### 4. notes that the agency , the european border and coast guard agency (frontex) and the european maritime safety agency continued following the tripartite working arrangement signed in 2019 defining cooperation between those agencies and cooperation with national authorities carrying out coast guard functions by providing services , information , equipment and training , as well as by coordinating multipurpose operations; notes that this specific inter-agency cooperation helps to create synergies and avoid duplication and/or redundancy of effort in cooperation between agencies as well as relevant member states , resulting in economies of scale; ### 4. notes that the agency , the european border and coast guard agency (frontex) and the european maritime safety agency continued following the tripartite working arrangement signed in 2019 defining cooperation between those agencies and cooperation with national authorities carrying out coast guard functions by providing services , information , equipment and training , as well as by coordinating multipurpose operations; notes that the agency assumed the chairmanship of that tripartite working arrangement in may 2020; notes that this specific inter-agency cooperation helps to create synergies and avoid duplication and/or redundancy of effort in cooperation between agencies as well as relevant member states , resulting in economies of scale; considers the arrangement an example of synergy between union agencies that should inspire agencies in other areas; calls on the agency to continue its efforts in that regard and considers it appropriate to increase the cooperation between the agency and the european environment agency as well;


### 6. notes the gender balance at the senior management level , at which the agency reported that it has one man and no women; notes that the gender balance on the administrative board is 46 men (70 %) and 20 women (30 %); further notes that women represent 57 ,44 % of the overall staff employed in the agency; ### 6. takes note of the agency’s policy of promoting equal treatment of staff and of its goal of gender equality in terms both of numbers and of grades and responsibility levels; strongly deplores the fact that women account for only 30 % of staff employed at grade ad 8 or higher; welcomes the recent nomination of susan steele as the new executive director of the agency; notes however that her nomination does not enable parity to be attained at management level , since all head of unit positions are held by men; calls on the agency to step up its efforts with regard to its gender parity policy with a view to making progress towards parity at management level as well;


### 12. welcomes the further steps taken in order to enhance the transparency of the agency’s activities by reporting the meetings that the agency’s staff has with external stakeholders , and their availability on the agency’s website; ### 12. welcomes the further steps taken , following the 2019 discharge report , in order to enhance the transparency of the agency’s activities by reporting the meetings that the agency’s staff has with external stakeholders , and their availability on the agency’s website; calls on the agency to regularly update the page so as to ensure full transparency and trust in the agency's activities;


### a. whereas the eu is aiming to become climate neutral by 2050; whereas offshore renewable energy should play a key role in achieving this objective; ### a. whereas the eu is aiming to become climate neutral by 2050 in line with the green deal objectives; whereas offshore renewable energy should play a key role in achieving this objective through an integrated approach taking into account the three pillars of sustainability;


### b. whereas according to the commission’s estimates , 30 % of the eu’s electricity demand in 2050 will be met by offshore wind , corresponding to an increase from the current 12 gw offshore wind capacity in the eu-27 to a target of 300 gw in 2050; ### b. whereas according to the commission’s estimates , 30 % of the eu’s electricity demand in 2050 will be met by offshore wind , corresponding to an increase from the current 12 gw offshore wind capacity in the eu-27 to a target of 300 gw in 2050 , and to reach 40 gw of ocean energy capacity by 2050;


### d. whereas other offshore renewable energy sources such as wave or tidal technology play an important role in the commission’s offshore renewable energy strategy , although there are currently no large-scale commercial wave or tidal technology installations in operation; ### d. whereas other offshore renewable energy sources such as wave , tidal and thermal technologies , floating offshore wind , floating photovoltaic installations and the use of algae to produce biofuels play an important role in the commission’s offshore renewable energy strategy , as they can contribute to reach climate neutrality and enhanced european leadership in these promising technologies , and create new jobs , whereas it is necessary to continue research and innovation as other offshore renewable energy could have less impact on fishing activities , fish stocks and marine environment;


### d. whereas other offshore renewable energy sources such as wave or tidal technology play an important role in the commission’s offshore renewable energy strategy , although there are currently no large-scale commercial wave or tidal technology installations in operation; ### d. whereas other offshore renewable energy sources such as wave or tidal technology play an important role in the commission’s offshore renewable energy strategy , although there are currently no large-scale commercial wave or tidal technology installations in operation , many of these other energy sources could be promising and more appropriate in some areas where fishing activities takes place if given the right research and development support;


### e. whereas offshore wind turbines have an average life cycle of 25 to 30 years; whereas very few turbines have so far been decommissioned; ### e. whereas offshore wind turbines have an average life cycle of 25 to 30 years; whereas very few turbines have so far been decommissioned , whereas a long-term vision based on a circular economy and life-cycle approach is necessary in order to assess the impacts on other activities , such as fishing , and on local communities and ecosystems , at the end of the project , whereas eco-conception through specific materials and designs of the infrastructures can foster the development of local biodiversity , whereas recycling methods or maintaining infrastructures as artificial reefs have to be assessed at an early stage of the conception of the project;


### f. whereas the most cost- and space-efficient way to achieve the 2050 offshore capacity target would be through multiple use of the same maritime space by different sectors; ### f. whereas the most cost- and space-efficient way to achieve the 2050 offshore capacity target would be through multiple use of the same maritime space by different sectors , by considering a co-benefit approach , according to which , each activity benefits from the other , as cohabitation of activities can be positive regarding the environment and socio-economic profits ;


### i. whereas the cumulation of current and future offshore renewable developments has the biggest impact on trawling fleets targeting demersal species and crustaceans; ### i. whereas the cumulation of current and future offshore renewable developments has the biggest impact on fishing operations targeting demersal species and crustaceans;


### 1. is concerned about the negative long-term impact that offshore wind turbines have on ecosystems , fish stocks and biodiversity , and consequently on fisheries as a whole , over their life cycle , from construction through operation and decommissioning; ### 1. highlights the need to avoid negative long-term impact caused by offshore wind turbines on ecosystems , fish stocks and biodiversity , and consequently on fisheries as a whole; emphasises the need for a life cycle approach on its development , from construction through operation and decommissioning


### 2. stresses that the large-scale roll-out of offshore wind farms (owfs) risks harming the physical functioning of the sea basin , in particular sea and air currents , which might contribute to a mixing of the stratified water column and consequently influence the nutrient cycle , wave generation , tidal amplitudes and bedload sediment transport , while infrasonic noise from rotating blades could chase fish away from owfs , and electromagnetic fields from underwater cables , as well as underwater noise from pile driving , could have severe negative impacts on marine life; ### 2. stresses the need to minimize the risk of large-scale roll-out of offshore wind farms (owfs) harming the physical functioning of the sea basin , in particular sea and air currents , which might contribute to a mixing of the stratified water column and consequently influence the nutrient cycle , wave generation , tidal amplitudes and bedload sediment transport , while infrasonic noise from rotating blades could chase fish away from owfs , and electromagnetic fields from underwater cables , as well as underwater noise from pile driving , could have severe negative impacts on marine life; stresses in this regard the need for further development and research on how to avoid and mitigate these negative effects;


### 3. stresses that potential artificial reef effects are limited to the operational phase of an offshore wind turbine and that decommissioning may make any benefits temporary; ### deleted


### 3. stresses that potential artificial reef effects are limited to the operational phase of an offshore wind turbine and that decommissioning may make any benefits temporary; ### 3. stresses that potential artificial reef effects are limited to the operational phase of an offshore wind turbine and that these positive effects must be taken preserved when decommissioning takes place; underlines that when owfs are decommissioned the sites need to be left in a state that allows fishing activities and protects and respects the environment.


### 3. stresses that potential artificial reef effects are limited to the operational phase of an offshore wind turbine and that decommissioning may make any benefits temporary; ### 3. stresses that potential artificial reef effects are limited to the operational phase of an offshore wind turbine and that decommissioning may make any benefits temporary , unless a long-term vision assessment of the project offers the choice to leave the infrastructure after its operation;


### 3. stresses that potential artificial reef effects are limited to the operational phase of an offshore wind turbine and that decommissioning may make any benefits temporary; ### 3. stresses that potential artificial reef effects are currently limited to the operational phase of an offshore wind turbine and that more research is needed on how to preserve these positive effects on the marine ecosystem after the decommissioning of the owfs.


### 3. stresses that potential artificial reef effects are limited to the operational phase of an offshore wind turbine and that decommissioning may make any benefits temporary; ### 3. stresses that potential artificial reef effects are in particular not confirmed for commercial species and are limited to the operational phase of an offshore wind turbine and that decommissioning may make any benefits temporary;


### 4. proposes to assess the combination and integration of owfs within maritime protected areas (mpas) against clearly defined habitat and biodiversity conservation objectives , including those pertaining to fisheries resources; ### 4. proposes to assess the combination and integration of owfs within maritime protected areas (mpas) against clearly defined habitat and biodiversity conservation objectives , including those pertaining to fisheries resources , underlines that management committees should be set up in these mpas for better coexistence of activities;


### 4. proposes to assess the combination and integration of owfs within maritime protected areas (mpas) against clearly defined habitat and biodiversity conservation objectives , including those pertaining to fisheries resources; ### 4. proposes to prohibit the settlement of owfs in mpas , which role is fundamental to preserve biodiversity


### 6. stresses that small-scale fishing enterprises will be particularly affected by displacement as they may not have the capacity to move to fishing grounds further afield or to change fishing method; ### 6. stresses that small-scale fishing enterprises will be particularly affected when displacement takes place as they may not have the capacity to move to fishing grounds further afield or to change fishing method; calls for tailor-made compensation in this regard;


### 7. stresses that insurance for fishing vessels operating in wind farms is very problematic owing to the insufficient indemnity levels offered by fishing vessels’ insurance policies; ### 7. stresses the need to facilitate access to insurance for fishing vessels operating in wind farms as it today is very problematic owing to the insufficient indemnity levels offered by fishing vessels’ insurance policies;


### 8. points out that any restriction on access to traditional fishing grounds directly affects the livelihoods of eu fishers and dependent jobs ashore , and that it undermines the responsible and sustainable provision of food security; ### 8. points out that any restriction on access to traditional fishing grounds , without appropriate compensation , directly affects the livelihoods of eu fishers and dependent jobs ashore , and that it undermines the responsible and sustainable provision of food security;


### 8. points out that any restriction on access to traditional fishing grounds directly affects the livelihoods of eu fishers and dependent jobs ashore , and that it undermines the responsible and sustainable provision of food security; ### 8. points out that any restriction on access to traditional fishing grounds directly affects the livelihoods of eu fishers and dependent jobs ashore , and that it could undermines the responsible and sustainable provision of food security;


### 9. stresses that overlap analysis of offshore renewables and fisheries suggests a sharp increase in special conflict potential in european waters over the coming years; ### 9. stresses that overlap analysis of offshore renewables and fisheries suggests a sharp increase in special conflict potential in european waters over the coming years , calls for consultation , dialogues and networks to be set up at an early stage , in order to reduce and avoid conflicts;


### 9. stresses that overlap analysis of offshore renewables and fisheries suggests a sharp increase in special conflict potential in european waters over the coming years; ### 9. notes that overlap analysis of offshore renewables and fisheries suggests a sharp increase in spatial conflict potential in european waters over the coming years; stresses in this regard the need for early and inclusive spatial planning , both with regards to placement and lay-out of ofws


### 10. stresses that today , fishing activities (active or passive) in owfs are limited or prohibited in most member states; ### 10. stresses that today , fishing activities (active or passive) in owfs are currently limited or prohibited in all member states;


### 11. is concerned about the fact that fishers tend to avoid fishing in owfs even if access is permitted because of the risk of accidental damage , snagging and loss of fishing gear , and that consequently the fear of potential exposure to prosecution is a source of concern that hinders co-existence; ### 11. is concerned about the fact that , separately from prohibitions and restrictions to fishing activities , fishers tend to avoid fishing in owfs even if access is permitted because of the risk of accidental damage , snagging and loss of fishing gear , and that consequently the fear of potential exposure to prosecution is a source of concern that hinders co-existence;


### 12. stresses that the decommissioning of offshore wind turbines must neither generate enduring environmental impacts nor pose safety risks to fishing vessels due to any remaining sub-seabed infrastructure; ### 12. stresses that the decommissioning of offshore wind turbines must neither generate enduring environmental impacts nor pose safety risks to fishing vessels due to any remaining sub-seabed infrastructure , points out , in addition , that recycling methods should be developed to reduce the impacts on the environment;


### 13. highlights that assessments of the economic and socio-cultural effects of offshore renewables on fisheries are lacking in recent empirical studies; urges the commission , therefore , to carry out further research looking beyond environmental impacts in order to assess the possible negative economic and social impacts on fisheries of investments in owfs; ### 13. highlights that assessments of the economic and socio-cultural effects of offshore renewables on fisheries are lacking in recent empirical studies; urges the commission , therefore , to carry out further research looking beyond environmental impacts in order to assess the possible negative economic and social impacts on fisheries of investments in offshore renewables and identify proper ways to overcome these negative impacts;


### 15. proposes that member states increase coordination in the field of owf research in order to facilitate the collection and exchange of research findings and data; ### 15. proposes that member states increase coordination in the field of owf research in order to facilitate the collection and exchange of research findings and data; recalls that offshore wind energy is one of the most advanced technologies , but that other technologies are promising and sometimes more appropriate in some areas where fishing activities takes place;calls for additional support for research and development in this regard;


### 15. proposes that member states increase coordination in the field of owf research in order to facilitate the collection and exchange of research findings and data; ### 15. proposes that member states increase coordination in the field of owf research in order to facilitate the collection and exchange of research findings and data , as well as exchange of best practices;


### 16. states that maritime spatial planning must play a key role and has to put greater emphasis on the assessment of achieving co-location options , which is of the utmost importance in achieving a win-win situation for both sustainable fisheries and the offshore energy sector; ### 16. states that maritime spatial planning must play a key role , by distinguishing each maritime area with regard to its own characteristics (baltic sea , north sea ,channel , atlantic and mediterranean sea) and has to put greater emphasis on the assessment of achieving co-location options , which is of the utmost importance in achieving a win-win situation for both sustainable fisheries and the offshore energy sector and including the effective participation of fisheries in the decision making process (as opposed to the overly vague notions of “consultation” and “observers”) , the satisfaction of commitments made and the prior resolution of usage conflicts;


### 21. notes that further eu legislation might be required in case member states’ maritime spatial planning does not guarantee the fair inclusion of fisheries; ### 21. notes that further eu legislation might be required in case member states’ maritime spatial planning does not guarantee the fair inclusion and , where appropriate , compensation of fisheries;


### 21. notes that further eu legislation might be required in case member states’ maritime spatial planning does not guarantee the fair inclusion of fisheries; ### 21. notes that further eu legislation is required given that evidence suggests that member states’ maritime spatial planning does not guarantee the fair inclusion of fisheries;


### (2) the european union has by council decision 98/392/ec3 approved the united nations convention on the law of the sea and the agreement for the implementation of the provisions of the united nations convention on the law of the sea of 10 december 1982 relating to the conservation and management of straddling fish stocks and highly migratory fish stocks4 , which contain principles and rules with regard to the conservation and management of the living resources of the sea. in the framework of its wider international obligations , the union participates in efforts made in international waters to conserve fish stocks. ### (2) the european union has by council decision 98/392/ec3 approved the united nations convention on the law of the sea and the agreement for the implementation of the provisions of the united nations convention on the law of the sea of 10 december 1982 relating to the conservation and management of straddling fish stocks and highly migratory fish stocks4 , which contain principles and rules with regard to the conservation and management of the living resources of the sea. in the framework of its wider international obligations , the union participates in efforts made in international waters to conserve fish stocks and should strive for orderly and sustainable global ocean governance and fisheries management.


### (6) while relevant key provisions of cmm are implemented on an annual basis in the context of the fishing opportunities regulation , the remaining provisions were last implemented through title v of council regulation (ec) no 520/20076 laying down technical measures for the conservation of certain stocks of highly migratory species. it is therefore necessary to ensure that the cmm adopted by the wcpfc are fully implemented into union law and are , therefore , uniformly and effectively implemented within the union. ### (6) while relevant key provisions of cmm are implemented on an annual basis in the context of the fishing opportunities regulation , the remaining provisions were last implemented through title v of council regulation (ec) no 520/20076 laying down technical measures for the conservation of certain stocks of highly migratory species. it is therefore necessary to ensure that the cmm adopted by the wcpfc are timely and fully implemented into union law and are , therefore , uniformly and effectively implemented within the union and give clarity and predictability to union vessels operators.


### — having regard to the commission communication of 11 december 2019 entitled ‘the european green deal’ (com(2019)0640) , ### — having regard to the commission communication of 11 december 2019 on the european green deal (com(2019)0640) and to parliament’s resolution of 15 january 2020 on the european green deal ,


### motion for a resolution ### amendment


### this regulation lays down rules for the sustainable use of plant protection products by providing for the setting , and achievement by 2030 , of reduction targets for the use and risk of chemical plant protection products , establishing requirements for use , storage , sale and disposal of plant protection products and for application equipment , providing for training and awareness raising , and providing for implementation of integrated pest management. ### this regulation lays down rules for the sustainable use of plant protection products while ensuring sustainable crop protection by;


### this regulation lays down rules for the sustainable use of plant protection products by providing for the setting , and achievement by 2030 , of reduction targets for the use and risk of chemical plant protection products , establishing requirements for use , storage , sale and disposal of plant protection products and for application equipment , providing for training and awareness raising , and providing for implementation of integrated pest management. ### this regulation lays down rules for the sustainable use of plant protection products by providing for the setting , and achievement by ... [op: please insert the date - 10 years after the application of the regulation] , of reduction targets for the use and risk of chemical plant protection products , establishing requirements for use , storage , sale and disposal of plant protection products and for application equipment , providing for training and awareness raising , and providing for implementation of integrated pest management.


