Regulation (EU) 2019/4 of the European Parliament and of the CouncilShow full title

ANNEX III SPECIFIC LABELLING REQUIREMENTS REFERRED TO IN ARTICLE 9(1)

The label of medicated feed and intermediate products shall include the following particulars, in a simple, clear and easily understandable manner for the end users:

(1)

the expression ‘Medicated feed’ or ‘Intermediate product for the manufacturing of medicated feed’ as appropriate;

(2)

the approval number of the feed business operator responsible for the labelling. In cases where the manufacturer is not the feed business operator responsible for the labelling, the following shall be provided:

(a)

the name or business name and address of the manufacturer; or

(b)

the approval number of the manufacturer;

(3)

the active substances with name, added amount (mg/kg), and the veterinary medicinal products with its marketing authorisation number and the marketing authorisation holder, preceded by the heading ‘medication’;

(4)

any contra-indications of the veterinary medicinal products and adverse events in so far as those particulars are necessary for the use;

(5)

in the case of a medicated feed or of intermediate product intended for food-producing animals, the withdrawal period or the indication ‘no withdrawal period’;

(6)

in the case of medicated feed for non-food-producing animals, except fur animals, a warning that the medicated feed is only for the treatment of animals and a warning that it must be kept out of the sight and reach of children;

(7)

a free telephone number or other appropriate means of communication in order to allow the animal keeper to obtain, in addition to the mandatory particulars, the package leaflet of each veterinary medicinal product;

(8)

the instructions for use in line with the veterinary prescription for medicated feed or the summary of the product characteristics;

(9)

the minimum storage life, which shall take into account the expiry dates of the veterinary medicinal products and shall be expressed as ‘use before…’, followed by the date, and special storage precautions, if appropriate;

(10)

information that inappropriate disposal of medicated feed poses serious threats to the environment and may, where relevant, contribute to antimicrobial resistance.

Points 1 to 10 shall not apply to mobile mixers exclusively manufacturing the medicated feed without supplying any components.