EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, 10.9.2014  
COM(2014) 556 final 
2014/0255 (COD) 
  
Proposal for a 
REGULATION OF THE EUROPEAN PA RLIAMENT AND OF THE COUNCIL 
on the manufacture, placing on the market  and use of medicated feed and repealing 
Council Directive 90/167/EEC 
(Text with EEA relevance) 
{SWD(2014) 271 final} 
{SWD(2014) 272 final}  EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  PROPOSAL 
Farmed animals in the EU are fed with roughage, feed materials and compound feed 
(mixture of feed materials). If animals ar e sick and need a treatment, veterinary 
medicinal products may be administered on the basis of a veterinary prescription. 
The vast majority of medicated feed for farmed animals contains antimicrobials or 
anti-parasites.  
As regards the oral administration of medi cines to animals, the animal holders can 
either add medicines themselves to the animal feed or drinking water or use 
medicated feed into which the medicine is  incorporated by themselves or by another 
approved manufacturer.  
Medicated feed is generally used to treat an imal diseases in large groups of animals, 
in particular pigs and poultry. There is a clear correlation between the level of manufacture standards and the quality of the treatment via medicated feed. High 
standards mean good homogenous distributi on of the medicine in the feed, good 
compatibility of the medicine with the f eed and as a result good dosage and efficient 
treatment of the animal and low carry-over of the medicine into non-target animal 
feed.  
There are 13.7 million animal holdings in the EU. The value of livestock farming 
output in the EU is €157 billion. The value of the EU`s aquaculture which includes production of crustaceans, molluscs, and finf ish is estimated to be €3.3 billion. Pet 
animals represent the second largest type of  animals kept in the EU. There are around 
64 million cats, 60 million dogs, 40 million pet birds, 25 million small mammals and many millions of ornamental fishes. All th ese farmed animals, aquaculture species 
and pets, depending on their health condition, may need medication. 
The aim of the review of th e medicated feed rules is to harmonise at a high safety 
level the manufacture, marketing and us e of medicated feed  and intermediate 
products in the EU and to re flect technical prog ress in this field.  The draft proposal 
updates the current legislation on medicated  feed by repealing Directive 90/167/EEC 
which sets out the conditions under wh ich medicated animal feed may be 
manufactured, placed on the market and used  within the EU. The Directive has been 
established before the creation of the internal market and it has never been adapted in substance. The national transposition of th is legal instrument has given freedom to 
Member States regarding interpretation a nd implementation of the legal provisions, 
but this flexibility has contributed to some problems. The Directive gives no 
indication on what standards to apply in  approving plants or the acceptable 
techniques to produce medicated feed, whether standards should be technology-
based or results-based, it does not provide for homogeneity criteria, it is totally silent 
on the concept of carry-over of medicated feed between batches, on the specific 
labelling of medicated feed and on medicated feed for pets and it is vague on whether feed may be prepared in advance of pres cription in the feed mill, allowing Member 
States to arrive with di fferent interpretations.  
Furthermore, the existing legislation is likely to perpetuate existing discrepancies in 
its implementation between the Member States. This creates an uneven playing field for professional operators on the single ma rket. There is a need to harmonise 
implementation of the legislation, reduce financial and admini strative burdens and 
support innovation.  EN 3   EN The draft proposal will allo w the anticipated medicated feed production, mobile and 
on-farm mixing, while simultaneously establis hing the parameters for these schemes. 
The provisions include measures for dispos al of not used medicated feed on farm. 
EU wide limits will be set for the carry-ove r of veterinary medicines in feed that 
should be adapted based on an assessment of  the risk for the animals and the humans 
with regard to the different  types of active substances. 
2. RESULTS  OF CONSULTATIONS  WITH  THE  INTERESTED  PARTIES  AND  
IMPACT  ASSESSMENT 
The impact assessment builds on the results of  an external study entitled "Evaluation 
of the EU Legislative Framework in the Field of Medicated Feed” carried out in 
2009/2010 by the Food Chain Evaluation Consortium (FCEC). 
