### (36) the ecdc , established by regulation (ec) no 851/2004 of the european parliament and of the council27 , is a union agency with the mission of strengthening europe's defences against communicable diseases. the work of the ecdc on developing and updating guidelines on safety and quality of sohos from a communicable disease threat perspective , should be considered an important contribution in the field of sohos in the union and should be reflected in this regulation. in addition , the ecdc established an expert network for the microbial safety of sohos , which ensures the implementation of the requirements on the ecdc’s relations with the union member states and eea member states stated in regulation (ec) no 851/2004 , regarding strategic and operational collaboration on technical and scientific issues , surveillance , responses to health threats , scientific opinions , scientific and technical assistance , collection of data , identification of emerging health threats , and public information campaigns related to the safety of sohos. this soho expert network should provide information or advice in relation to relevant outbreaks of communicable diseases , in particular regarding the eligibility and testing of donors and the investigation of serious adverse occurrences involving suspected transmission of a communicable disease. ### (36) the ecdc , established by regulation (ec) no 851/2004 of the european parliament and of the council27 , is a union agency with the mission of strengthening europe's defences against communicable diseases. the work of the ecdc on developing and updating guidelines on safety and quality of sohos from a communicable disease threat perspective , should be considered an important contribution in the field of sohos in the union and should be reflected in this regulation. in addition , the ecdc established an expert network for the microbial safety of sohos , which ensures the implementation of the requirements on the ecdc’s relations with the union member states and eea member states stated in regulation (ec) no 851/2004 , regarding strategic and operational collaboration on technical and scientific issues , surveillance , responses to health threats , scientific opinions , scientific and technical assistance , collection of data , identification of emerging health threats , and public information campaigns related to the safety of sohos. this soho expert network should provide information or advice in relation to relevant outbreaks of communicable diseases , in particular regarding the eligibility and testing of donors and the investigation of serious adverse occurrences involving suspected transmission of a communicable disease. in order to comply with the union requirements for review of union legislation , a transparent and participatory stakeholder consultation process shall be put in place for the development of those provisions and guidelines from the expert bodies.the committees referred to and any working parties and scientific advisory groups established within those committees shall develop appropriate contacts with public and private key stakeholders , including patients , consumers , health professionals , and industry representatives.


### (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.


### (38) in order to promote a coordinated application of this regulation , a soho coordination board (scb) should be set up. the commission should participate in its activities and chair it. the scb should contribute to a coordinating the application of this regulation throughout the union , including by helping member states to conduct soho supervisory activities. the scb should be composed of persons designated by the member states based on their role and expertise in their competent authorities , and should also involve experts that are not working for competent authorities , for specific tasks where access to necessary in-depth technical expertise in the field of sohos is required. in the latter case , appropriate consideration should be given to the possibility of involving european expert bodies such as the ecdc and the edqm and existing professional , scientific and donor and patient representative groups at union level in the field of sohos. ### (38) in order to promote a coordinated application of this regulation , a soho coordination board (scb) should be set up. the commission should participate in its activities and chair it. the scb should contribute to a coordinating the application of this regulation throughout the union , including by helping member states to conduct soho supervisory activities. the scb should be composed of persons designated by the member states based on their role and expertise in their competent authorities , and should also involve experts that are not working for competent authorities , for specific tasks where access to necessary in-depth technical expertise in the field of sohos is required. in the latter case , appropriate consideration should be given to the possibility of involving european expert bodies such as the ecdc and the edqm and existing professional , scientific and donor and patient representative groups and industry experts at union level in the field of sohos. when seeking the input of expert bodies such as the ecdc and the edqm , the scb shall have due regard to their respective areas of expertise and avoid duplication.


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


### (40) the concept of a plasma master file (pmf) was established in commission directive 2003/63/ec28. since that directive provided for a specific regulatory role for the european medicines agency (ema) in relation to authorisation of plasma for fractionation , the scb should also collaborate with the relevant ema expert working groups to exchange experience and good practices so that criteria for the eligibility of donors of plasma for fractionation and of donors of blood for transfusionare implemented by member states in a consistent and coherent way. ### (40) the concept of a plasma master file (pmf) was established in commission directive 2003/63/ec28. since that directive provided for a specific regulatory role for the european medicines agency (ema) in relation to authorisation of plasma for fractionation , the scb should also collaborate with the relevant ema expert working groups to exchange experience and good practices so that criteria for the eligibility of donors of plasma for fractionation are implemented by member states in a consistent and coherent way.


### (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 be limited to the extent necessary to carry out supervisory activities provided for in this regulation. in addition , the personal data and curriculum vitae of the persons responsible for the release of sohos should not be made public.


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


### (48) in order to be able to supplement this regulation where necessary with additional standards concerning the protection of donors , recipients and offspring from medically assisted reproduction to take into account technical and scientific developments in the field of sohos , and with additional rules on the authorisation of importing soho entities , on obligations and procedures for importing soho entities , on the organisation of union training and exchange programmes , on technical specifications concerning the eu soho platform , and on data protection , the power to adopt acts in accordance with article 290 tfeu should be delegated to the commission. it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement of 13 april 2016 on better law-making29. in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents at the same time as member states' experts , and their experts systematically have access to meetings of commission expert groups dealing with the preparation of delegated acts. ### (48) in order to be able to supplement this regulation where necessary with additional standards concerning the protection of donors , recipients and offspring conceived by means of fertility treatment to take into account technical and scientific developments in the field of sohos , and with additional rules on the authorisation of importing soho entities , on obligations and procedures for importing soho entities , on the organisation of union training and exchange programmes , on technical specifications concerning the eu soho platform , and on data protection , the power to adopt acts in accordance with article 290 tfeu should be delegated to the commission. it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement of 13 april 2016 on better law-making29. in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents at the same time as member states' experts , and their experts systematically have access to meetings of commission expert groups dealing with the preparation of delegated acts.


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


### 4. where non-viable sohos or their derivatives , as defined in article 2 , point (17) , of regulation (eu) 2017/745 , incorporate , as an integral part , a medical device , and where the action of the non-viable sohos or their derivatives is principal and not ancillary to that of the device , the non-viable sohos or their derivatives shall be governed by this regulation. if the action of the non-viable sohos or their derivatives is ancillary to that of the device and not principal , the provisions of this regulation , insofar as they concern donor recruitment , donor history review and eligibility assessment , testing of donors for eligibility or matching purposes , collection of sohos from donors or patients , shall apply. ### 4. where non-viable sohos or their derivatives , as defined in article 2 , point (17) , of regulation (eu) 2017/745 , incorporate , as an integral part , a medical device , and where the action of the non-viable sohos or their derivatives is principal and not ancillary to that of the device , the non-viable sohos or their derivatives shall be governed by this regulation. if the action of the non-viable sohos or their derivatives is ancillary to that of the device and not principal , the provisions of this regulation , insofar as they concern donor recruitment , donor history review and eligibility assessment , testing of donors for eligibility or matching purposes , collection of sohos from donors or patients , shall apply. in the case of sohos whose donation is not regulated by national law , the relevant procedures under health policy programme agreements shall apply.


