### 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 equally for basin-wide surveys to allow comparisons on marine litter composition and accumulation within and between countries;


### — having regard to the publication of the scientific , technical and economic committee for fisheries (stecf) of 20 august 2019 entitled ‘the 2019 annual economic report on the eu fishing fleet’ , ### — having regard to the publication of the scientific , technical and economic committee for fisheries (stecf) of 10 november 2021 entitled ‘the 2021 annual economic report on the eu fishing fleet’ ,


### — having regard to recital four of regulation (eu) no 1380/2013 of the european parliament and of the council of 11 december 2013 on the common fisheries policy1 (cfp) , which states that the cfp should contribute to ‘a fair standard of living for the fisheries sector including small-scale fisheries’ , ### — having regard to recital four of regulation (eu) no 1380/2013 of the european parliament and of the council of 11 december 2013 on the common fisheries policy1 (cfp) , which states that the cfp should contribute to 'long-term environmental , economic , and social sustainability' and to ‘a fair standard of living for the fisheries sector including small-scale fisheries’ ,


### a. whereas in 2018 the eu member states’ small-scale fisheries sector consisted in a fleet of 44702 vessels , accounting for 76% of the eu’s active fishing ships and 50% of its crew but only 8% of gross tonnage and 5% of landings , employing 67 760 fishers; ### a. whereas in 2019 the eu member states’ small-scale fisheries sector consisted in a fleet of 42838 vessels , accounting for 58% of the eu’s active fishing ships and 48% of its crew but only 7.5% of gross tonnage and 5.4% of landings , employing 62 650 fishers;


### b. whereas due account needs to be taken of the marked differences between fleets , fleet segments , target species , fishing gear , productivity , consumption preferences and the amount of fish consumed per inhabitant in the various eu member states; ### b. whereas due account needs to be taken of the marked differences between fleets , fleet segments , the environmental impact of different fleet segments , target species , fishing gear , productivity , consumption preferences and the amount of fish consumed per inhabitant in the various eu member states;


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


### 1. supports the just transition to agro-ecological and organic farming; reiterates its support for the ambitions , targets and goals of the farm to fork , biodiversity and zero-pollution strategies; welcomes their published and announced legislative proposals , including those related to the reduction in the use of pesticides and their associated risks and the setting of eu food waste reduction targets; ### 1. welcomes the commission’s comprehensive analysis of the drivers of food security; underlines its conclusions pointing at the urgency of transitioning to a sustainable food system capable of ensuring food security in both the short- and long-term; supports , therefore , the just transition to agro-ecological and organic farming as well as agroforestry; reiterates its support for the ambitions , targets and goals of the farm to fork , biodiversity and zero-pollution strategies;


### 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; notes the findings from the commission’s analysis of food security drivers that shifting towards more plant-based diets can contribute to global food security while being associated with a range of health and environmental benefits; stresses the need for rebalancing the proportion of eu land used for production of animal feed with that for producing human food; 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. 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 a comprehensive assessment of 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 large-scale intensive biofuel production negatively affects food security , biodiversity , soil health and market stability; denounces , moreover , the focus on short-term policy measures for example , on fertilisers;


### 5. reiterates its position on new genomic breeding techniques1 ; regrets the biased nature of the current impact assessment and calls on the commission to restart the process in an inclusive manner; ### 5. reiterates its position on new genomic breeding techniques1; regrets the biased nature of the current impact assessment and calls on the commission to restart the process in an inclusive manner , notably to fully take into account the impact of changes in the legal framework on the non-gmo farming and food sectors , and the impact of the enforcement of patents and intellectual property rights on the breeding sector; underscores that any new legal framework should allow the possibility of co-existence between farmers , including through the implementation of a mandatory traceability all along the production chain; notes that efsa opinions and statements on plants derived from ngts were a matter of dispute with several experts demanding to put more weight on the risks caused by the unintended effects resulting from the processes of ngts;


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


### 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 local and sustainable plant proteins primarily for human consumption;


### — having regard to the voluntary guidelines of the committee on world food security (cfs) on the responsible governance of tenure of land , fisheries and forests in the context of national food security (2012) and the cfs principles for responsible investment in agriculture and food systems (2015) , ### — having regard to the voluntary guidelines of the committee on world food security (cfs) on the responsible governance of tenure of land , fisheries and forests in the context of national food security (2012) , the cfs principles for responsible investment in agriculture and food systems (2015) , and the cfs voluntary guidelines on food systems and nutrition (2021) ,


### 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 ensuing significant increases in input prices and speculation 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; whereas , however , the commission has repeatedly confirmed that food availability has not decreased in the eu , and that the eu’s grain exports have even increased;


### (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. in that regard , when selecting soho donors , member states should use individual risk-based questions.


### (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 necessaryto 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) 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. donor recruitment campaigns should never refer to compensation to avoid risk of incentivising donations. 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 acceptableto 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 based on quantifiable and transparent criteriaset by national authorities , at a level appropriate in their member state to reach the principle of financial neutrality. any compensation regime should not serve as an inducement to donate nor lead to inappropriate financially-driven competition , including cross-border competition , between soho establishments and entities over donor recruitment.


### (20) competent authorities should be designated by the member states for all the areas that fall within the scope of this regulation. while member states are best placed to identify the competent authority or authorities for each area , for example by geography , topic or substance , they should also be required to designate a single national authority that ensures appropriately coordinated communication with other member states’ competent authorities and with the commission. the soho national authority should be considered the same as the designated competent authority in member states where only one competent authority is designated. ### (20) competent authorities should be designated by the member states for all the areas that fall within the scope of this regulation. while member states are best placed to identify the competent authority or authorities for each area , for example by geography , topic or substance , they should also be required to designate a single national authority that ensures appropriately coordinated communication with other member states’ competent authorities and with the commission. the soho national authority should be considered the same as the designated competent authority in member states where only one competent authority is designated. the list of all soho competent national authorities should be made publicly available.


### (28) with regard to soho preparations that pose a certain level of risk (low , moderate or high) , the applicant should propose a plan for clinical outcome monitoring that should fulfil different requirements appropriate to the risk indicated. the most up-to-date guidance of the european directorate for the quality of medicines & healthcare (edqm , a directorate of the council of europe) should be considered relevant in the design of clinical follow-up studies proportionate in extent and complexity to the identified level of risk of the soho preparation. in the case of low risk , in addition to the mandatory continuous vigilance reporting , the applicant should organise proactive clinical follow-up for a defined number of patients. for moderate and high risk , in addition to the mandatory vigilance reporting and the clinical follow-up , the applicant should propose clinical investigation studies with monitoring of pre-defined clinical end-points. in case of high risk , these should include a comparison with standard treatments , ideally in a study with subjects allocated to test and control groups in a randomised manner. the competent authority should approve the plans before they are implemented and should assess the outcome data as part of a soho preparation authorisation. ### (28) applicants requesting an authorisation of soho preparation should use the euro gtp ii methodologies or equivalent tools to assess the risk level of their soho preparation. applicants should share the results of the risk assessments with competent authorities when requesting authorisation. with regard to soho preparations that pose a certain level of risk (low , moderate or high) , the applicant should propose a plan for clinical outcome monitoring that should fulfil different requirements appropriate to the risk indicated. the most up-to-date guidance of the european directorate for the quality of medicines & healthcare (edqm , a directorate of the council of europe) should be considered relevant in the design of clinical follow-up studies proportionate in extent and complexity to the identified level of risk of the soho preparation. in the case of low risk , in addition to the mandatory continuous vigilance reporting , the applicant should organise proactive clinical follow-up for a defined number of patients. for moderate and high risk , in addition to the mandatory vigilance reporting and the clinical follow-up , the applicant should propose clinical investigation studies with monitoring of pre-defined clinical end-points. in case of high risk , these should include a comparison with standard treatments , ideally in a study with subjects allocated to test and control groups in a randomised manner. the competent authority should approve the plans before they are implemented and should assess the outcome data as part of a soho preparation authorisation.


