### (70) certain ai systems intended to interact with natural persons or to generate content may pose specific risks of impersonation or deception irrespective of whether they qualify as high-risk or not. in certain circumstances , the use of these systems should therefore be subject to specific transparency obligations without prejudice to the requirements and obligations for high-risk ai systems. in particular , natural persons should be notified that they are interacting with an ai system , unless this is obvious from the circumstances and the context of use. moreover , natural persons should be notified when they are exposed to an emotion recognition system or a biometric categorisation system. such information and notifications should be provided in accessible formats for persons with disabilities. further , users , who use an ai system to generate or manipulate image , audio or video content that appreciably resembles existing persons , places or events and would falsely appear to a person to be authentic , should disclose that the content has been artificially created or manipulated by labelling the artificial intelligence output accordingly and disclosing its artificial origin. ### (70) certain ai systems used to interact with natural persons or to generate content may pose specific risks of impersonation or deception irrespective of whether they qualify as high-risk or not. in certain circumstances , the use of these systems should therefore be subject to specific transparency obligations without prejudice to the requirements and obligations for high-risk ai systems. in particular , natural persons should be notified that they are interacting with an ai system , unless this is obvious from the circumstances and the context of use. moreover , natural persons should be notified when they are exposed to an emotion recognition system or a biometric categorisation system. such information and notifications , which should include a disclaimer , should be provided in accessible formats for children , the elderly , migrants and persons with disabilities. further , users , who use an ai system to generate or manipulate image , audio , text , scripts or video content that appreciably resembles existing persons , places , test , scripts or events and would falsely appear to a person to be authentic , should appropriately disclose that the content has been artificially created or manipulated by labelling the artificial intelligence output accordingly and disclosing its artificial origin , namely the name of the person or entity that created it. ai systems used to recommend , disseminate and order news or cultural and creative content displayed to users , should include an explanation of the parameters used for the moderation of content and personalised suggestions which should be easily accessible and understandable to the users.


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


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


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


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


### (74) in order to minimise the risks to implementation resulting from lack of knowledge and expertise in the market as well as to facilitate compliance of providers and notified bodies with their obligations under this regulation , the ai-on demand platform , the european digital innovation hubs and the testing and experimentation facilities established by the commission and the member states at national or eu level should possibly contribute to the implementation of this regulation. within their respective mission and fields of competence , they may provide in particular technical and scientific support to providers and notified bodies. ### (74) in order to minimise the risks to implementation resulting from lack of knowledge and expertise in the market as well as to facilitate compliance of providers and notified bodies with their obligations under this regulation , the ai-on demand platform , the european digital innovation hubs and the testing and experimentation facilities established by the commission and the member states at national or eu level should possibly contribute to the implementation of this regulation. within their respective mission and fields of competence , they may provide in particular technical and scientific support to providers and notified bodies. the commission should also create a pan-european university’ and research’ networks focused on ai for enhanced studying and research on the impact of ai and to update the digital education action plan in order to integrate ai and robotics innovation in education.


### (79) in order to ensure an appropriate and effective enforcement of the requirements and obligations set out by this regulation , which is union harmonisation legislation , the system of market surveillance and compliance of products established by regulation (eu) 2019/1020 should apply in its entirety. where necessary for their mandate , national public authorities or bodies , which supervise the application of union law protecting fundamental rights , including equality bodies , should also have access to any documentation created under this regulation. ### (79) in order to ensure an appropriate and effective enforcement of the requirements and obligations set out by this regulation , which is union harmonisation legislation , the system of market surveillance and compliance of products established by regulation (eu) 2019/1020 should apply in its entirety. where necessary for their mandate , national public authorities or bodies , which supervise the application of union law protecting fundamental rights , including equality bodies , should also have access to any documentation created under this regulation. where appropriate , national authorities or bodies , which supervise the application of union law or national law compatible with union law establishing rules regulating the health , safety , security and environment at work , should also have access to any documentation created under this regulation.


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


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


### (81) the development of ai systems other than high-risk ai systems in accordance with the requirements of this regulation may lead to a larger uptake of trustworthy artificial intelligence in the union. providers of non-high-risk ai systems should be encouraged to create codes of conduct intended to foster the voluntary application of the mandatory requirements applicable to high-risk ai systems. providers should also be encouraged to apply on a voluntary basis additional requirements related , for example , to environmental sustainability , accessibility to persons with disability , stakeholders’ participation in the design and development of ai systems , and diversity of the development teams. the commission may develop initiatives , including of a sectorial nature , to facilitate the lowering of technical barriers hindering cross-border exchange of data for ai development , including on data access infrastructure , semantic and technical interoperability of different types of data. ### (81) the development of ai systems other than high-risk ai systems in accordance with the requirements of this regulation may lead to a larger uptake of trustworthy , socially responsible and environmentally sustainable artificial intelligence in the union. providers of non-high-risk ai systems should create codes of conduct intended to foster the voluntary application of the mandatory requirements applicable to high-risk ai systems. developers and deployers of all ai systems should also draw up codes of conduct in order to ensure and demonstrate compliance with the ethical principles underpinning trustworthy ai as outlined in paragraph 2 of article 4a. the commission and the european agency for data and artificial intelligence may develop initiatives , including of a sectorial nature , to facilitate the lowering of technical barriers hindering cross-border exchange of data for ai development , including on data access infrastructure , semantic and technical interoperability of different types of data.


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


### (83) in order to ensure trustful and constructive cooperation of competent authorities on union and national level , all parties involved in the application of this regulation should respect the confidentiality of information and data obtained in carrying out their tasks. ### (83) in order to ensure trustful and constructive cooperation of competent authorities on union and national level , all parties involved in the application of this regulation should respect the confidentiality of information and data obtained in carrying out their tasks. a new set of common european guidelines and standards should be set up in order to protect privacy while making an effective use of the data available.


### (83) in order to ensure trustful and constructive cooperation of competent authorities on union and national level , all parties involved in the application of this regulation should respect the confidentiality of information and data obtained in carrying out their tasks. ### (83) in order to ensure trustful and constructive cooperation of competent authorities on union and national level , all parties involved in the application of this regulation should respect the confidentiality and property of information and data obtained in carrying out their tasks.


### (85) in order to ensure that the regulatory framework can be adapted where necessary , the power to adopt acts in accordance with article 290 tfeu should be delegated to the commission to amend the techniques and approaches referred to in annex i to define ai systems , the union harmonisation legislation listed in annex ii , the high-risk ai systems listed in annex iii , the provisions regarding technical documentation listed in annex iv , the content of the eu declaration of conformity in annex v , the provisions regarding the conformity assessment procedures in annex vi and vii and the provisions establishing the high-risk ai systems to which the conformity assessment procedure based on assessment of the quality management system and assessment of the technical documentation should apply. it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement of 13 april 2016 on better law-making58 . in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents at the same time as member states’ experts , and their experts systematically have access to meetings of commission expert groups dealing with the preparation of delegated acts. ### (85) in order to ensure that the regulatory framework can be adapted where necessary , the power to adopt acts in accordance with article 290 tfeu should be delegated to the commission to amend the union harmonisation legislation listed in annex ii , the high-risk ai systems listed in annex iii , the provisions regarding technical documentation listed in annex iv , the content of the eu declaration of conformity in annex v , the provisions regarding the conformity assessment procedures in annex vi and vii ,the provisions establishing the high-risk ai systems to which the conformity assessment procedure based on assessment of the quality management system and assessment of the technical documentation should apply and the provisions setting the content and presentation of the information , the methodology procedures , the minimum standards and the efficiency scale for the energy efficiency and carbon intensity marking and the green ai label of article 49a. it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement of 13 april 2016 on better law-making[58]. in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents at the same time as member states’ experts , and their experts systematically have access to meetings of commission expert groups dealing with the preparation of delegated acts.


### harmonised rules for the placing on the market , the putting into service and the use of artificial intelligence systems (‘ai systems’) in the union; ### harmonised rules for the development , deployment and the use of artificial intelligence systems (‘ai systems’) in the union;


### harmonised rules for the placing on the market , the putting into service and the use of artificial intelligence systems (‘ai systems’) in the union; ### harmonised rules for the development , placing on the market , the putting into service and the use of artificial intelligence systems (‘ai systems’) in the union;


### 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 ai systems


### 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 ai systems;


### 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;


### (8) ‘operator’ means the provider , the user , the authorised representative , the importer and the distributor; ### (8) ‘operator’ means the developer , the deployer , the user , the authorised representative , the importer and the distributor;


### (8) ‘operator’ means the provider , the user , the authorised representative , the importer and the distributor; ### (8) ‘operator’ means the provider , the user , the legal representative , the importer and the distributor;


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


### the death of a person or serious damage to a person’s health , to property or the environment , ### the death of a person or serious damage to a person’s fundamental rights , health , to property or the environment , to democracy or the democratic rule of law ,


### 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 children , or 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 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 by undertakings whose services for people's social participation are particularly significant , 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 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 scoring , evaluation or classification of natural persons or groups related to their education , employment , housing , socioeconomic situation , health , reliability , social behaviour , location or movements;


### 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 private actors or public authorities or on their behalf for the evaluation or classification of the trustworthiness of natural persons based on their 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 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 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 , unless and in as far as such use is strictly necessary for one of the following objectives: ### the putting into service or use of biometric or biometrics-based identification systems that allow the comprehensive or large-scale surveillance of natural persons in any context. , including surveillance in the workplace.


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


### in addition , the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement for any of the objectives referred to in paragraph 1 point d) shall comply with necessary and proportionate safeguards and conditions in relation to the use , in particular as regards the temporal , geographic and personal limitations. ### in addition , the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces in order to achieve any of the objectives referred to in paragraph 1 point d) shall comply with necessary and proportionate safeguards and conditions in relation to the use , in particular as regards the temporal , geographic and personal limitations.


### in addition , the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement for any of the objectives referred to in paragraph 1 point d) shall comply with necessary and proportionate safeguards and conditions in relation to the use , in particular as regards the temporal , geographic and personal limitations. ### deleted


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


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


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


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


### 8. when implementing the risk management system described in paragraphs 1 to 7 , specific consideration shall be given to whether the high-risk ai system is likely to be accessed by or have an impact on children. ### 8. when implementing the risk management system described in paragraphs 1 to 7 , specific consideration shall be given to whether the high-risk ai system is likely to be accessed by or have an impact on children , the elderly , migrants or other vulnerable groups.


### 8. when implementing the risk management system described in paragraphs 1 to 7 , specific consideration shall be given to whether the high-risk ai system is likely to be accessed by or have an impact on children. ### 8. when implementing the risk management system described in paragraphs 1 to 7 , specific consideration shall be given to whether the high-risk ai system is likely to be accessed by or have an impact on children and people from vulnerable groups.


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


### 1. high-risk ai systems shall be designed and developed in such a way to ensure that their operation is sufficiently transparent to enable users to interpret the system’s output and use it appropriately. an appropriate type and degree of transparency shall be ensured , with a view to achieving compliance with the relevant obligations of the user and of the provider set out in chapter 3 of this title. ### 1. high-risk ai systems shall be designed and developed in such a way to ensure that their operation is sufficiently transparent to enable developers , deployers , users and other relevant stakeholders to easily interpret the system’s functioning and output and use it appropriately on the basis of informed decisions , with a view to achieving compliance with the relevant obligations set out in chapter 3 of this title


