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# Tools for Navigating the EU AI Act: (1) provisional Final Text with Interactive Table of Contents

Shavine Menaf Sedik, Theodore Christakis

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## To cite this version:

Shavine Menaf Sedik, Theodore Christakis. Tools for Navigating the EU AI Act: (1) provisional Final Text with Interactive Table of Contents. 2024. hal-04845336

HAL Id: hal-04845336

https://hal.univ-grenoble-alpes.fr/hal-04845336v1

Submitted on 18 Dec 2024

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Distributed under a Creative Commons Attribution 4.0 International License
# Tools for Navigating the EU AI Act:
## (1) Final Text with Interactive
## Table of Contents

By AI Regulation Team

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# Tools for Navigating the EU AI Act:
## (1) Final Text with Interactive Table of Contents

After an intensive legislative process lasting almost three years, the world's first comprehensive rulebook for Artificial Intelligence - the EU AI Regulation, better known as the "EU AI Act" - is on the verge of adoption.

The [provisional agreement](#) on the proposal, reached in December between the Council presidency and the European Parliament's negotiators, has been finalised and unanimously [adopted](#) by the Council of the EU on 2 February 2024. As far as the European Parliament is concerned, MEPs at the level of the internal market and civil liberties committees [endorsed](#) the Council's finalised provisional agreement on 13 February. The text awaits formal adoption at the Parliament's plenary session in April and final endorsement by the Council. It will enter into force immediately afterwards but will only become applicable in two years. Still, companies and institutions need to study the text and start making the necessary preparations.

In anticipation of AI Act's publication on the Official Journal of the EU, expected in a few months, the [MIAI AI-Regulation Chair](#) intends to help practitioners and the academic community navigating the lengthy and complex text of 252 pages. To facilitate this, an interactive Table of Contents (ToC) is being published today. This allows for a comprehensive overview of the AI Act's structure, enabling users to "click" and be directly transferred to different Titles, Chapters, and Articles.

The work is based on the final text circulated on February 2, 2024, but is subject to formatting adjustments, including the attribution of final numbers for the articles (which, for the time being, reflect the additions made during the legislative process) and linguistic interventions. When the

definitive formatted text becomes available, the interactive ToC will be updated accordingly.

Shavine MENAF SEDIK, a post-graduate student in the Master of International Security, Cybersecurity, and Defense at the School of Law of the University Grenoble Alpes, prepared the interactive Table of Contents within the framework of the AI Governance and Regulation class taught by Professor Theodore Christakis. The AI-Regulation Chair expresses gratitude for her contribution.

The AI-Regulation Chair will soon publish additional materials to help researchers understand and navigate the EU AI Act.
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**Cover Photo** : Created by DALL-E, prompt by Theodore Christakis : "Generate an image for the cover of a publication titled 'Navigating the EU AI Act: Final Text with Interactive Table of Contents'. The image should be abstract art-inspired and prominently feature the flag of the European Union. Incorporate vibrant colors and dynamic shapes to convey a sense of modernity and innovation, reflecting the complex and evolving nature of AI legislation within the European Union."

**To cite this article:** AI Regulation, Tools for Navigating the EU AI Act: (1) Final Text with Interactive Table of Contents
AI Regulation Papers 24-02-2, AI-Regulation.com, February 19th, 2024.

This work has been partially supported by MIAI @ Grenoble Alpes, (ANR-19-P3IA-0003) and by the Interdisciplinary Project on Privacy (IPoP) of the Cybersecurity PEPR (ANR 22-PECY-0002 IPOP).
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Council of the
European Union

Brussels, 2 February 2024

Interinstitutional File:
2021/0106 (COD)

Subject: Proposal for a Regulation of the European Parliament and of the Council laying down harmonised rules on artificial intelligence (Artificial Intelligence Act) and amending certain union legislative acts

The Annex contains the consolidated compromise text of the above draft Regulation, subject to revisions by the legal linguists of both institutions.
Table of Contents

<table><tr><td>REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL</td><td>1</td></tr><tr><td>RECITALS</td><td>1</td></tr><tr><td>TITLE I GENERAL PROVISIONS</td><td>80</td></tr><tr><td>Article 1 - Subject matter</td><td>80</td></tr><tr><td>Article 2 - Scope</td><td>81</td></tr><tr><td>Article 3 - Definitions</td><td>83</td></tr><tr><td>Article 4b - AI literacy</td><td>92</td></tr><tr><td>TITLE II - PROHIBITED ARTIFICIAL INTELLIGENCE PRACTICES</td><td>92</td></tr><tr><td>Article 5 - Prohibited Artificial Intelligence Practices</td><td>92</td></tr><tr><td>TITLE III - HIGH-RISK AI SYSTEMS</td><td>97</td></tr><tr><td>Chapter 1 - CLASSIFICATION OF AI SYSTEMS AS HIGH-RISK</td><td>97</td></tr><tr><td>Article 6 - Classification rules for high-risk AI systems</td><td>97</td></tr><tr><td>Article 7 - Amendments to Annex III</td><td>99</td></tr><tr><td>Chapter 2 - REQUIREMENTS FOR HIGH-RISK AI SYSTEMS</td><td>101</td></tr><tr><td>Article 8 - Compliance with the requirements</td><td>101</td></tr><tr><td>Article 9 - Risk management system</td><td>102</td></tr><tr><td>Article 10 - Data and data governance</td><td>104</td></tr><tr><td>Article 11 - Technical documentation</td><td>106</td></tr><tr><td>Article 12 - Record-keeping</td><td>107</td></tr><tr><td>Article 13 - Transparency and provision of information to deployers</td><td>107</td></tr><tr><td>Article 14 - Human oversight</td><td>109</td></tr><tr><td>Article 15 - Accuracy, robustness and cybersecurity</td><td>111</td></tr><tr><td>Chapter 3 - OBLIGATIONS OF PROVIDERS AND DEPLOYERS OF HIGH-RISK AI SYSTEMS AND OTHER PARTIES</td><td>112</td></tr><tr><td>Article 16 - Obligations of providers of high-risk AI systems</td><td>112</td></tr><tr><td>Article 17 - Quality management system</td><td>113</td></tr><tr><td>Article 18 - Documentation keeping</td><td>115</td></tr><tr><td>Article 20 - Automatically generated logs</td><td>116</td></tr><tr><td>Article 21 - Corrective actions and duty of information</td><td>116</td></tr><tr><td>Article 23 - Cooperation with competent authorities</td><td>117</td></tr><tr><td>Article 25 - Authorised representatives</td><td>117</td></tr><tr><td>Article 26 - Obligations of importers</td><td>119</td></tr><tr><td>Article 27 - Obligations of distributors</td><td>120</td></tr><tr><td>Article 28 - Responsibilities along the AI value chain</td><td>121</td></tr><tr><td>Article 29 - Obligations of deployers of high-risk AI systems</td><td>123</td></tr><tr><td>Article 29a - Fundamental rights impact assessment for high-risk AI systems</td><td>126</td></tr><tr><td>Chapter 4 - NOTIFIYING AUTHORITIES AND NOTIFIED BODIES</td><td>127</td></tr><tr><td>Article 30 - Notifying authorities</td><td>127</td></tr><tr><td>Article 31 - Application of a conformity assessment body for notification</td><td>128</td></tr><tr><td>Article 32 - Notification procedure</td><td>129</td></tr><tr><td>Article 33 - Requirements relating to notified bodies</td><td>130</td></tr></table>
<table>
  <tbody>
    <tr>
      <td>Article 33a - Presumption of conformity with requirements relating to notified bodies</td>
      <td>132</td>
    </tr>
    <tr>
      <td>Article 34 - Subsidiaries of and subcontracting by notified bodies</td>
      <td>132</td>
    </tr>
    <tr>
      <td>Article 34a - Operational obligations of notified bodies</td>
      <td>132</td>
    </tr>
    <tr>
      <td>Article 35 - Identification numbers and lists of notified bodies designated under this Regulation</td>
      <td>133</td>
    </tr>
    <tr>
      <td>Article 36 - Changes to notifications</td>
      <td>133</td>
    </tr>
    <tr>
      <td>Article 37 - Challenge to the competence of notified bodies</td>
      <td>136</td>
    </tr>
    <tr>
      <td>Article 38 - Coordination of notified bodies</td>
      <td>137</td>
    </tr>
    <tr>
      <td>Article 39 - Conformity assessment bodies of third countries</td>
      <td>137</td>
    </tr>
    <tr>
      <td>Chapter 5 - STANDARDS, CONFORMITY ASSESSMENT, CERTIFICATES, REGISTRATION</td>
      <td>137</td>
    </tr>
    <tr>
      <td>Article 40 - Harmonised standards and standardisation deliverables</td>
      <td>137</td>
    </tr>
    <tr>
      <td>Article 41 - Common specifications</td>
      <td>139</td>
    </tr>
    <tr>
      <td>Article 42 - presumption of conformity with certain requirements</td>
      <td>140</td>
    </tr>
    <tr>
      <td>Article 43 - Conformity assessment</td>
      <td>141</td>
    </tr>
    <tr>
      <td>Article 44 - Certificates</td>
      <td>143</td>
    </tr>
    <tr>
      <td>Article 46 - Information obligations of notified bodies</td>
      <td>144</td>
    </tr>
    <tr>
      <td>Article 47 - Derogation from conformity assessment procedure</td>
      <td>145</td>
    </tr>
    <tr>
      <td>Article 48 - EU declaration of conformity</td>
      <td>146</td>
    </tr>
    <tr>
      <td>Article 49 - CE marking of conformity</td>
      <td>147</td>
    </tr>
    <tr>
      <td>Article 51 - Registration</td>
      <td>148</td>
    </tr>
    <tr>
      <td>TITLE IV - TRANSPARENCY OBLIGATIONS FOR PROVIDERS AND DEPLOYERS OF CERTAIN AI SYSTEMS</td>
      <td>149</td>
    </tr>
    <tr>
      <td>TITLE VIII - A GENERAL PURPOSE AI MODELS</td>
      <td>151</td>
    </tr>
    <tr>
      <td>Chapter 1 CLASSIFICATION RULES</td>
      <td>151</td>
    </tr>
    <tr>
      <td>Article 52a - Classification of general purpose AI models as general purpose AI models with systemic risk</td>
      <td>151</td>
    </tr>
    <tr>
      <td>Article 52b - Procedure</td>
      <td>152</td>
    </tr>
    <tr>
      <td>Chapter 2 - OBLIGATIONS FOR PROVIDERS OF GENERAL PURPOSE AI MODELS</td>
      <td>153</td>
    </tr>
    <tr>
      <td>Article 52c - Obligations for providers of general purpose AI models</td>
      <td>153</td>
    </tr>
    <tr>
      <td>Article 52ca - Authorised representative</td>
      <td>155</td>
    </tr>
    <tr>
      <td>Chapter 3 - OBLIGATIONS FOR PROVIDERS OF GENERAL PURPOSE AI MODELS WITH SYSTEMIC RISK</td>
      <td>156</td>
    </tr>
    <tr>
      <td>Article 52d - Obligations for providers of general purpose AI models with systemic risk</td>
      <td>156</td>
    </tr>
    <tr>
      <td>Article 52e - Codes of practice</td>
      <td>157</td>
    </tr>
    <tr>
      <td>TITLE V - MEASURES IN SUPPORT OF INNOVATION</td>
      <td>159</td>
    </tr>
    <tr>
      <td>Article 53 - AI regulatory sandboxes</td>
      <td>159</td>
    </tr>
    <tr>
      <td>Article 53a - Modalities and functioning of AI regulatory sandboxes</td>
      <td>163</td>
    </tr>
    <tr>
      <td>Article 54 - Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory sandbox</td>
      <td>165</td>
    </tr>
    <tr>
      <td>Article 54a - Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes</td>
      <td>167</td>
    </tr>
    <tr>
      <td>Article 54b - Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes</td>
      <td>171</td>
    </tr>
    <tr>
      <td>Article 55 - Measures for providers and deployers, in particular SMEs, including start-ups</td>
      <td>171</td>
    </tr>
    <tr>
      <td>Article 55a - Derogations for specific operators</td>
      <td>173</td>
    </tr>
    <tr>
      <td>TITLE VI GOVERNANCE</td>
      <td>173</td>
    </tr>
  </tbody>
</table>
<table>
  <tbody>
    <tr>
      <td>Article 55b - Governance at Union level</td>
      <td>173</td>
    </tr>
    <tr>
      <td>Chapter 1 - EUROPEAN ARTIFICIAL INTELLIGENCE BOARD</td>
      <td>174</td>
    </tr>
    <tr>
      <td>Article 56 - Establishment and structure of the European Artificial Intelligence Board</td>
      <td>174</td>
    </tr>
    <tr>
      <td>Article 58 - Tasks of the Board</td>
      <td>175</td>
    </tr>
    <tr>
      <td>Article 58a - Advisory forum</td>
      <td>178</td>
    </tr>
    <tr>
      <td>Chapter 1a - SCIENTIFIC PANEL OF INDEPENDENT EXPERTS</td>
      <td>179</td>
    </tr>
    <tr>
      <td>Article 58b - Scientific panel of independent experts</td>
      <td>179</td>
    </tr>
    <tr>
      <td>Article 58c - Access to the pool of experts by the Member States</td>
      <td>181</td>
    </tr>
    <tr>
      <td>Chapter 2 - NATIONAL COMPETENT AUTHORITIES</td>
      <td>181</td>
    </tr>
    <tr>
      <td>Article 59 - Designation of national competent authorities and single point of contact</td>
      <td>181</td>
    </tr>
    <tr>
      <td>TITLE VII - EU DATABASE FOR HIGH-RISK AI SYSTEMS LISTED IN ANNEX III</td>
      <td>183</td>
    </tr>
    <tr>
      <td>Article 60 - EU database for high-risk AI systems listed in Annex III</td>
      <td>183</td>
    </tr>
    <tr>
      <td>TITLE VIII - POST-MARKET MONITORING, INFORMATION SHARING, MARKET SURVEILLANCE</td>
      <td>184</td>
    </tr>
    <tr>
      <td>Chapter 1 - POST-MARKET MONITORING</td>
      <td>184</td>
    </tr>
    <tr>
      <td>Article 61 - Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems</td>
      <td>184</td>
    </tr>
    <tr>
      <td>Chapter 2 - SHARING OF INFORMATION ON SERIOUS INCIDENTS</td>
      <td>185</td>
    </tr>
    <tr>
      <td>Article 62 - Reporting of serious incidents</td>
      <td>185</td>
    </tr>
    <tr>
      <td>Chapter 3 - ENFORCEMENT</td>
      <td>187</td>
    </tr>
    <tr>
      <td>Article 63 - Market surveillance and control of AI systems in the Union market</td>
      <td>187</td>
    </tr>
    <tr>
      <td>Article 63a - Mutual Assistance, market surveillance and control of general purpose AI systems</td>
      <td>190</td>
    </tr>
    <tr>
      <td>Article 63b - Supervision of testing in real world conditions by market surveillance authorities</td>
      <td>191</td>
    </tr>
    <tr>
      <td>Article 64 - Powers of authorities protecting fundamental rights</td>
      <td>192</td>
    </tr>
    <tr>
      <td>Article 65 - Procedure for dealing with AI systems presenting a risk at national level</td>
      <td>193</td>
    </tr>
    <tr>
      <td>Article 65a - Procedure for dealing with AI systems classified by the provider as a not high-risk in application of Annex III</td>
      <td>195</td>
    </tr>
    <tr>
      <td>Article 66 - Union safeguard procedure</td>
      <td>196</td>
    </tr>
    <tr>
      <td>Article 67 - Compliant AI systems which present a risk</td>
      <td>197</td>
    </tr>
    <tr>
      <td>Article 68 - Formal non-compliance</td>
      <td>198</td>
    </tr>
    <tr>
      <td>Article 68a - EU AI testing support structures in the area of artificial intelligence</td>
      <td>198</td>
    </tr>
    <tr>
      <td>Chapter 3b - REMEDIES</td>
      <td>199</td>
    </tr>
    <tr>
      <td>Article 68a - Right to lodge a complaint with a market surveillance authority</td>
      <td>199</td>
    </tr>
    <tr>
      <td>Article 68c - A right to explanation of individual decision-making</td>
      <td>199</td>
    </tr>
    <tr>
      <td>Article 68d - Amendment to Directive (EU) 2020/1828</td>
      <td>200</td>
    </tr>
    <tr>
      <td>Article 68e - Reporting of breaches and protection of reporting persons</td>
      <td>200</td>
    </tr>
    <tr>
      <td>Chapter 3c - SUPERVISION, INVESTIGATION, ENFORCEMENT AND MONITORING IN RESPECT OF PROVIDERS OF GENERAL PURPOSE AI MODELS</td>
      <td>200</td>
    </tr>
    <tr>
      <td>Article 68f - Enforcement of obligations on providers of general purpose AI models</td>
      <td>200</td>
    </tr>
    <tr>
      <td>Article 68g - Monitoring actions</td>
      <td>201</td>
    </tr>
    <tr>
      <td>Article 68h - Alerts of systemic risks by the scientific panel</td>
      <td>201</td>
    </tr>
    <tr>
      <td>Article 68i - Power to request documentation and information</td>
      <td>202</td>
    </tr>
    <tr>
      <td>Article 68j - Power to conduct evaluations</td>
      <td>203</td>
    </tr>
  </tbody>
</table>
<table><tr><td>Article 68k - Power to request measures</td><td>204</td></tr><tr><td>Article 68m - Procedural rights of economic operators of the general purpose AI model</td><td>205</td></tr><tr><td>TITLE IX CODES OF CONDUCT</td><td>205</td></tr><tr><td>Article 69 - Codes of conduct for voluntary application of specific requirements</td><td>205</td></tr><tr><td>TITLE X - CONFIDENTIALITY AND PENALTIES</td><td>206</td></tr><tr><td>Article 70 - Confidentiality</td><td>206</td></tr><tr><td>Article 71 - Penalties</td><td>208</td></tr><tr><td>Article 72 - Administrative fines on Union institutions, agencies and bodies</td><td>211</td></tr><tr><td>Article 72a - Fines for providers of general purpose AI models</td><td>212</td></tr><tr><td>TITLE XI - DELEGATION OF POWER AND COMMITTEE PROCEDURE</td><td>214</td></tr><tr><td>Article 73 - Exercise of the delegation</td><td>214</td></tr><tr><td>Article 74 - Committee procedure</td><td>215</td></tr><tr><td>TITLE XII - FINAL PROVISIONS</td><td>215</td></tr><tr><td>Article 75 - Amendment to Regulation (EC) No 300/2008</td><td>215</td></tr><tr><td>Article 76 - Amendment to Regulation (EU) No 167/2013</td><td>215</td></tr><tr><td>Article 77 - Amendment to Regulation (EU) No 168/2013</td><td>216</td></tr><tr><td>Article 78 - Amendment to Directive 2014/90/EU</td><td>216</td></tr><tr><td>Article 79 - Amendment to Directive (EU) 2016/797</td><td>217</td></tr><tr><td>Article 80 - Amendment to Regulation (EU) 2018/858</td><td>217</td></tr><tr><td>Article 81 - Amendment to Regulation (EU) 2018/1139</td><td>218</td></tr><tr><td>Article 82 - Amendment to Regulation (EU) 2019/2144</td><td>219</td></tr><tr><td>Article 82a - Guidelines from the Commission on the implementation of this Regulation</td><td>219</td></tr><tr><td>Article 83 - AI systems already placed on the market or put into service</td><td>220</td></tr><tr><td>Article 84 - Evaluation and review</td><td>221</td></tr><tr><td>Article 85 - Entry into force and application</td><td>224</td></tr><tr><td>ANNEX II - List of Union harmonisation legislation</td><td>225</td></tr><tr><td>Part I - Section A. List of Union harmonisation legislation based on the New Legislative Framework</td><td>225</td></tr><tr><td>Part II - Section B. List of other Union harmonisation legislation</td><td>226</td></tr><tr><td>ANNEX IIa - List of criminal offences referred to in Article 5 (1)(iii)</td><td>228</td></tr><tr><td>ANNEX III - High-risk AI systems referred to in article 6(2)</td><td>229</td></tr><tr><td>ANNEX IV - Technical documentation referred to in article 11(1)</td><td>233</td></tr><tr><td>ANNEX V - EU declaration of conformity</td><td>236</td></tr><tr><td>ANNEX VI - Conformity assessment procedure based on internal control</td><td>237</td></tr><tr><td>ANNEX VII - Conformity based on assessment of quality management system and assessment of technical documentation</td><td>238</td></tr><tr><td>ANNEX VIII - Information to be submitted upon the registration of high-risk AI systems in accordance with Article 51</td><td>242</td></tr><tr><td>SECTION A - Information to be submitted by providers of high-risk AI systems in accordance with Article 51(1)</td><td>242</td></tr><tr><td>SECTION B - Information to be submitted by deployers of high-risk AI systems in accordance with Article 51(1b)</td><td>243</td></tr><tr><td>SECTION C - Information to be submitted by providers of high-risk AI systems in accordance with Article 51(1a)</td><td>243</td></tr><tr><td>ANNEX VIIIa - Information to be submitted upon the registration of high-risk ai systems listed in annex iii in</td><td></td></tr></table>
<table><tr><td>relation to testing in real world conditions in accordance with Article 54a</td><td>245</td></tr><tr><td>ANNEX IX - Union legislation on large-scale IT systems in the area of Freedom, Security and Justice</td><td>246</td></tr><tr><td>ANNEX IXa - Technical documentation referred to in Article 52c(1a): technical documentation for providers of general purpose AI models:</td><td>249</td></tr><tr><td>Section 1 - Information to be provided by all providers of general-purpose AI models</td><td>249</td></tr><tr><td>Section 2 - Additional information to be provided by providers of general purpose AI model with systemic risk</td><td>250</td></tr><tr><td>ANNEX IXb - Transparency information referred to in Article 52c(1b): technical documentation for providers of general purpose AI models to downstream providers that integrate the model into their AI system</td><td>251</td></tr><tr><td>ANNEX IXc - Criteria for the designation of general purpose AI models with systemic risk referred to in article 52a</td><td>252</td></tr></table>
Proposal for a

# REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL LAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE (ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNION LEGISLATIVE ACTS

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 16 and 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee<fnref n="1" />,

Having regard to the opinion of the European Central Bank<fnref n="2" />,

Having regard to the joint opinion of the European Data Protection Board and the European Data Protection Supervisor,

Having regard to the opinion of the Committee of the Regions<fnref n="3" />,

Acting in accordance with the ordinary legislative procedure,

Whereas:

<footnote>(1) The purpose of this Regulation is to improve the functioning of the internal market by laying down a uniform legal framework in particular for the development, placing on the market, putting into service and the use of artificial intelligence systems in the Union in</footnote>

<footnote n="1">¹ OJ C [...], [...], p. [...].</footnote>

<footnote n="2">² Reference to ECB opinion.</footnote>

<footnote n="3">³ OJ C [...], [...], p. [...].</footnote>
conformity with Union values, to promote the uptake of human centric and trustworthy artificial intelligence while ensuring a high level of protection of health, safety, fundamental rights enshrined in the Charter, including democracy and rule of law and environmental protection, against harmful effects of artificial intelligence systems in the Union and to support innovation. This regulation ensures the free movement of AI-based goods and services cross-border, thus preventing Member States from imposing restrictions on the development, marketing and use of Artificial Intelligence systems (AI systems), unless explicitly authorised by this Regulation.

(1a) This Regulation should be applied in conformity with the values of the Union enshrined in the Charter facilitating the protection of individuals, companies, democracy and rule of law and the environment while boosting innovation and employment and making the Union a leader in the uptake of trustworthy AI.

(2) 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, import 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, innovation, deployment and uptake 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 remote biometric identification for the purpose of law enforcement, for the use of AI systems for risk assessments of natural persons for the purpose of law enforcement and for the use of AI systems of biometric categorization 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.
(3) Artificial intelligence is a fast evolving family of technologies that contributes to a wide array of economic, environmental and societal benefits across the entire spectrum of industries and social activities. By improving prediction, optimising operations and resource allocation, and personalising digital solutions available for individuals and organisations, the use of artificial intelligence can provide key competitive advantages to companies and support socially and environmentally beneficial outcomes, for example in healthcare, farming, food safety, education and training, media, sports, culture, infrastructure management, energy, transport and logistics, public services, security, justice, resource and energy efficiency, environmental monitoring, the conservation and restoration of biodiversity and ecosystems and climate change mitigation and adaptation.

(4) At the same time, depending on the circumstances regarding its specific application, use, and level of technological development, artificial intelligence may generate risks and cause harm to public interests and fundamental rights that are protected by Union law. Such harm might be material or immaterial, including physical, psychological, societal or economic harm.

(4a) Given the major impact that artificial intelligence can have on society and the need to build trust, it is vital for artificial intelligence and its regulatory framework to be developed according to Union values enshrined in Article 2 TEU, the fundamental rights and freedoms enshrined in the Treaties, the Charter. As a pre-requisite, artificial intelligence should be a human-centric technology. It should serve as a tool for people, with the ultimate aim of increasing human well-being.

(4aa) In order to ensure a consistent and high level of protection of public interests as regards health, safety and fundamental rights, common rules for all high-risk AI systems should be established. Those rules should be consistent with the Charter of fundamental rights of the European Union (the Charter) and should be non-discriminatory and in line with the Union's international trade commitments. They should also take into account the European Declaration on Digital Rights and Principles for the Digital Decade (2023/C 23/01) and the Ethics Guidelines for Trustworthy Artificial Intelligence (AI) of the High-Level Expert Group on Artificial Intelligence.

(5) A Union legal framework laying down harmonised rules on artificial intelligence is therefore needed to foster the development, use and uptake of artificial intelligence in the internal market that at the same time meets a high level of protection of public interests, such as health and safety and the protection of fundamental rights, including democracy,
rule of law and environmental protection as recognised and protected by Union law. To
achieve that objective, rules regulating the placing on the market, putting into service and
use of certain AI systems should be laid down, thus ensuring the smooth functioning of the
internal market and allowing those systems to benefit from the principle of free movement
of goods and services. These rules should be clear and robust in protecting fundamental
rights, supportive of new innovative solutions, enabling to a European ecosystem of public
and private actors creating AI systems in line with Union values and unlocking the
potential of the digital transformation across all regions of the Union. By laying down
those rules as well as measures in support of innovation with a particular focus on SMEs
including startups, this Regulation supports the objective of promoting the European
human-centric approach to AI and being a global leader in the development of secure,
trustworthy and ethical artificial intelligence as stated by the European Council<fnref n="4" />, and it
ensures the protection of ethical principles, as specifically requested by the European
Parliament<fnref n="5" />.

(5a) The harmonised rules on the placing on the market, putting into service and use of AI systems laid down in this Regulation should apply across sectors and, in line with its New Legislative Framework approach, should be without prejudice to existing Union law, notably on data protection, consumer protection, fundamental rights, employment, and protection of workers, and product safety, to which this Regulation is complementary. As a consequence all rights and remedies provided for by such Union law to consumers, and other persons who may be negatively impacted by AI systems, including as regards the compensation of possible damages pursuant to Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products, remain unaffected and fully applicable. Furthermore, in the context of employment and protection of workers, this Regulation should therefore not affect Union law on social policy and national labour law, in compliance with Union law, concerning employment and working conditions, including health and safety at work and the relationship between employers and workers. This Regulation should also not affect the exercise of fundamental rights as recognised in the Member States and at Union level, including the right or freedom to strike or to take other action covered by the specific industrial relations systems in Member States as well as, the right to negotiate, to conclude and enforce collective agreements or to take collective

<footnote n="4">⁴ European Council, Special meeting of the European Council (1 and 2 October 2020) – Conclusions, EUCO 13/20, 2020, p. 6.</footnote>

<footnote n="5">⁵ European Parliament resolution of 20 October 2020 with recommendations to the Commission on a framework of ethical aspects of artificial intelligence, robotics and related technologies, 2020/2012(INL).</footnote>
action in accordance with national law. [This Regulation should not affect the provisions
aiming to improve working conditions in platform work set out in Directive ... [COD
2021/414/EC]] On top of that, this Regulation aims to strengthen the effectiveness of such
existing rights and remedies by establishing specific requirements and obligations,
including in respect of transparency, technical documentation and record-keeping of AI
systems. Furthermore, the obligations placed on various operators involved in the AI value
chain under this Regulation should apply without prejudice to national laws, in compliance
with Union law, having the effect of limiting the use of certain AI systems where such
laws fall outside the scope of this Regulation or pursue other legitimate public interest
objectives than those pursued by this Regulation. For example, national labour law and the
laws on the protection of minors (i.e. persons below the age of 18) taking into account the
United Nations General Comment No 25 (2021) on children's rights, insofar as they are
not specific to AI systems and pursue other legitimate public interest objectives, should not
be affected by this Regulation.

(5aa) The fundamental right to the protection of personal data is safeguarded in particular by Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive 2016/680. Directive 2002/58/EC additionally protects private life and the confidentiality of communications, including by way of providing conditions for any personal and non-personal data storing in and access from terminal equipment. Those Union legal acts provide the basis for sustainable and responsible data processing, including where datasets include a mix of personal and non-personal data. This Regulation does not seek to affect the application of existing Union law governing the processing of personal data, including the tasks and powers of the independent supervisory authorities competent to monitor compliance with those instruments. It also does not affect the obligations of providers and deployers of AI systems in their role as data controllers or processors stemming from national or Union law on the protection of personal data in so far as the design, the development or the use of AI systems involves the processing of personal data. It is also appropriate to clarify that data subjects continue to enjoy all the rights and guarantees awarded to them by such Union law, including the rights related to solely automated individual decision-making, including profiling. Harmonised rules for the placing on the market, the putting into service and the use of AI systems established under this Regulation should facilitate the effective implementation and enable the exercise of the data subjects' rights and other remedies guaranteed under Union law on the protection of personal data and of other fundamental rights.
(5ab) This Regulation should be without prejudice to the provisions regarding the liability of intermediary service providers set out in Directive 2000/31/EC of the European Parliament and of the Council [as amended by the Digital Services Act].

(6) The notion of AI system in this Regulation should be clearly defined and closely aligned with the work of international organisations working on artificial intelligence to ensure legal certainty, facilitate international convergence and wide acceptance, while providing the flexibility to accommodate the rapid technological developments in this field.

Moreover, it should be based on key characteristics of artificial intelligence systems, that distinguish it from simpler traditional software systems or programming approaches and should not cover systems that are based on the rules defined solely by natural persons to automatically execute operations. A key characteristic of AI systems is their capability to infer. This inference refers to the process of obtaining the outputs, such as predictions, content, recommendations, or decisions, which can influence physical and virtual environments and to a capability of AI systems to derive models and/or algorithms from inputs/data. The techniques that enable inference while building an AI system include machine learning approaches that learn from data how to achieve certain objectives; and logic- and knowledge-based approaches that infer from encoded knowledge or symbolic representation of the task to be solved. The capacity of an AI system to infer goes beyond basic data processing, enable learning, reasoning or modelling. The term "machine-based" refers to the fact that AI systems run on machines. The reference to explicit or implicit objectives underscores that AI systems can operate according to explicit defined objectives or to implicit objectives. The objectives of the AI system may be different from the intended purpose of the AI system in a specific context. For the purposes of this Regulation, environments should be understood as the contexts in which the AI systems operate, whereas outputs generated by the AI system, reflect different functions performed by AI systems and include predictions, content, recommendations or decisions. AI systems are designed to operate with varying levels of autonomy, meaning that they have some degree of independence of actions from human involvement and of capabilities to operate without human intervention. The adaptiveness that an AI system could exhibit after deployment, refers to self-learning capabilities, allowing the system to change while in use. AI systems can be used on a stand-alone basis or as a component of a product, irrespective of whether the system is physically integrated into the product (embedded) or serve the functionality of the product without being integrated therein (non-embedded).
(6a) The notion of 'deployer' referred to in this Regulation should be interpreted as any natural or legal person, including a 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. Depending on the type of AI system, the use of the system may affect persons other than the deployer.

(7) The notion of biometric data used in this Regulation should be interpreted in light of the notion of biometric data as defined in Article 4(14) of Regulation (EU) 2016/679 of the European Parliament and of the Council <fnref n="6" />, Article 3(18) of Regulation (EU) 2018/1725 of the European Parliament and of the Council <fnref n="7" /> and Article 3(13) of Directive (EU) 2016/680 of the European Parliament and of the Council <fnref n="8" />. Biometric data can allow for the authentication, identification or categorisation of natural persons and for the recognition of emotions of natural persons.

(7a) The notion of biometric identification as used in this Regulation should be defined as the automated recognition of physical, physiological and behavioural human features such as the face, eye movement, body shape, voice, prosody, gait, posture, heart rate, blood pressure, odour, keystrokes characteristics, for the purpose of establishing an individual's identity by comparing biometric data of that individual to stored biometric data of individuals in a reference database, irrespective of whether the individual has given its consent or not. This excludes AI systems intended to be used for biometric verification, which includes authentication, whose sole purpose is to confirm that a specific natural person is the person he or she claims to be and to confirm the identity of a natural person for the sole purpose of having access to a service, unlocking a device or having security access to premises.

(7b) The notion of biometric categorisation as used in this Regulation should be defined as assigning natural persons to specific categories on the basis of their biometric data. Such specific categories can relate to aspects such as sex, age, hair colour, eye colour, tattoos,

<footnote n="6">⁶ Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).</footnote>

<footnote n="7">⁷ Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39)</footnote>

<footnote n="8">⁸ Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (Law Enforcement Directive) (OJ L 119, 4.5.2016, p. 89).</footnote>
behavioural or personality traits, language, religion, membership of a national minority, sexual or political orientation. This does not include biometric categorization systems that are a purely ancillary feature intrinsically linked to another commercial service meaning that the feature cannot, for objective technical reasons, be used without the principal service and the integration of that feature or functionality is not a means to circumvent the applicability of the rules of this Regulation. For example, filters categorizing facial or body features used on online marketplaces could constitute such an ancillary feature as they can only be used in relation to the principal service which consists in selling a product by allowing the consumer to preview the display of the product on him or herself and help the consumer to make a purchase decision. Filters used on online social network services which categorise facial or body features to allow users to add or modify pictures or videos could also be considered as ancillary feature as such filter cannot be used without the principal service of the social network services consisting in the sharing of content online.

