### (5) a union legal framework laying down harmonised rules on artificial intelligence is therefore needed to foster the development , use and uptake of artificial intelligence in the internal market that at the same time meets a high level of protection of public interests , such as health and safety and the protection of fundamental rights , as recognised and protected by union law. to achieve that objective , rules regulating the placing on the market and putting into service of certain ai systems should be laid down , thus ensuring the smooth functioning of the internal market and allowing those systems to benefit from the principle of free movement of goods and services. by laying down those rules , this regulation supports the objective of the union of being a global leader in the development of secure , trustworthy and ethical artificial intelligence , as stated by the european council33 , and it ensures the protection of ethical principles , as specifically requested by the european parliament34 . ### (5) a union legal framework laying down harmonised rules on artificial intelligence is therefore needed to foster the development , use and uptake of artificial intelligence in the internal market that at the same time meets a high level of protection of public interests , such as health and safety , the environment , and the protection of fundamental rights , as recognised and protected by union law. to achieve that objective , rules regulating the placing on the market and putting into service of certain ai systems should be laid down , thus ensuring the smooth functioning of the internal market and allowing those systems to benefit from the principle of free movement of goods and services. by laying down those rules , this regulation supports the objective of the union of being a global leader in the development of secure , trustworthy and ethical artificial intelligence , as stated by the european council33 , and it ensures the protection of ethical principles , as specifically requested by the european parliament34 .


### (5) a union legal framework laying down harmonised rules on artificial intelligence is therefore needed to foster the development , use and uptake of artificial intelligence in the internal market that at the same time meets a high level of protection of public interests , such as health and safety and the protection of fundamental rights , as recognised and protected by union law. to achieve that objective , rules regulating the placing on the market and putting into service of certain ai systems should be laid down , thus ensuring the smooth functioning of the internal market and allowing those systems to benefit from the principle of free movement of goods and services. by laying down those rules , this regulation supports the objective of the union of being a global leader in the development of secure , trustworthy and ethical artificial intelligence , as stated by the european council33 , and it ensures the protection of ethical principles , as specifically requested by the european parliament34 . ### (5) a union legal framework laying down harmonised rules on artificial intelligence is therefore needed to foster the development , use and uptake of artificial intelligence in the internal market that at the same time guarantees a high level of protection of public interests , such as health and safety and the protection of fundamental rights , as recognised and protected by union law as well as the environment , society , rule of law and democracy , economic interests and consumer protection. to achieve that objective , rules regulating the placing on the market and putting into service of certain ai systems should be laid down , thus ensuring the smooth functioning of the internal market and allowing those systems to benefit from the principle of free movement of goods and services. by laying down those rules , this regulation supports the objective of the union of being a global leader in the development of secure , trustworthy and ethical artificial intelligence , as stated by the european council33 , and it ensures the protection of ethical principles , as specifically requested by the european parliament34 .


### (6) the notion of ai system should be clearly defined to ensure legal certainty , while providing the flexibility to accommodate future technological developments. the definition should be based on the key functional characteristics of the software , in particular the ability , for a given set of human-defined objectives , to generate outputs such as content , predictions , recommendations , or decisions which influence the environment with which the system interacts , be it in a physical or digital dimension. ai systems can be designed to operate with varying levels of autonomy and be used on a stand-alone basis or as a component of a product , irrespective of whether the system is physically integrated into the product (embedded) or serve the functionality of the product without being integrated therein (non-embedded). the definition of ai system should be complemented by a list of specific techniques and approaches used for its development , which should be kept up-to–date in the light of market and technological developments through the adoption of delegated acts by the commission to amend that list. ### (6) the notion of ai system should be clearly defined to ensure legal certainty , while providing the flexibility to accommodate future technological developments. the definition should be based on the key functional characteristics of the software , in particular the ability , for a given set of inputs and objectives , to generate outputs such as content , predictions , recommendations , or decisions which influence the environment with which the system interacts , be it in a physical or digital dimension. ai systems can be designed to operate with varying levels of autonomy and be used on a stand-alone basis or as a component of a product , irrespective of whether the system is physically integrated into the product (embedded) or serve the functionality of the product without being integrated therein (non-embedded). the definition of ai system should be complemented by a list of specific techniques and approaches used for its development , which should be kept up-to–date in the light of market and technological developments through the adoption of delegated acts by the commission to amend that list.


### (6) the notion of ai system should be clearly defined to ensure legal certainty , while providing the flexibility to accommodate future technological developments. the definition should be based on the key functional characteristics of the software , in particular the ability , for a given set of human-defined objectives , to generate outputs such as content , predictions , recommendations , or decisions which influence the environment with which the system interacts , be it in a physical or digital dimension. ai systems can be designed to operate with varying levels of autonomy and be used on a stand-alone basis or as a component of a product , irrespective of whether the system is physically integrated into the product (embedded) or serve the functionality of the product without being integrated therein (non-embedded). the definition of ai system should be complemented by a list of specific techniques and approaches used for its development , which should be kept up-to–date in the light of market and technological developments through the adoption of delegated acts by the commission to amend that list. ### (6) the notion of ai system should be clearly defined to ensure legal certainty , while providing the flexibility to accommodate future technological developments. the definition should be based on the key functional characteristics of the system , in particular the ability , for a given set of objectives , to generate outputs such as content , predictions , recommendations , or decisions. ai systems can be designed to operate with varying levels of autonomy and be used on a stand-alone basis or as a component of a product , irrespective of whether the system is physically integrated into the product (embedded) or serve the functionality of the product without being integrated therein (non-embedded). the definition of ai system should be complemented by a list of specific techniques and approaches used for its development , which should be kept up-to–date in the light of market and technological developments through the adoption of delegated acts by the commission to amend that list.


### (13) in order to ensure a consistent and high level of protection of public interests as regards health , safety and fundamental rights , common normative standards for all high-risk ai systems should be established. those standards should be consistent with the charter of fundamental rights of the european union (the charter) and should be non-discriminatory and in line with the union’s international trade commitments. ### (13) in order to ensure a consistent and high level of protection of public interests as regards health , safety , fundamental rights and the environment , common normative standards for all high-risk ai systems should be established. those standards should be consistent with the charter of fundamental rights of the european union (the charter) and should be non-discriminatory and in line with the union’s international trade commitments.


### (13) in order to ensure a consistent and high level of protection of public interests as regards health , safety and fundamental rights , common normative standards for all high-risk ai systems should be established. those standards should be consistent with the charter of fundamental rights of the european union (the charter) and should be non-discriminatory and in line with the union’s international trade commitments. ### (13) in order to ensure a consistent and high level of protection of public interests as regards health , safety , and fundamental rights , as well as the environment , society , rule of law and democracy , economic interests and consumer protection , common normative standards for all high-risk ai systems should be established. those standards should be consistent with the charter of fundamental rights of the european union (the charter) and should be non-discriminatory and in line with the union’s international trade commitments.


### (13) in order to ensure a consistent and high level of protection of public interests as regards health , safety and fundamental rights , common normative standards for all high-risk ai systems should be established. those standards should be consistent with the charter of fundamental rights of the european union (the charter) and should be non-discriminatory and in line with the union’s international trade commitments. ### (13) in order to ensure a consistent and high level of protection of public interests as regards health , safety , fundamental rights and environment , common normative standards for all high-risk ai systems should be established. those standards should be consistent with the charter of fundamental rights of the european union (the charter) and should be non-discriminatory and in line with the union’s international trade commitments.


### (18) the use of ai systems for ‘real-time’ remote biometric identification of natural persons in publicly accessible spaces for the purpose of law enforcement is considered particularly intrusive in the rights and freedoms of the concerned persons , to the extent that it may affect the private life of a large part of the population , evoke a feeling of constant surveillance and indirectly dissuade the exercise of the freedom of assembly and other fundamental rights. in addition , the immediacy of the impact and the limited opportunities for further checks or corrections in relation to the use of such systems operating in ‘real-time’ carry heightened risks for the rights and freedoms of the persons that are concerned by law enforcement activities. ### (18) the use of ai systems for biometric identification of natural persons in publicly accessible spaces is particularly corrosive to the rights and freedoms of the concerned persons and can ultimately affect the private life of a large part of the population , leave society with a justifiable feeling of constant surveillance , give parties deploying biometric identification in publicly accessible spaces a position of uncontrollable power and indirectly dissuade individuals from the exercise of their freedom of assembly and other fundamental rights at the core to the rule of law. biometric identification not carried out in real time carries different but equally problematic risks. due to the increase in pervasiveness , functionality and memory capacities of relevant devices , this would amount to a "surveillance time machine" , which could be used to track movements and social interactions stretching back an indeterminate period into the past.


