### 8. considers that the existing fault-based tort law of the member states offers in most cases a sufficient level of protection for persons that suffer harm caused by an interfering third person like a hacker or whose property is damaged by such a third person , as the interference regularly constitutes a fault-based action; notes that only for cases in which the third person is untraceable or impecunious , additional liability rules seem necessary; ### 8. considers that the existing fault-based tort law of the member states offers in most cases a sufficient level of protection for persons that suffer harm caused by an interfering third person like a hacker or whose property is damaged by such a third person , as the interference regularly constitutes a fault-based action; notes that only for cases in which the third person is untraceable or impecunious , or cases in which it would be disproportionately difficult for the injured party to bear the burden of proof , additional liability rules seem necessary;


### 10. opines that liability rules involving the deployer should in principle cover all operations of ai-systems , no matter where the operation takes place and whether it happens physically or virtually; remarks that operations in public spaces that expose many third persons to a risk constitute , however , cases that require further consideration; considers that the potential victims of harm or damage are often not aware of the operation and regularly do not have contractual liability claims against the deployer; notes that when harm or damage materialises , such third persons would then only have a fault-liability claim , and they might find it difficult to prove the fault of the deployer of the ai-system; ### (10) opines that liability rules involving the deployer should in principle cover all operations of ai-systems , no matter where the operation takes place and whether it happens physically or virtually; remarks that operations in public spaces that expose many third persons to a risk constitute , however , cases that require further consideration , especially where those possibly affected would not normally have a contractual relationship with the operator; considers that the potential victims of harm or damage are often not aware of the operation and regularly do not have contractual liability claims against the deployer; notes that when harm or damage materialises , such third persons would then only have a fault-liability claim , and they might find it difficult to prove the fault of the deployer of the ai-system;


### 10. opines that liability rules involving the deployer should in principle cover all operations of ai-systems , no matter where the operation takes place and whether it happens physically or virtually; remarks that operations in public spaces that expose many third persons to a risk constitute , however , cases that require further consideration; considers that the potential victims of harm or damage are often not aware of the operation and regularly do not have contractual liability claims against the deployer; notes that when harm or damage materialises , such third persons would then only have a fault-liability claim , and they might find it difficult to prove the fault of the deployer of the ai-system; ### 10. opines that liability rules involving the deployer should in principle cover all operations of ai-systems , no matter where the operation takes place and whether it happens physically or virtually; remarks that operations in public spaces that expose many third persons to a risk constitute , however , cases that require further consideration; considers that the potential victims of harm or damage are often not aware of the operation and regularly do not have contractual liability claims against the deployer; notes that when harm or damage materialises , such third persons would then only have a fault-liability claim , and they might find it difficult to prove the fault of the deployer of the ai-system and thus corresponding liability claims might fail;


### 11. considers it appropriate to define the deployer as the person who decides on the use of the ai-system , who exercises control over the risk and who benefits from its operation; considers that exercising control means any action of the deployer that affects the manner of the operation from start to finish or that changes specific functions or processes within the ai-system; ### 11. considers it appropriate to define the deployer as the person who decides on the use of the ai-system , who exercises control over the risk and who benefits from its operation; considers that exercising control means any action of the deployer that affects the manner of the operation from start to finish or that changes specific functions or processes within the ai-system; takes the view that those tasked with deployment should monitor the good intentions of the developers throughout the value chain in order to ensure the protection of consumers through trustworthy ai;


### 12. notes that there could be situations in which there is more than one deployer; considers that in that event , all deployers should be jointly and severally liable while having the right to recourse proportionally against each other; ### 12. notes that there could be situations in which there is more than one deployer; considers that in that event , all deployers should be jointly and severally liable while having the right to recourse proportionally against each other in line with the level of operational risk control;


### e. whereas artificial intelligence (ai)-systems present significant legal challenges for the existing liability framework and could lead to situations , in which their opacity could make it extremely expensive or even impossible to identify who was in control of the risk associated with the ai-system or which code or input has ultimately caused the harmful operation; ### e. whereas artificial intelligence (ai)-systems present significant legal challenges for the existing liability framework and could lead to situations , in which their opacity could make it extremely expensive or even impossible to identify who was in control of the risk associated with the ai-system or which code or input has ultimately caused the harmful operation; whereas these factors could make it harder to identify the relationship between injury and the behaviour causing it , with the result that victims might not receive adequate compensation;


### g. whereas sound ethical standards for ai-systems combined with solid and fair compensation procedures can help to address those legal challenges; whereas fair liability procedures means that each person who suffers harm caused by ai-systems or whose property damage is caused by ai-systems should have the same level of protection compared to cases without involvement of an ai-system. ### g. whereas sound ethical standards for ai-systems combined with solid and fair compensation procedures can help to address those legal challenges and eliminate the risk of users being less willing to accept emerging technology; whereas fair liability procedures means that each person who suffers harm caused by ai-systems or whose property damage is caused by ai-systems should have the same level of protection compared to cases without involvement of an ai-system.


### 13. recognises that the type of ai-system the deployer is exercising control over is a determining factor; notes that an ai-system that entails a high risk potentially endangers the general public to a much higher degree; considers that , based on the legal challenges that ai-systems pose to the existing liability regimes , it seems reasonable to set up a strict liability regime for those high-risk ai-systems; ### 13. recognises that the type of ai-system the deployer is exercising control over is a determining factor regarding liability; notes that an ai-system that entails a high inherent risk potentially endangers the general public to a much higher degree; considers that , based on the legal challenges that ai-systems pose to the existing liability regimes , it seems reasonable to set up a strict liability regime for those high-risk ai-systems;


### 13. recognises that the type of ai-system the deployer is exercising control over is a determining factor; notes that an ai-system that entails a high risk potentially endangers the general public to a much higher degree; considers that , based on the legal challenges that ai-systems pose to the existing liability regimes , it seems reasonable to set up a strict liability regime for those high-risk ai-systems; ### 13. recognises that the type of aisystem the deployer is exercising control over is a determining factor; notes that an ai-system that entails a high risk potentially endangers the general public to a much higher degree; considers that , based on the legal challenges that ai-systems pose to the existing civil liability regimes , it seems reasonable to set up a common strict liability regime for those high-risk ai-systems;


### 14. believes that an ai-system presents a high risk when its autonomous operation involves a significant potential to cause harm to one or more persons , in a manner that is random and impossible to predict in advance; considers that the significance of the potential depends on the interplay between the severity of possible harm , the likelihood that the risk materializes and the manner in which the ai-system is being used; ### 14. believes that an ai-system presents a high risk when its autonomous operation involves a significant potential to cause harm to one or more persons , in a manner that is random and impossible to predict in advance; considers that when determining whether an ai-system is high-risk , the sector in which significant risks can be expected to arise and the nature of the activities undertaken must also be taken into account; considers that the significance of the potential depends on the interplay between the severity of possible harm , the likelihood that the risk materializes and the manner in which the ai-system is being used;


### 15. recommends that all high-risk ai-systems be listed in an annex to the proposed regulation; recognises that , given the rapid technological change and the required technical expertise , it should be up to the commission to review that annex every six months and if necessary , amend it through a delegated act; believes that the commission should closely cooperate with a newly formed standing committee similar to the existing standing committee on precursors or the technical committee on motor vehicles , which include national experts of the member states and stakeholders; considers that the balanced membership of the ‘high-level expert group on artificial intelligence’ could serve as an example for the formation of the group of stakeholders; ### 15. recommends that all high-risk ai-systems be exhaustively listed in an annex to the proposed regulation; recognises that , given the rapid technological change and the required technical expertise , it should be up to the commission to review that annex every six months and if necessary , amend it through a delegated act; believes that the commission should closely cooperate with a newly formed standing committee similar to the existing standing committee on precursors or the technical committee on motor vehicles , which include national experts of the member states and stakeholders; considers that the balanced membership of the ‘high-level expert group on artificial intelligence’ could serve as an example for the formation of the group of stakeholders; is also of the opinion that the european parliament should appoint consultative experts to advise the newly established standing committee.


