PRODUCTS USED IN ANIMAL NUTRITION RULES *

PRODUCTS USED IN ANIMAL NUTRITION

SUBSIDIARY LEGISLATION 437.61

PRODUCTS USED IN ANIMAL NUTRITION

RULES *

1st April, 2005

LEGAL NOTICE 89 of 2005.

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

Nutrition Rules.

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

under European Union Council Directive 82/471/EEC of the 30th

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.

Name

of Name

o f Designation of C u l tu r e

C o m p o s i t i o n Animal species S p e c i a l

product group product

nutritive

substrate

characteris tics

provisions

principle

o r (specifications, of product

identity

o f if any)

micro-organism

1. Proteins

obtained from

the following

groups

of

micro-

organisms

1.1. Bacteria

1.1.1. Bacteria 1.1.1.1. Protein M e t h y l o p h i l u s Methanol

- Crude protein - Pigs

Declarations to

cultivated on p r o d u c t

o f meth ylo trophu s

m i n . 6 8 % - - Calves

be made on the

methanol

fermentation NCIB

strain

Reflectance

label

or

index at least 50 – Poultry

o b t a i n e d b y 10.515

packaging of

culture

of

the product

- Fish

Methylophilus

- name of the

Methylotrophus

product

on methanol

- crude protein,

- crude ash,

- crude fat,

-

moisture

content,

- instructions

for use,

- Declaration

of the words

' Av o i d

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 1.1.2.1 protein M e t h y l o c o c u s N a t u r a l g a s : c r u d e p r o t e i n : - P i g s f o r Declarations to

cultivated on p r o d u c t

o f capsulatus (Bath) ( a p p r o x . 9 1 % min. 65%

fattening from be made on the

natural gas

fermentation NCIMB strain methane, 5%

25 to 60 kg

label

or

f r o m n a tur a l 11132

ethane,

2%

- Calves from p a c k a g i n g o f

gas obtained by A l c a l i g e n e s

propane, 0, 5%

the product

80 kg on

culture

of: acidovorans

isobutane, 0,5%

- the names

- Salmon

Methylococus N C I M B s t r a i n n b u t a n e , 1 %

"Protein

capsulatus

12387 Bacillus o t h e r

product

of

(Bath),

brevis NCIMB components),

fermentation

Alcaligenes strain 13288 ammonia

from natural

a c i d o v o r a n s , B aci ll us fi rmu s mineral salts

gas obtained by

Bacillus brevis N C I M B s t r a i n

culture

of

et

B a c i l l u s 13280

M et hyl ococu s

firmus, and the

capsulatus

cells of which

(Bath),

have

been

Alcaligenes

killed

acidovorans,

Bacillus brevis

et Bacillus

firmus"

- crude protein

- crude ash

- crude fat

-

moisture

content

- instructions

for use

Name

of Name

o f Designation of C u lt u r e

C o m p o s i t i o n Animal species S p e c i a l

product group product

nutritive

substrate

char acteristi cs

provisions

principle

o r (specifications, of product

identity

o f if any)

micro-organism

- 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

All yeasts

Saccharomyces M o l a s s e s ,

-

All animal

1. 2. 1. Yeas ts - obtained from c e r e v i s i a e ,

distillery

species

m i c r o - S a c c h a r o m y c e s residues, cereals

cultivated on t h e

s u b s t ra t e s o f organisms and carlsbergiensis, a n d p r o d u c t s

o r substrates listed K l uyverom yces c o n t a i n i n g

animal

in columns 3 lactis,

starch, fruit

vegetable

4 K l uyverom yces j u i c e , w h e y,

origin

and

fragilis

lactic

add,

respectively

hydrolyzed

- the cell of

vegetable fibres

which have

been killed

1. 2. 2. Yeas ts -

-

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

Name

of Name

o f Designation of C u l tu r e

C o m p o s i t i o n Animal species S p e c i a l

product group product

nutritive

substrate

characteris tics

provisions

principle

o r (specifications, of product

identity

o f if any)

micro-organism

1.4.1.1.

Nitrogenous

Different

Nitrogen

Ruminants

Declaration to

Mycelium, wet c o m p o u n d

sources

o f e x p r e s s e d a s pigs

be made on the

by-product

Penicillium

carbohydrates crude protein

label

or

from

the chrysogenum

and

t h e i r min. 7%

packaging of

p r o d u c t i o n o f ATCC 48271

hydrolysates

the product

penicillin,

- the name

ensiled

by

"Mycelium

means

of

silage from the

lactobacillus

production of

brevis,

penicillin"

plantarun, sake,

collenoid and

-

Nitrogen

streptococcus

expressed as

lactis

to

crude protein

inactive the

- crude ash

penicillin and

heat treated

- moisture

-

animal

species

or

category

Declaration to

be made on the

label

or

packaging of

the com pound

feedingstuff

- the name

"Mycelium

silage from the

production of

penicillin"

