Preparations in Animal Nutrition Rules, 2006

L.N. 258 of 2006

VETERINARY SERVICES ACT

(CAP. 437)

Use and Marketing of Enzymes, Micro-organisms and their

Preparations in Animal Nutrition Rules, 2006

IN exercise of the powers conferred by article 5(1) of the

Veterinary Services Act, the Minister for Rural Affairs and the

Environment has made the following rules>-

(1) The title of these rules shall be Use and Marketing of Title, scope and

applicability.

Enzymes, Micro-organisms and their Preparations in Animal Nutrition

Rules, 2006.

(2) The scope of these regulations is to transpose the

provisions found in European Union Directive 93#113#EC of the 14th

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.

Definitions.

In these regulations>

Rule 3(2)(a)

Trade name

Active constituents

Activity units per g or

Person responsible for

number of

putting into circulation

Colony-forming units per g

“Commission” shall mean the European Commission<

“Community” shall mean 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 responsible for placing the product on the market, if he is not the

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.

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 Prohibition of all

forms of use other

incorporation of such products into feedingstuffs shall be prohibited. than incorporation

into feedingstuffs

(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.

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

Commission shall communicate to Malta the lists of enzymes,

microorganisms 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-organisms 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 (1) per gor 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<

(i) the indication “to be used exclusively for the manufacture

of feedingstuffs”<

B. 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.

(1) Units of activity expressed as µ mole of product released

per minute per gram of enzymatic preparation.

(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<

C. 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 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<

D. 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<

E. 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.

F. 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 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.

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.

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