Recital 22 AI systems not placed on the market


In light of their digital nature, certain AI systems means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; should fall within the scope of this Regulation even when they are not placed on the market, put into service, or used in the Union. This is the case, for example, where an operator means a provider, product manufacturer, deployer, authorised representative, importer or distributor; established in the Union contracts certain services to an operator means a provider, product manufacturer, deployer, authorised representative, importer or distributor; established in a third country in relation to an activity to be performed by an AI system means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; that would qualify as high-risk. In those circumstances, the AI system means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; used in a third country by the operator means a provider, product manufacturer, deployer, authorised representative, importer or distributor; could process data lawfully collected in and transferred from the Union, and provide to the contracting operator means a provider, product manufacturer, deployer, authorised representative, importer or distributor; in the Union the output of that AI system means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; resulting from that processing, without that AI system means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; being placed on the market, put into service or used in the Union. To prevent the circumvention of this Regulation and to ensure an effective protection of natural persons located in the Union, this Regulation should also apply to providers means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; and deployers means a 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; of AI systems means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; that are established in a third country, to the extent the output produced by those systems is intended to be used in the Union. Nonetheless, to take into account existing arrangements and special needs for future cooperation with foreign partners with whom information and evidence is exchanged, this Regulation should not apply to public authorities of a third country and international organisations when acting in the framework of cooperation or international agreements concluded at Union or national level for law enforcement means activities carried out by law enforcement authorities or on their behalf for the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including safeguarding against and preventing threats to public security; and judicial cooperation with the Union or the Member States, provided that the relevant third country or international organisation provides adequate safeguards with respect to the protection of fundamental rights and freedoms of individuals. Where relevant, this may cover activities of entities entrusted by the third countries to carry out specific tasks in support of such law enforcement means activities carried out by law enforcement authorities or on their behalf for the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including safeguarding against and preventing threats to public security; and judicial cooperation. Such framework for cooperation or agreements have been established bilaterally between Member States and third countries or between the European Union, Europol and other Union agencies and third countries and international organisations. The authorities competent for supervision of the law enforcement means activities carried out by law enforcement authorities or on their behalf for the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including safeguarding against and preventing threats to public security; and judicial authorities under this Regulation should assess whether those frameworks for cooperation or international agreements include adequate safeguards with respect to the protection of fundamental rights and freedoms of individuals. Recipient national authorities and Union institutions, bodies, offices and agencies making use of such outputs in the Union remain accountable to ensure their use complies with Union law. When those international agreements are revised or new ones are concluded in the future, the contracting parties should make utmost efforts to align those agreements with the requirements of this Regulation.

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