Products Used in Animal Nutrition Rules, 2005

L.N. 89 of 2005

VETERINARY SERVICES ACT

(CAP. 437)

Products Used in Animal Nutrition Rules, 2005

IN exercise of the powers conferred by articles 24 and 25 of the

Veterinary Services Act, the Minister for Rural Affairs and the

Environment, after consultation with the Minister of Health, the Elderly

and Community Care, has made the following rules>-

(1) The title of these rules is the Products Used in Animal

Nutrition Rules, 2005.

(2) The scope of these rules is to implement the rules found

under European Union Council Directive 82#471#EEC of the 30 th June,

1982 on certain products which act as direct or indirect protein sources,

are manufactured by certain technical processes and are put into

circulation as feedingstuffs or in feedingstuffs in accordance with articles

24 and 25 of the Veterinary Services Act.

(3) These rules shall be without prejudice to other provisions

concerning>

(a)

additives in feedingstuffs<

(b) the fixing of maximum levels for undesirable substances

and products in feedingstuffs<

(c) the fixing of maximum levels for pesticide residues on

and in products intended for human or animal nutrition<

(d) the marketing of compound feedingstuffs, pathogenic

micro-organisms in feedingstuffs, feedingstuffs for particular

nutritional purposes, the circulation of feed materials.

For the purpose of these rules, the following definitions shall

Culture substrate

Methanol

methylotrophus NCIB

NCIMB strain 11132

acidovorans NCIMB

nutritive principle or

identity of micro-

capsulatus (Bath)

Designation of

Methylophilus

Methylococus

strain 10.515

Alcaligenes

organism

fermentation obtained

natural gas obtained

Methylotrophus on

fermentation from

Name of product

1.1.1.1. Protein

Methylophilus

1.1.2.1 protein

by culture of

by culture of

product of

product of

methanol

cultivated on natural

1. Proteins obtained

from the following

Name of product

groups of micro-

1.1.1. Bacteria

1.1.2 Bacteria

cultivated on

1.1. Bacteria

organisms

methanol

group

gas

- declaration of the words

gas obtained by culture of

fermentation from natural

"Protein product obtained

- maximum incorporation

brevis et Bacillus firmus"

on the label or packaging

Methylococus capsulatus

by bacterial fermentation

- 33% salmon (seawater)

Declarations to be made

- amount of the product

- 8% pigs for fattening

acidovorans, Bacillus

- instructions for use

(Bath), Alcaligenes

"avoid inhalation".

- approval number

- moisture content

contained in the

- crude protein

of natural gas"

feedingstuffs

- 19% salmon

of compound

feedingstuff.

(freshwater)

- The name

- 8% calves

- crude ash

- crude fat

rate in

All animal species

-

residues, cereals and

products containing

Molasses, distillery

starch, fruit juice,

ammonia mineral

components),

salts

13288 Bacillus firmus

NCIMB strain 13280

strain 12387 Bacillus

brevis NCIMB strain

Saccharomyces

Saccharomyces

carlsbergiensis,

cerevisiae,

acidovorans, Bacillus

micro-organisms and

firmus, and the cells

of which have been

- obtained from the

substrates listed in

capsulatus (Bath),

brevis et Bacillus

Methylococus

Alcaligenes

All yeasts

killed

substrates of animal

cultivated on

1.2.1. Yeasts

1.2. Yeasts

category Declaration to be

Declaration to be made on

the label or packaging of

compound feedingstuff

- Nitrogen expressed as

"Mycelium silage from

"Mycelium silage from

made on the label or

- animal species or

the production of

the production of

packaging of the

crude protein

the product

- the name

- the name

- crude ash

penicillin"

penicillin"

