### (19) the use of those systems for the purpose of law enforcement should therefore be prohibited , except in three exhaustively listed and narrowly defined situations , where the use is strictly necessary to achieve a substantial public interest , the importance of which outweighs the risks. those situations involve the search for potential victims of crime , including missing children; certain threats to the life or physical safety of natural persons or of a terrorist attack; and the detection , localisation , identification or prosecution of perpetrators or suspects of the criminal offences referred to in council framework decision 2002/584/jha38 if those criminal offences are punishable in the member state concerned by a custodial sentence or a detention order for a maximum period of at least three years and as they are defined in the law of that member state. such threshold for the custodial sentence or detention order in accordance with national law contributes to ensure that the offence should be serious enough to potentially justify the use of ‘real-time’ remote biometric identification systems. moreover , of the 32 criminal offences listed in the council framework decision 2002/584/jha , some are in practice likely to be more relevant than others , in that the recourse to ‘real-time’ remote biometric identification will foreseeably be necessary and proportionate to highly varying degrees for the practical pursuit of the detection , localisation , identification or prosecution of a perpetrator or suspect of the different criminal offences listed and having regard to the likely differences in the seriousness , probability and scale of the harm or possible negative consequences. ### (19) the use of those systems for the purpose of law enforcement should therefore be prohibited , except in three exhaustively listed and narrowly defined situations , where the use is strictly necessary to achieve a substantial public interest , the importance of which outweighs the risks. in these specific cases , the authorities responsible for using ai systems must ensure that their use does not adversely affect fundamental rights in the field of justice , notably access to justice , the right to a fair trial , the right to an effective remedy and the presumption of innocence. those situations involve the search for potential victims of crime , including missing children; certain threats to the life or physical safety of natural persons or of a terrorist attack; and the detection , localisation , identification or prosecution of perpetrators or suspects of the criminal offences referred to in council framework decision 2002/584/jha38 if those criminal offences are punishable in the member state concerned by a custodial sentence or a detention order for a maximum period of at least three years and as they are defined in the law of that member state. such threshold for the custodial sentence or detention order in accordance with national law contributes to ensure that the offence should be serious enough to potentially justify the use of ‘real-time’ remote biometric identification systems. moreover , of the 32 criminal offences listed in the council framework decision 2002/584/jha , some are in practice likely to be more relevant than others , in that the recourse to ‘real-time’ remote biometric identification will foreseeably be necessary and proportionate to highly varying degrees for the practical pursuit of the detection , localisation , identification or prosecution of a perpetrator or suspect of the different criminal offences listed and having regard to the likely differences in the seriousness , probability and scale of the harm or possible negative consequences.


### (19) the use of those systems for the purpose of law enforcement should therefore be prohibited , except in three exhaustively listed and narrowly defined situations , where the use is strictly necessary to achieve a substantial public interest , the importance of which outweighs the risks. those situations involve the search for potential victims of crime , including missing children; certain threats to the life or physical safety of natural persons or of a terrorist attack; and the detection , localisation , identification or prosecution of perpetrators or suspects of the criminal offences referred to in council framework decision 2002/584/jha38 if those criminal offences are punishable in the member state concerned by a custodial sentence or a detention order for a maximum period of at least three years and as they are defined in the law of that member state. such threshold for the custodial sentence or detention order in accordance with national law contributes to ensure that the offence should be serious enough to potentially justify the use of ‘real-time’ remote biometric identification systems. moreover , of the 32 criminal offences listed in the council framework decision 2002/584/jha , some are in practice likely to be more relevant than others , in that the recourse to ‘real-time’ remote biometric identification will foreseeably be necessary and proportionate to highly varying degrees for the practical pursuit of the detection , localisation , identification or prosecution of a perpetrator or suspect of the different criminal offences listed and having regard to the likely differences in the seriousness , probability and scale of the harm or possible negative consequences. ### (19) the use of those systems for the purpose of law enforcement should therefore be prohibited , except in exhaustively listed and narrowly defined situations , where the use is strictly necessary to achieve a substantial public interest , the importance of which outweighs the risks. those situations involve the search for potential victims of crime , including missing children; certain threats to the life or physical safety of natural persons or of a terrorist attack;


### (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


### (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. ### (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. the reference databases must be strictly proportionate and must respect the principle of data minimisation , as provided for in regulation (eu) 2016/679. under no circumstances should they be fed with images gathered on a large scale , for example using a large number of images available on social networks.