### planned and adopted measures to support , or ensure through binding requirements laid down in national law , innovation and the development and use of non-chemical pest control methods; ### planned and adopted measures to support , or ensure through binding requirements laid down in national law , innovation and the development and use of non-chemical pest control methods , digital and precision-agriculture applications and innovative breeding techniques to improve access to resilient varieties;


### planned and adopted measures to support , or ensure through binding requirements laid down in national law , innovation and the development and use of non-chemical pest control methods; ### planned and adopted measures to support , or ensure through binding requirements laid down in national law , innovation and the development and use of non-chemical pest control methods and methods to reduce the environmental impact of chemical methods;


### 3. by way of derogation from paragraph 1 , a competent authority designated by a member state may permit a professional user to use a plant protection product in a sensitive area for a limited period with a precisely defined start and end date that is the shortest possible but does not exceed 60 days , provided that all of the following conditions are met: ### deleted


### (9) in the final report of the conference on the future of europe , published on 9 may 2022 , when it comes to the proposals on agriculture , food production , biodiversity and ecosystems , pollution , citizens ask the union in particular to significantly reduce the use of chemical pesticides and fertilizers , in line with the existing targets , while still ensuring food security , and support for research to develop more sustainable and natural-based alternatives. citizens ask for more research and innovations , including in technological solutions for sustainable production , plant resistance , and precision farming , and more communication , advisory systems , and training for and from farmers as well as asking the union to protect insects , in particular indigenous and pollinating insects.55. ### (9) in the final report of the conference on the future of europe , published on 9 may 2022 , when it comes to the proposals on agriculture , food production , biodiversity and ecosystems , pollution , citizens ask the union in particular to significantly reduce the use of chemical pesticides and fertilizers , in line with the existing targets , while still ensuring food security , and support for research to develop more sustainable and natural-based alternatives. citizens ask for more research and innovations , including in technological solutions for sustainable production , plant resistance , and precision farming , and more communication , advisory systems , and training for and from farmers as well as asking the union to protect insects , in particular indigenous and pollinating insects. citizens are also calling for water sources to be protected and for something to be done to combat pollution of rivers and oceans55.


### 3. by … [op: please insert the date of application of this regulation] , member states shall have in place appropriate measures to avoid deterioration of surface and groundwater status as well as coastal and marine waters and allow achievement of good surface and groundwater status , to protect the aquatic environment and drinking water supplies from the impact of plant protection products to achieve , at least , the objectives set out in directives 2000/60/ec , 2006/118/ec , 2008/105/ec , 2008/56/ec and (eu) 2020/2184. ### 3. by … [op: please insert the date of application of this regulation] , member states shall have in place appropriate measures to limit the extensive damage caused by diluted pesticides in aquatic ecosystems , halt the accelerating deterioration of surface and groundwater status as well as coastal and marine waters and allow achievement of good surface and groundwater status , to protect the aquatic environment and drinking water supplies from the impact of plant protection products to achieve , at least , the objectives set out in directives 2000/60/ec , 2006/118/ec , 2008/105/ec , 2008/56/ec and (eu) 2020/2184.


### a. whereas nature and biodiversity are the foundations of food and , without strong political action to conserve and restore nature and biodiversity , food security and the right to food will be irreversibly endangered; ### a. whereas farmers , sustainable use of nature resources , nature and biodiversity are the foundations of agriculture and food production and , without strong political action on cutting red tapes , enhancing competitiveness , supporting the european agriculture in being even more sustainable , decreasing the dependency on fossil inputs as well as our dependency on a small number of suppliers , together with minimising the negative impact on nature and biodiversity , the food security will decrease;


### a. whereas on 24 february 2022 the russian federation illegally invaded ukraine and , as a result , severely disrupted global food security; ### a. whereas , the russian's full scale invasion of ukraine has seriously aggravated an already difficult and challenging situation in the agri-food sector , which is still recovering from the consequences of the covid pandemic and is suffering from the on-going climate crisis , leading to an increase in global food insecurity;


### 1. supports the just transition to agro-ecological and organic farming; reiterates its support for the ambitions , targets and goals of the farm to fork , biodiversity and zero-pollution strategies; welcomes their published and announced legislative proposals , including those related to the reduction in the use of pesticides and their associated risks and the setting of eu food waste reduction targets; ### 1. supports the just transition to agro-ecological and organic farming; encourages the transformation of the food production sector via the use of techniques , behaviours and practices that restore the soils and enhance ecosystem services such as regenerative farming as means to increase fertility , soil health , water availability , yields and ultimately nutrition and food safety; reiterates its support for the ambitions , targets and goals of the farm to fork , biodiversity and zero-pollution strategies; welcomes their published and announced legislative proposals , including those related to the reduction in the use of pesticides and their associated risks and the setting of eu food waste reduction targets;


### 1. supports the just transition to agro-ecological and organic farming; reiterates its support for the ambitions , targets and goals of the farm to fork , biodiversity and zero-pollution strategies; welcomes their published and announced legislative proposals , including those related to the reduction in the use of pesticides and their associated risks and the setting of eu food waste reduction targets; ### 1. supports the transition to an more sustainable and circular agriculture , using less fossil inputs and antimicrobials; reiterates its support for an impact assessment on the targets in the farm to fork , biodiversity and zero-pollution strategies , especially in the light of russia’s illegal invasion and war in ukraine; notice the published and announced legislative proposals , including those related to the reduction in the use of pesticides and their associated risks and the setting of eu food waste reduction targets;


### 2. calls for the strict application of the one health principle in all policies that affect the availability and accessibility of food; stresses that food safety must never be jeopardised; ### 2. calls for the strict application of the one health principle in all policies that affect the availability and accessibility of food; stresses that food safety must never be jeopardised; reiterates the 50 percent reduction target of the usages of antimicrobials in agriculture and asks the commission to evaluate how member states have implemented the veterinary medicinal products package , especially the ban on the preventive use of antibiotics in groups of animals , the ban on the preventive use of antimicrobials via medicated feed and the import ban on meat that have been treated with antimicrobials for growth promotions;


### 3. highlights that the availability of plant proteins , if consumed directly , is more than sufficient to meet global protein needs; acknowledges the positive impact that plant-based diets have on humans , animals , the planet and food security; stresses that reducing the number and density of farmed animals can effectively combat the climate and biodiversity crises , decrease the risk of zoonotic diseases and contribute to food security in the short and long terms; ### 3. highlights that the production of sustainable plant protein for food and feed in europe need to increase in order to reinforce the food security; thinks that support for research and innovation , training and advisory and up-scaling of innovative projects , among others , are important the increase the protein production in europe;


### 4. emphasises that biofuel production negatively affects food security; denounces , moreover , the focus on short-term policy measures for example , on fertilisers; ### 4. emphasises that sustainable crop-based biofuel and biogas production have positive synergies with food security , as the production generate fertiliser , food and feed co-products essential for the food chain , as well as it decreases our dependency on import of fossil inputs; welcomes , moreover , the ongoing projects that can decarbonise the fertilisers production; underlines that closing the nutrient loop by reusing more high quality nutrients from different , streams , such as waste streams , sewage sludge and wastewater , is a further solution , that will allow to diversify fertilisers input , increase the sustainability of agriculture and the movement towards a more circular economy;


### 4. emphasises that biofuel production negatively affects food security; denounces , moreover , the focus on short-term policy measures for example , on fertilisers; ### 4. emphasises that large-scale intensive biofuel production negatively affects food security , biodiversity , soil health and market stability; denounces , moreover , the focus on short-term policy measures for example , on fertilisers;


### 5. reiterates its position on new genomic breeding techniques1 ; regrets the biased nature of the current impact assessment and calls on the commission to restart the process in an inclusive manner; ### 5. reiterates its position on new genomic breeding techniques1; underline the need for new genomic breeding techniques as it can decrease the need of inputs such as plant protection products and fertiliser , and in the same time increase the yields and profitability; ask the commission to put forward the legislative proposal on new genomic breeding techniques as soon as possible;


### 7. calls for a strategy to regionalise the supply chain of the most important commodities and to ensure the supply of local and sustainable plant proteins; ### 7. highlights the need to assess the whole supply chain in terms of resilience and transparency in order to strengthen primary producers' as well as consumers' position in the value chain; reiterates the strategic importance of local production and short supply chains; calls for a strategy to regionalise the supply chain of the most important commodities and to ensure the supply of local and sustainable plant and meat proteins;


### 9. considers it irresponsible that the eu continues to support environmentally harmful and cruel practices under the common agricultural policy and common fisheries policy. ### 9. calls on member states to develop and deploy , under the common agricultural policy , eco-schemes with support for practices that enable synergies between environmental performance and food production;


### having regard to the treaty on the functioning of the european union , and in particular article 114 thereof , ### having regard to the treaty on the functioning of the european union , and in particular articles 114 and 168(4)(c) thereof ,


### (9) in respect of new and innovative products , the competent authorities of the united kingdom should authorise the placing of these products on the market in northern ireland once certain conditions are fulfilled , including that the authorisation is granted in accordance with the law of the united kingdom and that the products are placed on the market in northern ireland under the terms of the authorisation granted by the competent authorities of the united kingdom , that these products comply with certain labelling requirements , and lastly that the written guarantees have been provided by the united kingdom to the european commission. ### (9) in respect of new and innovative products , the competent authorities of the united kingdom should be able to authorise the placing of these products on the market in northern ireland once certain conditions are fulfilled , including that the authorisation is granted in accordance with the law of the united kingdom and that the products are placed on the market in northern ireland under the terms of the authorisation granted by the competent authorities of the united kingdom , that these products comply with certain labelling requirements , and lastly that the written guarantees have been provided by the united kingdom to the european commission.


