus pentoxide water - soluble potassium oxide forms for the declared nutrient and other declared quality criteria electric conductivity ph quantity by volume quantity determination of materials with particle size greater than 60 mm quantity determination of pre - shaped gm water - soluble nitrogen water - soluble phosphorus pentoxide water - soluble potassium oxide ### permissible tolerances for the declared parameter ± 50% relative deviation at the time of manufacture ± 75% relative deviation at any time in the distribution chain ± 0 , 7 at the time of manufacture ± 1 , 0 at any time in the distribution chain - 5% relative deviation at the time of manufacture - 25% relative deviation at any time in the distribution chain - 5% relative deviation at the time of manufacture - 25% relative deviation at any time in the distribution chain - 5% relative deviation at the time of manufacture - 25% relative deviation at any time in the distribution chain ± 50% relative deviation at the time of manufacture ± 75% relative deviation at any time in the distribution chain ± 50% relative deviation at the time of manufacture ± 75% relative deviation at any time in the distribution chain ± 50% relative deviation at the time of manufacture ± 75% relative deviation at any time in the distribution chain permissible tolerances for the declared parameter ± 50% relative deviation at the time of manufacture ± 60% relative deviation at any time in the distribution chain ± 0 , 7 at the time of manufacture ± 0 , 9 at any time in the distribution chain - 5% relative deviation at the time of manufacture - 15% relative deviation at any time in the distribution chain - 5% relative deviation at the time of manufacture - 15% relative deviation at any time in the distribution chain - 5% relative deviation at the time of manufacture - 15% relative deviation at any time in the distribution chain ± 50% relative deviation at the time of manufacture ± 60% relative deviation at any time in the distribution chain ± 50% relative deviation at the time of manufacture ± 60% relative deviation at any time in the distribution chain ± 50% relative deviation at the time of manufacture ± 60% relative deviation at any time in the distribution chain


### 2 . the manufacturer shall draw up a written eu declaration of conformity for each ce marked fertilising product lot and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the ce marked fertilising product has been placed on the market . the eu declaration of conformity shall identify the ce marked fertilising product for which it has been drawn up . ### 2 . the manufacturer shall draw up a written eu declaration of conformity for each ce marked fertilising product lot and keep it together with the technical documentation at the disposal of the national authorities for 5 years after the ce marked fertilising product has been placed on the market . the eu declaration of conformity shall identify the ce marked fertilising product for which it has been drawn up .


### 2the manufacturer shall draw up a written eu declaration of conformity for a ce marked fertilising product lot and keep it at the disposal of the national authorities for 10 years after the ce marked fertilising product has been placed on the market . the eu declaration of conformity shall identify the ce marked fertilising product lot for which it has been drawn up . ### 2the manufacturer shall draw up a written eu declaration of conformity for a ce marked fertilising product lot and keep it at the disposal of the national authorities for 5 years after the ce marked fertilising product has been placed on the market . the eu declaration of conformity shall identify the ce marked fertilising product lot for which it has been drawn up .


### 2 . 1the manufacturer shall draw up a written eu declaration of conformity for each ce marked fertilising product lot and keep it at the disposal of the national authorities for 10 years after the ce marked fertilising product has been placed on the market . the eu declaration of conformity shall identify the product lot for which it has been drawn up . ### 2 . 1the manufacturer shall draw up a written eu declaration of conformity for each ce marked fertilising product lot and keep it at the disposal of the national authorities for 5 years after the ce marked fertilising product has been placed on the market . the eu declaration of conformity shall identify the product lot for which it has been drawn up .


### –test reports , and ### –test reports , including studies on agronomic efficiency , and


### the manufacturer shall keep a copy of the eu - type examination certificate , its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the ce marked fertilising product has been placed on the market . ### the manufacturer shall keep a copy of the eu - type examination certificate , its annexes and additions together with the technical documentation at the disposal of the national authorities for 5 years after the ce marked fertilising product has been placed on the market .


### conceptual design and manufacturing drawings and schemes , including a written description and a diagram of the production process , where each treatment , storage vessel and area is clearly identified , ### a written description and a diagram of the production process ;


### the manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the ce marked fertilising product has been placed on the market . ### the manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 5 years after the ce marked fertilising product has been placed on the market .