### 15. recommends that all high-risk ai-systems be listed in an annex to the proposed regulation; recognises that , given the rapid technological change and the required technical expertise , it should be up to the commission to review that annex every six months and if necessary , amend it through a delegated act; believes that the commission should closely cooperate with a newly formed standing committee similar to the existing standing committee on precursors or the technical committee on motor vehicles , which include national experts of the member states and stakeholders; considers that the balanced membership of the ‘high-level expert group on artificial intelligence’ could serve as an example for the formation of the group of stakeholders; ### 15. recommends that all high-risk ai-systems be listed in an annex to the proposed regulation; recognises that , given the rapid technological change and the required technical expertise , it should be up to the commission to review that annex every six months and if necessary , amend it through a delegated act; believes that the commission should closely cooperate with a newly formed standing committee similar to the existing standing committee on precursors or the technical committee on motor vehicles , which include national experts of the member states and stakeholders; considers that the balanced membership of the ‘high-level expert group on artificial intelligence’ could serve as an example for the formation of the group of stakeholders , with the addition of ethics experts and anthropologists , sociologists and mental-health specialists;


### 15. recommends that all high-risk ai-systems be listed in an annex to the proposed regulation; recognises that , given the rapid technological change and the required technical expertise , it should be up to the commission to review that annex every six months and if necessary , amend it through a delegated act; believes that the commission should closely cooperate with a newly formed standing committee similar to the existing standing committee on precursors or the technical committee on motor vehicles , which include national experts of the member states and stakeholders; considers that the balanced membership of the ‘high-level expert group on artificial intelligence’ could serve as an example for the formation of the group of stakeholders; ### 15. recognises that , given the rapid technological change and the required technical expertise , the commission should draw up a list of high-risk ai systems through a delegated act , in respect of which the european parliament may raise its objections; believes that the commission should closely cooperate with a newly formed standing committee similar to the existing standing committee on precursors or the technical committee on motor vehicles , which include national experts of the member states and stakeholders; considers that the balanced membership of the ‘high-level expert group on artificial intelligence’ could serve as an example for the formation of the group of stakeholders;


### 16. believes that in line with strict liability systems of the member states , the proposed regulation should only cover harm to the important legally protected rights such as life , health , physical integrity and property , and should set out the amounts and extent of compensation as well as the limitation period; ### 16. believes that the proposed regulation should set the limitation period and , in line with strict liability systems of the member states , should only cover harm to the important legally protected rights such as life , health , physical integrity and property , and in this context the commission should examine whether the scope should be extended to include economic damage;


### 17. determines that all activities , devices or processes driven by ai-systems that cause harm or damage but are not listed in the annex to the proposed regulation should remain subject to fault-based liability; believes that the affected person should nevertheless benefit from a presumption of fault of the deployer; ### 17. determines that all activities , devices or processes driven by ai-systems that cause harm or damage but are not listed in the annex to the proposed regulation should remain subject to fault-based liability; believes that the affected person should nevertheless benefit from a presumption of fault of the deployer; considers , in this connection , that the national law governing the amount and extent of the compensation and the deadline for claims against injury caused by the ai system remains applicable;


### 17. determines that all activities , devices or processes driven by ai-systems that cause harm or damage but are not listed in the annex to the proposed regulation should remain subject to fault-based liability; believes that the affected person should nevertheless benefit from a presumption of fault of the deployer; ### 17. determines that all activities , devices or processes driven by ai-systems that cause harm or damage but are not listed in the annex to the proposed regulation should remain subject to fault-based liability; believes that the affected person should nevertheless benefit from a presumption of fault of the deployer and that while that presumption of fault is rebuttable , the burden of proof lies with the deployer;


### 18. considers the liability risk to be one of the key factors that defines the success of new technologies , products and services; observes that proper risk coverage is also essential for assuring the public that it can trust the new technology despite the potential for suffering harm or for facing legal claims by affected persons; ### 18. considers the liability risk to be one of the key factors that defines the success of new technologies , products and services; observes that proper risk coverage is also essential for assuring the public that it can trust the new technology despite the potential for suffering harm or for facing legal claims by affected persons; notes at the same time that this regulatory system focuses on the need to exploit and enhance the advantages of ai-systems , while putting in place robust safeguards;


### 19. is of the opinion that , based on the significant potential to cause harm and by taking directive 2009/103/ec7 into account , all deployers of high-risk ai-systems listed in the annex to the proposed regulation should hold liability insurance; considers that such a mandatory insurance regime for high-risk ai-systems should cover the amounts and the extent of compensation laid down by the proposed regulation; ### 19. is of the opinion that , based on the significant potential to cause harm and by taking directive 2009/103/ec7 into account , all deployers of high-risk ai-systems listed in the annex to the proposed regulation should hold liability insurance;


### - there should be no over-regulation as this would hamper european innovation in ai , especially if the technology , product or service is developed by smes or start-ups. ### - there should be no over-regulation and more red tape must be prevented , as this would hamper european innovation in ai , especially if the technology , product or service is developed by smes or start-ups.


### - this report and the product liability directive are two pillars of a common liability framework for ai-systems and require close coordination between all political actors. ### - this report and the product liability directive are two pillars of a common liability framework for ai-systems and require close coordination and alignment between all political actors.


### - citizens need to be entitled to the same level of protection and rights , no matter if the harm is caused by an ai-system or not , or if it takes place physically or virtually. ### - citizens need to be entitled to the same level of protection and rights , no matter if the harm is caused by an ai-system or not , if it takes place physically or virtually , or if it is material or non-material. as set out in the commission communication of 19 february 2020 on the safety and liability implications of ai and robotics , ‘explicit obligations for producers , among others , of humanoid ai to explicitly take into account the non-material damage that their products could cause to users , in particular vulnerable users such as elderly people in care settings’ should be taken into account in this eu legislation.


### - citizens need to be entitled to the same level of protection and rights , no matter if the harm is caused by an ai-system or not , or if it takes place physically or virtually. ### - citizens need to be entitled to the same level of protection and rights , no matter if the harm is caused by an ai-system or not , or if it takes place physically or virtually so that their confidence in this new technology is strengthened.


### (1) the concept of ‘liability’ plays an important double role in our daily life: on the one hand , it ensures that a person who has suffered harm or damage is entitled to claim compensation from the party proven to be liable for that harm or damage , and on the other hand , it provides the economic incentives for persons to avoid causing harm or damage in the first place. any liability framework should strive to strike a balance between efficiently protecting potential victims of damage and at the same time , providing enough leeway to make the development of new technologies , products or services possible. ### (1) the concept of ‘liability’ plays an important double role in our daily life: on the one hand , it ensures that a person who has suffered harm or damage is entitled to claim compensation from the party proven to be liable for that harm or damage , and on the other hand , it provides the economic incentives for persons to avoid causing harm or damage in the first place. any liability framework should strive to instil confidence in the safety , reliability and consistency of products and services , including digital technologies , in order to strike a balance between efficiently protecting potential victims of damage and at the same time , providing enough leeway to make the development of new technologies , products or services possible.


### (1) the concept of ‘liability’ plays an important double role in our daily life: on the one hand , it ensures that a person who has suffered harm or damage is entitled to claim compensation from the party proven to be liable for that harm or damage , and on the other hand , it provides the economic incentives for persons to avoid causing harm or damage in the first place. any liability framework should strive to strike a balance between efficiently protecting potential victims of damage and at the same time , providing enough leeway to make the development of new technologies , products or services possible. ### (1) the concept of ‘liability’ plays an important double role in our daily life: on the one hand , it ensures that a person who has suffered harm or damage is entitled to claim compensation from the party proven to be liable for that harm or damage , and on the other hand , it provides the economic incentives for persons to avoid causing harm or damage , whether material or non-material , in the first place. any liability framework should strive to strike a balance between efficiently protecting potential victims of damage and at the same time , providing enough leeway to make the development of new technologies , products or services possible.


### (3) the rise of artificial intelligence (ai) however presents a significant challenge for the existing liability frameworks. using ai-systems in our daily life will lead to situations in which their opacity (“black box” element) makes it extremely expensive or even impossible to identify who was in control of the risk of using the ai-system in question or which code or input has caused the harmful operation. this difficulty is even compounded by the connectivity between an ai-system and other ai-systems and non-ai-systems , by its dependency on external data , by its vulnerability to cybersecurity breaches as well as by the increasing autonomy of ai-systems triggered by machine-learning and deep-learning capabilities. besides these complex features and potential vulnerabilities , ai-systems could also be used to cause severe harm , such as compromising our values and freedoms by tracking individuals against their will , by introducing social credit systems or by constructing lethal autonomous weapon systems. ### (3) the rise of artificial intelligence (ai) however presents a significant challenge for the existing liability frameworks. using ai-systems in our daily life will lead to situations in which their opacity (“black box” element) makes it extremely expensive or even impossible to identify who was in control of the risk of using the ai-system in question or which code or input has caused the harmful operation. this difficulty is even compounded by the connectivity between an ai-system and other ai-systems and non-ai-systems , by its dependency on external data , by its vulnerability to cybersecurity breaches as well as by the increasing autonomy of ai-systems triggered by machine-learning and deep-learning capabilities. besides these complex features and potential vulnerabilities , ai-systems could also be used to cause severe harm , such as compromising our human dignity , our values and freedoms by tracking individuals against their will , by introducing social credit systems or by constructing lethal autonomous weapon systems , or to take biased decisions in matters of health insurance , credit provision , court orders or recruitment or employment decisions.