### (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. ### (20) in order to ensure that those systems are used in a responsible and proportionate manner , it is also important to establish that , 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.


### (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. ### (23) the use of ai systems for ‘real-time’ remote biometric identification of natural persons in publicly accessible spaces necessarily results in 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.


### (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 harmful impact on the health , safety and fundamental rights of persons in the union and such limitation minimises any potential restriction to international trade.


### (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 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 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 harmful impact on the environment and 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 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 , but also on the environment , democracy and the rule of law in the union.


### (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 or reasonably foreseeable uses , 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. ### (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 foreseeable uses , 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.


### (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 biometric identification of natural persons in protected spaces can lead to biased results and entail discriminatory effects. this is particularly relevant when it comes to age , ethnicity , sex or disabilities. therefore , biometric identification systems used in the workplace , in higher education or within vocational training should be classified as high-risk. in view of the risks that they pose , both types of 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 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 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. ### (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. the use of ‘real-time’ remote biometric identification systems should be restricted to certain specific cases laid down in this regulation , should be strictly proportionate and should be subject to prior authorisation by the national competent authorities. 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.


### (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 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. 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 classified as 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 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 prohibited. 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 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 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 an unacceptable 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 and fundamental rights , as applicable in the light of the intended purpose or reasonably foreseeable use 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 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 foreseeable uses 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 of data sets used , technical documentation and record-keeping , transparency and the provision of information to users and final beneficiaries , 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.


### (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 foreseeable uses 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 foreseeable uses , 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 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 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 or reasonably foreseeable use 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 or reasonably foreseeable use , 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 or foreseeable 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 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 should 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 should ensure the bias monitoring , detection and correction in relation to high-risk ai systems.


### (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 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 , as well as the notified bodies , competent national authorities and market surveillance authorities , also taking into account as appropriate the underlying ict infrastructure.


### (64) given the more extensive experience of professional pre-market certifiers in the field of product safety and the different nature of risks involved , it is appropriate to limit , at least in an initial phase of application of this regulation , the scope of application of third-party conformity assessment for high-risk ai systems other than those related to products. therefore , the conformity assessment of such systems should be carried out as a general rule by the provider under its own responsibility , with the only exception of ai systems intended to be used for the remote biometric identification of persons , for which the involvement of a notified body in the conformity assessment should be foreseen , to the extent they are not prohibited. ### (64) the assessment of the conformity of high-risk ai systems with this regulation should be carried out by a notified body.


### (67) high-risk ai systems should bear the ce marking to indicate their conformity with this regulation so that they can move freely within the internal market. member states should not create unjustified obstacles to the placing on the market or putting into service of high-risk ai systems that comply with the requirements laid down in this regulation and bear the ce marking. ### (67) high-risk ai systems should bear the ce marking to indicate their conformity with this regulation so that they can move freely within the internal market.


### (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 forms of regulatory oversight and a safe and fully controlled space for experimentation , while ensuring responsible innovation and integration of appropriate ethical 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. regulatory sandboxes involving activities that may impact health , safety and fundamental rights , democracy and rule of law or the environment shall be developed in accordance with redress-by-design principles. any significant risks identified during the development and testing of such systems shall result in immediate mitigation and , failing that , in the suspension of the development and testing process until such mitigation takes place. the legal basis of such sandboxes should comply with the requirements established in the existing data protection framework and should be consistent with the charter of fundamental rights of the european union.


