### 5. competent authorities may , in accordance with national legislation , withdraw the authorisation of a soho establishment if the competent authorities have confirmed that the soho establishment no longer complies with updated criteria for authorisation or the soho establishment has repeatedly failed to comply with the conditions of its authorisation. ### 5. competent authorities may , in accordance with national legislation , withdraw the authorisation of a soho establishment if the competent authorities have confirmed that the soho establishment no longer complies with updated criteria for authorisation or the soho establishment has failed to comply with the conditions of its authorisation.


### 1. competent authorities shall provide guidelines and templates to allow that applications from soho entities for their authorisation as importing soho entities are submitted in accordance with article 43. in developing these guidelines and templates , competent authorities shall consult the relevant best practices agreed and documented by the scb as referred to in article 68(1) , point (c). ### 1. the soho coordination board shall provide guidelines and templates to allow that applications from soho entities for their authorisation as importing soho entities are submitted in accordance with article 43.


### that the soho entity in question does not comply with the conditions of the authorisation or the provisions of this regulation; and ### that the soho entity in question does not comply with the conditions of the authorisation or the provisions of this regulation; or


### 7. competent authorities may , in accordance with national legislation , withdraw the authorisation of an importing soho entity if the competent authorities have confirmed that the importing soho entity no longer complies with updated criteria for authorisation or the importing soho entity has repeatedly failed to comply with the conditions of its authorisation. ### 7. competent authorities may , in accordance with national legislation , withdraw the authorisation of an importing soho entity if the competent authorities have confirmed that the importing soho entity no longer complies with updated criteria for authorisation or the importing soho entity has failed to comply with the conditions of its authorisation.


### 1. soho entities shall not release or , in an autologous context , prepare and apply immediately to a recipient , soho preparations without prior soho preparation authorisation. in cases where a soho entity modifies an activity carried out for an authorised soho preparation , it shall obtain an authorisation for that modified soho preparation. ### 1. soho entities shall not release or , in an autologous context , prepare and apply immediately to a recipient , soho preparations without prior soho preparation authorisation. in cases where a soho entity modifies an activity carried out for an authorised soho preparation , it shall obtain an authorisation for that modified soho preparation. a substantial change is a change that has an impact on the quality , safety or efficacy of a soho preparation.


### in cases where the indicated risk is other than negligible , a proposal for clinical outcome monitoring to demonstrate safety , quality and efficacy of the soho preparation , in line with the results of the risk assessment; ### in cases where the indicated risk is other than negligible , a proposal for clinical outcome monitoring to demonstrate efficacy of the soho preparation , in line with the results of the risk assessment;


### 4. soho entities shall perform the clinical outcome monitoring once a conditional authorisation has been granted pursuant to article 21(2) , point (c) , and submit the results to their competent authorities. in conducting the clinical investigation study as referred to in paragraph 3 , points (b) and (c) , for the soho preparation concerned , the applicant may use an existing clinical registry to record its results provided that their competent authorities have verified that the registry has data quality management procedures in place that ensure accuracy and completeness of data. ### 4. soho entities shall perform the clinical outcome monitoring once a conditional authorisation has been granted pursuant to article 21(2) , point (c) , and submit the results and their analysis to their competent authorities at the frequency determined in the authorisation . in conducting the clinical investigation study as referred to in paragraph 3 , points (b) and (c) , for the soho preparation concerned , the applicant may use an existing clinical registry to record its results provided that their competent authorities have verified that the registry has data quality management procedures in place that ensure accuracy and completeness of data.


### 5. soho entities shall not make any change to the chain of activities performed for an authorised soho preparation , without the prior written approval of their competent authorities. soho entities shall also inform their competent authorities of changes in the soho preparation authorisation holder’s details. ### 5. soho entities shall not make any change to the chain of activities performed for an authorised soho preparation , without the prior written approval of their competent authorities. a substantial change is a change that has an impact on the quality , safety or efficacy of a soho preparation. soho entities shall also inform their competent authorities of changes in the soho preparation authorisation holder’s details.


### 1. soho entities shall send applications for authorisation as importing soho entities to their competent authorities. ### 1. soho entities shall send applications for authorisation as importing soho entities to their competent authorities of their territory.


### 4. the importing soho entity authorisation holder shall be based in the union , and be responsible for the physical reception and visual examination and verification of imported sohos prior to their release. the importing soho entity shall verify coherence between the soho received and the associated documentation and conduct an examination of the integrity of packaging and the compliance of labelling and transport conditions with the relevant standards and technical guidelines as referred to in articles 57 , 58 and 59. ### 4. the importing soho entity authorisation holder shall be based in the union , and be responsible for the physical reception and visual examination and verification of imported sohos prior to their release. the importing soho entity shall verify coherence between the soho received and the associated documentation and conduct an examination of the integrity of packaging and the compliance of labelling and transport conditions with the relevant standards and technical guidelines as referred to in articles 57 , 58 and 59. the importing soho entity shall make sure and certify that the imported sohos are of equivalent quality to what is required by european regulations.


### 1. soho establishments shall establish , maintain and update , as necessary , a quality management system achieving a high level of quality of sohos by following , in particular , the good practice guidelines published by the edqm and which are included in the technical guidelines referred to in article 56(4) , point (a) , and article 59(4) , point (a). ### 1. soho establishments shall establish , maintain and update , as necessary , a quality management system achieving a high level of quality of sohos by taking into account , in particular , the good practice guidelines published by the edqm and which are included in the technical guidelines referred to in article 56(4) , point (a) , and article 59(4) , point (a).


