### (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) 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 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.


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


### (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. 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. 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 , political orientation or personal opinions , or create new forms of discriminatory impacts. natural persons applying for or receiving public assistance benefits and services from public authorities are typically dependent on those benefits and services and in a vulnerable position in relation to the responsible authorities. if ai systems are used for determining whether such benefits and services should be denied , reduced , revoked or reclaimed by authorities , they 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.


### (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 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 advised 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.


### (76) in order to facilitate a smooth , effective and harmonised implementation of this regulation a european artificial intelligence board should be established. the board should be responsible for a number of advisory tasks , including issuing opinions , recommendations , advice or guidance on matters related to the implementation of this regulation , including on technical specifications or existing standards regarding the requirements established in this regulation and providing advice to and assisting the commission on specific questions related to artificial intelligence. ### (76) in order to facilitate a smooth , effective and harmonised implementation of this regulation a european artificial intelligence board should be established. the board should be responsible for a number of advisory tasks , including issuing opinions , recommendations , advice or guidance on matters related to the implementation of this regulation , including on technical specifications or existing standards regarding the requirements established in this regulation and providing advice to and assisting the commission on specific questions related to artificial intelligence. the board should work towards establishing a european regulatory agency for artificial intelligence in line with the provisions of article 56(3).


### specific requirements for high-risk ai systems and obligations for operators of such systems; ### specific requirements for high-risk and non-high-risk 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 system’ (ai system) means any software or machine-based system 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 , make predictions , recommendations , or decisions influencing real or virtual environments. the environments they interact with. ai systems can be designed with varying levels of autonomy.


### (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 an automated system or 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;


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


### the commission is empowered to adopt delegated acts in accordance with article 73 to amend the list of techniques and approaches listed in annex i , in order to update that list to market and technological developments on the basis of characteristics that are similar to the techniques and approaches listed therein. ### 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 competent judicial or administrative authority shall only grant the authorisation where it is satisfied , based on objective evidence or clear indications presented to it , that the use of the ‘real-time’ remote biometric identification system at issue is necessary for and proportionate to achieving one of the objectives specified in paragraph 1 , point (d) , as identified in the request. in deciding on the request , the competent judicial or administrative authority shall take into account the elements referred to in paragraph 2. ### deleted


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


### identification and analysis of the known and foreseeable risks associated with each high-risk ai system; ### identification and analysis of the known or any foreseeable risks associated with each high-risk ai system;


### 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 limited and acceptable by the user , 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.


### 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 sufficiently 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.


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


### (ii) the level of accuracy , robustness and cybersecurity referred to in article 15 against which the high-risk ai system has been tested and validated and which can be expected , and any known and foreseeable circumstances that may have an impact on that expected level of accuracy , robustness and cybersecurity; ### (ii) the level of accuracy , robustness and cybersecurity referred to in article 15 , where applicable , against which the ai system has been tested and validated and which can be expected , and any known and foreseeable circumstances that may have an impact on that expected level of accuracy , robustness and cybersecurity;


### (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 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;


### 2. human oversight shall aim at preventing or minimising the risks to health , safety or fundamental rights that may emerge when a high-risk ai system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse , in particular when such risks persist notwithstanding the application of other requirements set out in this chapter. ### 2. human oversight shall aim at preventing or minimising the risks to health , safety 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 can affect the wellbeing , health or physical integrity of children and minors , or persist notwithstanding the application of other requirements set out in this chapter. special attention shall be paid on ai systems used for the development or as components of children toys.


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


### be able to decide , in any particular situation , not to use the high-risk ai system or otherwise disregard , override or reverse the output of the high-risk ai system; ### be able to decide , in all cases , not to use the high-risk ai system or otherwise disregard , override or reverse the output of the high-risk ai system;


### 3. high-risk ai systems shall be resilient as regards errors , faults or inconsistencies that may occur within the system or the environment in which the system operates , in particular due to their interaction with natural persons or other systems. ### 3. all ai systems shall be resilient as regards errors , faults or inconsistencies that may occur within the system or the environment in which the system operates , in particular due to their interaction with natural persons or other 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 are informed that they are interacting with an ai system.


### 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 mitigation or closure of the sandbox and , failing that , in the suspension of the development and testing process until such mitigation takes place.


### measures for small-scale providers and users ### measures for sme providers and users


### 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. the european union agency for fundamental rights will have the status of observer in the board. other national authorities , as well as representatives of small and medium-sized enterprises and startups , may be invited to the meetings , where the issues discussed are of relevance for them.


### 2. the post-market monitoring system shall actively and systematically collect , document and analyse relevant data provided by users or collected through other sources on the performance of high-risk ai systems throughout their lifetime , and allow the provider to evaluate the continuous compliance of ai systems with the requirements set out in title iii , chapter 2. ### 2. the post-market monitoring system shall actively and systematically collect , document and analyse relevant data provided by users or collected through other sources on the performance of ai systems throughout their lifetime , and allow the provider to evaluate the continuous compliance of ai systems with the requirements set out in title iii , chapter 2.


### (2) artificial intelligence systems (ai systems) can be easily deployed in multiple sectors of the economy and society , including cross border , and circulate throughout the union. certain member states have already explored the adoption of national rules to ensure that artificial intelligence is safe and is developed and used in compliance with fundamental rights obligations. differing national rules may lead to fragmentation of the internal market and decrease legal certainty for operators that develop or use ai systems. a consistent and high level of protection throughout the union should therefore be ensured , while divergences hampering the free circulation of ai systems and related products and services within the internal market should be prevented , by laying down uniform obligations for operators and guaranteeing the uniform protection of overriding reasons of public interest and of rights of persons throughout the internal market based on article 114 of the treaty on the functioning of the european union (tfeu). to the extent that this regulation contains specific rules on the protection of individuals with regard to the processing of personal data concerning restrictions of the use of ai systems for ‘real-time’ remote biometric identification in publicly accessible spaces for the purpose of law enforcement , it is appropriate to base this regulation , in as far as those specific rules are concerned , on article 16 of the tfeu. in light of those specific rules and the recourse to article 16 tfeu , it is appropriate to consult the european data protection board. ### (2) artificial intelligence systems (ai systems) can be easily deployed in multiple sectors of the economy and society , including cross border , and circulate throughout the union. certain member states have already explored the adoption of national rules to ensure that artificial intelligence is safe and is developed and used in compliance with fundamental rights obligations. differing national rules may lead to fragmentation of the internal market and decrease legal certainty for operators that develop or use ai systems. a consistent and high level of protection throughout the union should therefore be ensured , while divergences hampering the free circulation of ai systems and related products and services within the internal market should be prevented or reduced , by laying down minimum uniform obligations for operators and guaranteeing the organic and consistent protection of overriding reasons of public interest and of rights of persons throughout the internal market based on article 114 of the treaty on the functioning of the european union (tfeu). to the extent that this regulation contains specific rules on the protection of individuals with regard to the processing of personal data concerning restrictions of the use of ai systems for ‘real-time’ remote biometric identification in publicly accessible spaces for the purpose of law enforcement , it is appropriate to base this regulation , in as far as those specific rules are concerned , on article 16 of the tfeu. in light of those specific rules and the recourse to article 16 tfeu , it is appropriate to consult the european data protection board.


