Commission Implementing Regulation (EU) 2017/1145 of 8 June 2017 on the withdrawal from the market of certain feed additives authorised pursuant to Council Directives 70/524/EEC and 82/471/EEC and repealing the obsolete provisions authorising those feed additives (Text with EEA relevance. )
Date: 2017-06-08
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, food additive, market approval, withdrawal from the market




L_2017166EN.01000101.xml










29.6.2017   


EN


Official Journal of the European Union


L 166/1








            COMMISSION IMPLEMENTING REGULATION (EU) 2017/1145
of 8 June 2017
         
on the withdrawal from the market of certain feed additives authorised pursuant to Council Directives 70/524/EEC and 82/471/EEC and repealing the obsolete provisions authorising those feed additives
(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 10(5) 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. In particular Article 10(2), in conjunction with Article 10(7) of that Regulation provide for specific procedures for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2) and Council Directive 82/471/EEC (3).












(2)


Article 10(5) of Regulation (EC) No 1831/2003 imposes an obligation on the Commission to adopt a Regulation withdrawing from the market feed additives which were entered in the Community Register of Feed Additives as existing products and for which no applications in accordance with Article 10(2) and (7) of Regulation (EC) No 1831/2003 were submitted before the deadline provided for in those provisions, or for which an application was submitted but subsequently withdrawn. Therefore such feed additives should be withdrawn from the market. As Article 10(5) does not differentiate between authorisations issued with a time limit and authorisations without a time limit, for clarity reasons it is appropriate to provide for the withdrawal from the market of feed additives whose limited authorisation periods pursuant to Directive 70/524/EEC have already expired.












(3)


As a consequence of the withdrawal from the market of the feed additives it is appropriate to repeal the provisions authorising them. Consequently Commission Regulations (EC) No 2316/98 (4), (EC) No 1353/2000 (5), (EC) No 2188/2002 (6), (EC) No 261/2003 (7), (EC) No 1334/2003 (8), (EC) No 1259/2004 (9), (EC) No 1288/2004 (10), (EC) No 1453/2004 (11), (EC) No 2148/2004 (12), (EC) No 255/2005 (13), (EC) No 358/2005 (14), (EC) No 521/2005 (15), (EC) No 600/2005 (16), (EC) No 833/2005 (17), (EC) No 943/2005 (18), (EC) No 1206/2005 (19), (EC) No 1458/2005 (20), (EC) No 1810/2005 (21), (EC) No 1811/2005 (22), (EC) No 2036/2005 (23), (EC) No 252/2006 (24), (EC) No 773/2006 (25), (EC) No 1284/2006 (26) and (EU) No 1270/2009 (27) should be amended accordingly and Commission Regulations (EC) No 937/2001 (28), (EC) No 871/2003 (29), (EC) No 277/2004 (30), (EC) No 278/2004 (31), (EC) No 1332/2004 (32), (EC) No 1463/2004 (33), (EC) No 1465/2004 (34), (EC) No 833/2005, (EC) No 492/2006 (35), (EC) No 1443/2006 (36), (EC) No 1743/2006 (37), (EC) No 757/2007 (38) and (EC) No 828/2007 (39) should be repealed.












(4)


In the case of feed additives for which applications have been submitted only for certain animal species or categories of animals, or applications have been withdrawn only for certain animal species or categories of animals, the withdrawal from the market should only concern the animal species and categories of animals for which no application has been submitted or the application has been withdrawn.












(5)


As regards feed additives whose authorisation did not expire until the date of entry into force of this Regulation it is appropriate to allow a transitional period for interested parties within which existing stocks of the additives concerned, premixtures, compound feed and feed materials which have been produced with those additives may be used up, taking account of the shelf-life of certain feed containing the additives in question.












(6)


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

Withdrawal


1.   The feed additives specified in Annex I shall be withdrawn from the market in respect of the animal species or categories of animals as specified in that Annex.


2.   The feed additives specified in Annex II shall be withdrawn from the market in respect of the animal species or categories of animals as specified in that Annex.



Article 2

Transitional measures


1.   Existing stocks of the additives listed in Annex I may continue to be placed on the market and used until 19 July 2018.


2.   Premixtures produced with the additives referred to in paragraph 1 may continue to be placed on the market and used until 19 October 2018.


3.   Compound feed and feed materials produced with the feed additives referred to in paragraph 1 or with the premixtures referred to in paragraph 2 may continue to be placed on the market and used until 19 July 2019.



Article 3

Repeals

Regulations (EC) No 937/2001, (EC) No 871/2003, (EC) No 277/2004, (EC) No 278/2004, (EC) No 1332/2004, (EC) No 1463/2004, (EC) No 1465/2004, (EC) No 833/2005, (EC) No 492/2006, (EC) No 1443/2006, (EC) No 1743/2006, (EC) No 757/2007 and (EC) No 828/2007 are repealed.


Article 4

Amendment to Regulation (EC) No 2316/98

Annex II to Regulation (EC) No 2316/98, is amended as follows:






(1)


in entry E 4 on Copper — Cu, the words ‘Cupric methionate’ and all content relating only to Cupric methionate are deleted;










(2)


in entry E 5 on Manganese — Mn, the words ‘Manganic oxide’ and all content relating only to Manganic oxide are deleted;










(3)


in entry E 5 on Manganese — Mn, the words ‘Manganous carbonate’ and all content relating only to Manganous carbonate are deleted;










(4)


in entry E 5 on Manganese — Mn, the words ‘Manganous hydrogen phosphate, trihydrate’ and all content relating only to Manganous hydrogen phosphate, trihydrate are deleted;










(5)


in entry E 5 on Manganese — Mn, the words ‘Manganous sulphate, tetrahydrate’ and all content relating only to Manganous sulphate, tetrahydrate are deleted;










(6)


in entry E 6 on Zinc — Zn, the words ‘Zinc carbonate’ and all content relating only to Zinc carbonate are deleted;










(7)


in entry E 6 on Zinc — Zn, the words ‘Zinc lactate, trihydrate’ and all content relating only to Zinc lactate, trihydrate are deleted;










(8)


in entry on E 6 Zinc — Zn, the words ‘Zinc chloride, monohydrate’ and all content relating only to Zinc chloride, monohydrate are deleted.