### keep records in accordance with article 80 , point (e) , of directive 2001/83/ec. ### keep records in accordance with the last indent of article 80 , point (e) , of directive 2001/83/ec.


### it shall apply from 1 january 2025 , provided that the united kingdom has provided the written guarantees referred to in article 8. ### it shall apply from 1 january 2025 , provided that the united kingdom has provided the written guarantees referred to in article 8 and that the commission has published prior to that date the notice referred to in the fifth subparagraph.


### (9) all sohos that are intended to be applied to humans fall within the scope of this regulation. sohos can be prepared and stored in a variety of ways , becoming soho preparations , which can be applied to recipients. in these circumstances , this regulation should apply to all activities from donor recruitment to human application and outcome monitoring. sohos or soho preparations can also be used to manufacture products regulated by other union legislation , or as the starting and raw material thereof , in particular on medical devices , regulated by regulation (eu) 2017/745 of the european parliament and of the council19 , on medicinal products , regulated by directive 2001/83/ec of the european parliament and of the council20and by regulation (ec) no 726/2004 of the european parliament and of the council21 , including on advanced therapy medicinal products , regulated by regulation (ec) no 1394/2007 of the european parliament and of the council22 , or on food , regulated by regulation (ec) no 1925/2006 of the european parliament and of the council23. the criteria that define when sohos or soho preparations becomeproducts regulated under other union legislation are not defined in this regulation but are defined in those other acts. in addition , this regulation should apply without prejudice to union legislation on genetically modified organisms. ### (9) all sohos that are intended to be applied to humans fall within the scope of this regulation. sohos can be prepared and stored in a variety of ways , becoming soho preparations , which can be applied to recipients. in these circumstances , this regulation should apply to all activities from donor recruitment to human application and outcome monitoring. sohos or soho preparations can also be used to manufacture products regulated by other union legislation , or as the starting and raw material thereof , in particular on medical devices , regulated by regulation (eu) 2017/745 of the european parliament and of the council19 , on medicinal products , regulated by directive 2001/83/ec of the european parliament and of the council20and by regulation (ec) no 726/2004 of the european parliament and of the council21 , including on advanced therapy medicinal products , regulated by regulation (ec) no 1394/2007 of the european parliament and of the council22 , or on food , regulated by regulation (ec) no 1925/2006 of the european parliament and of the council23. when sohos qualify or are used in medicinal products regulated by eu legislations mentioned above , only the provisions of this regulation related to donor protection should be applicable.the criteria that define when sohos or soho preparations areproducts regulated under other union legislation are not defined in this regulation but are defined in those other acts.


### (10) when sohos are used in the autologous setting without any manipulation , processing or storage , the application of this regulation would not be proportionate to the limited quality and safety risks arising in such a setting. when autologous sohos are collected and processed before being re-used in the same person , risks appear that should be mitigated. thus , there needs to be an assessment and authorisation of the processes applied to ensure that they are demonstrated to be safe and effective for the recipient. when autologous sohos are collected to be processed and also stored , risks of cross-contamination , loss of traceability or damage to the biological properties inherent to the substance , and necessary for efficacy in the recipient , also appear. thus , the requirements for soho establishment authorisation should apply. ### (10) when sohos are used in the autologous setting without any manipulation , processing or storage , the application of this regulation would not be proportionate to the limited quality and safety risks arising in such a setting. furthermore , if minimal processing is needed to restore applicability during a surgical procedure or the manipulation is done within a closed system , the regulation should not apply as well. when autologous sohos are collected and processed before being re-used in the same person , risks appear that should be mitigated. thus , there needs to be an assessment and authorisation of the processes applied to ensure that they are demonstrated to be safe and effective for the recipient. when autologous sohos are collected to be processed and also stored , risks of cross-contamination , loss of traceability or damage to the biological properties inherent to the substance , and necessary for efficacy in the recipient , also appear. thus , the requirements for soho establishment authorisation should apply.


### (11) when sohos are used to manufacture products regulated by other union legislation , or as the starting and raw material thereof , in order to ensure a high level of protection and contribute to legal clarity and certainty , this regulation should apply to the extent that the activities to which they are subjected are not regulated by the other union legislative framework. without prejudice to other union legislation , and in particular to directive 2001/83/ec , regulations (ec) no 726/2004 , (ec) no 1925/2006 , (ec) no 1394/2007 and (eu) 2017/745 , this regulation should at least apply to the recruitment and selection of donors , donation , collection and donor testing as well as to release , distribution , import and export when those activities concern sohos up to the point of their transfer to operators regulated by other union legislation. this means that close interaction between this regulatory framework and other related frameworks is essential to ensure interplay and coherence between relevant legal frameworks , without gaps or overlaps. ### (11) when sohos are used to manufacture products regulated by other union legislation , or as the starting and raw material thereof , in order to ensure a high level of protection and contribute to legal clarity and certainty , this regulation should apply to the extent that the activities to which they are subjected are not regulated by the other union legislative framework. without prejudice to other union legislation , and in particular to directive 2001/83/ec , regulations (ec) no 726/2004 , (ec) no 1925/2006 , (ec) no 1394/2007 , (eu) 2017/745 and (eu) no 536/2014 , this regulation should at least apply to the recruitment and selection of donors , donation , collection and donor testing as well as to release , distribution , import and export when those activities concern sohos up to the point of their transfer to operators regulated by other union legislation. this means that close interaction between this regulatory framework and other related frameworks is essential to ensure interplay and coherence between relevant legal frameworks , without gaps or overlaps.


### (13) given the special nature of sohos , resulting from their human origin , and the increasing demands for these substances for human application or for the manufacture of products regulated by other union legislation , or as the starting and raw material thereof , it is necessary to ensure a high level of health protection for donors as well as for recipients. sohos should be obtained from individuals whose health status is such that no detrimental effects will ensue as a result of the donation. this regulation should therefore include principles and technical rules to monitor and protect donors. as different types of donation imply different risks for donors , with varying levels of significance , the monitoring of donor health should be proportionate to those levels of risk. this is particularly important when donation involves some risk to the donor’s health due to a need for pre-treatment with medicinal products , a medical intervention to collect the substance or a need for donors to donate repeatedly. donations of oocytes , bone marrow , peripheral blood stem cells and plasma should be considered to imply a significant risk. ### (13) given the special nature of sohos , resulting from their human origin , and the increasing demands for these substances for human application or for the manufacture of products regulated by other union legislation , or as the starting and raw material thereof , it is necessary to ensure a high level of health protection for donors as well as for recipients. sohos should be obtained from individuals whose health status is such that no detrimental effects will ensue as a result of the donation. this regulation should therefore include principles and technical rules to monitor and protect donors. as different types of donation imply different risks for donors , with varying levels of significance , the monitoring of donor health should be proportionate to those levels of risk.


### (13) given the special nature of sohos , resulting from their human origin , and the increasing demands for these substances for human application or for the manufacture of products regulated by other union legislation , or as the starting and raw material thereof , it is necessary to ensure a high level of health protection for donors as well as for recipients. sohos should be obtained from individuals whose health status is such that no detrimental effects will ensue as a result of the donation. this regulation should therefore include principles and technical rules to monitor and protect donors. as different types of donation imply different risks for donors , with varying levels of significance , the monitoring of donor health should be proportionate to those levels of risk. this is particularly important when donation involves some risk to the donor’s health due to a need for pre-treatment with medicinal products , a medical intervention to collect the substance or a need for donors to donate repeatedly. donations of oocytes , bone marrow , peripheral blood stem cells and plasma should be considered to imply a significant risk. ### (13) given the special nature of sohos , resulting from their human origin , and the increasing demands for these substances for human application or for the manufacture of products regulated by other union legislation , or as the starting and raw material thereof , it is necessary to ensure a high level of health protection for donors as well as for recipients. sohos should be obtained from individuals whose health status is such that no detrimental effects will ensue as a result of the donation. this regulation should therefore address principles and technical rules to monitor and protect donors. as different types of donation imply different risks for donors , with varying levels of significance , the monitoring of donor health should be proportionate to those levels of risk. the respective risk-classifications shall be defined in the respective guidelines.