### (18) the use of ai systems for ‘real-time’ remote biometric identification of natural persons in publicly accessible spaces for the purpose of law enforcement is considered particularly intrusive in the rights and freedoms of the concerned persons , to the extent that it may affect the private life of a large part of the population , evoke a feeling of constant surveillance and indirectly dissuade the exercise of the freedom of assembly and other fundamental rights. in addition , the immediacy of the impact and the limited opportunities for further checks or corrections in relation to the use of such systems operating in ‘real-time’ carry heightened risks for the rights and freedoms of the persons that are concerned by law enforcement activities. ### (18) the use of ai systems for ‘real-time’ remote biometric identification of natural persons in publicly accessible spaces for the purpose of law enforcement is considered particularly intrusive in the rights and freedoms of the concerned persons , to the extent that it may affect the private life of a large part of the population , evoke a feeling of constant surveillance and indirectly dissuade the exercise of the freedom of assembly and other fundamental rights being core to the rule of law. in addition , the immediacy of the impact and the limited opportunities for further checks or corrections in relation to the use of such mass surveillance systems operating in ‘real-time’ carry heightened risks for the rights and freedoms of the persons that are concerned by law enforcement activities. such ai systems should be therefore prohibited.


### (20) in order to ensure that those systems are used in a responsible and proportionate manner , it is also important to establish that , in each of those three exhaustively listed and narrowly defined situations , certain elements should be taken into account , in particular as regards the nature of the situation giving rise to the request and the consequences of the use for the rights and freedoms of all persons concerned and the safeguards and conditions provided for with the use. in addition , the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement should be subject to appropriate limits in time and space , having regard in particular to the evidence or indications regarding the threats , the victims or perpetrator. the reference database of persons should be appropriate for each use case in each of the three situations mentioned above. ### deleted


### (21) each use of a ‘real-time’ remote biometric identification system in publicly accessible spaces for the purpose of law enforcement should be subject to an express and specific authorisation by a judicial authority or by an independent administrative authority of a member state. such authorisation should in principle be obtained prior to the use , except in duly justified situations of urgency , that is , situations where the need to use the systems in question is such as to make it effectively and objectively impossible to obtain an authorisation before commencing the use. in such situations of urgency , the use should be restricted to the absolute minimum necessary and be subject to appropriate safeguards and conditions , as determined in national law and specified in the context of each individual urgent use case by the law enforcement authority itself. in addition , the law enforcement authority should in such situations seek to obtain an authorisation as soon as possible , whilst providing the reasons for not having been able to request it earlier. ### deleted


### (22) furthermore , it is appropriate to provide , within the exhaustive framework set by this regulation that such use in the territory of a member state in accordance with this regulation should only be possible where and in as far as the member state in question has decided to expressly provide for the possibility to authorise such use in its detailed rules of national law. consequently , member states remain free under this regulation not to provide for such a possibility at all or to only provide for such a possibility in respect of some of the objectives capable of justifying authorised use identified in this regulation. ### deleted


### (23) the use of ai systems for ‘real-time’ remote biometric identification of natural persons in publicly accessible spaces for the purpose of law enforcement necessarily involves the processing of biometric data. the rules of this regulation that prohibit , subject to certain exceptions , such use , which are based on article 16 tfeu , should apply as lex specialis in respect of the rules on the processing of biometric data contained in article 10 of directive (eu) 2016/680 , thus regulating such use and the processing of biometric data involved in an exhaustive manner. therefore , such use and processing should only be possible in as far as it is compatible with the framework set by this regulation , without there being scope , outside that framework , for the competent authorities , where they act for purpose of law enforcement , to use such systems and process such data in connection thereto on the grounds listed in article 10 of directive (eu) 2016/680. in this context , this regulation is not intended to provide the legal basis for the processing of personal data under article 8 of directive 2016/680. however , the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for purposes other than law enforcement , including by competent authorities , should not be covered by the specific framework regarding such use for the purpose of law enforcement set by this regulation. such use for purposes other than law enforcement should therefore not be subject to the requirement of an authorisation under this regulation and the applicable detailed rules of national law that may give effect to it. ### deleted


### (27) high-risk ai systems should only be placed on the union market or put into service if they comply with certain mandatory requirements. those requirements should ensure that high-risk ai systems available in the union or whose output is otherwise used in the union do not pose unacceptable risks to important union public interests as recognised and protected by union law. ai systems identified as high-risk should be limited to those that have a significant harmful impact on the health , safety and fundamental rights of persons in the union and such limitation minimises any potential restriction to international trade , if any. ### (27) high-risk ai systems should only be placed on the union market or put into service if they comply with certain mandatory requirements. those requirements should ensure that high-risk ai systems available in the union or whose output is otherwise used in the union do not pose unacceptable risks to important union public interests as recognised and protected by union law. ai systems identified as high-risk should be limited to those that have a significant harmful impact on the health , safety and fundamental rights of persons in the union or the environment and such limitation minimises any potential restriction to international trade , if any.


### (27) high-risk ai systems should only be placed on the union market or put into service if they comply with certain mandatory requirements. those requirements should ensure that high-risk ai systems available in the union or whose output is otherwise used in the union do not pose unacceptable risks to important union public interests as recognised and protected by union law. ai systems identified as high-risk should be limited to those that have a significant harmful impact on the health , safety and fundamental rights of persons in the union and such limitation minimises any potential restriction to international trade , if any. ### (27) high-risk ai systems should only be placed on the union market or put into service if they comply with certain mandatory requirements. those requirements should ensure that high-risk ai systems available in the union or whose output is otherwise used in the union do not pose unacceptable risks to important union climate priorities , environmental imperatives and public interests as recognised and protected by union law. ai systems identified as high-risk should be limited to those that have a significant harmful impact on the health , safety , greenhouse gas emissions , crucial environmental parameters like biodiversity or soil pollution and fundamental rights of persons in the union and such limitation minimises any potential restriction to international trade , if any.


### (27) high-risk ai systems should only be placed on the union market or put into service if they comply with certain mandatory requirements. those requirements should ensure that high-risk ai systems available in the union or whose output is otherwise used in the union do not pose unacceptable risks to important union public interests as recognised and protected by union law. ai systems identified as high-risk should be limited to those that have a significant harmful impact on the health , safety and fundamental rights of persons in the union and such limitation minimises any potential restriction to international trade , if any. ### (27) high-risk ai systems should only be placed on the union market or put into service if they comply with certain mandatory requirements. those requirements should ensure that high-risk ai systems available in the union or whose output is otherwise used in the union do not pose unacceptable risks to important union climate priorities and public interests as recognised and protected by union law. ai systems identified as high-risk should be limited to those that have a significant harmful impact on the health , safety , greenhouse gas emissions and fundamental rights of persons in the union and such limitation minimises any potential restriction to international trade , if any.


### (27) high-risk ai systems should only be placed on the union market or put into service if they comply with certain mandatory requirements. those requirements should ensure that high-risk ai systems available in the union or whose output is otherwise used in the union do not pose unacceptable risks to important union public interests as recognised and protected by union law. ai systems identified as high-risk should be limited to those that have a significant harmful impact on the health , safety and fundamental rights of persons in the union and such limitation minimises any potential restriction to international trade , if any. ### (27) high-risk ai systems should only be placed on the union market or put into service if they comply with certain mandatory requirements. those requirements should ensure that high-risk ai systems available in the union or whose output is otherwise used in the union do not pose unacceptable risks to important union public interests as recognised and protected by union law. ai systems identified as high-risk should be limited to those that have a significant harmful impact on the health , safety and fundamental rights of persons in the union , but also on the environment , and such limitation minimises any potential restriction to international trade , if any. given the rapid path of technological development , but also given the potential changes in the use and the aim of authorised ai systems , regardless of whether they are high-risk or lower risk , the limited list of high-risk systems should nonetheless be subject to permanent review through the exercise of regular assessment as provided in title iii of this regulation.


