Article 97 - Exercise of the delegation

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt delegated acts referred to in Article 6(6) and (7), Article 7(1) and (3), Article 11(3), Article 43(5)
and (6), Article 47(5), Article 51(3), Article 52(4) and Article 53(5) and (6) shall be conferred on the Commission for
a period of five years from 1 August 2024. The Commission shall draw up a report in respect of the delegation of power
not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for
periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three
months before the end of each period.
3. The delegation of power referred to in Article 6(6) and (7), Article 7(1) and (3), Article 11(3), Article 43(5) and (6),
Article 47(5), Article 51(3), Article 52(4) and Article 53(5) and (6) may be revoked at any time by the European Parliament
or by the Council. A decision of revocation shall put an end to the delegation of power specified in that decision. It shall
take effect the day following that of its publication in the Official Journal of the European Union or at a later date specified
therein. It shall not affect the validity of any delegated acts already in force.
4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance
with the principles laid down

Article 97 - Exercise of the delegation

DELEGATION OF POWER AND COMMITTEE PROCEDURE


he validity of any delegated acts already in force.
4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance
with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to
the Council.
6. Any delegated act adopted pursuant to Article 6(6) or (7), Article 7(1) or (3), Article 11(3), Article 43(5) or (6),
Article 47(5), Article 51(3), Article 52(4) or Article 53(5) or (6) shall enter into force only if no objection has been
expressed by either the European Parliament or the Council within a period of three months of notification of that act to
the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council
have both informed the Commission that they will not object. That period shall be extended by three months at the
initiative of the European Parliament or of the Council.

Article 97 - Exercise of the delegation


Article 98 - Committee procedure

1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of
Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Article 98 - Committee procedure


Article 99 - Penalties

1. In accordance with the terms and conditions laid down in this Regulation, Member States shall lay down the rules on
penalties and other enforcement measures, which may also include warnings and non-monetary measures, applicable to
infringements of this Regulation by operators, and shall take all measures necessary to ensure that they are properly and
effectively implemented, thereby taking into account the guidelines issued by the Commission pursuant to Article 96. The
penalties provided for shall be effective, proportionate and dissuasive. They shall take into account the interests of SMEs,
including start-ups, and their economic viability.
2. The Member States shall, without delay and at the latest by the date of entry into application, notify the Commission
of the rules on penalties and of other enforcement measures referred to in paragraph 1, and shall notify it, without delay, of
any subsequent amendment to them.
3. Non-compliance with the prohibition of the AI practices referred to in Article 5 shall be subject to administrative
fines of up to EUR 35 000 000 or, if the offender is an undertaking, up to 7 % of its total worldwide annual turnover for the
preceding financial year, whichever is higher.
4. Non-compliance with any of the following provisions related to operators or notified bodies, other than those laid
down in Articles 5, shall be subject to administrative fines of up to EUR 15 000 000 or, if the offender is an undertaking, up
to 3 % of its total worldwid

Article 99 - Penalties


rs or notified bodies, other than those laid
down in Articles 5, shall be subject to administrative fines of up to EUR 15 000 000 or, if the offender is an undertaking, up
to 3 % of its total worldwide annual turnover for the preceding financial year, whichever is higher:
(a) obligations of providers pursuant to Article 16;
(b) obligations of authorised representatives pursuant to Article 22;
(c) obligations of importers pursuant to Article 23;
(d) obligations of distributors pursuant to Article 24;
(e) obligations of deployers pursuant to Article 26;
(f) requirements and obligations of notified bodies pursuant to Article 31, Article 33(1), (3) and (4) or Article 34;
(g) transparency obligations for providers and deployers pursuant to Article 50.
5. The supply of incorrect, incomplete or misleading information to notified bodies or national competent authorities in
reply to a request shall be subject to administrative fines of up to EUR 7 500 000 or, if the offender is an undertaking, up to
1 % of its total worldwide annual turnover for the preceding financial year, whichever is higher.
6. In the case of SMEs, including start-ups, each fine referred to in this Article shall be up to the percentages or amount
referred to in paragraphs 3, 4 and 5, whichever thereof is lower.
7. When deciding whether to impose an administrative fine and when deciding on the amount of the administrative fine
in each individual case, all relevant circumstances of the specific situation shall be ta

Article 99 - Penalties


n deciding whether to impose an administrative fine and when deciding on the amount of the administrative fine
in each individual case, all relevant circumstances of the specific situation shall be taken into account and, as appropriate,
regard shall be given to the following:
(a) the nature, gravity and duration of the infringement and of its consequences, taking into account the purpose of the AI
system, as well as, where appropriate, the number of affected persons and the level of damage suffered by them;
(b) whether administrative fines have already been applied by other market surveillance authorities to the same operator for
the same infringement;
(c) whether administrative fines have already been applied by other authorities to the same operator for infringements of
other Union or national law, when such infringements result from the same activity or omission constituting a relevant
infringement of this Regulation;
(d) the size, the annual turnover and market share of the operator committing the infringement;
(e) any other aggravating or mitigating factor applicable to the circumstances of the case, such as financial benefits gained,
or losses avoided, directly or indirectly, from the infringement;
(f) the degree of cooperation with the national competent authorities, in order to remedy the infringement and mitigate the
possible adverse effects of the infringement;
(g) the degree of responsibility of the operator taking into account the technical and organisational mea

Article 99 - Penalties


rder to remedy the infringement and mitigate the
possible adverse effects of the infringement;
(g) the degree of responsibility of the operator taking into account the technical and organisational measures implemented
by it;
(h) the manner in which the infringement became known to the national competent authorities, in particular whether, and
if so to what extent, the operator notified the infringement;
(i) the intentional or negligent character of the infringement;
(j) any action taken by the operator to mitigate the harm suffered by the affected persons.
8. Each Member State shall lay down rules on to what extent administrative fines may be imposed on public authorities
and bodies established in that Member State.
9. Depending on the legal system of the Member States, the rules on administrative fines may be applied in such
a manner that the fines are imposed by competent national courts or by other bodies, as applicable in those Member States.
The application of such rules in those Member States shall have an equivalent effect.
10. The exercise of powers under this Article shall be subject to appropriate procedural safeguards in accordance with
Union and national law, including effective judicial remedies and due process.
11. Member States shall, on an annual basis, report to the Commission about the administrative fines they have issued
during that year, in accordance with this Article, and about any related litigation or judicial proceedings.

Article 99 - Penalties


the Commission about the administrative fines they have issued
during that year, in accordance with this Article, and about any related litigation or judicial proceedings.