(8) The notion of remote biometric identification system as used in this Regulation should be defined functionally, as an AI system intended for the identification of natural persons without their active involvement, typically at a distance, through the comparison of a person's biometric data with the biometric data contained in a reference database, irrespectively of the particular technology, processes or types of biometric data used. Such remote biometric identification systems are typically used to perceive multiple persons or their behaviour simultaneously in order to facilitate significantly the identification of natural persons without their active involvement. This excludes AI systems intended to be used for biometric verification, which includes authentication, whose sole purpose is to confirm that a specific natural person is the person he or she claims to be and to confirm the identity of a natural person for the sole purpose of having access to a service, unlocking a device or having security access to premises. This exclusion is justified by the fact that such systems are likely to have a minor impact on fundamental rights of natural persons compared to the remote biometric identification systems which may be used for the processing of the biometric data of a large number of persons without their active involvement. In the case of 'real-time' systems, the capturing of the biometric data, the comparison and the identification occur all instantaneously, near-instantaneously or in any event without a significant delay. In this regard, there should be no scope for circumventing the rules of this Regulation on the 'real-time' use of the AI systems in question by providing for minor delays. 'Real-time' systems involve the use of 'live' or 'near-' live' material, such as video footage, generated by a camera or other device with similar functionality. In the case of 'post' systems, in contrast, the biometric data have
already been captured and the comparison and identification occur only after a significant
delay. This involves material, such as pictures or video footage generated by closed circuit
television cameras or private devices, which has been generated before the use of the
system in respect of the natural persons concerned.

(8a) The notion of emotion recognition system for the purpose of this regulation should be defined as an AI system for the purpose of identifying or inferring emotions or intentions of natural persons on the basis of their biometric data. This refers to emotions or intentions such as happiness, sadness, anger, surprise, disgust, embarrassment, excitement, shame, contempt, satisfaction and amusement. It does not include physical states, such as pain or fatigue. It does not refer for example to systems used in detecting the state of fatigue of professional pilots or drivers for the purpose of preventing accidents. It does also not include the mere detection of readily apparent expressions, gestures or movements, unless they are used for identifying or inferring emotions. These expressions can be basic facial expressions such as a frown or a smile, or gestures such as the movement of hands, arms or head, or characteristics of a person's voice, for example a raised voice or whispering.

(9) For the purposes of this Regulation the notion of publicly accessible space should be understood as referring to any physical place that is accessible to an undetermined number of natural persons, and irrespective of whether the place in question is privately or publicly owned and irrespective of the activity for which the place may be used, such as commerce (for instance, shops, restaurants, cafés), services (for instance, banks, professional activities, hospitality), sport (for instance, swimming pools, gyms, stadiums), transport (for instance, bus, metro and railway stations, airports, means of transport), entertainment (for instance, cinemas, theatres, museums, concert and conference halls) leisure or otherwise (for instance, public roads and squares, parks, forests, playgrounds). A place should be classified as publicly accessible also if, regardless of potential capacity or security restrictions, access is subject to certain predetermined conditions, which can be fulfilled by an undetermined number of persons, such as purchase of a ticket or title of transport, prior registration or having a certain age. By contrast, a place should not be considered publicly accessible if access is limited to specific and defined natural persons through either Union or national law directly related to public safety or security or through the clear manifestation of will by the person having the relevant authority on the place. The factual possibility of access alone (e.g. an unlocked door, an open gate in a fence) does not imply that the place is publicly accessible in the presence of indications or circumstances suggesting the contrary (e.g. signs prohibiting or restricting access). Company and factory
premises as well as offices and workplaces that are intended to be accessed only by
relevant employees and service providers are places that are not publicly accessible.
Publicly accessible spaces should not include prisons or border control. Some other areas
may be composed of both not publicly accessible and publicly accessible areas, such as the
hallway of a private residential building necessary to access a doctor's office or an airport.
Online spaces are not covered either, as they are not physical spaces. Whether a given
space is accessible to the public should however be determined on a case-by-case basis,
having regard to the specificities of the individual situation at hand.

(9b) In order to obtain the greatest benefits from AI systems while protecting fundamental rights, health and safety and to enable democratic control, AI literacy should equip providers, deployers and affected persons with the necessary notions to make informed decisions regarding AI systems. These notions may vary with regard to the relevant context and can include understanding the correct application of technical elements during the AI system's development phase, the measures to be applied during its use, the suitable ways in which to interpret the AI system's output, and, in the case of affected persons, the knowledge necessary to understand how decisions taken with the assistance of AI will impact them. In the context of the application this Regulation, AI literacy should provide all relevant actors in the AI value chain with the insights required to ensure the appropriate compliance and its correct enforcement. Furthermore, the wide implementation of AI literacy measures and the introduction of appropriate follow-up actions could contribute to improving working conditions and ultimately sustain the consolidation, and innovation path of trustworthy AI in the Union. The European Artificial Intelligence Board should support the Commission, to promote AI literacy tools, public awareness and understanding of the benefits, risks, safeguards, rights and obligations in relation to the use of AI systems. In cooperation with the relevant stakeholders, the Commission and the Member States should facilitate the drawing up of voluntary codes of conduct to advance AI literacy among persons dealing with the development, operation and use of AI.

(10) In order to ensure a level playing field and an effective protection of rights and freedoms of individuals across the Union, the rules established by this Regulation should apply to providers of AI systems in a non-discriminatory manner, irrespective of whether they are established within the Union or in a third country, and to deployers of AI systems established within the Union.

(11) In light of their digital nature, certain AI systems should fall within the scope of this Regulation even when they are neither placed on the market, nor put into service, nor
used in the Union. This is the case for example of an operator established in the Union that contracts certain
services to an operator established outside the Union in relation to an activity to be performed by an AI
system that would qualify as high-risk. In those circumstances, the AI system used by the operator outside
the Union could process data lawfully collected in and transferred from the Union, and provide to the
contracting operator in the Union the output of that AI system resulting from that processing, without that AI
system 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 national or European level for law enforcement and judicial cooperation with the
Union or with its Member States, under the condition that this third country or international organisations
provide adequate safeguards with respect to the protection of fundamental rights and freedoms of individuals.
Where relevant, this may also cover activities of entities entrusted by the third countries to carry out specific
tasks in support of such law enforcement 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 EU agencies and third countries and international organisations. The
authorities competent for supervision of the law enforcement and judicial authorities under the AI Act should
assess whether these frameworks for cooperation or international agreements include adequate safeguards
with respect to the protection of fundamental rights and freedoms of individuals. Recipient Member States
authorities and Union institutions, offices and bodies 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 undertake the utmost effort to align those
agreements with the requirements of this Regulation.

(12) This Regulation should also apply to Union institutions, offices, bodies and agencies when
acting as a provider or deployer of an AI system.
(12a) If and insofar AI systems are placed on the market, put into service, or used with or without modification of such systems for military, defence or national security purposes, those should be excluded from the scope of this Regulation regardless of which type of entity is carrying out those activities, such as whether it is a public or private entity. As regards military and defence purposes, such exclusion is justified both by Article 4(2) TEU and by the specificities of the Member States' and the common Union defence policy covered by Chapter 2 of Title V of the Treaty on European Union (TEU) that are subject to public international law, which is therefore the more appropriate legal framework for the regulation of AI systems in the context of the use of lethal force and other AI systems in the context of military and defence activities. As regards national security purposes, the exclusion is justified both by the fact that national security remains the sole responsibility of Member States in accordance with Article 4(2) TEU and by the specific nature and operational needs of national security activities and specific national rules applicable to those activities. Nonetheless, if an AI system developed, placed on the market, put into service or used for military, defence or national security purposes is used outside those temporarily or permanently for other purposes (for example, civilian or humanitarian purposes, law enforcement or public security purposes), such a system would fall within the scope of this Regulation. In that case, the entity using the system for other than military, defence or national security purposes should ensure compliance of the system with this Regulation, unless the system is already compliant with this Regulation. AI systems placed on the market or put into service for an excluded (i.e. military, defence or national security) and one or more non excluded purposes (e.g. civilian purposes, law enforcement, etc.), fall within the scope of this Regulation and providers of those systems should ensure compliance with this Regulation. In those cases, the fact that an AI system may fall within the scope of this Regulation should not affect the possibility of entities carrying out national security, defence and military activities, regardless of the type of entity carrying out those activities, to use AI systems for national security, military and defence purposes, the use of which is excluded from the scope of this Regulation. An AI system placed on the market for civilian or law enforcement purposes which is used with or without modification for military, defence or national security purposes should not fall within the scope of this Regulation, regardless of the type of entity carrying out those activities.

(12c) This Regulation should support innovation, respect freedom of science, and should not undermine research and development activity. It is therefore necessary to exclude from its scope AI systems and models specifically developed and put into service for the sole
purpose of scientific research and development. Moreover, it is necessary to ensure that the Regulation does not otherwise affect scientific research and development activity on AI systems or models prior to being placed on the market or put into service. As regards product oriented research, testing and development activity regarding AI systems or models, the provisions of this Regulation should also not apply prior to these systems and models being put into service or placed on the market. This is without prejudice to the obligation to comply with this Regulation when an AI system falling into the scope of this Regulation is placed on the market or put into service as a result of such research and development activity and to the application of provisions on regulatory sandboxes and testing in real world conditions. Furthermore, without prejudice to the foregoing regarding AI systems specifically developed and put into service for the sole purpose of scientific research and development, any other AI system that may be used for the conduct of any research and development activity should remain subject to the provisions of this Regulation. Under all circumstances, any research and development activity should be carried out in accordance with recognised ethical and professional standards for scientific research and should be conducted according to applicable Union law.

(14) In order to introduce a proportionate and effective set of binding rules for AI systems, a clearly defined risk-based approach should be followed. That approach should tailor the type and content of such rules to the intensity and scope of the risks that AI systems can generate. It is therefore necessary to prohibit certain unacceptable artificial intelligence practices, to lay down requirements for high-risk AI systems and obligations for the relevant operators, and to lay down transparency obligations for certain AI systems.

(14a) While the risk-based approach is the basis for a proportionate and effective set of binding rules, it is important to recall the 2019 Ethics Guidelines for Trustworthy AI developed by the independent High-Level Expert Group on AI (HLEG) appointed by the Commission. In those Guidelines the HLEG developed seven non-binding ethical principles for AI which should help ensure that AI is trustworthy and ethically sound. The seven principles include: human agency and oversight; technical robustness and safety; privacy and data governance; transparency; diversity, non-discrimination and fairness; societal and environmental well-being and accountability. Without prejudice to the legally binding requirements of this Regulation and any other applicable Union law, these Guidelines contribute to the design of a coherent, trustworthy and human-centric Artificial Intelligence, in line with the Charter and with the values on which the Union is founded. According to the Guidelines of HLEG, human agency and oversight means that AI systems
are developed and used as a tool that serves people, respects human dignity and personal autonomy, and that is functioning in a way that can be appropriately controlled and overseen by humans. Technical robustness and safety means that AI systems are developed and used in a way that allows robustness in case of problems and resilience against attempts to alter the use or performance of the AI system so as to allow unlawful use by third parties, and minimise unintended harm. Privacy and data governance means that AI systems are developed and used in compliance with existing privacy and data protection rules, while processing data that meets high standards in terms of quality and integrity. Transparency means that AI systems are developed and used in a way that allows appropriate traceability and explainability, while making humans aware that they communicate or interact with an AI system, as well as duly informing deployers of the capabilities and limitations of that AI system and affected persons about their rights. Diversity, non-discrimination and fairness means that AI systems are developed and used in a way that includes diverse actors and promotes equal access, gender equality and cultural diversity, while avoiding discriminatory impacts and unfair biases that are prohibited by Union or national law. Social and environmental well-being means that AI systems are developed and used in a sustainable and environmentally friendly manner as well as in a way to benefit all human beings, while monitoring and assessing the long-term impacts on the individual, society and democracy. The application of these principles should be translated, when possible, in the design and use of AI models. They should in any case serve as a basis for the drafting of codes of conduct under this Regulation. All stakeholders, including industry, academia, civil society and standardisation organisations, are encouraged to take into account as appropriate the ethical principles for the development of voluntary best practices and standards.

(15) Aside from the many beneficial uses of artificial intelligence, that technology can also be misused and provide novel and powerful tools for manipulative, exploitative and social control practices. Such practices are particularly harmful and abusive and should be prohibited because they contradict Union values of respect for human dignity, freedom, equality, democracy and the rule of law and Union fundamental rights, including the right to non-discrimination, data protection and privacy and the rights of the child.

(16) AI-enabled manipulative techniques can be used to persuade persons to engage in unwanted behaviours, or to deceive them by nudging them into decisions in a way that subverts and impairs their autonomy, decision-making and free choices. The placing on the market, putting into service or use of certain AI systems with the objective to or the effect
of materially distorting human behaviour, whereby significant harms, in particular having sufficiently important adverse impacts on physical, psychological health or financial interests are likely to occur, are particularly dangerous and should therefore be forbidden. Such AI systems deploy subliminal components such as audio, image, video stimuli that persons cannot perceive as those stimuli are beyond human perception or other manipulative or deceptive techniques that subvert or impair person's autonomy, decision-making or free choices in ways that people are not consciously aware of, or even if aware they are still deceived or not able to control or resist. This could be for example, facilitated by machine-brain interfaces or virtual reality as they allow for a higher degree of control of what stimuli are presented to persons, insofar as they may be materially distorting their behaviour in a significantly harmful manner. In addition, AI systems may also otherwise exploit vulnerabilities of a person or a specific group of persons due to their age, disability within the meaning of Directive (EU) 2019/882, or a specific social or economic situation that is likely to make those persons more vulnerable to exploitation such as persons living in extreme poverty, ethnic or religious minorities. Such AI systems can be placed on the market, put into service or used with the objective to or the effect of materially distorting the behaviour of a person and in a manner that causes or is reasonably likely to cause significant harm to that or another person or groups of persons, including harms that may be accumulated over time and should therefore be prohibited. The intention to distort the behaviour may not be presumed if the distortion results from factors external to the AI system which are outside of the control of the provider or the deployer, meaning factors that may not be reasonably foreseen and mitigated by the provider or the deployer of the AI system. In any case, it is not necessary for the provider or the deployer to have the intention to cause significant harm, as long as such harm results from the manipulative or exploitative AI-enabled practices. The prohibitions for such AI practices are complementary to the provisions contained in Directive 2005/29/EC, notably unfair commercial practices leading to economic or financial harms to consumers are prohibited under all circumstances, irrespective of whether they are put in place through AI systems or otherwise. The prohibitions of manipulative and exploitative practices in this Regulation should not affect lawful practices in the context of medical treatment such as psychological treatment of a mental disease or physical rehabilitation, when those practices are carried out in accordance with the applicable legislation and medical standards, for example explicit consent of the individuals or their legal representatives. In addition, common and legitimate commercial practices, for example in the field of advertising, that
are in compliance with the applicable law should not in themselves be regarded as constituting harmful manipulative AI practices.

(16a) Biometric categorisation systems that are based on individuals' biometric data, such as an individual person's face or fingerprint, to deduce or infer an individuals' political opinions, trade union membership, religious or philosophical beliefs, race, sex life or sexual orientation should be prohibited. This prohibition does not cover the lawful labelling, filtering or categorisation of biometric datasets acquired in line with Union or national law according to biometric data, such as the sorting of images according to hair colour or eye colour, which can for example be used in the area of law enforcement.

(17) AI systems providing social scoring of natural persons by public or private actors may lead to discriminatory outcomes and the exclusion of certain groups. They may violate the right to dignity and non-discrimination and the values of equality and justice. Such AI systems evaluate or classify natural persons or groups thereof based on multiple data points related to their social behaviour in multiple contexts or known, inferred or predicted personal or personality characteristics over certain periods of time. The social score obtained from such AI systems may lead to the detrimental or unfavourable treatment of natural persons or whole groups thereof in social contexts, which are unrelated to the context in which the data was originally generated or collected or to a detrimental treatment that is disproportionate or unjustified to the gravity of their social behaviour. AI systems entailing such unacceptable scoring practices leading to such detrimental or unfavourable outcomes should be therefore prohibited. This prohibition should not affect lawful evaluation practices of natural persons done for a specific purpose in compliance with national and Union law.

(18) The use of AI systems for 'real-time' remote biometric identification of natural persons in publicly accessible spaces for the purpose of law enforcement is particularly intrusive to the rights and freedoms of the concerned persons, to the extent that it may affect the private life of a large part of the population, evoke a feeling of constant surveillance and indirectly dissuade the exercise of the freedom of assembly and other fundamental rights. Technical inaccuracies of AI systems intended for the remote biometric identification of natural persons can lead to biased results and entail discriminatory effects. This is particularly relevant when it comes to age, ethnicity, race, sex or disabilities. In addition, the immediacy of the impact and the limited opportunities for further checks or corrections in relation to the use of such systems operating in 'real-time' carry heightened risks for the rights and freedoms of the persons that are concerned by law enforcement activities.
(19) The use of those systems for the purpose of law enforcement should therefore be prohibited, except in exhaustively listed and narrowly defined situations, where the use is strictly necessary to achieve a substantial public interest, the importance of which outweighs the risks. Those situations involve the search for certain victims of crime including missing people; certain threats to the life or physical safety of natural persons or of a terrorist attack; and the localisation or identification of perpetrators or suspects of the criminal offences referred to in Annex IIa if those criminal offences are punishable in the Member State concerned by a custodial sentence or a detention order for a maximum period of at least four years and as they are defined in the law of that Member State. Such threshold for the custodial sentence or detention order in accordance with national law contributes to ensure that the offence should be serious enough to potentially justify the use of 'real-time' remote biometric identification systems. Moreover, the list of criminal offences as referred in Annex IIa is based on the 32 criminal offences listed in the Council Framework Decision 2002/584/JHA<fnref n="9" />, taking into account that some are in practice likely to be more relevant than others, in that the recourse to 'real-time' remote biometric identification will foreseeably be necessary and proportionate to highly varying degrees for the practical pursuit of the localisation or identification of a perpetrator or suspect of the different criminal offences listed and having regard to the likely differences in the seriousness, probability and scale of the harm or possible negative consequences.
An imminent threat to life or physical safety of natural persons could also result from a serious disruption of critical infrastructure, as defined in Article 2, point (a) of Directive 2008/114/EC, where the disruption or destruction of such critical infrastructure would result in an imminent threat to life or physical safety of a person, including through serious harm to the provision of basic supplies to the population or to the exercise of the core function of the State.

