### 23. encourages the agency to work in closely cooperation with enisa (european union agency for cybersecurity); suggests to offer regularly updated cybersecurity-related training programmes for all staff within the agency; ### 23. encourages the agency to work in close cooperation with enisa (european union agency for cybersecurity) and cert-eu (computer emergency response team for the eu institutions , bodies and agencies) and to carry out regular risk assessments of its it infrastructure and to ensure regular audits and tests of its cyber defences; suggests to offer regularly updated cybersecurity-related training programmes to all staff members , including management , within the agency;


### 3. notes that the agency received a eur 16 ,9 million contribution under the general budget of the union in 2020 , representing an increase of 1 ,2 % in respect of 2019; points out that the agency’s annual budget ranks as one of the lowest amongst union agencies; ### 3. notes that the agency received a eur 16 ,9 million contribution under the general budget of the union in 2020 , representing an increase of 1.2 % in respect of 2019; points out that both the agency’s annual budget and its complement of staff are among the lowest amongst union agencies;


### 4. acknowledges that the financial year 2020 was dominated by the covid-19 pandemic; notes that this crisis has had a strong impact on the implementation rate of the agency’s work programmed , which dropped from 99 % in 2019 to 90 % in 2020; notes , however , that in spite of the circumstances the agency managed to implement its budget at a rate of 97 ,3 % for commitments and 81 ,2 % for payments; ### 4. acknowledges that the financial year 2020 was dominated by the covid-19 pandemic; notes that this crisis has had a strong impact on the implementation rate of the agency’s programmed work , which dropped from 99 % in 2019 to 90 % in 2020; emphasises , however , that in spite of the circumstances the agency managed to implement its budget at a rate of 97.3 % for commitments and 81.2 % for payments;


### 6. notes that , in 2020 ,the agency coordinated 38 452 fishing vessel inspections , which led to the detection of 1 682 suspected infringements , an increase , respectively , of 18 ,75 % and 44 ,25 % on the 2019 figures; believes that those figures show that inspections and follow-up activities remain a key tool for ensuring that the rules of the cfp are observed; notes , however , that that increase conceals disparities between areas , with an increase in western waters (+27 %) and in the mediterranean sea (+141 %) and a decrease in the baltic sea (-20 %) , the north sea (-49 %) , the black sea (-11%) and nafo-neafc (-36%); invites the agency to provide more detailed information on the reasons for those changes; ### 6. notes that , in 2020 ,the agency coordinated 38 452 fishing vessel inspections , which led to the detection of 1 682 suspected infringements , an increase , respectively , of 18.75 % and 44.25 % on the 2019 figures; believes that those figures show that inspections and follow-up activities remain a key tool for ensuring that the rules of the cfp are observed; notes , however , that that increase conceals disparities between areas , with an increase in western waters (+27 %) and in the mediterranean sea (+141 %) and a decrease in the baltic sea (-20 %) , the north sea (-49 %) , the black sea (-11%) and nafo-neafc (-36%); invites the agency to provide more detailed information on the reasons for those changes; points out that inspections and other follow-up activities play a key role not only in the proper management of fish stocks but also in guaranteeing a level playing field for european fishers;


### 10. 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 heads of unit positions are held by men; calls on the agency to keep up its efforts with regard to its gender parity policy; ### 10. 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;


### 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 at the latest; whereas the commission has proposed a greenhouse gas (ghg) emission reduction objective of at least 55% by 2030 , while the parliament has called for a ghg emission reduction target of 60% by 2030; whereas offshore renewable energy should play a key role in achieving these objectives;


### 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. notes the need to assess the potential negative long-term impact that offshore wind turbines may have on ecosystems , fish stocks and biodiversity , and consequently on fisheries as a whole , over their life cycle , from construction through operation and decommissioning; stresses that only a few studies have analysed the potential negative impacts of offshore wind farms on the fisheries sector;


### 1. recalls the eu’s sustainable commitment to achieving its zero-carbon climate target by 2050 , as confirmed in the european green deal and the recovery plan; ### 1. recalls the eu’s sustainable commitment to achieving its zero-carbon climate target by 2050 at the latest; and that these emissions should be reduced by at least [60%] by 2030 compared to 1990 emissions as set in the [european climate law] in order for the union to contribute to limiting global warming to less than 1.5°c above pre-industrial levels.


### 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. notes the need to assess the impact that the large-scale roll-out of offshore wind farms (owfs) may have on 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;


### 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 the need to investigate the potential benefits of offshore renewable installations for fisheries; stresses that empirical evidence of the ecological benefits resulting from the construction of artificial reefs is gradually increasing , but that these effects may be limited to the operational phase of the wind turbine and that decommissioning may cause any benefit to be 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; ### 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 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 fleet could be particularly affected by displacement as they may not have the capacity to move to fishing grounds further afield or to change fishing method;


### 10. stresses that today , fishing activities (active or passive) in owfs are limited or prohibited in most member states; ### 10. stresses that today there are some examples of cooperation of (active or passive) fishing activities in offshore wind farms; stresses that co-operative co-design approaches regarding the siting of owfs to combine them with other uses can reduce the potential impact on fisheries , strengthen the relationship between the various sectors involved and allow for beneficial cooperation between them.


