### (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 prohibit some 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 , prohibited 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 , 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 , and for profiling in the course of detection , investigation or prosecution of criminal offences. ai systems specifically intended to be used for administrative proceedings by tax and customs authorities should not be included in such a ban.


### (39) ai systems used in migration , asylum and border control management affect people who are often in particularly vulnerable position and who are dependent on the outcome of the actions of the competent public authorities. the accuracy , non-discriminatory nature and transparency of the ai systems used in those contexts are therefore particularly important to guarantee the respect of the fundamental rights of the affected persons , notably their rights to free movement , non-discrimination , protection of private life and personal data , international protection and good administration. it is therefore appropriate to classify as high-risk ai systems intended to be used by the competent public authorities charged with tasks in the fields of migration , asylum and border control management as polygraphs and similar tools or to detect the emotional state of a natural person; for assessing certain risks posed by natural persons entering the territory of a member state or applying for visa or asylum; for verifying the authenticity of the relevant documents of natural persons; for assisting competent public authorities for the examination of applications for asylum , visa and residence permits and associated complaints with regard to the objective to establish the eligibility of the natural persons applying for a status. ai systems in the area of migration , asylum and border control management covered by this regulation should comply with the relevant procedural requirements set by the directive 2013/32/eu of the european parliament and of the council49 , the regulation (ec) no 810/2009 of the european parliament and of the council50 and other relevant legislation. ### (39) ai systems used in migration , asylum and border control management affect people who are often in particularly vulnerable position and who are dependent on the outcome of the actions of the competent public authorities. the accuracy , non-discriminatory nature and transparency of the ai systems used in those contexts are therefore particularly important to guarantee the respect of the fundamental rights of the affected persons , notably their rights to free movement , non-discrimination , protection of private life and personal data , international protection and good administration. it is therefore appropriate to prohibit ai systems intended to be used by the competent public authorities charged with tasks in the fields of migration , asylum and border control management as polygraphs and similar tools or to detect the emotional state of a natural person; and for assessing certain risks posed by natural persons entering the territory of a member state or applying for visa or asylum. other ai systems in the area of migration , asylum and border control management covered by this regulation should comply with the relevant procedural requirements set by the directive 2013/32/eu of the european parliament and of the council49 , the regulation (ec) no 810/2009 of the european parliament and of the council50 and other relevant legislation.


### (40) certain ai systems intended for the administration of justice and democratic processes should be classified as high-risk , considering their potentially significant impact on democracy , rule of law , individual freedoms as well as the right to an effective remedy and to a fair trial. in particular , to address the risks of potential biases , errors and opacity , it is appropriate to qualify as high-risk ai systems intended to assist judicial authorities in researching and interpreting facts and the law and in applying the law to a concrete set of facts. such qualification should not extend , however , to ai systems intended for purely ancillary administrative activities that do not affect the actual administration of justice in individual cases , such as anonymisation or pseudonymisation of judicial decisions , documents or data , communication between personnel , administrative tasks or allocation of resources. ### (40) certain ai systems intended for the administration of justice and democratic processes should be classified as high-risk , considering their potentially significant impact on democracy , rule of law , individual freedoms as well as the right to an effective remedy and to a fair trial. in particular , to address the risks of potential biases , errors and opacity , it is appropriate to qualify as high-risk ai systems intended to assist judicial authorities in interpreting facts or the law for applying the law to a concrete set of facts. such qualification should not extend , however , to ai systems intended for purely ancillary administrative activities that do not affect the actual administration of justice in individual cases , such as anonymisation or pseudonymisation of judicial decisions , documents or data , communication between personnel , administrative tasks or allocation of resources.


### harmonised transparency rules for ai systems intended to interact with natural persons , emotion recognition systems and biometric categorisation systems , and ai systems used to generate or manipulate image , audio or video content; ### harmonised transparency rules for certain ai systems;


### the placing on the market , putting into service or use of an ai system that exploits any of the vulnerabilities of a specific group of persons due to their age , physical or mental disability , in order to materially distort the behaviour of a person pertaining to that group in a manner that causes or is likely to cause that person or another person physical or psychological harm; ### the placing on the market , putting into service or use of an ai system that exploits any of the vulnerabilities of a person or a specific group of persons due to their known or predicted personality or social or economic situation or due to their age , physical or mental capacity , in order to materially distort the behaviour of a person pertaining to that group in a manner that causes or is likely to cause that person or another person physical or psychological harm;


### the placing on the market , putting into service or use of an ai system that exploits any of the vulnerabilities of a specific group of persons due to their age , physical or mental disability , in order to materially distort the behaviour of a person pertaining to that group in a manner that causes or is likely to cause that person or another person physical or psychological harm; ### the placing on the market , putting into service or use of an ai system that exploits any of the vulnerabilities of a specific group of persons due to their age , physical or mental disability , sex , race , colour , ethnic or social origin , genetic features , language , religion or belief , political or any other opinion , membership of a national minority , property , birth , or sexual orientation , in order to materially distort the behaviour of a person pertaining to that group.


### 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 by public authorities , educational institutions 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 and emotional behaviour or known or predicted personal or personality characteristics , with the social score leading to either or all of the following:


### 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 calculation or establishment of a 'social score' resulting from the evaluation or classification of natural persons based on their physical attributes , social behaviour or known or predicted personal or personality characteristics.


### 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 by public authorities or on their behalf for the evaluation or classification of natural persons over an extended period of time based on their social behaviour or known or predicted personal or personality characteristics (social scoring) ,with the social score leading to either of the following:


### 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 ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement.


### 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. ### however , the first subparagraph shall not apply where 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.


### contribute to uniform administrative practices in the member states , including for the functioning of regulatory sandboxes referred to in article 53; ### contribute to uniform practices in the member states , including by assisting member states , the commission , and , where applicable , other authorities in the establishment , development , and functioning of regulatory sandboxes referred to in article 53 , including by providing input and support in drafting the delegated acts referred to in article 53(6);


### contribute to uniform administrative practices in the member states , including for the functioning of regulatory sandboxes referred to in article 53; ### contribute to uniform administrative practices in the member states , including for the assessment , establishing , managing with the meaning of fostering cooperation and guaranteeing consistency among regulatory sandboxes , and functioning of regulatory sandboxes referred to in article 53 , article54 and annex ixa;


### 1. the commission and the member states shall encourage and facilitate the drawing up of codes of conduct intended to foster the voluntary application to ai systems other than high-risk ai systems of the requirements set out in title iii , chapter 2 on the basis of technical specifications and solutions that are appropriate means of ensuring compliance with such requirements in light of the intended purpose of the systems. ### 1. the commission , ai office , and the member states shall encourage and facilitate the drawing up of codes of conduct intended to foster the development and use of safe and trustworthy ai for ai systems other than high-risk ai systems. these codes of conduct should be voluntary and should be based on the requirements set out in title iii , chapter 2 on the basis of technical specifications and solutions that are appropriate means of ensuring compliance with such requirements but be adapted in light of the intended purpose of the systems and of the lower risk involved


### 1. the commission and the member states shall encourage and facilitate the drawing up of codes of conduct intended to foster the voluntary application to ai systems other than high-risk ai systems of the requirements set out in title iii , chapter 2 on the basis of technical specifications and solutions that are appropriate means of ensuring compliance with such requirements in light of the intended purpose of the systems. ### 1. the commission and the board shall encourage and facilitate the drawing up of codes of conduct intended to foster the voluntary application to ai systems other than high-risk ai systems of the requirements set out in title iii , chapter 2 on the basis of technical specifications and solutions that are appropriate means of ensuring compliance with such requirements in light of the intended purpose of the systems.