### 1. high-risk ai systems shall be designed and developed in such a way to ensure that their operation is sufficiently transparent to enable users to interpret the system’s output and use it appropriately. an appropriate type and degree of transparency shall be ensured , with a view to achieving compliance with the relevant obligations of the user and of the provider set out in chapter 3 of this title. ### 1. high-risk ai systems shall be designed and developed in such a way to ensure that their operation is sufficiently transparent to enable developers , deployers , users and other relevant stakeholders to easily interpret the system’s functioning and output and use it appropriately on the basis of informed decisions , with a view to achieving compliance with the relevant obligations set out in chapter 3 of this title.


### 1. high-risk ai systems shall be designed and developed in such a way to ensure that their operation is sufficiently transparent to enable users to interpret the system’s output and use it appropriately. an appropriate type and degree of transparency shall be ensured , with a view to achieving compliance with the relevant obligations of the user and of the provider set out in chapter 3 of this title. ### 1. high-risk ai systems shall be designed and developed in such a way to ensure that their operation is sufficiently transparent to enable users to understand and interpret the system’s output and use it appropriately. an appropriate type and degree of transparency shall be ensured , with a view to achieving compliance with the relevant obligations of the user and of the provider set out in chapter 3 of this title.


### 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 , in a timely , clear and intelligible manner , of the operation of the system to the natural persons exposed thereto. this information shall also include , as appropriate , the rights and processes to allow natural persons to appeal against the application of such ai system to then. 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. 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 and obtain their consent prior to exposing them to it.


### 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 the use forms part of an evidently artistic , creative or fictional cinematographic or analogous work 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 the use is authorised by law to detect , prevent , investigate and prosecute criminal offences or it is necessary for the exercise of the right to freedom of expression and the right to freedom of the arts and sciences guaranteed in the charter of fundamental rights of the eu , and subject to appropriate safeguards for the rights and freedoms of third parties. ### deleted


### 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 the content forms part of an evidently artistic , creative or fictional cinematographic and analogous work , 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.


### 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 , including for the functioning of the regulatory sandboxes , as referred to in article 53;


### 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 member states shall support the mandatory drawing up of codes of conduct intended to demonstrate compliance with the ethical principles underpinning trustworthy ai set out in new article 4a and 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 purpose of the systems.


### 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 member states shall support the mandatory drawing up of codes of conduct intended to demonstrate compliance with the ethical principles underpinning trustworthy ai set out in article 4a and 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 purpose of the systems.


### 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 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 articles 10 , 13 and 15 of this regulation 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. in the drawing up codes of conduct intended to ensure and demonstrate compliance with the ethical principles underpinning trustworthy ai set out in article 4a , developers and deployers shall , in particular:


### 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 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 , energy efficiency and carbon intensity , 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 , applicable to infringements of this regulation , in particular for infringements which are not subject to administrative fines pursuant to article70a , 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.


### the size and market share of the operator committing the infringement; ### deleted


### artificial intelligence techniques and approachesreferred to in article 3 , point 1 ### deleted


### 1. biometric identification and categorisation of natural persons: ### 1. ai systems which use biometric or biometrics-based data:


### ai systems intended to be used for the purpose of determining access or assigning natural persons to educational and vocational training institutions; ### ai systems intended to be used for the purpose of determining access or assigning natural persons to educational and vocational training institutions or of determining the study program or areas of study to be followed by students;


### 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 educational institutions or monitoring of students during exams , for determining learning objectives , and for allocating personalised learning tasks to students;


### high-risk ai systems referred to in article 6(2) ### indicative list of high-risk ai systems referred to in article 6(2)


### 5. access to and enjoyment of essential private services and public services and benefits: ### 5. access to and enjoyment of essential private services and public services and benefits , including access to products:


### 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


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


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


### 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


### this regulation lays down: ### the purpose of this regulation is to ensure a high level of protection of fundamental rights , health , safety and the environment from harmful effects of the use of artificial intelligence systems in the union while enhancing innovation. this regulation lays down:


### providers placing on the market or putting into service ai systems in the union , irrespective of whether those providers are established within the union or in a third country; ### operators placing on the market or putting into service ai systems in the union , irrespective of whether those operators are established within the union or in a third country;


### providers placing on the market or putting into service ai systems in the union , irrespective of whether those providers are established within the union or in a third country; ### developers and deployers placing on the market or putting into service ai systems in the union , irrespective of whether those are established within the union or in a third country;


### providers placing on the market or putting into service ai systems in the union , irrespective of whether those providers are established within the union or in a third country; ### ‘developer’ placing on the market or putting into service ai systems in the union , irrespective of whether those providers are established within the union or in a third country or that adapts a general purpose ai system to a specific purpose and use;


### users of ai systems located within the union; ### users of ai systems that are located 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 that are located in a third country , where the output produced by the system is used in the union or affects natural persons 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; ### developers , deployers and users of ai systems that are located in a third country , where the output produced by the system is used in the union;


### 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. in the framework of those agreements , no eu public authority nor any member state shall obtain , or otherwise make use of , any ai system that is prohibited or limited under this regulation , unless safeguards similar to the ones established in this provision are adopted by those authorities or organisations


### (5) ‘authorised representative’ means any natural or legal person established in the union who has received a written mandate from a provider of an ai system to , respectively , perform and carry out on its behalf the obligations and procedures established by this regulation; ### (5) ‘legal representative’ means any natural or legal person established in the union who has received a written mandate from a provider of an ai system to , respectively , perform and carry out on its behalf any of the obligations and procedures established by this regulation;


### (20) ‘conformity assessment’ means the process of verifying whether the requirements set out in title iii , chapter 2 of this regulation relating to an ai system have been fulfilled; ### (20) ‘conformity assessment’ means the process of demonstrating whether the requirements set out in title iii , chapter 2 of this regulation relating to an ai system have been fulfilled;


### (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 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 including the use of an ai system beyond its reasonably foreseeable purpose;


### (30) ‘validation data’ means data used for providing an evaluation of the trained ai system and for tuning its non-learnable parameters and its learning process , among other things , in order to prevent overfitting; whereas the validation dataset can be a separate dataset or part of the training dataset , either as a fixed or variable split; ### (30) ‘validation data’ means data used for providing an evaluation of the trained ai system and for tuning its non-learnable parameters and its learning process , among other things , in order to prevent underfitting or overfitting; whereas the validation dataset is a separate dataset or part of the training dataset , either as a fixed or variable split;


### (33) ‘biometric data’ means personal data resulting from specific technical processing relating to the physical , physiological or behavioural characteristics of a natural person , which allow or confirm the unique identification of that natural person , such as facial images or dactyloscopic data; ### (33) ‘biometric data’ means personal data as defined in article 4 , point (14) of regulation (eu) 2016/679;


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


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


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


### a failure of the ai system to meet requirements set out in title iii , chapter 2; ### a failure of the ai system to meet requirements and obligations set out in this regulation;


### 7. the market surveillance authorities of the member states other than the market surveillance authority of the member state initiating the procedure shall without delay inform the commission and the other member states of any measures adopted and of any additional information at their disposal relating to the non-compliance of the ai system concerned , and , in the event of disagreement with the notified national measure , of their objections. ### 7. the market surveillance authorities or , where applicable , the national supervisory authorities of the other member states shall without delay inform the commission , the board and the authority initiating the procedure of any measures adopted and of any additional information at their disposal relating to the non-compliance of the ai system concerned , and , in the event of disagreement with the notified national measure , of their objections.


### 7. the market surveillance authorities of the member states other than the market surveillance authority of the member state initiating the procedure shall without delay inform the commission and the other member states of any measures adopted and of any additional information at their disposal relating to the non-compliance of the ai system concerned , and , in the event of disagreement with the notified national measure , of their objections. ### 7. the market surveillance authorities of the member states other than the market surveillance authority of the member state initiating the procedure shall without delay inform the agency , the commission and the other member states of any measures adopted and of any additional information at their disposal relating to the non-compliance of the ai system concerned , and , in the event of disagreement with the notified national measure , of their objections.


### 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 information referred to in paragraph 5 , no objection has been raised by either a market surveillance authority , a national supervisory authority , or the commission in respect of a provisional measure taken by a market surveillance authority or a national supervisory authority , 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.


### 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) , objections are raised by a member state against a measure taken by another member state , or where the agency or the commission considers the measure to be contrary to union law , the agency 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 agency shall decide whether the national measure is justified or not within 6 months from the notification referred to in article 65(5) and notify such decision to the member state concerned.


### 2. if the national measure is considered justified , all member states shall take the measures necessary to ensure that the non-compliant ai system is withdrawn from their market , and shall inform the commission accordingly. if the national measure is considered unjustified , the member state concerned shall withdraw the measure. ### 2. if the national measure is considered justified , all member states shall take the measures necessary to ensure that the non-compliant ai system is withdrawn from their market , and shall inform the agency accordingly. if the national measure is considered unjustified , the member state concerned shall withdraw the measure.


### compliant ai systems which present a risk ### compliant ai systems which present a risk to the health and safety


### 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 market surveillance authority shall immediately inform the commission , the board and the other member states’ market surveillance authorities. 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 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 agency , 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.


### 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 market surveillance authorities 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 market surveillance authorities and communicate it to them and to the relevant operators.


### 5. the commission shall address its decision to the member states. ### 5. the commission shall address its decision to the agency and the member states.


### the conformity marking has not been affixed; ### the conformity marking or the energy efficiency and carbon intensity marking has not been affixed;


### 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 european agency for data and ai shall take into account the specific interests and needs of the small-scale providers and start-ups when supporting the drawing up of codes of conduct.


### 2. without prejudice to paragraph 1 , information exchanged on a confidential basis between the national competent authorities and between national competent authorities and the commission shall not be disclosed without the prior consultation of the originating national competent authority and the user when high-risk ai systems referred to in points 1 , 6 and 7 of annex iii are used by law enforcement , immigration or asylum authorities , when such disclosure would jeopardise public and national security interests. ### 2. without prejudice to paragraphs 1 and 1a , information exchanged on a confidential basis among the national supervisory authorities , national competent authorities and the commission shall not be disclosed without the prior consultation of the originating authority and the user when high-risk ai systems referred to in points 1 , 6 and 7 of annex iii are used by law enforcement , immigration or asylum authorities , when such disclosure would jeopardise public and national security interests.


### 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 notify [by 3 months following the date of entry into force of this regulation] the commission and the board of those rules and of those measures and shall notify it , without delay , of any subsequent amendment affecting them.


### 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. within [three months following the entry into force of this regulation] , 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.


### 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: ### deleted


### 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. the non-compliance of the ai system with the requirements laid down in article 10 shall be subject to administrative fines of up to 40 000 000 eur or , if the offender is a company , up to 8 % 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. ### 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 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 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.


### 5. the supply of incorrect , incomplete or misleading information to notified bodies and national competent authorities in reply to a request 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. ### deleted


### 5. the supply of incorrect , incomplete or misleading information to notified bodies and national competent authorities in reply to a request 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. ### 5. the supply of incorrect , incomplete or misleading information to notified bodies and national competent authorities in reply to a request 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.


