### 9. considers it irresponsible that the eu continues to support environmentally harmful and cruel practices under the common agricultural policy and common fisheries policy. ### 9. recognises the positive steps taken in the eu to reduce and withdraw support for environmentally harmful and cruel practices under the common agricultural policy and common fisheries policy; notes , however , that progress is slow;


### 9. considers it irresponsible that the eu continues to support environmentally harmful and cruel practices under the common agricultural policy and common fisheries policy. ### 9. emphasizes the need that the eu continues to make efforts to end any environmentally harmful and cruel practices under the common agricultural policy and common fisheries policy.


### 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 energy and 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 some 20 million tonnes of grain have remained blocked in storage silos on the shores of the black sea; whereas food production and access to food must not be endangered or used as a geopolitical weapon;


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


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


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


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


### (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 and founded on the principle of voluntary and unpaid soho donation. member states should notify the commission via the soho platform set up by this regulation 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.


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


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


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


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


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


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


### (34) where evidence demonstrates that specific processing steps reduce or eliminate the risk of transmission of specific infectious or non-infectious disease agents , the quality and safety standards for the verification of donor eligibility by means of donor health evaluations , including testing , and the related guidelines for their implementation , should take this evidence into account. thus , in the case of , for example , plasma for fractionation , that in a subsequent step in the manufacturing process of medicinal products undergoes sterilisation steps , certain donor eligibility criteria used for donation of plasma for transfusion might not be necessary nor appropriate. ### (34) where evidence demonstrates that specific processing steps reduce or eliminate the risk of transmission of specific infectious or non-infectious disease agents , the quality and safety standards for the verification of donor eligibility by means of donor health evaluations , including testing , and the related guidelines for their implementation , should take this evidence into account. thus , in the case of , for example , plasma for fractionation , that in a subsequent step in the manufacturing process of medicinal products undergoes sterilisation steps , certain donor eligibility criteria used for donation of plasma for transfusion might not be necessary nor appropriate. some member states and soho entitites have introduced screening criteria that have been perceived to constiute discimination , notably against men who have sex with men. it is appropriate to lay down that such criteria to shall be science-based to avoid the perception that health systems engage in discrimination.


### (37) it is necessary to promote information and awareness campaigns at national and union level on the importance of sohos. the aim of these campaigns should be to help european citizens to decide whether to become donors during their lifetime and let their families or legal representatives know their wishes regarding donation after death. as there is a need to ensure the availability of sohos for medical treatments , member states should promote the donation of sohos , including plasma , of high quality and safety , thereby also increasing self-sufficiency in the union. member states are also urged to take steps to encourage a strong public and non-profit sector involvement in the provision of soho services , in particular for critical sohos and the related research and development. ### (37) it is necessary to promote information and awareness campaigns at national and union level on the importance of sohos. the aim of these campaigns should be to help european citizens to decide whether to become donors during their lifetime and let their families or legal representatives know their wishes regarding donation after death. as there is a need to ensure the availability of sohos for medical treatments , member states and the union should promote the voluntary , unpaid donation of sohos of high quality and safety , including plasma , used as base material for manufacturing plasma-derived medicinal products. these measures support european self-sufficiency , based on the broadest possible donor base , with a view to ensuring a more resilient supply system and safeguarding the health of donors and recipients. member states and the union should also take steps to encourage a strong public and non-profit sector involvement in the provision of soho services , in particular for critical sohos and the related research and development.


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


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


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


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


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


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


### (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 online platform could be further used for the sharing of best practice between member states with regard to initatives , such as campaigns , to support the supply of sohos.


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


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


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


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


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


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


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


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


### (10) ‘medically assisted reproduction’ means the facilitation of conception by intra-uterine insemination of sperm , in vitro fertilisation or any other laboratory or medical intervention that promotes conception; ### (10) ‘medically assisted reproduction’ means the facilitation of conception including all methods or techniques based on the manipulation of human reproductive cells;


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


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


### life-threatening , disabling or incapacitating condition , including transmission of a pathogen that might cause such condition; ### life-threatening , irreversable or incapacitating condition , including transmission of a pathogen that might cause such condition;