### (3) artificial intelligence is a fast evolving family of technologies that can contribute to a wide array of economic and societal benefits across the entire spectrum of industries and social activities. by improving prediction , optimising operations and resource allocation , and personalising digital solutions available for individuals and organisations , the use of artificial intelligence can provide key competitive advantages to companies and support socially and environmentally beneficial outcomes , for example in healthcare , farming , education and training , infrastructure management , energy , transport and logistics , public services , security , justice , resource and energy efficiency , and climate change mitigation and adaptation. ### (3) artificial intelligence is a fast evolving family of technologies that can contribute to a wide array of economic and societal benefits across the entire spectrum of industries and social activities. the use of artificial intelligence can provide key competitive advantages to companies and support socially and environmentally beneficial outcomes , for example in healthcare , farming , education and training , infrastructure management , energy , transport and logistics , public services , security , justice , resource and energy efficiency , and climate change mitigation and adaptation.


### (4) at the same time , depending on the circumstances regarding its specific application and use , artificial intelligence may generate risks and cause harm to public interests and rights that are protected by union law. such harm might be material or immaterial. ### (4) at the same time , depending on the circumstances regarding its specific application and use , artificial intelligence may generate risks and cause harm to public interests and fundamental rights of people in employment and in learning and of socially active people that are protected by union law. such harm might be material or immaterial.


### (4) at the same time , depending on the circumstances regarding its specific application and use , artificial intelligence may generate risks and cause harm to public interests and rights that are protected by union law. such harm might be material or immaterial. ### (4) at the same time , depending on the circumstances regarding its specific application and use , artificial intelligence may generate serious risks and cause harm to public interests and rights that are protected by union law. such harm might be material or immaterial.


### (9) for the purposes of this regulation the notion of publicly accessible space should be understood as referring to any physical place that is accessible to the public , irrespective of whether the place in question is privately or publicly owned. therefore , the notion does not cover places that are private in nature and normally not freely accessible for third parties , including law enforcement authorities , unless those parties have been specifically invited or authorised , such as homes , private clubs , offices , warehouses and factories. online spaces are not covered either , as they are not physical spaces. however , the mere fact that certain conditions for accessing a particular space may apply , such as admission tickets or age restrictions , does not mean that the space is not publicly accessible within the meaning of this regulation. consequently , in addition to public spaces such as streets , relevant parts of government buildings and most transport infrastructure , spaces such as cinemas , theatres , shops and shopping centres are normally also publicly accessible. whether a given space is accessible to the public should however be determined on a case-by-case basis , having regard to the specificities of the individual situation at hand. ### (9) for the purposes of this regulation the notion of publicly accessible space should be understood as referring to any physical or virtual place that is accessible to the public , irrespective of whether the place in question is privately or publicly owned or owned on a non-profit basis. therefore , the notion does not cover places that are private in nature and normally not freely accessible for third parties , including law enforcement authorities , unless those parties have been specifically invited or authorised , such as homes , private clubs , offices , warehouses and virtual protected spaces. however , the mere fact that certain conditions for accessing a particular space may apply , such as admission tickets or age restrictions , does not mean that the space is not publicly accessible within the meaning of this regulation. consequently , in addition to public spaces such as streets , parks , sports complexes , relevant parts of government buildings and most transport infrastructure , spaces such as cinemas , theatres , museums , libraries , shops and shopping centres are normally also publicly accessible. whether a given space is accessible to the public should however be determined on a case-by-case basis , having regard to the specificities of the individual situation at hand as regards the use made of that space.


### (14) in order to introduce a proportionate and effective set of binding rules for ai systems , a clearly defined risk-based approach should be followed. that approach should tailor the type and content of such rules to the intensity and scope of the risks that ai systems can generate. it is therefore necessary to prohibit certain artificial intelligence practices , to lay down requirements for high-risk ai systems and obligations for the relevant operators , and to lay down transparency obligations for certain ai systems. ### (14) in order to introduce a proportionate and effective set of binding rules for ai systems , a clearly defined risk-based approach should be followed. that approach should tailor the type and content of such rules to the intensity and scope of the risks that ai systems can generate. it is therefore necessary to prohibit certain artificial intelligence practices , including those defined as ‘high-risk’ , and to lay down requirements for medium/low-risk ai systems and obligations for the relevant operators , and to lay down transparency obligations for certain ai systems.


### (15) aside from the many beneficial uses of artificial intelligence , that technology can also be misused and provide novel and powerful tools for manipulative , exploitative and social control practices. such practices are particularly harmful and should be prohibited because they contradict union values of respect for human dignity , freedom , equality , democracy and the rule of law and union fundamental rights , including the right to non-discrimination , data protection and privacy and the rights of the child. ### (15) aside from the many beneficial uses of artificial intelligence , that technology can also be misused and provide novel and powerful tools for manipulative , exploitative and social control practices. such practices are particularly harmful and should be prohibited because they contradict union values of respect for human dignity , freedom , equality , democracy and the rule of law and union fundamental rights , including the right to non-discrimination , employee protection , data protection and privacy and the rights of the child.


### (15) aside from the many beneficial uses of artificial intelligence , that technology can also be misused and provide novel and powerful tools for manipulative , exploitative and social control practices. such practices are particularly harmful and should be prohibited because they contradict union values of respect for human dignity , freedom , equality , democracy and the rule of law and union fundamental rights , including the right to non-discrimination , data protection and privacy and the rights of the child. ### (15) aside from the many beneficial uses of artificial intelligence , that technology can also be misused and provide novel and powerful tools for manipulative , exploitative and social control practices. such practices are particularly harmful and absolutely must be prohibited because they contradict union values of respect for human dignity , freedom , equality , democracy and the rule of law and union fundamental rights , including the right to non-discrimination , data protection and privacy and the rights of the child.