It is furthermore based on a wide stakeholders’ consulta tion in the context of the 
evaluation conducted in 2009/2010, following which internal consultations and 
discussion with the Member States took pl ace. In addition, during the whole process 
consultations with the stakeholders were done in the margins of the Advisory Group 
on the Food Chain and Animal and Plant Health, the Animal Health Advisory 
Committee and the Advisory Committee on Fisheries and Aquaculture working group on aquaculture. Furtherm ore, targeted consultatio ns of the International 
Federation for Animal Health Europe, the European Feed Manufacturers` Federation, 
the Federation of Veterinarians in Europe and the EU Farmers and Agri-Cooperatives were undertaken. 
Following the stakeholders' consultation in  the margins of the FCEC evaluation, a 
new web-based stakeholders' survey was organised from 30 March to 31 May 2011, 
using an Interactive Policy  Making questionnaire to co llect comments on the policy 
options.  
Finally, focussed interviews with experts fr om the industry and competent authorities 
were undertaken mainly to collect data fo r the assessment of the different options. 
In June 2009 a questionnaire was sent to  the Member States plus Norway and 
Switzerland to gather information from the competent authorities on the status quo in 
the field of medicated feed.  
In addition, the Commission has consulte d and reported regularly to the working 
party of Chief Veterinary Officers, th e Standing Committee on the Food Chain and 
Animal Health (Section Animal Nutrit ion) and the Veterinary Pharmaceutical 
Committee. 
The purpose of the impact assessment was to support the changes proposed to the 
medicated feed legislation (Directive 90/167/ EEC) in line with the principles set out 
in the Commission's Work programme. This is related to similar on-going work in 
the field of veterinary medical products . The Health and Consumers Directorate-
General has taken the initiative to revise Directive 90/167/EEC at the same time as 
the revision of the veterinary medicinal products legislation. 
Member States and the different stakeholde rs involved in this field have on several 
times indicated the importance of ensuring that the revisi on of the medicated feed 
legislation takes the specificities of the sector into account. This can only be done by 
an independent approach which builds on the links with the feed legislation and the 
veterinary medicinal products legislation. EN 4   EN The impact assessment identified the follo wing main axes along which the system 
has to change in order to answer the stak eholders concerns: re sidues of veterinary 
medicines in feed, imprecise dosage of veterinary medicines, impossible market access to medicated feed for pets and barrier s to intra EU trade of medicated feed. 
The impact assessment concluded that an EU Regulation with detailed rules would 
have the most positive impacts and woul d provide for the best way forward to 
achieve the objectives for the EU. It should have a significant posi tive impact on cost 
efficiency and economic growth of the me dicated feed manufact uring sector, also 
considering innovative applications of veterinary medicines. Animal and public health can be expected to be improved bot h in Member States with currently lax 
standards for medicated feed and those w ith prohibitive standards. Safe tolerance 
levels for the unavoidable carry-over of veteri nary medicines in feed would lead to a 
pragmatic and solid level playing field for th e industry and the c ontrol authorities.  
3. LEGAL
 ELEMENTS  OF THE  PROPOSAL 
The aim of this proposal is to rep eal Directive 90/167/EEC by the proposed 
Regulation. 
General provisions 
The scope of the proposed Regulation covers  the manufacture, placing on the market 
and use of medicated feed for use in pets  and in food-producing animals within the 
Union. It does not apply to veterinary medicinal products used as the medicinal 
component of medicated feed (previously called "medicated premixes"), which are 
dealt with under the veterinary medicinal products legislation. 
The Regulation lays down rules for the manufacture, composition, placing on the 
market and use of medicated feed. The ge neral manufacture requirements laid down 
in Regulation (EC) No 183/2005 apply. Furt hermore, medicated feed may only be 
manufactured from veterinary medicinal products authorised under the veterinary 
medicinal products legislation. It also sets  rules for the approva l of feed business 
operators and rules they need to comply with in order to ma nufacture medicated 
feed. The Regulation lays down rules fo r the homogenous incorporation of the 
veterinary medicinal products into the medicated feed an d requirements in order to 
avoid carry-over of active substances from  veterinary medicina l products into non 
target feed. 
With respect to labelling, the general provisions laid down in Regulation (EC) No 
767/2009 apply. Specific rules for the prescrip tion, the validity of the prescription, 
the use of medicated feed containing an timicrobials in food-producing animals and 
the quantities required for the treatment of  animals with medicated feed are laid 
down. Manufacturers, distribut ors and users of medicated feed must keep daily 
records for the effective tracing of medica ted feed. For veterinary medicinal products 
authorised at national level, the Regula tion sets Intra-Union rules for trade of 
medicated feed in order to prevent distortions in competition.  
