9. Any Member States in which the AI system has been placed on the market, put into service or made available in the Union.

Section C — Information to be submitted by deployers of high-risk AI systems in accordance with Article 49(3)

The following information shall be provided and thereafter kept up to date with regard to high-risk AI systems to be registered in
accordance with Article 49(3):

1. The name, address and contact details of the deployer;

2. The name, address and contact details of the person submitting information on behalf of the deployer;

3. The URL of the entry of the AI system in the EU database by its provider;

4. A summary of the findings of the fundamental rights impact assessment conducted in accordance with Article 27;

5. A summary of the data protection impact assessment carried out in accordance with Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680 as specified in Article 26(8) of this Regulation, where applicable.
ANNEX IX

Information to be submitted upon the registration of high-risk AI systems listed in Annex III in relation to testing in real world conditions in accordance with Article 60

The following information shall be provided and thereafter kept up to date with regard to testing in real world conditions to be registered in accordance with Article 60:

1. A Union-wide unique single identification number of the testing in real world conditions;

2. The name and contact details of the provider or prospective provider and of the deployers involved in the testing in real world conditions;

3. A brief description of the AI system, its intended purpose, and other information necessary for the identification of the system;

4. A summary of the main characteristics of the plan for testing in real world conditions;

5. Information on the suspension or termination of the testing in real world conditions.
# ANNEX X

## Union legislative acts on large-scale IT systems in the area of Freedom, Security and Justice

### 1. Schengen Information System

a) Regulation (EU) 2018/1860 of the European Parliament and of the Council of 28 November 2018 on the use of the Schengen Information System for the return of illegally staying third-country nationals (OJ L 312, 7.12.2018, p. 1).

b) Regulation (EU) 2018/1861 of the European Parliament and of the Council of 28 November 2018 on the establishment, operation and use of the Schengen Information System (SIS) in the field of border checks, and amending the Convention implementing the Schengen Agreement, and amending and repealing Regulation (EC) No 1987/2006 (OJ L 312, 7.12.2018, p. 14).

c) Regulation (EU) 2018/1862 of the European Parliament and of the Council of 28 November 2018 on the establishment, operation and use of the Schengen Information System (SIS) in the field of police cooperation and judicial cooperation in criminal matters, amending and repealing Council Decision 2007/533/JHA, and repealing Regulation (EC) No 1986/2006 of the European Parliament and of the Council and Commission Decision 2010/261/EU (OJ L 312, 7.12.2018, p. 56).

### 2. Visa Information System

d) Regulation (EU) 2021/1133 of the European Parliament and of the Council of 7 July 2021 amending Regulations (EU) No 603/2013, (EU) 2016/794, (EU) 2018/1862, (EU) 2019/816 and (EU) 2019/818 as regards the establishment of the conditions for accessing other EU information systems for the purposes of the Visa Information System (OJ L 248, 13.7.2021, p. 1).

e) Regulation (EU) 2021/1134 of the European Parliament and of the Council of 7 July 2021 amending Regulations (EC) No 767/2008, (EC) No 810/2009, (EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU) 2018/1860, (EU) 2018/1861, (EU) 2019/817 and (EU) 2019/1896 of the European Parliament and of the Council and repealing Council Decisions 2004/512/EC and 2008/633/JHA, for the purpose of reforming the Visa Information System (OJ L 248, 13.7.2021, p. 11).

### 3. Eurodac

Regulation (EU) 2024/1358 of the European Parliament and of the Council of 14 May 2024 on the establishment of 'Eurodac' for the comparison of biometric data in order to effectively apply Regulations (EU) 2024/1315 and (EU) 2024/1350 of the European Parliament and of the Council and Council Directive 2001/55/EC and to identify illegally staying third-country nationals and stateless persons and on requests for the comparison with Eurodac data by Member States' law enforcement authorities and Europol for law enforcement purposes, amending Regulations (EU) 2018/1240 and (EU) 2019/818 of the European Parliament and of the Council and repealing Regulation (EU) No 603/2013 of the European Parliament and of the Council (OJ L 2024/1358, 22.5.2024, ELI: http://data.europa.eu/eli/reg/2024/1358/oj).

### 4. Entry/Exit System

Regulation (EU) 2017/2226 of the European Parliament and of the Council of 30 November 2017 establishing an Entry/Exit System (EES) to register entry and exit data and refusal of entry data of third-country nationals crossing the external borders of the Member States and determining the conditions for access to the EES for law enforcement purposes, and amending the Convention implementing the Schengen Agreement and Regulations (EC) No 767/2008 and (EU) No 1077/2011 (OJ L 327, 9.12.2017, p. 20).

### 5. European Travel Information and Authorisation System

a) Regulation (EU) 2018/1240 of the European Parliament and of the Council of 12 September 2018 establishing a European Travel Information and Authorisation System (ETIAS) and amending Regulations (EU) No 1077/2011, (EU) No 515/2014, (EU) 2016/399, (EU) 2016/1624 and (EU) 2017/2226 (OJ L 236, 19.9.2018, p. 1).

b) Regulation (EU) 2018/1241 of the European Parliament and of the Council of 12 September 2018 amending Regulation (EU) 2016/794 for the purpose of establishing a European Travel Information and Authorisation System (ETIAS) (OJ L 236, 19.9.2018, p. 72).
6. European Criminal Records Information System on third-country nationals and stateless persons

Regulation (EU) 2019/816 of the European Parliament and of the Council of 17 April 2019 establishing a centralised system for the identification of Member States holding conviction information on third-country nationals and stateless persons (ECRIS-TCN) to supplement the European Criminal Records Information System and amending Regulation (EU) 2018/1726 (OJ L 135, 22.5.2019, p. 1).

