S.I. No. 252/1996 - European Communities (Additives in Feedingstuffs) (Amendment) (No. 2) Regulations, 1996


I, Ivan Yates, Minister for Agriculture, Food and Forestry, in exercise of the powers conferred on me by section 3 of the European Communities Act, 1972 (No. 27 of 1972), and for the purposes of giving effect to Commission Directive 96/7/EC of 21 February, 19961,and for the purpose of giving further effect to Council Directive 70/524/EEC of 23 November, 19702, as amended, hereby make the following Regulations:

1OJ No L 51, 1. 3. 1996, p. 45

2OJ No L 270, 14. 12. 1970, p. 1

1. (1) These Regulations may be cited as the European Communities (Additives in Feedingstuffs) (Amendment) (No. 2) Regulations, 1996.

(2) The collective citation the European Communities (Additives in Feedingstuffs) Regulations, 1989 to 1996, shall include the European Communities (Additives in Feeding stuffs) (Amendment) (No. 2) Regulations, 1996.

2. In these Regulations "the Regulations of 1989" means the European Communities (Additives in Feedingstuffs) Regulations, 1989 ( S.I. No. 49 of 1989 ).

3. Regulation 2(1) of the Regulations of 1989 is hereby amended by the substitution, for the definition of "Council Directive", of the definition set out in the First Schedule to these Regulations.

4. The Regulations of 1989 are hereby amended by the substitution:—

(a) for the First Schedule thereto, of the Schedule set out in the Second Schedule to these Regulations;

(b) for the Second Schedule thereto, of the Schedule set out in the Third

Schedule to these Regulations.

FIRST SCHEDULE

"Council Directive" means Council Directive No. 70/524/EEC of 23 November 19701, as amended by:-

Council Directive No. 73/103/EEC of 28 April, 19732,

Council Directive No. 75/296/EEC of 28 April, 19753,

Council Directive No. 84/587/EEC of 29 November, 19844,

Commission Directive No. 91/248/EEC of 12 April, 19915,

Commission Directive No. 91/249/EEC of 19 April, 19916,

Commission Directive No. 91/336/EEC of 10 June, 19917,

Commission Directive No. 91/508/EEC of 9 September, 19918,

Commission Directive No. 91/620/EEC of 22 November, 19919,

Commission Directive No. 92/64/EEC of 13 July 199210,

Commission Directive No. 92/99/EEC of 17 November, 199211,

Commission Directive No. 92/113/EEC of 16 December, 199212,

Commission Directive No. 93/27/EEC of 4 June, 199313,

Commission Directive No. 93/55/EEC of 25 June, 199314,

Commission Directive No. 93/107/EEC of 26 November, 199315,

____________________________

1 OJ No L 270, 14. 12. 1970, p. 1

2 OJ No L 124, 10. 5. 1973, p. 17

3 OJ No L 124, 15. 5. 1975, p. 29

4 OJ No L 319, 8. 12. 1984, p. 13

5 OJ No L 124, 18. 5. 1991, p. 1

6 OJ No L 124, 18. 5. 1991, p. 43

7 OJ No L 185, 11. 7. 1991, p. 31

8 OJ No L 271, 27. 9. 1991, p. 67

9 OJ No L 334, 5. 12. 1991, p. 62

10 OJ No L 221, 6. 8. 1992, p. 51

11 OJ No L 350, 1. 12. 1992, p. 83

12 OJ No L 16, 25. 1. 1993, p. 2

13 OJ No L 179, 22. 7. 1993, p. 5

14 OJ No L 206, 18. 8. 1993, p. 11

15 OJ No L 299, 4. 12. 1993, p. 44

Council Directive No. 93/114/EC of 14 December, 19931,

Commission Directive No. 94/17/EC of 22 April, 19942,

Commission Directive No. 94/40/EC of 22 July, 19943,

Commission Directive No. 94/41/EC of 18 July, 19944,

Commission Directive No. 94/50/EC of 31 October, 19945,

Commission Directive No. 94/77/EC of 20 December, 19946,

Commission Directive No. 95/11/EC of 4 May, 19957,

Commission Directive No. 95/37/EC of 18 July, 19958,

Commission Directive No. 95/55/EC of 31 October, 19959, and

Commission Directive No. 96/7/EC of 21 February, 199610. " .

___________________________

1 OJ No L 334, 31. 12. 1993, p. 24

2 OJ No L 105, 26. 4. 1994, p. 19

3 OJ No L 208, 11. 8. 1994, p. 15

4 OJ No L 209, 12. 8. 1994, p. 18

5 OJ No L 297, 18. 11. 1994, p. 27

6 OJ No L 350, 31. 12. 94, p. 113

7 OJ No L 106, 11. 5. 1995, p. 23

8 OJ No L 172, 22. 7. 1995, p. 21

9 OJ No L 263, 4. 11. 1995, p. 18

10 OJ No L 51, 1. 3. 1996, p. 45

SECOND SCHEDULE

"FIRST SCHEDULE

Additives authorised in feedingstuffs and their conditions of use

EEC No.

