S.I. No. 127/1997 - European Communities (Additives in Feedingstuffs) (Amendment) Regulations, 1997


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 96/66/EC of 14 October, 19961, Commission Directive 97/6/EC of 30 January, 19972, and for the purpose of giving further effect to Council Directive 70/524/EEC of 23 November, 19703, as amended, hereby make the following Regulations:

1O.J. No L 272,25. 10. 1996, p. 32

2O.J. No. L35, 5.2.1997, p. 11

3O.J. No. L 270, 14.12.1970, p. 1I

1. (1) These Regulations may be cited as the European Communities (Additives in Feedingstuffs) (Amendment) Regulations, 1997.

(2) The European Communities (Additives in Feedingstuffs) Regulations 1989 to 1996, and these Regulations may be cited together as the European Communities (Additives in Feedingstuffs) Regulations, 1989 to 1997.

(3) These Regulations shall come into effect on 31^ day of March, 1997.

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:

1O.J. No. L 270, 14.12.1970, p.1

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

2O.J.No. L124, 10.5.1973, p.17

 Council Directive No. 75/296/EEC of 28 April, 1975 3

3O.J. No. L 124, 15.5.1975, p.29

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

4O.J. No. L 319, 8.12.1984, p.13

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

5O.J. No. L 124, 18.5.1991, p.1

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

6O.J. No. L 124, 18.5.1991, p.43

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

7O.J. No. L 185, 11.7.1991, p.31

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

8O.J. No. L 271, 27.9.1991, p.67

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

9O.J. No. L 334, 5.12.1991, p.62

 Commission Directive No. 92/64/EEC of 13 July 1992,10

10O.J. No. L221, 6.8.1992, p.51

 Commission Directive No. 92/99/EEC of 17 November, 1992,11

11O.J. No. L 350, 1.12.1992, p.83

 Commission Directive No. 92/113/EEC of 16 December, 1992,12

12O.J, No. L 16,25.1.1993, p.2

 Commission Directive No. 93/27/EEC of 4 June, 1993,13

13O.J. No. L 179, 22.7.1993, p.5

 Commission Directive No. 93/55/EEC of 25 June, 1993,14

14O.J. No. L 206, 18.8.1993, p.11

 Commission Directive No. 93/107/EEC of 26 November, 1993,15

15O.J. No. L 299,4.12.1993, p. 44 '

 Council Directive No. 93/114/EC of 14 December, 1993,16

16O.J. No. L 334, 31.12.1993, p. 24 '

 Commission Directive No. 94/17/EC of 22 April, 1994,17

17O.J. No. L 105, 26.4.1994, p. 19

 Commission Directive No. 94/40/EC of 22 July, 199418

18O.J. No. L 208, 11.8.1994, p. 15

 Commission Directive No. 94/4 I/EC of 18 July, 199419

19O.J. No. L 209, 12.8.1994, p. 18

 Commission Directive No. 94/50/EC of 31 October, 1994,20

20O.J. No. L 297, 18.11.1994, p. 27

 Commission Directive No. 94/77/EC of 20 December, 1994,21

21O.J. No. L 350, 31.12.94, p. 113

 Commission Directive No. 95/1 I/EC of 4 May, 199522,

22O.J. No. L106, 11.5.1995, p.23

 Commission Directive No. 95/37'/EC of 18 July, 199523,

23O.J. No. L 172,22.7.1995, p. 21

 Commission Directive No. 95/55/EC of 31 October, 19951,

1O.J. No. L 263,4.11.1995, p. 18

 Commission Directive No. 96/7/EC of 21 February, 19962

2O.J. No. L51, 1.3. 1996, p. 45

 Commission Directive No. 96/66/EC of 14 October, 19963, and

3O.J. No. L 272, 25. 10. 1996, p. 32

 Commission Directive No. 97/6/EC of 30 January, 19964

4O.J. No. L35, 5.2.1997, p. 11

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

C6H8O6

All species or categories of animals

-

-

-

All feedingstuffs

E 301

Sodium L-ascorbate

C6H7O6Na

All species or categories of animals

-

-

-

All feedingstuffs

E 302

Calcium L-ascorbate

C12H14O12Ca x 2H2O

All species or categories of animals

-

-

-

All feedingstuffs

E 303

5,6—Diacetyl-L-ascorbic acid

C10H12O8

All species or categories of animals

-

-

-

All feedingstuffs

E 304

6—Palmityl-L-ascorbic 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 α-tocopherol