In addition, this Regulation should preserve the ability for law enforcement, border control, immigration or asylum authorities to carry out identity checks in the presence of the person that is concerned in accordance with the conditions set out in Union and national law for such checks. In particular, law enforcement, border control, immigration or asylum authorities should be able to use information systems, in accordance with Union or national law, to identify a person who, during an identity check, either refuses to be identified or is unable to state or prove his or her identity, without being required by this Regulation to obtain prior authorisation. This could be, for example, a person involved in a crime, being

<footnote n="9">⁹ Council Framework Decision 2002/584/JHA of 13 June 2002 on the European arrest warrant and the surrender procedures between Member States (OJ L 190, 18.7.2002, p. 1).</footnote>
unwilling, or unable due to an accident or a medical condition, to disclose their identity to law enforcement authorities.

(20) In order to ensure that those systems are used in a responsible and proportionate manner, it is also important to establish that, in each of those exhaustively listed and narrowly defined situations, certain elements should be taken into account, in particular as regards the nature of the situation giving rise to the request and the consequences of the use for the rights and freedoms of all persons concerned and the safeguards and conditions provided for with the use. In addition, the use of 'real-time' remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement should only be deployed to confirm the specifically target individual's identity and should be limited to what is strictly necessary concerning the period of time as well as geographic and personal scope, having regard in particular to the evidence or indications regarding the threats, the victims or perpetrator. The use of the 'real-time' remote biometric identification system in publicly accessible spaces should only be authorised if the law enforcement authority has completed a fundamental rights impact assessment and, unless provided otherwise in this Regulation, has registered the system in the database as set out in this Regulation. The reference database of persons should be appropriate for each use case in each of the situations mentioned above.

(21) Each use of a 'real-time' remote biometric identification system in publicly accessible spaces for the purpose of law enforcement should be subject to an express and specific authorisation by a judicial authority or by an independent administrative authority whose decision is binding of a Member State. Such authorisation should in principle be obtained prior to the use of the system with a view to identify a person or persons. Exceptions to this rule should be allowed in duly justified situations of urgency, that is, situations where the need to use the systems in question is such as to make it effectively and objectively impossible to obtain an authorisation before commencing the use. In such situations of urgency, the use should be restricted to the absolute minimum necessary and be subject to appropriate safeguards and conditions, as determined in national law and specified in the context of each individual urgent use case by the law enforcement authority itself. In addition, the law enforcement authority should in such situations request such authorisation whilst providing the reasons for not having been able to request it earlier, without undue delay and, at the latest within 24 hours. If such authorisation is rejected, the use of real-time biometric identification systems linked to that authorisation should be stopped with immediate effect and all the data related to such use should be discarded and
deleted. Such data includes input data directly acquired by an AI system in the course of
the use of such system as well as the results and outputs of the use linked to that
authorisation. It should not include input legally acquired in accordance with another
national or Union law. In any case, no decision producing an adverse legal effect on a
person may be taken solely based on the output of the remote biometric identification
system.

(21a) In order to carry out their tasks in accordance with the requirements set out in this Regulation as well as in national rules, the relevant market surveillance authority and the national data protection authority should be notified of each use of the ‘real-time biometric identification system’. National market surveillance authorities and the national data protection authorities that have been notified should submit to the Commission an annual report on the use of ‘real-time biometric identification systems’.

(22) Furthermore, it is appropriate to provide, within the exhaustive framework set by this Regulation that such use in the territory of a Member State in accordance with this Regulation should only be possible where and in as far as the Member State in question has decided to expressly provide for the possibility to authorise such use in its detailed rules of national law. Consequently, Member States remain free under this Regulation not to provide for such a possibility at all or to only provide for such a possibility in respect of some of the objectives capable of justifying authorised use identified in this Regulation. These national rules should be notified to the Commission at the latest 30 days following their adoption.

(23) The use of AI systems for ‘real-time’ remote biometric identification of natural persons in publicly accessible spaces for the purpose of law enforcement necessarily involves the processing of biometric data. The rules of this Regulation that prohibit, subject to certain exceptions, such use, which are based on Article 16 TFEU, should apply as lex specialis in respect of the rules on the processing of biometric data contained in Article 10 of Directive (EU) 2016/680, thus regulating such use and the processing of biometric data involved in an exhaustive manner. Therefore, such use and processing should only be possible in as far as it is compatible with the framework set by this Regulation, without there being scope, outside that framework, for the competent authorities, where they act for purpose of law enforcement, to use such systems and process such data in connection thereto on the grounds listed in Article 10 of Directive (EU) 2016/680. In this context, this Regulation is not intended to provide the legal basis for the processing of personal data under Article 8 of Directive 2016/680. However, the use of ‘real-time’ remote biometric identification
systems in publicly accessible spaces for purposes other than law enforcement, including
by competent authorities, should not be covered by the specific framework regarding such
use for the purpose of law enforcement set by this Regulation. Such use for purposes other
than law enforcement should therefore not be subject to the requirement of an authorisation
under this Regulation and the applicable detailed rules of national law that may give effect
to it.

(24) Any processing of biometric data and other personal data involved in the use of AI systems for biometric identification, other than in connection to the use of 'real-time' remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement as regulated by this Regulation, should continue to comply with all requirements resulting from Article 10 of Directive (EU) 2016/680. For purposes other than law enforcement, Article 9(1) of Regulation (EU) 2016/679 and Article 10(1) of Regulation (EU) 2018/1725 prohibit the processing of biometric data subject to limited exceptions as provided in those articles. In application of Article 9(1) of Regulation (EU) 2016/679, the use of remote biometric identification for purposes other than law enforcement has already been subject to prohibition decisions by national data protection authorities.

(25) In accordance with Article 6a of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, as annexed to the TEU and to the TFEU, Ireland is not bound by the rules laid down in Article 5(1), point (d), (2), (3), (3a), (4) and (5), Article 5(1)(ba) to the extent it applies to the use of biometric categorisation systems for activities in the field of police cooperation and judicial cooperation in criminal matters, Article 5(1)(da) to the extent it applies to the use of AI systems covered by that provision and Article 29(6a) of this Regulation adopted on the basis of Article 16 of the TFEU which relate to the processing of personal data by the Member States when carrying out activities falling within the scope of Chapter 4 or Chapter 5 of Title V of Part Three of the TFEU, where Ireland is not bound by the rules governing the forms of judicial cooperation in criminal matters or police cooperation which require compliance with the provisions laid down on the basis of Article 16 of the TFEU.

(26) In accordance with Articles 2 and 2a of Protocol No 22 on the position of Denmark, annexed to the TEU and TFEU, Denmark is not bound by rules laid down in Article 5(1), point (d), (2), (3), (3a), (4) and (5), Article 5(1)(ba) to the extent it applies to the use of biometric categorisation systems for activities in the field of police cooperation and
judicial cooperation in criminal matters, Article 5(1)(da) to the extent it applies to the use of AI systems covered by that provision and Article 29(6a) of this Regulation adopted on the basis of Article 16 of the TFEU, or subject to their application, which relate to the processing of personal data by the Member States when carrying out activities falling within the scope of Chapter 4 or Chapter 5 of Title V of Part Three of the TFEU.

(26a) In line with the presumption of innocence, natural persons in the EU should always be judged on their actual behaviour. Natural persons should never be judged on AI-predicted behaviour based solely on their profiling, personality traits or characteristics, such as nationality, place of birth, place of residence, number of children, debt, their type of car, without a reasonable suspicion of that person being involved in a criminal activity based on objective verifiable facts and without human assessment thereof. Therefore, risk assessments of natural persons in order to assess the risk of them offending or for predicting the occurrence of an actual or potential criminal offence solely based on the profiling of a natural person or on assessing their personality traits and characteristics should be prohibited. In any case, this prohibition does not refer to nor touch upon risk analytics that are not based on the profiling of individuals or on the personality traits and characteristics of individuals, such as AI systems using risk analytics to assess the risk of financial fraud by undertakings based on suspicious transactions or risk analytic tools to predict the likelihood of localisation of narcotics or illicit goods by customs authorities, for example based on known trafficking routes.

(26b) The placing on the market, putting into service for this specific purpose, or use of AI systems that create or expand facial recognition databases through the untargeted scraping of facial images from the internet or CCTV footage should be prohibited, as this practice adds to the feeling of mass surveillance and can lead to gross violations of fundamental rights, including the right to privacy.

(26c) There are serious concerns about the scientific basis of AI systems aiming to identify or infer emotions, particularly as expression of emotions vary considerably across cultures and situations, and even within a single individual. Among the key shortcomings of such systems are the limited reliability, the lack of specificity and the limited generalizability. Therefore, AI systems identifying or inferring emotions or intentions of natural persons on the basis of their biometric data may lead to discriminatory outcomes and can be intrusive to the rights and freedoms of the concerned persons. Considering the imbalance of power in the context of work or education, combined with the intrusive nature of these systems, such systems could lead to detrimental or unfavourable treatment of certain natural
persons or whole groups thereof. Therefore, the placing on the market, putting into service, or use of AI systems intended to be used to detect the emotional state of individuals in situations related to the workplace and education should be prohibited. This prohibition should not cover AI systems placed on the market strictly for medical or safety reasons, such as systems intended for therapeutic use.

(26d) Practices that are prohibited by Union legislation, including data protection law, non-discrimination law, consumer protection law, and competition law, should not be affected by this Regulation.

(27) High-risk AI systems should only be placed on the Union market, put into service or used if they comply with certain mandatory requirements. Those requirements should ensure that high-risk AI systems available in the Union or whose output is otherwise used in the Union do not pose unacceptable risks to important Union public interests as recognised and protected by Union law. Following the New Legislative Framework approach, as clarified in Commission notice the 'Blue Guide' on the implementation of EU product rules 2022 (C/2022/3637) the general rule is that several pieces of the EU legislation, such as Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on In Vitro Diagnostic Devices or Directive 2006/42/EC on Machinery, may have to be taken into consideration for one product, since the making available or putting into service can only take place when the product complies with all applicable Union harmonisation legislation. To ensure consistency and avoid unnecessary administrative burden or costs, providers of a product that contains one or more high-risk artificial intelligence system, to which the requirements of this Regulation as well as requirements of the Union harmonisation legislation listed in Annex II, Section A apply, should have a flexibility on operational decisions on how to ensure compliance of a product that contains one or more artificial intelligence systems with all applicable requirements of the Union harmonised legislation in a best way. AI systems identified as high-risk should be limited to those that have a significant harmful impact on the health, safety and fundamental rights of persons in the Union and such limitation minimises any potential restriction to international trade, if any.

(28) AI systems could have an adverse impact to health and safety of persons, in particular when such systems operate as safety components of products. Consistently with the objectives of Union harmonisation legislation to facilitate the free movement of products in the internal market and to ensure that only safe and otherwise compliant products find their way into the market, it is important that the safety risks that may be generated by a product as a whole due to its digital components, including AI systems, are duly prevented and
mitigated. For instance, increasingly autonomous robots, whether in the context of manufacturing or personal assistance and care should be able to safely operate and performs their functions in complex environments. Similarly, in the health sector where the stakes for life and health are particularly high, increasingly sophisticated diagnostics systems and systems supporting human decisions should be reliable and accurate.

(28a) The extent of the adverse impact caused by the AI system on the fundamental rights protected by the Charter is of particular relevance when classifying an AI system as high-risk. Those rights include the right to human dignity, respect for private and family life, protection of personal data, freedom of expression and information, freedom of assembly and of association, and non-discrimination, right to education, consumer protection, workers' rights, rights of persons with disabilities, gender equality, intellectual property rights, right to an effective remedy and to a fair trial, right of defence and the presumption of innocence, right to good administration. In addition to those rights, it is important to highlight that children have specific rights as enshrined in Article 24 of the EU Charter and in the United Nations Convention on the Rights of the Child (further elaborated in the UNCRC General Comment No. 25 as regards the digital environment), both of which require consideration of the children's vulnerabilities and provision of such protection and care as necessary for their well-being. The fundamental right to a high level of environmental protection enshrined in the Charter and implemented in Union policies should also be considered when assessing the severity of the harm that an AI system can cause, including in relation to the health and safety of persons.

(29) As regards high-risk AI systems that are safety components of products or systems, or which are themselves products or systems falling within the scope of Regulation (EC) No 300/2008 of the European Parliament and of the Council<fnref n="10" />, Regulation (EU) No 167/2013 of the European Parliament and of the Council<fnref n="11" />, Regulation (EU) No 168/2013 of the European Parliament and of the Council<fnref n="12" />, Directive 2014/90/EU of the European Parliament and of the Council<fnref n="13" />, Directive (EU) 2016/797 of the European Parliament and

<footnote n="10">¹⁰ Regulation (EC) No 300/2008 of the European Parliament and of the Council of 11 March 2008 on common rules in the field of civil aviation security and repealing Regulation (EC) No 2320/2002 (OJ L 97, 9.4.2008, p. 72).</footnote>

<footnote n="11">¹¹ Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1).</footnote>

<footnote n="12">¹² Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52).</footnote>

<footnote n="13">¹³ Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146).</footnote>
of the Council<fnref n="14" />, Regulation (EU) 2018/858 of the European Parliament and of the Council<fnref n="15" />, Regulation (EU) 2018/1139 of the European Parliament and of the Council<fnref n="16" />, and Regulation (EU) 2019/2144 of the European Parliament and of the Council<fnref n="17" />, it is appropriate to amend those acts to ensure that the Commission takes into account, on the basis of the technical and regulatory specificities of each sector, and without interfering with existing governance, conformity assessment and enforcement mechanisms and authorities established therein, the mandatory requirements for high-risk AI systems laid down in this Regulation when adopting any relevant future delegated or implementing acts on the basis of those acts.

(30) As regards AI systems that are safety components of products, or which are themselves products, falling within the scope of certain Union harmonisation legislation listed in Annex II, it is appropriate to classify them as high-risk under this Regulation if the product in question undergoes the conformity assessment procedure with a third-party conformity assessment body pursuant to that relevant Union harmonisation legislation. In particular, such products are machinery, toys, lifts, equipment and protective systems intended for use in potentially explosive atmospheres, radio equipment, pressure equipment, recreational craft equipment, cableway installations, appliances burning gaseous fuels, medical devices, and in vitro diagnostic medical devices.

(31) The classification of an AI system as high-risk pursuant to this Regulation should not necessarily mean that the product whose safety component is the AI system, or the AI system itself as a product, is considered ‘high-risk’ under the criteria established in the relevant Union harmonisation legislation that applies to the product. This is notably the

<footnote n="14">¹⁴ Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system within the European Union (OJ L 138, 26.5.2016, p. 44).</footnote>

<footnote n="15">¹⁵ Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1).</footnote>

<footnote n="16">¹⁶ Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1).</footnote>

<footnote n="17">¹⁷ Regulation (EU) 2019/2144 of the European Parliament and of the Council of 27 November 2019 on type-approval requirements for motor vehicles and their trailers, and systems, components and separate technical units intended for such vehicles, as regards their general safety and the protection of vehicle occupants and vulnerable road users, amending Regulation (EU) 2018/858 of the European Parliament and of the Council and repealing Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 of the European Parliament and of the Council and Commission Regulations (EC) No 631/2009, (EU) No 406/2010, (EU) No 672/2010, (EU) No 1003/2010, (EU) No 1005/2010, (EU) No 1008/2010, (EU) No 1009/2010, (EU) No 19/2011, (EU) No 109/2011, (EU) No 458/2011, (EU) No 65/2012, (EU) No 130/2012, (EU) No 347/2012, (EU) No 351/2012, (EU) No 1230/2012 and (EU) 2015/166 (OJ L 325, 16.12.2019, p. 1).</footnote>
case for Regulation (EU) 2017/745 of the European Parliament and of the Council<sup>18</sup> and
Regulation (EU) 2017/746 of the European Parliament and of the Council<sup>19</sup>, where a third-
party conformity assessment is provided for medium-risk and high-risk products.

(32) 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.