### (4) at this point , it is important to point out that the advantages of deploying ai-systems will by far outweigh the disadvantages. they will help to fight climate change more effectively , to improve medical examinations , to better integrate disabled persons into the society and to provide tailor-made education courses to all types of students. to exploit the various technological opportunities and to boost people’s trust in the use of ai-systems , while at the same time preventing harmful scenarios , sound ethical standards combined with solid and fair compensation is the best way forward. ### (4) at this point , it is important to point out that the advantages of deploying ai-systems will by far outweigh the disadvantages. they will help to fight climate change more effectively , to improve medical examinations , to better integrate disabled and ageing persons into the society and to provide tailor-made education courses to all types of students. to exploit the various technological opportunities and to boost people’s trust in the use of ai-systems , while at the same time preventing harmful scenarios , sound ethical standards combined with solid and fair compensation is the best way forward.


### (6) nevertheless , it should always be clear that whoever creates , maintains , controls or interferes with the ai-system , should be accountable for the harm or damage that the activity , device or process causes. this follows from general and widely accepted liability concepts of justice according to which the person that creates a risk for the public is accountable if that risk materializes. consequently , the rise of ai-systems does not pose a need for a complete revision of liability rules throughout the union. specific adjustments of the existing legislation and very few new provisions would be sufficient to accommodate the ai-related challenges. ### (6) nevertheless , it should always be clear that whoever creates , maintains , controls or interferes with the ai-system , should be accountable for the harm or damage that the activity , device or process causes. this follows from general and widely accepted liability concepts of justice according to which the person that creates a risk for the public is accountable if that risk materializes. consequently , the rise of ai-systems does not pose a need for a complete revision of liability rules throughout the union. specific adjustments of the existing legislation and very few new provisions would be sufficient to accommodate the ai-related challenges , with a view to preventing regulatory fragmentation and ensuring the harmonisation of union civil liability legislation in connection with artificial intelligence.


### (7) council directive 85/374/eec3 (the product liability directive) has proven to be an effective means of getting compensation for damage triggered by a defective product. hence , it should also be used with regard to civil liability claims of a party who suffers harm or damage against the producer of a defective ai-system. in line with the better regulation principles of the union , any necessary legislative adjustments should be discussed during a review of that directive. the existing fault-based liability law of the member states also offers in most cases a sufficient level of protection for persons that suffer harm or damages caused by an interfering third person , as that interference regularly constitutes a fault-based action. consequently , this regulation should focus on claims against the deployer of an ai-system. ### (7) council directive 85/374/eec3 (the product liability directive) has proven to be an effective means of getting compensation for damage triggered by a defective product. however , so that it can also be used with regard to civil liability claims of a party who suffers harm or damage against the producer of a defective ai-system , legislative adjustments during a review of that directive are necessary. the existing fault-based liability law of the member states also offers in most cases a sufficient level of protection for persons that suffer harm or damages caused by an interfering third person , as that interference regularly constitutes a fault-based action. consequently , this regulation should focus on claims against the deployer of an ai-system.


### (12) all ai-systems with a high risk should be listed in an annex to this regulation. given the rapid technical and market developments as well as the technical expertise which is required for an adequate review of ai-systems , the power to adopt delegated acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission to amend this regulation in respect of the types of ai-systems that pose a high risk and the critical sectors where they are used. based on the definitions and provisions laid down in this regulation , the commission should review the annex every six months and , if necessary , amend it by means of delegated acts. to give businesses enough planning and investment security , changes to the critical sectors should only be made every 12 months. developers are called upon to notify the commission if they are currently working on a new technology , product or service that falls under one of the existing critical sectors provided for in the annex and which later could qualify for a high risk ai-system. ### (12) the power to adopt delegated acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission so that it can draw up a list of the types of ai-systems that pose a high risk and the critical sectors where they are used. to give businesses enough planning and investment security , subsequent changes to the critical sectors should only be made every 12 months.


### (12) all ai-systems with a high risk should be listed in an annex to this regulation. given the rapid technical and market developments as well as the technical expertise which is required for an adequate review of ai-systems , the power to adopt delegated acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission to amend this regulation in respect of the types of ai-systems that pose a high risk and the critical sectors where they are used. based on the definitions and provisions laid down in this regulation , the commission should review the annex every six months and , if necessary , amend it by means of delegated acts. to give businesses enough planning and investment security , changes to the critical sectors should only be made every 12 months. developers are called upon to notify the commission if they are currently working on a new technology , product or service that falls under one of the existing critical sectors provided for in the annex and which later could qualify for a high risk ai-system. ### (12) all ai-systems with a high risk should be exhaustively listed in an annex to this regulation. given the rapid technical and market developments as well as the technical expertise which is required for an adequate review of ai-systems , the power to adopt delegated acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission to amend this regulation in respect of the types of ai-systems that pose a high risk and the critical sectors where they are used. based on the definitions and provisions laid down in this regulation , the commission should review the annex every six months and , if necessary , amend it by means of delegated acts. to give businesses enough planning and investment security , changes to the critical sectors should only be made every 12 months. developers are called upon to notify the commission if they are currently working on a new technology , product or service that falls under one of the existing critical sectors provided for in the annex and which later could qualify for a high risk ai-system.


### (14) in line with strict liability systems of the member states , this regulation should cover only harm or damage to life , health , physical integrity and property. for the same reason , it should determine the amount and extent of compensation , as well as the limitation period for bringing forward liability claims. in contrast to the product liability directive , this regulation should set out a significantly lower ceiling for compensation , as it only refers to a single operation of an ai-system , while the former refers to a number of products or even a product line with the same defect. ### (14) in line with strict liability systems of the member states , this regulation should cover only harm or damage to life , health , physical integrity and property. for the same reason , it should determine the limitation period for bringing forward liability claims. in contrast to the product liability directive , this regulation should set out a significantly lower ceiling for compensation , as it only refers to a single operation of an ai-system , while the former refers to a number of products or even a product line with the same defect.


### (20) despite missing historical claim data , there are already insurance products that are developed area-by-area and cover-by-cover as technology develops. many insurers specialise in certain market segments (e.g. smes) or in providing cover for certain product types (e.g. electrical goods) , which means that there will usually be an insurance product available for the insured. if a new type of insurance is needed , the insurance market will develop and offer a fitting solution and thus , will close the insurance gap. in exceptional cases , in which the compensation significantly exceeds the maximum amounts set out in this regulation , member states should be encouraged to set up a special compensation fund for a limited period of time that addresses the specific needs of those cases. ### (20) despite missing historical claim data , there are already insurance products that are developed area-by-area and cover-by-cover as technology develops. many insurers specialise in certain market segments (e.g. smes) or in providing cover for certain product types (e.g. electrical goods) , which means that there will usually be an insurance product available for the insured. if a new type of insurance is needed , the insurance market will develop and offer a fitting solution and thus , will close the insurance gap.


### (20) despite missing historical claim data , there are already insurance products that are developed area-by-area and cover-by-cover as technology develops. many insurers specialise in certain market segments (e.g. smes) or in providing cover for certain product types (e.g. electrical goods) , which means that there will usually be an insurance product available for the insured. if a new type of insurance is needed , the insurance market will develop and offer a fitting solution and thus , will close the insurance gap. in exceptional cases , in which the compensation significantly exceeds the maximum amounts set out in this regulation , member states should be encouraged to set up a special compensation fund for a limited period of time that addresses the specific needs of those cases. ### (20) despite missing historical claim data for reasons such as updating algorithms or anonymising data , there are already insurance products that are developed area-by-area and cover-by-cover as technology develops. many insurers specialise in certain market segments (e.g. smes) or in providing cover for certain product types (e.g. electrical goods) , which means that there will usually be an insurance product available for the insured. if a new type of insurance is needed , the insurance market will develop and offer a fitting solution and thus , will close the insurance gap. in exceptional cases , in which the compensation significantly exceeds the maximum amounts set out in this regulation , member states should be encouraged to set up a special compensation fund for a limited period of time that addresses the specific needs of those cases.