### (5) ‘substance of human origin’ (soho) means any substance collected from the human body in whatever manner , whether it contains cells or not and whether those cells are living or not. for the purposes of this regulation , soho does not include organs in the sense of article 3 , point (h) , of directive 2010/53/eu; ### (5) ‘substance of human origin’ (soho) means any substance collected from the human body for health and medical purposes , respecting its human dignity and being able to form a new individual , whether it contains cells or not and whether those cells are living or not; for the purposes of this regulation , soho does not include organs in the sense of article 3 , point (h) , of directive 2010/53/eu;


### (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 person who , freely and voluntarily , alive or deceased , has with informed prior consent and in the presence of a medical practitioner authorised the donation of soho for altruistic medical purposes to a soho organisation that respects human dignity. if the donor is a minor , the consent of the parents shall be required.


### (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 by intra-uterine insemination of sperm or in vitro fertilisation;


### (11) ‘offspring from medically assisted reproduction’ means fetuses and children that are born following medically assisted reproduction; ### (11) ‘offspring from fertility treatments’ means embryos , foetuses and children resulting from conception through fertility treatments;


### (14) ‘collection’ means a process by which sohos are removed , procured , excreted , secreted or obtained by any other manner , including any preparatory steps , such as hormone treatment , needed to facilitate the process; ### 14) ‘collection’ means a process by which sohos are removed , procured , excreted , secreted or obtained by any other manner;


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


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


### (61) ‘reproductive cells’ means all cells intended to be used for the purpose of medically assisted reproduction; ### (61) 'reproductive cells' means all sexually reproductive haploid cells , a female and a male gamete that unite to form a new individual , whose genetic load is unique and unrepeatable;


### (64) ‘compensation’ means making good of any losses associated with donation; ### (64) 'compensation' means making good of any losses and expenses associated with donation; such compensation should help facilitate matters and remove obstacles for donors. it must be ensured that throughout the entire soho treatment , from donation to implantation in the recipient , the principle of compensation rather than that of profit-making is followed.


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


### 1. member states may maintain or introduce within their territories measures that are more stringent than the ones provided for in this regulation on condition that those national measures are compatible with union law , and are proportionate to the risk to human health. ### 1. member states may maintain or introduce within their territories measures that are more stringent than the ones provided for in this regulation in order to comply with national provisions in this field on condition that those national measures are proportionate to the risk to human health.


### 1. member states may maintain or introduce within their territories measures that are more stringent than the ones provided for in this regulation on condition that those national measures are compatible with union law , and are proportionate to the risk to human health. ### 1. member states may maintain or introduce within their territories measures that are more stringent than the ones provided for in this regulation on condition that those national measures are compatible with the law.


### 2. member states shall make available to the public details of measures put in place in accordance with paragraph 1 without undue delay , including on the internet. the soho national authority shall submit the details of any more stringent measure to the eu soho platform referred to in chapter xi. ### 2. member states may make available to the public details of measures put in place in accordance with paragraph 1 , including on the internet.


### 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. without prejudice to article 75 , competent authorities shall carry out their supervisory activities in a transparent manner and they shall make accessible and clear to the public decisions taken in cases where a soho entity has failed to comply with an obligation under this regulation and where such failure causes or may cause a serious risk to human health. ### 1. without prejudice to article 75 , competent authorities shall carry out their supervisory activities in a transparent manner and they shall make accessible and clear to the public decisions to revoke , suspend or reinstate authorisation for soho activities.


### a sufficient number of suitably qualified personnel to carry out the supervisory functions provided for in this regulation; ### a sufficient number of suitably qualified personnel and subject matter experts on specific types of sohos to carry out the supervisory functions provided for in this regulation;


### in the course of the consultation referred to in paragraph 1 , the competent authorities may also submit a request to the scb for its opinion on the regulatory status of the substance , product or activity under this regulation and shall do so in all cases where the competent authorities , after the consultations referred to in paragraph 1 , are not in a position to take a decision in that respect. ### in the course of the consultation referred to in paragraph 1 , the competent authorities shall submit a request to the scb for its opinion on the regulatory status of the substance , product or activity under this regulation.


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


### declare in writing any direct or indirect interests referred to in article 7(2) and update that declaration yearly and whenever the declared information changes or any new interest arises; ### before any inspection procedure is initiated , declare in writing any direct or indirect interests referred to in article 7(2) relating to inspection activities of the entity concerned;


### article 17 ### deleted


### the name and curriculum vitae of the responsible person for release of sohos as referred to in article 38 , if the soho entity releases sohos or soho preparations. ### deleted


### 4. paragraph 3 shall not apply to soho entities that import soho. ### deleted


### 1. competent authorities shall establish and maintain a system for receiving and processing requests for the authorisation of importing soho entities. ### 1. competent authorities shall establish and maintain a system for receiving and processing requests for the authorisation of importing soho entities. soho entities shall ensure that sohos and their preparations are imported where european supply management and the domestic supply chain are not compromised.


### the commission shall adopt implementing acts to specify uniform procedures and working methods for establishing and maintaining an importing soho entity authorisation system. ### the commission shall adopt implementing acts to specify uniform procedures and working methods for establishing and maintaining an importing soho entity authorisation system. such entities shall comply with the technical and ethical specifications in force within the union in order to maintain an optimal level of quality , safety and efficiency.


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


### acknowledge receipt of the application within 14 working days; ### deleted


### assess the application; ### assess the application on the basis of the provisions of national administrative law;


### 5. by derogation from paragraph 4 , competent authorities may conduct inspections , in full or in part , by means of a remote document review , provided that: ### 5. by derogation from paragraph 4 , competent authorities may conduct inspections , in full or in part , by means of a remote inspection , provided that:


### inspectors shall verify that soho establishments meet the general standards concerning soho donor protection laid down in article 53 , the standards concerning the voluntary and unpaid nature of soho donations laid down in article 54 , the standards concerning information to be provided prior to consent or authorisation laid down in article 55 and the general standards concerning recipient and offspring protection laid down in article 58 , as applicable. ### inspectors shall verify that soho establishments meet the general standards concerning soho donor protection laid down in article 53 , the standards concerning information to be provided prior to consent or authorisation laid down in article 55 and the general standards concerning recipient and offspring protection laid down in article 58 , as applicable.


### 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 it should be unified across the eu risk-based approach.


### 16. for the purpose of standardised inspections referred to in paragraph 1 of this article , competent authorities shall consult the relevant best practices agreed and documented by the scb as referred to in article 68(1) , point (c). ### 16. for the purpose of standardised inspections referred to in paragraph 1 of this article , competent authorities shall consult the relevant best practices agreed and documented by the scb as referred to in article 68(1) , point (c) , provided that they do not contravene the national legal provisions in force in the member state concerned.