### (29) as regards high-risk ai systems that are safety components of products or systems , or which are themselves products or systems falling within the scope of regulation (ec) no 300/2008 of the european parliament and of the council39 , regulation (eu) no 167/2013 of the european parliament and of the council40 , regulation (eu) no 168/2013 of the european parliament and of the council41 , directive 2014/90/eu of the european parliament and of the council42 , directive (eu) 2016/797 of the european parliament and of the council43 , regulation (eu) 2018/858 of the european parliament and of the council44 , regulation (eu) 2018/1139 of the european parliament and of the council45 , and regulation (eu) 2019/2144 of the european parliament and of the council46 , it is appropriate to amend those acts to ensure that the commission takes into account , on the basis of the technical and regulatory specificities of each sector , and without interfering with existing governance , conformity assessment and enforcement mechanisms and authorities established therein , the mandatory requirements for high-risk ai systems laid down in this regulation when adopting any relevant future delegated or implementing acts on the basis of those acts. ### (29) as regards high-risk ai systems that are safety components of products or systems , or which are themselves products or systems falling within the scope of regulation (ec) no 300/2008 of the european parliament and of the council39 , regulation (eu) no 167/2013 of the european parliament and of the council40 , regulation (eu) no 168/2013 of the european parliament and of the council41 , directive 2014/90/eu of the european parliament and of the council42 , directive (eu) 2016/797 of the european parliament and of the council43 , regulation (eu) 2018/858 of the european parliament and of the council44 , regulation (eu) 2018/1139 of the european parliament and of the council45 , and regulation (eu) 2019/2144 of the european parliament and of the council46 , it is appropriate to amend those acts to ensure that the commission takes into account , on the basis of the technical and regulatory specificities of each sector , and without interfering with existing governance , conformity assessment and enforcement mechanisms and authorities established therein , the mandatory requirements for high-risk ai systems laid down in this regulation when adopting any relevant future delegated or implementing acts on the basis of those acts. in order to avoid substantial legal uncertainty , and to ensure that the provisions of this legal act apply to all sectors concerned by it without undue delays , those acts should be amended to integrate the provisions of this regulation no later than by the application date of this regulation , that is , 24 months after its entry into force.


### (32) as regards stand-alone ai systems , meaning high-risk ai systems other than those that are safety components of products , or which are themselves products , it is appropriate to classify them as high-risk if , in the light of their intended purpose , they pose a high risk of harm to the health and safety or the fundamental rights of persons , taking into account both the severity of the possible harm and its probability of occurrence and they are used in a number of specifically pre-defined areas specified in the regulation. the identification of those systems is based on the same methodology and criteria envisaged also for any future amendments of the list of high-risk ai systems. ### (32) as regards stand-alone ai systems , meaning high-risk ai systems other than those that are safety components of products , or which are themselves products , it is appropriate to classify them as high-risk if , in the light of their intended purpose , they pose a high risk of harm to the health , safety or fundamental rights of persons or the environment , taking into account both the severity of the possible harm and its probability of occurrence and they are used in a number of specifically pre-defined areas specified in the regulation. the identification of those systems is based on the same methodology and criteria envisaged also for any future amendments of the list of high-risk ai systems.


### (32) as regards stand-alone ai systems , meaning high-risk ai systems other than those that are safety components of products , or which are themselves products , it is appropriate to classify them as high-risk if , in the light of their intended purpose , they pose a high risk of harm to the health and safety or the fundamental rights of persons , taking into account both the severity of the possible harm and its probability of occurrence and they are used in a number of specifically pre-defined areas specified in the regulation. the identification of those systems is based on the same methodology and criteria envisaged also for any future amendments of the list of high-risk ai systems. ### (32) as regards stand-alone ai systems , meaning high-risk ai systems other than those that are safety components of products , or which are themselves products , it is appropriate to classify them as high-risk if , in the light of their intended purpose , they pose a significant risk of harm to the health and safety or the fundamental rights of persons , as well as the environment , society , rule of law , democracy , economic interests and consumer protection , taking into account both the severity of the possible harm and its probability of occurrence and they are used in a number of specifically pre-defined areas specified in the regulation. the identification of those systems is based on the same methodology and criteria envisaged also for any future amendments of the list of high-risk ai systems. such classification should take place before the placing onto the market but also during the life-cycle of an ai system.


### (32) as regards stand-alone ai systems , meaning high-risk ai systems other than those that are safety components of products , or which are themselves products , it is appropriate to classify them as high-risk if , in the light of their intended purpose , they pose a high risk of harm to the health and safety or the fundamental rights of persons , taking into account both the severity of the possible harm and its probability of occurrence and they are used in a number of specifically pre-defined areas specified in the regulation. the identification of those systems is based on the same methodology and criteria envisaged also for any future amendments of the list of high-risk ai systems. ### (32) as regards stand-alone ai systems , meaning high-risk ai systems other than those that are safety components of products , or which are themselves products , it is appropriate to classify them as high-risk if , in the light of their intended purpose , they pose a high risk of harm to the health and safety or the fundamental rights of persons , taking into account both the severity of the possible harm and its probability of occurrence and they are used in a number of specifically pre-defined areas specified in the regulation. the identification of those systems is based on the same methodology and criteria envisaged also for any future amendments of the list of high-risk ai systems. such classification should take place before the placing onto the market but also during the life-cycle of an ai system.


### (33) technical inaccuracies of ai systems intended for the remote biometric identification of natural persons can lead to biased results and entail discriminatory effects. this is particularly relevant when it comes to age , ethnicity , sex or disabilities. therefore , ‘real-time’ and ‘post’ remote biometric identification systems should be classified as high-risk. in view of the risks that they pose , both types of remote biometric identification systems should be subject to specific requirements on logging capabilities and human oversight. ### (33) technical inaccuracies of ai systems intended for the remote biometric identification of natural persons can lead to biased results and entail discriminatory effects , which can have an effect on the health and safety of individuals , for instance in the context of operation and management of critical infrastructure. this is particularly relevant when it comes to age , ethnicity , sex or disabilities. therefore , ‘real-time’ and ‘post’ remote biometric identification systems should be classified as high-risk. in view of the risks that they pose , both types of remote biometric identification systems should be subject to specific requirements on logging capabilities and human oversight.


### (33) technical inaccuracies of ai systems intended for the remote biometric identification of natural persons can lead to biased results and entail discriminatory effects. this is particularly relevant when it comes to age , ethnicity , sex or disabilities. therefore , ‘real-time’ and ‘post’ remote biometric identification systems should be classified as high-risk. in view of the risks that they pose , both types of remote biometric identification systems should be subject to specific requirements on logging capabilities and human oversight. ### (33) technical inaccuracies , as well as conscious or subconscious design decisions , and the use of training data which codify and reinforce structural inequalities , mean that ai systems intended for the remote biometric identification of natural persons can lead to biased results and entail discriminatory effects. this is particularly relevant when it comes to age , ethnicity , sex or disabilities. as a result , ‘real-time’ and ‘post’ remote biometric identification systems undermine the essence of fundamental rights and therefore must be prohibited.


### (33) technical inaccuracies of ai systems intended for the remote biometric identification of natural persons can lead to biased results and entail discriminatory effects. this is particularly relevant when it comes to age , ethnicity , sex or disabilities. therefore , ‘real-time’ and ‘post’ remote biometric identification systems should be classified as high-risk. in view of the risks that they pose , both types of remote biometric identification systems should be subject to specific requirements on logging capabilities and human oversight. ### deleted


### (34) as regards the management and operation of critical infrastructure , it is appropriate to classify as high-risk the ai systems intended to be used as safety components in the management and operation of road traffic and the supply of water , gas , heating and electricity , since their failure or malfunctioning may put at risk the life and health of persons at large scale and lead to appreciable disruptions in the ordinary conduct of social and economic activities. ### (34) as regards the management and operation of critical infrastructure , it is appropriate to classify as high-risk the ai systems intended to be used as safety components in the management and operation of road traffic and the supply of water , gas , heating and electricity , and internet , since their failure or malfunctioning may put at risk the life and health of persons at large scale and lead to appreciable disruptions in the ordinary conduct of social and economic activities.