### 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;


### 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 economic and social impacts on fisheries of investments in owfs;


### 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 is required given that evidence suggests that member states’ maritime spatial planning does not guarantee the fair inclusion of fisheries;


### — having regard to the mid-term strategy (2017-2020) towards the sustainability of mediterranean and black sea fisheries and the decision on a new strategy for the period 2021-2025 , ### — having regard to the mid-term strategy (2017-2020) of gfcm towards the sustainability of mediterranean and black sea fisheries and the decision on a new strategy for the period 2021-2025 ,


### — having regard to ministerial declarations adopted at the meetings in burgas (31 may 2018) and bucharest (9 may 2019) on a common maritime agenda for the black sea , ### — having regard to ministerial declarations adopted at the meetings in burgas (31 may 2018) and bucharest (9 may 2019) on a common maritime agenda for the black sea , which have been signed by all 6 littoral black sea states ,


### — having regard to the 1992 convention for the protection of the black sea against pollution and its protocols , to which bulgaria and romania are parties and in respect of which the european union has observer status , ### — having regard to the 1992 convention for the protection of the black sea against pollution and its protocols , to which bulgaria and romania are parties and in respect of which the european union has observer status , and also having regard to the work of the commission on the protection of the black sea against pollution on the basis of this convention ,


### — having regard to the blacksea4fish project for ensuring the sustainable management of fish stocks in the black sea , ### — having regard to the blacksea4fish project with the financial support of the eu and annual budget of around 1 100 000 eur for ensuring the sustainable management of fish stocks in the black sea ,


### — having regard to the pan-european action plan for sturgeons (paneuap) adopted within the framework of the berne convention , ### — having regard to the berne convention , the bon convention (cms) , cites , the convention on biological diversity (cbd) , the pan-european action plan for sturgeons (paneuap) adopted within the framework of the berne convention ,


### a. whereas the black sea is a semi-enclosed sea , which is only connected to an ocean by the mediterranean and is bordered upon by six countries , of which only two are eu member states; ### a. whereas the black sea is a semi-enclosed sea , which is only connected to an ocean by the mediterranean via the marmara and the aegean seas and is bordered upon by six countries (bulgaria , romania , turkey , georgia , ukraine , the russian federation) , of which only two are eu member states (bulgaria and romania);


### b. whereas the black sea has a large anoxic layer (87%) and its oxic layer has thinned by 20 to 25 metres over the last 20 years; ### b. whereas the black sea has a large anoxic layer (87%) and its oxic layer has thinned by 20 to 25 metres over the last 20 years; whereas with the exception of few anaerobic bacteria , marine life is absent at depths below 50-200 m under the sea surface;


### c. whereas eight species fished in the black sea are of major interest to the fishing sector , most of which form part of shared stocks , while two species are subject to quotas – sprat (autonomous quota) and turbot (quota set by the gfcm); ### c. whereas eight species fished in the black sea are of major interest to the fishing sector (european anchovy (ergaulis encrasicolus) , european sprat (sprattus sprattus) , horse mackerel (trachurus mediterraneus) , turbot (scophthalmus maximus) , whiting (merlangius merlangus) , red mullet (mullus barbatus) , rapa whelk (rapana venosa) , piked dogfish (squalus acanthias) , most of which form part of shared stocks , while two species are subject to quotas – sprat (sprattus sprattus) , which has an autonomous quota and turbot (scophthalmus maximus) , which has a tac quota set by the gfcm; where as the quota for sprat for the period 2020-2022 remained unchanged since 2011 at the rate of 11 445 tonnes per year for the eu (8 032 ,5 tonnes for bulgaria and 3 442 ,5 tonnes for romania) , while that for turbot was increased for the eu from 114 to 150 tonnes per year , divided equally between bulgaria and romania;


### d. whereas , according to 2018 figures , fish consumption per capita in bulgaria (7.00 kg) and romania (7.99 kg) is below the eu average (24.36 kg); ### d. whereas , according to 2018 figures , annual fish consumption per capita in bulgaria (7.00 kg) and romania (7.99 kg) is well below the eu average (24.36 kg) , which can be seen as an opportunity for the local fishing sector to grow;


### e. whereas 91% of the black sea fishing fleet consists of small vessels , which make up almost 95% of the bulgarian fleet; ### e. whereas on average 91% of the black sea fishing fleet of all 6 littoral countries consists of small vessels; whereas almost 95% of the bulgarian and 87% of the romanian fleet falls under this category;


### f. whereas illegal , unreported and unregulated fishing vessels are operating in the black sea; ### f. whereas illegal , unreported and unregulated fishing vessels are operating in the black sea; whereas per the latest available data of gfcm from 4-8 november 2019 there have been 65 vessels identified as iuu fishing vessels;


### g. whereas the emff allocated more than eur 88 million to bulgaria and more than eur 168 million to romania for the period 2014-2020; ### g. whereas the emff allocated more than eur 88 million to bulgaria and more than eur 168 million to romania for the period 2014-2020; whereas the absorption rates of both countries according to the latest available information until 31.12.2020 remain among the lowest in the eu at rates of funds spent at 36 ,34% for bulgaria and 33 ,72% for romania; whereas lower absorption rates could mean missed opportunities for the fishing communities in these countries;


### i. whereas according to the report drawn as part of the emblas-plus project on the black sea , the black sea has almost twice as much waste as the mediterranean; ### i. whereas according to the report drawn as part of the emblas-plus project on the black sea , the black sea has almost twice as much waste as the mediterranean sea , which undoubtedly has consequences for the biodiversity and respectively for the stocks and the fishing sector;