### specific requirements for high-risk ai systems and obligations for operators of such systems; ### specific requirements for ai systems and obligations for operators of such systems;


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


### (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 (ai)' means computer systems that act in the physical or digital world and that , in an automated manner:


### (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 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 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 (and possibly also hardware) systems designed by humans that , given a complex goal , act in the physical or digital dimension by perceiving their environment through data acquisition , interpreting the collected structured or unstructured data , reasoning on the knowledge , or processing the information , derived from this data and deciding the best action(s) to take to achieve the given goal; ai systems can either use symbolic rules or learn a numeric model , and they can also adapt their behaviour by analysing how the environment is affected by their previous actions; ai systems can be developed with one or more of the techniques and approaches listed in annex i;


### (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) ‘user’ means any natural or legal person , data subject , public authority , agency or other body using an ai system under its authority and on its own responsibility , 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) ‘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 strictly 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 user or for own use on the union market for its intended purpose or reasonably foreseeable use ;


### (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 user or for own use on the union market for its foreseeable uses;


### (12) ‘intended purpose’ means the use for which an ai system is intended by the provider , including the specific context and conditions of use , as specified in the information supplied by the provider in the instructions for use , promotional or sales materials and statements , as well as in the technical documentation; ### (12) ‘foreseeable use’ means the use that can reasonably be expected to be made of an ai system , including but not limited to the use for which the ai system is intended for consumers or the likely use by consumers under reasonably foreseeable conditions;


### (12) ‘intended purpose’ means the use for which an ai system is intended by the provider , including the specific context and conditions of use , as specified in the information supplied by the provider in the instructions for use , promotional or sales materials and statements , as well as in the technical documentation; ### (12) ‘foreseeable uses’ means uses that can reasonably be expected to be made of an ai system , including but not limited to the use for which the ai system is intended for consumers or the likely use by consumers under reasonably foreseeable conditions;


### (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 , and with 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 direct or indirect safety function for that product or system or the failure or malfunctioning of which endangers the health and safety of persons or property;


### (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 , health , personal traits , ethnic origin or sexual or political orientation , on the basis of their biometric data;


### (44) ‘serious incident’ means any incident that directly or indirectly leads , might have led or might lead to any of the following: ### (44) ‘serious incident’ means any incident or malfunctioning that directly or indirectly leads , might have led or might lead to any of the following:


### (44) ‘serious incident’ means any incident that directly or indirectly leads , might have led or might lead to any of the following: ### (44) ‘serious incident’ means any incident or malfunctioning of an ai system that directly or indirectly leads , might have led or might lead to any of the following:


### 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 in order to materially distort , voluntarily or for a reasonably foreseeable misuse , a person’s behaviour in a manner that causes or is likely to cause that person or another person 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


### (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/jha62and 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


### (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 system is intended to be used as a safety component of a product , or is itself a product , covered by the union harmonisation legislation listed in annex ii; ### the ai system is intended to be used as a component the failure or malfunctioning of which endangers the health , safety or fundamental rights of persons or of property , covered by the union harmonisation legislation listed in annex ii;


### 2. in addition to the high-risk ai systems referred to in paragraph 1 , ai systems referred to in annex iii shall also be considered high-risk. ### 2. in addition to the high-risk ai systems referred to in paragraph 1 , ai systems referred to in annex iii shall also be considered high-risk. the provider shall apply a precautionary principle and , in case of uncertainty over the ai system's classification , shall consider the ai system high-risk.


### 1. the commission is empowered to adopt delegated acts in accordance with article 73 to update the list in annex iii by adding high-risk ai systems where both of the following conditions are fulfilled: ### 1. the commission is empowered to adopt delegated acts in accordance with article 73 to update the list in annex ii and iii by adding high-risk ai systems.


### 1. the commission is empowered to adopt delegated acts in accordance with article 73 to update the list in annex iii by adding high-risk ai systems where both of the following conditions are fulfilled: ### 1. the commission is empowered to adopt delegated acts in accordance with article 73 , following an adequate consultation with all relevant stakeholders , including , the european artificial intelligence board , the eu agency for fundamental rights , and the european data protection supervisor , to update the list in annex iii , by adding high-risk ai systems where the following conditions are fulfilled:


### the ai systems are intended to be used in any of the areas listed in points 1 to 8 of annex iii; ### deleted


### the ai systems are intended to be used in any of the areas listed in points 1 to 8 of annex iii; ### the ai systems are used in any of the areas listed 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. ### 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 health and safety , an economic risk 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 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 economic harm , negative societal impacts or harm to the environment , health and safety , or a risk of adverse impact on fundamental rights , democracy and the rule of law , 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 on 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 , including but not limited to , 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 fundamental rights or on the environment , democracy and rule of law , 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 intended purpose of the ai system; ### the intended purpose or reasonably foreseeable use of the ai system;