### 2. the commission and the board shall encourage and facilitate the drawing up of codes of conduct intended to foster the voluntary application to ai systems of requirements related for example to environmental sustainability , accessibility for persons with a disability , stakeholders participation in the design and development of the ai systems and diversity of development teams on the basis of clear objectives and key performance indicators to measure the achievement of those objectives. ### 2. the commission and the ai office shall encourage and facilitate the drawing up of codes of conduct intended to foster the voluntary application to ai systems of requirements related for example to environmental sustainability , accessibility for persons with a disability , stakeholders participation in the design and development of the ai systems and diversity of development teams on the basis of clear objectives and key performance indicators to measure the achievement of those objectives.


### 1. in compliance with the terms and conditions laid down in this regulation , member states shall lay down the rules on penalties , including administrative fines , applicable to infringements of this regulation and shall take all measures necessary to ensure that they are properly and effectively implemented. the penalties provided for shall be effective , proportionate , and dissuasive. they shall take into particular account the interests of small-scale providers and start-up and their economic viability. ### 1. in compliance with the terms and conditions laid down in this regulation , member states shall lay down the rules on penalties , including administrative fines , applicable to infringements of this regulation and shall take all measures necessary to ensure that they are properly and effectively implemented. the penalties provided for shall be effective , proportionate , and dissuasive. they shall take into particular account the interests and size of small-scale providers and start-ups and their economic viability.


### 1. in compliance with the terms and conditions laid down in this regulation , member states shall lay down the rules on penalties , including administrative fines , applicable to infringements of this regulation and shall take all measures necessary to ensure that they are properly and effectively implemented. the penalties provided for shall be effective , proportionate , and dissuasive. they shall take into particular account the interests of small-scale providers and start-up and their economic viability. ### 1. in compliance with the terms and conditions laid down in this regulation , member states shall lay down the rules on penalties , including administrative fines , applicable to infringements of this regulation and shall take all measures necessary to ensure that they are properly and effectively implemented. the penalties provided for shall be effective , proportionate , and dissuasive. they shall take into particular account the size and interests of smes and start-ups and their economic viability


### the size and market share of the operator committing the infringement; ### the size , the annual turnover and market share of the operator committing the infringement;


### 1. biometric identification and categorisation of natural persons: ### 1. 1.biometric and biometrics-based systems:


### ai systems intended to be used for the purpose of determining access or assigning natural persons to educational and vocational training institutions; ### deleted


### ai systems intended to be used for the purpose of assessing students in educational and vocational training institutions and for assessing participants in tests commonly required for admission to educational institutions. ### ai systems intended to be used for the purpose of assessing students in educational and vocational training institutions and for assessing participants in tests commonly required for admission to those institutions.


### ai systems intended to be used for the purpose of assessing students in educational and vocational training institutions and for assessing participants in tests commonly required for admission to educational institutions. ### deleted


### high-risk ai systems referred to in article 6(2) ### critical areas referred to in article 6(2)


### ai systems intended to be used by public authorities or on behalf of public authorities to evaluate the eligibility of natural persons for public assistance benefits and services , as well as to grant , reduce , revoke , or reclaim such benefits and services; ### deleted


### ai systems intended to be used by public authorities or on behalf of public authorities to evaluate the eligibility of natural persons for public assistance benefits and services , as well as to grant , reduce , revoke , or reclaim such benefits and services; ### ai systems intended to be used by public authorities or on behalf of public authorities to evaluate the eligibility of natural persons for public assistance benefits and services , as well as to grant , reduce , revoke , increase , or reclaim such benefits and services;


### 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 or establish their credit score , with the exception of ai systems put into service by smes and start-ups for their own use;


### 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; ### deleted


### ai systems intended to be used by law enforcement authorities for making individual risk assessments of natural persons in order to assess the risk of a natural person for offending or reoffending or the risk for potential victims of criminal offences; ### ai systems intended to be used by law enforcement authorities or on their behalf for making individual risk assessments of natural persons in order to assess the risk of a natural person for offending or reoffending or the risk for potential victims of criminal offences;


### ai systems intended to be used by law enforcement authorities for making individual risk assessments of natural persons in order to assess the risk of a natural person for offending or reoffending or the risk for potential victims of criminal offences; ### deleted


### ai systems intended to be used by law enforcement authorities as polygraphs and similar tools or to detect the emotional state of a natural person; ### deleted


### 1 subject matter ### 1 aim and subject matter


### rules on market monitoring and surveillance. ### rules on market monitoring , market surveillance and governance;


### users of ai systems located within the union; ### users of ai systems who are established within the union;


### providers and users of ai systems that are located in a third country , where the output produced by the system is used in the union; ### providers and users of ai systems who are established in a third country , where the output produced by the system is used in the union;


### regulation (ec) 300/2008; ### deleted


### regulation (eu) no 167/2013; ### deleted


### regulation (eu) no 168/2013; ### deleted


### directive 2014/90/eu; ### deleted


### directive (eu) 2016/797; ### deleted


### regulation (eu) 2018/858; ### deleted


### regulation (eu) 2018/1139; ### deleted


### regulation (eu) 2019/2144. ### deleted


### 4. this regulation shall not apply to public authorities in a third country nor to international organisations falling within the scope of this regulation pursuant to paragraph 1 , where those authorities or organisations use ai systems in the framework of international agreements for law enforcement and judicial cooperation with the union or with one or more member states. ### deleted


### 4. this regulation shall not apply to public authorities in a third country nor to international organisations falling within the scope of this regulation pursuant to paragraph 1 , where those authorities or organisations use ai systems in the framework of international agreements for law enforcement and judicial cooperation with the union or with one or more member states. ### 4. this regulation shall not apply to public authorities in a third country nor to international organisations falling within the scope of this regulation pursuant to paragraph 1 , where those authorities or organisations use ai systems in the framework of international agreements for law enforcement and judicial cooperation with the union or with one or more member states and are subject of a decision of the commission adopted in accordance with article 36 of directive (eu)2016/680 or article 45 of regulation 2016/679 (‘adequacy decision’) or are part of an international agreement concluded between the union and that third country or international organisation pursuant to article 218 tfeu adducing adequate safeguards with respect to the protection of privacy and fundamental rights and freedoms of individuals;


### (3) ‘small-scale provider’ means a provider that is a micro or small enterprise within the meaning of commission recommendation 2003/361/ec61 ; ### deleted


