Skip to content

GlobalLawDBby GenieAI

Laws Search Sanctions Map Data Developers

Search the text of the law

Log in Get an API key

Laws Search Sanctions Map Data Developers

Log in Get an API key

European Union
Commission Regulation (EU) No 234/2011
Chapter II
Article 5
1.

Commission Regulation (EU) No 234/2011

law://eu/reg/2011/234/art_5__para_1@2026-11-13

Version in force onWhereEuropean Union

The Global Law Database. Free to read, built for people and AI agents.

Explore

All laws
Search the text
Sanctions
Map of connections
Compare UK and EU

Developers

AI agents (MCP)
REST API
Bulk data
API keys

Coverage

United Kingdom
European Union
United States
Canada
Australia
France
Germany
Netherlands
Spain
Austria
Norway
Finland
Switzerland
Ireland

GlobalLawDB is made by GenieAI, London. It is not legal advice: check the official text before relying on it. Text comes from official publishers under their licences, listed on the Data page.

ThemeMatch my systemLightDark

Defined terms · 1

Show every defined term

Status of Qualified Presumption of Safety
means the safety status assigned by the Authority to selected groups of micro-organisms on the basis of an assessment showing no safety concerns.

eu/reg/2011/234

Key facts

Type: Implementing regulation · Commission Regulation (EU) No 234/2011 · EEA relevant
Adopted: 10 Mar 2011
In force: 31 Mar 2011
Applies from: 11 Sept 2011
Text current to: 27 Mar 2021
Made by: European Commission
Official: EUR-Lex 32011R0234 · ELI

Topics

approximation of laws consumer protection enzyme food additive food safety foodstuffs legislation human nutrition public health Food – ingredients, traces, residues, marketing standards Foodstuffs

Contents

1. The dossier submitted in support of an application for the…
2. The application dossier shall include all the available da…
3. The applicant shall take into account the latest guidance…
4. The documentation on the procedure followed when gathering…
5. The safety evaluation strategy and the corresponding testi…
6. The individual raw data of the unpublished studies and, wh…
7. For each biological or toxicological study, it shall be cl…
8. The applicant shall propose an overall conclusion on the s…

Contents

1. The dossier submitted in support of an application for the…
2. The application dossier shall include all the available da…
3. The applicant shall take into account the latest guidance…
4. The documentation on the procedure followed when gathering…
5. The safety evaluation strategy and the corresponding testi…
6. The individual raw data of the unpublished studies and, wh…
7. For each biological or toxicological study, it shall be cl…
8. The applicant shall propose an overall conclusion on the s…

History · 1 version

27 Mar 2021Reading

This text since 27 Mar 2021

In force

1.The dossier submitted in support of an application for the safety evaluation of a substance shall enable a comprehensive risk assessment of the substance and shall permit verification that the substance does not pose a safety concern to consumers within the meaning of Article 6(a) of Regulation (EC) No 1332/2008, Article 6(1)(a) of Regulation (EC) No 1333/2008 and Article 4(a) of Regulation (EC) No 1334/2008.

Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.

Connections

Cited by 4: Regulation (EU) 2025/2455; Commission Implementing Regulation (EU) 2020/18233 provisions; Commission Regulation (EU) No 1056/20122 provisions; Commission Implementing Regulation (EU) No 562/20122 provisions
Cites 3: Regulation (EC) No 1332/2008; Regulation (EC) No 1333/2008; Regulation (EC) No 1334/2008