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

CHAPTER II MANUFACTURE, STORAGE, TRANSPORT AND PLACING ON THE MARKET

Article 4 General obligations

1. Feed business operators shall manufacture, store, transport and place on the market medicated feed and intermediate products in compliance with Annex I.

2. This Article shall not apply to farmers that only buy, store or transport medicated feed for the exclusive use on their farm.

Notwithstanding the first subparagraph, Section 5 of Annex I shall apply to such farmers.

3. Article 101(2) and Article 105(9) of Regulation (EU) 2019/6 shall apply, mutatis mutandis, to the supply of intermediate products.

4. Article 57 and Section 5 of Chapter IV of Regulation (EU) 2019/6 shall apply, mutatis mutandis, to medicated feed and intermediate products.

Article 5 Composition

1. Medicated feed and intermediate products shall only be manufactured from veterinary medicinal products, including veterinary medicinal products intended to be used in accordance with Article 112, Article 113 or Article 114 of Regulation (EU) 2019/6, authorised for the purpose of the manufacture of medicated feed in accordance with the conditions laid down in that Regulation.

2. The feed business operator manufacturing the medicated feed or intermediate product shall ensure that:

(a) the medicated feed or intermediate product is manufactured in compliance with the relevant conditions laid down in the veterinary prescription for medicated feed or, in the cases referred to in Article 8 of this Regulation, in the summary of the product characteristics, related to the veterinary medicinal products to be incorporated in the feed; those conditions shall include particular provisions regarding known interactions between the veterinary medicinal products and the feed that may impair the safety or the efficacy of the medicated feed or intermediate product;

(b) a feed additive authorised as a coccidiostat or a histomonostat for which a maximum content is set in the respective authorisation act is not incorporated in the medicated feed or intermediate product if it is already used as active substance in the veterinary medicinal product;

(c) where the active substance in the veterinary medicinal product is the same as a substance in a feed additive contained in the feed concerned, the total content of that active substance in the medicated feed does not exceed the maximum content set out in the veterinary prescription for the medicated feed or, in the cases referred to in Article 8, in the summary of product characteristics;

(d) the veterinary medicinal products incorporated in the feed combine with it to form a stable mixture for the entire storage life of the medicated feed, and respect the expiry date of the veterinary medicinal product, as referred to in point (f) of Article 10(1) of Regulation (EU) 2019/6, provided that the medicated feed or intermediate product is properly stored and handled.

3. Feed business operators supplying medicated feed to the animal keeper shall ensure that the medicated feed complies with the prescription referred to in Article 16.

Article 6 Homogeneity

1. Feed business operators manufacturing medicated feed or intermediate products shall ensure that the veterinary medicinal product is homogeneously dispersed in the medicated feed and in the intermediate product.

2. The Commission may, by means of implementing acts, establish criteria for the homogenous dispersion of the veterinary medicinal product into the medicated feed or into the intermediate product, taking into account the specific properties of the veterinary medicinal products and of the mixing technology. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 21(2).

Article 7 Cross-contamination

1. Feed business operators manufacturing, storing, transporting or placing on the market medicated feed or intermediate products shall apply measures in accordance with Article 4 to avoid cross-contamination.

2. The Commission is empowered to adopt delegated acts in accordance with Article 20 in order to supplement this Regulation by establishing specific maximum levels of cross-contamination for active substances in non-target feed, unless such levels are already established in accordance with Directive 2002/32/EC. Those delegated acts may also set out methods of analysis for active substances in feed.

Regarding maximum levels of cross-contamination, those delegated acts shall be based on a scientific risk assessment carried out by EFSA.

3. The Commission shall, by 28 January 2023, adopt delegated acts in accordance with Article 20 in order to supplement this Regulation by establishing, as regards the antimicrobial active substances listed in Annex II, specific maximum levels of cross-contamination for active substances in non-target feed and methods of analysis for active substances in feed.

Regarding maximum levels of cross contamination, those delegated acts shall be based on a scientific risk assessment carried out by EFSA.

4. For active substances in the veterinary medicinal product which are the same as a substance in a feed additive, the applicable maximum level of cross-contamination in non-target feed shall be the maximum content of feed additive in complete feed established in the relevant Union act.

5. Until maximum levels of cross-contamination are established in accordance with paragraphs 2 and 3, Member States may apply national maximum levels of cross-contamination.

Article 8 Anticipated production

Medicated feed and intermediate products may be manufactured and placed on the market, except as regards the supply to the animal keeper, before the prescription referred to in Article 16 is issued.

The first paragraph of this Article shall not apply to:

(a)

on-farm mixers and mobile mixers;

(b)

manufacture of medicated feed or intermediate products incorporating veterinary medicinal products intended to be used in accordance with Article 112 or Article 113 of Regulation (EU) 2019/6.

Article 9 Specific labelling requirements

1. The labelling of medicated feed and intermediate products shall comply with Annex III to this Regulation.

In addition, the specific requirements provided for in Regulation (EC) No 767/2009 for the labelling of feed materials and compound feed shall apply to medicated feed and intermediate products containing, respectively, feed materials or compound feed.

2. Where containers are used instead of packages, they shall be accompanied by a document complying with paragraph 1.

3. Permitted tolerances for discrepancies between the labelled content of an active substance in a medicated feed or an intermediate product and the content analysed in official controls performed in accordance with Regulation (EU) 2017/625 shall be as set out in Annex IV to this Regulation.

Article 10 Packaging

1. Medicated feed and intermediate products shall be placed on the market only in sealed packages or containers. Packages or containers shall be sealed in such a way that, when the package or container is opened, the seal is damaged and cannot be reused. Packages shall not be reused.

2. Paragraph 1 shall not apply to mobile mixers that supply medicated feed directly to the animal keeper.

Article 11 Advertising of medicated feed and intermediate products

1. The advertising of medicated feed and intermediate products shall be prohibited. That prohibition shall not apply to advertising made exclusively to veterinarians.

2. The advertising shall not include information in any form which could be misleading or lead to incorrect use of the medicated feed.

3. Medicated feed shall not be distributed for promotional purposes except for small quantities of samples.

4. Medicated feed containing antimicrobial veterinary medicinal products shall not be distributed for promotional purposes as samples or in any other presentation.

5. The samples referred to in paragraph 3 shall be appropriately labelled indicating that they are samples and shall be given directly to veterinarians during sponsored events or by sales representatives during their visits.

Article 12 Intra-Union trade and import

1. The feed business operator distributing medicated feed or intermediate products in a Member State which is different from the Member State where it was manufactured shall ensure that the veterinary medicinal products used for the manufacturing of that medicated feed or those intermediate products are allowed for use, in accordance with Regulation (EU) 2019/6, in the Member State of use.

2. The feed business operator importing medicated feed or intermediate products into the Union shall ensure that the veterinary medicinal products used for the manufacturing of that medicated feed or those intermediate products are allowed for use, in accordance with Regulation (EU) 2019/6, in the Member State of use.