Maltese Laws

1

2

3

4

5

6

7

Name of product

group

Name of product

Designation of

nutritive principle or identity of micro- organism

Culture substrate

(specifications, if any)

Composition

characteristics of product

Animal species

Special provisions

1. Proteins obtained

from the following groups of micro- organisms

1.1. Bacteria

1.1.1. Bacteria

cultivated on methanol

1.1.1.1. Protein

product of fermentation obtained by culture of Methylophilus Methylotrophus on methanol

Methylophilus

methylotrophus NCIB

strain 10.515

Methanol

-Crude protein

min. 68 % - Reflectance index at least 50

- Pigs

- Calves

– Poultry

- Fish

Declarations to be made

on the label or packaging of the product:

- name of the product

- crude protein,

- crude ash,

- crude fat,

- moisture content,

- instructions for use,

- Declaration of the words

'Avoid inhalation.

- approval number Declarations to be made on the label or packaging of compound feedingstuffs:

- amount of the product contained in the feedingstuff.'

1.1.2 Bacteria

cultivated on natural gas

1.1.2.1 protein

product of fermentation from natural gas obtained

by culture of:

Methylococus

capsulatus (Bath) NCIMB strain 11132

Alcaligenes acidovorans NCIMB

Natural gas: (approx.

91% methane, 5%

ethane, 2% propane,

0, 5% isobutane, 0,

5% nbutane, 1% other

crude protein:

min. 65%

- Pigs for fattening

from 25 to 60 kg

- Calves from 80 kg on

- Salmon

Declarations to be made

on the label or packaging of the product:

- the names: "Protein product of

Methylococus

capsulatus (Bath), Alcaligenes

acidovorans, Bacillus

brevis et Bacillus firmus, and the cells of which have been killed

strain 12387 Bacillus

brevis NCIMB strain

13288 Bacillus firmus

NCIMB strain 13280

components),

ammonia mineral salts

fermentation from natural

gas obtained by culture of

Methylococus capsulatus (Bath), Alcaligenes acidovorans, Bacillus brevis et Bacillus firmus"

- crude protein

- crude ash

- crude fat

- moisture content

- instructions for use

- maximum incorporation rate in

- 8% pigs for fattening

- 8% calves

- 19% salmon

(freshwater)

- 33% salmon (seawater)

- declaration of the words: "avoid inhalation".

- approval number

Declarations to be made on the label or packaging

of compound

feedingstuffs :

- The name:

"Protein product obtained by bacterial fermentation of natural gas"

- amount of the product

contained in the feedingstuff.

1.2. Yeasts

1.2.1. Yeasts cultivated on substrates of animal

All yeasts

- obtained from the micro-organisms and substrates listed in

Saccharomyces

cerevisiae, Saccharomyces carlsbergiensis,

Molasses, distillery

residues, cereals and products containing starch, fruit juice,

-

All animal species

or vegetable origin

columns 3 and 4

respectively

- the cell of which have been killed

Kluyveromyces lactis,

Kluyveromyces fragilis

whey, lactic add,

hydrolyzed vegetable fibres

1.2.2. Yeasts

cultivated on substrates other than those given in 1.2.1

-

-

1.3. Algae

1.4. Lower fungi

1.4.1. Products from

production of antibiotics by fermentation

1.4.1.1. Mycelium,

wet byproduct from the production of penicillin, ensiled by means of lactobacillus brevis, plantarun,

sake, collenoid and streptococcus lactis to inactive the penicillin and heat treated

Nitrogenous

compound Penicillium chrysogenum ATCC

48271

Different sources of

carbohydrates and their hydrolysates

Nitrogen

expressed as crude protein: min. 7 %

Ruminants pigs

Declaration to be made on

the label or packaging of the product:

- the name:

"Mycelium silage from the production of penicillin"

- Nitrogen expressed as crude protein

- crude ash

- moisture

- animal species or category Declaration to be made on the label or packaging of the compound feedingstuff:

- the name:

"Mycelium silage from the production of penicillin"

2. Nonp-rotein

nitrogenous compounds

Declarations to be made

on the label or packaging of the product:

- the name 'Urea', 'Biuret',

' Urcaphosphate' or' Diureidoisobutane', as the case may be,

- nitrogen level;

and in addition for

product 2.1.3, phosphorus level,

- animal species or category,

- approval number

Declarations to be made on the label or packaging of compound feedingstuffs:

- the name 'Urea', 'Biuret',

'Ureaphosphate' or

'Diureidoisobutane' as the case may be,

- amount of the product contained in the

feedingstuff,

- percentage of the total crude protein provided by non-protein nitrogen,

- indication, in the instructions for use, of the level of total non-protein nitrogen which should not be extended in the daily ration of each animal species or category.

