委员会实施决定(EU) 2017/2078,根据欧洲议会和理事会条例(EC) No 258/97,批准酵母β-葡聚糖的延伸使用作为新型食品成分上市(通报文件号C(2017)7391)

技术法规类型:欧盟Eurlex法规 来源:tbtmap

EURLEX ID:32017D2078

OJ编号:OJ L 295, 14.11.2017, p. 77–80 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

中文标题:委员会实施决定(EU) 2017/2078,根据欧洲议会和理事会条例(EC) No 258/97,批准酵母β-葡聚糖的延伸使用作为新型食品成分上市(通报文件号C(2017)7391)

原文标题:Commission Implementing Decision (EU) 2017/2078 of 10 November 2017 authorising an extension of use of yeast beta-glucans as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2017) 7391)

生效日期:2017-11-14

废止日期:9999-12-31

法规全文:查看欧盟官方文件

14.11.2017   

EN

Official Journal of the European Union

L 295/77


COMMISSION IMPLEMENTING DECISION (EU) 2017/2078

of 10 November 2017

authorising an extension of use of yeast beta-glucans as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council

(notified under document C(2017) 7391)

(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)

Commission Implementing Decision 2011/762/EU (2) authorised, in accordance with Regulation (EC) No 258/97, the placing on the market of yeast beta-glucans as a novel food ingredient to be used in certain foods and foodstuffs, including beverages, as well as in food supplements and in food for special medical purposes, and total diet replacement for weight control.

(2)

On 25 April 2016, the company Leiber GmbH made a request to the competent authority of Ireland for extension of uses and use levels of yeast beta-glucans as a novel food ingredient. In particular, they asked to extend the use of yeast beta-glucans to additional food categories and to increase maximum use levels of yeast beta-glucans per day for food categories already authorised by Implementing Decision 2011/762/EU.

(3)

On 7 November 2016, the competent authority of Ireland issued its initial assessment report. In that report, it came to the conclusion that the extension of uses and proposed maximum use levels of yeast beta-glucans meets the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97.

(4)

On 15 November 2016, the Commission forwarded the initial assessment report to the other Member States.

(5)

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. The applicant consequently modified the request concerning the food categories and use levels proposed. That change and additional explanations by the applicant alleviated the concerns to the satisfaction of the Member States and the Commission.

(6)

Directive 2002/46/EC of the European Parliament and of the Council (3) lays down requirements for food supplements. Regulation (EC) No 1925/2006 of the European Parliament and of the Council (4) lays down requirements on the addition of vitamins and minerals and certain other substances to foods. Regulation (EU) No 609/2013 of the European Parliament and of the Council (5) lays down general compositional and information requirements on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control. Those acts may apply to the yeast beta-glucans. Therefore yeast beta-glucans should be authorised without prejudice to the requirements of that and of any other legislation applying in parallel to Regulation (EC) No 258/97.

(7)

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 the provisions of Directive 2002/46/EC, Regulation (EC) No 1925/2006 and Regulation (EU) No 609/2013, yeast (Saccharomyces cerevisiae) beta-glucans as specified in Annex I to this Decision may be placed on the Union market as a novel food ingredient for the uses defined and at the maximum levels established in Annex II to this Decision.

Article 2

The designation of yeast (Saccharomyces cerevisiae) beta-glucans authorised by this Decision on the labelling of the foodstuffs shall be ‘yeast (Saccharomyces cerevisiae) beta-glucans’.

Article 3

This Decision is addressed to Leiber GmbH, Hafenstraße 24, 49565 Bramsche, Germany.

Done at Brussels, 10 November 2017.

For the Commission

Vytenis ANDRIUKAITIS

Member of the Commission


(1)  OJ L 43, 14.2.1997, p. 1.

(2)  Commission Implementing Decision 2011/762/EU of 24 November 2011 authorising the placing on the market of yeast beta-glucans as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 313, 26.11.2011, p. 41).

(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).

(4)  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).

(5)  Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC, and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 12.6.2013, p. 35).


ANNEX I

SPECIFICATIONS OF YEAST (SACCHAROMYCES CEREVISIAE) BETA-GLUCANS

Description

Beta-glucans are complex, high molecular mass (100–200 kDa) polysaccharides, found in the cell wall of many yeasts and cereals. The chemical name for ‘yeast beta-glucans’ is (1-3), (1-6)-β-D-glucans.