Rules for the adoption of delegated acts a nd of implementing acts on the basis of the 
Regulation are laid down in the proposal. EN 5   EN Legal basis 
Articles 43 and 168(4)(b) of the TFEU provi de for the legal basis of the proposal. 
Directive 90/167/EEC was based on Article  43 of the Treaty establishing the 
European Economic Community (now Artic le 43 of the TFEU), implementing the 
Common Agricultural Policy. The objectiv es of that policy are to increase 
agricultural productivity, to en sure a fair standard of living for the agricultural 
community, to stabilise markets, to assure the availability of supplies and to ensure 
that supplies reach consumers at reasona ble prices. To aim for harmonised and 
adequate production conditions for the EU livestock farmers can be also derived 
from this Article. 
Article 168(4)(b) of the TFEU covers measur es in the veterinary and phytosanitary 
fields which have as their direct ob jective the protecti on of public health. 
The proposal takes the form of a Regulation of the European Parliament and of the 
Council. Other means would not be appr opriate because the objectives of the 
measure can be achieved most effici ently by fully harmonised requirements 
throughout the Union. EN 6   EN 2014/0255 (COD) 
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on the manufacture, placing on the market and use of medicated feed and repealing 
Council Directive 90/167/EEC 
(Text with EEA relevance) 
THE EUROPEAN PARLIAMENT AND THE CO UNCIL OF THE EUROPEAN UNION, 
Having regard to the Treaty on the Functioning of the European Union, and in particular 
Articles 43 and 168(4)(b) 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 Eu ropean Economic and Social Committee
1,  
Having regard to the opinion of  the Committee of the Regions2,  
Acting in accordance with the or dinary legislative procedure, 
Whereas: (1) Council Directive 90/167/EEC
3 constitutes the Union`s regulatory framework for the 
manufacture, placing on the market  and use of medicated feed. 
(2) Livestock production occupies a very impor tant place in the agriculture of the Union. 
The rules concerning medicated feed have significant influence on the keeping and on 
the rearing of animals, including non-f ood 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 food law, as laid down in Regulation (EC)  No 178/2002 of the European 
Parliament and of the Council4, and the general principles laid down in that Regulation 
should apply to the placing on the market a nd use of feed without  prejudice to more 
specific Union legislation. In addition, the protection of animal health constitutes one 
of the general objectiv es of EU food law. 
(4) Experience with the application of Directive 90/167/EEC has shown that further 
measures should be taken to strengthen the e ffective functioning of the Internal Market 
and to explicitly give and improve the possi bility to treat non- food producing animals 
by medicated feed. 
                                                 
1 OJ C , , p. . 
2 OJ C , , p. . 
3 Council Directive 90/167/EEC of 26 March 1990 laying down the conditions governing the preparation, 
placing on the market and use of medicated feedingstuffs in the Community (OJ L 92, 7.4.1990, p. 42). 
4 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
down the general principles and requirements of food law, establishing the European Food Safety 
Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1). EN 7   EN (5) Medicated feed is one of the routes fo r the administration of veterinary medicinal 
products, which are incorporated into fee d. The authorisation for use in feed, the 
manufacture, distribution, adve rtising and supervision of those veterinary medicinal 
products are governed by Directive 2001/82/EC of  the European Parliament and of the 
Council5. 
(6) As a type of feed, medicated feed falls  within the scope of Regulation (EC) No 
183/2005 of the European Parliament and of the Council6, of Regulation (EC) No 
767/2009 of the European Parliament and of the Council7, of Regulation (EC) No 
1831/2003 of the European Parliament and of the Council8 and of Directive 
2002/32/EC of the European Pa rliament and of the Council9. Specific provisions for 
medicated feed and intermediate products s hould be established concerning facilities 
and equipment, personnel, manufacture quality control, storage and transport, record-
keeping, complaints and product recalls, the application of pro cedures based on the 
hazard analysis and critical control points (HACCP) principles and labelling. 
(7) Medicated feed imported into the Union must satisfy the general obligations laid down 
in Article 11 of Regulation (EC) No 178/ 2002 and the import conditions laid down in 
Regulation (EC) No 183/2005 and in Regula tion (EC) No 882/2004 of the European 
Parliament and of the Council10. Within this framework, medicated feed imported into 
the Union is to be considered as fall ing within the scope of this Regulation. 
