当前位置: 首页 » 政策法规 » 国外法规 »2014/907/EU:根据欧洲议会和理事会条例(EC) No 258/97,批准酪酸梭状芽孢杆菌(CBM 588)作为新型食品配料投放市场(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)

2014/907/EU:根据欧洲议会和理事会条例(EC) No 258/97,批准酪酸梭状芽孢杆菌(CBM 588)作为新型食品配料投放市场(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)

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核心提示:2014年12月16日,欧盟发布委员会实施决定2014/907/EU,批准酪酸梭状芽孢杆菌(CBM 588)作为新型食品配料投放市场。酪酸梭状芽孢杆菌(CBM 588)可用于食品补充剂,在不违反指令2002/46/EC具体规定的前提下,其最大使用量为1,35 × 10^8 CFU/天。含有该成分的食品标签上需标注“宫入菌588(CBM588)”或“酪酸梭状芽孢杆菌(CBM 588)”。
发布单位
欧盟委员会
欧盟委员会
发布文号 2014/907/EU
发布日期 2014-12-16 生效日期 暂无
有效性状态 废止日期 暂无
属性 法规 专业属性 产品及原料
备注 2012年2月2日,日本米雅利桑株式会社请求英国主管机构批准酪酸梭状芽孢杆菌(CBM 588)作为新型食品配料用于食品补充剂。2013年5月14日,英国食品评估主管机构发布初步评估报告,得出结论:酪酸梭状芽孢杆菌(CBM 588)满足(EC) No 258/97第3(1)条规定的新型食品标准。2013年9月4日,欧盟委员会向各成员国转发初步评估报告。各成员国在60天之内提交了合理的反对意见。在考虑收到的异议后,欧盟制定委员会实施决定。申请者提供的附加说明减轻了各成员国和委员会的担忧。欧洲议会和理事会指令2002/46/EC制定了食品补充剂相关要求,在不违反本法规规定的前提下,可批准使用酪酸梭状芽孢杆菌(CBM 588)。本决定规定的应对措施与动植物和食品饲料常设委员会的意见相一致。基于上述情况,批准酪酸梭状芽孢杆菌(CBM 588)作为新型食品配料投放市场。酪酸梭状芽孢杆菌(CBM 588)可用于食品补充剂,在不违反指令2002/46/EC具体规定的前提下,其最大使用量为1,35 × 10^8 CFU/天。含有该成分的食品标签上需标注“宫入菌588(CBM588)”或“酪酸梭状芽孢杆菌(CBM 588)”。

  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)

  (Only the English text is authentic)

  (2014/907/EU)

  THE EUROPEAN COMMISSION,

  Having regard to the Treaty on the Functioning of the European Union,

  Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (1), and in particular Article 7 thereof,

  Whereas:

  (1)

  On 2 February 2012, the company Miyarisan Pharmaceutical Co. Ltd made a request to the competent authorities of the United Kingdom to place Clostridium butyricum (CBM 588) on the market as a novel food ingredient to be used in food supplements.

  (2)

  On 14 May 2013, the competent food assessment body of the United Kingdom issued its initial assessment report. In that report it came to the conclusion that Clostridium butyricum (CBM 588) meets the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97.

  (3)

  On 4 September 2013, the Commission forwarded the initial assessment report to the other Member States.

  (4)

  Reasoned objections were raised within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97. In accordance with Article 7(1) of Regulation (EC) No 258/97 a Commission Implementing Decision should be made that takes into account the objections raised. The additional explanations provided by the applicant alleviated the concerns to the satisfaction of the Member States and the Commission.

  (5)

  Directive 2002/46/EC of the European Parliament and of the Council (2) lays down requirements on food supplements. The use of Clostridium butyricum (CBM 588) should be authorised without prejudice to the requirements of that legislation.

  (6)

  The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

  HAS ADOPTED THIS DECISION:

  Article 1

  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 × 108 CFU per day without prejudice to the specific provisions of Directive 2002/46/EC.

  Article 2

  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

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

  Done at Brussels, 11 December 2014.

  For the Commission

  Vytenis ANDRIUKAITIS

  Member of the Commission
 

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 103 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 102 CFU/g


 

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