Additive

Chemical formula, description

Species or category of animal

Maximum Age

Minimum content

Maximum content

Other provisions

mg/kg complete feedingstuff

B. Antioxidants

E 300

L-Ascorbic acid

C6,H8,O6,

All species or categories of animals

-

-

-

All feedingstuffs

E 301

Sodium L-ascorbate

C6,H7,O6, Na

All species or categories of animals

-

-

-

All feedingstuffs

E 302

Calcium L-ascorbate

C12,H14,O12, Ca x 2H2,O

All species or categories of animals

-

-

-

All feedingstuffs

E 303

5,6-Diacetyl-L-ascorbic acid

C10H12,O8

All species or categories of animals

-

-

-

All feedingstuffs

E 304

6 Palmityl-Lascorbic acid

C22H38O7

All species or categories of animals

-

-

-

All feedingstuffs

E 306

Tocopherol-rich extracts of natural origin

-

All species or categories of animals

-

-

-

All feedingstuffs

E 307

Synthetic a-tocopherol

C29H50O2

All species or categories of animals

-

-

-

All feedingstuffs

E 308

Synthetic g-tocopherol

C28H48O2

All species or categories of animals

-

-

-

All feedingstuffs

E 309

Synthetic d-tocopherol

C27H46O2

All species or categories of animals

-

-

-

All feedingstuffs

E 310

Propyl gallate

C10H12O5

All species or categories of animals

-

-

100 alone or together with E 311 or E 312

All feedingstuffs

E 311

Octyl gallate

C15H22O5

All species or categories of animals

-

-

100 alone or together with E 310 or E 312

All feedingstuffs

E 312

Dodecyl gallate

C19H30O5

All species or categories of animals

-

-

100 alone or together with E 310 or E 311

All feedingstuffs

E 320

Butylated hydroxyanisole (BHA)

C11H16O2

All species or categories of animals

-

-

150 alone or together with E 321 or E 324

All feedingstuffs

E 321

Butylated hydroxytoluene (BHT)

Cl5H24O

All species or categories of animals

-

-

150 alone or together with E 320 or E 324-

All feedingstuffs

E 324

Ethoxyquin

C14H19NO

All species or categories of animals

-

-

150 alone or together with E 320 or E 321-

All feedingstuffs

EEC No.

Additive

Chemical formula, description

Species or category of animal

Maximum Age

Minimum content

Maximum content

Other provisions

mg/kg complete feedingstuff

C. Aromatic substances and appetising substances

1. All natural products and corresponding synthetic products

-

All species or categories of animals

-

-

-

-

2. Artificial substances:

E 954 (i)

Saccharin

C7H5NO3S

Piglets

4 months

-

150

-

E 954 (ii)

Calcium saccharin

C7H3NCaO3S

Piglets

4 months

-

150

-

E 954 (iii)

Sodium saccharin

C7H4NNaO3S

Piglets

4 months

-

150

-

E 959

Neohesperidine dihydrochalcone

C28H36O15

Piglets

4 months

-

35

-

Dogs

-

-

35

-

Calves

-

-

30

-

Ovines

-

-

30

-

EEC No.

Additive

Chemical formula, description

Species or category of animal

Maximum Age

Minimum content

Maximum content

Other provisions

mg/kg complete feedingstuff

E. Emulsifiers, stabilisers, thickeners and gelling agents

E 322

Lecithins

All species or categories of animals

-

-

-

All feedingstuffs

E400

Alginic acid

All species or categories of animals

-

-

-

All feedingstuffs

E401

Sodium alginate

All species or categories of animals

-

-

-

All feedingstuffs

E402

Potassium alginate

All species or categories of animals

-

-

-

All feedingstuffs

E403

Ammonium alginate

All species or categories of animals

-

-

-

All feedingstuffs

E404

Calcium alginate

All species or categories of animals

-

-

-

All feedingstuffs

E405

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

All species or categories of animals

-

-

-

All feedingstuffs

E406

Agar

All species or categories of animals

-

-

-

All feedingstuffs

E407

Carrageenan

All species or categories of animals

-

-

-

All feedingstuffs

E408

Furcelleran

All species or categories of animals

-

-

-

All feedingstuffs

E410

Locust bean gum (Carob gum)

All species or categories of animals

-

-

-

All feedingstuffs

E411

Tamarind seed flour

All species or categories of animals

-

-

-

All feedingstuffs

E412

Guargum

All species or categories of animals

-

-

-

All feedingstuffs

E413

Tragacanth

All species or categories of animals

-

-

-

All feedingstuffs

E414

Acacia (Gum arabic)

All species or categories of animals

-

-

-

All feedingstuffs

E415

Xanthan gum

All species or categories of animals

-

-

-

All feedingstuffs

E418

Gellan gum

Polytetrasaccharide containing glucose, glucuronic acid and rhamnose (2:1:1) produced by Pseudomonas elodea (ATCC 31466)

Dogs

-

-

-

Only canned feedingstuffs

Cats

-

-

-

Only canned feedingstuffs

E 420

Sorbitol

-

All species or categories of animals

-

-

-

All feedingstuffs

E 421

Mannitol

-

All species or categories of animals

-

-

-

All feedingstuffs

E 422

Glycerol

-

All species or categories of animals

-

-

-

All feedingstuffs

E 432

Polyoxyethylene (20)-sorbitan monolaurate

-

All species or categories of animals

-

-

5 000 alone or with the other polysorbates

Milk replacers only

E 433

Polyoxyethylene(20)-sorbitanmonooleate

-

All species or categories of animals

-

-

5 000 alone or with the other polysorbates

Milk replacers only

E 434

Polyoxyethylene (20)sorbitan monopalmitate

-

All species or categories of animals

-

-

5 000 alone or with the other polysorbates

Milk replacers only

E 435

Polyoxyethylene(20)-sorbitan monostearate

-

All species or categories of animals

-

-

5 000 alone or with the other polysorbates

Milk replacers only

E 436

Polyoxyethylene(20)-sorbitan tristearate

-

All species or categories of animals

-

-

5 000 alone or with the other polysorbates

Milk replacers only

E 440

Pectins

-

All species or categories of animals

-

-

-

All feedingstuffs

E 450 b (i)

pentaSodium triphosphate

-

Dogs

-

-

5 000

All feedingstuffs

Cats

-

-

5 000

All feedingstuffs

E 460

Microcrystalline cellulose

-

All species or categories of animals

-

-

-

All feedingstuffs

E 460 (ii)

