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


### (76) in order to facilitate a smooth , effective and harmonised implementation of this regulation a european artificial intelligence board should be established. the board should be responsible for a number of advisory tasks , including issuing opinions , recommendations , advice or guidance on matters related to the implementation of this regulation , including on technical specifications or existing standards regarding the requirements established in this regulation and providing advice to and assisting the commission on specific questions related to artificial intelligence. ### (76) in order to facilitate a smooth , effective and harmonised implementation of this and other regulations a european agency for data and artificial intelligence should be established. the agency should be responsible for a number of advisory tasks , including issuing opinions , recommendations , advice or guidance on matters related to the implementation of this regulation and other present or future legislations , including on technical specifications or existing standards regarding the requirements established in this regulation and providing advice to and assisting the commission on specific questions related to artificial intelligence. the agency should establish a permanent stakeholders' group composed of experts representing the relevant stakeholders , such as representatives of developers , deployers and users of ai systems , including smes and start-ups , consumer groups , trade unions , fundamental rights organisations and academic experts and it should communicate its activities to citizens as appropriate.


### (76) in order to facilitate a smooth , effective and harmonised implementation of this regulation a european artificial intelligence board should be established. the board should be responsible for a number of advisory tasks , including issuing opinions , recommendations , advice or guidance on matters related to the implementation of this regulation , including on technical specifications or existing standards regarding the requirements established in this regulation and providing advice to and assisting the commission on specific questions related to artificial intelligence. ### (76) in order to facilitate a smooth , effective and harmonised implementation of this regulation a european artificial intelligence board should be established. the board should be responsible for a number of advisory tasks , including issuing opinions , recommendations , advice or guidance on matters related to the implementation of this regulation , including on technical specifications or existing standards regarding the requirements established in this regulation and providing expert advice to and assisting the commission on specific questions related to artificial intelligence and to address the challenges rising from the fast evolving development of ai technologies.


### (76) in order to facilitate a smooth , effective and harmonised implementation of this regulation a european artificial intelligence board should be established. the board should be responsible for a number of advisory tasks , including issuing opinions , recommendations , advice or guidance on matters related to the implementation of this regulation , including on technical specifications or existing standards regarding the requirements established in this regulation and providing advice to and assisting the commission on specific questions related to artificial intelligence. ### (76) in order to facilitate a smooth , effective and harmonised implementation of this and other regulations a european agency for data and artificial intelligence should be established. the agency should be responsible for a number of advisory tasks , including issuing opinions , recommendations , advice or guidance on matters related to the implementation of this regulation and other present or future legislations , including on technical specifications or existing standards regarding the requirements established in this regulation and providing advice to and assisting the commission on specific questions related to artificial intelligence.


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


### 3. this regulation shall not apply to ai systems developed or used exclusively for military purposes. ### 3. this regulation shall not apply to ai systems developed or used exclusively for military purposes. the use or development of ai systems in connection with autonomous weapon systems is prohibited and shall be proscribed internationally.


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


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


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


### (1) ‘artificial intelligence system’ (ai system) means software that is developed with one or more of the techniques and approaches listed in annex i and can , for a given set of human-defined objectives , generate outputs such as content , predictions , recommendations , or decisions influencing the environments they interact with; ### (1) 'artificial intelligence system’ (ai system) means software that can for example perceive , learn , reason or model based on machine and/or human based inputs , to generate outputs such as content , hypotheses , predictions , recommendations , or decisions influencing the real or virtual environments they interact with;


### (1) ‘artificial intelligence system’ (ai system) means software that is developed with one or more of the techniques and approaches listed in annex i and can , for a given set of human-defined objectives , generate outputs such as content , predictions , recommendations , or decisions influencing the environments they interact with; ### (1) ‘artificial intelligence system’ (ai system) means any software or machine-based system that is developed with one or more of the techniques and approaches listed in annex i and can , for a given set of human-defined objectives , make predictions , recommendations , or decisions influencing real or virtual environments. the environments they interact with. ai systems can be designed with varying levels of autonomy.


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


### (2) ‘provider’ means a natural or legal person , public authority , agency or other body that develops an ai system or that has an ai system developed with a view to placing it on the market or putting it into service under its own name or trademark , whether for payment or free of charge; ### (2) ‘developer’ means a natural or legal person , public authority , agency or other body that develops an ai system or that has an ai system developed with a view to placing it on the market or putting it into service under its own name or trademark , whether for payment or free of charge , or that adapts a general purpose ai system to a specific purpose and use;


### (2) ‘provider’ means a natural or legal person , public authority , agency or other body that develops an ai system or that has an ai system developed with a view to placing it on the market or putting it into service under its own name or trademark , whether for payment or free of charge; ### (2) ‘provider’ means a natural or legal person , public authority , agency or other body that develops an ai system or that has an ai system developed or places that system on the market or puts it into service under its own name or trademark , whether for payment or free of charge;