### (31) ‘eu soho platform’ means the digital platform established by the commission to exchange information concerning soho activities; ### (31) 'eu soho platform' means the digital platform established by the commission , and interoperable with the other existing union platforms , to exchange information concerning soho activities , in particular between competent authorities , european union agencies and the commission;


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


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


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


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


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


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


### 1. in all cases where questions arise as to the regulatory status of a substance , product or activity , competent authorities shall consult with authorities established in other relevant union legislation referred to in article 2(3) , as relevant. in such cases , competent authorities shall also consult the compendium referred to article 3 point (33). ### 1. in all cases where questions arise as to the regulatory status of a substance , product or activity , competent authorities shall consult with authorities established in other relevant union legislation referred to in article 2(3) , such as the european medicine agency (ema). in such cases , competent authorities shall also consult the compendium referred to article 3 point (33). the ema and the soho coordination board (scb) shall have close collaboration and establish a permanent panel for reviewing such questions , while consulting other authorities , such as the medical devices coordination group.


### 11. the interval between two on-site inspections shall not exceed 4 years. ### 11. the interval between two on-site inspections shall be decided based on the necessary frequency to mitigate any identified risks and shall not exceed 4 years.


### 11. the interval between two on-site inspections shall not exceed 4 years. ### 11. the interval between inspections should be decided based on the necessary frequency to mitigate any identified risks and shall not exceed 4 years.


### verify , by means of a registry , that donors are not donating more frequently than indicated as safe in technical guidelines as referred to in article 56 and demonstrate that their health is not compromised; ### verify , by means of a registry , that donors are not donating more frequently than indicated as safe in technical guidelines as referred to in article 56 and demonstrate that they meet medical conditions if required in specific donation types on the basis of the latest available scientific evidence and medical expertise;


### verify , by means of a registry , that donors are not donating more frequently than indicated as safe in technical guidelines as referred to in article 56 and demonstrate that their health is not compromised; ### verify , by means of a registry , that donors are not donating more frequently than indicated as safe in technical guidelines as referred to in article 56;


### verify , by means of a registry , that donors are not donating more frequently than indicated as safe in technical guidelines as referred to in article 56 and demonstrate that their health is not compromised; ### for donations referred to in paragraph 3 , verify , by means of interconnected registries , that donors are not donating more frequently than indicated as safe in technical guidelines as referred to in article 56;


### develop and implement a plan for monitoring the donor’s health after the donation in cases where the soho donations imply a significant risk to a donor as referred to in paragraph 3; ### develop and implement a plan for monitoring the donor’s health after the donation in cases specified in paragraph 3;


### develop and implement a plan for monitoring the donor’s health after the donation in cases where the soho donations imply a significant risk to a donor as referred to in paragraph 3; ### develop and implement a plan for monitoring the donor’s health after the donation in the cases referred to in paragraph 3;


### develop and implement a plan for monitoring the donor’s health after the donation in cases where the soho donations imply a significant risk to a donor as referred to in paragraph 3; ### develop and implement a plan for monitoring the donor’s health after the donation in cases where the soho donations imply a risk to a donor as referred to in paragraph 3;


### 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 expenses and inconveniences related to their participation in donations through , for example , fixed rate allowances , days off , or tax reduction. 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. the compensation shall be limited to travel expenses , loss of earnings , or medical costs related to the medical procedure and possible side effects.


### 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 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. in this regard , the commission shall support the exchange of best practice between member states.


### 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 making good any expenses and inconveniences associated with their donation 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 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 expenses and inconveniences related to their participation in donations , for example , 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 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 any expenses and inconveniences associated with their donation through among others 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 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 making good any expenses and inconveniences associated with their donation 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.


### 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 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. in the case of medically assisted reproduction , the option of the respective persons refusing genetic screening should be retained and the procedure is subject to national legislation according to the principle of subsidiarity hence with regard to the transmission of genetic diseases to offspring , the provisions apply only if member states decide to allow this technology , and subsequently if it corresponds to the wish of the donor or the recipient


### (ii) testing prospective recipients to identify any relevant genetic risk , combined with testing donors for such identified genetic conditions to ensure matching that will prevent the concerned condition in the offspring. ### (ii) testing prospective recipients to identify any relevant genetic risk , combined with testing donors for such identified genetic conditions to ensure matching that will prevent the concerned condition in the offspring. in the case of medically assisted reproduction , the option of the respective persons refusing genetic screening should be retained and the procedure is subject to national legislation according to the principle of subsidiarity hence with regard to the transmission of genetic diseases to offspring , the provisions apply only if member states decide to allow this technology , and subsequently if it corresponds to the wish of the donor or the recipient.


### conducting comprehensive process validation and equipment qualification as referred to in article 41(2) , point (a)(vii); ### conducting comprehensive process validation and equipment qualification as referred to in article 41(2) , point (a)(vii) , unless the equipment has already been assessed and carries ec certification as provided for in regulations (eu) 2017/7461 aand (eu) 2017/745 for an identical use;


### apply soho preparations to recipients without proven benefit , except in the context of a clinical investigation approved in the context of a conditional authorisation of the soho preparation by their competent authority pursuant to article 41(4); ### apply soho preparations to recipients without proven benefit , except in the context of a clinical investigation approved in the context of a conditional authorisation of the soho preparation by their competent authority pursuant to article 41(4) or compassionate use and experimental therapy as described in article 61;


### 1. member states , in collaboration with national soho authorities , shall draw up national soho emergency plans setting out measures to be applied without undue delay when the supply situation for critical sohos presents or is likely to present a serious risk to human health. ### 1. member states , in collaboration with national soho authorities , shall draw up national soho emergency plans setting out measures to be applied without undue delay when the supply situation for critical sohos presents or is likely to present a serious risk to human health. in this regard , the commission shall support the exchange of best practice between member states.


### 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 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.


### 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 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 strongly encourage the collection of soho with the involvement of all relevant stakeholders.


### 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 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 sohos with the involvement of all relevant stakeholders.


### 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 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 the involvement of all relevant stakeholders.


### 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 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 sohos with the involvement of all relevant stakeholders


### 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 at least on an annual basis review 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.


### 2. each member state shall nominate two permanent members and two alternates representing the soho national authority and , where the member state chooses , the ministry of health. the soho national authority may nominate members from other competent authorities , but those members shall ensure that the views and suggestions they make are endorsed by the soho national authority. the board may also invite experts and observers to attend its meetings , and may cooperate with other external experts as appropriate. other union institutions , bodies , offices and agencies shall have an observer role. ### 2. each member state shall nominate two permanent members and two alternates representing the soho national authority and , where the member state chooses , the ministry of health. the soho national authority may nominate members from other competent authorities , but those members shall ensure that the views and suggestions they make are endorsed by the soho national authority. the board shall , in agreement with the commission , invite representatives of the industry , including both the public and private sector , as well as consumers , patients and health professionals , to participate in certain aspects of the board’s work , under conditions determined beforehand by the board. other union institutions , bodies , offices and agencies shall have an observer role.


### 2. each member state shall nominate two permanent members and two alternates representing the soho national authority and , where the member state chooses , the ministry of health. the soho national authority may nominate members from other competent authorities , but those members shall ensure that the views and suggestions they make are endorsed by the soho national authority. the board may also invite experts and observers to attend its meetings , and may cooperate with other external experts as appropriate. other union institutions , bodies , offices and agencies shall have an observer role. ### 2. each member state shall nominate two permanent members and two alternates representing the soho national authority and , where the member state chooses , the ministry of health. the soho national authority may nominate members from other competent authorities , but those members shall ensure that the views and suggestions they make are endorsed by the soho national authority. the board shall , where relevant , invite experts and other relevant stakeholders to attend its meetings and to cooperate on aspects of its work. such stakeholders may include actors of the public and private sector , patients , health professionals , and researchers. other union institutions , bodies , offices and agencies shall have an observer role.


### 2. each member state shall nominate two permanent members and two alternates representing the soho national authority and , where the member state chooses , the ministry of health. the soho national authority may nominate members from other competent authorities , but those members shall ensure that the views and suggestions they make are endorsed by the soho national authority. the board may also invite experts and observers to attend its meetings , and may cooperate with other external experts as appropriate. other union institutions , bodies , offices and agencies shall have an observer role. ### 2. each member state shall nominate two permanent members and two alternates representing the soho national authority and , where the member state chooses , the ministry of health. the soho national authority may nominate members from other competent authorities , but those members shall ensure that the views and suggestions they make are endorsed by the soho national authority. the board shall , in agreement with the commission , invite representatives of different staleholders , including industry representatives , to participate in certain aspects of the board’s work , under conditions determined beforehand by the board. other union institutions , bodies , offices and agencies shall have an observer role.


### 2. each member state shall nominate two permanent members and two alternates representing the soho national authority and , where the member state chooses , the ministry of health. the soho national authority may nominate members from other competent authorities , but those members shall ensure that the views and suggestions they make are endorsed by the soho national authority. the board may also invite experts and observers to attend its meetings , and may cooperate with other external experts as appropriate. other union institutions , bodies , offices and agencies shall have an observer role. ### 2. each member state shall nominate two permanent members and two alternates representing the soho national authority and , where the member state chooses , the ministry of health. the soho national authority may nominate members from other competent authorities , but those members shall ensure that the views and suggestions they make are endorsed by the soho national authority. the board may also invite experts , stakeholders and observers to attend its meetings , and may cooperate with other external experts as appropriate. other union institutions , bodies , offices and agencies , particularily the ones defining boardelines with other legislation , shall have an observer role.


### 10. notes with concern the gender imbalance within the centre’s senior management , with four out of six (66 , 67%) being men; notes the gender balance among the centre’s overall staff , with 170 out of 271 (62 ,73 %) being women; calls on the centre to take concrete measures to increase gender balance at all levels of hierarchy as soon as possible and report back to the discharge authority; ### 10. notes with concern the gender imbalance within the centre’s senior management , with four out of six (66 , 67%) being men; notes the gender balance among the centre’s overall staff , with 170 out of 271 (62 ,73 %) being women; calls on the centre to take concrete measures to increase gender balance at all levels of hierarchy as soon as possible and report back to the discharge authority; recalls also the importance of ensuring a balanced geographical representation among the agency's management and staff personnel;


### digitalisation & green transition ### digitalisation & sustainability


### 30. notes that the centre continued to have a high level of attention in media , social media and through its websites in 2021 in connection with the natural evolution covid-19 pandemic; notes that the centre’s website had over 18 million page views in 2021 , a decrease compared to 32 million in 2020 ,; notes that the centre’s press and media team handled 963 media requests , as opposed to approximately 1917 the year before; notes that the centre observed an increase of 18 % in the number of followers on twitter and a 44 % increase in the number of fans and followers on facebook; ### 30. welcomes that the centre continued to have a high level of attention in media , social media and through its websites in 2021 in connection with the natural evolution covid-19 pandemic; notes that the centre’s website had over 18 million page views in 2021 , a decrease compared to 32 million in 2020; notes that the centre’s press and media team handled 963 media requests , as opposed to approximately 1917 the year before; notes that the centre observed an increase of 18 % in the number of followers on twitter and a 44 % increase in the number of fans and followers on facebook; encourages the centre to continue this trend and to consider sharing the best practices among other eu agencies to maximize dissemination of their activities among the general public;


### 4. recalls that on 27 march 2021 , the transparency regulation came into effect , necessitating considerable investment for the development of new processes , the review of efsa’s organisation design , and the leveraging of its technology and information management capabilities. ### 4. recalls that on 27 march 2021 , the transparency regulation came into effect , necessitating considerable investment for the development of new processes , the review of efsa’s organisation design , and the leveraging of its technology and information management capabilities. draws attention in this context to the importance of maximum possible transparency in strengthening trust in eu institutions; welcomes in this context the increase in the sustainability of efsa's activities through the broader acquisition of resources from member states and more coordinated communication;


### 18. notes that in 2021 the ias issued a final report on the procurement and grant award processes in the authority covering the years 2019-2020; notes that the ias concluded that the governance , risk management and internal control framework set up by the authority for its procurement and grant award processes is adequately designed , efficient and effective , therefore providing reasonable assurance that the key internal control objectives are achieved; notes that the ias issued three important recommendations; calls on the authority to report to the discharge authority any development in that regard; ### 18. notes that in 2021 the ias issued a final report on the procurement and grant award processes in the authority covering the years 2019-2020; notes that the ias concluded that the governance , risk management and internal control framework set up by the authority for its procurement and grant award processes is adequately designed , efficient and effective , therefore providing reasonable assurance that the key internal control objectives are achieved; notes that the ias issued three important recommendations; calls on the authority to report to the discharge authority any development in that regard; notes also that on december 2021 the board endorsed efsa’s performance framework and the organisation’s strategic key performance indicators and adopted the programming document 2022-2024.