### (35) the edqm is a structural part of the council of europe working under the european pharmacopoeia partial agreement. the text of the convention on the elaboration of a european pharmacopoeia (ets no. 050) , accepted by council decision 94/358/ec26 , is considered to be the text of the european pharmacopoeia partial agreement. member states of the council of europe that have signed and ratified the european pharmacopoeia convention are the member states of the european pharmacopoeia partial agreement and are therefore the members of the intergovernmental bodies functioning within the framework of this partial agreement , including among others: the european pharmacopoeia commission , the european committee on organ transplantation (cd-p-to) , the european committee on blood transfusion (cd-p-ts) and the european committee on pharmaceuticals and pharmaceutical care (cd-p-ph). the european pharmacopoeia convention has been signed and ratified by the european union and all its member states , all of whom are represented in their intergovernmental bodies. in this context , the work of the edqm on developing and updating guidelines on safety and quality of blood , tissues and cells , should be considered an important contribution to the field of sohos in the union and should be reflected in this regulation. the guidelines address issues of quality and safety beyond the risks of communicable disease transmission , such as donor eligibility criteria for the prevention of the transmission of cancer and other non-communicable diseases and the assurance of safety and quality during collection , processing , storage and distribution. it should therefore be possible to use those guidelines as one of the means to implement the technical standards provided for in this regulation. ### (35) the edqm is a structural part of the council of europe working under the european pharmacopoeia partial agreement. the text of the convention on the elaboration of a european pharmacopoeia (ets no. 050) , accepted by council decision 94/358/ec26 , is considered to be the text of the european pharmacopoeia partial agreement. member states of the council of europe that have signed and ratified the european pharmacopoeia convention are the member states of the european pharmacopoeia partial agreement and are therefore the members of the intergovernmental bodies functioning within the framework of this partial agreement , including among others: the european pharmacopoeia commission , the european committee on organ transplantation (cd-p-to) , the european committee on blood transfusion (cd-p-ts) and the european committee on pharmaceuticals and pharmaceutical care (cd-p-ph). the european pharmacopoeia convention has been signed and ratified by the european union and all its member states , all of whom are represented in their intergovernmental bodies. in this context , the work of the edqm on developing and updating guidelines on safety and quality of blood , tissues and cells , should be considered an important contribution to the field of sohos in the union and should be reflected in this regulation. the guidelines address issues of quality and safety beyond the risks of communicable disease transmission , such as donor eligibility criteria for the prevention of the transmission of cancer and other non-communicable diseases and the assurance of safety and quality during collection , processing , storage and distribution. it should therefore be possible to use those guidelines as one of the means to implement the technical standards provided for in this regulation. in order to ensure impartiality and independence , and safeguard public interest , the commission should establish a memorandum of understanding with the edqm related to transparency of membership and outputs and conflict of interest rules for experts and stakeholders involved in drafting edqm guidelines.


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


### (38) in order to promote a coordinated application of this regulation , a soho coordination board (scb) should be set up. the commission should participate in its activities and chair it. the scb should contribute to a coordinating the application of this regulation throughout the union , including by helping member states to conduct soho supervisory activities. the scb should be composed of persons designated by the member states based on their role and expertise in their competent authorities , and should also involve experts that are not working for competent authorities , for specific tasks where access to necessary in-depth technical expertise in the field of sohos is required. in the latter case , appropriate consideration should be given to the possibility of involving european expert bodies such as the ecdc and the edqm and existing professional , scientific and donor and patient representative groups at union level in the field of sohos. ### (38) in order to promote a coordinated application of this regulation , a soho coordination board (scb) should be set up. the commission should participate in its activities and chair it. the scb should contribute to a coordinating the application of this regulation throughout the union , including by helping member states to conduct soho supervisory activities. the scb should be composed of persons designated by the member states based on their role and expertise in their competent authorities , and should also involve experts that are not working for competent authorities , for specific tasks where access to necessary in-depth technical expertise in the field of sohos is required. in the latter case , appropriate consideration should be given to the possibility of involving european expert bodies such as the ecdc and the edqm and existing professional , scientific and donor and patient representative groups at union level in the field of sohos. the scb should adhere to high degree of transparency of its outputs and all it members , observers and experts should act independently , in the public interest and be free from any external influence that might affect the impartiality of their professional conduct.


### (41) in order to limit administrative burden on competent authorities and the commission , the latter should establish an online platform (the ‘eu soho platform’) to facilitate timely submission of data and reports as well as improved transparency of national reporting and supervisory activities. ### (41) in order to limit administrative burden on competent authorities and the commission , the latter should establish an online platform (the ‘eu soho platform’) to facilitate timely submission of data and reports as well as improved transparency of national reporting and supervisory activities. the eu soho platform should also serve as a reliable source of information for the general public regarding the work of the soho coordination board , national competent authorities and other expert bodies , including the edqm , and soho entities and establishments.


### (43) as the eu soho platform requires the processing of personal data , it will be designed respecting the principles of data protection. any processing of personal data should be limited to achieving the objectives and obligations of this regulation. access to the eu soho platform should be limited to the extent necessary to carry out supervisory activities provided for in this regulation. ### (43) as the eu soho platform requires the processing of personal data , it will be designed respecting the principles of data protection laid down in article 5 of regulation (eu) 2016/679. any processing of personal data should be limited to achieving the objectives and obligations of this regulation. access to the eu soho platform should be limited to the extent necessary to carry out supervisory activities provided for in this regulation.


### (44) this regulation respects the fundamental rights and observes the principles recognised in particular by the charter of fundamental rights of the european union and in particular human dignity , the integrity of the person , the protection of personal data , the freedom of art and science and to conduct business , non-discrimination , the right to health protection and access to health care , and the rights of the child. to achieve these aims , all supervisory and soho activities should always be carried out in a manner that fully respects those rights and principles. the right for dignity and integrity of donors , recipients and of offspring born from medically assisted reproduction should always be taken into account , amongst others , by ensuring that consent for donation is freely given and donors or their representatives are informed with regards to the intended use of the donated material , that donor eligibility criteria are based on scientific evidence , that the use of sohos in humans is not promoted for commercial purposes or with false or misleading information regarding efficacy so that the donors and recipients can make well-informed and deliberate choices , that activities are conducted in a transparent manner that prioritises the safety of donors and recipients , and that allocation and equitable access to sohos are defined in a transparent manner , on the basis of an objective evaluation of medical needs. this regulation should therefore be applied accordingly. ### (44) this regulation respects the fundamental rights and observes the principles recognised in particular by the charter of fundamental rights of the european union and in particular human dignity , the integrity of the person and the prohibition of making the human body and its parts as such a source of financial gain the protection of natural persons with regard to the processing of their personal data , the freedom of art and science and to conduct business , non-discrimination , the right to health protection and access to health care , and the rights of the child. to achieve these aims , all supervisory and soho activities should always be carried out in a manner that fully respects those rights and principles. the right for dignity and integrity of donors , recipients and of offspring born from medically assisted reproduction should always be taken into account , amongst others , by ensuring that consent for donation is freely given and donors or their representatives are informed with regards to the intended use of the donated material , that donor eligibility criteria are based on scientific evidence , that the use of sohos in humans is not promoted for commercial purposes or with false or misleading information regarding efficacy so that the donors and recipients can make well-informed and deliberate choices , that activities are conducted in a transparent manner that prioritises the safety of donors and recipients , and that allocation and equitable access to sohos are defined in a transparent manner , on the basis of an objective evaluation of medical needs. this regulation should therefore be applied accordingly.