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


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


### (12) ‘intended purpose’ means the use for which an ai system is intended by the provider , including the specific context and conditions of use , as specified in the information supplied by the provider in the instructions for use , promotional or sales materials and statements , as well as in the technical documentation; ### (12) ‘reasonably foreseeable purpose’ means the use for which an ai system is intended by the provider , including the specific context and conditions of use , as specified in the information supplied by the provider in the instructions for use , promotional or sales materials and statements , as well as in the technical documentation;


### (12) ‘intended purpose’ means the use for which an ai system is intended by the provider , including the specific context and conditions of use , as specified in the information supplied by the provider in the instructions for use , promotional or sales materials and statements , as well as in the technical documentation; ### (12) ‘purpose’ means the use for which an ai system is used by the provider , including the specific context and conditions of use , as specified in the information supplied by the provider in the instructions for use , promotional or sales materials and statements , as well as in the technical documentation;


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


### (14) ‘safety component of a product or system’ means a component of a product or of a system which fulfils a safety function for that product or system or the failure or malfunctioning of which endangers the health and safety of persons or property; ### (14) ‘safety component of a product or system’ means a component of a product or of a system which fulfils a safety or security function for that product or system or the failure or malfunctioning of which endangers the fundamental rights , health or safety of persons , or which damages property or the environment;


### (14) ‘safety component of a product or system’ means a component of a product or of a system which fulfils a safety function for that product or system or the failure or malfunctioning of which endangers the health and safety of persons or property; ### (14) ‘safety component of a product or system’ means a component of a product or of a system which fulfils a safety or security function for that product or system or the failure or malfunctioning of which endangers the health , safety , fundamental rights of persons or which damages property , or the environment;


### (14) ‘safety component of a product or system’ means a component of a product or of a system which fulfils a safety function for that product or system or the failure or malfunctioning of which endangers the health and safety of persons or property; ### (14) ‘safety component of a product or system’ means a component of a product or of a system which fulfils a safety function for that product or system or the failure or malfunctioning of which endangers the health and safety of persons or property or causes a serious damage to the environment;


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


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


### article 4 ### deleted


### the commission is empowered to adopt delegated acts in accordance with article 73 to amend the list of techniques and approaches listed in annex i , in order to update that list to market and technological developments on the basis of characteristics that are similar to the techniques and approaches listed therein. ### for the amendment of the list of techniques and approaches listed in annex i , in order to update that list to market and technological developments on the basis of characteristics that are similar to the techniques and approaches listed therein , the ordinary legislative procedure should be followed.


### the commission is empowered to adopt delegated acts in accordance with article 73 to amend the list of techniques and approaches listed in annex i , in order to update that list to market and technological developments on the basis of characteristics that are similar to the techniques and approaches listed therein. ### deleted


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


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


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


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


### (iii) the detection , localisation , identification or prosecution of a perpetrator or suspect of a criminal offence referred to in article 2(2) of council framework decision 2002/584/jha62and punishable in the member state concerned by a custodial sentence or a detention order for a maximum period of at least three years , as determined by the law of that member state. ### (iii) the detection , localisation , identification or prosecution of a perpetrator or suspect of a criminal offence referred to in article 2(2) of council framework decision 2002/584/jha62 and punishable in the member state concerned by a custodial sentence or a detention order for a period of at least three years , as determined by the law of that member state.


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


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


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


### the competent judicial or administrative authority shall only grant the authorisation where it is satisfied , based on objective evidence or clear indications presented to it , that the use of the ‘real-time’ remote biometric identification system at issue is necessary for and proportionate to achieving one of the objectives specified in paragraph 1 , point (d) , as identified in the request. in deciding on the request , the competent judicial or administrative authority shall take into account the elements referred to in paragraph 2. ### the competent judicial authority shall only grant the authorisation where it is satisfied , based on objective evidence or clear indications presented to it , that the use of the ‘real-time’ remote biometric identification system at issue is necessary for and proportionate to achieving one of the objectives specified in paragraph 1 , point (d) , as identified in the request. in deciding on the request , the competent judicial authority shall take into account the elements referred to in paragraph 2.


### the competent judicial or administrative authority shall only grant the authorisation where it is satisfied , based on objective evidence or clear indications presented to it , that the use of the ‘real-time’ remote biometric identification system at issue is necessary for and proportionate to achieving one of the objectives specified in paragraph 1 , point (d) , as identified in the request. in deciding on the request , the competent judicial or administrative authority shall take into account the elements referred to in paragraph 2. ### deleted


### 2. in addition to the high-risk ai systems referred to in paragraph 1 , ai systems referred to in annex iii shall also be considered high-risk. ### 2. in addition to the high-risk ai systems referred to in paragraph 1 , ai systems referred to in annex iii shall also be considered high-risk due to their risk to cause harm to health , safety , the environment , fundamental rights or to democracy and the rule of law.


