Source

2014/907/EU: Commission Implementing Decision of 11 December 2014 authorising the placing on the market of Clostridium butyricum (CBM 588) as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2014) 9345)

Regulation (EC) No 258/97 · Decision · 4 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

Open ↗

Clostridium butyricum (CBM 588) as specified in the Annex may be placed on the market in the Union as a novel food ingredient to be used in food supplements with a maximum dose of 1,35 × 10 8 CFU per day without prejudice to the specific provisions of Directive 2002/46/EC.

Article 2

Open ↗

The designation of Clostridium butyricum (CBM 588) authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘ Clostridium butyricum MIYAIRI 588 (CBM 588)’ or ‘ Clostridium butyricum (CBM 588)’.

Article 3

Open ↗

This Decision is addressed to Miyarisan Pharmaceutical Co. Ltd, 1-10-3, Kaminakazato, Kita-Ku, Tokyo 114-0016, Japan.

Supplementary provisions

SPECIFICATION OF CLOSTRIDIUM BUTYRICUM (CBM 588)

ANNEXSupplementary provisions

Open ↗

ANNEX SPECIFICATION OF CLOSTRIDIUM BUTYRICUM (CBM 588) Definition : Clostridium butyricum (CBM 588) is a Gram-positive, spore-forming, obligate anaerobic, non-pathogenic, non-genetically modified bacterium. Description : White or pale grey tablets with characteristic odour and sweet taste. Microbiological criteria: Total viable aerobic count Not more than 10 3 CFU/g Escherichia coli Not detected in 1 g Staphylococcus aureus Not detected in 1 g Pseudomonas aeruginosa Not detected in 1 g Yeast and moulds Not more than 10 2 CFU/g

Other acts of the same type

Council Decision (CFSP) 2021/38 of 15 January 2021 establishing a common approach on the elements of end-user certificates in the context of the export of small arms and light weapons and their ammunition Commission Implementing Decision (EU) 2021/31 of 13 January 2021 on laying down rules for the application of Regulation (EU) 2018/1862 of the European Parliament and of the Council as regards the minimum data quality standards and technical specifications for entering photographs, DNA profiles and dactyloscopic data in the Schengen Information System (SIS) in the field of police cooperation and judicial cooperation in criminal matters and repealing Commission Implementing Decision (EU) 2016/1345 (notified under document C(2020) 9228)Commission Implementing Decision (EU) 2021/32 of 13 January 2021 concerning the extension of the action taken by the Environment Agency of Luxembourg permitting the making available on the market and use of the biocidal product BIOBOR JF in accordance with Article 55(1) of Regulation (EU) No 528/2012 of the European Parliament and of the Council (notified under document C(2021) 13) (Only the French text is authentic)Council Decision (CFSP) 2021/14 of 7 January 2021 amending Decision 2014/219/CFSP on the European Union CSDP Mission in Mali (EUCAP Sahel Mali)Commission Implementing Decision (EU) 2021/27 of 7 January 2021 on the request for registration of the European citizens’ initiative entitled ‘Civil society initiative for a ban on biometric mass surveillance practices‘ (notified under document C(2021) 32) (Only the English text is authentic)Commission Implementing Decision (EU) 2021/7 of 5 January 2021 concerning the extension of the action taken by the Finnish Safety and Chemicals Agency permitting the making available on the market and use of the biocidal product Biobor JF in accordance with Article 55(1) of Regulation (EU) No 528/2012 of the European Parliament and of the Council (notified under document C(2021) 7) (Only the Finnish and Swedish texts are authentic)Council Decision (EU) 2020/2252 of 29 December 2020 on the signing, on behalf of the Union, and on provisional application of the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part, and of the Agreement between the European Union and the United Kingdom of Great Britain and Northern Ireland concerning security procedures for exchanging and protecting classified information Council Decision (Euratom) 2020/2253 of 29 December 2020 approving the conclusion, by the European Commission, of the Agreement between the Government of the United Kingdom of Great Britain and Northern Ireland and the European Atomic Energy Community for Cooperation on the Safe and Peaceful Uses of Nuclear Energy and the conclusion, by the European Commission, on behalf of the European Atomic Energy Community, of the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part Commission Decision (Euratom) 2020/2255 of 29 December 2020 on the conclusion, by the European Commission, and provisional application of the Agreement between the Government of the United Kingdom of Great Britain and Northern Ireland and the European Atomic Energy Community for Cooperation on the Safe and Peaceful Uses of Nuclear Energy and on the conclusion, by the European Commission, on behalf of the European Atomic Energy Community, and provisional application of the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part Decision (EU) 2020/2228 of the European Parliament and of the Council of 23 December 2020 on a European Year of Rail (2021)Decision (EU) 2020/2229 of the European Parliament and of the Council of 23 December 2020 amending Decision No 445/2014/EU establishing a Union action for the European Capitals of Culture for the years 2020 to 2033 (Text with EEA relevance)Council Decision (EU) 2020/2233 of 23 December 2020 concerning the commitment of the funds stemming from reflows under the ACP Investment Facility from operations under the 9th, 10th and 11th European Development Funds

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

What to look at next

Browse all EU Legal ActsEvery instrument by type and year, full text free to read section by sectionEuropean Union legislation EU Legal Acts by type and yearGrouped by instrument type and year of enactment, so you can find others of the same kindBrowse by type and year European Union: what this database coversWhich datasets are here, which official source they come from, and how current they areEuropean Union overview