7. Interoperability

a) Regulation (EU) 2019/817 of the European Parliament and of the Council of 20 May 2019 on establishing a framework for interoperability between EU information systems in the field of borders and visa and amending Regulations (EC) No 767/2008, (EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU) 2018/1726 and (EU) 2018/1861 of the European Parliament and of the Council and Council Decisions 2004/512/EC and 2008/633/JHA (OJ L 135, 22.5.2019, p. 27).

b) Regulation (EU) 2019/818 of the European Parliament and of the Council of 20 May 2019 on establishing a framework for interoperability between EU information systems in the field of police and judicial cooperation, asylum and migration and amending Regulations (EU) 2018/1726, (EU) 2018/1862 and (EU) 2019/816 (OJ L 135, 22.5.2019, p. 85).
# ANNEX XI

## Technical documentation referred to in Article 53(1), point (a) — technical documentation for providers of general-purpose AI models

### Section 1
Information to be provided by all providers of general-purpose AI models

The technical documentation referred to in Article 53(1), point (a) shall contain at least the following information as appropriate to the size and risk profile of the model:

1. A general description of the general-purpose AI model including:

(a) the tasks that the model is intended to perform and the type and nature of AI systems in which it can be integrated;

(b) the acceptable use policies applicable;

(c) the date of release and methods of distribution;

(d) the architecture and number of parameters;

(e) the modality (e.g. text, image) and format of inputs and outputs;

(f) the licence.

2. A detailed description of the elements of the model referred to in point 1, and relevant information of the process for the development, including the following elements:

(a) the technical means (e.g. instructions of use, infrastructure, tools) required for the general-purpose AI model to be integrated in AI systems;

(b) the design specifications of the model and training process, including training methodologies and techniques, the key design choices including the rationale and assumptions made; what the model is designed to optimise for and the relevance of the different parameters, as applicable;

(c) information on the data used for training, testing and validation, where applicable, including the type and provenance of data and curation methodologies (e.g. cleaning, filtering, etc.), the number of data points, their scope and main characteristics; how the data was obtained and selected as well as all other measures to detect the unsuitability of data sources and methods to detect identifiable biases, where applicable;

(d) the computational resources used to train the model (e.g. number of floating point operations), training time, and other relevant details related to the training;

(e) known or estimated energy consumption of the model.

With regard to point (e), where the energy consumption of the model is unknown, the energy consumption may be based on information about computational resources used.

### Section 2
Additional information to be provided by providers of general-purpose AI models with systemic risk

1. A detailed description of the evaluation strategies, including evaluation results, on the basis of available public evaluation protocols and tools or otherwise of other evaluation methodologies. Evaluation strategies shall include evaluation criteria, metrics and the methodology on the identification of limitations.

2. Where applicable, a detailed description of the measures put in place for the purpose of conducting internal and/or external adversarial testing (e.g. red teaming), model adaptations, including alignment and fine-tuning.
3. Where applicable, a detailed description of the system architecture explaining how software components build or feed into each other and integrate into the overall processing.
ANNEX XII

Transparency information referred to in Article 53(1), point (b) — technical documentation for providers of general-
purpose AI models to downstream providers that integrate the model into their AI system

The information referred to in Article 53(1), point (b) shall contain at least the following:

1. A general description of the general-purpose AI model including:

(a) the tasks that the model is intended to perform and the type and nature of AI systems into which it can be integrated;

(b) the acceptable use policies applicable;

(c) the date of release and methods of distribution;

(d) how the model interacts, or can be used to interact, with hardware or software that is not part of the model itself, where applicable;

(e) the versions of relevant software related to the use of the general-purpose AI model, where applicable;

(f) the architecture and number of parameters;

(g) the modality (e.g. text, image) and format of inputs and outputs;

(h) the licence for the model.

2. A description of the elements of the model and of the process for its development, including:

(a) the technical means (e.g. instructions for use, infrastructure, tools) required for the general-purpose AI model to be integrated into AI systems;

(b) the modality (e.g. text, image, etc.) and format of the inputs and outputs and their maximum size (e.g. context window length, etc.);

(c) information on the data used for training, testing and validation, where applicable, including the type and provenance of data and curation methodologies.
ANNEX XIII

Criteria for the designation of general-purpose AI models with systemic risk referred to in Article 51

For the purpose of determining that a general-purpose AI model has capabilities or an impact equivalent to those set out in Article 51(1), point (a), the Commission shall take into account the following criteria:

(a) the number of parameters of the model;

(b) the quality or size of the data set, for example measured through tokens;

(c) the amount of computation used for training the model, measured in floating point operations or indicated by a combination of other variables such as estimated cost of training, estimated time required for the training, or estimated energy consumption for the training;

(d) the input and output modalities of the model, such as text to text (large language models), text to image, multi-modality, and the state of the art thresholds for determining high-impact capabilities for each modality, and the specific type of inputs and outputs (e.g. biological sequences);

(e) the benchmarks and evaluations of capabilities of the model, including considering the number of tasks without additional training, adaptability to learn new, distinct tasks, its level of autonomy and scalability, the tools it has access to;

(f) whether it has a high impact on the internal market due to its reach, which shall be presumed when it has been made available to at least 10 000 registered business users established in the Union;

(g) the number of registered end-users.