### 2. competent authorities shall provide inspectors with a specific induction training before inspectors take up their duties. for the specific induction training , competent authorities shall consult the relevant best practices agreed and documented by the scb as referred to in article 68(1) , point (c). ### 2. competent authorities may organise specific induction training for inspectors before they take up their duties. for the specific induction training , competent authorities shall consult the relevant best practices agreed and documented by the scb as referred to in article 68(1) , point (c).


### 1. competent authorities shall verify that soho entities have appropriate procedures in place to ensure traceability and coding of sohos as referred to in article 45. ### 1. competent authorities shall verify that soho entities have appropriate procedures in place to ensure traceability and coding of sohos as referred to in article 45. the authorities shall ensure that enhanced traceability is put in place for donations where the medical , bioethical and legal implications are of particular relevance. in such cases , access to information and traceability shall be guaranteed for the recipient and the offspring conceived following fertility treatment.


### 1. competent authorities shall be responsible for the management of vigilance associated with soho activities. they shall provide guidance and templates for the submission of sao notifications and of sao investigation reports as referred to in article 47. ### 1. competent authorities shall be responsible for the management of vigilance associated with soho activities. they shall provide guidance for the submission of sao notifications and of sao investigation reports as referred to in article 47.


### 10. competent authorities shall submit to their soho national authorities an annual summary of the sao notifications and sao investigation reports received. the soho national authorities shall submit an annual summary of those sao notifications and investigation reports to the eu soho platform referred to in chapter xi before 31 may of the subsequent year and shall make an aggregated version of that summary available to the public in their member state , including on the internet. they shall include in the annual summary the numbers and types of those sao reported to them that meet thresholds of seriousness and imputability that are agreed at union level within the scb. ### 10. competent authorities shall submit to their soho national authorities a summary of the sao notifications and sao investigation reports received in accordance with the provisions of the national law of the member state concerned. the soho national authorities shall submit an annual summary of those sao notifications and investigation reports to the eu soho platform referred to in chapter xi before 31 may of the subsequent year and shall make an aggregated version of that summary available to the public in their member state , including on the internet. they shall include in the annual summary the numbers and types of those sao reported to them that meet thresholds of seriousness and imputability that are agreed at union level within the scb.


### 2. where applicable , soho entities shall make all reasonable efforts to encourage prospective parents of children born from third party donation to commit to communicate information concerning any genetic conditions that emerge , as those children grow up , to the soho entity where they were treated. that entity shall communicate , without undue delay , the information to the soho entity that distributed or applied the reproductive cells with a view to preventing further distribution of soho from the implicated soho donor. ### 2. where applicable , soho entities shall make all reasonable efforts to encourage prospective parents of children born from third party donation to commit to communicate information concerning any genetic conditions that emerge , as those children grow up , to the soho entity where they were treated.


### 51 physician ### 51 physicians and embryologists


### 1. each soho establishment shall designate a physician who resides and carries out its tasks in the same member state and who shall at least fulfil the following conditions and have the following qualifications: ### 1. each soho establishment shall designate a physician or embryologist who resides and carries out its tasks in the same member state and who shall at least fulfil the following conditions and have the following qualifications:


### possession of formal qualification as a physician; ### possession of formal qualification as a physician or have a degree in biology , biotechnology or medical analytics;


### 2. the physician referred to in paragraph 1 shall be responsible for at least the following tasks: ### 2. the person referred to in paragraph 1 shall be responsible for at least the following tasks:


### 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 , where justified , 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 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;


### 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 referred to in paragraph 3;


### 6. the commission is empowered to adopt delegated acts in accordance with article 77 in order to be able to supplement this regulation in cases where additional standards are needed in order to ensure the protection of donors. ### deleted


### 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.


### 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 and expenses 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.


### 4. for those standards concerning donor protection or elements thereof for which no implementing act has been adopted , in order to apply such standards or elements thereof , soho entities shall follow: ### 4. for those standards concerning donor protection or elements thereof for which no implementing act has been adopted , in order to apply such standards or elements thereof in accordance with what has been decided by the member state , soho entities shall follow:


### 4. for those standards concerning donor protection or elements thereof for which no implementing act has been adopted , in order to apply such standards or elements thereof , soho entities shall follow: ### 4. for those standards concerning donor protection or elements thereof for which no implementing act has been adopted , in order to apply such standards or elements thereof , and upon decision of eu member states , soho entities shall follow:


### other guidelines accepted by competent authorities , as achieving an equivalent level of donor safety as set by the technical guidelines referred to in point (a); ### other guidelines accepted by competent authorities , as achieving a comparable level of donor safety as set by the technical guidelines referred to in point (a);


### where the guidelines referred to in points (a) or (b) do not address a particular technical method , other technical methods in line with relevant international guidelines and scientific evidence in peer-reviewed scientific publications , where available. ### where the guidelines referred to in points (a) or (b) do not address a particular technical method , other technical methods in line with relevant internationally recognised guidelines and scientific evidence in peer-reviewed scientific publications , where available.


### soho entities shall protect the health of soho recipients and offspring from medically assisted reproduction from risks posed by soho preparations. they shall do so by identifying , minimising or eliminating those risks. ### soho entities shall protect the health of soho recipients and offspring conceived following fertility treatment from risks posed by soho preparations. they shall do so by identifying , minimising or eliminating those risks , guaranteeing the right of individuals to know their genetic origin.


### 58 standards concerning soho recipient and offspring protection ### 58 standards concerning protection of soho recipients and of offspring conceived following fertility treatment


### 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 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.


### where the transmission of genetic conditions is an identified risk , and in particular in the case of medically assisted reproduction with third party donation: ### where the transmission of genetic conditions is a genuinely identified risk , and in particular in the case of medically assisted reproduction with third party donation:


### the safeguards intended to protect their data and the data of the offspring in the case of medically assisted reproduction; ### the safeguards intended to protect their data and the data of the offspring conceived following fertility treatment;


### 15. the commission is empowered to adopt delegated acts in accordance with article 77 in order to be able to supplement this regulation in cases where additional standards are deemed necessary to ensure the protection of soho recipients or offspring from risks posed by the application of soho preparations. ### deleted


### 16. where , in the case of risk to soho recipients and offspring from medically assisted reproduction arising from inadequate levels of safety and quality of sohos , imperative grounds of urgency so require , the procedure provided for in article 78 shall apply to delegated acts adopted pursuant to this article. ### 16. where , in the case of risk to soho recipients and offspring conceived following fertility treatment arising from inadequate levels of safety and quality of sohos , imperative grounds of urgency so require , the procedure provided for in article 78 shall apply to delegated acts adopted pursuant to this article.