### j. whereas the black sea has three endemic sub-species of cetaceans , two of which have the status of endangered species; whereas these are carnivores which feed mainly on fish; ### j. whereas the black sea has three endemic sub-species of cetaceans - black sea common dolphin (delphinus delphis ponticus) , black sea common bottlenose dolphin (tursiops truncatus ponticus) and black sea harbour porpoise (phocoena phocoena relicta) , all of which are classified as endangered species and two of them black sea common bottlenose dolphin (tursiops truncatus ponticus) and black sea harbour porpoise (phocoena phocoena relicta) are included under the habitats directive; whereas all of these these are carnivores which feed mainly on fish;


### k. whereas the veined rapa whelk (rapana venosa) is a source of income , but is an invasive species that poses a serious threat to populations of other organisms; ### k. whereas the veined rapa whelk (rapana venosa) is considered as an invasive species without natural enemies in the black sea , which poses a serious threat to the populations of other organisms , however at the same time it has become an important source of income and is also a species subject of commercial fishing;


### l. whereas the black sea ecosystem depends on major european rivers such as the danube; whereas both the danube and the black sea are home to certain species , including the sturgeon; ### l. whereas the black sea ecosystem depends on major european rivers such as the danube; whereas both the danube and the black sea are home to certain species , including the sturgeons (acipenseriformes) and the pontic shads (clupeiformes);


### m. whereas factors such as the degradation of the habitat of these species , disruption of their migration corridors and their overexploitation for caviar and their flesh , as well as pollution , have brought danube and black sea sturgeon to the verge of extinction; whereas , due to the drastic reduction in the number of reproductive sturgeon , this species can no longer breed in the wild; ### m. whereas factors such as the degradation of the habitat of these species , disruption of their migration corridors and their overexploitation for caviar and their flesh , as well as pollution , have brought danube and black sea sturgeon to the verge of extinction; whereas , due to the drastic reduction in the number of reproductive sturgeon , this species can only very rarely breed in the wild nowadays;


### n. whereas the covid-19 pandemic is having a serious impact on the black sea fishing sector; ### n. whereas the covid-19 pandemic is having a serious impact on the black sea fishing sector; whereas analyses showed that the fisheries sector in the black sea suffered drastically during the pandemic with reduction of up to 80% of the work of the operating ships as well as initial reduction with around 75% of the production;


### 1. stresses the need to strengthen cooperation with third countries in the region with a view to efficiently managing fisheries resources and meeting challenges; ### 1. underlines the high strategic and geopolitical stakes in the black sea basin due to the very specific environmental conditions , which demand special attention , tailored approach and collective actions aiming at sustainable blue economy and growth; stresses the need to further strengthen and deepen the cooperation among all littoral black sea countries with a view to efficiently managing fisheries resources and meeting challenges; calls in this regard for a regional capacity plan , which ensures appropriate balance among available natural resources , environmental safety and the fleet capacity of all black sea littoral countries;


### 2. notes that statistics show that a large proportion of key fish stocks are being overfished; stresses that this has been a growing trend in recent years; ### 2. is concerned that after decades of increasing human pressure on the black sea marine and the danube river's ecosystems and fisheries resources , the latest data suggests that more than 75% of the fish stocks are overfished; notes that there have been some positive trends in the past years for some stocks , for example the turbot , whose tac quota has been increased for the period 2020-2022 , however there is no significant improvement on a general scale for the black sea yet;


### 3. stresses the need for funding for scientific bodies researching stocks both of fish species , including migratory species such as the sturgeon , and non-fish species (veined whelks , mussels , etc.); ### 3. stresses the need for funding for scientific bodies researching stocks both of fish species , including migratory species such as the sturgeon and the black sea shads , and non-fish species (veined whelks , mussels , etc.);


### 4. stresses that through the fishing sector seafood can be offered for sale on local markets where consumption rates for such products are low; ### 4. stresses that through the fishing sector seafood can be offered for sale on local markets where consumption rates for such products are low; invites the competent authorities in bulgaria and romania to help the fishing and aquaculture sectors increase awareness about local consumption and the cumulative positive effects the sustainably grown or caught fisheries have for the local economy;


### 5. points out that there is rising global demand for the proteins found in fishery and aquaculture products; ### 5. points out that there is rising global demand for the proteins , to which both the fisheries and the aquaculture production can have great contribution; considers that the possibility of supporting marine aquaculture can help the sector develop and grow in the years to come and also reduce the pressure on the wild stocks; is of the opinion , that sustainable aquaculture would require also further scientific research on issues such as density and side effects , which need to be taken into account , when designing policies for the aquaculture sector in the black sea;


### 6. calls on local fishing communities to consider classifying black sea products as coming from an area of regional or local importance; ### 6. calls on local fishing communities to consider introducing designations origin for the black sea products as coming from an area of regional or local importance; calls on the local and regional authorities help these communities in their efforts of doing so;


### 7. calls on the member states in the region to consider supporting the sector by , for example , developing specialised trade channels and markets; ### 7. calls on the member states in the region to consider supporting the sector through inclusion in their national programmes for 2021-2027 or other national instruments , allocations for campaigns dedicated to the benefits of fish consumption and the importance of sustainable fisheries production and to support the sector create local food chains , to facilitate easier access to the market , especially for the small-scale fishers and to develop , improve or facilitate the fisheries infrastructure (f.e. fish markets or fish auction places etc.);