### 2. in addition to the high-risk ai systems referred to in paragraph 1 , ai systems referred to in annex iii shall also be considered high-risk. ### 2. in addition to the high-risk ai systems referred to in paragraph 1 of this article , ai systems referred to in annex iii shall also be considered high-risk. in case there is uncertainty over the ai system's classification , the provider shall deem the ai system high-risk if its use or application poses a risk of harm to the health and safety or a risk of adverse impact on fundamental rights of individuals affected by these technologies.


### 1. the commission is empowered to adopt delegated acts in accordance with article 73 to update the list in annex iii by adding high-risk ai systems where both of the following conditions are fulfilled: ### 1. the commission is empowered to adopt delegated acts in accordance with article 73 , after ensuring adequate consultation with relevant stakeholders and the european agency for data and ai , to update the list in annex iii by adding high-risk ai systems where both of the following conditions are fulfilled:


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


### the ai systems are intended to be used in any of the areas listed in points 1 to 8 of annex iii; ### the ai systems are intended to be used in any of the areas listed in points 1 to 9 of annex iii;


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


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


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


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


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


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


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


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


### the intended purpose of the ai system; ### the purpose of the ai system;


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


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


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


### 1. high-risk ai systems shall comply with the requirements established in this chapter. ### 1. high-risk ai systems shall comply with the requirements established in this chapter , taking into account the generally acknowledged state of the art and industry standards , including as reflected in relevant harmonised standards or common specifications.


### 2. the risk management system shall consist of a continuous iterative process run throughout the entire lifecycle of a high-risk ai system , requiring regular systematic updating. it shall comprise the following steps: ### 2. the risk management system shall consist of a continuous iterative process run throughout the entire lifecycle of a high-risk ai system , requiring regular systematic updating , and in any event when the high-risk ai system is subject to significant changes in its design or purpose. it shall comprise the following steps:


### identification and analysis of the known and foreseeable risks associated with each high-risk ai system; ### identification and analysis of the known and the reasonably foreseeable risks that the high-risk ai system , and ai systems with indeterminate uses , can pose to:


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


### 1. high-risk ai systems which make use of techniques involving the training of models with data shall be developed on the basis of training , validation and testing data sets that meet the quality criteria referred to in paragraphs 2 to 5. ### 1. high-risk ai systems which make use of techniques involving the training of models with data shall be developed on the basis of training , validation and testing data sets that meet the quality criteria referred to in paragraphs 2 to 5. techniques such as unsupervised learning and reinforcement learning that do not use validation and testing data sets shall be developed on the basis of training data sets the quality criteria referred to in paragraphs 2 to 5.


### examination in view of possible biases; ### examination in view of possible biases , including where data outputs are used as an input for future operations;


### examination in view of possible biases; ### examination in view of possible biases; that could affect fundamental rights or lead to discriminatory results , affecting both or either the individual right to non-discrimination and equality as a value recognised in article 2 teu.


### the identification of any possible data gaps or shortcomings , and how those gaps and shortcomings can be addressed. ### the identification of any possible data gaps or shortcomings , and how those gaps and shortcomings can be addressed , as well as any other relevant variables.


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


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


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


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


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


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


### the technical documentation shall be drawn up in such a way to demonstrate that the high-risk ai system complies with the requirements set out in this chapter and provide national competent authorities and notified bodies with all the necessary information to assess the compliance of the ai system with those requirements. it shall contain , at a minimum , the elements set out in annex iv. ### the technical documentation shall be drawn up in such a way to demonstrate that the high-risk ai system complies with the requirements set out in this chapter and provide national competent authorities and notified bodies with all the necessary information to assess the compliance of the ai system with those requirements as well as their energy consumption and carbon intensity information. it shall contain , at a minimum , the elements set out in annex iv.


### the technical documentation shall be drawn up in such a way to demonstrate that the high-risk ai system complies with the requirements set out in this chapter and provide national competent authorities and notified bodies with all the necessary information to assess the compliance of the ai system with those requirements. it shall contain , at a minimum , the elements set out in annex iv. ### the technical documentation shall be drawn up , without unduly compromising intellectual property rights or trade secrets , in such a way to demonstrate that the high-risk ai system complies with the requirements set out in this chapter and provide national competent authorities and notified bodies with all the necessary information to assess the compliance of the ai system with those requirements. it shall contain , at a minimum , the elements set out in annex iv.


### 2. the logging capabilities shall ensure a level of traceability of the ai system’s functioning throughout its lifecycle that is appropriate to the intended purpose of the system. ### 2. the logging capabilities shall ensure a level of traceability of the ai system’s functioning throughout its lifecycle that is appropriate to the purpose of the system.


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


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


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


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


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


### the expected lifetime of the high-risk ai system and any necessary maintenance and care measures to ensure the proper functioning of that ai system , including as regards software updates. ### the expected lifetime of the high-risk ai system , its level of extraction and consumption of natural resources , and any necessary maintenance and care measures to ensure the proper functioning of that ai system , including as regards software updates.