### 24. notes that in 2021 the authority continued its activities and was able to deliver its work programme despite the impact of the covid-19 pandemic; notes , that the authority suspended its staff missions , as well as physical meetings/events and gave priority to virtualisation , thus decreasing the budget in expenses in the related budget lines compared to the 2020 financial year; notes , moreover , that return to the office by staff was postponed and teleworking was promoted; ### 24. notes that in 2021 the authority continued its activities and was able to deliver its work programme despite the impact of the covid-19 pandemic; notes , that the authority suspended its staff missions , as well as physical meetings/events and gave priority to virtualisation , thus decreasing the budget in expenses in the related budget lines compared to the 2020 financial year; notes , moreover , that return to the office by staff was postponed and teleworking was promoted; encourages the agency to make use of the lessons learned regarding staff travel , in order to better recognize meetings that are more efficient to be held remotely than in-person in the future.


### (1) chemical pollution of surface and groundwater poses a threat to the aquatic environment , with effects such as acute and chronic toxicity in aquatic organisms , accumulation of pollutants in the ecosystem and loss of habitats and biodiversity , as well as to human health. setting environmental quality standards helps to implement the zero pollution ambition for a toxic-free environment. ### (1) chemical pollution of surface and groundwater poses a threat to the aquatic environment , with effects such as acute and chronic toxicity in aquatic organisms , accumulation of pollutants in the ecosystem and loss of habitats and biodiversity , as well as to human health. setting environmental quality standards helps to implement the zero pollution ambition for achieving a toxic-free environment as one of the priority objectives of the 8th environmental action programme[1].


### (1) chemical pollution of surface and groundwater poses a threat to the aquatic environment , with effects such as acute and chronic toxicity in aquatic organisms , accumulation of pollutants in the ecosystem and loss of habitats and biodiversity , as well as to human health. setting environmental quality standards helps to implement the zero pollution ambition for a toxic-free environment. ### (1) chemical pollution of surface and groundwater poses a threat to the aquatic environment , with effects such as acute and chronic toxicity in aquatic organisms , accumulation of pollutants in the ecosystem and loss of habitats and biodiversity , as well as to human health. setting achievable and enforcable environmental quality standards helps the efforts towards the zero pollution ambition for a toxic-free environment.


### (1) chemical pollution of surface and groundwater poses a threat to the aquatic environment , with effects such as acute and chronic toxicity in aquatic organisms , accumulation of pollutants in the ecosystem and loss of habitats and biodiversity , as well as to human health. setting environmental quality standards helps to implement the zero pollution ambition for a toxic-free environment. ### (1) chemical pollution of surface and groundwater poses a threat to the aquatic environment , with effects such as acute and chronic toxicity in aquatic organisms , accumulation of pollutants in the ecosystem and loss of habitats and biodiversity , as well as to human health. setting environmental quality standards helps to implement the minimum-level pollution ambition , thus helping to protect the environment and human health by limiting exposure and towards a toxic-free environment.


### (1) chemical pollution of surface and groundwater poses a threat to the aquatic environment , with effects such as acute and chronic toxicity in aquatic organisms , accumulation of pollutants in the ecosystem and loss of habitats and biodiversity , as well as to human health. setting environmental quality standards helps to implement the zero pollution ambition for a toxic-free environment. ### (1) chemical pollution of surface and groundwater poses a threat to the aquatic environment , with effects such as acute and chronic toxicity in aquatic organisms , accumulation of pollutants in the ecosystem and loss of habitats and biodiversity , to forestry and agriculture , especially wet agriculture , as well as to human health. setting environmental quality standards helps to implement the zero pollution ambition for a toxic-free environment.


### (2) pursuant to article 191(2) , second sentence , of the treaty on the functioning of the european union (tfeu) , union policy on the environment is to be based on the precautionary principle and on the principles that preventive action is to be taken , that environmental damage is , as a priority , to be rectified at source and that the polluter is to pay. ### (does not affect the english version.)