- moisture

Ruminants pigs

crude protein

expressed as

min. 7 %

Nitrogen

hydrolyzed vegetable

Different sources of

carbohydrates and

their hydrolysates

whey, lactic add,

fibres

Kluyveromyces lactis,

chrysogenum ATCC

Kluyveromyces

Nitrogenous

Penicillium

compound

fragilis

48271

-

means of lactobacillus

streptococcus lactis to

inactive the penicillin

penicillin, ensiled by

wet byproduct from

sake, collenoid and

1.4.1.1. Mycelium,

- the cell of which

brevis, plantarun,

the production of

columns 3 and 4

have been killed

and heat treated

respectively

-

substrates other than

1.4.1. Products from

those given in 1.2.1

or vegetable origin

1.4. Lower fungi

production of

antibiotics by

cultivated on

1.2.2. Yeasts

fermentation

1.3. Algae

instructions for use, of the

nitrogen which should not

product 2.1.3, phosphorus

- the name 'Urea', 'Biuret',

Diureidoisobutane', as the

- the name 'Urea', 'Biuret',

crude protein provided by

'Diureidoisobutane' as the

on the label or packaging

on the label or packaging

level of total non-protein

Declarations to be made

Declarations to be made

be extended in the daily

- percentage of the total

- amount of the product

non-protein nitrogen,

ration of each animal

species or category.

' Urcaphosphate' or'

- animal species or

'Ureaphosphate' or

and in addition for

- approval number

- indication, in the

- nitrogen level;

contained in the

of the product

feedingstuffs

of compound

case may be,

case may be,

feedingstuff,

category,

level,

Ruminants from the

beginning of

rumination

5% Phosphorus

Isobutyraldehyd

minimum 18 %

minimum 35 %

minimum 97%

minimum 97%

minimum 30%

minimum 16,

Nitrogen

Nitrogen

Biuret

Urea

e

-

-

-

-

CO (NH 2 ) 2 H 3 PO 4

(CH 3 ) 2 (CH) 2

(CONH 2 ) 2NH

(NHCONH 2 ) 2

CO (NH 2 ) 2

2.1.3. Ureaphosphate,

Diureidoisobutane,

technically pure

technically pure

technically pure

technically pure

2.1.2. Biuret,

2.1.1. Urea,

2.1.4.

2.1. Urea and its

2. Nonp-rotein

nitrogenous

compounds

derivatives

lactate from fermentation',

lactate from fermentation',

instructions for use, of the

nitrogen which should not

on the label or packaging

on the label or packaging

on the label or packaging

level of total non-protein

of the total crude protein

feedingstuff- percentage

provided by non-protein

Declarations to be made

Declarations to be made

Declarations to be made

be exceeded in the daily

- the name 'Ammonium

- the name 'Ammonium

- nitrogen expressed as

ration of each animal

Ammonium acetate,

- amount of product

species or category.

- animal species or

- approval number

- indication, in the

contained in the

of the product

of the product

crude protein,

feedingstuffs

of compound

- the words

- crude ash,

- moisture,

category,

nitrogen,

Ruminants, from the

Ruminants from the

start of rumination

beginning of

rumination

minimum 44 %

acetate min. 55

crude protein

expressed as

Ammonium

Nitrogen

%

Whey

-

CH 3 CHOHCOONH 4

CH 3 COONH 4

lactate, produced by

acetate in aqueuous

2.2.1. Ammonium

2.2.2. Ammonium

fermentation with

Lactobacillus

bulgaricus

solution

2.2. Ammonium salts

nitrogen which should not

crude protein provided by

instructions for use of the

on the label or packaging

on the label or packaging

on the label or packaging

level of total non-protein

Declarations to be made

product contained in the

Declarations to be made

Declarations to be made

be exceeded in the daily

- percentage of the total

- nitrogen and moisture

- nitrogen and moisture

ration of each animal

non protein nitrogen,

species or category.'

Ammonium sulfate,

Ammonium acetate

- the amount of the

- animal species or

- approval number

- approval number

- indication in the

- animal species,

of the product

feedingstuffs

of compound

of compound

feedingstuff,

- the words

- the words

category,

contents,

contents,

Ruminants from the

start of rumination

minimum 35%

Ammonium

sulfate

-

(NH 4 ) 2SO 4

sulfate in aqueous

2.2.3 Ammonium

solution

nitrogen which should not

crude protein provided by

'By-Products of L-Lysine'

instructions for use of the

on the label or packaging

level of total non-protein

product contained in the

Declarations to be made

be exceeded in the daily

- the name 'By-Products

incorporation rate in the

- percentage of the total

- nitrogen, expressed as

from the production of

"Ammonium sulfate",

Lglutamic acid' in the

case of product 2.3.1;

- in the case of young

in the case of product

ration of each animal

non protein nitrogen,

daily ration may not

- the amount of the

- indication in the

of the product

crude protein,

feedingstuffs

exceed 0, 5%

ruminats, the

feedingstuff,

- the words

- crude ash,

- moisture,

species,

2.3.2,

Ruminants from the

beginning of

rumination

minimum 48 %

maximum 28%

crude protein

expressed as

Moisture

Nitrogen

starch products and

Sucrose, molasses,

their hydrolysates

Ammonium salts and

other nitrogenous

compounds

of Lglutamic acid by

from the production

2.3.1. Concentrated

liquid By-Products

fermentation with

Corynebacterium

melassecola

2.3. By-Products from

the production of

amino acids by

fermentation

production of L-Lysine' in

instructions for use, of the

nitrogen which should not

crude protein provided by

on the label or packaging

on the label or packaging

the case of product 2.3.2,

level of total non-protein

Declarations to be made

Declarations to be made

be exceeded in the daily

- the name 'By-Products

- percentage of the total

from the production of

'By-Products from the

Lglutamic acid' in the

case of product 2.3.1;

non-protein nitrogen,

ration of each animal

species or category.

- animal species or

- approval number

- indication, in the

of the product

feedingstuffs

of compound

category,

Ruminants from the

All animal species

beginning of

rumination

DL-Methionine

minimum 45 %

minimum 98 %

crude protein

expressed as

Nitrogen

starch products and

Sucrose, molasses,

their hydrolysates

-

Ammonium salts and

CH 3 S (CH 2 ) 2CH

other nitrogenous

(NH 2 ) COOH

compounds

by fermentation with

from the production

monohydrochloride

2.3.2. Concentrated

liquid By-Products

technically pure

lactofermentum

Brevibacterium

Methionine,

of L-Lysine

3.1.1. DL-

3. Amino acids and

3.1. Methionine

their salts

Methionine" in the case of

methionine, in the case of

on the label or packaging

on the label or packaging

- DL-Methionine content

"Dihydrated calcium salt

"Zincmethionine", in the

products 3.1.2 and 3.1.3,

of Nhydroxy methylDL-

- the name 'concentrated

Declarations to be made

Declarations to be made

- "Protected methionine

category in the case of

vinylpyridine/styrene"

case of product 3.1.3,

- DL-Methionine and

- DL-Methionine and

- animal species or

- approval number

- approval number

- approval number

moisture contents,

- moisture content

liquid sodiumDL-

moisture contents

- the name "DL L

- animal species

with copolymer

products 3.1.1,

of the product

of the product

product 3.1.2,

Methionine'

Ruminants from the

All animal species

beginning of

Dairy cows

rumination

minimum 6, 2 %

DL-Methionine

DL-Methionine

DL-Methionine

minimum 65 %

maximum 14%

minimum 40, 0

Formaldehyde

minimum 67%

maximum 3 %

vinylpyridine/

minimum 9%

% Sodium

copolymer

Calcium

styrene

minimum 80% Zn

maximum 18, 5%

DL-Methionine

-

-

-

[CH 3 S (CH 2 ) 2CH

[CH 3 S (CH 2 ) 2CH

(CH 3 S (CH 2 ) 2CH

CH 3 S (CH 2 ) 2CH

(NH 2 ) COO]2Zn

COO]2Ca.2H 2 O

(NH 2 ) COO) Na

(NH 2 ) COOH

(NHH 2 OH)

