ARTIFICIAL INTELLIGENCE ACT

2021版欧盟人工智能法案（中英文对照完全版）



The Commission adopted the proposal for a Regulation laying down harmonised rules on artificial intelligence (Artificial Intelligence Act) on 21 April 2021.

欧盟委员会于 2021 年 4 月 21 日通过了制订人工智能统一规则的条例提案（《人工智能法》）。

TABLE OF CONTENTS 总目录（第二部分）

CHAPTER 5 STANDARDS, CONFORMITY ASSESSMENT, CERTIFICATES, REGISTRATION

第 5 章标准、合格评定、证书、注册



Article 40 Harmonised standards

第 40 条统一标准

Article 41 Common specifications

第 41 条普通规格

Article 42 Presumption of conformity with certain requirements

第 42 条符合某些哀求的推定

Article 43 Conformity assessment

第 43 条符合性评估

Article 44 Certificates

第 44 条证书

Aticle 45 Appeal against decisions of notified bodies

第 45 条针对关照机构决定的上诉

Article 46 Information obligations of notified bodies

第 46 条关照机构的信息责任

Article 47 Derogation from conformity assessment procedure

第 47 条符合性评估程序的减损

Article 48 EU declaration of conformity

第 48 条欧盟合格声明

Article 49 CE marking of conformity

第 49 条 CE 认证标志

Article 50 [deleted] 第 50 条 [删除］

Article 51 Registration of relevant operators and of high-risk AI systems listed in Annex III

第 51 条有关经营者和附件 III 所列高风险人工智能系统的注册



TITLE IV TRANSPARENCY OBLIGATIONS FOR PROVIDERS AND USERS OF CERTAIN AI SYSTEMS

第四章某些人工智能系统的供应者和利用者的透明度责任



Article 52 Transparency obligations for providers and users of certain AI systems

第 52 条某些人工智能系统的供应者和利用者的透明度责任



TITLE V MEASURES IN SUPPORT OF INNOVATION

第五章支持创新的方法

Article 53 AI regulatory sandboxes

第 53 条人工智能监管沙盒

Article 54 Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory sandbox

第 54 条为在人工智能监管沙盒中开拓某些符合公共利益的人工智能系统而进一步处理个人数据

Article 54a Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes

第 54a 条在人工智能监管沙盒之外的真实天下条件下测试高风险人工智能系统

rticle 55 Support measures for operators, in particular SMEs, including start-ups

第 55 条对经营者，特殊是中小企业，包括初创企业的支持方法

Article 55a Derogations for specific operators

第 55a 条对特定经营者的例外规定



TITLE VI GOVERNANCE 第 VI 章管理

CHAPTER 1 EUROPEAN ARTIFICIAL INTELLIGENCE BOARD

第 1 章欧洲人工智能委员会



Article 56 Establishment and structure of the European Artificial Intelligence Board

第 56 条欧洲人工智能委员会的设立和构造

Article 57 [deleted] 第 57 条 [删除］

Article 58 Tasks of the Board

第 58 条委员会的任务



CHAPTER 1 A GUIDELINES FROM THE COMMISSION

第 1 章 A 委员会的辅导方针



Article 58a Guidelines from the Commission on the implementation of this Regulation

第 58a 条委员会关于履行本条例的辅导方针



CHAPTER 2 NATIONAL COMPETENT AUTHORITIES

第 2 章国家主管当局

Article 59 Designation of national competent authorities

第 59 条国家主管当局的指定



TITLE VII EU DATABASE FOR HIGH-RISK AI SYSTEMS LISTED IN ANNEX III

第 VII 部分欧盟附件 III 所列高风险人工智能系统数据库



Article 60 EU database for high-risk AI systems listed in Annex III

第 60 条欧盟附件 III 所列高风险人工智能系统数据库

TITLE VIII POST-MARKET MONITORING, INFORMATION SHARING, MARKET SURVEILLANCE

第 VIII 章上市后监测、信息共享和市场监督

CHAPTER 1 P OST - MARKET MONITORING

第 1 章市场监测

Article 61 Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems

第 61 条供应商的市场后监测和高风险人工智能系统的市场后监测操持



CHAPTER 2 SHARING OF INFORMATION ON SERIOUS INCIDENTS

第 2 章重大事宜信息的共享

Article 62 Reporting of serious incidents

第 62 条严重事宜的报告

CHAPTER 3 ENFORCEMENT

第 3 章履行

Article 63 Market surveillance and control of AI systems in the Union market

第 63 条同盟市场中人工智能系统的市场监督与掌握

Article 64 Powers of authorities protecting fundamental rights

第 64 条保护基本权利机构的权力

Article 65 Procedure for dealing with AI systems presenting a risk at national level