### (16) the placing on the market , putting into service or use of certain ai systems intended to distort human behaviour , whereby physical or psychological harms are likely to occur , should be forbidden. such ai systems deploy subliminal components individuals cannot perceive or exploit vulnerabilities of children and people due to their age , physical or mental incapacities. they do so with the intention to materially distort the behaviour of a person and in a manner that causes or is likely to cause harm to that or another person. the intention may not be presumed if the distortion of human behaviour results from factors external to the ai system which are outside of the control of the provider or the user. research for legitimate purposes in relation to such ai systems should not be stifled by the prohibition , if such research does not amount to use of the ai system in human-machine relations that exposes natural persons to harm and such research is carried out in accordance with recognised ethical standards for scientific research. ### (16) the placing on the market , putting into service or use of certain ai systems intended to distort human behaviour , whereby physical or psychological harms are likely to occur , should be forbidden. such ai systems deploy subliminal components individuals cannot perceive , access brain or brain-generated data without consent , or exploit vulnerabilities of children and people due to their age , physical or mental incapacities. they do so with the intention to materially distort the behaviour of a person and in a manner that causes or is likely to cause harm to that or another person. the intention may not be presumed if the distortion of human behaviour results from factors external to the ai system which are outside of the control of the provider or the user. research for legitimate purposes in relation to such ai systems should not be stifled by the prohibition , if such research does not amount to use of the ai system in human-machine relations that exposes natural persons to harm and such research is carried out in accordance with recognised ethical standards for scientific research.


### (16) the placing on the market , putting into service or use of certain ai systems intended to distort human behaviour , whereby physical or psychological harms are likely to occur , should be forbidden. such ai systems deploy subliminal components individuals cannot perceive or exploit vulnerabilities of children and people due to their age , physical or mental incapacities. they do so with the intention to materially distort the behaviour of a person and in a manner that causes or is likely to cause harm to that or another person. the intention may not be presumed if the distortion of human behaviour results from factors external to the ai system which are outside of the control of the provider or the user. research for legitimate purposes in relation to such ai systems should not be stifled by the prohibition , if such research does not amount to use of the ai system in human-machine relations that exposes natural persons to harm and such research is carried out in accordance with recognised ethical standards for scientific research. ### (16) the placing on the market , putting into service or use of certain ai systems intended to distort human behaviour , whereby physical or psychological harms are likely to occur , should be forbidden. such ai systems deploy subliminal components individuals cannot perceive or exploit vulnerabilities of children and people due to their age , physical or mental incapacities. they do so with the intention to materially distort the behaviour of a person and in a manner that causes or is likely to cause harm to that or another person. the intention may not be presumed if the distortion of human behaviour results from factors external to the ai system which are outside of the control of the provider or the user.


### (17) ai systems providing social scoring of natural persons for general purpose by public authorities or on their behalf may lead to discriminatory outcomes and the exclusion of certain groups. they may violate the right to dignity and non-discrimination and the values of equality and justice. such ai systems evaluate or classify the trustworthiness of natural persons based on their social behaviour in multiple contexts or known or predicted personal or personality characteristics. the social score obtained from such ai systems may lead to the detrimental or unfavourable treatment of natural persons or whole groups thereof in social contexts , which are unrelated to the context in which the data was originally generated or collected or to a detrimental treatment that is disproportionate or unjustified to the gravity of their social behaviour. such ai systems should be therefore prohibited. ### (17) ai systems providing social scoring of natural persons for general purpose may lead to discriminatory outcomes and the exclusion of certain groups. they may violate the right to dignity and non-discrimination and the values of equality and justice. such ai systems evaluate or classify the trustworthiness , interests and abilities of natural persons based on their social behaviour in multiple contexts or known or predicted personal , personality or identity characteristics. such ai systems should be therefore prohibited.


### (17) ai systems providing social scoring of natural persons for general purpose by public authorities or on their behalf may lead to discriminatory outcomes and the exclusion of certain groups. they may violate the right to dignity and non-discrimination and the values of equality and justice. such ai systems evaluate or classify the trustworthiness of natural persons based on their social behaviour in multiple contexts or known or predicted personal or personality characteristics. the social score obtained from such ai systems may lead to the detrimental or unfavourable treatment of natural persons or whole groups thereof in social contexts , which are unrelated to the context in which the data was originally generated or collected or to a detrimental treatment that is disproportionate or unjustified to the gravity of their social behaviour. such ai systems should be therefore prohibited. ### (17) ai systems providing social scoring of natural persons , assessing the risk of natural person for offending or reoffending , or categorising persons based on biometrics or biometrics-based data , may lead to discriminatory outcomes and the exclusion of certain groups. they may violate the right to dignity and non-discrimination and the values of equality and justice. such ai systems evaluate or classify the trustworthiness of natural persons based on their social behaviour in multiple contexts or known or predicted personal or personality characteristics. the social score or risk assessment obtained from such ai systems may lead to the detrimental or unfavourable treatment of natural persons or whole groups thereof in social and legal contexts , which are unrelated to the context in which the data was originally generated or collected or to a detrimental treatment that is disproportionate or unjustified to the gravity of their social behaviour. such ai systems should be therefore prohibited.


### (17) ai systems providing social scoring of natural persons for general purpose by public authorities or on their behalf may lead to discriminatory outcomes and the exclusion of certain groups. they may violate the right to dignity and non-discrimination and the values of equality and justice. such ai systems evaluate or classify the trustworthiness of natural persons based on their social behaviour in multiple contexts or known or predicted personal or personality characteristics. the social score obtained from such ai systems may lead to the detrimental or unfavourable treatment of natural persons or whole groups thereof in social contexts , which are unrelated to the context in which the data was originally generated or collected or to a detrimental treatment that is disproportionate or unjustified to the gravity of their social behaviour. such ai systems should be therefore prohibited. ### (17) ai systems providing social scoring of natural persons for general purpose by public authorities or on their behalf may lead to discriminatory outcomes and the exclusion of certain groups. they may violate the right to dignity and non-discrimination and the values of equality and justice. such ai systems evaluate or classify the trustworthiness of natural persons based on their social behaviour in multiple contexts or known or predicted personal or personality characteristics. the social score obtained from such ai systems may lead to the detrimental or unfavourable treatment of natural persons or whole groups thereof in social contexts , which are unrelated to the context in which the data was originally generated or collected or to a detrimental treatment that is disproportionate or unjustified to the gravity of their social behaviour. it is therefore extremely important for such ai systems to be prohibited.