### establishment of national soho emergency plans ### establishment of national soho plans


### 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 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.


### 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 involvement of all relevant stakeholders.


### additional emergency measures by member states ### additional measures by member states


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


### 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.


### liaising for the exchange of experience and good practices , as relevant , with the edqm and the ecdc regarding technical standards , and with the ema on authorisations and supervisory activities concerning the implementation of the pmf certification pursuant to directive 2003/63/ec , to support the harmonised implementation of standards and technical guidelines; ### liaising for the exchange of experience and good practices , as relevant , with the edqm and the ecdc regarding technical standards within their respective areas of expertise , and with the ema on authorisations and supervisory activities concerning the implementation of the pmf certification pursuant to directive 2003/63/ec , to support the harmonised implementation of standards and technical guidelines;


### 1. the commission shall perform controls , including audits , in the member states to verify the effective application of the requirements relating to: ### 1. the commission , with the agreement of the member state and in duly justified cases , shall perform controls , including audits , in the member states to verify the effective application of the requirements relating to:


### the commission shall establish and maintain cooperation with the edqm in relation to the guidelines published by the edqm. ### the commission shall establish and maintain cooperation with the edqm in relation to the guidelines published by the edqm. such cooperation is without prejudice to the autonomy of union law and should take into account union principles on transparency and stakeholder participation.


### 4. the commission shall adopt delegated acts in accordance with article 77 supplementing this regulation by laying down technical specifications regarding the establishment , management and maintenance of the eu soho platform. ### deleted


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


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


### unless otherwise provided for in paragraph 2 , it shall apply from … [op please insert the date = two years after the date of entry into force of this regulation]. ### unless otherwise provided for in paragraph 2 , it shall apply from … [op please insert the date = three years after the date of entry into force of this regulation].


### article 81(3) to (6) and article 82(3) shall apply from … [op please insert the date = three years after the date of entry into force of this regulation]. ### article 81(3) to (6) and article 82(3) shall apply from … [op please insert the date = four years after the date of entry into force of this regulation].


### 8. notes that the court , in its special report no 13/20222 , found that the centre does not comprehensively assess the usefulness and impact of its guidance and calls on the centre to obtain regular feedback from its stakeholders to fill this gap; ### 8. notes that the court , in its special report no 13/20222 , observes that that the centre does not comprehensively assess the usefulness and impact of its guidance , as it is not legally obliged to do so , and calls on the centre to improve the monitoring of the extent to which its guidance is implemented;


### 5. notes with satisfaction that eea achieved excellent budget implementation in 2021 , with cancelled appropriations well below the 3% threshold and that a positive budgetary outturn of eur 171 ,623 is to be reimbursed to the commission. ### 5. notes that the eea achieved excellent budget implementation in 2021 , with cancelled appropriations well below the 3% threshold and that a positive budgetary outturn of eur 171 ,623 is to be reimbursed to the commission.


### 6. notes that the eea has 236 posts , out of which 85% are dedicated to operational activities and 15% to support; considers that , in order to properly perform the tasks on the union’s path to climate neutrality , this number should grow in the years to come; ### 6. notes that the eea has 236 posts , out of which 85% are dedicated to operational activities and 15% to support;


### 8. regrets that the court of auditors (the ‘court’) , in its annual report on eu agencies for the financial year 2021 , identified some minor failures on the regularity of transactions and on the sound management of contracts , notably by failing to file timely exception notes when extending framework contracts ; notes that the eea recognises these failures and will reinforce its controls and procedures; ### 8. regrets that the court of auditors (the ‘court’) , in its annual report on eu agencies for the financial year 2021 , identified some minor failures on the regularity of transactions and on the sound management of contracts , notably by failing to file timely exception notes when extending framework contracts; notes that the eea recognises these failures and will reinforce its controls and procedures while ensuring exception notes are filed where involuntary breaches of the finance regulation occur;


### 7. welcomes that ema recommended for approval in 2021 4 more vaccines and 5 new treatments to combat covid-19 pandemic; ### 7. acknowledges that ema recommended for approval in 2021 4 more vaccines and 5 new treatments for use in combatting the covid-19 pandemic;


### 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 chemicals strategy for sustainability and the zero pollution ambition for a toxic-free environment , the circular economy action plan , as well as the 8th environmental action programme (eap).


### 8. notes that the agency collaborates closely with other union agencies , such as the european food safety authority , the european centre for disease prevention and control and the european medicines agency , by means of memoranda of understanding; underlines the importance of such an approach , in order to ensure that the work of each agency is consistent with that of the other agencies and to meet the requirements of sound financial management; welcomes the sharing of services and encourages cooperation among the union agencies where and when possible; ### 8. notes that the agency collaborates closely with other union agencies , such as the european food safety authority , the european centre for disease prevention and control and the european medicines agency , by means of memoranda of understanding to strengthen exchanges of information , better mutual understanding and , where appropriate , joint projects; underlines the importance of such an approach , in order to ensure that the work of each agency is consistent with that of the other agencies and to meet the requirements of sound financial management; welcomes the sharing of services and encourages cooperation among the union agencies where and when possible;


### 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 regulatory stability and predictability is key to give direction to the necessary innovation for the transition to a circular and sustainable chemicals sector that uses renewable feedstock which is able to reconvert industrial sites into bio-refineries , and long-term investments;


### 34. highlights the need for union chemicals legislation to provide incentives for sustainable chemistry , materials (including plastics) and technologies , including non-chemical alternatives , that are safe and non-toxic by design; ### 34. highlights the need for union chemicals legislation to provide incentives for sustainable and bio-based chemistry , such as the funds dedicated to the bio-based chemistry (i.e. the bio-based joint undertaking) , materials (including plastics) and technologies , including non-chemical alternatives , that are safe and non-toxic by design;


### 37. calls on the commission to ensure that imported products abide by the same standards as those governing chemicals and products produced in the union; considers that control checks of non-compliance inside the union and at its borders should be enhanced; ### 37. calls on the commission to ensure that imported products abide by the same standards as those governing chemicals and products produced in the union; considers that control checks of non-compliance inside the union and at its borders should be enhanced through a reinforced cooperation among customs authorities and the development of specific digital tools;


### 3. stresses that the new strategy should be coherent with , and complementary to , the other policy objectives of the green deal; ### 3. stresses that the new strategy should be coherent with , and complementary to , the other policy objectives of the green deal and the new context for european economy after covid 19;


### 4. considers that the chemicals strategy should achieve coherence and synergies between chemicals legislation (e.g. reach , clp , pops , mercury , plant protection products , biocides) and related union legislation , including specific product legislation (e.g. toys , cosmetics , food contact materials , construction products , packaging) , general product legislation (e.g. eco-design , eco-label) , legislation on environmental compartments (e.g. water and air) , as well as legislation on industrial installations (e.g. ied , seveso iii directive); ### 4. considers that the chemicals strategy should achieve coherence and synergies between chemicals legislation (e.g. reach , clp , pops , mercury , plant protection products , biocides) and related union legislation , including specific product legislation (e.g. toys , cosmetics , food contact materials , construction products , packaging) , general product legislation (e.g. eco-design , eco-label) , legislation on environmental compartments (e.g. water and air) , as well as legislation on industrial installations (e.g. ied , seveso iii directive); considers that special attention should be paid to reducing overlaps between legal frameworks , and between tasks allocated to echa , efsa and ema;