### the manufacturer shall , for a period ending at least 10 years after the product has been placed on the market , keep at the disposal of the national authorities : ### the manufacturer shall , for a period ending at least 5 years after the product has been placed on the market , keep at the disposal of the national authorities :


### proposal for a regulation of the european parliament and of the council laying down common provisions on the european regional development fund , the european social fund plus , the cohesion fund , and the european maritime and fisheries fund and financial rules for those and for the asylum and migration fund , the internal security fund and the border management and visa instrument ### proposal for a regulation of the european parliament and of the council laying down common provisions on the european regional development fund , the european social fund plus , the cohesion fund , the european agricultural fund for rural development , and the european maritime and fisheries fund and financial rules for those and for the asylum and migration fund , the internal security fund and the border management and visa instrument .


### proposal for a regulation of the european parliament and of the council laying down common provisions on the european regional development fund , the european social fund plus , the cohesion fund , and the european maritime and fisheries fund and financial rules for those and for the asylum and migration fund , the internal security fund and the border management and visa instrument ### proposal for a regulation of the european parliament and of the council laying down common provisions on the european regional development fund , the european social fund plus , the cohesion fund , the european agricultural fund for rural development , and the european maritime and fisheries fund and financial rules for those and for the asylum and migration fund , the internal security fund and the border management and visa instrument


### in order to further develop a coordinated and harmonised implementation of union funds implemented under shared management namely the european regional development fund , the european social fund plus , the cohesion fund , measures financed under shared management in the european maritime and fisheries fund , the asylum and migration fund , internal security fund and integrated border management fund , financial rules based on article 322 of the tfeu should be established for all these funds , clearly specifying the scope of application of the relevant provisions . in addition , common provisions based on article 177 of the tfeu should be established to cover policy specific rules for the erdf , the esf + , the cohesion fund and the emff . ### in order to further coordinate , harmonise and simplify , develop a coordinated and harmonised implementation of union funds implemented under shared management namely the european regional development fund , the european social fund plus , the cohesion fund , measures financed under shared management in the european maritime and fisheries fund , the asylum , migration and integration fund , internal security fund and integrated border management fund , financial rules based on article 322 of the tfeu should be established for all these funds , clearly specifying the scope of application of the relevant provisions . in addition , common provisions based on article 177 of the tfeu should be established to cover policy specific rules for the erdf , the esf + , the cohesion fund and the emff .


### horizontal principles as set out in article 3 of the treaty on the european union and in article 10 of the tfeu , including principles of subsidiarity and proportionality as set out in article 5 of the teu should be respected in the implementation of the funds , taking into account the charter of fundamental rights of the european union . member states should also respect the obligations of the un convention on the rights of persons with disabilities and ensure accessibility in line with its article 9 and in accordance with the union law harmonising accessibility requirements for products and services . member states and the commission should aim at eliminating inequalities and at promoting equality between men and women and integrating the gender perspective , as well as at combating discrimination based on sex , racial or ethnic origin , religion or belief , disability , age or sexual orientation . the funds should not support actions that contribute to any form of segregation . the objectives of the funds should be pursued in the framework of sustainable development and the union ' s promotion of the aim of preserving , protecting and improving the quality of the environment as set out in article 11 and article 191 of the tfeu , taking into account the polluter pays principle . in order to protect the integrity of the internal market , operations benefitting undertakings shall comply with union state aid rules as set out in articles 107 and 108 of the tfeu . ### horizontal principles and values as set out in article 3 of the treaty on the european union and in article 10 of the tfeu , including principles of subsidiarity and proportionality as set out in article 5 of the teu should be respected in the implementation of the funds , taking into account the charter of fundamental rights of the european union . member states should also respect the obligations of the un convention on the rights of persons with disabilities and ensure accessibility in line with its article 9 and in accordance with the union law harmonising accessibility requirements for products and services . operations financed by the funds should contribute to eliminating inequalities , to promoting equality between men and women , as well as at combating discrimination based on any ground , including sex , racial or ethnic origin , colour or social origin , genetic features , religion or belief , political or any other opinion , membership of a national minority , property , birth , disability , age or sexual orientation . the funds should not support actions that contribute to any form of segregation or social exclusion . the objectives of the funds should be pursued in the framework of sustainable development and the union ' s promotion of the aim of preserving , protecting and improving the quality of the environment and combating climate change as set out in article 11 and article 191 of the tfeu , taking into account the polluter pays principle . in order to protect the integrity of the internal market , operations benefitting undertakings shall comply with union state aid rules as set out in articles 107 and 108 of the tfeu . to achieve a better and more sustainable future for all , it is necessary to target support of the funds towards the principles set out in the european pillar of social rights and the sustainable development goals set out in the 2030 united nations agenda , to which the union and its member states have committed . the funds should furthermore contribute to the eradication of poverty in the union . when implementing the funds , member states should ensure consistency , coherence and synergies with the aforementioned principles and targets , taking into account local and regional challenges .


