Text · Comparison of two versions

Changes from plenary report to adopted text

A-10-2026-0073 → TA-10-2026-0098

From: A-10-2026-0073 Plenary report of 19 Mar 2026
To: TA-10-2026-0098 Adopted text of 26 Mar 2026
Changes: 10 changes to the text
Paragraphs: +4 added · −20 removed · 12 changed

More facts (3)

Dossier: 2025/0359(COD)
Title (from): on the proposal for a regulation of the European Parliament and of the Council amending Regulations (EU) 2024/1689 and (EU) 2018/1139 as regards the simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI)
Title (to): Simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI)

Dossier: 2025/0359(COD)
Title (from): on the proposal for a regulation of the European Parliament and of the Council amending Regulations (EU) 2024/1689 and (EU) 2018/1139 as regards the simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI)
Title (to): Simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI)

What changed, in short Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026

The main substantive change adds a new condition for high-risk AI systems requiring third-party conformity assessment.3 Other changes are formal or wording: correcting references, punctuation, and formatting.1 2 4 5

The notes class 1 change as substance, 8 as formal, 1 as wording only.

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Changes that matter, 10

Changes to the text in document order — the ones the change notes describe. Cover page, renumbering and punctuation-only edits are left out (see “Every difference”); changes to citations and references stay in and are marked as formal in the notes.

Change 1

ChangedRecital 4: (4) 99,8% of all Union companies are small and medium-sized enterprises, the majority of which are micro and small enterprises.3a Enterprises outgrowing the micro, small and medium-sized enterprises (‘SME’) definition – the ‘small mid-cap enterprises’ (‘SMCs’) – play a vital role in the Union’s economy. Compared to SMEs, SMCs tend to demonstrate a higher pace of growth, and level of innovation and digitisation. Nevertheless, they face challenges similar to SMEs in relation to administrative burden, leading to a need for proportionality in the implementation of Regulation (EU) 2024/1689 and for targeted support. To enable the smooth transition of enterprises from SMEs into SMCs, it is important to address in a coherent manner the effect that regulation may have on their activity once those enterprises outgrow the segment of SMEs and are faced with rules that apply to large enterprises. Regulation (EU) 2024/1689 provides for several measures for small-scale providers, which should be extended to SMCs where appropriate while safeguarding the overarching objectives and level of protection afforded under Regulation (EU) 2024/16893b. In order to clarify the treatment of SMEs and SMCs in Regulation (EU) 2024/1689, it is necessary to introduce definitions for SMEs and SMCs, which should correspond to the definition set out in the Annex to Commission Recommendation 2003/361/EC4 and Annex to Commission Recommendation ~~2025/3500/EC5~~(EU) 2025/35005 . / 3a ~~https://single-market-economy.ec.europa.eu/syste…~~https://single-market-economy.ec.europa.eu/sys…

Note on change 1 · formal Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026

Updates the reference to Commission Recommendation 2025/3500/EC and the footnote URL.

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Change 2

ChangedRecital 9: (9) To streamline compliance and reduce the associated costs, the registration of AI systems referred to in Article 6(3) of Regulation (EU) 2024/1689 in the EU database pursuant to Article 49(2) of that Regulation should be simplified by streamlining the required content in Section B of Annex VIII to that Regulation. While it remains crucial for effective market surveillance and public accountability that such AI systems are registered in the EU database, the registration requirements should be simplified and made more proportionate. This simplification will strike a better balance without undermining the protection laid down by Regulation (EU) 2024/1689. Such systems are not considered high-risk under certain conditions where they do not pose significant risk of harm to the health, safety or fundamental rights of persons. Furthermore, a provider applying Article 6(3) remains obligated to document its assessment before that system is placed on the market or put into service. This assessment may be requested by national competent authorities.

Note on change 2 · formal Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026

Adds the acronym "EU" before the regulation number 2024/1689.

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Change 3

ChangedArticle 1 – paragraph 1 – point 5 b (new), Article 6 – paragraph 1: (5b) Article 6(1) is amended as follows: / "1. Irrespective of whether an AI system is placed on the market or put into service independently of the products referred to in points (a) and (b), that AI system shall be considered to be high-risk where both of the following conditions are fulfilled: / (a) the AI system is intended to be used as a safety component of a product and whose functioning is necessary to ensure that the product or AI system complies with applicable Union safety requirements, or the AI system is itself a product, covered by the Union harmonisation legislation listed in Annex I; / "(b) the product whose safety component pursuant to point (a) is the AI system, or the AI system itself as a product, is required to undergo a third-party conformity assessment, with a view to the placing on the market or the putting into service of that product pursuant to the Union harmonisation legislation listed in Annex I."

Note on change 3 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026

Adds a new condition (b) to Article 6(1) requiring a third-party conformity assessment for high-risk AI systems.

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Change 4

ChangedArticle 1 – paragraph 1 – point 6, Article 6 – paragraph 4: deleted / (deleted) ~~/ (deleted) / (deleted)~~

Note on change 4 · formal Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026

Removes repeated "(deleted)" markers in the amendment text.

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Change 5

ChangedArticle 1 – paragraph 1 – point 9 b (new), Article 27 – paragraph 4: (9b) in Article 27, paragraph 4 is replaced by the following: / "4. If any of the obligations laid down in this Article is already met through the data protection impact assessment conducted pursuant to Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680, the deployer shall, when conducting the fundamental rights impact assessment referred to in paragraph 1 of this Article include cross references to the relevant sections of that data protection impact assessment or include relevant parts of that data protection impact assessment into the fundamental rights impact ~~assessment. / "~~assessment."