### 3. stresses that the european environment agency (eea) provides sound , independent information on the environment; commends the quality of its outputs released in 2021 , such as the launch of the mapmytree tool , under the 3 billion trees commitment of the eu biodiversity strategy; the support to the negotiations on the european climate law and the establishment of the european scientific advisory board on climate change; and the launch of a new web portal to support noise reporting; ### 3. presupposes that the european environment agency (eea) provides sound , independent information on the environment; notes with interest the quality of its outputs released in 2021 , such as the launch of the mapmytree tool , under the 3 billion trees commitment of the eu biodiversity strategy; the support to the negotiations on the european climate law and the establishment of the european scientific advisory board on climate change; and the launch of a new web portal to support noise reporting;


### 4. notes that the agency uses key performance indicators aimed to monitor quantitative the agency's performance in relation to its operational work planning , delivery of the annual work programme and financial and human resource management , among others; notes , in particular , the 2021delivery rate of key reports and assessments of 89% achieved; ### 4. notes that the agency uses key performance indicators aimed to monitor quantitatively the agency's performance in relation to its operational work planning , delivery of the annual work programme and financial and human resource management , among others; notes , in particular , the 2021delivery rate of key reports and assessments of 89% achieved; appreciates the kpis fulfilled and the fact that the agency has drawn attention to measures that can improve the efficiency and effectiveness of the agency’s work; however points out to the agency to take note on the indicators that are not achieved or lagging behind; recalls that according to agency’s annual report the delivery of key reports and assessments was slightly below target a total of 61 publications were planned , of which 49 were published and six carried over to 2022;


### 15. notes from the court’s report that the agency amended a framework service contract for the provision of repair and maintenance services by doubling the initial maximum budget , and that the justification used was the derogation applicable to negotiated procedures without prior publication , for which the conditions were not met , and that , moreover , conditions of the financial regulation that allow contracts to be modified without a new procurement procedure were not met; notes with concern that the court finds that the amendment was irregular; notes , moreover , that in 2021 there were no related payments; ### 15. notes from the court’s report that the agency amended a framework service contract for the provision of repair and maintenance services by doubling the initial maximum budget from €500 000 to €1 000 000 , and that the justification used was the derogation applicable to negotiated procedures without prior publication , for which the conditions were not met , and that , moreover , conditions of the financial regulation that allow contracts to be modified without a new procurement procedure were not met; notes with concern that the court finds that the amendment was irregular; notes , moreover , that in 2021 there were no related payments;


### 25. notes with appreciation that the agency has adopted the eea-eionet digitalisation framework in april 2021 , undertaking a number of key activities such as the modernisation of the agency data infrastructure and the start of projects exploring the use of artificial intelligence; ### 25. notes with appreciation that the agency has adopted the eea-eionet digitalisation framework in april 2021 , undertaking a number of key activities such as the modernisation of the agency data infrastructure and the start of projects exploring the use of artificial intelligence; welcomes that the eea launched several new digital and knowledge products in 2021 , including the european climate and health observatory and the european climate data explorer within the climate-adapt platform and interactive web reports on air quality and climate hazards;


### 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 and promoting public and animal health , as well as european innovation and competitiveness , by assessing and supervising medicines for human or veterinary use;


### 2. notes that the ema's authorised appropriations in the initial budget totalled eur 385 ,919 ,000 , representing a 7.78% increase over the 2020 initial budget , nevertheless , the final 2021 budget of the ema mounted to eur 379 ,288 ,000; ### 2. notes that the ema's authorised appropriations in the initial budget totalled eur 385 ,919 ,000 , representing a 7.78% increase over the 2020 initial budget , nevertheless , the final 2021 budget of the ema mounted to eur 379 ,288 ,000; stresses the need to maintain a cost-efficient organisation while at the same time living up to its obligations;


### 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. 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; points out that on ema’s annual report in the year 2021 the number of heads of department was 18 , while the year 2020 number of heads of departments was 13.