C29H50O2

All species or categories of animals

-

-

-

All feedingstuffs

E 308

Synthetic γ-tocopherol

C28H48O2

All species or categories of animals

-

-

-

All feedingstuffs

E 309

Synthetic δ-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 E311 or E312

All feedingstuffs

E 311

Octyl gallate

C15H22O5

All species or categories of animals

-

-

100 alone or together with E310 or E312

All feedingstuffs

E 312

Dodecyl gallate

C19H30O5

All species or categories of animals

-

-

100 alone or together with E310 or E311

All feedingstuffs

E 320

Butylated hydroxyanisole (BHA)

C11H16O2

All species or categories of animals

-

-

150 alone or together with E321 or E324

All feedingstuffs

E 321

Butylated hydroxytoluene (BHT)

C15H24O

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 E320 or E321

All feedingstuffs

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

C7H2NcaO3S

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

-

E. Emulsifiers, stabilisers, thickeners and gelling agents

E 322

Lecithins

-

All species or categories of animals

-

-

-

All feedingstuffs

E 400

Alginic acid

-

All species or categories of animals

-

-

-

All feedingstuffs

E 401

Sodium alginate

-

All species or categories of animals

-

-

-

All feedingstuffs

E 402

Potassium alginate

-

All species or categories of animals

-

-

-

All feedingstuffs

E 403

Ammonium alginate

-

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

-

-

-

All feedingstuffs

E 404

Calcium alginate

-

All species or categories of animals

-

-

-

All feedingstuffs

E 405

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

-

All species or categories of animals

-

-

-

All feedingstuffs

E 406

Agar

-

All species or categories of animals

-

-

-

All feedingstuffs

E 407

Carrageenan

-

All species or categories of animals

-

-

-

All feedingstuffs

E 408

Furcelleran

-

All species or categories of animals

-

-

-

All feedingstuffs

E 410

Locust bean gum (Carob gum)

-

All species or categories of animals

-

-

-

All feedingstuffs

E 411

Tamarind seed flour

-

All species or categories of animals

-

-

-

All feedingstuffs

E 412

Guar gum

-

All species or categories of animals

-

-

-

All feedingstuffs

E 413

Tragacanth

-

All species or categories of animals

-

-

-

All feedingstuffs

E 414

Acacia (Gum arabic)

-

All species or categories of animals

-

-

-

All feedingstuffs

E 415

Xanthan gum

-

All species or categories of animals

-

-

-

All feedingstuffs

E 418

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)—sorbitan monooleate

-

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 450b (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

Hydroxypropylmethyl-cellulose

-

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

E470

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

E471

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) acetic

b) lactic

c) citric

d) tartaric

e) 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 propane-1,2—diol (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

-

-

-

AH 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

Dextrans

-

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

Polyoxypropylene-polyoxyethylene 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

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

β-apo-8-carotenal

C30H40O

Poultry

-

-

80 (alone or with the other carotenoids and xanthophylls)

-

E 160f

Ethyl ester of β-apo-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

-

-

-

-

2. Other colourants:

E 102

Tartrazine

C16H9N4O9S2Na3

Ornamental fish

-

-

-

-

E 110

Sunset Yellow FCF

C16H10N207S2Na2

Ornamental fish

-

-

-

-

E 124

Ponceau 4 R

C20H11N2O10S3Na3

Ornamental fish

-

-

-

-

E 127

Erythrosine

C20H6I4O5Na2 x H2O

Ornamental fish

-

-

-

-

E 131

Patent Blue V

Calcium salt of the disulphonic acid of m-hydroxytetraethyl-diaminotriphenyl-carbinol anhydride

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,

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

C16H8N2O8S2Na2

Ornamental fish

-

-

-

-

E 141

Chlorophyll copper complex

Ornamental fish

-

-

-

-

E 142

Acid Brilliant Green BS (Lissamine Green)

Sodium salt of 4,4-bis(dimethylamino)

diphenylmethylene-2—naphtol-3,6-disulphonic acid

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

-

-

-

Permitted in animal feedingstuffs only in products processed 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

-

-

-

-

G Preservatives

E 200

Sorbic acid

C6H8O2

All species or categories of animals

-

-

-

All feedingstuffs

E 201

Sodium sorbate

C6H2O2Na

All species or categories of animals

-

-

-

All feedingstuffs

E 202

Potassium sorbate

C6H2O2K

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 4—hydroxybenzoate

C8H3O3

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 E223: 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 E222: 500 expressed as SO2