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


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


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


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


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


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


### the most recent technical guidelines , as indicated on the eu soho platform referred to in chapter xi , as follows: ### the most recent technical guidelines established through a transparent and comprehensive consultation process with a broad selection of stakeholders based on latest scientific knowledge and relevant expertise , and as indicated on the eu soho platform referred to in chapter xi , as follows:


### the most recent technical guidelines , as indicated on the eu soho platform referred to in chapter xi , as follows: ### first of all , the most recent technical guidelines , as indicated on the eu soho platform referred to in chapter xi , as follows:


### 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); ### then , 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);


### 5. in those cases referred to in paragraph 4 , point (a) , for the purpose of article 30 in conjunction with article 29 , soho entities shall be able to demonstrate to their competent authorities , for each of the standards or elements thereof , which and to what extent they follow the guidelines referred to in paragraph 4 , point (a). ### 5. in those cases referred to in paragraph 4 , point (a) and (b) , for the purpose of article 30 in conjunction with article 29 , soho entities shall be able to demonstrate to their competent authorities , for each of the standards or elements thereof , which and to what extent they follow the respective guidelines referred to in paragraph 4 , point (a) and point (b).


### 6. in those cases referred to in paragraph 4 , point (b) , for the purpose of article 30 in conjunction with article 29 , soho entities shall demonstrate to their competent authorities , for each of the standards or elements thereof , the equivalence of the other guidelines applied in terms of the level of safety , quality and efficacy to the level set by the technical guidelines referred to in paragraph 4 , point (a). ### deleted


### 1. soho entities shall establish procedures with measures , and , where necessary , combinations of measures , that ensure high levels of safety and quality and demonstrate benefits for soho recipients and offspring from medically assisted reproduction that outweigh any risks. they shall , in particular , achieve a high level of assurance that pathogens , toxins or genetic conditions are not transmitted to recipients or offspring from medically assisted reproduction. ### 1. soho entities shall establish procedures with measures , and , where necessary , combinations of measures , that ensure high levels of safety and quality and demonstrate benefits for soho recipients and offspring from medically assisted reproduction that outweigh any risks. they shall , in particular , achieve a high level of assurance that pathogens , toxins or genetic conditions are not transmitted to recipients or offspring from medically assisted reproduction. in the case of medically assisted reproduction , the option of the respective persons refusing genetic screening should be retained and the procedure is subject to national legislation according to the principle of subsidiarity hence with regard to the transmission of genetic diseases to offspring , the provisions apply only if member states decide to allow this technology , and subsequently if it corresponds to the wish of the donor or the recipient


### 2. in the procedures referred to in paragraph 1 , soho entities shall mitigate the risks of communicable disease transmission from soho donors to recipients by combining , at least , the following measures: ### 2. in the procedures referred to in paragraph 1 , soho entities shall follow the latest technical guidelines from edqm and ecdc to mitigate the following risks:


### reviewing and evaluating the donors’ current and past health , travel and relevant behavioural histories to allow the application of temporary or permanent deferrals when risks cannot be fully eliminated by donor testing; ### deleted


### testing of donors for communicable diseases using certified and validated testing methods; ### deleted


### when feasible , using processing technologies that reduce or eliminate any potential communicable pathogens. ### deleted


### 3. in the procedures referred to in paragraph 1 , soho entities shall mitigate the risks of non-communicable disease transmission , including genetic conditions and cancer , from donors to the recipients or to offspring from medically assisted reproduction by combining , at least , the following measures: ### deleted


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


### 4. in the procedures referred to in paragraph 1 , soho entities shall mitigate the risks of communicable or non-communicable disease transmission to the recipients through cross-contamination of donations during collection , processing , storage and distribution by measures that ensure that physical contact between sohos from different donors is avoided or , in cases where combining donations is necessary for efficacy of the soho preparation , is minimised. ### deleted


### 5. in the procedures referred to in paragraph 1 , soho entities shall mitigate risks arising from microbial contamination of sohos from the environment , the personnel , the equipment , materials or solutions coming into contact with sohos during collection , processing , storage or distribution. soho entities shall mitigate such risks by , at least , the following measures: ### deleted


### 6. in the procedures referred to in paragraph 1 , soho entities shall mitigate the risks that any reagents and solutions added to sohos or coming in contact with sohos during collection , processing , storage and distribution might be transmitted to recipients and have a toxic , or other , detrimental effect on their health by combining , at least , the following measures: ### deleted


### 7. in the procedures referred to in paragraph 1 , soho entities shall mitigate the risks that inherent properties of sohos , necessary for clinical efficacy , have been changed by any soho activity performed , in a manner that renders soho preparations ineffective or less effective when applied to recipients by combining , at least , the following measures: ### deleted


### 8. in the procedures referred to in paragraph 1 , soho entities shall mitigate the risks that sohos cause an immune reaction in recipients by combining , at least , the following measures: ### deleted


### 9. in the procedures referred to in paragraph 1 , soho entities shall mitigate any other risk to the health of soho recipients or of offspring from medically assisted reproduction arising from the application of sohos or soho preparations and not addressed in paragraphs 2 to 8 by applying procedures that they have validated as safely and effectively mitigating the risk concerned or that are demonstrated as mitigating the risk by published scientific evidence. ### deleted


