Regulation 2019/4 - Manufacture, placing on the market and use of medicated feed - Main contents
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official title
Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC| Legal instrument | Regulation |
|---|---|
| Number legal act | Regulation 2019/4 |
| Original proposal | COM(2014)556  |
| CELEX number i | 32019R0004 |
| Document | 11-12-2018; Date of signature |
|---|---|
| Publication in Official Journal | 07-01-2019; OJ L 4 p. 1-23 |
| Signature | 11-12-2018 |
| Effect | 27-01-2019; Entry into force Date pub. +20 See Art 26 28-01-2022; Application See Art 26 |
| Deadline | 27-01-2019; See Art 24 28-01-2022; See Art 22.2 26-01-2024; See Art 20.2 |
| End of validity | 31-12-9999 |
7.1.2019 |
EN |
Official Journal of the European Union |
L 4/1 |
REGULATION (EU) 2019/4 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 11 December 2018
on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2) and point (b) of Article 168(4) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
After consulting the Committee of the Regions,
Acting in accordance with the ordinary legislative procedure (2),
Whereas:
(1) |
Council Directive 90/167/EEC (3) constitutes the Union’s regulatory framework for the preparation, placing on the market and use of medicated feed. |
(2) |
Livestock production occupies a very important place in the agriculture of the Union. The rules concerning medicated feed have a significant influence on the keeping and on the rearing of animals, including non-food-producing animals, and on the production of products of animal origin. |
(3) |
The pursuit of a high level of protection of human health is one of the fundamental objectives of Union food law, as laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council (4), and the general principles laid down in that Regulation should apply to the placing on the market and use of feed without prejudice to more specific Union legislation. In addition, the protection of animal health constitutes one of the general objectives of Union food law. |
(4) |
Prevention of disease is better than cure. Medicinal treatments, especially with antimicrobials, should never replace good husbandry, bio-security and management practices. |
(5) |
Experience with the application of Directive 90/167/EEC has shown that further measures should be taken to strengthen the effective functioning of the internal market and to explicitly give and improve the possibility to treat non-food-producing animals with medicated feed. |
(6) |
Medicated feed is one of the routes for the oral administration of veterinary medicinal products. Medicated feed is a homogeneous mixture of feed and veterinary medicinal products. Other routes for oral administration, such as mixing of water for drinking with a veterinary medicinal product or manual mixing of a veterinary medicinal product into feed should not fall within the scope of this Regulation. The authorisation for use in feed, the manufacture, distribution, advertising and supervision of those veterinary medicinal products are governed by Regulation (EU) 2019/6 of the European Parliament and of the Council (5). |
(7) |
Regulation (EU) 2019/6 applies to veterinary medicinal products, including those products which Directive 90/167/EEC referred to as ‘pre-mixes’, until such time as those products are included in medicated feed or intermediate products, after which this Regulation applies to the exclusion of Regulation (EU) 2019/6. |
(8) |
As a type of feed, medicated feed and intermediate products fall within the scope of Regulations (EC) No 183/2005 (6), (EC) No 767/2009 (7), (EC) No 1831/2003 (8) and Directive 2002/32/EC (9) of the European Parliament and of the Council. Thus, whenever medicated feed is manufactured with a compound feed all relevant Union legislation on compound feed applies and whenever medicated feed is manufactured from a feed material, all relevant Union legislation on feed material applies. This applies... |
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