Article 99 - Penalties


Article 100 - Administrative fines on Union institutions, bodies, offices and agencies

1. The European Data Protection Supervisor may impose administrative fines on Union institutions, bodies, offices and
agencies falling within the scope of this Regulation. When deciding whether to impose an administrative fine and when
deciding on the amount of the administrative fine in each individual case, all relevant circumstances of the specific situation
shall be taken into account and due regard shall be given to the following:
(a) the nature, gravity and duration of the infringement and of its consequences, taking into account the purpose of the AI
system concerned, as well as, where appropriate, the number of affected persons and the level of damage suffered by
them;
(b) the degree of responsibility of the Union institution, body, office or agency, taking into account technical and
organisational measures implemented by them;
(c) any action taken by the Union institution, body, office or agency to mitigate the damage suffered by affected persons;
(d) the degree of cooperation with the European Data Protection Supervisor in order to remedy the infringement and
mitigate the possible adverse effects of the infringement, including compliance with any of the measures previously
ordered by the European Data Protection Supervisor against the Union institution, body, office or agency concerned
with regard to the same subject matter;
(e) any similar previous infringements by the Union institution, body, office or agency;
(f) the manner in which the infringement became known


agency concerned
with regard to the same subject matter;
(e) any similar previous infringements by the Union institution, body, office or agency;
(f) the manner in which the infringement became known to the European Data Protection Supervisor, in particular
whether, and if so to what extent, the Union institution, body, office or agency notified the infringement;
(g) the annual budget of the Union institution, body, office or agency.
2. Non-compliance with the prohibition of the AI practices referred to in Article 5 shall be subject to administrative
fines of up to EUR 1 500 000.
3. The non-compliance of the AI system with any requirements or obligations under this Regulation, other than those
laid down in Article 5, shall be subject to administrative fines of up to EUR 750 000.
4. Before taking decisions pursuant to this Article, the European Data Protection Supervisor shall give the Union
institution, body, office or agency which is the subject of the proceedings conducted by the European Data Protection
Supervisor the opportunity of being heard on the matter regarding the possible infringement. The European Data
Protection Supervisor shall base his or her decisions only on elements and circumstances on which the parties concerned
have been able to comment. Complainants, if any, shall be associated closely with the proceedings.
5. The rights of defence of the parties concerned shall be fully respected in the proceedings. They shall be entitled to
have access to the European


, shall be associated closely with the proceedings.
5. The rights of defence of the parties concerned shall be fully respected in the proceedings. They shall be entitled to
have access to the European Data Protection Supervisor’s file, subject to the legitimate interest of individuals or
undertakings in the protection of their personal data or business secrets.
6. Funds collected by imposition of fines in this Article shall contribute to the general budget of the Union. The fines
shall not affect the effective operation of the Union institution, body, office or agency fined.
7. The European Data Protection Supervisor shall, on an annual basis, notify the Commission of the administrative fines
it has imposed pursuant to this Article and of any litigation or judicial proceedings it has initiated.


Article 101 - Fines for providers of general-purpose AI models

1. The Commission may impose on providers of general-purpose AI models fines not exceeding 3 % of their annual total
worldwide turnover in the preceding financial year or EUR 15 000 000, whichever is higher., when the Commission finds
that the provider intentionally or negligently:
(a) infringed the relevant provisions of this Regulation;
(b) failed to comply with a request for a document or for information pursuant to Article 91, or supplied incorrect,
incomplete or misleading information;
(c) failed to comply with a measure requested under Article 93;
(d) failed to make available to the Commission access to the general-purpose AI model or general-purpose AI model with
systemic risk with a view to conducting an evaluation pursuant to Article 92.
In fixing the amount of the fine or periodic penalty payment, regard shall be had to the nature, gravity and duration of the
infringement, taking due account of the principles of proportionality and appropriateness. The Commission shall also into
account commitments made in accordance with Article 93(3) or made in relevant codes of practice in accordance with
Article 56.
2. Before adopting the decision pursuant to paragraph 1, the Commission shall communicate its preliminary findings to
the provider of the general-purpose AI model and give it an opportunity to be heard.
3. Fines imposed in accordance with this Article shall be effective, proportionate and dissuasive.
4. Information on fines imposed under this Article shall also be co


ve it an opportunity to be heard.
3. Fines imposed in accordance with this Article shall be effective, proportionate and dissuasive.
4. Information on fines imposed under this Article shall also be communicated to the Board as appropriate.
5. The Court of Justice of the European Union shall have unlimited jurisdiction to review decisions of the Commission
fixing a fine under this Article. It may cancel, reduce or increase the fine imposed.
6. The Commission shall adopt implementing acts containing detailed arrangements and procedural safeguards for
proceedings in view of the possible adoption of decisions pursuant to paragraph 1 of this Article. Those implementing acts
shall be adopted in accordance with the examination procedure referred to in Article 98(2).


Article 102 - Amendment to Regulation (EC) No 300/2008

In Article 4(3) of Regulation (EC) No 300/2008, the following subparagraph is added:
‘When adopting detailed measures related to technical specifications and procedures for approval and use of security
equipment concerning Artificial Intelligence systems within the meaning of Regulation (EU) 2024/1689 of the European
Parliament and of the Council (*), the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into
account.
(*) Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised
rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013,
(EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU)
2024/1689/oj).’.


Article 103 - Amendment to Regulation (EU) No 167/2013

In Article 17(5) of Regulation (EU) No 167/2013, the following subparagraph is added:
‘When adopting delegated acts pursuant to the first subparagraph concerning artificial intelligence systems which are safety
components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council (*), the
requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
(*) Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised
rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013,
(EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU)
2024/1689/oj).’.


Article 104 - Amendment to Regulation (EU) No 168/2013

In Article 22(5) of Regulation (EU) No 168/2013, the following subparagraph is added:
‘When adopting delegated acts pursuant to the first subparagraph concerning Artificial Intelligence systems which are safety
components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council (*), the
requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
(*) Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised
rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013,
(EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU)
2024/1689/oj).’.


Article 105 - Amendment to Directive 2014/90/EU

In Article 8 of Directive 2014/90/EU, the following paragraph is added:
‘5. For Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of
the European Parliament and of the Council (*), when carrying out its activities pursuant to paragraph 1 and when adopting
technical specifications and testing standards in accordance with paragraphs 2 and 3, the Commission shall take into
account the requirements set out in Chapter III, Section 2, of that Regulation.
(*) Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised
rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013,
(EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU)
2024/1689/oj).’.


Article 106 - Amendment to Directive (EU) 2016/797

In Article 5 of Directive (EU) 2016/797, the following paragraph is added:
‘12. When adopting delegated acts pursuant to paragraph 1 and implementing acts pursuant to paragraph 11
concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689
of the European Parliament and of the Council (*), the requirements set out in Chapter III, Section 2, of that Regulation shall
be taken into account.
(*) Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised
rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013,
(EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU)
2024/1689/oj).’.


Article 107 - Amendment to Regulation (EU) 2018/858

In Article 5 of Regulation (EU) 2018/858 the following paragraph is added:
‘4. When adopting delegated acts pursuant to paragraph 3 concerning Artificial Intelligence systems which are safety
components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council (*), the
requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
(*) Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised
rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013,
(EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU)
2024/1689/oj).’.


