# EUR-Lex - 52014PC0556 - EN

*|*

# 52014PC0556

**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 /* COM/2014/0556 final - 2014/0255 (COD) */**

			*

			*

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 are
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 medicines
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
animal 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 distribution of the medicine in the feed, good compatibility of the
medicine with the feed 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
finfish 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 these farmed animals, aquaculture species and pets,
depending on their health condition, may need medication.

The aim of the review of the medicated feed
rules is to harmonise at a high safety level the manufacture, marketing and use
of medicated feed and intermediate products in the EU and to reflect technical
progress 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 which 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 this legal instrument has given freedom to Member States
regarding interpretation and 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 prescription in the feed mill,
allowing Member States to arrive with different 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 market. There is a need to harmonise
implementation of the legislation, reduce financial and administrative burdens
and support innovation.

The draft proposal will allow the anticipated medicated feed production, mobile and
on-farm mixing, while simultaneously establishing the parameters for these
schemes. The provisions include measures for disposal of not used medicated
feed on farm. EU wide limits will be set for the carry-over 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’
consultation in the context of the evaluation conducted in 2009/2010, following
which internal consultations and discussion with the Member States took place.
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. Furthermore,
targeted consultations 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 collect comments on the policy options.

Finally, focussed interviews with experts from
the industry and competent authorities were undertaken mainly to collect data
for 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 consulted and
reported regularly to the working party of Chief Veterinary Officers, the
Standing Committee on the Food Chain and Animal Health (Section Animal
Nutrition) 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 stakeholders involved in this field have on
several times indicated the importance of ensuring that the revision 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.

The impact
assessment identified the following main axes along which the system has to
change in order to answer the stakeholders concerns: residues of veterinary
medicines in feed, imprecise dosage of veterinary medicines, impossible market
access to medicated feed for pets and barriers 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 would
provide for the best way forward to achieve the objectives for the EU. It
should have a significant positive impact on cost efficiency and economic
growth of the medicated feed manufacturing sector, also considering innovative
applications of veterinary medicines. Animal and public health can be expected
to be improved both in Member States with currently lax standards for medicated
feed and those with prohibitive standards. Safe tolerance levels for the
unavoidable carry-over of veterinary medicines in feed would lead to a
pragmatic and solid level playing field for the industry and the control
authorities.

3.           LEGAL ELEMENTS OF THE
PROPOSAL

The aim of this proposal is to repeal 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
general manufacture requirements laid down in Regulation (EC) No 183/2005
apply. Furthermore, medicated feed may only be manufactured from veterinary
medicinal products authorised under the veterinary medicinal products
legislation. It also sets rules for the approval of feed business operators and
rules they need to comply with in order to manufacture medicated feed. The
Regulation lays down rules for the homogenous incorporation of the veterinary
medicinal products into the medicated feed and requirements in order to avoid
carry-over of active substances from veterinary medicinal 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 prescription, the validity of the prescription, the use of medicated feed
containing antimicrobials in food-producing animals and the quantities required
for the treatment of animals with medicated feed are laid down. Manufacturers,
distributors and users of medicated feed must keep daily records for the
effective tracing of medicated feed. For veterinary medicinal products
authorised at national level, the Regulation sets Intra-Union rules for trade
of medicated feed in order to prevent distortions in competition.

Rules for the adoption of delegated acts and of
implementing acts on the basis of the Regulation are laid down in the proposal.

Legal basis

Articles 43 and 168(4)(b) of the TFEU provide 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 Article 43 of the TFEU),
implementing the Common Agricultural Policy. The objectives of that policy are
to increase agricultural productivity, to ensure 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 reasonable 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 measures
in the veterinary and phytosanitary fields which have as their direct objective
the protection of public health.

The proposal takes the form of a Regulation of
the European Parliament and of the Council. Other means would not be
appropriate because the objectives of the measure can be achieved most
efficiently by fully harmonised requirements throughout the Union.

