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)

In forceVersion 2017-06-08from 2017-07-19

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Contents

Preamble
Article 7 Amendment to Regulation (EC) No 261/2003
(1)
1. Article 1
Article 9 Amendment to Regulation (EC) No 1259/2004
(1)
1. Article 2
ANNEX
ANNEX I Additives referred to in Article 1(1)
PART A Feed additives to be withdrawn for all species and categories of animals
PART B Feed additives to be withdrawn for certain species or categories of animals
ANNEX II Feed additives referred to in Article 1(2)

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, 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 and Council Directive 82/471/EEC.

(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before the deadline provided for in those provisions, or for which an application was submitted but subsequently withdrawn. Therefore such feed additives should be withdrawn from the market.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, (EC) No 1353/2000, (EC) No 2188/2002, (EC) No 261/2003, (EC) No 1334/2003, (EC) No 1259/2004, (EC) No 1288/2004, (EC) No 1453/2004, (EC) No 2148/2004, (EC) No 255/2005, (EC) No 358/2005, (EC) No 521/2005, (EC) No 600/2005, (EC) No 833/2005, (EC) No 943/2005, (EC) No 1206/2005, (EC) No 1458/2005, (EC) No 1810/2005, (EC) No 1811/2005, (EC) No 2036/2005, (EC) No 252/2006, (EC) No 773/2006, (EC) No 1284/2006 and (EU) No 1270/2009 should be amended accordingly and Commission 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 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 7 Amendment to Regulation (EC) No 261/2003

(1)

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.;

Article 7 Amendment to Regulation (EC) No 261/2003

(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 9 Amendment to Regulation (EC) No 1259/2004

(1)

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.;

Article 9 Amendment to Regulation (EC) No 1259/2004

(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

ANNEX

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. 6800-9000) 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: E 161j Astaxanthin All species with the exception of: 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

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)

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)

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

Versions

2017-06-08

Cited by

Commission Implementing Regulation (EU) 2021/758 of 7 May 2021 on the status of certain products as feed additives within the scope of Regulation (EC) No 1831/2003 of the European Parliament and of the Council and on the withdrawal from the market of certain feed additives (Text with EEA relevance) Regulation · Grade B
As a consequence of the withdrawal from the market of the feed additives, it is appropriate to repeal the provisions authorising them, where such provisions are still in force. Consequently, Commission Regulation (EC) No 358/2005 should be amended accordingly. In addition, Commission Regulation (EC) No 880/2004 should be repealed, as both entries in the Annex thereto are to be deleted as a result of the withdrawal from the market of beta-carotene for use for canaries as provided in Annex I, Chapter I.A, part 2, and as a result of the authorisation of canthaxanthin for use for ornamental birds
Commission Implementing Regulation (EU) 2018/353 of 9 March 2018 correcting Implementing Regulation (EU) 2017/1145 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) Regulation · Grade B
Commission Implementing Regulation (EU) 2017/1145 requires the withdrawal from the market of feed additives which were placed on the market and entered in the Community Register of Feed Additives as existing products in accordance with Article 10(1) of Regulation (EC) No 1831/2003, and for which no applications in accordance with Article 10(2) and (7) of that Regulation were submitted before the deadline provided for in those provisions, or for which an application was submitted but subsequently withdrawn. Implementing Regulation (EU) 2017/1145 also repeals the regulations or deletes the provi
Commission Implementing Regulation (EU) 2018/353 of 9 March 2018 correcting Implementing Regulation (EU) 2017/1145 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) Regulation · Grade B
By mistake, Annex II to Implementing Regulation (EU) 2017/1145 setting out the list of additives to be withdrawn from the market in respect of certain animal species included the feed additive coccidiostat authorised by Commission Regulation (EC) No 1463/2004, although an application was submitted in due time in accordance with Article 10(2) of Regulation (EC) No 1831/2003. That Regulation was therefore repealed by mistake by Article 3 of Implementing Regulation (EU) 2017/1145. By mistake, Commission Regulation (EC) No 833/2005 was mentioned in recital 3 of Implementing Regulation (EU) 2017/11
Commission Implementing Regulation (EU) 2018/353 of 9 March 2018 correcting Implementing Regulation (EU) 2017/1145 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) Regulation · Grade B
By mistake, the provisions of Commission Regulation (EC) No 1334/2003 authorising some iron compounds, to be withdrawn from the market in accordance with Implementing Regulation (EU) 2017/1145, were not deleted by Article 8 of that Regulation amending Regulation (EC) No 1334/2003. That Article should be corrected.
Commission Implementing Regulation (EU) 2018/353 of 9 March 2018 correcting Implementing Regulation (EU) 2017/1145 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) Regulation · Grade B
In Part A of Annex I to Implementing Regulation (EU) 2017/1145 setting out the feed additives to be withdrawn for all species and categories of animals, in the table concerning vitamins, the L form of the vitamin menadione sodium bisulphite is included. This should be corrected as no reference to this L form was made in the authorisation.
Commission Implementing Regulation (EU) 2018/353 of 9 March 2018 correcting Implementing Regulation (EU) 2017/1145 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) Regulation · Grade B
Parts A and B of Annex I to Implementing Regulation (EU) 2017/1145 should be corrected as regards some colourants as the species and categories of animals for which those colourants are required to be withdrawn from the market and the functions of those colourants were not indicated correctly. The requirement to withdraw the additive from the market for some of them applies only for certain species and the use as colourant is restricted to certain functions.
Commission Implementing Regulation (EU) 2018/353 of 9 March 2018 correcting Implementing Regulation (EU) 2017/1145 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) Regulation · Grade B
Implementing Regulation (EU) 2017/1145 should therefore be corrected accordingly.
Commission Implementing Regulation (EU) 2018/353 of 9 March 2018 correcting Implementing Regulation (EU) 2017/1145 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) Regulation · Grade B
The erroneous provisions have given rise to confusion for the feed business operators as regards the actual regulatory status of the additives concerned. That situation has created legal uncertainty as to the applicable regulatory framework. Those errors have therefore resulted in some market disturbance linked to the questioned authorisation to place on the market and use certain additives. The corrections to Implementing Regulation (EU) 2017/1145 should therefore apply retroactively on the day of entry into force of that Implementing Regulation, in order to restore legal certainty in relatio
Commission Implementing Regulation (EU) 2018/353 of 9 March 2018 correcting Implementing Regulation (EU) 2017/1145 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) Regulation · Grade B
Implementing Regulation (EU) 2017/1145 is corrected as follows: