S.I. No. 345/1991 - European Communities (Additives in Feedingstuffs) (Amendment) (No. 2) Regulations, 1991

1. Vitamin A

—

Chickens for fattening

—

13,500

All feedingstuffs except feedingstuffs for young animals

Ducks for fattening

—

13,500

Turkeys for fattening

—

13,500

Lambs for fattening

—

13,500

Pigs for fattening

—

13,500

Bovines for fattening

—

13,500

Calves for fattening

—

25,000

Milk replacers only

Other species or categories of animals

—

—

All feedingstuffs

2. Vitamin D

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

E670

Vitamin D

2

—

Piglets

—

2,000

—

Pigs

—

10,000

Milk replacers only

Bovines

—

4,000

Ovines

—

4,000

Calves

—

10,000

Milk replacers only

Simultaneous use of vitamin D

3

prohibited

Equines

—

4,000

—

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

—

2,000

—

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

E671

Vitamin D

3

—

Pigs

—

2,000

—

Piglets

—

10,000

Milk replacers only

Bovines

—

4,000

Ovines

—

4,000

Calves

—

10,000

Milk replacers only

Simultaneous use of vitamin D

3

prohibited

Equines

—

4,000

—

Chickens for fattening

—

5,000

—

Turkeys

—

5,000

—

Other poultry

—

3,000

—

Fish

—

3,000

—

Other species or categories of animals

—

2,000

—

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

—

All species or categories of animals

—

—

All feedingstuffs

EEC No.

Element

Additive

Chemical formula

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

Other provisions

G. Trace elements

E 1

Iron-Fe

1,250 (total)

—

Ferrous carbonate

FeCO

3

—

Ferrous chloride, tetrahydrate

FeCl

2

.4H

2

O

—

Ferrous chloride, tetrahydrate

—

Ferric chloride, hexahydrate

FeCl

3

.6H

2

O

—

Ferrous citrate, hexahydrate

Fe

3

(C

6

H

5

O

7

)

2

.6H

2

O

—

Ferrous fumarate

FeC

4

H

2

O

4

—

Ferrous lactate, trihydrate

Fe(C

3

H

5

O

3

)

2

.3H

2

O

—

Ferric oxide

Fe

2

O

3

—

Ferrous sulphate monohydrate

FeSO

4

.H

2

O

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.

EEC No.

Element

Additive

Chemical formula

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

Other provisions

—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

FeSO

4

.7H

2

O

Permitted

(i) in denatured skimmed-milk powder and in compound feedingstuffs manufactured from denatured skimmed-milk powder

—Subject to the mandatory provisions of Commission

EEC No.

Element

Additive

Chemical formula

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

Other provisions

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

.n H

2

o (where x equals an anion of any amino acids derived from hydrolyzed soya protein). Molecular weight not exceeding 1 500.

EEC No.

Element

Additive

Chemical formula

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

Other provisions

E 2

Iodine — I

Calcium iodate, hexahydrate

Ca(IO

3

)

2

.6H

2

O

40 (total)

—

Calcium iodate, anhydrous

Ca(IO

3

)

2

—

Sodium iodite

NaI

—

Potassium iodite

KI

—

E 3

Cobalt-Co

10 (total)

Cobaltous acetate, tetrahydrate

Co(CH

3

COO)

2

.4H

2

O

—

Basic cobaltous carbonate, monohydrate

2CoCO

3

.3Co(OH)

2

.H

2

O

—

Cobaltous chloride, hexahydrate

CoCL

2

.6H

2

O

—

Cobaltous sulphate, heptahydrate

CoSO

4

.7H

2

O

—

Cobaltous nitrate, hexahydrate

Co(NO

3

)2.

6

H

2

O

—

E 4

Copper-Cu

Cupric acetate, monohydrate

Cu(CH

3

COO)

2

.H

2

O

Pigs for fattening

—

Basic cupric carbonate, monohydrate

CuCo3.Cu(OH)2.H

2

O

—In Member States

—

Cupric chloride, dihydrate

CuCl

2

2H

2

O

where the mean density of the porcine population is equal to or higher than 175 pigs per 100 ha of utilizable agricultural land

—

Cupric methionate

Cu(C

5

H

10

NO

2

S)

2

—

Cupric oxide

CuO

—

Cupric sulphate, pentahydrate

CuSO

4

.

5

H

2

O

—

EEC No.

Element

Additive

Chemical formula

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

Other provisions

— 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 utilized agricultural land

— up to 16 weeks: 175 (total)

— from 17th week up to six months: 100 (total)

— over six months up to slaughter: 35 (total)

Breeding Pigs: 35 (total)

EEC No.

Element

Additive

Chemical formula

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

Other provisions

Calves

— milk replacers: 30 (total)

— other complete feedingstuffs: 50 (total)

Ovines: 15 (total)

Other species or categories of animals: 35 (total)

Cupric sulphate, monohydrate

CuSO

4

.H

2

O

Pigs for fattening

Denatured skimmed milk powder and compound feedingstuffs manufactured from denatured skimmed-milk powder

Cupric sulphate, pentahydrate

CuSO

4

.5H

2

O

— In Member States where the mean density of the porcine population is equal to or higher than 175 pigs per 100 ha of utilizable agricultural land

EEC No.