### 6. stresses that the strategy should fully reflect the precautionary principle and the polluter pays principle; ### 6. stresses that the strategy should fully reflect the precautionary principle , the innovation principle and the polluter pays principle;


### 7. highlights that the new chemicals strategy should be based upon robust and up-to-date scientific evidence and that subsequent regulatory action should be accompanied by impact assessments , taking into account the input of relevant stakeholders; ### 7. highlights that the new chemicals strategy should be based upon robust and up-to-date scientific evidence and that subsequent regulatory action should be accompanied by impact assessments , taking into account the input of relevant stakeholders to increase clarity about priorities;


### 8. reaffirms that all regulatory gaps in eu chemicals legislation should be closed and that the new chemicals strategy should effectively contribute to the rapid substitution of substances of very high concern and other hazardous chemicals , including endocrine disruptors , very persistent chemicals , neurotoxicants and immuno-toxicants , as well as tackling the combination effects of chemicals , nano-forms of substances and exposure to hazardous chemicals from products; reiterates that any ban of these chemicals should take all aspects of sustainability into account; ### 8. reaffirms that all regulatory challenges in eu chemicals legislation should be addressed and that the new chemicals strategy should effectively contribute to the rapid substitution of substances of very high concern and other hazardous chemicals of equivalent level of concern to the possible extent , including endocrine disruptors , very persistent chemicals , neurotoxicants and immuno-toxicants , as well as tackling the combination effects of chemicals , nano-forms of substances and exposure to hazardous chemicals from products; reiterates that any ban of these chemicals should take all aspects of sustainability into account;


### 8. reaffirms that all regulatory gaps in eu chemicals legislation should be closed and that the new chemicals strategy should effectively contribute to the rapid substitution of substances of very high concern and other hazardous chemicals , including endocrine disruptors , very persistent chemicals , neurotoxicants and immuno-toxicants , as well as tackling the combination effects of chemicals , nano-forms of substances and exposure to hazardous chemicals from products; reiterates that any ban of these chemicals should take all aspects of sustainability into account; ### 8. reaffirms that all regulatory gaps in eu chemicals legislation should be closed and that the new chemicals strategy should effectively contribute to the rapid substitution of substances of very high concern and other hazardous chemicals , including endocrine disruptors , very persistent chemicals , neurotoxicants and immuno-toxicants , as well as tackling the combination effects of chemicals and exposure to hazardous chemicals from products; reiterates that any ban of these chemicals should take all aspects of sustainability such as the availability and feasibility/efficacy of (safe and sustainable) substitutes into account;


### 10. reiterates the need to minimise animal testing with the help of new approach methodologies and calls for increased efforts and funds to this end with aim to establish non-animal based safety assessments in all relevant legislation , in addition to cosmetics; regrets that there are still barriers to the use and acceptance of alternative (non-animal) test methods for regulatory purposes , partially linked to gaps in the available test guidelines4 , requests action to remedy this situation; ### 10. reiterates the need to avoid unnecessary animal testing with the help of new approach methodologies and intelligent testing strategies and calls for increased efforts and funds to this end with aim to establish non-animal based safety assessments in all relevant legislation , in addition to cosmetics; regrets that there are still barriers to the use and acceptance of alternative (non-animal) test methods for regulatory purposes , partially linked to gaps in the available test guidelines4 , requests action to remedy this situation as this will allow for faster delivery of data;


### 11. considers that the strategy should extend the use of generic risk assessment across legislation; ### 11. considers that the strategy should ensure a balance between the use of generic and specific risk assessment across legislation;


### 12. calls on the commission to take all necessary action to ensure that combination effects are fully addressed across all relevant legislation , including the development of new test methods and the revision of data requirements , where necessary; ### 12. calls on the commission to take all necessary action to ensure that combination effects are fully addressed across all relevant legislation , including the development of new test methods and the revision of data requirements , where necessary and according to methodologies and guidelines agreed by eu agencies and in consultation with relevant stakeholders;


### 15. considers that regulatory measures are needed to protect vulnerable groups; calls on the commission to adopt a cross-cutting definition of vulnerable groups , to adapt risk assessments and to align the protection of vulnerable groups throughout all chemical legislation; ### 15. considers that regulatory measures are needed to protect vulnerable groups; calls on the commission to adopt a cross-cutting definition of vulnerable groups , to adapt risk assessments where necessary and to align the protection of vulnerable groups throughout all chemical legislation;


### 17. considers that the evaluation of substances needs both to improve and speed-up; ### 17. considers that the evaluation of substances needs both to improve and speed-up taking into account the available robust , sound scientific evidence on the substances;


### 17. considers that the evaluation of substances needs both to improve and speed-up; ### 17. considers that the evaluation of substances needs both to improve and speed-up following common methodologies across eu agencies;


### 28. underlines the importance of developing non-toxic material cycles; reaffirms that , in accordance with the waste hierarchy , prevention takes priority over recycling and that , accordingly , recycling should not justify the perpetuation of the use of hazardous legacy substances; ### 28. underlines the importance of developing non-toxic material cycles that could be achieved through the development of bio-based chemicals; reaffirms that , in accordance with the waste hierarchy , prevention takes priority over recycling and that , accordingly , recycling should not justify the perpetuation of the use of hazardous legacy substances;


### 29. considers that the disclosure of all hazardous chemicals in articles along the supply chain to consumers and waste managers is a prerequisite to achieve non-toxic material cycles; ### 29. considers that the disclosure of non-confidential information on relevant hazardous chemicals in articles along the supply chain to consumers and waste managers is a prerequisite to achieve non-toxic material cycles and invites the commission to identify innovative , highly secure digital technologies to support the effective and timely communication of such information.


### 31. points out that the strategy should help the chemical industry to reach climate-neutrality and the zero pollution objectives as well as support the good functioning of the internal market while enhancing the competitiveness and innovation of eu industry; ### 31. points out that the strategy should help the chemical industry to reach climate-neutrality and the zero pollution objectives highlighting the contribution given by the use of renewable feedstock (i.e. biomass) , as well as support the good functioning of the internal market while enhancing the competitiveness and innovation of eu industry; considers that the strategy should mitigate the administrative burden and not undermine the union’s industrial production and economy;


### 1. recalls that the 2021 union budget is the first one under the multiannual financial framework (mff) for 2021-2027; stresses that the amounts allocated to the 2021 budget should match up to the expectations of union citizens in a post-covid-19 europe , fostering strong economic recovery , and should be aligned with the paris agreement and with the green deal objectives , and in particular that of becoming climate neutral by 2050 , while supporting the member states that have suffered the most; calls on the commission to assess the 2021 union budget in the light of the provisions of this paragraph , and to make the appropriate corrections if they are not met; ### 1. recalls that the 2021 union budget is the first one under the multiannual financial framework (mff) for 2021-2027; stresses that the amounts allocated to the 2021 budget should match up to the expectations of union citizens in a post-covid-19 europe , fostering strong economic recovery , and should be aligned with the paris agreement , while supporting the member states that have suffered the most; calls on the commission to assess the 2021 union budget in the light of the provisions of this paragraph , and to make the appropriate corrections if they are not met;