Nhydroxy methyl DL-

copolymer vinylpyridi

3.1.5 DL-Methionine,

3.1.4. Concentrated

liquid sodium DL-

3.1.2. Dihydrated

Methioninezinc,

technically pure

technically pure

technically pure

technically pure

calcium salt of

protected with

Methionine,

Methionine

nelstyrene

3.1.3.

Lysinemonohydrochloride

"L-Lysine sulphate and its

fermentation", in the case

DL-Methionine protected

on the label or packaging

on the label or packaging

- "L-Lysine and moisture

on the label or packaging

the case of product 3.2.1,

the case of product 3.2.4,

- the name "L-Lysine" in

Declarations to be made

- L-Lysine and moisture

Declarations to be made

Declarations to be made

Lysine base" in the case

monohydrochloride and

"Concentrated liquid L-

monohydrochloride" in

" in the case of product

- the name "mixture of

of product 3.2.2, "L-

3.2.3, "Concentrated

- approval number

- approval number

By-Products from

of product 3.2.5,

liquid L-Lysine

of the product

of the product

of the product

contents

Ulysine

content

All animal species

Poultry, pigs

Dairy cows

minimum 15 %)

L-Lysine + DL-

nlinimum 98 %

minimum 50 %

(including DL-

minimum 98%

minimum 60%

minimum 78%

minimum 40%

minimum 22,

L-Threonine

Phosphorus

min. 4, 3 %

Methionine

Methionine

Copolymer

min. 35 %

L-Lysine

L-Lysine

L-Lysine

L-Lysine

L-Lysine

L-Lysine

4%

Saccharose, molasses,

Saccharose, molasses,

Sucrose ammonia and

starch products and

starch products and

starch products and

molasses, cereals,

their hydrolysates

their hydrolysates

their hydrolysates

Sugar syrup,

fish solubles

-

-

-

(NH 2 ) COOH.HCl

(NH 2 ) COOH.HCl

(NH 2 ) COOHHCl

- NH 2 (CH 2 ) 4CH

CH 3 S (CH 2 ) 2CH

[NH 2 (CH 2 ) 4CH

[NH 2 (CH 2 ) 4CH

NH 2 (CH 2 ) 4CH

NH 2 (CH 2 ) 4CH

NH 2 (CH 2 ) 4CH

NH 2 (CH 2 ) 4CH

(NH 2 ) COOH] 2

(NH 2 ) COOH]

(NH 2 ) COOH

(NH 2 ) COOH

(NH 2 ) COOH

H 2 SO 4

oride, technically pure

oride, technically pure

liquid L-Lysine (base)

Products produced by

phosphate and its By-

Lysinemonohydrochl

Lysinemonohydrochl

Lysinemonohydrochl

3.2.2. Concentrated

3.2.4. Concentrated

3.2.7 Mixtures of

fermentation with

fermentation with

Corynebacterium

3.2.1. L-Lysine,

technically pure

technically pure

lactofermentum

Brevibacterium

3.2.6. L-Lysine

NRRL B11470

Lysinesulphate

and, (b) DL-

produced by

Methionine,

glutamicum

liquid L-

3.2.3. L-

3.2.5. L-

(a) L-

oride

3.2. Lysine

- the name "L-Threonine"

on the label or packaging

on the label or packaging

on the label or packaging

Declarations to be made

Declarations to be made

Declarations to be made

vinylpyridine/styrene"

- L-Tryptophan and

- L-Tryptophan and

DLrnethionine and

- approval number

- approval number

- approval number

- approval number

- L-Threonine and

moisture contents

moisture contents

moisture contents

moisture contents

- animal species

"L-Tryptophan"