### (15) this regulation does not prevent member states from maintaining or introducing more stringent protective measures that are compatible with union law. member states should notify the commission of any such measures. more stringent protective measures put in place by member states should be evidence-based and proportionate to the risk to human health , for example based on overall safety concerns and corresponding risks in a member state or specific local risks. they should not discriminate against persons on grounds of sex , racial or ethnic origin , religion or belief , disability , age or sexual orientation , unless that measure or its application is objectively justified by a legitimate aim , and the means of achieving that aim are appropriate and necessary. ### (15) this regulation does not prevent member states from maintaining or introducing more stringent protective measures that are compatible with union law. member states should notify the commission of any such measures. more stringent protective measures put in place by member states should be evidence-based and proportionate to the risk to human health , for example based on overall safety concerns and corresponding risks in a member state or specific local risks. they should not discriminate against persons on grounds of sex , racial or ethnic origin , religion or belief , disability , age or sexual orientation , unless that measure or its application is objectively justified by a legitimate aim , and the means of achieving that aim are science-based , appropriate and necessary.


### (18) as a matter of principle , programmes promoting the donation of sohos should be founded on the principle of voluntary and unpaid donation , altruism of the donor and solidarity between donor and recipient. voluntary and unpaid soho donation is also a factor which can contribute to high safety standards for sohos and therefore to the protection of human health. it is also recognised , including by the council of europe committee on bioethics24 , that while financial gain should be avoided , it may also be necessary to ensure that donors are not financially disadvantaged by their donation. thus , compensation to remove any such risk is acceptable but should never constitute an incentive that would cause a donor to be dishonest when giving their medical or behavioural history or to donate more frequently than is allowed , posing risks to their own health and to that of prospective recipients. such compensation should , therefore , be set by national authorities , at a level appropriate in their member state to reach such objectives. ### (18) as a matter of principle , programmes promoting the donation of sohos should be founded on the principle of voluntary and unpaid donation , altruism of the donor and solidarity between donor and recipient. it is also recognised , including by the council of europe committee on bioethics24 , that while financial gain should be avoided , it may also be necessary to ensure that donors are not financially disadvantaged by their donation. thus , compensation to remove any such risk is acceptable but should never constitute an incentive that would cause a donor to be dishonest when giving their medical or behavioural history or to donate more frequently than is allowed , posing risks to their own health and to that of prospective recipients. such compensation should , therefore , be set by national authorities , at a level appropriate in their member state to reach such objectives.


### (24) when there is doubt about the regulatory status of a particular substance , product or activity under this regulation , competent authorities should consult with the relevant authorities responsible for other relevant regulatory frameworks , namely medicinal products , medical devices , organs or food , with the aim of ensuring coherent procedures for the application of this regulation. competent authorities should inform the soho coordination board of the outcome of their consultations. when sohos or soho preparations are used to manufacture products regulated under other union legislation , or as the starting and raw material thereof , competent authorities should cooperate with the relevant authorities on their territory. this cooperation should aim to reach an agreed approach for any subsequent communications between the authorities responsible for soho and for the other relevant sectors , as needed , regarding authorisation and monitoring of the sohos or the product manufactured from sohos. it should in principle be the responsibility of the member states to decide on a case-by-case basis on the regulatory status of a substance , product or activity. however , in order to ensure consistent decisions across all member states with regard to borderline cases , the commission should be empowered to , on its own initiative or at the duly substantiated request of a member state , decide on the regulatory status of a particular substance , product or activity under this regulation. ### (24) when there is doubt about the regulatory status of a particular substance , product or activity under this regulation , competent authorities should consult with the relevant authorities responsible for other relevant regulatory frameworks , namely medicinal products , medical devices , organs or food , with the aim of ensuring coherent procedures for the application of this regulation and other relevant eu legislations. when sohos or soho preparations meet the criteria to be defined as a medicinal products or an advanced therapy medicinal product , the classification as medicinal product or as advanced therapy medicinal product should prevail. national authority should inform the soho coordination board of the outcome of their consultations. when sohos or soho preparations are used to manufacture products regulated under other union legislation , or as the starting and raw material thereof , competent authorities should cooperate with the relevant authorities on their territory. this cooperation should aim to reach an agreed approach for any subsequent communications between the authorities responsible for soho and for the other relevant sectors , as needed , regarding authorisation and monitoring of the sohos or the product manufactured from sohos. it should in principle be the responsibility of the member states to decide on a case-by-case basis on the regulatory status of a substance , product or activity. however , in order to ensure consistent decisions across all member states with regard to borderline cases , the commission should be empowered to , on its own initiative or at the duly substantiated request of a member state , decide on the regulatory status of a particular substance , product or activity under this regulation. in case of doubt on the classification of a substance , product or activity as medicinal product , the commission should consult the permanent panel composed of representatives of the european medicine agency and the soho coordination board (scb) for advice and to implement the classification decision taken by the panel across all eu member states.


### (28) with regard to soho preparations that pose a certain level of risk (low , moderate or high) , the applicant should propose a plan for clinical outcome monitoring that should fulfil different requirements appropriate to the risk indicated. the most up-to-date guidance of the european directorate for the quality of medicines & healthcare (edqm , a directorate of the council of europe) should be considered relevant in the design of clinical follow-up studies proportionate in extent and complexity to the identified level of risk of the soho preparation. in the case of low risk , in addition to the mandatory continuous vigilance reporting , the applicant should organise proactive clinical follow-up for a defined number of patients. for moderate and high risk , in addition to the mandatory vigilance reporting and the clinical follow-up , the applicant should propose clinical investigation studies with monitoring of pre-defined clinical end-points. in case of high risk , these should include a comparison with standard treatments , ideally in a study with subjects allocated to test and control groups in a randomised manner. the competent authority should approve the plans before they are implemented and should assess the outcome data as part of a soho preparation authorisation. ### (28) with regard to soho preparations that pose a certain level of risk (low , moderate or high) , the applicant should propose a plan for clinical outcome monitoring that should fulfil different requirements appropriate to the risk indicated. the most up-to-date guidance of the european directorate for the quality of medicines & healthcare (edqm , a directorate of the council of europe) should be considered relevant in the design of clinical follow-up studies proportionate in extent and complexity to the identified level of risk of the soho preparation. in the case of low risk , in addition to the mandatory continuous vigilance reporting , the applicant should organise proactive clinical follow-up for a defined number of patients. for moderate and high risk , in addition to the mandatory vigilance reporting and the clinical follow-up , the applicant should propose clinical investigation studies with monitoring of pre-defined clinical end-points. in case of high risk , these should include a comparison with standard treatments , ideally in a study with subjects allocated to test and control groups in a randomised manner. in case the standard treatment or control group is based on medcinal products , the studies are considered as clinical trials as defined and regulated by regulation 536/2014. the competent authority should approve the plans before they are implemented and should assess the outcome data as part of a soho preparation authorisation.


### (30) in order to facilitate innovation and reduce administrative burden , competent authorities should share with each other information on the authorisation of new soho preparations and the evidence used for such authorisations , including for the validation of certified medical devices used for soho collection , processing , storage or application to patients. such sharing could allow authorities to accept previous authorisations granted to other entities , including in other member states and to thus significantly reduce the requirements to generate evidence. ### (30) in order to facilitate innovation and reduce administrative burden , competent authorities must share with each other information on the authorisation of new soho preparations and the evidence used for such authorisations , including for the validation of certified medical devices used for soho collection , processing , storage or application to patients. such sharing could allow authorities to accept previous authorisations granted to other entities , including in other member states and to thus significantly reduce the requirements to generate evidence.