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
COUNCIL 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
European Economic and Social Committee[1],

Having regard to the opinion of the Committee
of the Regions[2],

Acting in accordance with the ordinary
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 important 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-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
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 EU food law.

(4)       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 by medicated
feed.

(5)       Medicated feed is one of
the routes for the administration of veterinary medicinal products, which are
incorporated into feed. The authorisation for use in feed, the manufacture,
distribution, advertising and supervision of those veterinary medicinal
products are governed by Directive 2001/82/EC of the European Parliament and of
the Council[5].

(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 Council[6],
of Regulation (EC) No 767/2009 of the European Parliament and of the Council[7], of Regulation (EC) No
1831/2003 of the European Parliament and of the Council[8] and of Directive
2002/32/EC of the European Parliament and of the Council[9]. Specific provisions
for medicated feed and intermediate products should be established concerning
facilities and equipment, personnel, manufacture quality control, storage and
transport, record-keeping, complaints and product recalls, the application of
procedures 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 Regulation (EC) No 882/2004 of the European Parliament and of
the Council[10].
Within this framework, medicated feed imported into the Union is to be
considered as falling within the scope of this Regulation.

(8)       Without prejudice to the
general obligations laid down in Article 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 only with authorised veterinary medicinal products and the
compatibility of all compounds used should be ensured for the purpose of safety
and efficacy of the product. Additional specific requirements or instructions
for the inclusion of the veterinary medicinal products into feed should be
foreseen to ensure a safe and efficient treatment of the animals.

(10)     Homogeneous incorporation
of the veterinary 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.

(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 medicinal 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 substance 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 equipment, storage facilities or means of transport are used for
feed with different 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
considered 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 protect 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 feed
should comply with the general principles laid down in Regulation (EC) No
767/2009 and 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 deviations of the labelled 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 feed, 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 operate in a feed mill, with a specially equipped
lorry or on-farm, storing, 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 and product traceability. Provision should be
made for a transition procedure concerning establishments already approved
under Directive 90/167/EEC.

(17)     In order to ensure the safe
use of medicated feed, its supply and use should be subject to presentation of a
valid veterinary prescription which has been issued after examination of the
animals to be treated. 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 prudent 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 concerning the use and the validity of the
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 should 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 developments, the power to adopt acts in accordance with Article 290
of the Treaty on the Functioning 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 Annexes 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 intermediate products, the
permitted tolerances for the compositional labelling of medicated feed or
intermediate products and the specimen form to be used for the veterinary
prescription. The Commission, when preparing and drawing-up delegated acts,
should ensure a simultaneous, timely and appropriate transmission of relevant
documents 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 Commission. 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 laying down the rules and general principles
concerning mechanisms for control by Member States of the Commission's exercise
of implementing powers[11].

(23)     Member States should lay
down penalties for 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 users and strengthening the
effective functioning of the internal market, cannot be sufficiently achieved
by the Member States and can therefore be better achieved at Union level, the
Union may adopt measures, in accordance with the principle of subsidiarity as
set out in Article 5 of the Treaty on European Union. In accordance with the
principle of proportionality, as set out in that Article, this Regulation does
not go beyond what is necessary in order to achieve that objective,

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 medicated feed and intermediate products. However,
Articles 9, 15, 16 and 17 shall not apply to medicated feed and intermediate
products whose label indicates that they are intended for export to third
countries.

Article 2
Definitions

1.           For the purposes of this
Regulation, the 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', 'labelling',
'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 down 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 feeds 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 intended to
contain a specific veterinary medicinal product;

(e) 
'carry-over': the transfer of traces of an
active substance into non-target feed;

(f) 
'feed business operator': any natural or legal
person responsible for ensuring that the requirements of this Regulation are
met within 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 the
manufacture of medicated feed;

(i) 
'on-farm mixer': a feed business operator
manufacturing medicated feed on the farm of use.

