USE AND MARKETING OF ENZYMES, MICRO- ORGANISMS AND THEIR PREPARATIONS IN ANIMAL NUTRITION RULES *

SUBSIDIARY LEGISLATION 437.91

USE AND MARKETING OF ENZYMES, MICRO-

ORGANISMS AND THEIR PREPARATIONS

IN ANIMAL NUTRITION RULES *

27th October, 2006

LEGAL NOTICE 258 of 2006.

(1) The title of these rules is the Use and Marketing of

Enzymes, Micro-organisms and their Preparations in Animal

Nutrition Rules.

(2) The scope of these rules is to transpose the provisions

f o un d i n E u r o p e a n U n i on D i r e c t i v e 9 3 / 11 3 / E C of t h e 1 4t h

December, 1993 concerning the use and marketing of enzymes,

micro-organisms and their preparations in animal nutrition, as

amended by Directive 97/40/EC of the 25th June, 1997.

(3) These rules shall apply to the use and marketing of

enzymes, micro-organisms and their preparations in animal

nutrition and shall apply without prejudice to Directive 70/524/

EEC and particularly to the provisions concerning the authorization

of enzymes, micro-organisms and their preparations for use as

additives.

(4) By way of derogation from Article 3 of Directive 70/524/

EEC, Malta shall temporarily allow the use and marketing of

enzymes, micro-organisms and their preparations in animal

nutrition within their territory, provided that, on the basis of the

information available, the products do not present a danger to

human or animal health, and that they are included in the list

established by virtue of Article 3.

Rule 3(2)(a)

Trade name

Active constituents

Activity units per g or

Person responsible

number of Colony-forming

for putting into

units per g

circulation

USE AND MARKETING OF ENZYMES, MICRO-ORGANISMS

AND THEIR PREPARATIONS IN ANIMNAL NUTRITION

In these regulations

"Commission" means the European Commission;

"Community" means the European Community.

MODEL OF IDENTIFICATION NOTE REFERRED TO REGULATION 3(a)(ii)

(to be filled in by the person responsible for putting the product into circulation)

1. Identity of the product

Trade name.

Qualitative and quantitative composition

active substance (if the active substance is a mixture of clearly

definable active components, indicate the main components),

other components,

impurities,

undesirable substances.

Name or business name and address or registered place of business of the

manufacturer.

Place of manufacture

Name or business name and address or registered place of business of the

person r espo nsi bl e f or p laci ng t he prod uct o n the m arket , if h e i s n ot t he

manufacturer.

2. Specifications concerning the active substance

2.1. For micro-organisms

name and taxonomic description according to an international code of

nomenclature (Such as “Bergeyís Manual of Systematic Bacteriology”,

“The Yeasts, a taxonomic study” by Lodder and Kreger van Rij,

“Ainsworth and Bisbyís Dictionary of the Fungi” by Hawksworth,

Sutton and Ainsworth or “The Genus Asperigillus” by Raper and

Fennel),

name and place of culture collection where the strain is registered and

deposited and the number of registration and deposit,

state whether genetic manipulation has taken place,

the number of colony-forming units (CFU/g).

2.2. For enzymes

name according to main enzymatic activities and Community number

(Enzyme Nomenclature Recommendations (1984) of the Nomenclature

Committee of the International Union of Biochemistry, Academic Press

1984),

state the biological origin. In the case of microbial origin, the

information required in the first two indents of point 2.1, must be given,

state whether the organism of origin has been genetically manipulated,

relevant activities with regard to appropriate types of chemically pure

substrates (expressed in activity units per g Activity units expressed as

µmole of product released per minute per gram of enzymatic

preparation).

NB: If the active substance is a mixture of active components, all the components

must be described separately with an indication of their proportion in the mixture.

3. Properties of the product

Main effect

-

information concerning effectiveness,

-

justification for the presence of each component if the substance is a

mixture of active components.

Other effects.

4. Product safety

Available information on safety.

5. Conditions for the use of product

Uses provided for in animal nutrition (species or categories of animal, type

of feedingstuffs, period of use, etc).

Proposed dosage in premixes and feedingstuffs (appropriate units of

biological activity such as CFU per gram of product for micro-organisms or activity

units per gram for enzyme preparations).

Other known uses of the active substance or the preparation (in foodstuffs,

human or veterinary medicine, industry etc).

Recommendations concerning product safety in relation to targeted species,

the consumer and the environment.

If necessary, measures for the prevention of risks and means of protection

during manufacture and use.

6. Technological information

Stability of the product

-

with regard to atmospheric agents,

-

during the preparation of premixes and feedingstuffs,

-

during the storage of premixes and feedingstuffs,

-

description of the process of manufacture and methods used concerning

the control of the quality of the product during its manufacture.

(1) All forms of use for animal nutrition other than the

i n c o r p o r a t i o n o f s u c h p r o d u c t s i n t o f e e d i n g s t u ff s s h a l l b e

prohibited.

(2) On the basis of the information provided by the persons

responsible for putting the products into circulation Malta shall

forward to the Commission

(a) a list of enzymes and micro-organisms and their

preparations according to the model given in Schedule

I,

(b) an identification note drawn up for each product

according to the model given in Schedule II by the

person responsible for putting the product into

circulation.

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

(1) As and when the requested information reaches it, the

Commission shall communicate to Malta the lists of enzymes,

micro-organisms or their preparations sent to it in accordance with

rule 3.

(2) Where enzymes, micro-organisms or preparations

manufactured by Member States are included in several national

lists, it may be agreed between the Malta and the Member States

concerned that a single dossier should be submitted by one of them.