### (24) any processing of biometric data and other personal data involved in the use of ai systems for biometric identification , other than in connection to the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement as regulated by this regulation , including where those systems are used by competent authorities in publicly accessible spaces for other purposes than law enforcement , should continue to comply with all requirements resulting from article 9(1) of regulation (eu) 2016/679 , article 10(1) of regulation (eu) 2018/1725 and article 10 of directive (eu) 2016/680 , as applicable. ### deleted


### (24) any processing of biometric data and other personal data involved in the use of ai systems for biometric identification , other than in connection to the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement as regulated by this regulation , including where those systems are used by competent authorities in publicly accessible spaces for other purposes than law enforcement , should continue to comply with all requirements resulting from article 9(1) of regulation (eu) 2016/679 , article 10(1) of regulation (eu) 2018/1725 and article 10 of directive (eu) 2016/680 , as applicable. ### (24) any processing of biometric data and other personal data involved in the use of ai systems , should continue to comply with all requirements resulting from article 9(1) of regulation (eu) 2016/679 , article 10(1) of regulation (eu) 2018/1725 and article 10 of directive (eu) 2016/680 , as applicable.


### (28) ai systems could produce adverse outcomes to health and safety of persons , in particular when such systems operate as components of products. consistently with the objectives of union harmonisation legislation to facilitate the free movement of products in the internal market and to ensure that only safe and otherwise compliant products find their way into the market , it is important that the safety risks that may be generated by a product as a whole due to its digital components , including ai systems , are duly prevented and mitigated. for instance , increasingly autonomous robots , whether in the context of manufacturing or personal assistance and care should be able to safely operate and performs their functions in complex environments. similarly , in the health sector where the stakes for life and health are particularly high , increasingly sophisticated diagnostics systems and systems supporting human decisions should be reliable and accurate. the extent of the adverse impact caused by the ai system on the fundamental rights protected by the charter is of particular relevance when classifying an ai system as high-risk. those rights include the right to human dignity , respect for private and family life , protection of personal data , freedom of expression and information , freedom of assembly and of association , and non-discrimination , consumer protection , workers’ rights , rights of persons with disabilities , right to an effective remedy and to a fair trial , right of defence and the presumption of innocence , right to good administration. in addition to those rights , it is important to highlight that children have specific rights as enshrined in article 24 of the eu charter and in the united nations convention on the rights of the child (further elaborated in the uncrc general comment no. 25 as regards the digital environment) , both of which require consideration of the children’s vulnerabilities and provision of such protection and care as necessary for their well-being. the fundamental right to a high level of environmental protection enshrined in the charter and implemented in union policies should also be considered when assessing the severity of the harm that an ai system can cause , including in relation to the health and safety of persons. ### (28) ai systems could produce adverse outcomes to health and safety of persons , in particular when such systems operate as components of products. consistently with the objectives of union harmonisation legislation to facilitate the free movement of products in the internal market and to ensure that only safe and otherwise compliant products find their way into the market , it is important that the safety risks that may be generated by a product as a whole due to its digital components , including ai systems , are duly prevented and mitigated. for instance , increasingly autonomous robots , whether in the context of manufacturing or personal assistance and care should be able to safely operate and performs their functions in complex environments and always under close supervision by human intelligence , with the ability to stop any of their actions quickly , if necessary. similarly , in the health sector where the stakes for life and health are particularly high , increasingly sophisticated diagnostics systems and systems supporting human decisions should be reliable and accurate and never totally independent of human control. the extent of the adverse impact caused by the ai system on the fundamental rights protected by the charter is of particular relevance when classifying an ai system as high-risk or medium/low-risk. those rights include the right to human dignity , respect for private and family life , protection of personal data , freedom of expression and information , freedom of assembly and of association , and non-discrimination , consumer protection , workers’ rights , rights of persons with disabilities , right to an effective remedy and to a fair trial , right of defence and the presumption of innocence , right to good administration. in addition to those rights , it is important to highlight that children have specific rights as enshrined in article 24 of the eu charter and in the united nations convention on the rights of the child (further elaborated in the uncrc general comment no. 25 as regards the digital environment) , both of which require consideration of the children’s vulnerabilities and provision of such protection and care as necessary for their well-being. the fundamental right to a high level of environmental protection enshrined in the charter and implemented in union policies should also be considered when assessing the severity of the harm that an ai system can cause , including in relation to the health and safety of persons.


### (36) ai systems used in employment , workers management and access to self-employment , notably for the recruitment and selection of persons , for making decisions on promotion and termination and for task allocation , monitoring or evaluation of persons in work-related contractual relationships , should also be classified as high-risk , since those systems may appreciably impact future career prospects and livelihoods of these persons. relevant work-related contractual relationships should involve employees and persons providing services through platforms as referred to in the commission work programme 2021. such persons should in principle not be considered users within the meaning of this regulation. throughout the recruitment process and in the evaluation , promotion , or retention of persons in work-related contractual relationships , such systems may perpetuate historical patterns of discrimination , for example against women , certain age groups , persons with disabilities , or persons of certain racial or ethnic origins or sexual orientation. ai systems used to monitor the performance and behaviour of these persons may also impact their rights to data protection and privacy. ### (36) ai systems used in employment , employment support , workers management and access to self-employment , notably for the recruitment and selection of persons , for making decisions on promotion and termination and for task allocation , monitoring or evaluation of persons in work-related contractual relationships , should also be classified as high-risk , since those systems may appreciably impact future career prospects and livelihoods of these persons. relevant work-related contractual relationships should involve employees and persons providing services through platforms as referred to in the commission work programme 2021. such persons should in principle not be considered users within the meaning of this regulation. throughout the recruitment process and in the evaluation , promotion , or retention of persons in work-related contractual relationships , such systems may perpetuate historical patterns of discrimination , for example against women , certain age groups , persons with disabilities , or persons of certain racial or ethnic origins or sexual orientation. ai systems used to monitor the performance and behaviour of these persons may also impact their rights to data protection and privacy.


