Recital 22
(22)
In light of their digital nature, certain AI systems 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 operatoroperatormeans a provider, product manufacturer, deployer, authorised representative, importer or distributorArticle 3(8) established in the Union contracts certain services to an operatoroperatormeans a provider, product manufacturer, deployer, authorised representative, importer or distributorArticle 3(8) established in a third country in relation to an activity to be performed by an AI systemAI systemmeans 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 environmentsArticle 3(1) that would qualify as high-risk. In those circumstances, the AI systemAI systemmeans 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 environmentsArticle 3(1) used in a third country by the operatoroperatormeans a provider, product manufacturer, deployer, authorised representative, importer or distributorArticle 3(8) could process data lawfully collected in and transferred from the Union, and provide to the contracting operatoroperatormeans a provider, product manufacturer, deployer, authorised representative, importer or distributorArticle 3(8) in the Union the output of that AI systemAI systemmeans 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 environmentsArticle 3(1) resulting from that processing, without that AI systemAI systemmeans 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 environmentsArticle 3(1) being placed on the market, put into service or used in the Union. To prevent the circumvention of this Regulation and to ensure an effective protection of natural persons located in the Union, this Regulation should also apply to providers and deployers of AI systems 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 enforcementlaw enforcementmeans 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 securityArticle 3(46) 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 rightsfundamental rightsIncludes human dignity, right to life, prohibition of torture, protection of personal datapersonal dataAny information relating to an identified or identifiable natural person ('data subjectsubjectfor the purpose of real-world testing, means a natural person who participates in testing in real-world conditionsArticle 3(58)data subjectsubjectfor the purpose of real-world testing, means a natural person who participates in testing in real-world conditionsArticle 3(58)An identified or identifiable natural person to whom personal data relateGDPR Art. 4(1)'). Includes name, ID number, location data, online identifiers, or factors specific to physical, physiological, genetic, mental, economic, cultural or social identityGDPR Art. 4(1), freedom of expression, non-discrimination, equality between women and men, rights of the child, right to an effective remedy and fair trialCharter of Fundamental Rights Art. 1–54 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 enforcementlaw enforcementmeans 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 securityArticle 3(46) 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 enforcementlaw enforcementmeans 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 securityArticle 3(46) 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 rightsfundamental rightsIncludes human dignity, right to life, prohibition of torture, protection of personal datapersonal dataAny information relating to an identified or identifiable natural person ('data subjectsubjectfor the purpose of real-world testing, means a natural person who participates in testing in real-world conditionsArticle 3(58)data subjectsubjectfor the purpose of real-world testing, means a natural person who participates in testing in real-world conditionsArticle 3(58)An identified or identifiable natural person to whom personal data relateGDPR Art. 4(1)'). Includes name, ID number, location data, online identifiers, or factors specific to physical, physiological, genetic, mental, economic, cultural or social identityGDPR Art. 4(1), freedom of expression, non-discrimination, equality between women and men, rights of the child, right to an effective remedy and fair trialCharter of Fundamental Rights Art. 1–54 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.