### (45) sohos , by definition , relate to persons , and there are circumstances where the processing of personal data relating to donors and recipients may be necessary to achieve the objectives and requirements of this regulation , especially provisions relating to vigilance and communication between competent authorities. this regulation should provide a legal basis under article 6 and , where relevant , fulfil the conditions under article 9(2) , point (i) , of regulation (eu) 2016/679 for processing of such personal data. with respect to personal data processed by the commission , this regulation should provide a legal basis under article 5 and , where relevant , fulfil the conditions under article 10(2) , point (i) , of regulation (eu) 2018/1725. data on safety and efficacy of new soho preparations in recipients should also be shared , with appropriate protective measures , to allow aggregation at union level for more robust evidence gathering on the clinical efficacy of soho preparations. for all data processing , such processing should be necessary and appropriate with a view to ensuring compliance with this regulation in order to protect human health. data on donors , recipients and offspring should hence be limited to the minimum necessary and pseudonymised. donors , recipients and offspring should be informed of the processing of their personal data in line with the requirements of regulations (eu) 2016/679 and (eu) 2018/1725 , and in particular as provided for under this regulation , including the possibility of exceptional cases where circumstances require such processing. ### (45) sohos , by definition , relate to natural persons , and there are circumstances where the processing of personal data relating to donors and recipients may be necessary to achieve the objectives and requirements of this regulation , especially provisions relating to vigilance and communication between competent authorities. this regulation should provide a legal basis under article 6 and , where relevant , fulfil the conditions under article 9(2) , point (i) , of regulation (eu) 2016/679 for processing of such personal data. with respect to personal data processed by the commission , this regulation should provide a legal basis under article 5 and , where relevant , fulfil the conditions under article 10(2) , point (i) , of regulation (eu) 2018/1725. data on safety and efficacy of new soho preparations in recipients should also be shared , with appropriate protective measures , to allow aggregation at union level for more robust evidence gathering on the clinical efficacy of soho preparations. for all data processing , such processing should be necessary and appropriate with a view to ensuring compliance with this regulation in order to protect human health. data on donors , recipients and offspring should hence be limited to the minimum necessary and pseudonymised. donors , recipients and offspring should be informed of the processing of their personal data in line with the requirements of regulations (eu) 2016/679 and (eu) 2018/1725 , and in particular as provided for under this regulation , including the possibility of exceptional cases where circumstances require such processing.


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


### (9) ‘soho recipient’ means the person to whom sohos are applied; ### (9) ‘soho recipient’ means the person to whom sohos are applied or such an application is envisaged;


### (11) ‘offspring from medically assisted reproduction’ means fetuses and children that are born following medically assisted reproduction; ### (11) ‘offspring from medically assisted reproduction’ means children that are born following medically assisted reproduction;


### (47) ‘traceability’ means the ability to locate and identify sohos during any step from collection through processing and storage to distribution or disposal , including the ability to: ### (47) ‘traceability’ means the ability to locate and identify sohos during any step from collection through processing and storage to human application or disposal , including the ability to:


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


### (63) ‘within couple use’ means use of reproductive cells for medically assisted reproduction from two persons with an intimate physical relationship , where one person supplies their own oocytes and the other person supplies their own sperm; ### (63) ‘within couple use’ means use of reproductive cells for medically assisted reproduction from two persons with an intimate physical relationship (‘partners’) , where one person supplies their own oocytes and the other person supplies their own sperm;


### (64) ‘compensation’ means making good of any losses associated with donation; ### (64) ‘compensation’ means making good of quantifiable losses associated with donation; such compensation shall respect the principle of financial neutrality and not be intended as an incentive to donate;


### 4. each member state shall designate a single soho national authority , in conformity with member states’ constitutional requirements , responsible for coordinating exchanges with the commission and with other member states’ soho national authorities. ### 4. each member state shall designate a single soho national authority , in conformity with member states’ constitutional requirements , responsible for coordinating exchanges with the commission and with other member states’ soho national authorities. the commission shall make publicly available the list of soho national authorities on the eu soho platform.


### 2. competent authorities shall ensure that their personnel have no direct or indirect economic , financial or personal interest that might be considered prejudicial to their independence and , in particular , that they are not in a situation that may , directly or indirectly , affect the impartiality of their professional conduct. ### 2. competent authorities shall ensure that their personnel have no direct or indirect economic , financial or personal interest that might be considered prejudicial to their independence and , in particular , that they are not in a situation that may , directly or indirectly , affect the impartiality of their professional conduct. all relevant personnel shall make an annual declaration of their interests , which shall be published on the authorities’ web-portal.


### the competent authorities may also indicate that they consider there is a need that the scb consults , in accordance with article 68(1) , point (b) , with the equivalent advisory bodies established in other relevant union legislation referred to in article 2(3). ### the scb shall consult , in accordance with article 68(1) , point (b) , with the equivalent advisory bodies established in other relevant union legislation referred to in article 2(3).


### the commission may , upon a duly substantiated request of a member state following the consultation referred to in paragraph 1 , or on its own initiative , by means of implementing acts , determine the regulatory status of a substance , product or activity under this regulation , in case questions arise in that respect , notably when these questions cannot be resolved at the member state level , or in discussions between the scb and the advisory bodies established in other relevant union legislation , in accordance with article 68(1) , point (b). ### the commission may , upon a duly substantiated request of a member state following the consultation referred to in paragraphs 1 and 2 , or on its own initiative after a consultation with the scb and relevant advisory bodies established under union legislation referred to in article 2(3) , by means of implementing acts , determine the regulatory status of a substance , product or activity under this regulation , in case questions arise in that respect , notably when these questions cannot be resolved at the member state level , or in discussions between the scb and the advisory bodies established in other relevant union legislation , in accordance with article 68(1) , point (b).


### the commission may , by means of implementing acts , lay down rules concerning procedures for consultation referred to in paragraph 1 and cooperation referred to in paragraph 5 by the competent authorities when they consult the authorities established in other relevant union legislation referred to in article 2(3). ### the commission may , by means of delegated acts , lay down rules concerning procedures for consultation referred to in paragraph 1 and cooperation referred to in paragraph 5 by the competent authorities when they consult the authorities established in other relevant union legislation referred to in article 2(3).


### those implementing acts shall be adopted in accordance with the examination procedure referred to in article 79(2). ### those delegated acts shall be adopted in accordance with the procedure laid down in article 77.


### have , or have access to , a sufficient number of personnel so that soho supervisory activities can be performed efficiently and effectively; ### have , or have access to , a sufficient number of personnel so that soho supervisory activities can be performed efficiently and effectively; the declarations shall be made publicly available on the authorities’ web-portal;


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


### that this non-compliance , or suspected non-compliance , implies a risk to the safety of recipients or offspring from medically assisted reproduction. ### that this non-compliance , or suspected non-compliance , implies a risk to the safety of soho donors , recipients or offspring from medically assisted reproduction.


### the inspection techniques and procedures to be followed , including practical exercises; ### the inspection techniques and procedures to be followed , including practical exercises and conflict of interest rules;


### 4. soho entities shall submit to the eu soho platform an annual summary of the data collected pursuant to this article. in cases where national or international registries collect activity data meeting the criteria defined in the soho platform and such registries have been verified by competent authorities as having in place data quality management procedures that ensure accuracy and completeness of data , soho entities may delegate the submission of the activity data referred to in this article to such registries. the commission shall aggregate the annual summaries of the soho entities , prepare and publish an annual soho activity report. ### 4. soho entities shall submit to the eu soho platform an annual summary of the data collected pursuant to this article. in cases where national or international registries collect activity data meeting the criteria defined in the soho platform and such registries have been verified by competent authorities as having in place data quality management procedures that ensure accuracy and completeness of data , soho entities may delegate the submission of the activity data referred to in this article to such registries. national competent authorities shall ensure all data from national registries are submitted to the eu soho platform in accordance with article 18(4). the commission shall aggregate the annual summaries of the soho entities , prepare and publish an annual soho activity report.


### does not reveal the identity of the donor; ### does not directly reveal the identity of the donor;


### investigation of suspected adverse occurrences in soho donors and recipients; ### investigation of suspected adverse occurrences in soho donors , recipients and , where relevant , offspring from medically assisted reproduction;


### 3. by derogation from paragraph 2 , in the case of soho entities that are authorised as soho establishments in accordance with article 25(3) , the physician shall be responsible for those tasks that are relevant to the soho activities performed by the soho entities and that have a direct influence on the health of soho donors and recipients. ### 3. by derogation from paragraph 2 , in the case of soho entities that are authorised as soho establishments in accordance with article 25(3) , the physician shall be responsible for those tasks that are relevant to the soho activities performed by the soho entities and that have a direct influence on the health of soho donors , recipients , and , where relevant , offspring from medically assisted reproduction.