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


### for the measures referred to in paragraphs 2 and 3 , soho entities shall verify the eligibility of a donor by means of an interview with him/her , his/her legal guardian or , in case of a donation after death , a relevant individual that is informed regarding the donor’s health and lifestyle history. the interview may be combined with any interview conducted as part of the evaluation referred to in article 53(1) , point (f). ### for the measures referred to in paragraphs 2 , point (a) and (b) , soho entities shall verify the eligibility of a donor by means of an interview with him/her , his/her legal guardian or , in case of a donation after death , a relevant individual that is informed regarding the donor’s health and lifestyle history. the interview may be combined with any interview conducted as part of the evaluation referred to in article 53(1) , point (f).


### the most recent technical guidelines , as indicated on the eu soho platform referred to in chapter xi , as follows: ### first of all , the most recent technical guidelines , as indicated on the eu soho platform referred to in chapter xi , as follows:


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


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


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


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


### 2. each member state shall nominate two permanent members and two alternates representing the soho national authority and , where the member state chooses , the ministry of health. the soho national authority may nominate members from other competent authorities , but those members shall ensure that the views and suggestions they make are endorsed by the soho national authority. the board may also invite experts and observers to attend its meetings , and may cooperate with other external experts as appropriate. other union institutions , bodies , offices and agencies shall have an observer role. ### 2. each member state shall nominate two permanent members and two alternates representing the soho national authority and , where the member state chooses , the ministry of health. the soho national authority may nominate members from other competent authorities , but those members shall ensure that the views and suggestions they make are endorsed by the soho national authority. the board may also invite experts and observers to attend its meetings , and may cooperate with other external experts as appropriate. other union institutions , agencies , bodies , offices or services hall have an observer role. the european parliament shall designate a technical representative to participate in the soho coordination board as an observer.


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


### 3. member states shall submit the names and affiliation of their nominated members to the commission , who shall publish the membership list in the eu soho platform. ### 3. member states shall submit the names and affiliation of their nominated members to the commission , who shall publish the membership list in the eu soho platform. the list setting out the authorities , organisations or bodies to which the soho coordination board participants belong shall be published on the commission's website.


### 20. insists on the need to put in place more systematic rules on transparency , incompatibilities , conflict of interests , illegal lobbying and revolving doors; calls on the agency to strengthen its internal control mechanisms , including the setting up of an internal anticorruption mechanism; ### 20. insists on the need to maintain systematic rules on transparency , incompatibilities , conflict of interests , illegal lobbying and revolving doors; calls on the agency to continue strengthening its internal control mechanisms , including the setting up of an internal anticorruption mechanism;


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


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


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


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


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


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


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


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


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


### 1. welcomes the zero pollution ambition for a toxic-free environment; ### 1. welcomes the zero pollution ambition for a toxic-free environment; acknowledges the essential role of the chemicals sector in reaching the multiple targets of the green deal , notably the energy transition , the promotion of energy efficiency and the circular economy , by providing innovative production processes and materials;


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


### 2. calls on the commission to come up with a chemicals strategy for sustainability that effectively ensures a high level of protection of human health and the environment , minimising exposure to hazardous chemicals; ### 2. calls on the commission to come up with a chemicals strategy for sustainability that effectively ensures a high level of protection of human health and the environment , minimising the risks posed by exposure to hazardous chemicals;


### 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; is of the opinion that the commission should come up with a comprehensive strategy where sustainability is the key pillar , and which should contain the consolidation of all relevant policies , including chemicals , trade , tax , innovation , competition , and ensure their enforcement so as to attract investments into europe and create markets for circular and low-carbon products developed by the industry;


### 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 , including the objectives of the new industrial strategy for europe and the new circular economy action plan;


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


### 5. stresses that the chemicals strategy has to be aligned with the hierarchy of actions in risk management that prioritises exposure prevention , elimination and substitution over control measures; ### 5. stresses that the chemicals strategy has to be aligned with the hierarchy of actions in risk management that prioritises exposure prevention , elimination of risks and substitution over control measures while taking into account all aspects of sustainability ;


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


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


### 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. takes note of the fact that the commission has identified certain room for improvement in their refit of eu chemicals legislation; stresses that these improvements should be realised by improving the implementation of legislation and , where necessary , by further appropriate measures; stresses that the new chemicals strategy should effectively contribute to the rapid substitution of substances of very high concern , including hazardous chemicals of equivalent level of concern as foreseen by art. 57 of regulation1907/2006 , such as 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 be based on an impact assessment taking into account all aspects of sustainability including socio-economic impacts;


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


### 9. underlines the need for a clear commitment to securing funds for improved research into safer alternatives and to promoting substitution of harmful chemicals , non-toxic production and sustainable innovation; ### 9. underlines the need for a clear commitment to securing funds for improved research into safer and more sustainable alternatives and to promoting substitution of unsafe uses of harmful chemicals , safe production and sustainable innovation;


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


### 11. considers that the strategy should extend the use of generic risk assessment across legislation; ### 11. considers that the strategy should extend the scope and use of generic risk assessment across legislation including for additional hazard categories such as edcs and pbts substances and other pieces of legislation including fcm;