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


### 2. human oversight shall aim at preventing or minimising the risks to health , safety or fundamental rights that may emerge when a high-risk ai system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse , in particular when such risks persist notwithstanding the application of other requirements set out in this chapter. ### 2. human oversight shall aim at preventing or minimising unethical risks to the environment , health , safety , fundamental rights and democracy or the rule of law that may emerge when a high-risk ai system is used in accordance with its purpose or under conditions of reasonably foreseeable misuse , in particular when such risks persist notwithstanding the application of other requirements set out in this chapter and where decisions based solely on automated processing by ai systems produce legal or otherwise significant effects on the persons or groups of persons on which the system is to be used.


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


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


### fully understand the capacities and limitations of the high-risk ai system and be able to duly monitor its operation , so that signs of anomalies , dysfunctions and unexpected performance can be detected and addressed as soon as possible; ### sufficiently understand the capacities and limitations of the high-risk ai system and be able to duly monitor its operation , so that signs of anomalies , dysfunctions and unexpected performance can be detected and addressed as soon as possible;


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


### 5. for high-risk ai systems referred to in point 1(a) of annex iii , the measures referred to in paragraph 3 shall be such as to ensure that , in addition , no action or decision is taken by the user on the basis of the identification resulting from the system unless this has been verified and confirmed by at least two natural persons. ### 5. for high-risk ai systems referred to in areas 1 , 6 and 7 of annex iii , the measures referred to in paragraph 3 shall be such as to ensure that , in addition , no action or decision is taken by the user on the basis of the output resulting from the system unless this has been verified and confirmed by at least two natural persons.


### 3. high-risk ai systems shall be resilient as regards errors , faults or inconsistencies that may occur within the system or the environment in which the system operates , in particular due to their interaction with natural persons or other systems. ### 3. providers of high-risk ai systems shall take appropriate technical and organizational measures to ensure that high-risk ai systems are resilient as regards to errors , fault or inconsistencies that may occur within the system or the environment in which the system operates , consistent with industry best practices.


### 1. each member state shall designate or establish a notifying authority responsible for setting up and carrying out the necessary procedures for the assessment , designation and notification of conformity assessment bodies and for their monitoring. ### 1. each member state shall designate or establish a notifying authority responsible for setting up and carrying out the necessary procedures for the assessment , designation and notification of conformity assessment bodies and for their monitoring , including the energy efficiency and carbon intensity information.


### 2. the commission , when preparing the common specifications referred to in paragraph 1 , shall gather the views of relevant bodies or expert groups established under relevant sectorial union law. ### 2. the commission , when preparing the common specifications referred to in paragraph 1 , shall gather , where relevant , the views of relevant stakeholders , such as sme's and start-ups , civil society and social partners or expert groups established under relevant sectorial union law.


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


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


### 1. providers shall ensure that ai systems intended to interact with natural persons are designed and developed in such a way that natural persons are informed that they are interacting with an ai system , unless this is obvious from the circumstances and the context of use. this obligation shall not apply to ai systems authorised by law to detect , prevent , investigate and prosecute criminal offences , unless those systems are available for the public to report a criminal offence. ### 1. developers and deployers shall ensure that ai systems used to interact with natural persons are designed and developed in such a way that natural persons are informed , in a timely , clear and intelligible manner that they are interacting with an ai system , unless this is obvious from the circumstances and the context of use. this information shall also include , as appropriate , the functions that are ai enabled , and the rights and processes to allow natural persons to appeal against the application of such ai systems to them. this obligation shall not apply to ai systems authorised by law to detect , prevent , investigate and prosecute criminal offences , unless those systems are available for the public to report a criminal offence.


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


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


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


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


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


### 3. users of an ai system that generates or manipulates image , audio or video content that appreciably resembles existing persons , objects , places or other entities or events and would falsely appear to a person to be authentic or truthful (‘deep fake’) , shall disclose that the content has been artificially generated or manipulated. ### 3. users of an ai system that generates or manipulates text , scripts , image , audio or video content that appreciably resembles existing persons , objects , places or other entities or events and would falsely appear to a person to be authentic or truthful (‘deep fake’) , shall label the content in a way that informs that the content is inauthentic and untruthful , has been artificially generated or manipulated , and that is clearly visible for the person exposed to it .