### 3. soho entities that collect sohos from donors that are subjected to a surgical procedure in order to donate , that are treated with hormones to facilitate donation , or that donate on a frequent and repeated basis , shall register such donors and the results of their donor health evaluations in a cross-entity registry that allows interconnection with other such registries , as referred to in paragraph 1 , point (j). soho entities that manage such registries shall ensure interconnectivity between them. ### 3. soho entities that collect sohos from donors that are subjected to a surgical procedure in order to donate , that are treated with hormones to facilitate donation , or that donate sohos that can be donated on a frequent and repeated basis , shall register such donors and the results of their donor health evaluations in a cross-entity registry that allows interconnection with other such registries , as referred to in paragraph 1 , point (j). soho entities that manage such registries shall ensure interconnectivity between them.


### 2. member states may allow for the compensation or reimbursement from the soho entities to donors for losses related to their participation in donations through fixed rate allowances. in such case , member states shall establish the conditions for such allowances in national legislation , including the setting of an upper limit that ensures that allowances are financially neutral and consistent with the standards laid down in this article. they may delegate the setting of conditions for such allowances to independent bodies that are established in accordance with national legislation. ### 2. member states may allow for the compensation or reimbursement from the soho entities to donors for losses related to their participation in donations through fixed rate allowances. in such case , member states shall establish the conditions for such allowances in national legislation , including the setting of an upper limit and transparent criteria based on quantifiable elements that ensures that allowances are financially neutral and consistent with the standards laid down in this article. they may delegate the setting of conditions for such allowances to independent bodies that are established in accordance with national legislation.


### 3. soho entities may compensate or reimburse donors as provided for by their competent authorities pursuant to paragraph 2. ### 3. soho entities may compensate or reimburse donors as provided for by their competent authorities pursuant to paragraph 2. any compensation or reimbursement must never serve as an inducement to donate.


### 55 standards concerning information to be provided prior to consent or authorisation ### 55 standards concerning information to be provided prior to consent or authorisation to donate sohos


### when the commission deems it necessary to provide binding rules on the implementation of a particular standard or element of a standard referred to in articles 53 , 54 or 55 , in order to ensure convergent and high levels of donor safety , the commission may adopt implementing acts describing particular procedures to be followed and applied to meet such standard , or element thereof. ### when the commission deems it necessary to provide binding rules on the implementation of a particular standard or element of a standard referred to in articles 53 , 54 or 55 , in order to ensure convergent and high levels of donor safety , the commission may adopt delegated acts describing particular procedures to be followed and applied to meet such standard , or element thereof.


### those implementing acts shall be adopted in accordance with the examination procedure referred to in article 79(2). ### those delegated acts shall be adopted in accordance with the examination procedure referred to in article 77.


### 3. in order to apply the standards concerning donor protection or elements thereof , referred to in articles 53 , 54 and 55 , soho entities shall follow the procedures laid down in any implementing act adopted in accordance with paragraphs 1 and 2 of this article. ### 3. in order to apply the standards concerning donor protection or elements thereof , referred to in articles 53 , 54 and 55 , soho entities shall follow the procedures laid down in any delegated and implementing act adopted in accordance with paragraphs 1 and 2 of this article.


### soho entities shall protect the health of soho recipients and offspring from medically assisted reproduction from risks posed by soho preparations. they shall do so by identifying , minimising or eliminating those risks. ### soho entities shall protect the health of soho recipients and offspring from medically assisted reproduction from risks posed by soho preparations and their application. they shall do so by identifying , minimising or eliminating those risks.


### 1. soho entities shall establish procedures with measures , and , where necessary , combinations of measures , that ensure high levels of safety and quality and demonstrate benefits for soho recipients and offspring from medically assisted reproduction that outweigh any risks. they shall , in particular , achieve a high level of assurance that pathogens , toxins or genetic conditions are not transmitted to recipients or offspring from medically assisted reproduction. ### 1. soho entities shall , based on latest technical guidelines from the edqm and the ecdc , establish procedures with measures , and , where necessary , combinations of measures , that ensure high levels of safety and quality and demonstrate benefits for soho recipients and offspring from medically assisted reproduction that outweigh any risks. they shall , in particular , achieve a high level of assurance that pathogens , toxins or genetic conditions are not transmitted to recipients or offspring from medically assisted reproduction.


### testing of donors for communicable diseases using certified and validated testing methods; ### testing of donors for communicable diseases using certified and validated testing methods or other methods deemed adequate by edqm and ecdc guidelines;


### when feasible , using processing technologies that reduce or eliminate any potential communicable pathogens. ### when feasible and deemed appropriate by the relevant technical guidelines , using processing technologies that reduce or eliminate any potential communicable pathogens.


### 2. member states shall make all reasonable efforts to promote public participation in soho donation activities , in particular for critical sohos , with a view to ensuring a resilient supply and responsive increases in donation rates when risks of shortage are detected. in so doing , they shall encourage the collection of soho with a strong public and non-profit sector involvement. ### 2. member states shall make all reasonable efforts , in line with voluntary unpaid principle established in this regulation , to promote public participation in soho donation activities , in particular for critical sohos , with a view to ensuring a resilient supply and responsive increases in donation rates when risks of shortage are detected. in so doing , they shall encourage the collection of soho with a strong public and non-profit sector involvement.


### 6. member states shall review regularly their national soho emergency plans to take into account changes in the organisation of competent authorities and experience gained from implementing the plans and simulation exercises. ### 6. member states shall review regularly their national soho emergency plans to take into account changes in the organisation of competent authorities and experience gained from implementing the plans and simulation exercises. member states shall inform without delay the commission and the scb of any substantial revision of the national plans.


### the commission may adopt implementing acts describing: ### the commission may adopt delegated acts describing:


### the role of stakeholders and the supportive role of the ecdc in the establishment and operation of national soho emergency plans. ### the role of stakeholders and the supportive role of the ecdc and the edqm in the establishment and operation of national soho emergency plans.


### 3. the soho national authorities may submit to the eu soho platform the soho supply alert received in cases where the supply interruption might affect other member states or where such interruption might be addressed through cooperation between member states pursuant to article 62(3) , point (d). ### 3. the soho national authorities shall without undue delay submit to the eu soho platform the soho supply alert received.


### member states may take additional measures to the ones set out in their national soho emergency plans to ensure critical sohos supply in case of shortages on their territory , on a case-by-case basis. member states taking such measures shall inform the other member states and the commission without undue delay and give reasons for the measures taken. ### member states may take additional measures to the ones set out in their national soho emergency plans to ensure critical sohos supply in case of shortages on their territory , on a case-by-case basis. member states taking such measures shall inform the other member states , the scb and the commission without undue delay and give reasons for the measures taken.


### 3. member states shall submit the names and affiliation of their nominated members to the commission , who shall publish the membership list in the eu soho platform. ### 3. member states shall submit the names and affiliation of their nominated members to the commission , who shall make the membership list publicly available in the eu soho platform.


### the rules for declarations regarding conflict of interests of invited experts; ### the rules for declarations regarding conflict of interests of scb members , alternates , observers and invited experts;


### the commission shall , by means of implementing acts , adopt the necessary measures for the establishment , management and functioning of the scb. ### the commission shall , by means of delegated acts , adopt the necessary measures for the establishment , management and functioning of the scb.


### the commission shall establish and maintain cooperation with the edqm in relation to the guidelines published by the edqm. ### the commission shall establish and maintain cooperation with the edqm in relation to the guidelines published by the edqm. in order to ensure impartiality and independence and safeguard public interest , the commission shall establish a memorandum of understanding with the edqm related to high standards of transparency of membership and outputs and conflict of interest rules for experts and stakeholders involved in drafting of edqm guidelines. the commission shall make publicly available in the eu soho platform a list of all members , experts and stakeholders involved in edqm committees and their conflict of interest declarations.