(32a) It is also important to clarify that there may be specific cases in which AI systems referred to pre-defined areas specified in this Regulation do not lead to a significant risk of harm to the legal interests protected under those areas, because they do not materially influence the decision-making or do not harm those interests substantially. For the purpose of this Regulation an AI system not materially influencing the outcome of decision-making should be understood as an AI system that does not impact the substance, and thereby the outcome, of decision-making, whether human or automated. This could be the case if one or more of the following conditions are fulfilled. The first criterion should be that the AI system is intended to perform a narrow procedural task, such as an AI system that transforms unstructured data into structured data, an AI system that classifies incoming documents into categories or an AI system that is used to detect duplicates among a large number of applications. These tasks are of such narrow and limited nature that they pose only limited risks which are not increased through the use in a context listed in Annex III. The second criterion should be that the task performed by the AI system is intended to improve the result of a previously completed human activity that may be relevant for the purpose of the use case listed in Annex III. Considering these characteristics, the AI system only provides an additional layer to a human activity with consequently lowered risk. For

<footnote n="18">¹⁸ Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).</footnote>

<footnote n="19">¹⁹ Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).</footnote>
example, this criterion would apply to AI systems that are intended to improve the language used in previously drafted documents, for instance in relation to professional tone, academic style of language or by aligning text to a certain brand messaging. The third criterion should be that the AI system is intended to detect decision-making patterns or deviations from prior decision-making patterns. The risk would be lowered because the use of the AI system follows a previously completed human assessment which it is not meant to replace or influence, without proper human review. Such AI systems include for instance those that, given a certain grading pattern of a teacher, can be used to check ex post whether the teacher may have deviated from the grading pattern so as to flag potential inconsistencies or anomalies. The fourth criterion should be that the AI system is intended to perform a task that is only preparatory to an assessment relevant for the purpose of the use case listed in Annex III, thus making the possible impact of the output of the system very low in terms of representing a risk for the assessment to follow. For example, this criterion covers smart solutions for file handling, which include various functions from indexing, searching, text and speech processing or linking data to other data sources, or AI systems used for translation of initial documents. In any case, AI systems referred to in Annex III should be considered to pose significant risks of harm to the health, safety or fundamental rights of natural persons if the AI system implies profiling within the meaning of Article 4(4) of Regulation (EU) 2016/679 and Article 3(4) of Directive (EU) 2016/680 and Article 3(5) of Regulation 2018/1725. To ensure traceability and transparency, a provider who considers that an AI system referred to in Annex III is not high-risk on the basis of the aforementioned criteria should draw up documentation of the assessment before that system is placed on the market or put into service and should provide this documentation to national competent authorities upon request. Such provider should be obliged to register the system in the EU database established under this Regulation. With a view to provide further guidance for the practical implementation of the criteria under which AI systems referred to in Annex III are exceptionally not high-risk, the Commission should, after consulting the AI Board, provide guidelines specifying this practical implementation completed by a comprehensive list of practical examples of high risk and non-high risk use cases of AI systems.

(33a) As biometric data constitutes a special category of sensitive personal data, it is appropriate to classify as high-risk several critical use-cases of biometric systems, insofar as their use is permitted under relevant Union and national law. Technical inaccuracies of AI systems intended for the remote biometric identification of natural persons can lead to biased results and entail discriminatory effects. This is particularly relevant when it comes to age
ethnicity, race, sex or disabilities. Therefore, remote biometric identification systems
should be classified as high-risk in view of the risks that they pose. This excludes AI
systems intended to be used for biometric verification, which includes authentication,
whose sole purpose is to confirm that a specific natural person is the person he or she
claims to be and to confirm the identity of a natural person for the sole purpose of having
access to a service, unlocking a device or having secure access to premises.

In addition, AI systems intended to be used for biometric categorisation according to
sensitive attributes or characteristics protected under Article 9(1) of Regulation (EU)
2016/679 based on biometric data, in so far as these are not prohibited under this
Regulation, and emotion recognition systems that are not prohibited under this Regulation,
should be classified as high-risk. Biometric systems which are intended to be used solely
for the purpose of enabling cybersecurity and personal data protection measures should not
be considered as high-risk systems.

(34) As regards the management and operation of critical infrastructure, it is appropriate to classify as high-risk the AI systems intended to be used as safety components in the management and operation of critical digital infrastructure as listed in Annex I point 8 of the Directive on the resilience of critical entities, road traffic and the supply of water, gas, heating and electricity, since their failure or malfunctioning may put at risk the life and health of persons at large scale and lead to appreciable disruptions in the ordinary conduct of social and economic activities. Safety components of critical infrastructure, including critical digital infrastructure, are systems used to directly protect the physical integrity of critical infrastructure or health and safety of persons and property but which are not necessary in order for the system to function. Failure or malfunctioning of such components might directly lead to risks to the physical integrity of critical infrastructure and thus to risks to health and safety of persons and property. Components intended to be used solely for cybersecurity purposes should not qualify as safety components. Examples of safety components of such critical infrastructure may include systems for monitoring water pressure or fire alarm controlling systems in cloud computing centres.

(35) Deployment of AI systems in education is important to promote high-quality digital education and training and to allow all learners and teachers to acquire and share the necessary digital skills and competences, including media literacy, and critical thinking, to take an active part in the economy, society, and in democratic processes. However, AI systems used in education or vocational training, notably for determining access or admission, for assigning persons to educational and vocational training institutions or
programmes at all levels, for evaluating learning outcomes of persons, for assessing the
appropriate level of education for an individual and materially influencing the level of
education and training that individuals will receive or be able to access or for monitoring
and detecting prohibited behaviour of students during tests should be classified as high-risk
AI systems, since they may determine the educational and professional course of a
person's life and therefore affect their ability to secure their livelihood. When improperly
designed and used, such systems can be particularly intrusive and may violate the right to
education and training as well as the right not to be discriminated against and perpetuate
historical patterns of discrimination, for example against women, certain age groups,
persons with disabilities, or persons of certain racial or ethnic origins or sexual orientation.

(36) AI systems used in employment, workers management and access to self-employment, notably for the recruitment and selection of persons, for making decisions affecting terms of the work related relationship promotion and termination of work-related contractual relationships for allocating tasks based on individual behaviour, personal traits or characteristics and for monitoring or evaluation of persons in work-related contractual relationships, should also be classified as high-risk, since those systems may appreciably impact future career prospects, livelihoods of these persons and workers' rights. Relevant work-related contractual relationships should meaningfully involve employees and persons providing services through platforms as referred to in the Commission Work Programme 2021. Throughout the recruitment process and in the evaluation, promotion, or retention of persons in work-related contractual relationships, such systems may perpetuate historical patterns of discrimination, for example against women, certain age groups, persons with disabilities, or persons of certain racial or ethnic origins or sexual orientation. AI systems used to monitor the performance and behaviour of these persons may also undermine their fundamental rights to data protection and privacy.

(37) Another area in which the use of AI systems deserves special consideration is the access to and enjoyment of certain essential private and public services and benefits necessary for people to fully participate in society or to improve one's standard of living. In particular, natural persons applying for or receiving essential public assistance benefits and services from public authorities namely healthcare services, social security benefits, social services providing protection in cases such as maternity, illness, industrial accidents, dependency or old age and loss of employment and social and housing assistance, are typically dependent on those benefits and services and in a vulnerable position in relation to the responsible authorities. If AI systems are used for determining whether such benefits and services
should be granted, denied, reduced, revoked or reclaimed by authorities, including whether beneficiaries are legitimately entitled to such benefits or services, those systems may have a significant impact on persons' livelihood and may infringe their fundamental rights, such as the right to social protection, non-discrimination, human dignity or an effective remedy and should therefore be classified as high-risk. Nonetheless, this Regulation should not hamper the development and use of innovative approaches in the public administration, which would stand to benefit from a wider use of compliant and safe AI systems, provided that those systems do not entail a high risk to legal and natural persons. In addition, AI systems used to evaluate the credit score or creditworthiness of natural persons should be classified as high-risk AI systems, since they determine those persons' access to financial resources or essential services such as housing, electricity, and telecommunication services. AI systems used for this purpose may lead to discrimination of persons or groups and perpetuate historical patterns of discrimination, for example based on racial or ethnic origins, gender, disabilities, age, sexual orientation, or create new forms of discriminatory impacts. However, AI systems provided for by Union law for the purpose of detecting fraud in the offering of financial services and for prudential purposes to calculate credit institutions' and insurances undertakings' capital requirements should not be considered as high-risk under this Regulation. Moreover, AI systems intended to be used for risk assessment and pricing in relation to natural persons for health and life insurance can also have a significant impact on persons' livelihood and if not duly designed, developed and used, can infringe their fundamental rights and can lead to serious consequences for people's life and health, including financial exclusion and discrimination. Finally, AI systems used to evaluate and classify emergency calls by natural persons or to dispatch or establish priority in the dispatching of emergency first response services, including by police, firefighters and medical aid, as well as of emergency healthcare patient triage systems, should also be classified as high-risk since they make decisions in very critical situations for the life and health of persons and their property.

(38) Given their role and responsibility, actions by law enforcement authorities involving certain uses of AI systems are characterised by a significant degree of power imbalance and may lead to surveillance, arrest or deprivation of a natural person's liberty as well as other adverse impacts on fundamental rights guaranteed in the Charter. In particular, if the AI system is not trained with high quality data, does not meet adequate requirements in terms of its performance, its accuracy or robustness, or is not properly designed and tested before being put on the market or otherwise put into service, it may single out people in a discriminatory or otherwise incorrect or unjust manner. Furthermore, the exercise of
important procedural fundamental rights, such as the right to an effective remedy and to a
fair trial as well as the right of defence and the presumption of innocence, could be
hampered, in particular, where such AI systems are not sufficiently transparent,
explainable and documented. It is therefore appropriate to classify as high-risk, insofar as
their use is permitted under relevant Union and national law, a number of AI systems
intended to be used in the law enforcement context where accuracy, reliability and
transparency is particularly important to avoid adverse impacts, retain public trust and
ensure accountability and effective redress. In view of the nature of the activities in
question and the risks relating thereto, those high-risk AI systems should include in
particular AI systems intended to be used by or on behalf of law enforcement authorities or
by Union agencies, offices or bodies in support of law enforcement authorities for
assessing the risk of a natural person to become a victim of criminal offences, as
polygraphs and similar tools, for the evaluation of the reliability of evidence in the
course of investigation or prosecution of criminal offences, and, insofar not prohibited
under this regulation, for assessing the risk of a natural person of offending or reoffending
not solely based on profiling of natural persons nor based on assessing personality traits
and characteristics or past criminal behaviour of natural persons or groups, for profiling in
the course of detection, investigation or prosecution of criminal offences. AI systems
specifically intended to be used for administrative proceedings by tax and customs
authorities as well as by financial intelligence units carrying out administrative tasks
analysing information pursuant to Union anti-money laundering legislation should not be
classified as high-risk AI systems used by law enforcement authorities for the purposes of
prevention, detection, investigation and prosecution of criminal offences. The use of AI
tools by law enforcement and authorities should not become a factor of inequality, or
exclusion. The impact of the use of AI tools on the defence rights of suspects should not be
ignored, notably the difficulty in obtaining meaningful information on the functioning of
these systems and the consequent difficulty in challenging their results in court, in
particular by individuals under investigation.

(39) AI systems used in migration, asylum and border control management affect people who are often in particularly vulnerable position and who are dependent on the outcome of the actions of the competent public authorities. The accuracy, non-discriminatory nature and transparency of the AI systems used in those contexts are therefore particularly important to guarantee the respect of the fundamental rights of the affected persons, notably their rights to free movement, non-discrimination, protection of private life and personal data, international protection and good administration. It is therefore appropriate to classify as
high-risk, insofar as their use is permitted under relevant Union and national law AI
systems intended to be used by or on behalf of competent public authorities or by Union
agencies, offices or bodies charged with tasks in the fields of migration, asylum and border
control management as polygraphs and similar tools, for assessing certain risks posed by
natural persons entering the territory of a Member State or applying for visa or asylum, for
assisting competent public authorities for the examination, including related assessment of
the reliability of evidence, of applications for asylum, visa and residence permits and
associated complaints with regard to the objective to establish the eligibility of the natural
persons applying for a status, for the purpose of detecting, recognising or identifying
natural persons in the context of migration, asylum and border control management with
the exception of travel documents. AI systems in the area of migration, asylum and border
control management covered by this Regulation should comply with the relevant
procedural requirements set by the Directive 2013/32/EU of the European Parliament and
of the Council<fnref n="20" />, the Regulation (EC) No 810/2009 of the European Parliament and of the
Council<fnref n="21" /> and other relevant legislation. The use of AI systems in migration, asylum and
border control management should in no circumstances be used by Member States or
Union institutions, agencies or bodies as a means to circumvent their international
obligations under the Convention of 28 July 1951 relating to the Status of Refugees as
amended by the Protocol of 31 January 1967, nor should they be used to in any way
infringe on the principle of non-refoulement, or deny safe and effective legal avenues into
the territory of the Union, including the right to international protection.

(40) Certain AI systems intended for the administration of justice and democratic processes should be classified as high-risk, considering their potentially significant impact on democracy, rule of law, individual freedoms as well as the right to an effective remedy and to a fair trial. In particular, to address the risks of potential biases, errors and opacity, it is appropriate to qualify as high-risk AI systems intended to be used by a judicial authority or on its behalf to assist judicial authorities in researching and interpreting facts and the law and in applying the law to a concrete set of facts. AI systems intended to be used by alternative dispute resolution bodies for those purposes should also be considered high-risk when the outcomes of the alternative dispute resolution proceedings produce legal effects for the parties. The use of artificial intelligence tools can support the decision-making power of judges or judicial independence, but should not replace it, as the final decision-

<footnote n="20">20 Directive 2013/32/EU of the European Parliament and of the Council of 26 June 2013 on common procedures for granting and withdrawing international protection (OJ L 180, 29.6.2013, p. 60).</footnote>

<footnote n="21">21 Regulation (EC) No 810/2009 of the European Parliament and of the Council of 13 July 2009 establishing a Community Code on Visas (Visa Code) (OJ L 243, 15.9.2009, p. 1).</footnote>
making must remain a human-driven activity and decision. Such qualification should not extend, however, to AI systems intended for purely ancillary administrative activities that do not affect the actual administration of justice in individual cases, such as anonymisation or pseudonymisation of judicial decisions, documents or data, communication between personnel, administrative tasks.

(40a) Without prejudice to the rules provided for in [Regulation xxx on the transparency and targeting of political advertising], and in order to address the risks of undue external interference to the right to vote enshrined in Article 39 of the Charter, and of adverse effects on democracy, and the rule of law, AI systems intended to be used to influence the outcome of an election or referendum or the voting behaviour of natural persons in the exercise of their vote in elections or referenda should be classified as high-risk AI systems with the exception of AI systems whose output natural persons are not directly exposed to, such as tools used to organise, optimise and structure political campaigns from an administrative and logistical point of view.

(41) The fact that an AI system is classified as a high-risk AI system under this Regulation should not be interpreted as indicating that the use of the system is lawful under other acts of Union law or under national law compatible with Union law, such as on the protection of personal data, on the use of polygraphs and similar tools or other systems to detect the emotional state of natural persons. Any such use should continue to occur solely in accordance with the applicable requirements resulting from the Charter and from the applicable acts of secondary Union law and national law. This Regulation should not be understood as providing for the legal ground for processing of personal data, including special categories of personal data, where relevant, unless it is specifically provided for otherwise in this Regulation.

(42) To mitigate the risks from high-risk AI systems placed on the market or put into service and to ensure a high level of trustworthiness, certain mandatory requirements should apply to high-risk AI systems, taking into account the intended purpose and the context of use of the AI system and according to the risk management system to be established by the provider. The measures adopted by the providers to comply with the mandatory requirements of this Regulation should take into account the generally acknowledge state of the art on artificial intelligence, be proportionate and effective to meet the objectives of this Regulation. Following the New Legislative Framework approach, as clarified in Commission notice the ‘Blue Guide’ on the implementation of EU product rules 2022 (C/2022/3637), the general rule is that several pieces of the EU legislation may have to be
taken into consideration for one product, since the making available or putting into service
can only take place when the product complies with all applicable Union harmonisation
legislation. Hazards of AI systems covered by the requirements of this Regulation concern
different aspects than the existing Union harmonisation acts and therefore the requirements
of this Regulation would complement the existing body of the Union harmonisation acts.

For example, machinery or medical devices products incorporating an AI system might
present risks not addressed by the essential health and safety requirements set out in the
relevant Union harmonised legislation, as this sectoral legislation does not deal with risks
specific to AI systems. This calls for a simultaneous and complementary application of the
various legislative acts. To ensure consistency and avoid unnecessary administrative
burden or costs, providers of a product that contains one or more high-risk artificial
intelligence system, to which the requirements of this Regulation as well as requirements
of the Union harmonisation legislation listed in Annex II, Section A apply, should have a
flexibility on operational decisions on how to ensure compliance of a product that contains
one or more artificial intelligence systems with all applicable requirements of the Union
harmonised legislation in a best way. This flexibility could mean, for example a decision
by the provider to integrate a part of the necessary testing and reporting processes,
information and documentation required under this Regulation into already existing
documentation and procedures required under the existing Union harmonisation legislation
listed in Annex II, Section A. This however should not in any way undermine the
obligation of the provider to comply with all the applicable requirements.