Cellulose powder

-

All species or categories of animals

-

-

-

All feedingstuffs

E 461

Methylcellulose

-

All species or categories of animals

-

-

-

All feedingstuffs

E 462

Ethylcellulose

-

All species or categories of animals

-

-

-

All feedingstuffs

E 463

Hydroxypropylcellulose

-

All species or categories of animals

-

-

-

All feedingstuffs

E 464

Hydroxypropylmethylcellulose

-

All species or categories of animals

-

-

-

All feedingstuffs

E 465

Ethylmethylcellulose

-

All species or categories of animals

-

-

-

All feedingstuffs

E 466

Carboxymethylcellulose (Sodium salt of carboxymethyl ether of cellulose)

-

All species or categories of animals

-

-

-

All feedingstuffs

E 470

Sodium, potassium and calcium salts of edible fatty acids, alone or in mixtures, derived either from edible fats or from distilled edible fatty acids

-

All species or categories of animals

-

-

-

All feedingstuffs

E 471

Mono and diglycerides of fatty acids

-

All species or categories of animals

-

-

-

All feedingstuffs

E 472

Mono and diglycerides of edible fatty acids esterified with the following acids:a) aceticb) lacticc) citricd)tartarice) mono-and diacetyltartaric

-

All species or categories of animals

-

-

-

All feedingstuffs

E 473

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

-

All species or categories of animals

-

-

-

All feedingstuffs

E 474

Sucroglycerides (mixture of esters of saccharose and mono and diglycerides of edible fatty acids)

-

All species or categories of animals

-

-

-

All feedingstuffs

E 475

Polyglycerol esters of non-polymerised edible fatty acids

-

All species or categories of animals

-

-

-

All feedingstuffs

E 477

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

-

All species or categories of animals

-

-

-

All feedingstuffs

E 480

Stearoyl-2-lactylic acid

-

All species or categories of animals

-

-

-

All feedingstuffs

E 481

Sodium stearoyl-2-lactylate

-

All species or categories of animals

-

-

-

All feedingstuffs

E 482

Calcium stearoyl-2-lactylate

-

All species or categories of animals

-

-

-

All feedingstuffs

E 483

Stearyl tartrate

-

All species or categories of animals

-

-

-

All feedingstuffs

E 484

Glyceryl polyethyleneglycol ricinoleate

-

All species or categories of animals

-

-

-

All feedingstuffs

E 486

Dextraus

-

All species or categories of animals

-

-

-

All feedingstuffs

E 487

Polyethyleneglycol ester of fatty acids from soya oil

-

Calves

-

-

6 000

Milk replacers only

E 488

Polyoxyethylated glyceride of tallow fatty acids

-

Calves

-

-

5 000

Milk replacers only

E 489

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

-

Calves

-

-

5 000

Milk replacers only

E 490

Propane-1,2-diol

-

Dairy cows

-

-

12 000

All feedingstuffs

Cattle for fattening

-

-

36 000

All feedingstuffs

Calves

-

-

36 000

All feedingstuffs

Lambs

-

-

36 000

All feedingstuffs

Kids

-

-

36 000

All feedingstuffs

Pigs

-

-

36 000

All feedingstuffs

Poultry

-

-

36 000

All feedingstuffs

E 491

Sorbitan monostearate

-

All species or categories of animals

-

-

-

All feedingstuffs

E 492

Sorbitan tristearate

-

All species or categories of animals

-

-

-

All feedingstuffs

E 493

Sorbitan monolaurate

-

All species or categories of animals

-

-

-

All feedingstuffs

E 494

Sorbitan monooleate

-

All species or categories of animals

-

-

-

All feedingstuffs

E 495

Sorbitan monopalmitate

-

All species or categories of animals

-

-

-

All feedingstuffs

E 496

Polyethyleneglycol 6,000

-

All species or categories of animals

-

-

300

All feedingstuffs

E 497

Polyoxypropylenepolyoxyethylene polymers (M.W. 6 800-9 000)

-

All species or categories of animals

-

-

50

All feedingstuffs

E 498

Partial polyglycerol esters of polycondensed fatty acids of castor oil

-

Dogs

-

-

-

All feedingstuffs

E 499

Cassia gum

-

Dogs

-

-

17 600

Canned feedingstuffs only

Cats

-

-

17 600

Canned feedingstuffs only

EEC No.

Additive

Chemical formula, description

Species or category of animal

Maximum Age

Minimum content

Maximum content

Other provisions

mg/kg complete feedingstuff

F. Colouring matters including pigments 1. Carotenoids and xanthophylls:

E 160c

Capsanthin

C40H56O3

Poultry

-

-

80 (alone or with the other carotenoids and xanthophylls)

-

E 160e

á-apo-8'-carotenal

C30H40O

Poultry

-

-

80 (alone or with the other carotenoids and xanthophylls)

-

E 160f

Ethyl ester of á-papo-8'-carotenoic acid

C32H44O2

Poultry

-

-

80 (alone or with the other carotenoids and xanthophylls)

-

E 161b

Lutein

C40H56O2

Poultry

-

-

80 (alone or with the other carotenoids and xanthophylls)

-

E 161c

Cryptoxanthin

C40H56O

Poultry

-

-

80 (alone or with the other carotenoids and xanthophylls)

-

E 161g

Canthaxanthin

C40H52O2

Poultry

-

-

80 (alone or with the other carotenoids and xanthophylls)

-

Salmon

-

-

80

Use permitted from the age of 6 months onwards The mixture of canthaxanthin with astaxanthin is allowed provided that the total concentration of the mixture does not exceed 100 mg/kg in the complete feedingstuff.

Trout

-

-

80

Use permitted from the age of 6 months onwards The mixture of canthaxanthin with astaxanthin is allowed provided that the total concentration of the mixture does not exceed 100 mg/kg in the complete feedingstuff.