### (33) with regards to standards concerning donor , recipient and offspring protection , this regulation should provide for a hierarchy of rules for their implementation. as risks and technologies change , this hierarchy of rules should facilitate an efficient and responsive uptake of the most up-to-date guidelines for implementing the standards set out in this regulation. as part of that hierarchy , in the absence of union legislation describing particular procedures to be applied and followed to meet the standards set out in this regulation , following the guidelines of the european centre for disease prevention and control (ecdc) and the edqm should be considered as a means to demonstrate compliance with the standards laid down in this regulation to ensure high level of quality , safety and efficacy. soho entities should be permitted to follow other guidelines , provided that it has been demonstrated that those other guidelines achieve the same level of quality , safety and efficacy. in cases of detailed technical issues for which neither union legislation nor the ecdc and the edqm have defined a technical guideline or rule , operators should apply a locally defined rule that is in line with relevant internationally recognised guidelines and scientific evidence and is appropriate to mitigate any risk identified. ### (33) with regards to standards concerning donor , recipient and offspring protection , this regulation should provide for a hierarchy of rules for their implementation. as risks and technologies change , this hierarchy of rules should facilitate an efficient and responsive uptake of the most up-to-date guidelines based on scientific evidence for implementing the standards set out in this regulation. as part of that hierarchy , in the absence of union legislation describing particular procedures to be applied and followed to meet the standards set out in this regulation , following the guidelines of the european centre for disease prevention and control (ecdc) and the edqm should be one of the means to demonstrate compliance with the standards laid down in this regulation to ensure high level of quality , safety and efficacy. soho entities should be permitted to follow other guidelines , provided that it has been demonstrated that those other guidelines achieve the same level of quality , safety and efficacy. in cases of detailed technical issues for which neither union legislation nor the ecdc and the edqm have defined a technical guideline or rule , operators should apply a locally defined rule that is in line with relevant internationally recognised guidelines and scientific evidence and is appropriate to mitigate any risk identified.


### (33) with regards to standards concerning donor , recipient and offspring protection , this regulation should provide for a hierarchy of rules for their implementation. as risks and technologies change , this hierarchy of rules should facilitate an efficient and responsive uptake of the most up-to-date guidelines for implementing the standards set out in this regulation. as part of that hierarchy , in the absence of union legislation describing particular procedures to be applied and followed to meet the standards set out in this regulation , following the guidelines of the european centre for disease prevention and control (ecdc) and the edqm should be considered as a means to demonstrate compliance with the standards laid down in this regulation to ensure high level of quality , safety and efficacy. soho entities should be permitted to follow other guidelines , provided that it has been demonstrated that those other guidelines achieve the same level of quality , safety and efficacy. in cases of detailed technical issues for which neither union legislation nor the ecdc and the edqm have defined a technical guideline or rule , operators should apply a locally defined rule that is in line with relevant internationally recognised guidelines and scientific evidence and is appropriate to mitigate any risk identified. ### (33) with regards to standards concerning donor , recipient and offspring protection , this regulation should provide for a hierarchy of rules for their implementation. as risks and technologies change , this hierarchy of rules should facilitate an efficient and responsive uptake of the most up-to-date guidelines for implementing the standards set out in this regulation. as part of that hierarchy , in the absence of union legislation describing particular procedures to be applied and followed to meet the standards set out in this regulation , following the guidelines of the european centre for disease prevention and control (ecdc) and the edqm should be one of the means to demonstrate compliance with the standards laid down in this regulation to ensure high level of quality , safety and efficacy. soho entities should be permitted to follow other guidelines , provided that it has been demonstrated that those other guidelines achieve the same level of quality , safety and efficacy. in cases of detailed technical issues for which neither union legislation nor the ecdc and the edqm have defined a technical guideline or rule , operators should apply a locally defined rule that is in line with relevant internationally recognised guidelines and scientific evidence and is appropriate to mitigate any risk identified.


### (36) the ecdc , established by regulation (ec) no 851/2004 of the european parliament and of the council27 , is a union agency with the mission of strengthening europe's defences against communicable diseases. the work of the ecdc on developing and updating guidelines on safety andquality of sohos from a communicable disease threat perspective , should be considered an important contribution in the field of sohos in the union and should be reflected in this regulation. in addition , the ecdc established an expert network for the microbial safety of sohos , which ensures the implementation of the requirements on the ecdc’s relations with the union member states and eea member states stated in regulation (ec) no 851/2004 , regarding strategic and operational collaboration on technical and scientific issues , surveillance , responses to health threats , scientific opinions , scientific and technical assistance , collection of data , identification of emerging health threats , and public information campaigns related to the safety of sohos. this soho expert network should provide information or advice in relation to relevant outbreaks of communicable diseases , in particular regarding the eligibility and testing of donors and the investigation of serious adverse occurrences involving suspected transmission of a communicable disease. ### (36) the ecdc , established by regulation (ec) no 851/2004 of the european parliament and of the council27 , is a union agency with the mission of strengthening europe's defences against communicable diseases. the work of the ecdc on developing and updating guidelines on safety ,quality and susainabilityof sohos from a communicable disease threat perspective , should be considered an important contribution in the field of sohos in the union and should be reflected in this regulation. in addition , the ecdc established an expert network for the microbial safety of sohos , which ensures the implementation of the requirements on the ecdc’s relations with the union member states and eea member states stated in regulation (ec) no 851/2004 , regarding strategic and operational collaboration on technical and scientific issues , surveillance , responses to health threats , scientific opinions , scientific and technical assistance , collection of data , identification of emerging health threats , and public information campaigns related to the safety of sohos. this soho expert network should provide information or advice in relation to relevant outbreaks of communicable diseases , in particular regarding the eligibility and testing of donors and the investigation of serious adverse occurrences involving suspected transmission of a communicable disease.


### (37) it is necessary to promote information and awareness campaigns at national and union level on the importance of sohos. the aim of these campaigns should be to help european citizens to decide whether to become donors during their lifetime and let their families or legal representatives know their wishes regarding donation after death. as there is a need to ensure the availability of sohos for medical treatments , member states should promote the donation of sohos , including plasma , of high quality and safety , thereby also increasing self-sufficiency in the union. member states are also urged to take steps to encourage a strong public and non-profit sector involvement in the provision of soho services , in particular for critical sohos and the related research and development. ### (37) it is necessary to promote information and awareness campaigns at national and union level on the importance of sohos. the aim of these campaigns should be to help european citizens to decide whether to become donors during their lifetime and let their families or legal representatives know their wishes regarding donation after death. as there is a need to ensure the availability of sohos for medical treatments , member states should promote the donation of sohos , including plasma , of high quality and safety , thereby also increasing self-sufficiency in the union. member states are also urged to take steps to encourage the provision of soho services , in particular for critical sohos and the related research and development.


### (37) it is necessary to promote information and awareness campaigns at national and union level on the importance of sohos. the aim of these campaigns should be to help european citizens to decide whether to become donors during their lifetime and let their families or legal representatives know their wishes regarding donation after death. as there is a need to ensure the availability of sohos for medical treatments , member states should promote the donation of sohos , including plasma , of high quality and safety , thereby also increasing self-sufficiency in the union. member states are also urged to take steps to encourage a strong public and non-profit sector involvement in the provision of soho services , in particular for critical sohos and the related research and development. ### (37) it is necessary to promote information and awareness campaigns at national and union level on the importance of sohos. the aim of these campaigns should be to help european citizens to decide whether to become donors during their lifetime and let their families or legal representatives know their wishes regarding donation after death. as there is a need to ensure the availability of sohos for medical treatments , member states should promote the donation of sohos , including plasma , of high quality and safety , thereby also increasing self-sufficiency in the union. member states are also urged to take steps to strongly encourage involvement in the provision of soho services , in particular for critical sohos and the related research and development.


### (38) in order to promote a coordinated application of this regulation , a soho coordination board (scb) should be set up. the commission should participate in its activities and chair it. the scb should contribute to a coordinating the application of this regulation throughout the union , including by helping member states to conduct soho supervisory activities. the scb should be composed of persons designated by the member states based on their role and expertise in their competent authorities , and should also involve experts that are not working for competent authorities , for specific tasks where access to necessary in-depth technical expertise in the field of sohos is required. in the latter case , appropriate consideration should be given to the possibility of involving european expert bodies such as the ecdc and the edqm and existing professional , scientific and donor and patient representative groups at union level in the field of sohos. ### (38) in order to promote a coordinated application of this regulation , a soho coordination board (scb) should be set up. the commission should participate in its activities and chair it. the scb should contribute to a coordinating the application of this regulation throughout the union , including by helping member states to conduct soho supervisory activities. the scb should be composed of persons designated by the member states based on their role and expertise in their competent authorities , and should also involve experts that are not working for competent authorities , for specific tasks where access to necessary in-depth technical expertise in the field of sohos is required. in the latter case , appropriate consideration should be given to the possibility of involving european expert agencies and bodies such as the ecdc , the ema , the health emergency preparedness and response authority (hera) established as a commission service by commission decision of 16 september 2021 and the edqm and existing professional , scientific and donor and patient representative groups at union level in the field of sohos. other union institutions , bodies , offices and agencies should have an observer role. a representative designated by the european parliament should be able to participate in the soho coordination board (scb) as an observer. all members of the scb should provide declarations of interest.


