当前位置: 首页? 政策法规? 国外法规? 欧盟批准麦角硫因作为新资源食品配斘/a>

欧盟批准麦角硫因作为新资源食品配斘/h1>
扫描二维 分享好友和朋友圈
放大字体缩小字体2017-07-18 08:22:00 来源9a href="http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2017.184.01.0065.01.ENG&toc=OJ:L:2017:184:TOC" target="_blank" rel="nofollow">欧盟委员伙/a> 浏览次数9span id="hits">5620
核心提示?017??3日,欧盟发布(EU) 2017/1281法规,批准麦角硫因作为新资源食品配料。并在附件中列明了麦角硫因的规格标准,重金属含量,微生物标准,使用限量等。其中铅的限量为3ppm,汞的限量为0.1ppm,镉的限量为1ppm。麦角硫因在一般人群(孕妇和哺乳期妇女除外)中的使用限量为30mg/d,在3岁以上儿童中的使用限量为20mg/d、/div>
发布单位
欧盟委员
欧盟委员伙/div>
发布文号 (EU) 2017/1281
发布日期 2017-07-13 生效日期 2017-07-13
有效性状?/th> 废止日期 暂无
备注 2017??3日,欧盟发布(EU) 2017/1281法规,批准麦角硫因作为新资源食品配料。并在附件中列明了麦角硫因的规格标准,重金属含量,微生物标准,使用限量等。其中铅的限量为3ppm,汞的限量为0.1ppm,镉的限量为1ppm。麦角硫因在一般人群(孕妇和哺乳期妇女除外)中的使用限量为30mg/d,在3岁以上儿童中的使用限量为20mg/d、/td>

COMMISSION IMPLEMENTING DECISION (EU) 2017/1281 of 13 July 2017

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

(notified under document C(2017) 4844)

(Only the English text is authentic)

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 25 July 2013, the company Tetrahedron made a request to the competent authorities of France to place synthetic L-ergothioneine (L-ergothioneine) on the Union market as a novel food ingredient within the meaning of point (c) of Article 1(2) of Regulation (EC) No 258/97. The application excluded from the use infants, young children, pregnant and lactating women.

(2)

On 19 February 2015, the competent food assessment body of France issued its initial assessment report. In that report it came to the conclusion that L-ergothioneine meets the criteria for novel food ingredient set out in Article 3(1) of Regulation (EC) No 258/97.

(3)

On 9 March 2015, the Commission forwarded the initial assessment report to the other Member States.

(4)

Reasoned objections were raised by other Member States within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97.

(5)

On 14 October 2015, the Commission consulted the European Food Safety Authority (EFSA) asking it to carry out an additional assessment for L-ergothioneine as novel food ingredient in accordance with Regulation (EC) No 258/97.

(6)

On 26 October 2016, EFSA in its Scientific Opinion on the safety of L-ergothioneine as a novel food pursuant to Regulation (EC) No 258/97 (2)concluded that L-ergothioneine is safe for the proposed uses and use levels.

(7)

That opinion gives sufficient grounds to establish that L-ergothioneine in the proposed uses and use levels complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.

(8)

Directive 2002/46/EC of the European Parliament and of the Council (3) lays down requirements on food supplements. The use of L-ergothioneine should be authorised without prejudice to the provisions of that Directive.

(9)

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

Without prejudice to Directive 2002/46/EC, L-ergothioneine as specified in Annex I may be placed on the Union market as a novel food ingredient to be used in food supplements intended for the general population, excluding infants and young children, and pregnant and lactating women, for the uses defined and at the maximum levels established in Annex II.

Article 2

The designation of L-ergothioneine authorised by this Decision on the labelling of the foodstuffs shall be L-ergothioneine.

Article 3

This Decision is addressed to Tetrahedron, 14, avenue de l'Opra, 75001 Paris, France.

Done at Brussels, 13 July 2017.

For the Commission

Vytenis ANDRIUKAITIS

Member of the Commission


(1) OJ L 43, 14.2.1997, p. 1.

(2) EFSA Journal 2016;14(11):4629.

(3) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).


ANNEX I

SPECIFICATIONS OF L-ERGOTHIONEINE

Definition

Chemical name (IUPAC)

(2S)-3-(2-thioxo-2,3-dihydro-1H-imidazol-4-yl)-2-(trimethylammonio)-propanoate

Chemical formula

C9H15N3O2S

Molecular mass

229,3 Da

CAS No

497-30-3

IUPAC: International Union for Pure and Applied Chemistry

Specifications

Parameter

Specification

Method

Appearance

White powder

Visual

Optical rotation

[]D (+) 122 (c = 1, H20) (1)

Polarimetry

Chemical purity

99,5 %

HPLC [Eur. Ph. 2.2.29]

99 %

1H-NMR

Identification

Compliant with the structure

1H-NMR

C: 47,14 0,4 %

H: 6,59 0,4 %

N: 18,32 0,4 %

Elemental analysis

Total residual solvents

(methanol, ethyl acetate, isopropanol, ethanol)

[Eur. Ph. 01/2008:50400]

< 1 000 ppm

Gas chromatography

[Eur. Ph. 01/2008:20424]

Loss on drying

Internal standard < 0,5 %

[Eur. Ph. 01/2008:20232]

Impurities

< 0,8 %

HPLC/GPC or 1H-NMR

Heavy metals (2) (3)

Lead

< 3 ppm

ICP/AES

(Pb, Cd)

Atomic fluorescence (Hg)

Cadmium

< 1 ppm

Mercury

< 0,1 ppm

Microbiological specifications (2)

Total viable aerobic count (TVAC)

1 103 CFU/g

[Eur. Ph. 01/2011:50104]

Total yeast and mould count (TYMC)

1 102 CFU/g

Escherichia coli

Absent in 1 g

Eur. Ph.: European Pharmacopoeia; 1H-NMR: proton nuclear magnetic resonance; HPLC: high-performance liquid chromatography; GPC: gel permeation chromatography; ICP/AES: Inductively coupled plasma atomic emission spectroscopy;

CFU: colony-forming units.


(1) Lit. []D = (+) 126,6 (c = 1, H20)

(2) Analyses conducted on each batch

(3) Maximum levels in accordance with Commission Regulation (EC) No 1881/2006 (OJ L 364, 20.12.2006, p. 5).


ANNEX II

AUTHORISED USES OF L-ERGOTHIONEINE

Food category

Maximum levels

Food supplements as defined in Directive 2002/46/EC

30 mg/day for general population (excluding pregnant and lactating women)

20 mg/day for children older than 3 years

地区9/font>欧盟
标签9/font>含量新资源食?nbsp;限量配料标准
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、br/>电询?535-2129301
QQ?891238009
食品标法? border=
实时把握 食品标法动?/span>
请扫码关?span class="color2">食品标法圇/span>

声明9/p>

凡本网所有原?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”、br> 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、br> 邮箱:law#www.sqrdapp.com(发邮件时请?换成@ QQ?39307733

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


按分类浏觇/strong>
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 0.238 second(s), 10 queries, Memory 4.51 M
    Baidu
    map