2014年5月8日，日本Japan Bio Science Laboratory公司向歐盟成員國比利時遞交了相關申請。這種發(fā)酵大豆提取物由30%的發(fā)酵大豆提取物粉與70%的玉米淀粉源抗性糊精組成。

 

    歐盟食品安全局對此進行了評估并于2016年6月28日發(fā)布意見認為，在每日最大攝入量不超過100毫克的條件下，將發(fā)酵大豆提取物用于成人膳食補充劑是安全的，孕婦和哺乳期婦女除外。

    部分原文報道如下:

 

    COMMISSION IMPLEMENTING DECISION （EU） 2017/115 of 20 January 2017

 

    authorising the placing on the market of fermented soybean extract as a novel food ingredient under Regulation （EC） No 258/97 of the European Parliament and of the Council

 

    THE EUROPEAN COMMISSION,

 

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

 

    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（1） thereof,

 

    wheras:

 

    （1）

 

    On 8 May 2014, the company Japan Bio Science Laboratory made a request to the competent authorities of Belgium to place fermented soybean extract on the unio market as a novel food ingredient within the meaning of point （d） of Article 1（2） of Regulation （EC） No 258/97. The application excluded from the use pregnant and lactating women.

 

    HAS ADOPTED THIS DECISION:

 

    Article 1

 

    Without prejudice to Directive 2002/46/EC, fermented soybean extract as specified in the Annex to this Decision may be placed on the market in the unio as a novel food ingredient to be used in food supplements in capsule, tablet or powder form intended for the adult population, excluding pregnant and lactating women with a maximum dose of 100 mg fermented soybean extract per day.

 

    Article 2

 

    1.   The designation of fermented soybean extract authorised by this Decision on the labelling of the foodstuffs containing it shall be fermented soybean extract。

 

    2.   Without prejudice to further labelling requirements under Article 8 of Regulation （EC） No 258/97 and Regulation （EU） No 1169/2011, the labelling of food supplements containing fermented soybean extract shall also bear a statement that persons taking medication should only consume the product under medical supervision.

 

    Article 3

 

    This Decision is addressed to Japan Bio Science Laboratory Osaka Head Office 1-4-40 Fukushima-ku, Osaka-city Osaka 5533-0003 Japan.

 

    原文鏈接：http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017D0115