### (38) actions by law enforcement authorities involving certain uses of ai systems are characterised by a significant degree of power imbalance and may lead to surveillance , arrest or deprivation of a natural person’s liberty as well as other adverse impacts on fundamental rights guaranteed in the charter. in particular , if the ai system is not trained with high quality data , does not meet adequate requirements in terms of its accuracy or robustness , or is not properly designed and tested before being put on the market or otherwise put into service , it may single out people in a discriminatory or otherwise incorrect or unjust manner. furthermore , the exercise of important procedural fundamental rights , such as the right to an effective remedy and to a fair trial as well as the right of defence and the presumption of innocence , could be hampered , in particular , where such ai systems are not sufficiently transparent , explainable and documented. it is therefore appropriate to classify as high-risk a number of ai systems intended to be used in the law enforcement context where accuracy , reliability and transparency is particularly important to avoid adverse impacts , retain public trust and ensure accountability and effective redress. in view of the nature of the activities in question and the risks relating thereto , those high-risk ai systems should include in particular ai systems intended to be used by law enforcement authorities for individual risk assessments , polygraphs and similar tools or to detect the emotional state of natural person , to detect ‘deep fakes’ , for the evaluation of the reliability of evidence in criminal proceedings , for predicting the occurrence or reoccurrence of an actual or potential criminal offence based on profiling of natural persons , or assessing personality traits and characteristics or past criminal behaviour of natural persons or groups , for profiling in the course of detection , investigation or prosecution of criminal offences , as well as for crime analytics regarding natural persons. ai systems specifically intended to be used for administrative proceedings by tax and customs authorities should not be considered high-risk ai systems used by law enforcement authorities for the purposes of prevention , detection , investigation and prosecution of criminal offences. ### (38) actions by law enforcement authorities involving certain uses of ai systems are characterised by a significant degree of power imbalance and may lead to surveillance , arrest or deprivation of a natural person’s liberty as well as other adverse impacts on fundamental rights guaranteed in the charter. in particular , if the ai system is not trained with high quality data , does not meet adequate requirements in terms of its accuracy or robustness , or is not properly designed and tested before being put on the market or otherwise put into service , it may single out people in a discriminatory or otherwise incorrect or unjust manner. furthermore , the exercise of important procedural fundamental rights , such as the right to an effective remedy and to a fair trial as well as the right of defence and the presumption of innocence , could be hampered , in particular , where such ai systems are not sufficiently transparent , explainable and documented. it is therefore appropriate to classify as high-risk a number of ai systems intended to be used in the law enforcement context where accuracy , reliability and transparency is particularly important to avoid adverse impacts , retain public trust and ensure accountability and effective redress. in view of the nature of the activities in question and the risks relating thereto , those high-risk ai systems should include in particular ai systems intended to be used by law enforcement authorities for individual risk assessments , polygraphs and similar tools or to detect the emotional state of natural person , to detect ‘deep fakes’ , for the evaluation of the reliability of evidence in criminal proceedings , for predicting the occurrence or reoccurrence of an actual or potential criminal offence based on profiling of natural persons , or assessing personality traits and characteristics or past criminal behaviour of natural persons or groups , for profiling in the course of detection , investigation or prosecution of criminal offences , as well as for crime analytics regarding natural persons.


### (70) certain ai systems intended to interact with natural persons or to generate content may pose specific risks of impersonation or deception irrespective of whether they qualify as high-risk or not. in certain circumstances , the use of these systems should therefore be subject to specific transparency obligations without prejudice to the requirements and obligations for high-risk ai systems. in particular , natural persons should be notified that they are interacting with an ai system , unless this is obvious from the circumstances and the context of use. moreover , natural persons should be notified when they are exposed to an emotion recognition system or a biometric categorisation system. such information and notifications should be provided in accessible formats for persons with disabilities. further , users , who use an ai system to generate or manipulate image , audio or video content that appreciably resembles existing persons , places or events and would falsely appear to a person to be authentic , should disclose that the content has been artificially created or manipulated by labelling the artificial intelligence output accordingly and disclosing its artificial origin. ### (70) certain ai systems intended to interact with natural persons or to generate content may pose specific risks of impersonation or deception irrespective of whether they qualify as high-risk or not. the use of these systems should therefore be subject to specific transparency obligations without prejudice to the requirements and obligations for high-risk ai systems. in particular , natural persons should be notified that they are interacting with an ai system. moreover , natural persons should be notified when they are exposed to an emotion recognition system or a biometric categorisation system. such information and notifications should be provided in accessible formats for persons with disabilities. further , users , who use an ai system to generate or manipulate image , audio or video content that appreciably resembles existing persons , places or events and would falsely appear to a person to be authentic , should disclose that the content has been artificially created or manipulated by labelling the artificial intelligence output accordingly and disclosing its artificial origin.


### (70) certain ai systems intended to interact with natural persons or to generate content may pose specific risks of impersonation or deception irrespective of whether they qualify as high-risk or not. in certain circumstances , the use of these systems should therefore be subject to specific transparency obligations without prejudice to the requirements and obligations for high-risk ai systems. in particular , natural persons should be notified that they are interacting with an ai system , unless this is obvious from the circumstances and the context of use. moreover , natural persons should be notified when they are exposed to an emotion recognition system or a biometric categorisation system. such information and notifications should be provided in accessible formats for persons with disabilities. further , users , who use an ai system to generate or manipulate image , audio or video content that appreciably resembles existing persons , places or events and would falsely appear to a person to be authentic , should disclose that the content has been artificially created or manipulated by labelling the artificial intelligence output accordingly and disclosing its artificial origin. ### (70) certain ai systems intended to interact with natural persons or to generate content may pose specific risks of impersonation or deception irrespective of whether they qualify as high-risk or not. in certain circumstances , the use of these systems should therefore be subject to specific transparency obligations without prejudice to the requirements and obligations for high-risk ai systems. in particular , natural persons should be notified that they are interacting with an ai system. moreover , natural persons should be notified when they are exposed to an emotion recognition system or a biometric categorisation system. such information and notifications should be provided in accessible formats for persons with disabilities. further , users , who use an ai system to generate or manipulate image , audio or video content that appreciably resembles existing persons , places or events and would falsely appear to a person to be authentic , should disclose that the content has been artificially created or manipulated by labelling the artificial intelligence output accordingly and disclosing its artificial origin.


