委员会实施条例(EU) No 290/2014,关于授权内型-1,4-β-木聚糖酶和内型-1,由Talaromyces versatilis sp. nov. IMI CC 378536生产 的3(4)-β葡聚糖酶作为家禽、断奶仔猪、育肥猪的饲料添加剂并修订条例(EC) No 1259/2004、(EC) No 943/2005、(EC) No 1206/2005和(EC) No 322/2
技术法规类型:欧盟Eurlex法规 来源:tbtmap
EURLEX ID:32014R0290
OJ编号:OJ L 87, 22.3.2014, p. 84-86
中文标题:委员会实施条例(EU) No 290/2014,关于授权内型-1,4-β-木聚糖酶和内型-1,由Talaromyces versatilis sp. nov. IMI CC 378536生产 的3(4)-β葡聚糖酶作为家禽、断奶仔猪、育肥猪的饲料添加剂并修订条例(EC) No 1259/2004、(EC) No 943/2005、(EC) No 1206/2005和(EC) No 322/2009 (授权持有者Adisseo France S.A.S.)
原文标题:Commission Implementing Regulation (EU) No 290/2014 of 21 March 2014 concerning the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Talaromyces versatilis sp. nov. IMI CC 378536 as a feed additive for poultry, weaned piglets and pigs for fattening and amending Regulations (EC) No 1259/2004, (EC) No 943/2005, (EC) No 1206/2005 and (EC) No 322/2009 (holder of the authorisation Adisseo France S.A.S.) Text with EEA relevance
分类:03.50.10_动物饲料
文件类型:二级立法 Regulation|条例
生效日期:2014-04-11
废止日期:2058-12-31
法规全文:查看欧盟官方文件
| 22.3.2014 | EN | Official Journal of the European Union | L 87/84 |
COMMISSION IMPLEMENTING REGULATION (EU) No 290/2014
of 21 March 2014
concerning the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Talaromyces versatilis sp. nov. IMI CC 378536 as a feed additive for poultry, weaned piglets and pigs for fattening and amending Regulations (EC) No 1259/2004, (EC) No 943/2005, (EC) No 1206/2005 and (EC) No 322/2009 (holder of the authorisation Adisseo France S.A.S.)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
Whereas:
| (1) | Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2). |
| (2) | A preparation of endo-1,4-beta-xylanase EC 3.2.1.8 and endo-1,3(4)-beta-glucanase EC 3.2.1.6 produced by Penicillium funiculosum IMI SD 101 was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for chickens for fattening by Commission Regulation (EC) No 1259/2004 (3); for laying hens and turkeys for fattening by Commission Regulation (EC) No 943/2005 (4); for pigs for fattening by Commission Regulation (EC) No 1206/2005 (5); and for ducks for fattening and weaned piglets by Commission Regulation (EC) No 322/2009 (6). That preparation was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003. |
| (3) | In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regulation, an application was submitted for the re-evaluation of that preparation of endo-1,4-beta-xylanase EC 3.2.1.8 and endo-1,3(4)-beta-glucanase EC 3.2.1.6 produced by Talaromyces versatilis sp. nov. IMI CC 378536 (formerly Penicillium funiculosum IMI SD 101), as a feed additive for chickens, turkeys and ducks for fattening, laying hens, weaned piglets, pigs for fattening, and, in accordance with Article 7 of that Regulation, for a new use for all major and minor poultry species, requesting that additive to be classified in the additive category ‘榸ootechnical additives‘� That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| (4) | The European Food Safety Authority (‘the Authority‘� concluded in its opinion of 10 July 2013 (7) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase EC 3.2.1.8 and endo-1,3(4)-beta-glucanase EC 3.2.1.6 produced by Talaromyces versatilis sp. nov. IMI CC 378536 does not have an adverse effect on animal health, human health or the environment, and that it has a potential to favourably affect animal performance in chickens and turkeys for fattening, laying hens, weaned piglets and pigs for fattening. Since the mode of action can be considered to be similar in all poultry species, this conclusion can be extrapolated to ducks, guinea fowls, quails, geese, pheasant and pigeons. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
| (5) | The assessment of the preparation of endo-1,4-beta-xylanase EC 3.2.1.8 and endo-1,3(4)-beta-glucanase EC 3.2.1.6 produced by Talaromyces versatilis sp. nov. IMI CC 378536 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation. |