### (39) some substances , products or activities have been subject to different legal frameworks with different requirements in the member states. this causes confusion among operators in the field , and the consequent legal uncertainty is a disincentive to professionals to develop new ways to prepare and use sohos. the scb should receive relevant information on national decisions made on cases where questions were raised on the regulatory status of sohos. the scb should keep a compendium of the opinions issued by the scb or the competent authorities and of decisions made at member state level , so that competent authorities considering the regulatory status under this regulation of a particular substance , product or activity may inform their decision-making process by referring to that compendium. the scb should also document agreed best practices to support a common union approach. it should also cooperate with similar union level bodies established in other union legislation with a view to facilitating coordinated and coherent application of this regulation between member states and across bordering legislative frameworks. these measures should promote a coherent cross-sectoral approach and facilitate soho innovation. ### (39) some substances , products or activities have been subject to different legal frameworks with different requirements in the member states. this causes confusion among operators in the field , and the consequent legal uncertainty is a disincentive to professionals to develop new ways to prepare and use sohos. in case a product could be classified both as soho or soho preparation and medicinal product , the classification as medicinal product should prevail.the scb should receive relevant information on national decisions made on cases where questions were raised on the regulatory status of sohos. the scb should keep a compendium of the opinions issued by the scb or the competent authorities and of decisions made at member state level , so that competent authorities considering the regulatory status under this regulation of a particular substance , product or activity may inform their decision-making process by referring to that compendium. the scb should also document agreed best practices to support a common union approach. it should also cooperate with similar union level bodies established in other union legislation with a view to facilitating coordinated and coherent application of this regulation between member states and across bordering legislative frameworks. these measures should promote a coherent cross-sectoral approach , ensure high protection of public health , and facilitate innovation.


### (41) in order to limit administrative burden on competent authorities and the commission , the latter should establish an online platform (the ‘eu soho platform’) to facilitate timely submission of data and reports as well as improved transparency of national reporting and supervisory activities. ### (41) in order to limit administrative burden on competent authorities and the commission , the latter should establish an online platform (the ‘eu soho platform’) to facilitate timely submission of data and reports as well as improved transparency of national reporting and supervisory activities. the eu soho platform might also be utilized by member states as a channel for national initiatives and campaigns to encourage the exchange of best practices. said national campaigns and campaigns shall , in close cooperation with patient organizations , aim to promote donation and sustainable supplies of soho products.


### (42) the processing of personal data under this regulation should be subject to strict guarantees of confidentiality and should comply with the rules on the protection of personal data laid down in regulation (eu) 2016/679 of the european parliament and of the council and in regulation (eu) 2018/1725 of the european parliament and of the council . ### (42) the processing of personal data under this regulation should be subject to strict guarantees of confidentiality and should comply with the rules on the protection of personal data laid down in regulation (eu) 2016/679 of the european parliament and of the council and in regulation (eu) 2018/1725 of the european parliament and of the council. the commission may also decide that information on soho donations are added to donors electronic health records (ehrs).


### (43) as the eu soho platform requires the processing of personal data , it will be designed respecting the principles of data protection. any processing of personal data should be limited to achieving the objectives and obligations of this regulation. access to the eu soho platform should be limited to the extent necessary to carry out supervisory activities provided for in this regulation. ### (43) as the eu soho platform requires the processing of personal data , it will be designed respecting the principles of data protection. any processing of personal data should be limited to achieving the objectives and obligations of this regulation. access to the eu soho platform should , once it is established , be granted within the framework of the european health data space and otherwise be limited to the extent necessary to carry out supervisory activities provided for in this regulation.


### (46) in order to enable better access to health data in the interests of public health , member states should entrust competent authorities as data controllers within the meaning of regulation (eu) 2016/679 with powers to take decisions on the access to and re-use of such data. ### (46) in order to enable better access to health data in the interests of public health , member states should entrust competent authorities as data controllers within the meaning of regulation (eu) 2016/679 with powers to take decisions on the access to and re-use of such data. furthermore , access to secondary data for reseach purposes should be made available via the european health data space , once it is established.


### this regulation establishes measures setting high standards of quality and safety for all substances of human origin (‘sohos’) intended for human application and for activities related to those substances in order to ensure a high level of human health protection , in particular for soho donors , soho recipients and offspring from medically assisted reproduction. this regulation is without prejudice to national legislation which establishes rules relating to aspects of sohos other than their quality and safety and the safety of soho donors. ### this regulation establishes measures setting high standards of quality and safety for all substances of human origin (‘sohos’) intended for human application and for activities related to those substances in order to ensure a high level of human health protection , in particular for soho donors , soho recipients and offspring from medically assisted reproduction. this regulation is without prejudice to national legislation which establishes rules relating to aspects of sohos other than their efficacy , quality and safety and the safety of soho donors.


### 1. this regulation shall apply to sohos intended for human application , to soho preparations , to products manufactured from sohos and intended for human application , to soho donors and recipients , and to the following soho activities: ### 1. this regulation shall apply to sohos intended for human application , to soho preparations , to products manufactured from sohos and intended for human application , to soho donors and recipients , and to the following soho activities that have a direct impact on the safety , quality or efficacy of sohos :


### soho donor recruitment; ### soho donor recruitment; except if the entity is not subject to further soho activites as listed in this paragraph.


### 2. in cases of autologous use of sohos where: ### 2. in cases of autologous use of sohos , with the exception of processes involving a substantial manipulation or application intended for a non-homologous use , where:


### sohos are not processed and not stored before application , this regulation shall not apply. ### sohos are not or minimally processed to maintain or establish their applicability during medical treatment and surgeries and not stored before application , this regulation shall not apply


### for sohos that are used to manufacture products in accordance with union legislation on medical devices , regulated by regulation (eu) 2017/745 , on medicinal products , regulated by regulation (ec) no 726/2004 and directive 2001/83/ec , including on advanced therapy medicinal products , regulated by regulation (ec) no 1394/2007 , or on food , regulated by regulation (ec) no 1925/2006 , or as the starting and raw material thereof , the provisions of this regulation applicable to the activities of soho donor recruitment , donor history review and eligibility assessment , testing of donors for eligibility or matching purposes , and collection of sohos from donors or patients shall apply. insofar as the activities of soho release , distribution , import and export relate to sohos prior to their distribution to an operator regulated by the other union legislation referred to in this subparagraph , the provisions of this regulation shall also apply. ### for sohos that are used to manufacture products in accordance with union legislation on medical devices , regulated by regulation (eu) 2017/745 , on medicinal products , regulated by regulation (ec) no 726/2004 and directive 2001/83/ec , including on advanced therapy medicinal products , regulated by regulation (ec) no 1394/2007 , on investigational medicinal products regulated by regulation 536/2014 , or on food , regulated by regulation (ec) no 1925/2006 , or as the starting and raw material thereof , the provisions of this regulation applicable to the activities of soho donor recruitment , donor history review and eligibility assessment , testing of donors for eligibility or matching purposes , and collection of sohos from donors or patients shall apply. insofar as the activities of soho release , distribution , import and export relate to sohos prior to their distribution to an operator regulated by the other union legislation referred to in this subparagraph , the provisions of this regulation shall also apply.


### by way of derogation from the first subparagraph , in cases where sohos , soho preparations , or products manufactured from soho , as referred to in that subparagraph , are exclusively for autologous use , only those provisions of this regulation that concern the collection of sohos from patients shall apply. ### by way of derogation from the first subparagraph , in cases where sohos , soho preparations , or products manufactured from soho , as referred to in that subparagraph , are exclusively for autologous use , only those provisions of this regulation that concern the collection and testing of sohos from patients shall apply.


### (1) ‘blood’ means the liquid that circulates in arteries and veins carrying oxygen to and carbon dioxide from the tissues of the body; ### (1) “blood’ means whole blood collected from a donor and processed either for transfusion or for further manufacturing;


### (3) ‘cell’ means a mass of cytoplasm with or without a nucleus , that is bound externally by a cell membrane. usually microscopic in size , cells are the smallest structural and functional unit of an organism; ### (3) a typical cell is the smallest unit of an organism that has been generated directly through mitosis. a cell comprises a nucleus (eukaryotic cells) or nucleoid material (prokaryotic cells) and cytoplasma enclosed by a cell membrane.