### 8. stresses the role of fisheries local action groups (flags) in exchanging and promoting best practices; ### 8. stresses the role of fisheries local action groups (flags) in exchanging and promoting best practices of interest for the sciences , local stakeholders and the industry both among the members of the respective fishing communities , but also through international cooperation; urges the competent authorities in bulgaria and romania to foresee national support for exchange of best practices with the other black sea littoral states , which have shown good practices in stock management for the economically important species , such as turbot , among others;


### 9. calls for training in the sector to be made more attractive; ### 9. calls for training and education in the sector on both secondary and higher education level to be made more attractive through for example targeted information campaigns , open days for perspective students in cooperation with the public and private sector;


### environment and biodiversity ### environment , biodiversity and climate change


### 10. calls for targeted measures and adequate resources to reduce pollution throughout the basin through joint programmes and budgets; ### 10. calls for targeted measures and adequate resources to reduce pollution throughout the basin through joint programmes and budgets; calls for extensive research and estimates on the plastic pollution and the effects of plastics and other pollutants on the living organisms in the black sea; calls for systemic measurement of the nitrogen pollution in the black sea basin;


### 11. invites the member states to develop the ex situ farming of sturgeon; invites the member states to provide retraining programmes and access to other livelihoods for sturgeon fishermen , with an eye to reducing illegal catch levels; ### 11. invites the member states to develop the ex situ farming of sturgeon; invites the member states to provide retraining programmes and access to other livelihoods for sturgeon fishers , with an eye to reducing illegal catch levels;


### 13. instructs its president to forward this resolution to the council and to the commission. ### 13. instructs its president to forward this resolution to the council , the commission , the governments and parliaments of the member states , the governments and parliaments of the ukraine , the russian federation , georgia and turkey , the general fisheries commission for the mediterranean and the black sea , the organisation of the black sea economic cooperation , the commission on the protection of the black sea against pollution.


### 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 with the aim to reduce the risks and impacts of these products on human health and the environment and promote the implementation of integrated pest management based on non-chemical alternatives to plant protection products and low input farming systems , such as agroecology and organic farming.


### 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 aims at reducing the risks and impacts of pesticide use on human health and the environment and reducing pesticide dependency. it 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 pesticides , by promoting and implementing integrated pest management , based on non-chemical preventive and alternative agroecological approaches and techniques such as biological control , and encouraging the transition to low-input farming systems , and by establishing requirements for use , storage , sale and disposal of plant protection products and for application equipment , worker protection and training , independent advice and awareness raising


### 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 establishing requirements for use , storage , sale and disposal of plant protection products and for plant protection products application equipment , providing for training and awareness raising , and providing for implementation of integrated pest management , and providing for member state contributions to the european union reduction targets for the use and risk of chemical plant protection products by 2035.


### — protection and enhancement of important beneficial organisms , including beneficial plant protection measures or the utilisation of ecological infrastructures inside and outside production sites , ### — protection and enhancement of important beneficial organisms , including beneficial plant protection measures as well as the utilisation of ecological infrastructures covering at least 10% of the uua inside and outside production sites ,


### methodology for calculating progress towards achieving the two union and two national 2030 reduction targets ### methodology for calculating progress towards achieving the two union 2035 reduction targets and two national 2035 reduction contributions


### a member state may reduce its national target for the use and risk of chemical plant protection products referred to in paragraph 4 to a percentage that is a mid-point between the figure related to intensity as laid down in the second subparagraph of this paragraph and the figure related to the use and risk as laid down in the third subparagraph of this paragraph. where that percentage is higher than 50% , the member state shall increase its national target to that percentage. ### a member state may reduce its national contributions for the use and risk of chemical plant protection products referred to in paragraph 4 to a percentage that is a mid-point between the figure related to intensity as laid down in the second subparagraph of this paragraph and the figure related to the use and risk as laid down in the third subparagraph of this paragraph.


### national measures for encouraging the use of non-chemical methods by professional users through financial incentives , in accordance with union legislation on state aid; ### national measures for encouraging the use of non-chemical methods and low-input farming systems by professional users through financial incentives , in accordance with union legislation on state aid;


### 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 , and ensure through binding requirements laid down in national law the reduction of the dependency on chemical plant protection products , innovation and the development and use of non-chemical pest control methods , as well as timelines for the implementation of these measures;


### 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: ### 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 authorized in accordance with article 28 of regulation (eu) 1107/2009 and at national level 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 , where an intervention is necessary to allow infrastructure managers to fulfil their legal safety obligations on corine land cover levels 1.2 and 1.3 and where non-chemical methods of vegetation control would not allow to fulfil these obligations , or provided that all of the following conditions are met:


### 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 nature and biodiversity are the foundations of food and , without strong political action to conserve and restore nature and biodiversity , including access to clean water and good conditions for pollinators , food security and the right to food will be irreversibly endangered;


### 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 nature and biodiversity are the foundations of food and , without strong political action to conserve and restore nature and biodiversity , at both european and international level , food security for all citizens and the right to food will be irreversibly endangered;


### a. whereas on 24 february 2022 the russian federation illegally invaded ukraine and , as a result , severely disrupted global food security; ### a. whereas on 24 february 2022 the russian federation illegally invaded ukraine and , as a result , severely disrupted global food security as , according to the international grains council , russia and ukraine accounted for 8.6% of global grain production , excluding rice , and 24% of exports during the 2021 harvest year;


