Commission Delegated Regulation (EU) 2024/1159 of 7 February 2024 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council by laying down rules on appropriate measures to ensure the effective and safe use of veterinary medicinal products authorised and prescribed for oral administration via routes other than medicated feed and administered by the animal keeper to food-producing animals

• CELEX: Delegated Regulation (EU) 2024/1159
• Articles: 11

Article 1 Scope

1.   This Regulation applies to authorised and prescribed veterinary medicinal products administered orally in drinking water, mixed into feed, or administered on the surface of feed immediately prior to feeding and administered by the animal keeper to food-producing animals.

2.   This Regulation does not apply to the use of medicated feed manufactured in accordance with Regulation (EU) 2019/4.

Article 2 Definitions

For the purposes of this Regulation, the following definitions apply:

(a)

‘feed’ means feed as defined in Article 3, point 4 of Regulation (EC) No 178/2002 of the European Parliament and of the Council  ( 4 ) ;

(b)

‘non-target feed’ means non-targeted feed as defined in Article 3(2), point (c), of Regulation (EU) 2019/4;

(c)

‘biocidal product’ means biocidal product as defined in Article 3(1), point (a), of Regulation (EU) No 528/2012 of the European Parliament and of the Council  ( 5 ) ;

(d)

‘liquid feed’ means any feed material or compound feed in a liquid or semi-liquid form, including milk or diluted milk replacers and ready to use for oral animal feeding;

(e)

‘solid feed’ means all types of feed other than liquid feed.

Article 3 Decision on the use of the veterinary medicinal product

When deciding whether to administer a veterinary medicinal product to food producing animals by oral route of administration, the veterinarian shall take account of the following:

(1)

the diagnosis;

(2)

the availability of appropriate veterinary medicinal products;

(3)

ensuring individual treatment of animals whenever possible, except for immunological veterinary medicines;

(4)

the animal species, production system and the number of animals to be treated;

(5)

the properties of the veterinary medicinal product;

(6)

the relevant characteristics of the feed or drinking water;

(7)

the presence of biocidal products, feed additives or other substances in the feed or drinking water that might impact the uptake or the efficacy or safety of the veterinary medicinal product, including by interaction or incompatibility of the veterinary medicinal product, and in particular the requirements set out in Article 4;

(8)

the state of the facilities and equipment for oral administration of veterinary medicinal products on the farm, such as the mixing and dosing equipment, type of feeding or drinking equipment and storage premises, as well as the maintenance conditions of those facilities and equipment;

(9)

the expertise and skills of the animal keeper or staff on the farm to ensure the correct storage, preparation, administration and disposal of veterinary medicinal products for oral administration, including the ability to use the necessary equipment or dosing devices.

Article 4 Simultaneous use of veterinary medicinal products and other categories of products

1.   Biocidal products, feed additives or other substances used in drinking water shall not be used simultaneously with a veterinary medicinal product where there is evidence of negative interactions or incompatibilities between those products and the veterinary medicinal product when added to drinking water.

2.   Veterinary medicinal products containing an anticoccidial or antihistomonal active substance shall not be used in feed containing the same substance as a feed additive authorised as a coccidiostat or a histomonostat with a maximum content.

3.   For active substances other than anticoccidial or antihistomonal substances, where the active substance in the veterinary medicinal product is the same as a substance in a feed additive contained in the feed, the total content of that active substance in the feed once the veterinary medicinal product has been mixed into it or added onto its surface shall not exceed the maximum content set out in the prescription.

Article 5 Information and instructions on disposal

1.   The veterinarian shall inform the animal keeper that the inappropriate disposal of feed or drinking water containing veterinary medicinal products prescribed for oral administration may pose a threat to the environment and, where relevant, may contribute to the development and spread of antimicrobial or antiparasitic resistance.

2.   The veterinarian shall provide the animal keeper with instructions for the safe disposal of unused veterinary medicinal products prescribed and give advice on how to minimise the exposure of the environment to feed or water containing the veterinary medicinal products.

Article 6 Prescription of antimicrobial and antiparasitic veterinary medicinal products

1.   The veterinarian shall not prescribe more than one antibiotic veterinary medicinal product to be administered orally in the same course of treatment.

2.   The veterinarian shall only prescribe veterinary medicinal products containing antimicrobial or antiparasitic active substances administered by means of mixing into solid feed or administered on the surface of solid feed immediately prior to feeding, for the treatment of individually fed animals or a small group of animals where the intake of the veterinary medicinal product by individual animals can be effectively controlled.

