COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document 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
Date: 2014-09-10
Institutions: European Commission
Subjects: animal nutrition, labelling, marketing standard, quality standard, veterinary drug, veterinary inspection













EUR-Lex - 52014SC0271 - EN











|



52014SC0271

COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document 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 /* SWD/2014/0271 final */









TABLE
OF CONTENTS
1..... Procedural issues and
consultation of interested parties 6
1.1.     Overview........................................................................................................... 6
1.2.     Preparatory work and
consultation of interested parties................................... 6
1.2.1.       Stakeholder consultation..................................................................... 6
1.2.2.       Member States consultation................................................................. 7
1.2.3.       Scientific input..................................................................................... 7
1.3.     Scrutiny by the Commission
Impact Assessment Board................................... 7
1.4.     Consistency with other EU
policies and horizontal objectives; Links with other legislation under review................................................................................................................ 8
2..... Problem
definition......................................................................................... 9
2.1.     Context.............................................................................................................. 9
2.1.1.       Costs – Supply – Demand................................................................. 10
2.1.2.       Legislative context............................................................................. 13
2.1.3.       Public perception............................................................................... 15
2.1.4.       Need for medicated feed
production................................................ 15
2.2.     Problem identification, its
drivers and consequences...................................... 16
2.2.1.       Presence of residues of
veterinary medicines in feed........................ 16
2.2.1.1.     Driver 1: Carry-over of
veterinary medicines, notably antibiotics, into compound feed.................................................................. 17
2.2.1.2.     Driver 2: "Zero
tolerance".................................................. 18
2.2.1.3.     Consequences.................................................................... 19
2.2.2.       Imprecise dosage of
veterinary medicines......................................... 19
2.2.2.1.     Driver 1: Preventive costs
for medicated feed production in some Member States................................................................................. 20
2.2.2.2.     Driver 2: Poor homogeneity
of medicated feed in some Member States 21
2.2.2.3.     Consequences.................................................................... 21
2.2.3.       Barriers to expand the
production and intra EU trade of medicated feed  21
2.2.3.1.     Driver 1: EU-Directive with
vague provisions re manufacturing, differently interpreted by the Member States...................................... 22
2.2.3.2.     Driver 2: Options for Member
States' national regimes offered in the EU-Directive............................................................................ 23
2.2.3.3.     Consequences.................................................................... 24
2.2.4.       Impossible market access
of medicated feed for pets....................... 24
2.2.4.1.     Driver 1: Unclear scope of
the EU-Directive.................... 24
2.2.4.2.     Driver 2: National
implementation of the Directive.......... 24
2.2.4.3.     Consequences.................................................................... 25
2.3.     Justification for EU action............................................................................... 25
2.3.1.       The choice of legal
instrument........................................................... 25
2.3.2.       Subsidiarity - Conferral..................................................................... 25
2.3.3.       Proportionality of EU action............................................................. 26
2.4.     Small and Medium Enterprises
- Micro-enterprises......................................... 26
2.5.     Problem Tree.................................................................................................... 27
2.6.     Forward looking - Baseline.............................................................................. 28
3..... Objectives........................................................................................................... 28
4..... Policy
options.................................................................................................. 29
4.1.     Option 1 - Maintain status
quo........................................................................ 29
4.2.     Option 2 - Amend Directive
90/167 combined with "soft law"...................... 29
4.3.     Option 3 - New EU Regulation
with detailed rules........................................ 30
4.4.     Discarded Options........................................................................................... 32
4.4.1.       Repeal of Directive 90/167................................................................ 32
4.4.2.       No-stand-alone medicated
feed law.................................................. 32
5..... Analysis
of impacts...................................................................................... 33
5.1.     Maintain Status quo......................................................................................... 33
5.1.1.       Economic impacts.............................................................................. 33
5.1.1.1.     Costs of MF production.................................................... 33
5.1.1.2.     Market access..................................................................... 33
5.1.1.3.     Compliance and
administrative costs................................ 33
5.1.2.       Impact on animal and
public health................................................... 34
5.1.2.1.     Animal health..................................................................... 34
5.1.2.2.     Public health...................................................................... 35
5.1.2.3.     Occupational health........................................................... 35
5.1.3.       Other impacts..................................................................................... 35
5.1.3.1.     Animal welfare.................................................................. 35
5.1.3.2.     Environment...................................................................... 35
5.1.3.3.     Subsidiarity........................................................................ 35
5.2.     Amend Directive 90/167
combined with soft law.......................................... 36
5.2.1.       Economic impacts.............................................................................. 36
5.2.1.1.     Costs of MF production.................................................... 36
5.2.1.2.     Market access and products
availability............................ 36
5.2.1.3.     Compliance and
administrative costs................................ 36
5.2.2.       Impacts on health............................................................................... 37
5.2.2.1.     Animal health..................................................................... 37
5.2.2.2.     Public health...................................................................... 37
5.2.3.       Other impacts..................................................................................... 37
5.3.     New EU Regulation with
detailed rules.......................................................... 37
5.3.1.       Economic impacts.............................................................................. 37
5.3.1.1.     Costs of medicated feed
production................................. 38
5.3.1.2.     Market access –
competitiveness....................................... 38
5.3.1.3.     Compliance and administrative
costs................................ 39
5.3.1.4.     Prices of animal products................................................... 39
5.3.2.       Impacts on health............................................................................... 39
5.3.2.1.     Animal health..................................................................... 39
5.3.2.2.     Public health...................................................................... 40
5.3.2.3.     Occupational health........................................................... 41
5.3.3.       Other impacts..................................................................................... 41
5.3.3.1.     Animal welfare.................................................................. 41
5.3.3.2.     Environment...................................................................... 41
5.3.3.3.     International trade............................................................. 41
5.3.3.4.     Subsidiarity........................................................................ 41
5.3.4.       Plausibility check with
the views expressed by stakeholders............ 42
6..... Comparing
the options............................................................................... 42
6.1.     Comparing options in terms
of economic, health and other impacts............... 42
6.2.     Comparing the options in the
light of the objectives....................................... 43
6.3.     Preferred option............................................................................................... 44
7..... Monitoring
and Evaluation................................................................... 44
8..... Annexes................................................................................................................ 46
8.0.     Glossary........................................................................................................... 46
8.1.     List of relevant legislation
and schema illustrating how medicated feed provisions are embedded into related
EU-legislation............................................................................... 47
8.2.     Economic data on the
upstream and downstream activities............................ 49
8.3.     Number of authorised
medicated pre-mixes in the EU................................... 50
8.4.     Number of approved operators
for manufacturing and placing on the market of medicated feed......................................................................................................................... 51
8.5.     Rules of good manufacturing
practice of medicated feed.............................. 52
8.6.     Use of veterinary
antimicrobials – use of MF.................................................. 54
8.7.     FVO findings re
cross-contamination and homogeneity in different Member States      56
8.8.     Situation about carry-over
in the Member States and their position about harmonised tolerance levels................................................................................................................ 60
8.9.     Medicated feed and
antimicrobial resistance.................................................. 65
8.10.   Notifications to the Rapid
Alert System for Food and Feed of unauthorised veterinary medicines in feed   67
8.11.   Results of the online
stakeholder consultation................................................ 68
8.12.   Summary of the online
consultation complemented by the results of targeted consultations       77
8.13.   Aggregated data base and
assumptions for the modelling.............................. 86

1.         
Procedural issues and consultation of interested
parties
1.1.       
Overview

The purpose of this impact assessment (IA) is
to support the changes proposed to the medicated feed legislation in line with
the principles set out in the Commission's Work programme 2013[1]. It is related to
similar on-going work in the field of veterinary medical products. This review
can be considered embedded in the general "Fitness Check Strategy"
(assessment of the legal framework).
Giving veterinary medicinal products to sick
animals via feed is one of several options for the animal holder. The current
IA is concerned with this specific way of administering the veterinary
medicinal products and will not elaborate on the other routes of
administration, such as: by ointments or tinctures, by injections, oral powders
or via drinking water.
Medicated feed is a mixture of feed materials
and an authorised medicated premix. Whereas the premix is a veterinary medicine,
fully subject to the medicines requirements, the final product is considered a
feed. 
Directive 90/167/EEC sets out the conditions
under which medicated animal feeds may be manufactured, placed on the market
and used within the EU. The Directive provides that only authorised medicated
premixes may be used to manufacture medicated feed and that precise
instructions must be given for the use of such feed. Medicated feed may be
supplied to holders of animals only on presentation of a prescription from a
veterinarian, subject to certain conditions. Food producing animals that have
been fed with medicated feed must not be slaughtered before the end of the
legally stipulated withdrawal period for each of the active substances
contained in it. 
The Health and Consumers Directorate-General has
taken the initiative of revising Directive 90/167/EEC which is being done at
the same time as the revision of the veterinary medicinal products legislation
(Directive 2001/82/EC and Directive 2004/28/EC). The respective roadmap was
submitted on 12 September 2012.
A glossary with
technical terms and acronyms can be found in Annex 8.0 and full list of
relevant legislation and a schema illustrating how medicated feed provisions
are embedded into related EU-legislation can be found in Annex 8.1.

1.2.       
Preparatory work and consultation of interested
parties

This IA builds on the
results of an external study "Evaluation of the EU Legislative Framework
in the Field of Medicated Feed"[2]
carried out in 2009/2010 by the Food Chain Evaluation Consortium (FCEC). 

1.2.1.         
Stakeholder consultation

Stakeholders were consulted 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, 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 stakeholder consultation in the
margins of the FCEC evaluation, a new web-based stakeholder 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 options.

1.2.2.         
Member States consultation

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 group of Chief
Veterinary Officers, the Standing Committee on the Food Chain and Animal Health,
Section Animal Nutrition and the Veterinary Pharmaceutical Committee.

1.2.3.         
Scientific input

Studies, data and scientific
opinions from the European Food Safety Authority and the European Medicines Agency
have been used as input into this assessment.

1.3.       
Scrutiny by the Commission Impact Assessment Board

Within the Commission, internal consultation
was pursued through an Impact Assessment Steering Group (IASG) involving DG
Agriculture, Competition, Employment, Environment, Mare, Research and
Innovation, Trade and the Secretariat-General. The IASG was established in 2010
and met five times; in December 2012 a final electronic consultation was
undertaken. The IA report was submitted to the IA Board on 12 December 2012.
The IAB delivered an opinion on 18 January 2013. A revised IA report
considering the board's recommendations was submitted on 12 July 2013 for which
a positive opinion was issued on 11 September 2013.
The report was amended in line with the
recommendations from the IAB, as follows: 
(1) An effort was made to reduce the overlap
between the different problem areas and drivers. Furthermore, the issues were
explained more in detail and backed by the stakeholder contributions. 
(2) Better explain the link to the regulatory
framework on coccidiostats: The report better explains the differences between
the current regimes for the administration of veterinary medicines via medicated
feed and of coccidiostats (feed additives); this concerns approval of
manufacturers, provisions about the incorporation into feed and their
unintended residues in feed. Furthermore, the analogies in practice are
outlined in order to better understand similar measures proposed in the policy
options. 
(3) The options are more concretely described
in order to better indicate how the successive translation into a legal text
would be made. 
(4) Potential shortcomings of the preferred
option, particularly against the criterion of proportionality, are addressed.
Furthermore, additional robustness checks have been undertaken and a more
detailed presentation of the impacts in the different Member States.  
The results are
presented now more disaggregated. Concerns of stakeholders were raised in a
clearer way and the report indicates how it copes with them. A glossary had
been added.

1.4.       
Consistency with other EU policies and
horizontal objectives; Links with other legislation under review

The aim of the review of the medicated feed
rules is to harmonise at an appropriate safety level the marketing of medicated
feed in the EU and to reflect technical progress in this field. The review of
the legislation on medicated feed must be seen in the context of the
Commission’s efforts to strengthen the internal market, and foster industrial
competitiveness, innovation and economic growth. 
The project is in line with the Communication
from the Commission to the European Parliament, the Council, the European
Economic and Social Committee and the Committee of the Regions, "Commission
Work Programme 2012, Delivering European renewal (Building a Union of
sustainable growth and solidarity – a single market for growth, and smart
regulation and effective implementation".
Medicated feed
and antimicrobial resistance
The proposals listed in this impact
assessment also aim to implement the actions set out in the Communication from
the Commission to the European Parliament and the Council "Action Plan
against the rising threats from Antimicrobial Resistance"[3]. Furthermore, the European Parliament called in its resolution on
the public health threat of antimicrobial resistance of 27 October 2011[4]
on appropriate actions in the field of animal nutrition. Also, the Resolution
of the European Parliament of 11 December 2012 on the Microbial Challenge –
Rising threats from Antimicrobial Resistance[5]
requested a European response to the issue. Additionally, the Council called
upon the Commission in its conclusions (Doc 10582/12) on the impact of
antimicrobial resistance in the human health sector and in the veterinary
sector - a “One Health” perspective - to expedite the review of the medicated
feed directive.
Medicated feed
and veterinary medicinal products 
The revision of the directive on medicated
feed is part of the same package as the revision of the veterinary medicinal
products legislation. The respective IA tackles amongst others the issue of
antimicrobial resistance and the better availability of veterinary medicines with
respect to the marketing authorisation of medicines.
Medicated feed is a mixture of feed materials
and additives with veterinary premixes authorised under the veterinary
medicinal products legislation. Nonetheless, medicated feed is considered a
very particular feed, with specific rules on the incorporation of the medicine
into the feed. 
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.

2.         
Problem definition
2.1.       
Context 

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, the veterinary medicine can be
prescribed by a veterinarian and administered to animals via the following main
routes: (1) topically i.e. externally as paste, cream or tincture (2) by
injection or (3) orally. The vast majority of medicated feed for farmed animals
contains antimicrobials or anti-parasites.
As regards the oral administration of
medicine to animals, the animal holders can either (1) add oral medicines
themselves to the animal feed or drinking water or (2) use medicated feed into
which the medicine is incorporated by an authorised manufacturer. At best, the
farmer has a special device[6]
to incorporate the "ready to use" powder into his feed but often they
just distribute the powders with a scoop. Also top dressing medication is
rather common: the farmer sprinkles the dissolved medicine on top of the feed
in the manger. The competent control authorities depend on the re-assurance
from the farmers that they properly add the veterinary medicine to the feed or
drinking water. On the other hand, medicated feed is usually manufactured by
feed mills with sophisticated mixing technology and the authorities can verify
the mixing quality upon approval of the establishment. 
The following schema illustrates the oral
administration of medicines to animals:
Medicated feed is generally used to treat
animal disease in large groups of animals, particularly pigs and poultry. There
is a clear correlation between the level of manufacturing 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 ensuring an efficient
treatment of the animal and low carry-over (sometimes called also "cross
contamination") of the medicine into non target animal feed.
The evolution of the quantities of
antimicrobials and the quantities of medicated feed used in the EU shows that
the decision to use therapeutic antimicrobials is totally independent from the
possibility to use medicated feed. Therefore, specific restrictions on
medicated feed do not lead to a reduction of the use of antimicrobials in
livestock farming because oral alternatives (ready to use powders mixed in
feed, top dressing, via drinking water) or the administration via injection still
remain available. 
Measures concerning the
prescription and availability of all forms of antimicrobial veterinary
medicines (including premixes for medicated feed) are addressed in the parallel
IA on the review of the veterinary medicines directive.

2.1.1.         
Costs – Supply – Demand

There are 13.7 mio. animal holdings in the
EU.[7] The value of livestock
farming output in the EU is €157 bn[8].
The value of the EU's aquaculture which includes production of crustaceans,
molluscs, and finfish[9]
is estimated to be €3.3 bn. Pet animals represent the second largest type of
animals kept in the EU. There are around 64 million cats, 60 mio. dogs, 40 mio.
pet birds, 25 mio. small mammals and many millions of ornamental fish. All
these farmed animals, aquaculture species and pets may need medication from
time to time.
Animal feed (feed materials, additives and
compound feed) are the main input into livestock production and the most
important cost factor for the famers with an average of 47% of the total
production costs. The production of compound feed for food producing animals was
151 mio. t in 2011 resulting in a turnover of €50 bn. More than 110,000 persons
are employed in approximately 4,000 production sites. These companies are
generally SMEs with a turn over between €10 mio. to €100 mio  and 20 to 100
employees. The structure of the pet food sector is similar with 650 plants a
turnover of € 13.5 bn (2010)[10].
The production structure is optimised by the industry leading to interregional
supply chains of a very broad range of different feed types (dry/wet, complete
feed/speciality feed, different target animals, packed in can/bag/poach/treat).
Despite its large size, the pet food market in the EU is by and large
irrelevant with regard to the use of medicated feed[11].
The EU veterinary medicines market was valued
at € 4.3 bn. in 2011. The sales
figures by value according to IFAH-Europe include parasiticides (27 %),
vaccines (26%), antimicrobials (19%), topical products (7%) and other products
(20%).[12]
Based on information from the European Group for Generic Veterinary Products,
there are no evident differences in the businesses with premixes depending on
whether the VMP is a branded or a generic product; in other words: it does not
matter for the manufacturing and use of medicated feed whether the veterinary
medicine is a generic or a protected brand.
More data on the upstream and downstream
activities can be found in Annex 8.2.
In 18 Member States, oral
routes of medication with antimicrobials represented
91% (2010) of the total sales of antimicrobials[13]. The respective share
according to the FCEC case study[14]
in 2006 for France, United Kingdom and Finland was 88%, 90% and 55%. Premixes
for medicated feed manufacture represented in 18 Member States 54% (2010) of orally
administered antimicrobials[15].
According to the FCEC case study[16]
for France, United Kingdom and seven big manufacturers of veterinary medicines that
share was 59%, 70% and 64%, respectively. 
Premixes for medicated feed: The number of nationally authorised premixes varies
significantly between the Member States from just a few in some Member States
to more than 300 in France (see Annex 8.3). Only two premixes have been
approved centrally and therefore only medicated feed based on these two
medicines can be marketed throughout the EU. For all the other medicated feeds,
an authorisation of the respective premix must be obtained in the Member State of destination. The authorisation of veterinary medicines, including premixes
for MF, is not covered in this impact assessment but in the parallel one on
veterinary medicines which is addressing the fragmented market for VMPs in the
EU.
The significance of medicated feed varies
drastically amongst EU Member States[17].
In 2008, production figures were highest in Spain (2 - 3 mio t), Italy (1.3 mio t) and France (0.8 - 1 mio. t). The United Kingdom (0,5 mio t), Belgium (0,3 mio t) and the Czech Republic (0,1 mio t) are also quite important producers whereas Germany (12,000 t) and Denmark (12,000 t) are of minor relevance. The share of medicated feed
production from the total compound feed output ranges from 9% in some Member
States to only 0.1% in Germany[18]
(for more data see Annex 8.6).
Table 1: Production of
medicated feed (in 000’ tonnes) in some Member States and the evolution from
2004-2008
   || 2004 || 2005 || 2006 || 2007 || 2008 
 Belgium || n.a. || n.a. || n.a. || n.a. || 300 
 Czech Republic || 92 || 111 || 154 || 149 || 99 
 Denmark (a) || n.a. || 0.01 || 3 || 9 || 12 
 France || 800 – 1,000 || 800 – 1,000 || 800 – 1,000 || 800 – 1,000 || 800 – 1,000 
 Germany || 225 || 150 || 80 || 20 || 12 
 Italy || n.a. || n.a. || 1,085 || 1,260 || 1,330 
 Spain || 2,600 || 2,500 || 2,200 || 2,000 || 2,000 – 3,000 
 United Kingdom || n.a. || n.a. || n.a. || n.a. || 500 
Source: Civic Consulting 
Notes: (a)
Only medicated feed containing zinc oxides (see country case study Denmark).
In Member States such
as France, Poland, Portugal and Spain, where the national system does not
result in significant extra-costs for the production, the businesses can market
the medicated feed at competitive prices and thus the trend for production and
marketing is stable to slightly positive. In Member States where the national
system imply high extra costs, the industry either cross-subsidises the
medicated feed in order to retain their clients for their normal feed sales or
they abstain from offering medicated feed because they know that the farmers would
not pay the extra costs and instead would use the other routes of medication.
Table 2: Additional costs of manufacturing
medicated feed compared with production costs of compound feed in Member States
with different national schemes (in €/tonne) 
 Cost factor (in €/tonne) || Denmark || France || Germany || United Kingdom 
 Additional consumption of fixed capital (additional equipment and buildings) || 2.32 || 0.02 || 50.5 (a) || 0.36 
 Additional labour costs (b) || 6.33 || 0.59 || 12.5 || 3.17 
 Additional cleaning costs (costs of flushing/rinsing) || 1.75 || 0.08 || n.a.(c) || n.a.(d) 
 Cost of tests (homogeneity test, test of drug carry-over, analytical control of concentration of active substance in medicated feed) || 1.21 || 0.12 || 4.80 || 0.06 
 Administrative costs (annual administrative fee) || 0.28 || 0.06 || 2.50 || 0.02 
 Total additional cost of manufacturing medicated feed (excluding cost of the medicine) || 11.89 || 0.87 || 70.33 || 3.62 
Source: FCEC Consulting (see Annex 11)
Notes: 
(a) In the case of Germany, the additional
consumption of fixed capital includes 50 Euro of depreciation cost per
tonne of medicated feed for the end-of-line mixer and 0.5 Euro of depreciation
cost per tonne of medicated feed for storing of medicated pre-mixes.
(b) Additional labour costs for medicated feed
production include the labour costs for a veterinarian/pharmacist, where
applicable, and the share of labour costs of staff members performing tasks
related to the production of medicated feed (e.g. production manager, quality
control officer and feed mill workers).
(c) Because of the use of an end-of-line mixer,
there is no need to clean the production line following medicated feed
production. 
(d) In the feed mill selected for the case
study, most flushed materials are used to produce medicated feeds.
The manufacture of medicated feed is usually
done by the compound feed industry as a special service for their clients that
opt, on their veterinarian's advice and prescription, for the medicated feed
route. Thus the vast majority of medicated feed production is integrated into
the compound feed mills and comes from the approximately 1600 authorised
operators (N.B. 4000 compound feed sites in total). The share of turnover of
the medicated feed activity in the compound feed industry ranges on average from
3% to 5%. In some specialised feed mills, this value can be up to 30%[19] but these plants
usually belong to companies with several production sites, one specialised on
medicated feed and the others exclusively ordinary compound feed which makes an
overall share of medicated feed for the company in the above mentioned range. Besides
these, there are also independent mobile mixers which come with their
specifically equipped lorries to the farms. Finally, a rather limited share of
the medicated feed[20]
is produced in the approximately 5700 farms with specifically authorised premises
(N.B. a total 13,7 mio. livestock farmers can potentially administer veterinary
medicines to their animals)[21].

The diverging situation in the Member States
with respect to numbers of the different kinds of manufacturers of medicated
feed and the authorised distributers involved in supplying the market is shown
in Annex 8.4. The activities of authorised distributers
significantly contribute to a smooth functioning of the medicated feed market.
However this activity is not allowed in 11 Member States. Where the national
rules for medicated feed manufacturing imply high extra costs, the industry
either cross-subsidises the medicated feed in order to retain their clients for
their normal feed sales or they abstain from offering medicated feed because
they know that the farmers do not pay the high extra costs and use instead the
other routes of medication. Thus, for the compound feed industry concerned, the
manufacturing of medicated feed cannot generally be considered a business
branch to evidently contribute per se to the company's profit. In Member States
where the national scheme does not result in significant extra-costs for the
production, the businesses can sell the medicated feed at least at cost prices
and the trend for medicated feed is stable to slightly positive. As, in these
Member States, competition exists between the feed mills but also between feed
mills and mobile mixers, medicated feed is at a competitive price compared to
the other routes of medication.
An estimation of the total EU production of medicated
feed would indicate a range between 4% and 5% which represents a quantity of 6
– 7.5 mio t of medicated feed, creating a total turnover of medicated feed in
the order of € 1.6 – 2 bn. This turnover includes the input of the veterinary
medicines and the feed. The isolated employment effect, solely for the
additional activity "incorporation of the premix into the feed" is
estimated to be in the order of less than 1000 manpower units for the total EU[22]. 
The EU trade in compound
feed is not very evident. This is because feed imports and deliveries from the
production regions in the EU are usually in the form of bulk raw materials for
processing, mixing and compounding close to where the animals are kept. In
addition, Member States' regimes are different both for veterinary medicinal
products (generally national authorisations) and for medicated feed (no
harmonisation at all). This complicates also deliveries in regions close to
borders. Thus, the trade in medicated feed within the EU is currently even more
negligible than for compound feed. 
-     The significance of medicated feed for farmed animals varies
extremely between the Member States
-     It is a niche market with no specialised medicated feed industry.
Medicated feed production can be rather considered a service of the compound
feed industry to their clients.
-     Medicated feed for pets is negligible. 
-     The national regimes determine the costs for medicated feed production
and consequently the supply. The demand is an endogen variable of the specific
supply situation in a Member State.
-     Trade
between the Member States - even in regions near to borders - and also exports
and imports of medicated feed are negligible.