(42a) The risk management system should consist of a continuous, iterative process that is planned and run throughout the entire lifecycle of a high-risk AI system. This process should be aimed at identifying and mitigating the relevant risks of artificial intelligence systems on health, safety and fundamental rights. The risk management system should be regularly reviewed and updated to ensure its continuing effectiveness, as well as justification and documentation of any significant decisions and actions taken subject to this Regulation. This process should ensure that the provider identifies risks or adverse impacts and implements mitigation measures for the known and reasonably foreseeable risks of artificial intelligence systems to the health, safety and fundamental rights in light of its intended purpose and reasonably foreseeable misuse, including the possible risks arising from the interaction between the AI system and the environment within which it operates. The risk management system should adopt the most appropriate risk management measures in the light of the state of the art in AI. When identifying the most appropriate risk management measures, the provider should document and explain the choices made
and, when relevant, involve experts and external stakeholders. In identifying reasonably foreseeable misuse of high-risk AI systems the provider should cover uses of the AI systems which, while not directly covered by the intended purpose and provided for in the instruction for use may nevertheless be reasonably expected to result from readily predictable human behaviour in the context of the specific characteristics and use of the particular AI system. Any known or foreseeable circumstances, 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 should be included in the instructions for use provided by the provider. This is to ensure that the deployer is aware and takes them into account when using the high-risk AI system. Identifying and implementing risk mitigation measures for foreseeable misuse under this Regulation should not require specific additional training measures for the high-risk AI system by the provider to address them. The providers however are encouraged to consider such additional training measures to mitigate reasonable foreseeable misuses as necessary and appropriate.

(43) Requirements should apply to high-risk AI systems as regards risk management, the quality and relevance of data sets used, technical documentation and record-keeping, transparency and the provision of information to deployers, human oversight, and robustness, accuracy and cybersecurity. Those requirements are necessary to effectively mitigate the risks for health, safety and fundamental rights, and no other less trade restrictive measures are reasonably available, thus avoiding unjustified restrictions to trade.

(44) High quality data and access to high quality data plays a vital role in providing structure and in ensuring the performance of many AI systems, especially when techniques involving the training of models are used, with a view to ensure that the high-risk AI system performs as intended and safely and it does not become a source of discrimination prohibited by Union law. High quality datasets for training, validation and testing require the implementation of appropriate data governance and management practices. Datasets for training, validation and testing, including the labels, should be relevant, sufficiently representative, and to the best extent possible free of errors and complete in view of the intended purpose of the system. In order to facilitate compliance with EU data protection law, such as Regulation (EU) 2016/679, data governance and management practices should include, in the case of personal data, transparency about the original purpose of the data collection, The datasets should also have the appropriate statistical properties, including as regards the persons or groups of persons in relation to whom the high-risk AI
system is intended to be used, with specific attention to the mitigation of possible biases in
the datasets, that are likely to affect the health and safety of persons, negatively impact
fundamental rights or lead to discrimination prohibited under Union law, especially where
data outputs influence inputs for future operations ('feedback loops'). Biases can for
example be inherent in underlying datasets, especially when historical data is being used,
or generated when the systems are implemented in real world settings. Results provided by
AI systems could be influenced by such inherent biases that are inclined to gradually
increase and thereby perpetuate and amplify existing discrimination, in particular for
persons belonging to certain vulnerable groups including racial or ethnic groups. The
requirement for the datasets to be to the best extent possible complete and free of errors
should not affect the use of privacy-preserving techniques in the context of the
development and testing of AI systems. In particular, datasets should take into account, to
the extent required by their intended purpose, the features, characteristics or elements that
are particular to the specific geographical, contextual, behavioural or functional setting
which the AI system is intended to be used. The requirements related to data governance
can be complied with by having recourse to third parties that offer certified compliance
services including verification of data governance, data set integrity, and data training,
validation and testing practices, as far as compliance with the data requirements of this
Regulation are ensured.

(45) For the development and assessment of high-risk AI systems, certain actors, such as providers, notified bodies and other relevant entities, such as digital innovation hubs, testing experimentation facilities and researchers, should be able to access and use high quality datasets within their respective fields of activities which are related to this Regulation. European common data spaces established by the Commission and the facilitation of data sharing between businesses and with government in the public interest will be instrumental to provide trustful, accountable and non-discriminatory access to high quality data for the training, validation and testing of AI systems. For example, in health, the European health data space will facilitate non-discriminatory access to health data and the training of artificial intelligence algorithms on those datasets, in a privacy-preserving, secure, timely, transparent and trustworthy manner, and with an appropriate institutional governance. Relevant competent authorities, including sectoral ones, providing or supporting the access to data may also support the provision of high-quality data for the training, validation and testing of AI systems.
(45a) The right to privacy and to protection of personal data must be guaranteed throughout the entire lifecycle of the AI system. In this regard, the principles of data minimisation and data protection by design and by default, as set out in Union data protection law, are applicable when personal data are processed. Measures taken by providers to ensure compliance with those principles may include not only anonymisation and encryption, but also the use of technology that permits algorithms to be brought to the data and allows training of AI systems without the transmission between parties or copying of the raw or structured data themselves, without prejudice to the requirements on data governance provided for in this Regulation.

(44c) In order to protect the right of others from the discrimination that might result from the bias in AI systems, the providers should, exceptionally, to the extent that it is strictly necessary for the purposes of ensuring bias detection and correction in relation to the high-risk AI systems, subject to appropriate safeguards for the fundamental rights and freedoms of natural persons and following the application of all applicable conditions laid down under this Regulation in addition to the conditions laid down in Regulation (EU) 2016/679, Directive (EU) 2016/680 and Regulation (EU) 2018/1725, be able to process also special categories of personal data, as a matter of substantial public interest within the meaning of Article 9(2)(g) of Regulation (EU) 2016/679 and Article 10(2)(g) of Regulation (EU) 2018/1725.

(46) Having comprehensible information on how high-risk AI systems have been developed and how they perform throughout their lifetime is essential to enable traceability of those systems, verify compliance with the requirements under this Regulation, as well as monitoring of their operations and post market monitoring. This requires keeping records and the availability of a technical documentation, containing information which is necessary to assess the compliance of the AI system with the relevant requirements and facilitate post market monitoring. Such information should include the general characteristics, capabilities and limitations of the system, algorithms, data, training, testing and validation processes used as well as documentation on the relevant risk management system and drawn in a clear and comprehensive form. The technical documentation should be kept up to date, appropriately throughout the lifetime of the AI system. Furthermore, high risk AI systems should technically allow for automatic recording of events (logs) over the duration of the lifetime of the system.

(47) To address concerns related to opacity and complexity of certain AI systems and help deployers to fulfil their obligations under this Regulation, transparency should be
required for high-risk AI systems before they are placed on the market or put it into
service. High-risk AI systems should be designed in a manner to enable deployers to
understand how the AI system works, evaluate its functionality, and comprehend its
strengths and limitations. High-risk AI systems should be accompanied by appropriate
information in the form of instructions of use. Such information should include the
characteristics, capabilities and limitations of performance of the AI system. These would
cover information on possible known and foreseeable circumstances related to the use of
the high-risk AI system, including deployer action that may influence system behaviour
and performance, under which the AI system can lead to risks to health, safety, and
fundamental rights, on the changes that have been pre-determined and assessed for
conformity by the provider and on the relevant human oversight measures, including the
measures to facilitate the interpretation of the outputs of the AI system by the deployers.
Transparency, including the accompanying instructions for use, should assist deployers in
the use of the system and support informed decision making by them. Among others,
deployers should be in a better position to make the correct choice of the system they
intend to use in the light of the obligations applicable to them, be educated about the
intended and precluded uses, and use the AI system correctly and as appropriate. In order to
enhance legibility and accessibility of the information included in the instructions of use,
where appropriate, illustrative examples, for instance on the limitations and on the
intended and precluded uses of the AI system, should be included. Providers should ensure
that all documentation, including the instructions for use, contains meaningful,
comprehensive, accessible and understandable information, taking into account the needs
and foreseeable knowledge of the target deployers. Instructions for use should be made
available in a language which can be easily understood by target deployers, as determined
by the Member State concerned.

(48) High-risk AI systems should be designed and developed in such a way that natural persons can oversee their functioning, ensure that they are used as intended and that their impacts are addressed over the system's lifecycle. For this purpose, appropriate human oversight measures should be identified by the provider of the system before its placing on the market or putting into service. In particular, where appropriate, such measures should guarantee that the system is subject to in-built operational constraints that cannot be overridden by the system itself and is responsive to the human operator, and that the natural persons to whom human oversight has been assigned have the necessary competence, training and authority to carry out that role. It is also essential, as appropriate, to ensure that high-risk AI systems include mechanisms to guide and inform a natural
person to whom human oversight has been assigned to make informed decisions if, when and
how to intervene in order to avoid negative consequences or risks, or stop the system if it does
not perform as intended. Considering the significant consequences for persons in case of
incorrect matches by certain biometric identification systems, it is appropriate to provide for
an enhanced human oversight requirement for those systems so that no action or decision
may be taken by the deployer on the basis of the identification resulting from the system
unless this has been separately verified and confirmed by at least two natural persons. Those
persons could be from one or more entities and include the person operating or using the
system. This requirement should not pose unnecessary burden or delays and it could be
sufficient that the separate verifications by the different persons are automatically recorded in
the logs generated by the system. Given the specificities of the areas of law enforcement,
migration, border control and asylum, this requirement should not apply in cases where
Union or national law considers the application of this requirement to be disproportionate.

(49) High-risk AI systems should perform consistently throughout their lifecycle and meet an appropriate level of accuracy, robustness and cybersecurity, in the light of their intended purpose and in accordance with the generally acknowledged state of the art. The Commission and relevant organisations and stakeholders are encouraged to take due consideration of mitigation of risks and negative impacts of the AI system. The expected level of performance metrics should be declared in the accompanying instructions of use. Providers are urged to communicate this information to deployers in a clear and easily understandable way, free of misunderstandings or misleading statements. The EU legislation on legal metrology, including on Measuring Instruments Directive (MID) and Non-automatic weighing instruments (NAWI) Directive, aims to ensure the accuracy of measurements and to help the transparency and fairness of commercial transactions. In this context, in cooperation with relevant stakeholders and organisation, such as metrology and benchmarking authorities, the Commission should encourage, as appropriate, the development of benchmarks and measurement methodologies for AI systems. In doing so, the Commission should take note and collaborate with international partners working on metrology and relevant measurement indicators relating to Artificial Intelligence.

(50) The technical robustness is a key requirement for high-risk AI systems. They should be resilient in relation to harmful or otherwise undesirable behaviour that may result from limitations within the systems or the environment in which the systems operate (e.g. errors, faults, inconsistencies, unexpected situations). Therefore, technical and organisational measures should be taken to ensure robustness of high-risk AI systems, for example by
designing and developing appropriate technical solutions to prevent or minimize harmful or otherwise undesirable behaviour. Those technical solution may include for instance mechanisms enabling the system to safely interrupt its operation (fail-safe plans) in the presence of certain anomalies or when operation takes place outside certain predetermined boundaries. Failure to protect against these risks could lead to safety impacts or negatively affect the fundamental rights, for example due to erroneous decisions or wrong or biased outputs generated by the AI system.

(51) Cybersecurity plays a crucial role in ensuring that AI systems are resilient against attempts to alter their use, behaviour, performance or compromise their security properties by malicious third parties exploiting the system's vulnerabilities. Cyberattacks against AI systems can leverage AI specific assets, such as training data sets (e.g. data poisoning) or trained models (e.g. adversarial attacks or membership inference), or exploit vulnerabilities in the AI system's digital assets or the underlying ICT infrastructure. To ensure a level of cybersecurity appropriate to the risks, suitable measures, such as security controls, should therefore be taken by the providers of high-risk AI systems, also taking into account as appropriate the underlying ICT infrastructure.

(51a) Without prejudice to the requirements related to robustness and accuracy set out in this Regulation, high-risk AI systems which fall within the scope of the Regulation 2022/0272, in accordance with Article 8 of the Regulation 2022/0272 may demonstrate compliance with the cybersecurity requirement of this Regulation by fulfilling the essential cybersecurity requirements set out in Article 10 and Annex I of the Regulation 2022/0272. When high-risk AI systems fulfil the essential requirements of Regulation 2022/0272, they should be deemed compliant with the cybersecurity requirements set out in this Regulation in so far as the achievement of those requirements is demonstrated in the EU declaration of conformity or parts thereof issued under Regulation 2022/0272. For this purpose, the assessment of the cybersecurity risks, associated to a product with digital elements classified as high-risk AI system according to this Regulation, carried out under Regulation 2022/0272, should consider risks to the cyber resilience of an AI system as regards attempts by unauthorised third parties to alter its use, behaviour or performance, including AI specific vulnerabilities such as data poisoning or adversarial attacks, as well as, as relevant, risks to fundamental rights as required by this Regulation. The conformity assessment procedure provided by this Regulation should apply in relation to the essential cybersecurity requirements of a product with digital elements covered by Regulation 2022/0272 and classified as a high-risk AI system under this Regulation. However, this
rule should not result in reducing the necessary level of assurance for critical products with digital elements covered by Regulation 2022/0272. Therefore, by way of derogation from this rule, high-risk AI systems that fall within the scope of this Regulation and are also qualified as important and critical products with digital elements pursuant to Regulation 2022/0272 and to which the conformity assessment procedure based on internal control referred to in Annex VI of this Regulation applies, are subject to the conformity assessment provisions of Regulation 2022/0272 insofar as the essential cybersecurity requirements of Regulation 2022/0272 are concerned. In this case, for all the other aspects covered by this Regulation the respective provisions on conformity assessment based on internal control set out in Annex VI of this Regulation should apply. Building on the knowledge and expertise of ENISA on the cybersecurity policy and tasks assigned to ENISA under the Regulation 2019/1020 the European Commission should cooperate with ENISA on issues related to cybersecurity of AI systems.

(52) As part of Union harmonisation legislation, rules applicable to the placing on the market, putting into service and use of high-risk AI systems should be laid down consistently with Regulation (EC) No 765/2008 of the European Parliament and of the Council<sup>22</sup> setting out the requirements for accreditation and the market surveillance of products, Decision No 768/2008/EC of the European Parliament and of the Council<sup>23</sup> on a common framework for the marketing of products and Regulation (EU) 2019/1020 of the European Parliament and of the Council<sup>24</sup> on market surveillance and compliance of products ('New Legislative Framework for the marketing of products').

(53) It is appropriate that a specific natural or legal person, defined as the provider, takes the responsibility for the placing on the market or putting into service of a high-risk AI system, regardless of whether that natural or legal person is the person who designed or developed the system.

(53a) As signatories to the United Nations Convention on the Rights of Persons with Disabilities (UNCRPD), the Union and the Member States are legally obliged to protect persons with disabilities from discrimination and promote their equality, to ensure that persons with

<footnote n="22"><sup>22</sup> Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).</footnote>

<footnote n="23"><sup>23</sup> Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).</footnote>

<footnote n="24"><sup>24</sup> Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (Text with EEA relevance) (OJ L 169, 25.6.2019, p. 1-44).</footnote>
disabilities have access, on an equal basis with others, to information and communications
technologies and systems, and to ensure respect for privacy for persons with disabilities.
Given the growing importance and use of AI systems, the application of universal design
principles to all new technologies and services should ensure full and equal access for
everyone potentially affected by or using AI technologies, including persons with
disabilities, in a way that takes full account of their inherent dignity and diversity. It is
therefore essential that Providers ensure full compliance with accessibility requirements,
including Directive (EU) 2016/2102 and Directive (EU) 2019/882. Providers should ensure
compliance with these requirements by design. Therefore, the necessary measures should
be integrated as much as possible into the design of the high-risk AI system.

(54) The provider should establish a sound quality management system, ensure the accomplishment of the required conformity assessment procedure, draw up the relevant documentation and establish a robust post-market monitoring system. Providers of high-risk AI systems that are subject to obligations regarding quality management systems under relevant sectorial Union law should have the possibility to include the elements of the quality management system provided for in this Regulation as part of the existing quality management system provided for in that other sectorial Union legislation. The complementarity between this Regulation and existing sectorial Union law should also be taken into account in future standardization activities or guidance adopted by the Commission. Public authorities which put into service high-risk AI systems for their own use may adopt and implement the rules for the quality management system as part of the quality management system adopted at a national or regional level, as appropriate, taking into account the specificities of the sector and the competences and organisation of the public authority in question.

(56) To enable enforcement of this Regulation and create a level-playing field for operators, and taking into account the different forms of making available of digital products, it is important to ensure that, under all circumstances, a person established in the Union can provide authorities with all the necessary information on the compliance of an AI system. Therefore, prior to making their AI systems available in the Union, providers established outside the Union shall, by written mandate, appoint an authorised representative established in the Union. This authorised representative plays a pivotal role in ensuring the compliance of the high-risk AI systems placed on the market or put into service in the Union by those providers who are not established in the Union and in serving as their contact person established in the Union.
(56a) In the light of the nature and complexity of the value chain for AI systems and in line with New Legislative Framework principles, it is essential to ensure legal certainty and facilitate the compliance with this Regulation. Therefore, it is necessary to clarify the role and the specific obligations of relevant operators along the value chain, such as importers and distributors who may contribute to the development of AI systems. In certain situations those operators could act in more than one role at the same time and should therefore fulfil cumulatively all relevant obligations associated with those roles. For example, an operator could act as a distributor and an importer at the same time.