### a. whereas on 24 february 2022 the russian federation illegally invaded ukraine and , as a result , severely disrupted global food security; ### a. whereas on 24 february 2022 the russian federation illegally invaded ukraine and , as a result , severely disrupted global food security which , nevertheless , had already been threatened before;


### a. whereas on 24 february 2022 the russian federation illegally invaded ukraine and , as a result , severely disrupted global food security; ### a. whereas on 24 february 2022 the russian federation illegally invaded ukraine and , as a result , severely disrupted global food security , with the most vulnerable countries being hardest hit;


### 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 and urgent transition to agro-ecological practices and organic farming that require less or no fertilisers to enable the european union to break the vicious circle of dependence on russian imports of especially fertilisers and fossil fuels; reiterates its full support for the european green deal and 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 which will be crucial to safeguard long-term sustainability of food production by e.g. protecting pollinators;


### 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; 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 for the entire food chain;


### 1. reaffirms the right to food as a fundamental human right; recalls sustainable development goal 2 of eradicating hunger by 2030; ### 1. reaffirms the right to food as a fundamental human right; recalls sdg 1 to end poverty in all its forms everywhere , sdg 2 to end hunger , achieve food security and improved nutrition and promote sustainable agriculture , sdg 3 to ensure healthy lives and promote well-being for all at all ages , sdg 5 to achieve gender equality and empower all women and girls , sdg 6 to ensure access to water and sanitation for all , sdg 10 to reduce inequality within and among countries , sdg 12 to ensure sustainable consumption and production patterns , sdg 13 to take urgent action to combat climate change and its impacts and sdg 17 to strengthen the means of implementation and revitalise the global partnership for sustainable development;


### 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 to link human health , animal health and environmental issues in all policies that affect the availability and accessibility of food; stresses that food safety must never be jeopardised and emphasises the importance of steering policies in a just and socioeconomically fair way towards promoting nutritional , affordable and long-term sustainably produced food in line with nature-based solutions and for proper and transparent labelling to facilitate healthy choices by the consumer;


### 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 and hence citizens’ health must never be jeopardised;


### 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 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; calls on the commission to promote plant based diets and steer up its production; 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: highlights that land used for livestock and animal feedstock production occupies nearly 80% of global agricultural land while producing less than 20% of the world’s supply of calories;


### 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 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 to the extent that consumers agree to these reductions which affect their diet and dietary habits;


### 3. notes that the european green deal could be a milestone in the eu transition to a greener and more sustainable economy , while pointing out that many of the resulting measures might have adverse effects , which have not yet been properly assessed , on eu farms and food security; calls on the commission to carry out a comprehensive assessment of the cumulative impact of green deal legislative proposals on the eu farming sector; ### 3. notes that the european green deal is a milestone in the eu transition to a greener and more sustainable economy , while pointing out the need to ensure a just and inclusive transition , promoting rural economic vitality and territorial and social cohesion , and to provide adequate support and resources to face the challenges in this regard; calls on the commission to carry out a comprehensive assessment of the cumulative impact of green deal legislative proposals on the eu farming sector covering all dimensions of sustainability: social , environmental and economic ;


### 3. notes that the european green deal could be a milestone in the eu transition to a greener and more sustainable economy , while pointing out that many of the resulting measures might have adverse effects , which have not yet been properly assessed , on eu farms and food security; calls on the commission to carry out a comprehensive assessment of the cumulative impact of green deal legislative proposals on the eu farming sector; ### 3. notes that the european green deal could be a milestone in the eu transition to a greener and more sustainable economy provided that the cap undergoes a comprehensive reform that moves away from the ‘market orientation’ approach , while pointing out that many of the resulting measures might have adverse effects , which have not yet been properly assessed , on eu farms and food security if they cause european farmers to face unfair competition from imports that do not meet our standards;


### 3. notes that the european green deal could be a milestone in the eu transition to a greener and more sustainable economy , while pointing out that many of the resulting measures might have adverse effects , which have not yet been properly assessed , on eu farms and food security; calls on the commission to carry out a comprehensive assessment of the cumulative impact of green deal legislative proposals on the eu farming sector; ### 3. notes that the european green deal is a milestone in the eu transition to a greener and more sustainable economy; calls on the commission to ensure that the mid-term evaluation of the farm-to-fork strategy reflects on the cumulative impact of green deal legislative proposals on the eu farming sector in a holistic and systemic manner , covering all dimensions of sustainability , be they environmental , economic or social , including health;


### 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 crop-based biofuel production negatively affects food security in instances where it directly competes with food production; recognises that sustainably produced biofuels , e.g. from by-products from farming could also replace fossil fuels and reduce dependency on russia and thus play a positive role to ensure food security; 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 ; regrets the biased nature of the current impact assessment and calls on the commission to restart the process in an inclusive manner; calls on the commission to properly assess the long-term practical consequences on health , biodiversity and social inclusion of approving gmos targeted at increasing resistance against pesticides;


### 6. is concerned that the resumption of ukrainian grain exports mainly benefits western feed and livestock industries instead of alleviating pressures in the global south2 ; ### 6. highlights how conflict , the climate and biodiversity crisis and the pandemic have been turning points for a previously declining world hunger , now affecting around 10% of the world population; is concerned that the resumption of ukrainian grain exports mainly benefits western feed and livestock industries instead of alleviating pressures in the global south2 ;


