Proposal for a Directive of the European Parliament and of the Council amending Council Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyreostatic action and of beta agonists {SEC(2007)733}
Date: 2007-06-04
Institutions: European Commission
Subjects: application of EU law, hormone, market approval, marketing, veterinary drug, veterinary legislation

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 4.6.2007 
COM(2007) 292 final 

2007/0102 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Council Directive 96/22/EC concerning the prohibition on the use in 
stockfarming of certain substances having a hormonal or thyreostatic action 
and of beta-agonists 

{SEC(2007)733} 

(presented by the Commission) 

EN 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

●  General context 

1. 

Prohibition of the use of certain substances for non food producing 
species (pet animals)  

Article 2 (a) of Council Directive 96/22/EC specifically prohibits 
the  placing  on  the  market  of  substances  listed  in  Annex  II  for 
administering  to  animals  of  "all  species".  The  motive  behind  the 
prohibition  of  substances  for  all  species  is  that  misuse  would  be 
more difficult if no product authorised for whatever species were 
on the market.  

the  Member  States  related 

Comparison  of  the  prices  and  presentations  of  products  with  e.g. 
thyreostatic  action  intended  for  use  in  pet  animals,  however, 
shows that it is economically unattractive to use pet products e.g. 
in  cattle.  Reports  of 
the 
implementation  of  the  national  residue  plans  to  be  established 
according to Directive 96/23/EC1 show that illegal use can rather 
be  linked  to  illegal  production  or  import  of  substances.  This  is 
emphasised  by  the  growing  importance  of  the  Internet  and  the 
increasing  international  trade.  The  same  reports  show  that  no 
illegal  uses  of  stilbenes,  stilbene  derivates,  their  salts  and  esters 
could be discovered in more than five years past. 

to 

to 

Several Member States and the veterinary pharmaceutical industry 
that  marketing 
the  Commission 
complained 
services 
authorisations  cannot  be  granted 
for  products  containing 
substances  to  treat  hyperthyroidism  in  pet  animals  due  to  the 
restrictions  of  Directive  96/22/EC.  They  appealed 
the 
Commission to mitigate the situation.  

to 

2.  Oestradiol 17ß and its ester like derivates 

In 1981 (with Directive 81/602/EEC), the EU prohibited the use of 
substances  having  a  hormonal  action  for  growth  promotion  in 
farm  animals.  These  prohibitions  apply  to  Member  States  and 
imports  from  third  countries  alike.  One  of  these  substances  is 
oestradiol 17ß. The legal instrument in force is Directive 96/22/EC 
as  amended  by  Directive  2003/74/EC.  The  legislative  proposal 
that  preceded  Directive  2003/74/EC2  intended  the  prohibition  of 
oestradiol 17ß and its ester like derivates for all purposes (growth 
promotion,  zootechnical  purposes  and  treatment  applications).  In 

1 
2 

OJ L 125, 23.5.1996, p. 10. 
OJ C 337, 28.11.2000, p. 163. 

EN 

2 

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of 

control: 

treatment 

veterinary 

the  adoption  procedure  it  was,  however,  amended  to  only  reduce 
the  circumstances  under  which  oestradiol  17ß  may  be 
administered  for  purposes  other  than  growth  promotion.  Only 
three uses remained permissible on a transitional basis and under 
foetus 
strict 
maceration/mummification, pyometra in cattle (for animal welfare 
reasons)  and  oestrus  induction  in  cattle,  horses,  sheep  and  goats 
(Article  5a).  The  latter  use  has  to  be  phased  out  by  until 
14 October 2006 and for the rest of the uses the Commission was 
to present a report in October 2005. The report was presented on 
11 October  2005  to  Council  and  Parliament.  It  comes  to  the 
conclusion  that  the  use  of  the  alternative  substances  such  as 
prostaglandins  is  already  common.  Veterinarians  predict  an 
insignificant impact of future unavailability of oestradiol 17ß and 
its  ester  like  derivates  on  farmers  and  on  animal  welfare.  It  was 
moreover  observed  that  the  unavailability  of  oestradiol  and  its 
ester  like  derivates  would  have  minimal  economic  effect.  This  is 
because the incidence of fetal mummification and fetal maceration 
is low, and although the incidence of pyometra is higher, methods 
of  prevention  not  involving  use  of  oestradiol  do  exist  and  would 
be preferable. 

 vcz 

● 

Existing provisions in the area of the proposal 

in 
Directive  96/22/EC  concerning 
stockfarming  of  certain  substances  having  a  hormonal  or  thyrostatic 
action  and  of  ß-agonists,  and  repealing  Directives  81/602/EEC, 
88/146/EEC and 88/299/EEC, 29 April 1996, as amended by Directive 
2003/74/EC. This proposal intends to modify the above directive. 

the  prohibition  on 

the  use 

● 

Consistency with the other policies and objectives of the Union 

The proposal is consistent with the marketing authorisation provisions in 
Directive  2001/82/EC3  (Veterinary  Medicinal  Products  Code)  and 
Regulation  (EC)  n°726/2004  of  the  European  Parliament  and  of  the 
Council of 31 March 20044. 

Oestradiol  17ß  is  currently  classified  in  Annex  II  of  Regulation  (EEC) 
No 2377/905 with restrictions of use. This entry will have to be modified 
if  the  proposal  is  adopted  because  it  identifies  oestradiol  17ß  as  a 
substance that can be used in food producing animals. 

Further  specified  exemptions  for  pet  animals  would  make  this  already 
complex legislation even more complex. It will therefore be in line with 

3 
4 
5 

OJ L 311, 28.11.2001, p. 1. 
OJ L 136, 30.4.2004, p. 1. 
OJ L 224, 18.8.1990, p. 1. 

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3 

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the Communities goal to simplify legislation if pet animals are deleted 
from the scope of this legislation. 

2. 

CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

● 

Consultation of interested parties 

Member  States  and  the  veterinary  pharmaceutical  industry  have 
provided  their  opinion  on  thyrostatic  substances.  The  Member  States 
have  also  confirmed  in  a  Council meeting  on  11  October  2005  in  July 
20066  that  if  oestradiol  17ß  and  its  ester  like  derivates  were  to  be 
prohibited  for  food  producing  animals,  the  substance  should  remain 
available for pet animals. 

Moreover,  pet  animals  affected  by  hyperthyroidism  suffer  due  the 
continuous  unavailability  of  appropriate  treatment.  In  can  therefore  be 
taken  for  granted  that  a  proposal  allowing  such  treatment  is  supported 
by veterinarians and pet owners. 

The changes proposed in relation to oestradiol 17ß are the direct result 
of  the  activities  required  by  Article  11a  of  Directive  2003/74/EC. 
Council discussed the report presented on 11 October 2005 in July 2006. 

● 

Collection and use of expertise 

Scientific/expertise domains concerned 

Veterinary medicine, endocrinology 

Methodology used 

Study 

Main organisations/experts consulted 

University  of  Liverpool,  Department  of  Veterinary  Clinical  Science,  Prof 
Hilary Dobson 

Summary of advice received and used 

The existence of potentially serious risks with irreversible consequences 
has not been mentioned. 

The  advice  asserts  that  in  the  majority  of  cases,  prostaglandin  is  the 
main currently available alternative for oestradiol 17ß and its ester like 
derivates and that the use of this alternative by practising veterinarians is 
already common. It concludes that the non-availability of oestradiol 17ß 
and its ester like derivates would have minimal effect on farm industry 

6 

Council Document 11303/06 AGRILEG 122 of 05/07/2006. 

EN 

4 

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economics,  veterinarians and farmer's  decisions, and animal health  and 
welfare.  

EN 

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Means used to make the expert advice publicly available 

The  report  was  sent  to  Council  and  Parliament  and  made  available  on 
the homepage of Directorate General Health and Consumer Protection at 
http://ec.europa.eu/food/animal/resources/publications_en.htm under the 
heading "Prevention and Control of Animal Diseases". 

● 

Impact assessment 

Information  campaigns,  financial  incentives,  self  regulation  or  co-
regulation  are  not  an  option  where  the  authorisation  of  an  appropriate 
treatment of pet animals is barred by a legal prohibition to place on the 
market certain substances for all animal species. It can moreover not be 
expected  that  Member  States  withdraw  their  marketing  authorisations 
for oestradiol 17ß for food producing animals if the existing legislation 
still allows its use for certain purposes.  

On  the  other  hand,  lack  of  action  would  mean  ignoring  the  needs  of 
animal welfare and the advice provided by the Scientific Committee on 
Veterinary Measures relating to Public Health (concluding that there is a 
substantial body of recent evidence suggesting that oestradiol 17ß has to 
be considered as a complete carcinogen) as well as the advice provided 
by  the  expert  report  on  the  necessity  of  the  use  of  oestradiol  17ß  in 
animal production. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

● 

Summary of the proposed action 

1. 