2.1. Urea and its

derivatives

2.1.1. Urea,

technically pure

CO (NH2) 2

-

Urea:

minimum 97%

Ruminants from the

beginning of rumination

Declarations to be made

on the label or packaging of the product:

- the name 'Urea', 'Biuret',

' Urcaphosphate' or' Diureidoisobutane', as the case may be,

- nitrogen level;

and in addition for

product 2.1.3, phosphorus level,

- animal species or category,

- approval number

Declarations to be made on the label or packaging of compound feedingstuffs:

- the name 'Urea', 'Biuret',

'Ureaphosphate' or

'Diureidoisobutane' as the case may be,

- amount of the product contained in the

feedingstuff,

- percentage of the total crude protein provided by non-protein nitrogen,

- indication, in the instructions for use, of the level of total non-protein nitrogen which should not be extended in the daily ration of each animal species or category.

2.1.2. Biuret,

technically pure

(CONH2) 2NH

-

Biuret:

minimum 97%

Declarations to be made

on the label or packaging of the product:

- the name 'Urea', 'Biuret',

' Urcaphosphate' or' Diureidoisobutane', as the case may be,

- nitrogen level;

and in addition for

product 2.1.3, phosphorus level,

- animal species or category,

- approval number

Declarations to be made on the label or packaging of compound feedingstuffs:

- the name 'Urea', 'Biuret',

'Ureaphosphate' or

'Diureidoisobutane' as the case may be,

- amount of the product contained in the

feedingstuff,

- percentage of the total crude protein provided by non-protein nitrogen,

- indication, in the instructions for use, of the level of total non-protein nitrogen which should not be extended in the daily ration of each animal species or category.

2.1.3. Ureaphosphate,

technically pure

CO (NH2) 2 H3PO4

-

Nitrogen:

minimum 16,

5% Phosphorus:

minimum 18 %

Declarations to be made

on the label or packaging of the product:

- the name 'Urea', 'Biuret',

' Urcaphosphate' or' Diureidoisobutane', as the case may be,

- nitrogen level;

and in addition for

product 2.1.3, phosphorus level,

- animal species or category,

- approval number

Declarations to be made on the label or packaging of compound feedingstuffs:

- the name 'Urea', 'Biuret',

'Ureaphosphate' or

'Diureidoisobutane' as the case may be,

- amount of the product contained in the

feedingstuff,

- percentage of the total crude protein provided by non-protein nitrogen,

- indication, in the instructions for use, of the level of total non-protein nitrogen which should not be extended in the daily ration of each animal species or category.

2.1.4.

Diureidoisobutane, technically pure

(CH3) 2 (CH) 2 (NHCONH2) 2

-

Nitrogen:

minimum 30% Isobutyraldehyd e:

minimum 35 %

Declarations to be made

on the label or packaging of the product:

- the name 'Urea', 'Biuret',

' Urcaphosphate' or' Diureidoisobutane', as the case may be,

- nitrogen level;

and in addition for

product 2.1.3, phosphorus level,

- animal species or category,

- approval number

Declarations to be made on the label or packaging of compound feedingstuffs:

- the name 'Urea', 'Biuret',

'Ureaphosphate' or

'Diureidoisobutane' as the case may be,

- amount of the product contained in the

feedingstuff,

- percentage of the total crude protein provided by non-protein nitrogen,

- indication, in the instructions for use, of the level of total non-protein nitrogen which should not be extended in the daily ration of each animal species or category.

2.2. Ammonium salts

2.2.1. Ammonium

lactate, produced by fermentation with

Lactobacillus

bulgaricus

CH3CHOHCOONH4

Whey

Nitrogen

expressed as crude protein:

minimum 44 %

Ruminants from the

beginning of rumination

Declarations to be made

on the label or packaging of the product:

- the name 'Ammonium

lactate from fermentation',

- nitrogen expressed as crude protein,

- crude ash,

- moisture,

- animal species or category,

- approval number

Declarations to be made on the label or packaging of compound

feedingstuffs:

- the name 'Ammonium lactate from fermentation',

- amount of product contained in the feedingstuff- percentage

of the total crude protein

provided by non-protein nitrogen,

- indication, in the instructions for use, of the

level of total non-protein

nitrogen which should not be exceeded in the daily ration of each animal species or category.