### 1. the commission shall establish , manage and maintain the eu soho platform to facilitate effective and efficient exchange of information concerning soho activities in the union , as provided for in this regulation. ### 1. the commission shall establish , manage and maintain the eu soho platform to facilitate effective and efficient exchange of information concerning soho activities and supply of critical sohos in the union , as provided for in this regulation.


### the commission shall adopt implementing acts laying down technical specifications for the eu soho platform , including its functions , the roles and responsibilities of each of the parties listed in paragraph 1 , the retention periods for personal data and the technical and organisational measures to ensure the safety and security of personal data processed. ### the commission shall adopt delegated acts laying down technical specifications for the eu soho platform , including its functions , the roles and responsibilities of each of the parties listed in paragraph 1 , the retention periods for personal data and the technical and organisational measures to ensure the safety and security of personal data processed.


### those implementing acts shall be adopted in accordance with the examination procedure referred to in article 79(2). ### those delegated acts shall be adopted in accordance with the examination procedure referred to in article 77.


### 1. unless otherwise provided for in this regulation or in national legislation on confidentiality , and without prejudice to regulation (ec) no 1049/2001 of the european parliament and of the council33 , each party involved in the application of this regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following: ### 1. unless otherwise provided for in this regulation , and without prejudice to regulation (ec) no 1049/2001 of the european parliament and of the council33 , each party involved in the application of this regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following:


### personal data in accordance with article 76; ### natural persons with regard to the processing of personal data in accordance with article 76;


### 3. paragraphs 1 and 2 shall not affect the rights and obligations of the commission , member states and competent authorities with regard to the exchange of information and the dissemination of alerts , nor the obligations of persons to provide information under national criminal law. ### 3. paragraphs 1 and 2 shall not affect the rights and obligations of the commission , member states and competent authorities with regard to the exchange of information and the dissemination of alerts , nor the obligations of persons to provide information under national criminal law or other applicable law , including on access to information.


### 5. competent authorities may publish or make otherwise available to the public the outcome of soho supervisory activities regarding individual soho entities provided that the following conditions are met: ### 5. competent authorities shall publish or make otherwise available to the public the outcome of soho supervisory activities regarding individual soho entities provided that the following conditions are met:


### the information or data made available to the public does not unnecessarily undermine the protection of commercial interests of a soho entity or any other natural or legal person; ### the information or data made available to the public does not disproportionately undermine the protection of commercial interests of a soho entity;


### 3. personal data , including data concerning health , required for the application of articles 35 , 36 , 41 and 47 , article 53(1) , points (f) and (g) , article 53(3) , and article 58(11) , (13) and (14) , shall only be processed for the purpose of ensuring safety and quality of sohos and protecting the concerned soho donors , soho recipients and offspring from medically assisted reproduction. those data shall be directly related to the performance of the supervisory activities and soho activities concerned and be limited to the extent necessary and proportionate for that purpose. ### 3. personal data , including data concerning health , required for the application of articles 35 , 36 , 41 and 47 , article 53(1) , points (f) and (g) , article 53(3) , and article 58(11) , (13) and (14) , shall only be processed for the purpose of ensuring safety and quality of sohos and protecting the concerned soho donors , soho recipients and offspring from medically assisted reproduction. those data shall be directly related to the performance of the supervisory activities and soho activities concerned and be limited to the extent necessary and proportionate for that purpose. the commission shall adopt implementing acts laying down categories of personal data necessary to fulfilling the above listed obligations.


### 6. in relation to their responsibilities to process personal data to comply with the obligations of this regulation , the soho entities and competent authorities of the member states shall be regarded as controllers as defined in article 4 , point (7) , of regulation (eu) 2016/679 and they are bound by the rules of that regulation. ### 6. in relation to their responsibilities to process personal data to comply with the obligations of this regulation , the soho entities and competent authorities of the member states shall be regarded as controllers as defined in article 4 , point (7) , of regulation (eu) 2016/679 and they are bound by the rules of that regulation. the same provisions shall apply to any third party contracted by a soho entity for the processing of personal data , who shall be considered a processor as defined in article 4 , point (8) of the gdpr.


### 2. the power to adopt delegated acts referred to in articles 28(10) , 42(3) , 53(6) , 58(15) , 69(6) , 73(4) , and 76(8) shall be conferred on the commission for an indeterminate period of time from … [op please insert the date = date of entry into force of this regulation]. ### 2. the power to adopt delegated acts referred to in articles 14(7) , 28(10) , 42(3) , 53(6) , 56(1) , 58(15) , 62(7) , 62a(4) , 67(7) , 69(6) , 73(4) , 74(3) and 76(8) shall be conferred on the commission for an indeterminate period of time from … [op please insert the date = date of entry into force of this regulation].


### 3. the delegation of power referred to in articles 28(10) , 42(3) , 53(6) , 58(15) , 69(6) , 73(4) , and 76(8) may be revoked at any time by the european parliament or by the council. a decision to revoke shall put an end to the delegation of the power specified in that decision. it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein. it shall not affect the validity of any delegated acts already in force. ### 3. the delegation of power referred to in articles 14(7) , 28(10) , 42(3) , 53(6) , 56(1) , 58(15) , 62(7) , 62a(4) , 67(7) , 69(6) , 73(4) , 74(3)and 76(8) may be revoked at any time by the european parliament or by the council. a decision to revoke shall put an end to the delegation of the power specified in that decision. it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein. it shall not affect the validity of any delegated acts already in force.


### member states shall lay down the rules on penalties applicable to infringements of this regulation and shall take all measures necessary to ensure that they are implemented. the penalties provided for shall be effective , proportionate and dissuasive. member states shall , by … [op please insert the date = 3 years after the date of entry into force of this regulation] , notify the commission of those rules and of those measures and shall notify it , without delay , of any subsequent amendment affecting them. ### member states shall lay down the rules on penalties applicable to infringements of this regulation and shall take all measures necessary to ensure that they are implemented. the penalties provided for shall be effective , proportionate and dissuasive. member states shall , by … [op please insert the date = 2 years after the date of entry into force of this regulation] , notify the commission and the scb of those rules and of those measures and shall notify it , without delay , of any subsequent amendment affecting them. the commissions shall make those provisions on penalties and their use publicly available on the eu soho platform.


### without prejudice to the dates of application referred to in article 87 and the transitional provisions provided for in this chapter , the commission is empowered to adopt the delegated acts referred to in articles 42(3) and 73(4) and the implementing acts referred to in articles 26(4) , 43(6) , 44(3) , 46(3) , 67(7) and 74(3) as from … [op please insert the date = one day after the date of entry into force of this regulation]. such acts shall apply from the date of application in accordance with article 87(1) , second subparagraph , without prejudice to any transitional rules provided for in this chapter. ### without prejudice to the dates of application referred to in article 87 and the transitional provisions provided for in this chapter , the commission is empowered to adopt the delegated acts referred to in articles 42(3) , 67(7) and 73(4) and the implementing acts referred to in articles 26(4) , 43(6) , 44(3) , 46(3) and 74(3) as from … [op please insert the date = one day after the date of entry into force of this regulation]. such acts shall apply from the date of application in accordance with article 87(1) , second subparagraph , without prejudice to any transitional rules provided for in this chapter.