All feedingstuffs except unprocessed meat and fish

E 236

Formic acid

CH2O2

All species or categories of animals

-

-

-

All feedingstuffs

E 237

Sodium formate

CHO2Na

All species or categories of animals

-

-

-

All feedingstuffs

E 238

Calcium formate

C2H2O4Ca

All species or categories of animals

-

-

-

All feedingstuffs

E 240

Formaldehyde

CH2O

Pigs

6 months

-

-

Skimmed milk only: maximum content: 600 mg

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

C2H3O2K

All species or categories of animals

-

-

-

All feedingstuffs

E 262

Sodium diacetate

C4H2O4Na

All species or categories of animals

-

-

-

All feedingstuffs

E 263

Calcium acetate

C4H5O4Ca

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

C3H5O2

All species or categories of animals

-

-

-

All feedingstuffs

E 281

Sodium propionate

C3H5O2Na

All species or categories of animals

-

-

-

All feedingstuffs

E 282

Calcium propionate

C6H10O4Ca

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

C3H2O2N

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

C3H5O3Na

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

C6H10O6Ca

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

HCl

All species or categories of animals

-

-

-

For silage only

E 513

Sulphuric acid

H2SO4

All species or categories of animals

-

-

-

For silage only

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 feedingstuffs 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

E 670

2. Vitamin D

Vitamin D2

-

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 D2 prohibited

Calves

-

10 000

Milk replacers only

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

E 671

Vitamin D3

-

Pigs

-

2 000

-

Simultaneous use of vitamin D2 prohibited

Piglets

-

10 000

Milk replacers only

Simultaneous use of vitamin D2 prohibited

Bovines

-

4 000

-

Simultaneous use of vitamin D2 prohibited

Ovines

-

4 000

-

Simultaneous use of vitamin D2 prohibited

Calves

-

10 000

Milk replacers only

Simultaneous use of vitamin D2 prohibited

Equines

-

4 000

-

Simultaneous use of vitamin D2 prohibited

Chickens for fattening

-

5 000

-

Simultaneous use of vitamin D2 prohibited

Turkeys

-

5 000

-

Simultaneous use of vitamin D2 prohibited

Other poultry

-

3 000

-

Simultaneous use of vitamin D2 prohibited

Fish

-

3 000

-

Simultaneous use of vitamin D2 prohibited

Other species or categories of animals

-

2 000

-

Simultaneous use of vitamin D2 prohibited

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

-

All species or categories of animals

-

-

All feedingstuffs

I. Trace elements

E 1

Iron - Fe

1250 (total)

Ferrous carbonate

FeCO3

-

Ferrous chloride, tetrahydrate

FeCL2 x 4H2O

-

Ferric chloride, hexahydrate

FeCL3x 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)1—3 x nH2O (where x equals an anion of any amino acid derived from hydrolysed soya protein).

Molecular weight not exceeding 1500

-

E 2

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

Kl

Equines: 4 (total)

Fish: 20 (total)

Other species or categories of animal: 10 (total)

-

E 3

Cobalt Co

10 (total)

Cobaltous acetate, tetrahydrate

Co(CH3COO) 2 4H2O

-

Basic cobaltous carbonate, monohydrate

2CoCo3 3Co(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

-

E 4

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: 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)

Calves:

- milk replacers 30 (total)

- other complete feedingstuffs: 50 (total)

Ovines: 15 (total)

Other species or categories of animals: 35 (total)

-

Basic cupric carbonate, monohydrate

CuCO2 Cu(OH) 2 H2O

-

Cupric chloride, dihydrate

CuCl2 2H2O

-

Cupric methionate

Cu(C5H10NO2S) 2

-

Cupric oxide

CuO

-

Cupric sulphate, pentahydrate

CuSO4 5H2O

-

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

Cupric sulphate, pentahydrate

CuSO4 5H2O

Declaration of the amount of copper added, expressed as the element, on the label or package or container of denatured skimmed milk powder

E 5

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

-

E 6

Zinc-Zn

250 (total)

Zinc lactate, trihydrate

Zn(C3H5O3) 2 3H2O

-

Zinc acetate, dihydrate

Zn(CH3COO)22H2O

-

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

-

E 7

Molybdenum - Mo

2.5 (total)

Ammonium molybdate

(NH4) 6Mo7O24 4H2O

-

Sodium molybdate

Na2MoO4 2H2O

-

E 8

Selenium - Se

0.5 (total)

Sodium selenite

Na2SeO3

-

Sodium selenate

Na2SeO4

-

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(l)(g).