### part of the budget of the union allocated to the funds should be implemented by the commission under shared management with member states within the meaning of regulation [ number of the new financial regulation ] of the european parliament and of the council12 . therefore , when implementing the funds under shared management , the commission and the member states should respect the principles referred to in the financial regulation , such as sound financial management , transparency and non - discrimination . _________________ 12 oj l [ … ] , [ … ] , p . [ … ] . ### part of the budget of the union allocated to the funds should be implemented by the commission under shared management with member states within the meaning of regulation [ number of the new financial regulation ] of the european parliament and of the council12 . therefore , when implementing the funds under shared management , the commission and the member states should respect the principles referred to in the financial regulation , such as budgetary accuracy , sound financial management , transparency and non - discrimination . member states should refrain from adding rules that complicate the use of the funds for the beneficiary . _________________ 12 oj l [ … ] , [ … ] , p . [ … ] .


### to strengthen the integrated territorial development approach , investments in the form of territorial tools such as integrated territorial investments , community - led local development or any other territorial tool under policy objective ' a europe closer to citizens ' supporting initiatives designed by the member state for investments programmed for the erdf should be based on territorial and local development strategies . for the purposes of itis and territorial tools designed by member states , minimum requirements should be set out for the content of territorial strategies . those territorial strategies should be developed and endorsed under the responsibility of relevant authorities or bodies . to ensure the involvement of relevant authorities or bodies in implementing territorial strategies , those authorities or bodies should be responsible for the selection of operations to be supported , or involved in that selection . ### to strengthen the integrated territorial development approach , investments in the form of territorial tools such as integrated territorial investments , community - led local development or any other initiatives such as the smart villages and other territorial tools under policy objective ' a europe closer to citizens ' supporting initiatives designed by the member state for investments programmed for the erdf should be based on territorial and local development strategies . for the purposes of itis and territorial tools designed by member states , minimum requirements should be set out for the content of territorial strategies . those territorial strategies should be developed and endorsed under the responsibility of relevant authorities or bodies . to ensure the involvement of relevant authorities or bodies in implementing territorial strategies , those authorities or bodies should be responsible for the selection of operations to be supported , or involved in that selection .


### to better mobilise potential at the local level , it is necessary to strengthen and facilitate clld . it should take into account local needs and potential , as well as relevant socio - cultural characteristics , and should provide for structural changes , build community capacity and stimulate innovation . the close cooperation and integrated use of the funds to deliver local development strategies should be strengthened . local action groups , representing the interests of the community , should be , as an essential principle responsible for the design and implementation of clld strategies . in order to facilitate coordinated support from different funds to clld strategies and to facilitate their implementation , the use of a ' lead fund ' approach should be facilitated . ### to better mobilise potential at the local level , it is necessary to strengthen and facilitate clld . it should take into account local needs and potential , as well as relevant socio - cultural characteristics , and should provide for structural changes , build community capacity , its project management capabilities and stimulate innovation . the close cooperation and integrated use of the funds to deliver local development strategies should be strengthened . local action groups , representing the interests of the community , should be , as an essential principle responsible for the design and implementation of clld strategies . in order to facilitate coordinated support from different funds to clld strategies and to facilitate their implementation , the use of a ' lead fund ' approach should be facilitated .