Article 108 - Amendments to Regulation (EU) 2018/1139

Regulation (EU) 2018/1139 is amended as follows:
(1) in Article 17, the following paragraph is added:
‘3. Without prejudice to paragraph 2, when adopting implementing acts pursuant to paragraph 1 concerning
Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the
European Parliament and of the Council (*), the requirements set out in Chapter III, Section 2, of that Regulation shall be
taken into account.
(*) Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down
harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU)
No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797
and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.
eu/eli/reg/2024/1689/oj).’;
(2) in Article 19, the following paragraph is added:
‘4. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which
are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III,
Section 2, of that Regulation shall be taken into account.’;
(3) in Article 43, the following paragraph is added:
‘4. When adopting implementing acts pursuant to paragraph 1 concerning Artificial Intelligence systems which are
safety components within the meaning of Regulation (EU) 2024/1689, the requiremen


dded:
‘4. When adopting implementing acts pursuant to paragraph 1 concerning Artificial Intelligence systems which are
safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III,
Section 2, of that Regulation shall be taken into account.’;
(4) in Article 47, the following paragraph is added:
‘3. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which
are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III,
Section 2, of that Regulation shall be taken into account.’;
(5) in Article 57, the following subparagraph is added:
‘When adopting those implementing acts concerning Artificial Intelligence systems which are safety components within
the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall
be taken into account.’;
(6) in Article 58, the following paragraph is added:
‘3. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which
are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III,
Section 2, of that Regulation shall be taken into account.’.


Article 109 - Amendment to Regulation (EU) 2019/2144

In Article 11 of Regulation (EU) 2019/2144, the following paragraph is added:
‘3. When adopting the implementing acts pursuant to paragraph 2, concerning artificial intelligence systems which are
safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council (*),
the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
(*) Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised
rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013,
(EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU)
2024/1689/oj).’.


Article 110 - Amendment to Directive (EU) 2020/1828

In Annex I to Directive (EU) 2020/1828 of the European Parliament and of the Council (58), the following point is added:
‘(68) Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised
rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013,
(EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU)
2024/1689/oj).’.


Article 111 - AI systems already placed on the market or put into service and general-purpose AI models already placed on the

marked
1. Without prejudice to the application of Article 5 as referred to in Article 113(3), point (a), AI systems which are
components of the large-scale IT systems established by the legal acts listed in Annex X that have been placed on the market
or put into service before 2 August 2027 shall be brought into compliance with this Regulation by 31 December 2030.
The requirements laid down in this Regulation shall be taken into account in the evaluation of each large-scale IT system
established by the legal acts listed in Annex X to be undertaken as provided for in those legal acts and where those legal acts
are replaced or amended.
2. Without prejudice to the application of Article 5 as referred to in Article 113(3), point (a), this Regulation shall apply
to operators of high-risk AI systems, other than the systems referred to in paragraph 1 of this Article, that have been placed
on the market or put into service before 2 August 2026, only if, as from that date, those systems are subject to significant
changes in their designs. In any case, the providers and deployers of high-risk AI systems intended to be used by public
authorities shall take the necessary steps to comply with the requirements and obligations of this Regulation by 2 August
2030.
3. Providers of general-purpose AI models that have been placed on the market before 2 August 2025 shall take the
necessary steps in order to comply with the obligations laid down in this Regulation by 2 August 2027.
(58) Directive


AI models that have been placed on the market before 2 August 2025 shall take the
necessary steps in order to comply with the obligations laid down in this Regulation by 2 August 2027.
(58) Directive (EU) 2020/1828 of the European Parliament and of the Council of 25 November 2020 on representative actions for the
protection of the collective interests of consumers and repealing Directive 2009/22/EC (OJ L 409, 4.12.2020, p. 1).


Article 112 - Evaluation and review

1. The Commission shall assess the need for amendment of the list set out in Annex III and of the list of prohibited AI
practices laid down in Article 5, once a year following the entry into force of this Regulation, and until the end of the period
of the delegation of power laid down in Article 97. The Commission shall submit the findings of that assessment to the
European Parliament and the Council.
2. By 2 August 2028 and every four years thereafter, the Commission shall evaluate and report to the European
Parliament and to the Council on the following:
(a) the need for amendments extending existing area headings or adding new area headings in Annex III;
(b) amendments to the list of AI systems requiring additional transparency measures in Article 50;
(c) amendments enhancing the effectiveness of the supervision and governance system.
3. By 2 August 2029 and every four years thereafter, the Commission shall submit a report on the evaluation and review
of this Regulation to the European Parliament and to the Council. The report shall include an assessment with regard to the
structure of enforcement and the possible need for a Union agency to resolve any identified shortcomings. On the basis of
the findings, that report shall, where appropriate, be accompanied by a proposal for amendment of this Regulation. The
reports shall be made public.
4. The reports referred to in paragraph 2 shall pay specific attention to the following:
(a) the status of the financial, technical and

Article 112 - Evaluation and review


amendment of this Regulation. The
reports shall be made public.
4. The reports referred to in paragraph 2 shall pay specific attention to the following:
(a) the status of the financial, technical and human resources of the national competent authorities in order to effectively
perform the tasks assigned to them under this Regulation;
(b) the state of penalties, in particular administrative fines as referred to in Article 99(1), applied by Member States for
infringements of this Regulation;
(c) adopted harmonised standards and common specifications developed to support this Regulation;
(d) the number of undertakings that enter the market after the entry into application of this Regulation, and how many of
them are SMEs.
5. By 2 August 2028, the Commission shall evaluate the functioning of the AI Office, whether the AI Office has been
given sufficient powers and competences to fulfil its tasks, and whether it would be relevant and needed for the proper
implementation and enforcement of this Regulation to upgrade the AI Office and its enforcement competences and to
increase its resources. The Commission shall submit a report on its evaluation to the European Parliament and to the
Council.
6. By 2 August 2028 and every four years thereafter, the Commission shall submit a report on the review of the progress
on the development of standardisation deliverables on the energy-efficient development of general-purpose AI models, and
asses the need for further measures or actions, includ

Article 112 - Evaluation and review


e review of the progress
on the development of standardisation deliverables on the energy-efficient development of general-purpose AI models, and
asses the need for further measures or actions, including binding measures or actions. The report shall be submitted to the
European Parliament and to the Council, and it shall be made public.
7. By 2 August 2028 and every three years thereafter, the Commission shall evaluate the impact and effectiveness of
voluntary codes of conduct to foster the application of the requirements set out in Chapter III, Section 2 for AI systems
other than high-risk AI systems and possibly other additional requirements for AI systems other than high-risk AI systems,
including as regards environmental sustainability.
8. For the purposes of paragraphs 1 to 7, the Board, the Member States and national competent authorities shall provide
the Commission with information upon its request and without undue delay.
9. In carrying out the evaluations and reviews referred to in paragraphs 1 to 7, the Commission shall take into account
the positions and findings of the Board, of the European Parliament, of the Council, and of other relevant bodies or sources.
10. The Commission shall, if necessary, submit appropriate proposals to amend this Regulation, in particular taking into
account developments in technology, the effect of AI systems on health and safety, and on fundamental rights, and in light
of the state of progress in the information society.
11. To guide