第 65 条在国家一级处理有风险的人工智能系统的程序

Article 66 Union safeguard procedure

第 66 条同盟保障程序

Article 67 Compliant high-risk or general purpose AI systems which present a risk

第 67 条存在风险的合规高风险或通用人工智能系统

Article 68 Formal non-compliance

第 68 条本色性违约



TITLE IX CODES OF CONDUCT

第九章行为准则

Article 69 Codes of conduct for voluntary application of specific requirements

第 69 条志愿适用特定哀求的行为守则



TITLE X CONFIDENTIALITY AND PENALTIES

第十章保密和惩罚

Article 70 Confidentiality

第 70 条保密

Article 71 Penalties

第 71 条惩罚

Article 72 Administrative fines on Union institutions, agencies and bodies

第 72 条对联盟机构、机关和团体的行政罚款

TITLE XI DELEGATION OF POWER AND COMMITTEE PROCEDURE

第十一章权力下放和委员会程序

Article 73 Exercise of the delegation

第 73 条授权的行使

Article 74 Committee procedure

第 74 条委员会的程序

TITLE XII FINAL PROVISIONS

第十二章终极条款

第 75 条至82条为改动案

Article 83 AI systems already placed on the market or put into service

第 83 条已投放市场或投入利用的人工智能系统

Article 84 Evaluation and review

第 84 条评估和审查

Article 85 Entry into force and application

第 85 条生效和适用



部分章节示例如下：

Article 40Harmonised standards

第 40 条统一标准



1. High-risk AI systems or general purpose AI systems which are in conformity with harmonizedstandards or parts thereof the references of which have been published in the Official Journalof the European Union shall be presumed to be in conformity with the requirements set out inChapter 2 of this Title or, as applicable, with requirements set out in Article 4a and Article 4b,to the extent those standards cover those requirements.

1. 高风险人工智能系统或通用人工智能系统，如符合欧洲同盟官方公报公布的统一标准或其部分内容，应推定为符合本标题第 2 章的哀求，或在适用情形下，符合第 4a 条和第 4b 条的哀求，只要这些标准涵盖了这些哀求。



2. When issuing a standardisation request to European standardisation organisations inaccordance with Article 10 of Regulation 1025/2012, the Commission shall specify thatstandards are coherent, clear and drafted in such a way that they aim to fulfil in particular thefollowing objectives:

2. 在根据第 1025/2012 号法规第 10 条向欧洲标准化组织发出标准化要求时，欧盟委员会应明确规定，标准应连贯、清晰，其起草办法应特殊旨在实现以下目标：



a) ensure that AI systems placed on the market or put into service in the Union are safeand respect Union values and strengthen the Union's open strategic autonomy;

a) 确保在欧盟市场上发卖或投入利用的人工智能系统是安全的，并尊重欧盟的代价不雅观，加强欧盟的开放计策自主权；



b) promote investment and innovation in AI, including through increasing legal certainty, aswell as competitiveness and growth of the Union market;

b) 促进人工智能领域的投资和创新，包括通过提高法律确定性以及同盟市场的竞争力和增长；



Article 48EU declaration of conformity

第 48 条欧盟合格声明



1. The provider shall draw up a written or electronically signed EU declaration of conformityfor each AI system and keep it at the disposal of the national competent authorities for 10years after the AI system has been placed on the market or put into service. The EUdeclaration of conformity shall identify the AI system for which it has been drawn up. Acopy of the EU declaration of conformity shall be submitted to the relevant nationalcompetent authorities upon request.

1. 供应者应为每个人工智能系统起草一份书面或电子署名的欧盟合格声明，并在人工智能系统投放市场或投入利用后的 10 年内将其交由国家主管当局保存。
欧盟合格声明应标明所针对的人工智能系统。
欧盟合格声明的副本应按哀求提交给干系国家主管当局。



2. The EU declaration of conformity shall state that the high-risk AI system in question meetsthe requirements set out in Chapter 2 of this Title. The EU declaration of conformity shallcontain the information set out in Annex V and shall be translated into a language that canbe easily understood by the national competent authorities of the Member State(s) in whichthe high-risk AI system is made available.