### (37) another area in which the use of ai systems deserves special consideration is the access to and enjoyment of certain essential private and public services and benefits necessary for people to fully participate in society or to improve one’s standard of living. in particular , ai systems used to evaluate the credit score or creditworthiness of natural persons should be classified as high-risk ai systems , since they determine those persons’ access to financial resources or essential services such as housing , electricity , and telecommunication services. ai systems used for this purpose may lead to discrimination of persons or groups and perpetuate historical patterns of discrimination , for example based on racial or ethnic origins , disabilities , age , sexual orientation , or create new forms of discriminatory impacts. considering the very limited scale of the impact and the available alternatives on the market , it is appropriate to exempt ai systems for the purpose of creditworthiness assessment and credit scoring when put into service by small-scale providers for their own use. natural persons applying for or receiving public assistance benefits and services from public authorities are typically dependent on those benefits and services and in a vulnerable position in relation to the responsible authorities. if ai systems are used for determining whether such benefits and services should be denied , reduced , revoked or reclaimed by authorities , they may have a significant impact on persons’ livelihood and may infringe their fundamental rights , such as the right to social protection , non-discrimination , human dignity or an effective remedy. those systems should therefore be classified as high-risk. nonetheless , this regulation should not hamper the development and use of innovative approaches in the public administration , which would stand to benefit from a wider use of compliant and safe ai systems , provided that those systems do not entail a high risk to legal and natural persons. finally , ai systems used to dispatch or establish priority in the dispatching of emergency first response services should also be classified as high-risk since they make decisions in very critical situations for the life and health of persons and their property. ### (37) another area in which the use of ai systems deserves special consideration is the access to and enjoyment of certain essential private and public services and benefits necessary for people to fully participate in society or to improve one’s standard of living. in particular , ai systems used to evaluate the credit score or creditworthiness of natural persons should be classified as high-risk ai systems , since they determine those persons’ access to financial resources or essential services such as housing , electricity , and telecommunication services. ai systems used for this purpose may lead to discrimination of persons or groups and perpetuate historical patterns of discrimination , for example based on racial or ethnic origins , gender , disabilities , age , sexual orientation , or create new forms of discriminatory impacts. considering the very limited scale of the impact and the available alternatives on the market , it is appropriate to exempt ai systems for the purpose of creditworthiness assessment and credit scoring when put into service by small-scale providers for their own use. natural persons applying for or receiving public assistance benefits and services from public authorities are typically dependent on those benefits and services and in a vulnerable position in relation to the responsible authorities. if ai systems are used for determining whether such benefits and services should be denied , reduced , revoked or reclaimed by authorities , they may have a significant impact on persons’ livelihood and may infringe their fundamental rights , such as the right to social protection , non-discrimination , human dignity or an effective remedy. those systems should therefore be classified as high-risk. nonetheless , this regulation should not hamper the development and use of innovative approaches in the public administration , which would stand to benefit from a wider use of compliant and safe ai systems , provided that those systems do not entail a high risk to legal and natural persons. finally , ai systems used to dispatch or establish priority in the dispatching of emergency first response services should also be classified as high-risk since they make decisions in very critical situations for the life and health of persons and their property.


### (37) another area in which the use of ai systems deserves special consideration is the access to and enjoyment of certain essential private and public services and benefits necessary for people to fully participate in society or to improve one’s standard of living. in particular , ai systems used to evaluate the credit score or creditworthiness of natural persons should be classified as high-risk ai systems , since they determine those persons’ access to financial resources or essential services such as housing , electricity , and telecommunication services. ai systems used for this purpose may lead to discrimination of persons or groups and perpetuate historical patterns of discrimination , for example based on racial or ethnic origins , disabilities , age , sexual orientation , or create new forms of discriminatory impacts. considering the very limited scale of the impact and the available alternatives on the market , it is appropriate to exempt ai systems for the purpose of creditworthiness assessment and credit scoring when put into service by small-scale providers for their own use. natural persons applying for or receiving public assistance benefits and services from public authorities are typically dependent on those benefits and services and in a vulnerable position in relation to the responsible authorities. if ai systems are used for determining whether such benefits and services should be denied , reduced , revoked or reclaimed by authorities , they may have a significant impact on persons’ livelihood and may infringe their fundamental rights , such as the right to social protection , non-discrimination , human dignity or an effective remedy. those systems should therefore be classified as high-risk. nonetheless , this regulation should not hamper the development and use of innovative approaches in the public administration , which would stand to benefit from a wider use of compliant and safe ai systems , provided that those systems do not entail a high risk to legal and natural persons. finally , ai systems used to dispatch or establish priority in the dispatching of emergency first response services should also be classified as high-risk since they make decisions in very critical situations for the life and health of persons and their property. ### (37) another area in which the use of ai systems deserves special consideration is the access to and enjoyment of certain essential private and public services and benefits necessary for people to fully participate in society or to improve one’s standard of living. in particular , ai systems used to evaluate the credit score or creditworthiness of natural persons should be prohibited , since they determine those persons’ access to financial resources or essential services such as housing , electricity , and telecommunication services. ai systems used for this purpose lead to an unacceptably high risk of discrimination against persons or groups and perpetuate historical patterns of discrimination , for example based on racial or ethnic origins , disabilities , age , sexual orientation , or create new forms of discriminatory impacts. natural persons applying for or receiving public assistance benefits and services from public authorities are typically dependent on those benefits and services and in a vulnerable position in relation to the responsible authorities. if ai systems are used for determining whether such benefits and services should be denied , reduced , revoked or reclaimed by authorities , they have a significant impact on persons’ livelihood and infringe their fundamental rights , such as the right to social protection , non-discrimination , human dignity or an effective remedy. those systems should therefore be prohibited. nonetheless , this regulation should not hamper the development and use of innovative approaches in the public administration , which would stand to benefit from a wider use of compliant and safe ai systems , provided that those systems do not entail a high risk to legal and natural persons. finally , ai systems used to dispatch or establish priority in the dispatching of emergency first response services should also be classified as high-risk since they make decisions in very critical situations for the life and health of persons and their property.


### (43) requirements should apply to high-risk ai systems as regards the quality of data sets used , technical documentation and record-keeping , transparency and the provision of information to users , human oversight , and robustness , accuracy and cybersecurity. those requirements are necessary to effectively mitigate the risks for health , safety and fundamental rights , as applicable in the light of the intended purpose of the system , and no other less trade restrictive measures are reasonably available , thus avoiding unjustified restrictions to trade. ### (43) requirements should apply to high-risk ai systems as regards the quality of data sets used , technical documentation and record-keeping , transparency and the provision of information to users , human oversight , and robustness , accuracy and cybersecurity. those requirements are necessary to effectively mitigate the risks for health , safety , fundamental rights and the environment , as applicable in the light of the intended purpose of the system , and no other less trade restrictive measures are reasonably available , thus avoiding unjustified restrictions to trade.


### (43) requirements should apply to high-risk ai systems as regards the quality of data sets used , technical documentation and record-keeping , transparency and the provision of information to users , human oversight , and robustness , accuracy and cybersecurity. those requirements are necessary to effectively mitigate the risks for health , safety and fundamental rights , as applicable in the light of the intended purpose of the system , and no other less trade restrictive measures are reasonably available , thus avoiding unjustified restrictions to trade. ### (43) requirements should apply to high-risk ai systems as regards the quality and relevance of data sets used , technical documentation and record-keeping , transparency and the provision of information to users , human oversight , and robustness , accuracy and security. those requirements are necessary to effectively mitigate the risks for health , safety and fundamental rights , as well as the environment , society , rule of law , democracy , economic interests and consumer protection , as applicable in the light of the intended purpose , the potential or reasonably foreseeable use or misuse of the system , and no other less trade restrictive measures are reasonably available , thus avoiding unjustified restrictions to trade.


### (44) high data quality is essential for the performance of many ai systems , especially when techniques involving the training of models are used , with a view to ensure that the high-risk ai system performs as intended and safely and it does not become the source of discrimination prohibited by union law. high quality training , validation and testing data sets require the implementation of appropriate data governance and management practices. training , validation and testing data sets should be sufficiently relevant , representative and free of errors and complete in view of the intended purpose of the system. they should also have the appropriate statistical properties , including as regards the persons or groups of persons on which the high-risk ai system is intended to be used. in particular , training , validation and testing data sets should take into account , to the extent required in the light of their intended purpose , the features , characteristics or elements that are particular to the specific geographical , behavioural or functional setting or context within which the ai system is intended to be used. in order to protect the right of others from the discrimination that might result from the bias in ai systems , the providers shouldbe able to process also special categories of personal data , as a matter of substantial public interest , in order to ensure the bias monitoring , detection and correction in relation to high-risk ai systems. ### (44) high data quality is essential for the performance of many ai systems , especially when techniques involving the training of models are used , with a view to ensure that the high-risk ai system performs as intended and safely and it does not become the source of discrimination prohibited by union law. high quality training , validation and testing data sets require the implementation of appropriate data governance and management practices. training , validation and testing data sets should be sufficiently relevant , representative and free of errors and complete in view of the intended purpose of the system. they should also have the appropriate statistical properties , including as regards the persons or groups of persons on which the high-risk ai system is intended to be used. in particular , training , validation and testing data sets should take into account , to the extent required in the light of their intended purpose , the features , characteristics or elements that are particular to the specific geographical , behavioural or functional setting or context within which the ai system is intended to be used. in order to protect the right of others from the discrimination that might result from the bias in ai systems , the providers should ensure that databases contain adequate data on groups which are more vulnerable to discriminatory effects posed by ai , such as people with disabilities , and be able to process also special categories of personal data , as a matter of substantial public interest , in order to ensure the bias monitoring , detection and correction in relation to high-risk ai systems.