Article 112 - Evaluation and review


taking into
account developments in technology, the effect of AI systems on health and safety, and on fundamental rights, and in light
of the state of progress in the information society.
11. To guide the evaluations and reviews referred to in paragraphs 1 to 7 of this Article, the AI Office shall undertake to
develop an objective and participative methodology for the evaluation of risk levels based on the criteria outlined in the
relevant Articles and the inclusion of new systems in:
(a) the list set out in Annex III, including the extension of existing area headings or the addition of new area headings in
that Annex;
(b) the list of prohibited practices set out in Article 5; and
(c) the list of AI systems requiring additional transparency measures pursuant to Article 50.
12. Any amendment to this Regulation pursuant to paragraph 10, or relevant delegated or implementing acts, which
concerns sectoral Union harmonisation legislation listed in Section B of Annex I shall take into account the regulatory
specificities of each sector, and the existing governance, conformity assessment and enforcement mechanisms and
authorities established therein.
13. By 2 August 2031, the Commission shall carry out an assessment of the enforcement of this Regulation and shall
report on it to the European Parliament, the Council and the European Economic and Social Committee, taking into
account the first years of application of this Regulation. On the basis of the findings, that report shall, wh

Article 112 - Evaluation and review


opean Parliament, the Council and the European Economic and Social Committee, taking into
account the first years of application of this Regulation. On the basis of the findings, that report shall, where appropriate, be
accompanied by a proposal for amendment of this Regulation with regard to the structure of enforcement and the need for
a Union agency to resolve any identified shortcomings.

Article 112 - Evaluation and review


Article 113 - Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
It shall apply from 2 August 2026.
However:
(a) Chapters I and II shall apply from 2 February 2025;
(b) Chapter III Section 4, Chapter V, Chapter VII and Chapter XII and Article 78 shall apply from 2 August 2025, with the
exception of Article 101;
(c) Article 6(1) and the corresponding obligations in this Regulation shall apply from 2 August 2027.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 13 June 2024.
For the European Parliament
The President
R. METSOLA
For the Council
The President
M. MICHEL


Annex I - List of Union harmonisation legislation

Section A. List of Union harmonisation legislation based on the New Legislative Framework
1. Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending
Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24);
2. Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ
L 170, 30.6.2009, p. 1);
3. Directive 2013/53/EU of the European Parliament and of the Council of 20 November 2013 on recreational craft
and personal watercraft and repealing Directive 94/25/EC (OJ L 354, 28.12.2013, p. 90);
4. Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of
the laws of the Member States relating to lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251);
5. Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of
the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive
atmospheres (OJ L 96, 29.3.2014, p. 309);
6. Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the
laws of the Member States relating to the making available on the market of radio equipment and repealing Directive
1999/5/EC (OJ L 153, 22.5.2014, p. 62);
7. Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the
laws of the Member States relati


ling Directive
1999/5/EC (OJ L 153, 22.5.2014, p. 62);
7. Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the
laws of the Member States relating to the making available on the market of pressure equipment (OJ L 189,
27.6.2014, p. 164);
8. Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway
installations and repealing Directive 2000/9/EC (OJ L 81, 31.3.2016, p. 1);
9. Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective
equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51);
10. Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning
gaseous fuels and repealing Directive 2009/142/EC (OJ L 81, 31.3.2016, p. 99);
11. 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);
12. 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).
Section B. List of other Union harmonisation legislation
13. Regulation (EC) No 300/2008 of the European Parliament and of


e 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017,
p. 176).
Section B. List of other Union harmonisation legislation
13. 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);
14. 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);
15. 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);
16. 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);
17. 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);
18. 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


ilers, 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);
19. 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);
20. 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 re


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), in so far as the design, production and placing on the market of aircrafts referred to in Article 2(1),
points (a) and (b) thereof, where it concerns unmanned aircraft and their engines, propellers, parts and equipment to
control them remotely, are concerned.


Annex II - List of criminal offences referred to in Article 5(1), first subparagraph, point (h)(iii)

Criminal offences referred to in Article 5(1), first subparagraph, point (h)(iii):
— terrorism,
— trafficking in human beings,
— sexual exploitation of children, and child pornography,
— illicit trafficking in narcotic drugs or psychotropic substances,
— illicit trafficking in weapons, munitions or explosives,
— murder, grievous bodily injury,
— illicit trade in human organs or tissue,
— illicit trafficking in nuclear or radioactive materials,
— kidnapping, illegal restraint or hostage-taking,
— crimes within the jurisdiction of the International Criminal Court,
— unlawful seizure of aircraft or ships,
— rape,
— environmental crime,
— organised or armed robbery,
— sabotage,
— participation in a criminal organisation involved in one or more of the offences listed above.


Annex III - High-risk AI systems referred to in Article 6(2)

High-risk AI systems pursuant to Article 6(2) are the AI systems listed in any of the following areas:
1. Biometrics, in so far as their use is permitted under relevant Union or national law:
(a) remote biometric identification systems.
This shall not include AI systems intended to be used for biometric verification the sole purpose of which is to
confirm that a specific natural person is the person he or she claims to be;
(b) AI systems intended to be used for biometric categorisation, according to sensitive or protected attributes or
characteristics based on the inference of those attributes or characteristics;
(c) AI systems intended to be used for emotion recognition.
2. Critical infrastructure: AI systems intended to be used as safety components in the management and operation of
critical digital infrastructure, road traffic, or in the supply of water, gas, heating or electricity.
3. Education and vocational training:
(a) AI systems intended to be used to determine access or admission or to assign natural persons to educational and
vocational training institutions at all levels;
(b) AI systems intended to be used to evaluate learning outcomes, including when those outcomes are used to steer
the learning process of natural persons in educational and vocational training institutions at all levels;
(c) AI systems intended to be used for the purpose of assessing the appropriate level of education that an individual
will receive or will be able to access, in the context of or


utions at all levels;
(c) AI systems intended to be used for the purpose of assessing the appropriate level of education that an individual
will receive or will be able to access, in the context of or within educational and vocational training institutions
at all levels;
(d) AI systems intended to be used for monitoring and detecting prohibited behaviour of students during tests in the
context of or within educational and vocational training institutions at all levels.
4. Employment, workers’ management and access to self-employment:
(a) AI systems intended to be used for the recruitment or selection of natural persons, in particular to place targeted
job advertisements, to analyse and filter job applications, and to evaluate candidates;
(b) AI systems intended to be used to make decisions affecting terms of work-related relationships, the promotion or
termination of work-related contractual relationships, to allocate tasks based on individual behaviour or personal
traits or characteristics or to monitor and evaluate the performance and behaviour of persons in such
relationships.
5. Access to and enjoyment of essential private services and essential public services and benefits:
(a) AI systems intended to be used by public authorities or on behalf of public authorities to evaluate the eligibility
of natural persons for essential public assistance benefits and services, including healthcare services, as well as to
grant, reduce, revoke, or reclaim such benefits and services;
(