### to better mobilise potential at the local level , it is necessary to strengthen and facilitate clld . it should take into account local needs and potential , as well as relevant socio - cultural characteristics , and should provide for structural changes , build community capacity and stimulate innovation . the close cooperation and integrated use of the funds to deliver local development strategies should be strengthened . local action groups , representing the interests of the community , should be , as an essential principle responsible for the design and implementation of clld strategies . in order to facilitate coordinated support from different funds to clld strategies and to facilitate their implementation , the use of a ' lead fund ' approach should be facilitated . ### to better mobilise potential at the local level , it is necessary to strengthen and facilitate clld . it should take into account local needs and potential , as well as relevant socio - cultural characteristics , and should provide for structural changes , build human capital and knowledge community capacity and stimulate innovation . the close cooperation and integrated use of the funds to deliver local development strategies should be strengthened . local action groups , representing the interests of the community , should be , as an essential principle responsible for the design and implementation of clld strategies . local action groups have achieved remarkable results to date , and should therefore receive more comprehensive financial support . in order to facilitate coordinated support from different funds , including those not covered by this regulation , to clld strategies and to facilitate their implementation , the use of a ' lead fund ' approach should be facilitated .


### in order to reduce the administrative burden , technical assistance at the initiative of the member state should be implemented through a flat rate based on progress in programme implementation . that technical assistance may be complemented with targeted administrative capacity building measures using reimbursement methods that are not linked to costs . actions and deliverables as well as corresponding union payments can be agreed in a roadmap and can lead to payments for results on the ground . ### in order to reduce the administrative burden , technical assistance at the initiative of the member state should be implemented through a flat rate based on progress in programme implementation . that technical assistance may be complemented with targeted administrative capacity building measures , such as the evaluation of the skills set of human resources , using reimbursement methods that are not linked to costs . actions and deliverables as well as corresponding union payments can be agreed in a roadmap and can lead to payments for results on the ground .


### in order to support the preparation of related programmes and activities of the next programming period , the commission should carry out a mid - term assessment of the funds . at the end of the programming period , the commission should carry out retrospective evaluations of the funds , which should focus on the impact of the funds . ### in order to support the preparation of related programmes and activities of the next programming period , the commission should carry out a mid - term evaluation of the funds . at the end of the programming period , the commission should evaluate the impact of the funds . the results of these evaluations should be published to ensure transparency and to increase citizens’ trust in the union and its institutions .