### 2. welcomes the provision of the solvency support instrument that stipulates that beneficiaries of financial support will be encouraged to put in place a green transition plan; is of the opinion that that provision should be mandatory; ### 2. welcomes the provision of the solvency support instrument that stipulates that beneficiaries of financial support will be encouraged to put in place a green transition plan;


### 3. considers that the union should also show global climate leadership through its budgeting; highlights that every effort should be made to ensure that the overall climate and biodiversity mainstreaming targets are reached as soon as possible; recalls parliament’s position calling for 10 % of the union budget to be allocated to biodiversity expenditures; points out that climate and biodiversity-related expenditure must be tracked using a more robust , transparent and comprehensive methodology; is of the opinion that the taxonomy regulation provides the proper framework to update that methodology; ### 3. highlights that every effort should be made to ensure that the overall climate and biodiversity mainstreaming targets are reached as soon as possible; recalls parliament’s position calling for 10 % of the union budget to be allocated to biodiversity expenditures; points out that climate and biodiversity-related expenditure must be tracked using a more robust , transparent and comprehensive methodology;


### 4. calls on the commission to implement green budgeting tools as of 2021; underlines in that regard the importance of effective climate and biodiversity proofing of the budget; ### 4. calls on the commission to implement green budgeting tools as of 2021; underlines in that regard that the introduction of these tools must not be to the detriment of important low-carbon bridging technologies such as natural gas , carbon capture and storage , and nuclear power;


### 5. stresses that sufficient funding should be allocated to the union civil protection mechanism , in order to help tackle public health emergencies , forest fires , floods , earthquakes , and other natural and human-made disasters , the effects of which are expected to be further exacerbated by climate change; ### 5. stresses that sufficient funding should be allocated to the union civil protection mechanism , in order to help tackle public health emergencies , forest fires , floods , earthquakes , and other natural and human-made disasters , the effects of which are exacerbated by severe drought and poor land management practices;


### 9. notes that echa collaborates closely with other agencies , such as the european food safety authority , the european centre for disease prevention and control and the european medicines agency , through memoranda of understanding; underlines the importance of such an approach , in order to ensure consistency between the work of those agencies and to meet the requirements of sound financial management; ### 9. notes that echa collaborates closely with other agencies , such as the european food safety authority , the european centre for disease prevention and control and the european medicines agency , by means of memoranda of understanding; underlines the importance of such an approach , in order to ensure consistency between the work of those agencies and to meet the requirements of sound financial management;


### 2. emphasises that the agency is partly financed from the fees it receives from companies that request the registration of chemicals as required under regulation (ec) no 1907/2006; notes that the applicable fees depend on the size of the companies and the volume of chemicals registered (different thresholds); notes that , according to the court’s report , since the first registrations in 2009 , some 26 % of the companies claimed to be micro , small or medium sized; notes with concern , however , that thanks to the agency’s effective system of ex-post verifications , the agency has identified that some 50 % of the companies had incorrectly declared their size , resulting in lower fees; stresses that this finding demonstrates the limitations of a system that relies excessively on self-declarations made by applicants; notes that , in order to mitigate this situation , the agency has , over the years , invoiced fee corrections and administrative charges amounting to eur 32 ,2 million , and that the agency has made considerable progress in recovering undue fee reductions and collecting overdue administrative charges; notes , however , that there is still a considerable verification workload ahead and that the remaining amount of necessary fee corrections was unknown at the end of 2019; calls on the agency to report to the discharge authority on its efforts , and on the results achieved , to continue to reduce the considerable verification backlog and to implement the fee corrections; ### 2. emphasises that the agency is partly financed from the fees it receives from companies that request the registration of chemicals as required under regulation (ec) no 1907/2006; notes that the applicable fees depend on the size of the companies and the volume of chemicals registered (different thresholds); notes that , according to the court’s report , since the first registrations in 2009 , some 26 % of the companies claimed to be micro , small or medium sized; notes with concern , however , that thanks to the agency’s effective system of ex-post verifications , the agency has identified that some 50 % of the companies had incorrectly declared their size , resulting in lower fees; stresses that this finding demonstrates the limitations of a system that relies excessively on self-declarations made by applicants; notes that , in order to mitigate this situation , the agency has , over the years , invoiced and cashed fee corrections and administrative charges amounting to eur 32 ,2 million , and that the agency has made considerable progress in recovering undue fee reductions and collecting overdue administrative charges; notes , however , that there is still a considerable verification workload ahead and that the remaining amount of necessary fee corrections was unknown at the end of 2019; calls on the agency to report to the discharge authority on its efforts , and on the results achieved , to continue to reduce the considerable verification workload and to implement the fee corrections;


### 18. notes that the process of moving to the agency’s new premises in helsinki began on 21 december 2019 and the new building was open and operational for the agency’s staff at the beginning of january 2020 , concluding four years of preparations for relocating staff; notes that the move is due to the partial malfunctioning of its previous building , particularly as regards air quality; ### 18. notes that the process of moving to the agency’s new premises in helsinki began on 21 december 2019 and the new building was open and operational for the agency’s staff at the beginning of january 2020 , concluding four years of preparations for relocating staff; notes that the move is due to the expiry of the lease of its previous building , particularly as regards air quality;


### c. whereas europe’s forests are of immense value in terms of climate mitigation , since they absorb and store 10 % of eu carbon emissions; ### c. whereas europe’s forests are of immense value in terms of climate mitigation , since they absorb and store 10 % of eu carbon emissions; whereas forests play a multifunctional role and whereas in future they should not be regarded purely as carbon sinks;


### 1. welcomes the decision from the commission to introduce a new forest strategy; stresses the need for the forest strategy to fully observe the principle of subsidiarity; emphasises , in this regard , the need for a holistic and consistent forest strategy that enhances the multifunctional role of forests and the forest-based sector in the eu and that promotes the far-reaching societal , economic and environmental benefits of forests; underlines the urgent need to prevent and manage natural disturbances; highlights that the forest strategy should not be subordinate to any other sectoral strategy; ### 1. welcomes the decision from the commission to introduce a new forest strategy; stresses the need for the forest strategy to fully observe the principle of subsidiarity and observes that , in all circumstances , forest owners have the power to decide on forest management within the framework of national law; emphasises , in this regard , the need for a holistic and consistent forest strategy that enhances the multifunctional role of forests and the forest-based sector in the eu and that promotes the far-reaching societal , economic and environmental benefits of forests; underlines the urgent need to prevent and manage natural disturbances; highlights that the forest strategy should not be subordinate to any other sectoral strategy;