### 11. considers that the strategy should extend the use of generic risk assessment across legislation; ### 11. considers that the strategy should extend the use of risk-based assessment approaches 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 and consistently addressed across all relevant legislation , including the development of new test methods and the revision of data requirements , where necessary and according to methodologies agreed jointly across eu agencies and in consultation with stakeholders;


### 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 by reducing exposure and , where necessary , the development of new test methods and the revision of data requirements;


### 13. welcomes the ‘one substance – one hazard assessment’ principle in order to better use the resources of the union’s agencies and scientific bodies , avoid duplication of efforts , reduce the risk of diverging outcomes of assessments , speed up and bring consistency to chemicals regulation , and to ensure enhanced health and environment protection and a level playing field for industry; ### 13. underlines the need to reinforce cooperation and coordination between european evaluation agencies efsa and echa together with national agencies , by developing common guidelines for risk assessment namely for biocidal and phytopharmaceutical products , which take into account the most recent scientific results , so as to avoid inconsistencies; welcomes the ‘one substance – one hazard assessment’ principle in order to better use the resources of the union’s agencies and scientific bodies , avoid duplication of efforts , reduce the risk of diverging outcomes of assessments , speed up and bring consistency to chemicals regulation , and to ensure enhanced health and environment protection and a level playing field for industry;


### 14. stresses the need for a more integrated approach towards assessing chemicals with similar hazard , risk or function as a group; calls therefore on the commission to rely on a grouping approach more widely both in evaluation and in subsequent regulatory actions , to avoid regrettable substitution; stresses that the ‘one substance – one hazard assessment’ approach should not contradict nor prevent the development of a grouping approach to assess families as a whole; ### 14. stresses the need for a more integrated approach towards assessing chemicals with similar hazard , risk or function as a group; calls therefore on the commission to rely on a science-based grouping approach more widely both in evaluation and in subsequent regulatory actions while taking into account other sustainability aspects to avoid regrettable substitution; stresses that the ‘one substance – one hazard assessment’ approach should not contradict nor prevent the development of a grouping approach to assess families as a whole;


### 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 assess the need for a cross-cutting definition of vulnerable groups and propose if appropriate , as well as to assess the need to adapt accordingly current scientific risk assessment approaches , e.g. based on derived no-effect levels (dnels) , in order to align the protection of vulnerable groups throughout all chemical legislation;


### 16. calls for the strategy to improve the implementation of reach , with regard to registration , evaluation and authorisation; reiterates the principle of ‘no data , no market’; calls for ensuring the mandatory updating of registration dossiers , based on latest available science; calls for transparency with regard to the compliance with registration obligations , and for giving explicit power to echa to withdraw registration numbers in case of continued non-compliance; ### 16. calls for the strategy to improve the implementation of reach , with regard to registration , evaluation and authorisation; reiterates the principle of ‘no data , no market’; calls for ensuring the mandatory updating of registration dossiers , based on latest available science; calls for transparency with regard to the compliance with registration obligations , and for giving explicit power to echa to withdraw registration numbers in case of continued non-compliance with any requirement;


### 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; stresses the added value of a grouping approach for chemicals with similar characteristics in this regard;


### 17. considers that the evaluation of substances needs both to improve and speed-up; ### 17. considers that the evaluation and risk management of substances needs both to improve and speed-up;


### 18. asks the commission and the member states to refrain from authorising substances and approving products with incomplete data sets about health and environment hazards; ### 18. stresses that all registration dossiers should be compliant with the chemicals legislation; asks the commission and the member states to refrain from authorising substances and approving products with incomplete data sets about health and environment hazards , or if applicant is not able to demonstrate non-existence of suitable alternatives , where this is prerequisite for authorisation18a;


### 18. asks the commission and the member states to refrain from authorising substances and approving products with incomplete data sets about health and environment hazards; ### 18. asks the commission and the member states to refrain from authorising substances and approving products where gaps in datasets about health and environment hazards and exposure do not allow a sufficient risk assessment;


### 20. stresses that the legislation on food contact materials should be revised; ### 20. stresses that the legislation on food contact materials should be revised and better aligned with the clp regulation and reach;


### 21. is worried by the many inconsistencies in the union legislation concerning pbts/vpvbs as identified in the fitness check; calls on the commission to come up with a clear action plan and legislative proposals on how to address all persistent , bioaccumulative and toxic , as well as very persistent and very bioaccumulative , and persistent and mobile chemicals , across all relevant legislation and environmental media , including the action plan to phase-out all non-essential use of perfluoroalkylated substances (pfas) as part of the chemicals strategy for sustainability; ### 21. is worried by the many inconsistencies in the union legislation concerning pbts/vpvbs as identified in the fitness check; calls on the commission to come up with a clear action plan and legislative proposals on how to address all persistent , bioaccumulative and toxic , as well as very persistent and very bioaccumulative , and persistent and mobile chemicals , across all relevant legislation and environmental media;


### 21. is worried by the many inconsistencies in the union legislation concerning pbts/vpvbs as identified in the fitness check; calls on the commission to come up with a clear action plan and legislative proposals on how to address all persistent , bioaccumulative and toxic , as well as very persistent and very bioaccumulative , and persistent and mobile chemicals , across all relevant legislation and environmental media , including the action plan to phase-out all non-essential use of perfluoroalkylated substances (pfas) as part of the chemicals strategy for sustainability; ### 21. is worried by the many inconsistencies in the union legislation concerning pbts/vpvbs as identified in the fitness check; calls on the commission to come up with a clear action plan and , if necessary , based on impact assessments and scientific knowledge , with legislative proposals on how to address all persistent , bioaccumulative and toxic , as well as very persistent and very bioaccumulative , and persistent and mobile chemicals , while considering all relevant legislation and environmental media , including the action plan to phase-out all non-essential use of perfluoroalkylated substances (pfas) as part of the chemicals strategy for sustainability;


### 22. reaffirms its calls of 18 april 2019 for a comprehensive union framework on endocrine disruptors (edcs) , in particular to adopt a horizontal definition based on the who definition for suspected edcs , as well as for known and presumed edcs in line with the classification of cmrs in the clp regulation , revise data requirements accordingly , effectively minimise overall exposure of humans and the environment to edcs , make legislative proposals to insert specific provisions on edcs into the legislation on toys and cosmetics to treat edcs like substances that are carcinogenic , mutagenic or toxic for reproduction and to revise legislation on food contact materials to substitute edcs; ### 22. reaffirms its calls of 18 april 2019 for a comprehensive union framework on endocrine disruptors (edcs) , in particular to adopt a horizontal definition based on the who definition for suspected edcs , as well as for known and presumed edcs in line with the classification of cmrs in the clp regulation , revise data requirements accordingly , effectively minimise overall exposure of humans and the environment to edcs , make legislative proposals to insert specific provisions on edcs into the legislation on toys , food contact materials and cosmetics to treat edcs like substances that are carcinogenic , mutagenic or toxic for reproduction and to revise all relevant legislation , including legislation on food contact materials to substitute edcs;


### 22. reaffirms its calls of 18 april 2019 for a comprehensive union framework on endocrine disruptors (edcs) , in particular to adopt a horizontal definition based on the who definition for suspected edcs , as well as for known and presumed edcs in line with the classification of cmrs in the clp regulation , revise data requirements accordingly , effectively minimise overall exposure of humans and the environment to edcs , make legislative proposals to insert specific provisions on edcs into the legislation on toys and cosmetics to treat edcs like substances that are carcinogenic , mutagenic or toxic for reproduction and to revise legislation on food contact materials to substitute edcs; ### 22. reaffirms its calls of 18 april 2019 for a comprehensive union framework on endocrine disruptors (edcs) , in particular to adopt a horizontal definition based on the who definition for edcs in line with the classification of cmrs in the clp regulation , revise data requirements accordingly , effectively minimise overall exposure of humans and the environment to edcs , make legislative proposals to insert application-specific provisions on edcs into the legislation on toys and cosmetics to treat edcs like substances that are carcinogenic , mutagenic or toxic for reproduction and to revise legislation on food contact materials to substitute edcs;


### 22. reaffirms its calls of 18 april 2019 for a comprehensive union framework on endocrine disruptors (edcs) , in particular to adopt a horizontal definition based on the who definition for suspected edcs , as well as for known and presumed edcs in line with the classification of cmrs in the clp regulation , revise data requirements accordingly , effectively minimise overall exposure of humans and the environment to edcs , make legislative proposals to insert specific provisions on edcs into the legislation on toys and cosmetics to treat edcs like substances that are carcinogenic , mutagenic or toxic for reproduction and to revise legislation on food contact materials to substitute edcs; ### 22. reaffirms its calls of 18 april 2019 for a comprehensive union framework on endocrine disruptors (edcs) , in particular to adopt a horizontal definition based on the who definition for known and presumed edcs in line with the classification of cmrs in the clp regulation , revise data requirements accordingly , effectively minimise overall exposure of humans and the environment to edcs , make legislative proposals to insert specific provisions on edcs into the legislation on toys and cosmetics to treat edcs like substances that are carcinogenic , mutagenic or toxic for reproduction and to revise legislation on food contact materials to substitute edcs;


### 23. reaffirms its call of 14 march 2013 that edcs should be regarded as non-threshold substances; ### 23. reaffirms its call of 14 march 2013 that testing methods and guidance documents should be developed so as to take better account of endocrine disrupters , possible low-dose effects , combination effects and non-monotonic dose-response relationships , in particular with regard to critical windows of exposure during development; stresses that edcs should be regarded as non-threshold substances unless an applicant can scientifically demonstrate a safe threshold for certain uses;


### 23. reaffirms its call of 14 march 2013 that edcs should be regarded as non-threshold substances; ### 23. reaffirms its call of 14 march 2013 that edcs should be regarded as non-threshold substances unless a threshold can be established scientifically;


### 24. calls on the commission to introduce new hazard classes in the clp regulation (e.g. for edcs); ### 24. calls on the commission to introduce new hazard classes in the clp regulation; demands the direct inclusion of endocrine disruptors as a separate classification in the clp regulation , in line with the classification of cmr substances and based on a horizontal definition of edcs;


### 24. calls on the commission to introduce new hazard classes in the clp regulation (e.g. for edcs); ### 24. calls on the commission to strive for a multilaterally agreed upon approach for adapting the un globally harmonised system (ghs) with regards to hazard classes;