2.1.2.                              
Legislative context

Directive 90/167[23] introduced some
important and still valid concepts into Community legislation. In particular,
it provided that medicated feed had to be manufactured in approved premises in
accordance with Community legislation using staff with adequate qualifications.
It provides that medicated feed can be made with feed complying with feed law (a.o.
Regulation (EC) No 767/2009), issued on the prescription of a veterinarian,
with records being retained in the feed mill. However, the Directive gives no
indication on what standards to apply in approving plants or the acceptable
techniques to produce medicated feed, and whether standards should be
technology based or results based. 
In addition, while it provides that medicated
feed shall be homogenous, it does not define this critically important term and
provides no means to do this at EU level. It is silent on the concept of
carry-over of medicated feed between batches and provides no mechanism to
regulate this. It is vague on whether feed may be prepared in advance of
prescription in the feed mill, allowing Member States to interpret it differently.
It does not address either the labelling of medicated feed which has both
internal market and safety implications. It allows that each individual
consignment moving between Member States be accompanied by a (paper)
certificate from the Competent Authority of origin. It makes no provision for
electronic communication either for prescriptions, feed movement or product
information.
The enforcement of the provisions established
by the Directive in the EU is regularly checked in audits of the FVO (Food and
Veterinary Office, a DG SANCO Directorate). As the Directive is quite general
and giving much flexibility to the Member States, those EU-controls for
compliance cannot be very concrete in practice. There was only one infringement
procedure launched some years ago because one Member State contradicted the
EU-Directive in a national legal implementing act.
There are specific additional issues concerning
medicated feed for pet animals. This was an unknown concept in 1990 and there
is no mention of pet animals in the legislation. Furthermore a provision that
the feed mills must keep a record of all individual animal keepers using their
feed is valid for local farm deliveries but is a major obstacle for a pet food
factory providing specialised medicated feed for pets throughout the EU.
For the manufacture of medicated feed, an
authorised premix is mandatory. Veterinary medicines can be approved in the EU
centrally or at national level[24];
the latter is still predominant for the medicated feed premixes. The
authorisation of veterinary medicines, including premixes, is addressed in the parallel
impact assessment on veterinary medicines. 
Coccidiostats and histomonostats are
considered to be veterinary medicines but their authorisation is regulated
under the scope of the Feed Additive Regulation. Thus, authorisation and use of
these substances are fully harmonised. Furthermore, in 2009 maximum levels of
their unavoidable carry-over in non-target feed were established. Feed
additives cannot be directly fed to the animals, but have to be added to feed
materials or water. In order to ensure the correct dosage of a coccidiostat to
the animal, the incorporation of the additive into the feed materials can be
only done by approved feed business operators which apply the HACCP principle.
They deliver the formulated complete or complementary feed to the livestock
farmer. 
-     Medicated feed is a specific form of feed but with strong legal
links to veterinary medicines. 
-     The enforcement of the Directive by the EU in practice is rather
limited due to its general and vague character.
-     The revision of the veterinary medicines regime aims to improve
the smooth functioning of the internal market in this area.
-     Legislation on feed marketing, feed additives and maximum residues
limits of undesirable substances in feed has been fully harmonised.

2.1.3.                              
Public perception

As a niche in an area
between feeding and treating animals, public interest or concern about
medicated feed is marginal. However, the often vehement discussions at national
and European level about antimicrobial resistance also call for EU-action in
the area of medicated feed (see 1.4). Numerous announcements for national
action plans in this context show the citizens concern regarding the emergence
of multi-resistant bugs. 
Furthermore, there are
a huge number of pet animals (estimated to number several millions, see Annex
8.13) which suffer from chronic diseases but their owners struggle to
administer their medication in the form of pills. On the one hand, a small
number of pet owners are aware of medication via ordinary pet food (medicated
feed) as a good way of treatment but they do not have regular access to
medicated pet food and on the other hand the vast majority of owners are not
yet aware of this convenient treatment possibility.

2.1.4.                              
Need for medicated feed production

Evidently,
the crucial criterion for the choice of the medication route is the cost
situation[25]:
Whether medicated feed is a more costly or a more cost efficient route of
administering oral VMPs compared to water medication or via ready to use
powders depends on 
·     
the manufacturing standards pursuant to the
specific Member States` requirements, 
·     
the pricing strategy applied by manufacturers of
medicated feed (see 2.1.1) and
·     
the pricing strategy of the VMP industry for the
active substance. 
Additional factors are subjective perceptions
of cost advantages or effectiveness of the different routes of medication,
specific taxation rules, monetary incentives of veterinarians and traditions.
Finally, investments in equipment to administer the VMPs via a certain route
(e.g. dosing devices or specific storage containers for medicated feed) are
sunk cost and thus provide an incentive to continue the practice.
Medicated feed (apart from pets) is not an
industry but a small process or service provided within an industry. Individual
decisions on pricing of the MF industry are not transparent (largely elaborated
in Annex 11 of the FCEC report). In some cases, profit margins for MF can be up
to 11% (compared to 6% of non-medicated feed) and in other cases the MF may be
cross subsidised by sales of non-medicated feed.
Cost delta for the 2 main oral routes
(see 4 case studies in Annex 11 of FCEC report):
-    In DK and UK choice depended on the drug prescribed (for some drugs MF-medication was cheaper, for
others water medication),
-    In FR, MF medication has
cost advantage (8-24%), 
-    In DE water medication
is cheaper (10-14%).
Based on the consultations of the
concerned stakeholders (feed industry, veterinarians and farmers), the decision
of the veterinarian, in coordination with the farmer, depends in the first
place on the availability at the price set under the national framework for the
various routes of medication (FCEC report p. 42). In the second place, other
factors such as perceived convenience, efficacy and safety are also important
as is whether investment has already taken place on the farm to use one or
another method. On tax, an issue on value added tax (VAT) has an effect in DE but
not in other MS. There, the high VAT-rate is charged for the MF in its totality
which cannot be reclaimed by some farmers, usually smaller ones that have some
tax privileges; but MF is mostly used in bigger holdings with regular taxation.
If the farmers buy the feed part and the veterinary drug separately, they only
are charged for the VMP with the high VAT-rate. This can only be considered a
marginal further cost disadvantage for MF, because only the farmers with that
tax privilege cannot reclaim the higher VAT paid.
Several MSs (HU, RO, SI) did note
that administration by water/powder was gaining market share over medicated
feed which would be a continuation of the current trend. SI related this
specifically to the greater regulatory controls on MF than on the alternative
routes.
It can be concluded that the farmer's and pet
owner's choice for a specific route of medication depends from the supply side
i.e. the decision for medicated feed or alternative routes is done based on the
specific options offered to him.

2.2.       
Problem identification, its drivers and
consequences
2.2.1.                              
Presence of residues of veterinary medicines in
feed 

The development of antimicrobial resistance (AMR)
is a serious public health risk (more details can be found in Annex 8.9). For
the treatment of infections in animals oral medication with antimicrobials is
most common. For oral administration of antimicrobials there are several
routes, one of them is medicated feed. The FCEC survey and the ESVAC data show that the use of
medicated feed has no influence on the overall quantity of antibiotics used in
livestock farming (for more details see Annex 8.6). Similarly, the excessive
use of antimicrobials can be only satisfactorily addressed in the context of
the holistic AMR strategy. The most important element
with respect to AMR is the frequency of use and the type of the specific
antimicrobial; these issues are addressed in the parallel IA on veterinary
medicines. 
Concerning medicated feed (i.e. apart from
the frequency/quantities of AM-use) AMR can arise from sub-therapeutic (incorrect
dosage) or residual (carry-over from a medicated feed) levels of antimicrobials
in feed. The issue of incorrect dosage is covered under 2.2.2.
Depending on the active substance, above a
certain level (minimum inhibitory concentration, MIC) of the antimicrobial,
combined with a longer duration of the exposure of the commensal bacteria in
the gut, selective amplification of the resistant subpopulation of the pathogen
can be expected. 
Figure extracted
From (Hesji et al., 2007).
On the other hand, residue levels below the
MIC have no evident impact on AMR.
EU ban on antibiotic growth promoters 
Administering
antibiotics and other antimicrobial agents to animals in doses significantly
below the level used for treatment of diseases can have positive impacts on the
micro-biota in the intestine of the animals and thus improve zootechnical
parameters. Such applications are known as antibiotic growth promoters. However,
such sub-therapeutic use of antimicrobials can increase the risk of bacteria
becoming resistant and subsequently causing problems in human health.
Considering the emerging risk of antimicrobial resistance, the EU decided in
2003 to ban the use of antibiotics in feed for growth promoting purposes from
2006 onwards. EU-controls found residues of antimicrobials in un-medicated feed
in the order of those growth promoter levels.
2.2.1.1.  Driver 1: Carry-over of veterinary
medicines, notably antibiotics, into compound feed
The Food and Veterinary Office found that
many Member States had in place measures to avoid or minimise
cross-contamination (for details see 8.7). These measures comprised a variety
of actions at production level such as using dedicated lines, setting up
manufacturing sequences for production or flushing and/or in-depth cleaning of
equipment. However, in 18 Member States, feed operators did not ascertain the
effectiveness of these measures related to cross-contamination and, therefore,
it could not be ensured that they were sufficient. In some countries,
cross-contamination tests were not performed at all and the level of
cross-contamination was not quantified by operators. In a couple of Member
States, the level of cross-contamination measured by these tests was
underestimated as samples were taken after the mixer. In a couple of countries,
cross-contamination tests were run on a very limited number of samples. In a
small number of Member States, the limit of detection of the analytical method
used for these tests did not allow to quantify cross-contamination levels lower
than 10%. Furthermore, findings of veterinary medicines
in feed are reported in the Rapid Alert System for Food and Feed (RASFF)[26] and a list of such
notifications can be found in Annex 8.10. 
Also the online stakeholder consultation
showed an absence of any common ground with respect to carry-over: 42% respondents
indicated that tolerance levels exist in their Member State, whereas 30%
claimed that a zero tolerance is to be applied and 28% did not know. The large
group of undefined responses illustrates that the
situation in many Member States is unclear. A further analysis
of the 42% respondents showed that in many Member States, even from a
formalistic legal point of view, tolerances for VMP residues are officially accepted
up to 5% of the therapeutic level which might be, for many antibiotics, above
the MIC level. The Belgian compound feed industry claims that due to efforts in
recent years the cross contamination had been significantly decreased but even
if they consider levels of 10% "very extreme" they are not
unrealistic.
16 Member States have no clear rules on the carry-over
("no value", see Annex 8.8). Both competent authorities and MF
manufactures have to undergo a burdensome case by case evaluation if residues
of veterinary medicine are found in feed. Three Member States have already
established tolerance levels which are, on the one hand, arbitrary from a legal
point of view and, on the other hand, are more derived from the application of
the ALARA (as low as reasonable achievable) principle than from an assessment
for public health risks.
The
manufacturing of medicated feed cannot totally avoid a carry-over of veterinary
medicines into batches of feed that should be free of such substances ("zero
tolerance"). This carry-over, also called cross contamination, appears
even if medicated feed is produced in dedicated lines of the compound feed mill
with end of the line mixers (e.g. during transport of feed) or if it is manufactured
on the farms where the medicated feed is used. However, the carry-over can be
significantly reduced.[27]

2.2.1.2.  Driver 2: "Zero tolerance" 
From a
legal point of view, residues of veterinary medicinal products in ordinary
compound feed are not allowed (zero tolerance) i.e. that positive findings of
VMPs make the feed not marketable. Eight Member States apply, according to the
central authorities, officially a zero tolerance for the carry-over of
veterinary medicines. The situation in the Member States is detailed in Annex 8.8.
Zero tolerance in the food chain is difficult to implement, thus in practice
for VMPs, stakeholders 
-    try
to find "pragmatic solutions" together with the local competent
authorities or
-    by-pass the rules using other ways of
administration.
An example
for the unclear, contradictory situation in a Member State where medicated feed
is of high importance can be seen from the response of the central Italian
authority: 
"… Officially, the national control plan sets a zero tolerance
regarding residues of veterinary medicines in feed. In fact the tolerance level
is the level of analytical detection related to the accredited laboratory
method. Any positive finding has to be followed by corrective actions imposed
by local competent authorities (case by case: seizure, destruction, penalties,
RASFF notification, procedures of the national control plan of residues in food
etc) … From the official control point of view, maximum levels of unavoidable
carry-over of VMPs in non-target feed is a necessity. Feed operators are …
committed to adopt any measures in order to minimise the carry-over, according
to Reg. 183/2005 and Directive 90/167/EEC. However, even in the best
situations, carry-over cannot be completely eliminated to zero, as well known.
Moreover, Community levels are necessary in order to avoid different practices
among Member States, and different standards related to safety of feed."
This position of the competent authorities is
very unsatisfactory for the business operators as they cannot be sure that, even
if they follow the national rules, they are not prosecuted by the authorities in
the case of positive findings. 
The by-passing of a strict zero tolerance
implementation can be increasingly observed in the EU as for the administration
of veterinary medicines to animals, several alternatives to MF exist, notably
direct use on the farm of oral powders, top dressing or administration via
drinking water. However, they entail weaknesses also concerning residual
presence of veterinary medicines on the farm mainly due to cross contamination
of the equipment used to administer the veterinary medicines. Additional
weaknesses are tackled in 2.2.2.
Case studies on AM-use in Germany
-     Medicated Feed has no significance in Germany for the administration of antimicrobials to animals
-     But, in one Land 92,5% of broilers (generally aged
under 40 days) have been treated at least with one antimicrobial, mostly at
therapeutically incorrect doses (NRW 2011)
-     76% of the broilers, 97% of the turkeys, 68% of the
pigs, 100% of the calves for fattening and 92% of the cattle for fattening have
been treated at least with one antibiotic (NI 2011)
-     In 62% of the poultry houses, at least one
antimicrobial was found in the drinking water though it was not used in the
time of sampling (NRW 2012)
2.2.1.3.  Consequences
·               
AMR risk in those Member States with generous
tolerance levels.
·               
Burdensome case by case evaluation in Member States where no carry-over level exists and possibility that follow up of positive
findings does not fully guarantee public health protection.
·               
Legal uncertainty for stakeholders in Member
States with a "pragmatic" implementation of the zero tolerance.
·               
Cross contaminations on farms in Member States
with a strict application of the zero tolerance due to increased use of less
controllable alternatives to medicated feed.
·               
Unavailability of medicated feed in Member
States with strict application of the zero tolerance.

2.2.2.                              
Imprecise dosage of veterinary medicines

The precise dosage of oral VMPs is crucial for
an effective group treatment i.e. to ensure that each individual animal gets
the correct therapeutic dose. Incorrect dosage may cause toxicity in the animal
(too high dosage) or increase the risk that animals are not cured (too low
dosage). The animal health problem due to under-dosage is particularly severe
for the weak animals because they need the medication in the first place and
these individuals already suffer from competing with stronger individuals in
their access to feed. 
Field
study in Germany (DPT 90:12 (2009)
-     96 % of farms used oral powders
for group or herd treatment.
-     76% of the oral powders were
given via feed, 11% via drinking water, 12% of the farms apply both routes
-     1/3 of farmers dosed the oral
powder per hand to the feed
-     Only in 18.5% of the samples
was the correct therapeutic dose given (in 70.4% there was under-dosage and in
7.4%, an overdose)
-     There were severe carry-over
problems: 40% of samples had 1-4 unintended active substances of which 20% were
at or above the respective therapeutic level.
Conclusion: objective of improving
safety in on farm use of medicines, by increasing the regulatory burden for medicated
feed alone, has not been achieved.
Report of the French food safety agency (Anses)
2012 (saisine no 2011-SA-0048):
-     Significant weaknesses of
mixing oral powders into feed by the farmer even if done in compliance with the
summary of the product characteristics (SPCs) of the VMP. Oral powders are only
first choice under very specific conditions. 
-     In general, medicated feed with advantages in terms of safe and efficient
medication.
Precise dosage is at risk on the one hand if
the medicated feed manufacturing does not guarantee a homogeneous incorporation
of the medicine into the feed or if the medicated feed intake of animals is
lower than expected and on the other hand if less precise routes of dosage
(e.g. top dressing of oral powders) are dominating. If
the microbes in the animal are exposed to sub-therapeutic dosage of
antimicrobials[28],
a significant number of pathogens survive the treatment and their presence will
stimulate the selection of resistant strains of microbes. 
The legislation for coccidiostats and other
sensitive feed additives does not allow the farmer to add them on their own to
the feed. Instead, it requires that this is done by approved feed manufacturers
to ensure the homogenous incorporation of these additives into the feed and
thus a precise dosage ("premixture obligation"). This is EU wide
enforced. However, the oral administration of veterinary medicines ("ready
to use powders") can be done by each farmer without any official licensing.
And even if the medication is via medicated feed, depending on the rigidity of
the respective national regime, the homogeneity of the medicated feed is in
various Member States hardly enforced. 
2.2.2.1.  Driver
1: Preventive costs for medicated feed production in some Member States
Some Member States impose burdensome
requirements for the manufacturing of medicated feed in order to avoid misuse
of medicated feed leading to costly medicated feed. For example, producers of
medicated feed in Germany must comply with pharmacology production standards.
This means installing totally separated production lines for compound feed and
medicated feed. This involves not only additional investment in a separate
medicated feed line but also extra costs for the equipment (materials,
technology), the workers and control staff. These extra costs do not apply in
other Member States because medicated feed production can be done in the
ordinary compound feed production lines. Also in Austria, the national rules impose high burden for the feed industry whereas on-farm
manufacturing of medicated feed is implemented at a pragmatic level.
Consequently, the manufacturers with the best mixing technology are not operating
in this business and all the premixes used are mixed on farm[29] into the feed, apart
from the oral powders directly applied via the feed or water. Other Member
States where, due to national rules, a trend away from expensive, controlled
medicated feed manufacturing to alternative routes of administration can be
observed are Luxemburg, Malta, Romania, Bulgaria, Hungary, Greece and Cyprus.
In about 1/3 of the Member States the costs for professionally medicated feed
can be assumed to be preventive.
As the quantity of veterinary medicines used
are independent from the availability of the different routes of
administration, such high and thus preventive costs of medicated
feed manufacturing result in more use of the other, less precise routes. The
oral powders are usually not incorporated into the feed by specific, calibrated
devices. The top dressing of the medicines risks that the strong, dominant,
animals have an excessive uptake while the weak animals do not have access to
feed and are thus deficient. An important percentage of the oral powders is
dosed per hand by the farmers (see above) with evident weaknesses concerning
precise dosage in group treatments. The authorities in these Member States try
to tackle this issue by supporting the investments in dosage devices but there
is no hard law to oblige the farmers.
The imprecision of the drinking water route
is the quantity of water that is spilled and also the variation of the water
quantity drunk by the animals. Furthermore, practical experience from drinking
water medication has reported the creation of solid complexes in the pipes, jamming
the drinking taps, which can affect the dose precision. 
These problems of the oral powder medication
cannot be tackled in the margins of the medicated feed legislation but are
under the scope of the veterinary medicine law. The leverage on more precise
dosage of the livestock in the medicated feed area is to induce for more
animals the treatment via medicated feed instead of less precise "ready to
use" powders.
2.2.2.2.  Driver
2: Poor homogeneity of medicated feed in some Member States
The non-homogeneous mixing of medicines into
a quantity of feed means that a part of the feed is under-dosed whereas another
part is overdosed. The problem of under-dosage is further aggravated for weak
diseased animals.
The homogenous incorporation of the
veterinary medicine into the feed is a general requirement for the operators in
the EU-Directive. In some Member States this provision is quite diligently
implemented by means of explicit measures to achieve and control this. However,
in other Member States the requirement is not enforced to this extent.
Medicated feed manufacturers are usually
aware of the requirement about homogeneity. However, in nine Member States out
of 25 inspected by the FVO, operators did not verify that they achieved
homogeneous mixtures. This lack of verification concerned on-farm and mobile
mixers, but also a number of feed mills. In some Member States, the
verification of the feed homogeneity was only based on visual examinations or
on the analysis of only one sample (more details can be found in Annex 8.7). If
the competent authority has no willingness or resources to insist on a good
homogeneity test, the FVO has no means to conclude non-compliance with the
EU-Directive due to missing indicators. Evidence from practical application of
the valid homogeneity tests shows that homogeneity cannot be assumed per se by
using a certain technology but that each establishment has to be optimised to
achieve it.
The evidence produced in France, Germany and Ireland indicates that homogeneity cannot be automatically assumed if the
operator merely relies on the technology he installed. Instead, it is crucial
to measure recovery rates of the medicine in the finished medicated feed
(homogeneity) and residues of medicines in the on target animal feed. Based on
these criteria the optimisation of the dosage and mixing process or the concrete
design of the flushing regime taking into account the different active
substances and feed materials has to be done for each manufacturing site. 
2.2.2.3.  Consequences
·               
Ineffective treatment of sick animals as they do
not get the therapeutic level of the veterinary medicine (failure of therapy
for under-dosed) and residues of the medicines in the animal products
(over-dosed animals) both in Member States where medicated feed is displaced by
less precise oral powders and in those where homogeneity of medicated feed is
not sufficiently ensured.
·               
Development of antimicrobial resistance as many
animals are treated at sub-therapeutic levels (=MSW, see chapter 2.2.1.1), 70%
according to the DE-study (see above).

2.2.3.         
Barriers to expand the production and intra EU
trade of medicated feed

Today,
each Member State has created its own national system for MF which means in
reality an extremely complicated but also costly situation, particularly for
the concerned industries: 
·               
67% of the experts interviewed in the margins of
the FCEC survey indicated at least "fairly significant negative consequences"
of the different national frameworks for the competitiveness of the
manufacturers of medicated feed. The group "Business organisation / enterprise / farmer"
called in the online consultation with 86% for "action at EU level instead
of national level". Even though a reminder to the subsidiarity and
proportionality principles was made in the question the figure in the group of
public authorities was 82%.
·               
The extreme differences in practice between the
Member States were addressed by 88% of the respondents to the online
consultation who pleaded for more harmonised rules at EU level (results of the
online consultation can be found in Annex 8.11).
2.2.3.1.  Driver 1: EU-Directive with vague
provisions re manufacturing, differently interpreted by the Member States 
If the medicated feed industry intends to
expand their manufacturing to other Member States they must study and cope with
the specific national rules in the Member States. The vague provisions in the
EU-Directive about homogeneity, qualification of staff, labelling and record
keeping have led to diverging interpretations by the national authorities. In
addition, the majority of Member States have mandatory rules for good
manufacturing practice in place, in others such rules are only voluntary and a
third group does not have them at all (for more details see Annex 8.5). Finally,
the character and content of the rules of good manufacturing practice applied
varies between Member States. As the manufacturers of medicated feed are
pre-dominantly SMEs that cannot afford expensive regulatory affairs departments
to research in national manufacturing requirements in potential Member States
and the margins in medicated feed are so small (see 2.1.1), the expansion
outside the "home" Member State is very limited.
With respect to manufacturing practice, the
current Directive only mentions national measures but no European measures.
Nonetheless, the European Feed Manufacturers’ Guide
(EFMC)[30],
an industry driven document based on the Feed Hygiene Regulation, whose application
by the operators is voluntary, contains since 2009 a chapter on medicated feed
manufacturing. However, this soft law measure evidently has not improved the manufacturing
of medicated feed. Based on their audits in the Member
States, the FVO identifies the following as key weaknesses of the existing
voluntary EFMC guide:
"Once control measures for the
reduction of cross-contamination are in place (e.g. flushing, production
sequencing, cleaning, etc.), the determination of the level of carry-over as a
tool to determine whether these control measures are effective or not is not
foreseen; operators flush and take it for granted that this is reducing their
carry-over to acceptable limits without any verification."
The effectiveness of the control measures
should be assessable against the concrete legal limits of the substance
concerned (e.g. Directive 2002/32/EC for coccidiostats in non-target feed).
This is another main weakness identified by the FVO, that even when operators
see a reduction in carry-over, they do not know whether it means that they are
in compliance or not. 
The determination of the level of carry-over
should be done according to a sampling plan where the number of samples and
their timing should be determined with the purpose of determining the content
of the substance concerned (i.e. the actual level of cross-contamination) in
feed placed on the market."
Soft law measures still
lack the leverage to change a situation that has intentionally evolved. Neither
the Member State Authorities nor the operators for which the EFMC is voluntary
can be forced to commit themselves. It can be only an offer to interested
parties. As long as strong commitment of specific manufacturers to apply such
soft law is missing, manufacturing quality of medicated feed cannot be assured.
2.2.3.2.  Driver 2: Options for Member States' national regimes offered in the EU-Directive
The Directive foresees several measures,
which the Member States can chose to apply on their territory, that influence
production and deliveries of medicated feed:
·     Anticipated (advance/pre-) production of medicated feed      
The feed mill can produce medicated feed based on past sales patterns in
advance of receiving the veterinary prescription from the distributor or farmer.
The feed mill can optimise the batch sizes according to the expected orders
thus reducing costs and the carry-over of the VMPs in non-target animal feed
(larger batch production means less problems of carry-over). Another benefit is
the timely delivery: if the veterinarian prescribes a veterinary medicine it is
usually quite urgent that the animals be treated. If the medicated feed can be
dispatched directly upon arrival of the prescription the treatment is more
efficient. On the other hand, some Member State fear, that once the medicated
feed is produced without prescription, there is a strong incentive to use it by
any means. They therefore forbid pre-production. 
·     Mobile mixers   
Lorries with a specific mixing technology can deliver the feed separate from
the premix to the farm and do the manufacturing of the medicated feed on site.
The competent authorities have -both when approving the operator and when
controlling later in the field- the means to ensure that the respective
technology and its application in practice meet the requirements for medicated
feed. However, as the precision of the inclusion of the premix into the feed is
usually not as good as in specialised feed mills, just a few Member States
authorise mobile mixers even though one could cope with this e.g. by setting
specific production parameters. 
·     On-farm mixing        
The farmer himself is approved to produce the medicated feed he needs for his
animals on the condition that he meets the respective requirements. It is the
competence of the national authorities to enforce this. Some Member States do
not allow on-farm manufacturing because they think that the, nationally set,
high standards for medicated feed (these are mainly the MS with the
"preventive standards") cannot be achieved on the farms. Indeed the
quality of medicated feed from specialised feed mills is superior and requires
certain technology and production skills. However, it cannot be assumed that a
priori these conditions cannot be fulfilled by farmers and specific
measures and parameters can be foreseen to cope with this. Furthermore, the
alternatives applied in these Member States (water, powder) are usually much
less safe and efficient.
·     Distributors 
Under certain conditions Member States can authorise distributors, apart from
the manufacturer, to issue medicated feed to the animal holder. The existence
of intermediaries between manufacturers and users increases the flexibility of
the system and allows, particularly for medicated feed with small volumes, to
be produced remote from the final user. Some Member States forbid the activity
of distributors which they consider represent a risk of misuse of medicated
feed and because controls would be even more complicated : apart from the
manufacturers on their territory they must also control the distributors. However,
the risk inherent to internet sales of veterinary medicines for direct use seems
much more evident than the risk with the distribution of well controlled
medicated feed manufactured in the EU.
The denial of these
options decreases the economic viability of the medicated feed route and increases
the costs for a treatment via medicated feed[31].
Examples for Member States which allow these options are FR, IT, ES, PL and UK and it can be observed that the MF-route is quite important there. The actual combinations
of the options chosen by the Member States in their national regimes lead to
the fragmentation of the EU market for medicated feed.
2.2.3.3.  Consequences
·               
Barriers to intra EU trade of medicated feed (walling-off),
restricted competition and obstacles to the dissemination of innovations.
·               
High regulatory burden to the industry if they
do not limit their business to the local market.
·               
Unsatisfactory MF manufacturing (poor guides for
stakeholders) in MS with lax rules.
·               
Excessive costs in MS that "gold plated"
the MF regime (one after the other MS stop MF production, thereby diverting
medication to less controllable routes).

