Report from the Commission to the Council and the European Parliament on the use of coccidiostats and histomonostats as feed additives submitted pursuant to article 11 of regulation (ec) no 1831/2003 of the European Parliament and of the Council of 22 september 2003 on additives for use in animal nutrition
Date: 2008-05-05
Institutions: European Commission
Subjects: animal nutrition, food additive, foodstuffs legislation, market approval, veterinary drug, veterinary legislation

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 5.5.2008 
COM(2008)233 final 

REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN 
PARLIAMENT 

ON THE USE OF COCCIDIOSTATS AND HISTOMONOSTATS  
AS FEED ADDITIVES 

submitted pursuant to  
article 11 of regulation (ec) no 1831/2003  
of the european parliament and of the council  
of 22 september 2003  
on additives for use in animal nutrition 

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TABLE OF CONTENTS 

1. 

1.1. 

1.2. 

2. 

3. 

3.1. 

3.2. 

4. 

5. 

6. 

6.1. 

6.2. 

6.3. 

6.4. 

7. 

8. 

Background .................................................................................................................. 3 

Introduction .................................................................................................................. 3 

Feed additives Legislation............................................................................................ 3 

Current legislative situation of coccidiostats and histomonostats as feed additives.... 5 

Use of histomonostats and coccidiostats...................................................................... 5 

Nature of coccidiosis and histomoniasis and their prevalence..................................... 5 

Uses of coccidiostats .................................................................................................... 6 

Safety of the use of coccidiostats as feed additives ..................................................... 7 

Statistics on Use ........................................................................................................... 8 

Alternatives to the use of coccidiostats and histomonostats ........................................ 8 

Vaccination .................................................................................................................. 8 

Herbal products ............................................................................................................ 8 

Use of prescription veterinary medicines..................................................................... 9 

Other means ................................................................................................................. 9 

Contributions from Member States and stakeholders .................................................. 9 

Conclusions ................................................................................................................ 10 

ANNEX.................................................................................................................................... 11 

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REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN 
PARLIAMENT 

ON THE USE OF COCCIDIOSTATS AND HISTOMONOSTATS  
AS FEED ADDITIVES 

1. 

BACKGROUND 

1.1. 

Introduction 

Article 11 of Regulation (EC) No 1831/2003 of the European Parliament and of the 
Council  of  22 September  2003  on  additives  for  use  in  animal  nutrition1  lays  down 
that  the  Commission  shall  submit  to  the  European  Parliament  and  the  Council  a 
report on the use of coccidiostats and histomonostats as feed additives with a view to 
a  decision  on  the  phasing  out  of  the  use  of  these  substances  as  feed  additives  by 
31 December 2012. The report also has to address available alternatives and should 
be accompanied, where appropriate, by legislative proposals.  

The Commission has prepared this report on the basis of information gathered from 
contributions from Member States authorities and stakeholders. 

Coccidiostats  and  histomonostats  are  chemicals,  either  obtained  by  synthesis  or 
produced  by  micro-organisms,  which  inhibit  or  destroy  protozoan  parasites  which 
cause coccidiosis or histomoniasis in farmed animals. Coccidiostats may have also a 
secondary  and  residual  activity  against  the  micro  flora  of  the  gut,  but  they  are 
different  from  the  antibiotics  used  as  growth  promoters,  which  have  their  primary 
action on the gut micro flora. The use of those antibiotics as growth promoters has 
been forbidden in the European Community since 1 January 2006.  

1.2. 

Feed additives Legislation 

Over the last 40 years coccidiosis in farmed animals has been controlled by adding 
substances  to  feed  and  since  1970  the  Community  regulates  and  authorises 
coccidiostats  as  feed  additives  under  Directive  70/524/EEC  of  23 November  1970 
concerning  additives  in  feeding-stuffs2.  The  Directive  was  fully  reviewed  in  2003 
and Regulation (EC) No 1831/2003 represented a major overhaul of the existing EU 
legislation on feed additives.  

1 
2 

OJ L 268, of 18.10.2003, p. 29. 
OJ L 270, of 14.12.1970, p. 1. Directive as last amended by Regulation (EC) No 1756/2002 (OJ L 265, 
of 3.10.2002, p. 1). 

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laying  down 

(EC)  No 178/2002 

The  Regulation  introduced  many  new  aspects  into  the  then  existing  legislation  on 
feed additives, having been one of the first pieces of food safety legislation adopted 
following  Regulation 
the  principles  and 
requirements  of  food  law,  establishing  the  European  Food  Safety  Authority  and 
laying  down  procedures  in  matters  of  food  safety3.  Apart  from  giving  the 
responsibility  for  safety  assessment  and  scientific  advice  to  the  European  Food 
Safety Authority, Regulation (EC) No 1831/2003 followed the principles laid down 
in  Regulation  (EC)  No 178/2002  by  introducing  the  granting  of  time-limited 
authorisations  valid  for  a  period  of  10  years,  the  setting  up  of  a  Community 
Reference  Laboratory  for  feed  additives,  the  possibility  of  establishing  Maximum 
Residue  Limits  for  certain  additives  which  may  result  in  residues  when  added  to 
feed,  and  the  possibility  of  laying  down  post-marketing  monitoring  programmes  at 
the  time  of  authorisation,  as  well  as  other  provisions.  The  Regulation  also  kept 
coccidiostats  and  introduced  histomonostats  as  a  new  category  of  feed  additive, 
whilst  establishing  the  phasing  out  of  the  use  (and  marketing)  of  the  existing 
antibiotics  as  feed  additives  from  1 January  2006,  taking  into  account  the  risks  of 
selecting  bacterial  strains  resistant  to  human  or  veterinary  medicine  drugs  when 
using antimicrobials as growth promoters.  

Labelling  requirements  for  feeding-stuffs  incorporating  certain  categories  of 
additives, including coccidiostats and histomonostats, are still covered by Article 16 
of Directive 70/524/EEC, which remains in force until Directive 79/373/EEC on the 
marketing of compound feeding-stuffs4 has been revised to include rules concerning 
the labelling of feeding-stuffs incorporating additives. 

Veterinary  medicinal  products  are  regulated  in  the  European  Union  by  Directive 
2001/82/EC5

. 

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4 
5 

OJ L 31, of 1.2.2002, p. 1 as last amended by Regulation (EC) N° 1642/2003 (OJ L 245, of 29.9.2003, 
p. 4). 
OJ L 86, of 6.4.1979, p. 30. 
OJ L 311, of 28.11.2001, p. 1. 

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2. 

CURRENT  LEGISLATIVE  SITUATION  OF  COCCIDIOSTATS  AND  HISTOMONOSTATS  AS 
FEED ADDITIVES. 

At present there are 11 different coccidiostats which have been granted 28 different 
authorisations for different species and under certain conditions of use. The products 
are authorised currently for chickens, turkeys and rabbits. These coccidiostats can be 
grouped  into  two  major  types.  In  the  first  group  are  ionophores  (substances  which 
contain a polyether  group and  are  produced by fermentation with several strains of 
Streptomyces  spp  and  Actinomadura  spp)  comprising  the  following  six  substances: 
monensin sodium, lasalocid sodium, maduramicin ammonium, narasin, salinomycin 
sodium  and  semduramicin  sodium.  The  second  group  includes  four  other  synthetic 
products  not  of  an  ionophoric  nature:  decoquinate  (a  compound  belonging  to  the 
chemical group quinolones), robenidine hydrochloride (chemical group guanidines), 
halofuginone  (chemical  group  quinazolinones)  and  diclazuril  (chemical  group 
benzene  acetonitriles)  and  nicarbazin.  No  products  are  currently  authorised  as 
histomonostats  and  used  as  feed  additives  in  the  EU.  All  coccidiostats  have 
undergone  a  safety  evaluation  performed  by  EFSA  or  by  the  Scientific  Committee 
for Animal Nutrition. 

the  authorisation  holder, 

The  individual  authorisations  contain  the  characteristics  of  the  products,  the 
identification  of 
the  maximum,  minimum  and/or 
recommended dosages, the animal categories in which they can be used, Maximum 
Residue Limits (MRL) and withdrawal periods where necessary, as well as specific 
labelling provisions and other further conditions where necessary. The current time-
limited authorisations come to an end between 2009 and 2017. The details of these 
authorisations are summarised in Annex I. 

3. 

USE OF HISTOMONOSTATS AND COCCIDIOSTATS 

3.1. 