### (23) ‘substantial modification’ means a change to the ai system following its placing on the market or putting into service which affects the compliance of the ai system with the requirements set out in title iii , chapter 2 of this regulation or results in a modification to the intended purpose for which the ai system has been assessed; ### (23) ‘substantial modification’ means a change to the ai system following its placing on the market or putting into service , which is not foreseen or planned by the provider and as a result of which the compliance of the ai system with the requirements set out in title iii , chapter 2 of this regulation is affected or which results in a modification to the intended purpose for which the ai system has been assessed. a substantial modification is given if the remaining risk is increased by the modification of the ai system under the application of all necessary protective measures;


### (24) ‘ce marking of conformity’ (ce marking) means a marking by which a provider indicates that an ai system is in conformity with the requirements set out in title iii , chapter 2 of this regulation and other applicable union legislation harmonising the conditions for the marketing of products (‘union harmonisation legislation’) providing for its affixing; ### (24) ‘ce marking of conformity’ (ce marking) means a physical or digital marking by which a provider indicates that an ai system or a product with an embedded ai system is in conformity with the requirements set out in title iii , chapter 2 of this regulation and other applicable union legislation harmonising the conditions for the marketing of products (‘union harmonisation legislation’) providing for its affixing;


### (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 capable of identifying , categorizing or inferring emotions , thoughts , states of mind (such as 'deception' , 'trustworthiness' , or 'trustfulness') or intentions of natural persons on the basis of their biometric data;


### 6. the information referred to in paragraph 5 shall include all available details , in particular the data necessary for the identification of the non-compliant ai system , the origin of the ai system , the nature of the non-compliance alleged and the risk involved , the nature and duration of the national measures taken and the arguments put forward by the relevant operator. in particular , the market surveillance authorities shall indicate whether the non-compliance is due to one or more of the following: ### 6. the notification referred to in paragraph 5 shall include all available details , in particular the information necessary for the identification of the non-compliant ai system , the origin of the ai system , the nature of the non-compliance alleged and the risk involved , the nature and duration of the national measures taken and the arguments put forward by the relevant operator. in particular , the market surveillance authorities shall indicate whether the non-compliance is due to one or more of the following:


### a failure of the ai system to meet requirements set out in title iii , chapter 2; ### a failure of the high-risk ai system to meet requirements set out in title iii , chapter 2;


### 8. where , within three months of receipt of the information referred to in paragraph 5 , no objection has been raised by either a member state or the commission in respect of a provisional measure taken by a member state , that measure shall be deemed justified. this is without prejudice to the procedural rights of the concerned operator in accordance with article 18 of regulation (eu) 2019/1020. ### 8. where , within three months of receipt of the notification referred to in paragraph 5 , no objection has been raised by either a member state or the commission in respect of a provisional measure taken by a member state , that measure shall be deemed justified. this is without prejudice to the procedural rights of the concerned operator in accordance with article 18 of regulation (eu) 2019/1020. the period referred to in the first sentence of this paragraph shall be reduced to 30 days in the case of non-compliance with the prohibition of the artificial intelligence practices referred to in article 5.


### 9. the market surveillance authorities of all member states shall ensure that appropriate restrictive measures are taken in respect of the product concerned , such as withdrawal of the product from their market , without delay. ### 9. the market surveillance authorities of all member states shall ensure that appropriate restrictive measures are taken in respect of the ai system concerned , such as withdrawal of the product from their market , without delay.


### 1. where , within three months of receipt of the notification referred to in article 65(5) , objections are raised by a member state against a measure taken by another member state , or where the commission considers the measure to be contrary to union law , the commission shall without delay enter into consultation with the relevant member state and operator or operators and shall evaluate the national measure. on the basis of the results of that evaluation , the commission shall decide whether the national measure is justified or not within 9 months from the notification referred to in article 65(5) and notify such decision to the member state concerned. ### 1. where , within three months of receipt of the notification referred to in article 65(5) , or 30 days in the case of non-compliance with the prohibition of the artificial intelligence practices referred to in article 5 , objections are raised by a member state against a measure taken by another member state , or where the commission considers the measure to be contrary to union law , the commission shall without delay enter into consultation with the relevant member state’s market surveillance authority and operator or operators and shall evaluate the national measure. on the basis of the results of that evaluation , the commission shall decide whether the national measure is justified or not within 9 months , or 60 days in the case of non-compliance with the prohibition of the artificial intelligence practices referred to in article 5 , starting from the notification referred to in article 65(5) and notify such decision to the member state concerned. the commission shall also inform all other member states of such decision.


### 3. the member state shall immediately inform the commission and the other member states. that information shall include all available details , in particular the data necessary for the identification of the ai system concerned , the origin and the supply chain of the ai system , the nature of the risk involved and the nature and duration of the national measures taken. ### 3. the member state shall immediately inform the commission , the ai office , and the other member states. that information shall include all available details , in particular the data necessary for the identification of the ai system concerned , the origin and the supply chain of the ai system , the nature of the risk involved and the nature and duration of the national measures taken.


### 4. the commission shall without delay enter into consultation with the member states and the relevant operator and shall evaluate the national measures taken. on the basis of the results of that evaluation , the commission shall decide whether the measure is justified or not and , where necessary , propose appropriate measures. ### 4. the commission shall without delay enter into consultation with the member states concerned and the relevant operator and shall evaluate the national measures taken. on the basis of the results of that evaluation , the commission shall decide whether the measure is justified or not and , where necessary , propose appropriate measures.


### 5. the commission shall address its decision to the member states. ### 5. the commission shall address its decision to the member states concerned , and inform all other member states.


### 2. where the non-compliance referred to in paragraph 1 persists , the member state concerned shall take all appropriate measures to restrict or prohibit the high-risk ai system being made available on the market or ensure that it is recalled or withdrawn from the market. ### 2. where the non-compliance referred to in paragraph 1 persists , the member state concerned shall take all appropriate and proportionate measures to restrict or prohibit the high-risk ai system being made available on the market or ensure that it is recalled or withdrawn from the market.


### 4. the commission and the board shall take into account the specific interests and needs of the small-scale providers and start-ups when encouraging and facilitating the drawing up of codes of conduct. ### 4. the commission and the ai office shall take into account the specific interests and needs of the small-scale providers and start-ups when encouraging and facilitating the drawing up of codes of conduct.


### 4. the commission and the board shall take into account the specific interests and needs of the small-scale providers and start-ups when encouraging and facilitating the drawing up of codes of conduct. ### 4. the commission and the board shall take into account the specific interests and needs of smes and start-ups when encouraging and facilitating the drawing up of codes of conduct.


### 2. the member states shall notify the commission of those rules and of those measures and shall notify it , without delay , of any subsequent amendment affecting them. ### 2. the member states shall without delay notify the commission of those rules and of those measures and of any subsequent amendment affecting them.


### 3. the following infringements shall be subject to administrative fines of up to 30 000 000 eur or , if the offender is company , up to 6 % of its total worldwide annual turnover for the preceding financial year , whichever is higher: ### 3. non-compliance with the prohibition of the artificial intelligence practices referred to in article 5 shall be subject to administrative fines of up to 20 000 000 eur or , if the offender is a company , up to 4 % of its total worldwide annual turnover for the preceding financial year , and in case of smes and start-ups , up to 3% of its worldwide annual turnover for the preceding financial year , whichever is higher.