2. 欧盟合格声明应解释有关高风险人工智能系统符合本标题第 2 章规定的哀求。
欧盟合格声明应包含附件五所列信息，并应翻译成高风险人工智能系统所在成员国国家主管当局易于理解的措辞。



Article 52Transparency obligations for providers and users of certain AI systems

第 52 条某些人工智能系统的供应者和利用者的透明度责任



1. Providers shall ensure that AI systems intended to interact with natural persons aredesigned and developed in such a way that natural persons are informed that they areinteracting with an AI system, unless this is obvious from the point of view of a naturalperson who is reasonably well-informed, observant and circumspect, taking into accountthe circumstances and the context of use. This obligation shall not apply to AI systemsauthorised by law to detect, prevent, investigate and prosecute criminal offences, subject toappropriate safeguards for the rights and freedoms of third parties, unless those systems areavailable for the public to report a criminal offence.

1. 供应者应确保意在与自然人互动的人工智能系统的设计和开拓能让自然人知道他们正在与人工智能系统互动，除非考虑到利用的环境和背景，从合理知情、不雅观察和谨慎的自然人的角度来看这是显而易见的。
这一责任不适用于法律授权侦查、预防、调查和起诉刑事犯罪的人工智能系统，但第三方的权利和自由应得到适当保障，除非这些系统可供公众年夜众举报刑事犯罪。



CHAPTER 1EUROPEAN ARTIFICIAL INTELLIGENCE BOARD

第 1 章欧洲人工智能委员会



Article 56Establishment and structure of the European Artificial Intelligence Board

第 56 条欧洲人工智能委员会的设立和构造



1. A ‘European Artificial Intelligence Board’ (the ‘Board’) is established.

1. 设立 "欧洲人工智能委员会"（"委员会"）。



2. The Board shall be composed of one representative per Member State. The European DataProtection Supervisor shall participate as an observer. The Commission shall also attendthe Board’s meetings without taking part in the votes.

Other national and Union authorities, bodies or experts may be invited to the meetings bythe Board on a case by case basis, where the issues discussed are of relevance for them.

2. 委员会由每个成员国一名代表组成。
欧洲数据保护监督员应作为不雅观察员参加。
欧盟委员会也应出席委员会会议，但不参与表决。

如果谈论的问题与其他国家和欧盟当局、机构或专家干系，委员会可根据详细情形约请其参加会议。



Article 65Procedure for dealing with AI systems presenting a risk at national level

第 65 条在国家一级处理有风险的人工智能系统的程序



1. AI systems presenting a risk shall be understood as a product presenting a risk defined inArticle 3, point 19 of Regulation (EU) 2019/1020 insofar as risks to the health or safety orto fundamental rights of persons are concerned.

1. 就对人的康健或安全或基本权利的风险而言，存在风险的人工智能系统应被理解为存在第(EU)2019/1020号条例第3条第19点所定义的风险的产品。



2. Where the market surveillance authority of a Member State has sufficient reasons toconsider that an AI system presents a risk as referred to in paragraph 1, they shall carry outan evaluation of the AI system concerned in respect of its compliance with all therequirements and obligations laid down in this Regulation. When risks to fundamentalrights are identified, the market surveillance authority shall also inform the relevantnational public authorities or bodies referred to in Article 64(3). The relevant operatorsshall cooperate as necessary with the market surveillance authorities and the other nationalpublic authorities or bodies referred to in Article 64(3).

2. 如果成员国的市场监督当局有充分情由认为人工智能系统存在第 1 款所述的风险，则应评估有关人工智能系统是否符合本条例规定的所有哀求和责任。
当创造基本权利面临风险时，市场监督机构还应关照第 64(3)条所述的干系国家公共当局或机构。
干系经营者应与市场监督机构和第 64(3)条所指的其他国家公共当局或机构进行必要的互助。



Article 68bCentral pool of independent experts

第 68b 条独立专家中心人才库



1. Upon request of the AI Board, the Commission shall, by means of an implementing act,make provisions on the creation, maintenance and financing of a central pool ofindependent experts to support the enforcement activities under this Regulation.

1. 委员会应根据理事会的哀求，通过履行法案，就建立、坚持和帮助中心独立专家库以支持本条例规定的司法活动作出规定。



2. Experts shall be selected by the Commission and included in the central pool on the basisof up-to-date scientific or technical expertise in the field of artificial intelligence, havingdue regard to the technical areas covered by the requirements and obligations in thisRegulation and the activities of market surveillance authorities pursuant to Article 11 ofRegulation (EU) 1020/2019. The Commission shall determine the number of experts in thepool in accordance with the required needs.

2. 专家应由委员会根据人工智能领域的最新科学或技能专业知识进行甄选并纳入中心专家库，同时适当考虑本条例中的哀求和责任所涵盖的技能领域以及市场监管当局根据第(EU) 1020/2019号条例第11条开展的活动。
委员会应根据所需需求确定专家库中的专家人数。