### 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. calls for a strategy to regionalise the supply chain of the most important commodities , including gm-free animal feed for which ukraine was previously a key source , in light of current geopolitical tensions , while also supporting food autonomy in third countries , and to ensure the supply of local and sustainable plant proteins;


### 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. calls for a strategy to regionalise the supply chain of the most important commodities and to ensure the supply of both local and sustainable traditional products , in correlation with the characteristics of each region , and also local and sustainable plant 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. considers it irresponsible that the eu continues to support environmentally harmful and cruel practices under the common agricultural policy and common fisheries policy and regrets that the €100 billion of cap funds attributed during 2014-2020 to climate action had little impact on agricultural emissions , which have not changed significantly since 20102a; calls on the commission to develop a roadmap to reduce methane emissions from the agricultural sector by 2030 in line with the global methane pledge.


### b. whereas the war against ukraine and the ensuing significant increases in input prices are leading to a significant cumulative distortion on global agricultural , fisheries and aquaculture markets , in particular on the cereals and vegetable oil markets; whereas food production and access to food must not be endangered or used as a geopolitical weapon; ### b. whereas the war against ukraine and the prior significant increases in agricultural product and input prices are leading to significant tensions on global agricultural , fisheries and aquaculture markets , in particular on the cereals and vegetable oil markets; whereas food production and access to food must not be endangered or used as a geopolitical weapon but it must be acknowledged that this has happened many times in history;


### b. whereas the war against ukraine and the ensuing significant increases in input prices are leading to a significant cumulative distortion on global agricultural , fisheries and aquaculture markets , in particular on the cereals and vegetable oil markets; whereas food production and access to food must not be endangered or used as a geopolitical weapon; ### b. whereas the war against ukraine and the significant increases in input prices resulting from the conflict are leading to a significant cumulative distortion on global agricultural , fisheries and aquaculture markets , in particular on the cereals and vegetable oil markets; whereas food production and access to food must not be endangered and must under no circumstances be used as a geopolitical weapon , as this will have an impact on economies worldwide;


### the specific rules should include the prohibition to display the safety features referred to in directive 2001/83/ec on the outer packaging or , where there is no outer packaging , on the immediate packaging of medicinal products for human use intended to be placed on the market in northern ireland and the prohibition to place on the market in northern ireland new and innovative medicinal products that have been granted a marketing authorisation in accordance with regulation (ec) no 726/2004. furthermore , the specific rules should include certain labelling requirements for medicinal products for human use intended to be placed on the market in northern ireland. as a consequence , commission delegated regulation (eu) 2016/1616 should not apply to medicinal products for human use intended to be placed on the market in northern ireland. ### the specific rules should include the prohibition to display the safety features referred to in directive 2001/83/ec on the outer packaging or , where there is no outer packaging , on the immediate packaging of medicinal products for human use intended to be placed on the market in northern ireland , with the exception of the anti-tampering device measures set out in directive 2011/62/eu which should remain in place. the specific rules should also include and the prohibition to place on the market in northern ireland new and innovative medicinal products that have been granted a marketing authorisation in accordance with regulation (ec) no 726/2004. furthermore , the specific rules should include certain labelling requirements for medicinal products for human use intended to be placed on the market in northern ireland. as a consequence , commission delegated regulation (eu) 2016/1616 should not apply to medicinal products for human use intended to be placed on the market in northern ireland.


### the safety features referred to in article 54 , point (o) , of directive 2001/83/ec shall not appear on the outer packaging or , where there is no outer packaging , on the immediate packaging of medicinal products referred to in article 1(1) of this regulation ### the safety features referred to in article 54 , point (o) with the exception of the anti-tampering device measures , of directive 2001/83/ec shall not appear on the outer packaging or , where there is no outer packaging , on the immediate packaging of medicinal products referred to in article 1(1) of this regulation


### where a medicinal product referred to in article 1(1) of this regulation bears the safety feature referred to in article 54 , point (o) , of directive 2001/83/ec , it shall be fully removed or covered. ### where a medicinal product referred to in article 1(1) of this regulation bears the safety feature referred to in article 54 , point (o) with the exception of the anti-tampering device measures , of directive 2001/83/ec , it shall be fully removed or covered.


### the qualified person referred to in article 48 of directive 2001/83/ec shall , in the case of medicinal products referred to in article 1(1) of this regulation , ensure that the safety features referred to in article 54 , point (o) , of directive 2001/83/ec have not been affixed on the packaging of the medicinal product. ### the qualified person referred to in article 48 of directive 2001/83/ec shall , in the case of medicinal products referred to in article 1(1) of this regulation , ensure that the safety features referred to in article 54 , point (o) with the exception of the anti-tampering device measures , of directive 2001/83/ec have not been affixed on the packaging of the medicinal product.


### (3) as regards article 168(4) , point (a) , tfeu , standards for the safety and quality of organs and sohos , blood and blood derivatives should ensure a high level of human health protection. therefore , this regulation aims at setting high standards by ensuring , amongst others , the protection of soho donors , taking into consideration their fundamental role in the provision of sohos and for recipients , as well as measures to monitor and support the sufficiency of the supply of sohos that are critical for the health of patients. ### (3) as regards article 168(4) , point (a) , tfeu , standards for the safety and quality of organs and sohos , blood and blood derivatives should ensure a high level of human health protection. therefore , this regulation aims at setting high safety standards by ensuring , amongst others , the protection of soho donors , taking into consideration their fundamental role in the provision of sohos and for recipients , as well as measures to monitor and support the sufficiency of the supply of sohos that are critical for the health of patients.