### 3. the following infringements shall be subject to administrative fines of up to 30 000 000 eur or , if the offender is company , up to 6 % of its total worldwide annual turnover for the preceding financial year , whichever is higher: ### 3. non-compliance with the prohibition of the artificial intelligence practices referred to in article 5 shall be subject to administrative fines of up to 30 000 000 eur or , if the offender is a company , up to 6 % of its total worldwide annual turnover for the preceding financial year , whichever is higher;


### non-compliance with the prohibition of the artificial intelligence practices referred to in article 5; ### deleted


### non-compliance of the ai system with the requirements laid down in article 10. ### deleted


### 4. 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 20 000 000 eur or , if the offender is a company , up to 4 % of its total worldwide annual turnover for the preceding financial year , whichever is higher. ### 4. the grossly negligent non-compliance by the provider or the user of the ais ystem with any requirements or obligations under this regulation , other than those laid down in article 5 , shall be subject to administrative fines of up to 10 000 000 eur or , if the offender is a company , up to 2 % of its total worldwide annual turnover for the preceding financial year , whichever is higher.


### 4. 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 20 000 000 eur or , if the offender is a company , up to 4 % of its total worldwide annual turnover for the preceding financial year , whichever is higher. ### 4. 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 10 000 000 eur or , if the offender is a company , up to 2 % of its total worldwide annual turnover for the preceding financial year , whichever is higher.


### whether administrative fines have been already applied by other market surveillance authorities to the same operator for the same infringement. ### whether administrative fines have been already applied by other market surveillance authorities of one or more member states to the same operator for the same infringement.


### 7. each member state shall lay down rules on whether and to what extent administrative fines may be imposed on public authorities and bodies established in that member state. ### 7. each member state shall lay down rules on administrative fines to be imposed on public authorities and bodies established in that member state , with a view to ensure compliance with this regulation.


### 2. the following infringements shall be subject to administrative fines of up to 500 000 eur: ### 2. non-compliance with the prohibition of the artificial intelligence practices referred to in article 5 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 300 000 eur.


### 2. the delegation of power referred to in article 4 , article 7(1) , article 11(3) , article 43(5) and (6) and article 48(5) shall be conferred on the commission for an indeterminate period of time from [entering into force of the regulation]. ### 2. the delegation of power referred to in article 4 , article 5a(1) , article 7(1) , article 11(3) , article 43(5) and (6) and article 48(5) shall be conferred on the commission for an indeterminate period of time from [entering into force of the regulation].


### 3. the delegation of power referred to in article 4 , article 7(1) , article 11(3) , article 43(5) and (6) and article 48(5) may be revoked at any time by the european parliament or by the council. a decision of revocation shall put an end to the delegation of power specified in that decision. it shall take effect the day following that of its publication in the official journal of the european union or at a later date specified therein. it shall not affect the validity of any delegated acts already in force. ### 3. the delegation of power referred to in article 4 , article 5a(1) , article 7(1) , article 11(3) , article 43(5) and (6) and article 48(5) may be revoked at any time by the european parliament or by the council. a decision of revocation shall put an end to the delegation of power specified in that decision. it shall take effect the day following that of its publication in the official journal of the european union or at a later date specified therein. it shall not affect the validity of any delegated acts already in force.


### 4. as soon as it adopts a delegated act , the commission shall notify it simultaneously to the european parliament and to the council. ### 4. as soon as it adopts a delegated act , the commission shall notify it simultaneously to the european parliament , the council , and the ai office.


### 5. any delegated act adopted pursuant to article 4 , article 7(1) , article 11(3) , article 43(5) and (6) and article 48(5) shall enter into force only if no objection has been expressed by either the european parliament or the council within a period of three months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object. that period shall be extended by three months at the initiative of the european parliament or of the council. ### 5. any delegated act adopted pursuant to article 4 , article 5a(1) , article 7(1) , article 11(3) , article 43(5) and (6) and article 48(5) shall enter into force only if no objection has been expressed by either the european parliament or the council within a period of three months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object. that period shall be extended by three months at the initiative of the european parliament or of the council.


### 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 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 , with a transitional period of two years after the entry into force of this regulation.


### 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. operators of 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 [the date of application of this regulation referred to in article 85(2)] shall take the necessary steps to comply with the requirements of the present regulation within 4 years of its entry into force.


### (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 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. these requirements should be objective-driven , fit to purpose , reasonable and effective , without adding undue regulatory burdens or costs on operators.


### (56) to enable enforcement of this regulation and create a level-playing field for operators , and taking into account the different forms of making available of digital products , it is important to ensure that , under all circumstances , a person established in the union can provide authorities with all the necessary information on the compliance of an ai system. therefore , prior to making their ai systems available in the union , where an importer cannot be identified , providers established outside the union shall , by written mandate , appoint an authorised representative established in the union. ### (56) to enable enforcement of this regulation and create a level-playing field for operators , and taking into account the different forms of making available of digital products , it is important to ensure that , under all circumstances , a person established in the union can provide authorities with all the necessary information on the compliance of an ai system. therefore , prior to making their ai systems available in the union , providers established outside the union shall , by written mandate , appoint an authorised representative established in the union.


### estimation and evaluation of the risks that may emerge when the high-risk ai system is used in accordance with its intended purpose and under conditions of reasonably foreseeable misuse; ### deleted


### adoption of suitable risk management measures in accordance with the provisions of the following paragraphs. ### adoption of appropriate and targeted risk management measures to address identified significant risks in accordance with the provisions of the following paragraphs.


### (11) in light of their digital nature , certain ai systems should fall within the scope of this regulation even when they are neither placed on the market , nor put into service , nor used in the union. this is the case for example of an operator established in the union that contracts certain services to an operator established outside the union in relation to an activity to be performed by an ai system that would qualify as high-risk and whose effects impact natural persons located in the union. in those circumstances , the ai system used by the operator outside the union could process data lawfully collected in and transferred from the union , and provide to the contracting operator in the union the output of that ai system resulting from that processing , without that ai system being placed on the market , put into service or used in the union. to prevent the circumvention of this regulation and to ensure an effective protection of natural persons located in the union , this regulation should also apply to providers and users of ai systems that are established in a third country , to the extent the output produced by those systems is used in the union. nonetheless , to take into account existing arrangements and special needs for cooperation with foreign partners with whom information and evidence is exchanged , this regulation should not apply to public authorities of a third country and international organisations when acting in the framework of international agreements concluded at national or european level for law enforcement and judicial cooperation with the union or with its member states. such agreements have been concluded bilaterally between member states and third countries or between the european union , europol and other eu agencies and third countries and international organisations. ### (11) in light of their digital nature , certain ai systems should fall within the scope of this regulation even when they are neither placed on the market , nor put into service , nor used in the union. this is the case for example of an operator established in the union that contracts certain services to an operator established outside the union in relation to an activity to be performed by an ai system that would qualify as high-risk and whose effects impact natural persons located in the union. in those circumstances , the ai system used by the operator outside the union could process data lawfully collected in and transferred from the union , and provide to the contracting operator in the union the output of that ai system resulting from that processing , without that ai system being placed on the market , put into service or used in the union. to prevent the circumvention of this regulation and to ensure an effective protection of natural persons located in the union , this regulation should also apply to providers and users of ai systems that are established in a third country , to the extent the output produced by those systems is used in the union. nonetheless , to take into account existing arrangements and special needs for cooperation with foreign partners with whom information and evidence is exchanged , this regulation should not apply to public authorities of a third country and international organisations when acting in the framework of international agreements concluded at national or european level for law enforcement and judicial cooperation with the union or with its member states. such agreements have been concluded bilaterally between member states and third countries or between the european union , europol and other eu agencies and third countries and international organisations. this exception should nevertheless be limited to trusted countries and international organizations that share the union’s values.