Dogs

-

-

-

-

Cats

-

-

-

-

Ornamental fish

-

-

-

-

E 161h

Zeaxanthin

C40H56O2

Poultry

-

-

80 (alone or with the other carotenoids and xanthophylls)

-

E 161i

Citranaxanthin

C33H44O

Laying hens

-

-

80 (alone or with the other carotenoids and xanthophylls)

-

E 161j

Astaxanthin

C40H52O4

Salmon

-

-

100

Use only permitted from the age of 6 months onwards. The mixture of astaxanthin with canthaxanthin is allowed provided that the total concentration of the mixture does not exceed 100 mg/kg in the complete feedingstuff.

Trout

-

-

100

Use only permitted from the age of 6 months onwards. The mixture of astaxanthin with canthaxanthin is allowed provided that the total concentration of the mixture does not exceed 100 mg/kg in the complete feedingstuff.

Ornamental fish

-

-

-

-

E 102

2. Other colourants: Tartrazine

C16H9N4O9S2 Na3

Ornamental fish

-

-

-

-

E 110

Sunset Yellow FCF

C16H10N2O7S2 Na2

Ornamental fish

-

-

-

-

E 124

Ponceau 4 R

C20H11N2O10S3 Na3

Ornamental fish

-

-

-

-

E 127

Erythrosine

C20H6I4O5 Na2 x H2O

Ornamental fish

-

-

-

-

E 131

Patent Blue V

Calcium salt of the disulphonic acid of m-hydroxy tetraethyl diamino triphenyl carbinol anhydride

All species or categories of animals with the exception of dogs and cats

-

-

-

Permitted in animals feedingstuffs only in product from: a) waste products of foodstuffs, b) denatured cereals or manioc flour, or c) other base substances denatured by means of these agents or coloured during technical preparation to ensure the necessary identification during manufacture

Dogs

-

-

-

-

Cats

-

-

-

-

E 132

Indigotine

C16H8N2O8S2 Na2

Ornamental fish

-

-

-

-

E 141

Chlorophyll copper complex

-

Ornamental fish

-

-

-

-

E 142

Acid Brilliant Green BS (Lissamine Green)

Sodium salt of 4,4'-bis (dimethylamino) diphenyl methylene-2- naphtol-3,-6- disulphonic acid

All species or categories of animals with the exception of dogs, cats and ornamental fish

-

-

-

Permitted in animals feedingstuffs only in product from: a) waste products of foodstuffs, b) denatured cereals or manioc flour, or c) other base substances denatured by means of these agents or coloured during technical preparation to ensure the necessary identification during manufacture

Dogs

-

-

-

-

Cats

-

-

-

-

Ornamental fish

-

-

-

-

E 153

Carbon black

C

Ornamental fish

-

-

-

-

E 160 B

Bixin

C25H30O4

Ornamental fish

-

-

-

-

E 172

Iron oxide, red

Fe2O3

Ornamental fish

-

-

-

-

3. Colouring agents authorised for colouring foodstuffs by Community rules, other than Patent Blue V and Acid Brilliant Green BS

-

All species or categories of animals with the exception of dogs and cats

-

-

-

Permitted in animal feedingstuffs only in products processed from: a) waste products of foodstuffs, or b) other base substances with the exception of cereals and manioc flour denatured by means of these agents or coloured during technical preparation to ensure the necessary identification during manufacture

Dogs

-

-

-

-

Cats

-

-

-

-

EEC No.