### (20) despite missing historical claim data , there are already insurance products that are developed area-by-area and cover-by-cover as technology develops. many insurers specialise in certain market segments (e.g. smes) or in providing cover for certain product types (e.g. electrical goods) , which means that there will usually be an insurance product available for the insured. if a new type of insurance is needed , the insurance market will develop and offer a fitting solution and thus , will close the insurance gap. in exceptional cases , in which the compensation significantly exceeds the maximum amounts set out in this regulation , member states should be encouraged to set up a special compensation fund for a limited period of time that addresses the specific needs of those cases. ### (20) despite missing historical claim data , there are already insurance products that are developed area-by-area and cover-by-cover as technology develops. many insurers specialise in certain market segments (e.g. smes) or in providing cover for certain product types (e.g. electrical goods) , which means that there will usually be an insurance product available for the insured. if a new type of insurance is needed , the insurance market will develop and offer a fitting solution and thus , will close the insurance gap. in exceptional cases , such as an event incurring collective damages , in which the compensation significantly exceeds the maximum amounts set out in this regulation , member states should be encouraged to set up a special compensation fund for a limited period of time that addresses the specific needs of those cases.


### ‘ai-system’ means a system that displays intelligent behaviour by analysing certain input and taking action , with some degree of autonomy , to achieve specific goals. ai-systems can be purely software-based , acting in the virtual world , or can be embedded in hardware devices; ### ‘artificial intelligence’ means a system that includes methods and procedures that enable technical systems to perceive their environment , process what is perceived and solve problems independently , make decisions , act and learn from the consequences of those decisions and actions; ai-systems can be purely software-based , acting in the virtual world , or can be embedded in hardware devices;


### ‘high risk’ means a significant potential in an autonomously operating ai-system to cause harm or damage to one or more persons in a manner that is random and impossible to predict in advance; the significance of the potential depends on the interplay between the severity of possible harm or damage , the likelihood that the risk materializes and the manner in which the ai-system is being used; ### ‘high risk’ means a significant potential in an autonomously operating ai-system to cause significant harm or damage to one or more persons in a manner that is random and impossible to predict in advance; the significance of the potential depends on the interplay between the severity of possible harm or damage , the likelihood that the risk materializes and the manner in which the ai-system is being used;


### ‘deployer’ means the person who decides on the use of the ai-system , exercises control over the associated risk and benefits from its operation; ### ‘deployer’ means any natural or legal person who decides on the specific use of the ai-system , exercises control over the associated risk and benefits from its operation;


### 1. the deployer of a high-risk ai-system shall be strictly liable for any harm or damage that was caused by a physical or virtual activity , device or process driven by that ai-system. ### 1. the deployer of a high-risk ai-system shall be strictly liable for any harm or damage occasioned to the life , health , physical integrity or possessions of natural or legal persons that was caused by a physical or virtual activity , device or process driven by that ai-system.


### 2. the high-risk ai-systems as well as the critical sectors where they are used shall be listed in the annex to this regulation. the commission is empowered to adopt delegated acts in accordance with article 13 , to amend the exhaustive list in the annex , by: ### 2. the commission shall be tasked with drawing up a list of high-risk ai-systems as well as the critical sectors where they are used , by means of delegated acts in accordance with article 13.


### including new types of high-risk ai-systems and critical sectors in which they are deployed; ### deleted


### deleting types of ai-systems that can no longer be considered to pose a high risk; and/or ### deleted


### changing the critical sectors for existing high-risk ai-systems. ### deleted


### any delegated act amending the annex shall come into force six months after its adoption. when determining new critical sectors and/or high-risk ai-systems to be inserted by means of delegated acts in the annex , the commission shall take full account of the criteria set out in this regulation , in particular those set out in article 3(c). ### deleted


### 4. the deployer of a high-risk ai-system shall ensure they have liability insurance cover that is adequate in relation to the amounts and extent of compensation provided for in article 5 and 6 of this regulation. if compulsory insurance regimes already in force pursuant to other union or national law are considered to cover the operation of the ai-system , the obligation to take out insurance for the ai-system pursuant to this regulation shall be deemed fulfilled , as long as the relevant existing compulsory insurance covers the amounts and the extent of compensation provided for in articles 5 and 6 of this regulation. ### 4. the deployer of a high-risk ai-system shall ensure they have liability insurance cover. if compulsory insurance regimes already in force pursuant to other union or national law are considered to cover the operation of the ai-system , the obligation to take out insurance for the ai-system pursuant to this regulation shall be deemed fulfilled.


### 1. a deployer of a high-risk ai-system that has been held liable for harm or damage under this regulation shall compensate: ### 1. the level of compensation to be paid by a deployer of a high-risk ai-system that has been held liable for harm or damage under this regulation shall be determined in accordance with the relevant national provisions.


### up to a maximum total amount of eur ten million in the event of death or of harm caused to the health or physical integrity of one or several persons as the result of the same operation of the same high-risk ai-system; ### deleted


### up to a maximum total amount of eur two million in the event of damage caused to property , including when several items of property of one or several persons were damaged as a result of the same operation of the same high-risk ai-system; where the affected person also holds a contractual liability claim against the deployer , no compensation shall be paid under this regulation if the total amount of the damage to property is of a value that falls below eur 500. ### deleted


### 2. where the combined compensation to be paid to several persons who suffer harm or damage caused by the same operation of the same high-risk ai-system exceeds the maximum total amounts provided for in paragraph 1 , the amounts to be paid to each person shall be reduced pro-rata so that the combined compensation does not exceed the maximum amounts set out in paragraph 1. ### deleted


### article 6 ### deleted


### 1. civil liability claims , brought in accordance with article 4(1) , concerning harm to life , health or physical integrity , shall be subject to a special limitation period of 30 years from the date on which the harm occurred. ### 1. civil liability claims , brought in accordance with article 4(1) , concerning harm to life , health or physical integrity , shall be subject to an absolute limitation period of 30 years from the date on which the harm occurred.


### 2. civil liability claims , brought in accordance with article 4(1) , concerning damage to property shall be subject to a special limitation period of: ### 2. civil liability claims , brought in accordance with article 4(1) , concerning damage to property shall be subject to an absolute limitation period of:


### 3. this article shall be without prejudice to national law regulating the suspension or interruption of limitation periods. ### deleted


### by 1 january 202x [5 years after the date of application of this regulation] , and every three years thereafter , the commission shall present to the european parliament , the council and the european economic and social committee a detailed report reviewing this regulation in the light of the further development of artificial intelligence. ### by 1 january 202x [5 years after the date of application of this regulation] , and every three years thereafter , the commission shall present to the european parliament , the council and the european economic and social committee a detailed report reviewing this regulation in the light of the further development of artificial intelligence. in the context of this report , the commission shall examine , inter alia , whether the scope of this regulation should be extended to include economic damage.


### exhaustive list of ai-systems that pose a high risk as well as of critical sectors where the ai-systems are being deployed1 ### deleted


### 2. stresses that the internal market remains one of the union’s greatest and most tangible achievements , bringing benefits to businesses , consumers and citizens across europe; further deepening the single market and developing the digital single market should be prioritised in the 2020 budget; ### 2. stresses that the internal market remains one of the union’s greatest and most tangible achievements , bringing benefits to businesses , consumers and citizens across europe; further deepening the single market and developing the digital single market should be prioritised in the 2020 budget; in this context stresses that it is important to systematically monitor advances , detect emerging issues and provide policy recommendations for the further development of the digital single market;


### 2. considers that important efforts have been made to increase sound scientific knowledge of marine biological resources. although knowledge has improved , we are still far from optimum in order to provide for an appropriate assessment; considers that union funds must therefore be increased for both international and member states’ scientific research organisations to further improve the evaluation of stocks. ### 2. considers that important efforts have been made to increase sound scientific knowledge of marine biological resources. although knowledge has improved , we are still far from optimum in order to provide for an appropriate assessment; considers that union funds must therefore be coherent with these objectives for both international and member states’ scientific research organisations to further improve the evaluation of stocks.