### member states should also prevent , detect and deal effectively with any irregularities including fraud committed by beneficiaries . moreover , in accordance with regulation no 883 / 201318 , and regulations no 2988 / 9519 and no 2185 / 9620 the european anti - fraud office may carry out administrative investigations , including on - the - spot checks and inspections , with a view to establishing whether there has been fraud , corruption or any other illegal activity affecting the financial interests of the union . in accordance with regulation 2017 / 193921 , the european public prosecutor ' s office may investigate and prosecute fraud and other criminal offences affecting the financial interests of the union as provided for in directive 2017 / 137122 on the fight against fraud to the union ' s financial interests by means of criminal law . member states should take the necessary measures so that any person or entity receiving union funds fully cooperates in the protection of the union’s financial interests , grants the necessary rights and access to the commission , the european anti - fraud office , the european public prosecutor ' s office and the european court of auditors and ensures that any third parties involved in the implementation of union funds grant equivalent rights . member states should report to the commission on detected irregularities including fraud , and on their follow - up as well as on the follow - up of olaf investigations . _________________ 18 regulation no 883 / 2013 of the european parliament and of the council of 11 september 2013 concerning investigations conducted by the european anti - fraud office and repealing regulation no 1073 / 1999 of the european parliament and of the council and council regulation no 1074 / 1999 . 19 council regulation no 2988 / 95 of 18 december 1995 on the protection of the european communities financial interests . 20 council regulation no 2185 / 96 of 11 november 1996 concerning on - the - spot checks and inspections carried out by the commission in order to protect the european communities ' financial interests against fraud and other irregularities . 21 council regulation 2017 / 1939 of 12 october 2017 implementing enhanced cooperation on the establishment of the european public prosecutor’s office . 22 directive 2017 / 1371 of the european parliament and of the council of 5 july 2017 on the fight against fraud to the union ' s financial interests by means of criminal law . ### member states should also prevent , detect and deal effectively with any irregularities including fraud committed by beneficiaries . moreover , in accordance with regulation no 883 / 201318 , and regulations no 2988 / 9519 and no 2185 / 9620 the european anti - fraud office may carry out administrative investigations , including on - the - spot checks and inspections , with a view to establishing whether there has been fraud , corruption or any other illegal activity affecting the financial interests of the union . in accordance with regulation 2017 / 193921 , the european public prosecutor ' s office may investigate and prosecute fraud and other criminal offences affecting the financial interests of the union as provided for in directive 2017 / 137122 on the fight against fraud to the union ' s financial interests by means of criminal law . member states should take the necessary measures so that any person or entity receiving union funds fully cooperates in the protection of the union’s financial interests , grants the necessary rights and access to the commission , the european anti - fraud office , the european public prosecutor ' s office and the european court of auditors and ensures that any third parties involved in the implementation of union funds grant equivalent rights . member states should report in a detailed manner to the commission on detected irregularities including fraud , and on their follow - up as well as on the follow - up of olaf investigations and , if applicable , the reasons why no follow - up was made on olaf investigations . member states that do not participate in the enhanced cooperation on the eppo should report in a detailed manner to the commission on the prosecution of detected cases of fraud and , if applicable , on the cooperation with eurojust for the matters that are in the scope of competence of the eppo . _________________ 18 regulation no 883 / 2013 of the european parliament and of the council of 11 september 2013 concerning investigations conducted by the european anti - fraud office and repealing regulation no 1073 / 1999 of the european parliament and of the council and council regulation no 1074 / 1999 . 19 council regulation no 2988 / 95 of 18 december 1995 on the protection of the european communities financial interests . 20 council regulation no 2185 / 96 of 11 november 1996 concerning on - the - spot checks and inspections carried out by the commission in order to protect the european communities ' financial interests against fraud and other irregularities . 21 council regulation 2017 / 1939 of 12 october 2017 implementing enhanced cooperation on the establishment of the european public prosecutor’s office . 22 directive 2017 / 1371 of the european parliament and of the council of 5 july 2017 on the fight against fraud to the union ' s financial interests by means of criminal law .


### a certain amount of the resources from erdf , the esf + and the cohesion fund should be allocated to the european urban initiative which should be implemented through direct or indirect management by the commission . ### a certain amount of the resources from erdf , the esf + and the cohesion fund should be allocated to the european urban initiative which should be implemented through direct or indirect management by the commission . following the ep resolution calling for an eu agenda for rural , mountainous and remote areas , similar provision should be addressed to those areas as well .


### in addition the power to adopt acts in accordance with article 290 of the tfeu should be delegated to the commission in respect of the establishment of the criteria for determining the cases of irregularities to be reported , the definition of unit costs , lump sums , flat rates and financing not linked to costs applicable to all member states as well as the establishment of standardised off - the - shelf sampling methodologies . ### in addition the power to adopt acts in accordance with article 290 of the tfeu should be delegated to the commission in respect of the creation of a european code of conduct on partnership in order to support and facilitate member states in the organisation of partnerships , the establishment of the criteria for determining the cases of irregularities to be reported , the definition of unit costs , lump sums , flat rates and financing not linked to costs applicable to all member states as well as the establishment of standardised off - the - shelf sampling methodologies .


### a smarter europe by promoting innovative and smart economic transformation ; ### a competitive and a smarter europe by strengthening its economic , social and territorial cohesion and by promoting innovative and smart economic transformation ;


### a europe closer to citizens by fostering the sustainable and integrated development of urban , rural and coastal areas and local initiatives . ### a europe closer to citizens by fostering the sustainable and integrated and balanced development of urban , rural and coastal areas and local initiatives .


### at least once a year , the commission shall consult the organisations which represent the partners at union level on the implementation of programmes . ### at least once a year , the commission shall consult the organisations which represent the partners at union level on the implementation of programmes , and shall report to the european parliament and council on the outcome .