### 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 on 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 health , safety and the 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 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 , democracy , rule of law and 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 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 on the environment;


### 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;


### 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 of the high-risk ai system , the foreseeable uses and foreseeable misuses of ai systems within determinate uses 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 , including when the high-risk ai system is subject to significant changes in its design or purpose. 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 the reasonably foreseeable risks that the high-risk ai system , and ai systems with indeterminate uses can pose to:


### 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; in particular the risks that a high-risk ai system will:


### 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 reasonably foreseeable use 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 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 shall be communicated to the user in a clear , easily understandable and intelligible way.


### 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 for their foreseeable use 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 foreseeable use of the ai system and do not need to go beyond what is necessary to achieve that purpose.


### 7. the testing of the high-risk ai systems shall be performed , as appropriate , at any point in time throughout the development process , and , in any event , prior to the placing on the market or the putting into service. testing shall be made against preliminarily defined metrics and probabilistic thresholds that are appropriate to the intended purpose of the high-risk ai system. ### 7. the testing of the high-risk ai systems shall be performed , as appropriate , at any point in time throughout the development process , and , in any event , prior to the placing on the market or the putting into service. testing shall be made against preliminarily defined metrics and probabilistic thresholds that are appropriate to the foreseeable use of the high-risk ai system.


### 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 for the entire lifecycle of data processing. those practices shall concern in particular ,


### examination in view of possible biases; ### examination in view of biases;


### examination in view of possible biases; ### examination in view of biases , including where data outputs are used as an input for future operations (‘feedback loops’) that are likely to affect health , fundamental rights and safety of persons or lead to discrimination prohibited by union law;


### 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 , sufficiently 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 data sets shall consist of sufficiently large volumes of data , and they shall take account of all of the relevant aspects of gender , social , geographical and ethnic group , and other grounds for discrimination prohibited under union law. they shall cover all the necessary relevant scenarios in order to avoid hazardous situations. 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 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 , and to the best extent possible 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 to be used. these characteristics of the data sets may be met at the level of individual data sets or a combination thereof.


### 4. training , validation and testing data sets shall take into account , to the extent required by the intended purpose , the characteristics or elements that are particular to the specific geographical , behavioural or functional setting within which the high-risk ai system is intended to be used. ### 4. training , validation and testing data sets shall take into account , to the extent required by the foreseeable use , the characteristics or elements that are particular to the specific geographical , behavioural or functional setting within which the high-risk ai system is intended to be used.


### (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 health and safety , the protection of personal data or fundamental rights;


### 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 the risks to health , safety or fundamental rights that 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. the commission , when preparing the common specifications referred to in paragraph 1 , shall gather the views of relevant bodies or expert groups established under relevant sectorial union law. ### 2. the commission , when preparing the common specifications referred to in paragraph 1 , shall gather the views of relevant bodies or expert groups established under relevant sectorial union law. it shall also consult the european artificial intelligence board.


### 6. the commission is empowered to adopt delegated acts to amend paragraphs 1 and 2 in order to subject high-risk ai systems referred to in points 2 to 8 of annex iii to the conformity assessment procedure referred to in annex vii or parts thereof. the commission shall adopt such delegated acts taking into account the effectiveness of the conformity assessment procedure based on internal control referred to in annex vi in preventing or minimizing the risks to health and safety and protection of fundamental rights posed by such systems as well as the availability of adequate capacities and resources among notified bodies. ### deleted


### transparency obligations for certain ai systems ### transparency obligations for ai systems


### transparency obligations for certain ai systems ### transparency obligations for all ai systems


### 1. providers shall ensure that ai systems intended to interact with natural persons are designed and developed in such a way that natural persons are informed that they are interacting with an ai system , unless this is obvious from the circumstances and the context of use. this obligation shall not apply to ai systems authorised by law to detect , prevent , investigate and prosecute criminal offences , unless those systems are available for the public to report a criminal offence. ### 1. providers shall ensure that ai systems intended to interact with natural persons are designed and developed in such a way that natural persons , especially those who are least familiar with digital technologies , are informed that they are interacting with an ai system.