2.2.4.                       
Impossible market access of medicated feed for
pets

Generally medicated
feed is used for the treatment of larger animal groups in livestock farming.
However, for certain veterinary medicinal products the treatment of pets via a
medicated feed could be an excellent route allowing owners to provide for their
pets medication in the form of prepared feed. Besides, as pets get older and
older, many of them with chronic non-transmissible diseases require long term
medication, which is not based on antimicrobials. For such pets, the
professional incorporation of the medicine into the ordinary food for the
animal is an interesting proposition and would also be a major business
opportunity. Medicated feed for pets to treat chronic conditions, particularly
in older animals or in difficult to medicate animals (especially cats) is
potentially a very large and untapped business opportunity. Experiences of pet
owners and veterinarians specialised on pets show that it is very difficult to
administer a pill or other separately formulated medicine to the pet animal.
2.2.4.1.  Driver 1: Unclear scope of the EU-Directive
Today, medicated pet food
is only available in three Member States. A  combination of factors have
resulted in many Member States feeling unable to authorise these products and
in the industry believing that there are too many regulatory obstacles to
placing products on the market[32].
Several Member States are unsure if the medicated feed legislation can even
apply to pets as it is based on old Article 43 of the Treaty (Common
Agricultural Policy), thus considered to be applicable only for farmed animals
and have therefore been reluctant to approve medicated premixes for pets. 
2.2.4.2.  Driver 2: National
implementation of the Directive 
The requirement for a
prescription to be available in advance of production (as distinct to delivery)
goes against central production and distribution. Several Member States do not
allow anticipated manufacturing of medicated feed. Or others do not agree on
distributors acting as intermediaries between manufacturer and user, insisting
instead on distribution direct from the feed mill to the holder of the animal,
which pet food distribution cannot comply with. 
2.2.4.3.  Consequences
·     Barriers for innovative companies that want to expand their business
in medicated pet food.
·    
Owners of pets with chronic diseases are prevented
from treating them in this comfortable and efficient way. 

2.3.       
Justification for EU action
2.3.1.         
The choice of legal instrument

The current legislation
on medicated feed is a Directive that has been established before the creation
of the internal market and that had 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 the problems as laid down in 2.2. With respect
to the development of the national systems, the trend over the decades shows
that those problems have rather deteriorated instead of improved even though
many Member States tried to tackle the problems with national action plans.
Thus, the legal instrument is an elementary issue for the different policy
options and their evaluation. 

2.3.2.         
Subsidiarity - Conferral

The Member States have established their
national regimes for medicated feed under the current Directive which has led
to diverging situations in practice and to the problems explained in 2.2. Besides,
the Communication from the Commission Europe 2010 "A strategy for smart,
sustainable and inclusive growth" identifies the incomplete functioning of
the single market as a missing link and a bottle neck for growth in the Union[33]. To
achieve a strong single market in the area of medicated feed, there is a need
to streamline across the Union the regulatory system and remove inefficiencies
and barriers to intra EU trade. 
The protection of public health is a competence
conferred upon the EU by the Treaty. With respect to the AMR almost all Member
States came up with national action plans tackling, at least partially,
medicated feed. These national efforts either contain an explicit call for
EU-action or they implicitly hint that EU-action would be sensible. Thus, as
extensively explained in the impact assessment on veterinary medicines, a
holistic EU-Action plan against the rising threats from AMR had been developed.
One of the concrete actions is the revision of the medicated feed Directive. Also, the Resolution of the European Parliament on "the
Microbial Challenge – Rising threats from Antimicrobial Resistance" demanded
a European response to the issue. Additionally, in 2012 the Council called upon
the Commission in its conclusions (Doc 10582/12) to expedite the review of the
medicated feed directive.
The Directive 90/167 was based on Art 43 of the
Treaty establishing the European
 Economic Community (now article 43 of the TFEU),
implementing the Common Agricultural Policy. However, there is evidence that
the existing provisions do not deliver the ambition of a functioning internal
market. For this, there is a need across the EU to simplify and streamline the
regulatory system for the production of medicated feed and remove barriers for
new products.[34] 
The general and vague requirements in the old
Directive are difficult to enforce: The Commission Services have difficulties
to police the, unambiguously important, requirement "homogenous
incorporation of the veterinary medicine in the medicated feed" in Member
States that actually do nothing. Action
at EU level would produce clear benefits compared with action at the level of
Member States. The EU is in a better position than the
Member States to draw up a harmonised and proportionate system to regulate the production
and use of medicated feed. A single set of EU rules would
reduce the distortions in production conditions for the feed industry and in
competitiveness for the livestock farmers. Measures for medicated feed are
essentially no more than those already very successfully applied for feed
additives, a category of products which is fully
harmonised at EU level and which is incorporated in every
batch of compound feed and pet food produced. It is not logical that medicines
can be included in feed with fewer safeguards that apply to feed additives at
present. In the FCEC study, the online consultation and targeted consultations
the stakeholders overwhelmingly pleaded for concrete
harmonised measures at EU level.

2.3.3.                       
Proportionality of EU action

With a view to ensure
proportionality of measures the new legislation should reflect the
technological progress in feed manufacturing and feeding techniques and flank
the measures taken in the area of veterinary medicinal products. The choice for
the new scheme is representing the least onerous way to achieve the objectives.
Further is will ensure flexibility of implementation to reflect the regional
specificities and variations in livestock farming practices in the EU.

2.4.       
Small and Medium Enterprises - Micro-enterprises

The cross-cutting principles of promoting
health, safety and the interests of European consumers are directly embedded in
the Treaty. Therefore, as a matter of principle, all EU legislation regarding
food safety and public health should apply to all business operators as their
impact on the health and safety of citizens is highly significant. The
Commission is therefore cautious when considering any exemptions or lighter
regimes for SMEs and micro-enterprises for these policy areas, since such
exemptions should not undermine the high level of protection which has already
been achieved.
The medicated feed business is driven by SMEs
and micro-enterprises even if the medicated feed is only one activity of a
bigger feed compounder; multinational players are, so far, exceptional. SMEs
are reluctant to accept a high regulatory burden and large investments because
they cannot realise economies of scale comparable to very large enterprises.
Thus, the higher the burden for the manufacturing and the compliance costs, the
bigger the disadvantage for the SMEs and micro-enterprises.
It is not proposed to exempt
micro-enterprises from the scope of legislation on the production of medicated
feed though it may be possible to exempt them from some of the specific
requirements, depending on the nature of their business. For example, a mobile
mixer could occupy a critical point in the feed supply chain, mixing feed for
several hundred farms and would thus have a disproportionate negative impact if
this mixing is not done in a correct way. Medicated feed produced by these
methods should meet the same standards as a feed mill.
On the other hand, a
farmer mixing feed on his own farm for his own animals could be the same
enterprise size as a mobile mixer but would have a more limited impact if he
failed to meet the same standards. It may be possible in this case to apply
more final product characteristics (homogeneity etc.) than detailed process
requirements to provide the necessary flexibility for his business, while preserving
the essential safety elements.

2.5.   
Problem Tree


2.6.       
Forward looking - Baseline

It can
be expected that the trends observed above will carry on:
·     
An unclear situation for the manufacturers in
Member States where medicated feed is produced in big volumes continues. The
concerned industry is very uncomfortable with a situation where the authorities
can always police them e.g. because of carry-over residues or poor homogeneity.
The criticism of misuse of medicated feed with antibiotics from these Member States
will continue. AMR would stay high in the political agenda.
·     
The inconsistency between the specific tolerance
levels for coccidiostats in feed laid down in Directive 2002/32 and the unclear
situation with respect to carry-over of veterinary medicines into feed would
persist.
·     
The current downward trend in use of medicated
feed for food producing animals in Member States that stick to very rigid
requirements would continue because either the medicated feed route is not
offered at competitive prices or the industry does not offer it at all.
Measures to optimise the production in terms of safety and economics will continue
to be very restricted. On the other hand, the less controllable and less precise
routes of medication will become even more important. Even more animals will be
treated via the alternative, less controllable routes. This means another
inconsistency between the administration of veterinary medicines and the
sensitive feed additives for which legislation requires their inclusion into
the feed by qualified operator. Consequently, medicated feed survives mainly in
those Member States with poorer manufacturing standards. 
·     
As regards pets, little change is expected. The
industry cannot develop without changes that would allow them to benefit from the
scale of the single market. The pet industry has none of the transport
constraints that can apply to compound farm feed as individual volumes are by
far smaller (medicated feed for one cat versus for 100 pigs). 
·     
The activity of medicated feed manufacturers
will remain limited to the local markets within their "home" Member State. Notwithstanding the huge potential for high quality medicated feed, there is
only poor interest in the industry to expand in medicated feed as long as the
burden is so high.
In conclusion, AMR is
not adequately addressed and less and less animals are treated with high
quality medicated feed, even if this would be the first best route of
medication.

3.         
Objectives

The
general objectives of this initiative are 
(1) the
smooth functioning of a competitive and innovative internal market for
medicated feed whilst 
(2) ensuring a high level of protection of
animal and public health. 
For the functioning of
the internal market, a level playing field for production, marketing and use of
medicated feed across the EU should be established. The harmonised
manufacturing standard for the EU should be set at a safe level.
The specific
objectives derived from are linked to the problems and drivers identified
·  Overcome
the zero-tolerance for unavoidable carry-over of veterinary medicines
·  Make
medicated feed available to farmers and pet owners at a competitive price
·  Curb
AMR-risk from residual and sub-therapeutic administration of antimicrobials
·  Improve
animal health by precise dosage of oral veterinary medicines
· 
Remove barriers for innovative,
"novel" medicated feed.

4.         
Policy options
4.1.       
Option 1 - Maintain status quo

No EU action is undertaken in the area of
medicated feed. Thus, this option can be considered the Baseline Scenario: The
existing Directive will keep its
general character and still be subject to varying national interpretation and implementation.
Different sets of rules for manufacturing and use of medicated feed will apply
from one Member State to another. The Member States have a maximum of competence
in setting the rules while the responsibility for proper enforcement is also in
their hands.
The Commission`s function as guardian of the EU-law would be quite limited because
of the vague character of the Directive. The FVO just controls that the general
principles established in the Directive are applied by the Member States. As
long as enforcement remains only based on the existing medicated feed Directive,
efforts to tackle the problems can hardly materialise. In absence of criteria
for crucial issues such as homogeneity or residues of veterinary medicines, it
is impossible to leverage the controls. Bad and good performers can hardly be
detected.
The EFMC and, if
applicable, the national guides remain in place simultaneously. The medicated
feed Directive requires that operators "comply with hygiene rules and
principle of the Member State in question". These rules can span from a
pure transfer of the general wording of the EU-Directive to concrete mandatory
laws with any kind of guides built therein. Member States will continue to have
on their territories different regimes for residues of veterinary medicines in
feed, mirroring the full scenario explained in 2.2.1. 

4.2.       
Option 2 - Amend Directive 90/167 combined with "soft
law"

The scope of the Directive would be clarified
and also extended to cover the production, marketing and use of medicated feed
for pets with respect to the objective "remove barriers for innovative MF
applications". In addition, the amendment of the Directive would
streamline it with the currently revised veterinary medicines legislation to
flank the objectives to improve the internal market and the public health. In
concrete, the provisions for the intra-EU trade of medicated feed and
veterinary medicines would be fully aligned and the legislative measures to
fight AMR such as monitoring would be transferred to medicated feed. This could
result in a certain incompatibility if the new legislation on veterinary
medicines is a Regulation and also because the import procedures for medicated
feed are under the scope the horizontal Regulation on official controls on food
and feed whereas the import of veterinary medicines is separately regulated.
The intervention logic at EU level in terms
of manufacturing standards would charge the voluntary EFMC guide. A stringent
reference to the feed hygiene regulation would clarify that the EFMC is also
valid for the manufacturing of medicated feed (currently the legal base is only
the vague provision in Directive 90/167). In Member States without any guides,
the industry could take advantage of the EFMC and in those with voluntary
national guides a new benchmark would be established that could challenge the
further existence of these. 
With respect to the weaknesses of the EFMC
as outlined in 2.2.3.1, the
Commission would encourage the industry to improve the EFMC in particular by
including best practises with respect to minimising the carry-over or the
process of incorporation of veterinary medicines. The setting of more concrete
parameters about manufacturing would give the FVO a better base to monitor the
general objectives of the EU legislation. However, the consequent improvement
of the medicated feed manufacturing would be only feasible in those operations
that apply the improved voluntary EU guide. It remains very difficult for
control authorities and the FVO to prove that lax manufacturers are not in
compliance with the legislation.
The
option does not foresee any changes to the technical provisions of the current
legislation in terms of manufacturing standards (see 2.2.3). The general
character of the provisions and the possibilities for the MS to foresee
specific rules on their territory remain.

4.3.       
Option 3 - New EU Regulation with detailed rules

88% of the stakeholders pleaded for
harmonised rules set at EU level. The reasons for this request can be found in
all four problems identified: Residues of veterinary medicines in feed,
imprecise dosage of veterinary medicines, impossible market access of medicated
feed for pets and barriers to intra EU trade of medicated feed. Also the
Council and the European Parliament suggested concrete action at EU-level (see 1.4
and 2.3.2) though these focus mainly on EU-measures to curb AMR (see problems 2.2.1
and 2.2.2). 
In this option the clarifications concerning
the scope and the streamlining with the veterinary medicines in option 2 are
undertaken but in the legally directly binding form of a Regulation. Whereas
medicated feed for farmed animals is usually produced in bigger quantities for
the specific farm and for a short term treatment (often of a microbial
disease), medicated pet food would be rather produced more centrally in batches
for the treatment of mainly chronically diseased animals kept by many different
users. Therefore a specific distribution system will have to evolve in practice
and also specific rules for the veterinary prescription have to be foreseen. The
validity of the prescription and the quantity prescribed in case of the
treatment of a chronic disease in a cat must of course be different from the
validity and prescribed quantity of a medicated feed with an antimicrobial to
treat an infection in a group of 50 pigs.
Distributors will be allowed in the whole EU
to intermediate between the manufacturers and the users of medicated feed which
is critically important for medicated pet food. The rather centralised
production structure for ordinary pet food could integrate the activity of
controlled incorporation of veterinary medicines into dry and wet pet food in
existing establishments or certain producers of the relevant veterinary
medicines could expand into the manufacture of medicated pet food. The role of the
veterinarian as regards the prescription of medical treatments for pets would
be unchanged as the pet owners would still have to obtain a prescription from
them.
In line with the position of the stakeholders
(see following box), precise EU standards for medicated feed in terms of mixing
technology and homogeneity will be established in the Regulation, covering all possible
manufacturing schemes. Based on best practices in the Member States,
homogeneity criteria could be set in an implementing act. Consistent
EU-tolerances for the maximum deviation of the labelled concentration of the
veterinary medicine in the medicated feed from the actually analysed
concentration in a control sample could be established.
Manufacturing schemes – quality and safety (results of online consultation):
·      
For 79 % of the respondents (4%
no idea) anticipated production of MF does not raise concerns in terms of
efficient and safe use of the VMPs. 
·      
67 % of the respondents (20%
no idea) believe that mobile mixers can meet the requirements for MF with respect to homogeneity and
compatibility of the different components.
·       66 % of the respondents (12% no idea) believe
that on-farm manufacture of MF
can meet the requirements for homogeneity and compatibility of the different
components.
·      
41 % of the recorded responses believe that left
overs of MF on the farm, e.g. due to a change of treatment might cause
problems.
Anticipated medicated feed production, mobile
and on farm mixing will be authorised in the EU, while simultaneously tightening
the standards for these schemes. Considering that in terms of homogeneity
specialised feed mills have advantages over mobile mixers or on-farm
manufacturing, the latter are only allowed to use premixes with a higher
inclusion rate. Nonetheless, in the margins of the approval by the competent
authority, all manufacturers shall be subject to regular verification of
product quality, including the verification of homogeneity. Appropriate
qualification of the staff, functionality of the equipment particularly the
mixing technology and measures to segregate the medicated feed from other feed
are other conditions for the approval of the manufacturers.
The issuance of precise veterinary
prescriptions and their strict adherence by both the manufacturers and users of
medicated feed has to be severely policed by the competent authorities of the
Member States to prevent any misuse with medicated feed produced in advance of
the prescription is available. Also, these provisions include measures for
disposal of medicated feed on farm that is not used e.g. due to a therapy
change.[35]

EU wide tolerance levels will be set for the
unavoidable carry-over of veterinary medicines in non-medicated feed, based on
an assessment of the risk for the animals and the humans with regard to the
different types of active substances. For the antimicrobials the risk
assessment will take into account the MIC-levels (see 2.2.1). The resulting
tolerance level would be a percentage of the therapeutic dose of the veterinary
medicine. A similar approach has already been successfully applied for residue
levels of coccidiostats[36]
(veterinary medicines under the scope of the Feed Additive Regulation). The
EU-Authority for the risk assessment could take advantage of the evaluations
already undertaken by some Member States. In analogy to the approach for the
coccidiostats, the implementing risk management decision would choose the lower
level out of the result of the risk assessment and the carry-over levels that
following the ALARA-principle[37].

According to the targeted consultations of
stakeholders and the online consultation, the establishment of such tolerance
levels is strongly recommended to overcome the problems mentioned in 2.2.1.
Also 19 out of 22 competent authorities responding to a targeted survey in
spring 2013 were in favour of such tolerance levels (see Annex 8.8).
The weaknesses of the voluntary EU-guide that
will be sorted out. Product criteria are established that guarantee a safe and
efficient manufacturing of medicated feed. The operators have full flexibility
how to meet these criteria with their manufacturing process.
The competent authorities in the Member
States could concentrate on the control of the concrete product criteria and
would be released the task of trying interpret the general Directive. They
would be held responsible to ensure that medicated feed is only delivered upon
prescription, homogeneity criteria are met by all manufacturers and misuse of
medicated feed is avoided. The FVO could in practice check that the Member
States efficiently enforce the criteria set in the EU-Regulation, which they
are used to in many other areas of food and feed law.

4.4.       
Discarded Options
4.4.1.                       
Repeal of Directive 90/167

The removal of specific EU-legislation on the
manufacture and use of medicated feed would imply that
·     
for the rules on the manufacturing, marketing
and use of medicated feed, the general feed and veterinary medicine legislation
is applicable but with a totally unclear status of medicated feed and
·     
the Member States are totally independent to
establish specific requirements for their territory.
Each Member State would be forced to tackle with
national rules the evident risks and to render those national regimes
consistent with the harmonised legislation on feed and veterinary medicines in
order to avoid lacunae and loop holes. Member States would no longer be obliged
to approve the establishments. However, feed law requires the approval of
compound feed mills once they incorporate feed additives. Proper incorporation
of veterinary medicines into feed is at least as sensitive as additives. The
production of medicated feed would be conducted on the basis of requirements established
in the compound feed legislation. No specific labelling rules for medicated
feed would exist. The barriers to intra EU trade of
medicated feed and to innovation/dissemination of emerging medicated feed
applications would increase. Additionally, the high regulatory burden to the
industry (SMEs) that do not want to limit their business to the local market
becomes more evident. The administrative burden for the authorities in the
Member States increases because they have to cope with their mandate to create
and implement national rules specifically for medicated feed in the absence of
any EU framework.
Concerning subsidiarity, national authorities
would have the full responsibility to regulate particular medicated feed issues
within their competence. This is, both with respect to the legislative means
and to the substance, a big challenge because in the interlinked areas of feed
and veterinary medicines such national structures do not exist.
In conclusion, all the
problems identified in 2.2 would deteriorate if the Directive is deleted
without substitution.

4.4.2.         
No-stand-alone medicated feed law

The splitting of the substance to be
regulated between already existing legal acts (Feed Hygiene and Feed Marketing
Regulations, Directives on veterinary medicines and undesirable substances in
feed) would allow the Directive to be repealed without formally creating a new
law. 
However this option was discarded because of
the very particular status of medicated feed: though it is a special form of
feed, the link to the veterinary medicines is very strong. This refers to the
veterinary prescription but also the pharmacovigilance and other information
duties. There is serious concern amongst the authorities in the Member States
that strict rules concerning medicated feed would lose their clear status if
they are spread over different legal acts in the area of feed and VMPs. In
fact, several Member States strongly objected in the consultation to simply adding
this legislation to feed law. This is also mirrored in the Resolution of the European
Parliament of 11 December 2012 on the Microbial Challenge – Rising threats from
Antimicrobial Resistance.
Therefore, a
stand-alone legal act for medicated feed is appropriate in order to take into
account the sensitivities about this route of medication.

5.         
Analysis of impacts

As a result of the
problem identification, the major focus of the analysis is on economic and
public health impacts. 

5.1.       
Maintain Status quo 

This option is the
baseline scenario (see 2.6). Neither tangible provisions for the manufacturing
nor product criteria for medicated feed would be set at EU-level. The technical
provisions for the manufacture of medicated feed remain either vague or subject
to specific national rules. 

5.1.1.                       
Economic impacts 

5.1.1.1.  Costs of MF production
National implementation
of the general EU-rules still leads to a tremendously different set of economic
parameters for the manufacturers of medicated feed. The cost delta between
Member States with lesser and more demanding requirements for the manufacturers
of medicated feed would be fixed (extra costs from 1 €/t to 70 €/t, see 2.1.1) though
the internal market of feed and animal products is fully harmonised. This is
heavily criticised by the compound feed industry in the Member States with more
demanding standards (they took their consequences) but also by the famers that are
deprived of medicated feed as an option to cure their animals. 
5.1.1.2.  Market access
Mobile mixers and bigger livestock farmers would
be still hindered by national rules from producing medicated feed. The trend
that fewer animals are treated via medicated feed will continue because either
medicated feed is too expensive or not offered at all. The poor availability of
medicated feed in many areas is criticised by livestock farmers, explicitly including
aquaculture.
Deliveries of medicated feed from one Member State to another would force the producer to comply with potentially significantly
different requirements of the Member State of destination. More accentuation on
the existing, voluntary EU guidelines for good manufacturing practice could to
a limited extent improve the harmonisation of the conditions for MF production
in the EU. 
For
innovative, new applications of medicated feed the marketing environment remains
very scattered and exclusive. Industry that wants to expand in these areas
complains about this.
5.1.1.3.  Compliance and administrative costs
The pre-eminent task of the competent
authorities is to control the manufacturing and use of medicated feed. On top
of this, each of the national authorities would face the administrative burden to
set up or keep updated their existing concrete rules for MF manufacture on
their territory, triggered by the increased awareness of the weaknesses of
medicated feed manufacturing in many countries as explained in 2.2. Many Member
States (those with no national mandatory guides or with just general
references) do not engage in this field because they lack the resources for
this task. 
Despite the tendency that fewer MF
manufacturers have to be authorised and controlled under option 1, the implicit
increased use of alternative routes to administer medication by the farmers would
probably outweigh the reduced control activities at the manufacturer because
more farmers directly administering the veterinary medicines would have to be
controlled (no control "bottleneck" in the medicated feed operations[38]). Authorities stated that,
in times of scarce resources, they were more likely to prioritise direct
control activities than elaborate manufacturing rules. 
SMEs with manufacturing activities in
medicated feed could potentially market their feed in more than one Member State, not only if they are based close to a frontier or a small Member State. Such enterprises have to cope with a different national scheme for medicated feed in the
envisaged Member State which is in contrast to a fully harmonised system for
non-medicated feed. This creates considerable cost to comply with the
respective national system(s). The compound feed industry continuously raises
this issue. The maintenance of the different national systems would also
jeopardise the efforts for reduction of administrative burden and
centralisation in the field of veterinary medicines.
As the employment in medicated feed
production is very limited (see 2.1.1) no significant employment effect is
expected because of economic impacts.