### (81) the development of ai systems other than high-risk ai systems in accordance with the requirements of this regulation may lead to a larger uptake of trustworthy artificial intelligence in the union. providers of non-high-risk ai systems should be encouraged to create codes of conduct intended to foster the voluntary application of the mandatory requirements applicable to high-risk ai systems. providers should also be encouraged to apply on a voluntary basis additional requirements related , for example , to environmental sustainability , accessibility to persons with disability , stakeholders’ participation in the design and development of ai systems , and diversity of the development teams. the commission may develop initiatives , including of a sectorial nature , to facilitate the lowering of technical barriers hindering cross-border exchange of data for ai development , including on data access infrastructure , semantic and technical interoperability of different types of data. ### (81) the development of ai systems other than high-risk ai systems in accordance with the requirements of this regulation may lead to a larger uptake of trustworthy artificial intelligence in the union. providers of non-high-risk ai systems should nonetheless create codes of conduct intended to foster the application of the requirements applicable to high-risk ai systems. providers should also be encouraged to apply additional requirements related , for example , to environmental sustainability , accessibility to persons with disability , stakeholders’ participation in the design and development of ai systems , and diversity of the development teams. the commission may develop initiatives , including of a sectorial nature , to facilitate the lowering of technical barriers hindering cross-border exchange of data for ai development , including on data access infrastructure , semantic and technical interoperability of different types of data.


### (85) in order to ensure that the regulatory framework can be adapted where necessary , the power to adopt acts in accordance with article 290 tfeu should be delegated to the commission to amend the techniques and approaches referred to in annex i to define ai systems , the union harmonisation legislation listed in annex ii , the high-risk ai systems listed in annex iii , the provisions regarding technical documentation listed in annex iv , the content of the eu declaration of conformity in annex v , the provisions regarding the conformity assessment procedures in annex vi and vii and the provisions establishing the high-risk ai systems to which the conformity assessment procedure based on assessment of the quality management system and assessment of the technical documentation should apply. it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement of 13 april 2016 on better law-making58. in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents at the same time as member states’ experts , and their experts systematically have access to meetings of commission expert groups dealing with the preparation of delegated acts. ### (85) in order to ensure that the regulatory framework can be adapted where necessary , the power to adopt acts in accordance with article 290 tfeu should be delegated to the commission to amend the techniques and approaches referred to in annex i to define ai systems , the union harmonisation legislation listed in annex ii , the high-risk ai systems listed in annex iii , the provisions regarding technical documentation listed in annex iv , the content of the eu declaration of conformity in annex v , the provisions regarding the conformity assessment procedures in annex vi and vii and the provisions establishing the high-risk ai systems to which the conformity assessment procedure based on assessment of the quality management system and assessment of the technical documentation should apply. it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at the level of experts from different areas of society such as education , media and culture and from trade unions and consumer and data protection organisations , in accordance with the principles laid down in the interinstitutional agreement of 13 april 2016 on better law-making58. in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents at the same time as member states’ experts , and their experts systematically have access to meetings of commission expert groups dealing with the preparation of delegated acts.


### (39) ‘publicly accessible space’ means any physical place accessible to the public , regardless of whether certain conditions for access may apply; ### (39) ‘publicly accessible space’ means any physical or virtual place accessible to the public , regardless of whether certain conditions for access may apply and regardless of form of ownership;


### the placing on the market , putting into service or use of ai systems by public authorities or on their behalf for the evaluation or classification of the trustworthiness of natural persons over a certain period of time based on their social behaviour or known or predicted personal or personality characteristics , with the social score leading to either or both of the following: ### the placing on the market , putting into service or use of ai systems for the evaluation or classification of the trustworthiness of natural persons over a certain period of time based on their social behaviour or known or predicted personal or personality characteristics , with the social score leading to either or both of the following:


### the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement , unless and in as far as such use is strictly necessary for one of the following objectives: ### the use of remote biometric identification systems in publicly accessible spaces;


### the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement , unless and in as far as such use is strictly necessary for one of the following objectives: ### the putting into service or use of biometric or biometrics-based identification systems that allow the comprehensive or large-scale surveillance of natural persons in any context. , including surveillance in the workplace.


### in addition , 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 comply with necessary and proportionate safeguards and conditions in relation to the use , in particular as regards the temporal , geographic and personal limitations. ### 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. ### 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.


### 4. a member state may decide to provide for the possibility to fully or partially authorise the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement within the limits and under the conditions listed in paragraphs 1 , point (d) , 2 and 3. that member state shall lay down in its national law the necessary detailed rules for the request , issuance and exercise of , as well as supervision relating to , the authorisations referred to in paragraph 3. those rules shall also specify in respect of which of the objectives listed in paragraph 1 , point (d) , including which of the criminal offences referred to in point (iii) thereof , the competent authorities may be authorised to use those systems for the purpose of law enforcement. ### deleted


### 1. high-risk ai systems shall be designed and developed with capabilities enabling the automatic recording of events (‘logs’) while the high-risk ai system is operating. those logging capabilities shall conform to recognised standards or common specifications. ### 1. high-risk ai systems shall be designed and developed with capabilities offering the technical possibility of automatically recording events (‘logs’) while the high-risk ai system is operating. those logging capabilities shall conform to recognised standards or common specifications.


### 1. high-risk ai systems shall be designed and developed in such a way that they achieve , in the light of their intended purpose , an appropriate level of accuracy , robustness and cybersecurity , and perform consistently in those respects throughout their lifecycle. ### 1. all high-risk ai systems shall be designed and developed in such a way that they achieve , in the light of their intended purpose , an appropriate level of accuracy , robustness and cybersecurity , and perform consistently in those respects throughout their lifecycle.


### providers of high-risk ai systems shall , upon request by a national competent authority , provide that authority with all the information and documentation necessary to demonstrate the conformity of the high-risk ai system with the requirements set out in chapter 2 of this title , in an official union language determined by the member state concerned. upon a reasoned request from a national competent authority , providers shall also give that authority access to the logs automatically generated by the high-risk ai system , to the extent such logs are under their control by virtue of a contractual arrangement with the user or otherwise by law. ### all providers of ai systems , especially high-risk systems , shall , upon request by a national competent authority , provide that authority with all the information and documentation necessary to demonstrate the conformity of the ai system with the requirements set out in chapter 2 of this title , in an official union language determined by the member state concerned. upon a reasoned request from a national competent authority , providers shall also give that authority access to the logs automatically generated by the ai system , to the extent such logs are under their control by virtue of a contractual arrangement with the user or otherwise by law.


### 2. users of an emotion recognition system or a biometric categorisation system shall inform of the operation of the system the natural persons exposed thereto. this obligation shall not apply to ai systems used for biometric categorisation , which are permitted by law to detect , prevent and investigate criminal offences. ### 2. users of an emotion recognition system or a biometric categorisation system shall inform of the operation of the system the natural persons exposed thereto.