### 2. emphasises the importance of ensuring sufficient resources for the coordination and surveillance of macroeconomic policies as well transparent communication to eu citizens; ### 2. emphasises the importance of ensuring sufficient resources for the coordination and surveillance of macroeconomic policies and the adherence to fiscal rules and the economic government framework as well transparent communication to eu citizens;


### 3. underlines the importance of a robust consumer policy that gives protection and predictability to consumers both offline and online , and confidence to businesses to provide their goods and services across the internal market; ### 3. underlines the importance of a robust consumer policy that brings protection , predictability to consumers and fights against unfair commercial practices both offline and online , and confidence to businesses to provide their goods and services across the internal market;


### 3. points out that more than half of the union’s supply of fisheries products come from international waters and the exclusive economic zones of third countries; considers that adequate and reliable budgetary provisions must be calculated in the annual budget for 2020 in order to comply with the international fisheries agreement obligations and developing the union's participation in regional fisheries management organisations. ### 3. points out that more than half of the union’s supply of fisheries products come from international waters and the exclusive economic zones of third countries; stresses that the promotion , by the eu , of sustainable fisheries in third countries’ waters is essential for the eu fleet and for the prosperity of eu and third countries’ coastal communities , for the conservation of the fishery resources and the marine environment , the development of local industries , the employment generated by fishing , processing and trade , and the contribution of fishing to food security; recalls the strategic importance of the sustainable fisheries partnership agreements and , more broadly , the external dimension of the cfp; considers that adequate and reliable budgetary provisions must be calculated in the annual budget for 2020 and that the current budget should not be cut in order to comply with the international fisheries agreement obligations and to ensure the union's participation in regional fisheries management organisations;


### 3. calls for adequate resources for the european supervisory authorities (esas) in view of their new tasks; underlines that the esas should continue to increase their efficiency without compromising on the quality of their work with a focus on continuous re-assessment of working methods and of effective use of human and financial resources; emphasises that the esas must stick to the tasks and to the mandate assigned to them by the european legislator; ### 3. calls for adequate resources for the european supervisory authorities (esas) in view of their new tasks; underlines that the esas should continue to increase their efficiency without compromising on the quality of their work with a focus on continuous re-assessment of working methods and of effective use of human and financial resources; emphasises that in the interest of a prudent use of their budgets the esas must at all times stick to the tasks and to the mandate assigned to them by the european legislator and must not seek to broaden that mandate;


### 4. stresses the importance of appropriately financing the transition to a fully automated customs operation , in the interests of greater efficiency for european companies and streamlined protection for consumers; ### 4. stresses the importance of appropriately financing the transition to a fully automated customs operation , in the interests of greater efficiency for european companies and streamlined protection for consumers; to this end , it is essential to increase the funding of the customs 2020 programme which contains cooperation mechanisms that allow customs authorities and officers across the union to exchange and share information and best practices and to ensure funding for purchase and maintenance of up-to date , efficient customs control equipment;


### 6. reiterates the importance of coastal and small artisanal fleet emphasises that sector represents nearly 75 % of all fishing vessels registered in the union and nearly half of all employment in the fisheries sector; notes that operators from small-scale coastal fisheries are dependent on healthy fish stocks for their main source of income. ### 6. reiterates the importance of coastal and small artisanal fleet; emphasises that sector represents nearly 75 % of all fishing vessels registered in the union and nearly half of all employment in the fisheries sector; notes that operators from small-scale coastal fisheries are dependent on sustainable fish stocks for their main source of income.


### 7. calls on the commission and member states to help communities that depend on fisheries to diversify their economies into other maritime activities such as tourism , and help them to add more value to their fishing activities. ### 7. calls on the commission and member states to help communities that depend on fisheries to diversify their sources of income into other sectors of the blue economy , and help them to add more value to their fishing activities.


### 9. reminds that the commission and the member states have already accumulated delays in the scheduled implementation of the union customs code , and consequently strongly regrets the reduction in the budget appropriations for “supporting the functioning and modernisation of the customs union” (budget line 14 02 01) , which could lead to further delays; ### 9. reminds that the commission and the member states have already accumulated delays in the scheduled implementation of the union customs code , and consequently strongly rejects the reduction in the budget appropriations for “supporting the functioning and modernisation of the customs union” (budget line 14 02 01) , which could lead to further delays and undermine the enhancement of the efficiency of custom controls throughout the eu;


### 10. draws attention to the decision of the united kingdom to leave the union which will have an impact on the implementation of the 2014-2020 emff; points out that “brexit” means that the utmost importance needs to be given to the establishment of a new financial budgetary framework for the period 2021-2027; considers that a higher degree of additional flexibility of the union budget is necessary to cope with the new situation. ### 10. draws attention to the decision of the united kingdom to leave the union , which will have an impact on the implementation of the 2014-2020 emff; points out that “brexit” means that the utmost importance needs to be given to the establishment of a new financial budgetary framework for the period 2021-2027; considers that a higher degree of additional flexibility of the union budget is necessary to cope with the new situation; remarks that in no case shall brexit lead to a decrease in funds with respect to the current emff (2014-2027); on the contrary , requests that the 2021-2027 budget should be increased so that operators are able to cope with the serious consequences of brexit.


### 1. welcomes the proposed increase in funding for communication actions by 1 ,9% in commitment appropriations and 2 ,2% in payment appropriations , as compared to the 2019 budget. communication with citizens should be fostered in order to ensure a broad public debate and citizens’ involvement in the discussion on the future of europe. ### 1. welcomes the proposed increase in funding for communication actions by 1 ,9% in commitment appropriations and 2 ,2% in payment appropriations , as compared to the 2019 budget. communication with citizens should be fostered in order to ensure a broad public debate and citizens’ involvement in the discussion on the future of europe; recalls the benefits demonstrated by similar citizen consultation events already held in eu member states including ireland.


### 1. underlines that 21 ,0 % of the total commitments in the draft budget for 2020 (2020 db) are climate-related; regrets that the union budget trend would deliver only 19 ,7 % for the current multiannual financial framework (mff) period; stresses that every effort should be made to ensure that the overall eu budget target will be reached by the end of 2020; reiterates its call to have more ambitious climate mainstreaming in the next mff period and to its alignment with the paris agreement; ### 1. underlines that 21 ,0 % of the total commitments in the draft budget for 2020 (2020 db) are climate-related; objects that the union budget trend would deliver only 19 ,7 % for the current multiannual financial framework (mff) period; stresses that every effort should be made to ensure that the overall eu budget target will be reached by the end of 2020; reiterates its call to have more ambitious climate mainstreaming in the next mff period and to its alignment with the paris agreement;


### 1. calls for the 2020 budget to contribute to the fulfilment of the priorities outlined in the european semester , namely to deliver high-quality investment and reforms that increase productivity growth , continuing to ensure macro-financial stability and sound public finances , and deepening the single market , as well as the completion of the economic and monetary union (emu); ### 1. calls for the 2020 budget to contribute to the fulfilment of the priorities outlined in the european semester , namely to deliver high-quality investment and reforms that increase competitiveness , productivity growth , continuing to ensure macro-financial stability and sound public finances , and deepening the single market , as well as the completion of the economic and monetary union (emu);


### 5. highlights that special importance should be granted in the 2020 budget to the financial resources designated to help the fleet to a smooth implementation of the landing obligation schemes. ### 5. highlights that special importance should be granted in the 2020 budget to the financial resources designated needed to support the fishing sector while the landing obligation schemes are implemented.


### 8. remarks that the adoption of the current multiannual plans and the implementation of new technical measures to contribute to achieving fishing at sustainable levels requires a robust control policy supported by adequate funds. ### 8. remarks that the adoption of the current multiannual plans and the implementation of new technical measures to contribute to achieving fishing at sustainable levels requires a suitable control policy supported by adequate funds.


### 15. points out that pooling resources from the european development fund , the union budget and other donors in trust funds should not have as consequence that money flagged for development and cooperation policy does not reach its normal beneficiaries or pursue its original objectives , such as the eradication of poverty and the promotion of fundamental rights; ### 15. points out that pooling resources from the european development fund , the union budget and other donors in trust funds should not have as consequence that money flagged for development and cooperation policy does not pursue its original objectives , such as the eradication of poverty and the promotion of fundamental rights;


### 16. stresses that trust funds should be established only when their use is justified and the required action is not possible through other existing financing channels; further calls on the commission to consider putting an end to trust funds that are unable to attract a significant contribution from other donors or that do not provide an added value when compared to ‘traditional’ union external instruments; ### 16. stresses that trust funds should be established only when their use is justified and the required action is not possible through other existing financing channels; further calls on the commission to consider putting an end to trust funds that are unable to attract contribution from other donors or that do not provide an added value when compared to ‘traditional’ union external instruments;


### (6) regulation (eu) 2016/64621 introduced the dates of application of the rde test procedure , as well as the compliance criteria for rde. for that purpose , pollutant-specific conformity factors were used to take account of statistical and technical uncertainties of the measurements conducted by means of portable emission measurement systems (pems). ### (6) regulation (eu) 2016/64621 introduced the dates of application of the rde test procedure , as well as the compliance criteria for rde. for that purpose , pollutant-specific conformity factors were introduced , and separate error margins were used to take account of statistical and technical uncertainties of the measurements conducted by means of portable emission measurement systems (pems).


### (7) on 13 december 2018 , the general court delivered judgment in joined cases t-339/16 , t-352/16 and t-391/1622 concerning an action for annulment of regulation (eu) 2016/646. the general court annulled the part of regulation (eu) 2016/646 which established the conformity factors used to assess compliance of rde test results with the emission limits laid down in regulation (ec) no 715/2007. the court found that only the legislator could introduce those conformity factors as they touched upon an essential element of regulation (ec) no 715/2007. ### (7) on 13 december 2018 , the general court delivered judgment in joined cases t-339/16 , t-352/16 and t-391/1622 concerning an action for annulment of regulation (eu) 2016/646. the general court annulled the part of regulation (eu) 2016/646 which established the conformity factors and error margins used to assess compliance of rde test results with the emission limits laid down in regulation (ec) no 715/2007. the court found that only the legislator could introduce those conformity factors and error margins as they touched upon an essential element of regulation (ec) no 715/2007.


### (8) the general court did not question the technical justification of the conformity factors. therefore , and given that at the current stage of technological development there is still a discrepancy between emissions measured in real driving and those measured in a laboratory , it is appropriate to introduce the conformity factors into regulation (ec) no 715/2007. ### (8) the general court did not question the technical justification of the conformity factors and error margins. therefore , and given that at the current stage of technological development there is still a discrepancy between emissions measured in real driving and those measured in a laboratory , it is appropriate to introduce the exact same conformity factors and error margins into regulation (ec) no 715/2007.


### (11) in order to contribute to the achievement of the union’s air quality objectives and to reduce vehicle emissions , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union (tfue) should be delegated to the commission in respect of the detailed rules on the specific procedures , tests and requirements for type approval. that delegation should include supplementing regulation (ec) no 715/2007 by such revised rules as well as the test cycles used to measure emissions; the requirements for the implementation of the prohibition on the use of defeat devices that reduce the effectiveness of emission control systems; the measures necessary for the implementation of the obligation of a manufacturer to provide unrestricted and standardised access to vehicle repair and maintenance information; the adoption of a revised measurement procedure for particulates. the delegation should further include amending regulation (ec) no 715/2007 for the purposes of revising the final conformity factors downwards to reflect technical progress in pems and recalibrating the particulate mass based limit values and introducing particle number based limit values. it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level , and that those consultations are conducted in accordance with the principles laid down in the interinstitutional agreement on better law-making of 13 april 2016. in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council should receive all documents at the same time as member states’ experts , and their experts systematically should have access to meetings of commission expert groups dealing with the preparation of delegated acts. ### (11) in order to contribute to the achievement of the union’s air quality objectives and to reduce vehicle emissions , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union (tfue) should be delegated to the commission in respect of the detailed rules on the specific procedures , tests and requirements for type approval. that delegation should include supplementing regulation (ec) no 715/2007 by such revised rules as well as the test cycles used to measure emissions; the requirements for the implementation of the prohibition on the use of defeat devices that reduce the effectiveness of emission control systems. the delegation should further include amending regulation (ec) no 715/2007 for the purposes of revising the error margins to reflect technical progress in pems. it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level , and that those consultations are conducted in accordance with the principles laid down in the interinstitutional agreement on better law-making of 13 april 2016. in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council should receive all documents at the same time as member states’ experts , and their experts systematically should have access to meetings of commission expert groups dealing with the preparation of delegated acts.


### those obligations include meeting the emission limits set out in annex i. for the purposes of determining compliance with the euro 6 emission limits set out in table 2 of annex i , the emission values determined during any valid real driving emissions (rde) test shall be divided by the applicable conformity factor set out in table 2a of annex i. the result shall remain below the euro 6 emission limits set out in table 2 of that annex.; ### those obligations include complying with the emission limits set out in annex i. for the purposes of determining compliance with the euro 6 emission limits set out in table 2 of annex i , the emission values determined during any valid real driving emissions (rde) test shall be divided by the applicable conformity factor or , where specified , by the sum of the applicable conformity factor and error margin set out in table 2a of annex i. the result shall comply with the euro 6 emission limits set out in table 2 of that annex.;


### 1. the manufacturer shall equip vehicles so that the components likely to affect emissions are designed , constructed and assembled so as to enable the vehicle , in normal use , to comply with this regulation.; ### 1. the manufacturer shall equip vehicles so that the components likely to affect emissions are designed , constructed and assembled so as to enable the vehicle , in normal use , to comply with this regulation. the manufacturer shall also guarantee the reliability of the pollution control devices and shall aim to reduce the risk of theft of these devices or tampering therewith.


### 2. the commission is empowered to adopt delegated acts in accordance with article 14a in order to adopt the following measures based on the results of the unece particulate measurement programme , conducted under the auspices of the world forum for harmonisation of vehicle regulations , without lowering the level of environmental protection within the union: ### 2. the commission is empowered to adopt delegated acts in accordance with article 14a:


### amend this regulation for the purposes of reviewing the particulate mass and particle number limit values set out in annex i; ### supplementing this regulation in order to adapt the procedures , tests and requirements as well as the test cycles used to measure emissions in order to adequately reflect real driving emissions;


### supplement this regulation by the adoption of a revised measurement procedure for particle numbers. ### amending this regulation in order to revise the pollutant-specific error margins set out in table 2a to annex i in light of technical progress by taking into account the technical uncertainties linked with the use of portable emission measurement systems (pems);


### amending this regulation in order to adapt to technical progress the pollutant-specific final conformity factors set out in table 2a to annex i.; ### amending this regulation in order to adapt to technical progress the pollutant-specific margin of error set out in table 2a to annex i.;


### cf pollutant-final (2) ### 1 ,43


### (5) this regulation will contribute to making products fit for a climate-neutral , resource-efficient and circular economy , reducing waste and ensuring that the performance of frontrunners in sustainability progressively becomes the norm. it should provide for the setting of new ecodesign requirements to improve product durability , reusability , upgradability and reparability , improve possibilities for refurbishment and maintenance , address the presence of hazardous chemicals in products , increase their energy and resource efficiency , reduce their expected generation of waste materials and increase recycled content in products , while ensuring their performance and safety , enabling remanufacturing and high-quality recycling and reducing carbon and environmental footprints. ### (5) this regulation will contribute to making products fit for a climate-neutral , resource-efficient and circular economy , reducing waste and ensuring that the performance of frontrunners in sustainability progressively becomes the norm. it should provide for the setting of new ecodesign requirements to improve product durability , reusability , upgradability and reparability , improve possibilities for refurbishment and maintenance , address the presence of hazardous chemicals in products , increase their energy and resource efficiency , reduce their expected generation of waste materials and increase recycled content in products , while ensuring their performance and safety , enabling remanufacturing and high-quality recycling and reducing carbon and environmental footprints. by doing so , this regulation should aim at supporting production and consumption patterns that are aligned with union's overall sustainability targets , including climate , environmental , energy , resources-use and biodiversity. as this regulation will establish provisions to extend the lifecycle of products , it should not impede the re-use of components or spare parts for repairing products.


### 1. importers shall only place on the market products covered by a delegated act adopted pursuant to article 4 that comply with the requirements set out in the applicable delegated acts. ### 1. importers may only place on the market products complying with the requirements set out in a delegated act adopted pursuant to article 4 , that relate to them.


### 1. where a delegated act adopted pursuant to article 4 requires products to have a label as referred to in article 14 , the economic operator placing the product on the market or putting it into service shall ensure that products are accompanied , for each individual unit and free of charge , by printed labels in accordance with that delegated act. ### 1. where a delegated act adopted pursuant to article 4 requires products to have a label as referred to in article 14 , the economic operator placing the product on the market or putting it into service shall ensure that products are accompanied , for each individual unit and free of charge , by printed labels in accordance with that delegated act. for the verification of these requirements , random samples are sufficient.


### 1. where a delegated act adopted pursuant to article 4 requires products to have a label as referred to in article 14 , the economic operator placing the product on the market or putting it into service shall ensure that products are accompanied , for each individual unit and free of charge , by printed labels in accordance with that delegated act. ### 1. where a delegated act adopted pursuant to article 4 requires products to have a label as referred to in article 14 , the economic operator placing the product on the market or putting it into service shall ensure that products are accompanied , for each individual unit and free of charge , by printed labels or digital copies in accordance with that delegated act. preference should be given to digital labels.