E 470

Sodium, potassium and calcium stearates

C18H35O2Na C18H35O2K and C36H70O4Ca

All species or categories of animals

-

-

-

All feedingstuffs

E 516

Calcium sulphate, dihydrate

CaSO4 x 2H2O

All species or categories of animals

-

-

30 000

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

E558

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: lyiosin 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

E 560

Natural mixtures of steatite and chlorite

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

-

-

20 000

All feedingstuffs

E 565

Lignosulphonates

All species or categories of animals

-

-

-

All feedingstuffs

E 598

Synthetic calcium aluminates

Mixture of calcium aluminates containing between 35 and 51% of AI2O3 Maximum molybdenum content of 20 mg/kg

Poultry

-

-

20 000

All feedingstuffs

Rabbits

-

-

20 000

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

M. Acidity regulators

E 170

Calcium carbonate

-

Dogs

-

-

-

-

Cats

-

-

-

-

E 296

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

-

-

-

-

E 450(a)(iii)

tefraSodium diphosphate

-

Dogs

-

-

-

-

Cats

-

-

-

-

E 450(a)(iv)

tetraPotassium diphosphate

-

Dogs

-

-

-

-

Cats

-

-

-

-

E 450(b)(i)

pentaSodium triphosphate

-

Dogs

-

-

-

-

Cats

-

-

-

-

E 450(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 their 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 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

30.11.1997

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 canthaxanthinis allowed provided that the total concentration of astaxanthin and canthaxanthin does not exceed 100 mg/kg in the complete feedingstuff

30.11.1997

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

30.11.1997

Cattle for fattening

-

-

8 000

All feedingstuffs

30.11.1997

Calves

-

-

8 000

All feedingstuffs

30.11.1997

Lambs

-

-

8 000

All feedingstuffs

30.11.1997

Kids

-

-

8 000

All feedingstuffs

30.11.1997

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

30.11.1997

M. Acidity regulators

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)

-

-

-

-

30.11.1997

Chickens (All categories of animals)

-

-

-

-

30.11.1997

O. Micro-organisms

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

1 x 109

1 x 109

-

30.11.1997

4 months

0.5 x 109

1 x 109

-

30.11.1997

Pigs

6 months

0.2 x 109

1 x 109

-

30.11.1997

Sows

-

1 x 109

2 x 109

-

30.11.1997

2

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

Mixture of Bacillus licheniformis and Bacillus subtilis containing 3.2 /images/s36208b7ceb181b.jpg 10 CFU/g additive (1.610 CFU/g of each bacteria]

Piglets

4 months

1.28 x 109

3.2 x 19

-

30.11.1997

3

Saccharomyces cerevisiae (NCYC Sc 47)

Preparation of Saccharomyces cerevisiae containing a minimum of 5 /images/s3cd88b7ceb181c.jpg 109/g additive

Cattle for fattening

-

4 x 109

8 x 109

Indicate in the instructions for use:

"The quantity of Saccharomyces cerevisiae in the Daily ration must not exceed 2.51010 CPU for 100 kg bodyweight and 0.51010 CPU for each additional 100 kg bodyweight."

30.11.1997

4

Bacillus cereus (ATCC 14893 / CIP 5832)

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

Rabbits for fattening

-

0.5 x 109

2 x 109

-

30.11.1997

Breeding rabbits

-

0.5 x 19

2 x 109

-

30.11.1997

P. Radionuclide binders

1.

Redioactive caesium binders (137Cs and 134 Cs)

1.1

Ferric (III) ammonium hexacyanoferrate (II)

NH4 Fe(III)(Fe(II)(CN)6)

Ruminants (domestic and wild)

-

/images/s1997si003.jpg

50

500

Indicate in the instructions for use:

"The quantity of Ferric (III) ammonium hexacyanoferrate (II) in the daily ration must be between 10 mg and 150 mg for 10 kg of body weight"

30.11.1997

Calves prior to the start of rumination

-

30.11.1997

Lambs prior to the start of rumination

-

30.11.1997

Kids prior to the start of rumination

-

30.11.1997

Pigs (domestic and wild)

-

30.11.1997

GIVEN under my Official Seal, this 24th day of March, 1997.

__________________________

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 96/66/EC and Commission Directive 97/6/EC. Directive 96/66/EC provides for some minor amendments to the Schedules. Directive 97/6/EC provides that the use of avoparcin in feedingstuffs for all animal species is prohibited.