### however , the first subparagraph shall not apply where the use is authorised by law to detect , prevent , investigate and prosecute criminal offences or it is necessary for the exercise of the right to freedom of expression and the right to freedom of the arts and sciences guaranteed in the charter of fundamental rights of the eu , and subject to appropriate safeguards for the rights and freedoms of third parties. ### deleted


### 4. employment , workers management and access to self-employment: ### 4. employment and employment support , workers management and access to self-employment:


### ai systems intended to be used to evaluate the creditworthiness of natural persons or establish their credit score , with the exception of ai systems put into service by small scale providers for their own use; ### ai systems intended to be used to evaluate the creditworthiness of natural persons , establish their credit score , or predict human medical conditions and health-related outcomes


### ai systems intended to be used to evaluate the creditworthiness of natural persons or establish their credit score , with the exception of ai systems put into service by small scale providers for their own use; ### ai systems intended to be used to evaluate the creditworthiness of natural persons , establish their credit score , or predict medical human conditions and health-related outcomes , with the exception of ai systems put into service by small scale providers for their own use;


### (34) ‘emotion recognition system’ means an ai system for the purpose of identifying or inferring emotions or intentions of natural persons on the basis of their biometric data; ### (34) ‘emotion recognition system’ means an ai system for the purpose of identifying or inferring emotions , thoughts , memories , intentions , or other mental states of natural persons on the basis of their biometric or biometrics-based data;


### (34) ‘emotion recognition system’ means an ai system for the purpose of identifying or inferring emotions or intentions of natural persons on the basis of their biometric data; ### (34) ‘emotion recognition system’ means an ai system for the purpose of identifying or inferring emotions , thoughts , or intentions of natural persons on the basis of their biometric or biometrics-based data;


### 2. the following infringements shall be subject to administrative fines of up to 500 000 eur: ### 2. the following infringements shall be subject to administrative fines of up to 1 000 000 eur:


### 3. the non-compliance of the ai system with any requirements or obligations under this regulation , other than those laid down in articles 5 and 10 , shall be subject to administrative fines of up to 250 000 eur. ### 3. the non-compliance of the ai system with any requirements or obligations under this regulation , other than those laid down in articles 5 and 10 , shall be subject to administrative fines of up to 500 000 eur.


### 1. this regulation shall not apply to the ai systems which are components of the large-scale it systems established by the legal acts listed in annex ix that have been placed on the market or put into service before [12 months after the date of application of this regulation referred to in article 85(2)] , unless the replacement or amendment of those legal acts leads to a significant change in the design or intended purpose of the ai system or ai systems concerned. ### 1. this regulation shall not apply to the ai systems which are components of the large-scale it systems established by the legal acts listed in annex ix that have been placed on the market or put into service before [3 months after the date of application of this regulation referred to in article 85(2)] , unless the replacement or amendment of those legal acts leads to a significant change in the design or intended purpose of the ai system or ai systems concerned.


### (42) to mitigate the risks from high-risk ai systems placed or otherwise put into service on the union market for users and affected persons , certain mandatory requirements should apply , taking into account the intended purpose of the use of the system and according to the risk management system to be established by the provider. ### (42) to eliminate the risks from high-risk ai systems placed or otherwise put into service on the union market for users and affected persons , the use of these systems must be prohibited , and only systems known to be medium/low-risk must be permitted to be placed on the market , applying to the latter certain mandatory requirements , taking into account the intended purpose of the use of the system and according to the risk management system to be established by the provider.


### (12) this regulation should also apply to union institutions , offices , bodies and agencies when acting as a provider or user of an ai system. ai systems exclusively developed or used for military purposes should be excluded from the scope of this regulation where that use falls under the exclusive remit of the common foreign and security policy regulated under title v of the treaty on the european union (teu). this regulation should be without prejudice to the provisions regarding the liability of intermediary service providers set out in directive 2000/31/ec of the european parliament and of the council [as amended by the digital services act]. ### (12) this regulation should also apply to union institutions , offices , bodies and agencies when acting as a provider or user of an ai system. ai systems exclusively developed or used for military purposes should also be included in the scope of this regulation. this regulation should be without prejudice to the provisions regarding the liability of intermediary service providers set out in directive 2000/31/ec of the european parliament and of the council [as amended by the digital services act].


### 5. importers shall provide national competent authorities , upon a reasoned request , with all necessary information and documentation to demonstrate the conformity of a high-risk ai system with the requirements set out in chapter 2 of this title in a language which can be easily understood by that national competent authority , including access to the logs automatically generated by the high-risk ai system to the extent such logs are under the control of the provider by virtue of a contractual arrangement with the user or otherwise by law. they shall also cooperate with those authorities on any action national competent authority takes in relation to that system. ### 5. importers shall provide national competent authorities , upon a reasoned request , with all necessary information and documentation to demonstrate the conformity of an ai system with the requirements set out in chapter 2 of this title in a language which can be easily understood by that national competent authority , including access to the logs automatically generated by the ai system to the extent such logs are under the control of the provider by virtue of a contractual arrangement with the user or otherwise by law. they shall also cooperate with those authorities on any action national competent authority takes in relation to that system.


### 2. where a distributor considers or has reason to consider that a high-risk ai system is not in conformity with the requirements set out in chapter 2 of this title , it shall not make the high-risk ai system available on the market until that system has been brought into conformity with those requirements. furthermore , where the system presents a risk within the meaning of article 65(1) , the distributor shall inform the provider or the importer of the system , as applicable , to that effect. ### 2. where a distributor considers or has reason to consider that an ai system is not in conformity with the requirements set out in chapter 2 of this title , it shall not make the ai system available on the market until that system has been brought into conformity with those requirements. furthermore , where the system presents a risk within the meaning of article 65(1) , the distributor shall inform the provider or the importer of the system , as applicable , to that effect.


### 4. a distributor that considers or has reason to consider that a high-risk ai system which it has made available on the market is not in conformity with the requirements set out in chapter 2 of this title shall take the corrective actions necessary to bring that system into conformity with those requirements , to withdraw it or recall it or shall ensure that the provider , the importer or any relevant operator , as appropriate , takes those corrective actions. where the high-risk ai system presents a risk within the meaning of article 65(1) , the distributor shall immediately inform the national competent authorities of the member states in which it has made the product available to that effect , giving details , in particular , of the non-compliance and of any corrective actions taken. ### 4. a distributor that considers or has reason to consider that an ai system which it has made available on the market is not in conformity with the requirements set out in chapter 2 of this title shall take the corrective actions necessary to bring that system into conformity with those requirements , to withdraw it or recall it or shall ensure that the provider , the importer or any relevant operator , as appropriate , takes those corrective actions. where the ai system presents a risk within the meaning of article 65(1) , the distributor shall immediately inform the national competent authorities of the member states in which it has made the product available to that effect , giving details , in particular , of the non-compliance and of any corrective actions taken.