2. 

Take pet animals out of the scope of the legislation.  

Prohibit  the  use  of  oestradiol  17ß  in  food  producing  animals 
entirely. 

● 

Legal basis 

Treaty Article 152(4)(b) 

● 

Subsidiarity principle 

The subject of the proposal falls under the exclusive competence of the 
Community  since  1981.  There  is  a  long  standing  consensus  that  the 
subject is to be regulated at Community level. The subsidiarity principle 
therefore does not apply.  

● 

Proportionality principle 

The  proposal  complies  with  the  proportionality  principle  for  the 
following reason(s). 

EN 

6 

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Only  very  limited  changes  are  introduced  necessary  in  order  to  avoid 
futher  suffering  of  pet  animals  due  to  the  unavailability  of  an 
appropriate  treatment  and  in  order  to  take  scientific  and  expert  advice 
concerning oestradiol 17ß into account.  

Animal  owners,  practicing  veterinarians,  the  veterinary  pharmaceutical 
industry  and  Member  States  authorisation  agencies  will  be  affected  by 
this proposal.  

thyrostatic 

this  proposal  allows 

As  concerns 
the 
substances 
pharmaceutical  industry  to  successfully  apply  for  the  authorisation  of 
products containing thyrostatic substances for use in pet animals. It also 
keeps products containing oestradiol 17ß intended for pet animals on the 
market.  It  would  allow  the  authorisation  of  veterinary  medicinal 
products containing of stilbenes, stilbene derivates, their salts and esters. 
to  consider  potential  misuse. 
New  authorisation  have,  however 
Presentations that are likely to be misused can therefore be rejected. 

Products for pet animals are a growing market because the numbers of 
pet  animals  kept  is  raising  and  the  animals  are  kept  until  old  age. 
Hyperthyroidism  is  more  frequent  in  old  animals.  Thus  a  proposal  to 
allow  the  authorisation  of  veterinary  medicinal  products  containing 
thyrostatic substances for pet animals will have positive effect for their 
owners,  practicing  veterinarians  and  the  veterinary  pharmaceutical 
industry. 

The  withdrawal  of  products  containing  oestradiol  17β  will  have  no  or 
only a negligible negative effect on farmers practicing veterinarians and 
the veterinary pharmaceutical industry. Some veterinarians and farmers 
will have to accustom themselves to new veterinary medicinal products 
for  the  treatment  of  reproductive  disorders.  Member  States  agencies 
responsible  for  the  authorisation  of  veterinary  medicinal  products  will 
have to with draw respective marketing authorisations. This falls under 
the routine activities of these agencies. Nevertheless, as confirmed in the 
expert report, the withdrawal of products containing oestradiol 17β and 
its ester-like derivatives will have no or only a negligible negative effect 
on 
industry.  They  will,  however, 
contribute  to  achieving  a  high  level  of  human  health  protection.  The 
proposal  has  no  particular  geographical  focus  nor  has  it  a  particular 
effect for small industries. 

the  veterinary  pharmaceutical 

Considering  the  above,  it  is  unlikely  that  the  proposal  will  have 
measurable  effects  on  employment,  on  investment  and  the  creation  of 
new  businesses  or  on  the  competitiveness  of  businesses.  If  at  all 
measurable  the  effect  will  most  likely  be  positive  due  to  the  increased 
business  with  pet  animals.  Accordingly  the  proposal  does  not  have  to 
contain  measures  to  take  account  of  the  specific  situation  of  small  and 
medium-sized firms. 

EN 

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● 

Choice of instruments 

Proposed instruments: directive. 

Other means would not be adequate for the following reason(s): 

This proposal is an amendment of an existing Directive and therefore to 
maintain formal parallelism should take a form of a Directive. The only 
other  option  would  be  to  revoke  and  replace  the  existing  Directive  by 
another  instrument.  Considering  the  limited  changes  proposed  to  the 
current Directive this seems unnecessary and disproportionate. 

4. 

BUDGETARY IMPLICATION 

The proposal has no implication for the Community budget. 

5. 

ADDITIONAL INFORMATION 

● 

European Economic Area 

The proposed act concerns an EEA matter and should therefore extend 
to the European Economic Area. 