(57) To ensure legal certainty, it is necessary to clarify that, under certain specific conditions, any distributor, importer, deployer or other third-party should be considered a provider of a high-risk AI system and therefore assume all the relevant obligations. This would be the case if that party puts its name or trademark on a high-risk AI system already placed on the market or put into service, without prejudice to contractual arrangements stipulating that the obligations are allocated otherwise, or if that party make a substantial modification to a high-risk AI system that has already been placed on the market or has already been put into service and in a way that it remains a high-risk AI system in accordance with Article 6, or if it modifies the intended purpose of an AI system, including a general purpose AI system, which has not been classified as high-risk and has already been placed on the market or put into service, in a way that the AI system becomes a high-risk AI system in accordance with Article 6. These provisions should apply without prejudice to more specific provisions established in certain New Legislative Framework sectorial legislation with which this Regulation should apply jointly. For example, Article 16, paragraph 2 of Regulation 745/2017, establishing that certain changes should not be considered modifications of a device that could affect its compliance with the applicable requirements, should continue to apply to high-risk AI systems that are medical devices within the meaning of that Regulation.

(57a) General purpose AI systems may be used as high-risk AI systems by themselves or be components of other high risk AI systems. Therefore, due to their particular nature and in order to ensure a fair sharing of responsibilities along the AI value chain, the providers of such systems should, irrespective of whether they may be used as high-risk AI systems as such by other providers or as components of high-risk AI systems and unless provided otherwise under this Regulation, closely cooperate with the providers of the respective high-risk AI systems to enable their compliance with the relevant obligations under this Regulation and with the competent authorities established under this Regulation.
(57b) Where, under the conditions laid down in this Regulation, the provider that initially placed the AI system on the market or put it into service should no longer be considered the provider for the purposes of this Regulation, and when that provider has not expressly excluded the change of the AI system into a high-risk AI system, the former provider should nonetheless closely cooperate and make available the necessary information and provide the reasonably expected technical access and other assistance that are required for the fulfilment of the obligations set out in this Regulation, in particular regarding the compliance with the conformity assessment of high-risk AI systems.

(57c) In addition, where a high-risk AI system that is a safety component of a product which is covered by a relevant New Legislative Framework sectorial legislation is not placed on the market or put into service independently from the product, the product manufacturer as defined under the relevant New Legislative Framework legislation should comply with the obligations of the provider established in this Regulation and notably ensure that the AI system embedded in the final product complies with the requirements of this Regulation.

(57d) Within the AI value chain multiple parties often supply AI systems, tools and services but also components or processes that are incorporated by the provider into the AI system with various objectives, including the model training, model retraining, model testing and evaluation, integration into software, or other aspects of model development. These parties have an important role in the value chain towards the provider of the high-risk AI system into which their AI systems, tools, services, components or processes are integrated, and should provide by written agreement this provider with the necessary information, capabilities, technical access and other assistance based on the generally acknowledged state of the art, in order to enable the provider to fully comply with the obligations set out in this Regulation, without compromising their own intellectual property rights or trade secrets.

(57e) Third parties making accessible to the public tools, services, processes, or AI components other than general-purpose AI models, shall not be mandated to comply with requirements targeting the responsibilities along the AI value chain, in particular towards the provider that has used or integrated them, when those tools, services, processes, or AI components are made accessible under a free and open licence. Developers of free and open-source tools, services, processes, or AI components other than general-purpose AI models should be encouraged to implement widely adopted documentation practices, such as model cards and data sheets, as a way to accelerate information sharing along the AI value chain, allowing the promotion of trustworthy AI systems in the Union.
(57f) The Commission could develop and recommend voluntary model contractual terms between providers of high-risk AI systems and third parties that supply tools, services, components or processes that are used or integrated in high-risk AI systems, to facilitate the cooperation along the value chain. When developing voluntary model contractual terms, the Commission should also take into account possible contractual requirements applicable in specific sectors or business cases.

(58) Given the nature of AI systems and the risks to safety and fundamental rights possibly associated with their use, including as regards the need to ensure proper monitoring of the performance of an AI system in a real-life setting, it is appropriate to set specific responsibilities for deployers. Deployers should in particular take appropriate technical and organisational measures to ensure they use high-risk AI systems in accordance with the instructions of use and certain other obligations should be provided for with regard to monitoring of the functioning of the AI systems and with regard to record-keeping, as appropriate. Furthermore, deployers should ensure that the persons assigned to implement the instructions for use and human oversight as set out in this Regulation have the necessary competence, in particular an adequate level of AI literacy, training and authority to properly fulfil those tasks. These obligations should be without prejudice to other deployer obligations in relation to high-risk AI systems under Union or national law.

(58b) This Regulation is without prejudice to obligations for employers to inform or to inform and consult workers or their representatives under Union or national law and practice, including directive 2002/14/EC on a general framework for informing and consulting employees, on decisions to put into service or use AI systems. It remains necessary to ensure information of workers and their representatives on the planned deployment of high-risk AI systems at the workplace in cases where the conditions for those information or information and consultation obligations in other legal instruments are not fulfilled. Moreover, such information right is ancillary and necessary to the objective of protecting fundamental rights that underlies this Regulation. Therefore, an information requirement to that effect should be laid down in this regulation, without affecting any existing rights of workers.

(58b) Whilst risks related to AI systems can result from the way such systems are designed, risks can as well stem from how such AI systems are used. Deployers of high-risk AI system therefore play a critical role in ensuring that fundamental rights are protected, complementing the obligations of the provider when developing the AI system. Deployers are best placed to understand how the high-risk AI system will be used concretely and can
therefore identify potential significant risks that were not foreseen in the development phase, due to a more precise knowledge of the context of use, the people or groups of people likely to be affected, including vulnerable groups. Deployers of high-risk AI systems referred to in Annex III also play a critical role in informing natural persons and should, when they make decisions or assist in making decisions related to natural persons, where applicable, inform the natural persons that they are subject to the use of the high risk AI system. This information should include the intended purpose and the type of decisions it makes. The deployer should also inform the natural person about its right to an explanation provided under this Regulation. With regard to high-risk AI systems used for law enforcement purposes, this obligation should be implemented in accordance with Article 13 of Directive 2016/680.

(58d) Any processing of biometric data involved in the use of AI systems for biometric identification for the purpose of law enforcement needs to comply with Article 10 of Directive (EU) 2016/680, that allows such processing only where strictly necessary, subject to appropriate safeguards for the rights and freedoms of the data subject, and where authorised by Union or Member State law. Such use, when authorized, also needs to respect the principles laid down in Article 4 paragraph 1 of Directive (EU) 2016/680 including lawfulness, fairness and transparency, purpose limitation, accuracy and storage limitation.

(58e) Without prejudice to applicable Union law, notably the GDPR and Directive (EU) 2016/680 (the Law Enforcement Directive), considering the intrusive nature of post remote biometric identification systems, the use of post remote biometric identification systems shall be subject to safeguards. Post biometric identification systems should always be used in a way that is proportionate, legitimate and strictly necessary, and thus targeted, in terms of the individuals to be identified, the location, temporal scope and based on a closed dataset of legally acquired video footage. In any case, post remote biometric identification systems should not be used in the framework of law enforcement to lead to indiscriminate surveillance. The conditions for post remote biometric identification should in any case not provide a basis to circumvent the conditions of the prohibition and strict exceptions for real time remote biometric identification.

(58g) In order to efficiently ensure that fundamental rights are protected, deployers of high-risk AI systems that are bodies governed by public law, or private operators providing public services and operators deploying certain high-risk AI system referred to in Annex III, such as banking or insurance entities, should carry out a fundamental rights impact assessment
prior to putting it into use. Services important for individuals that are of public nature may
also be provided by private entities. Private operators providing such services of public
nature are linked to tasks in the public interest such as in the area of education, healthcare,
social services, housing, administration of justice. The aim of the fundamental rights
impact assessment is for the deployer to identify the specific risks to the rights of
individuals or groups of individuals likely to be affected, identify measures to be taken in
case of the materialisation of these risks. The impact assessment should apply to the first
use of the high-risk AI system, and should be updated when the deployer considers that
any of the relevant factors have changed. The impact assessment should identify the
deployer's relevant processes in which the high-risk AI system will be used in line with its
intended purpose, and should include a description of the period of time and frequency in
which the system is intended to be used as well as of specific categories of natural persons
and groups who are likely to be affected in the specific context of use. The assessment
should also include the identification of specific risks of harm likely to impact the
fundamental rights of these persons or groups. While performing this assessment, the
deployer should take into account information relevant to a proper assessment of impact,
including but not limited to the information given by the provider of the high-risk AI
system in the instructions for use. In light of the risks identified, deployers should
determine measures to be taken in case of the materialization of these risks, including for
example governance arrangements in that specific context of use, such as arrangements for
human oversight according to the instructions of use or, complaint handling and redress
procedures, as they could be instrumental in mitigating risks to fundamental rights in
concrete use-cases. After performing this impact assessment, the deployer should notify
the relevant market surveillance authority. Where appropriate, to collect relevant
information necessary to perform the impact assessment, deployers of high-risk AI system,
in particular when AI systems are used in the public sector, could involve relevant
stakeholders, including the representatives of groups of persons likely to be affected by the
AI system, independent experts, and civil society organisations in conducting such impact
assessments and designing measures to be taken in the case of materialization of the risks.
The AI Office should develop a template for a questionnaire in order to facilitate
compliance and reduce the administrative burden for deployers.

(60a) The notion of general purpose AI models should be clearly defined and set apart from the notion of AI systems to enable legal certainty. The definition should be based on the key functional characteristics of a general-purpose AI model, in particular the generality and the capability to competently perform a wide range of distinct tasks. These models are
typically trained on large amounts of data, through various methods, such as self-
supervised, unsupervised or reinforcement learning. General purpose AI models may be
placed on the market in various ways, including through libraries, application
programming interfaces (APIs), as direct download, or as physical copy. These models
may be further modified or fine-tuned into new models. Although AI models are essential
components of AI systems, they do not constitute AI systems on their own. AI models
require the addition of further components, such as for example a user interface, to become
AI systems. AI models are typically integrated into and form part of AI systems. This
Regulation provides specific rules for general purpose AI models and for general purpose
AI models that pose systemic risks, which should apply also when these models are
integrated or form part of an AI system. It should be understood that the obligations for the
providers of general purpose AI models should apply once the general purpose AI models
are placed on the market. When the provider of a general purpose AI model integrates an
own model into its own AI system that is made available on the market or put into service,
that model should be considered as being placed on the market and, therefore, the
obligations in this Regulation for models should continue to apply in addition to those for
AI systems. The obligations foreseen for models should in any case not apply when an own
model is used for purely internal processes that are not essential for providing a product or
a service to third parties and the rights of natural persons are not affected. Considering
their potential significantly negative effects, the general-purpose AI models with systemic
risk should always be subject to the relevant obligations under this Regulation. The
definition should not cover AI models used before their placing on the market for the sole
purpose of research, development and prototyping activities. This is without prejudice to
the obligation to comply with this Regulation when, following such activities, a model is
placed on the market.

(60b) Whereas the generality of a model could, among other criteria, also be determined by a number of parameters, models with at least a billion of parameters and trained with a large amount of data using self-supervision at scale should be considered as displaying significant generality and competently performing a wide range of distinctive tasks.

(60c) Large generative AI models are a typical example for a general-purpose AI model, given that they allow for flexible generation of content (such as in the form of text, audio, images or video) that can readily accommodate a wide range of distinctive tasks.

(60d) When a general-purpose AI model is integrated into or forms part of an AI system, this system should be considered a general-purpose AI system when, due to this
integration, this system has the capability to serve a variety of purposes. A general-
purpose AI system can be used directly, or it may be integrated into other AI systems.

(60e) Providers of general purpose AI models have a particular role and responsibility in the AI value chain, as the models they provide may form the basis for a range of downstream systems, often provided by downstream providers that necessitate a good understanding of the models and their capabilities, both to enable the integration of such models into their products, and to fulfil their obligations under this or other regulations. Therefore, proportionate transparency measures should be foreseen, including the drawing up and keeping up to date of documentation, and the provision of information on the general purpose AI model for its usage by the downstream providers. Technical documentation should be prepared and kept up to date by the general purpose AI model provider for the purpose of making it available, upon request, to the AI Office and the national competent authorities. The minimal set of elements contained in such documentations should be outlined, respectively, in Annex (IXb) and Annex (IXa). The Commission should be enabled to amend the Annexes by delegated acts in the light of the evolving technological developments.

(60i) Software and data, including models, released under a free and open-source licence that allows them to be openly shared and where users can freely access, use, modify and redistribute them or modified versions thereof, can contribute to research and innovation in the market and can provide significant growth opportunities for the Union economy. General purpose AI models released under free and open-source licences should be considered to ensure high levels of transparency and openness if their parameters, including the weights, the information on the model architecture, and the information on model usage are made publicly available. The licence should be considered free and open-source also when it allows users to run, copy, distribute, study, change and improve software and data, including models under the condition that the original provider of the model is credited, the identical or comparable terms of distribution are respected.

(60i+1) Free and open-source AI components covers the software and data, including models and general purpose AI models, tools, services or processes of an AI system. Free and open-source AI components can be provided through different channels, including their development on open repositories. For the purpose of this Regulation, AI components that are provided against a price or otherwise monetised, including through the provision of technical support or other services, including through a software platform, related to the AI component, or the use of personal data for reasons other than exclusively for improving
the security, compatibility or interoperability of the software, with the exception of
transactions between micro enterprises, should not benefit from the exceptions provided to
free and open source AI components. The fact of making AI components available through
open repositories should not, in itself, constitute a monetisation.

(60f) The providers of general purpose AI models that are released under a free and open source license, and whose parameters, including the weights, the information on the model architecture, and the information on model usage, are made publicly available should be subject to exceptions as regards the transparency-related requirements imposed on general purpose AI models, unless they can be considered to present a systemic risk, in which case the circumstance that the model is transparent and accompanied by an open source license should not be considered a sufficient reason to exclude compliance with the obligations under this Regulation. In any case, given that the release of general purpose AI models under free and open source licence does not necessarily reveal substantial information on the dataset used for the training or fine-tuning of the model and on how thereby the respect of copyright law was ensured, the exception provided for general purpose AI models from compliance with the transparency-related requirements should not concern the obligation to produce a summary about the content used for model training and the obligation to put in place a policy to respect Union copyright law in particular to identify and respect the reservations of rights expressed pursuant to Article 4(3) of Directive (EU) 2019/790.

(60i) General purpose models, in particular large generative models, capable of generating text, images, and other content, present unique innovation opportunities but also challenges to artists, authors, and other creators and the way their creative content is created, distributed, used and consumed. The development and training of such models require access to vast amounts of text, images, videos, and other data. Text and data mining techniques may be used extensively in this context for the retrieval and analysis of such content, which may be protected by copyright and related rights. Any use of copyright protected content requires the authorization of the rightholder concerned unless relevant copyright exceptions and limitations apply. Directive (EU) 2019/790 introduced exceptions and limitations allowing reproductions and extractions of works or other subject matter, for the purposes of text and data mining, under certain conditions. Under these rules, rightholders may choose to reserve their rights over their works or other subject matter to prevent text and data mining, unless this is done for the purposes of scientific research. Where the rights to opt out has been expressly reserved in an appropriate manner, providers of
general-purpose AI models need to obtain an authorisation from rightholders if they want to carry out text and data mining over such works.

(60j) Providers that place general purpose AI models on the EU market should ensure compliance with the relevant obligations in this Regulation. For this purpose, providers of general purpose AI models should put in place a policy to respect Union law on copyright and related rights, in particular to identify and respect the reservations of rights expressed by rightholders pursuant to Article 4(3) of Directive (EU) 2019/790. Any provider placing a general purpose AI model on the EU market should comply with this obligation, regardless of the jurisdiction in which the copyright-relevant acts underpinning the training of these general purpose AI models take place. This is necessary to ensure a level playing field among providers of general purpose AI models where no provider should be able to gain a competitive advantage in the EU market by applying lower copyright standards than those provided in the Union.

(60k) In order to increase transparency on the data that is used in the pre-training and training of general purpose AI models, including text and data protected by copyright law, it is adequate that providers of such models draw up and make publicly available a sufficiently detailed summary of the content used for training the general purpose model. While taking into due account the need to protect trade secrets and confidential business information, this summary should be generally comprehensive in its scope instead of technically detailed to facilitate parties with legitimate interests, including copyright holders, to exercise and enforce their rights under Union law, for example by listing the main data collections or sets that went into training the model, such as large private or public databases or data archives, and by providing a narrative explanation about other data sources used. It is appropriate for the AI Office to provide a template for the summary, which should be simple, effective, and allow the provider to provide the required summary in narrative form.

(60ka) With regard to the obligations imposed on providers of general purpose AI models to put in place a policy to respect Union copyright law and make publicly available a summary of the content used for the training, the AI Office should monitor whether the provider has fulfilled those obligations without verifying or proceeding to a work-by-work assessment of the training data in terms of copyright compliance. This Regulation does not affect the enforcement of copyright rules as provided for under Union law.
(60g) Compliance with the obligations foreseen for the providers of general purpose AI models should be commensurate and proportionate to the type of model provider, excluding the need for compliance for persons who develop or use models for non-professional or scientific research purposes, who should nevertheless be encouraged to voluntarily comply with these requirements. Without prejudice to Union Copyright law, compliance with these obligations should take due account of the size of the provider and allow simplified ways of compliance for SMEs including start-ups, that should not represent an excessive cost and not discourage the use of such models. In case of a modification or fine-tuning of a model, the obligations for providers should be limited to that modification or fine-tuning, for example by complementing the already existing technical documentation with information on the modifications, including new training data sources, as a means to comply with the value chain obligations provided in this Regulation.