### 25. stresses that the chemicals strategy for sustainability should improve the assessment of complex substances (e.g. substances of unknown or variable composition (uvcbs)) and registration of polymers , notably by supporting echa to develop further the solutions already put in place (e.g. substance identity profile); calls for the development of specific methods to assess this type of substances which allow for a solid scientific based approach and are practically applicable; ### 25. stresses that the chemicals strategy for sustainability should improve the assessment of complex substances (e.g. substances of unknown or variable composition (uvcbs)) and , if considered feasible and proportional , the registration of polymers , notably by supporting echa to develop further the solutions already put in place (e.g. substance identity profile); calls for the development of specific methods to assess this type of substances which allow for a solid scientific based approach and are practically applicable;


### 25. stresses that the chemicals strategy for sustainability should improve the assessment of complex substances (e.g. substances of unknown or variable composition (uvcbs)) and registration of polymers , notably by supporting echa to develop further the solutions already put in place (e.g. substance identity profile); calls for the development of specific methods to assess this type of substances which allow for a solid scientific based approach and are practically applicable; ### 25. stresses that the chemicals strategy for sustainability should introduce the registration of polymers and improve the assessment of complex substances (e.g. substances of unknown or variable composition (uvcbs)) , notably by supporting echa to develop further the solutions already put in place (e.g. substance identity profile); calls for the development of specific methods to assess this type of substances which allow for a solid scientific based approach and are practically applicable;


### 26. calls for full implementation of the plant protection products (ppp) legislation; calls on the commission to publish the results of the refit exercise of the ppp legislation as soon as possible; calls on the commission to accelerate europe’s transition towards low-risk pesticides and reduce pesticide dependency to meet the objectives of the directive on sustainable use of pesticides and support farmers in doing so; ### 26. calls for full implementation of the plant protection products (ppp) legislation; calls on the commission to publish the results of the refit exercise of the ppp legislation as soon as possible; calls on the commission to accelerate europe’s transition towards lower risk pesticides including low-risk pesticides as defined by article 47 of regulation1107/2009 , and reduce pesticide dependency by advocating and supporting the implementation of ipm to meet the objectives of the directive on sustainable use of pesticides and support farmers in doing so; insists that while it is appropriate to accelerate the development and approval of low-risk pesticides , it must be ensured that they go through an equally thorough regulatory assessment;


### 26. calls for full implementation of the plant protection products (ppp) legislation; calls on the commission to publish the results of the refit exercise of the ppp legislation as soon as possible; calls on the commission to accelerate europe’s transition towards low-risk pesticides and reduce pesticide dependency to meet the objectives of the directive on sustainable use of pesticides and support farmers in doing so; ### 26. calls for full implementation of the plant protection products (ppp) legislation and for following the european parliament´s calls of 16 january 2019 to improve the union’s authorisation procedure for pesticides; calls on the commission to publish the results of the refit exercise of the ppp legislation as soon as possible; calls on the commission to accelerate europe’s transition towards low-risk pesticides and reduce pesticide dependency to meet the objectives of the directive on sustainable use of pesticides and support farmers in doing so; calls on the commission to help to achieve that among others by improving risk indicators and statistics on plant protection products;


### 26. calls for full implementation of the plant protection products (ppp) legislation; calls on the commission to publish the results of the refit exercise of the ppp legislation as soon as possible; calls on the commission to accelerate europe’s transition towards low-risk pesticides and reduce pesticide dependency to meet the objectives of the directive on sustainable use of pesticides and support farmers in doing so; ### 26. calls for full implementation of the plant protection products (ppp) legislation; calls on the commission to publish the results of the refit exercise of the ppp legislation as soon as possible; calls on the commission to accelerate europe’s transition towards low-risk pesticides and reduce pesticide dependency to meet the objectives of the directive on sustainable use of pesticides and support farmers in doing so; considers that to ensure the protection of public health and the level playing field for european farmers , banned active substances should not enter the eu market through imported products;


### 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 transitioning to truly circular and climate neutral economy and developing non-toxic material cycles; underlines the need of applying equal authorisation conditions to primary substances as well as to recovered materials to achieve it; 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; 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; 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; therefore , notes that substances that are categorised as substances of very high concern according to the reach regulation should not be re-used in new products;


### 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; reaffirms that , in accordance with the waste hierarchy as defined by the waste framework directive , prevention takes priority over recycling and that , accordingly , recycling should favour the safe management 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 all hazardous chemicals in articles along the supply chain to consumers and waste managers is a prerequisite to achieve non-toxic material cycles; invites the commission to identify innovative , highly secure digital technologies to support the effective and timely communication of such information (e.g. blockchain , 5g);


### 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 as well as support the good functioning of the internal market while enhancing the competitiveness and innovation of eu industry; considers the strategy should also take into account the protection of workers against harmful chemicals , for example by encouraging the setting up of prevention committees;


### 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. 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 at least 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;


### 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 the importance of effective climate and biodiversity proofing of the budget , use of the “do no harm” principle and effective correction measures;


### 7. points to the importance of ensuring that sufficient financial resources and adequate human resources capacities are allocated to union agencies under the remit of the committee on the environment , public health and food safety , enabling them to fulfil their mandate , execute their tasks and respond optimally to the consequences of the covid-19 outbreak; underlines the fact that a proper coordination between agencies is needed to increase the effectiveness of their work and allow for a fair use of public money; ### 7. points to the importance of ensuring that sufficient financial resources and adequate human resources capacities are allocated to union agencies under the remit of the committee on the environment , public health and food safety (echa , ecdc , eea , efsa and ema) , enabling them to fulfil their mandate , execute their tasks and respond optimally to the consequences of the covid-19 outbreak; underlines the fact that a proper coordination between agencies is needed to increase the effectiveness of their work and allow for a fair use of public money;