Beta-glucans consist of a backbone of β-1-3-linked glucose residues that are branched by β-1-6-linkages, to which chitin and mannoproteins are linked by β-1-4-bonds.

This novel food is a highly purified (1,3)-(1,6)-β-D-glucan isolated from yeast Saccharomyces cerevisiae, insoluble in water, but dispersible in many liquid matrices.

Specifications of yeast (Saccharomyces cerevisiae) beta-glucans

Parameter

Specifications values

Solubility

Insoluble in water but dispersible in many liquid matrices

Chemical data

(1,3)-(1,6)-β-D-Glucan

> 80 %

Ash

< 2 %

Moisture

< 6 %

Protein

< 4 %

Total fat

< 3 %

Microbiological data

Total plate count

< 1 000 CFU/g

Enterobacteriaceae

< 100 CFU/g

Total coliforms

< 10 CFU/g

Yeast

< 25 CFU/g

Mould

< 25 CFU/g

Salmonella ssp.

Absent in 25 g

Escherichia coli

Absent in 1 g

Bacillus cereus

< 100 CFU/g

Staphylococcus aureus

Absent in 1 g

Heavy metals

Lead

< 0,2 mg/g

Arsenic

< 0,2 mg/g

Mercury

< 0,1 mg/g

Cadmium

< 0,1 mg/g


ANNEX II

AUTHORISED USES OF YEAST (SACCHAROMYCES CEREVISIAE) BETA-GLUCANS

Food category

Maximum level of yeast beta-glucans

Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children

1,275 g/day for children older than 12 years and general adult population

0,675 g/day for children younger than 12 years

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013

1,275 g/day

Food for special medical purposes as defined in Regulation (EU) No 609/2013, excluding food for special medical purposes intended for infants and young children

1,275 g/day

Beverages based on fruit and/or vegetable juices including concentrate and dehydrated juices

1,3 g/kg

Fruit-flavoured drinks

0,8 g/kg

Cocoa beverages preparation powder

38,3 g/kg (powder)

Cereal bars

6 g/kg

Breakfast cereals

15,3 g/kg

Wholegrain and high fibre instant hot breakfast cereals

1,5 g/kg

Cookie-type biscuits

2,2 g/kg

Cracker-type biscuits

6,7 g/kg

Milk based beverages

3,8 g/kg

Fermented milk products

3,8 g/kg

Milk product analogues

3,8 g/kg

Other beverages

0,8 g/kg (ready to drink)

Dried milk/milk powder

25,5 g/kg

Soup and soup mixes

0,9 g/kg (ready to eat)

1,8 g/kg (condensed)

6,3 g/kg (powder)

Chocolate and confectionary

4 g/kg

Protein bars and powder

19,1 g/kg

Jam, marmalade and other fruit spreads

11,3 g/kg


附件:

P020181031355600112574.pdf
P020181031355600252201.html

托管标准,您可以接收以下服务:

1 标准定期系统查新,若有最新版本,会以站内短信或邮件的形式通知用户;

2 随时在标准托管页面中查看到该条标准的最新状态;

3 若用户有在学习和科研中的需要,可以在标准托管页面中试阅标准;

4 企业如果需要上新产品,我院及时提供标准查询、采购等方面的支持;

5 为企业在标准制修订、企业良好行为创建以及标准化试点过程中遇到的困难,可联系我院指定相关专家负责进行指导帮助、提供政策咨询;

6 为企业提供标准化政策的解读、标准化知识的推广培训、标准自我公开声明、标准文献的免费查询、企业标准化体系建设等方面的标准化服务;

进入企业标准托管

您可以通过编辑查新模板,批量查询指定标准集的最新情况。我们会通过查询,向您展示您所查询标准的:

1. 准确的标准号及标准名称(我们通过人工智能技术对您提交的标准号进行自动纠正)

2. 标准的最新状态(现行、废止或未发布)

3. 若标准已废止并被新标准替代,会反馈被替代的标准

4. 若您已托管此标准,便可以实时跟踪这个标准的最新状态

标准查新 模板下载

您可以在这里检索全球超过140万条标准,支持上百个国内国际标准组织的标准查询。您也可以在这里检索国内各类国家、部委和地方的法律法规。

更多标准子库在持续建设中。

标准检索

标准资讯点击排行榜 全部

资讯标题点击

[[ n.title ]] [[ n.read ]]

大连标准化公共服务平台

版权:大连标准化研究院有限公司

地址:大连市中山区高原街56号

电话:0411-82740851

大连标准