Additive

Chemical formula, description

Species or category of animal

Maximum Age

Minimum content

Maximum content

Other provisions

mg/kg complete feedingstuff

G. Preservatives

E 200

Sorbic acid

C6H8O2

All species or categories of animals

-

-

-

All feedingstuffs

E 201

Sodium sorbate

C6H7O2 Na

All species or categories of animals

-

-

-

All feedingstuffs

E 202

Potassium sorbate

C6H7O2K

All species or categories of animals

-

-

-

All feedingstuffs

E 203

Calcium sorbate

C12H14O4Ca

All species or categories of animals

-

-

-

All feedingstuffs

E 214

Ethyl 4-hydroxybenzoate

C9H10O3

Pets

-

-

-

All feedingstuffs

E 215

Sodium ethyl 4-hydroxybenzoate

C9H9O3Na

Pets

-

-

-

All feedingstuffs

E 216

Propyl 4-hydroxybenzoate

C10H12O3

Pets

-

-

-

All feedingstuffs

E 217

Sodium propyl 4-hydroxybenzoate

C10H11O3Na

Pets

-

-

-

All feedingstuffs

E 218

Methyl -hydroxybenzoate

C8H8O3

Pets

-

-

-

All feedingstuffs

E 219

Sodium methyl 4-hydroxybenzoate

C8H7O3Na

Pets

-

-

-

All feedingstuffs

E 222

Sodium bisulphite

NaHSO3

Dogs

-

-

Separately or together with E 223: 500 expressed as SO2

All feedingstuffs except unprocessed meat and fish

Cats

-

-

Separately or together with E 223: 500 expressed as SO2

All feedingstuffs except unprocessed meat and fish

E 223

Sodium metabisulphite

Na2S2O5

Dogs

-

-

Separately or together with E222: 500 expressed as SO2

All feedingstuffs except unprocessed meat and fish

Cats

-

-

Separately or together with E 222: 500 expressed as SO2

All feeding stuffs except unprocessed meat and fish

E 236

Formic acid

CH2O2

All species or categories of animals

-

-

-

All feedingstuffs

E 237

Sodium formate

CHO2 Na

All species or categories of animals

-

-

-

All feedingstuffs

E238

Calcium formate

C2H2Ca

All species or categories of animals

-

-

-

All feedingstuffs

E 240

Formaldehyde

CH2O

Pigs

6 months

-

-

Skimmed milk only: maximum content:600mg

All species or categories of animals

-

-

-

For silage only

E 250

Sodium nitrite

NaNO2

Dogs

-

-

100

Canned feedingstuffs only

Cats

-

-

100

Canned feedingstuffs only

E 260

Acetic acid

C2H4O2

All species or categories of animals

-

-

-

All feedingstuffs

E 261

Potassium acetate

C2H302K

All species or categories of animals

-

-

-

All feedingstuffs

E 262

Sodium diacetate

C4H7O4Na

All species or categories of animals

-

-

-

All feedingstuffs

E 263

Calcium acetate

C4H6O4 Ca

All species or categories of animals

-

-

-

All feedingstuffs

E 270

Lactic acid

C3H6O3

All species or categories of animals

-

-

-

All feedingstuffs

E 280

Propionic acid

C3H6O2

All species or categories of animals

-

-

-

All feedingstuffs

E 281

Sodium propionate

C3H5O2 Na

All species or categories of animals

-

-

-

All feedingstuffs

E 282

Calcium propionate

C6H10O4 Ca

All species or categories of animals

-

-

-

All feedingstuffs

E 283

Potassium propionate

C3H5O2K

All species or categories of animals

-

-

-

All feedingstuffs

E 284

Ammonium propionate

C3H9O2N

All species or categories of animals

-

-

-

All feedingstuffs

E 285

Methylpropionic acid

C4H8O2

Ruminants from the beginning of rumination

-

1 000

4 000

All feedingstuffs

E 295

Ammonium formate

CH5O2N

All species or categories of animals

-

-

-

All feedingstuffs

E 296

DL-Malic acid

C4H6O5

All species or categories of animals

-

-

-

All feedingstuffs

E 297

Fumaric acid

C4H4O4

All species or categories of animals

-

-

-

All feedingstuffs

E 325

Sodium lactate

C3H5O3 Na

All species or categories of animals

-

-

-

All feedingstuffs

E 326

Potassium lactate

C3H5O3K

All species or categories of animals

-

-

-

All feedingstuffs

E 327

Calcium lactate

C6H10O6 Ca

All species or categories of animals

-

-

-

All feedingstuffs

E 330

Citric acid

C6H8O7

All species or categories of animals

-

-

-

All feedingstuffs

E 331

Sodium citrates

-

All species or categories of animals

-

-

-

All feedingstuffs

E 332

Potassium citrates

-

All species or categories of animals

-

-

-

All feedingstuffs

E 333

Calcium citrates

-

All species or categories of animals

-

-

-

All feedingstuffs

E 334

L-Tartaric acid

C4H6O6

All species or categories of animals

-

-

-

All feedingstuffs

E 335

Sodium L-tartrates

-

All species or categories of animals

-

-

-

All feedingstuffs

E 336

Potassium L-tartrates

-

All species or categories of animals

-

-

-

All feedingstuffs

E 337

Potassium sodium L-tartrate

C4H4O6KNa x 4H2O

All species or categories of animals

-

-

-

All feedingstuffs

E 338

Orthophosphoric acid

H3PO4

All species or categories of animals

-

-

-

All feedingstuffs

E 490

Propane-1,2-diol

C3H8O2

Dogs

-

-

53 000

All feedingstuffs

E 507

Hydrochloric acid

HCI

All species or categories of animals

-

-

-

For silage only

E 513

Sulphuric acid

H2SO4

All species or categories of animals

-

-

-

For silage only

EEC No.

Additive

Chemical formula, description

Species or category of animal

Maximum Age

Maximum content iu/kg of complete feedingstuff or of the daily ration

Other provisions

H. Vitamins, provitamins and chemically well defined substances having a similar effect

E 672

1. Vitamin A

-

Chickens for fattening

-

13 500

All feedingstuffs except feedingstuffs for young animals

Ducks for fattening

-

13 500

All feedingstuffs except feedingstuffs for young animals

Turkeys for fattening

-

13 500

All feedingstuffs except feedingstuffs for young animals

Lambs for fattening

-

13 500

All feeding stuffs except feedingstuffs for young animals

Pigs for fattening

-

13 500

All feedingstuffs except feedingstuffs for young animals

Bovines for fattening

-

13 500

All feedingstuffs except feedingstuffs for young animals

Calves for fattening

-

25 000

Milk replacers only

Others species or categories of animals

-

-

All feedingstuffs

2. Vitamin D

E670

Vitamin D2

-

Pigs

-

2 000

-

Simultaneous use of vitamin D3 prohibited

Piglets

-

10 000

Simultaneous use of vitamin D3 prohibited

Bovines

-

4 000

-

Simultaneous use of vitamin D3 prohibited

Ovines

-

4000

-

Simultaneous use of vitamin D3 prohibited

Calves

-

10 000

Simultaneous use of vitamin D3 prohibited

Equines

-

4 000

-

Simultaneous use of vitamin D3 prohibited

Other species or categories of animals with the exception of poultry and fish

-

2 000

-

Simultaneous use of vitamin D3 prohibited

E671

Vitamin D3

-

Pigs

-

2 000

-

Simultaneous use of vitamin D3 prohibited

Piglets

-

10 000

Milk replacers only

Simultaneous use of vitamin D3 prohibited

Bovines

-

4 000

-

Simultaneous use of vitamin D3 prohibited

Ovines

-

4 000

-

Simultaneous use of vitamin D3 prohibited

Calves

-

10 000

Milk replacers only

Simultaneous use of vitamin D3 prohibited

Equines

-

4 000

-

Simultaneous use of vitamin D3 prohibited

Chickens for fattening

-

5 000

-

Simultaneous use of vitamin D3 prohibited

Turkeys

-

5 000

-

Simultaneous use of vitamin D3 prohibited

Other poultry

-

3 000

-

Simultaneous use of vitamin D3 prohibited

Fish

-

3 000

-

Simultaneous use of vitamin D3 prohibited

Other species or categories of animals

-

2 000

-

Simultaneous use of vitamin D3 prohibited

3. All substances in the group except vitamins A and D

-

All species or categories of animals

-

-

All feedingstuffs

EEC

Element

Additive

Chemical formula

Maximum content of the element in mg/kg of the complete feedingstuff

Other provisions

I. Trace elements

E1

Iron - Fe

1250 (total)