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


### 1. ai regulatory sandboxes established by one or more member states competent authorities or the european data protection supervisor shall provide a controlled environment that facilitates the development , testing and validation of innovative ai systems for a limited time before their placement on the market or putting into service pursuant to a specific plan. this shall take place under the direct supervision and guidance by the competent authorities with a view to ensuring compliance with the requirements of this regulation and , where relevant , other union and member states legislation supervised within the sandbox. ### 1. ai regulatory sandboxes established by the commission in collaboration with one or more member states competent authorities or the european data protection supervisor shall provide a controlled environment that facilitates the safe development , testing and validation of innovative ai systems for a limited time before their placement on the market or putting into service pursuant to a specific plan. this shall take place under the direct supervision and guidance of the commission in collaboration with the competent authorities with a view to ensuring compliance with the requirements of this regulation and , where relevant , other union and member states legislation supervised within the sandbox. the commission shall play a complementary role , allowing those member states with demonstrated experience with sandboxing to build on their expertise and , on the other hand , assisting and providing technical understanding and resources to those member states that seek guidance on the set-up and running of these regulatory sandboxes.


### 1. ai regulatory sandboxes established by one or more member states competent authorities or the european data protection supervisor shall provide a controlled environment that facilitates the development , testing and validation of innovative ai systems for a limited time before their placement on the market or putting into service pursuant to a specific plan. this shall take place under the direct supervision and guidance by the competent authorities with a view to ensuring compliance with the requirements of this regulation and , where relevant , other union and member states legislation supervised within the sandbox. ### 1. ai regulatory sandboxes established by one or more member states competent authorities or the european data protection supervisor , and in collaboration with smes , start-ups , enterprises and other innovators , shall provide a controlled environment that facilitates the development , testing and validation of innovative ai systems for a limited time before their placement on the market or putting into service pursuant to a specific plan. for member states competent authorities or the european data protection supervisor , this shall take place under the direct supervision and guidance by the competent authorities with a view to ensuring compliance with the requirements of this regulation and , where relevant , other union and member states legislation supervised within the sandbox. smes , start-ups , enterprises and other innovators shall conduct live experiments for new business models in collaboration with the member state competent authorities.


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


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


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


### 5. member states’ competent authorities that have established ai regulatory sandboxes shall coordinate their activities and cooperate within the framework of the european artificial intelligence board. they shall submit annual reports to the board and the commission on the results from the implementation of those scheme , including good practices , lessons learnt and recommendations on their setup and , where relevant , on the application of this regulation and other union legislation supervised within the sandbox. ### 5. member states’ competent authorities that have established ai regulatory sandboxes shall coordinate their activities and cooperate within the framework of the european artificial intelligence board. they shall submit annual reports to the board and the commission on the results from the implementation of those scheme , including good practices , lessons learnt and recommendations on their setup and , where relevant , on the application of this regulation and other union legislation supervised within the sandbox. smes , start-ups , enterprises and other innovators are invited to share their good practices , lessons learnt and recommendations on their ai sandboxes with member state competent authorities.


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


### (iii) a high level of protection and improvement of the quality of the environment; ### (iii) a high level of protection and improvement of the quality of the environment , with particular emphasis on the three global environmental challenges: climate change , biodiversity loss and pollution;


### provide small-scale providers and start-ups with priority access to the ai regulatory sandboxes to the extent that they fulfil the eligibility conditions; ### provide sme providers , including start-ups with priority access to the ai regulatory sandboxes established by one or more member states competent authorities or the european data protection supervisor to the extent that they fulfil the eligibility conditions;


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


### 1. the board shall be composed of the national supervisory authorities , who shall be represented by the head or equivalent high-level official of that authority , and the european data protection supervisor. other national authorities may be invited to the meetings , where the issues discussed are of relevance for them. ### 1. the agency shall establish a board. the board shall be composed of the national supervisory authorities , who shall be represented by the head or equivalent high-level official of that authority , representatives of the european commission as well as , high level representatives from the european data protection supervisor , the eu agency for fundamental rights and the eu agency for cybersecurity. other national authorities , as well as other union bodies , offices , agencies and advisory groups shall be invited to the meetings , where the issues discussed are of relevance for them.


### 1. the board shall be composed of the national supervisory authorities , who shall be represented by the head or equivalent high-level official of that authority , and the european data protection supervisor. other national authorities may be invited to the meetings , where the issues discussed are of relevance for them. ### 1. the board shall be composed of the national supervisory authorities , who shall be represented by the head or equivalent high-level official of that authority , the european data protection supervisor. the european union agency for fundamental rights will have the status of observer in the board. other national authorities , as well as representatives of small and medium-sized enterprises and startups , may be invited to the meetings , where the issues discussed are of relevance for them.


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


### 3. the board shall be chaired by the commission. the commission shall convene the meetings and prepare the agenda in accordance with the tasks of the board pursuant to this regulation and with its rules of procedure. the commission shall provide administrative and analytical support for the activities of the board pursuant to this regulation. ### 3. the agency shall establish a permanent stakeholders' group composed of experts representing the relevant stakeholders , such as representatives of developers , deployers and users of ai systems , including smes and start-ups , consumer groups , trade unions , fundamental rights organisations and academic experts.