### 1. providers shall ensure that ai systems intended to interact with natural persons are designed and developed in such a way that natural persons are informed that they are interacting with an ai system , unless this is obvious from the circumstances and the context of use. this obligation shall not apply to ai systems authorised by law to detect , prevent , investigate and prosecute criminal offences , unless those systems are available for the public to report a criminal offence. ### 1. providers shall ensure that ai systems intended to interact with natural persons are designed and developed in such a way that natural persons are informed in a clear , easily understandable and intelligible way that they are interacting with an ai system , unless this is obvious from the circumstances and the context of use. this obligation shall not apply to ai systems authorised by law to detect , prevent , investigate and prosecute criminal offences , unless those systems are available for the public to report a criminal offence.


### 3. users of an ai system that generates or manipulates image , audio or video content that appreciably resembles existing persons , objects , places or other entities or events and would falsely appear to a person to be authentic or truthful (‘deep fake’) , shall disclose that the content has been artificially generated or manipulated. ### 3. users of an ai system that generates or manipulates image , audio or video content that appreciably resembles existing persons , objects , places or other entities or events and would falsely appear to a person to be authentic or truthful (‘deep fake’) , shall disclose in an appropriate , clear and visible manner , that the content has been artificially generated or manipulated.


### 4. paragraphs 1 , 2 and 3 shall not affect the requirements and obligations set out in title iii of this regulation. ### 4. paragraphs 1 , 2 , 3 and 4 shall not affect the requirements and obligations set out in title iii of this regulation.


### 4. paragraphs 1 , 2 and 3 shall not affect the requirements and obligations set out in title iii of this regulation. ### 4. 5. paragraphs 1 , 2 , 3 and 3a shall not affect the requirements and obligations set out in title iii of this regulation.


### 1. ai regulatory sandboxes established by one or more member states competent authorities or the european data protection supervisor shall provide a controlled environment that facilitates the development , testing and validation of innovative ai systems for a limited time before their placement on the market or putting into service pursuant to a specific plan. this shall take place under the direct supervision and guidance by the competent authorities with a view to ensuring compliance with the requirements of this regulation and , where relevant , other union and member states legislation supervised within the sandbox. ### 1. ai regulatory sandboxes established by one or more member states competent authorities or the european data protection supervisor shall provide a controlled environment that facilitates the development , testing and validation of innovative ai systems for a limited time before their placement on the market or putting into service pursuant to a specific plan. this shall take place under the direct supervision and guidance by the competent authorities with a view to identifying risks to health and safety and fundamental rights , testing mitigation measures for identified risks and demonstrating prevention of these risks in order to ensure compliance with the requirements of this regulation and , where relevant , other union and member states legislation supervised within the sandbox.


### 1. ai regulatory sandboxes established by one or more member states competent authorities or the european data protection supervisor shall provide a controlled environment that facilitates the development , testing and validation of innovative ai systems for a limited time before their placement on the market or putting into service pursuant to a specific plan. this shall take place under the direct supervision and guidance by the competent authorities with a view to ensuring compliance with the requirements of this regulation and , where relevant , other union and member states legislation supervised within the sandbox. ### 1. ai regulatory sandboxes established by one or more member states competent authorities or the european data protection supervisor shall provide a strictly controlled environment that facilitates the development , testing and validation of innovative ai systems for a limited time before their placement on the market or putting into service pursuant to a specific plan. this shall take place under the direct supervision and guidance by the competent authorities with a view to identifying risks in particular to health , safety , and fundamental rights , ensuring compliance with the requirements of this regulation and , where relevant , other union and member states legislation supervised within the sandbox.


### 3. the ai regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. any significant risks to health and safety and fundamental rights identified during the development and testing of such systems shall result in immediate mitigation and , failing that , in the suspension of the development and testing process until such mitigation takes place. ### 3. the ai regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. any significant risks to health and safety and fundamental rights identified during the development and testing of such systems shall result in immediate rectification and , failing that , in the suspension of the development and testing process until such rectification takes place.