Ferrous carbonate

FeCO3

-

Ferrous chloride, tetrahydrate

FeCL2 x 4H2O

-

Ferric chloride, hexahydrate

FeCL3 x 6H2O

-

Ferrous citrate, hexahydrate

Fe3(C6H5O7)2 x 6H2O

-

Ferrous fumarate

FeC4H2O4

-

Ferrous lactate, trihydrate

Fe(C3H5O3)2 x 3H2O

-

Ferric oxide

Fe2O3

-

Ferrous sulphate, monohydrate

FeSO4 x H2O

Permitted:(i) in denatured skimmed milk powder and in compound feedingstuffs manufactured from denatured skimmed milk powder: – subject to the mandatory provisions of Commission Regulations (EEC) No 368/77 and (EEC) No 443/77 – declaration of the amount of iron added, expressed as the element, on the label or package or container of denatured skimmed milk powder (ii) in compound feedingstuffs other than those listed under (i)

Ferrous sulphate, heptahydrate

FeSO4 x 7H2O

Permitted: (i) in denatured skimmed milk powder and in compound feedingstuffs manufactured from denatured skimmed milk powder: - subject to the mandatory provisions of Commission Regulations (EEC) No. 368/77 and (EEC) No 443/77 – declaration of the amount of iron added, expressed as the element, on the label or package or container of denatured skimmed milk powder (ii) in compound feedingstuffs other than those listed under (i)

Ferrous chelate of amino acids, hydrate

Fe(x)13 x nH2O where x equals an anion of any amino acid derived from hydrolysed soya protein). Molecular weight not exceeding 1500

E2

Iodine - I

Calcium iodate, hexahydrate

Ca(IO3)2 • 6H2O

Equines: 4 (total)Fish: 20 (total) Other species or categories of animal: 10 (total)

Calcium iodate, anhydrous

Ca(IO3)2

Equines: 4 (total) Fish: 20 (total) Other species or categories of animal: 10 (total)

Sodium iodide

Nal

Equines: 4 (total) Fish: 20 (total) Other species or categories of animal: 10 (total)

Potassium iodide

KI

Equines: 4 (total) Fish: 20 (total) Other species or categories of animal: 10 (total)

E3

Cobalt - Co

10 (total)

Cobaltous acetate, tetrahydrate

Co(CH3COO)2 • 4H2O

-

Basic cobaltous carbonate, monohydrate

2 CoCO3 • 3 Co(OH)2 • H2O

-

Cobaltous chloride, hexahydrate

CoCl2 • 6H2O

-

Cobaltous sulphate, heptahydrate

CoSO4 • 7H2O

-

Cobaltous sulphate, monohydrate

CoSO4 • H2O

-

Cobaltous nitrate, hexahydrate

CO(NO3)2 • 6H2O

-

E4

Copper - Cu

Cupric acetate, monohydrate

Cu(CH3COO)2 • H2O

Pigs for fattening: -in Member States where the mean density of the porcine population is equal to or higher than 175 pigs per 100 ha of utilisable agricultural land: - up to 16 weeks: 175 (total) - from 17th week up to slaughter: 35m (total) - in Member States where the mean density of the porcine population is lower than 175 pigs per 100 ha of utilisable agricultural land: - up to 16 weeks: 175 (total) - from 17th week up to 6 months: 100 (total) - over 6 months up to slaughter: 35 (total) Breeding pigs: 35 (total)Calves: - milk replacers 30 (total) - other complete feedingstuffs: 50 (total) Ovines: 15 (total) - categories of animals: 35 (total)

-

Basic cupric carbonate, monohydrate

CuCO3 • Cu(OH)2 • H2O

-

Cupric chloride, dihydrate

CuCl2 . 2H2O

-

Cupric methionate

Cu(C5H10NO2S)2

-

Cupric oxide

CuO

-

Cupric sulphate, pentahydrate

CuSO4 • 5H20

-

Cupric sulphate, monohydrate

CuSO4 • H2O

Pigs for fattening: - in Member States where the mean density of the porcine population is equal to or higher than 175 pigs per 100 ha of utilisable agricultural land: - up to 16 weeks: 175 (total) - from 17th week up to slaughter: 35(total) - in Member States where the mean density of the porcine population is lower than 175 pigs per 100 ha of utilisable agricultural land: - up to 16 weeks: 175 (total) - from 17th week up to 6 months: 100 (total) - over 6 months up to slaughter: 35 (total) Breeding pigs: 35 (total) Ovines: 15 (total) Other species or categories of animals with the exception of calves: 35 (total)

Denatured skimmed milk powder and compound feedingstuffs manufactured from denatured skimmed milk powder - subject to the relevant provisions of Commission Regulations (EEC) No. 368/77 and (EEC) No. 443/77 - Declaration of the amount of copper added, expressed as the element, on the label or package or container of denatured skimmed milk powder

Cupric sulphate, pentahydrate

CuSO4 • 5H2O

E5

Manganese -Mn

250 (total)

Manganous carbonate

MnCO3

-

Manganous chloride, tetrahydrate

MnCl2 • 4H2O

-

Manganous hydrogen phosphate, trihydrate

MnHPO4 • 3H2O

-

Manganous oxide

MnO

-

Manganic oxide

Mn2O3

-

Manganous sulphate, tetrahydrate

MnSO4 • 4H2O

-

Manganous sulphate, monohydrate

MnSO4 • H2O

-

E6

Zinc - Zn

250 (total)

Zinc lactate, trihydrate

Zn(C3H5O3)2 • 3H2O

-

Zinc acetate, dihydrate

Zn(CH3COO)2 • 2H2O

-

Zinc carbonate

ZnCO3

-

Zinc chloride, monohydrate

ZnCl2 • H2O

-

Zinc oxide

ZnO

Maximum content of lead: 600mg/kg

Zinc sulphate, heptahydrate

ZnSO4 • 7H2O

-

Zinc sulphate, monohydrate

ZnSO4 • H2O

-

E7

Molybdenum - Mo

2.5 (total)

Ammonium molybdate

(NH4)6 Mo7O24 • 4H2O

-

Sodium molybdate

Na2 MoO4 • 2H2O

-

E8

Selenium - Se

0.5 (total)

Sodium selenite

Na2 SeO3

-

Sodium selenate

Na2 SeO4

-

EEC No.