Article 5

Amendment to Regulation (EC) No 1353/2000

Regulation (EC) No 1353/2000 is amended as follows:






(1)


Article 1 is deleted;










(2)


Annex I is deleted.






Article 6

Amendment to Regulation (EC) No 2188/2002

In Annex I to Regulation (EC) No 2188/2002 in entry 11, on ‘Endo-1,4-beta-glucanase EC 3.2.1.4 Endo-1,3(4)-beta-glucanase EC 3.2.1.6 Endo-1,4-beta-xylanase EC 3.2.1.8’ the words ‘laying hens’ and all content relating only to laying hens are deleted.


Article 7

Amendment to Regulation (EC) No 261/2003

Regulation (EC) No 261/2003 is amended as follows:






(1)


Article 1 is replaced by the following:

‘Article 1
The preparation specified in Annex I, belonging to the group “Enzymes” is authorised for use as additive in animal nutrition under the conditions laid down in that Annex.’;











(2)


Annex II is deleted.






Article 8

Amendment to Regulation (EC) No 1334/2003

The Annex to Regulation (EC) No 1334/2003, is amended as follows:






(1)


in entry E 4 on Copper — Cu, the words ‘Cupric methionate’ and all content relating only to Cupric methionate are deleted;










(2)


in entry E 5 on Manganese — Mn, the words ‘Manganic oxide’ and all content relating only to Manganic oxide are deleted;










(3)


in entry E 5 on Manganese — Mn, the words ‘Manganomanganic oxide’ and all content relating only to Manganomanganic oxide are deleted;










(4)


in entry E 5 on Manganese — Mn, the words ‘Manganous carbonate’ and all content relating only to Manganous carbonate are deleted;










(5)


in entry E 5 on Manganese — Mn, the words ‘Manganous hydrogen phosphate, trihydrate’ and all content relating only to Manganous hydrogen phosphate, trihydrate are deleted;










(6)


in entry E 5 on Manganese — Mn, the words ‘Manganous sulphate, tetrahydrate’ and all content relating only to Manganous sulphate, tetrahydrate are deleted;










(7)


in entry E 6 on Zinc — Zn, the words ‘Zinc carbonate’ and all content relating only to Zinc carbonate are deleted;










(8)


in entry E 6 on Zinc — Zn, the words ‘Zinc lactate, trihydrate’ and all content relating only to Zinc lactate, trihydrate are deleted;










(9)


in entry E 6 on Zinc — Zn, the words ‘Zinc chloride, monohydrate’ and all content relating only to Zinc chloride, monohydrate are deleted.






Article 9

Amendment to Regulation (EC) No 1259/2004

Regulation (EC) No 1259/2004 is amended as follows:






(1)


Article 2 is replaced by the following:

‘Article 2
The preparations belonging to the group “enzymes”, as set out in Annexes III 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 V is deleted.






Article 10

Amendment to Regulation (EC) No 1288/2004

Annex I to Regulation (EC) No 1288/2004 is amended as follows:






(1)


entry E 161(z), on ‘Astaxantin-rich Phaffia Rhodozyma (ATCC 74219)’ is deleted;










(2)


entry E 1704, on ‘Saccharomyces cerevisiae CBS 493.94’ for calves is deleted.






Article 11

Amendment to Regulation (EC) No 1453/2004

Annex II to Regulation (EC) No 1453/2004 is amended as follows:






(1)


Entry E 1609 on ‘Endo-1,4-beta-xylanase EC 3.2.1.8 Endo-1,4-beta-glucanase EC 3.2.1.4’ is deleted;










(2)


Entry E 1610 on ‘Endo-1,4-beta-glucanase EC 3.2.1.4 Endo-1,4-beta-xylanase EC 3.2.1.8’ is deleted;










(3)


Entry E 1611 on ‘Endo-1,3(4)-beta-glucanase EC 3.2.1.6 Endo-1,4-beta-xylanase; EC 3.2.1.8 Polygalacturonase EC 3.2.1.15’ is deleted.






Article 12

Amendment to Regulation (EC) No 2148/2004

Regulation (EC) No 2148/2004 is amended as follows:






(1)


Articles 3, 4 and 5 are deleted;










(2)


in Annex I, in entry E 567, on ‘Clinoptilolite of volcanic origin’ the word ‘rabbits’ and all content relating only to rabbits are deleted;










(3)


in Annex II, entry E 1706 on ‘Enterococcus faecium DSM 7134, Lactobacillus rhamnosus DSM 7133’ is deleted;










(4)


Annexes III, IV and V are deleted.






Article 13

Amendment to Regulation (EC) No 255/2005

In Annex II to Regulation (EC) No 255/2005, entry E 1618 on ‘Endo-1,4-beta-xylanase EC 3.2.1.8’ is deleted.


Article 14

Amendment to Regulation (EC) No 358/2005

Annex I to Regulation (EC) No 358/2005 is amended as follows:






(1)


entry E 1619 on ‘Alpha-amylase EC 3.2.1.1 and Endo-1,3(4)-beta-glucanase EC 3.2.1.6’ is deleted;










(2)


entry E 1622 on ‘Endo-1,3(4)-beta-glucanase EC 3.2.1.6 and Endo-1,4-beta-xylanase EC 3.2.1.8’ is deleted.






Article 15

Amendment to Regulation (EC) No 521/2005

Regulation (EC) No 521/2005 is amended as follows:






(1)


Article 1 is deleted;










(2)


Annex I is deleted.






Article 16

Amendment to Regulation (EC) No 600/2005

Regulation (EC) No 600/2005 is amended as follows:






(1)


Articles 1 and 2 are deleted;










(2)


Annexes I and II are deleted;










(3)


in Annex III, entry E 1709 on ‘Enterococcus faecium ATCC 53519 and Enterococcus faecium ATCC 55593 (In a 1/1 ratio)’ is deleted.






