当前位置: 首页 » 政策法规 » 国外法规 »欧盟授权羟基酪醇作为油脂产品的新资源食品配料

欧盟授权羟基酪醇作为油脂产品的新资源食品配料

扫描二维码 分享好友和朋友圈
放大字体  缩小字体 2017-12-20 08:51:08  来源:欧盟委员会  浏览次数:8309
核心提示:欧盟委员会授权羟基酪醇作为新资源食品用于一般食品中(除了年龄小于3岁的儿童,哺乳期妇女、孕妇的食品),其中附录规定了羟基酪醇的规格标准及在食品中的最大使用量,其在鱼和植物油中的最大水平为0.215g/kg;涂抹油脂的最大水平为0.175g/kg。
发布单位
欧盟委员会
欧盟委员会
发布文号 (EU) 2017/2373
发布日期 2017-12-14 生效日期 2017-12-19
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 欧盟委员会授权羟基酪醇作为新资源食品用于一般食品中(除了年龄小于3岁的儿童,哺乳期妇女、孕妇的食品),其中附录规定了羟基酪醇的规格标准及在食品中的最大使用量,其在鱼和植物油中的最大水平为0.215g/kg;涂抹油脂的最大水平为0.175g/kg。

COMMISSION IMPLEMENTING DECISION (EU) 2017/2373

of 14 December 2017

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

(notified under document number C(2017) 8423)

(Only the Spanish 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 12 June 2014, the company Seprox Biotech made a request to the competent authority of Spain to place synthetic hydroxytyrosol (‘hydroxytyrosol’) 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 target population is the general population excluding children under the age of three years, pregnant women, and lactating women.

(2) On 2 March 2015, the competent authority of Spain issued its initial assessment report. In that report it came to the conclusion that hydroxytyrosol meets the criteria for novel food ingredient set out in Article 3(1) of Regulation (EC) No 258/97.

(3) On 10 April 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 19 November 2015, the Commission consulted the European Food Safety Authority (EFSA) asking it to carry out an additional assessment for hydroxytyrosol as novel food ingredient in accordance with Regulation (EC) No 258/97.

(6) On 31 January 2017, EFSA in its ‘Scientific Opinion on the safety of hydroxytyrosol as a novel food pursuant to Regulation (EC) No 258/97’ (2) concluded that hydroxytyrosol is safe for the proposed uses and use levels.

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

(8) Taking into account that the request for authorisation excludes certain groups of population and imposes certain conditions for the technical performance of foods containing hydroxytyrosol when heated, food products containing hydroxytyrosol should be appropriately labelled.

(9) Regulation (EC) No 1925/2006 of the European Parliament and of the Council (3) lays down requirements on the addition of vitamins and minerals and of certain other substances to foods. The use of hydroxytyrosol should be authorised without prejudice to that Regulation.

(10) 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 Regulation (EC) No 1925/2006, hydroxytyrosol as specified in Annex I to this Decision may be placed on the Union market as a novel food ingredient intended for the general population, excluding children under the age of three years, pregnant women, and lactating women, for the uses defined and at the maximum levels established in Annex II to this Decision.

Article 2

1.   The designation of hydroxytyrosol authorised by this Decision for the labelling of the food products shall be ‘hydroxytyrosol’.

2.   The labelling of the food products containing hydroxytyrosol shall bear the following statements:

(a)‘This food product should not be consumed by children under the age of three years, pregnant women, and lactating women;

(b)This food product should not be used for cooking, baking or frying’

 

Article 3

This Decision is addressed to Seprox Biotech, Centro Empresarial Ingenia N-8, Parque Tecnológico Fuente Álamo, 30320 Fuente Álamo, Murcia, Spain.

Done at Brussels, 14 December 2017.

For the Commission

Vytenis ANDRIUKAITIS

Member of the Commission

 

(1)  OJ L 43, 14.2.1997, p. 1.

(2)  EFSA Journal 2017;15(3):4728.

(3)  Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (OJ L 404, 30.12.2006, p. 26).

 

ANNEX I

SPECIFICATIONS OF HYDROXYTYROSOL

Definition:

Chemical name

IUPAC name: 4-(2-hydroxyethyl)-benzene-1,2-diol

Synonyms:

3-Hydroxytyrosol

3,4-dihydroxyphenylethanol

Dihydroxyphenylethanol

2-(3,4-Di-hydroxyphenyl)-ethanol

Chemical formula

C8H10O3

Molecular mass

154,16 Da

CAS No.

10597-60-1

Description: Hydroxytyrosol is a pale-yellow viscous liquid.

Specifications:

Parameter

Specifications

Description

Slightly yellow viscous liquid

Moisture

≤ 4,0 %

Odour

Characteristic

Taste

Slightly bitter

Solubility (water)

Miscible with water

pH

3,5-4,5

Refractive Index (25 °C)

1,571-1,575

Hydroxytyrosol and organic by-products of the chemical synthesis

 

Hydroxytyrosol

≥ 99,0 %

Acetic acid

≤ 0,4 %

Hydroxytyrosol acetate

≤ 0,3 %

Sum of homovanillic alcohol, iso-homovanillic alcohol, and 3-methoxy-4-hydroxyphenylglycol

≤ 0,3 %

Heavy Metals

 

Lead

≤ 0,03 mg/kg

Cadmium

≤ 0,01 mg/kg

Mercury

≤ 0,01 mg/kg

Residual solvents

 

Ethyl acetate

≤ 25,0 mg/kg

Isopropanol

≤ 2,50 mg/kg

Methanol

≤ 2,00 mg/kg

Tetrahydrofuran

≤ 0,01 mg/kg

 

ANNEX II

Authorised uses of hydroxytyrosol

Food category

Maximum level

Fish and vegetable oils, (except olive oils and olive pomace oils as defined in Part VIII of Annex VII of Regulation (EU) No 1308/2013 (1)), placed as such on the market

0,215 g/kg

Spreadable fats as defined in Part VII of Annex VII of Regulation (EU) No 1308/2013, placed as such on the market

0,175 g/kg

 

(1)  Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulation (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) 1234/2007 (OJ L 347, 20.12.2013, p. 671).

 

 

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 (11359) 国外法规 (3603)
地方法规 (39764) 法规动态 (85)
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 0.363 second(s), 10 queries, Memory 4.74 M