(8) Without prejudice to the general obliga tions laid down in Ar ticle 12 of Regulation 
(EC) No 178/2002 concerning exports of feed to  third countries, the provisions of this 
Regulation should apply to medicated feed  and intermediate products which are 
manufactured, stored, transported or placed on the market within the Union with the 
intention to be exported. However, the specific requirements concerning labelling, prescription and use of medicated feed and intermediate products should not apply to 
products intended to be exported. 
(9) Medicated feed should be manufactured on ly with authorised veterinary medicinal 
products and the compatibility  of all compounds used should be ensured for the 
purpose of safety and efficacy of the pr oduct. Additional specific requirements or 
instructions for the inclusion of the veteri nary medicinal products into feed should be 
foreseen to ensure a safe and efficient treatment of the animals. 
(10) Homogeneous incorporation of the veterina ry medicinal product into  the feed is also 
crucial for the manufacture of a safe and efficient medicated feed. Therefore, the 
possibility to establish criteria, such as  target values, for the homogeneity of the 
medicated feed should be provided for.  
                                                
 
5 Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the 
Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1). 
6 Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying 
down requirements for feed hygiene (OJ L 35, 8.2.2005, p. 1). 
7 Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the 
placing on the market and use of feed (OJ L 229, 1.9.2009, p. 1). 
8 Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 
on additives for use in animal nutrition (OJ L  268, 18.10.2003, p. 29). 
9 Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed (OJ L 140, 30.5.2002, p. 10). 
10 Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on 
official controls performed to ensure the verification of compliance with feed and food law, animal 
health and welfare rules (OJ L 165, 30.4.2004, p. 1) (Corrigendum : OJ L 191, 28.5.2004, p. 1). EN 8   EN (11) Feed business operators may produce within one establishment a broad range of feeds 
for different target animals and containing different types of compounds such as feed 
additives or veterinary medi cinal products. The manufacture of different types of feed 
after each other in the same production line may result in the presence of traces of a substance in the line, which ends up in  the beginning of the production of another 
feed. This transfer of traces of a substan ce from one production lot to another is called 
"carry-over".  
(12) Carry-over may occur during production, processing, storage and transport of feed 
where the same production and processing equi pment, storage facilities or means of 
transport are used for feed with differe nt components. For the purposes of this 
Regulation, the concept of "carry -over" is used specifically to  designate the transfer of 
traces of an active substance contained in a medicated feed to a non-target feed, while 
the term "cross-contamination" is to be c onsidered as a contamination resulting from a 
carry-over or from the transfer in feed of any unintended substance. Carry-over of 
active substances contained in medicated feed  to non-target feed should be avoided or 
kept as low as possible. In order to pr otect animal health, human health and the 
environment, maximum levels of carry- over for active substances contained in 
medicated feed should be established, based on a scientific risk assessment performed 
by the European Food Safety Authority and taking into account the application of 
good manufacturing practice and the ALARA (As Low As Reasonably Achievable) 
principle. General limits should be set out in this Regulation, taking into account the 
unavoidable carry-over and the risk caused  by the active substances concerned.  
(13) Labelling of medicated f eed should comply with the gene ral principles laid down in 
Regulation (EC) No 767/2009 a nd be subject to specific labelling requirements in 
order to provide the user with the information necessary to correctly administer the medicated feed. Similarly, limits for the de viations of the la belled content of 
medicated feed from the actual content should be established. 
(14) Medicated feed should be marketed in sealed containers for safety reasons and to 
protect user's interest.  
(15) For intra Union trade of medicated fee d, it should be ensured that the veterinary 
medicinal product contained therein has been duly authorised in the Member State of 
destination according to  Directive 2001/82/EC.  
(16) Feed business operators manufacturing, whether they opera te in a feed mill, with a 
specially equipped lorry or on-farm, stor ing, transporting or placing on the market 
medicated feed and intermediate products, should be approved by the competent authority, in line with  the approval system laid down in Regulation (EC) No 183/2005, 
in order to ensure both feed safety a nd product traceability. Provision should be made 
for a transition procedure concerning estab lishments already approved under Directive 
90/167/EEC. 
(17) In order to ensure the sa fe use of medicated feed, its s upply and use should be subject 
to presentation of a valid veterinary pr escription which has been issued after 
examination of the animals to be treate d. However, the possibility to manufacture 
medicated feed before a prescription is presented to the manufacturer should not be 
excluded. 