2.2.2. Ammonium

acetate in aqueuous solution

CH3COONH4

-

Ammonium

acetate min. 55

%

Ruminants, from the

start of rumination

Declarations to be made

on the label or packaging of the product:

- the words: Ammonium acetate,

- nitrogen and moisture

contents,

- animal species or category,

- approval number

Declarations to be made on the label or packaging of compound feedingstuffs:

- the words: Ammonium acetate

- the amount of the product contained in the

feedingstuff,

- percentage of the total crude protein provided by non protein nitrogen,

- indication in the instructions for use of the level of total non-protein nitrogen which should not be exceeded in the daily ration of each animal species or category.'

2.2.3 Ammonium

sulfate in aqueous solution

(NH4) 2SO4

-

Ammonium

sulfate:

minimum 35%

Ruminants from the

start of rumination

Declarations to be made

on the label or packaging of the product:

- the words: Ammonium sulfate,

- nitrogen and moisture contents,

- animal species,

- approval number Declarations to be made on the label or packaging of compound

feedingstuffs:

- the words: "Ammonium sulfate",

- the amount of the

product contained in the feedingstuff,

- percentage of the total crude protein provided by non protein nitrogen,

- indication in the

instructions for use of the level of total non-protein nitrogen which should not be exceeded in the daily ration of each animal species,

- in the case of young ruminats, the incorporation rate in the daily ration may not exceed 0, 5%

2.3. By-Products from

the production of amino acids by fermentation

2.3.1. Concentrated

liquid By-Products from the production of Lglutamic acid by fermentation with Corynebacterium melassecola

Ammonium salts and

other nitrogenous compounds

Sucrose, molasses,

starch products and their hydrolysates

Nitrogen

expressed as crude protein: minimum 48 % Moisture: maximum 28%

Ruminants from the

beginning of rumination

Declarations to be made

on the label or packaging of the product:

- the name 'By-Products from the production of

Lglutamic acid' in the

case of product 2.3.1;

'By-Products of L-Lysine' in the case of product

2.3.2,

- nitrogen, expressed as crude protein,

- crude ash,

- moisture,

- animal species or

category,

- approval number Declarations to be made on the label or packaging of compound feedingstuffs:

- the name 'By-Products from the production of Lglutamic acid' in the case of product 2.3.1;

'By-Products from the production of L-Lysine' in the case of product 2.3.2,

- percentage of the total crude protein provided by non-protein nitrogen,

- indication, in the instructions for use, of the level of total non-protein nitrogen which should not be exceeded in the daily ration of each animal species or category.

2.3.2. Concentrated

liquid By-Products from the production of L-Lysine monohydrochloride by fermentation with Brevibacterium lactofermentum

Ammonium salts and

other nitrogenous compounds

Sucrose, molasses,

starch products and their hydrolysates

Nitrogen

expressed as crude protein: minimum 45 %

Ruminants from the

beginning of rumination

3. Amino acids and

their salts

3.1. Methionine

3.1.1. DL-

Methionine, technically pure

CH3S (CH2) 2CH (NH2) COOH

-

DL-Methionine:

minimum 98 %

All animal species

Declarations to be made

on the label or packaging of the product:

3.1.2. Dihydrated

calcium salt of

Nhydroxy methyl DL- Methionine, technically pure

[CH3S (CH2) 2CH (NHH2OH) COO]2Ca.2H2O

-

DL-Methionine:

minimum 67% Formaldehyde:

maximum 14%

Calcium:

minimum 9%

Ruminants from the

beginning of rumination

- the name "DL L

methionine, in the case of products 3.1.1,

"Dihydrated calcium salt

of Nhydroxy methylDL- Methionine" in the case of product 3.1.2, "Zincmethionine", in the case of product 3.1.3,

- DL-Methionine and moisture contents,

- animal species or category in the case of

products 3.1.2 and 3.1.3,

- approval number

3.1.3.