"L-Tryptophan"

with copolymer

of the product

of the product

of the product

- L-Lysine,

- the name

- the name

All animal species

All animal species

minimum 98 %

minimum 98%

maximum 3 %

L-Tryptophan

vinylpyridine/

L-Threonine

All animal

styrene

species

DL-Tryptophan

minimum 98 %

-

-

(C 8 H 5 NH) CH 2 CH

CH 3 CH (OH) CH

(NH 2 ) COOH

(NH 2 ) COOH

-

vinylpyridine/ styrene

3.4.1. L-Tryptophan,

(C, H, NH) CH, CH

3.3.1. L-Threonine,

technically pure

technically pure

protected with

(NH,) COOH

copolymer

technically pure,

3.4. Tryptophan

4. Analogues of

3.3. Threonine

Tryptophan,

amino acids

3.4.2. DL-

- if appropriate, the name

- if appropriate, the name

on the label or packaging

acids contents in the case

on the label or packaging

acids contents in the case

the case of product 4.1.2,

the case of product 4.1.2,

- monomer acid and total

- monomer acid and total

monomer acid content in

monomer acid content in

Declarations to be made

Declarations to be made

- amount of the product

of compound feeding

of product 4.1.1 and

of product 4.1.1 and

- moisture content,

- approval number

All animal species

- animal species

contained in the

of the product

feedingstuff.

(column 2),

(column 2),

Stuffs

minimum 85 %

minimum 65 %

minimum 83 %

minimum 12 %

Monomer acid

Monomer acid

Total of acids

Calcium

The contents laid down or to be declared in accordance with columns 5 and 7 refer to the product as such.

-

-

[CH 3 S (CH 2 ) 2CH

CH 3 S (CH 2 ) 2CH

(OH) COO]2Ca

(OH) COOH

4.1.2 Calcium salt of

hydroxy analogue of

4.1.1 Hydroxy

analogue of

methionine

methionine

4.1. Analogues of

methionine

Mitbug] fl-Istamperija tal-Gvern - Printed at the Government Printing Press

apply>

“additives” means substances which, when incorporated in

feeding-stuffs, are likely to affect their characteristics or livestock

production<

“complete feeding-stuffs” means mixtures of feedingstuffs

which, by reason of their composition, are sufficient for a daily

ration<

“daily ration” means the average total quantity of feeding-

stuffs, calculated on a moisture content of 12 %, required daily by

an animal of a given species, age category and yield, to satisfy all

its needs<

“feeding-stuffs” means organic or inorganic substances, used

singly or in mixtures, whether or not containing additives, for oral

animal feeding<

“premixtures” means additive concentrates intended for the

industrial manufacture of compound animal feeding-stuffs<

“supplementary feeding-stuffs” means mixtures of feeding-

stuffs which have a high content of certain substances and which,

by reason of their composition, are sufficient for a daily ration

only if they are used in combination with other feeding-stuffs.

(1) Feedingstuffs belonging to one of the product groups Marketing of

feedingstuffs.

listed in the Schedule or containing such products may be marketed

only if>

(a)

the product in question appears in the Schedule.

(b) any conditions laid down therein are fulfilled.

(2) Competent authorities may, for experimental or scientific

purposes, provide for derogations from the provisions of sub-rule (1),

provided that an adequate official inspection is carried out.

(3) Products referred to in Chapter I. 1 (a) of Council

Directive 95#69#EC of 22 December 1995 laying down the conditions

and arrangements for approving and registering certain establishments

and intermediaries operating in the animal feed sector may be put into

circulation only by establishments or intermediaries which meet the

conditions laid down in Article 2 or Article 3 of that Directive, as

appropriate.

(4) Sub-rule (3) shall apply without prejudice to Article 4

(2) of Council Directive 95#69#EC.

