ARTIFICIAL INTELLIGENCE ACT

2021版欧盟人工智能法案（中英文对照完整版）

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 日通过了制定人工智能统一规则的条例提案（《人工智能法》）。

TABLE OF CONTENTS 总目录2021版欧盟人工智能法案（中英文对照完整版）

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 日通过了制定人工智能统一规则的条例提案（《人工智能法》）。

TABLE OF CONTENTS 总目录第一部分

TITLEL I GENERAL PROVISIONS

第一章总则

Article 1 Subject matter

第 1 条主题

Article 2 Scope

第 2 条适用范围

Article 3 Definitions

第 3 条定义

Article 4 Implementing acts

第 4 条实施法案

TITLE I A GENERAL PURPOSE AI SYSTEMS

第 I 章 A 通用人工智能系统

Article 4a Compliance of general purpose AI systems with this Regulation

第 4a 条通用人工智能系统遵守本条例的情况

Article 4c Exceptions to Article 4b

第 4c 条第 4b 条的例外情形

TITLE II PROHIBITED ARTIFICIAL INTELLIGENCE PRACTICES

第二章禁止的人工智能行为

Article 5 第五条

TITLE III HIGH-RISK AI SYSTEMS

第 III 章高风险人工智能系统

C HAPTER 1 CLASSIFICATION OF AI SYSTEMS AS HIGH-RISK

第 1 章高风险人工智能系统的分类

Article 6 Classification rules for high-risk AI systems

第 6 条高风险人工智能系统的分类规则

Article 7 Amendments to Annex III

第 7 条对附件 III 的修正

CHAPTER 2 REQUIREMENTS FOR HIGH-RISK AI SYSTEMS

第 2 章对高风险 AI 系统的要求

Article 8 Compliance with the requirements

第 8 条要求的遵守

Article 9 Risk management system

第 9 条风险管理系统

Article 10 Data and data governance

第 10 条数据和数据管理

Article 11 Technical documentation

第 11 条技术文件

Article 12 Record-keeping

第 12 条记录保存

Article 13 Transparency and provision of information to users

第 13 条透明度和向用户提供信息

Article 14 Human oversight

第 14 条对人的监督

Article 15 Accuracy, robustness and cybersecurity

第 15 条准确性、稳健性和网络安全

CHAPTER 3 OBLIGATIONS OF PROVIDERS AND USERS OF HIGH-RISK AI SYSTEMS AND OTHER PARTIES

第 3 章高风险人工智能系统的提供者和使用者以及其他各方的义务

Article 16 Obligations of providers of high-risk AI systems

第 16 条高风险人工智能系统提供者的义务

Article 17 Quality management system

第 17 条质量管理体系

Article 18 Documentation keeping

第 18 条文件保存

Article 19 Conformity assessment

第 19 条符合性评估

Article 20 Automatically generated logs

第 20 条自动生成的日志

Article 21 Corrective actions

第 21 条纠正行动

Article 22 Duty of information

第 22 条提供信息的义务

Article 23 Cooperation with competent authorities

第 23 条与主管当局的合作

Article 23a Conditions for other persons to be subject to the obligations of a provider

第 23a 条其他人承担提供者义务的条件

Article 24 [deleted]

第 24 条[删除]

Article 25 Authorised representatives

第 25 条授权代表

Article 26 Obligations of importers

第 26 条进口商的义务

Article 27 Obligations of distributors

第 27 条经销商的义务

Article 28 [deleted] 第 28 条[删除]

Article 29 Obligations of users of high-risk AI systems

第 29 条高风险人工智能系统用户的义务

CHAPTER 4 NOTIFIYING AUTHORITIES AND NOTIFIED BODIES

第 4 章通知机关和被通知机构

Article 30 Notifying authorities

第 30 条通知机构

第 31 条合格评定机构的通知申请

Article 32 Notification procedure

第 32 条通知程序

Article 33 Requirements relating to notified bodies

第 33 条有关通知机构的要求

Article 33a Presumption of conformity with requirements relating to notified bodies

第 33a 条推定符合与通知机构有关的要求

Article 34 Subsidiaries of and subcontracting by notified bodies

第 34 条被通知机构的附属机构和分包合同

Article 34a Operational obligations of notified bodies

第 34a 条通知机构的业务义务

Article 35 Identification numbers and lists of notified bodies designated under this Regulation

第三十五条根据本条例指定的通知机构的识别号和名单

Article 36 Changes to notifications

第 36 条通知的变更

Article 37 Challenge to the competence of notified bodies

第 37 条对通知机构权限的质疑

Article 38 Coordination of notified bodies

第 38 条通知机构的协调

Article 39 Conformity assessment bodies of third countries

第 39 条第三国合格评定机构

部分章节示例如下：

(30) ‘validation data’ means data used for providing an evaluation of the trained AI system and for tuning its non-learnable parameters and its learning process, among other things, in order to prevent overfitting; whereas the validation dataset can be a separate dataset or part of the training dataset, either as a fixed or variable split;

(30) "验证数据 "是指用于对训练有素的人工智能系统进行评估、调整其不可学参数和学习过程等以防止过度拟合的数据；而验证数据集可以是一个单独的数据集，也可以是训练数据集的一部分，可以是固定的，也可以是可变的；

(31) ‘testing data’ means data used for providing an independent evaluation of the trained and validated AI system in order to confirm the expected performance of that system before its placing on the market or putting into service;

(31) "测试数据 "是指用于对经过训练和验证的人工智能系统进行独立评估的数据，以便在该系统投放市场或投入使用之前确认其预期性能；

(32) ‘input data’ means data provided to or directly acquired by an AI system on the basis of which the system produces an output;

(32) "输入数据 "是指提供给人工智能系统或由人工智能系统直接获取的数据，该系统根据这些数据产生输出；

Article 4 Implementing acts 第 4 条实施法案

In order to ensure uniform conditions for the implementation of this Regulation as regards machine learning approaches and logic- and knowledged based approaches referred to in Article 3(1), the Commission may adopt implementing acts to specify the technical elements of those approaches, taking into account market and technological developments. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 74(2).