### (44) high data quality is essential for the performance of many ai systems , especially when techniques involving the training of models are used , with a view to ensure that the high-risk ai system performs as intended and safely and it does not become the source of discrimination prohibited by union law. high quality training , validation and testing data sets require the implementation of appropriate data governance and management practices. training , validation and testing data sets should be sufficiently relevant , representative and free of errors and complete in view of the intended purpose of the system. they should also have the appropriate statistical properties , including as regards the persons or groups of persons on which the high-risk ai system is intended to be used. in particular , training , validation and testing data sets should take into account , to the extent required in the light of their intended purpose , the features , characteristics or elements that are particular to the specific geographical , behavioural or functional setting or context within which the ai system is intended to be used. in order to protect the right of others from the discrimination that might result from the bias in ai systems , the providers shouldbe able to process also special categories of personal data , as a matter of substantial public interest , in order to ensure the bias monitoring , detection and correction in relation to high-risk ai systems. ### (44) high data quality is essential for the performance of many ai systems , especially when techniques involving the training of models are used , with a view to ensure that the high-risk ai system performs as intended and safely and it does not become a source of discrimination prohibited by union law. high quality training , validation and testing data sets require the implementation of appropriate data governance and management practices. training , validation and testing data sets should be sufficiently relevant , representative and free of errors , statistically complete and relevant in view of the intended purpose of the system and the context of its use. they should also have the appropriate statistical properties , including as regards the persons or groups of persons in relation to whom the high-risk ai system is intended to be used. in particular , training , validation and testing data sets should take into account , to the extent necessary in the light of their intended purpose , the features , characteristics or elements that are particular to the specific geographical , behavioural or functional setting or context within which the ai system is intended to be used. solely in order to protect the right of others from the discrimination that might result from the bias in ai systems , the providers should be able to process special categories of personal data , as a matter of substantial public interest , in order to ensure bias monitoring , detection and correction in relation to high-risk ai systems.


### (48) high-risk ai systems should be designed and developed in such a way that natural persons can oversee their functioning. for this purpose , appropriate human oversight measures should be identified by the provider of the system before its placing on the market or putting into service. in particular , where appropriate , such measures should guarantee that the system is subject to in-built operational constraints that cannot be overridden by the system itself and is responsive to the human operator , and that the natural persons to whom human oversight has been assigned have the necessary competence , training and authority to carry out that role. ### (48) high-risk ai systems should be designed and developed in such a way that natural persons can oversee their functioning. for this purpose , appropriate human oversight measures should be identified by the provider of the system before its placing on the market or putting into service. in particular , where appropriate , such measures should guarantee that the system is subject to in-built operational constraints that cannot be overridden by the system itself and is responsive to the human operator , and that the natural persons to whom human oversight has been assigned have the necessary competence , training and authority to carry out that role. these operational constraints should be allowed to be amended in the future , in case increased understanding and technological developments in the field lead to the conclusion that they do not constitute the safest possible option.


### (48) high-risk ai systems should be designed and developed in such a way that natural persons can oversee their functioning. for this purpose , appropriate human oversight measures should be identified by the provider of the system before its placing on the market or putting into service. in particular , where appropriate , such measures should guarantee that the system is subject to in-built operational constraints that cannot be overridden by the system itself and is responsive to the human operator , and that the natural persons to whom human oversight has been assigned have the necessary competence , training and authority to carry out that role. ### (48) high-risk ai systems should be designed and developed in such a way that natural persons can meaningfully oversee and regulate their functioning or investigate in case of an accident. for this purpose , appropriate human oversight measures should be ensured by the provider of the system before its placing on the market or putting into service. in particular , where appropriate , such measures should guarantee that the system is subject to in-built operational constraints that cannot be overridden by the system itself and is responsive to the human operator , and that the natural persons to whom human oversight has been assigned have the necessary competence , training and authority to carry out that role.


### (51) cybersecurity plays a crucial role in ensuring that ai systems are resilient against attempts to alter their use , behaviour , performance or compromise their security properties by malicious third parties exploiting the system’s vulnerabilities. cyberattacks against ai systems can leverage ai specific assets , such as training data sets (e.g. data poisoning) or trained models (e.g. adversarial attacks) , or exploit vulnerabilities in the ai system’s digital assets or the underlying ict infrastructure. to ensure a level of cybersecurity appropriate to the risks , suitable measures should therefore be taken by the providers of high-risk ai systems , also taking into account as appropriate the underlying ict infrastructure. ### (51) cybersecurity plays a crucial role in ensuring that ai systems are resilient against attempts to alter their use , behaviour , performance or compromise their security properties by malicious third parties exploiting the system’s vulnerabilities. cyberattacks against ai systems can target ai specific assets , such as training data sets (e.g. data poisoning) or trained models (e.g. adversarial attacks) , or exploit vulnerabilities in the ai system’s digital assets or the underlying ict infrastructure. to ensure a level of cybersecurity appropriate to the risks , suitable measures should therefore be taken by the providers of high-risk ai systems , also taking into account as appropriate the underlying ict infrastructure.


### (54) the provider should establish a sound quality management system , ensure the accomplishment of the required conformity assessment procedure , draw up the relevant documentation and establish a robust post-market monitoring system. public authorities which put into service high-risk ai systems for their own use may adopt and implement the rules for the quality management system as part of the quality management system adopted at a national or regional level , as appropriate , taking into account the specificities of the sector and the competences and organisation of the public authority in question. ### (54) the provider and , where applicable , deployer should establish a sound quality management system , ensure the accomplishment of the required conformity assessment procedure , draw up the relevant documentation and establish a robust post-market monitoring system. public authorities which put into service high-risk ai systems for their own use may adopt and implement the rules for the quality management system as part of the quality management system adopted at a national or regional level , as appropriate , taking into account the specificities of the sector and the competences and organisation of the public authority in question. deployers should have strategies in place to ensure that the data management , including data acquisition , data collection , data analysis , data labelling , data storage , data filtration , data mining , data aggregation , data retention and any other operation regarding the data during the deployment lifetime of high-risk ai systems , complies with applicable rules and ensure regulatory compliance , in particular regarding modifications to the high-risk ai systems.


### (71) artificial intelligence is a rapidly developing family of technologies that requires novel forms of regulatory oversight and a safe space for experimentation , while ensuring responsible innovation and integration of appropriate safeguards and risk mitigation measures. to ensure a legal framework that is innovation-friendly , future-proof and resilient to disruption , national competent authorities from one or more member states should be encouraged to establish artificial intelligence regulatory sandboxes to facilitate the development and testing of innovative ai systems under strict regulatory oversight before these systems are placed on the market or otherwise put into service. ### (71) artificial intelligence is a rapidly developing family of technologies that requires novel and effective forms of regulatory oversight and a safe space for experimentation , while ensuring responsible innovation and integration of appropriate safeguards and risk mitigation measures. to ensure a legal framework that is innovation-friendly , future-proof and resilient to disruption , national competent authorities from one or more member states should be encouraged to establish artificial intelligence regulatory sandboxes to facilitate the development and testing of innovative ai systems under strict regulatory oversight before these systems are placed on the market or otherwise put into service.


### (73) in order to promote and protect innovation , it is important that the interests of small-scale providers and users of ai systems are taken into particular account. to this objective , member states should develop initiatives , which are targeted at those operators , including on awareness raising and information communication. moreover , the specific interests and needs of small-scale providers shall be taken into account when notified bodies set conformity assessment fees. translation costs related to mandatory documentation and communication with authorities may constitute a significant cost for providers and other operators , notably those of a smaller scale. member states should possibly ensure that one of the languages determined and accepted by them for relevant providers’ documentation and for communication with operators is one which is broadly understood by the largest possible number of cross-border users. ### (73) in order to promote and protect innovation , it is important that the interests of small-scale providers and users of ai systems are taken into particular account. to this objective , member states should develop initiatives , which are targeted at those operators , including on awareness raising and information communication. moreover , the specific interests and needs of small-scale providers should be taken into account when notified bodies set conformity assessment fees. translation costs related to mandatory documentation and communication with authorities may constitute a significant cost for providers and other operators , notably those of a smaller scale. member states should possibly ensure that one of the languages determined and accepted by them for relevant providers’ documentation and for communication with operators is one which is broadly understood by the largest possible number of cross-border users.