(1) Without prejudice to the labelling provisions applicable

particulars to appear

to straight and compound feedingstuffs, the products listed in the

Schedule may not be marketed as feedingstuffs or incorporated in

feedingstuffs unless any particulars laid down in the Schedule appear

in the package or container or on a label attached thereto.

(2) For material marketed in bulk the particulars referred to

in sub-rule (1) appear on an accompanying document.

(1) In the Schedule, the following principles are observed>

(a)

A product shall not be included in the Schedule unless>

(i) it has nutritional value for animals because it

provides nitrogen,or

(ii) when used sensibly it has no detrimental effect on

human or animal health or on the environment and does not

harm the consumer by impairing the distinctive features of

animal products, or

(iii)

it can be monitored in feedingstuffs.

(b) A product shall be deleted from the Schedule if one of

the conditions listed in paragraph (A) is not satisfied.

(2) Criteria making it possible to define the products

included in these rules, particularly the criteria of composition and purity

and the physicochemical and biological properties, may be set in the

light of scientific and technical knowledge.

(1) In order to ensure that the products referred to in sections

Product conformity.

1.1 and 1.2 of the Schedule comply with the principles set out in rule 5

(1), the dossier, prepared in accordance with the provisions of sub-rule

(2) hereof, is sent officially to the Member States, to the relevant

international organisation and, if it is requested that they be consulted,

to the necessary scientific committees.

(2) The competent authorities and the other recipients of

the dossier referred to in sub-rule (1) shall ensure, if requested on good

grounds by an applicant, that information whose disclosure could

adversely affect industrial or commercial property rights is kept

confidential. Industrial and commercial secrecy shall not apply to>

(a) The names and composition of the product, and any

information concerning the substrate and the micro-organism,

(b) The physicochemical and biological properties of the

product,

(c) The interpretation of the pharmacological, toxicological

and ecotoxicological data,

(d) The analytical methods for monitoring the product in

the feedingstuffs.

If, on the basis of detailed grounds due to new data or a new Temporary

suspension etc. of

evaluation of existing data that have become evident since the adoption applications

of the provisions in question, the competent authorities find that one of provisions.

the products listed in the Schedule or its use under any conditions that

have been set represents a danger to human or animal health even though

it complies with the provisions of these rles, they may temporarily

suspend or restrict the application of those provisions. They shall

immediately inform the other Member States and the relevant

international organisation thereof, giving the reasons for its decision.

With regard to marketing between Malta and other Member Particulars to be

given in official

States, the particulars referred to in rule 4 shall be given in at least one language.

of the official languages of the country of destination.

As far as the presence and labelling of the products listed in Marketing

restrictions.

the Schedule is concerned, feedingstuffs that comply with the provisions

of these rules are subject only to the marketing restrictions contained in

these rules.

Animal products are not subject to any marketing restriction Animal products not

subject to marketing

as a result of the application of these rules.

restrictions.

The competent authorities shall take all necessary measures Monitoring of

compliance of

to ensure that the compliance of feedingstuffs with the requirements of feedingstuffs.

these rules is officially monitored, at least by sampling during marketing.

- Declaration of the words

on the label or packaging

on the label or packaging

on the label or packaging

Declarations to be made

Declarations to be made

Declarations to be made

- amount of the product

- name of the product

- instructions for use,

"Protein product of

- moisture content,

- approval number

Special provisions

'Avoid inhalation.

contained in the

- crude protein,

of the product

of the product

feedingstuffs

of compound

feedingstuff.'

- the names

- crude ash,

- crude fat,

- Calves from 80 kg on

- Pigs for fattening

from 25 to 60 kg

Animal species

– Poultry

- Salmon

- Calves

- Pigs

- Fish

index at least 50

-Crude protein

characteristics

crude protein

Composition

min. 68 % -

Reflectance

of product

min. 65%

(specifications, if any)

5% nbutane, 1% other

Natural gas: (approx.

ethane, 2% propane,

0, 5% isobutane, 0,

91% methane, 5%