e the eligibility
of natural persons for essential public assistance benefits and services, including healthcare services, as well as to
grant, reduce, revoke, or reclaim such benefits and services;
(b) AI systems intended to be used to evaluate the creditworthiness of natural persons or establish their credit score,
with the exception of AI systems used for the purpose of detecting financial fraud;
(c) AI systems intended to be used for risk assessment and pricing in relation to natural persons in the case of life
and health insurance;
(d) AI systems intended to evaluate and classify emergency calls by natural persons or to be used to dispatch, or to
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.
6. Law enforcement, in so far as their use is permitted under relevant Union or national law:
(a) AI systems intended to be used by or on behalf of law enforcement authorities, or by Union institutions, bodies,
offices or agencies in support of law enforcement authorities or on their behalf to assess the risk of a natural
person becoming the victim of criminal offences;
(b) AI systems intended to be used by or on behalf of law enforcement authorities or by Union institutions, bodies,
offices or agencies in support of law enforcement authorities as polygraphs or similar tools;
(c) AI systems intended to be used by or on behalf of law enforcement


s or by Union institutions, bodies,
offices or agencies in support of law enforcement authorities as polygraphs or similar tools;
(c) AI systems intended to be used by or on behalf of law enforcement authorities, or by Union institutions, bodies,
offices or agencies, in support of law enforcement authorities to evaluate the reliability of evidence in the course
of the investigation or prosecution of criminal offences;
(d) AI systems intended to be used by law enforcement authorities or on their behalf or by Union institutions,
bodies, offices or agencies in support of law enforcement authorities for assessing the risk of a natural person
offending or re-offending not solely on the basis of the profiling of natural persons as referred to in Article 3(4)
of Directive (EU) 2016/680, or to assess personality traits and characteristics or past criminal behaviour of
natural persons or groups;
(e) AI systems intended to be used by or on behalf of law enforcement authorities or by Union institutions, bodies,
offices or agencies in support of law enforcement authorities for the profiling of natural persons as referred to in
Article 3(4) of Directive (EU) 2016/680 in the course of the detection, investigation or prosecution of criminal
offences.
7. Migration, asylum and border control management, in so far as their use is permitted under relevant Union or
national law:
(a) AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies,
o


gement, in so far as their use is permitted under relevant Union or
national law:
(a) AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies,
offices or agencies as polygraphs or similar tools;
(b) AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies,
offices or agencies to assess a risk, including a security risk, a risk of irregular migration, or a health risk, posed
by a natural person who intends to enter or who has entered into the territory of a Member State;
(c) AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies,
offices or agencies to assist competent public authorities for the examination of applications for asylum, visa or
residence permits and for associated complaints with regard to the eligibility of the natural persons applying for
a status, including related assessments of the reliability of evidence;
(d) AI systems intended to be used by or on behalf of competent public authorities, or by Union institutions, bodies,
offices or agencies, in the context of migration, asylum or border control management, for the purpose of
detecting, recognising or identifying natural persons, with the exception of the verification of travel documents.
8. Administration of justice and democratic processes:
(a) AI systems intended to be used by a judicial authority or on their behalf to assist a judicial au


on of the verification of travel documents.
8. Administration of justice and democratic processes:
(a) AI systems intended to be used by a judicial authority or on their behalf to assist a judicial authority in
researching and interpreting facts and the law and in applying the law to a concrete set of facts, or to be used in
a similar way in alternative dispute resolution;
(b) AI systems intended to be used for influencing the outcome of an election or referendum or the voting
behaviour of natural persons in the exercise of their vote in elections or referenda. This does not include AI
systems to the output of which natural persons are not directly exposed, such as tools used to organise, optimise
or structure political campaigns from an administrative or logistical point of view.


Annex IV - Technical documentation referred to in Article 11(1)

The technical documentation referred to in Article 11(1) shall contain at least the following information, as applicable to
the relevant AI system:
1. A general description of the AI system including:
(a) its intended purpose, the name of the provider and the version of the system reflecting its relation to previous
versions;
(b) how the AI system interacts with, or can be used to interact with, hardware or software, including with other AI
systems, that are not part of the AI system itself, where applicable;
(c) the versions of relevant software or firmware, and any requirements related to version updates;
(d) the description of all the forms in which the AI system is placed on the market or put into service, such as
software packages embedded into hardware, downloads, or APIs;
(e) the description of the hardware on which the AI system is intended to run;
(f) where the AI system is a component of products, photographs or illustrations showing external features, the
marking and internal layout of those products;
(g) a basic description of the user-interface provided to the deployer;
(h) instructions for use for the deployer, and a basic description of the user-interface provided to the deployer, where
applicable;
2. A detailed description of the elements of the AI system and of the process for its development, including:
(a) the methods and steps performed for the development of the AI system, including, where relevant, recourse to
pre-trained systems or tools provided by thi


he process for its development, including:
(a) the methods and steps performed for the development of the AI system, including, where relevant, recourse to
pre-trained systems or tools provided by third parties and how those were used, integrated or modified by the
provider;
(b) the design specifications of the system, namely the general logic of the AI system and of the algorithms; the key
design choices including the rationale and assumptions made, including with regard to persons or groups of
persons in respect of who, the system is intended to be used; the main classification choices; what the system is
designed to optimise for, and the relevance of the different parameters; the description of the expected output
and output quality of the system; the decisions about any possible trade-off made regarding the technical
solutions adopted to comply with the requirements set out in Chapter III, Section 2;
(c) the description of the system architecture explaining how software components build on or feed into each other
and integrate into the overall processing; the computational resources used to develop, train, test and validate the
AI system;
(d) where relevant, the data requirements in terms of datasheets describing the training methodologies and
techniques and the training data sets used, including a general description of these data sets, information about
their provenance, scope and main characteristics; how the data was obtained and selected; labelling procedures
(e.g. f


sets used, including a general description of these data sets, information about
their provenance, scope and main characteristics; how the data was obtained and selected; labelling procedures
(e.g. for supervised learning), data cleaning methodologies (e.g. outliers detection);
(e) assessment of the human oversight measures needed in accordance with Article 14, including an assessment of
the technical measures needed to facilitate the interpretation of the outputs of AI systems by the deployers, in
accordance with Article 13(3), point (d);
(f) where applicable, a detailed description of pre-determined changes to the AI system and its performance,
together with all the relevant information related to the technical solutions adopted to ensure continuous
compliance of the AI system with the relevant requirements set out in Chapter III, Section 2;
(g) the validation and testing procedures used, including information about the validation and testing data used and
their main characteristics; metrics used to measure accuracy, robustness and compliance with other relevant
requirements set out in Chapter III, Section 2, as well as potentially discriminatory impacts; test logs and all test
reports dated and signed by the responsible persons, including with regard to pre-determined changes as referred
to under point (f);
(h) cybersecurity measures put in place;
3. Detailed information about the monitoring, functioning and control of the AI system, in particular with regard to:
its capa