Article 17

Amendment to Regulation (EC) No 943/2005

Annex II to Regulation (EC) No 943/2005 is amended as follows:






(1)


entry E 1630 on ‘Endo-1,4-betaxylanase EC 3.2.1.8 and Subtilisin EC 3.4.21.62’ is deleted;










(2)


entry E 1631 on ‘Endo-1,3(4)-beta-glucanase EC 3.2.1.6 and Endo-1,4-beta-xylanase EC 3.2.1.8’ is deleted;










(3)


entry E 1632 ‘3-Phytase EC 3.1.3.8’ is deleted.






Article 18

Amendment to Regulation (EC) No 1206/2005

In the Annex to Regulation (EC) No 1206/2005, entry E 1633 ‘on Endo-1,3(4)-beta-glucanase EC 3.2.1.6, Endo-1,4-beta-xylanase EC 3.2.1.8 and Subtilisin and EC 3.4.21.62’ is deleted.


Article 19

Amendment to Regulation (EC) No 1458/2005

Regulation (EC) No 1458/2005 is amended as follows:






(1)


Article 1 is deleted;










(2)


Annex I is deleted;










(3)


in Annex II to the Regulation, entry 60 on ‘on Endo-1,4-beta-xylanase EC 3.2.1.8, Endo-1,3(4)-beta-glucanase EC 3.2.1.6’ is deleted.






Article 20

Amendment to Regulation (EC) No 1810/2005

In Annex IV to Regulation (EC) No 1810/2005, entry 15 on ‘Enterococcus faecium NCIMB 11181’ is deleted.


Article 21

Amendment to Regulation (EC) No 1811/2005







(1)


In Annex I to Regulation (EC) No 1811/2005, entry E 1635 on ‘Endo-1,3(4)-beta-glucanase EC 3.2.1.6’ is deleted.










(2)


In Annex II to Regulation (EC) No 1811/2005, entry 63 on ‘on 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 22

Amendment to Regulation (EC) No 2036/2005

Regulation (EC) No 2036/2005 is amended as follows:






(1)


Article 2 is deleted;










(2)


Annex II is deleted.






Article 23

Amendment to Regulation (EC) No 252/2006

Regulation (EC) No 252/2006 is amended as follows:






(1)


Article 2 is deleted;










(2)


Annex II is deleted;










(3)


in Annex III, entry 28 on ‘3-Phytase EC 3.1.3.8’ is deleted.






Article 24

Amendment to Regulation (EC) No 773/2006

Regulation (EC) No 773/2006 is amended as follows:






(1)


Article 3 is deleted;










(2)


Annex III is deleted.






Article 25

Amendment to Regulation (EC) No 1284/2006

Regulation (EC) No 1284/2006 is amended as follows:






(1)


Article 1 and Article 3 are deleted;










(2)


Annex I and Annex III are deleted.






Article 26

Amendment to Regulation (EU) No 1270/2009

Regulation (EU) No 1270/2009 is amended as follows:






(1)


Article 1 is deleted;










(2)


Annex I is deleted.






Article 27

Entry into force

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, 8 June 2017.


For the Commission


The President

Jean-Claude JUNCKER
            





(1)  
            OJ L 268, 18.10.2003, p. 29.

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feeding-stuffs (OJ L 270, 14.12.1970, p. 1).

(3)  Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition (OJ L 213, 21.7.1982, p. 8).

(4)  Commission Regulation (EC) No 2316/98 of 26 October 1998 concerning authorisation of new additives and amending the conditions for authorisation of a number of additives already authorised in feedingstuffs (OJ L 289, 28.10.1998, p. 4).

(5)  Commission Regulation (EC) No 1353/2000 of 26 June 2000 concerning the permanent authorisation of an additive and the provisional authorisation of new additives, new additive uses and new preparations in feedingstuffs (OJ L 155, 28.6.2000, p. 15).

(6)  Commission Regulation (EC) No 2188/2002 of 9 December 2002 concerning the provisional authorisation of new uses of additives in feedingstuffs (OJ L 333, 10.12.2002, p. 5).

(7)  Commission Regulation (EC) No 261/2003 of 12 February 2003 concerning the provisional authorisation of new uses of additives in feedingstuffs (OJ L 37, 13.2.2003, p. 12).

(8)  Commission Regulation (EC) No 1334/2003 of 25 July 2003 amending the conditions for authorisation of a number of additives in feedingstuffs belonging to the group of trace elements (OJ L 187, 26.7.2003, p. 11).

(9)  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).

(10)  Commission Regulation (EC) No 1288/2004 of 14 July 2004 concerning the permanent authorisation of certain additives and the provisional authorisation of a new use of an additive already authorised in feedingstuffs (OJ L 243, 15.7.2004, p. 10).

(11)  Commission Regulation (EC) No 1453/2004 of 16 August 2004 concerning the permanent authorisation of certain additives in feedingstuffs (OJ L 269, 17.8.2004, p. 3).

(12)  Commission Regulation (EC) No 2148/2004 of 16 December 2004 concerning the permanent and provisional authorisations of certain additives and the authorisation of new uses of an additive already authorised in feedingstuffs (OJ L 370, 17.12.2004, p. 24).

(13)  Commission Regulation (EC) No 255/2005 of 15 February 2005 concerning the permanent authorisations of certain additives in feedingstuffs (OJ L 45, 16.2.2005, p. 3).

(14)  Commission Regulation (EC) No 358/2005 of 2 March 2005 concerning the authorisations without a time limit of certain additives and the authorisation of new uses of additives already authorised in feedingstuffs (OJ L 57, 3.3.2005, p. 3).

(15)  Commission Regulation (EC) No 521/2005 of 1 April 2005 concerning the permanent authorisation of an additive and the provisional authorisation of new uses of certain additives already authorised in feedingstuffs (OJ L 84, 2.4.2005, p. 3).