Additive

Chemical formula, description

Species or category of animal

Maximum Age

Minimum content

Maximum content

Other provisions

mg/kg complete feeding stuff

L. Binders, anti-caking agents and coagulants

E 330

Citric acid

C6H8O7

All species or categories of animals

All feedingstuffs. Compliance with provisions of Article 16(1)(g).

E470

Sodium, potassium and calcium stearates

C18H35O2 Na C18H35O2K and C36H70O4 Ca

All species or categories of animals

All feedingstuffs

E 516

Calcium sulphate, dihydrate

CaSO4 x 2H2O

All species or categories of animals

30000

All feedingstuffs

E 551a

Silicic acid, precipitated and dried

All species or categories of animals

All feedingstuffs

E 551b

Colloidal silica

All species or categories of animals

All feedingstuffs

E 551c

Kieselguhr (Diatomaceous earth, purified)

All species or categories of animals

All feedingstuffs

E 552

Calcium silicate, synthetic

All species or categories of animals

All feedingstuffs

E 554

Sodium aluminosilicate, synthetic

All species or categories of animals

All feedingstuffs

E 558

Bentonite-montmorillonite

All species or categories of animals

20 000

All feedingstuffs Mixing with additives from the groups of "Antibiotics", "Growth promoters", "Coccidiostats and other medicinal substances" is prohibited except in the case of: tylosin phosphate, monensin sodium, narasin, ipronidazole, lasalocid sodium, avoparcin, flavophospholipol, salinomycin sodium, ronidazole, virginiamycin, nicarbazin, robenidine, maduramicin ammonium Indication on the label of the specific name of the additive.

E 559

Kaolinitic clays, free of asbestos

Naturally occurring mixtures of minerals containing at least 65% complex hydrated aluminium silicates whose main constituent is kaolinite

All species or categories of animals

All feedingstuffs

E560

Natural mixtures of steatite and chlorite free of asbestos: minimum purity of the mixture: 85%

All species or categories of animals

All feedingstuffs

E 561

Vermiculite

Natural silicate of magnesium, aluminium and iron, expanded by heating, free of asbestos. Maximum fluorine content: 0.3%

All species or categories of animals

All feedingstuffs

E 562

Sepiolite

Hydrated magnesium silicate of sedimentary origin, containing at least 60% sepiolite and a maximum of 30% montmorillonite, free of asbestos

All species or categories of animals

20 000

All feedingstuffs

E 563

Sepiolitic clay

Hydrated magnesium silicate of sedimentary origin, containing at least 40% sepiolite and 25% illite, free of asbestos.

All species or categories of animals

20000

All feedingstuffs

E565

Lignosulphonates

All species or categories of animals

All feedingstuffs

E 598

Synthetic calcium aluminates

Mixture of calcium aluminates containing between 35 and 51% of Al203 Maximum molybdenum content of 20 mg/kg

Poultry

20 000

All feedingstuffs

Rabbits

20000

All feedingstuffs

Pigs

20 000

All feedingstuffs

E 599

Perlite

Natural silicate of sodium and Aluminium, expanded by heating, free of asbestos

All species or categories of animals

All feedingstuffs

EEC No.

Additive

Chemical formula, description

Species or category of animal

Maximum Age

Minimum content

Maximum content

Other provisions

mg/kg complete feedingstuff

M. Acidity regulators

E 170

Calcium carbonate

Dogs

Cats

DL– and L–Malic acid

Dogs

Cats

Ammonium dihydrogen orthophosphate

Dogs

Cats

diAmmonium hydrogen orthophosphate

Dogs

Cats

E 339(i)

Sodium dihydrogen orthophosphate

Dogs

Cats

E 339(ii)

diSodium hydrogen orthophosphate

Dogs

Cats

E 339(iii)

triSodium orthophosphate

Dogs

Cats

E 340(i)

Potassium dihydrogen orthophosphate

Dogs

Cats

E 340(ii)

diPotassium hydrogen orthophosphate

Dogs

Cats

E 340(iii)

triPotassium orthophosphate

Dogs

Cats

E 341(i)

Calcium tetrahydrogen diorthophosphate

Dogs

Cats

E 341(ii)

Calcium hydrogen orthophosphate

Dogs

Cats

E 350(i)

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

Dogs

Cats

E 450(a)(i)

diSodium dihydrogen diphosphate

Dogs

Cats

E450(a)(iii)

tetraSodium diphosphate

Dogs

Cats

E450(a)(iv)

tetraPotassium diphosphate

Dogs

Cats

E 450(b)(i)

pentaSodium triphosphate

Dogs

Cats

E450(b)(ii)

pentaPotassium triphosphate

Dogs

Cats

E 500(i)

Sodium carbonate

Dogs

Cats

500(ii)

Sodium hydrogen carbonate

Dogs

Cats

500(iii)

Sodium sesquicarbonate

Dogs

Cats

501(ii)

Potassium hydrogen carbonate

Dogs

Cats

503(i)

Ammonium carbonate

Dogs

Cats

503(ii)

Ammonium hydrogen carbonate

Dogs

Cats

507

Hydrochloric acid

Dogs

Cats

510

Ammonium chloride

Dogs

Cats

513

Sulphuric acid

Dogs

Cats

524

Sodium hydroxide

Dogs

Cats

525

Potassium hydroxide

Dogs

Cats

526

Calcium hydroxide

Dogs

Cats

529

Calcium oxide

Dogs

Cats

540

diCalcium diphosphate

Dogs

Cats

THIRD SCHEDULE

"SECOND SCHEDULE

Additives authorised in feedingstuffs and conditions of use

No.