as referred
to under point (f);
(h) cybersecurity measures put in place;
3. Detailed information about the monitoring, functioning and control of the AI system, in particular with regard to:
its capabilities and limitations in performance, including the degrees of accuracy for specific persons or groups of
persons on which the system is intended to be used and the overall expected level of accuracy in relation to its
intended purpose; the foreseeable unintended outcomes and sources of risks to health and safety, fundamental rights
and discrimination in view of the intended purpose of the AI system; the human oversight measures needed in
accordance with Article 14, including the technical measures put in place to facilitate the interpretation of the
outputs of AI systems by the deployers; specifications on input data, as appropriate;
4. A description of the appropriateness of the performance metrics for the specific AI system;
5. A detailed description of the risk management system in accordance with Article 9;
6. A description of relevant changes made by the provider to the system through its lifecycle;
7. A list of the harmonised standards applied in full or in part the references of which have been published in the
Official Journal of the European Union; where no such harmonised standards have been applied, a detailed description
of the solutions adopted to meet the requirements set out in Chapter III, Section 2, including a list of other relevant
standards and technical s


ed standards have been applied, a detailed description
of the solutions adopted to meet the requirements set out in Chapter III, Section 2, including a list of other relevant
standards and technical specifications applied;
8. A copy of the EU declaration of conformity referred to in Article 47;
9. A detailed description of the system in place to evaluate the AI system performance in the post-market phase in
accordance with Article 72, including the post-market monitoring plan referred to in Article 72(3).


Annex V - EU declaration of conformity

The EU declaration of conformity referred to in Article 47, shall contain all of the following information:
1. AI system name and type and any additional unambiguous reference allowing the identification and traceability of
the AI system;
2. The name and address of the provider or, where applicable, of their authorised representative;
3. A statement that the EU declaration of conformity referred to in Article 47 is issued under the sole responsibility of
the provider;
4. A statement that the AI system is in conformity with this Regulation and, if applicable, with any other relevant
Union law that provides for the issuing of the EU declaration of conformity referred to in Article 47;
5. Where an AI system involves the processing of personal data, a statement that that AI system complies with
Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680;
6. References to any relevant harmonised standards used or any other common specification in relation to which
conformity is declared;
7. Where applicable, the name and identification number of the notified body, a description of the conformity
assessment procedure performed, and identification of the certificate issued;
8. The place and date of issue of the declaration, the name and function of the person who signed it, as well as an
indication for, or on behalf of whom, that person signed, a signature.

Annex V - EU declaration of conformity


Annex VI - Conformity assessment procedure based on internal control

1. The conformity assessment procedure based on internal control is the conformity assessment procedure based on
points 2, 3 and 4.
2. The provider verifies that the established quality management system is in compliance with the requirements of
Article 17.
3. The provider examines the information contained in the technical documentation in order to assess the compliance
of the AI system with the relevant essential requirements set out in Chapter III, Section 2.
4. The provider also verifies that the design and development process of the AI system and its post-market monitoring
as referred to in Article 72 is consistent with the technical documentation.


Annex VII - Conformity based on an assessment of the quality management system and an assessment of the

technical documentation
1. Introduction
Conformity based on an assessment of the quality management system and an assessment of the technical
documentation is the conformity assessment procedure based on points 2 to 5.
2. Overview
The approved quality management system for the design, development and testing of AI systems pursuant to
Article 17 shall be examined in accordance with point 3 and shall be subject to surveillance as specified in point 5.
The technical documentation of the AI system shall be examined in accordance with point 4.
3. Quality management system
3.1. The application of the provider shall include:
(a) the name and address of the provider and, if the application is lodged by an authorised representative, also their
name and address;
(b) the list of AI systems covered under the same quality management system;
(c) the technical documentation for each AI system covered under the same quality management system;
(d) the documentation concerning the quality management system which shall cover all the aspects listed under
Article 17;
(e) a description of the procedures in place to ensure that the quality management system remains adequate and
effective;
(f) a written declaration that the same application has not been lodged with any other notified body.
3.2. The quality management system shall be assessed by the notified body, which shall determine whether it satisfies the
requirements referred to in Article 17.
The decision shall be notified to the provider or i


ity management system shall be assessed by the notified body, which shall determine whether it satisfies the
requirements referred to in Article 17.
The decision shall be notified to the provider or its authorised representative.
The notification shall contain the conclusions of the assessment of the quality management system and the reasoned
assessment decision.
3.3. The quality management system as approved shall continue to be implemented and maintained by the provider so
that it remains adequate and efficient.
3.4. Any intended change to the approved quality management system or the list of AI systems covered by the latter shall
be brought to the attention of the notified body by the provider.
The proposed changes shall be examined by the notified body, which shall decide whether the modified quality
management system continues to satisfy the requirements referred to in point 3.2 or whether a reassessment is
necessary.
The notified body shall notify the provider of its decision. The notification shall contain the conclusions of the
examination of the changes and the reasoned assessment decision.
4. Control of the technical documentation.
4.1. In addition to the application referred to in point 3, an application with a notified body of their choice shall be
lodged by the provider for the assessment of the technical documentation relating to the AI system which the
provider intends to place on the market or put into service and which is covered by the quality management sys


der for the assessment of the technical documentation relating to the AI system which the
provider intends to place on the market or put into service and which is covered by the quality management system
referred to under point 3.
4.2. The application shall include:
(a) the name and address of the provider;
(b) a written declaration that the same application has not been lodged with any other notified body;
(c) the technical documentation referred to in Annex IV.
4.3. The technical documentation shall be examined by the notified body. Where relevant, and limited to what is
necessary to fulfil its tasks, the notified body shall be granted full access to the training, validation, and testing data
sets used, including, where appropriate and subject to security safeguards, through API or other relevant technical
means and tools enabling remote access.
4.4. In examining the technical documentation, the notified body may require that the provider supply further evidence
or carry out further tests so as to enable a proper assessment of the conformity of the AI system with the
requirements set out in Chapter III, Section 2. Where the notified body is not satisfied with the tests carried out by
the provider, the notified body shall itself directly carry out adequate tests, as appropriate.
4.5. Where necessary to assess the conformity of the high-risk AI system with the requirements set out in Chapter III,
Section 2, after all other reasonable means to verify conformity have been exhau