5.1.2.         
Impact on animal and public health

5.1.2.1.  Animal health
In MSs with very
demanding manufacturing standards for MF, the farmers apply other routes of VMP
administration because MF is either not offered by the industry or it is too
expensive compared to the other methods of orally administering medicines.
These routes (powders added to feed or water by the farmer) have often significant
shortcomings (see boxes in 2.2.2): firstly with respect to correct dosage
(under and over-dosage due to poor homogenisation); secondly, the problem of
veterinary medicines present at residual levels in feed or water for animals
for which the VMPs are not intended for. Though the Summary of the Product
Characteristics (SPC) of the veterinary medicines gives information on their
correct administration this cannot exclude these consequences in practice. In
particular when the oral powders are top dressed on feed, animal health is at
risk as weak animals in a group often do not get the therapeutic dose because
stronger ones push them aside when new "feed" is offered.[39] This aggravates the
animal health problem because the weak animals are those who most need the
medication in the first place. 
5.1.2.2.  Public health
The respondents of the stakeholder consultation were divided on the
question of AMR occurring from the residual traces of VMPs in feed: 28%
consider that VMPs residues may increase the occurrence of antimicrobial
resistance. 45% consider the contrary and 23% do not know. A closer look shows
that 85% of the public authorities (33 respondents) stated carry-over as an
AMR-issue whereas only 15% of the "business organisations, enterprises,
farmers" (147 respondents). A verification of the qualitative answers
shows that the latter mainly opposed to the generalisation "carry-over =>
AMR" which is in line with the scientific evaluation in 2.2.1 stressing that
this depends from the MIC of the medicine.
In the absence of product criteria set at EU
level, the majority of the Member States nonetheless abstain from setting stringent
rules on the control of carry-over of VMPs in the non-target animal feed
("no value" or with zero tolerance but no strict enforcement). 
As detailed in 2.2.1
this increases the risk for AMR development because in those Member States and those with generous tolerance levels the residues of antimicrobials in feed are
likely above the MIC and below MPC (MSW). In Member States with a strict
enforcement of the zero tolerance, sub-therapeutic dosage of antimicrobials is
also frequent due to the weaknesses of the applied alternatives (see 2.2.1 and 2.2.2).
5.1.2.3.  Occupational health
Veterinary medicines,
in particular antimicrobials, are frequently skin and eye irritants, dermal and
inhalation sensitizers or can provoke allergic reactions. The oral powders usually
have a high dusting potential which represents a hazard to persons handling them.
Exposure by inhalation must be avoided and can in general better be achieved if
trained personnel in the feed mills handle the medicines. Qualified staff in a
feed mill as a rule are better trained and equipped in this respect than the
farming community. In option 1 the number of farmers with direct contact to the
pharmaceutical substances is greater to the extent that alternative routes of
oral medication (oral powders) are practised. This reinforces the negative
effect on occupational health. 

5.1.3.                       
Other impacts

5.1.3.1.  Animal welfare
As many animals are
treated sub-optimally with the VMPs ("weak animal" problem mentioned
above and substitution of medicated feed route by injection), option 1 has a
slightly negative impact on animal welfare. 
5.1.3.2.  Environment
Slightly unfavourable environmental
impacts can be expected because of poor control on the unintentional release of
antibiotics in the environment. Other issues such as waste water or
contaminated feed were not raised in any consultation.
5.1.3.3.  Subsidiarity
Maintaining the character of the Directive
would allow the national authorities to tackle the issues under their
competence depending on the respective situation in practice and national
actions in related areas. Member States can still decide whether they deem it
appropriate to establish product criteria. In case national programs are established
for certain issues, the provisions on Medicated Feed can be consistently
integrated. However, national regimes do not exist in manufacturing or
marketing feed and also the revision of the veterinary medicines aims to move
away from decentralised systems.

5.2.       
Amend Directive 90/167 combined with soft law

In Option 2 the
Directive has the internal market as legal base. It clearly includes pets under
its scope and the integration into the legislation for feed and veterinary
medicines is modernised. Building up on option 1, there is EU-action to improve
the voluntary EFMC with more concrete provisions about best manufacturing
practice. However, in Member States with mandatory national regimes the
reference to the feed hygiene would not materialise. Furthermore, the missing
willingness of operators to apply the voluntary guide jeopardises its success
and leads to the difficulty for the control authorities to enforce and police
the Directive.

5.2.1.                       
Economic impacts 

5.2.1.1.  Costs of MF production
The economic parameters
for the manufacturers of medicated feed still differ significantly because of
the dominant role of the national regimes on the costs of medicated feed thus
no significant change to the baseline. 
5.2.1.2.  Market access and products
availability
The clarifications of the legal framework
improve the business environment for the stakeholders. In particular, the
explicit inclusion of pets into the scope and the clarification that medicated
feed can be also given to individual animals opens a window of opportunities
for innovative medicated feed. 
The short term additional
potential for medicated pet food is € 50 mio if all barriers are removed (see Annex
8.12). The inclusion of the pets under the scope of medicated feed would, according
to industry surveys, open the market in about one third of the Member States. Consequently,
in this option, the potentially additional gross margin from medicated feed for
pets could be in the order of € 6 mio thus having a marginally positive employment
impact in SMEs.
5.2.1.3.  Compliance and administrative costs
Compared to option 1 there is a minimal
increase of administrative burden for the national authorities as they need to
engage in the assessment of the revision of the EU-guide. On the other hand, several
authorities could further reduce their efforts on maintaining national guides
for MF manufacturing (Member States where the national law simply establishes
the framework and the technical details are up to voluntary guides: BU, CY, ES,
FI, IE, NL, PT, RO, SE, SI, UK; FCEC table 32). However, in Member States
regulating the MF manufacturing with "hard law", such savings cannot
be expected.
For the industry (SMEs),
administrative and compliance costs might be slightly smaller because they
could rely more on the, then revised, EU-guide as a reference for their
manufacturing processes. 

5.2.2.                       
Impacts on health

The developments in the
past prove that due to unwillingness of Authorities and industry to improve the
quality of medicated feed in the Member States with lax manufacturing standards
such approach usually fails. The "soft law" option has no leverage to
induce more efforts to improve health in those Member States.
5.2.2.1.  Animal
health
A limited positive
impact on animal health can be expected due to the improved adherence to the revised
EU guide for good manufacturing but only in the parts of the EU with poor
national requirements and no or weak national guides. Thus, more manufacturers
in these regions would have an improved homogenisation of the medicated feed with
the result that more animals get the correct therapeutic dosage (more efficient
treatment). Additionally, pets could be treated more easily thus more
efficiently in the Member States that allow medicated feed for pets due to the
clarification of the scope.
5.2.2.2.  Public
health
In addition to the
partially improved homogenisation to be expected because of wider application
of the revised EU-guide, public health would be slightly improved as the guides
could mean better measures to reduce carry-over in place. Both impacts would
help that more animals get the correct and less sub-therapeutic dosage which
all helps to curb AMR. 

5.2.3.                       
Other impacts

Regarding animal welfare, the increased
availability of medicated feed for pets, particularly for chronically diseased
pets, allows an easy and sure way of medicating, ensuring that pets received
the medicine that they need.
On occupational health, the environment and subsidiarity,
no other impacts are expected than those outlined for option 1.

5.3.       
New EU Regulation with detailed rules

Option
3 will lead to full harmonisation of the provisions on manufacture, marketing
and use of medicated feed. This will be achieved by compulsory product criteria
that
·         
overcome the impractical zero tolerance, 
·         
reduce administrative burden for the industry
linked the existence of 27 different national schemes,
·         
allow a cost efficient MF production due to
economies of scale,
·         
support the spread of innovative medicated feed
applications over the whole EU,
·         
tackle the hazards of the EU-wide established
regime where it might be less rigid than the current national system (e.g.
rules for distributors, possibility of anticipated production),
·         
decrease the use of antimicrobials at
sub-therapeutic levels and
·         
minimise the risk for AMR due to carry-over of
antibiotics in feed.

5.3.1.                       
Economic impacts 

The significant potential
for market expansion and reduction of production costs of medicated feed is
more evident than the positive impacts on compliance and administrative costs.
5.3.1.1.  Costs of medicated feed production
Overall, a considerable reduction in the
costs of manufacturing medicated feed can be expected but these reductions will
not be evenly spread:
In MS with low manufacturing standards for MF
(those with small additional costs), in particular with respect to homogeneity
and carry-over limits, the new EU standard will increase the costs of medicated
feed. Assuming that 50% of the current production would be concerned by this
upgrade of standard, the additional costs are estimated at € 19 mio (see Annex 8.12).
No significant shift from medicated feed to oral powders is expected in these
Member States as the implicit price increase for medicated feed is only about
2%[40]. Such price increase
does not trigger a change in the farms that are convinced of medicated feed as
a good route of treatment and that are equipped for this route. For 25% of the
current production no change would result from the new EU standard. The
remaining 25% could realise cost reductions as the suppliers of MF in a certain
region can choose the most cost efficient production technology (anticipated
production, mobile mixers) and profit from economies of scale because the
demand for MF will increase once they are able to offer it at a lower price. The
resulting cost reductions are € 31 mio which means for the total EU cost
reductions of € 12 mio.
As a sensitivity analysis, a second scenario
has been calculated in which the percentage of medicated feed production that
would be faced with cost increases is 65% (instead of 50%) and the share of
current production at very high costs is 10% (instead of 25%). In this scenario
the additional costs in the first group would be € 24 mio and the decrease in
the second would be € 12 mio resulting EU wide in additional production costs of
€ 12 mio.
5.3.1.2.  Market access – competitiveness
The EU-wide possibility for advance
production of MF and the licence for distributors between manufacturers and
users increases the marketing potential for the manufacturers because new,
innovative applications of medicated feed, such as certain medicated pet food, will
not be limited to the respective local markets and specialised manufacturers
will have economy of scale to market new innovative niche products. Within the
new harmonised EU standard for medicated feed production, the full potential
mentioned in 5.2.1.2 could be activated which means only in the area of
medicated feed for pets an additional gross margin in the order of € 15 mio in
the short term and considerably more beyond. This new revenue in the medicated
pet food industry is to be paid by the pet owners in exchange for a more convenient
treatment of their pets. Other trade-offs cannot be expected as the volumes of
pet food and veterinary medicines for pets remains the same. Furthermore, as
there are no evident changes in the production structure for pet food expected,
no significant additional transport costs would arise. In practice, medicated
pet food would probably to the largest extent be integrated into the existing distribution
systems for the veterinary medicines that are currently administered separately
from the pet food. 
For food producing
animals, the lower prices for medicated feed in Member States with currently
very high or even preventive national standards make medicated feed more
attractive which could lead to a shift from the alternative routes. Experts
estimate the potential for additional medicated feed production due to more
competitive production conditions to be 30 – 50 % of the current quantities
i.e. 2–3,4 mio t. The revenue solely for the inclusion of the veterinary
medicine into the feed by an authorised medicated feed manufacturer under the
new standards would consequently be in the range of € 11 – 18,6 mio. Assuming
that under the competitive internal market environment in option 3 the manufactures
can only enforce a profit of 6%, the additional income for the feed operators
would be € 12 - 20 mio. There is no trade-off from another actor in the
production stream (the quantity of veterinary medicines sold is not influenced)
but is an additional cost for the livestock farmer. Either he can reduce any envisaged
investments linked to the proper administration via the alternative routes or
he benefits from a more efficient treatment of his animals if he did not yet
invest in the efficiency of the alternative routes.
5.3.1.3.  Compliance and administrative costs
The setting of product criteria at EU-level implies
some administrative costs for the national Authorities, the Commission and EFSA.
Considering that one can take advantage of existing best practices available in
the EU and the experiences with the approach applied for the coccidiostats[41], which did not result
in significant increase of costs in EFSA and the Commission, to elaborate product
criteria, costs for the EU and involved Member State Authorities would be
limited. Indeed, the enforcement of the criteria will reduce the burden for the
authorities in a longer term: on the one hand, the control of the concrete
criteria is simpler than the interpretation of general principles. On the other
hand, the Member States can save resources necessary for the establishment of
the national standards, if applicable. 
In line with the cost recovery principle
established in the chapter on fees of the Regulation 882/2004 on official
controls of food and feed[42],
the costs of the authorities for the start-up approval of the new manufacturers
of medicated feed in this option would be recovered from those manufacturers.
This one-off fee would be included by the manufacturers into their cost
calculation of the medicated feed, naturally with a negligible price impact.
Further compliance
costs for the industry (SMEs) are significantly reduced because they are no longer
obliged to follow the different national rules which is particularly relevant for
those manufacturers that may wish to market medicated feed in several Member States.
5.3.1.4.  Prices
of animal products
Feed is the biggest cost factor in livestock
farming thus having an evident influence on the prices of the animal products (EU
output € 157 bn). Compound feed alone has a turnover of €50 bn. However, even
if, as in scenario 2, 65% of the current medicated feed production, an
additional 3,4 mio t, shifts from the alternatives routes to medicated feed,
charged at €5.5/t, the total cost of the medicated feed would be € 44 mio. This
is less than 0.1% of the costs of the livestock production and thus a price
effect on the animal products can be excluded.

5.3.2.         
Impacts on health

5.3.2.1.  Animal health
In this option, the use of MF, produced at
optimised standards, can be practiced as 'first best route' for the
administration of antimicrobials and other veterinary medicines to a significant
higher percentage of animals: The reasons for this positive effect are that in
Member States with currently preventive standards for medicated feed a
substitution from the less precise and less controllable routes can be
expected. Secondly, the manufacturing standards in Member States with currently
low manufacturing standards will be improved. Both trends result in a
significantly higher number of animals treated at the correct dosage which has
in the first place a positive impact on animal health. 
Besides, the reduced carry-over residues of
veterinary medicines in the feed for non-target animals mitigates the animal
health risk because there is no indication for these veterinary drugs for the non-target
animals receiving such feed.
In the online stakeholder consultation, 39%
of the authorities stated that anticipated production may raise concerns in
terms of safe and efficient use[43].
A strict enforcement of the requirement that medicated feed can be delivered to
the farmer or pet owner only upon presentation of a prescription from a
veterinarian minimises the risk that medication is given in a less restrictive
way if advance production is allowed in the feed mills and pet food factories. 
With respect to mobile mixers and on-farm
manufacture of MF, 30% and 33% of the authorities indicated in the online
stakeholder consultation concerns that these operators meet the requirements
for MF on homogeneity and compatibility of the different compounds[44]. For mobile mixers and
on farm manufactures, the competent authority must enforce, when authorising,
that the mixing technology complies with the homogeneity criteria. Whereas feed
mills with advanced technology (e.g. extra production line for medicated feed
production or an end of the line mixer) could use premixes with a lower inclusion
rate, for mobile mixers and on-farm manufacturers a restriction to higher
inclusion rates might be appropriate.
In the online stakeholder consultation, 73%
of the authorities agreed that left overs of MF on the farm might cause
problems[45].
Thus, for the rare cases of left-overs of medicated feed on the farm, usually
because a change of medication is prescribed before the end of the treatment
with the initially prescribed medicated feed, a recall system should be
installed. The veterinarian prescribing the new veterinary medicine has a
crucial role to ensure that the left-over from the previous prescriptions are
disposed of and not given to the animals. With all these measures, any negative
health impacts due to the more economically viable rules for manufacture of
medicated feed can be eliminated.
5.3.2.2.  Public health
With respect to antimicrobials, the risk arising
from treatment at sub-therapeutic level is reduced in those countries where the
homogeneity requirements for medicated feed are currently poor. This positive
impact can be also expected in those regions where, due to preventive
requirements for medicated feed manufacturing, the less precise routes of
administration are currently dominant. In these countries the farmers might
shift to medicated feed which is, under the new regime, more competitive compared
to the alternatives. 
Furthermore, a significant positive public health
impact will be achieved because the carry-over limits are set, EU-wide, below
the MICs thus marginalising the risk for the development of AMR both in the Member States with generous tolerance levels or those with unclear situation ("no
value").
In addition, the possibility for anticipated
production facilitates the industry's task to comply with these carry-over levels
because it enables the manufacturing of larger production runs with fewer
change over points from medicated to non-medicated batches. Consequently, there
will be a trend for generally reduced residues of VMPs in feed.
5.3.2.3.  Occupational health
Facilitating the use of
medicated feed will reduce the number of farmers who have direct contact with
antimicrobials in form of oral powders, with a positive effect on occupational
health. 82% of the stakeholders agreed in the online consultation that, compared
to other methods of oral administration of VMPs, the MF method has a lower risk
in terms of direct exposure of staff handling veterinary medicines (e.g.
sensitising, allergic or resistance-enhancing properties of VMPs).

5.3.3.                       
Other impacts

5.3.3.1.  Animal welfare
Significantly more
animals receive the veterinary medicine at the correct therapeutic level and
with their "normal" feed thus in a more comfortable manner (pets). Both
have a positive impact on animal welfare which is of the same order as found
for animal health. 
5.3.3.2.  Environment
The environmental
impacts are positive because of better control on the unintentional release of
veterinary medicines in the environment due to the established control measures
and because of the expected shift from the less controllable routes of VMP
administration.
5.3.3.3.  International
trade
No significant trade
impacts can be expected even in a harmonised internal market for medicated feed
for farmed animals, mainly because of the requirements linked to the veterinary
prescription and the logistics. If the distribution channels for medicated feed
for pets are established there could be an interest for imports into the EU and
conversely the development of successful products in Europe could prompt export
developments or foreign marketing by European companies.
5.3.3.4.  Subsidiarity
The individual Member States lose their
flexibility to set the concrete rules for manufacture and use of MF. Several
Member States have implemented this flexibility, others did not establish a
precise regime. The problems identified in 2.2 show that in both groups of
Member States the national competence lead to unsatisfactory results, in
particular with respect to imprecise dosage of veterinary medicines and residues
of antimicrobials in normal feed (AMR). On AMR the call for EU-measures rather
than national ones is prominent, even from the Member States themselves. The
envisaged Regulation would by means of setting product criteria for the
homogeneity of the medicated feed and the carry over limits in compound feed
restrict the EU measures to the minimum and leave it up to the Member States
and local operators how these criteria will be met.
The harmonised levels
for physical checks of non-animal origin feed imported into the EU[46] (before it was totally
up to the Member States to decide the frequency) and the tolerance levels for
coccidiostats in non-target animal feed set Directive 2002/32/EC clearly
delivered an EU added value. Thus, an evident EU value added can be expected
due to the establishment of precise criteria in the medicated feed Regulation
because the implementation of the objectives can be better guaranteed. 

5.3.4.         
Plausibility check with the views expressed by
stakeholders

A summary of the online consultation
complemented by the results of targeted consultations can be found in 8.12.
There are no fundamental concerns raised by the stakeholders with respect to
option 3. Furthermore, the design of option 3 considered in particular the
concerns expressed by mainly authorities with restrictive schemes for medicated
feed with respect to mobile mixers, on-farm manufacturing of medicated feed,
tolerance levels for residues of veterinary medicines, misuse of antibiotics
and distribution channels of medicated feed. 
The manufacturing industry in the Member
States with high national manufacturing standards complains strongly about
those regimes. The regulators in the Member States where medicated feed has
quasi disappeared are trying with national action plans to solve the problems
that occurred consequently to the shift to the alternative routes of treatment.
Several authorities noted in the consultations that administration by water or powders
was gaining market share over medicated feed linking this specifically to the
greater regulatory controls on medicated feed than on the alternative routes.
In the Member States with currently low
standards for the medicated feed production, the Authorities suggest to
establish tangible product criteria at EU-level. This can be explained by the
increased pressure in the context of antimicrobial resistance. Also the feed
industry in these Member States supports more concrete, harmonised
manufacturing standards even if this means additional production costs. This might
also be due to the positive experiences with tolerance levels for coccidiostats
in normal feed. The manufacturers of the veterinary medicines (branded and
generics) strongly call for this, too. Trade-offs for the veterinarians e.g.
due to the potential shift from oral powders to medicated feed have been neither
stated by the European Association nor the national associations that have been
consulted.

6.         
Comparing the options
6.1.       
Comparing options in terms of economic, health
and other impacts

In order to compare the impacts outlined in
chapter 5 for the different options, option 1 is calibrated to 0 and the
relative change to option 1 is presented in the following table:
   ||   || Option 1 || Option 2 || Option 3 
 Economic Impacts || MF production costs* in MS with high standards || 0 || 0 || +++ 
 MF production costs* of MS with low standards || 0 || 0 || -- 
 Market access - competitiveness || 0 || ++ || +++ 
 Administrative and compliance costs* || 0 || + || ++ 
 Health impacts || Animal Health in MS with high standards || 0 || + || +++ 
 Animal Health in MS with low standards || 0 || + || ++ 
 Public Health in MS with high standards || 0 || + || ++ 
 Public Health in MS with low standards || 0 || + || +++ 
 Occupational Health || 0 || 0 || + 
   Other impacts || Animal welfare || 0 || + || ++ 
 Environment || 0 || 0 || + 
 Regulatory competence of the MS || 0 || 0 || -- 
* "+(+)" means a (slight) reduction of costs
Magnitude of impact:    +++ strongly positive; ++
positive; + slightly positive; 0 none 
--- strongly negative; -- negative; - slightly negative
A comparison of the quantified economic
impacts of the options shows, due to additional gross margin in medicated pet
food, a positive impact of € 6 mio in option 2. Under scenario 1 in option 3,
the expected increased costs in Member States with low standards would be
overcompensated by the reductions in those with very high standards which would
lead together with the additional gross margin in medicated pet food (€ 15 mio)
to a total benefit of € 27 mio. In scenario 2 the cost increase exceeds the
reductions which results only in a small positive effect (€ 3 mio) resulting
from the extra profit in the pet area. 
Furthermore, option 3 accounts for an
estimated additional turnover (extra costs for medicated feed and profit
margin) of € 12 - 20 mio for the medicated feed manufacturers due to the shift
from less favourable routes of medication to the use of medicated feed. As
explained in 5.3.1.2, it is very difficult to estimate to what extent these
extra costs for the farmers can be compensated by interdependent savings on the
farms that shift to medicated feed.
Animal Health in Member States with high
standards will be improved in option 3 compared to option 2 because of the
expected shift from the less controllable routes of medication to medicated
feed resulting in more animals getting the correct therapeutic dose. The same
result –to a slightly smaller extent- can be expected in the Member States with
low standards because the quality criteria for the medicated feed are
increased.
The improved public
health status in Member States with high standards comes from the more precise
dosage of the antimicrobials compared to the currently predominant direct
administration by the farmers which means that less animals are exposed to
sub-therapeutic levels of antimicrobials (AMR risk). In the Member States with
low standards, significant positive impacts on public health can be expected
because of the established carry-over limits which assure that the public
health risk of the residues of the veterinary medicine in the compound feed is
negligible.

6.2.       
Comparing the options in the light of the
objectives

The following table
compares the options about their effectiveness to meet the objectives:
   ||   || Options 
   ||   || 1 || 2 || 3 
 Objectives || Overcome the zero-tolerance for unavoidable carry-over of veterinary medicines || -- || -- || ++ 
 Curb AMR-risk from residual and sub-therapeutic administration of antimicrobials || -- || - || ++ 
 Improve animal health by precise dosage of oral veterinary medicines || -- || - || ++ 
 Make medicated feed available to the farmers at a competitive price || 0 || 0 || + 
 Remove barriers for innovative, "novel" MF applications || -- || + || ++ 
Magnitude of
impact: ++ strongly positive; + positive; −− strongly negative; − negative; 0 neutral. 

6.3.       
Preferred option 

In the light of the assessment above, it is
considered that option 3 would have the most positive impacts and provides the
best way forward to achieve the objectives for the EU as a whole: Option 3
should have a significant positive impact on cost efficiency and economic
growth of the medicated feed manufacturing, also considering innovative
applications of veterinary medicines. Trade-offs in upstream and downstream
activities are very limited. 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 leads to a pragmatic and solid level
playing field for the industry and the control authorities. 
The interface with the AMR-issue makes it
quite evident that the Member States cannot solve the problem on their own and
a balanced EU-Regulation would create a value added. Finally, the enforcement
and control of the harmonised rules would remain fully in the competence of the
Member States. 