(18) In order to ensure a particularly pr udent use of medicated feed for food-producing 
animals and therefore provide the basis for the assurance of  a high level of protection 
of public health, specific conditions con cerning the use and the validity of the EN 9   EN prescription, compliance with the withdrawal  period and record-keeping by the animal 
holder should be provided for. 
(19) Taking into account the serious public  health risk posed by resistance to 
antimicrobials, it is appropriate to limit the use of medicated feed containing antimicrobials for food-producing animals. Preventive use or use to enhance the 
performance of food-producing animals s hould in particular not be allowed. 
(20) A system for the collection of unused or  expired products should be put in place in 
order to control any risk that  such products might raise with  regard to the protection of 
animal, human health or the environment. 
(21) In order to comply with the objective of this Regulation and to take into account 
technical progress and scientific developmen ts, the power to adopt acts in accordance 
with Article 290 of the Treaty on the Func tioning of the European Union should be 
delegated to the Commission in respect of  the establishment of specific carry-over 
limits and of the amendment to the Anne xes to this Regulation. Those Annexes 
concern provisions on feed business operators  obligations related to the manufacture, 
storage, transport and placing on the market  of medicated feed and intermediate 
products, the incorporation of the veterinary medicinal product into  feed, the labelling 
particulars for medicated feed and intermed iate products, the permitted tolerances for 
the compositional labelling of medicated feed or intermediate products and the specimen form to be used for the vete rinary prescription. The Commission, when 
preparing and drawing-up dele gated acts, should ensure  a simultaneous, timely and 
appropriate transmission of relevant docum ents to the European Parliament and 
Council. 
(22) In order to ensure uniform conditions  for the implementation of this Regulation 
regarding the establishment of  homogeneity criteria for medicated feed, implementing 
powers should be conferred on the Commissi on. Those powers should be exercised in 
accordance with Regulation (EU) No 182/2011 of  the European Parliament and of the 
Council of 16 February 2011 la ying down the rules and gene ral principles concerning 
mechanisms for control by Member Stat es of the Commission's exercise of 
implementing powers
11. 
(23) Member States should lay down penalties fo r infringement to the provisions of this 
Regulation and should take all measures necessary to ensure that they are 
implemented. Such penalties should be effective, proportionate and dissuasive. 
(24) Since the objective of this Regulation, namely ensuring a high level of protection of 
human and animal health, providing adequate  information for user s and strengthening 
the effective functioning of the internal ma rket, cannot be sufficiently achieved by the 
Member States and can therefore be bette r achieved at Union level, the Union may 
adopt measures, in accordance with the principl e of subsidiarity as set out in Article 5 
of the Treaty on European Union. In accordan ce with the principl e of proportionality, 
as set out in that Ar ticle, this Regulation does not go beyond what is  necessary in order 
to achieve that objective, 
                                                 
11 OJ L 55, 28.2.2011, p. 13. EN 10   EN HAVE ADOPTED THIS REGULATION: 
Chapter I 
Scope and definitions 
Article 1 
Scope 
This Regulation shall apply to: 
(a) the manufacture, storage and transport of  medicated feed and intermediate products; 
(b) the placing on the market, including import, and use of medicated feed and 
intermediate products;  
(c) the export to third countries of medicat ed feed and intermedia te products. However, 
Articles 9, 15, 16 and 17 shall not apply to medicated feed and in termediate products 
whose label indicates that they are intended for export to third countries. 
Article 2 
Definitions 
1. For the purposes of this Regulation, th e following definitions shall apply:  
(a) the definitions of 'feed', 'feed business'  and 'placing on the market' as laid down 
in Article 3 of Regulation (EC) No 178/2002; 
(b) the definitions of 'feed additive' and 'daily  ration' as laid down in Article 2(2) of 
Regulation (EC) No 1831/2003; 
(c) the definitions of 'food-producing animal ', 'feed materials', 'compound feed', 
'complementary feed', 'mineral feed', 'l abelling', 'label', 'minimum storage life' 
and 'batch' as laid down in Article 3(2) of Regulation (EC) No 767/2009;  
(d) the definition of 'establishment' as laid  down in Article 3 of Regulation (EC) 
No 183/2005; 
(e) the definitions of 'official control' and 'competent authority' as laid down in 
Article 2 of Regulation (EC) No 882/2004; 
(f) the definitions of 'veterinary medicinal product', 'withdrawal period', 'strength' 
and 'veterinary prescription' as laid dow n in Article 1 of Directive 2001/82/EC.  