Methioninezinc, technically pure

[CH3S (CH2) 2CH (NH2) COO]2Zn

DL-Methionine:

minimum 80% Zn:

maximum 18, 5%

Ruminants from the

beginning of rumination

- the name "DL L

methionine, in the case of products 3.1.1,

"Dihydrated calcium salt

of Nhydroxy methylDL- Methionine" in the case of product 3.1.2, "Zincmethionine", in the case of product 3.1.3,

- DL-Methionine and moisture contents,

- animal species or category in the case of

products 3.1.2 and 3.1.3,

- approval number

3.1.4. Concentrated

liquid sodium DL- Methionine technically pure

(CH3S (CH2) 2CH (NH2) COO) Na

-

DL-Methionine:

minimum 40, 0

% Sodium:

minimum 6, 2 %

All animal species

Declarations to be made

on the label or packaging of the product:

- the name 'concentrated liquid sodiumDL-

Methionine'

- DL-Methionine content

- moisture content

- approval number

3.1.5 DL-Methionine,

technically pure protected with copolymer vinylpyridi nelstyrene

CH3S (CH2) 2CH (NH2) COOH

-

DL-Methionine:

minimum 65 % copolymer vinylpyridine/ styrene: maximum 3 %

Dairy cows

Declarations to be made

on the label or packaging of the product:

- "Protected methionine with copolymer vinylpyridine/styrene"

- DL-Methionine and

moisture contents

- animal species

- approval number

3.2. Lysine

3.2.1. L-Lysine,

technically pure

NH2 (CH2) 4CH (NH2) COOH

-

L-Lysine:

minimum 98%

All animal species

Declarations to be made

on the label or packaging of the product:

- the name "L-Lysine" in

the case of product 3.2.1, "Concentrated liquid L- Lysine base" in the case of product 3.2.2, "L-

Lysinemonohydrochloride

" in the case of product

3.2.3, "Concentrated liquid L-Lysine monohydrochloride" in the case of product 3.2.4,

"L-Lysine sulphate and its By-Products from fermentation", in the case of product 3.2.5,

- L-Lysine and moisture contents

- approval number

3.2.2. Concentrated

liquid L-Lysine (base)

NH2 (CH2) 4CH (NH2) COOH

Saccharose, molasses,

starch products and their hydrolysates

L-Lysine:

minimum 60%

All animal species

Declarations to be made

on the label or packaging of the product:

- the name "L-Lysine" in

the case of product 3.2.1, "Concentrated liquid L- Lysine base" in the case of product 3.2.2, "L-

Lysinemonohydrochloride

" in the case of product

3.2.3, "Concentrated liquid L-Lysine monohydrochloride" in the case of product 3.2.4,

"L-Lysine sulphate and its By-Products from fermentation", in the case of product 3.2.5,

- L-Lysine and moisture contents

- approval number

3.2.3. L-

Lysinemonohydrochl oride, technically pure

NH2 (CH2) 4CH (NH2) COOH.HCl

-

L-Lysine:

minimum 78%

All animal species

Declarations to be made

on the label or packaging of the product:

- the name "L-Lysine" in

the case of product 3.2.1, "Concentrated liquid L- Lysine base" in the case of product 3.2.2, "L-

Lysinemonohydrochloride

" in the case of product

3.2.3, "Concentrated liquid L-Lysine monohydrochloride" in the case of product 3.2.4,

"L-Lysine sulphate and its By-Products from fermentation", in the case of product 3.2.5,

- L-Lysine and moisture contents

- approval number

3.2.4. Concentrated

liquid L- Lysinemonohydrochl oride

- NH2 (CH2) 4CH (NH2) COOH.HCl

Saccharose, molasses,

starch products and their hydrolysates

L-Lysine:

minimum 22,

4%

All animal species

Declarations to be made

on the label or packaging of the product:

- the name "L-Lysine" in

the case of product 3.2.1, "Concentrated liquid L- Lysine base" in the case of product 3.2.2, "L-

Lysinemonohydrochloride

" in the case of product

3.2.3, "Concentrated liquid L-Lysine monohydrochloride" in the case of product 3.2.4,

"L-Lysine sulphate and its By-Products from fermentation", in the case of product 3.2.5,

- L-Lysine and moisture contents

- approval number

3.2.5. L-

Lysinesulphate produced by fermentation with

Corynebacterium

glutamicum

[NH2 (CH2) 4CH (NH2) COOH]2

H2SO4

Sugar syrup,

molasses, cereals, starch products and their hydrolysates

L-Lysine:

minimum 40%

All animal species

Declarations to be made

on the label or packaging of the product:

- the name "L-Lysine" in

the case of product 3.2.1, "Concentrated liquid L- Lysine base" in the case of product 3.2.2, "L-

Lysinemonohydrochloride

" in the case of product

3.2.3, "Concentrated liquid L-Lysine monohydrochloride" in the case of product 3.2.4,

"L-Lysine sulphate and its By-Products from fermentation", in the case of product 3.2.5,

- L-Lysine and moisture contents

- approval number

3.2.6. L-Lysine

phosphate and its By- Products produced by fermentation with Brevibacterium lactofermentum NRRL B11470

[NH2 (CH2) 4CH (NH2) COOH]

Sucrose ammonia and

fish solubles

L-Threonine

nlinimum 98 % L-Lysine:

min. 35 % Phosphorus: min. 4, 3 %

Poultry, pigs

Declarations to be made

on the label or packaging of the product:

- "L-Lysine and moisture content

- approval number

3.2.7 Mixtures of:

(a) L- Lysinemonohydrochl oride, technically pure and, (b) DL- Methionine, technically pure

NH2 (CH2) 4CH (NH2) COOHHCl CH3S (CH2) 2CH (NH2) COOH

-

L-Lysine + DL-

Methionine minimum 50 % (including DL- Methionine minimum 15 %) Copolymer

Dairy cows

Declarations to be made

on the label or packaging of the product:

- the name "mixture of Ulysine monohydrochloride and

DL-Methionine protected

protected with

copolymer vinylpyridine/ styrene

vinylpyridine/

styrene maximum 3 %

with copolymer

vinylpyridine/styrene"

- L-Lysine, DLrnethionine and moisture contents

- animal species

- approval number

3.3. Threonine

3.3.1. L-Threonine,

technically pure

CH3CH (OH) CH (NH2) COOH

-

L-Threonine:

minimum 98%

All animal species

Declarations to be made

on the label or packaging of the product:

- the name "L-Threonine"

- L-Threonine and moisture contents

- approval number

3.4. Tryptophan

3.4.1. L-Tryptophan,

technically pure

(C8H5NH) CH2CH (NH2) COOH

-

L-Tryptophan:

minimum 98 %

All animal species

Declarations to be made

on the label or packaging of the product:

- the name:

"L-Tryptophan"

- L-Tryptophan and moisture contents

- approval number

3.4.2. DL-

Tryptophan, technically pure,

(C, H, NH) CH, CH

(NH,) COOH

-

DL-Tryptophan:

minimum 98 %

All animal

species

Declarations to be made

on the label or packaging of the product:

- the name:

"L-Tryptophan"

- L-Tryptophan and moisture contents

- approval number

4. Analogues of

amino acids

4.1. Analogues of

methionine

4.1.1 Hydroxy

analogue of methionine

CH3S (CH2) 2CH (OH) COOH

-

Total of acids:

minimum 85 % Monomer acid:

minimum 65 %

All animal species

Declarations to be made on the label or packaging

of the product:

- if appropriate, the name

(column 2),

- monomer acid and total acids contents in the case of product 4.1.1 and

monomer acid content in

the case of product 4.1.2,

- moisture content,

- animal species

- approval number Declarations to be made on the label or packaging of compound feeding Stuffs :

- if appropriate, the name

(column 2),

- monomer acid and total acids contents in the case of product 4.1.1 and monomer acid content in the case of product 4.1.2,

- amount of the product contained in the feedingstuff.

4.1.2 Calcium salt of

hydroxy analogue of methionine

[CH3S (CH2) 2CH (OH) COO]2Ca

-

Monomer acid:

minimum 83 % Calcium: minimum 12 %

All animal species

Declarations to be made on the label or packaging

of the product:

- if appropriate, the name

(column 2),

- monomer acid and total acids contents in the case of product 4.1.1 and

monomer acid content in

the case of product 4.1.2,

- moisture content,

- animal species

- approval number Declarations to be made on the label or packaging of compound feeding Stuffs :

- if appropriate, the name

(column 2),

- monomer acid and total acids contents in the case of product 4.1.1 and monomer acid content in the case of product 4.1.2,

- amount of the product contained in the feedingstuff.