为确保本条例在第 3 条第(1)款提及的机器学习方法以及基于逻辑和知识的方法方面的统一实施条件，委员会可通过实施法案，在考虑市场和技术发展的情况下，明确规定这些方法的技术要素。这些实施法案应根据第 74(2)条提及的审查程序通过。

TITLE I A GENERAL PURPOSE AI SYSTEMS

第 1章 A 通用人工智能系统

Article 4a Compliance of general purpose AI systems with this Regulation

第 4a 条通用人工智能系统遵守本条例的情况

1. Without prejudice to Articles 5, 52, 53 and 69 of this Regulation, general purpose AI systems shall only comply with the requirements and obligations set out in Article 4b.

1. 在不影响本条例第 5、52、53 和 69 条的情况下，通用人工智能系统只应符合第 4b 条所列的要求和义务。

2. Such requirements and obligations shall apply irrespective of whether the general purpose AI system is placed on the market or put into service as a pre-trained model and whether further fine-tuning of the model is to be performed by the user of the general purpose AI system.

2. 无论通用人工智能系统是作为预训练模型投放市场还是投入使用，也无论通用人工智能系统的用户是否要对模型作进一步的微调，上述要求和义务均应适用。

CHAPTER 1 CLASSIFICATION OF AI SYSTEMS AS HIGH-RISK

第 1 章高风险人工智能系统的分类

Article 6 Classification rules for high-risk AI systems

第 6 条高风险人工智能系统的分类规则

1. An AI system that is itself a product covered by the Union harmonisation legislation listed in Annex II shall be considered as high risk if it is required to undergo a third-party conformity assessment with a view to the placing on the market or putting into service of that product pursuant to the above mentioned legislation.

1. 如果一个人工智能系统本身是附件 II 所列欧盟协调立法所涵盖的产品，而根据上述立法，为了将该产品投放市场或投入使用，需要对其进行第三方合格评定，则该系统应被视为高风险系统。

2. An AI system intended to be used as a safety component of a product covered by the legislation referred to in paragraph 1 shall be considered as high risk if it is required to undergo a third-party conformity assessment with a view to the placing on the market or putting into service of that product pursuant to above mentioned legislation. This provision shall apply irrespective of whether the AI system is placed on the market or put into service independently from the product.

2. 拟用作第 1 段所述立法所涵盖的产品的安全部件的人工智能系统，如必须根据上述立法接受第三方合格性评估，以便将该产品投放市场或投入使用，则该系统应被视为高风险系统。无论人工智能系统是否独立于产品投放市场或投入使用，本规定均应适用。

Article 9 Risk management system

第 9 条风险管理系统

1. A risk management system shall be established, implemented, documented and maintained in relation to high-risk AI systems.

1. 应建立、实施、记录和维护与高风险人工智能系统有关的风险管理系统。

2. The risk management system shall be understood as a continuous iterative process planned and run throughout the entire lifecycle of a high-risk AI system, requiring regular systematic updating. It shall comprise the following steps:

2. 风险管理系统应被理解为在高风险人工智能系统的整个生命周期内规划和运行的一个持续迭代过程，需要定期系统更新。它应包括以下步骤：

(a) identification and analysis of the known and foreseeable risks most likely to occur to health, safety and fundamental rights in view of the intended purpose of the high-risk AI system;

(b) [deleted];

(a) 根据高风险人工智能系统的预期目的，确定和分析最有可能对健康、安全和基本权利造成损害的已知和可预见的风险；

Article 27 Obligations of distributors

第 27 条经销商的义务

1. Before making a high-risk AI system available on the market, distributors shall verify that the high-risk AI system bears the required CE conformity marking, that it is accompanied by a copy of EU declaration of conformity and instruction of use, and that the provider and the importer of the system, as applicable, have complied with their obligations set out Article 16, point (b) and 26(3) respectively.

1. 在市场上销售高风险人工智能系统之前，分销商应核实高风险人工智能系统是否带有所需的 CE 符合性标志，是否附有欧盟符合性声明和使用说明的副本，以及系统的提供商和进口商（如适用）是否已分别遵守第 16 条(b)点和第 26(3)条规定的义务。

Article 38 Coordination of notified bodies

第 38 条通知机构的协调

1. The Commission shall ensure that, with regard to high-risk AI systems, appropriate coordination and cooperation between notified bodies active in the conformity assessment procedures pursuant to this Regulation are put in place and properly operated in the form of a sectoral group of notified bodies.

1. 对于高风险人工智能系统，欧盟委员会应确保在根据本条例开展合格评定程序的通知机构之间进行适当的协调与合作，并以通知机构部门小组的形式妥善运作。

2. The notifying authority shall ensure that the bodies notified by them participate in the work of that group, directly or by means of designated representatives.

2. 通知机构应确保其通知的机构直接或通过指定的代表参与该小组的工作。

Article 39 Conformity assessment bodies of third countries

第 39 条第三国合格评定机构

Conformity assessment bodies established under the law of a third country with which the Union has concluded an agreement may be authorised to carry out the activities of notified Bodies under this Regulation, provided that they meet the requirements in Article 33.

根据与欧盟缔结了协定的第三国法律建立的合格评定机构，只要符合第 33 条的要求，可被授权开展本条例规定的通知机构的活动。