### 6. when deciding on the amount of the administrative fine in each individual case , all relevant circumstances of the specific situation shall be taken into account and due regard shall be given to the following: ### deleted


### 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. ### deleted


### 8. depending on the legal system of the member states , the rules on administrative fines may be applied in such a manner that the fines are imposed by competent national courts of other bodies as applicable in those member states. the application of such rules in those member states shall have an equivalent effect. ### deleted


### 8. depending on the legal system of the member states , the rules on administrative fines may be applied in such a manner that the fines are imposed by competent national courts of other bodies as applicable in those member states. the application of such rules in those member states shall have an equivalent effect. ### 8. depending on the legal system of the member states , the rules on administrative fines may be applied in such a manner that the fines are imposed by competent national courts of other bodies as applicable in those member states. the application of such rules in those member states shall have an equivalent effect. in any event , the fines imposed shall be effective , proportionate and dissuasive.


### 1. the european data protection supervisor may impose administrative fines on union institutions , agencies and bodies falling within the scope of this regulation. when deciding whether to impose an administrative fine and deciding on the amount of the administrative fine in each individual case , all relevant circumstances of the specific situation shall be taken into account and due regard shall be given to the following: ### 1. the agency may impose administrative fines on union institutions , agencies and bodies falling within the scope of this regulation. when deciding whether to impose an administrative fine and deciding on the amount of the administrative fine in each individual case , all relevant circumstances of the specific situation shall be taken into account and due regard shall be given to the following:


### the cooperation with the european data protection supervisor in order to remedy the infringement and mitigate the possible adverse effects of the infringement , including compliance with any of the measures previously ordered by the european data protection supervisor against the union institution or agency or body concerned with regard to the same subject matter; ### the cooperation with the agency in order to remedy the infringement and mitigate the possible adverse effects of the infringement , including compliance with any of the measures previously ordered by the agency against the union institution or agency or body concerned with regard to the same subject matter;


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


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


### 5. the rights of defense of the parties concerned shall be fully respected in the proceedings. they shall be entitled to have access to the european data protection supervisor’s file , subject to the legitimate interest of individuals or undertakings in the protection of their personal data or business secrets. ### 5. the rights of defense of the parties concerned shall be fully respected in the proceedings. they shall be entitled to have access to the european data protection supervisor’s file , subject to the legitimate interest of individuals or undertakings in the protection of their personal data.


### 5. the rights of defense of the parties concerned shall be fully respected in the proceedings. they shall be entitled to have access to the european data protection supervisor’s file , subject to the legitimate interest of individuals or undertakings in the protection of their personal data or business secrets. ### 5. the rights of defense of the parties concerned shall be fully respected in the proceedings. they shall be entitled to have access to the agency’s file , subject to the legitimate interest of individuals or undertakings in the protection of their personal data or business secrets.


### 6. funds collected by imposition of fines in this article shall be the income of the general budget of the union. ### 6. funds collected by imposition of fines in this article shall contribute to the general budget of the union.


### 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 7(1) , article 11(3) , article 43(5) , article 48(5) and article 68a 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 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 7(1) , article 11(3) , article 43(5) and (6) ,article 48(5) and article 49a(3) 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 7(1) , article 11(3) , article 43(5) , article 48(5) and article 68a 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 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 7(1) , article 11(3) , article 43(5) and (6) , article 48(5) and article 49a(3) 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.


### 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 7(1) , article 11(3) , article 43(5) , article 48(5) and 68d 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 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 7(1) , article 11(3) , article 43(5) and (6) , article 48(5) and article 49a(3) 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.