### (76) in order to facilitate a smooth , effective and harmonised implementation of this regulation a european artificial intelligence board should be established. the board should be responsible for a number of advisory tasks , including issuing opinions , recommendations , advice or guidance on matters related to the implementation of this regulation , including on technical specifications or existing standards regarding the requirements established in this regulation and providing advice to and assisting the commission on specific questions related to artificial intelligence. ### (76) in order to facilitate a smooth , effective and harmonised implementation of this regulation a european artificial intelligence board should be established. the board should be responsible for a number of advisory tasks , including issuing opinions , recommendations , advice or guidance on matters related to the implementation of this regulation , the establishment of an ai sustainability taskforce for the sustainable development of ai and the development towards a harmonised criteria for sustainable technical specifications , existing standards and best practice regarding the requirements established in this regulation and to provide expert advice to and assisting the commission on specific questions related to artificial intelligence to better address emerging cross-border challenges arising from rapid technological development.


### 3. this regulation shall not apply to ai systems developed or used exclusively for military purposes. ### deleted


### 3. this regulation shall not apply to ai systems developed or used exclusively for military purposes. ### 3. this regulation shall not apply to ai systems developed or used exclusively for operations having military or defence implications carried out by military capabilities under the exclusive remit of the common foreign and security policy regulated under title v of the treaty on the european union (teu).


### (1) ‘artificial intelligence system’ (ai system) means software that is developed with one or more of the techniques and approaches listed in annex i and can , for a given set of human-defined objectives , generate outputs such as content , predictions , recommendations , or decisions influencing the environments they interact with; ### (1) ‘artificial intelligence system’ (ai system) means software that is developed with one or more of the techniques and approaches listed in annex i and can , for a given set of inputs and objectives , generate outputs such as content , predictions , recommendations , or decisions;


### (1) ‘artificial intelligence system’ (ai system) means software that is developed with one or more of the techniques and approaches listed in annex i and can , for a given set of human-defined objectives , generate outputs such as content , predictions , recommendations , or decisions influencing the environments they interact with; ### (1) ‘artificial intelligence system’ (ai system) means software that is developed with one or more of the techniques and approaches listed in annex i and can , for a given set of input data and objectives , generate outputs such as content , predictions , recommendations , or decisions.


### (4) ‘user’ means any natural or legal person , public authority , agency or other body using an ai system under its authority , except where the ai system is used in the course of a personal non-professional activity; ### (4) ‘deployer’ means any natural or legal person , public authority , agency or other body using an ai system under its authority , except where the ai system is used in the course of a personal non-professional activity;


### (4) ‘user’ means any natural or legal person , public authority , agency or other body using an ai system under its authority , except where the ai system is used in the course of a personal non-professional activity; ### (4) ‘deployer' means any natural or legal person , public authority , agency or other body using an ai system under its authority , except where the ai system is used in the course of a personal non-professional activity;


### (11) ‘putting into service’ means the supply of an ai system for first use directly to the user or for own use on the union market for its intended purpose; ### (11) ‘putting into service’ means the supply of an ai system for first use directly to the deployer or for own use on the union market for its intended purpose;


### (13) ‘reasonably foreseeable misuse’ means the use of an ai system in a way that is not in accordance with its intended purpose , but which may result from reasonably foreseeable human behaviour or interaction with other systems; ### (13) ‘reasonably foreseeable misuse’ means the use of an ai system in a way that is not in accordance with its intended purpose , but which may result from reasonably foreseeable human behaviour or interaction with other systems , including other ai systems;


### (13) ‘reasonably foreseeable misuse’ means the use of an ai system in a way that is not in accordance with its intended purpose , but which may result from reasonably foreseeable human behaviour or interaction with other systems; ### (13) ‘reasonably foreseeable misuse’ means the use of an ai system in a way that is not in accordance with its intended purpose , but which may result from reasonably foreseeable human behaviour or interaction with other systems , including other ai systems;;


### (14) ‘safety component of a product or system’ means a component of a product or of a system which fulfils a safety function for that product or system or the failure or malfunctioning of which endangers the health and safety of persons or property; ### (14) ‘safety component of a product or system’ means a component of a product or of a system which fulfils a safety function for that product or system or the failure or malfunctioning of which endangers the health and safety of persons or property or climate and environmental protection;


### (35) ‘biometric categorisation system’ means an ai system for the purpose of assigning natural persons to specific categories , such as sex , age , hair colour , eye colour , tattoos , ethnic origin or sexual or political orientation , on the basis of their biometric data; ### (35) ‘biometric categorisation system’ means an ai system for the purpose of assigning natural persons to specific categories , such as sex , age , disability , hair colour , eye colour , tattoos , ethnic origin or sexual or political orientation , on the basis of their biometric data;


### (35) ‘biometric categorisation system’ means an ai system for the purpose of assigning natural persons to specific categories , such as sex , age , hair colour , eye colour , tattoos , ethnic origin or sexual or political orientation , on the basis of their biometric data; ### (35) ‘biometric categorisation system’ means an ai system for the purpose of assigning natural persons to specific categories , such as sex , age , hair colour , eye colour , tattoos , ethnic origin , health , mental ability , personality traits or sexual or political orientation , on the basis of their biometric or biometrics-based data , whether or not allowing or confirming identification of a natural person;


### (36) ‘remote biometric identification system’ means an ai system for the purpose of identifying natural persons at a distance through the comparison of a person’s biometric data with the biometric data contained in a reference database , and without prior knowledge of the user of the ai system whether the person will be present and can be identified ; ### (36) ‘remote biometric identification system’ means an ai system for the purpose of identifying natural persons at a distance through the comparison of a person’s biometric data with the biometric data contained in a reference database , without prior knowledge of the user of the ai system whether the person will be present and can be identified , and independent of whether a person identified is an ai subject or interacts directly and purposefully with the system;


### the placing on the market , putting into service or use of an ai system that deploys subliminal techniques beyond a person’s consciousness in order to materially distort a person’s behaviour in a manner that causes or is likely to cause that person or another person physical or psychological harm; ### the placing on the market , putting into service or use of an ai system that deploys subliminal , psychological techniques beyond a person’s consciousness in order to materially distort a person’s behaviour in a manner that causes or is likely to cause that person or another person economic , physical or psychological harm;


### the placing on the market , putting into service or use of an ai system that deploys subliminal techniques beyond a person’s consciousness in order to materially distort a person’s behaviour in a manner that causes or is likely to cause that person or another person physical or psychological harm; ### the placing on the market , putting into service or use of an ai system that deploys techniques with the effect or likely effect of materially distorting a person’s behaviour , by appreciably impairing the person’s ability to make an informed decision , thereby causing the person to take a decision that they would not have taken otherwise , in a manner that causes or is likely to cause that person or another person material or non-material harm , including physical , psychological or economic harm;


### the placing on the market , putting into service or use of an ai system that deploys subliminal techniques beyond a person’s consciousness in order to materially distort a person’s behaviour in a manner that causes or is likely to cause that person or another person physical or psychological harm; ### the placing on the market , putting into service or use of an ai system that deploys techniques beyond a person’s consciousness in order to materially distort a person’s behaviour in a manner that causes or is likely to cause that person or another person , economic , physical or psychological harm;


### detrimental or unfavourable treatment of certain natural persons or whole groups thereof in social contexts which are unrelated to the contexts in which the data was originally generated or collected; ### deleted


### detrimental or unfavourable treatment of certain natural persons or whole groups thereof in social contexts which are unrelated to the contexts in which the data was originally generated or collected; ### detrimental or unfavourable treatment of certain natural persons or whole groups thereof in social contexts that are unrelated to the contexts in which the data was originally generated or collected;


### (ii) detrimental or unfavourable treatment of certain natural persons or whole groups thereof that is unjustified or disproportionate to their social behaviour or its gravity; ### deleted


### the targeted search for specific potential victims of crime , including missing children; ### deleted


### (ii) the prevention of a specific , substantial and imminent threat to the life or physical safety of natural persons or of a terrorist attack; ### deleted


### (iii) the detection , localisation , identification or prosecution of a perpetrator or suspect of a criminal offence referred to in article 2(2) of council framework decision 2002/584/jha62 and punishable in the member state concerned by a custodial sentence or a detention order for a maximum period of at least three years , as determined by the law of that member state. ### deleted


### 2. the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement for any of the objectives referred to in paragraph 1 point d) shall take into account the following elements: ### deleted


### 3. as regards paragraphs 1 , point (d) and 2 , each individual use for the purpose of law enforcement of a ‘real-time’ remote biometric identification system in publicly accessible spaces shall be subject to a prior authorisation granted by a judicial authority or by an independent administrative authority of the member state in which the use is to take place , issued upon a reasoned request and in accordance with the detailed rules of national law referred to in paragraph 4. however , in a duly justified situation of urgency , the use of the system may be commenced without an authorisation and the authorisation may be requested only during or after the use. ### deleted


### the ai systems pose a risk of harm to the health and safety , or a risk of adverse impact on fundamental rights , that is , in respect of its severity and probability of occurrence , equivalent to or greater than the risk of harm or of adverse impact posed by the high-risk ai systems already referred to in annex iii. ### the ai systems pose a risk of harm to the health or safety , or a risk of adverse impact on fundamental rights or the environment , that is , in respect of its severity and probability of occurrence , equivalent to or greater than the risk of harm or of adverse impact posed by the high-risk ai systems already referred to in annex iii.