### 3. the ai regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. any significant risks to health and safety and fundamental rights identified during the development and testing of such systems shall result in immediate mitigation and , failing that , in the suspension of the development and testing process until such mitigation takes place. ### 3. the ai regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. regulatory sandboxes involving activities that may impact health , safety and fundamental rights , democracy and rule of law or the environment shall be developed in accordance with redress-by-design principles. any significant risks identified during the development and testing of such systems shall result in immediate mitigation and , failing that , in the suspension of the development and testing process until such mitigation takes place.


### 5. member states’ competent authorities that have established ai regulatory sandboxes shall coordinate their activities and cooperate within the framework of the european artificial intelligence board. they shall submit annual reports to the board and the commission on the results from the implementation of those scheme , including good practices , lessons learnt and recommendations on their setup and , where relevant , on the application of this regulation and other union legislation supervised within the sandbox. ### 5. member states’ competent authorities that have established ai regulatory sandboxes shall coordinate their activities and cooperate within the framework of the european artificial intelligence board , in particular with the european data protection supervisor. they shall submit annual reports to the board and the commission on the results from the implementation of those scheme , including good practices , lessons learnt and recommendations on their setup and , where relevant , on the application of this regulation and other union legislation supervised within the sandbox.


### provide small-scale providers and start-ups with priority access to the ai regulatory sandboxes to the extent that they fulfil the eligibility conditions; ### provide small-scale providers and start-ups established in the eu with priority access to the ai regulatory sandboxes to the extent that they fulfil the eligibility conditions;


### 1. the board shall be composed of the national supervisory authorities , who shall be represented by the head or equivalent high-level official of that authority , and the european data protection supervisor. other national authorities may be invited to the meetings , where the issues discussed are of relevance for them. ### 1. the board shall be composed of the national supervisory authorities , who shall be represented by the head or equivalent high-level official of that authority , and the european data protection supervisor , the eu agency for fundamental rights , enisa , eige and social partners as well representratives of civil society. other national authorities may be invited to the meetings , where the issues discussed are of relevance for them.


### 1. the board shall be composed of the national supervisory authorities , who shall be represented by the head or equivalent high-level official of that authority , and the european data protection supervisor. other national authorities may be invited to the meetings , where the issues discussed are of relevance for them. ### 1. the board shall be composed of the national supervisory authorities , who shall be represented by the head or equivalent high-level official of that authority , the european data protection supervisor and the fundamental rights agency. other national authorities or eu agencies may be invited to the meetings , where the issues discussed are of relevance for them.


### 1. the board shall be composed of the national supervisory authorities , who shall be represented by the head or equivalent high-level official of that authority , and the european data protection supervisor. other national authorities may be invited to the meetings , where the issues discussed are of relevance for them. ### 1. the board shall be composed of the national supervisory authorities , who shall be represented by the head or equivalent high-level official of that authority , representatives of the ethics committees of the member states or , for those countries that have no such committees , ethics academics , researchers or experts , and the european data protection supervisor. other national authorities shall be invited to the meetings , where the issues discussed are of relevance for them. the board shall cooperate closely with the national data protection authorities as defined by article 51 of regulation (eu) 2016/679.


### 1. the board shall be composed of the national supervisory authorities , who shall be represented by the head or equivalent high-level official of that authority , and the european data protection supervisor. other national authorities may be invited to the meetings , where the issues discussed are of relevance for them. ### 1. the board shall be composed of the national supervisory authorities , who shall be represented by the head or equivalent high-level official of that authority , and the european data protection supervisor , the eu agency for fundamental rights , enisa and eige. other national authorities may be invited to the meetings , where the issues discussed are of relevance for them.


### 3. the board shall be chaired by the commission. the commission shall convene the meetings and prepare the agenda in accordance with the tasks of the board pursuant to this regulation and with its rules of procedure. the commission shall provide administrative and analytical support for the activities of the board pursuant to this regulation. ### 3. the commission shall provide administrative and analytical support for the activities of the board pursuant to this regulation.


### 3. the board shall be chaired by the commission. the commission shall convene the meetings and prepare the agenda in accordance with the tasks of the board pursuant to this regulation and with its rules of procedure. the commission shall provide administrative and analytical support for the activities of the board pursuant to this regulation. ### 3. the board shall be chaired by the commission.