‍Updated on Feb 6^th 2024 based on the version endorsed by the Coreper I on Feb 2^nd

As regards stand-alone AI systems, meaning high-risk AI systems other than those that are safety components of products, or which are themselves products, it is appropriate to classify them as high-risk if, in the light of their intended purpose, they pose a high risk of harm to the health and safety or the fundamental rights of persons, taking into account both the severity of the possible harm and its probability of occurrence and they are used in a number of specifically pre-defined areas specified in the Regulation. The identification of those systems is based on the same methodology and criteria envisaged also for any future amendments of the list of high-risk AI systems that the Commission should be empowered to adopt, via delegated acts, to take into account the rapid pace of technological development, as well as the potential changes in the use of AI systems.

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Classification of Safety Components by Intended Purpose

As regards high-risk AI systems other than those that are safety components of products, or which are themselves products, it is appropriate to classify them as high-risk if, in the light of their intended purpose, they pose a high risk of harm to the health and safety or the fundamental rights of persons, taking into account both the severity of the possible harm and its probability of occurrence, and they are used in a number of specifically pre-defined areas specified in the Regulation. The identification of those systems is based on the same methodology and criteria envisaged also for any future amendments of the list of high-risk AI systems. It is also important to clarify that within the high-risk scenarios referred to in Annex III there may be systems that do not lead to a significant risk to the legal interests protected under those scenarios, taking into account the output produced by the AI system. Therefore only when such output has a high degree of importance (i.e. is not purely accessory) in respect of the relevant action or decision so as to generate a significant risk to the legal interests protected, the AI system generating such output should be considered as high-risk. For instance, when the information provided by an AI systems to the human consists of the profiling of natural persons within the meaning of Article 4(4) Regulation (EU) 2016/679 and Article 3(4) of Directive (EU) 2016/680 and Article 3(5) of Regulation (EU) 2018/1725, such information should not typically be considered of accessory nature in the context of high risk AI systems as referred to in Annex III. However, if the output of the AI system has only negligible or minor relevance for human action or decision, it may be considered purely accessory, including for example, AI systems used for translation for informative purposes or for the management of documents.