### 2. notes that the agency's final budget for 2021 was eur 111 091 291 , representing an increase of 1 ,4% compared to 2020; ### 2. notes that the agency's final budget for 2021 was eur 111 091 291 , representing an increase of 1 ,4% compared to 2020; underlines the need to have a cost-efficient organisation while at the same time living up to its obligations;


### 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 need for continued efforts towards establishing a fully sustainable financing model; notes its declining trend of the agency’s fee income , and calls on the commission to present its proposal to strengthen the governance of echa and increase the sustainability of its financing model , with the aim to avoid cost increases and further expenditures , 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 and the union chemical strategy for sustainability , circular economy action plan and zero pollution ambition in particular; acknowledges that the agency's staff capacity is largely exhausted and that any further tasks to be undertaken by the agency will inevitably require adequate additional staffing and , with it , the provision of sufficiently predictable funding;


### 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 implementing the european green deal and the union chemical strategy for sustainability , circular economy action plan and zero pollution ambition in particular;


### 4. notes that the agency reviewed the programming document for 2019-2023; notes that the agency achieved 194 out of 214 actions and outputs set in the 2021 work programme and that the 18 actions and outputs not met were mainly due to the covid-19 pandemic , specifically , to delayed , or less than foreseen , input received from partners; ### 4. notes that the agency reviewed the programming document for 2019-2023; notes that the agency achieved 194 out of 214 actions and outputs set in the 2021 work programme and that the 18 actions and outputs not met were mainly due to the covid-19 pandemic , specifically , to delayed , or less than foreseen , input received from partners; appreciates the kpi’s fulfilled and the fact that the agency has drawn attention to measures that can improve the efficiency and effectiveness of the agency’s work; however points out to the agency to take note on the indicators that are not achieved or lagging behind.


### 11. regrets that the high gender imbalance within the agency’s senior and middle management increased , with 27 (82 %) positions occupied by men and 6 (18 %) by women; notes that the agency reports , for the management board , a gender balance distribution of 15 men (42 %) and 21 women (58 %) and , for staff overall , 261 men (46 %) and 312 women (54 %); calls on the agency to take concrete measures to increase gender balance at all levels of hierarchy as soon as possible and report back to the discharge authority; ### 11. regrets that the high gender imbalance within the agency’s senior and middle management increased , with 27 (82 %) positions occupied by men and 6 (18 %) by women; notes that the agency reports , for the management board , a gender balance distribution of 15 men (42 %) and 21 women (58 %) and , for staff overall , 261 men (46 %) and 312 women (54 %); welcomes that in march 2022 , echa adopted its charter on diversity and inclusion , which aims to increase the ratio of underrepresented genders at both support and management levels; calls on the agency to take concrete measures to increase gender balance at all levels of hierarchy as soon as possible and report back to the discharge authority;


### 16. 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; ### 16. insists on the need to put in place more systematic rules on transparency , incompatibilities , conflict of interests , illegal lobbying and revolving doors; notes nevertheless that members of echa staff must notify new occupational activities for the first two years after leaving the service of the agency and that echa can forbid the new activity or impose conditions; notes that the echa anti-fraud strategy was revised by the echa management board in december 2016; calls on the agency to strengthen its internal control mechanisms , including the setting up of an internal anticorruption mechanism;


### 27. welcomes that the agency introduced a mandate for non-animal methods into its unit b2; acknowledges that this is a necessary step to the right direction , but it is not sufficient enough; encourages therefore the agency to work with all stakeholders in order to accelerate the transition to a full use of non-animal methods for chemical safety testing; ### 27. welcomes that the agency introduced a mandate for non-animal methods into its unit b2; acknowledges that this is a necessary step to the right direction , but it is not sufficient enough; encourages therefore the agency to work with all stakeholders in order to accelerate the transition to a full use of non-animal methods for chemical safety testing; reiterates that the law requires companies to use alternative methods whenever possible , so companies should only test on animals as a last resort.


### 32. calls for support to be given to smes to help them comply with eu chemical legislation; ### 32. calls for a chemical legislation that allows smes to prosper; stresses that chemicals legislation should be designed in a way that smes are able to implement it;


### 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 in order to promote the production of 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 providing regulatory stability and predictability is key to give direction to the necessary innovation for the transition to a circular and sustainable industry and long-term investments , for which rigorous stakeholder involvement and collaboration should be incentivised;


### 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 sustainable chemistry , materials (including plastics) and technologies , including non-chemical alternatives , that are safe and safe by design; calls the commission to develop sustainability assessment principles , complemented with product standards (such as the sustainable product policy framework);


### 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 animal protection and non-animal methods promotion across all echa activities;