### (5) ‘substance of human origin’ (soho) means any substance collected from the human body in whatever manner , whether it contains cells or not and whether those cells are living or not. for the purposes of this regulation , soho does not include organs in the sense of article 3 , point (h) , of directive 2010/53/eu; ### (5) ‘substance of human origin’ (soho) means any substance collected from the human body in whatever manner , whether it contains cells or not and whether those cells are living or not. for the purposes of this regulation , soho does not include organs in the sense of article 3 , point (h) , of directive 2010/53/eu , medicinal products regulated by regulation (ec) no 726/2004 and directive 2001/83/ec and investigational medicinal products regulated by regulation (ec) no 536/2014;


### (8) ‘soho donor’ means any person who has presented themselves to a soho entity with a view to making a donation of sohos , whether that donation is successful or not; ### (8) ‘soho donor’ means any living soho donor or deceased soho donor , whether that donation is successful or not;


### has been subjected to one or more soho activities , including processing , in accordance with defined quality and safety parameters; ### has been subjected to one or more soho activities in accordance with defined quality and safety parameters;


### meets a pre-defined specification; and ### meets a pre-defined specification;


### is intended for application to a recipient for a specific clinical indication or is intended for distribution for manufacture of a product regulated by other union legislation , or as the starting and raw material thereof; ### is intended for application to a recipient for a specific clinical indication or is intended for distribution for manufacture of a product regulated by other union legislation , or as the starting and raw material thereof; and


### (15) ‘processing’ means any operation involved in the handling of sohos , including washing , shaping , separation , fertilisation , decontamination , sterilisation , preservation and packaging; ### (15) ‘processing’ means any operation involved in the non-autologous handling of sohos , including washing , shaping , separation , fertilisation , decontamination , sterilisation , preservation and packaging; in autologous use it means only handling beyond minimal operations including immediate application of soho within a closed system;


### (15) ‘processing’ means any operation involved in the handling of sohos , including washing , shaping , separation , fertilisation , decontamination , sterilisation , preservation and packaging; ### (15) ‘processing’ means any operation involved in the handling of sohos , including washing , shaping , separation , fertilisation , decontamination , sterilisation , preservation and packaging with the exception of activities requiring substantial manipulation;


### (15) ‘processing’ means any operation involved in the handling of sohos , including washing , shaping , separation , fertilisation , decontamination , sterilisation , preservation and packaging; ### (15) ‘processing’ means any operation involved in the different steps of preparation processes of sohos;


### (23) ‘autologous use’ means collection of soho from one individual for subequent application to the same individual , with or without further soho activities between collection and application; ### (23) ‘autologous use’ means collection of soho from one individual for application to the same individual , with or without further soho activities between collection and application;


### (31) ‘eu soho platform’ means the digital platform established by the commission to exchange information concerning soho activities; ### (31) ‘eu soho platform’ means the digital platform established by the commission to exchange information concerning soho activities which should be interoperable with existing and upcoming frameworks;


### (51) ‘imputability’ means the likelihood that a serious adverse occurrence , in a soho donor , is related to the donation process or , in a recipient , to the application of the sohos; ### (51) ‘imputability’ means the likelihood that an adverse occurrence , in a soho donor , is related to the donation process or , in a recipient , to the application of the sohos;


### (59) ‘edqm soho monograph’ means a specification of the critical quality parameters of a particular soho preparation defined by the european directorate for the quality of medicines and healthcare of the council of europe; ### (59) ‘edqm soho monograph’ means a specification of the critical quality parameters related to the therapeutic indication of a particular soho preparation defined by the european directorate for the quality of medicines and healthcare of the council of europe;


### (60) ‘annual soho activity report’ means the annual report published by the commission aggregating the data reports from soho entities carrying out the following activities: donor recruitment , collection , distribution , import , export and human application of sohos; ### (60) ‘annual soho activity report’ means the annual report published by the commission aggregating the data reports from soho entities carrying out the following activities: donor recruitment , collection , storage , distribution , import , export and human application of sohos;


### (64) ‘compensation’ means making good of any losses associated with donation; ### (64) ‘compensation’ means making good of any expenses and inconveniences associated with donation;


### (64) ‘compensation’ means making good of any losses associated with donation; ### (64) ‘compensation’ means making good any expenses and inconveniences associated with donation;


### (65) ‘allogeneic use’ means collection of soho from one individual for subsequent application to another individual; ### (65) ‘allogeneic donor’ means any person who make a donation to a soho entity for subsequent application to another individual;


### 1. member states may maintain or introduce within their territories measures that are more stringent than the ones provided for in this regulation on condition that those national measures are compatible with union law , and are proportionate to the risk to human health. ### 1. member states may maintain or introduce within their territories measures that are more stringent than the ones provided for in this regulation on condition that those national measures are based on scientific evidence , are compatible with union law , do not discriminate against persons on grounds of sex , racial or ethnic origin , religion or belief , disability , age or sexual orientation , and are proportionate to the risk to human health.


### (ii) to order the immediate suspension or cessation of a soho activity that poses immediate risk to soho donors , soho recipients or the general public; ### (ii) to order the immediate suspension or cessation of a soho activity that poses immediate risk to soho donors , soho recipients or the general public or do not comply with the conditions of its authorisation or the requirements of this regulation;


### have sufficient resources , operational capacity , and expertise to achieve the aims of , and fulfil their obligations under , this regulation; ### have sufficient resources , operational capacity , and subject matter expertise to achieve the aims of , and fulfil their obligations under , this regulation;


### the commission may , upon a duly substantiated request of a member state following the consultation referred to in paragraph 1 , or on its own initiative , by means of implementing acts , determine the regulatory status of a substance , product or activity under this regulation , in case questions arise in that respect , notably when these questions cannot be resolved at the member state level , or in discussions between the scb and the advisory bodies established in other relevant union legislation , in accordance with article 68(1) , point (b). ### the commission may , upon a duly substantiated request of a member state following the consultation referred to in paragraph 1 , or on its own initiative , by means of implementing acts , determine the regulatory status of a substance , product or activity under this regulation , in case questions arise in that respect , notably when these questions cannot be resolved at the member state level , or in discussions between the scb and the advisory bodies established in other relevant union legislation , in accordance with article 68(1) , point (b) , or in accordance with paragraph 2a (c).


### 6. the consultation and cooperation referred to in paragraphs 1 , 2 and 5 may also be initiated on the basis of a request for advice from a soho entity , as referred to in article 40. ### 6. the consultation and cooperation referred to in paragraphs 1 , 2 and 5 may also be initiated on the basis of a request for advice from a soho entity , as referred to in article 40 , or in the case of paragraph 2a , the ema.


### the commission may , by means of implementing acts , lay down rules concerning procedures for consultation referred to in paragraph 1 and cooperation referred to in paragraph 5 by the competent authorities when they consult the authorities established in other relevant union legislation referred to in article 2(3). ### the commission may , by means of implementing acts , lay down rules concerning procedures for consultation referred to in paragraph 1 and cooperation referred to in paragraph 5 by the competent authorities when they consult the authorities established in other relevant union legislation referred to in article 2(3). the commission may also lay down rules concerning the procedure referred to in paragraph 2a and the operation of the permanent panel in coherence with the specific provisions foreseen in regulation (ec) 726/2004 , directive 2001/83/ec and regulation (eu) 2017/745.


### grant a conditional authorisation for the use of the soho preparation in all cases where clinical outcome data is required for authorisation , pursuant to article 22(4) , points (d) and (e); ### grant a conditional authorisation for the use of the soho preparation in all cases where clinical outcome data is required for authorisation , pursuant to article 22(4) , points (d) and (e); in this case , an appropriate information for practitioners and patients on the conditional nature of the authorization is put in place by the soho entity ;


### 4. competent authorities shall conclude the soho preparation authorisation steps , referred to in paragraph 2 of this article , within 3 months from receipt of the application , excluding the time needed for clinical outcome monitoring or studies. they may suspend this time limit for the duration of the consultation processes referred to in article 14(1) and (2). ### 4. competent authorities shall conclude the soho preparation authorisation steps , referred to in paragraph 2 of this article , within 3 months from receipt of the application , excluding the time needed for clinical outcome monitoring or studies. they may suspend this time limit for the duration of the consultation processes referred to in article 14(1) and (2) or if further information are required from the soho entity who made the request.


### such preparation , or any of the activities performed for that preparation , do not comply with the conditions of its authorisation or the requirements of this regulation; and ### such preparation , or any of the activities performed for that preparation , do not comply with the conditions of its authorisation or the requirements of this regulation; or


### 8. competent authorities may , in accordance with national legislation , withdraw the authorisation of a soho preparation if the competent authorities have confirmed that the soho preparation in question does not comply with subsequently updated criteria for authorisation or the soho entity has repeatedly failed to comply with the conditions of its authorisation. ### 8. competent authorities may , in accordance with national legislation , withdraw the authorisation of a soho preparation if the competent authorities have confirmed that the soho preparation in question does not comply with subsequently updated criteria for authorisation or the soho entity has failed to comply with the conditions of its authorisation.


### 1. competent authorities shall provide guidelines and templates to allow that applications from soho entities for their authorisation as soho establishments are submitted in accordance with article 49. when developing these guidelines and templates , competent authorities shall consult the relevant best practices agreed and documented by the scb as referred to in article 68(1) , point (c). ### 1. the soho coordination board shall provide guidelines and templates to allow that applications from soho entities for their authorisation as soho establishments are submitted in accordance with article 49.


### carry out an on-site system inspection of the applicant soho establishment and , where applicable , of third parties contracted by the soho establishment to perform soho activities , pursuant to article 29; ### carry out an on-site system inspection of the applicant soho establishment in the year following the launch of the site and , where applicable , of third parties contracted by the soho establishment to perform soho activities , pursuant to article 29;


### does not comply with the conditions of its authorisation or the provisions of this regulation; and ### does not comply with the conditions of its authorisation or the provisions of this regulation; or