3.   By way of derogation from paragraph 2, where medicated feed produced in accordance with Regulation (EU) 2019/4 is not available or where a veterinarian considers animal treatment is necessary to commence before the delivery of the medicated feed, the veterinarian may prescribe group treatments with antimicrobial or antiparasitic veterinary medicinal products to be mixed into solid feed for food producing aquatic species.

4.   By way of further derogation from paragraph 2, a Member State may restrict on its territory the prescription and oral administration of veterinary medicinal products containing antimicrobial or antiparasitic active substances administered by means of mixing into solid feed or administered on the surface of solid feed immediately prior to feeding, to individually fed animals only. Such restriction shall be duly justified on grounds of sufficient availability of veterinary medicinal products, access to medicated feed produced in accordance with Regulation (EU) 2019/4 and/or local husbandry and farming practices.

5.   The Member State shall inform the Commission of any measure it has adopted on the basis of paragraph 4.

Article 7 Handling and use of veterinary medicinal products by animal keepers

1.   The animal keeper is responsible for:

(a)

providing the veterinarian with the relevant information concerning Article 3, points (6), (7), (8) and (9);

(b)

using veterinary medicinal products subject to veterinary prescription for oral administration in feed or drinking water only in accordance with the veterinary prescription;

(c)

the proper storage, preparation and administration of veterinary medicinal products in feed or drinking water, including:

(i)

the proper dosage of the veterinary medicinal products in accordance with the veterinary prescription and ensure the uptake of the appropriate amount of feed and water by all target animals;

(ii)

the proper, homogeneous dilution of the veterinary medicinal products in the liquid feed or the drinking water;

(d)

ensuring that any person administering veterinary medicinal products under their supervision, has the relevant expertise and skills or has been trained with regard to the responsibilities set out in point (c).

2.   The animal keeper shall take the necessary measures to:

(a)

avoid contamination of non-targeted feed or drinking water from feed or drinking water containing veterinary medicinal products;

(b)

ensure the safe disposal of unused veterinary medicinal products and avoid exposing the environment to feed or drinking water containing veterinary medicinal products according to the product information and to the instructions of the veterinarian;

(c)

ensure that the water used for the administration of veterinary medicinal products via drinking water or liquid feed is appropriate for the oral administration of the veterinary medicinal product.

Article 8 Equipment

1.   The animal keeper is responsible for ensuring that the equipment used for preparing and mixing veterinary medicinal products for oral administration in drinking water, milk, milk replacers or other forms of liquid feed:

(a)

corresponds to the range of weights or volumes being mixed;

(b)

allows the preparation of homogeneous dilutions;

(c)

is designed, built and placed in such a way that:

(i)

medication is supplied to the target animals only;

(ii)

contamination of untreated drinking water or feed is avoided;

(iii)

treatment of drinking water with biocidal products and use of feed additives via drinking water, may be decreased or stopped, if necessary, before and during the treatment with the veterinary medicinal product to ensure the safety and efficacy of the treatment.

2.   The animal keeper shall ensure that all scales and metering devices used correspond to the range of weights or volumes to be measured and are calibrated in accordance with the manufacturer’s instructions.

3.   The animal keeper is responsible for ensuring that the equipment, watering systems or dosing devices used for the oral administration of veterinary medicinal products in feed or drinking water are properly used, maintained and cleaned after being used for the administration of veterinary medicinal products in feed or drinking water.

Article 9 Product information

1.   The product information of an antimicrobial or antiparasitic veterinary medicinal product to be administered to a terrestrial food-producing animal species by means of mixing into solid feed or administered on the surface of solid feed immediately prior to feeding shall clearly indicate that the product is to be administered only for the treatment of individually fed animals or a small group of animals where the intake of veterinary medicinal products by individual animals can be effectively controlled.

2.   The product information of a veterinary medicinal product to be administered orally by means of mixing into drinking water or liquid feed shall provide appropriate guidance on known interactions and incompatibilities between the veterinary medicinal product and biocidal products, feed additives or other substances used in drinking water. Where no data or information on potential interactions or incompatibilities is available, the product information shall include a warning indicating that no such information is available.

3.   Where relevant, marketing authorisation holders of veterinary medicinal products authorised before 9 November 2025 shall amend their existing marketing authorisations or product information, as appropriate, in accordance with paragraphs 1 and 2 at the latest by 9 May 2029.

Article 10 Guidelines on good practice

Member States may develop national guidelines on good practice to facilitate the application of this Regulation, taking into account the different food-producing animal species and production systems in their territories.

Article 11 Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

It shall apply from 9 November 2025.