2. Non-protein

Declarations to

nitrogenous

be made on the

compounds

label

or

packaging of

2.1. Urea and 2 . 1 . 1 . U r e a , CO (NH 2 ) 2

-

Urea: minimum R u m i n a n t s

the product

its derivatives technically pure

97%

from

the

beginning of - the name

'Urea', 'Biuret',

rumination

'

2 . 1 . 2 . B i u r e t , (CONH 2 ) 2NH

-

Biuret

Urcaphosphate'

technically pure

minimum 97%

or

'Diureidoisobut

2.1.3.

CO (NH 2 )

2 -

Nitrogen

ane', as the

Ureaphosphate, H3PO4

minimum 16,5%

case may be,

technically pure

Phosphorus

-

nitrogen

minimum 18%

level;

2.1.4.

(CH 3 ) 2 (CH) 2

-

Nitrogen

and in addition

D i u r e i d o i s o - (NHCONH )

minimum 30%

for product

2 2

butane,

Isobutyralde-

2.1.3,

technically pure

hyde: minimum

phosphorus

35%

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

'Diureidoisobu-

tane' as the

case may be,

Name

of Name

o f Designation of C u lt u r e

C o m p o s i t i o n Animal species S p e c i a l

product group product

nutritive

substrate

char acteristi cs

provisions

principle

o r (specifications, of product

identity

o f if any)

micro-organism

- 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.

2.2.1.

CH 3 CHOHCOO Whey

Nitrogen

Ruminants

Declarations to

Ammonium Ammonium

NH 4

expressed as from

t h e be made on the

salts

lactate,

crude protein: beginning of l a b e l

or

produced by

minimum 44% rumination

packaging of

fermentation

the product

with

- the name

Lactobacillus

'Ammonium

bulgaricus

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,

Name

of Name

o f Designation of C u l tu r e

C o m p o s i t i o n Animal species S p e c i a l

product group product

nutritive

substrate

characteris tics

provisions

principle

o r (specifications, of product

identity

o f if any)

micro-organism

- 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.

CH 3 COONH 4

-

Ammonium

R u m i n a n t s , Declarations to

Ammonium

acetate

from the start be made on the

acetate,

in

min. 55%

of rumination l a b e l

or

aqueuous

packaging of

solution

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

(NH 4 ) 2SO 4

-

Ammonium

Ruminants

Declarations to

Ammonium

sulfate

from the start be made on the

sulfate

in

minimum 35%

of rumination l a b e l

or

aqueous

packaging of

solution

the product

- the words

Ammonium

sulfate,

Name

of Name

o f Designation of C u lt u r e

C o m p o s i t i o n Animal species S p e c i a l

product group product

nutritive

substrate

char acteristi cs

provisions

principle

o r (specifications, of product

identity

o f if any)

micro-organism

- 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- 2.3.1.

Ammonium salts S u c r o s e ,

Nitrogen

Ruminants

Declarations to

Products from C o n c e n t r a t e d a n d

o t h e r molasses, starch e x p r e s s e d a s f r o m

t h e be made on the

the production l i q u i d

By- nitrogenous

p r o d u c t s a n d crude protein

beginning of label

or

of amino acids Produ ct s fro m compounds

their

minimum 48% rumination

packaging of

by

the production

hydrolysates

Moisture

the product

fermentation o f L g l u t a m i c

maximum 28%

- the name 'By-

acid

by

Products from

fermentation

the production

with

of Lglutamic

Corynebac-

acid' in the case

terium

of

product

melassecola

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,

Name

of Name

o f Designation of C u l tu r e

C o m p o s i t i o n Animal species S p e c i a l

product group product

nutritive

substrate

characteris tics

provisions

principle

o r (specifications, of product

identity

o f if any)

micro-organism

-

approval

number

Declarations to

be made on the

label

or

packaging of

compound

feedingstuffs

- the name 'By-

Products from

the production

o f L- g lu t a m ic

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.

Ammonium salts S u c r o s e ,

Nitrogen

Ruminants

Concentrated and

o t h e r molasses, starch e x p r e s s e d a s f r o m

the

liquid

By- nitrogenous

p r o d u c t s a n d crude protein

beginning of

Prod ucts from compounds

their

minimum 45% rumination

the production

hydrolysates

o f L - Ly s i n e

monohydro-

chloride by

fermentation

with

Brevibacterium

lactofermentum

Name

of Name

o f Designation of C u lt u r e

C o m p o s i t i o n Animal species S p e c i a l

product group product

nutritive

substrate

char acteristi cs

provisions

principle

o r (specifications, of product

identity

o f if any)

micro-organism

3. Amino 3.1.1.

DL- CH 3 S

(CH 2 ) -

DL-Methionine: A l l a n i m a l Declarations to

acids and their M e t h i o n i n e , 2CH

minimum 98% species

be made on the

salts

technically pure (NH ) COOH

label

or

packaging of

3.1.

the product

Methionine

- the name "DL

3.1.2.