2. The following definitions shall also apply:  
(a) 'medicated feed': a mixture of one or more veterinary medicinal products or 
intermediate products with one or more f eeds which is ready to be directly fed 
to animals without further processing; 
(b) 'intermediate product': a mixture of one or more veterinary medicinal products 
with one or more feeds, intended to be  used for the manufacture of medicated 
feed; 
(c) 'active substance': a substance with a pharmacological activity;  
(d) 'non-target feed': feed which is not in tended to contain a specific veterinary 
medicinal product; 
(e) 'carry-over': the transfer of traces of an active substance into non-target feed; EN 11   EN (f) 'feed business operator': any natural or  legal person respon sible for ensuring 
that the requirements of this Regulation are met with in the feed business under 
their control;  
(g) 'distributor': any feed business operator that supplies medicated feed, packaged 
and ready for use, to the animal holder; 
(h) 'mobile mixer': a feed business operator with a feed establishment consisting of 
a specifically equipped lorry for th e manufacture of medicated feed; 
(i) 'on-farm mixer': a feed business operat or manufacturing medicated feed on the 
farm of use. 
Chapter II 
Manufacture, storage, transpor t and placing on the market  
Article 3 
General obligations 
Feed business operators shall manufacture, stor e, transport and place on the market medicated 
feed and intermediate products in compliance with Annex I. 
Article 4 
Hazard analysis and critical control points system 
Feed business operators manuf acturing, storing, transportin g and placing on the market 
medicated feed and intermediate products shal l put in place, implement and maintain a 
permanent written procedure or procedures based on the hazard analysis and critical control points (hereinafter: 'HACCP') system as provided for in Regulation (EC) No 183/2005. 
Article 5 
Composition 
1. Medicated feed and intermediate produc ts shall only be manufactured from 
veterinary medicinal products authorised  for the purpose of the manufacture of 
medicated feed in accordance with the conditions laid down in Directive 2001/82/EC . 
2. The manufacturer of medicated feed shall ensure the following: 
(a) the veterinary medicinal product is incorporated in to the feed in accordance 
with Annex II; 
(b) the medicated feed is manufactured in compliance with the relevant conditions 
laid down in the summary of the product characteristics refe rred to in Article 
14 of Directive 2001/82/EC, related to the veterinary medicinal products to be 
incorporated in the medicated feed; 
(c) there is no possibility of an interact ion between the veterinary medicinal 
products and the feed impai ring the safety or the e fficacy of the medicated 
feed;  
(d) a feed additive for which a maximum content is set in the respective 
authorisation act is not inco rporated in the medicated f eed if it is already used 
as active substance in the veterinary medicinal product. EN 12   EN Article 6 
Homogeneity 
1. Feed business operators manu facturing medicated feed sh all ensure the homogeneous 
incorporation of the veterinary medicinal product or the intermediate product into the 
feed.  
2. The Commission may, by means of implemen ting acts, establish criteria for the 
homogenous incorporation of the veterinary  medicinal product into the medicated 
feed or into the intermedia te product, taking into account the specific properties of 
the veterinary medicinal pr oducts and of the mixing t echnology. Those implementing 
acts shall be adopted in accordance with the examination procedure referred to in 
Article 20(2).  
Article 7 
Carry-over 
1. Feed business operators manufacturing, storing, tran sporting and placing on the 
market medicated feed and intermediate pr oducts shall apply measures in accordance 
with Article 3 and 4 to  avoid carry-over.  
2. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 19 concerning the establishment of specific carry-over limits for active 
substances.  
Where no specific carry-over limits have been set for an active substance, the 
following carry-over li mits shall apply: 
(a) for antimicrobial active substances, 1% of  the active substance in the last batch 
of medicated feed or of intermediate product produced  before the production of 
non-target feed;  
(b) for the other active substances, 3% of the active substance in the last batch of 
medicated feed or of intermediate pr oduct produced before the production of 
non-target feed. 
Article 8 
Anticipated production 
Medicated feed and intermediate products ma y be manufactured and stored before the 
prescription referred to in Article 15 is issu ed. This provision shall not apply to on-farm 
mixers or in case of manufacture of medicated f eed or intermediate products from veterinary 
medicinal products in accordance with Arti cles 10 or 11 of Directive 2001/82/EC. 