(16)  Commission Regulation (EC) No 600/2005 of 18 April 2005 concerning a new authorisation for 10 years of a coccidiostat as an additive in feedingstuffs, the provisional authorisation of an additive and the permanent authorisation of certain additives in feedingstuffs (OJ L 99, 19.4.2005, p. 5).

(17)  Commission Regulation (EC) No 833/2005 of 31 May 2005 concerning the permanent authorisation of additives in feedingstuffs (OJ L 138, 1.6.2005, p. 5).

(18)  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).

(19)  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).

(20)  Commission Regulation (EC) No 1458/2005 of 8 September 2005 concerning the permanent and provisional authorisations of certain additives in feedingstuffs and the provisional authorisation of new uses of certain additives already authorised in feedingstuffs (OJ L 233, 9.9.2005, p. 3).

(21)  Commission Regulation (EC) No 1810/2005 of 4 November 2005 concerning a new authorisation for 10 years of an additive in feedingstuffs, the permanent authorisation of certain additives in feedingstuffs and the provisional authorisation of new uses of certain additives already authorised in feedingstuffs (OJ L 291, 5.11.2005, p. 5).

(22)  Commission Regulation (EC) No 1811/2005 of 4 November 2005 concerning the provisional and permanent authorisations of certain additives in feedingstuffs and the provisional authorisation of a new use of an additive already authorised in feedingstuffs (OJ L 291, 5.11.2005, p. 12).

(23)  Commission Regulation (EC) No 2036/2005 of 14 December 2005 concerning the permanent authorisations of certain additives in feedingstuffs and the provisional authorisation of a new use of certain additives already authorised in feedingstuffs (OJ L 328, 15.12.2005, p. 13).

(24)  Commission Regulation (EC) No 252/2006 of 14 February 2006 concerning the permanent authorisations of certain additives in feedingstuffs and the provisional authorisations of new uses of certain additives already authorised in feedingstuffs (OJ L 44, 15.2.2006, p. 3).

(25)  Commission Regulation (EC) No 773/2006 of 22 May 2006 concerning the provisional and permanent authorisation of certain additives in feedingstuffs and the provisional authorisation of a new use of an additive already authorised in feedingstuffs (OJ L 135, 23.5.2006, p. 3).

(26)  Commission Regulation (EC) No 1284/2006 of 29 August 2006 concerning the permanent authorisations of certain additives in feedingstuffs (OJ L 235, 30.8.2006, p. 3).

(27)  Commission Regulation (EU) No 1270/2009 of 21 December 2009 concerning the permanent authorisations of certain additives in feedingstuffs (OJ L 339, 22.12.2009, p. 28).

(28)  Commission Regulation (EC) No 937/2001 of 11 May 2001 concerning the authorisation of new additive uses, new additive preparation, the prolongation of provisional authorisations and the 10 year authorisation of an additive in feedingstuffs (OJ L 130, 12.5.2001, p. 25).

(29)  Commission Regulation (EC) No 871/2003 of 20 May 2003 permanently authorising a new additive manganomanganic oxide in feedingstuffs (OJ L 125, 21.5.2003, p. 3).

(30)  Commission Regulation (EC) No 277/2004 of 17 February 2004 concerning the authorisation without a time limit of an additive in feedingstuffs (OJ L 47, 18.2.2004, p. 20).

(31)  Commission Regulation (EC) No 278/2004 of 17 February 2004 concerning the provisional authorisation of a new use of an additive already authorised in feedingstuffs (OJ L 47, 18.2.2004, p. 22).

(32)  Commission Regulation (EC) No 1332/2004 of 20 July 2004 concerning the permanent authorisation of certain additives in feedingstuffs (OJ L 247, 21.7.2004, p. 8).

(33)  Commission Regulation (EC) No 1463/2004 of 17 August 2004 concerning the authorisation for 10 years of the additive ‘Sacox 120 microGranulate’ in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances (OJ L 270, 18.8.2004, p. 5).

(34)  Commission Regulation (EC) No 1465/2004 of 17 August 2004 concerning the permanent authorisation of an additive in feedingstuffs (OJ L 270, 18.8.2004, p. 11).

(35)  Commission Regulation (EC) No 492/2006 of 27 March 2006 concerning the provisional and permanent authorisation of certain additives in feedingstuffs (OJ L 89, 28.3.2006, p. 6).

(36)  Commission Regulation (EC) No 1443/2006 of 29 September 2006 concerning the permanent authorisations of certain additives in feedingstuffs and an authorisation for 10 years for a coccidiostat (OJ L 271, 30.9.2006, p. 12).

(37)  Commission Regulation (EC) No 1743/2006 of 24 November 2006 concerning the permanent authorisation of an additive in feedingstuffs (OJ L 329, 25.11.2006, p. 16).

(38)  Commission Regulation (EC) No 757/2007 of 29 June 2007 concerning the permanent authorisation of certain additives in feedingstuffs (OJ L 172, 30.6.2007, p. 43).

(39)  Commission Regulation (EC) No 828/2007 of 13 July 2007 concerning the permanent and provisional authorisation of certain additives in feedingstuffs (OJ L 184, 14.7.2007, p. 12).




ANNEX I

Additives referred to in Article 1(1)

PART A


Feed additives to be withdrawn for all species and categories of animals









Identification Number


Additive


Species or category of animals





Preservatives






E 201


Sodium sorbate


All species




E 203


Calcium sorbate


All species




E 261


Potassium acetate


All species




E 283


Potassium propionate


All species




E 333


Calcium citrates


All species




E 334


L-Tartaric acid


All species




E 335


Sodium L-tartrates


All species




E 336


Potassium L-tartrates


All species




E 337


Potassium sodium L-tartrate


All species




E 507


Hydrochloric acid


All species




E 513


Sulphuric acid


All species





Antioxidants






E 308


Synthetic gamma tocopherol


All species




E 309


Synthetic delta tocopherol


All species




E 311


Octyl gallate


All species




E 312


Dodecyl gallate


All species





Binders, anti-caking agents and coagulants






E 330


Citric acid


All species





Colourants, including pigments







Other colourants







Relevant E number



Colouring agents authorised for colouring foodstuffs by Community rules, with the exception of Allura Red E 129; Brilliant Black PN E 151; Brilliant Blue FCF E 133; Caramel colours E150b, E150c and E150d; Chlorophyllin Copper Complex E 141; Erythrosine E 127; Indigotine E 132; Iron Oxide Red, Black & Yellow E 172; Ponceau 4 R E 124; Titanium dioxide (anatase & rutile structure) E 171; Vegetal Carbon E 153; Tartrazine E 102; Sunset yellow FCF E 110;