### the ai systems pose a risk of harm to the health and safety , or a risk of adverse impact on fundamental rights , that is , in respect of its severity and probability of occurrence , equivalent to or greater than the risk of harm or of adverse impact posed by the high-risk ai systems already referred to in annex iii. ### the ai systems pose a risk of harm to the health and safety , or a risk of adverse impact on climate change mitigation and adaptation , the environment and fundamental rights , that is , in respect of its severity and probability of occurrence , equivalent to or greater than the risk of harm or of adverse impact posed by the high-risk ai systems already referred to in annex iii.


### the ai systems pose a risk of harm to the health and safety , or a risk of adverse impact on fundamental rights , that is , in respect of its severity and probability of occurrence , equivalent to or greater than the risk of harm or of adverse impact posed by the high-risk ai systems already referred to in annex iii. ### the ai systems pose a risk of harm to the health and safety , a risk to climate or environment or a risk of adverse impact on fundamental rights , that is , in respect of its severity and probability of occurrence , equivalent to or greater than the risk of harm or of adverse impact posed by the high-risk ai systems already referred to in annex iii.


### 2. when assessing for the purposes of paragraph 1 whether an ai system poses a risk of harm to the health and safety or a risk of adverse impact on fundamental rights that is equivalent to or greater than the risk of harm posed by the high-risk ai systems already referred to in annex iii , the commission shall take into account the following criteria: ### 2. when assessing for the purposes of paragraph 1 whether an ai system poses a risk of harm to the health and safety or a risk of adverse impact on fundamental rights or the environment that is equivalent to or greater than the risk of harm posed by the high-risk ai systems already referred to in annex iii , the commission shall take into account the following criteria:


### 2. when assessing for the purposes of paragraph 1 whether an ai system poses a risk of harm to the health and safety or a risk of adverse impact on fundamental rights that is equivalent to or greater than the risk of harm posed by the high-risk ai systems already referred to in annex iii , the commission shall take into account the following criteria: ### 2. when assessing for the purposes of paragraph 1 whether an ai system poses a risk of harm to the health and safety or a risk of adverse impact on the climate , the environment or fundamental rights that is equivalent to or greater than the risk of harm posed by the high-risk ai systems already referred to in annex iii , the commission shall take into account the following criteria:


### 2. when assessing for the purposes of paragraph 1 whether an ai system poses a risk of harm to the health and safety or a risk of adverse impact on fundamental rights that is equivalent to or greater than the risk of harm posed by the high-risk ai systems already referred to in annex iii , the commission shall take into account the following criteria: ### 2. when assessing for the purposes of paragraph 1 whether an ai system poses a risk of harm to the health and safety , a risk to climate or environment or a risk of adverse impact on fundamental rights that is equivalent to or greater than the risk of harm posed by the high-risk ai systems already referred to in annex iii , the commission shall take into account the following criteria:


### the extent to which the use of an ai system has already caused harm to the health and safety or adverse impact on the fundamental rights or has given rise to significant concerns in relation to the materialisation of such harm or adverse impact , as demonstrated by reports or documented allegations submitted to national competent authorities; ### the extent to which the use of an ai system has already caused harm to the health and safety or adverse impact on the fundamental rights or the environment or has given rise to significant concerns in relation to the materialisation of such harm or adverse impact , as demonstrated by reports or documented allegations submitted to national competent authorities;


### the extent to which the use of an ai system has already caused harm to the health and safety or adverse impact on the fundamental rights or has given rise to significant concerns in relation to the materialisation of such harm or adverse impact , as demonstrated by reports or documented allegations submitted to national competent authorities; ### the extent to which the use of an ai system has already caused harm to the health and safety or adverse impact on the climate , the environment and fundamental rights or has given rise to significant concerns in relation to the materialisation of such harm or adverse impact , as demonstrated by reports or documented allegations submitted to national competent authorities;


### the extent to which the use of an ai system has already caused harm to the health and safety or adverse impact on the fundamental rights or has given rise to significant concerns in relation to the materialisation of such harm or adverse impact , as demonstrated by reports or documented allegations submitted to national competent authorities; ### the extent to which the use of an ai system has already caused harm to the health and safety , to climate or environment or adverse impact on the fundamental rights or has given rise to significant concerns in relation to the materialisation of such harm or adverse impact , as demonstrated by reports or documented allegations submitted to national competent authorities;


### the potential extent of such harm or such adverse impact , in particular in terms of its intensity and its ability to affect a plurality of persons; ### the potential extent of such harm or such adverse impact , in particular in terms of its intensity and its ability to affect a plurality of persons or the environment;


### the extent to which the outcome produced with an ai system is easily reversible , whereby outcomes having an impact on the health or safety of persons shall not be considered as easily reversible; ### the extent to which the outcome produced with an ai system is easily reversible , whereby outcomes having an impact on the health or safety of persons , or an adverse impact on the environment shall not be considered as easily reversible;


### the extent to which the outcome produced with an ai system is easily reversible , whereby outcomes having an impact on the health or safety of persons shall not be considered as easily reversible; ### the extent to which the outcome produced with an ai system is easily reversible , whereby outcomes having an adverse impact on the climate , the environment or negatively affecting the ability to achieve greenhouse gas reduction targets or the health or safety of persons shall not be considered as easily reversible;


### the extent to which the outcome produced with an ai system is easily reversible , whereby outcomes having an impact on the health or safety of persons shall not be considered as easily reversible; ### the extent to which the outcome produced with an ai system is easily reversible , whereby outcomes having an adverse impact on the climate , the environment or negatively affecting the ability to achieve energy efficiency targets or the health or safety of persons shall not be considered as easily reversible;


### 1. high-risk ai systems shall comply with the requirements established in this chapter. ### 1. high-risk ai systems shall comply with the requirements established in this chapter , taking into account sectoral legislation where applicable.


### 2. the intended purpose of the high-risk ai system and the risk management system referred to in article 9 shall be taken into account when ensuring compliance with those requirements. ### 2. the intended purpose and reasonably foreseeable misuse of the high-risk ai system and the risk management system referred to in article 9 shall be taken into account when ensuring compliance with those requirements.


### 2. the risk management system shall consist of a continuous iterative process run throughout the entire lifecycle of a high-risk ai system , requiring regular systematic updating. it shall comprise the following steps: ### 2. the risk management system shall consist of a continuous iterative process run throughout the entire lifecycle of a high-risk ai system , requiring regular systematic review and updating. it shall comprise the following steps:


### 2. the risk management system shall consist of a continuous iterative process run throughout the entire lifecycle of a high-risk ai system , requiring regular systematic updating. it shall comprise the following steps: ### 2. the risk management system shall consist of a continuous iterative process run throughout the entire environmental lifecycle of a high-risk ai system , requiring regular systematic updating. it shall comprise the following steps:


### identification and analysis of the known and foreseeable risks associated with each high-risk ai system; ### identification and analysis of the known and foreseeable risks associated with each high-risk ai system that might cause harm or damage to the environment or the health , safety or fundamental rights of persons in view of the intended purpose or misuse of the high-risk ai system.;


### identification and analysis of the known and foreseeable risks associated with each high-risk ai system; ### identification and analysis of the known and reasonably foreseeable risks associated with each high-risk ai system with respect to health , safety , fundamental rights , and the values of the union as enshrined in article 2 teu;


### identification and analysis of the known and foreseeable risks associated with each high-risk ai system; ### identification and analysis of the known and foreseeable risks associated with each high-risk ai system , including by means of a fundamental rights impact assessment as provided for in article 9a;


### 3. the risk management measures referred to in paragraph 2 , point (d) shall give due consideration to the effects and possible interactions resulting from the combined application of the requirements set out in this chapter 2. they shall take into account the generally acknowledged state of the art , including as reflected in relevant harmonised standards or common specifications. ### 3. the risk management measures referred to in paragraph 2 , point (d) shall give due consideration to the effects and possible interactions resulting from the combined application of the requirements set out in this chapter 2. they shall take into account the state of the art , including as reflected in relevant harmonised standards or common specifications.