Note on change 5 · wording only Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026

Changes the punctuation at the end of a sentence in Article 27(4), replacing a period and quote with just a quote.

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Change 6

ChangedArticle 1 – paragraph 1 – point 13, Article 43 – paragraph 3: deleted / (deleted) / (deleted) / (deleted) / (deleted) ~~/ (deleted) / (deleted)~~

Note on change 6 · formal Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026

Removes repeated "(deleted)" markers in the amendment text.

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Change 7

ChangedArticle 1 – paragraph 1 – point 17 – point a, Article 57 – paragraph 3 a (new): (3a) The AI Office may also establish an AI regulatory sandbox at Union level for AI systems covered by Article 75(1). Such an AI regulatory sandbox shall be implemented in close cooperation with relevant competent authorities, in particular when Union legislation other than this Regulation is supervised in the AI regulatory sandbox, and shall provide priority access to SMEs, including startups.; / The AI Office shall ensure that, to the extent innovative AI systems referred to in paragraph 5 involve the processing of personal data or otherwise fall under the supervisory remit of other national authorities or competent authorities providing or supporting access to data, the national data protection authorities, the EDPB and those other national or competent authorities are associated with the operation of the AI regulatory sandbox established at Union level and involved in the supervision of those aspects to the extent that they relate to their respective tasks and powers, in accordance with Regulation (EU) 2016/679, Regulation (EU) 2018/1725 and Directive ~~(EU)2018/680.;~~(EU) 2018/680.;

Note on change 7 · formal Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026

Adds a space in the directive reference "(EU) 2018/680".

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Change 8

ChangedArticle 1 – paragraph 1 – point 25 – point b a (new), Article 75 – paragraph –1a (new): (ba) in Article 75, paragraph -1a is inserted: / ‘-1a. In the implementation and enforcement of this Regulation, the AI Office shall promote innovation, competitiveness and the protection of fundamental rights, taking them into consideration in the exercise of their functions. The AI Office shall coordinate closely with the competent data protection authorities designated pursuant to Regulation (EU) ~~2016/1679~~2016/679 in matters involving the processing of personal data falling within the scope of that Regulation.’

Note on change 8 · formal Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026

Corrects the regulation number from 2016/1679 to 2016/679 in Article 75.

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Change 9

ChangedArticle 1 – paragraph 1 – point 28, Article 96 – paragraph 1 – point a: ~~-1.~~ (a) the application of the requirements and obligations referred to in Articles 8 to 15 and in Articles 25 and 26;

Note on change 9 · formal Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026

Removes the leading "-1." from the text of point (a).

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Change 10

ChangedArticle 1 – paragraph 1 – point 29 a (new), Article 110 a (new): (29a) The following articles: Article 110a – Article 110l are inserted: / Article 110a / Amendment to Regulation (EU) 2023/1230 / In Article 8 of Regulation (EU) 2023/1230, the following paragraphs 2 and 3 are added: / ‘2. The Commission is empowered to adopt delegated acts in accordance with Article 48 to amend the essential health and safety requirements set out in Annex III in order to adapt them to scientific or technical progress or to international developments or to add requirements in relation to emerging risks or technologies. For high-risk AI systems referred to in Article 6(1) of Regulation ~~(EU)2024/1689~~(EU) 2024/1689 the relevant requirements set out in Chapter III, Section 2 of (EU) Regulation (EU) 2024/1689 shall be deemed to constitute essential health and safety requirements for the purpose of this Regulation. / 3. When adopting delegated acts pursuant to paragraph 2 of this Article or Common Specifications pursuant to Article 20 of this Regulation concerning machinery and related products that are high-risk AI systems as referred to in Article 6(1) of Regulation (EU) 2024/1689 of the European Parliament and of the Council, or that use high-risk AI systems as safety components, the Commission shall take into account the requirements set out in Chapter III, Section 2, of that Regulation as well as relevant harmonised standards. With regard to high-risk AI systems, the Commission shall not go beyond the requirements laid down in Regulation (EU) 2024/1689.’ / Article 110b / ~~Amendme…~~A…

Note on change 10 · formal Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026

Fixes formatting in the regulation references, adding "(EU)" and spaces, and shortens the article title.

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Sources & citation

Where the facts on this page come from, and how to cite it.

Permalink: https://news.eu-parl.st-solutions.dev/texts/A-10-2026-0073/compare/TA-10-2026-0098
Data source: European Parliament Open Data
Licensed CC BY 4.0.
Retrieved: 25 September 2026

Cite as

European Parliament (2026). “Changes between A-10-2026-0073 and TA-10-2026-0098”. Text, 26 March 2026. from A-10-2026-0073, to TA-10-2026-0098, reference 2025/0359(COD). EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/texts/A-10-2026-0073/compare/TA-10-2026-0098 (retrieved 25 September 2026). Data: European Parliament Open Data, https://data.europarl.europa.eu/ (CC BY 4.0).

BibTeX

@misc{epw-text-2026-03-26,
  author = {{European Parliament}},
  title = {{Changes between A-10-2026-0073 and TA-10-2026-0098}},
  year = {2026},
  date = {2026-03-26},
  howpublished = {\url{https://news.eu-parl.st-solutions.dev/texts/A-10-2026-0073/compare/TA-10-2026-0098}},
  url = {https://news.eu-parl.st-solutions.dev/texts/A-10-2026-0073/compare/TA-10-2026-0098},
  urldate = {2026-09-25},
  publisher = {EU Parl Watch Research},
  note = {Text. from A-10-2026-0073, to TA-10-2026-0098, reference 2025/0359(COD). Data: European Parliament Open Data (CC BY 4.0)}
}