[CH 3 S (CH 2 ) -

DL-Methionine: R u m i n a n t s

L methionine,

Dihydrated

2CH

minimum 67% f r o m

t h e in the case of

calcium salt of (NHH 2 OH)

Formaldehyde: b e g i n n i n g o f products 3.1.1,

Nhydroxy

COO]2Ca.2H 2 O

maximum 14% rumination

"Dihydrated

methyl

Calcium

calcium salt of

DLMethionine,

minimum 9%

Nhydroxy

technically pure

methylDL-

3.1.3.

[ C H 3 S ( C H 2 ) DL-Methionine

Methionine" in

M e t h i o n i n e - 2CH

minimum 80%

the case of

zinc,

(NH 2 ) COO]2Zn Zn

product 3.1.2,

technically pure

maximum

"Zincmethio-

18,5%

nine", 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.

(CH 3 S (CH 2 ) -

DL-Methionine: A l l a n i m a l Declarations to

C o n c e n t r a t e d 2CH

minimum 40,0% species

be made on the

l i q u i d s o d i u m (NH 2 ) COO) Na

Sodium

label

or

DL-Methionine

minimum 6,2%

packaging of

technically pure

the product

- the name

'concentrated

l iq ui d s od i um

DL-

Methionine'

-

DL-

Methionine

content

-

moisture

content

-

approval

number

3.1.5

DL- CH 3 S

(CH 2 ) -

DL-Methionine: Dairy cows

Declarations to

M e t h i o n i n e , 2CH

minimum 65%

be made on the

technically pure (NH 2 ) COOH

copolymer

label

or

protected with

vinylpyridine/

packaging of

copolymer

styrene

the product

vinylpyridi-

maximum 3%

- "Protected

nelstyrene

methionine

with copolymer

vinylpyridine/

styrene"

-

DL-

Methionine and

moisture

contents

-

animal

species

-

approval

number

Name

of Name

o f Designation of C u l tu r e

C o m p o s i t i o n Animal species S p e c i a l

product group product

nutritive

substrate

characteris tics

provisions

principle

o r (specifications, of product

identity

o f if any)

micro-organism

3.2. Lysine

3.2.1. L-Lysine, NH 2 (CH 2 ) 4CH

-

L-Lysine

A l l a n i m a l Declarations to

technically pure (NH 2 ) COOH

minimum 98%

species

be made on the

label

or

3.2.2.

NH 2 (CH 2 ) 4CH S a c c h a r o s e ,

L-Lysine

packaging of

C o n c e n t r a t e d (NH 2 ) COOH

molasses, starch minimum 60%

the product

liquid L-Lysine

products and

- the name "L-

(base)

their

Lysine" in the

hydrolysates

case of product

3.2.3.

L - NH 2 (CH 2 ) 4CH -

L-Lysine

3.2.1,

Ly s i n e m o n o - ( N H 2 )

minimum 78%

"Concentrated

hydrochloride, COOH.HCl

liquid L-Lysine

technically pure

base" in the

3.2.4.

NH 2 (CH 2 ) 4CH S a c c h a r o s e ,

L-Lysine

case of product

Concentrated (NH 2 )

molasses, starch minimum 22,4%

3.2.2,

liquid

L - COOH.HCl

products and

"L-

Ly s i n e m o n o -

their

Ly s i n e m o n o -

hydrochloride

hydrolysates

hydrochloride"

3.2.5.

L - [NH 2 (CH 2 ) 4CH S u g a r s y r u p , L-Lysine

i n t h e ca s e o f

Lysinesulphate (NH 2 ) COOH] 2 m o l a s s e s ,

minimum 40%

product 3.2.3,

p r o d u c e d b y H 2 SO 4

cereals, starch

"Concentrated

fermentation

products and

liquid L-Lysine

with

their

monohydro-

Corynebacte-

hydrolysates

chloride" in the

rium

case of product

glutamicum

3.2.4,

" L - Ly s i n e

sulphate and its

By-Products

from

fermentation",

i n t h e ca s e o f

product 3.2.5,

- L-Lysine and

moisture

contents

-

approval

number

3.2.6. L-Lysine [NH 2 (CH 2 ) 4CH S u c r o s e

L-

Poultry, pigs

Declarations to

phosphate and (NH 2 ) COOH]

a m m o n i a a n d Threoninenlini

be made on the

its By-Products

fish solubles

min. 98%

label

or

produced by

packaging of

L-Lysine

fermentation

the product

min. 35%

with

- "L-Lysine and

Phosphorus

Brevibacterium

moisture

min. 4,3%

lactofermentum

content

NRRL B11470

-

approval

number

3.2.7 Mixtures NH 2 (CH 2 ) 4CH -

L-Lysine + DL- Dairy cows

Declarations to

of

(NH 2 )