### 4. the risk management measures referred to in paragraph 2 , point (d) shall be such that any residual risk associated with each hazard as well as the overall residual risk of the high-risk ai systems is judged acceptable , provided that the high-risk ai system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse. those residual risks shall be communicated to the user. ### 4. the risk management measures referred to in paragraph 2 , point (d) shall be such that any residual risk associated with each hazard as well as the overall residual risk of the high-risk ai systems is judged acceptable , provided that the high-risk ai system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse. those residual risks and the reasoned judgements made shall be communicated to the deployer and made available to ai subjects.


### 4. the risk management measures referred to in paragraph 2 , point (d) shall be such that any residual risk associated with each hazard as well as the overall residual risk of the high-risk ai systems is judged acceptable , provided that the high-risk ai system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse. those residual risks shall be communicated to the user. ### 4. the risk management measures referred to in paragraph 2 , point (d) shall be such that any residual risk associated with each hazard as well as the overall residual risk of the high-risk ai systems is judged acceptable , provided that the high-risk ai system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse. those residual risks and the reasoned judgements made shall be communicated to the user.


### 5. high-risk ai systems shall be tested for the purposes of identifying the most appropriate risk management measures. testing shall ensure that high-risk ai systems perform consistently for their intended purpose and they are in compliance with the requirements set out in this chapter. ### 5. high-risk ai systems shall be tested for the purposes of identifying the most appropriate risk management measures. testing shall ensure that high-risk ai systems perform consistently safely for their intended purpose and during reasonably foreseeable misuse , and they are in compliance with the requirements set out in this chapter.


### 6. testing procedures shall be suitable to achieve the intended purpose of the ai system and do not need to go beyond what is necessary to achieve that purpose. ### 6. testing procedures shall be suitable to achieve the intended purpose of the ai system , and its reasonably foreseeable misuse , and do not need to go beyond what is necessary to achieve this.


### 1. high-risk ai systems which make use of techniques involving the training of models with data shall be developed on the basis of training , validation and testing data sets that meet the quality criteria referred to in paragraphs 2 to 5. ### 1. ai systems which make use of techniques involving the training of models with data shall be developed on the basis of training , validation and testing data sets that meet the quality criteria referred to in paragraphs 2 to 5.


### 2. training , validation and testing data sets shall be subject to appropriate data governance and management practices. those practices shall concern in particular , ### 2. training , validation and testing data sets shall be subject to appropriate data governance and management practices practices throughout the entire lifecycle of the ai system . those practices shall concern in particular ,


### the identification of any possible data gaps or shortcomings , and how those gaps and shortcomings can be addressed. ### the identification of possible data gaps or shortcomings , and how those gaps and shortcomings can be addressed.


### 3. training , validation and testing data sets shall be relevant , representative , free of errors and complete. they shall have the appropriate statistical properties , including , where applicable , as regards the persons or groups of persons on which the high-risk ai system is intended to be used. these characteristics of the data sets may be met at the level of individual data sets or a combination thereof. ### 3. training , validation and testing data sets shall be relevant , representative , free of errors and statistically complete. they shall have the appropriate statistical properties , including , where applicable , as regards the persons or groups of persons on which the high-risk ai system is intended to be used. these characteristics of the data sets may be met at the level of individual data sets or a combination thereof.


### the technical documentation shall be drawn up in such a way to demonstrate that the high-risk ai system complies with the requirements set out in this chapter and provide national competent authorities and notified bodies with all the necessary information to assess the compliance of the ai system with those requirements. it shall contain , at a minimum , the elements set out in annex iv. ### the technical documentation shall be drawn up in such a way to demonstrate that the high-risk ai system complies with the requirements set out in this chapter and provide national competent authorities and notified bodies with all the necessary information to assess the compliance of the ai system with those requirements. it shall contain , at a minimum , the elements set out in annex iv and be kept up to date throughout its entire lifecycle , and where appropriate , beyond.


### 2. high-risk ai systems shall be accompanied by instructions for use in an appropriate digital format or otherwise that include concise , complete , correct and clear information that is relevant , accessible and comprehensible to users. ### 2. high-risk ai systems shall be accompanied by instructions for use in an appropriate digital format or otherwise that include concise , statistically complete , correct and clear information that is relevant , accessible and comprehensible to users.


### (iii) any known or foreseeable circumstance , related to the use of the high-risk ai system in accordance with its intended purpose or under conditions of reasonably foreseeable misuse , which may lead to risks to the health and safety or fundamental rights; ### (iii) any known or foreseeable circumstance , related to the use of the high-risk ai system in accordance with its intended purpose or under conditions of reasonably foreseeable misuse , which may lead to risks to the health and safety , fundamental rights or the environment;


### (iii) any known or foreseeable circumstance , related to the use of the high-risk ai system in accordance with its intended purpose or under conditions of reasonably foreseeable misuse , which may lead to risks to the health and safety or fundamental rights; ### (iii) any known or foreseeable circumstance , related to the use of the high-risk ai system in accordance with its intended purpose or under conditions of reasonably foreseeable use or misuse , which may lead to risks to the health , safety , fundamental rights or environment;


### 2. human oversight shall aim at preventing or minimising the risks to health , safety or fundamental rights that may emerge when a high-risk ai system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse , in particular when such risks persist notwithstanding the application of other requirements set out in this chapter. ### 2. human oversight shall aim at preventing or minimising the risks to health , safety , fundamental rights or the environment that may emerge when a high-risk ai system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse , in particular when such risks persist notwithstanding the application of other requirements set out in this chapter.


### 2. human oversight shall aim at preventing or minimising the risks to health , safety or fundamental rights that may emerge when a high-risk ai system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse , in particular when such risks persist notwithstanding the application of other requirements set out in this chapter. ### 2. human oversight shall aim at preventing or minimising disinformation as well as the risks to health , safety , the climate and environment or fundamental rights that may emerge when a high-risk ai system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse , in particular when such risks persist notwithstanding the application of other requirements set out in this chapter.


### 2. human oversight shall aim at preventing or minimising the risks to health , safety or fundamental rights that may emerge when a high-risk ai system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse , in particular when such risks persist notwithstanding the application of other requirements set out in this chapter. ### 2. human oversight shall aim at preventing or minimising the risks to health , safety , fundamental rights or environment that may emerge when a high-risk ai system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse , in particular when such risks persist notwithstanding the application of other requirements set out in this chapter.


### be able to intervene on the operation of the high-risk ai system or interrupt the system through a “stop” button or a similar procedure. ### be able to intervene on the operation of the high-risk ai system or interrupt the system through a “stop” button or a similar procedure that allows the system to come to a halt in a safe state.


### 5. for high-risk ai systems referred to in point 1(a) of annex iii , the measures referred to in paragraph 3 shall be such as to ensure that , in addition , no action or decision is taken by the user on the basis of the identification resulting from the system unless this has been verified and confirmed by at least two natural persons. ### 5. for high-risk ai systems referred to in point 1(a) and 1(b) of annex iii , the measures referred to in paragraph 3 shall be such as to ensure that , in addition , no action or decision is taken by the user on the basis of the output from the system unless this has been verified and confirmed by at least two natural persons


### 1. users of high-risk ai systems shall use such systems in accordance with the instructions of use accompanying the systems , pursuant to paragraphs 2 and 5. ### 1. deployers of high-risk ai systems shall take appropriate technical and organisational measures and ensure that the use of such systems is in accordance with the instructions of use accompanying the systems and enables human oversight and decision-making , pursuant to paragraphs 2 and 5.


### 1. users of high-risk ai systems shall use such systems in accordance with the instructions of use accompanying the systems , pursuant to paragraphs 2 and 5. ### 1. users of high-risk ai systems shall use such systems and implement human oversight in accordance with the instructions of use accompanying the systems , pursuant to paragraphs 2 and 5.


### 1. users of high-risk ai systems shall use such systems in accordance with the instructions of use accompanying the systems , pursuant to paragraphs 2 and 5. ### 1. users of high-risk ai systems shall take appropriate organisational measures and ensure that use of such systems takes place in accordance with the instructions of use accompanying the systems and enables human oversight and decision-making.