### 3. emphasises the important role forests can play in substituting fossil-based materials with bio-based products; believes that the new forest strategy should reflect the importance of the role played by european forests and the eu’s circular bio-economy in reaching climate neutrality by 2050 and that measures to this end should be included; ### 3. emphasises the important role forests can play in substituting fossil-based materials with bio-based products; believes that the new forest strategy should reflect the importance of the role played by european forests and the eu’s circular bio-economy in reaching climate neutrality by 2050 and that measures to this end should be included; observes that wood has great potential as a renewable building material which sequesters carbon; believes that there is a need for better communication concerning the environmental impact of using wood for building , so that the use of wood as a sustainable construction material can be promoted;


### 3. emphasises the important role forests can play in substituting fossil-based materials with bio-based products; believes that the new forest strategy should reflect the importance of the role played by european forests and the eu’s circular bio-economy in reaching climate neutrality by 2050 and that measures to this end should be included; ### 3. emphasises the important role forests can play in supplementing and substituting fossil-based materials with bio-based products; believes that the new forest strategy should reflect the importance of the role played by european forests and the eu’s circular bio-economy in reaching climate neutrality by 2050 and that measures to this end should be included;


### 4. notes that research and technology have come a long way since the forest strategy was introduced in 2013; stresses the importance of encouraging further research in forestry and bio-based products and believes that eu funds for research should be further directed towards this; stresses that more research and funding would make a positive contribution to climate change mitigation , sustainable economic growth and employment , especially in rural areas; ### 4. notes that research and technology have come a long way since the forest strategy was introduced in 2013; stresses the importance of encouraging further research in forestry and bio-based products and believes that eu funds for research should be further directed towards this; stresses that more research and funding would make a positive contribution to climate change mitigation , sustainable economic growth and employment , especially in rural areas; stresses that the union should allocate sufficient resources to funding forestry measures in accordance with the expectations of policy on climate and the environment , including investment in protecting and restoring forests;


### 5. expresses its concern over the health condition and resilience of forests in many parts of europe; highlights the need to strengthen and make full use of eu mechanisms to tackle the transboundary pressures on forests from the spread of invasive alien species , pests , and diseases. ### 5. expresses its concern over the health condition and resilience of forests in many parts of europe; highlights the need to strengthen and make full use of eu mechanisms to tackle the transboundary pressures on forests from the spread of invasive alien species , pests , and diseases , and considers that comprehensive pest management should be promoted and facilitated as the climate cycle moves into a warmer phase.


### — having regard to the commission communication to the european parliament , the european council , the council , the european economic and social committee and the committee of the regions of 11 december 2019 on the european green deal (com(2019)0640) , and the political guidelines of ursula von der leyen of 10 september 2019 , ### deleted


### — having regard to the 2050 climate strategy , ### deleted


### 16. highlights the need to take into consideration the links between the forest-based sector and other sectors as well as the importance of digitalisation and investing in research and innovation; stresses the crucial role of wood-based materials in substituting fossil-based alternatives in industries such as the construction industry , the textile industry , the chemical industry and the packaging industry; ### 16. highlights the need to take into consideration the links between the forest-based sector and other sectors as well as the importance of digitalisation and investing in research and innovation; stresses the crucial role of wood-based materials in substituting fossil-based alternatives in industries such as the construction industry , the textile industry , the chemical industry and the packaging industry; considers it important to stress the benefits to health of the forest-based sector not only from the point of view of clean air and recreation but also from the point of view of providing raw materials for the medicines industry and particularly the production of hygiene products , which serve to limit the spread of pandemics;


### 5. acknowledges the impact of the united kingdom’s decision to withdraw from the european union on the ema's activities and the resulting additional expenditure , amounting to eur 51 ,44 million , including the costs related to staff relocation to the netherlands , and to buildings; welcomes the extent to which the quality and continuity of the ema's operations were maintained whilst undertaking the relocation; ### 5. acknowledges the impact of the united kingdom’s decision to withdraw from the european union on the ema's activities and the resulting additional expenditure , amounting to eur 51 ,44 million , including the staff , office and workspace costs related to the relocation of the ema from london to amsterdam; welcomes the extent to which the quality and continuity of the ema's operations were maintained whilst undertaking the relocation;


### (1) commission estimates derived from firm-level data suggest that the equity repair needs resulting from the covid-19 pandemic could be in the region of eur 720 billion in 2020. the number could go higher in case lockdown measures were to stay in place for longer than currently assumed , or if they had to be re-imposed due to a resurgence of contaminations. if left unaddressed these capital shortfalls may lead to a prolonged period of lower investment and higher unemployment. the impact of the capital shortfall will be uneven across sectors and member states , leading to divergences in the single market. this is compounded by the fact that the capacity of member states to provide state aid differs greatly. ### (1) commission estimates derived from firm-level data suggest that the equity repair needs resulting from the covid-19 pandemic could be in the region of eur 720 billion in 2020. the number could go higher in case lockdown measures were to stay in place for longer than currently assumed , or if they had to be re-imposed due to a resurgence of contaminations. if left unaddressed these capital shortfalls may lead to a prolonged period of lower investment and higher unemployment. the impact of the capital shortfall will be uneven across sectors and member states , leading to divergences in the internal market. this is compounded by the fact that the capacity of member states to provide state aid differs greatly.


### (4) companies supported under the solvency support instrument should be established and operating in the union , meaning that they should have their registered office in a member state and should be active in the union in the sense that they have substantial activities in terms of staff , manufacturing , research and development or other business activities in the union. they should pursue activities in support of objectives covered by this regulation. they should have a viable business model and not have been in difficulty in terms of the state aid framework7 already at end 2019. support should be targeted at eligible companies operating in those member states and sectors which are most impacted by the covid-19 crisis and/or where the availability of state solvency support is more limited. ### (4) companies supported under the solvency support instrument should be established and operating in the union , meaning that they should have their registered office in a member state and should be active in the union in the sense that they have substantial activities in terms of staff , manufacturing , research and development or other business activities in the union. they should pursue activities in support of objectives covered by this regulation. they should have a viable business model. support should be targeted at eligible companies operating in those member states and sectors which are most impacted by the covid-19 crisis and/or where the availability of state solvency support is more limited.


### (4) companies supported under the solvency support instrument should be established and operating in the union , meaning that they should have their registered office in a member state and should be active in the union in the sense that they have substantial activities in terms of staff , manufacturing , research and development or other business activities in the union. they should pursue activities in support of objectives covered by this regulation. they should have a viable business model and not have been in difficulty in terms of the state aid framework7 already at end 2019. support should be targeted at eligible companies operating in those member states and sectors which are most impacted by the covid-19 crisis and/or where the availability of state solvency support is more limited. ### (4) companies supported under the solvency support instrument should be established and operating in the union , meaning that they should have their registered office in a member state and should be active in the union in the sense that they have substantial activities in terms of staff , manufacturing , research and development or other business activities in the union. they should pursue activities in support of objectives covered by this regulation. they should have a viable business model and not have been in difficulty in terms of the state aid framework7 already at end 2019. support should be targeted at eligible companies operating in those member states and sectors which are most impacted by the covid-19 crisis. the efsi steering board should predefine objective parameters and the concentration of support should be based on these parameters. the parameters should indicate the extend of the economic impact of the covid-19 pandemic in the member states. they should not indicate the ability of a member state to provide state aid on its own.


