当前位置: 首页 » 政策法规 » 国外法规 »欧盟更改富含亚精胺的小麦胚芽提取物(Triticum aestivum)的新资源食品的规格

欧盟更改富含亚精胺的小麦胚芽提取物(Triticum aestivum)的新资源食品的规格

扫描二维码 分享好友和朋友圈
放大字体  缩小字体 2020-04-02 08:31:13  来源:欧盟委员会  浏览次数:8539
核心提示:欧盟更改新资源食品富含亚精胺的小麦胚芽提取物(Triticum aestivum)的规格,并在附件中对其定义、黄曲霉毒素限量、微生物标准进行了规定。
发布单位
欧盟委员会,欧盟健康与食品安全署
欧盟委员会,欧盟健康与食品安全署
发布文号 实施法规 (EU) 2020/443
发布日期 2020-03-25 生效日期 2020-04-15
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 欧盟更改新资源食品富含亚精胺的小麦胚芽提取物(Triticum aestivum)的规格,并在附件中对其定义、黄曲霉毒素限量、微生物标准进行了规定。
 COMMISSION IMPLEMENTING REGULATION (EU) 2020/443

of 25 March 2020

authorising the change of the specifications of the novel food spermidine-rich wheat germ extract (Triticum aestivum) under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,

Whereas:

(1)

Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.

(2)

Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) establishing a Union list of authorised novel foods was adopted.

(3)

Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on the updating of the Union list.

(4)

On 6 December 2017, the company TLL The Longevity Labs GmbH (‘the applicant’), informed the Commission in accordance with Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council (3) of its intention to place on the market spermidine-rich wheat germ extract (Triticum aestivum) as a novel food ingredient. Therefore, spermidine-rich wheat germ extract was included in the Union list of novel foods.

(5)

On 6 August 2019, the applicant made a request to the Commission to change the specifications of spermidine-rich wheat germ extract in accordance with Article 10(1) of Regulation (EU) 2015/2283. The applicant requested to increase the level of cadaverine from the current < 0,1 μg/g to ≤ 16,0 μg/g.

(6)

The applicant justifies the request by indicating that the change is necessary in order to reflect the natural levels of up to ≤ 16,0 μg/g of cadaverine that are analytically detectable in the wheat germ of the Triticum aestivum plant. The currently authorised level of < 0,1 μg/g cadaverine in spermidine-rich wheat germ extract represents the limit of detection with the analytical method that the applicant had erroneously included in the initial notification as the specification limit for cadaverine, and which was subsequently included in the Union list specifications of this novel food.

(7)

Cadaverine is a diamine which together with histamine, tyramine, and putrescine belong to the class of the biogenic amines that are naturally formed as the result of bacterial metabolism of proteins.

(8)

The health risks of biogenic amines were evaluated by the European Food Safety Authority (‘the Authority’) in 2011 (4). In the scientific opinion, the Authority noted that analytical information and food consumption data from the Member States has shown that cadaverine is present in a number of foods (alcoholic beverages, condiments, fish and fish products, meats, dairy products, vegetables and vegetable products) at mean levels up to 184 mg/kg of food with the resulting intakes reaching up to 116,1 mg of cadaverine per day.

(9)

Considering that the proposed maximum levels of cadaverine in the novel food and the resulting intakes on the basis of the authorised conditions of use of the novel food will be at least three orders of magnitude lower than the levels of cadaverine that are ingested from a normal diet, the Commission considers that the proposed changes in the cadaverine levels in the specifications of the spermidine-rich wheat germ extract do not alter the safety considerations that supported the authorisation of this novel food, and that a safety evaluation of the current application by the Authority in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessary. Therefore, it is appropriate to amend the specifications of the novel food spermidine-rich wheat germ extract at the level for cadaverine requested by the applicant.

(10)

The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

(11)

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

HAS ADOPTED THIS REGULATION:

Article 1

The entry in the Union list of authorised novel foods, as provided for in Article 6 of Regulation (EU) 2015/2283 and included in Implementing Regulation (EU) 2017/2470, referring to the novel food spermidine-rich wheat germ extract (Triticum aestivum), is amended as specified in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 25 March 2020.

For the Commission

The President

Ursula VON DER LEYEN


(1)  OJ L 327, 11.12.2015, p. 1.

(2)  Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).

(3)  Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients. OJ L 43, 14.2.1997, p. 1.

(4)  EFSA Journal 2011;9(10):2393.


ANNEX

In the Annex to Implementing Regulation (EU) 2017/2470, the entry for ‘Spermidine-rich wheat germ extract (Triticum aestivum)’ in Table 2 (Specifications) is replaced by the following:

Authorised Novel Food

Specifications

Spermidine-rich wheat germ extract (Triticum aestivum)

Description/Definition:

Spermidine-rich wheat germ extract is obtained from non-fermented, non-sprouting wheat germs (Triticum aestivum) by the process of solid-liquid extraction targeting specifically, but not exclusively polyamines.

Spermidine:(N-(3-aminopropyl)butane-1,4-diamine):0,8-2,4 mg/g

Spermine: 0,4-1,2 mg/g

Spermidine trichloride < 0,1 μg/g

Putrescine: < 0,3 mg/g

Cadaverine: ≤ 16,0 μg/g

Mycotoxins:

Aflatoxins (total): < 0,4 μg/kg

Microbiological criteria:

Total aerobic bacteria: < 10 000 CFU/g

Yeast and moulds: < 100 CFU/g

Escherichia coli: < 10 CFU/g

Salmonella: Absence/25g

Listeria monocytogenes: Absence/25g’


Top
食品伙伴网提供标准法规解读、舆情监控、合规咨询、申报注册等服务。
电询:0535-2129301
QQ:2891238009
食品标法圈
实时把握食品标法动态
请扫码关注食品标法圈

声明:

① 凡本网所有原始/编译文章及图片、图表的版权均属食品伙伴网所有,如要转载,需注明“信息来源:食品伙伴网”。
② 凡本网注明“信息来源:XXX(非食品伙伴网)”的作品,均转载自其他媒体,转载目的在于传递更多的信息,并不代表本网赞同其观点和对其真实性负责。
※ 邮箱:law#foodmate.net(发邮件时请将#换成@) QQ:139307733

 
 
[ 政策法规搜索 ]  [ 加入收藏 ]  [ 告诉好友 ]  [ 打印本文 ]  [ 关闭窗口 ]

 

 
 
按分类浏览
国家法规 (11358) 国外法规 (3603)
地方法规 (39745) 法规动态 (210)
法规解读 (2623) 其他法规 (506)
推荐国外法规
点击排行
按国家或地区浏览

法规中心  关于我们  广告业务  联系我们  信息服务

Processed in 0.360 second(s), 10 queries, Memory 4.58 M