### (4) directives 2002/98/ec16and 2004/23/ec17of the european parliament and of the council constitute the union’s regulatory framework for blood and for tissues and cells , respectively. although these directives have harmonised to a certain degree the rules of member states in the area of safety and quality of blood , tissues and cells , they include a significant number of options and possibilities for member states to implement the rules they laid down. this results in divergences between national rules , which can create obstacles to cross-border sharing of these substances. a fundamental revision of those directives is needed for a robust , transparent , up-to-date and sustainable regulatory framework for these substances , which achieves safety and quality for all parties involved , enhances legal certainty and supports continuous supply , whilst facilitating innovation for the benefit of public health. in order to achieve a coherent application of the legal framework , it is appropriate to repeal directives 2002/98/ec and 2004/23/ec and to replace them by a regulation. ### (4) directives 2002/98/ec16and 2004/23/ec17of the european parliament and of the council constitute the union’s regulatory framework for blood and for tissues and cells , respectively. although these directives have harmonised to a certain degree the rules of member states in the area of safety and quality of blood , tissues and cells , they include a significant number of options and possibilities for member states to implement the rules they laid down. this results in divergences between national rules , which can create obstacles to cross-border sharing of these substances. a fundamental revision of those directives is needed for a robust , transparent , up-to-date and sustainable regulatory framework for these substances , which achieves safety and quality for all parties involved , enhances legal certainty and supports continuous supply , whilst facilitating innovation for the benefit of public health and cross-border cooperation. in order to achieve a coherent application of the legal framework , it is appropriate to repeal directives 2002/98/ec and 2004/23/ec and to replace them by a regulation.


### (5) directives 2002/98/ec and 2004/23/ec are highly interconnected and contain very similar provisions for oversight and equivalent principles for safety and quality in the two sectors they regulate. in addition , many authorities and operators work across these sectors. as this regulation aims to define high level principles that will be common to both the blood and of tissues and cells sectors , it would be appropriate that it replaces these directives and merges the revised provisions into one legal act. ### (5) directives 2002/98/ec and 2004/23/ec are highly interconnected and contain very similar provisions for oversight and equivalent principles for safety and quality in the two sectors they regulate. in addition , many authorities and operators work across these sectors. as this regulation aims to define high level principles that will be common to both the blood and of tissues and cells sectors , it would be appropriate that it replaces these directives and merges the revised provisions into one legal act , taking into consideration the special characteristics of each type of substance.


### (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 become products 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. the criteria that define when sohos or soho preparations become products regulated under other union legislation are not defined in this regulation but are defined in those other acts. in case of products covered by other legislation of the union , this regulation shall only apply to those parts specified on it , without prejudice to other legislation of the union.inaddition , 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. the criteria that define when sohos or soho preparations become products 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 in order to preserve all properties that ensure their compatibility with recipients , 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 become products 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.


### (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. 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 , or environmental contamination , loss of traceability or damage to the biological properties inherent to the substance , and necessary for efficacy and/or functionality in the recipient , also appear. thus , the requirements for soho establishment authorisation should apply. furthermore , in case of substances meant for autologous but non-homologous application , this regulation shall apply without prejudice to regulation (ec) no 1394/2007 on advanced therapy medicinal products.


### (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. 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 , especially following transport to other hospital units , including cross-border transport. 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 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 , issuing , 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.


### (12) sohos can also be combined with other regulated products before human application. in these circumstances , close interaction between this regulatory framework and other related frameworks is also necessary to ensure a high level of human health protection for all cases where these substances are used. ### (12) sohos can also be combined with other regulated products before human application. in these circumstances , close interaction between this regulatory framework and other related frameworks is also necessary to ensure a high level of protection when handling these products and hence human health protection for all cases where these substances are used.


### (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 when handling these products and hence 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 from undesirable short-term and long-term side-effects. 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. 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 on them 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 the possibility for donors to donate repeatedly. donations of oocytes , bone marrow , peripheral blood stem cells and frequent donation of plasma should be considered to imply a significant risk.


### (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 as soon as possible after their introduction so that the other member states can be informed accordingly. 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 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 where necessary supported by scientific evidence , and the means of achieving that aim are appropriate and necessary.


### (16) this regulation should not interfere with national legislation in the health area with objectives other than quality and safety of sohos that is compatible with union law , in particular legislation concerning ethical aspects. such aspects arise due to the human origin of the substances , which touches upon various sensitive and ethical concerns for member states and citizens , such as access to particular services that use sohos. this regulation should also not interfere with decisions of an ethical nature made by member states. such ethical decisions might concern the use , or limitation of the use , of specific types of sohos or specific uses of sohos , including reproductive cells and embryonic stem cells. when a member state allows the use of such cells , this regulation should apply in full with a view to ensuring safety and quality and to protecting human health. ### (16) this regulation should not interfere with national legislation in the health area with objectives other than quality and safety of sohos that is compatible with union law , in particular legislation concerning ethical aspects. such aspects arise due to the human origin of the substances , which touches upon various sensitive and ethical concerns for member states and citizens , such as access to particular services that use sohos. this regulation should also not interfere with decisions of an ethical nature made by member states , provided that they adhere to the charter of fundamental rights of the european union. such ethical decisions might concern the use , or limitation of the use , of specific types of sohos or specific uses of sohos , including reproductive cells and embryonic stem cells. when a member state allows the use of such cells , this regulation should apply in full with a view to ensuring safety and quality and to protecting human health.