In such case, the Member State appointed to submit such dossier

shall inform the Commission accordingly.

Where Malta finds it impossible to satisfy any of the

conditions referred to in regulation 3, for an enzyme, micro-

organism or preparation used in their territory, it shall take all the

necessary measures to ensure that the enzyme, micro-organism or

preparation obtained from them is no longer used or marketed in

their territories.

(1) Enzymes, micro-organisms and their preparations, as

well as premixtures and compound feedingstuffs in which they

have been incorporated, may be marketed only if the particulars

listed below, which must be clearly visible, legible and indelible

and for which the producer, packer, importer, vendor or distributor

established within the Community shall be held responsible, are

shown on the packaging, the container or on a label attached

thereto

A. for enzymes and their preparations

(a) the specific name of the active constituent or

constituents according to their enzymatic activity or

activities and the identification number or numbers

according to the International Union of Biochemistry;

(b) the activity units (activity units * per g or activity units

per ml);

(c) the name or business name and the address or

registered place of business of the person responsible

for the particulars in this paragraph;

(d) the name or business name and address or registered

place of business of the manufacturer if he is not

responsible for the particulars on the label;

(e) the expiry date of the guarantee or the storage life

from the date of manufacture;

(f)

the batch reference

number

and

the

date

of

manufacture;

(g) directions for use and where appropriate, a safety

recommendation;

(h) the net weight and for liquid additives either the net

volume or the net weight;

*Units of activity expressed as µ mole of product released per minute per gram of

enzymatic preparation.

(i)

the indication "to be used exclusively for the

manufacture of feedingstuffs";

for micro-organisms and their preparations

(a) the identifications of the strain or strains according to

a recognized international code of nomenclature and

the deposit number of the strain or strains;

(b) the number of colony-forming units (CFU/g);

(c) the name or business name and address or registered

place of business of the person responsible for the

particulars referred to in this paragraph;

(d) the name or business name and address or registered

place of business of the manufacturer if he is not

responsible for the particulars on the label;

(e) the expiry date of the guarantee or the storage life

from the date of manufacture;

(f)

the batch reference

number

and

the

date

of

manufacture;

(g) the directions for use and, where appropriate, a safety

recommendation;

(h) the net weight and for liquid additives either the net

volume or the net weight;

(i)

the indication "to be used exclusively in the

manufacture of feedingstuffs";

(j)

where appropriate, indication of any particular

significant characteristics due to the manufacturing

process;

for premixtures containing enzymes

(a) the description "premixture";

(b) the indication "to be used exclusively in the

manufacture of feedingstuffs";

(c) the directions for use and any safety recommendations

regarding the use of premixtures;

(d) the animal species or category of animals for which

the premixture is intended;

(e) the name or business name and the address or

registered place of business of the person responsible

for the particulars referred to in this paragraph;

(f)

the net weight and for liquids either the net volume or

the net weight;

(g) the specific name of the active constituent or

constituents according to their enzymatic activity or

activities and the identification number(s) according to

the International Union of Biochemistry;

(h) the activity units (activity units per gor activity units

per ml);

(i)

the expiry date of the guarantee or the storage life

USE AND MARKETING OF ENZYMES, MICRO-ORGANISMS

AND THEIR PREPARATIONS IN ANIMNAL NUTRITION

from the date of manufacture;

(j)

the name or business name and address or registered

place of business of the manufacturer if he is not

responsible for the particulars on the label;

for premixtures containing micro-organisms

(a) the description "premixture";

(b) the indication "to be used exclusively in the

manufacture of feedingstuffs";

(c) the directions for use and any safety recommendations

regarding the use of premixtures;

(d) the animal species or category of animals for which

the premixture is intended;

(e) the name or business name and the address or

registered place of business of the person responsible

for the particulars referred to in this paragraph;

(f)

the net weight and for liquids either the volume or net

weight;

(g) the identification of the strain or strains according to a

recognized international code of nomenclature and the

deposit number or numbers of the strain(s);

(h) the number of colony-forming units (CFU/g);

(i)

the expiry date of the guarantee or the storage life

from the date of manufacture;

(j)

the name or business name and address or registered

place of business of the manufacturer if he is not

responsible for the particulars on the label;

(k) where appropriate, indication of any particular

significant characteristics due to the manufacturing

process;

for compound feeds into which enzymes have been

incorporated

(a) the specific name of the active constituent or

constituents according to their enzymatic activity or

activities and the identification number according to

the International Union of Biochemistry;

(b) the activity units (activity units per kg or activity units

per l) provided that such units are measurable by an

official or scientifically valid method);

(c) the expiry date of the guarantee or the storage life

from the date of manufacture;

for compound feeds into which micro-organisms have been

incorporated

(a) the identification of the strain or strains according to a

recognized international code of nomenclature and the

deposit number or numbers of the strain or strains;

(b) the

number

of

colony-forming

units

(CFU/kg)

provided that the number is measurable by an official

or scientifically valid method;

(c) the expiry date of the guarantee or the storage life

from the date of manufacture;

(d) where appropriate, indication of any particular

significant characteristics due to the manufacturing

process.

(2) Particulars other than those prescribed in sub-rule (1),

under paragraphs A, B, C and D such as the trade name, may be

included on the packaging, containers or on a label attached

thereto, provided that they are clearly separated from the said

particulars.

USE AND MARKETING OF ENZYMES, MICRO-ORGANISMS

AND THEIR PREPARATIONS IN ANIMNAL NUTRITION

Control

Method(s) of analysis for determining the active component(s) in

-

the product itself,

-

premixes,

-

feedingstuffs.

Attestation of the person responsible certifying the accuracy of the

information given.