| (6) | As a consequence of the granting of a new authorisation under Regulation (EC) No 1831/2003, Regulations (EC) No 1259/2004, (EC) No 943/2005, (EC) No 1206/2005 and (EC) No 322/2009 should be amended accordingly. |
| (7) | Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation. |
| (8) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
HAS ADOPTED THIS REGULATION:
Article 1
Authorisation
The preparation specified in the Annex, belonging to the additive category ‘榸ootechnical additives‘�and to the functional group ‘榙igestibility enhancers‘� is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2
Amendments to Regulation (EC) No 1259/2004
Regulation (EC) No 1259/2004 is amended as follows:
| (1) | Article 2 is replaced by the following: ‘楢rticle 2 The preparations belonging to the group ‘渆nzymes‘� as set out in Annexes III, V and VI are authorised for use without a time limit as additive in animal nutrition under the conditions laid down in those Annexes.‘� |
| (2) | Annex IV is deleted. |
Article 3
Amendment to Regulation (EC) No 943/2005
In Annex II to Regulation (EC) No 943/2005 the entry on E 1604, endo-1,4-beta-xylanase EC 3.2.1.8 and endo-1,3(4)-beta-glucanase EC 3.2.1.6, is deleted.
Article 4
Amendment to Regulation (EC) No 1206/2005
In Annex to Regulation (EC) No 1206/2005 the entry on E 1604, endo-1,4-beta-xylanase EC 3.2.1.8 and endo-1,3(4)-beta-glucanase EC 3.2.1.6, is deleted.
Article 5
Amendment to Regulation (EC) No 322/2009
In Regulation (EC) No 322/2009, Article 3 and Annex III are deleted.
Article 6
Transitional measures
The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 11 October 2014 in accordance with the rules applicable before 11 April 2014 may continue to be placed on the market and used until the existing stocks are exhausted.
Article 7
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, 21 March 2014.
For the Commission
The President
José Manuel BARROSO
(1) OJ L 268, 18.10.2003, p. 29.
(2) Directive 70/524/EEC of the Council of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).
(3) Commission Regulation (EC) No 1259/2004 of 8 July 2004 concerning the permanent authorisation of certain additives already authorised in feedingstuffs (OJ L 239, 9.7.2004, p. 8).
(4) Commission Regulation (EC) No 943/2005 of 21 June 2005 concerning the permanent authorisation of additives in feedingstuffs (OJ L 159, 22.6.2005, p. 6).
(5) Commission Regulation (EC) No 1206/2005 of 27 July 2005 concerning the permanent authorisation of certain additives in feedingstuffs (OJ L 197, 28.7.2005, p. 12).
(6) Commission Regulation (EC) No 322/2009 of 20 April 2009 concerning the permanent authorisations of certain additives in feedingstuffs (OJ L 101, 21.4.2009, p. 9).
(7) EFSA Journal 2013; 11(7):3321.
ANNEX
| Identification number of the additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation | ||||||||||||||||||||
| Units of activity/kg of complete feedingstuff with a moisture content of 12 % | |||||||||||||||||||||||||||||
| Category of zootechnical additives. Functional group: digestibility enhancers | |||||||||||||||||||||||||||||
| 4a1604i | Adisseo France S.A.S. | Endo-1,3(4)-beta-glucanase EC 3.2.1.6 Endo-1,4-beta-xylanase EC 3.2.1.8 |
| All poultry species Piglets (weaned) Pigs for fattening | ‘�/p> | endo-1,3(4)-beta-glucanase 1 500 VU endo-1,4-beta-xylanase 1 100 VU | ‘�/p> |
| 11 April 2024 | ||||||||||||||||||||
(1) VU (viscosimetry unit) is the amount of enzyme which hydrolyzes the substrate (barley betaglucan and wheat arabinoxylan, respectively), reducing the viscosity of the solution, to give a change in relative fluidity of 1 (dimensionless unit)/min at 30 掳C and pH 5,5.
(2) Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx
附件:
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;
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