7.         
Monitoring and Evaluation

The general monitoring of the new legislation
on medicated feed is embedded in Regulation 882/2004 on official controls of
food and feed. This Regulation foresees that the Member States efficiently implement
the requirements in the feed sector and veterinary medicines. The Commission
(Food and Veterinary Office) controls the correct enforcement by the Member
States. The monitoring would be eased because of the EU-wide establishment of
product criteria. Thus, for the evaluation to which extent the objectives of
the legislation have been met does not require additional data collection. The
national controls according to the Member States` multi-annual control plans (established
by Regulation 882/2004) are checked by the Commission Services and thus
regulative action could be envisaged if there is evidence for unintended
developments.
With respect to the internal
market, the following additional indicators could be sourced from
representatives of the industry (pharmaceutical and medicated feed). With
respect to the considerable numbers of end users (several millions livestock farmers
and several millions pet owners with chronically diseased animals) and the
limited duties with respect to data collection, the additional indicators
should be compiled according to the “bottle neck principle” (acquisition of the
data where the fewest operators are involved). 
 Objective || Potential Indicators || Data Source || Frequency 
 Competitiveness of medicated feed manufacturing || Share of VMPs sold as premixes || Pharmaceutical industry, EMA || yearly 
 Competitiveness of medicated feed manufacturing || Quantities of medicated feed produced separated for food producing animals and for pets || Manufacturers of medicated feed || Bi-annual 
 Competitiveness of medicated feed manufacturing || Price difference medicated feed -compound feed || Manufacturers of medicated feed || Bi-annual 
Apart from the potentially new monitoring
system established for the use of antimicrobials against the background of AMR
which would then cover also the antimicrobials in medicated feed, the approved
manufacturers of the veterinary premixes and of medicated feed must in the
context of traceability and reporting duties already collect the raw data for
the indicators. The additional burden to process this data into the new
indicators will therefore be quite limited.
All this data is used for the evaluation that
examines whether or not the policies implemented achieve the objectives, in
particular with respect to the internal market for medicated feed, the competitiveness
of medicated feed production, animal and public health.

8.         
Annexes
8.0.       
Glossary

AMR:
  Antimicrobial resistance; phenomena that certain micro-organisms previously
sensitive to specific antimicrobial agents overcome this sensitiveness.
Carry-over:
the unintentional transfer of VMPs into non-target feed;
EEA:
   European Economic Area
EFMC: European
Feed Manufacturers’ Guide; a concrete GMP
EFSA:
 European Food Safety Authority; independent risk assessment body of the EU
EMA:
  European Medicines Agency; independent assessment body for medicines
ESVAC:
European Surveillance of Veterinary Antimicrobial Consumption, EMA project
EU:
      European Union
GMP:
   Good Manufacturing Practice; guidelines to improve feed business operations
HACCP:
Hazard Analysis and Critical Control Points; risk management tool for feed
business operators
IAB:
    Impact Assessment Board; quality check entity within the European
Commission
MF:       Medicated
Feed; mixture of a medicated premix with feed which is ready prepared to be
directly fed to animals without further processing
Medicated
premix: VMP authorised and prepared for the subsequent manufacture of MF
Non-target
feed; feed that may contain traces of VMPs due to carry-over that is intended
for animals for which no veterinary prescription for such VMPs is issued.
SME:
   Small and Medium-sized Enterprise
TFEU:  Treaty
on the Functioning of the European Union
VMP:    Veterinary
Medicinal Product; substance - presented as having properties for treating or
preventing disease in animals - which may be used in or administered to animals
with a view either to restoring, correcting or modifying physiological
functions by exerting a pharmacological, immunological or metabolic action, or
to making a medical diagnosis  - which may be used for euthanasia of animals

8.1.       
List of relevant legislation and schema
illustrating how medicated feed provisions are embedded into related EU-legislation

·     
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[47]
·     
Directive 2001/82/EC of the European Parliament
and of the Council of 6 November 2001on the Community code relating to
veterinary medicinal products[48]
·     
Regulation (EC) No 470/2009 of the European
parliament and of the Council of 6 May 2009 laying down Community procedures
for the establishment of residue limits of pharmacologically active substances
in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90
and amending Directive 2001/82/EC of the European Parliament and of the Council
and Regulation (EC) No 726/2004 of the European Parliament and of the Council[49]
·     
Regulation (EC) No 183/2005 of the European
Parliament and of the Council of 12 January 2005 laying down requirements for
feed hygiene[50]
·     
Directive 2002/32/EC of the European Parliament
and of the Council of 7 May 2002 on undesirable substances in animal feed[51]
·     
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, amending European Parliament and Council Regulation (EC) No
1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive
80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and
96/25/EC and Commission Decision 2004/217/EC[52]
·     
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 [53] 
·     
European Parliament resolution of 27 October
2011 on the public health threat of antimicrobial resistance[54]
·      Communication from the Commission to the European Parliament and the
Council "Action plan against the rising threats from Antimicrobial
Resistance"[55]

8.2.       
Economic data on the upstream and downstream
activities

Livestock farming – aquaculture – pets
in the EU
Across the EU, most animals are kept in the
farming sector with at least 2 billion birds (chickens, laying hens, turkeys,
etc.) and 340 mio. mammals (pigs, sheep, goats, cattle, fur animals, etc.). Pet
animals represent the second largest type of animals kept in the EU. There are
around 64 million cats, 60 mio. dogs, 40 mio. pet birds, 25 mio. small mammals
and many millions of ornamental fish. Fewer animals are used for
experimentation (public research bodies, animal feeding and zootechnical
industries plus pharmaceutical and cosmetic industries): around 12 million
animals in the EU, of which most are rodents. There are between 2,000 and 3,000
zoos in the EU and there are an estimated 800,000 captive wild animals. No
reliable data could be obtained for circuses or other activities such as
animals used in sports, shows, etc.
There are 13.7 mio. animal farming holdings
in the EU. The value of livestock farming output in the EU is €157 bn of which
pigs and poultry represent 39%. Animal output value represents 41% of the
overall agricultural output. In 2011, the EU-27 livestock population produced
48 mio. t of meat (thereof 8.4 mio. t of beef, 23 mio. t of pork and 12.2 mio.
t of poultry meat), 150 mio. t of milk and 7.1 mio. t of eggs. According to
Eurostat, total aquaculture production in the EU-27 was 1.3 mio. t tonnes live weight. This includes
production of crustaceans, molluscs, and finfish. The
total value of production is estimated as €3.3 bn. 
Feed industry
Animal feedingstuffs, including feed
materials and compound feeds, are the main input into livestock production.
Within the EU over 470 mio. t of feedingstuffs are consumed by livestock each
year. Out of this quantity, 230 mio. t mostly are roughages grown and used on
the farm of origin. The balance, i.e. 240 mio. t of feed, includes cereals
grown and used on the farm of origin (53 mio. t) and feed purchased by
livestock producers to supplement their own feed resources (either feed materials
or compound feed).
In 2010, 151 mio. t of compound feed were
produced by EU compounders, accounting for 80% of all purchased feedingstuffs.
The value of all feedingstuffs used by EU livestock producers including forages
produced on the farm is estimated at €79 bn in 2010. This accounts for 37% of
all inputs and 60% of the turnover in livestock production. Purchases of
compound feed amounted, in 2009, to €42 billion and
increased to €44 bn in 2010. 
Pet food is produced in the EU in 650
plants with a direct employment of 50.000, annual sales of 8.3 mio tons
creating a turnover of € 13.5 bn (2010)[56].
The annual growth rate in the recent years has been 2%.
Trade
The EU is an important player on the world market for animal
products. Only for meat and meat preparations, the imports amounted 1.37 mio. t
in 2011 and the exports 4.64 mio. t[57].
Also in trade with feed materials of plant origin such as cereals and oil seeds
or fruit, the EU plays a major role globally. However, the trade in medicated
feed of the EU is negligible.

8.3.       
Number of authorised medicated pre-mixes in the
EU
 
   || 2004 || 2005 || 2006 || 2007 || 2008 
 Austria || 41 || 43 || 44 || 48 || 57 
 Belgium ||   || 23 || 24 || 27 || 34 
 Bulgaria || 1 || 3 || 6 || 11 || 22 
 Cyprus || 24 || 24 || 27 || 31 || 38 
 Czech Republic || 53 || 55 || 60 || 61 || 66 
 Denmark || 12 || 13 || 16 || 16 || 15 
 Estonia || 23 || 22 || 20 || 21 || 17 
 Finland || 10 || 10 || 11 || 12 || 12 
 France ||   ||   ||   ||   || 312 (a) 
 Germany || 60 || 55 || 61 || 65 || 64 
 Greece || 34 || 34 || 30 || 39 || 36 
 Hungary ||   ||   ||   ||   ||   
 Ireland ||   ||   ||   ||   || 11 
 Italy || 87 || 92 || 96 || 100 || 103 
 Latvia ||   ||   ||   ||   ||   
 Lithuania ||   ||   ||   ||   || 21 (b) 
 Luxembourg || 5 || 7 || 7 || 9 || 12 
 Netherlands || n.a. || n.a. || n.a. || n.a. || 52 (c) 
 Norway || 3 || 4 || 4 || 4 || 4 
 Poland || n.a. || n.a. || n.a. || n.a. || 58 (d) 
 Portugal ||   ||   ||   ||   || 157 (e) 
 Romania || 53 || 53 || 63 || 60 (f) || 59 (g) 
 Slovakia ||   ||   ||   ||   ||   
 Slovenia || 23 || 21 || 20 || 14 || 11 
 Spain ||   ||   ||   ||   ||   
 Sweden (h) || 18 || 17 || 14 || 14 || 14 
 United Kingdom || 55 || 60 || 50 || 53 || 53 
Source: Civic
consulting 
Notes:
(a)       
Data refers to the total
number of authorised medicated pre-mixes as of August 2009. The total number of
medicated pre-mixes authorised (312) includes 19 medicated pre-mixes for which
authorisations are currently suspended.
(b)      
Data refers to the
number of authorised medicated pre-mixes as of August 2009.
(c)       
Data refers to the
number of authorised medicated pre-mixes as of August 2009. According to the
competent authority, due to the authorisation system used in the Netherlands, it is not possible to reproduce lists of VMP of precedent years. 
(d)      
The competent authority
provided a list of 58 authorised pre-mixes.
(e)       
Data refers to the
number of authorised medicated pre-mixes as of August 2009.
(f)       
Figure includes 6
medicated pre-mixes prohibited for food producing animals.
(g)       
Figure includes 3
medicated pre-mixes prohibited for food producing animals.
(h)      
Figures relate to the
number of medicated pre-mixes reported to be in use to the Swedish Board of
Agriculture.

8.4.       
Number of approved operators for manufacturing
and placing on the market of medicated feed
 
   || Number of approved manufacturing establishments || Distributors (Art. 9(2)) 
 Total number || Thereof mobile mixers || Thereof on farm producers 
 Austria || 3,986 (a) || n.a. || 3,986 || 0 (b) 
 Belgium || 63 || 10 || 0 || 0 (c) 
 Bulgaria || 6 || 0 || n.a. || n.a. 
 Cyprus || 47 || 0 || 47 || 16 (d) 
 Czech Rep. || 71 (e) || 0 || 0 || 13 
 Denmark || 15 || 0 || 0 || 4 
 Estonia || 6 || 0 || 0 || 0 (f) 
 Finland || 15 (g) || 0 || 0 || 1 
 France || 247 (h) || 0 || 19 || 241(i) 
 Germany || 31 (j) || 3 || 0 || 0 
 Greece || n.a. || 4 || 1 || 0 
 Hungary || 133 || 0 || 0 (k) || 0 (l) 
 Ireland || 84 || 0 || 62 || 22 
 Italy || ~ 1000 || 0 || ~ 700 (m) || ~ 230 
 Latvia || 7 || 0 || 5 (n) || 0 
 Lithuania || n.a. || n.a. || 2 || n.a. 
 Luxembourg || 2 || 0 || 0 || 0 
 Netherlands || 115 || 0 || 0 || 1 
 Norway || 2 || 0 || 0 || 28 (n) 
 Poland || 56 || 0 || 0 || 71 
 Portugal || n.a. || 37 || 9 || 22 
 Romania || 17 || n.a. || n.a. || 9 
 Slovakia || 30 || 0 || 0 || 53 
 Slovenia || 8 || 0 || 1 || 0 
 Spain || 543 || 0 || 175 || 652 
 Sweden || 63 (p) || 0 || 50 || 0 
 Unit. Kingdo || 734 (q) || 10 – 12 || 640 || 366 
Source: Civic consulting
Notes:
(a) 
No manufacturer (feed
mill) is authorised for manufacturing and placing on the market of medicated
feed at present. For 3 manufacturers the authorisation procedure is in
progress.
(b)
No distributor of
medicated feed is authorised at present; the authorisation procedure is in
progress for one distributor.
(c) 
This is not foreseen in
national rules.
(d)
Includes 14 commercial mills/distributors and
2 distributors.
(e) 
71 manufacturers are
approved; this corresponds to 81 manufacture sites.
(f)13 distributors (Art. 9(1)) are approved by the competent authority.
There are no authorised distributors for sepecial cases of medicated
feedingstuffs (Art. 9(2)).
(g) 
Includes 3
establishments manufacturing medicated feed for food producing animals and 12
establishments manufacturing medicated feed for fur animals.
(h)
164 establishments have
both the status of manufacturer and distributor. 64 establishments have the
status of manufacturers of medicated feed only.
(i)
64 establishments have
the status of manufacturers of medicated feed only. No mobile mixers have been
approved. 77 establishments have the status of distributors only.
(j)
Includes 5 enterprises
which currently do not make use of the permit, 10 enterprises with limited
permit and 3 mobile mixers.
(k)
Small units producing
medicated feed on-the-spot do not exist, however, large plants authorized by
the competent authority, producing medicated feed exclusively for the purposes
of their own establishments or even for placing on the market do exist. In the
latter case they are located separately from the animal holding, even if
located on the same site. 
(l)
Medicated feed is placed
on the market only by the manufacturing establishments.
(m)      
There are also
approximately 948 farmers that are approved for using “intermediate products”
for the exclusive requirements of their own farm. “Intermediate products” are
medicated feed that contain multiple of daily dosage of VMP (max 20 times) and
are intended to production of medicated feed ready
to use.
(n)
Farms producers include
4 fur animal farms and 1 pig farm.
(o)
Includes both
wholesalers and distributors (both approved Premix and Zink).
(p)
Includes 13 feed mills. 
(q) Includes 94 feed mills. Additionally, 39
establishments manufacture intermediate products from medicated pre-mixes
intended to be mixed into final feed (Art. 3 1. first indent).

8.5.       
Rules of good manufacturing practice of
medicated feed

Art. 4 of 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 stipulates that “…the manufacturing
process [of medicated feedingstuffs] must conform to the rules of good
manufacturing practice”. Most of the 26 Member States (and Norway) for which data was available have rules of good manufacturing in place. Only five Member States do not have rules of good
manufacturing practice established, according to the competent authorities.
Where rules of good manufacturing practice exist, they are often mandatory: 
   || Rules of good manufacturing practice || Details 
 AT || ü || Rules in force include the Fütterungsarzneimittelbetriebsordnung 2006, BGBl II Nr. 394/2006 and others (see Annex 7) (a) 
 BE || ü || The concrete application of the rules is mandatory by law. (b) 
 BG || ü || Medicated feed manufacturers are required to apply the GMP and HACCP of the Bulgarian feed manufacturers association. (a) 
 CY || ü || The concrete application of the rules is not mandatory by law. (a) 
 CZ || ü || The concrete application of the rules is mandatory by law. (a) 
 DE || ü || The concrete application of the rules is mandatory by law. (a) 
 DK || ü || In Denmark the manufacturing process must conform to the rules of good manufacturing practice of the EU GMP on the rules governing medicinal products in EU; however, some exceptions from these rules are allowed. (a) 
 EE ||   || No rules of good manufacturing practice exist in Estonia. (a) 
 ES || ü || A new Royal Decree amending Royal Decree 109/1995 which introduces hygiene rules in compliance with Council Regulation 183/2005 is officially available since September 2009 and it includes an approach to rules of good manufacturing practice and specific requirements for Intermediate (feed) products among other considerations. (a)  
 FI || ü || The concrete application of the rules is not mandatory by law. (a) 
 FR || ü || The concrete application of the rules is mandatory by law. (a) 
 GR || ü || Commission Directive 91/412/EEC has been implemented in Greece by the 94/313314/GMD Greek Ministerial Decision. Circular 98/310584 refines particular matters. (a) 
 HU || ü || The concrete application of the rules is mandatory by law. (a) 
 IE || ü || The Regulations in Ireland transposing EU Directive 90/167 are entitled 'European Communities (Animal Remedies and Medicated Feedingstuffs) Regulations 1994'. Regulation 6(1)(e) of the aforementioned regulations gives effect to Article 4(1d) of the Directive. (a) 
 IT || ü || Circolare 23 gennaio 1996 n.1 and the document “Production of medicated feed, measures for reducing cross- contaminations” provide indications about the way to put into practice the requirements of national and Community law. Most requirements of these guidelines are mandatory by law. (a) 
 LT ||   || There are no approved rules for good manufacturing practise for medicated feed in Lithuania. (a) 
 LU ||   || No rules of good manufacturing practice exist in Luxembourg. (a) 
 LV ||   || There are no rules for good manufacturing practice in Latvia. (a) 
 NL || ü || Rules are established in the GMP Standards by the Product Board Animal Feed. The concrete application of the rules is not mandatory by law. (a) 
 NO || ü || The concrete application of the rules is mandatory by law. (a) 
 PL || ü || The principles of good practice for medicated feed (production and distribution) are included in national regulations. (a) 
 PO || ü || The concrete application of the rules is not mandatory by law. (a) 
 RO || ü || The concrete application of the rules is not mandatory by law. (a) 
 SE ||   || No specific rules for good manufacturing practice are established in Sweden. (a) 
 SI || ü || The concrete application of the rules is not mandatory by law. (a) 
 SK || ü || The concrete application of the rules is mandatory by law. (a) 
 UK || ü || There are no nationally approved Industry Codes in the UK. However manufacturers are required to comply with the Veterinary Medicines Regulations. (a) 
Note: Extracted from Civic Report 3.2 (more
details are presented in its Annex 7 
Sources:  (a)Competent authority,      (b)    National feed manufacturers’
association.
The character of the rules of good manufacturing
practice applied varies between Member States. This is illustrated by the
following examples: 
q  In Denmark the manufacturing process
must conform to the rules of good manufacturing practice of the EU GMP on the
rules governing medicinal products in EU, but some exceptions from these rules
are allowed.[58]
q  In France manufacturers of medicated
feed must follow the requirements applicable for pharmaceuticals
establishments. For the production of medicated feed, the presence of a
veterinarian or a pharmacist in the feed mill is not required to be permanent,
but must occur at least 2 times a month. Feed mills must conduct a series of
mandatory tests.[59] 
q  In Germany, the pharmaceutical law
applies for the production of medicated feed. Rules of good manufacturing
practice for medicated feed relate to the EU GMP on the rules governing
medicinal products in the EU. An
expert group responsible for surveillance and control in the federal states has
produced a leaflet on the application of these guidelines.[60] This document requires for instance the use of the end-of-line mixing
technology to be authorised to produce medicated feed.
q  In the United Kingdom manufacturers
of medicated feed are required (in accordance with Articles 6 and 7 of EC
Regulation 183/2005) to document and implement a HACCP plan, which identifies
the risk of cross-contamination of non-target feed with medicinal pre-mixes. To
this end, manufacturers have to define a cross-contamination matrix which, when
followed, ensures that cross-contamination is minimised or avoided. The
cross-contamination matrix specifies the order of mixing that can take place
(scheduling) and, where necessary, where and how flushing of the production
line must take place.[61] 

8.6.       
Use of veterinary antimicrobials – use of MF

Use of antimicrobials in 18 Member States
(year 2010, in tonnes)
 Country/MS || Total Antimicrobials Used || Thereof given orally || Thereof given  via medicated feed 
 Austria || 63 || 56 || 6 
 Belgium || 299 || 261 || 60 
 Czech republic || 71 || 62 || 23 
 Denmark || 119 || 78 || 3 
 Estonia || 8 || 5 || 0 
 Finland || 13 || 5 || 2 
 France || 997 || 888 || 499 
 Hungary || 206 || 193 || 135 
 Ireland || 93 || 62 || 39 
 Latvia || 7 || 4 || 0 
 Lithuania || 16 || 8 || 0 
 Netherlands || 461 || 426 || 35 
 Portugal || 176 || 166 || 133 
 Slovenia || 8 || 5 || 1 
 Spain || 1746 || 1641 || 1087 
 Sweden || 13 || 3 || 0 
 United Kingdom || 456 || 406 || 292 
 All 18 MS || 4752 || 4270 || 2313 
Source: Extracted from ESVAC 2010 tables 1-6 and A1
The evolution of the quantities of
antimicrobials and the quantities of medicated feed used in the EU shows that
the decision to use therapeutic antimicrobials is totally independent from the
possibility to use medicated feed:
In the period from 2002 to 2007 sales of
therapeutic antimicrobials remained stable or increased in Denmark, Finland, France, the Netherlands and Sweden. In the only country where during this period a
significant decrease of sales was noted in the available reports, the United Kingdom, this appears to be mainly due to decreasing livestock production but may
also be influenced by management measures, more vaccination and use of VMPs
with a higher potency per kg (FCEC, 2.4.2). This is in line with the findings
in ESVAC 2010 (see figure 45)
Whereas the overall share of oral
application of antimicrobials remains relatively stable, the importance of MF compared to other routes of oral application is
decreasing (FCEC, 4.3)
Production
figures of MF (FCEC, 3.1) have not changed significantly since 2004. Germany is a special case, reflecting the high relevance of the regulatory framework for
the market relevance of MF: Since 2006 the production of MF is only allowed in
establishments authorised under pharmaceuticals law. This has had a severe
disruptive effect on the market there. The production volume decreased by 95% (225,000
t in 2004 to 12,000 t in 2008). However, the use of antimicrobials in Germany did not decrease in that period.
Table: Production of
medicated feed in several Member States, its relation to the compound feed
production, the importance of the different oral routes and the trend:
   || Production of medicated feed (‘000 tons) || Production of medicated feed as percentage of production of compound feed (a) || Most common route of oral administration of VMPs (b) || Evolution of the use of medicated feed over the last 5 years (b) 
 Belgium || 300 || 4.8 % || Top dressing / incorporation of ready-to-use VMPs in the feed and mixing into water || Increased fairly significantly 
 Czech Republic || 99 || 3.4 % || Medicated feed and mixing into water || Decreased fairly significantly 
 Denmark || 12 (c) || 0.2 % (c) || Top dressing/ incorporation of ready-to-use VMPs in the feed and mixing into water || Increased very significantly (d) 
 France || 800 – 1,000 || 3.5 % – 4.4 % || Medicated feed || Remained the same 
 Germany || 12(e) || 0.1 % || Top dressing / incorporation of ready-to-use VMPs in the feed and mixing into water || Decreased very significantly 
 Italy || 1,330 || 9.1% || Medicated feed and mixing into water || n.a. (f) 
 Poland || n.a. || n.a. || Medicated feed || Increased very significantly 
 Portugal || n.a. || n.a. || Medicated feed || Increased fairly significantly 
 Spain || 2,000 (g) || 6.6 % (g) || Medicated feed || Remained the same 
 UK || 500 || 4.0 % || Medicated feed || Decreased fairly significantly(h) 
Source: Civic Consulting 
Notes: 
(a) Ratios based on figures of compound feed production and
medicated feed production as provided by national feed manufacturers’
associations. Compound feed production figures include medicated feed. Data for
the Czech Republic, Spain and the United Kingdom include on-farm mixing.
(b) Assessments of stakeholders, as provided through the
survey and during the case studies.
(c) Estimates of sales of medicated feed containing zinc
oxides only.
(d) The increase in the use of medicated feed in Denmark is due to the authorisation of zinc oxides as veterinary medicine in 2005.
(e) decrease in 2011 to 2,500 – 3,000 tonnes representing 0.014 % of the
total compound feed production.
(f) Inconsistent data were obtained from stakeholders. An
Italian farmers’ association reported that the use of medicated feed remained
the same over the last five years. However, industrial production figures of
medicated feed in Italy (estimated on basis of a sample representing 35 % of
total industrial production) show an increase in production during the period
2006 – 2008 (see Table 2). According to the Italian feed manufacturers
association (ASSALZOO), while the industrial production of medicated feed
increased during the period 2006 – 2008, the total production of  medicated
feed (including on-farm mixing) decreased fairly significantly over the same
period. The reduction of on-farm production of medicated feed in favour of
industrial production may be explained by the good payment condition (180 days)
granted to farmers by feed producers, according to the association.
(g) 2007 data.
(g) from 2008 to 2011: Remained the same.