### 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 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 well as the market surveillance authorities , as applicable , to that effect.


### 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 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 market surveillance authority and 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 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 provider or the importer of the system as well as 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.


### 5. upon a reasoned request from a national competent authority , distributors of high-risk ai systems shall provide that authority with all the information and documentation necessary to demonstrate the conformity of a high-risk system with the requirements set out in chapter 2 of this title. distributors shall also cooperate with that national competent authority on any action taken by that authority. ### 5. upon a reasoned request from a national competent authority , distributors of high-risk ai systems shall provide that authority with all the information and documentation regarding its activities pursuant to paragraphs 1 to 4.


### 5. upon a reasoned request from a national competent authority , distributors of high-risk ai systems shall provide that authority with all the information and documentation necessary to demonstrate the conformity of a high-risk system with the requirements set out in chapter 2 of this title. distributors shall also cooperate with that national competent authority on any action taken by that authority. ### 5. upon a reasoned request from a national competent authority , distributors of high-risk ai systems shall provide that authority with all the information and documentation in its possession or available to it , in accordance with the obligations of distributors as outlined by this regulation , that are necessary to demonstrate the conformity of a high-risk system with the requirements set out in chapter 2 of this title. distributors shall also cooperate with that national competent authority on any action taken by that authority.


### article 28 ### deleted


### 3. without prejudice to paragraph 1 , to the extent the user exercises control over the input data , that user shall ensure that input data is relevant in view of the intended purpose of the high-risk ai system. ### 3. without prejudice to paragraph 1 , to the extent the user exercises control over the input data , that user shall ensure that input data is relevant in view of the intended purpose of the high-risk ai system. to the extent the user exercises control over the high-risk ai system , that user shall also ensure that relevant and appropriate robustness and cybersecurity measures are in place and are regularly adjusted or updated.


### 4. users shall monitor the operation of the high-risk ai system on the basis of the instructions of use. when they have reasons to consider that the use in accordance with the instructions of use may result in the ai system presenting a risk within the meaning of article 65(1) they shall inform the provider or distributor and suspend the use of the system. they shall also inform the provider or distributor when they have identified any serious incident or any malfunctioning within the meaning of article 62 and interrupt the use of the ai system. in case the user is not able to reach the provider , article 62 shall apply mutatis mutandis. ### 4. users shall monitor the operation of the high-risk ai system on the basis of the instructions of use and , when relevant , inform providers in accordance with article 61. to the extent the user exercises control over the high-risk ai system , the user shall also establish a risk management system in line with article 9 but limited to the potential adverse effects of using the high-risk ai system , the respective mitigation measures. when they have reasons to consider that the use in accordance with the instructions of use may result in the ai system presenting a risk within the meaning of article 65(1) they shall inform the provider or distributor and suspend the use of the system. they shall also inform the provider or distributor when they have identified any serious incident or any malfunctioning within the meaning of article 62 and interrupt the use of the ai system. in case the user is not able to reach the provider , article 62 shall apply mutatis mutandis.


### 5. users of high-risk ai systems shall keep the logs automatically generated by that high-risk ai system , to the extent such logs are under their control. 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. ### 5. users of high-risk ai systems shall keep the logs automatically generated by that high-risk ai system , to the extent such logs are under their control. the logs shall be kept for a period that is appropriate in the light of industry standards , the intended purpose of the high-risk ai system and applicable legal obligations under union or national law.


### a short summary of the ai project developed in the sandbox , its objectives and expected results published on the website of the competent authorities. ### a short summary of the ai project developed in the sandbox , its objectives , hypotheses and expected results , and non-confidential testing results , is published on the website of the competent authorities.


### 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 smes and start-ups 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 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 smes and start-ups 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 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 , including start-ups , shall be taken into account when setting the fees for conformity assessment under article 43 , reducing those fees proportionately to their development stage , size and market size.


### 1 european artificial intelligence board ### 1 european artificial intelligence office


### establishment of the european artificial intelligence board ### establishment of the european artificial intelligence office


### 1. a ‘european artificial intelligence board’ (the ‘board’) is established. ### deleted


### 1. a ‘european artificial intelligence board’ (the ‘board’) is established. ### 1. a ‘european artificial intelligence board’ (the ‘board’) is established as a body of the union and shall have legal personality.


### 2. the board shall provide advice and assistance to the commission in order to: ### deleted


### 2. the board shall provide advice and assistance to the commission in order to: ### 2. the board shall provide advice and assistance to the commission and to the national supervisory authorities in order to:


### coordinate and contribute to guidance and analysis by the commission and the national supervisory authorities and other competent authorities on emerging issues across the internal market with regard to matters covered by this regulation; ### coordinate and provide guidance and analysis by the commission and the national supervisory authorities and other competent authorities on emerging issues across the internal market with regard to matters covered by this regulation;


### assist the national supervisory authorities and the commission in ensuring the consistent application of this regulation. ### contribute to the effective and consistent application of this regulation and assist the national supervisory authorities and the commission in that regard.


### article 57 ### deleted


### tasks of the board ### tasks


### when providing advice and assistance to the commission in the context of article 56(2) , the board shall in particular: ### when providing advice and assistance to the commission and to the national supervisory authorities in the context of article 56(2) , the board shall in particular:


### when providing advice and assistance to the commission in the context of article 56(2) , the board shall in particular: ### in fulfilling its objectives , the ai office shall in particular:


### issue opinions , recommendations or written contributions on matters related to the implementation of this regulation , in particular ### issue opinions , recommendations , written contributions , or studies on matters related to the technical specifications or existing standards regarding the requirements set out in title iii , chapter 2 and on the use of harmonised standards or common specifications referred to in articles 40and 41;


### on technical specifications or existing standards regarding the requirements set out in title iii , chapter 2 , ### deleted


### (ii) on the use of harmonised standards or common specifications referred to in articles 40 and 41 , ### deleted


### (iii) on the preparation of guidance documents , including the guidelines concerning the setting of administrative fines referred to in article 71. ### deleted


### 5. member states shall report to the commission on an annual basis on the status of the financial and human resources of the national competent authorities with an assessment of their adequacy. the commission shall transmit that information to the board for discussion and possible recommendations. ### 5. member states shall report to the commission on an annual basis on the status of the financial and human resources of the national competent authorities with an assessment of their adequacy. the commission shall transmit that information to the ai office for discussion and possible recommendations.