### article 83 ### deleted


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


### (45) for the development of high-risk ai systems , certain actors , such as providers , notified bodies and other relevant entities , such as digital innovation hubs , testing experimentation facilities and researchers , should be able to access and use high quality datasets within their respective fields of activities which are related to this regulation. european common data spaces established by the commission and the facilitation of data sharing between businesses and with government in the public interest will be instrumental to provide trustful , accountable and non-discriminatory access to high quality data for the training , validation and testing of ai systems. for example , in health , the european health data space will facilitate non-discriminatory access to health data and the training of artificial intelligence algorithms on those datasets , in a privacy-preserving , secure , timely , transparent and trustworthy manner , and with an appropriate institutional governance. relevant competent authorities , including sectoral ones , providing or supporting the access to data may also support the provision of high-quality data for the training , validation and testing of ai systems. ### (45) for the development of high-risk ai systems , certain actors , such as providers , notified bodies and other relevant entities , such as digital innovation hubs , testing experimentation facilities and researchers , should be able to access and use high quality datasets within their respective fields of activities which are related to this regulation. european common data spaces established by the commission , competitive and fair european data economy structured around interoperable data intermediation services and the facilitation of data sharing between businesses and with government in the public interest will be instrumental to provide trustful , accountable and non-discriminatory access to high quality data for the training , validation and testing of ai systems. for example , in health , the european health data space will facilitate non-discriminatory access to health data and the training of artificial intelligence algorithms on those datasets , in a privacy-preserving , secure , timely , transparent and trustworthy manner , and with an appropriate institutional governance. relevant competent authorities , including sectoral ones , providing or supporting the access to data may also support the provision of high-quality data for the training , validation and testing of ai systems.


### (46) having information on how high-risk ai systems have been developed and how they perform throughout their lifecycle is essential to verify compliance with the requirements under this regulation. this requires keeping records and the availability of a technical documentation , containing information which is necessary to assess the compliance of the ai system with the relevant requirements. such information should include the general characteristics , capabilities and limitations of the system , algorithms , data , training , testing and validation processes used as well as documentation on the relevant risk management system. the technical documentation should be kept up to date. ### (46) having information on how high-risk ai systems have been designed and developed and how they perform throughout their lifecycle is essential to verify compliance with the requirements under this regulation. this requires keeping records and the availability of a technical documentation , containing information which is necessary to assess the compliance of the ai system with the relevant requirements. such information should include the general characteristics , capabilities and limitations of the system , algorithms , data , training , testing and validation processes used as well as documentation on the relevant risk management system. the technical documentation should be kept up to date.


### (46) having information on how high-risk ai systems have been developed and how they perform throughout their lifecycle is essential to verify compliance with the requirements under this regulation. this requires keeping records and the availability of a technical documentation , containing information which is necessary to assess the compliance of the ai system with the relevant requirements. such information should include the general characteristics , capabilities and limitations of the system , algorithms , data , training , testing and validation processes used as well as documentation on the relevant risk management system. the technical documentation should be kept up to date. ### (46) having comprehensible information on how high-risk ai systems have been developed and how they perform throughout their lifecycle is essential to verify compliance with the requirements under this regulation and to allow users to make informed and autonomous decisions about their use. this requires keeping records and the availability of technical documentation , containing information which is necessary to assess the compliance of the ai system with the relevant requirements. such information should include the general characteristics , capabilities and limitations of the system , namely with regard to the extraction and consumption of natural resources , algorithms and any pre-determined changes on it and its performance , data , training , testing and validation processes used as well as documentation on the relevant risk management system and on the entity that carried out the conformity assessment. the technical documentation should be kept up to date.


### (46) having information on how high-risk ai systems have been developed and how they perform throughout their lifecycle is essential to verify compliance with the requirements under this regulation. this requires keeping records and the availability of a technical documentation , containing information which is necessary to assess the compliance of the ai system with the relevant requirements. such information should include the general characteristics , capabilities and limitations of the system , algorithms , data , training , testing and validation processes used as well as documentation on the relevant risk management system. the technical documentation should be kept up to date. ### (46) having comprehensible information on how high-risk ai systems have been developed and how they perform throughout their lifecycle is essential to verify compliance with the requirements under this regulation and to allow users to make informed and autonomous decisions about their use. this requires keeping records and the availability of a technical documentation , containing information which is necessary to assess the compliance of the ai system with the relevant requirements. such information should include the general characteristics , capabilities and limitations of the system , algorithms , data , training , testing and validation processes used as well as documentation on the relevant risk management system. the technical documentation should be kept up to date.