The Feeding Stuffs Regulations 1995

Regulations 5 and 9

SCHEDULE 8 LABELLING AND MARKING OF ADDITIVES AND PREMIXTURES

PART I ADDITIVES

1.  The label or mark shall give—

(a) in the case of an additive referred to in paragraph 6(1) of, or in the Table to, Schedule 4 (other than an enzyme);

(i) the name of the additive;

(ii) the name or business name and the address or registered business address of the person responsible within the European Community for the particulars referred to in this Part of this Schedule;

(iii) the net weight of any non-liquid additive; and

(iv) either the net weight or the net volume of any liquid additive;

(b) in the case of vitamin E,

(i) the alpha-tocopherol level as acetate; and

(ii) an indication of the period during which that level will remain present;

(c) in the case of any vitamin other than vitamin E, or any added provitamin or substance having a similar effect,

(i) the active substance level; and

(ii) an indication of the period during which that level will remain present;

(d) in the case of any trace element, colourant (including pigment), preservative or other additive referred to in the Table to Schedule 4 but not specified above (other than an enzyme), the active substance level;

(e) in the case of any enzyme (whether or not contained in a preparation where the enzyme is not of a type referred to in Part X of the Table to Schedule 4):

(i) the names of the active constituents according to their enzymatic activities (in the case of an enzyme of a type referred to in Part X of the Table to Schedule 4, as specified in column 3 of that Part);

(ii) the identification number allotted by the International Union of Biochemistry;

(iii) the name or business name and the address or registered business address of the person responsible for the particulars referred to in this sub-paragraph;

(iv) the name or business name and the address or registered business address of the manufacturer if he is not responsible for the particulars in the label or mark;

(v) the activity units(1) (expressed as activity units per gram or activity units per millilitre);

(vi) an indication of the period during which the activity units will remain present;

(vii) the batch reference number and the date of manufacture;

(viii) directions for use, including any safety recommendation (in the case of an enzyme of a type referred to in Part X of the Table to Schedule 4, as specified in column 3 of that Part);

(ix) the net weight for any non-liquid additive;

(x) either the net weight or the net volume of any liquid additive; and

(xi) in the case of an enzyme of a type referred to in Part X of the Table to Schedule 4, an indication of any significant characteristics of the enzyme arising during manufacture, specified in column 8 of that Part;

(f) in the case of any micro-organism (whether or not contained in a preparation);

(i) the identification of the strain(s) according to a recognised international code of nomenclature;

(ii) the deposit number of the strain(s);

(iii) the number of colony-forming units (expressed as CFU/g);

(iv) the name or business name and address or registered business address of the person responsible for the particulars referred to in this sub-paragraph;

(v) the name or business name and address or registered business address of the manufacturer if he is not responsible for the particulars in the label or mark;

(vii) the batch reference number and the date of manufacture;

(viii) directions for use, including any safety recommendation;

(ix) the net weight of any non-liquid additive;

(x) either the net weight or the net volume of any liquid additive; and

(xi) an indication of any significant characteristics of the micro-organism arising during manufacture.

2.  The label or mark may give, in addition to the name used in relation to any additive referred to in paragraph 6(1) of, or in the Table to, Schedule 4—

(a) the trade name of the additive and its EEC number;

(b) the name or business name and the address or registered business address of the manufacturer;

(c) directions for use, including any appropriate safety recommendation;

(d) any other information, provided that it is clearly separated from the particulars referred to in paragraph 1(a)–(d) above and in the foregoing provisions of this paragraph, and from the relevant particulars referred to in paragraph 1(e) above.

3.  In the case of any enzyme (other than of a type referred to in Part X of the Table to Schedule 4) or micro-organism, whether or not the enzyme or micro-organism is contained in a preparation, the label or mark may give any other information, provided that it is clearly separated from the relevant particulars referred to in paragraph 1(e) and (f) above.

PART II PREMIXTURES

1.  The label or mark shall give—

(a) in the case of any premixture,

(i) the description “premixture”;

(ii) directions for use, including any appropriate safety recommendation;

(iii) the species or category of animal for which the premixture is intended;

(iv) the name or business name and the address or registered business address of the person responsible within the European Community for the particulars referred to in this Part of this Schedule;

(v) the net weight of any non-liquid premixture; and

(vi) either the net weight or the net volume of any liquid premixture;

(b) in the case of any antioxidant, colourant (including pigment), trace element or preservative in a premixture, for which a maximum content in a complete feeding stuff is provided for by the appropriate Part of the Table to Schedule 4,

(i) the name of the additive; and

(ii) the active substance level;

(c) in the case of vitamin E in a premixture,

(i) the name of the additive;

(ii) the alpha-tocopherol level as acetate; and

(iii) an indication of the period during which that level will remain present;

(d) in the case of any vitamin other than vitamin E, or any provitamin or substance having a similar effect in a premixture,

(i) the name of the additive;

(ii) the active substance level; and

(iii) an indication of the period during which that level will remain present;

(e) in the case of any enzyme in a premixture:

(i) the names of the active constituents according to their enzymatic activities (in the case of an enzyme of a type referred to in Part X of the Table to Schedule 4, as specified in column 3 of that Part);

(ii) the identification number allotted by the International Union of Biochemistry;

(iii) the activity units (expressed as activity units per gram or activity units per millilitre);

(iv) an indication of the period during which the activity units will remain present;

(v) the name or business name and address or registered business address of the manufacturer if he is not responsible for the particulars referred to in the label or mark; and

(f) in the case of any micro-organism in a premixture:

(i) the identification of the strain(s) according to a recognised international code of nomenclature;

(ii) the deposit number of the strain(s);

(iii) the number of colony-forming units (expressed as CFU/g);

(iv) an indication of the period during which the colony-forming units will remain present;

(v) the name or business name and address or registered business address of the manufacturer if he is not responsible for the particulars referred to in the label or mark; and

(vi) an indication of any significant characteristics of the micro-organism arising during manufacture;

(g) in the case of any additive in a premixture—

(i) which is an additive of a type referred to in Schedule 4 (other than any additive ofa type referred to in sub-paragraphs (b)–(e) above) or an additive of a type referredto in that Schedule and in those subparagraphs in respect of which no maximum levelis laid down;

(ii) which fulfills a function in the feeding stuff as such, and

(iii) in respect of which the amount which is present in the premixture can be determinedby using one of the methods of analysis specified in Schedule 2 to the Feeding Stuffs (Sampling and Analysis) Regulations 1982(2), or by some other valid scientific method—

(A) the name of the additive, and

(B) the active substance level.

2.  In relation to any additive referred to in paragraph 6(1) of, or in the Table to, Schedule 4, the label or mark may give—

(a) the trade name of the additive; or

(b) its EEC number; or

(c) both such trade name and the EEC number; and

(d) any other information, provided that it is clearly separated from the particulars referredto in paragraph 1(a)–(d) above and in the foregoing provisions of this paragraph, and from the relevant particulars referred to in paragraph 1(e) above.

3.  In relation to any enzyme (other than of a type referred to in Part X of the Table to Schedule 4) or micro-organism, in a premixture, the label or mark may give any otherinformation, provided that it is clearly separated from the relevant particulars referred to inparagraphs 1(a), (e) and (f) above.

4.  In the case of a premixture containing more than one vitamin (other than vitamin E), provitamin or substance having a similar effect, the requirement for the indication of the period for which the active substance level will remain present shall apply only to thatone of those additives which has the shortest such period.

(1)

Units of activity expressed as μmole of product released per minute per gram of enzymatic preparation.

(2)

S.I. 1982/1144, amended by S.I. 1984/52, 1985/1119 and 1994/1610.