Nature of coccidiosis and histomoniasis and their prevalence 

The disease coccidiosis is caused by highly host-specific protozoan parasites of the 
genera  Eimeria  (phylum  Apicomplexa).  There  are  seven  main  species  that  affect 
poultry  (E. acervulina,  brunetti, mitis, necatrix,  praecox,  tenella and maxima),  five 
other species specific to turkeys (such as E. meleagrimitis) and six to rabbits (such as 
E.  stiedae).  Coccidiosis  can  also  occur  in  cattle  and  pigs,  but  the  main  focus  is  on 
poultry,  turkeys  and  rabbits,  since  those  are  the  largest  sectors  using  control 
measures to prevent this fatal disease for these more sensitive species. 

Eimeria is widespread in the environment, can be carried in its dormant form in the 
environment  by  vermin  and  birds  and  is  highly  tolerant  to  changing  weather 
conditions  and  disinfectants,  making  it  virtually  impossible  to  eradicate.  Once 
ingested, it rapidly invades the intestinal tissues, multiplies and is excreted again as 
multiple viable ‘eggs’ (oocysts) that re-infect neighbouring animals and buildings. 

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The effect on the host, without treatment, ranges from mild intestinal inflammation 
resulting in reduced feed intake through loss of appetite and subsequent poor weight 
gain,  to  haemorrhagic  diarrhoea  and  death,  depending  upon  the  severity  of  the 
infection  and  the  species  involved.  Even  in  cases  of  mild  infection,  the  intestinal 
lesions  frequently  leave  the  door  open  to  other  microbial  infections  which  may 
worsen the condition of the affected animal. 

Coccidiosis  affects  all  wild  and  domestic  birds.  Although  there  are  no  exact 
prevalence and incidence data on clinical and subclinical coccidiosis in commercial 
poultry  and  rabbit  production,  it  is  widely  acknowledged  that  the  parasites  are 
present  in  all  commercial  herds.  The  nature  of  the  parasitic  infestation  is  such  that 
coccidiosis  is  present  on  all  poultry  farms,  even  in  the  presence  of  high  sanitary 
standards and good management, with a high potential impact on animal welfare. 

The  disease  histomoniasis  is  also  caused  by  a  protozoan  parasite,  Histomonas 
meleagridis.  The  most  severe  effects  are  seen  in  turkeys  ('black  head'),  although  a 
broad spectrum of birds can be affected. 

3.2. 

Uses of coccidiostats 

In commercial production, the main method of controlling coccidiosis is through the 
addition  of  coccidiostats  to  the  feed  at  the  authorised  levels  and  observing  the 
prescribed  hygiene  requirements.  Generally,  coccidiostats  need  to  be  administered 
throughout  the  life  of  the  animal  (in  the  case  of  chickens  for  fattening)  in  order  to 
protect against re-infection from the ever-present oocyst stage of the disease. 

All coccidiostats inhibit reproduction and do not fully eliminate the parasite from the 
intestine of the animal. Therefore, the authorised synthetic chemicals play a vital role 
in  conjunction  with  the  ionophores,  making  it  possible  to  rotate  or  switch  the 
products  from  production  cycle  to  production  cycle  or  to  use  them  in  so-called 
'shuttle'  programmes  in  order  to  ensure  proper  control  of  the  disease  and  also  to 
minimise the development of immunity in the parasite. 

The availability and the continuous preventive use of coccidiostats have contributed 
significantly to the development of poultry production with a high level of health and 
welfare  of  the  animals.  The  introduction  of  the  first  ionophore  coccidiostat 
(monensin)  in  the  seventies  represented  a  major  achievement  in  the  control  of 
coccidiosis. Prior to this, coccidiosis outbreaks were common and more difficult to 
treat or prevent, as only non-ionophoric coccidiostats were available and these were 
much less effective because of the rapid development of immunity by the parasite. 

As  regards  histomonostats,  although  no  products  belonging  to  this  category  are 
currently  authorised  in  the  EU,  the  mechanism  exists  for  authorising  them  if  an 
application  for  authorisation  of  a  product  were  to  be  submitted  with  enough  data 
supporting  its  safety  for  the  animals,  the  consumers  and  the  environment,  and  its 
efficacy. There are indications in some turkey-producing Member States that, since 
the withdrawal of the authorisation of the only histomonostat in 2003 there has been 
a  significant  decrease  in  technical  performance  indicators  in  turkey  production  and 
an increase in veterinary costs, which supports the search for a suitable product. 

