S.L. 437.91 Art. 6Conditions for marketing. Trade name 3(a)(ii) circulation)

(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"; 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;

(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 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. SCHEDULE I

Rule 3(2)(a) Active constituents Activity units per g or Person responsible number of Colony-forming for putting into units per g circulation SCHEDULE II

MODEL OF IDENTIFICATION NOTE REFERRED TO REGULATION (to be filled in by the person responsible for putting the product into