### 13. recalls the importance to develop a long term hr policy on work-life balance , lifelong guidance and career development , gender balance , teleworking , geographical balance and recruitment and integration of people with disabilities; ### 13. highlights the importance to develop a long term hr policy on work-life balance , lifelong guidance and career development , gender balance , teleworking , geographical balance and recruitment and integration of people with disabilities;


### 24. recalls the importance to increase the digitalisation of the centre in terms of internal operation and management but also in order to speed up the digitalisation of procedures; stresses the need for the centre to continue to be proactive in this regard in order to avoid a digital gap between the agencies at all costs; draws attention , however , to the need to take all the necessary security measures to avoid any risk to the online security of the information processed; ### 24. recalls the importance to increase the digitalisation of the centre in terms of internal operation and management but also in order to speed up the digitalisation of procedures; invites the centre to switch ot paper-less document management and internal processes where possible; stresses the need for the centre to continue to be proactive in this regard in order to avoid a digital gap between the agencies at all costs; draws attention , however , to the need to take all the necessary security measures to avoid any risk to the online security of the information processed;


### 6. notes certain limitations in the application of the recent rules proposed by the european commission on teleworking , which efsa applies by analogy , in particular when it comes to partial teleworking outside the country of employment; is concerned about the fact that current limited rules on teleworking abroad may impact on efsa’s attractiveness when recruiting candidates from the different eu member states wishing to join efsa; calls for more flexibility in the application of these rules , which would help increasing efsa’s attractiveness and leading to a better nationality balance of its staff. ### 6. notes certain limitations in the application of the recent rules proposed by the european commission on teleworking , which efsa applies by analogy , in particular when it comes to partial teleworking outside the country of employment; is concerned about the fact that current limited rules on teleworking abroad impact on efsa’s attractiveness when recruiting candidates from the different eu member states wishing to join efsa; calls for a review of those rules in order to allow for more flexibility , which would help increasing efsa’s attractiveness and leading to a better nationality balance of its staff;


### 8. notes that the corrective actions to follow the court of auditors' observations of 2020 have been completed; recalls the necessity to complete the corrective actions to follow the court of auditors' observations of 2017; ### 8. notes that the corrective actions to follow the court of auditors' observations of 2020 have been completed; recalls the necessity to complete the corrective actions to follow the court of auditors' observations of 2017 , in particular to strengthen the accounting officer’s independence by making them directly responsible to efsa’s director;


### 11. recommends , based on the facts available , that discharge be granted to the executive director of the european food safety authority in respect of the implementation of the authority's budget for the financial year 2021. ### 11. conditions , based on the facts available , the granting of discharge to the executive director of the european food safety authority in respect of the implementation of the authority's budget for the financial year 2021 to new commitments in terms of independence policy and management of conflict of interests.


### (4) directive 2000/60/ec of the european parliament and of the council45establishes a framework for the protection of inland surface waters , transitional waters , coastal waters and groundwater. that framework involves the identification of priority substances amongst those that pose a significant risk to , or via , the aquatic environment at union level. directive 2008/105/ec of the european parliament and of the council46lays down union-wide environmental quality standards (eqs) for the 45 priority substances listed in annex x to directive 2000/60/ec and eight other pollutants that were already regulated at union level before annex x was introduced by decision no 2455/2001/ec of the european parliament and of the council47. directive 2006/118/ec of the european parliament and of the council48lays down union-wide groundwater quality standards for nitrates and for active substances in pesticides and criteria for establishing national threshold values for other groundwater pollutants. it also sets out a minimum list of 12 pollutants and their indicators for which member states are required to consider establishingsuch national threshold values. the groundwater quality standards are set out in annex i to directive 2006/118/ec. ### (4) directive 2000/60/ec of the european parliament and of the council45establishes a framework for the protection of inland surface waters , transitional waters , coastal waters and groundwater. that framework involves the identification of priority substances amongst those that pose a significant risk to , or via , the aquatic environment at union level. directive 2008/105/ec of the european parliament and of the council46lays down union-wide environmental quality standards (eqs) for the 45 priority substances listed in annex x to directive 2000/60/ec and eight other pollutants that were already regulated at union level before annex x was introduced by decision no 2455/2001/ec of the european parliament and of the council47. directive 2006/118/ec of the european parliament and of the council48lays down union-wide groundwater quality standards for nitrates and for active substances in pesticides and criteria for establishing national threshold values for other groundwater pollutants. it also sets out a minimum list of 12 pollutants and their indicators for which member states are required to establishsuch national threshold values. the groundwater quality standards are set out in annex i to directive 2006/118/ec.


### (5) substances are considered for listing in annex x to directive 2000/60/ec or in annex i or annex ii to directive 2006/118/ec based on an assessment of the risk they pose to humans and the aquatic environment. the key components of that assessment are knowledge of the environmental concentrations of the substances , including information collected from watch-list monitoring , and of the (eco)toxicology of the substances , as well as of their persistence , bioaccumulation , carcinogenicity , mutagenicity , reprotoxicity and endocrine disrupting potential. ### (5) substances are considered for listing in annex x to directive 2000/60/ec or in annex i or annex ii to directive 2006/118/ec based on an assessment of the risk they pose to humans and the aquatic environment. the key components of that assessment are knowledge of the environmental concentrations of the substances , including information collected from watch-list monitoring , and of the (eco)toxicology of the substances , as well as of their persistence , bioaccumulation , toxicity , mobility , carcinogenicity , mutagenicity , reprotoxicity and endocrine disrupting potential.


### 3. recalls that , in 2021 , the eea undertook new tasks supporting the delivery of europe's environment ambitions as part of the european green deal (egd) and the 8th environment action programme (8th eap) , also contributing to europe's global commitments , thus strengthening eea's position as a major source for policy-relevant environmental information. ### 3. recalls that , in 2021 , the eea undertook new tasks supporting the delivery of europe's environment ambitions as part of the european green deal (egd) and the 8th environment action programme (8th eap) , also contributing to europe's global commitments , thus strengthening eea's position as a major source for policy-relevant environmental information; appreciates the eea’s support of members of the envi committee with excellent , up-to-date data and information;


### 6. notes that the eea has 236 posts , out of which 85% are dedicated to operational activities and 15% to support; considers that , in order to properly perform the tasks on the union’s path to climate neutrality , this number should grow in the years to come; ### 6. notes that the eea has 236 posts , out of which 85% are dedicated to operational activities and 15% to support; considers that taking into account the substantial increase of workload related to the monitoring the union’s goals for , inter alia , climate neutrality , circular economy and nature restoration , this number should grow in the years to come; recalls that according to the proposal of the commission , for monitoring the goals of the nature restoration law alone , 12 additional posts will be needed;


### 1. reiterates the key role of the european medicines agency ('the ema') in protecting and promoting public and animal health by assessing and supervising medicines for human or veterinary use; ### 1. reiterates the key role of the european medicines agency ('the ema') in protecting human and animal health by assessing and supervising medicines for human or veterinary use and protecting public health by raising awareness on key issues including antimicrobial resistance and prevention of communicable diseases through vaccination;


### 3. recalls that the ema is a fee-funded agency , with 89 ,37 % of its 2021 revenue stemming from fees paid by the pharmaceutical industry , 9 ,92 % stemming from the union budget and 0 ,7 % from various other sources; ### 3. recalls that the ema is a fee-funded agency , with 89 ,37 % of its 2021 revenue stemming from fees paid by the pharmaceutical industry , 9 ,92 % stemming from the union budget and 0 ,7 % from various other sources; notes that the percentage of funding from pharmaceutical companies increased in 2021 , compared to 2020 (approximately 84%); calls for more balance in public-private funding sources to maintain trust in the work of the agency;


### 5. acknowledges that in 2021 , the ema continued to focus on the assessment of vaccines and therapeutics for covid-19 and on the evaluation of the quality , safety , and efficacy of these products as part of the eu response to the global pandemic; welcomes the continued efforts of the ema to maintain a high level on transparency in relation to medicines against covid-19; ### 5. reiterates that transparency and the timely release of information about medicines is key to reinforcing public trust in regulatory decisions and the medicines placed onto the eu market; acknowledges that in 2021 , the ema continued to focus on the assessment of vaccines and therapeutics for covid-19 and on the evaluation of the quality , safety , and efficacy of these products as part of the eu response to the global pandemic; welcomes the continued efforts of the ema to maintain a high level on transparency in relation to medicines against covid-19;