Chapter II
Manufacture, storage, transport and placing on the market

Article 3
General obligations

Feed business operators shall manufacture,
store, 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 manufacturing, storing,
transporting and placing on the market medicated feed and intermediate products
shall 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 products 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
into 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 referred 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 interaction
between the veterinary medicinal products and the feed impairing the safety or
the efficacy of the medicated feed;

(d) 
a feed additive for which a maximum content is
set in the respective authorisation act is not incorporated in the medicated
feed if it is already used as active substance in the veterinary medicinal
product.

Article 6
Homogeneity

1.           Feed business operators
manufacturing medicated feed shall ensure the homogeneous incorporation of the
veterinary medicinal product or the intermediate product into the feed.

2.           The Commission may, by
means of implementing acts, establish criteria for the homogenous incorporation
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 20(2).

Article 7
Carry-over

1.           Feed business operators
manufacturing, storing, transporting and placing on the market medicated feed
and intermediate products shall apply measures in accordance with Article 3 and
4 to avoid carry-over.

2.           The Commission shall be
empowered to adopt 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 limits 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 product
produced before the production of non-target feed.

Article 8
Anticipated production

Medicated feed and intermediate products
may be manufactured and stored before the prescription referred to in Article 15
is issued. This provision shall not apply to on-farm mixers or in case of
manufacture of medicated feed or intermediate products from veterinary
medicinal products in accordance with Articles 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 shall 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 product and the values analysed in official controls performed
in accordance with Regulation (EC) No 882/2004 are as set out in Annex IV.

Article 10
Packaging

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.

Article 11
Intra Union trade

Where the Member State of manufacture of
medicated 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 manufacturing,
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 establishments only where an on-site visit, prior to start-up of
any activity, has demonstrated that the system put in place for the
manufacture, storage, transport and placing 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 subject 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 referred to in Article 19(2) of
Regulation (EC) No 183/2005 under an individual 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 area their facilities are located, in
a form 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 procedures 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 Article 14 of Regulation (EC) No 183/2005.

Chapter IV
Prescription and use

Article 15
Prescription

1.           The supply of medicated
feed to animal holders 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 information set out in Annex V. The original prescription shall be
kept by the manufacturer or, where appropriate, the distributor. The person
issuing the prescription and the 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 maximum period of six months for non-food producing animals and
three weeks for food-producing animals.

5.           The prescribed medicated
feed may be used 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 medication 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-indication 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 inclusion 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
supplying medicated feed to the holder of food-producing animals, or on-farm
mixers of medicated 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 antimicrobial
veterinary medicinal products.

2.           Medicated feed containing
antimicrobial veterinary medicinal products shall not be used to prevent
diseases in food-producing animals or to enhance their performance.

3.           When administering
medicated feed, the holder of food-producing animals shall ensure compliance
with the withdrawal period provided for in the veterinary prescription.

4.           Feed business operators
feeding food-producing 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 date 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
collection 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 delegated acts in
accordance 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 time from the date of entry into force of this
Regulation.

3.           The delegation of powers
referred to in Articles 7 and 18 may be revoked at any time by the European
Parliament or by the Council. 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 already 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 Articles 7 and 18 shall enter into force only if no objection has
been expressed either by the European Parliament or the Council within a period
of two months of notification of that act to the European Parliament and the
Council or if, before the expiry of that period, the European Parliament and
the Council have both informed the Commission that they will not object. That
period shall be extended by two months at the 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 ‘Committee’. That Committee is a Committee within the
meaning of Regulation (EU) No 182/2011.

2.           Where reference is made to
this paragraph, 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 result 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 take all measures necessary to ensure that they are
implemented. The penalties provided for must be effective, proportionate and
dissuasive.

2.           Member States shall notify
those provisions to the Commission by [Office of Publications, please insert
date counting [12] months from the date of entry into force of this Regulation]
at the latest and shall notify 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].

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

[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).

[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).

[11]             OJ L 55, 28.2.2011, p. 13.