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4. 

SAFETY OF THE USE OF COCCIDIOSTATS AS FEED ADDITIVES 

Authorised  coccidiostats  for  use  in  animal  feed  are  not  used  for  human  medical 
purposes.  

The  safety  of  the  coccidiostats  that  are  currently  authorised  has  recently  been 
extensively  assessed,  mainly  by  the  European  Food  Safety  Authority  (EFSA).  This 
evaluation covers safety for the animals, consumers and users, and the environment. 
This safety assessment also pays attention to the risk of development of immunity in 
protozoa  and  cross  resistance  for  micro  organisms  to  avoid  the  theoretical 
development  of  resistance  to  antimicrobials  used  in  human  or  veterinary  medicine, 
unknown to date. 

The  fact  that  Regulation  (EC)  No 1831/2003  makes  provision  for  the  fixing  of 
Maximum Residue Limits (MRLs) for residues of an additive in relevant foodstuffs 
of  animal  origin  has  meant  that,  with  the  MRLs  established  in  the  last  few  years, 
there are now more effective and clearer ways than before of controlling the uses of 
coccidiostats in feed. 

According  to  Regulation  (EC)  No  183/2005  of the European Parliament and  of the 
Council  of  12  January  2005  laying  down  requirements  for  feed  hygiene6, 
establishments  manufacturing  and/or  placing  on  the  market  coccidiostats  and 
histomonostats,  and  premixtures  and  compound  feedingstuffs  containing  these 
additives,  shall  be  approved  by  the  competent  authority  for  these  activities.  What 
these  provisions  mean  in  practice  is  that,  as  a  general  rule,  farmers  wishing  to  use 
coccidiostats  and  histomonostats  will  obtain  only  ready-for-use  complete  or 
complementary feeding-stuffs manufactured by approved feed compounders. This is 
an important safety feature as it ensures the accuracy and homogeneity of the mixture 
and allows effective official controls by the competent authorities. 

Some  Member  States,  such  as  Sweden,  have  surveillance  programmes  in  force  to 
detect  increase  in  resistance  to  antimicrobials  related  to  the  use  of  coccidiostats  as 
feed additives in which no signs of such an increase have so far been observed. 

6 

OJ L 35, of 8.2.2005, p. 1. 

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5. 

STATISTICS ON USE 

It  is  not  easy  to  compile  accurate  figures  of  production  and  use  for  the  whole  of 
Europe,  given  the  free  movement  of  products  within  the  internal  market  and  the 
overlaps between the figures used by national authorities. The figures which appear 
in  Annex  II,  compiled  jointly  by  the  International  Federation  for  Animal  Health 
Europe (IFAH Europe), the European Feed Manufacturers' Federation (FEFAC) and 
the  European  poultry  producers  and  traders  association  (AVEC)  concerning  the 
concentration  of  these  products  in  several  types  of  feeds  for  different  animal 
categories for the EU–27 as a whole, are considered to be the best estimate. 

The figures indicate that coccidiostats are widely used in feed for broiler and turkey 
production  in  EU-27.  Although  the  statistics  do  not  indicate  a  particular  trend  over 
time, it seems that this use has been generally stable in recent years. 

6. 

ALTERNATIVES TO THE USE OF COCCIDIOSTATS AND HISTOMONOSTATS 

6.1. 

Vaccination 

Since  1992  vaccines  have  been  developed  based  on  precocious  oocysts  of  parasite 
strains. Commercial use of vaccines for coccidiosis started in 1992 for replacement 
hens  ready to  lay  and  in  2000  for commercial chickens for fattening.  Currently  the 
vaccines  are  used  as  the  primary  method  for  preventing  coccidiosis  in  breeding 
flocks  and  laying  hens.  There  is  one  vaccine  that  is  authorised  EU-wide,  and  two 
others are available in a small number of countries. Proponents of vaccines argue that 
continued  use  of  coccidiostats  increases  resistance,  and  therefore  there  is  a  need  to 
keep  developing  new  products.  Vaccines  however  are  species-specific  and  are  not 
available for all types of animals.  