### 8. calls on the commission to swiftly implement pilot projects and preparatory actions; ### 8. calls on the commission to swiftly implement pilot projects and preparatory actions and stresses that these instruments and their results should be integrated in union policy actions and programmes to fulfil their objective;


### 3. notes , regarding follow-up of the court’s previous years’ findings , that the agency has revenues coming both from fees and charges payable by industry and a balancing subsidy from the union budget; notes that , as the third registration deadline under regulation (ec) no 1907/2006 expired in may 2018 , income from fees and charges is expected to drop significantly from 2019 onwards; points out that there is a risk that relatively stable expenditure and much less predictable revenue may have a negative effect on the agency’s operations and budget implementation; takes note , however , that according to the agency’s reply , it has engaged proactively and has on-going discussions with the commission to work towards ensuring sustainable financing and overcoming challenges in its financing model; calls on the agency to keep the discharge authority updated on developments in this regard; ### 3. notes , regarding follow-up of the court’s previous years’ findings , that the agency has revenues coming both from fees and charges payable by industry and a balancing subsidy from the union budget; notes that , as the third registration deadline under regulation (ec) no 1907/2006 expired in may 2018 , income from fees and charges has started to drop significantly from 2019 onwards and this trend is expected to continue; points out that there is a risk that relatively stable expenditure and much less predictable revenue may have a negative effect on the agency’s operations and budget implementation; takes note , however , that according to the agency’s reply , it has engaged proactively and has on-going discussions with the commission to work towards ensuring sustainable financing and overcoming challenges in its financing model; calls on the agency and the commission to keep the discharge authority updated on developments in this regard; points out that relying on a predictable balancing subsidy from the union budget , combined with transferring the income from fees and charges to the commission , may guarantee more predictable revenue for the agency , necessary to fulfil its mandate;


### 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;


### 15. stresses that the publication of cvs and declarations of interest of management board members should be obligatory as currently not all management board members’ cvs and declarations of interest are published on the agency’s website; ### 15. recalls that the publication of cvs and declarations of interest of management board members should be obligatory as currently not all management board members’ cvs and declarations of interest are published on the agency’s website;


### a. whereas forests and other wooded land cover at least 43 % of the eu’s territory , and some member states have more than half of their territories covered by forests and are heavily invested in forestry; ### a. whereas forests and other wooded land cover at least 43 % of the eu’s territory , and some member states have more than half of their territories covered by forests and are heavily invested in forestry; half of the natura 2000 network is made by forest areas , though this covers around 20% of the total forest surface of the eu. forest areas are crucial for regulating the water cycle , absorbing co2 and providing close-to-nature recreation possibilities.


### a. whereas forests and other wooded land cover at least 43 % of the eu’s territory , and some member states have more than half of their territories covered by forests and are heavily invested in forestry; ### a. whereas forests and other wooded land cover at least 43 % of the eu’s territory , and some member states have more than half of their territories covered by forests and are heavily invested in forestry; whereas forests in the eu has grown substantially between 1990-2015 as a result of afforestation , reforestation programmes and natural growth;


### a. whereas forests and other wooded land cover at least 43 % of the eu’s territory , and some member states have more than half of their territories covered by forests and are heavily invested in forestry; ### a. whereas forests and other wooded land cover at least 43 % of the eu’s territory , and some member states have more than half of their territories covered by forests and are heavily invested in forestry; whereas about 60 % of eu forests are privately owned , most of which by small-scale owners with less than 3 ha of forest;


### b. whereas more than 3 million people in the eu are employed by the eu forest sector; ### b. whereas more than 3 million people in the eu are employed by the eu forest sector and these jobs are dependent on resilient forest ecosystems in the long-term;


### b. whereas more than 3 million people in the eu are employed by the eu forest sector; ### b. whereas more than 3 million people in the eu are employed by the eu forest sector , making it an important pillar of rural economies;


### 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 the short-term effect of logged forest on climate is negative 1a whatever the use of logged wood , and potential future re-growth of logged site is of no use in the critical time we have left to act;


### 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 they store about 2.5 times more c in soils than in tree biomass 1a , highlights therefore the importance of complex forest ecosystems for the terrestrial carbon cycling in europe;


### 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 recognize both competences of eu member states and the european union in the area of protection of forests; 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 understand and manage accordingly the natural disturbances; highlights that the forest strategy should be built on an eu biodiversity strategy as laid down in the european green deal communication;


### 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 to respect the national competence for forest policies; 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 and hence contributes to the achievement of the un 2030 sdgs; underlines the urgent need to prevent and manage natural disturbances; highlights that the forest strategy should be consistent with other high level strategies , while it 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; 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 strategy for forests; stresses the need for the strategy to fully recognise eu competences in forest protection; emphasises , in this regard , the need for a holistic and consistent forest strategy that enhances the protection of forests , their multifunctional role , as well as the resilience of the forest-based sector in the eu , based on the cascading use of wood , and that promotes the far-reaching societal , economic and environmental benefits of forests; underlines the urgent need to prevent the further intensification of forest management: highlights that the strategy should be subordinate to the biodiversity strategy , as proposed by the european green deal;


### 2. stresses that according to scientific research , sustainably managed forests have a higher co2 absorption capacity than unmanaged forests; urges , therefore , that the new forest strategy should promote sustainable forest management; recognises the positive impact of sustainable forest management on european forest biodiversity; notes that forest protection and production do not act in contradiction , but can in fact be complementary to one another; ### 2. stresses that according to scientific research6a there is a reduction in forest carbon stocks as a result of increased wood harvesting , and the long periods required (decades to centuries) before the initial increase in emissions is reabsorbed.; urges , therefore , that the new forest strategy should promote sustainable forest management; recognises the positive impact of sustainable forest management , in particular non-intervention management , on european forest biodiversity; notes that forest protection and production can act in contradiction , but could in fact be compatible with one another and have positive result also for climate when principles of nature-based solutions are adopted7a;


### 2. stresses that according to scientific research , sustainably managed forests have a higher co2 absorption capacity than unmanaged forests; urges , therefore , that the new forest strategy should promote sustainable forest management; recognises the positive impact of sustainable forest management on european forest biodiversity; notes that forest protection and production do not act in contradiction , but can in fact be complementary to one another; ### 2. stresses that according to scientific research , sustainably managed forests have a higher co2 absorption capacity than unmanaged forests; urges , therefore , that the new forest strategy should promote sustainable forest management; highlights the overall climate benefits stemming from forests and the forest-based value chain , namely fostered co2-sequestration , carbon storage and substitution of fossil-based raw materials and energy; recognises the positive impact of sustainable forest management on european forest biodiversity; notes that forest protection and production do not act in contradiction , but can in fact be complementary to one another;


### 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 and energies 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; stresses that these measures should make use of the full potential of substitution-effects;


### 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 role forests can play in substituting to some extent 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 and that science is now unequivocal that parts of the bio-based economy were and are a false solution , in particular when it comes to bioenergy; stresses the importance of encouraging further research in forestry and bio-based products and incorporating scientific findings into policy to turn bioeconomy into a no regret and success story , 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; ### 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 , particularly regarding the substitution of fossil-based raw materials and energies , 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;


### 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 transboundary pressures , including those man-induced , on forests from the spread of invasive alien species , pests , and diseases , excessive or illegal logging.


### 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; encourages european commission to explore different market-based mechanisms to incentivise a substitution from fossil to renewable raw materials such as wood in constructions , which offer climate benefits;


### 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 and the need to fully take into account the climate and environmental benefits of this material substitution;


### (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. this would have particularly negative effects on smes at the core of european industry , whereby reduced investments in research and innovation would lead to technological regression and to loss of technological edge in global competition. the impact of the capital shortfall will be uneven across sectors and member states , leading to divergences and distortions in the single market. this is compounded by the fact that the capacity of member states to provide state aid differs greatly. the allocation of resources within the framework of the solvency support instrument should avoid to the largest extent possible any negative impacts on the internal market.


### (3) in order to counter the severe economic consequences of the covid-19 pandemic in the union , companies that have encountered difficulties because of the economic crisis caused by the pandemic and that cannot obtain sufficient support through market financing , or measures undertaken by member states , should be provided with a facility for solvency support as a matter of urgency under a solvency support instrument which should be added as a third window under the efsi. ### (3) in order to counter the severe economic consequences of the covid-19 pandemic in the union , companies , in particular smes and especially innovative and technology-based micro and family-run business entities , that have encountered difficulties because of the economic crisis caused by the pandemic and that cannot obtain sufficient support through market financing , or measures undertaken by member states , should be provided with a facility for solvency support as a matter of urgency under a solvency support instrument which should be added as a third window under the efsi.


### (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 be aligned with current policy priorities of the union such as the european green deal , the eu biodiversity strategy for 2030 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 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 be aligned with current policy priorities of the union such as the european green deal and the strategy on shaping europe’s digital future. due to the interconnectedness of the union economy , support to cross-border activities should also be targeted to prevent potential spill-over effects and to maximise the benefits of cross-border supply chains.


### (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 be fully aligned with current policy priorities and targets 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.


### the solvency of companies established in a member state and operating in the union. ### the solvency of companies established in a member state and operating in the union that have been adversely affected by the covid-19 pandemic.


### (2) in accordance with regulation [european union recovery instrument] and within the limits of resources allocated therein , recovery and resilience measures under the solvency support window of the european fund for strategic investments should be carried out to address the unprecedented impact of the covid-19 crisis. such additional resources should be used in such a way as to ensure compliance with the time limits provided for in regulation [euri]. ### (2) in accordance with regulation [european union recovery instrument] and within the limits of resources allocated therein , recovery and resilience measures under the solvency support window of the european fund for strategic investments should be carried out to address the unprecedented impact of the covid-19 crisis. such additional resources should be used in such a way as to ensure compliance with the time limits provided for in regulation [euri] , whilst supporting technological progress and creating market opportunities for companies , thereby creating jobs and preventing unemployment.


### (14) the investment committee under the investeu regulation should become responsible for granting the eu guarantee also under this regulation once it is established. ### deleted


### – support to funds , special purpose vehicles , investment platforms or other arrangements under the solvency support window. ### – support to funds , special purpose vehicles , investment platforms or other arrangements under the solvency support window , especially those facilitating investment in member states and sectors most adversely affected by the covid-19 pandemic.