### 1. member states shall undertake the following actions: ### 1. member states may undertake the following actions:


### 2. the specific interests and needs of the small-scale providers shall be taken into account when setting the fees for conformity assessment under article 43 , reducing those fees proportionately to their size and market size. ### 2. the specific interests and needs of the sme providers in relation to their size , annual turnover or similar indicator shall be taken into account when setting the fees for conformity assessment under article 43 , reducing those fees proportionately to their size and market size.


### collect and share expertise and best practices among member states; ### collect and share technical and regulatory expertise and best practices among member states;


### 1. providers shall establish and document a post-market monitoring system in a manner that is proportionate to the nature of the artificial intelligence technologies and the risks of the high-risk ai system. ### 1. providers shall establish and document a post-market monitoring system in a manner that is proportionate to the nature of the artificial intelligence technologies and the risks of the ai system.


### 1. providers of high-risk ai systems placed on the union market shall report any serious incident or any malfunctioning of those systems which constitutes a breach of obligations under union law intended to protect fundamental rights to the market surveillance authorities of the member states where that incident or breach occurred. ### 1. providers of ai systems placed on the union market shall report any serious incident or any malfunctioning of those systems which constitutes a breach of obligations under union law intended to protect fundamental rights to the market surveillance authorities of the member states where that incident or breach occurred.


### (68) under certain conditions , rapid availability of innovative technologies may be crucial for health and safety of persons and for society as a whole. it is thus appropriate that under exceptional reasons of public security or protection of life and health of natural persons and the protection of industrial and commercial property , member states could authorise the placing on the market or putting into service of ai systems which have not undergone a conformity assessment. ### deleted


### providers of high-risk ai systems which consider or have reason to consider that a high-risk ai system which they have placed on the market or put into service is not in conformity with this regulation shall immediately take the necessary corrective actions to bring that system into conformity , to withdraw it or to recall it , as appropriate. they shall inform the distributors of the high-risk ai system in question and , where applicable , the authorised representative and importers accordingly. ### all providers of ai systems , and high-risk systems in particular , which consider or have reason to consider that an ai system which they have placed on the market or put into service is not in conformity with this regulation shall immediately take the necessary corrective actions to bring that system into conformity , to withdraw it or to recall it , as appropriate. they shall inform the distributors of the ai system in question and , where applicable , the authorised representative and importers accordingly.


### 4. participants in the ai regulatory sandbox shall remain liable under applicable union and member states liability legislation for any harm inflicted on third parties as a result from the experimentation taking place in the sandbox. ### deleted


### 1. high-risk ai systems shall be designed and developed in such a way , including with appropriate human-machine interface tools , that they can be effectively overseen by natural persons during the period in which the ai system is in use. ### 1. high-risk ai systems shall be designed and developed in such a way , including with appropriate human-machine interface tools , that they can be effectively overseen by natural persons during the whole lifecycle of the ai system. ai systems shall not be used to substitute , but rather to complement human decision-making. all ai systems shall be explainable by design.


### 1. high-risk ai systems shall be designed and developed in such a way , including with appropriate human-machine interface tools , that they can be effectively overseen by natural persons during the period in which the ai system is in use. ### 1. high-risk ai systems shall be designed and developed in such a way , including with appropriate human-machine interface tools , that they can always be effectively overseen by natural persons during the period in which the ai system is in use.


### the technical solutions aimed at ensuring the cybersecurity of high-risk ai systems shall be appropriate to the relevant circumstances and the risks. ### the technical solutions aimed at ensuring the cybersecurity of all ai systems shall be appropriate to the relevant circumstances and the risks.


### the technical solutions to address ai specific vulnerabilities shall include , where appropriate , measures to prevent and control for attacks trying to manipulate the training dataset (‘data poisoning’) , inputs designed to cause the model to make a mistake (‘adversarial examples’) , or model flaws. ### the technical solutions to address ai specific vulnerabilities shall include , where appropriate , measures to prevent and control for attacks trying to manipulate the training dataset (‘data poisoning’) , inputs designed to cause the model to make a mistake (‘adversarial examples’) , or model flaws which could lead to harmful decision-making.


### the technical solutions to address ai specific vulnerabilities shall include , where appropriate , measures to prevent and control for attacks trying to manipulate the training dataset (‘data poisoning’) , inputs designed to cause the model to make a mistake (‘adversarial examples’) , or model flaws. ### the technical solutions to address ai specific vulnerabilities shall include , where appropriate , measures to prevent and control for every possible attack , including attacks trying to manipulate the training dataset (‘data poisoning’) , inputs designed to cause the model to make a mistake (‘adversarial examples’) , or model flaws.


### when under their control , keep the logs automatically generated by their high-risk ai systems; ### when under their control , keep the logs automatically generated by their ai systems;


### 1. providers of high-risk ai systems shall keep the logs automatically generated by their high-risk ai systems , to the extent such logs are under their control by virtue of a contractual arrangement with the user or otherwise by law. the logs shall be kept for a period that is appropriate in the light of the intended purpose of the high-risk ai system and applicable legal obligations under union or national law. ### 1. providers of ai systems shall keep the logs automatically generated by their ai systems , to the extent such logs are under their control by virtue of a contractual arrangement with the user or otherwise by law. the logs shall be kept for a period that is appropriate in the light of the intended purpose of the ai system and applicable legal obligations under union or national law.


### 2. providers that are credit institutions regulated by directive 2013/36/eu shall maintain the logs automatically generated by their high-risk ai systems as part of the documentation under article 74 of that directive. ### 2. providers that are credit institutions regulated by directive 2013/36/eu shall maintain the logs automatically generated by their ai systems as part of the documentation under article 74 of that directive.


### where the high-risk ai system presents a risk within the meaning of article 65(1) and that risk is known to the provider of the system , that provider shall immediately inform the national competent authorities of the member states in which it made the system available and , where applicable , the notified body that issued a certificate for the high-risk ai system , in particular of the non-compliance and of any corrective actions taken. ### where the ai system presents a risk within the meaning of article 65(1) and that risk is known to the provider of the system , that provider shall immediately inform the national competent authorities of the member states in which it made the system available and , where applicable , the notified body that issued a certificate for the ai system , in particular of the non-compliance and of any corrective actions taken.