All species




E 142


Acid brilliant green BS/(Lissamine green)


All species





Emulsifying and stabilizing agents, thickeners and gelling agents






E322


Lecithins (only as stabilizing agents, thickeners and gelling agents)


All species




E 400


Alginic acid


All species




E 402


Potassium alginate


All species




E 404


Calcium alginate


All species




E 405


Propane-1,2-diol alginate (Propyleneglycol alginate)


All species




E 432


Polyoxyethylene (20)-sorbitan monolaurate


All species




E 434


Polyoxyethylene (20)-sorbitan monopalmitate


All species




E 435


Polyoxyethylene (20)-sorbitan monostearate


All species




E 436


Polyoxyethylene (20)-sorbitan tristearate


All species




E 465


Ethylmethylcellulose


All species




E 473


Sucrose esters of fatty acids (esters of saccharose and edible fatty acids)


All species




E 474


Sucroglycerides (mixture of esters of saccharose and mono- and di-glycerides of edible fatty acids)


All species




E 475


Polyglycerol esters of non-polymerised edible fatty acids


All species




E 477


Mono-esters of propane-1,2-diol (propyleneglycol) and edible fatty acids, alone or in mixtures with diesters


All species




E 480


Stearoyl 2-lactylic acid


All species




E 481


Sodium stearoyl 2-lactylate


All species




E 482


Calcium stearoyl 2-lactylate


All species




E 483


Stearyl tartrate


All species




E 486


Dextrans


All species




E 491


Sorbitan monostearate


All species




E 492


Sorbitan tristearate


All species




E 494


Sorbitan monooleate


All species




E 495


Sorbitan monopalmitate


All species




E 496


Polyethyleneglycol 6000


All species




E 497


Polyoxypropylene-polyoxyethylene polymers (M.W. 6 800 -9 000 )


All species





Trace elements






E 1



Iron — Fe, Ferrous chloride, tetrahydrate


All species




E 1



Iron — Fe, Ferrous citrate, hexahydrate


All species




E 1



Iron — Fe, Ferrous lactate, trihydrate


All species




E 2



Iodine — I, Calcium iodate, hexahydrate


All species




E 2



Iodine — I, Sodium iodide


All species




E 4



Copper — Cu, Cupric methionate


All species




E 5



Manganese — Mn, Manganic oxide


All species




E 5



Manganese — Mn, Manganomanganic oxide


All species




E 5



Manganese — Mn, Manganous carbonate


All species




E 5



Manganese — Mn, Manganous hydrogen phosphate, trihydrate


All species




E 5



Manganese — Mn, Manganous sulphate, tetrahydrate


All species




E 6



Zinc — Zn, Zinc carbonate


All species




E 6



Zinc — Zn, Zinc chloride monohydrate


All species




E 6



Zinc — Zn, Zinc lactate, trihydrate


All species




E 7



Molybdenum — Mo, Ammonium molybdate


All species




E 8



Selenium — Se, Sodium selenate


All species





Vitamins, provitamins and chemically well-defined substances having similar effect






 


Betaine. All forms with the exception of betaine anhydrous and betaine hydrochloride


All species




 


Biotin. All forms with the exception of D-(+)-biotin


All species




 


Carnitine. All forms with the exception of L carnitine and L carnitine L-tartrate


All species




 


Choline. All forms with the exception of choline chloride


All species




 


Folate. All forms of folate with the exception of folic acid


All species




 


Niacin. All forms of niacin with the exception of niacin 99 % and niacinamide


All species




 


Omega-3 Essential Unsaturated Fatty acids


All species




 


Omega-6 Essential Unsaturated Fatty acids (all with exception of octadecadienoic acid)


All species




 


Pantothenic acid. All forms with the exception of Calcium-D-pantothenate and D-panthenol


All species




 


Para-amino benzoic acid (PABA)


All species




 


Thiamine. All forms with the exception of thiamine hydrochloride and thiamine mononitrate


All species




 


Vitamin A. All forms with the exception of retinyl acetate, retinyl palmitate and retinyl propionate


All species




 


Vitamin B6. All forms with the exception of pyridoxine hydrochloride


All species




 


Vitamin C. All forms with the exception of ascorbic acid, sodium ascorbyl phosphate, sodium calcium ascorbyl phosphate


All species




 


Vitamin E. All forms with the exception of all-rac-alpha-tocopheryl acetate, RRR-alpha-tocopheryl acetate and RRR alpha tocopherol



All species




 


Vitamin K. All forms of Vitamin K with the exception of Vitamin K3 as menadione nicotinamide bisulphite and as L-menadione sodium bisulphite


All animal species





Amino acids, their salts and analogues






3.1.3.


Methionine/Methionine-zinc, technically pure


All species




3.2.1.


Lysine/L-lysine, technically pure


All species




3.4.2.