Article 9  
Labelling 
1. In addition to Article 11(1), Articles 12 and 14 of Regulation (EC) No 767/2009, the 
labelling of medicated feed and intermediate products sh all comply with Annex III to 
this Regulation. 
2. Where containers are used instead of packaging material, they shall be accompanied 
by documents complying with paragraph 1. 
3. Permitted tolerances for discrepancies between the labelled compositional values of a 
medicated feed or an intermediate produc t and the values analysed in official EN 13   EN controls performed in accordance with Regul ation (EC) No 882/2004 are as set out in 
Annex IV. 
Article 10 
Packaging 
Medicated feed and intermediate products shal l 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 s eal is damaged and cannot be reused. 
Article 11 
Intra Union trade 
Where the Member State of manufacture of medi cated feed is not the same as the Member 
State where it is used by the animal holder,  the veterinary medicinal product shall be 
authorised in accordance with Directive 2001/82/EC in the Member State of use. 
Chapter III 
Approval of establishments 
Article 12 
Approval obligation  
Feed business operators manuf acturing, storing, transporting or placing on the market 
medicated feed or intermediate products shall ensure that establishments under their control 
are approved by the competent authority.  
Article 13 
Approval procedure and lists of approved establishments 
1. The competent authority shall approve esta blishments only where an on-site visit, 
prior to start-up of any activit y, has demonstrated that the system put in place for the 
manufacture, storage, transport and placi ng on the market of medicated feed and 
intermediate products meets the requirements of Chapter II.  
2. The procedure for the granting, suspension, revocation of, or amendment to the 
approval of establishments shall be subj ect to Article 13(2) and Articles 14, 15, 16 
and 17 of Regulation (EC) No 183/2005. 
3. The establishments shall be recorded in the national list as referre d to in Article 19(2) 
of Regulation (EC) No 183/2005 under an i ndividual identifying number which has 
been attributed in the form set out in Annex V, Chapter II, to that Regulation. 
Article 14 
Establishments approved in accordance with Directive 90/167/EEC 
1. Establishments falling under the scope of  this Regulation which have already been 
approved in accordance with Directive 90 /167/EEC may continue their activities 
subject to the submission, by [ Office of Publications, please insert date counting 
18 months from the date of entry into force of this Regulation ], of a declaration to the 
relevant competent authority in whose ar ea their facilities are located, in a form EN 14   EN decided upon by this competent authority, that they meet the requirements for 
approval referred to in Article 13(1).  
2. The competent authorities shall renew, suspend, revoke or amend the approval of 
those establishments in accordance with the relevant rules and pro cedures referred to 
in Article 13(1) of this Regulation and in Articles 13(2), 14, 15 and 16 of Regulation 
(EC) No 183/2005. Where the declaration referred to in paragraph 1 is not submitted within the period specified, the competent authority shall suspend the existing approval in accordance with Articl e 14 of Regulation (EC) No 183/2005. 
Chapter IV 
Prescription and use 
Article 15 
Prescription 
1. The supply of medicated feed to animal hol ders shall be subject to the presentation 
and, in case of manufacturing by on-farm mixers, the possession  of a veterinary 
prescription and to the conditions laid down in paragraphs 2 to 6. 
2. The prescription shall contain the inform ation set out in Anne x V. The original 
prescription shall be kept by the manufactur er or, where appropria te, the distributor. 
The person issuing the prescription and th e animal holder shall keep a copy of the 
prescription. The original and copies shall be kept for three years from the date of 
issuance. 
3. With the exception of medicated feed for non-food producing animals, medicated 
feed shall not be used for more than one treatment under the same prescription. 
4. The prescription shall be valid for a ma ximum period of six months for non-food 
producing animals and three weeks for food-producing animals. 
5. The prescribed medicated feed may be us ed only for animals examined by the person 
who issued the prescription and only for a diagnosed disease. The person who issued 
the prescription shall verify that this medica tion is justified for the target animals on 
veterinary grounds. Furthermore he shall ensure that the administration of the 
veterinary medicinal product concerned is not  incompatible with another treatment or 
use and that there is no contra-indicati on or interaction where several medicinal 
products are used.  