### 6. the commission shall facilitate the exchange of experience between national competent authorities. ### 6. the commission and the board shall facilitate the exchange of experience between national competent authorities.


### 8. when union institutions , agencies and bodies fall within the scope of this regulation , the european data protection supervisor shall act as the competent authority for their supervision. ### 8. when union institutions , agencies and bodies fall within the scope of this regulation , the european data protection supervisor shall act as the competent authority for their supervision and coordination.


### 1. the commission shall , in collaboration with the member states , set up and maintain a eu database containing information referred to in paragraph 2 concerning high-risk ai systems referred to in article 6(2) which are registered in accordance with article 51. ### 1. the commission shall , in collaboration with the member states , set up and maintain a eu database containing information referred to in paragraph 2 concerning high-risk ai systems in one of the areas listed in annex iii which are registered in accordance with article 51 and their uses by public authorities and union institutions , bodies , offices or agencies or on their behalf.


### 3. the post-market monitoring system shall be based on a post-market monitoring plan. the post-market monitoring plan shall be part of the technical documentation referred to in annex iv. the commission shall adopt an implementing act laying down detailed provisions establishing a template for the post-market monitoring plan and the list of elements to be included in the plan. ### 3. the post-market monitoring system shall be based on a post-market monitoring plan. the post-market monitoring plan shall be part of the technical documentation referred to in annex iv. the commission shall adopt an implementing act laying down detailed provisions establishing a template for the post-market monitoring plan and the list of elements to be included in the plan by ... [12 months following the entry into force of this regulation].


### 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 and , where applicable , users 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.


### such notification shall be made immediately after the provider has established a causal link between the ai system and the incident or malfunctioning or the reasonable likelihood of such a link , and , in any event , not later than 15 days after the providers becomes aware of the serious incident or of the malfunctioning. ### such notification shall be made without undue delay after the provider has established a causal link between the ai system and the incident or malfunctioning or the reasonable likelihood of such a link , and , in any event , not later than 72 hours after the providers becomes aware of the serious incident or of the malfunctioning.


### 2. the national supervisory authority shall report to the commission on a regular basis the outcomes of relevant market surveillance activities. the national supervisory authority shall report , without delay , to the commission and relevant national competition authorities any information identified in the course of market surveillance activities that may be of potential interest for the application of union law on competition rules. ### 2. the national supervisory authority shall report annually to the commission the outcomes of relevant market surveillance activities. the national supervisory authority shall report , without delay , to the commission and relevant national competition authorities any information identified in the course of market surveillance activities that may be of potential interest for the application of union law on competition rules.


### 3. national public authorities or bodies which supervise or enforce the respect of obligations under union law protecting fundamental rights in relation to the use of high-risk ai systems referred to in annex iii shall have the power to request and access any documentation created or maintained under this regulation when access to that documentation is necessary for the fulfilment of the competences under their mandate within the limits of their jurisdiction. the relevant public authority or body shall inform the market surveillance authority of the member state concerned of any such request. ### 3. national public authorities or bodies which supervise or enforce the respect of obligations under union law protecting fundamental rights in relation to the use of high-risk ai systems referred to in annex iii shall have the power to request and access any documentation created or maintained under this regulation , including data protection impact assessments and human rights impact assessments carried out by the users of such systems , when access to that documentation is necessary for the fulfilment of the competences under their mandate within the limits of their jurisdiction. the relevant public authority or body shall inform the market surveillance authority of the member state concerned of any such request.


### 2. where the market surveillance authority of a member state has sufficient reasons to consider that an ai system presents a risk as referred to in paragraph 1 , they shall carry out an evaluation of the ai system concerned in respect of its compliance with all the requirements and obligations laid down in this regulation. when risks to the protection of fundamental rights are present , the market surveillance authority shall also inform the relevant national public authorities or bodies referred to in article 64(3). the relevant operators shall cooperate as necessary with the market surveillance authorities and the other national public authorities or bodies referred to in article 64(3). ### 2. where the market surveillance authority of a member state has sufficient reasons to consider that an ai system presents a risk as referred to in paragraph 1 , they shall carry out an evaluation of the ai system concerned in respect of its compliance with all the requirements and obligations laid down in this regulation. when risks to the protection of fundamental rights are present , the market surveillance authority shall also inform the relevant national public authorities or bodies referred to in article 64(3). where there is sufficient reason to consider that that an ai system exploits the vulnerabilities of children or violates their rights intentionally or unintentionally , the market surveillance authority shall have the duty to investigate the design goals , data inputs , model selection , implementation and outcomes of the ai system and the burden of proof shall be on the operator or operators of that system to demonstrate compliance with the provisions of this regulation. the relevant operators shall cooperate as necessary with the market surveillance authorities and the other national public authorities or bodies referred to in article 64(3) , including by providing access to personnel , documents , internal communications , code , data samples and on platform testing as necessary. where , in the course of its evaluation , the market surveillance authority finds that the ai system does not comply with the requirements and obligations laid down in this regulation , it shall without delay require the relevant operator to take all appropriate corrective actions to bring the ai system into compliance , to withdraw the ai system from the market , or to recall it within a reasonable period , commensurate with the nature of the risk , as it may prescribe. the corrective action can also be applied to ai systems in other products or services judged to be similar in their objectives , design or impact.


### 2. where the market surveillance authority of a member state has sufficient reasons to consider that an ai system presents a risk as referred to in paragraph 1 , they shall carry out an evaluation of the ai system concerned in respect of its compliance with all the requirements and obligations laid down in this regulation. when risks to the protection of fundamental rights are present , the market surveillance authority shall also inform the relevant national public authorities or bodies referred to in article 64(3). the relevant operators shall cooperate as necessary with the market surveillance authorities and the other national public authorities or bodies referred to in article 64(3). ### 2. where the market surveillance authority of a member state has sufficient reasons to consider that an ai system presents a risk as referred to in paragraph 1 , they shall carry out an evaluation of the ai system concerned in respect of its compliance with all the requirements and obligations laid down in this regulation. when risks to fundamental rights are present , the market surveillance authority shall also inform the relevant national public authorities or bodies referred to in article 64(3). the relevant operators shall cooperate as necessary with the market surveillance authorities and the other national public authorities or bodies referred to in article 64(3).


### 3. where the market surveillance authority considers that non-compliance is not restricted to its national territory , it shall inform the commission and the other member states of the results of the evaluation and of the actions which it has required the operator to take. ### 3. where the market surveillance authority considers that non-compliance is not restricted to its national territory , it shall inform the commission and the other member states without undue delay of the results of the evaluation and of the actions which it has required the operator to take.


### 3. where the market surveillance authority considers that non-compliance is not restricted to its national territory , it shall inform the commission and the other member states of the results of the evaluation and of the actions which it has required the operator to take. ### 3. where the market surveillance authority considers that non-compliance is not restricted to its national territory , it shall inform the commission , the ai office and the other member states of the results of the evaluation and of the actions which it has required the operator to take.