DL-Tryptophan, technically pure


All species





Silage additives







Enzymes






 


Xylanase EC 3.2.1.8 from Trichoderma longibrachiatum rifar IMI SD185


All species





Microorganisms






 



Enterococcus faecium BIO 34


All species




 



Lactobacillus salivarius CNCM I-3238/ATCC 11741


All species




 



Pediococcus pentosaceus NCIMB 30089


All species





Substances






 


Formaldehyde


All species




 


Sodium bisulphate


All species




 


 


 





Flavouring and appetising substances







Natural products — botanically defined






 


Birch tincture CoE 88


All species





Natural products and corresponding synthetic products






 


CAS No 16630-52-7/3-(Methylthio)butanal/Flavis No 12.056


All species




 


CAS No 2179-60-4/Methyl propyl disulfide/Flavis No 12.019


All species




 


CAS No 36431-72-8/Theaspirane/Flavis No 13.098


All species




 


CAS No 3738-00-9/1,5,5,9-Tetramethyl-13-oxatricyclo [8.3.0.0.(4.9)]tridecane/Flavis No 13.072


All species




 


CAS No 40789-98-8/3-Mercaptobutan-2-one/Flavis No 12.047


All species




 


CAS No 43040-01-3/3-Methyl-1,2,4-trithiane/Flavis No 15.036


All species




 


CAS No 495-62-5/1,4(8),12-Bisabolatriene/Flavis No 01.016


All species




 


CAS No 516-06-3/D,L-Valine/Flavis No 17.023


All species




 


CAS No 5756-24-1/Dimethyl tetrasulfide/Flavis No 12.116


All species




 


CAS No 6028-61-1/Dipropyl trisulfide/Flavis No 12.023


All species




 


CAS No 689-67-8/6,10-Dimethyl-5,9-undecadien-2-one/Flavis No 07.216


All species




 


CAS No 78-98-8/2-Oxopropanal/Flavis No 7.001


All species




PART B


Feed additives to be withdrawn for certain species or categories of animals









Identification Number


Additive


Species or category of animals





Preservatives






E 214


Ethyl 4-hydroxybenzoate


Pets




E 215


Sodium ethyl 4-hydroxybenzoate


Pets




E 216


Propyl 4-hydroxybenzoate


Pets




E 217


Sodium propyl 4-hydroxybenzoate


Pets




E 218


Methyl 4-hydroxybenzoate


Pets




E 219


Sodium methyl 4-hydroxybenzoate


Pets




E 222


Sodium bisulphite


Dogs; Cats




E 223


Sodium metabisulphite


Dogs; Cats




E 285


Methylpropionic acid


Ruminants, at the beginning of rumination





Acidity regulators






E 210


Benzoic acid


Pigs for fattening




E 340(iii)


Tripotassium orthophosphate


Cats; Dogs




E 350(i)


Sodium malate (Salt of DL- or L-Malic Acid)


Cats; Dogs




E 507


Hydrochloric acid


Cats; Dogs




E 513


Sulphuric acid


Cats; Dogs





Binders, anti-caking agents and coagulants






E 567


Clinoptilolite of volcanic origin


Rabbits




E 598


Synthetic calcium aluminates


Dairy cows; Cattle for fattening; Calves; Lambs; Kids; Poultry; Rabbits; Pigs





Colourants, including pigments







Carotenoids and xanthophylls






E 161b


Lutein


Cats & dogs




E 160c


Capsanthin


Turkeys




E 161c


Cryptoxanthin


Poultry




E 160e


Beta-apo-8′-carotenal


Poultry




E 161g


Canthaxanthin


All species and uses with the exception of:






—


Chickens for fattening and minor poultry species for fattening for uses belonging to the functional group 2 (a) (ii)










—


Laying poultry and poultry reared for laying for uses belonging to the functional group 2 (a) (ii).










—


Ornamental birds and ornamental fish for uses belonging to the functional group 2 (a) (iii)








E 161j


Astaxanthin


All species with the exception of:






—


Salmon and trout for uses belonging to the functional groups 2(a) (i) and 2(a) (iii)










—


Ornamental fish for uses belonging to the functional group 2(a) (i)








E 161z


Astaxantin-rich Phaffia Rhodozyma (ATCC 74219)


Salmon; Trout





Other colourants






E 155


Brown HT


Cats; Dogs




E 104


Quinoline yellow


Food producing animals




E 122


Azorubine (carmoisine)


All species with the exception of cats and dogs




E 160b


Bixin


All species with the exception of dogs and cats





Emulsifying and stabilizing agents, thickeners and gelling agents






E 401


Sodium alginate


All species with the exception of Fish; Pets and other non-food producing animals (non-food fur animals)




E 403


Ammonium alginate


All species or categories of animals with the exception of aquarium fish




E 406


Agar


All species with the exception of Pets and other non-food producing animals (non-food fur animals)




E 407


Carrageenan


All species with the exception of Pets and other non-food producing animals (non-food fur animals)




E 418


Gellan gum


Dogs; cats




E 488


Polyoxyethylated glyceride of tallow fatty acids


Calves




E 489


Ether of polyglycerol and of alcohols obtained by the reduction of oleic and palmitic acids


Calves




E 498


Partial polyglycerol esters of polycondensed fatty acids of castor oil


Dogs




 


 


 





Enzymes






E 1600


3-Phytase/EC 3.1.3.8 produced by Aspergillus niger (CBS 114.94)


Piglets; Pigs for fattening; Sows; Chickens for fattening; Laying hens




E 1600


3-Phytase/EC 3.1.3.8 produced by Aspergillus niger (CBS 114.94)


Turkeys for fattening




E 1605


Endo-1,4-beta-xylanase/EC 3.2.1.8 produced by Aspergillus niger (CBS 520.94)


Chickens for fattening




E 1608


Endo-1,4-beta-xylanase/EC 3.2.1.8/Endo-1,4-beta-glucanase/EC 3.2.1.4 produced by Humicola insolens (DSM 10442)


Chickens for fattening




E 1609


Endo-1,4-beta-xylanase/EC 3.2.1.8/Endo-1,4-beta-glucanase/EC 3.2.1.4 produced by Aspergillus niger (CBS 600.94) (coated, solid and liquid forms)


Chickens for fattening; Turkeys for fattening; Piglets (weaned)




E 1609


Endo-1,4-beta-xylanase/EC 3.2.1.8/Endo-1,4-beta-glucanase/EC 3.2.1.4 produced by Aspergillus niger (CBS 600.94) (granulate form)


Chickens for fattening; Turkeys for fattening; Piglets (weaned)




