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before the deadline provided for in those provisions, or for which an application was submitted but subsequently withdrawn. Therefore such feed additives should be withdrawn from the market.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 byTrichoderma 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