### 4. the board may invite external experts and observers to attend its meetings and may hold exchanges with interested third parties to inform its activities to an appropriate extent. to that end the commission may facilitate exchanges between the board and other union bodies , offices , agencies and advisory groups. ### 4. the board may invite national authorities , such as national equality bodies , to its meetings , where the issues discussed are of relevance for them. the board may also invite , where appropriate , external experts , and observers and interested third parties , including stakeholders , such as those referred to in article 58 , paragraph 1c , to attend its meetings and may hold exchanges with them.


### 4. the board may invite external experts and observers to attend its meetings and may hold exchanges with interested third parties to inform its activities to an appropriate extent. to that end the commission may facilitate exchanges between the board and other union bodies , offices , agencies and advisory groups. ### 4. the board may invite external experts and observers to attend its meetings and may hold exchanges with interested third parties of a wide array of organisations to inform its activities to an appropriate extent. to that end the commission may facilitate exchanges between the board and other union bodies , offices , agencies and advisory groups.


### 4. the board may invite external experts and observers to attend its meetings and may hold exchanges with interested third parties to inform its activities to an appropriate extent. to that end the commission may facilitate exchanges between the board and other union bodies , offices , agencies and advisory groups. ### 4. the agency shall also inform interested third parties and citizens on its activities to an appropriate extent.


### 4. the board may invite external experts and observers to attend its meetings and may hold exchanges with interested third parties to inform its activities to an appropriate extent. to that end the commission may facilitate exchanges between the board and other union bodies , offices , agencies and advisory groups. ### 4. when relevant , the board shall invite external experts , in particular a standing expert on fundamental rights , and other observers to attend its meetings and shall hold exchanges with interested third parties to inform its activities to an appropriate extent. to that end the commission shall facilitate exchanges between the board , other union bodies , offices , agencies and advisory groups and civil society and social partners.


### 4. member states shall ensure that national competent authorities are provided with adequate financial and human resources to fulfil their tasks under this regulation. in particular , national competent authorities shall have a sufficient number of personnel permanently available whose competences and expertise shall include an in-depth understanding of artificial intelligence technologies , data and data computing , fundamental rights , health and safety risks and knowledge of existing standards and legal requirements. ### 4. member states shall ensure that the national competent authorities are provided with adequate technical , financial and human resources , premises and infrastructure necessary to fulfil their tasks under this regulation. in particular , national competent authorities shall have a sufficient number of personnel permanently available whose competences and expertise shall include an in-depth understanding of artificial intelligence technologies , data and data computing , personal data protection , fundamental rights , health and safety risks and knowledge of existing standards and legal requirements. member states shall assess and update competence and resource requirements referred to in this paragraph on an annual basis.


### 4. member states shall ensure that national competent authorities are provided with adequate financial and human resources to fulfil their tasks under this regulation. in particular , national competent authorities shall have a sufficient number of personnel permanently available whose competences and expertise shall include an in-depth understanding of artificial intelligence technologies , data and data computing , fundamental rights , health and safety risks and knowledge of existing standards and legal requirements. ### 4. member states shall ensure that national competent authorities are provided with adequate financial and human resources to fulfil their tasks under this regulation. in particular , national competent authorities shall have a sufficient number of personnel permanently available whose competences and expertise shall include an in-depth understanding of artificial intelligence technologies , data and data computing , fundamental rights , environment , health and safety risks and knowledge of existing standards and legal requirements.


### 7. national competent authorities may provide guidance and advice on the implementation of this regulation , including to small-scale providers. whenever national competent authorities intend to provide guidance and advice with regard to an ai system in areas covered by other union legislation , the competent national authorities under that union legislation shall be consulted , as appropriate. member states may also establish one central contact point for communication with operators. ### 7. national competent authorities may provide guidance and advice on the implementation of this regulation , including to small-scale providers. whenever national competent authorities intend to provide guidance and advice with regard to an ai system in areas covered by other union legislation , the guidance shall be drafted in consultation with the competent national authorities under that union legislation , as appropriate.


### 3. information contained in the eu database shall be accessible to the public. ### 3. information contained in the eu database shall be accessible to the public , user-friendly and machine-readable.


### 4. the eu database shall contain personal data only insofar as necessary for collecting and processing information in accordance with this regulation. that information shall include the names and contact details of natural persons who are responsible for registering the system and have the legal authority to represent the provider. ### 4. the eu database shall contain personal data only insofar as necessary for collecting and processing information in accordance with this regulation. that information shall include the names and contact details of natural persons who are responsible for registering the system and have the legal authority to represent the provider or the user.


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


### 1. access to data and documentation in the context of their activities , the market surveillance authorities shall be granted full access to the training , validation and testing datasets used by the provider , including through application programming interfaces (‘api’) or other appropriate technical means and tools enabling remote access. ### 1. in the context of their activities , the national supervisory authorities , the market surveillance authorities , or the commission , shall be granted full access to the training data sets , and where applicable , validation and testing datasets used by the provider or , where relevant , the user , including through application programming interfaces (‘api’) or other appropriate technical means and tools enabling remote access.