E 1610


Endo-1,4-beta-glucanase/EC 3.2.1.4/Endo-1,4-beta-xylanase/EC 3.2.1.8 produced by Aspergillus niger (CBS 600.94)


Chickens for fattening




E 1611


Endo-1,3(4)-beta-glucanase/EC 3.2.1.6 produced by Trichoderma longibrachiatum (ATCC 2106)/Endo-1,4-beta-xylanase/EC 3.2.1.8 produced by Trichoderma longibrachiatum (IMI SD 135)/Polygalacturonase/EC 3.2.1.15 produced by Aspergillus aculeatus (CBS 589.94)


Pigs for fattening




E 1614


6-Phytase/EC 3.1.3.26 produced by Aspergillus oryzae (DSM 11857)


Chickens for fattening; Laying hens; Turkeys for fattening; Piglets; Pigs for fattening; Sows




E 1615


Endo-1,3(4)-beta-glucanase/EC 3.2.1.6 produced by Trichoderma longibrachiatum (CNCM MA 6-10 W)


Chickens for fattening




E 1618


Endo-1,4-beta-xylanase/EC 3.2.1.8 produced by Aspergillus niger (CBS 270.95)


Chickens for Fattening; Turkeys for Fattening




E 1619


Alpha-amylase/EC 3.2.1.1/Endo-1,3(4)-beta-glucanase/EC 3.2.1.6 produced by Bacillus amyloliquefaciens (DSM 9553)


Chickens for fattening




E 1622


Endo-1,3(4)-beta-glucanase/EC 3.2.1.6/Endo-1,4-beta-xylanase/EC 3.2.1.8 produced by Trichoderma longibrachiatum (CBS 357.94)


Chickens for fattening




E 1623


Endo-1,3(4)-beta-glucanase/EC 3.2.1.6 produced by Trichoderma longibrachiatum (ATCC 2106), endo-1,4-beta-xylanase/EC 3.2.1.8 produced by Trichoderma longibrachiatum (ATCC 2105) and subtilisin/EC 3.4.21.62 produced by Bacillus subtilis (ATCC 2107)


Chickens for fattening




E 1624


Endo-1,3(4)-beta-glucanase/EC 3.2.1.6 produced by Trichoderma longibrachiatum (ATCC 2106), endo-1,4-beta-xylanase/EC 3.2.1.8 produced by Trichoderma longibrachiatum (IMI SD 135) and alpha-amylase/EC 3.2.1.1 produced by Bacillus amyloliquefaciens (DSM 9553)


Piglets (weaned)




E 1625


Endo-1,3(4)-beta-glucanase/EC 3.2.1.6 produced by Trichoderma longibrachiatum (ATCC 2106), endo-1,4-beta-xylanase/EC 3.2.1.8 produced by Trichoderma longibrachiatum (IMI SD 135), alpha-amylase/EC 3.2.1.1 produced by Bacillus amyloliquefaciens (DSM 9553) and polygalacturonase/EC 3.2.1.15 produced by Aspergillus aculeatus (CBS 589.94)


Piglets (weaned)




E 1626


Endo-1,4-beta-xylanase/EC 3.2.1.8 produced by Trichoderma longibrachiatum (ATCC 2105) and subtilisin/EC 3.4.21.62 produced by Bacillus subtilis (ATCC 2107)


Piglets (weaned)




E 1627


Endo-1,3(4)-beta-glucanase/EC 3.2.1.6 produced by Trichoderma longibrachiatum (ATCC 2106) and endo-1,4-beta-xylanase/EC 3.2.1.8 produced by Trichoderma longibrachiatum (ATCC 2105)


Pigs for fattening




E 1628


Endo-1,4-beta-xylanase/EC 3.2.1.8 produced by Trichoderma longibrachiatum (ATCC 2105)


Piglets (weaned); Pigs for fattening; Chickens for fattening




E 1629


Endo-1,4-beta-xylanase/EC 3.2.1.8 produced by Trichoderma longibrachiatum (ATCC 2105) and endo-1,3(4)-beta-glucanase/EC 3.2.1.6 produced by Trichoderma longibrachiatum (ATCC 2106)


Chickens for fattening




E 1630


Endo-1,4-beta-xylanase/EC 3.2.1.8 produced by Trichoderma longibrachiatum (ATCC 2105) and subtilisin/EC 3.4.21.62 produced by Bacillus subtilis (ATCC 2107)


Chickens for fattening




E 1631


Endo-1,3(4)-beta-glucanase/EC 3.2.1.6 produced by Trichoderma longibrachiatum (ATCC 2106) and endo-1,4-beta-xylanase/EC 3.2.1.8 produced by Trichoderma longibrachiatum (IMI SD 135)


Chickens for fattening




E 1632


3-Phytase/EC 3.1.3.8 produced by Trichoderma reesei (CBS 528.94)


Chickens for fattening; Piglets (weaned); Pigs for fattening




E 1633


Endo-1,3(4)-beta-glucanase/EC 3.2.1.6 produced by Trichoderma longibrachiatum (ATCC 2106), endo-1,4-beta-xylanase/EC 3.2.1.8 produced by Trichoderma longibrachiatum (ATCC 2105) and subtilisin/EC 3.4.21.62 produced by Bacillus subtilis (ATCC 2107)


Chickens for fattening




E 1634


Endo-1,3(4)-beta-glucanase/EC 3.2.1.6 produced by Aspergillus niger (MUCL 39199)


Chickens for fattening




E 1635


Endo-1,3(4)-beta-glucanase/EC 3.2.1.6 produced by Trichoderma longibrachiatum (ATCC 2106)


Chickens for fattening




E 1636


Endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (CBS 526.94/EC 3.2.1.6)


Piglets (weaned); Chickens for fattening




E 1637


Endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 2105)/EC 3.2.1.8 and Endo-1,3(4)-beta-glucanase/EC 3.2.1.6 and alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553)/EC 3.2.1.1; subtilisin produced by Bacillus subtilis (ATCC 2107)/EC 3.4.21.62 and polygalacturonase produced by Aspergillus aculeatus (CBS 589.94)/EC 3.2.1.15