### at least once a year , the commission shall consult the organisations which represent the partners at union level on the implementation of programmes . ### at least once a year , the commission shall consult the organisations which represent the partners at union level on the implementation of programmes and shall report to the european parliament and the council on the outcome .


### at least once a year , the commission shall consult the organisations which represent the partners at union level on the implementation of programmes . ### at least once a year , the commission shall consult the organisations which represent the partners at union level on the implementation of programmes and shall report to the european parliament and to the council on the outcome .


### the preliminary financial allocation from each of the funds by policy objective at national level , respecting fund - specific rules on thematic concentration ; ### the preliminary financial allocation from each of the funds by policy objective at national level and at regional level , respecting fund - specific rules on thematic concentration ;


### the preliminary financial allocation from each of the funds by policy objective at national level , respecting fund - specific rules on thematic concentration ; ### the preliminary financial allocation from each of the funds by policy objective at national and regional level , respecting fund - specific rules on thematic concentration ;


### where relevant , the breakdown of financial resources by category of regions drawn up in accordance with article 102 and the amounts of allocations proposed to be transferred between categories of regions pursuant to article 105 ; ### where relevant , the breakdown of financial resources and the amounts of allocations proposed to be transferred between categories of regions pursuant to article 105 ;


### where relevant , the breakdown of financial resources by category of regions drawn up in accordance with article 102 and the amounts of allocations proposed to be transferred between categories of regions pursuant to article 105 ; ### the breakdown of financial resources by category of regions drawn up in accordance with article 102 and the amounts of allocations proposed to be transferred between categories of regions pursuant to article 105 ;


### the member state shall review the partnership agreement taking into account the observations made by the commission . ### the member state shall review the partnership agreement in case the commission has made observations and take these observations into account .


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


### member states may allocate , in the partnership agreement or in the request for an amendment of a programme , the amount of erdf , the esf + , the cohesion fund and the emff to be contributed to investeu and delivered through budgetary guarantees . the amount to be contributed to investeu shall not exceed 5 % of the total allocation of each fund , except in duly justified cases . such contributions shall not constitute transfers of resources under article 21 . ### as of 1 january 2022 member states may allocate , in the partnership agreement or in the request for an amendment of a programme , the amount of erdf , the esf + , the cohesion fund and the emff to be contributed to investeu and delivered through budgetary guarantees . the amount to be contributed to investeu shall not exceed 4 % of the total allocation of each fund , except in duly justified cases i . e . territorial cooperation , and the financing of innovative actions or pilot projects with transfer of the results obtained to other eu territories . such contributions shall not constitute transfers of resources under article 21 in full respect of the code of conduct for partnership and multi - level governance , and shall be governed by the rules of investeu . whenever an amount of erdf , esf + , cohesion fund and the emff is contributed to invest eu , the enabling conditions as described in article 11 of this regulation should apply .


### member states may allocate , in the partnership agreement or in the request for an amendment of a programme , the amount of erdf , the esf + , the cohesion fund and the emff to be contributed to investeu and delivered through budgetary guarantees . the amount to be contributed to investeu shall not exceed 5 % of the total allocation of each fund , except in duly justified cases . such contributions shall not constitute transfers of resources under article 21 . ### member states may allocate , in the partnership agreement or in the request for an amendment of a programme , the esf + , cohesion fund and emff amount to be contributed to investeu and delivered through budgetary guarantees . the amount to be contributed to investeu shall not exceed 5&#160 ; % of the total allocation of each fund , except in duly justified cases . such contributions shall not constitute transfers of resources under article 21 .


### the amount referred to in paragraph 1 shall be used for the provisioning of the part of the eu guarantee under the member state compartment . ### the amount referred to in paragraph 1 shall be used for the provisioning of the part of the eu guarantee under the respective member state compartment .


### the contribution agreement for an amount referred to in paragraph 1 allocated in the request of the amendment of a programme shall be concluded simultaneously with the adoption of the decision amending the programme . ### the contribution agreement for an amount referred to in paragraph 1 shall be concluded simultaneously with the adoption of the decision amending the programme .