### 5. where the operator of an ai system does not take adequate corrective action within the period referred to in paragraph 2 , the market surveillance authority shall take all appropriate provisional measures to prohibit or restrict the ai system's being made available on its national market , to withdraw the product from that market or to recall it. that authority shall inform the commission and the other member states , without delay , of those measures. ### 5. where the operator of an ai system does not take adequate corrective action within the period referred to in paragraph 2 , the market surveillance authority shall take all appropriate provisional measures to prohibit or restrict the ai system's being made available on its national market , to withdraw the product from that market or to recall it. that authority shall notify the commission and the other member states , without delay , of those measures.


### machine learning approaches , including supervised , unsupervised and reinforcement learning , using a wide variety of methods including deep learning; ### machine learning approaches , including supervised , unsupervised , reinforcement learning and computational scientific discovery , using a wide variety of methods including deep learning;


### ai systems intended to be used by law enforcement authorities for predicting the occurrence or reoccurrence of an actual or potential criminal offence based on profiling of natural persons as referred to in article 3(4) of directive (eu) 2016/680 or assessing personality traits and characteristics or past criminal behaviour of natural persons or groups; ### deleted


### ai systems intended to be used by law enforcement authorities for profiling of natural persons as referred to in article 3(4) of directive (eu) 2016/680 in the course of detection , investigation or prosecution of criminal offences; ### deleted


### ai systems intended to be used by competent public authorities as polygraphs and similar tools or to detect the emotional state of a natural person; ### deleted


### ai systems intended to be used by competent public authorities to assess a risk , including a security risk , a risk of irregular immigration , or a health risk , posed by a natural person who intends to enter or has entered into the territory of a member state; ### deleted


### ai systems intended to assist competent public authorities for the examination of applications for asylum , visa and residence permits and associated complaints with regard to the eligibility of the natural persons applying for a status. ### deleted


### 2. the levels of accuracy and the relevant accuracy metrics of high-risk ai systems shall be declared in the accompanying instructions of use. ### 2. the levels of accuracy and the relevant accuracy metrics of high-risk ai systems shall be declared in the accompanying instructions of use. european artificial intelligence board shall define a common methodology for the definition and communication of these metrics also referred to in article 9(7).


### the robustness of high-risk ai systems may be achieved through technical redundancy solutions , which may include backup or fail-safe plans. ### the robustness of high-risk ai systems may be achieved through technical redundancy solutions , which may include backup or fail-safe plans by the provider , or where appropriate the users of the product with input from the user , where considered necessary.


### 1. taking into account their intended purpose , high-risk ai systems that have been trained and tested on data concerning the specific geographical , behavioural and functional setting within which they are intended to be used shall be presumed to be in compliance with the requirement set out in article 10(4). ### 1. taking into account their intended purpose and based on the risk evaluation , high-risk ai systems that have been trained and tested on data concerning the specific geographical , behavioural and functional setting within which they are intended to be used shall be presumed to be in compliance with the requirement set out in article 10(4).


### (4) digitalisation is changing the world of work , improving productivity and enhancing flexibility , while also carrying some risks for employment and working conditions. algorithm-based technologies , including automated monitoring and decision-making systems , have enabled the emergence and growth of digital labour platforms. ### (4) digitalisation is changing the world of work , improving productivity and enhancing flexibility , creating new employment and business opportunities , particularly in the context of the covid-19 pandemic , as well as increasing consumers’ choice while also potentially carrying some risks for employment and working conditions. algorithm-based technologies , including automated monitoring and decision-making systems , have enabled the emergence and growth of digital labour platforms.


### (6) platform work can provide opportunities for accessing the labour market more easily , gaining additional income through a secondary activity or enjoying some flexibility in the organisation of working time. at the same time , platform work brings challenges , as it can blur the boundaries between employment relationship and self-employed activity , and the responsibilities of employers and workers. misclassification of the employment status has consequences for the persons affected , as it is likely to restrict access to existing labour and social rights. it also leads to an uneven playing field with respect to businesses that classify their workers correctly , and it has implications for member states’ industrial relations systems , their tax base and the coverage and sustainability of their social protection systems. while such challenges are broader than platform work , they are particularly acute and pressing in the platform economy. ### (6) platform work can provide opportunities for accessing the labour market more easily , gaining additional income through a secondary activity or enjoying some flexibility in the organisation of working time. in this regard , platform economy has become an integral and rapidly growing part of the european transport and tourism sectors , providing new business models , talent and work opportunities. at the same time , platform work brings challenges , as it can blur the boundaries between employment relationship and self-employed activity , and the responsibilities of employers and workers. misclassification of the employment status has consequences for the persons affected , as it is likely to restrict access to existing labour and social rights. it also leads to an uneven playing field with respect to businesses that classify their workers correctly , and it has implications for member states’ industrial relations systems , their tax base and the coverage and sustainability of their social protection systems. while such challenges are broader than platform work , they are particularly acute and pressing in the platform economy.


### (17) this directive should apply to all digital labour platforms , irrespective of their place of establishment and irrespective of the law otherwise applicable , provided that the platform work organised through that digital labour platform is performed in the union. a targeted set of mandatory rules should be established at union level to ensure minimum rights on working conditions in platform work. ### (17) this directive should apply to all digital labour platforms , irrespective of their place of establishment and irrespective of the law otherwise applicable , provided that the platform work organised through that digital labour platform is performed in the union. a targeted set of mandatory rules should be established at union level to ensure minimum rights on working conditions in platform work while ensuring legal certainty and predictability for the most concerned sectors , such as in the fields of transport and tourism .


### (24) when digital labour platforms control certain elements of the performance of work , they act like employers in an employment relationship. direction and control , or legal subordination , is an essential element of the definition of an employment relationship in the member states and in the case-law of the court of justice. therefore contractual relationships in which digital labour platforms exert a certain level of control over certain elements of the performance of work should be deemed , by virtue of a legal presumption , to be an employment relationship between the platform and the person performing platform work through it. as a result , that person should be classified as a worker having all the rights and obligations in accordance with that status , as laid down in national and union law , collective agreements and practice. the legal presumption should apply in all relevant administrative and legal proceedings and should benefit the person performing platform work. authorities in charge of verifying the compliance with or enforcing relevant legislation , such as labour inspectorates , social protection bodies or tax authorities , should also be able to rely on that presumption. member states should put in place a national framework to reduce litigation and increase legal certainty. ### (24) when digital labour platforms control certain elements of the performance of work , they act like employers in an employment relationship. direction and control , or legal subordination , is an essential element of the definition of an employment relationship in the member states and in the case-law of the court of justice. therefore contractual relationships in which digital labour platforms exert a certain level of control over certain elements of the performance of work should be deemed , by virtue of a legal presumption , to be an employment relationship between the platform and the person performing platform work through it. as a result , that person should be classified as a worker having all the rights and obligations in accordance with that status , as laid down in national and union law , collective agreements and practice. the legal presumption should apply in all relevant administrative and legal proceedings and should benefit the person performing platform work. authorities in charge of verifying the compliance with or enforcing relevant legislation , such as labour inspectorates , social protection bodies or tax authorities , should also be able to rely on that presumption. member states should put in place a national framework to reduce litigation and increase legal certainty. in this regards , national frameworks should take into account the opportunities provided by the collaborative services and platforms in the transport and tourism sectors. furthermore , the national framework should foresee the necessary autonomy and flexibility for these sectors.