4.5. Where necessary to assess the conformity of the high-risk AI system with the requirements set out in Chapter III,
Section 2, after all other reasonable means to verify conformity have been exhausted and have proven to be
insufficient, and upon a reasoned request, the notified body shall also be granted access to the training and trained
models of the AI system, including its relevant parameters. Such access shall be subject to existing Union law on the
protection of intellectual property and trade secrets.
4.6. The decision of the notified body shall be notified to the provider or its authorised representative. The notification
shall contain the conclusions of the assessment of the technical documentation and the reasoned assessment
decision.
Where the AI system is in conformity with the requirements set out in Chapter III, Section 2, the notified body shall
issue a Union technical documentation assessment certificate. The certificate shall indicate the name and address of
the provider, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for the
identification of the AI system.
The certificate and its annexes shall contain all relevant information to allow the conformity of the AI system to be
evaluated, and to allow for control of the AI system while in use, where applicable.
Where the AI system is not in conformity with the requirements set out in Chapter III, Section 2, the notified body
shall refuse to issue a Union te


ol of the AI system while in use, where applicable.
Where the AI system is not in conformity with the requirements set out in Chapter III, Section 2, the notified body
shall refuse to issue a Union technical documentation assessment certificate and shall inform the applicant
accordingly, giving detailed reasons for its refusal.
Where the AI system does not meet the requirement relating to the data used to train it, re-training of the AI system
will be needed prior to the application for a new conformity assessment. In this case, the reasoned assessment
decision of the notified body refusing to issue the Union technical documentation assessment certificate shall
contain specific considerations on the quality data used to train the AI system, in particular on the reasons for
non-compliance.
4.7. Any change to the AI system that could affect the compliance of the AI system with the requirements or its intended
purpose shall be assessed by the notified body which issued the Union technical documentation assessment
certificate. The provider shall inform such notified body of its intention to introduce any of the abovementioned
changes, or if it otherwise becomes aware of the occurrence of such changes. The intended changes shall be assessed
by the notified body, which shall decide whether those changes require a new conformity assessment in accordance
with Article 43(4) or whether they could be addressed by means of a supplement to the Union technical
documentation assessment cert


ther those changes require a new conformity assessment in accordance
with Article 43(4) or whether they could be addressed by means of a supplement to the Union technical
documentation assessment certificate. In the latter case, the notified body shall assess the changes, notify the
provider of its decision and, where the changes are approved, issue to the provider a supplement to the Union
technical documentation assessment certificate.
5. Surveillance of the approved quality management system.
5.1. The purpose of the surveillance carried out by the notified body referred to in Point 3 is to make sure that the
provider duly complies with the terms and conditions of the approved quality management system.
5.2. For assessment purposes, the provider shall allow the notified body to access the premises where the design,
development, testing of the AI systems is taking place. The provider shall further share with the notified body all
necessary information.
5.3. The notified body shall carry out periodic audits to make sure that the provider maintains and applies the quality
management system and shall provide the provider with an audit report. In the context of those audits, the notified
body may carry out additional tests of the AI systems for which a Union technical documentation assessment
certificate was issued.


assessment
certificate was issued.


Annex VIII - Information to be submitted upon the registration of high-risk AI systems in accordance with

Article 49
Section A — Information to be submitted by providers of high-risk AI systems in accordance with Article 49(1)
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(1):
1. The name, address and contact details of the provider;
2. Where submission of information is carried out by another person on behalf of the provider, the name, address and
contact details of that person;
3. The name, address and contact details of the authorised representative, where applicable;
4. The AI system trade name and any additional unambiguous reference allowing the identification and traceability of
the AI system;
5. A description of the intended purpose of the AI system and of the components and functions supported through
this AI system;
6. A basic and concise description of the information used by the system (data, inputs) and its operating logic;
7. The status of the AI system (on the market, or in service; no longer placed on the market/in service, recalled);
8. The type, number and expiry date of the certificate issued by the notified body and the name or identification
number of that notified body, where applicable;
9. A scanned copy of the certificate referred to in point 8, where applicable;
10. Any Member States in which the AI system has been placed on the market, put into service or made available in the
Union;
11. A copy of the EU declaration of conformity referred to in


applicable;
10. Any Member States in which the AI system has been placed on the market, put into service or made available in the
Union;
11. A copy of the EU declaration of conformity referred to in Article 47;
12. Electronic instructions for use; this information shall not be provided for high-risk AI systems in the areas of law
enforcement or migration, asylum and border control management referred to in Annex III, points 1, 6 and 7;
13. A URL for additional information (optional).
Section B — Information to be submitted by providers of high-risk AI systems in accordance with Article 49(2)
The following information shall be provided and thereafter kept up to date with regard to AI systems to be registered in
accordance with Article 49(2):
1. The name, address and contact details of the provider;
2. Where submission of information is carried out by another person on behalf of the provider, the name, address and
contact details of that person;
3. The name, address and contact details of the authorised representative, where applicable;
4. The AI system trade name and any additional unambiguous reference allowing the identification and traceability of
the AI system;
5. A description of the intended purpose of the AI system;
6. The condition or conditions under Article 6(3)based on which the AI system is considered to be not-high-risk;
7. A short summary of the grounds on which the AI system is considered to be not-high-risk in application of the
procedure under Article 6(3);
8


which the AI system is considered to be not-high-risk;
7. A short summary of the grounds on which the AI system is considered to be not-high-risk in application of the
procedure under Article 6(3);
8. The status of the AI system (on the market, or in service; no longer placed on the market/in service, recalled);
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
(a) 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).
(b) Regulation (EU) 2021/


019/818 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).
(b) 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 Eur


(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


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,


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


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.


Article 1 - Subject-matter and objectives

1. This Regulation lays down rules relating to the protection of natural persons with regard to the processing of
personal data and rules relating to the free movement of personal data.
2. This Regulation protects fundamental rights and freedoms of natural persons and in particular their right to the
protection of personal data.
3. The free movement of personal data within the Union shall be neither restricted nor prohibited for reasons
connected with the protection of natural persons with regard to the processing of personal data.


Article 2 - Material scope

1. This Regulation applies to the processing of personal data wholly or partly by automated means and to the
processing other than by automated means of personal data which form part of a filing system or are intended to form
part of a filing system.
2. This Regulation does not apply to the processing of personal data:
(a)  in the course of an activity which falls outside the scope of Union law;
(b)  by the Member States when carrying out activities which fall within the scope of Chapter 2 of Title V of the TEU;
(c)  by a natural person in the course of a purely personal or household activity;
(d)  by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal
offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to
public security.
3. For the processing of personal data by the Union institutions, bodies, offices and agencies, Regulation (EC)
No 45/2001 applies. Regulation (EC) No 45/2001 and other Union legal acts applicable to such processing of personal
data shall be adapted to the principles and rules of this Regulation in accordance with Article 98.
4. This Regulation shall be without prejudice to the application of Directive 2000/31/EC, in particular of the liability
rules of intermediary service providers in Articles 12 to 15 of that Directive.

Article 2 - Material scope


Article 3 - Territorial scope

1. This Regulation applies to the processing of personal data in the context of the activities of an establishment of a
controller or a processor in the Union, regardless of whether the processing takes place in the Union or not.
2. This Regulation applies to the processing of personal data of data subjects who are in the Union by a controller or
processor not established in the Union, where the processing activities are related to:
(a)  the offering of goods or services, irrespective of whether a payment of the data subject is required, to such data
subjects in the Union; or
(b)  the monitoring of their behaviour as far as their behaviour takes place within the Union.
3. This Regulation applies to the processing of personal data by a controller not established in the Union, but in a
place where Member State law applies by virtue of public international law.