Element

Additive

Chemical formula

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

Other provisions

— up to 16 weeks: 175 (total)

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

— 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 utilizable agricultural land

— up to 16 weeks: 175 (total)

— from 17th week up to six months: 100 (total)

— over six 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)

EEC No.

Element

Additive

Chemical formula

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

Other provisions

E 5

Manganese—Mn

250 (total)

Manganous carbonate

MnCO

3

Manganous chloride, tetrahydrate

MnCl

2

.4H

2

0

Manganous hydrogen phosphate, trihydrate

MnHPO

4

.3H

2

O

Manganous oxide

MnO

Manganic oxide

Mn

2

O

3

Manganous sulphate, tetrahydrate

MnSO

4

.4H

2

O

Manganous sulphate, monohydrate

MnSO

4

.H

2

O

E 6

Zinc—Zn

250 (total)

Zinc lactate, trihydrate

Zn(C

3

H

5

O

3

)

2

.3H

2

O

Zinc acetate, dihydrate

Zn(CH

3

COO)

2

.2H

2

O

Zinc carbonate

ZnCO

3

Zinc chloride, monohydrate

ZnCl

2

.H

2

O

Zinc oxide

ZnO

Zinc sulphate, heptahydrate

ZnSO

4

.7H

2

O

Zinc sulphate, monohydrate

ZnSO

4

.H

2

O

EEC No.

Element

Additive

Chemical formula

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

Other provisions

E7

Molybdenum—Mo

2,5 (total)

Ammonium molybdate

(NH

4

)

6

Mo

7

O

24

.4H

2

O

Sodium molybdate

Na

2

MoO

4

.2H

2

o

E8

Selenium—Se

0,5 (total)

Sodium selenite

Na

2

SeO

3

Sodium selenite

Na

2

SeO

4

EEC No.

Additive

Chemical formula, description

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

mg/kg of complete feedingstuff

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

H. Binders, anti-caking agents and coagulants

E330

Citric acid

C

6

H

8

O

7

All species or categories of animals

—

—

—

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

E 470

Sodium, potassium

C

18

H

35

O

2

Na,

—

—

—

All feedingstuffs

and calcium

C

18

H

35

O

2

K and

—

—

—

stearates

C

36

H

70

O

4

Ca

—

—

—

E 516

Calcium sulphate dihydrate

CaSO

4

.2H

2

O

—

—

30,000

E 551a

Silicic acid, precipitated and dried

—

—

—

E 551b

Colloidal silica

—

—

—

—

E 551c

Kieselgur (diatomaceous earth, purified)

—

—

—

—

E 552

Calcium silicate, synthetic

—

—

—

—

E 553

Sepiolite

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

—

—

20,000

EEC No.

Additive

Chemical formula, description

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

mg/kg of complete feedingstuff

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

E 554

Sodiumaluminosilicate, synthetic

—

}

All species of categories of animals

—

—

—

}

E 558

Bentonite/montmorillonite

—

—

—

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,

EEC No.

Additive

Chemical formula, description

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

mg/kg of complete feedingstuff

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

Salinomycin sodium, Ronidazole, Virginiamycin, Nicarbazin and Robenidine

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%

—

—

—

EEC No.

Additive

Chemical formula, description

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

mg/kg of complete feedingstuff

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

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

—

—

—

E 565

Lignosulphonates

—

—

—

E 599

Perlite

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

—

—

—

I. Acidity regulators

E 170

Calcium carbonate

—

—

—

—

296

DL-and L-Malic acid

—

—

—

—

—

Ammonium dihydrogen orthophosphate

—

—

—

—

—

di Ammonium hydrogen orthophosphate

Dogs, cats

—

—

—

—

E 339(i)

Sodium dihydrogen orthophosphate

—

—

—

—

E 339(ii)

di Sodium hydrogen orthophosphate

—

—

—

—

EEC No.

Additive

Chemical formula, description

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

mg/kg of complete feedingstuff

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

E 339 (iii)

tri Sodium orthophosphate

—

—

—

—

E 340 (i)

Potassium dihydrogen orthophosphate

Dogs, Cats

—

—

—

—

E 340 (ii)

di Potassium hydrogen orthophosphate

—

—

—

—

E 340 (iii)

tri Potassium orthophosphate

—

—

—

—

E 341(i)

Calcium tetrahydrogen diorthophosphate

—

—

—

—

E 341(ii)

Calcium hydrogen orthophosphate

—

—

—

—

350 (i)

Sodium malate (salt of DL or L-Malic acid)

—

—

—

—

E 450 (a)(i)

di Sodium dihydrogen diphosphate

—

—

—

—

E 450 (a)(iii)

tetra Sodium diphosphate

—

—

—

—

E 450(a)(iv)

tetra Potassium diphosphate

—

—

—

—

E 450(b)(i)

penta Sodium triphosphate

Dogs, cats

—

—

—

—

E 450(b)(ii)

penta Potassium triphosphate

—

—

—

—

E 500(i)

Sodium carbonate

—

—

—

—

—

EEC No.