### 9. welcomes the court of auditors acknowledgment of the ema as one of the nine agencies that had introduced their own internal rules to deal with the governing of the activities of members of agencies’ boards2 ; ### 9. welcomes the court of auditors acknowledgment of the ema as one of the nine agencies that had introduced their own internal rules to deal with the governing of the activities of members of agencies’ boards2 ; calls on the agency to ensure that all management board members , members of ema advisory bodies and stakeholder groups and their alternates have dutifully submitted the required declarations of interest that a high level of compliance with conflict of interest rules is maintained;


### 12. recalls the importance to develop a long term hr policy on work-life balance , lifelong guidance and career development , gender balance , teleworking , geographical balance and recruitment and integration of people with disabilities; ### 12. highlights the importance to develop a long term hr policy on work-life balance , lifelong guidance and career development , gender balance , teleworking , geographical balance and recruitment and integration of people with disabilities;


### 6. recalls that the replacement of animal testing shall be a priority in medicine development during the application of the 3rs - replace , reduce and refine – principles; notes that in 2021 3rs working party had to be put on hold due to the business continuity planning policy as a result of covid-19 , therefore the agency did not prepare an activity report on this issue; welcomes the activity restart of the 3rs working party in late 2022 and the organization of meetings with stakeholders on this issue in 2023; expects that the agency will produce its biennial reports on 3rs actions as soon as possible. ### 6. stresses that the replacement of animal testing shall be a priority in medicine development during the application of the 3rs - replace , reduce and refine – principles; regrets that in 2021 3rs working party had to be put on hold due to the business continuity planning policy as a result of covid-19 , therefore the agency did not prepare an activity report on this issue; welcomes the activity restart of the 3rs working party in late 2022 and the organization of meetings with stakeholders on this issue in 2023; expects that the agency will produce its biennial reports on 3rs actions as soon as possible.


### 8. expresses concern that the addition of new tasks and increasing fee-related workload due to the growing portfolio of authorised medicines over the years was not accompanied by an adequate increase in the ema's staff , which puts the agency under significant pressure; ### 8. expresses concern that the addition of new tasks and increasing fee-related workload due to the growing portfolio of authorised medicines over the years was not accompanied by an adequate increase in the ema's staff , which puts the agency under significant pressure; invites the agency to explore ways of surveying the staff regarding their well-being and deploying methods that would prevent burn-out and decreased performance;


### 13. notes with concern that 2021 was the third year in a row when the court raised new procurement-related observations for the agency; notes from the court’s report the observation regarding the agency’s overestimation of the value of a framework contract whereby a lower threshold regarding the financial and economic capacity requirement (annual turnover) would have allowed more companies to submit tenders; ### 13. notes with concern that 2021 was the third year in a row when the court raised new procurement-related observations for the agency; notes from the court’s report the observation regarding the agency’s overestimation of the value of a framework contract whereby a lower threshold regarding the financial and economic capacity requirement (annual turnover) would have allowed more companies to submit tenders; calls on the agency to review the shortcomings of its procurement processes and also follow court's recommendations;


### 20. insists on the need to put in place more systematic rules on transparency , incompatibilities , conflict of interests , illegal lobbying and revolving doors; calls on the agency to strengthen its internal control mechanisms , including the setting up of an internal anticorruption mechanism; ### 20. insists on the need to put in place more systematic rules on transparency , incompatibilities , conflict of interests , illegal lobbying and revolving doors through a revised and strenghtened code of conduct; calls on the agency to strengthen its internal control and audit mechanisms , including the setting up of an internal anticorruption mechanism;


### 23. recalls that procedural deficiencies in recruitment procedures undermine the principles of transparency and equal treatment. requests that the agency improves its internal recruitment procedure to clarify evaluation processes and vacancy notices; ### 23. deplores that procedural deficiencies in recruitment procedures undermine the principles of transparency and equal treatment. requests that the agency improves its internal recruitment procedure to clarify evaluation processes and vacancy notices;


### 28. recalls the importance to increase the digitalisation of the agency in terms of internal operation and management but also in order to speed up the digitalisation of procedures; stresses the need for the agency to continue to be proactive in this regard in order to avoid a digital gap between the agencies at all costs; draws attention , however , to the need to take all the necessary security measures to avoid any risk to the online security of the information processed; ### 28. recalls the importance to increase the digitalisation of the agency in terms of internal operation and management but also in order to speed up the digitalisation of procedures; invites the agency to switch to paper-less document management and processes where possible; stresses the need for the agency to continue to be proactive in this regard in order to avoid a digital gap between the agencies at all costs; draws attention , however , to the need to take all the necessary security measures to avoid any risk to the online security of the information processed;


### 5. stresses the need to address the lack of predictability of the agency’s fee income; notes its declining trend , and calls on the commission to present its proposal to strengthen the governance of echa and increase the sustainability of its financing model without delay , in line with its commitment expressed in the chemicals strategy for sustainability2 ; ### 5. stresses the long-standing problem and need to address the lack of predictability of the agency’s fee income; notes its declining trend , and calls on the commission to present its proposal to strengthen the governance of echa together with the revised reach regulation , and increase the sustainability of its financing model without delay , in line with its commitment expressed in the chemicals strategy for sustainability2 ;


### 6. underlines the necessity of ensuring adequate staffing reflecting the needs of the european green deal and the union chemical strategy for sustainability , circular economy action plan and zero pollution ambition in particular; ### 6. underlines the necessity of ensuring adequate staffing reflecting the needs of the european green deal , the union chemical strategy for sustainability , circular economy action plan , zero pollution ambition and related legislation in particular;


### 8. notes that the agency collaborates closely with other union agencies , such as the european food safety authority , the european centre for disease prevention and control and the european medicines agency , by means of memoranda of understanding; underlines the importance of such an approach , in order to ensure that the work of each agency is consistent with that of the other agencies and to meet the requirements of sound financial management; welcomes the sharing of services and encourages cooperation among the union agencies where and when possible; ### 8. notes that the agency collaborates closely with other union agencies , such as the european food safety authority , the european centre for disease prevention and control and the european medicines agency , by means of memoranda of understanding; underlines the importance of such an approach , in order to ensure that the work of each agency is consistent with that of the other agencies and to meet the requirements of sound financial management; welcomes the sharing of services and encourages active cooperation among the union agencies where and when possible , including in dedicated joint work teams on specific environmental topics such as pollinators and soil;


### 32. calls for support to be given to smes to help them comply with eu chemical legislation; ### 32. calls for support to be given to smes to help them comply with eu chemicals legislation , including technical support for the substitution of hazardous substances by safe alternatives;


### 32. calls for support to be given to smes to help them comply with eu chemical legislation; ### 32. calls for support to be given to smes to help them comply with eu chemicals legislation and to move towards producing and using safe and sustainable products;


### 33. stresses that legislation is key to give direction to the necessary innovation for the transition to a circular and sustainable chemicals sector and long-term investments; ### 33. stresses that legislation is key to give direction to the necessary innovation for the transition to a circular , safe and sustainable chemicals sector and long-term investments to achieve a toxic-free environment;


### 33. stresses that legislation is key to give direction to the necessary innovation for the transition to a circular and sustainable chemicals sector and long-term investments; ### 33. stresses that legislation is key to give direction to the necessary innovation for the transition to a circular , safe and sustainable chemicals sector and long-term investments;


### 34. highlights the need for union chemicals legislation to provide incentives for sustainable chemistry , materials (including plastics) and technologies , including non-chemical alternatives , that are safe and non-toxic by design; ### 34. highlights the need for union chemicals legislation to provide incentives for safe and sustainable chemistry , materials (including plastics) and technologies , including non-chemical alternatives , that are safe and non-toxic by design;


### 35. recalls that the fee income received by the echa will be substantially reduced; calls for a sustainable funding mechanism , in order to ensure its proper long-term functioning and to remove the inefficiencies due to the separation of budget lines , providing the resources needed to meet the increasing demands on its current work and sufficient additional resources for any additional work required; ### 35. recalls that the fee income received by the echa will be substantially reduced; calls for the revision of its financing model and for the introduction of a predictable and sustainable funding mechanism , in order to ensure its proper long-term functioning and to remove the inefficiencies due to the separation of budget lines , providing the resources needed to meet the increasing demands on its current work and sufficient additional resources for any additional work required within the new multiannual financial framework; calls on the commission and council to refrain from cutting echa´s resources in annual budget procedures; and provide additional resources for any additional tasks required such as conducting own evaluations of substances;