Currently, there are no vaccines available for the prevention of histomoniasis. 

6.2. 

Herbal products 

A number of plant extracts and essential oil preparations are used commercially.  

However, there are currently no controlled studies to provide measurable coccidiosis 
and  histomoniasis  prevention,  and  no  applications  for  authorization  and  evaluation 
by EFSA have been submitted to date under Regulation (EC) No 1831/2003. 

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6.3. 

Use of prescription veterinary medicines 

A limited number of chemicals are approved for veterinary use. They are toltrazuril, 
amprolium,  and  a  number  of  sulfamides  (sulfamiderazin,  sulfadimethoxin, 
trimethoprime associated with sulfadimethoxin or sulfamethoxypyridazin). These are 
effective  in  treating  animals  in  the  event  of  sporadic  coccidiosis  outbreaks  which 
may  occur  if  there  is  no  coccidiostat  in  the  feed,  or  in  the  case  of  development  of 
resistance,  or  even  where  the  use  of  a  vaccine  is  ineffective.  If  widely  used,  these 
veterinary medicine alternatives are sensitive to the build-up of resistance and cannot 
be  relied  upon  for  the  purposes  of  standard  coccidiostat  control  programmes. 
Moreover,  they  cannot  prevent  major  animal  welfare  problems  occurring,  since 
clinical  signs  (reduced  feed  intake,  diarrhoea,  mortality  etc)  only  occur  when  the 
Eimeria species are in a late stage of development and the oocysts are largely already 
excreted, thereby infecting  other birds.  There are currently no veterinary  medicines 
approved for prevention of histomoniasis. 

6.4. 

Other means 

Other  possible  alternatives  have  also  been  tried,  such  as  the  use  of  acidifiers  and 
enzymes or micro-organism suspensions of prebiotics or probiotics to create barriers 
at  the  entrance  of  the  digestive  tract  in  order  to  prevent  the  infection.  Very 
specialised disinfectants are also used, given that the oocysts are highly resistant to 
the most widely used disinfectants. 

The development of resistance to the oocysts through genetic selection of the animals 
is also the subject of research, but it seems that there is little immediate prospect of 
reaching the objective of obtaining resistant breeds in the short term. 

So far there have not been sufficient data to support the efficacy of using these other 
alternative means for prevention of coccidiosis and histomoniasis. 

7. 

CONTRIBUTIONS FROM MEMBER STATES AND STAKEHOLDERS 

For  the  preparation  of  this  report  the  Commission  requested  information  both  from 
Member States and operators.  

Organisations  of  interested  parties  who  have  sent  information  are:  the  International 
Federation  for  Animal  Health  Europe  (IFAH  Europe),  the  European  Feed 
Manufacturers'  Federation  (FEFAC),  the  European  poultry  producers  and  traders 
association  (AVEC),  COPA-COGECA,  le  Comité  européen  de  la  dinde  and  the 
Association of Veterinary Consultants. 

Fifteen Member States have provided detailed information and the responses indicate 
consensus that there are at present no better alternatives to the current regulatory and 
inspection  system  in  place  (MRLs,  feed  hygiene  rules,  registration  and  approval  of 
establishments  handling  coccidiostats,  and  traceability)  regulating  the  use  of 
coccidiostats as feed additives. 

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8. 

CONCLUSIONS 

At the present time, the use of coccidiostats as a preventive measure for the control 
of  coccidiosis  in  modern  poultry  production  is  essential.  This  practice  contributes 
significantly  to  the  protection  of  both  animal  health  and  animal  welfare  by 
preventing a disease that is present on all farms. Production without coccidiostats in 
the  present  circumstances  in  Europe  would  be  very  severely  economically 
compromised  and  the  effect  of  not  using  coccidiostats  would  be  to  deprive  EU 
consumers  of  access  to  poultry,  turkey  and  rabbit  meat  produced  according  to  the 
high EU safety and welfare standards. 

The  alternatives  mentioned  above,  as  indicated,  currently  do  not  offer  the  same 
advantages as the use of coccidiostats as feed additives.  