Chickens for fattening




E 1638


Endo-1,3(4)-beta-glucanase/EC 3.2.1.6 produced by Trichoderma longibrachiatum (ATCC 2106), endo-1,4-beta-xylanase/EC 3.2.1.8 produced by Trichoderma longibrachiatum (ATCC 2105) and alpha-amylase/EC 3.2.1.1 produced by Bacillus amyloliquefaciens (DSM 9553)


Piglets (weaned)




E 1639


3-Phytase produced by Hansenula polymorpha (DSM 15087)


Chickens for fattening; Turkeys for fattening; Laying hens; Piglets; Pigs for fattening; Sows




E 1640


6-Phytase produced by Schizosaccharomyces pombe (ATCC 5233)/EC 3.1.3.26


Chickens for fattening




E 1641


Endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (MUCL 39203)/EC 3.2.1.8


Chickens for fattening





Micro-organisms






E 1704



Saccharomyces cerevisiae CBS 493.94


Calves




E 1706



Enterococcus faecium DSM 7134, Lactobacillus rhamnosus DSM 7133


Piglets (weaned)




E 1709



Enterococcus faecium ATCC 53519, Enterococcus faecium ATCC 55593 (In a 1/1 ratio)


Chickens for fattening




E 1714



Lactobacillus farciminis CNCM MA 67/AR


Piglets (weaned)





Chemically well-defined substances having a similar biological effect to vitamins






3a900


Inositol


All species with the exception of fish and crustacean




—


Omega-6 Essential Unsaturated Fatty acids (as octadecadienoic acid)


All species with the exception of Pigs for fattening; Sows for reproduction; Sows, in order to have benefit in piglets; Cows for reproduction; Dairy cows for milk production




3a370


Taurine


All species with the exception of canidae, felidae mustelidae and carnivorous fish




E 670


Vitamin D2



Pigs; Piglets; Bovines; Ovines; Calves; Equines; Other species or categories of animals with the exception of poultry and fish





Urea and its derivatives






2.1.2.


Biuret, technically pure


Ruminants from the beginning of rumination




2.1.3.


Urea-phosphate, technically pure


Ruminants from the beginning of rumination




2.1.4.


Diureidoisobutane, technically pure


Ruminants from the beginning of rumination





Flavouring and appetising substances







Natural products and corresponding synthetic products






 


CAS No 134-20-3/Methyl anthranilate/Flavis No 09.715


Avian species




 


CAS No 85-91-6/Methyl N-methylanthranilate/Flavis No 09.781


Avian species




 


CAS No 93-28-7/Eugenyl acetate/Flavis No 09.020


Poultry and fish




 


CAS No 97-53-0/Eugenol/Flavis No 04.003


Fish




 


CAS No 107-85-7/3-Methylbutylamine/Flavis No 11.001


Laying hens




 


CAS No 75-50-3/Trimethylamine/Flavis No 11.009


Laying hens




 


CAS No 6627-88-9/4-Allyl-2,6-dimethoxyphenol/Flavis No 04.051


Fish and poultry




 


CAS No 593-81-7/Trimethylamine hydrochloride/Flavis No 11.024


Laying hens









ANNEX II

Feed additives referred to in Article 1(2)








Identification Number


Additive


Species or category of animals





Enzymes






11


Endo-1,4-beta-glucanase/EC 3.2.1.4/Endo-1,3(4)-beta-glucanase/EC 3.2.1.6 and endo-1,4-beta-xylanase/EC 3.2.1.8 produced by Trichoderma longibrachiatum (ATCC 74 252)


Laying hens




28


3-Phytase/EC 3.1.3.8 produced by Trichoderma reesei (CBS 528.94)


Laying hens




30


Endo-1,3(4)-beta-glucanase/EC 3.2.1.6/Endo-1,4-beta-xylanase/EC 3.2.1.8 produced by Penicillium funiculosum (IMI SD 101)


Piglets (weaned); Ducks for fattening




37


Endo-1,4-beta-xylanase/EC 3.2.1.8 produced by Trichoderma longibrachiatum (ATCC 2105)/and subtilisin/EC 3.4.21.62 produced by Bacillus subtilis (ATCC 2107)


Laying hens




51


Endo-1,4-beta-xylanase/EC 3.2.1.8 produced by Bacillus subtilis (LMG S-15136)


Pigs for fattening




60


Endo-1,4-beta-xylanase/EC 3.2.1.8 produced by Trichoderma longibrachiatum (ATCC 2105)and endo-1,3(4)-beta-glucanase/EC 3.2.1.6 produced by Trichoderma longibrachiatum (ATCC 2106)


Turkeys for fattening




63


Endo-1,4-beta-xylanase/EC 3.2.1.8 produced by Trichoderma reesei (CBS 529.94) and endo-1,3(4)-beta-glucanase/EC 3.2.1.6 produced by Trichoderma reesei (CBS 526.94)


Turkeys for fattening; Chickens for fattening




64


Endo-1,3(4)-beta-glucanase/EC 3.2.1.6 produced by Aspergillus aculeatus (CBS 589.94) and endo-1,4-beta-xylanase/EC 3.2.1.8 produced by Aspergillus oryzae (DSM 10287)


Chickens for fattening; Piglets (weaned)





Micro-organisms






15



Enterococcus faecium NCIMB 11181


Chickens for fattening




24



Kluyveromyces marxianus var. lactis K1 BCCM/MUCL 39434


Dairy cows




25



Lactobacillus acidophilus DSM 13241


Cats, Dogs





Coccidiostats and other medicinal substances






E 764


Halofuginone hydrobromide 6g/kg (Stenorol)


Chickens reared for laying




E 766


Salinomycin sodium 120 g/kg (Sacox 120) (holder of the authorisation Huvepharma NV)


Rabbits for fattening




E 766


Salinomycin sodium 120 g/kg (Salinomax 120G) (holder of the authorisation Zoetis Belgium SA)


Chickens for fattening