### 1. access to data and documentation in the context of their activities , the market surveillance authorities shall be granted full access to the training , validation and testing datasets used by the provider , including through application programming interfaces (‘api’) or other appropriate technical means and tools enabling remote access. ### 1. access to data and documentation in the context of their activities , the market surveillance authorities shall be granted access to the training , validation and testing datasets used by the provider , including through application programming interfaces (‘api’) or other appropriate technical means and tools enabling remote access.


### 2. where necessary to assess the conformity of the high-risk ai system with the requirements set out in title iii , chapter 2 and upon a reasoned request , the market surveillance authorities shall be granted access to the source code of the ai system. ### 2. where necessary to assess the conformity of the high-risk ai system with the requirements set out in title iii , chapter 2 and upon a reasoned request , the national supervisory authority , the market surveillance authorities or , where applicable , the commission shall be granted access to the source code of the ai system.


### 2. where necessary to assess the conformity of the high-risk ai system with the requirements set out in title iii , chapter 2 and upon a reasoned request , the market surveillance authorities shall be granted access to the source code of the ai system. ### 2. where necessary to assess the conformity of the high-risk ai system with the requirements set out in title iii , chapter 2 and upon a reasoned request , the market surveillance authorities shall be granted access to the source code , or if impossible , all related data sets used to train or place the ai system on the market.


### 1. ai systems presenting a risk shall be understood as a product presenting a risk defined in article 3 , point 19 of regulation (eu) 2019/1020 insofar as risks to the health or safety or to the protection of fundamental rights of persons are concerned. ### 1. ai systems presenting a risk means an ai system having the potential to affect adversely fundamental rights , health and safety of persons in general , including in the workplace , protection of consumers , the environment , public security , the values enshrined in article 2 teu and other public interests , that are protected by the applicable union harmonisation legislation , to a degree which goes beyond that considered reasonable and acceptable in relation to its intended purpose or under the normal or reasonably foreseeable conditions of use of the system concerned , including the duration of use and , where applicable , its putting into service , installation and maintenance requirements.


### 1. ai systems presenting a risk shall be understood as a product presenting a risk defined in article 3 , point 19 of regulation (eu) 2019/1020 insofar as risks to the health or safety or to the protection of fundamental rights of persons are concerned. ### 1. ai systems presenting a risk shall be understood as ai systems having the potential to affect adversely the fundamental rights of persons , their health or safety , as well as ai systems having the potential to breach the principles defined in art. 4a or the union values as enshrined in article 2 teu.


### 1. ai systems presenting a risk shall be understood as a product presenting a risk defined in article 3 , point 19 of regulation (eu) 2019/1020 insofar as risks to the health or safety or to the protection of fundamental rights of persons are concerned. ### 1. ai systems presenting a risk shall be understood as a product presenting a risk defined in article 3 , point 19 of regulation (eu) 2019/1020 insofar as risks to the health or safety , to the protection of fundamental rights of persons or to the environment are concerned.


### 1. where , having performed an evaluation under article 65 , the market surveillance authority of a member state finds that although an ai system is in compliance with this regulation , it presents a risk to the health or safety of persons , to the compliance with obligations under union or national law intended to protect fundamental rights or to other aspects of public interest protection , it shall require the relevant operator to take all appropriate measures to ensure that the ai system concerned , when placed on the market or put into service , no longer presents that risk , to withdraw the ai system from the market or to recall it within a reasonable period , commensurate with the nature of the risk , as it may prescribe. ### 1. where , having performed an evaluation under article 65 in full cooperation with the relevant national public authority referred to in article 64(3) ,the market surveillance authority of a member state finds that although an ai system is in compliance with this regulation , it presents a risk to the health or safety of persons , to the compliance with obligations under union or national law intended to protect fundamental rights , environment , european values as enshrined in article 2 teu or to other aspects of public interest protection , it shall require the relevant operator to take all appropriate measures to ensure that the ai system concerned , when placed on the market or put into service , no longer presents that risk , to withdraw the ai system from the market or to recall it within a reasonable period , commensurate with the nature of the risk , as it may prescribe.


### 1. where , having performed an evaluation under article 65 , the market surveillance authority of a member state finds that although an ai system is in compliance with this regulation , it presents a risk to the health or safety of persons , to the compliance with obligations under union or national law intended to protect fundamental rights or to other aspects of public interest protection , it shall require the relevant operator to take all appropriate measures to ensure that the ai system concerned , when placed on the market or put into service , no longer presents that risk , to withdraw the ai system from the market or to recall it within a reasonable period , commensurate with the nature of the risk , as it may prescribe. ### 1. where , having performed an evaluation under article 65 , the market surveillance authority of a member state finds that although an ai system is in compliance with this regulation , it presents a risk to the health or safety of persons , it shall require the relevant operator to take all appropriate measures to ensure that the ai system concerned , when placed on the market or put into service , no longer presents that risk , to withdraw the ai system from the market or to recall it within a reasonable period , commensurate with the nature of the risk , as it may prescribe.