### 35. recalls that the fee income received by the echa will be substantially reduced; calls for a sustainable funding mechanism , in order to ensure its proper long-term functioning and to remove the inefficiencies due to the separation of budget lines , providing the resources needed to meet the increasing demands on its current work and sufficient additional resources for any additional work required; ### 35. recalls that the fee income received by the echa will be substantially reduced; calls for a sustainable funding mechanism , in order to ensure its proper long-term functioning and to remove the inefficiencies due to the separation of budget lines , providing the resources needed to meet the increasing demands on its current work and sufficient additional resources for any additional work required , including a ring-fenced budget for a team within echa exclusively dedicated to non-animal methods promotion across all echa activities;


### 37. calls on the commission to ensure that imported products abide by the same standards as those governing chemicals and products produced in the union; considers that control checks of non-compliance inside the union and at its borders should be enhanced; ### 37. calls on the commission to ensure that imported products as well as exported chemicals and products abide by the same standards as those governing chemicals and products produced and used in the union; considers that control checks of non-compliance inside the union and at its borders should be enhanced; welcomes the long term action plan for better implementation and enforcement of single market rules 5a and calls on the commission to make full use of forthcoming proposals (customs single window , consumer agenda , digital services act etc.) to ensure enforcement of eu chemicals laws;


### 37. calls on the commission to ensure that imported products abide by the same standards as those governing chemicals and products produced in the union; considers that control checks of non-compliance inside the union and at its borders should be enhanced; ### 37. calls on the commission to ensure that imported and exported chemicals and products abide by the same standards as those governing chemicals and products produced in the union in order to ensure a level playing field between eu and non-eu manufacturers; considers that control checks of non-compliance inside the union and at its borders should be enhanced;


### 2. calls on the commission to come up with a chemicals strategy for sustainability that effectively ensures a high level of protection of human health and the environment , minimising exposure to hazardous chemicals; ### 2. calls on the commission to come up with a comprehensive chemicals strategy for sustainability to bring about , in conjunction with the new circular economy action plan and the new industrial strategy , the necessary paradigm shift to implement the zero-pollution ambition for a toxic-free environment , ensuring a high level of protection of human health and the environment , fostering innovation in sustainable chemicals based on a toxic-free hierarchy of measures as the basis for a european strategy for a resource-efficient , circular , safe , sustainable and competitive economy;


### 2. calls on the commission to come up with a chemicals strategy for sustainability that effectively ensures a high level of protection of human health and the environment , minimising exposure to hazardous chemicals; ### 2. calls on the commission to come up with a chemicals strategy for sustainability that effectively ensures a high level of protection of human health and the environment , minimising exposure to hazardous chemicals , and that will together with the new circular economy action plan help to achieve the shift towards truly circular economy;


### 4. considers that the chemicals strategy should achieve coherence and synergies between chemicals legislation (e.g. reach , clp , pops , mercury , plant protection products , biocides) and related union legislation , including specific product legislation (e.g. toys , cosmetics , food contact materials , construction products , packaging) , general product legislation (e.g. eco-design , eco-label) , legislation on environmental compartments (e.g. water and air) , as well as legislation on industrial installations (e.g. ied , seveso iii directive); ### 4. considers that the chemicals strategy should achieve coherence and synergies between chemicals legislation (e.g. reach , clp , pops , mercury , plant protection products , biocides) and related union legislation , including specific product legislation (e.g. toys , cosmetics , food contact materials , construction products , packaging , pharmaceuticals) , general product legislation (e.g. eco-design , eco-label , upcoming sustainable product policy) , legislation on workers’ protection , legislation on environmental compartments (e.g. water and air) , legislation on sources of pollution , including industrial installations (e.g. ied , seveso iii directive) , as well as legislation on waste (e.g. rohs , elv);


### 4. considers that the chemicals strategy should achieve coherence and synergies between chemicals legislation (e.g. reach , clp , pops , mercury , plant protection products , biocides) and related union legislation , including specific product legislation (e.g. toys , cosmetics , food contact materials , construction products , packaging) , general product legislation (e.g. eco-design , eco-label) , legislation on environmental compartments (e.g. water and air) , as well as legislation on industrial installations (e.g. ied , seveso iii directive); ### 4. considers that the chemicals strategy should achieve coherence and synergies between chemicals legislation (e.g. reach , clp , pops , mercury , plant protection products , biocides) and related union legislation , including specific product legislation (e.g. toys , cosmetics , food contact materials , construction products , packaging) , general product legislation (e.g. eco-design , eco-label) , legislation on environmental compartments (e.g. water and air) , as well as legislation on industrial installations (e.g. ied , seveso iii directive) , and waste (e.g. , rohs);


### 5. stresses that the chemicals strategy has to be aligned with the hierarchy of actions in risk management that prioritises exposure prevention , elimination and substitution over control measures; ### 5. stresses that the chemicals strategy for sustainability should implement a toxic-free hierarchy of measures , starting with avoidance of non-essential uses and substitution of hazardous substances , then minimisation of exposure to hazardous substances , then elimination of hazardous legacy substances , and lastly remediation of damage1a;


### 6. stresses that the strategy should fully reflect the precautionary principle and the polluter pays principle; ### 6. stresses that the strategy should fully reflect the precautionary principle and the principles that preventive action should be taken , that environmental damage should as a priority be rectified at source and that the polluter should pay;


### 6. stresses that the strategy should fully reflect the precautionary principle and the polluter pays principle; ### 6. stresses that the strategy should fully reflect the precautionary and prevention principle , rectifying pollution at source , and the polluter pays principle;


### 7. highlights that the new chemicals strategy should be based upon robust and up-to-date scientific evidence and that subsequent regulatory action should be accompanied by impact assessments , taking into account the input of relevant stakeholders; ### 7. highlights that the new chemicals strategy for sustainability should be based upon robust and up-to-date scientific evidence and that subsequent regulatory action , other than scientific matters (e.g. hazard identification and hazard classification) , should be accompanied by impact assessments , taking into account the input of relevant stakeholders;


### 9. underlines the need for a clear commitment to securing funds for improved research into safer alternatives and to promoting substitution of harmful chemicals , non-toxic production and sustainable innovation; ### 9. underlines the need for a clear commitment to securing funds for improved research into green chemistry based on safety-by-design to develop safe and sustainable alternatives , including non-chemical alternatives , and to promoting substitution of harmful chemicals , non-toxic production and safe and sustainable innovation;


### 9. underlines the need for a clear commitment to securing funds for improved research into safer alternatives and to promoting substitution of harmful chemicals , non-toxic production and sustainable innovation; ### 9. underlines the need for a clear commitment to securing funds for improved research into safer alternatives , including non-chemical , and to promoting substitution of harmful chemicals and non-toxic production , ensuring the adequate preconditions for sustainable innovation and development of new and safer chemicals;


### 10. reiterates the need to minimise animal testing with the help of new approach methodologies and calls for increased efforts and funds to this end with aim to establish non-animal based safety assessments in all relevant legislation , in addition to cosmetics; regrets that there are still barriers to the use and acceptance of alternative (non-animal) test methods for regulatory purposes , partially linked to gaps in the available test guidelines4 , requests action to remedy this situation; ### 10. reiterates the need to minimise animal testing with the help of new approach methodologies and calls for increased efforts and funds to this end with the aim to establish fast , reliable and robust non-animal based safety assessments in all relevant legislation , in addition to cosmetics; regrets that there are still barriers to the use and acceptance of alternative (non-animal) test methods for regulatory purposes , partially linked to gaps in the available test guidelines4 , requests action to remedy this situation; considers that best-available science should be used as a benchmark for the validation of new approach methods , rather than outdated animal models;