6. The prescription shall, in line with the summary of the product characteristics of the 
veterinary medicinal product, indicate the in clusion rate of the veterinary medicinal 
product calculated on the basis of the relevant parameters. 
Article 16 
Use in food-producing animals 
1. Feed business operators s upplying medicated feed to th e holder of food-producing 
animals, or on-farm mixers of medicat ed feed for food-producing animals shall 
ensure that the quantities supplied or mixed do not exceed: 
(a) the quantities provided in  the prescription and 
(b) the quantities required for one month's treatment or two weeks in case of 
medicated feed containing antimicrobi al veterinary medicinal products. EN 15   EN 2. Medicated feed containing antimicrobial ve terinary medicinal pr oducts shall not be 
used to prevent diseases in  food-producing animals or to  enhance their performance. 
3. When administering medicated feed, th e holder of food-producing animals shall 
ensure compliance with the withdrawal period provided for in the veterinary 
prescription.  
4. Feed business operators feeding food-pr oducing animals with medicated feed shall 
keep records in accordance with Article 69 of Directive 2001/82/EC. Those records 
shall be kept for five years after the da te of administration of medicated feed, 
including when the animal is slaughtered during the five-year period. 
Article 17 
Collection systems of unused or expired products 
Member States shall ensure that appropriate co llection systems are in place for medicated feed 
and intermediate products that are expired or in case the animal holder has received a bigger 
quantity of medicated feed than he actually uses for the treatment referred to in the veterinary 
prescription. 
Chapter V 
Procedural and final provisions 
Article 18 
Amendment of Annexes 
The Commission shall be empowered to adopt de legated acts in accord ance with Article 19 
concerning amendments to Annexes I to V, in order to take into account technical progress 
and scientific developments. 
Article 19 
Exercise of the delegation 
1. The power to adopt delegated acts is conferred on the Commission subject to the 
conditions laid down in this Article. 
2. The delegation of power referred to in Articles 7 and 18 shall be conferred on the 
Commission for an indeterminate period of tim e from the date of entry into force of 
this Regulation. 
3. The delegation of powers refe rred to in Articles 7 and 18 may be revoked at any time 
by the European Parliament or by the Counc il. A decision of revocation shall put an 
end to the delegation of the power specified in  that decision. It shall take effect the 
day following the publication of the decision in the Official Journal of the European 
Union  or at a later date specified therein. It shall not affect the validity of any 
delegated acts al ready in force. 
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council.  
5. A delegated act adopted pursuant to Article s 7 and 18 shall enter into force only if no 
objection has been expressed either by th e European Parliament or the Council 
within a period of two months of notificati on of that act to the European Parliament 
and the Council or if, before the expiry of  that period, the European Parliament and EN 16   EN the Council have both informed the Commi ssion that they will not object. That 
period shall be extended by two months at th e initiative of the European Parliament 
or the Council. 
Article 20 
Committee procedure 
1. The Commission shall be assisted by the Standing Committee on Plants, Animals, 
Food and Feed established by Article 58(1) of Regulation (EC) No 178/2002, 
hereinafter referred to as the ‘Committ ee’. That Committee is a Committee within 
the meaning of Regulation (EU) No 182/2011. 
2. Where reference is made to this para graph, Article 5 of Regulation (EU) No 
182/2011 shall apply. 
3. Where the opinion of the Committee is to be obtained by written procedure, that 
procedure shall be terminated without re sult when, within the time-limit for delivery 
of the opinion, the chair of the Committee so decides or a simple majority of 
Committee members so request. 
Article 21 
Penalties 
1. Member States shall lay down the rules on penalties applicable to infringements of 
the provisions of this Regulation and shall ta ke all measures necessary to ensure that 
they are implemented. The penalties provide d for must be effective, proportionate 
and dissuasive. 
2. Member States shall notify thos e provisions to the Commission by [ Office of 
Publications, please insert date counting [12] months fr om the date of entry into 
force of this Regulation ] at the latest and shall not ify it without delay of any 
subsequent amendment affecting them. 
Article 22 
Repeal 
Directive 90/167/EEC is repealed.  
References to the repealed Directive shall be construed as references to this Regulation and 
shall be read in accordance with the correlation table in Annex VI. 
Article 23 
Entry into force 
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 [ Office of Publications, please insert  date counting [12] months from the 
date of entry into force of this Regulation ]. EN 17   EN This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
For the European Parliament For the Council 
The President The President