### 1. where , having performed an evaluation under article 65 , the market surveillance authority of a member state finds that although an ai system is in compliance with this regulation , it presents a risk to the health or safety of persons , to the compliance with obligations under union or national law intended to protect fundamental rights or to other aspects of public interest protection , it shall require the relevant operator to take all appropriate measures to ensure that the ai system concerned , when placed on the market or put into service , no longer presents that risk , to withdraw the ai system from the market or to recall it within a reasonable period , commensurate with the nature of the risk , as it may prescribe. ### 1. where , having performed an evaluation under article 65 , the market surveillance authority of a member state finds that although an ai system is in compliance with this regulation , it presents a risk to the health or safety of persons , to the environment , to the compliance with obligations under union or national law intended to protect fundamental rights or to other aspects of public interest protection , it shall require the relevant operator to take all appropriate measures to ensure that the ai system concerned , when placed on the market or put into service , no longer presents that risk , to withdraw the ai system from the market or to recall it within a reasonable period , commensurate with the nature of the risk , as it may prescribe.


### 3. codes of conduct may be drawn up by individual providers of ai systems or by organisations representing them or by both , including with the involvement of users and any interested stakeholders and their representative organisations. codes of conduct may cover one or more ai systems taking into account the similarity of the intended purpose of the relevant systems. ### 3. codes of conduct may be drawn up by individual providers of ai systems or by organisations representing them or by both , including with the involvement of users and any interested stakeholders and their representative organisations , including in particular trade unions and consumers organisations. codes of conduct may cover one or more ai systems taking into account the similarity of the intended purpose of the relevant systems.


### 3. codes of conduct may be drawn up by individual providers of ai systems or by organisations representing them or by both , including with the involvement of users and any interested stakeholders and their representative organisations. codes of conduct may cover one or more ai systems taking into account the similarity of the intended purpose of the relevant systems. ### 3. codes of conduct may be drawn up by individual developers and deployers of ai systems or by organisations representing them or by both , including with the involvement of users and any interested stakeholders and their representative organisations , in particular trade unions , and consumer organisations. codes of conduct may cover one or more ai systems taking into account the similarity of the purpose of the relevant systems.


### 1. national competent authorities and notified bodies involved in the application of this regulation shall respect the confidentiality of information and data obtained in carrying out their tasks and activities in such a manner as to protect , in particular: ### 1. national supervisory authorities , national competent authorities and notified bodies involved in the application of this regulation shall respect the confidentiality of information and data obtained in carrying out their tasks and activities in such a manner as to protect , in particular:


### the nature , gravity and duration of the infringement and of its consequences; ### the nature , gravity and duration of the infringement and of its consequences , including to affected persons;


### ai systems intended to be used for the ‘real-time’ and ‘post’ remote biometric identification of natural persons; ### deleted


### ai systems intended to be used for the ‘real-time’ and ‘post’ remote biometric identification of natural persons; ### ai systems that are or may be used for the biometric identification of natural persons , including in workplaces , in educational settings and in border surveillance , or for the provision of public or essential services;


### ai systems intended to be used as safety components in the management and operation of road traffic and the supply of water , gas , heating and electricity. ### ai systems intended to be used as safety components in the management and operation of road traffic and the supply of water , gas , heating , telecommunications , and electricity.


### ai systems intended to be used as safety components in the management and operation of road traffic and the supply of water , gas , heating and electricity. ### ai systems intended to be used as safety components in the management and operation of road traffic , digital infrastructure , and the supply of water , gas , heating and electricity;


### ai intended to be used for making decisions on promotion and termination of work-related contractual relationships , for task allocation and for monitoring and evaluating performance and behavior of persons in such relationships. ### ai intended to be used for making decisions on establishment , promotion and termination of work-related contractual relationships , for task allocation and for monitoring and evaluating performance and behavior of persons in such relationships.


### ai intended to be used for making decisions on promotion and termination of work-related contractual relationships , for task allocation and for monitoring and evaluating performance and behavior of persons in such relationships. ### ai intended to be used for making decisions affecting the initiation , establishment , implementation , promotion and termination of an employment relationship , including ai systems intended to support collective legal and regulatory matters , particularly for task allocation and for monitoring and evaluating performance and behavior of persons or in matters of training or further education in such relationships.


### ai intended to be used for making decisions on promotion and termination of work-related contractual relationships , for task allocation and for monitoring and evaluating performance and behavior of persons in such relationships. ### ai intended to be used for making decisions affecting the initiation , establishment , implementation and termination of an employment relationship , including ai systems intended to support collective legal and regulatory matters , particularly for task allocation and for monitoring and evaluating performance and behavior of persons in such relationships. .


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