### (10) the financing and investment operations should be aligned with current policy priorities of the union such as the european green deal and the strategy on shaping europe’s digital future. support to cross-border activities should also be targeted. ### (10) the financing and investment operations should support a symmetric macroeconomic recovery in the aftermath of the covid-19 pandemic.


### (10) the financing and investment operations should be aligned with current policy priorities of the union such as the european green deal and the strategy on shaping europe’s digital future. support to cross-border activities should also be targeted. ### (10) the solvency support instrument is not designed to steer the economies of the member states in another direction. the financing and investment operations should focus on the rapid recovery of the economies of the member states and thus prevent further unemployment.


### (13) an amount of eur 100 000 000 should be established to support the set-up and management of investment funds , special purpose vehicles and investment platforms in member states , in particular in those which do not have developed equity fund markets , and to support the green and digital transformation of companies financed under the solvency support window. ### (13) an amount of eur 100 000 000 should be established to support the set-up and management of investment funds , special purpose vehicles and investment platforms in member states , in particular in those which do not have developed equity fund markets , while taking into account the digital transformation and the objectives of the european green deal.


### however , support under the solvency support window shall only be granted if it is to the benefit of companies that were not in difficulty in state aid terms8 already at the end of 2019 but since then face significant solvency risks due to the crisis caused by the covid-19 pandemic; ### however , support under the solvency support window shall only be granted if it is to the benefit of companies that face significant solvency risks due to the crisis caused by the covid-19 pandemic;


### b. whereas the wide use of pharmaceuticals in human and veterinary medicines , including antimicrobial agents , has increased their concentrations in many environmental reservoirs such as soils , sediments and waterbodies in the past 20 years; whereas the largest source of pharmaceuticals entering the environment is their use and disposal; ### b. whereas the wide use of pharmaceuticals in human and veterinary medicines , including antimicrobial agents , has increased their concentrations in many environmental reservoirs such as soils , sediments and waterbodies in the past 20 years; whereas with changes to the size and age of population this trend may increase; whereas the largest source of pharmaceuticals entering the environment is their use and disposal;


### g. whereas there is sufficient evidence that action should be taken to reduce the risk from pharmaceuticals in the environment; ### g. whereas there is sufficient evidence that action should be taken to reduce the risk from pharmaceuticals in the environment; including the protection of water resources in line with the water framework directive


### 9. points to the need to regulate pharmaceuticals under water legislation; recalls that interinstitutional negotiations are on-going on a review of the directive on the quality of water intended for human consumption and on a regulation on minimum requirements for water reuse; ### 9. points to the need to regulate pharmaceuticals under water legislation; recalls that interinstitutional negotiations are on-going on a review of the directive on the quality of water intended for human consumption and on a regulation on minimum requirements for water reuse; asks that regulation for other compartments such as soils be implement as well;


### 13. calls on the member states and on the commission to promote awareness-raising campaigns among veterinaries and physicians on the prudent use of pharmaceuticals , particularly of antimicrobials; calls on actors in the pharmaceutical supply chain to contribute to providing to patients with sufficient information on how incorrectly disposed medicines may negatively impact the environment; calls for on-pack labelling in the form of an appropriate pictogramme to inform consumers how to properly dispose of unused medicines; ### 13. calls on the member states and on the commission to promote awareness-raising campaigns and training among pharmacists , veterinaries , and physicians on the prudent use of pharmaceuticals , particularly of antimicrobials; calls on actors in the pharmaceutical supply chain to contribute to providing to patients with sufficient information on how incorrectly disposed medicines may negatively impact the environment; calls for on-pack labelling in the form of an appropriate pictogramme to inform consumers how to properly dispose of unused medicines;


### 20. points to the important role of procurement policy in promoting greener pharmaceuticals; calls on the commission to develop clear guidance on this issue; ### 20. points to the important role of procurement policy in promoting greener pharmaceuticals in design and manufacturing; calls on the commission to develop clear guidance on this issue;


### 27. considers that the overall per capita drug consumption should be reduced , without jeopardising patients’ health; is of the opinion that the overall per animal veterinary medicines consumption should also decrease; ### 27. considers that the overall per capita drug consumption should be reduced , without jeopardising patients’ health; is of the opinion that the overall per animal veterinary medicines consumption should also decrease without compromising animal health and welfare;


### 32. is concerned that monitoring of pharmaceuticals in the environment is still very limited; stresses the need to strengthen post-marketing control mechanisms into comprehensive monitoring , also with regard to environmental effects , as the current surveillance system (pharmacovigilance) is not adequately and systematically covering the environmental data deficit; ### 32. is concerned that monitoring of pharmaceuticals in the environment , notably in soil , is still very limited; stresses the need to strengthen post-marketing control mechanisms into comprehensive monitoring , also with regard to environmental effects , as the current surveillance system (pharmacovigilance) is not adequately and systematically covering the environmental data deficit;


### – having regard to its resolution of 8 september 2015 on the follow-up to the european citizens’ initiative right2water , ### deleted


### a. whereas climate change is continuing globally and in europe and there is further evidence that future climate change will increase climate-related extremes in many eu regions; ### a. whereas extreme temperatures , increases in overall precipitation , and drought conditions are becoming more common , and it is therefore essential to augment the capacity to prepare for , and respond to , these events through local level policy;


### 1. welcomes the commission’s intention to establish the european union as a standard-setting and world-leading region for hydrogen; stresses that hydrogen is an important tool to decarbonise the energy system and to achieve the goals of the paris agreement; notes that an ambitious strategy can generate up to 1 million jobs and eur 150 billion in annual revenue by 2030 , while reducing annual co2 emissions by roughly 560 mt by 2050; calls , therefore , on the commission to introduce a comprehensive terminology and criteria for the certification of renewable and low-carbon hydrogen , since this constitutes the basis for any future investments; ### 1. welcomes the commission’s intention to establish the european union as a standard-setting and world-leading region for hydrogen; stresses that hydrogen is an important tool to decarbonise the energy system where electrification is impossible or economically ineffective and that it will contribute to achieve the goals of the paris agreement; notes that an ambitious strategy can generate up to 1 million jobs and eur 150 billion in annual revenue by 2030 , while reducing annual co2 emissions by roughly 560 mt by 2050; calls , therefore , on the commission to introduce a comprehensive terminology and criteria for the certification of renewable and low-carbon hydrogen , and to apply a consistent eu-wide methodology based on life-cycle ghg emission analyses enabling a transparent comparison of different energy sources , since this constitutes the basis for any future investments;