Additive

Chemical formula, description

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

Period of authorisation

mg/kg of complete feedingstuff

B. Antioxidants

E. Emulsifiers, stabilisers, thickeners and gelling agents

F. Colouring matters including pigments

1. Carotenoids and xanthophylls:

2. Other colouring matter:

11

Astaxanthin-rich Phaffia rhodozyma

Concentrated biomass of the yeast Phaffia rhodozyma (CBS 116.94), killed, containing at least 2.5 g astaxanthin per kilogram additive

Salmon

-

-

100

The maximum content is expressed as astaxanthinUse only permitted from the age of 6 months onwards The mixture of the additive with canthaxanthin is allowed provided that the total concentration of astaxanthin and canthaxanthin does not exceed 100 mg/kg in the complete feedingstuff

30.11.1996

Trout

-

-

100

The maximum content is expressed as astaxanthin Use only permitted from the age of 6 months onwards The mixture of the additive with canthaxanthin is allowed provided that the total concentration of astaxanthin and canthaxanthin does not exceed 100 mg/kg in the complete feedingstuff

30.11.1996

G. Preservatives

I. Trace elements

J. Growth promoters

L. Binders, anti-caking agents and coagulants

1

Synthetic calcium aluminates

Mixture of calcium aluminates containing between 35% and 51% Al2O3 Maximum molybdenum content: 20 mg/kg

Dairy cows

-

-

8 000

All feedingstuffs

30.11.1996

Cattle for fattening

-

-

8 000

All feedingstuffs

30.11.1996

Calves

-

-

8 000

All feedingstuffs

30.11.1996

Lambs

-

-

8 000

All feedingstuffs

30.11.1996

Kids

-

-

8 000

All feedingstuffs

30.11.1996

2

Natrolite-phonolite

Natural mixture of aluminium silicates, alkalines and alkaline-earth and aluminium hydrosilicates, natrolite (43-46.5%) and feldspar

All species or categories of animals

-

25 000

All feedingstuffs

30.11.1996

M. Acidity regulators

No.

Additive

Chemical formula, description

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

Period of authorisation

Units of activity per kg of complete feedingstuff

N. Enzymes

1

3-phytase (EC 3.1.3.8)

Preperation of 3-phytase produced by Aspergillus niger (CBS 114.94) having a minimum, activity of 5 000 FTU/g for solid and liquid preparations

Pigs (All categories of animals)

-

-

-

-

30.11.1996

Chickens (All categories of animals)

-

-

-

-

30.11.1996

2

Endo-1,4-b-xylanase(EC 3.2.1.8)

Preperations of Endo-1,4-b-xylanase and Endo-1,4-bglucanase produced by Humicola insolens (DSM 10442) having a maximum activity of:

Chickens for fattening

-

200 FXU19FBG

-

-

30.11.1996

2

Endo-1,4-b-glucanase (EC 3.2.1.4)

- CT (coated, thermotolerant granulate): 800 FXU/g 75 FBG/g

Piglets

-

200 FXU19 FBG

-

-

30.11.1996

- MG (micro granulate):

Pigs

-

200 FXU

-

-

30.11.1996

800 FXU/g

19FBG

75 FBG/g

- L (aqueous liquid):

550 FXU/g

50 FBG/g

- SL (vegetable oil based slurry):

1600 FXU/g

150 FBG/g

No.

Additive

Chemical formula, description

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

Period of authorisation

CFU/kg of complete feedingstuff

O. Microorganisms

1

Bacillus cereus var. toyoi (CNCM I-1012/NCIB 40 112)

Preparation of Bacillus cereus var toyoi containing a minimum of 1010 CFU/g additive

Piglets

2 months

1x109

1x109

-

30.11.1996

4 months

0.5 x 109

1x109

-

30.11.1996

Pigs

6 months

0.2 x 109

1x109

-

30.11.1996

Sows

-

1x109

2x109

-

30.11.1996

2

Bacillus licheniformis (DSM 5749) /Bacillus subtilis(DSM 5750) [In a 1/1 ratio]

Mixture of Bacillus licheniformisandBacillus subtilis containing 3.2x109 CFU/g additive (1.6 x 109 CFU/g of each bacteria)

Piglets

4 months

1.28 x 109

3.2 x 109

-

30.11.1996

3

Saccharomyces cerevisiae (NCYC Sc 47)

Preparation of Saccharomyces cerevisiae containing a minimum of 5x109/g additive

Cattle for fattening

-

4x109

8x109

Indicate in the instructions for use:

30.11.1996

"The quantity of Saccharomyces cerevisiae in the daily ration must not exceed 2.5x1010 CFU for 100 kg bodyweight and 0.5x1010 CFU for each additional 100 kg bodyweight."

4

Bacillus cereus (ATCC 14893 / CIP 5832)

Preparation of Bacillus cereus containing a minimum of 1010 CFU/g additive

Rabbits for fattening

-

0.5x109

2x109

-

30.11.1996

Breeding rabbits

-

0.5 x 109

2x109

-

30.11.1996

GIVEN under my Official Seal, this 22nd day of August, 1996

___________________

Ivan Yates

Minister for Agriculture, Food and Forestry

EXPLANATORY NOTE

These Regulations amend the European Communities (Additives in Feedingstuffs) Regulations, 1989, so as to give effect to Commission Directive 96/7/EC, which amends Annexes I and II to Council Directive 70/524/EEC concerning additives in feedingstuffs, with regard to the additives authorised in feedingstuffs and their conditions of use.