### 1. where a delegated act adopted pursuant to article 4 requires products to have a label as referred to in article 14 , the economic operator placing the product on the market or putting it into service shall ensure that products are accompanied , for each individual unit and free of charge , by printed labels in accordance with that delegated act. ### 1. where a delegated act adopted pursuant to article 4 requires products to have a label as referred to in article 14 , the economic operator placing the product on the market or putting it into service shall ensure that products are accompanied , for each individual unit and free of charge , by digital copies of the labels , or where duly justified , by printed labels in accordance with that delegated act.


### 1. where a delegated act adopted pursuant to article 4 requires products to have a label as referred to in article 14 , the economic operator placing the product on the market or putting it into service shall ensure that products are accompanied , for each individual unit and free of charge , by printed labels in accordance with that delegated act. ### 1. where a delegated act adopted pursuant to article 4 requires products to have a label as referred to in article 14 , the economic operator placing the product on the market or putting it into service shall ensure that products are accompanied , for each individual unit and free of charge , by printed or digital labels in accordance with that delegated act.


### not provide or display other labels , marks , symbols or inscriptions that are likely to mislead or confuse customers with respect to the information included on the label. ### not provide or display other labels , marks , symbols or inscriptions that are likely to mislead or confuse customers with respect to the information included on the label. these provisions are without prejudice to the eu ecolabel and other state commissioned type 1-ecolabels (iso 14024).


### fulfilment service providers shall ensure that , for products that they handle that are covered by a delegated act adopted pursuant to article 4 , the conditions during warehousing , packaging , addressing or dispatching , do not jeopardise the products’ compliance with the requirements set out in that delegated act . ### fulfilment service providers shall ensure that , for products that they handle that are covered by a delegated act adopted pursuant to article 4 , they only service products which comply with the delegated acts matching the obligations of importers and the conditions during warehousing , packaging , addressing or dispatching , do not jeopardise the products’ compliance with the requirements set out in that delegated act .


### the commission shall ensure that the resulting data is processed securely and in compliance with union law. ### the commission shall ensure that the resulting data is processed securely and in compliance with union law and that any publication of the resulting data by the commission is aggregated.


### the technical feasibility of recording in-use data; ### the technical feasibility of recording in-use data , taking into account cost , cybersecurity , data protection and data storage;


### economic operators placing a product covered by a delegated act adopted pursuant to article 4 shall not prescribe instructions specific to testing that alter the behaviour or the properties of products in order to reach a more favourable result for any of the product parameters regulated in delegated acts adopted pursuant to article 4 by which the products are covered. ### economic operators placing a product covered by a delegated act adopted pursuant to article 4 must not issue instructions specific to testing that alter the behaviour or the properties of products in order to reach a more favourable result for any of the product parameters regulated in delegated acts adopted pursuant to article 4 by which the products are covered.


### software or firmware updates shall not worsen product performance in relation to any of the product parameters regulated in delegated acts adopted pursuant to article 4 by which the products are covered or the functional performance from the perspective of the user when measured with the test method used for the conformity assessment , except with explicit consent of the end-user prior to the update. no performance change shall occur as a result of rejecting the update. ### software or firmware updates must not worsen product performance in relation to any of the product parameters regulated in delegated acts adopted pursuant to article 4 by which the products are covered or the functional performance from the perspective of the user when measured with the test method used for the conformity assessment , except with explicit consent of the end-user prior to the update. no performance change shall occur as a result of rejecting the update.


### software or firmware updates shall not worsen performance referred to in the first subparagraph to the extent that the product becomes non-compliant with the requirements set out in delegated acts adopted pursuant to article 4 applicable at the time of the placing on the market or putting into service of the product. ### software or firmware updates must not worsen performance referred to in the first subparagraph to the extent that the product becomes non-compliant with the requirements set out in delegated acts adopted pursuant to article 4 applicable at the time of the placing on the market or putting into service of the product.


### 2. the eu declaration of conformity shall have the model structure set out in annex v , shall contain the elements specified in the applicable conformity assessment procedure and a reference to the applicable delegated acts adopted pursuant to article 4. it shall be continuously updated. it shall be translated into the language or languages required by the member state in which the product is placed or made available. ### 2. the eu declaration of conformity shall have the model structure set out in annex v , shall contain the elements specified in the applicable conformity assessment procedure and a reference to the applicable delegated acts adopted pursuant to article 4. it shall be continuously updated. it shall be translated into the language or languages required by the member state in which the product is placed or made available.


### 3. a conformity assessment body shall be a third-party body independent of the organisation or the product it assesses. it shall not have any business ties with organisations that have an interest in the products it assesses , in particular manufacturers , their trade partners and their shareholding investors. this shall not preclude the conformity assessment body from carrying out conformity assessment activities for competing manufacturers. ### 3. a conformity assessment body shall be a third-party body independent of the organisation or the product it assesses. it must not have any business ties with organisations that have an interest in the products it assesses , in particular manufacturers , their trade partners and their shareholding investors. this shall not preclude the conformity assessment body from carrying out conformity assessment activities for competing manufacturers.


### 1. member states incentives relating to products covered by a delegated act adopted pursuant to article 4 that determines classes of performance in accordance with article 7(4) , in relation to a product parameter referred to in annex i , shall concern the highest two classes of performance that are populated at union level or , where relevant , products with an eu ecolabel , unless otherwise specified in that delegated act. ### 1. member states incentives relating to products covered by a delegated act adopted pursuant to article 4 that determines classes of performance in accordance with article 7(4) , in relation to a product parameter referred to in annex i , shall concern the highest two classes of performance that are populated at union level or , where relevant , products with an eu ecolabel , and other officially recognised type 1 ecolabels , unless otherwise specified in that delegated act.


### where , in the course of that evaluation , the market surveillance authorities find that the product does not comply with the requirements laid down in the applicable delegated acts adopted pursuant to article 4 , they shall without delay require the relevant economic operator to take appropriate and proportionate corrective action , within a reasonable period prescribed by the market surveillance authorities and commensurate with the nature and where relevant the degree of the non-compliance , to bring the non-compliance to an end. the corrective action required to be taken by the economic operator may include the actions listed in article 16(3) of regulation (eu) 2019/1020. ### where , in the course of that evaluation , the market surveillance authorities find that the product does not comply with the requirements laid down in the applicable delegated acts adopted pursuant to article 4 , they shall without delay summon the relevant economic operator to take appropriate and proportionate corrective action , within a reasonable period prescribed by the market surveillance authorities and commensurate with the nature and where relevant the degree of the non-compliance , to bring the non-compliance to an end. the corrective action required to be taken by the economic operator may include the actions listed in article 16(3) of regulation (eu) 2019/1020.


### where the relevant economic operator does not take corrective action within the period referred to in the second subparagraph of paragraph 1 or the non-compliance persists , the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the making available of the product concerned on their national market , to withdraw the product from that market or to recall it. ### where the relevant economic operator does not take corrective action within the period referred to in the second subparagraph of paragraph 1 or the non-compliance persists , the market surveillance authorities shall take all appropriate interim measures to prohibit or restrict the making available of the product concerned on their national market , to withdraw the product from that market or to recall it.


### 4. before adopting a delegated act , the commission shall consult experts designated by each member state acting in accordance with the principles laid down in the interinstitutional agreement of 13 april 2016 on better law-making. ### 4. before adopting a delegated act , the commission shall consult experts designated by each member state acting in accordance with the principles laid down in the interinstitutional agreement of 13 april 2016 on better law-making. the commission shall consult member states' experts after completion of the consultation pursuant to article 5(4)(d).


### member states shall lay down the rules on penalties applicable to infringements of this regulation and shall take all measures necessary to ensure that they are implemented. the penalties provided for shall be effective , proportionate and dissuasive , taking into account the extent of non-compliance and the number of units of non-complying products placed on the union market. member states shall notify the commission of those provisions by [one year after the date of application of this regulation] at the latest and shall notify it without delay of any subsequent amendment affecting them. ### member states shall lay down the rules on penalties applicable to infringements of this regulation and shall take all measures necessary to ensure that they are implemented. the penalties provided for shall be effective , proportionate and dissuasive , taking into account the extent of non-compliance and the number of units of non-complying products placed on the union market , as well as any repeated violation of the obligations established by this regulation by the economic entity. member states shall notify the commission of provisions on penalties by [one year after the date of application of this regulation] at the latest and shall notify it without delay of any subsequent amendment affecting them.