8.7.       
FVO findings re cross-contamination and
homogeneity in different Member States[62]
 
 Audit || Concerned operators visited || FINDINGS ON CROSS-CONTAMINATION || FINDINGS ON HOMOGENEITY || RELEVANT CONCLUSIONS 
 UK 8955-2011 || 2 approved feed mills (using coccidiostats and other antibiotics) 3 registered feed mills 1 approved mobile mixer || The manufacturers of feed and premixtures visited which were using coccidiostats or medicated premixtures had arrangements in place to minimise cross-contamination of non-target feed with coccidiostats. However, in two establishments visited, the audit team noted that the analytical method used for measuring the level of cross-contamination achieved was not sensitive enough to ensure that it was below the maximum permitted levels set by Directive 2002/32/EC. In one of them, the audit team confirmed that feed for non-target species exceeding maximum permitted levels of cross-contamination for decoquinate was regularly placed on the market. The operator of this establishment was not aware of the applicable legislation and therefore did not take any corrective actions. In the other establishment, cross-contamination was measured just after the mixer and therefore did not take account of the additional contamination occurring in the remaining part of the production process. || The feed mills visited had adequate arrangements in place for ensuring and measuring the homogeneity of the feed produced. However, in one feed mill visited, coefficients of variation (a parameter used to measure homogeneity of feed) ranging from 27 to 50 were measured over a period of nine months in 2011. This issue had been identified by the operator and the feed inspectors but no actions were taken in order to address it. || [...] arrangements in place for minimisation of cross-contamination are not sufficient to ensure compliance with Directive 2002/32/EC [...]. Consequently, the relevant recommendation of report 2009-8092 has not been addressed and important requirements of Annex II to Regulation (EC) No 183/2005 are still not met. 
 RO 8479-2010 || 2 approved feed mills (using coccidiostats and other antibiotics) 2 on-farm mixers (1 using antibiotics) || In one of the feed mills visited, one of the production lines was used for production of feed with or without antibiotics and coccidiostats. According to the operator, production sequencing was used to minimise cross-contamination. However, the audit team noted that there was no sequencing procedure in place and no tests had been carried out in order to establish the level of cross-contamination. In one of the on-farm mixers visited, its mixer and production line were used both for production of feedstuffs with or without medicines. Although there was a flushing procedure in place, it was not followed by the operator; the audit team noted that the concerned inspectors from the Unit in charge of Control and the Unit in charge of Feed had recorded in their report that the procedure and its implementation was satisfactory. In the above on-farm mixer, the operator declared that  cross-contamination tests  were performed twice a year with two samples taken from the mixer; however, the results of the tests were not available for inspectors, who had never questioned this, nor performed any verification in this respect. The audit team noted that samples for the detection of banned antibiotics had been collected by officials; however, they have never collected samples for analysis on antibiotics which were used in the production of medicated feed, for the purpose of establishing the level of cross contamination || The audit team noted that, although homogeneity tests (with amino acids as tracers) were carried out regularly in one of the feed mills visited (with satisfactory results), in the other feed mill and in one on-farm mixer visited, the design of the test was incorrect (they were carried out on the basis of one sample), and in the other on-farm mixer visited no homogeneity test had been carried out. With the exception of the first feed mills mentioned above, homogeneity has never been assessed by the inspectors from the Unit in charge of Control and the Unit in charge of Feed || In most of the establishments visited, there are significant deficiencies in the requirements for HACCP based procedures as well as in the design and implementation of quality control programmes which, in particular, presented shortcomings as regards measures to minimise cross-contamination and homogeneity tests. Moreover, these deficiencies are very often overlooked by the concerned competent authorities during official controls. Therefore, the requirements laid down by Articles 5(2) 6 and 7 of Regulation (EC) No 183/2005 are not met yet and the relevant recommendation of the previous report has not been satisfactorily addressed 
 PT 8942-2011 || 3 approved feed mills (using coccidiostats and other antibiotics) 2 registered feed mills 1 approved on-farm mixer || In the three feed mills using coccidiostats and antibiotics visited, some measures to minimize cross-contamination during production were used […]. However: • In one feed mill, flushing was not used as a preventive measure. The level of cross-contamination with antibiotics had been found to be satisfactory; however, the audit team noted that this level had only been verified once and using one sample taken from the following production batch (this sample was a pool of 10 samples taken consecutively), with the consequence that the initial part of the production batch could contain a higher level of cross-contamination. The level of cross-contamination of coccidiostats has never been determined. • In another feed mill, flushing procedures were in place. The level of cross-contamination with antibiotics had been found to be satisfactory; however, the audit team noted that this level had only been verified once and using one sample taken randomly from the following production batch. • In the third feed mill, flushing procedures were in place but only to minimize cross-contamination with antibiotics. The feed operator explained that for coccidiostats they had installed an aspiration system aimed at removing residues through the production line (after the use of coccidiostats the manufacturing programme foresees a certain cleaning time during which the production line remains empty and the ventilation system removes the residues left). In this feed mill the level of cross-contamination with coccidiostats was  determined once a year by using a coccidiostats (robenidine hydrochloride) as a tracer. Until 2011 such a test was based on the result of only one sample taken randomly from the following production batch. Since 2011, a new sampling procedure has been introduced where three samples have to be taken for each of the three following production batches; subsequently the three samples of each batch are mixed together in one sample and analyzed. The audit team noted that, although the result of the last test was satisfactory, there was no information concerning the collection times of the three samples, and the pooling of samples could result in the initial part of the production batch containing a higher level of cross-contamination without it being detected. The audit team noted that all the above mentioned deficiencies as regards cross-contamination and homogeneity had been overlooked during official controls. || In the two registered feed mills visited the audit team noted that no test on homogeneity had ever been performed. In one approved feed mill visited, homogeneity of compound feed containing coccidiostats or antibiotics was verified twice a year with the use of manganese as a tracer and analysing 10 samples; the results were satisfactory (coefficient of variation between 5% and 10%). However, in the other two approved feed mills visited, the audit team noted that it was tested only by measuring the level of humidity, proteins, ash and fat in a few samples or even only in one (i.e. in one establishment 10 samples were taken but they were subsequently mixed together before the analysis. || The feed establishments visited implement largely satisfactory procedures based on the HACCP principles. However, the technical and organisational measures in place as regards homogeneity and cross-contamination are not satisfactory; therefore, the relevant requirements laid down by Article 5(2) of Regulation (EC) No 183/2005 and specified in its Annex II are not complied with. 
 PL  8465-2010 || 3 approved feed mills (using coccidiostats and other antibiotics) 1 registered feed mill 1 approved on-farm mixer 2 registered on-farm mixers || One feed mill visited, which is using coccidiostats, had not performed tests to determine the level of carry-over. They relied on sequencing production to minimise carry-over to feeding stuffs in which additives are not authorised. Flushes were only used in cases where the following feed was one in which the relevant additive was not authorised. Another feed mill using coccidiostats and veterinary medical products had a carry-over of 20% and no adequate measures had been taken to comply with maximum levels of coccidiostats in non target feed. They relied on sequencing production to minimise carry-over to feed in which additives are not authorised. Flushes were only used in cases where the following feed was one in which the relevant additive was not authorised. This practice is not in line with the procedures explained to the audit team by the competent authorities || One approved and one registered feed mill relied on the homogeneity tests that had been carried out by the competent authorities. They did not perform own checks to guarantee homogeneity || The HACCP based procedures required by Article 6(1) of Regulation (EC) No 183/2005 are still absent in several registered feed establishments. Moreover, while the said procedures and quality control measures were in place in approved establishments visited, deficiencies were noted in most of them and official controls overlooked these. Therefore, the relevant requirements of Regulation (EC) No 183/2005 are not satisfactorily met. 
 FR 8464-2010 || 2 approved feed mills (producing medicated feed) 2 registered feed mills 2 on-farm mixers || According to the competent authorities, the results of the above mentioned own-checks tests for assessing the level of cross-contamination linked to the manufacturing of medicated feed are considered to be compliant if the level of cross-contamination in the first batch following the batch of medicated feedingstuffs is less than 5% (of the concentration of the medicine in the medicated feed); from the second batch on, this figure must be less than 1%. In one of the above feed mills, the audit team confirmed that the operator flushed the production lines with 500 kg of feed material after manufacturing medicated feed and this feed material was 20 subsequently used for production of next batch of medicated feed. However, the audit team noted that this flushing material was used, in some cases, for the production of medicated feed which did not necessarily contain the same medicine. The audit team also noted that, in this establishment, the last official sampling discovered traces of oxytetracycline in various feedingstuffs produced several days after its last incorporation. In two departments located in two different regions visited, the audit team noted a similar approach to these issues || No negative findings || Quality control and HACCP based procedures are largely satisfactory at large-scale feed mills, with the exception of procedures for minimising the carry-over of veterinary medicines, which allow for the presence in medicated feed of up to 5% of another medicinal substance used in a previous production batch; moreover, quality control and HACCP based procedures are either absent or deficient at small-scale feed mills and food recyclers. This is not in compliance with the relevant provisions of Regulation (EC) No 183/2005 
 EE 7233-2007 || 2 approved feed mills (using coccidiostats and other antibiotics) || In one feed mill, pre-mixtures containing coccidiostats and other medicinal substances were used for the production of feed. The mission team noted that technical and organisational measures were taken to minimize the risk of cross-contamination arising from the use of such substances. However, the FBO had not verified if such measures were sufficient as the bound carry-over of its equipment was not quantified. Although the FBO stated that he considered the carry-over linked to the mixer as a CCP, no critical limits were defined and no monitoring was in place. || None of the two approved feed mills had carried out homogeneity tests || Shortcomings in relation to essential aspects of feed hygiene requirements laid down in Annex II to Regulation (EC) No 183/2005 were detected by the mission team; in particular, the HACCP systems required by Art. 6 of Regulation (EC) No 183/2005 were incomplete, non-adapted or not fully implemented. 
 CZ 8087-2009 || 4 approved feed mills (using coccidiostats) 1 approved on-farm mixer || Feed businesses using coccidiostats as feed additives generally did not flush production lines following manufacture of a compound feed containing coccidiostats. They relied on sequencing production to minimise carry-over to feeding stuffs in which additives are not authorised. Flushes were only used in cases where the following feeding stuff was one in which the relevant additive was not authorised. One feed business visited had been approved to use coccidiostats and medicated feed on the basis of a 2,000 kg flush being used following use of such products to minimise the risk of carry-over. However, the feed business operator informed the mission team that he used a 200 kg flush to minimise carry-over although this had not been validated as being effective || No negative findings || Reasonable measures to avoid carry-over of cocccidiostats were not always taken as required by Annex II to Regulation (EC) No 183/2005. 
 BG 8478-2010 || 3 approved feed mills (using coccidiostats) 1 registered feed mill 3 registered farms || In one feed mill visited, the approach used for minimising cross-contamination was that for a batch of feedingstuffs with a given active substance, the last production run did not contain any active substance (and, hence, acted as a flushing batch). However, the audit team noted that the effectiveness of this procedure in minimising the level of cross-contamination had not been established; more importantly, the impact of this practice in the homogeneity of the batch, notably as regards the content of the concerned active substance, had never been investigated. The audit team noted that competent authorities were well aware of this practice with which they were not in agreement, and that they have tried to rectify the situation in the past, without success. With the exception of the above, all feed manufacturers visited carried out cross-contamination and homogeneity tests, and had in place flushing procedures to minimise cross-contamination; the audit team noted that these procedures had been subject to adequate controls by the competent authorities over the past years. || The requirements on HACCP based programmes laid down by Articles 6 and 7 of Regulation (EC) No 183/2005 and quality control programmes set out in its Annex II are largely complied with, with the exception of one establishment, where the measures to avoid or minimise cross-contamination were not in place. 
 BE 8469-2010 || 3 approved feed mills (using coccidiostats) 2 registered feed mills || All approved feed mills and premixture manufacturers visited where coccidiostats were used, had performed carry-over tests. However, most of these operators were not following their internal procedures which had been designed to minimise the presence of residues of coccidiostats in feed for non-target species. Instead of cleaning the circuit by flushing the required number of times corresponding to their measured level of carry-over, they were using grower, and even in one case, finisher feed to clean their production lines. Some results of carry-over tests indicated levels of residues well above the 3% laid down in Directive 2002/32/EC. || No negative findings || Most of applicable requirements of Annex II to Regulation (EC) No 183/2005 were met by the feed establishments visited. However, weaknesses were identified in certain preliminary steps to the identification of hazards and in the appropriation of HACCP based procedures by certain operators. The measures put in place in order to minimise carry-over of coccidiostats were also very limited. 

8.8.       
Situation about carry-over in the Member States and their
position about harmonised tolerance levels.
 
 Member State || 1. Tolerance value in place || Comment 
 AT || Zero || The tolerance level is the level of analytical detection related to the methods of analyses. 
 BE || (Zero de iuris) Action levels 1% - 3% (for exact values for different molecules consult the Belgian study on carry-over levels) || From a legal point of view, zero-tolerance applies to the presence of residus of medicinal substances in non-target feed. However  the Federal food agency (FASFC) and the sector developed initiatives to lower the level of cross contamination as low as reasonable achievable (ALARA). In the convention guideline values are expressed (Annex II) per active substance on what the FASFC considers as ALARA. These values are expressed for antibiotics and paracetamol as a percentage of the minimal authorized dosage, for  anthelmintics this is a % of the maximum authorized dosage. So regardless of the actual dose of the active substance 1 maximum level is valid per active substance. The values are not arbitrary but need to comply with three conditions: a. the level of cross contamination may not cause animal health issues. b. The level of cross contamination may not cause an exceeding of the MRL of the products of animal origin c. The level of cross contamination may not provoke an increased antimicrobial resistance selection. the upper bound limit of the cross contamination is never higher than 2,5% for antibiotics or 3% for anthelmintics (this is technical achievable so ALARA). 
 BU || No value || positive findings are dealt with on a case by case assessment based on which the measures to take are decided 
 CY || No value || Positive findings are dealt with on a case by case assessment based on which the measures to take are decided 
 CZ || No value (Min Agri: 0,5% see below) || No national limits for unavoidable carry-over of veterinary medicine in non-target feed is established in the Czech Republic, the competent authority, Institute for State Control of Veterinary Biologicals and Medicines considers each kind of carry-over individually. ó Ministry of Agriculture: 0,5% 
 DE || Zero || VMP in feed means "not of merchantable quality 
 DK || No value || No maximum limits. If carry-over is found, the result will be evaluated before action is taken, if necessary. 
 EE || No value || We have no legal values for residues of VMP in feedingstuffs and the zero tolerance is not officially established. Nevertheless, according to the Estonian Feedingstuffs Act is any positive finding residue of veterinary medicines in feed violation of requirements. 
 ES || No specific levels established || Maximum level of cross contamination must be justified by the FBO (according to EU regulations where available i.e. coccidiostats). No specific levels have been established for medicated feedingstuffs, despite the presence of non-prescribed drugs in feed is prosecuted under the National Residues Surveillance Scheme. As far as analytical methods are very sensitive, positive findings are dealt with on a case by case assessment based on which the measures to take are decided. 
 FI || No value || There are no national legislation related to VMP residues in feed in Finland.  Positive findings are dealt case by case . 
 FR || 5% || IPM: Thresholds for validation of the manufacturing process: max 5% in the first batch collector and max 1% in the second batch collector. 
 GR || Zero || No tolerance limits established Limit of detection 
 HU || Zero || The zero tolerance is laid down in national legislation, in practice, however, at points requiring “zero tolerance” the carry-over limit is defined by the sensitivity of the relevant laboratory method which should be approved by the competent authority. 
 IE || No value || There is no legal basis in Ireland setting ‘tolerance limits’ for medications in non target feed. ‘Positive findings’ are dealt with on a case by case----corrective actions are carried out by the Competent Authority (CA) . Where appropriate, the ‘positive non-target feed’ will be detained and may be destroyed. 
 ISLAND || No value || No national limits established 
 IT || Zero || The Italian national control plan of animal feed, set for zero tolerance regarding residues of veterinary medicines in feed. In fact the tolerance levels is the level of analytical detection related to the LAB accredited method. Any positive finding has to be followed by corrective actions imposed by local competent authorities. 
 LT || No value || Not regulated 
 LU || Zero "No value, BUT applying zero tolerance" || We have no legal values for residues of VMP in feedingstuffs and the zero tolerance is not officially established, but in the national regulation regulating the manufacturing of medicated feed is the condition that all recipients, which are used for medicated feed, have to be cleaned after use, in order to avoid any undesirable interaction or cross contamination. Therefore we apply the zero-tolerance and any positive findings have to be withdrawn. 
 LV || No value || Not regulated 
 MT || No value (neither 0 nor tolerance) || If for any reason there are positive findings, an investigation is launched => case by case 
 NL || Shouldn't exceed the MRL's of antibiotics in animal products || The legal status of the current “rule of thumb” used by the Dutch Food and Consumer Product Safety Authority (VWA) is still under discussion, they have introduced an action limit for VMP in non-target feed of 2.5% of the lowest dosage in target feed. 
 PL || Zero || Not set in legislation but positive finding => withdrawal 
 PT || No value || Awaiting confirmation 
 RO || No value || Romania does not have a national tolerance level, established in national legislation, for carry-over of VMP into non target feed. 
 SE || No value || If for any reason there are positive findings, an investigation is launched => case by case 
 SI || Zero || The zero tolerance is laid down in national legislation, in practice, however, at points requiring “zero tolerance” the carry-over limit is defined by the sensitivity of the relevant laboratory method which should be approved by the competent authority. 
 SK || No value || Slovak national legislation does not lay down exact limits. Institute for State Control of Veterinary Biologicals and Medicaments in Nitra and they evaluate each incident of carry-over individually on following type and significant of veterinary medicine in nontarget feed with help of EU limits for contamination medicinal residues in food. 
 UK || No value || Carry-over of VMP in non target feed is considered on a case by case basis but generally we inform Feed Business Operators to aim for as low as reasonably possible and at least within the tolerances set for coccidiostats in Commission Directive 2009/8/EC, however, we are also limited to the levels that can be detected.   
   || 2. Support for EU-limits || Reasoning   
 AT || YES || Yes, we prefer common maximum levels. 
 BE || YES || YES, we are in favour of an EU harmonisation regarding unavoidable carry-over levels for medicinal substances to non-target feed 
 BU || YES ||   
 CY || YES || YES, we are in favour to set maximum levels of unavoidable carry-over in a similar way as for coccidiostats and histomonostats. 
 CZ || YES || Yes, we are in favour to set maximum levels of unavoidable carry-over in a similar way as for coccidiostats and histomonostats. 
 DE || YES ||   
 DK || ? ||   
 EE || YES || Estonia is in favour of establishing maximum levels of unavoidable carry-over of VMPs in non-target feed 
 ES || YES ||   
 FI || YES || The feasibily has to be evaluated separately. From the feed control point of view, maximum levels would be welcomed . 
 FR || YES || But maximum RATES of carry-over 
 GR || YES ||   
 HU || ? ||   
 IE || YES || It is recognized that even the best compound feedmill is unable to achieve a ‘zero carry-over’ at all times.  EC Regulation 183/2005 and Directive 90/167 require FBOs to ensure that in the production of feed that hazards are eliminated or minimised to avoid compromising feed safety. FBOs are committed to abide by such regulation. Ireland would welcome the EC setting maximum limits as this would set an equivalent standard for all Member States. 
 IT || YES || The maximum levels of unavoidable carry-over of VMPs in non target feed is a necessity. The IT national competent authority will welcome that the EC sets these limits for VMP authorised as medicated premix within the EU. 
 LT || NO || Lithuania would be against establishing maximum levels of carry-over of veterinary medicinal products in non-target feed 
 LU || NO || In front of the general increase of antimicrobiotic resistance to antibiotics in animals and humans in Europe, setting tolerance levels for residues of VMP in feed, is a contra-productive action. Carry-over is not unavoidable, the producers of medicated feed in Luxembourg have to run after production of medicated feed as many flushing batches as needed until there is no more carry-over, before they produce non-medicated feed. […] During the last +/-10 years, we have seen in Luxembourg a very important reduction of manufacturing of medicated feed up to nearly 0 batches of medicated feed/year. Nearly all the pig farmers give VMP to their animals via mixing into drinking water and not into feed. Therefore is no need for setting maximum limits of residues of VMP in feedingstuffs. 
 LV || ? ||   
 MT || YES ||   
 NL || YES || NVWA is in favour with clear MRL's or ML's 
 PL || NO || No tolerance because AMR! 
 PT || YES || Taking into consideration unavoidable carry-over/ cross contamination at feed mill level, we are in favour of establishing admissible maximum levels in non target feeds 
 RO || YES || In principle in favour of establishing maximum levels. 
 SE || YES ||   
 SI || ? ||   
 SK || ? ||   
 UK || YES || The UK is in favour of establishing maximum levels of unavoidable carry-over of VMPs in non-target feed in a similar way set for coccidiostats and histomonostats. However, we would ask that tolerances be set based on sound science, taking into consideration the risk to human health and to non-target species health.   Consideration should be given to the potential for the development of anti-microbial resistance based on scientific evidence. 
Sources: Competent
authorities, surveys in 2009, 2011 and 2013

8.9.       
Medicated feed and antimicrobial resistance

1.
Resistance to Antimicrobials
Since the introduction of penicillin in the 1940s antimicrobial
medicines, such as antibiotics, have become essential for the treatment of many
microbial infections in humans and animals. 
These applications are now seriously jeopardized by the emergence
and spread of microbes that are resistant to affordable and effective first
choice, or "first-line" medicines, rendering the drugs concerned
ineffective for the treatment of the infection. This resistance is a natural
biological phenomenon but is amplified by a variety of factors. The
inappropriate use of therapeutic antimicrobials in human and veterinary
medicine, the use of antimicrobials for non-therapeutic purposes as well as the
pollution of the environment by antimicrobials is accelerating the emergence
and spread of resistant microorganisms. The consequences are severe: 
A subset of drug-resistant bacteria is responsible for about 25,000
human deaths annually. In addition to avoidable death, this also translates
into extra healthcare costs and productivity losses of at least EUR 1.5 billion[63]
per annum. 
Common bacteria causing e.g. diarrhoea or respiratory infections in
several animal species have become more resistant to commonly used veterinary
antimicrobials causing increased suffering and mortality in animals, and
consequently, production losses and extra costs as well as occupational hazards
to animal keepers.
Resistance was high among gram positive and gram negative bacteria
that cause serious infections in man (up to 25% in several Member States) and
was growing in bacteria such as Escherichia coli.
This is important in the context of medicated feed since over-use of
antibiotics in animals, particularly at low doses has been indicated as one
possible source of antibiotic resistance. Once resistance has arisen in
bacteria in animals, they can transfer to man or in some cases transfer their
resistance to other bacteria which can infect man. 
Methicilin
resistant Staphylococcus aureus (MRSA) is a major cause of resistant hospital
infections. In a 2008 baseline survey coordinated by EFSA, it has been
demonstrated that pigs are a major reservoir of a new emerging type of MRSA. A
joint ECDC/EFSA/EMA scientific report published in 2009[64] concludes
that "the extensive use of antimicrobials for prevention of disease
appears to be an important risk factor for the spread of MRSA".
The Commission
communicated an action plan to respond to the issue of antimicrobial resistance
in November 2011[65].
This recognised the multifaceted nature of the problem and the need to tackle
it from many angles. Regarding animal health it concluded that:
The appropriate
use of antimicrobials is essential for reducing and preventing AMR and is the
cornerstone of EU policy against AMR, both in human and veterinary medicines.
Antimicrobials should only be used if necessary and in accordance with best practices.
The sub-optimal
use of therapeutic antimicrobials for animals, in particular under-dosage, can
enhance the development of AMR. Efforts to ensure that the medicines are
administered to the animals only at the correct therapeutic level are undertaken
in the enforcement of the current rules on veterinary medicines and medicated
feed but also in the margins of the on-going revision of these legal acts.
Between Member
States significant differences exist in the sales of antimicrobials that cannot
be explained by the animal husbandry practices.
To respond to
this situation, it was important to strengthen the regulatory framework on
veterinary medicines and on medicated feed.
2. Use of
antimicrobials – use of MF - alternatives
Whereas the
oral use of antimicrobials remains relatively stable, the importance of MF,
compared to other routes of oral application, is decreasing (FCEC, chapter
4.3). Thus, it can be concluded that the decision to use therapeutic AMs is
totally independent from the possibility to use medicated feed. 