Vaccines  are  species-specific  and  are  not  available  for  all  types  of  animals.  The 
limited veterinary medicines available are used only for healing purposes, and their 
use  for  prophylactic  purposes  could  create  resistance  to  them  and  could  also 
compromise their efficacy as drugs. Both the ubiquity and the permanence of the risk 
characteristics of the disease make it more appropriate to prevent its occurrence than 
to treat it. 

As  regard  histomoniasis,  since  at  the  moment  no  alternative  treatments  exist,  the 
specific  category  shall  be  maintained  under  the  Regulation  to  keep  a  possibility  to 
authorise future  products  for prevention of the disease, provided that they meet the 
safety and efficacy criteria. 

The  regulatory  framework  established  by  Regulation  1831/2003  can  therefore  be 
considered as working properly. The Commission believes that it is inappropriate to 
change the existing situation at the present time and that the current system is well 
placed  to  deal  with  the  present  situation,  as  it  provides  a  high  level  of  safety  for 
consumers and adequately protects animal health and welfare and the environment, 
while  providing  a  fair  framework  within  which  operators  can  do  business.  The 
European Commission will continue to monitor the development of new substances 
and techniques for the prevention of the diseases. 

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Annex I - Authorisations of coccidiostats and histomonostats as feed additives in Community legislation 

Additive 

Authorization and expiry dates 

Summary of conditions of use 

ANNEX 

Number 

Name of 
additive 

Trade 
name 

Authorisation 
holder 

Date of 
Authorisation 

Expiry date of 
authorisation(s) 

Target species 

Withdrawal period 

MRL 

E 756 

Decoquinate 

Deccox 

Alpharma AS 

E 757  Monensin sodium  Elancoban 

Eli Lilly and 
Company Limited 

2004 

2004 

17.07.2014 

Chickens for fattening 

30.07.2014 

Chickens for fattening, chickens 
reared for laying, turkeys (<16 
weeks) 

3 days withdrawal 
period 

3 days withdrawal 
period 

5 1701  Monensin sodium  Coxidin 

Huvepharma NV 
Belgium 

2007 

06.02.2017 

Chickens for fattening, turkeys 
(<16 weeks) 

3 days withdrawal 
period 

E 758 

Robenidine 
hydrochloride  

Cycostat 

Alpharma 
(Belgium) BVBA 

2004 

1999 

29.10.2014 

Chickens for fattening, turkeys, 
rabbits for fattening 

5 days withdrawal 
period 

30.09.2009 

Rabbits for breeding purposes 

5 days withdrawal 
period 

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- 

25 µg/kg 
skin+fat 

8 µg/kg 
liver, 
kidney and 
muscle 

25 µg/kg 

skin+fat 

8µg/kg 
liver, 
kidney and 
muscle 

- 

- 

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Authorisations of coccidiostats and histomonostats as feed additives in Community legislation (Continued) 

Additive 

Authorization and expiry dates 

Summary of conditions of use 

Number  Name of additive 

Trade 
name 

Authorisation 
holder 

Date of 
Authorisation 

Expiry date of 
authorisation(s) 

Target species 

Withdrawal period 

MRL 

E 763 

Lasalocid A 
sodium  

Avatec 

Alpharma 
(Belgium) BVBA 

E 764 

Halofuginone 
hydrobromide  

- 

E 764 

Halofuginone 
hydrobromide 

Stenorol 

Huvepharma NV 

E 765 

Narasin  

Monteban 

Eli Lilly and 
Company Limited 

2004 

1999 

1996 

1999 

2004 

20.08.2014 

Chickens for fattening, chickens 
reared for laying (<16 weeks) 

5 days withdrawal 
period 

30.09.2009 

Turkeys (<12 weeks) 

5 days withdrawal 
period 

Subject to the 
provisions of Art 
10 § 2 of Reg. 