### 1. the purpose of this directive is to improve the working conditions of persons performing platform work by ensuring correct determination of their employment status , by promoting transparency , fairness and accountability in algorithmic management in platform work and by improving transparency in platform work , including in cross-border situations , while supporting the conditions for the sustainable growth of digital labour platforms in the union. ### 1. the purpose of this directive is to improve the working conditions of persons performing platform work by ensuring correct determination of their employment status , by promoting transparency , fairness and accountability in algorithmic management in platform work and by improving transparency in platform work , including in cross-border situations , while supporting the conditions for the sustainable growth of digital labour platforms in the union , maintaining their development , autonomy and flexibility and providing legal certainty.


### 1. the contractual relationship between a digital labour platform that controls , within the meaning of paragraph 2 , the performance of work and a person performing platform work through that platform shall be legally presumed to be an employment relationship. to that effect , member states shall establish a framework of measures , in accordance with their national legal and judicial systems. ### 1. the contractual relationship between a digital labour platform that controls , within the meaning of paragraph 2 , the performance of work and a person performing platform work through that platform shall be legally presumed to be an employment relationship. to that effect , member states shall establish a framework of measures , in accordance with their national legal and judicial systems , in order to ensure that the legal presumption can be relied upon by competent authorities verifying compliance with or enforcing relevant legislation as well as persons performing platform work who dispute the classification of their employment status.


### the legal presumption shall apply in all relevant administrative and legal proceedings. competent authorities verifying compliance with or enforcing relevant legislation shall be able to rely on that presumption. ### the legal presumption shall apply in all relevant administrative and legal proceedings.


### 2. controlling the performance of work within the meaning of paragraph 1 shall be understood as fulfilling at least two of the following: ### 2. controlling the performance of work within the meaning of paragraph 1 shall be understood as fulfilling a majority of the following:


### effectively determining , or setting upper limits for the level of remuneration; ### de facto determining , or setting upper limits for the level of remuneration;


### requiring the person performing platform work to respect specific binding rules with regard to appearance , conduct towards the recipient of the service or performance of the work; ### requiring the person performing platform work to respect specific binding rules with regard to appearance , conduct towards the recipient of the service or performance of the work beyond what is required by law or necessary to safeguard the health and safety of the recipients of the service or to ensure the essential functioning of the service;;


### supervising the performance of work or verifying the quality of the results of the work including by electronic means; ### closely supervising the performance of work or thoroughly verifying the quality of the results of the work including by electronic means beyond what is required by law or necessary to safeguard the health and safety of the recipients of the service or to ensure the essential functioning of the service;


### effectively restricting the freedom , including through sanctions , to organise one’s work , in particular the discretion to choose one’s working hours or periods of absence , to accept or to refuse tasks or to use subcontractors or substitutes; ### de facto effectively restricting the freedom , including through sanctions , to organise one’s work , in particular the discretion to choose one’s working hours or periods of absence , to accept or to refuse tasks , including from other digital platforms or to use subcontractors or substitutes;


### effectively restricting the possibility to build a client base or to perform work for any third party. ### de facto effectively restricting the possibility to build a client base or to perform work for any third party.


### 3. member states shall take supporting measures to ensure the effective implementation of the legal presumption referred to in paragraph 1 while taking into account the impact on start-ups , avoiding capturing the genuine self-employed and supporting the sustainable growth of digital labour platforms. in particular they shall: ### 3. member states shall take supporting measures to ensure the effective implementation of the legal presumption referred to in paragraph 1 while taking into account the impact on entrepreneurs and start-ups , avoiding capturing the genuine self-employed and supporting the conditions for innovation and the sustainable growth of digital labour platforms. in particular they shall:


### develop guidance for digital labour platforms , persons performing platform work and social partners to understand and implement the legal presumption including on the procedures for rebutting it in accordance with article 5; ### develop comprehensive guidance for digital labour platforms , persons performing platform work and social partners to understand and implement the legal presumption including on the procedures for rebutting it in accordance with article 5;


### develop guidance for enforcement authorities to proactively target and pursue non-compliant digital labour platforms; ### develop capacity building guidance , training for enforcement authorities to proactively target and pursue non-compliant digital labour platforms;


### where the digital labour platform argues that the contractual relationship in question is not an employment relationship as defined by the law , collective agreements or practice in force in the member state in question , with consideration to the case-law of the court of justice , the burden of proof shall be on the digital labour platform. such proceedings shall not have suspensive effect on the application of the legal presumption. ### where the digital labour platform argues that the contractual relationship in question is not an employment relationship as defined by the law , collective agreements or practice in force in the member state in question , with consideration to the case-law of the court of justice , the burden of proof shall be on the digital labour platform.


### where the person performing the platform work argues that the contractual relationship in question is not an employment relationship as defined by the law , collective agreements or practice in force in the member state in question , with consideration to the case-law of the court of justice , the digital labour platform shall be required to assist the proper resolution of the proceedings , notably by providing all relevant information held by it. ### where the person performing the platform work argues that the contractual relationship in question is not an employment relationship as defined by the law , collective agreements or practice in force in the member state in question , with consideration to the case-law of the court of justice , the digital labour platform shall be required to assist the proper resolution of the proceedings , by providing all relevant information held by it.


### (6) buildings account for 40 % of final energy consumption in the union and 36% of its energy-related greenhouse gas emissions . therefore , reduction of energy consumption , in line with the energy efficiency first principle as laid down in article 3 [revised eed] and defined in article 2(18) of regulation (eu) 2018/1999 of the european parliament and of the council32 and the use of energy from renewable sources in the buildings sector constitute important measures needed to reduce the union’s greenhouse gas emissions. reduced energy consumption and an increased use of energy from renewable sources also have an important part to play in reducing the union’s energy dependency , promoting security of energy supply and technological developments and in creating opportunities for employment and regional development , in particular in islands and rural areas. ### (6) buildings account for 40 % of final energy consumption in the union and 36% of its energy-related greenhouse gas emissions . therefore , reduction of energy consumption , in line with cost-efficient energy efficiency and the use of energy from renewable sources in the buildings sector constitute important measures needed to reduce the union’s greenhouse gas emissions. reduced energy consumption and an increased use of energy from renewable sources also have an important part to play in reducing the union’s energy dependency , promoting security of energy supply and technological developments and in creating opportunities for employment and regional development , in particular in islands and rural areas.


### (11) measures to improve further the energy performance of buildings should take into account climatic conditions , including adaptation to climate change , local conditions as well as indoor climate environment and cost-effectiveness. those measures should not affect other requirements concerning buildings such as accessibility , fire safety and seismic safety and the intended use of the building. ### (11) measures to improve further the energy performance of buildings should take into account climatic conditions , including adaptation to climate change , local conditions as well as indoor climate environment and cost-effectiveness. those measures should not affect other requirements concerning buildings such as accessibility , fire safety , acoustic safety and seismic safety and the intended use of the building.