### (17) this regulation is not meant to cover research using sohos when that research does not involve application to the human body , for example in vitro research or research in animals. however , human substances used in research involving studies where they are applied to the human body should comply with the rules laid down in this regulation. ### (17) this regulation is not meant to cover research using sohos when that research does not involve application to the human body , for example in vitro research or research in animals. however , human substances used in research involving studies where they are applied to the human body should comply with the rules laid down in this regulation , regarding clinical studies with soho.


### (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 , posingrisks 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) article 3 of the charter of fundamental rights of the european union prohibits the human body or parts of it from becoming a source of financial gain. programmes promoting the donation of sohos must 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 contributes to high safety standards for sohos and therefore to the protection of human health , and increases public trust in donation systems. 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 , financially neutralcompensation to remove any such risk is acceptable but should never produce a financial gain for the donor orconstitute an incentive that would cause a donor to be dishonest when giving their medical or behavioural history or to donate in any way that could poserisks to their own health and to that of prospective recipients.compensation and reimbursements should under no circumstances be an incentive or a claim to recruit donors , should not expose vulnerable persons in society to exploitation and should not promote competition among soho entities for the recruitment of donors. such compensation should , therefore , be set by national authorities , at a level justified andappropriate 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. 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 bioethics , 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. .


### (19) in order to maintain public trust in soho donation and use programmes , information that is given to prospective donors , recipients or physicians regarding the likely use and benefits of particular sohos or soho preparations when applied to recipients should accurately reflect reliable scientific evidence. this should ensure that donors , or their families , are not coerced to donate by exaggerated descriptions of benefits and prospective patients are not given false hopes when making decisions on their options for treatment. the verification of compliance with this regulation through supervisory activities is of fundamental importance to ensure that , across the union , the objectives of the regulation are effectively achieved. the responsibility to enforce this regulation lies with the member states , whose competent authorities should monitor and verify , through the organisation of supervisory activities , that relevant union requirements are effectively complied with and enforced. ### (19) in order to maintain public trust in soho donation and use programmes , information that is given to prospective donors , recipients or physicians regarding the likely use and benefits of particular sohos or soho preparations when applied to recipients should accurately reflect reliable scientific evidence and under no circumstances attribute or imply levels of safety or efficacy not supported by scientific methods. this should ensure that donors , or their families , are not coerced to donate by exaggerated descriptions of benefits and prospective recipients are not given false hopes when making decisions on their options for treatment. the verification of compliance with this regulation through supervisory activities is of fundamental importance to ensure that , across the union , the objectives of the regulation are effectively achieved. the responsibility to enforce this regulation lies with the member states , whose competent authorities should monitor and verify , through the organisation of supervisory activities , that relevant union requirements are effectively complied with and enforced.


### (21) for the performance of supervisory activities aimed at verifying the correct application of soho legislation , member states should designate competent authorities that act independently and impartially. it is therefore important that their function of oversight is separate and independent from the performance of soho activities. in particular , competent authorities should be free from undue political influence and from industry interference that might affect their operational impartiality. ### (21) for the performance of supervisory activities aimed at verifying the correct application of soho legislation , member states should designate competent authorities that act independently and impartially. it is therefore important that their function of oversight is separate and independent from the performance of soho activities. in particular , competent authorities should be free from undue political influence and from industry interference that might affect their operational impartiality. in order to prevent such interference , it is advisable to make any appointment within these authorities incompatible with decision-making or management positions in the industry.


### (21) for the performance of supervisory activities aimed at verifying the correct application of soho legislation , member states should designate competent authorities that act independently and impartially. it is therefore important that their function of oversight is separate and independent from the performance of soho activities. in particular , competent authorities should be free from undue political influence and from industry interference that might affect their operational impartiality. ### (21) for the performance of supervisory activities aimed at verifying the correct application of soho legislation , member states should designate competent authorities that act independently and impartially. it is therefore important that their function of oversight is separate and independent from the performance of soho activities. in particular , competent authorities should be free from undue political influence and from industry or other actors’ interference that might affect their operational impartiality.


### (23) the correct application and enforcement of the rules falling within the scope of this regulation require an appropriate knowledge of those rules. it is therefore important that the staff performing supervisory activities have an appropriate professional background and are regularly trained , in accordance with their area of competence , on the obligations resulting from this regulation. ### (23) the correct application and enforcement of the rules falling within the scope of this regulation require an appropriate knowledge of those rules. it is therefore important that the staff performing supervisory activities have an appropriate professional background and are regularly trained , in accordance with their area of competence , on the obligations resulting from this regulation , in order to make informed decisions and to be able to provide the target public with the correct information.


### (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 the clasification advisory council , defined in this regulation and composed by representatives of the relevant authorities responsible for other relevant regulatory frameworks , namely medicinal products , advanced therapies , medical devices and the soho coordination board , with the aim of ensuring coherent procedures for the application of this regulation. 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 , at the duly substantiated request of a member state or the classification advisory council , 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. 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. 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 informed sufficiently early to be able to decide , on its own initiative or at the duly substantiated request of a member state , on the regulatory status of a particular substance , product or activity under this regulation.