Rheoliadau Porthiant (Cymru) 2001

1.   In relation to additives not excluded from application of the Additives Directive by Article 22 thereof, the following particulars shall be contained in the statutory statement (where an authorised additive is sold or otherwise put into circulation by any person) —

(a) in the case of any additive permitted to be contained in material pursuant to paragraph 5(1) of, or referred to in any of Parts I to VIII of, the Table to Schedule 3 or which is otherwise authorised (not being an enzyme, micro-organism, zootechnical additive, an authorised intermediate product or an authorised medicated premix) —

(i) the name of the additive;

(ii) the EC registration number of the additive;

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

(iv) the net weight, in the case of any non-liquid additive;

(v) either the net weight or the net volume, in the case of any liquid additive; and

(vi) as from 1st April 2001, the approval or registration number allocated, pursuant to Article 5, or, as the case may be, 10 of the Establishments Directive, to the establishment which manufactured the additive, or to the intermediary holding it;

(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 additive permitted to be contained in material pursuant to paragraph 5(1) of, or referred to in any of Parts I to VIII of the Table to Schedule 3 or which is otherwise authorised (not being an enzyme, micro-organism, zootechnical additive, authorised intermediate product or authorised medicated premix), the active substance level;

(e) in the case of any enzyme —

(i) the names of the active constituents according to their enzymatic activities as specified in the authorisation concerned;

(ii) the EC registration number;

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

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

(v) the name or business name and the address or registered business address of the manufacturer, if he is not responsible for the particulars referred to in this Part of this Schedule;

(vi) the activity units(1) per gram or per millilitre;

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

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

(ix) directions for use, including the recommended dosage or, where appropriate, range of dosages, expressed as a percentage by weight of target feed material per kilogram of feeding stuff, as prescribed in the authorisation concerned;

(x) any safety recommendation as specified in the authorisation concerned;

(xi) the net weight, in the case of any non-liquid enzyme;

(xii) either the net weight or the net volume, in the case of any liquid enzyme;

(xiii) an indication of any significant characteristics of the enzyme arising during manufacture, specified in the authorisation concerned; and

(xiv) as from 1st April 2001, the approval number allocated, pursuant to Article 5 of the Establishments Directive, to the establishment which manufactured the enzyme, or to the intermediary holding it; and

(f) in the case of any micro-organism —

(i) the identification of each strain, in accordance with the authorisation;

(ii) the file number of each strain;

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

(iv) the EC registration number;

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

(vi) the number or business name and the address or registered business address of the manufacturer, if he is not responsible for the particulars referred to in this Part of this Schedule;

(vii) as from 1st April 2001, the approval number allocated, pursuant to Article 5 of the Establishments Directive, to the establishment which manufactured the micro-organism, or to the intermediary holding it;

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

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

(x) directions for use;

(xi) any safety recommendation specified in the authorisation concerned;

(xii) the net weight, in the case of any non-liquid micro-organism;

(xiii) either the net weight or the net volume, in the case of any liquid micro-organism; and

(xiv) an indication of any significant characteristics of the micro-organism arising during manufacture, specified in the authorisation concerned.

(1)

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