Paragraph 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;

(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 enzvme (whether or not contained in a nreoaration 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^f1 (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 of 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 numer 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;

(vi)

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

(vii)

the bath reference number and the date of manufacture;

(viii)

directions for use, including any safety recommendation;

(ix)

the net wefght 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.

Annotations

Footnotes

f1: Units of activity expressed as umole of product released per minute per gram of enzymatic preparation