8.10.    Notifications to the Rapid Alert System for Food and Feed of
unauthorised veterinary medicines in feed 
 
 RASFF Code || Subject 
 2006.0056 || prednisolone, medroxy progesterone acetate (MPA) and dexamethasone in aqueous premixture for farm animals from the Slovak Republic 
 2012.0982 || oxytetracycline (219 µg/kg - ppb) unauthorised in feed for farming trout from Spain, via the Czech Republic 
 2012.0984 || oxytetracycline (605 µg/kg - ppb) in feed for farming trout from Spain, via the Czech Republic 
 2012.0970 || bacitracin (2.22 mg/kg - ppm) in compound feed for rabbits from the Czech Republic 
 2012.0078 || amoxicillin, oxytetracycline, doxycycline, norfloxacin, florfenicol, thiamphenicol, flumequine and chloramphenicol in feed for shrimps from Singapore 
 2011.0256 || zilpaterol (15 µg/kg - ppb) in feed for broilers for fattening from Poland 
 2008.1202 || chloramphenicol in acid casein destined for feed from Ukraine 
 2008.AIE || chloramphenicol (7.18 µg/kg - ppb) in skimmed milk powder from Ukraine 
 2008.AEO || chloramphenicol (50.77; 32.99 µg/kg - ppb) in full fat milk powder from Ukraine 
 2007.0210 || tetracycline (traces) and colistin (traces) unauthorised in complete feed for piglets from France 
 2007.0070 || oxytetracycline (1.255 mg/kg - ppm) in single feed for trout from Portugal 
 2006.0761 || oxytetracycline (79.3 mg/kg - ppm) in complete feed for trout from Portugal 
 2012.0812 || chlortetracycline (224 µg/dm²) unauthorised in colostrum for lambs from the United Kingdom 
 2011.1887 || residue level above MRL for oxytetracycline (0.18 mg/kg - ppm) in salmon meal from Chile 
 2010.1237 || tetracycline unauthorised in feed for rabbits from Italy 
 2011.0257 || chloramphenicol (19; 8.2 µg/kg - ppb) in  vitamin A complementary feed from China 
 2011.0058 || chloramphenicol (32.6 µg/kg - ppb) in vitamin A / D3 premixtures from China 

8.11.   
 Results of the online stakeholder consultation 

Response statistics (N=252) for 'Smart
Regulation of Medicated Feed How to safeguard public and animal health while
increasing the competitiveness of the EU’s livestock sector'.
4. ISSUES 
4.1.
General aspects and MF manufacturing standards 
4.1.1. Do you
agree that the standards for MF manufacturing have an impact on feed, food and
occupational safety? -multiple choices reply- (optional) 
   ||   || Number of requested records || Requested records (252) || % of total number records (252) || % of total number records (249) 
   || Yes || 243 || (96.4%) || (96.4%) || (97.6%) 
   || No || 1 || (0.4%) || (0.4%) || (0.4%) 
   || Do not know || 5 || (2%) || (2%) || (2%) 
   || N/A || 3 || (1.2%) || (1.2%) || - 
4.1.2. If you represent /are based in a MS, do you
think that the way MF is manufactured there, reflects the appropriate safety
level in terms of animal and public health? -multiple choices reply- (optional)

   ||   || Number of requested records || Requested records (252) || % of total number records (252) || % of total number records (242) 
   || Yes || 191 || (75.8%) || (75.8%) || (78.9%) 
   || No, too low || 18 || (7.1%) || (7.1%) || (7.4%) 
   || No, too high || 30 || (11.9%) || (11.9%) || (12.4%) 
   || Do not know || 3 || (1.2%) || (1.2%) || (1.2%) 
   || N/A || 10 || (4%) || (4%) || - 
4.1.3.
Do you agree that manufacturing standards have an impact on the costs of MF
production? -multiple choices reply- (optional) 
   ||   || Number of requested records || Requested records (252) || % of total number records (252) || % of total number records (246) 
   || Yes || 240 || (95.2%) || (95.2%) || (97.6%) 
   || No || 5 || (2%) || (2%) || (2%) 
   || Do not know || 1 || (0.4%) || (0.4%) || (0.4%) 
   || N/A || 6 || (2.4%) || (2.4%) || - 
   ||   ||   ||   ||   ||   
4.1.4. The cost of manufacturing MF in a feed mill is
higher than for non-medicated compound feed because specific measures have to
be taken.
If you represent /are based in a Member State, do you think that,
apart from the cost of VMP, the additional costs for manufacturing MF are
reasonable? -multiple choices reply- (optional) 
   ||   || Number of requested records || Requested records (252) || % of total number records (252) || % of total number records (242) 
   || Yes || 157 || (62.3%) || (62.3%) || (64.9%) 
   || No, too low || 7 || (2.8%) || (2.8%) || (2.9%) 
   || No, too high || 54 || (21.4%) || (21.4%) || (22.3%) 
   || Do not know || 24 || (9.5%) || (9.5%) || (9.9%) 
   || N/A || 10 || (4%) || (4%) || - 
4.1.5. If you represent /are based in a MS, do you think
that MF is a practically feasible method for all livestock farmers to
administer VMPs to their animals? -multiple choices reply- (optional) 
   ||   || Number of requested records || Requested records (252) || % of total number records (252) || % of total number records (240) 
   || Yes, for all || 122 || (48.4%) || (48.4%) || (50.8%) 
   || No, only viable and feasible for very few farming systems || 15 || (6%) || (6%) || (6.2%) 
   || Not for all, but for the vast majority of farming systems MF is viable and feasible || 100 || (39.7%) || (39.7%) || (41.7%) 
   || Do not know || 3 || (1.2%) || (1.2%) || (1.2%) 
   || N/A || 12 || (4.8%) || (4.8%) || - 
4.1.6. The main aim of this initiative is to modernise
and harmonise MF production at the appropriate standard. Do you agree that
these objectives can only be achieved by taking action at EU level instead of
national level (respect of subsidiarity and proportionality principles)?
-multiple choices reply- (optional) 
   ||   || Number of requested records || Requested records (252) || % of total number records (252) || % of total number records (242) 
   || Yes || 212 || (84.1%) || (84.1%) || (87.6%) 
   || No || 23 || (9.1%) || (9.1%) || (9.5%) 
   || Do not know || 7 || (2.8%) || (2.8%) || (2.9%) 
   || N/A || 10 || (4%) || (4%) || - 
4.2
Specific provisions on MF manufacturing
4.2.1. The
inclusion rates of the pre-mixes into MF differ currently from MS to MS.
Do you agree that
inclusion rates should be the same throughout the EU and depend only on the
manufacturing standard (i.e. the quality of the manufacturing practice) of the
MF producer? -multiple choices reply- (optional) 
   ||   || Number of requested records || Requested records (252) || % of total number records (252) || % of total number records (246) 
   || Yes || 119 || (47.2%) || (47.2%) || (48.4%) 
   || No || 120 || (47.6%) || (47.6%) || (48.8%) 
   || Do not know || 7 || (2.8%) || (2.8%) || (2.8%) 
   || N/A || 6 || (2.4%) || (2.4%) || - 
4.2.2.
The current rules allow MF to be manufactured before the specific prescription
is available in the feed mill (anticipated production of MF). Do you agree that
anticipated production of MF may raise concerns in terms of efficient and safe
use of the VMPs? -multiple choices reply- (optional) 
   ||   || Number of requested records || Requested records (252) || % of total number records (252) || % of total number records (246) 
   || Yes || 42 || (16.7%) || (16.7%) || (17.1%) 
   || No || 195 || (77.4%) || (77.4%) || (79.3%) 
   || Do not know || 9 || (3.6%) || (3.6%) || (3.7%) 
   || N/A || 6 || (2.4%) || (2.4%) || - 
4.2.3. Do you agree that the use of more than one
pre-mix to manufacture a MF may raise concerns in term of safe and efficient
use of VMPs? -multiple choices reply- (optional) 
   ||   || Number of requested records || Requested records (252) || % of total number records (252) || % of total number records (247) 
   || Yes || 45 || (17.9%) || (17.9%) || (18.2%) 
   || No || 179 || (71%) || (71%) || (72.5%) 
   || Do not know || 23 || (9.1%) || (9.1%) || (9.3%) 
   || N/A || 5 || (2%) || (2%) || - 
4.2.4. MF can be manufactured in feed mills and in
specifically equipped mobile mixers. Do you agree that the manufacture of MF in
mobile mixers can meet the requirements for MF with respect to homogeneity and
compatibility of the compounds? -multiple choices reply- (optional) 
   ||   || Number of requested records || Requested records (252) || % of total number records (252) || % of total number records (243) 
   || Yes || 163 || (64.7%) || (64.7%) || (67.1%) 
   || No || 32 || (12.7%) || (12.7%) || (13.2%) 
   || Do not know || 48 || (19%) || (19%) || (19.8%) 
   || N/A || 9 || (3.6%) || (3.6%) || - 
4.2.5.
Do you agree that on-farm manufacture of MF can meet the requirements for MF
with respect to homogeneity and compatibility of the compounds? -multiple
choices reply- (optional) 
   ||   || Number of requested records || Requested records (252) || % of total number records (252) || % of total number records (248) 
   || Yes || 164 || (65.1%) || (65.1%) || (66.1%) 
   || No || 55 || (21.8%) || (21.8%) || (22.2%) 
   || Do not know || 29 || (11.5%) || (11.5%) || (11.7%) 
   || N/A || 4 || (1.6%) || (1.6%) || - 
4.3
Use of MF in practice
4.3.1. A
homogenous incorporation of VMP into MF is crucial for the safe and efficient
use of MF. Do you agree that transport of MF from the manufacturing feed mill
to the farm significantly reduces the homogeneity of feed? -multiple choices
reply- (optional) 
   ||   || Number of requested records || Requested records (252) || % of total number records (252) || % of total number records (245) 
   || Yes || 10 || (4%) || (4%) || (4.1%) 
   || No || 219 || (86.9%) || (86.9%) || (89.4%) 
   || Do not know || 16 || (6.3%) || (6.3%) || (6.5%) 
   || N/A || 7 || (2.8%) || (2.8%) || - 
4.3.2. Sometimes, during a treatment, a change in
medication is necessary. Do you agree that, compared to other methods of oral
administration of VMPs (e.g. top dressing or on-farm mixing of VMPs), the use
of MF reduces the flexibility and thus willingness to change a treatment?
-multiple choices reply- (optional) 
   ||   || Number of requested records || Requested records (252) || % of total number records (252) || % of total number records (241) 
   || Yes || 106 || (42.1%) || (42.1%) || (44%) 
   || No || 127 || (50.4%) || (50.4%) || (52.7%) 
   || Do not know || 8 || (3.2%) || (3.2%) || (3.3%) 
   || N/A || 11 || (4.4%) || (4.4%) || - 
4.3.3. Do you agree that left overs of MF on the farm
might cause problems? -multiple choices reply- (optional) 
   ||   || Number of requested records || Requested records (252) || % of total number records (252) || % of total number records (247) 
   || Yes || 103 || (40.9%) || (40.9%) || (41.7%) 
   || No || 137 || (54.4%) || (54.4%) || (55.5%) 
   || Do not know || 7 || (2.8%) || (2.8%) || (2.8%) 
   || N/A || 5 || (2%) || (2%) || - 
4.3.4. Do you agree that the MF method has advantages
in terms of animal welfare over medication that is not administered orally?
-multiple choices reply- (optional) 
   ||   || Number of requested records || Requested records (252) || % of total number records (252) || % of total number records (246) 
   || Yes || 227 || (90.1%) || (90.1%) || (92.3%) 
   || No || 11 || (4.4%) || (4.4%) || (4.5%) 
   || Do not know || 8 || (3.2%) || (3.2%) || (3.3%) 
   || N/A || 6 || (2.4%) || (2.4%) || - 
4.3.5. Do you agree that, prescription rules for VMP
and MF should be identical? -multiple choices reply- (optional) 
   ||   || Number of requested records || Requested records (252) || % of total number records (252) || % of total number records (245) 
   || Yes || 226 || (89.7%) || (89.7%) || (92.2%) 
   || No || 17 || (6.7%) || (6.7%) || (6.9%) 
   || Do not know || 2 || (0.8%) || (0.8%) || (0.8%) 
   || N/A || 7 || (2.8%) || (2.8%) || - 
4.3.6.
Would you agree that MF could be prescribed by qualified personnel other than
veterinarians, which is already a possibility for the prescription of VMPs?
-multiple choices reply- (optional) 
   ||   || Number of requested records || Requested records (252) || % of total number records (252) || % of total number records (248) 
   || Yes || 15 || (6%) || (6%) || (6%) 
   || No || 231 || (91.7%) || (91.7%) || (93.1%) 
   || Do not know || 2 || (0.8%) || (0.8%) || (0.8%) 
   || N/A || 4 || (1.6%) || (1.6%) || - 
4.4
Public and occupational health
4.4.1. Do you
agree that, compared to other methods of oral administration of VMPs to
animals, the MF method has a lower risk in terms of direct exposure of staff
handling VMPs i.e. with respect to occupational health (e.g. sensitising,
allergic or resistance-enhancing properties of VMPs)? -multiple choices reply-
(optional) 
   ||   || Number of requested records || Requested records (252) || % of total number records (252) || % of total number records (244) 
   || Yes || 201 || (79.8%) || (79.8%) || (82.4%) 
   || No || 24 || (9.5%) || (9.5%) || (9.8%) 
   || Do not know || 19 || (7.5%) || (7.5%) || (7.8%) 
   || N/A || 8 || (3.2%) || (3.2%) || - 
4.4.2. Residues of VMPs can be carried over into feed
for animals for which the VMPs are not intended. Do you agree that finding of
residues of non-prescribed VMPs can be minimised e.g. by flushing or production
planning but not totally excluded in practice? -multiple choices reply-
(optional) 
   ||   || Number of requested records || Requested records (252) || % of total number records (252) || % of total number records (243) 
   || Yes || 230 || (91.3%) || (91.3%) || (94.7%) 
   || No || 7 || (2.8%) || (2.8%) || (2.9%) 
   || Do not know || 6 || (2.4%) || (2.4%) || (2.5%) 
   || N/A || 9 || (3.6%) || (3.6%) || - 
4.4.3. If you represent / are based in a MS, are you
aware of tolerance levels for carry-over of non-target species VMPs under the
current legal framework? -multiple choices reply- (optional) 
   ||   || Number of requested records || Requested records (252) || % of total number records (252) || % of total number records (233) 
   || Yes || 98 || (38.9%) || (38.9%) || (42.1%) 
   || No || 70 || (27.8%) || (27.8%) || (30%) 
   || Do not know || 65 || (25.8%) || (25.8%) || (27.9%) 
   || N/A || 19 || (7.5%) || (7.5%) || - 
4.4.4. Do you agree that residual traces of VMPs in
feed, e.g. from carry-over, can increase the occurrence of micro-organisms
resistant to antibiotics? -multiple choices reply- (optional) 
   ||   || Number of requested records || Requested records (252) || % of total number records (252) || % of total number records (246) 
   || Yes || 71 || (28.2%) || (28.2%) || (28.9%) 
   || No || 115 || (45.6%) || (45.6%) || (46.7%) 
   || Do not know || 60 || (23.8%) || (23.8%) || (24.4%) 
   || N/A || 6 || (2.4%) || (2.4%) || - 
5.
INFORMATION ON RESPONDENTS  
5.2
Please indicate to what category you belong: -multiple choices reply-
(compulsory) 
   ||   || Number of requested records || Requested records (252) || % of total number records (252) 
   || Citizen || 41 || (16.3%) || (16.3%) 
   || Non-business organisation || 31 || (12.3%) || (12.3%) 
   || Business organisation / enterprise / farmers || 147 || (58.3%) || (58.3%) 
   || A public authority || 33 || (13.1%) || (13.1%) 
5.4 In case
of a business organisation or enterprise, please indicate the type of stakeholder
you belong to or represent -multiple
choices reply- (compulsory) 
   ||   || Number of requested records || Requested records (147) || % of total number records (252) || % of total number records (147) 
   || Farmer || 11 || (7.5%) || (4.4%) || (7.5%) 
   || Veterinarian || 30 || (20.4%) || (11.9%) || (20.4%) 
   || Manufacturer of MF || 45 || (30.6%) || (17.9%) || (30.6%) 
   || Wholesaler/trader/importer of MF || 5 || (3.4%) || (2%) || (3.4%) 
   || Pharmaceutical industry, manufacturer of VMPs || 51 || (34.7%) || (20.2%) || (34.7%) 
   || Trader of VMPs || 0 || (0%) || (0%) || (0%) 
   || Researcher || 0 || (0%) || (0%) || (0%) 
   || Other || 5 || (3.4%) || (2%) || (3.4%) 
   || N/A || 0 || - || (41.7%) || - 

