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)
CHAPTER I
SUBJECT MATTER, SCOPE AND DEFINITIONS
Article 1
Subject matter
Article 2
Scope
Article 3
Definitions
CHAPTER II
MANUFACTURE, STORAGE, TRANSPORT AND PLACING ON THE MARKET
Article 4
General obligations
Article 5
Composition
Article 6
Homogeneity
Article 7
Cross-contamination
Article 8
Anticipated production
Article 9
Specific labelling requirements
Article 10
Packaging
Article 11
Advertising of medicated feed and intermediate products
Article 12
Intra-Union trade and import
CHAPTER III
APPROVAL OF ESTABLISHMENTS
Article 13
Approval obligations
Article 14
Lists of approved establishments
Article 15
Transitional measures concerning the implementation of the requirements for approval and registration
CHAPTER IV
PRESCRIPTION AND USE
Article 16
Prescription
Article 17
Use of medicated feed
Article 18
Collection or discard systems of unused or expired products
CHAPTER V
PROCEDURAL AND FINAL PROVISIONS
Article 19
Amendment of Annexes
Article 20
Exercise of the delegation
Article 21
Committee procedure
Article 22
Penalties
Article 23
Amendment to Regulation (EC) No 183/2005
Article 24
Transitional measures
Article 25
Repeal
Article 26
Entry into force and application
ANNEX I
SPECIFIC REQUIREMENTS FOR FEED BUSINESS OPERATORS IN ACCORDANCE WITH ARTICLE 4
SECTION 1
Facilities and equipment
SECTION 2
Personnel
SECTION 3
Manufacture
SECTION 4
Quality control
SECTION 5
Storage and transport
SECTION 6
Record-keeping
SECTION 7
Complaints and product recall
SECTION 8
Additional requirements for mobile mixers
ANNEX II
Active substance |
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ANNEX III
SPECIFIC LABELLING REQUIREMENTS REFERRED TO IN ARTICLE 9(1)
ANNEX IV
PERMITTED TOLERANCES FOR THE COMPOSITIONAL LABELLING OF MEDICATED FEED OR INTERMEDIATE PRODUCTS AS REFERRED TO IN ARTICLE 9(3)
Active substance per kg of medicated feed or intermediate products |
Tolerance |
> 500 mg |
± 10 % |
≤ 500 mg |
± 20 % |
ANNEX V
INFORMATION TO BE INCLUDED IN THE VETERINARY PRESCRIPTION FOR MEDICATED FEED AS REFERRED TO IN ARTICLE 16(6)
VETERINARY PRESCRIPTION FOR MEDICATED FEED
ANNEX VI
Directive 90/167/EEC |
This Regulation |
Article 1 |
Article 2 |
Article 2 |
Article 3 |
Article 3(1) |
Article 5(1) |
Article 3(2) |
— |
Article 4(1) |
Articles 4, 5(2), 6, 7(1), 13, 16 and Annex I |
Article 4(2) |
— |
Article 5(1) |
Article 10 |
Article 5(2) |
Articles 4, 7 and Annex I |
— |
Article 8 |
Article 6 |
Article 9 and Annex III |
Article 7 |
— |
Article 8(1) and (2) |
Article 16 |
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Article 8(3) |
Article 17(6) |
Article 9(1) |
Articles 13.17(1) and (2) |
Article 9(2) |
— |
Article 9(3) |
— |
— |
Article 11 |
Article 10 |
Article 12(1) |
— |
Article 14 |
— |
Article 15 |
— |
Article 17(3), (4) and (5) |
— |
Article 17(7) |
— |
Article 18 |
Article 11 |
— |
Article 12 |
Article 19 |
— |
Article 20 |
— |
Article 21 |
— |
Article 22 |
— |
Article 25 |
— |
Article 26 |
Article 13 |
— |
Article 14 |
Article 12(2) |
Article 15 |
— |
Article 16 |
— |
Annex A |
Annex V |
Annex B |
— |
— |
Annex II |
— |
Annex IV |