(60m) General purpose AI models could pose systemic risks which include, but are not limited to, any actual or reasonably foreseeable negative effects in relation to major accidents, disruptions of critical sectors and serious consequences to public health and safety; any actual or reasonably foreseeable negative effects on democratic processes, public and economic security; the dissemination of illegal, false, or discriminatory content. Systemic risks should be understood to increase with model capabilities and model reach, can arise along the entire lifecycle of the model, and are influenced by conditions of misuse, model reliability, model fairness and model security, the degree of autonomy of the model, its access to tools, novel or combined modalities, release and distribution strategies, the potential to remove guardrails and other factors. In particular, international approaches have so far identified the need to devote attention to risks from potential intentional misuse or unintended issues of control relating to alignment with human intent; chemical, biological, radiological, and nuclear risks, such as the ways in which barriers to entry can be lowered, including for weapons development, design acquisition, or use; offensive cyber capabilities, such as the ways in vulnerability discovery, exploitation, or operational use can be enabled; the effects of interaction and tool use, including for example the capacity to control physical systems and interfere with critical infrastructure; risks from models of making copies of themselves or "self-replicating" or training other models; the ways in which models can give rise to harmful bias and discrimination with risks to individuals, communities or societies; the facilitation of disinformation or harming privacy with threats to democratic values and human rights; risk that a particular event could lead to a chain reaction with considerable negative effects that could affect up to an entire city, an entire domain activity or an entire community.
(60n) It is appropriate to establish a methodology for the classification of general purpose AI models as general purpose AI model with systemic risks. Since systemic risks result from particularly high capabilities, a general-purpose AI models should be considered to present systemic risks if it has high-impact capabilities, evaluated on the basis of appropriate technical tools and methodologies, or significant impact on the internal market due to its reach. High-impact capabilities in general purpose AI models means capabilities that match or exceed the capabilities recorded in the most advanced general-purpose AI models. The full range of capabilities in a model could be better understood after its release on the market or when users interact with the model. According to the state of the art at the time of entry into force of this Regulation, the cumulative amount of compute used for the training of the general purpose AI model measured in floating point operations (FLOPs) is one of the relevant approximations for model capabilities. The amount of compute used for training cumulates the compute used across the activities and methods that are intended to enhance the capabilities of the model prior to deployment, such as pre-training, synthetic data generation and fine-tuning. Therefore, an initial threshold of FLOPs should be set, which, if met by a general-purpose AI model, leads to a presumption that the model is a general-purpose AI model with systemic risks. This threshold should be adjusted over time to reflect technological and industrial changes, such as algorithmic improvements or increased hardware efficiency, and should be supplemented with benchmarks and indicators for model capability. To inform this, the AI Office should engage with the scientific community, industry, civil society and other experts. Thresholds, as well as tools and benchmarks for the assessment of high-impact capabilities, should be strong predictors of generality, its capabilities and associated systemic risk of general-purpose AI models, and could take into taking into account the way the model will be placed on the market or the number of users it may affect. To complement this system, there should be a possibility for the Commission to take individual decisions designating a general-purpose AI model as a general-purpose AI model with systemic risk if it is found that such model has capabilities or impact equivalent to those captured by the set threshold. This decision should be taken on the basis of an overall assessment of the criteria set out in Annex YY, such as quality or size of the training data set, number of business and end users, its input and output modalities, its degree of autonomy and scalability, or the tools it has access to. Upon a reasoned request of a provider whose model has been designated as a general-purpose AI model with systemic risk, the Commission should take the request into account and may decide to reassess whether the general-purpose AI model can still be considered to present systemic risks.
(60o) It is also necessary to clarify a procedure for the classification of a general purpose AI model with systemic risks. A general purpose AI model that meets the applicable threshold for high-impact capabilities should be presumed to be a general purpose AI models with systemic risk. The provider should notify the AI Office at the latest two weeks after the requirements are met or it becomes known that a general purpose AI model will meet the requirements that lead to the presumption. This is especially relevant in relation to the FLOP threshold because training of general purpose AI models takes considerable planning which includes the upfront allocation of compute resources and, therefore, providers of general purpose AI models are able to know if their model would meet the threshold before the training is completed. In the context of this notification, the provider should be able to demonstrate that because of its specific characteristics, a general purpose AI model exceptionally does not present systemic risks, and that it thus should not be classified as a general purpose AI model with systemic risks. This information is valuable for the AI Office to anticipate the placing on the market of general purpose AI models with systemic risks and the providers can start to engage with the AI Office early on. This is especially important with regard to general-purpose AI models that are planned to be released as open-source, given that, after open-source model release, necessary measures to ensure compliance with the obligations under this Regulation may be more difficult to implement.

(60p) If the Commission becomes aware of the fact that a general purpose AI model meets the requirements to classify as a general purpose model with systemic risk, which previously had either not been known or of which the relevant provider has failed to notify the Commission, the Commission should be empowered to designate it so. A system of qualified alerts should ensure that the AI Office is made aware by the scientific panel of general-purpose AI models that should possibly be classified as general purpose AI models with systemic risk, in addition to the monitoring activities of the AI Office.

(60q) The providers of general-purpose AI models presenting systemic risks should be subject, in addition to the obligations provided for providers of general purpose AI models, to obligations aimed at identifying and mitigating those risks and ensuring an adequate level of cybersecurity protection, regardless of whether it is provided as a standalone model or embedded in an AI system or a product. To achieve these objectives, the Regulation should require providers to perform the necessary model evaluations, in particular prior to its first placing on the market, including conducting and documenting adversarial testing of models, also, as appropriate, through internal or independent external testing. In addition,
providers of general-purpose AI models with systemic risks should continuously assess and mitigate systemic risks, including for example by putting in place risk management policies, such as accountability and governance processes, implementing post-market monitoring, taking appropriate measures along the entire model's lifecycle and cooperating with relevant actors across the AI value chain.

(60r) Providers of general purpose AI models with systemic risks should assess and mitigate possible systemic risks. If, despite efforts to identify and prevent risks related to a general purpose AI model that may present systemic risks, the development or use of the model causes a serious incident, the general purpose AI model provider should without undue delay keep track of the incident and report any relevant information and possible corrective measures to the Commission and national competent authorities. Furthermore, providers should ensure an adequate level of cybersecurity protection for the model and its physical infrastructure, if appropriate, along the entire model lifecycle. Cybersecurity protection related to systemic risks associated with malicious use of or attacks should duly consider accidental model leakage, unsanctioned releases, circumvention of safety measures, and defence against cyberattacks, unauthorised access or model theft. This protection could be facilitated by securing model weights, algorithms, servers, and datasets, such as through operational security measures for information security, specific cybersecurity policies, adequate technical and established solutions, and cyber and physical access controls, appropriate to the relevant circumstances and the risks involved.

(60s) The AI Office should encourage and facilitate the drawing up, review and adaptation of Codes of Practice, taking into account international approaches. All providers of general-purpose AI models could be invited to participate. To ensure that the Codes of Practice reflect the state of the art and duly take into account a diverse set of perspectives, the AI Office should collaborate with relevant national competent authorities, and could, where appropriate, consult with civil society organisations and other relevant stakeholders and experts, including the Scientific Panel, for the drawing up of the Codes. Codes of Practice should cover obligations for providers of general-purpose AI models and of general-purpose models presenting systemic risks. In addition, as regards systemic risks, Codes of Practice should help to establish a risk taxonomy of the type and nature of the systemic risks at Union level, including their sources. Codes of practice should also be focused on specific risk assessment and mitigation measures.

(60t) The Codes of Practice should represent a central tool for the proper compliance with the obligations foreseen under this Regulation for providers of general-purpose AI models.
Providers should be able to rely on Codes of Practice to demonstrate compliance with the obligations. By means of implementing acts, the Commission may decide to approve a code of practice and give it a general validity within the Union, or, alternatively, to provide common rules for the implementation of the relevant obligations, if, by the time the Regulation becomes applicable, a Code of Practice cannot be finalised or is not deemed adequate by the AI Office. Once a harmonised standard is published and assessed as suitable to cover the relevant obligations by the AI Office, the compliance with a European harmonised standard should grant providers the presumption of conformity. Providers of general purpose AI models should furthermore be able to demonstrate compliance using alternative adequate means, if codes of practice or harmonized standards are not available, or they choose not to rely on those.

(60u) This Regulation regulates AI systems and models by imposing certain requirements and obligations for relevant market actors that are placing them on the market, putting into service or use in the Union, thereby complementing obligations for providers of intermediary services that embed such systems or models into their services regulated by Regulation (EU) 2022/2065. To the extent that such systems or models are embedded into designated very large online platforms or very large online search engines, they are subject to the risk management framework provided for in Regulation (EU) 2022/2065.

Consequently, the corresponding obligations of the AI Act should be presumed to be fulfilled, unless significant systemic risks not covered by Regulation (EU) 2022/2065 emerge and are identified in such models. Within this framework, providers of very large online platforms and very large search engines are obliged to assess potential systemic risks stemming from the design, functioning and use of their services, including how the design of algorithmic systems used in the service may contribute to such risks, as well as systemic risks stemming from potential misuses. Those providers are also obliged to take appropriate mitigating measures in observance of fundamental rights.

(60aa) Considering the quick pace of innovation and the technological evolution of digital services in scope of different instruments of Union law in particular having in mind the usage and the perception of their recipients, the AI systems subject to this Regulation may be provided as intermediary services or parts thereof within the meaning of Regulation (EU) 2022/2065, which should be interpreted in a technology-neutral manner. For example, AI systems may be used to provide online search engines, in particular, to the extent that an AI system such as an online chatbot performs searches of, in principle, all
websites, then incorporates the results into its existing knowledge and uses the updated knowledge to generate a single output that combines different sources of information.

(60v) Furthermore, obligations placed on providers and deployers of certain AI systems in this Regulation to enable the detection and disclosure that the outputs of those systems are artificially generated or manipulated are particularly relevant to facilitate the effective implementation of Regulation (EU) 2022/2065. This applies in particular as regards the obligations of providers of very large online platforms or very large online search engines to identify and mitigate systemic risks that may arise from the dissemination of content that has been artificially generated or manipulated, in particular risk of the actual or foreseeable negative effects on democratic processes, civic discourse and electoral processes, including through disinformation.

(61) Standardisation should play a key role to provide technical solutions to providers to ensure compliance with this Regulation, in line with the state of the art, to promote innovation as well as competitiveness and growth in the single market. Compliance with harmonised standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council<fnref n="25" />, which are normally expected to reflect the state of the art, should be a means for providers to demonstrate conformity with the requirements of this Regulation. A balanced representation of interests involving all relevant stakeholders in the development of standards, in particular SME's, consumer organisations and environmental and social stakeholders in accordance with Article 5 and 6 of Regulation 1025/2012 should therefore be encouraged. In order to facilitate compliance, the standardisation requests should be issued by the Commission without undue delay. When preparing the standardisation request, the Commission should consult the AI advisory Forum and the Board in order to collect relevant expertise. However, in the absence of relevant references to harmonised standards, the Commission should be able to establish, via implementing acts, and after consultation of the AI Advisory Forum, common specifications for certain requirements under this Regulation. The common specification should be an exceptional fall back solution to facilitate the provider's obligation to comply with the requirements of this Regulation, when the standardisation request has not been accepted by any of the European standardisation organisations, or when the relevant harmonized standards insufficiently address fundamental rights concerns, or when the harmonised standards do not comply

<footnote n="25">²⁵ Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).</footnote>
with the request, or when there are delays in the adoption of an appropriate harmonised
standard. If such delay in the adoption of a harmonised standard is due to the technical
complexity of the standard in question, this should be considered by the Commission
before contemplating the establishment of common specifications. When developing
common specifications, the Commission is encouraged to cooperate with international
partners and international standardisation bodies.

(61a) It is appropriate that, without prejudice to the use of harmonised standards and common specifications, providers of high-risk AI system that has been trained and tested on data reflecting the specific geographical, behavioural, contextual or functional setting within which the AI system is intended to be used, should be presumed to be in compliance with the respective measure provided for under the requirement on data governance set out in this Regulation. Without prejudice to the requirements related to robustness and accuracy set out in this Regulation, in line with Article 54(3) of Regulation (EU) 2019/881 of the European Parliament and of the Council, high-risk AI systems that have been certified or for which a statement of conformity has been issued under a cybersecurity scheme pursuant to that Regulation and the references of which have been published in the Official Journal of the European Union should be presumed to be in compliance with the cybersecurity requirement of this Regulation in so far as the cybersecurity certificate or statement of conformity or parts thereof cover the cybersecurity requirement of this Regulation This remains without prejudice to the voluntary nature of that cybersecurity scheme.

(62) In order to ensure a high level of trustworthiness of high-risk AI systems, those systems should be subject to a conformity assessment prior to their placing on the market or putting into service.

(63) It is appropriate that, in order to minimise the burden on operators and avoid any possible duplication, for high-risk AI systems related to products which are covered by existing Union harmonisation legislation following the New Legislative Framework approach, the compliance of those AI systems with the requirements of this Regulation should be assessed as part of the conformity assessment already foreseen under that legislation. The applicability of the requirements of this Regulation should thus not affect the specific logic, methodology or general structure of conformity assessment under the relevant specific New Legislative Framework legislation.
(64) Given the complexity of high-risk AI systems and the risks that are associated to them, it is important to develop an adequate system of conformity assessment procedure for high risk AI systems involving notified bodies, so called third party conformity assessment.

However, given the current experience of professional pre-market certifiers in the field of product safety and the different nature of risks involved, it is appropriate to limit, at least in an initial phase of application of this Regulation, the scope of application of third-party conformity assessment for high-risk AI systems other than those related to products.

Therefore, the conformity assessment of such systems should be carried out as a general rule by the provider under its own responsibility, with the only exception of AI systems intended to be used for biometrics.

(65) In order to carry out third-party conformity assessments when so required, notified bodies should be notified under this Regulation by the national competent authorities, provided they are compliant with a set of requirements, notably on independence, competence, absence of conflicts of interests and suitable cybersecurity requirements. Notification of those bodies should be sent by national competent authorities to the Commission and the other Member States by means of the electronic notification tool developed and managed by the Commission pursuant to Article R23 of Decision 768/2008.

(65a) In line with Union commitments under the World Trade Organization Agreement on Technical Barriers to Trade, it is adequate to facilitate the mutual recognition of conformity assessment results produced by competent conformity assessment bodies, independent of the territory in which they are established, provided that those conformity assessment bodies established under the law of a third country meet the applicable requirements of the Regulation and the Union has concluded an agreement to that extent.

In this context, the Commission should actively explore possible international instruments for that purpose and in particular pursue the conclusion of mutual recognition agreements with third countries.

(66) In line with the commonly established notion of substantial modification for products regulated by Union harmonisation legislation, it is appropriate that whenever a change occurs which may affect the compliance of a high risk AI system with this Regulation (e.g. change of operating system or software architecture), or when the intended purpose of the system changes, that AI system should be considered a new AI system which should undergo a new conformity assessment. However, changes occurring to the algorithm and the performance of AI systems which continue to 'learn' after being placed on the market or put into service (i.e. automatically adapting how functions are carried out) should not
constitute a substantial modification, provided that those changes have been pre-determined by the provider and assessed at the moment of the conformity assessment.

(67) High-risk AI systems should bear the CE marking to indicate their conformity with this Regulation so that they can move freely within the internal market. For high-risk AI systems embedded in a product, a physical CE marking should be affixed, and may be complemented by a digital CE marking. For high-risk AI systems only provided digitally, a digital CE marking should be used. Member States should not create unjustified obstacles to the placing on the market or putting into service of high-risk AI systems that comply with the requirements laid down in this Regulation and bear the CE marking.

(68) Under certain conditions, rapid availability of innovative technologies may be crucial for health and safety of persons, the protection of the environment and climate change and for society as a whole. It is thus appropriate that under exceptional reasons of public security or protection of life and health of natural persons, environmental protection and the protection of key industrial and infrastructural assets, market surveillance authorities could authorise the placing on the market or putting into service of AI systems which have not undergone a conformity assessment. In a duly justified situations as provided under this regulations, law enforcement authorities or civil protection authorities may put a specific high-risk AI system into service without the authorisation of the market surveillance authority, provided that such authorisation is requested during or after the use without undue delay.

(69) In order to facilitate the work of the Commission and the Member States in the artificial intelligence field as well as to increase the transparency towards the public, providers of high-risk AI systems other than those related to products falling within the scope of relevant existing Union harmonisation legislation, as well as providers who consider that an AI system referred to in annex III is by derogation not high-risk, should be required to register themselves and information about their AI system in a EU database, to be established and managed by the Commission. Before using a high-risk AI system listed in Annex III, deployers of high-risk AI systems that are public authorities, agencies or bodies, shall register themselves in such database and select the system that they envisage to use.. Other deployers should be entitled to do so voluntarily. This section of the database should be publicly accessible, free of charge, the information should be easily navigable, understandable and machine-readable. The database should also be user-friendly, for example by providing search functionalities, including through keywords, allowing the general public to find relevant information included in Annex VIII and on the areas of risk