Article 3 - Territorial scope


Article 4 - Definitions

For the purposes of this Regulation:
(1) ‘personal data’ means any information relating to an identified or identifiable natural person (‘data subject’); an
identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an
identifier such as a name, an identification number, location data, an online identifier or to one or more factors
specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person;
(2) ‘processing’ means any operation or set of operations which is performed on personal data or on sets of personal
data, whether or not by automated means, such as collection, recording, organisation, structuring, storage,
adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making
available, alignment or combination, restriction, erasure or destruction;
(3) ‘restriction of processing’ means the marking of stored personal data with the aim of limiting their processing in
the future;
(4) ‘profiling’ means any form of automated processing of personal data consisting of the use of personal data to
evaluate certain personal aspects relating to a natural person, in particular to analyse or predict aspects concerning
that natural person's performance at work, economic situation, health, personal preferences, interests, reliability,
behaviour, location or movements;
(5) ‘pseudonymisation’ means the processing of personal data

Article 4 - Definitions


person's performance at work, economic situation, health, personal preferences, interests, reliability,
behaviour, location or movements;
(5) ‘pseudonymisation’ means the processing of personal data in such a manner that the personal data can no longer
be attributed to a specific data subject without the use of additional information, provided that such additional
information is kept separately and is subject to technical and organisational measures to ensure that the personal
data are not attributed to an identified or identifiable natural person;
(6) ‘filing system’ means any structured set of personal data which are accessible according to specific criteria, whether
centralised, decentralised or dispersed on a functional or geographical basis;
(7) ‘controller’ means the natural or legal person, public authority, agency or other body which, alone or jointly with
others, determines the purposes and means of the processing of personal data; where the purposes and means of
such processing are determined by Union or Member State law, the controller or the specific criteria for its
nomination may be provided for by Union or Member State law;
(8) ‘processor’ means a natural or legal person, public authority, agency or other body which processes personal data
on behalf of the controller;
(9) ‘recipient’ means a natural or legal person, public authority, agency or another body, to which the personal data are
disclosed, whether a third party or not. However, public authorities whic

Article 4 - Definitions


ler;
(9) ‘recipient’ means a natural or legal person, public authority, agency or another body, to which the personal data are
disclosed, whether a third party or not. However, public authorities which may receive personal data in the
framework of a particular inquiry in accordance with Union or Member State law shall not be regarded as
recipients; the processing of those data by those public authorities shall be in compliance with the applicable data
protection rules according to the purposes of the processing;
(10) ‘third party’ means a natural or legal person, public authority, agency or body other than the data subject,
controller, processor and persons who, under the direct authority of the controller or processor, are authorised to
process personal data;
(11) ‘consent’ of the data subject means any freely given, specific, informed and unambiguous indication of the data
subject's wishes by which he or she, by a statement or by a clear affirmative action, signifies agreement to the
processing of personal data relating to him or her;
(12) ‘personal data breach’ means a breach of security leading to the accidental or unlawful destruction, loss, alteration,
unauthorised disclosure of, or access to, personal data transmitted, stored or otherwise processed;
(13) ‘genetic data’ means personal data relating to the inherited or acquired genetic characteristics of a natural person
which give unique information about the physiology or the health of that natural person and which res

Article 4 - Definitions


ns personal data relating to the inherited or acquired genetic characteristics of a natural person
which give unique information about the physiology or the health of that natural person and which result, in
particular, from an analysis of a biological sample from the natural person in question;
(14) ‘biometric data’ means personal data resulting from specific technical processing relating to the physical, physio
logical or behavioural characteristics of a natural person, which allow or confirm the unique identification of that
natural person, such as facial images or dactyloscopic data;
(15) ‘data concerning health’ means personal data related to the physical or mental health of a natural person, including
the provision of health care services, which reveal information about his or her health status;
(16) ‘main establishment’ means:
(a) as regards a controller with establishments in more than one Member State, the place of its central adminis
tration in the Union, unless the decisions on the purposes and means of the processing of personal data are
taken in another establishment of the controller in the Union and the latter establishment has the power to
have such decisions implemented, in which case the establishment having taken such decisions is to be
considered to be the main establishment;
(b) as regards a processor with establishments in more than one Member State, the place of its central adminis
tration in the Union, or, if the processor has no central administrat

Article 4 - Definitions


ain establishment;
(b) as regards a processor with establishments in more than one Member State, the place of its central adminis
tration in the Union, or, if the processor has no central administration in the Union, the establishment of the
processor in the Union where the main processing activities in the context of the activities of an establishment
of the processor take place to the extent that the processor is subject to specific obligations under this
Regulation;
(17) ‘representative’ means a natural or legal person established in the Union who, designated by the controller or
processor in writing pursuant to Article 27, represents the controller or processor with regard to their respective
obligations under this Regulation;
(18) ‘enterprise’ means a natural or legal person engaged in an economic activity, irrespective of its legal form, including
partnerships or associations regularly engaged in an economic activity;
(19) ‘group of undertakings’ means a controlling undertaking and its controlled undertakings;
(20) ‘binding corporate rules’ means personal data protection policies which are adhered to by a controller or processor
established on the territory of a Member State for transfers or a set of transfers of personal data to a controller or
processor in one or more third countries within a group of undertakings, or group of enterprises engaged in a
joint economic activity;
(21) ‘supervisory authority’ means an independent public authority which is established by a

Article 4 - Definitions


ird countries within a group of undertakings, or group of enterprises engaged in a
joint economic activity;
(21) ‘supervisory authority’ means an independent public authority which is established by a Member State pursuant to
Article 51;
(22) ‘supervisory authority concerned’ means a supervisory authority which is concerned by the processing of personal
data because:
(a)  the controller or processor is established on the territory of the Member State of that supervisory authority;
(b)  data subjects residing in the Member State of that supervisory authority are substantially affected or likely to be
substantially affected by the processing; or
(c)  a complaint has been lodged with that supervisory authority;
(23) ‘cross-border processing’ means either:
(a)  processing of personal data which takes place in the context of the activities of establishments in more than
one Member State of a controller or processor in the Union where the controller or processor is established in
more than one Member State; or
(b)  processing of personal data which takes place in the context of the activities of a single establishment of a
controller or processor in the Union but which substantially affects or is likely to substantially affect data
subjects in more than one Member State.
(24) ‘relevant and reasoned objection’ means an objection to a draft decision as to whether there is an infringement of
this Regulation, or whether envisaged action in relation to the controller or processor compli

Article 4 - Definitions


and reasoned objection’ means an objection to a draft decision as to whether there is an infringement of
this Regulation, or whether envisaged action in relation to the controller or processor complies with this
Regulation, which clearly demonstrates the significance of the risks posed by the draft decision as regards the
fundamental rights and freedoms of data subjects and, where applicable, the free flow of personal data within the
Union;
(25) ‘information society service’ means a service as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535 of
the European Parliament and of the Council (1);
(26) ‘international organisation’ means an organisation and its subordinate bodies governed by public international law,
or any other body which is set up by, or on the basis of, an agreement between two or more countries.

Article 4 - Definitions