Methionine

be made on the

L - COOHHCl

minimum 50%

label

or

(a)

Ly s i n e m o n o - C H 3 S

(CH 2 )

(including DL-

packaging of

hydrochloride, 2CH

Methionine

the product

(NH

)

COOH

minimum 15%)

technically pure

- the name

Copolymer

and, (b) DL-

"mixture of

vinylpyridine/

Methionine,

Ulysine

styrene

technically pure

monohydrochlo

maximum 3%

protected with

ride and DL-

copolymer

Methionine

vinylpyridine/

protected with

styrene

copolymer

vinylpyridine/

styrene"

- L - Ly s i n e ,

DL-rnethionine

and moisture

contents

-

animal

species

-

approval

number

Name

of Name

o f Designation of C u lt u r e

C o m p o s i t i o n Animal species S p e c i a l

product group product

nutritive

substrate

char acteristi cs

provisions

principle

o r (specifications, of product

identity

o f if any)

micro-organism

3.3. Threonine 3 . 3 . 1 .

L - CH 3 CH (OH) CH -

L-Threonine

A l l a n i m a l Declarations to

Threonine,

(NH 2 ) COOH

minimum 98%

species

be made on the

technically pure

label

or

packaging of

the product

- the name "L-

Threonine"

- L-Threonine

and moisture

contents

-

approval

number

3.4.

3.4.1.

L- (C 8 H 5 NH)

-

L-Tryptophan

A l l a n i m a l Declarations to

Tryptophan

T r y p t o p h a n , CH 2 CH

minimum 98%

species

be made on the

technically pure (NH 2 ) COOH

label

or

packaging of

the product

- the name

"L-

Tryptophan"

- L-Tryptophan

and moisture

contents

-

approval

number

3.4.2.

D L - (C, H, NH) CH, -

DL-Tryptophan: A l l a n i m a l Declarations to

T r y p t o p h a n , CH

minimum 98% species

be made on the

technically pure (NH,) COOH

label

or

packaging of

the product

- the name

"L-

Tryptophan"

- L-Tryptophan

and moisture

contents

-

approval

number

4. Analogues 4.1.1 Hydroxy C H 3 S

(CH 2 ) -

Total of acids

A l l a n i m a l Declarations to

of amino acids a n a l o g u e o f 2CH

minimum 85%

species

be made on the

methionine

(OH) COOH

Monomer acid

label

or

4.1.

minimum 65%

packaging of

Analogues of

the product

methionine

- if appropriate,

4 . 1. 2 C a l c i u m [ C H 3 S ( C H 2 ) -

Monomer acid

the

name

salt of hydroxy 2CH

minimum 83%

(column 2),

a n a l o g u e o f (OH) COO]2Ca

Calcium

- monomer acid

methionine

minimum 12%

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

feedingstuffs

Name

of Name

o f Designation of C u l tu r e

C o m p o s i t i o n Animal species S p e c i a l

product group product

nutritive

substrate

characteris tics

provisions

principle

o r (specifications, of product

identity

o f if any)

micro-organism

- if appropriate,

the

name

(column 2),

- monomer acid

and total acids

contents in the

case of product

4.1.1

and

monomer acid

cont ent in the

case of product

4.1.2,

- amount of the

product

contained in

the

feedingstuff.

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

For the purpose of these rules, the following definitions

shall 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 feedingstuffs,

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

*These rules have been repealed by Legal Notice 36 of 2025.

PRODUCTS USED IN ANIMAL NUTRITION

industrial manufacture of compound animal feeding-stuffs;

"supplementary feeding-stuffs" means mixtures of feedingstuffs

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

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 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.

PRODUCTS USED IN ANIMAL NUTRITION

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

sections 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), 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 evaluation of existing data that have become evident since the

adoption of the provisions in question, the competent authorities

find that one of 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

rules, 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 their decision.

With regard to marketing between Malta and other Member

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

one of the official languages of the country of destination.

As far as the presence and labelling of the products listed

in the Schedule is concerned, feedingstuffs that comply with the

provisions of these rules are subject on ly to t he marketing

restrictions contained in these rules.

Animal products are not subject to any marketing

restriction as a result of the application of these rules.

The competent authorities shall take all necessary

measures to ensure that the compliance of feedingstuffs with the

requirements of these rules is officially monitored, at least by

sampling during marketing.