COMMISSION IMPLEMENTING REGULATION (EU) 2017/1145

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before the deadline provided for in those provisions, or for which an application was submitted but subsequently withdrawn. Therefore such feed additives should be withdrawn from the market.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