### no sooner than [8 years after the date of application of this regulation] , the commission shall carry out an evaluation of this regulation and of its contribution to the functioning of the internal market and the improvement of the environmental sustainability of products. the commission shall present a report on the main findings to the european parliament , the council , the european economic and social committee , and the committee of the regions. member states shall provide the commission with the information necessary for the preparation of that report. ### 1) monitoring:


### no sooner than [8 years after the date of application of this regulation] , the commission shall carry out an evaluation of this regulation and of its contribution to the functioning of the internal market and the improvement of the environmental sustainability of products. the commission shall present a report on the main findings to the european parliament , the council , the european economic and social committee , and the committee of the regions. member states shall provide the commission with the information necessary for the preparation of that report. ### no later than [8 years after the date of application of this regulation] , the commission shall carry out an evaluation of this regulation and of its contribution to the functioning of the internal market and the improvement of the environmental sustainability of products. the commission shall present a report on the main findings to the european parliament , the council , the european economic and social committee , and the committee of the regions. member states shall provide the commission with the information necessary for the preparation of that report.


### the following parameters may , as appropriate , and where necessary supplemented by others , be used as a basis for improving the product aspects referred to in article 5(1): ### the following parameters may , as appropriate and justified by an assessment of the product’s life cycle and circularity , and where necessary supplemented by others , be used individually or aggregated , considering possible trade-offs between different parameters , as a basis for improving the product aspects referred to in article 5(1):


### ease of repair and maintenance as expressed through: characteristics , availability and delivery time of spare parts , modularity , compatibility with commonly available spare parts , availability of repair and maintenance instructions , number of materials and components used , use of standard components , use of component and material coding standards for the identification of components and materials , number and complexity of processes and tools needed , ease of non-destructive disassembly and re-assembly , conditions for access to product data , conditions for access to or use of hardware and software needed; ### ease of repair and maintenance , keeping in mind product safety , as expressed through: characteristics , availability and delivery time of spare parts , modularity , compatibility with commonly available spare parts , availability of repair and maintenance instructions , number of materials and components used , use of standard components , use of component and material coding standards for the identification of components and materials , number and complexity of processes and tools needed , ease of non-destructive disassembly and re-assembly , conditions for access to product data , conditions for access to or use of hardware and software needed; access to the information shall be facilitated on a need-to-know basis in line with intellectual property rules;


### ease of upgrading , re-use , remanufacturing and refurbishment as expressed through: number of materials and components used , use of standard components , use of component and material coding standards for the identification of components and materials , number and complexity of processes and tools needed , ease of non-destructive disassembly and re-assembly , conditions for access to product data , conditions for access to or use of hardware and software needed , conditions of access to test protocols or not commonly available testing equipment , availability of guarantees specific to remanufactured or refurbished products , conditions for access to or use of technologies protected by intellectual property rights , modularity; ### ease of upgrading , re-use , remanufacturing and refurbishment as expressed through: number of materials and components used , use of standard components , use of component and material coding standards for the identification of components and materials , number and complexity of processes and tools needed , ease of non-destructive disassembly and re-assembly , conditions for access to product data , conditions for access to or use of hardware and software needed , conditions of access to test protocols or not commonly available testing equipment , availability of guarantees specific to remanufactured or refurbished products , conditions for access to or use of technologies protected by intellectual property rights , modularity; access to the information shall be facilitated on a need-to-know basis in line with intellectual property rules;


### ease and quality of recycling as expressed through: use of easily recyclable materials , safe , easy and non-destructive access to recyclable components and materials or components and materials containing hazardous substances , material composition and homogeneity , possibility for high-purity sorting , number of materials and components used , use of standard components , use of component and material coding standards for the identification of components and materials , number and complexity of processes and tools needed , ease of non-destructive disassembly and re-assembly , conditions for access to product data , conditions for access to or use of hardware and software needed; ### ease and quality of recycling , given the product is technically and economically suitable for recycling , as expressed through: use of easily recyclable materials , safe , easy and non-destructive access to recyclable components and materials or components and materials containing hazardous substances , material composition and homogeneity , possibility for high-purity sorting , number of materials and components used , use of standard components , use of component and material coding standards for the identification of components and materials , number and complexity of processes and tools needed , ease of non-destructive disassembly and re-assembly , conditions for access to product data , conditions for access to or use of hardware and software needed;


### avoidance of technical solutions detrimental to re-use , upgrading , repair , maintenance , refurbishment , remanufacturing and recycling of products and components; ### avoidance of technical solutions detrimental to re-use , upgrading , repair , maintenance , refurbishment , remanufacturing and recycling of products and components , unless required to ensure that the product is safe;


### use of substances , on their own , as constituents of substances or in mixtures , during the production process of products , or leading to their presence in products , including once these products become waste; ### use of substances present in the end product , which have negative , measurable effect on its sustainability;


### use of substances , on their own , as constituents of substances or in mixtures , during the production process of products , or leading to their presence in products , including once these products become waste; ### use of substances , on their own , as constituents of substances or in mixtures , during the production process of products which results in their presence in products , including once these products become waste;


### use of substances , on their own , as constituents of substances or in mixtures , during the production process of products , or leading to their presence in products , including once these products become waste; ### use of substances , on their own , as constituents of substances or in mixtures , during the production process of products leading to their presence in products , including once these products become waste;


### use or content of recycled materials; ### use or content of recycled materials in line with product specific european legislation;


### this regulation establishes a framework to improve the environmental sustainability of products and to ensure free movement in the internal market by setting ecodesign requirements that products shall fulfil to be placed on the market or put into service. those ecodesign requirements , which shall be further elaborated by the commission in delegated acts , relate to: ### this regulation establishes a framework to meet the global science-based environmental sustainability targets of products in order to make sustainable products the norm and to reduce their overall environmental footprint over their lifecycle , as well as to improve their social sustainability and to ensure free movement in the internal market by setting ecodesign requirements that products shall fulfil to be placed on the market or put into service. those ecodesign requirements based on global science-based and indicator-based life cycle assessment methods to pursue the overall resource-efficiency of all products by ten folds , which shall be further elaborated by the commission in delegated acts , relate to:


### this regulation establishes a framework to improve the environmental sustainability of products and to ensure free movement in the internal market by setting ecodesign requirements that products shall fulfil to be placed on the market or put into service. those ecodesign requirements , which shall be further elaborated by the commission in delegated acts , relate to: ### this regulation establishes a framework to improve the environmental sustainability of products in order to make sustainable products the predominant type of products on the market and to reduce their overall environmental footprint over their lifecycle as well as to ensure free movement in the internal market by setting ecodesign requirements that products shall fulfil to be placed on the market or put into service. those ecodesign requirements , which shall be further elaborated by the commission in delegated acts , relate to:


### this regulation establishes a framework to improve the environmental sustainability of products and to ensure free movement in the internal market by setting ecodesign requirements that products shall fulfil to be placed on the market or put into service. those ecodesign requirements , which shall be further elaborated by the commission in delegated acts , relate to: ### this regulation establishes a framework to improve the environmental sustainability of the movement of products and to ensure free movement in the internal market by setting ecodesign requirements that products shall fulfil to be placed on the market or put into service. those ecodesign requirements , which shall be further elaborated by the commission in delegated acts , relate to:


### product reusability; ### product reusability , with the objective that before 2050 all products are reusable;


### product upgradability , reparability , maintenance and refurbishment; ### product upgradability , reparability , maintenance and refurbishment , with the objective that before 2050 all products are upgradable , reparable , maintainable and refurbishable;


### recycled content in products; ### recycled content in products and recyclability of products;


### product remanufacturing and recycling; ### product remanufacturing;


### product remanufacturing and recycling; ### product remanufacturing and recycling , with the objective that before 2050 all products are recyclable based on the highest material use value;


### products’ expected generation of waste materials. ### products’ expected generation of waste materials , with the objective to ensure that all products are designed with the designing out waste principle and designed to maximise the products' lifespan;


### 2. this regulation shall apply to any physical good that is placed on the market or put into service , including components and intermediate products. however , it shall not apply to: ### (does not affect english version.)


### products of human origin; ### (does not affect english version.)


### products of plants and animals relating directly to their future reproduction. ### (does not affect english version.)


### (1) ‘product’ means any physical good that is placed on the market or put into service; ### (does not affect english version.)


### (3) ‘intermediate product’ means a product that requires further manufacturing or transformation such as mixing , coating or assembling to make it suitable for end-users; ### (3) ‘intermediate product’ means a product that requires further manufacturing or processing such as synthesis , mixing , coating or assembling to make it suitable for end-users;