8.12.   
Summary of the online consultation complemented
by the results of targeted consultations

Pretext: The examination
of the responses showed that there were, particularly from the business associations
and their affiliates, identical responses. As the consultation does not have
the pretence to be a representative survey, such responses have been considered
and not rejected.
4.1.1 The vast majority of all
the respondents (96%) agree that the standards for MF manufacturing have an
impact on feed, food and occupational safety. 
27 veterinarians (vets)
from a total of 30 respondents also agree that the standards for MF
manufacturing have an impact on feed, food and occupational safety.
33 public authorities (PA)
of a total of 33 agree that the standards for MF manufacturing have an impact
on feed, food and occupational safety.
142 farmers & business
(F&B) of a total of 147 have answered "yes" to this question.
The Federation of
Veterinarians of Europe commented: Mixing & homogenisation can influence individual
doses, efficacy of therapy, withdrawal periods & MRLs//Preparation of
different MF mix at the same plants may result to additional MRLs, when
standards not respected, & consists an AMR risk //occupational risks.
4.1.2 The majority of the respondents (75%) agree that the way MF
is manufactured in their MS of origin reflects the appropriate safety level for
MF. Some respondents (12%) consider the safety level of their country too high.
24 vets /30 agree that the
way MF is manufactured in their MS of origin reflects the appropriate safety
level for MF.
22 PA /33 agree that the
way MF is manufactured in their MS of origin reflects the appropriate safety
level for MF.
111 F&B/147 have
answered "yes" to this question.
4.1.3 The vast majority of the respondents (95%) consider that
manufacturing standards have an impact on the costs of MF production. 
27 vets /30 and 30 PA/33
consider that manufacturing standards have an impact on the costs of MF
production.
141 F&B/147 consider
that manufacturing standards have an impact on the costs of MF production.
4.1.4 More than half of the respondents (62%) consider the
additional costs for the manufacturing of MF to be reasonable. 20% consider
them too high.
19 vets /30 and 20 PA /33
consider the additional costs for the manufacturing of MF to be reasonable.
89 F&B/147 consider
the additional costs for the manufacturing of MF to be reasonable.
4.1.5 Less than half of the respondents (48%) consider that MF is
a practically feasible method for all farming.  40% consider it to be feasible
for the vast majority of farming systems. 6% consider it feasible for very few
farming systems.
Half of the responding
veterinarians and 18 PA/ 33 consider that MF is a practically feasible method
for all farming.
75 F&B/147 replied
"yes for all" to this question. 60 F&B replied "Not for all,
but for the vast majority of farming systems MF is viable and feasible".
The Federation of
Veterinarians of Europe commented: In principal it could be feasible for all livestock
farmers, but there are technical difficulties to overcome.
Copa-Cogeca commented:
Other “routes” of administration of VMPs may be more appropriate for the
treatment of individual animals. It only remains a practically feasible method
provided that the farms are well equipped for the management and distribution
of MF.
The British Veterinary
Association commented that MF is not a practically feasible method for all
farming, but for the vast majority of farming systems.
IFAH considers MF as a
practically feasible method for all farming and comments: medicated feed assures
freedom from stress for livestock in all types of farming settings; there is no
stress to animals or staff – especially in major groups, individual dosing
would be an enormous exercise, possibly resulting in injuries and certainly
inducing a level of stress in the herd or flock; medicated feed is universally
suitable; in-feed medication is equally appropriate to all sizes of unit and
all types of production systems - intensive or extensive;  medicated feed
allows an uncomplicated therapy method for all livestock farmers, ensuring the
prescribed dose is correctly delivered; from the farmer’s perspective medicated
feed allows efficient use of the economic resources at farm level (manpower and
equipment).
Germany comments: In principal it could be
feasible for all livestock farmers. Manufacturers often make deliveries in
quantities that are too large for smaller farms. This leads to longer treatment
periods, although according to the German Act on Medicinal Products it is
possible to sell medicated feed in smaller quantities, it is, in addition,
rarely possible to predict what quantities and concentrations will be needed.
Reference is here made to the German Guidelines on the Oral Use of Veterinary
Medicinal Products in Livestock regarding feed and drinking water. These
guidelines compare the typical characteristics of medicated feed with those of
orally administered proprietary medicinal products. For example, the guidelines
state that medicated feed does not permit a change of active substance or
dosage at short notice. From a pharmaceutical perspective, medicated feed must
be classified as low-quality medicine. There is, for instance, a considerable
risk of under-dosing. Nevertheless, medicated feed is an indispensable and
sensible treatment form for larger farms. On account of their various areas of
application, both medicated feed and orally administered proprietary medicinal
products are indispensable as well as effective and safe when properly
administered.
4.1.6 84% of the respondents would prefer action at EU level for
the harmonisation and modernisation of the sector. 
25 vets /30 and 27 PA / 33
support EU action instead of action at national level.
124 F&B/147 support EU
action instead of action at national level.
4.2.1 The respondents are divided on the issue of inclusion rates.
Almost half (47%) agree that inclusion rates should be the same throughout the
EU and depend only on the manufacturing standard. The other half (47%) of
respondents disagrees with this statement. 
13 vets /30 and 31 PA /33
agree that inclusion rates should be the same throughout the EU and depend only
on the manufacturing standard.
15 vets /30 disagree with
this statement.
88 F&B/147 disagree
with this statement. 52 F&B agree that inclusion rates should be the same
throughout the EU and depend only on the manufacturing standard.
Copa-Cogeca commented: Achieving a  “complete”
harmonization is neither a realistic nor a desirable approach:  levels may vary
depending on animal needs, characteristics of domestic production systems,
methods of inclusion, ability of the manufacturer, etc.
The British Veterinary Association
commented: However, there must
be some flexibility in inclusion rates to achieve the correct dosage rate for a
particular group of animals and certain age. For example, a dry sow eats about
1% of its bodyweight/day, a lactating sow, 2.5% and a growing pig 5%. Therefore
there needs to be flexibility in the inclusion rate to accommodate this to
achieve the correct dose in mg drug/kg bodyweight terms.
IFAH considers that
inclusion rates should not be the same throughout Europe and comments: The different inclusion
rates in the Member States are based on the established good manufacturing
practices within the individual countries. These “country inclusion rates” have
been set up based on the technologies used in the feed mills in each Member State. Any European harmonization not respecting these established practices and
inclusion rates would necessarily impose significant structural, practical,
administrative and financial burdens to the feed industry decreasing the
competitiveness of the EU livestock farming sector. An option could be to
establish a harmonized range of inclusion rates at EU level, embracing the
existing national levels and leaving the implementation up to national
decisions governed by tried and tested national inspection procedures.
FEFAC commented:
Harmonisation of inclusion rates is not technically feasible as what matters is
the amount of the active substance in the final feed, which often depends on
the dose prescribed by the veterinarian. This is why for a given medicated
premixtures, a range of inclusion rates is suitable to allow the medicated feed
manufacturer to incorporate the right dose. However, we believe that a minimum
inclusion rate should be established at EU level.
France comments: La réponse n'est ni
positive ni négative car la question porte plus sur l'équivalence des normes de
production au sein de l'Union européenne :
Une norme harmonisée existe : dans la
monographie de la pharmacopée européenne no 07/2010 1037, le taux
d'incorporation de 0.5% est posé comme un minimum. Cependant, il est possible
d'utiliser un autre taux d'incorporation dans des cas exceptionnels justifiés
et autorisés. Le taux d'incorporation est pris en compte dans l'évaluation du
dossier d'autorisation de mise sur le marché, ils dépendent de la posologie et
de la concentration du principe actif autorisé dans le prémélange. Le taux d'incorporation
des prémélanges dépend en grande partie des standards de fabrication pour
s'assurer que les animaux reçoivent le traitement approprié. En effet, si
chaque animal reçoit le bon traitement, les risques de résidus et
d'antibiorésistance s'en trouvent réduits. C'est la raison pour laquelle les
standards de production des aliments médicamenteux devraient être harmonisés.
4.2.2 70% of the respondents consider that
anticipated production of MF may not raise concerns in terms of efficient and
safe use of VMPs. 16% consider that it does raise concerns. 
22 vets /30
and 17 PA /33 consider that anticipated production of MF may not raise concerns
in terms of efficient and safe use of VMPs.
13 PA /33 consider that
anticipated production of MF may raise concerns.
119 F&B/147 consider
that anticipated production of MF may not raise concerns in terms of efficient
and safe use of VMPs.
The Federation of
Veterinarians of Europe commented the following: This system creates possibilities for
confusion, accidents & potential fraud. ‘Anticipated production of MF’
might lead to undue pressure on the market to use the already produced MF.
Digital technology potentials should be considered for cases of emergency.
EMA commented: Concerns:
Potential that MF not within shelf-life (must be ensured for entire duration of
treatment); Risk that if MF available at feed mill with “non-ideal” VMP or not
ideal dosage, be prescribed/used; Advantages: Cheaper production, quickly
available.
IFAH commented: By pre-manufacturing of
medicated feed, there is less time lost between the disease diagnosis by the
veterinarian and the treatment of the concerned livestock. Even if this time
gap can be reduced by the use of an electronic system (like in Belgium) of prescription transmission, it still takes up to 48 hours from the diagnosis
until the actual availability of the medicated feed for the animals. By
reducing the time gap between the diagnosis and the actual availability of the
medicated feed (see point 1 above), the treatment as such will be more
efficient and will reduce economic losses in the concerned livestock holding.In
addition, the possibility to pre-manufacture medicated feed prior to a
veterinarian prescription will allow the feed manufacturer  to structure and
organize the production of medicated feed in a more efficient and economic way
within the feed mill sector and therefore reduce the cost of production.
Anticipated or pre-manufacture of medicated feed allows the feed manufacturer
to plan medicated feed production such that he can manage unavoidable
carry-over more effectively   and comply with high quality standards in terms
of homogeneity and stability of the mix.
FEFAC answered “no” to
this question and commented: There may be concerns but they are effectively
addressed through the principle of “no delivery before the prescription is
received”. On the other hand, pre-manufacturing may reduce the risk of
cross-contamination in facilitating the scheduling for the manufacturing of
compound feed batches.
France comments: La préoccupation
majeure n'est pas la fabrication à l'avance des aliments médicamenteux mais
leur distribution au détail immédiate sur présentation d'une ordonnance. C'est
pourquoi il est nécessaire de définir un cadre légal explicitant dans quelles
conditions et dans quels cas la fabrication à l'avance des aliments
médicamenteux peut être effectuée et quelles sont les mesures appropriées qui
doivent être prises en conséquence. Certaines espèces ont besoin d'un
traitement approprié pour traiter certaines pathologies. Dans ces cas, il
convient d'avoir un aliment médicamenteux spécifique dont la fabrication ne
peut être anticipée.
UK comments: There is no
concern in the UK because stability testing is carried out on medicated feed. 
Also the medicated feed cannot be released to the owner of the animals to be
treated until a prescription is presented. These conditions must be in place.  
We believe there are sound health reasons for allowing the manufacture of
medicated feed in anticipation of a prescription.  If this is not permitted,
treatment could be delayed by 24 hours. In addition more efficiency in terms of
production scheduling can be achieved.
4.2.3 70% of the respondents consider that the use of more than
one pre-mix to manufacture MF may not raise safety and efficiency concerns. 17%
consider that it does raise concerns. 
20 vets /30 respondents
consider that the use of more than one pre-mix to manufacture MF may not raise
safety and efficiency concerns.
20 PA /33 consider that
the use of more than one pre-mix to manufacture MF may raise safety and
efficiency concerns.
115 F&B/147 consider
that the use of more than one pre-mix to manufacture MF may not raise safety
and efficiency concerns.
EMA commented: Question not entirely
clear (meant as use of different premixes (=VMPs) per feeding stuff or VMPplus
eg. feed additive, in feeding stuff? Thus answer may be misinterpreted.
explanation provided separately.
IFAH commented: With good manufacturing
practices for medicated feed, including rules for combinations, and under the
authority of the veterinarian prescription, there are no concerns in terms of
safe and efficient use of VMPs. The ability to combine premixes in one
medicated feed allows the veterinarian to opt for the best treatment.  The
experience of those countries, where combinations are authorized, shows that
this option can help to improve animal health and animal welfare, without
compromising safety and efficiency.
Federal Ministry of Food,
Agriculture and Consumer Protection of Germany commented: The use of more than
one premix raises concerns, yet principally, the possibility to mix in more
than one premix per MF should survive. Use of more than one premix (VMP), or
the use of a premix and feed additive in the same feeding stuff may increase
the risk of incompatibilities between the active substances of the premix, or
the active substance of the premix and a feed additive, means the safety or
potency might be affected. Within the authorisation process of premixes (VMP),
the applicant should substantiate any claims of compatibility. Substances
should be listed with which the premix is known to be compatible or
incompatible. Mixing different antimicrobials in a MF could support development
of antimicrobial resistance. For animal welfare reasons it should be a
possibility to allow, only on prescription, based on a decision of a competent
veterinarian, the manufacture of MF to use more than one premix in cases if a
combination of different active substances is necessary to treat a specific
condition.
The Federal Chamber of
Veterinary Surgeons in Germany commented: Where several pre-mixes
are simultaneously added to medicated feed there is, from
the pharmacological
perspective, a risk of unmanageable interactions. Under
German law, the mixing in
of a maximum of three pre-mixes with no more than two antibacterial substances
is permitted. There are, however, situations in which the treatment
necessitates the use of several pre-mixes.
France considers that
the use of
more than one pre-mix to manufacture MF raises safety and efficacy concerns.
UK comments: There may be
concerns, however in the UK we allow this practice and it is the vet’s
responsibility to check that there are no contra-indications which are set out
in the summary of product characteristics of the marketing authorisation.  It
is recognised that this cannot cover every scenario, however we do not have
evidence under our residue surveillance or suspected adverse reactions schemes
to suggest a problem.
4.2.4 More than half of the respondents (64%) agree that mobile
mixers respect the homogeneity and compatibility requirements to manufacture
MF. 20% do not know.12% do not agree with the statement above. 
22 vets /30  and 19 PA /33
agree that mobile mixers respect the homogeneity and compatibility requirements
to manufacture MF.
101 F&B/147 agree that
mobile mixers respect the homogeneity and compatibility requirements to
manufacture MF.
Germany comments: it might theoretically be
feasible; however this is not realistic in practice. Medicated feed that is manufactured
on-farm in mobile mixers is not homogenously blown out when being blown into a
storage container because the structure of the feed varies. This results in
different feed structures in the storage silo due to the high airspeed, and
thus in varying pre-mix concentration in the medicated feed.
4.2.5 More than half of the respondents (65%) agree that on-farm
manufacture of MF can meet the homogeneity and compatibility requirements for
MF.  20% do not agree with the statement above and 11% do not know. 
22 vets /30 and 15 PA /33
agree that on-farm manufacture of MF can meet the homogeneity and compatibility
requirements for MF.
11 PA /33 consider that
on-farm manufacture of MF cannot meet the homogeneity and compatibility
requirements for MF.
106 F&B/147 agree that
on-farm manufacture of MF can meet the homogeneity and compatibility
requirements for MF.
Federal Ministry of Food,
Agriculture and Consumer Protection of Germany commented: In Germany the
on-farm manufacturing of a MF is forbidden.
FEFAC comments: Although
there is no EU standard for homogeneity, FEFAC answered “yes” to this question,
based on the existing practical standards used by the feed manufacturers.
However, it must be clear that there cannot be different requirements for
compound feed mills vs. on-farm manufacturers and controls should be exerted
the same.
4.3.1 The majority of the respondents (86%) consider that
transport of MF from the manufacturing feed mill to the farm may not
significantly reduce the homogeneity of the feed.
26 vets /30 and 23 PA /33
consider that transport of MF from the manufacturing feed mill to the farm may
not significantly reduce the homogeneity of the feed.
136 F&B/147 consider
that transport of MF from the manufacturing feed mill to the farm may not significantly
reduce the homogeneity of the feed.
4.3.2 Half of the respondents consider that the use of MF does not
reduce the flexibility and thus the willingness to change a treatment when
compared to other methods of oral administration of VMPs.. Less than half of
the respondents (42%) consider that the use of MF reduces the flexibility and
the willingness to change a treatment.
Half of the respondent
veterinarians and 20 PA /33 consider that the use of MF reduces the flexibility
and the willingness to change a treatment.
14 vets /30 consider the
contrary.
78 F&B/147 consider MF
does not reduce flexibility in changing a treatment.
63 F&B consider that
it does reduce flexibility.
4.3.3 The respondents are divided on the question of left overs of
MF on the farm. 40% consider that it does not cause problems, whereas 54%
considers the contrary. 
17 vets /30 consider that
left overs of MF on the farm may not cause problems.
11 vets /30 and 24 PA /33
consider that left overs may cause problems.
87 F&B/147 consider leftovers
may not raise concerns.
55 F&B consider the
contrary.
The Federation of
Veterinarians of Europe commented that:  left overs represent money & will
always be used, for example in animals which do not need medication & where
no withdrawal time is considered, eg: weaned piglets. This contributes to
irresponsible use of VMP & may be unnecessary increased risk of AMR.
EMA commented: concern of
continued administration of "leftovers" to same or other animals when
no longer necessary (potential for AMR development and problems re residues in
food). If inappropriate disposal it may lead to negative impact on environment.
The Federal Chamber of
Veterinary Surgeons in Germany commented: Please refer to the German Guidelines
on the Oral use of Veterinary Medicinal Products in Livestock regarding feed
and drinking water. The guidelines state that all equipment and facilities that
come into contact with medicated feed or feed/drinking water with pre-mixed
OA.F (spades, pipes, troughs etc) are subsequently contaminated with the active
substance. This can lead to the carryover of the active substance and,
possibly, to uninvolved animals absorbing the active substance. Along with the
danger of developing antimicrobial resistance, this can also lead to positive
residue findings in food as well as to complaints under feed law (cf. the
requirements set out in Regulation (EC) No 183/2004). Equipment and facilities
that have come into contact with the medicated feed/drinking water must
therefore be cleaned by the livestock owner. The livestock owner must take
suitable measures to avoid carry-over. This risk is minimised by having
separate feed pipes or feeding straight from a trough.
France considers that leftovers may
constitute a problem.
Germany comments: A continued administration
of “leftovers” to same or other animals, may lead to antimicrobial resistance
development or residues in food of animal origin. “Leftovers” disposed of
inappropriately, may lead to negative impact on environment.
4.3.4 The vast majority of the respondents (90%) consider that the
MF method has advantages in terms of animal welfare over medication that is not
administered orally. 
23 vets /30 and 29 PA /33
consider that the MF method has advantages in terms of animal welfare over
medication that is not administered orally.
134 F&B/147 consider
that the MF method has advantages in terms of animal welfare over medication
that is not administered orally.
The British Veterinary Association
commented: Medicated feed is
an essential route for the treatment of fish, whether antiparasitic or
antimicrobial and is even used for vaccine boosters. Sick fish cannot be
handled and moved easily to be treated by bath administration, and in any case,
absorption through the skin is extremely variable and cannot be relied upon as
a universal route of administration, even were it feasible for other reasons.
In addition, all licensed
products are designed and licensed to be used via the oral route.
4.3.5 The vast majority of the respondents (90%) agree that
prescription rules for VMPs and MF should be identical. 
28 vets /30 and 28 PA /33
agree that prescription rules for VMPs and MF should be identical.
133 F&B/147 agree that
prescription rules for VMPs and MF should be identical.
FEFAC answered “yes” to
that question, assuming that the question was meant to tackle harmonisation of
the rules for the prescription of e.g. a vaccine or a medicated feed to an
animal. If the question was meant to call for the prescription rules for MF to
also apply to the delivery of medicated premixtures to compound feed
manufacturers, then we would disagree.
UK comments: There should be
equivalence rather than the need for them to be identical.    In principle, the
prescriptions should be the same in that a written prescription must be given if
the supplier is not the prescriber. An oral (verbal) prescription would not be
appropriate in such a case as information on inclusion rates, dosage and
handling precautions will need to be in writing
4.3.6 The vast majority of the respondents (91%) consider that MF
should only be prescribed by veterinarians.
29 vets /30 and 28 PA /33
consider that MF should only be prescribed by veterinarians.
134 F&B/147 consider
that MF should only be prescribed by veterinarians.
4.4.1 The majority of the respondents (80%) consider that the MF
method, compared to other methods of oral administration of VMPs presents lower
risks in terms of occupational health. 
22 vets /30 and 21 PA /33
consider that the MF method, compared to other methods of oral administration
of VMPs presents lower risks in terms of occupational health.
124 F&B/147 consider
that the MF method, compared to other methods of oral administration of VMPs
presents lower risks in terms of occupational health.
Federal Ministry of Food,
Agriculture and Consumer Protection of Germany commented: The risk depends on
the conditions on the farm, which equipment is available/used, who is involved
in administration of medicine or MF, the number of animals treated, and the
availability of alternative medication etc.
UK comments: We have answered yes, but
it would depend on the VMP being prescribed for the MF. In the UK we only allow veterinary surgeons to prescribe premixes for medicated feed, including
antimicrobials.  This should remain the case. The exception is in-feed
anthelmintics which can be prescribed by pharmacists and suitably qualified
persons which the UK would continue to support.
4.4.2 The vast majority of the respondents (91%) consider that
residues of VMPs in non-target feed may not be totally excluded in practice. 
26 vets /30 and 30 PA /33
consider that residues of VMPs in non-target feed may not be totally excluded
in practice.
136 F&B/147 consider
that residues of VMPs in non-target feed may not be totally excluded in
practice.
4.4.3 The respondents are divided on the
issue of awareness of any tolerance levels for carry-over of non target species
VMP's in their MS of origin. 38% are aware of the existence of such tolerance
levels, whereas 27% of the respondents claim they do not exist in their country
and 25% do not know of their existence. 
11 vets /30
say that in their MS there are no tolerance levels. 
11 vets /30 say they are
not aware of their existence.
6 vets /30 and 19 PA /33
say that such tolerance levels exist in their country.
63 F&B/147 are aware
of tolerance levels, 36 say there aren't any and 35 say they are not aware.
IFAH commented: Technically there are no “non target
species VMPs”, so we understand the question as asking about  existing national
carry-over levels of VMPs in non target species feed (medicated feed or other
types of feed); There are indeed countries that follow a so-called
“zero-tolerance” approach  which makes MF production technically impossible,
since carry-over is technically unavoidable (see above).Other countries have
established carry-over limits in the framework of their national GMP.
France comments: En France, on ne parle
pas de seuil de tolérance mais les fabricants doivent se livrer chaque année à
une validation des équipements de mélange afin de prouver qu'ils sont en mesure
de réduire les contaminations croisées. Les méthodes pour tester les
équipements sont décrites dans une décision française du 12 février 2007
relative à la préparation et à la distribution en gros des aliments
médicamenteux. "
4.4.4 The respondents are divided on the question of antimicrobial
resistance occurring from the residual traces of VMPs in feed.28% consider that
VMPs residues may increase the occurrence of antimicrobial resistance. 45%
consider the contrary and 23% do not know. 
17 vets /30 consider VMPs
residues may not increase the occurrence of antimicrobial resistance. 9 vets /
30 consider the contrary.
28 PA /33 consider that
residues of VMPs may increase the occurrence of antimicrobial resistance.
81 F&B/147 consider
VMPs residues may not increase the occurrence of antimicrobial resistance. 40
F&B do not know and 22 F&B think it may increase AMR.
EMA commented: Residual traces of
antibiotics can increase occurrence of resistance; increase depends on many
factors eg. active substance, baseline resistance, amount carried over, no. or
mass of animals treated; not possible to quantify pharmacological efficient
level.

8.13.   
Aggregated data base and assumptions for the
modelling 

Medicated Feed for pets:
Based on information from the few companies
already in this business (SMEs), the current turnover is estimated to be in the
order of € 5 mio. The high willingness of pet owners to pay for the food and
treatment of their pets results in a lower price elasticity for pet food. Also
innovative market segments allow the supplier to enforce high prices.
Therefore, a gross profit margin of 30% is assumed, which is plausible with the
cost-price situation of the medicated feed for pets already on the market. 
If all limitations for the expansion of medicated
pet food are removed, the additional potential for the short term is 10 fold
the current volume. The increase could be tremendous for the midterm: Based on estimated
numbers of 2,9 mio. chronically diseased dogs and 5,5 mio. chronically diseased
cats (no application of antibiotics) in the EU, the potential market is in the
order of one billion €.
Segmentation of the current medicated feed
production in order of manufacturing standards:
Based on the FCEC-report and additional
surveys it can be assumed that roughly half of the current MF-volume is
produced at low standards (FR, PT, ES, IT, CZ, PL). The high cost group
contains AT, DE, FI, LU, NL, SE, SI.
                                                    Scenario 1                      Scenario 2
low standards:                                   50%                                65%
appropriate standards:                        25%                                25%
very high standards:                          25%                                10%
Medicated feed manufacturing for food
production animals:
To cope with the potential tolerance levels
for carry-over of antimicrobials into feed, separated lines in the compound
feed mills for medicated feed would be needed. According to an industry survey,
plausible additional costs for separated lines (investment in equipment and
logistics € 1 mio / site with 20000 t capacity, € 2 mio / site with 50000 t
capacity) are estimated at app € 6 / t medicated feed including additional
labours costs. The additional equipment for a mobile mixer is estimated to be €
25000 / truck for a yearly capacity of 1000 t. The total additional costs for
medicated feed including extra labour are app € 5 / t. These figures have been
cross checked with the FCEC-survey. 
An industry survey indicates that the recall
costs of not used medicated feed from farms would amount € 7-15 / t for
logistics and € 100 / t for disposal (land fill). All stakeholders consider
residual quantities as extremely exceptional. In case of 1% medicated feed that
must be  recalled, the cost share to be added to the medicated feed price is €
1 / t .
The cost increase in Member States with low
standards is assumed to be for 50% of production € 4 / t and 50% of production €
7 / t.
Considering the current cost delta of almost
€ 70 / t, cost benefits of € 10 – 25 / t for the current high standard
production are realistic. Cost reduction in Member States with very high
standards: 50% of production: € 10 / t and 50% of production: € 25 / t.
[1]       COM (2012) 629, 23/10/2012
[2]       http://ec.europa.eu/food/food/animalnutrition/labelling/medicated_feed_report_20100224.pdf
[3]       http://ec.europa.eu/dgs/health_consumer/docs/communication_amr_2011_748_en.pdf
[4]       http://www.europarl.europa.eu/sides/getDoc.do?type=TA&reference=P7-TA-2011-0473&language=EN&ring=B7-2011-0538
[5]       http://www.europarl.europa.eu/sides/getDoc.do?type=TA&reference=P7-TA-2012-0483&language=EN&ring=A7-2012-0373
[6]       The quality of homogenisation varies significantly, many use
concrete mixers
[7]       Data from Eurostat 2007, Number of farms and heads by
economic size of farm (ESU):
http://epp.eurostat.ec.europa.eu/cache/ITY_OFFPUB/KS-AF-07-001/EN/KS-AF-07-001-EN.PDF
[8]       Data from Eurostat 2011
[9]       Finfish is the aggregate term for freshwater, diadromous and
marine fish
[10]     www.fediaf.org
[11]
    FCEC, chapter 4.6
[12]     IFAH-Europe annual report 2011. IFAH-Europe (International
Federation for Animal Health Europe) is the federation representing
manufacturers of veterinary medicines, vaccines and other animal health products
in Europe. Its membership covers 95% of the European market for veterinary
products and the companies comprise both local medium-size enterprises (SMEs)
and international companies
[13]     See Annex 8.5
[14]     FCEC, table 9
[15]     See Annex 8.5
[16]     FCEC, table 10
[17]     FCEC, chapter 3.1
[18]     As medicated feed is mainly produced by the compound feed
industry it is commonly put in relation with the compound feed production to
see the significance of medicated feed in country. However, this might lead to
an overestimation in a country where the farmers purchase relative little
compound feed because they pre-dominantly purchase or produce instead the feed
materials and mix their own feed.
[19]     Source: expert interviews
[20]     The range according to the expert interviews is between 20t and
2000t per year and based on the assumption of 50t, the total medicated feed
production on farm (ex. mobile mixers) would be 0.3 mio t.
[21]     On farm mixing is frequently done in "integrated
farms" where entrepreneurial activity from feed to meat is in one hand
(quite common in the EU for poultry); assessment of impacts is more difficult
as these data are hardly available.
[22]      Based on the
labour costs in the survey (FCEC table 6 and Annex 11) a range between 170 and
1040 full time manpower units was
calculated.
[23]     The interface with other pieces of EU-legislation is
illustrated in Annex 8.1.
[24]     National authorisations can be expanded to other Member States
by a mutual recognition scheme.
[25]     See Chapter 4.4 of FCEC report
[26]     The RASFF has been set out in Article
50 of Regulation (EC) N° 178/2002. The RASFF is a network which informs the
competent authorities in the Member States of the presence of a risk to human
health deriving from food or feed. For specific information relating to
notifications within the RASFF see http://ec.europa.eu/rasff
[27]     "Causes
and control of carry-over and cross contamination" W. Strauch
(Kraftfutter/feed magazine 04/02); "Avoiding carry-over" W. Strauch
and A. Feil (Kraftfutter/feed magazine 4/06); "Avoiding cross
contamination, part I" W. Strauch and A. Feil (Kraftfutter/feed magazine
7-8/08); "Avoiding cross contamination, part II" W. Strauch and A.
Feil (Kraftfutter/feed magazine 9-10/08)
[28]    Real AM-concentration below MPC (mutant prevention
concentration) and above MIC = MSW (mutant selection window) 2.2.1
[29]    3986 farms were authorised for this activity according to the
CIVIC report
[30]     http://ec.europa.eu/food/food/animalnutrition/feedhygiene/efmc_1_0_en.pdf
[31]     FCEC report chapter 3.5
[32]     Company survey: 9 MS: favourable,  5 MS: opposed,  13 MS: No
answer
[33]      "A
stronger, deeper, extended single market is vital for growth and job creation
... Often, businesses and citizens still need to deal with 27 different legal
systems for one and the same transaction."
[34]      Examples from
company survey: "Medicated premixes for pets are not authorised in the Netherlands as pets are not considered to be under the scope of Directive 90/167. Medicated
feed is to be sent directly from the manufacturer to the user in Slovenia." A distribution system from the manufacturer of medicated feed for pets to
the individual pet owner is not feasible.
[35]     In order to avoid misuse, the recall costs should be priced
into the all medicated feed marketed as a levy. Thus, in the concrete case of
unused medicated feed the farmer is not confronted with extra costs.
[36]     OJ L 40, 11.2.2009, p.19 (2009/8/EC)
[37]     "As low as reasonable achievable": The level for the
technically unavoidable carry-over is determined based on the application of
good manufacturing practice.
[38]     The MF route offers a typical bottle neck solution: Whereas the
13,7 mio. livestock farmers in the EU can potentially mix ready-to-use VMPs
into the feed or drinking water, only 7281 (thereof 5692 on-farm) are approved
to manufacture MF.
[39]     In the case of
medicated feed, the therapeutic dose of the medicine is homogenously
incorporated in 50% of the daily feed uptake of the animal. Thus, even if the
strong animals push away the weak ones when new feed is offered, there will be
sufficient –medicated- feed for the weaker ones left once the stronger are
satisfied. 
[40]     Corresponding to 5,5€ / t MF, calculated based on the necessary
additional costs, robustness confirmed by cost delta between Member States with
low standards and adequate standards taking into account the implicit
possibilities for increased economic feasibility.
[41]     The scientific risk assessment of residue levels for
coccidiostats was done by EFSA very diligently (11 opinions issued) and did not
lead to an unbearable workload that would have required extra resources.
[42]     OJ L 165, 30.4.2004, p. 1–141
[43]     The figure for the businesses and farmers  is just 15%
[44]     The figure for the businesses and farmers –not surprisingly- is
just 8,5% and 17% (on farm manufacture)
[45]     The figure for the businesses and farmers –not surprisingly- is
just 38%
[46] Regulation (EC) No 669/2009 (OJ L 194, 25.7.2009, p. 11)
[47] OJ L 92, 7.4.1990, p. 42–48
[48] OJ L 136, 30.4.2004, p.58
[49] OJ L
152, 16.6.2009, p.11
[50] OJ L 35, 8.2.2005, p.1
[51] OJ L 140, 30.5.2002, p. 10
[52] OJ L 229, 1.9.2009, p.1
[53] OJ L 31, 1.2.2002, p. 1
[54]
http://www.europarl.europa.eu/sides/getDoc.do?type=TA&reference=P7-TA-2011-0473&language=EN&ring=B7-2011-0538
[55] COM (2011) 748
[56] www.fediaf.org
[57] EUROSTAT 2012
[58] Rules governing the production of medicated
feed by feed mills are described in the executive orders number 1228, 1251 and
1254 implementing Directive 90/167/EEC.
[59] Rules governing the production of medicated
feed by feed mills are described in the Décision du 12 février 2007 fixant
les bonnes pratiques de fabrication et de distribution en gros des aliments médicamenteux
(BPFDAM). The application of these rules is mandatory by law.
[60] Merkblatt
für die Antragstellung auf Erteilung einer Erlaubnis zur Herstellung von
Fütterungsarzneimitteln aus Arzneimittel-Vormischungen nach § 13 Abs. 1 des
Arzneimittelgesetzes.
[61] Where cross-contamination is identified as
a Critical Control Point (CCP), tests of drug carry-over must be conducted to
verify that the measures put in place to control that risk, are effective.
Manufacturers must also conduct further quality control tests, including a
mixer dispersion (homogeneity) test. Manufacturers must also test a number of
samples each year to control the level of medicinal active ingredient in
medicated feeds. Manufacturers of medicated feed are required to comply with
the Veterinary Medicines Regulations which implements 90/167 and 183/2005 and
guidance is provided in Veterinary Medicines Guidance Notes 21 and 22 on the
Veterinary Medicines Directorate website. Complying with the Regulations is
mandatory. 
[62] For more details: http://ec.europa.eu/food/fvo/index_en.cfm
[63] ECDC/EMEA JOINT
TECHNICAL REPORT The bacterial challenge: time to react. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2009/11/WC500008770.pdf
[64] Joint scientific report of ECDC, EFSA and
EMEA on meticillin resistant Staphylococcus aureus
(MRSA) in livestock, companion
animals and foods. Available from:
http://www.ema.europa.eu/docs/en_GB/document_library/Report/2009/10/WC500004306.pdf
[65]
http://ec.europa.eu/dgs/health_consumer/docs/communication_amr_2011_748_en.pdf