Chickens for fattening, Turkeys 
(<12 weeks) 

5 days withdrawal 
period 

30.09.2009 

Chickens reared for laying 

- 

20 µg/kg 

muscle 

100 µg/kg 
skin+fat 

100 µg/kg 

liver 

50 µg/kg 

kidney 

150µg/kg 
eggs 

- 

- 

21.08.2014 

Chickens for fattening 

1 day withdrawal 
period 

50 µg/kg all 
tissues 

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Authorisations of coccidiostats and histomonostats as feed additives in Community legislation (Continued) 

Additive 

Authorization and expiry dates 

Summary of conditions of use 

Number  Name of additive 

Trade 
name 

Authorisation 
holder 

Date of 
Authorisation 

Expiry date of 
authorisation(s) 

Target species 

Withdrawal period 

MRL 

E 766 

Salinomycin 
sodium  

Sacox 

Huvepharma NV 

Salinomax 

Alpharma 
(Belgium) BVBA 

E 770  Maduramicin 

Cygro 

Alpharma AS 

ammonium  

E 771 

Diclazuril  

Clinacox 

Janssen Animal 
Health 

BVBA 

2004 

2003 

2001 

2005 

2001 

1999 

2003 

2001 

1999 

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21.08.2014 

Chickens for fattening 

1 days withdrawal 
period 

5 µg/kg 

all tissues 

11.11.2013 

Chickens reared for laying (<12 
weeks) 

- 

31.05.2011 

Rabbits for fattening 

22.04.2015 

Chickens for fattening 

15.12.2011 

Turkeys (<16 weeks) 

30.09.2009 

Chickens for fattening 

5 days withdrawal 
period 

1 days withdrawal 
period 

5 days withdrawal 
period 

5 days withdrawal 
period 

20.01.2013 

Chickens reared for laying (<16 
weeks) 

5 days withdrawal 
period 

28.02.2011 

Turkeys (<12 weeks) 

30.09.2009 

Chickens for fattening 

5 days withdrawal 
period 

5 days withdrawal 
period 

- 

5 µg/kg  

all tissues 

- 

- 

- 

- 

EN 

 
  
 
 
 
 
Authorisations of coccidiostats and histomonostats as feed additives in Community legislation (Continued) 

Additive 

Authorization and expiry dates 

Summary of conditions of use 

Number  Name of additive 

Trade 
name 

Authorisation 
holder 

Date of 
Authorisation 

Expiry date of 
authorisation(s) 

Target species 

Withdrawal period 

MRL 

E 772 

Narasin 
Nicarbazin 

Maxiban 

Eli Lilly and 
Company Ltd 

E 773 

Semduramicin 
sodium  

Aviax 

Phibro Animal 
Health, s.a. 

1999 

2006 

30.09.2009 

Chickens for fattening, turkeys 
for fattening 

5 days withdrawal 
period 

20.10.2016 

Chickens for fattening 

5 days withdrawal 
period 

- 

- 

EN 

14 

EN 

 
  
 
 
Annex II - Estimated EU 27 feed production and use of coccidiostats by segment for 2006  

Table : Estimated EU 27 feed production and use of coccidiostats by segment for 2006 

Type of feed 

Volume 

% use 

With 
coccidiostat 

No coccidiostats 

’000 Tns  coccidiostat  Vaccine Blank 

‘000 Tns 

‘000 Tns 

BROILER 

Broiler starter 

3,825 

84% 

12% 

2% 

3,290 

86% 

536 

14%

Broiler 

grower/finisher 

13,515 

84% 

12% 

2% 

11,623 

86% 

1,892 

14%

Broiler 

withdrawal 

8,160 

0% 

0% 

100% 

0 

0% 

8160 

100%

Total Broiler 

25,500 

14,912 

58% 

10,588 

42%

TURKEY 

Turkey 

starter/grower 

2,050 

97% 

0% 

3% 

1,989 

97% 

62 

3%

Turkey 

withdrawal 

6,150 

0% 

0% 

100% 

0 

0% 

6,150 

100%

Total Turkey 

8,200 

1,989 

24% 

6,212 

76%

OTHER 

Broiler breeder 

2,550 

2% 

98% 

0% 

51 

2% 

2,499 

98%

Replacement 
pullets 

2,000 

15% 

50% 

35% 

300 

15%  

1,700 

Rabbit  

2,400 

45% 

0% 

55% 

1,080 

45% 

1,320 

85%

55%

Total other 

6,950 

1,431 

21% 

5,519 

79%

TOTAL 

40.650 

18,332 

45% 

22,318 

55%

Source: Data compiled jointly by the International Federation for Animal Health Europe (IFAH Europe),  
the European Feed Manufacturers' Federation (FEFAC)  
and the European poultry producers and traders association (a.v.e.c.) 

EN 

15 

   EN