Additive

Chemical formula, description

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

mg/kg of complete feedingstuff

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

500 (ii)

Sodium hydrogen carbonate

Dogs, cats

—

—

—

—

500(iii)

Sodium sesquicarbonate

—

—

—

—

501 (ii)

Potassium hydrogen carbonate

—

—

—

—

503 (i)

Ammonium carbonate

—

—

—

—

503 (ii)

Ammonium hydrogen carbonate

—

—

—

—

507

Hydrochloric acid

—

—

—

—

510

Ammonium chloride

—

—

—

—

513

Sulphuric acid

—

—

—

—

524

Sodium hydroxide

—

—

—

—

529

Calcium oxide

Dogs, cats

—

—

—

—

540

di Calcium diphosphate

—

—

—

—

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

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(9)

A. Antioxidants

C. Emulsifiers, stabilizers, thickeners and gelling agents

D. Colouring matters including pigments

E. Preservatives

20

Methylpropionic acid

C4H8O2

All species or categories of animals with the exception of laying hens

—

1,000

4,000

—

30.11.92

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

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(9)

G. Trace elements

H. Binders, anti-caking agents and coagulants

1

Synthetic calcium aluminates

Mixture of calcium aluminates containing between 35 and 51% of Al2O3.

Poultry, rabbits and pigs

—

—

20,000

All feedingstuffs

30.11.92

Maximum Molybdenum content of 20 mg/kg

I. Acidity Regulators

GIVEN under my Official Seal, this 19th day of December, 1991.

MICHAEL WOODS,

Minister for Agriculture and Food.

EXPLANATORY NOTE

These Regulations amend the European Communities (Additives in Feedingstuffs) Regulations, 1989, so as to give effect to Commission Directive 91/248/EEC of 12 April, 1991, which consolidates Annexes I and II to Council Directive 70/524/EEC concerning additives in feedingstuffs, and to Commission Directives 91/249/EEC, 91/336/EEC, 91/508/EEC, and 91/620/EEC, which further amends these Annexes with regard to the additives authorised in feedingstuffs and their conditions of use.

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, 1970,

(1)

as amended by:—

(1)

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

Council Directive No. 73/103/EEC of 28 April, 1973,

(2)

(2)

O.J. No. L. 124, 10.5.1973, p. 17.

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

(3)

(3)

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

Council Directive No. 84/587/EEC of 29 November, 1984,

(4)

(4)

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

Commission Directive No. 91/248/EEC of 12 April, 1991,

(5)

(5)

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

Commission Directive No. 91/249/EEC of 19 April, 1991,

(6)

(6)

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

Commission Directive No. 91/336/EEC of 10 June, 1991,

(7)

(7)

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

Commission Directive No. 91/508/EEC of 9 September, 1991,

(8)

and

(8)

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

Commission Directive No. 91/620/EEC of 22 November, 1991.

(9)

(9)

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

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 of complete feedingstuff

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

A. Antioxidants

All species or categories of animals

—

—

—

All feedingstuff

E300

L-Ascorbic acid

C

6

H

8

O

6

—

—

—

E301

Sodium L-ascorbate

C

6

H

7

O

6

Na

—

—

—

E302

Calcium L-ascorbate

(C

12

H

14

O

12)

Ca.2H

2

O

—

—

—

E303

5, 6-Diacetyl-L-ascorbic acid

C

10

H

12

O

8

—

—

—

E304

6-Palmitoyl-L-ascorbic acid

C

22

H

38

O

7

—

—

—

E306

Tocopherol-rich extracts of natural origin

—

—

—

—

E307

Synthetic alpha-tocopherol

C

29

H

50

O

2

—

—

—

E308

Synthetic gamma-tocopherol

C

28

H

48

O

2

—

—

—

E309

Synthetic delta-tocopherol

C

27

H

46

O

2

—

—

—

EEC No.

Additive

Chemical formula, description

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

mg/kg of complete feedingstuff

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

E310

Propyl gallate

C

10

H

12

O

5

All species or categories of animals

—

—

}

100

alone or together

All feedingstuff

E311

Octyl gallate

C

15

H

22

O

5

—

—

E312

Dodecyl gallate

C

19

H

30

O

5

—

—

E320

Butylated hydroxyanisole (BHA)

C

11

H

16

O

2

—

—

E321

Butylated hydrotoluene (BHT)

C

15

H

24

O

—

—

}

E324

Ethoxyquin

C

14

H

19

NO

—

—

B. Aromatic substances and appetising substances

I, MICHAEL WOODS, Minister for Agriculture and Food, 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 No. 91/248//EEC of 12 April, 1991,

(1)

Commission Directive 91/249/EEC of 19 April, 1991,

(2)

Commission Directive 91/336/EEC of 10 June, 1991,

(3)

Commission Directive 91/508/EEC of 9 September, 1991,

(4)

and Commission Directive 91/620/EEC of 22 November, 1991,

(5)

and for the purposes of giving further effect to Council Directive 70/524/EEC of 23 November, 1970,

(6)

as amended, hereby make the following Regulations

(1)

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

(2)

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

(3)

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

(4)

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

(5)

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

(6)

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