EN 

8 

   EN 

 
 
 
 
 
2007/0102 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Council Directive 96/22/EC concerning the prohibition on the use in 
stockfarming of certain substances having a hormonal or thyreostatic action 
and of beta-agonists 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article 152(4)(b) thereof, 

Having regard to the proposal from the Commission7, 

Having regard to the opinion of the Economic and Social Committee8, 

Having regard to the opinion of the Committee of the Regions9, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty 

Whereas: 

(1) 

(2) 

(3) 

7 
8 
9 
10 

11 

Article 2 of Council Directive 96/22/EC10 prohibits inter alia the placing on the market 
of  thyrostatic  substances,  stilbenes,  stilbene  derivatives,  their  salts  and  esters  for 
administering to animals of all species. 

The reason for that absolute prohibition was that potential abuse or misuse would be 
more difficult if there was on the market no product authorised for any animal species 
whatsoever.  

However, experience gained in particular with national residue plans submitted under 
Directive  96/23/EC  of  29  April  1996  on  measures  to  monitor  certain  substances  and 
residues  thereof  in  live  animals  and  animal  products  and  repealing  Directives 
85/358/EEC  and  86/469/EEC  and  Decisions  89/187/EEC  and  91/664/EEC11  has 
shown that the misuse of product presentations intended for pet animals does not play 
a  role  as  a  source  of  abuse  or  misuse.  That  is  partly  because  it  is  economically 

OJ C … 
OJ C … 
OJ C … 
OJ L 125, 23.5.1996, p. 3. Directive as amended by Directive 2003/74/EC of the European Parliament 
and of the Council (OJ L 262, 14.10.2003, p. 17). 
OJ L 125, 23.5.1996, p. 10. Directive as last amended by Regulation (EC) No 882/2004 of the European 
Parliament and of the Council (OJ L 165, 30.4.2004, p. 1). 

EN 

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unattractive  to  use  presentations  for  pet  animals  for  growth  promotion  in  food 
producing animals. 

(4)  Moreover, the prohibition of thyrostatic substances has harmful consequences for the 
welfare of pet animals (dogs and cats) due to the lack of an alternative treatment for 
hyperthyroidism in those animals.  

(5) 

(6) 

(7) 

(8) 

The Protocol on protection and welfare of animals annexed to the Treaty establishing 
the European Community provides that the Community and the Member States are to 
pay  full  regard  to  the  welfare  requirements  of  animals  in  the  implementation  of 
Community policies, in particular with regard to the internal market. 

It is therefore appropriate to limit the scope of this Directive only to food producing 
animals and withdraw the prohibition for pet animals. 

The  Opinion  of  the  Scientific  Committee  on  Veterinary  Measures  relating  to  Public 
Health (SCVPH) of 30 April 1999 on potential adverse effects to human health from 
hormone residues in bovine meat and meat products (which was reviewed on 3 May 
2000  and  confirmed  on  10  April  2002)  concluded  that  there  is  a  substantial  body  of 
recent  evidence  suggesting  that  oestradiol  17ß  has  to  be  considered  as  a  complete 
carcinogen, as it exerts both tumour-initiating and tumour-promoting effects, and that 
the data currently available do not make it possible to give a quantitative estimate of 
the risk to human health. As a result, Directive 96/22/EC was amended by Directive 
2003/74/EC  which  inter  alia  prohibited  permanently  the  use  of  oestradiol  17ß  as  a 
growth promoter and reduced substantively all other circumstances in which it can be 
administered  to  all  farm  animals  for  therapeutic  or  zootechnical  purposes  pending 
further examination of the factual and scientific situation and the veterinary practices 
in the Member States. 

Article  11a  of  Directive  96/22/EC  called  for  the  presentation  of  a  report  on  the 
necessity  of  the  use  of  the  hormone  oestradiol  17β  in  animals  (food  producing 
animals) for therapeutic purposes by 14 October 2005. The European Commission has 
sought  expert  advice  and  established  the  relevant  scientific  report,  which  has  been 
forwarded  to  the  European  Parliament  and  the  Council  on  11  October  200512.  That 
Report  concludes  that  oestradiol  17β  is  not  essential  in  food  animal  production, 
because the use of the available alternatives (especially prostaglandins) by practising 
veterinarians  is  already  quite  common  in  the  Member  States  and  that  the  complete 
prohibition of the use of oestradiol 17ß for food-producing animals would have no or 
only a negligible impact on farming and animal welfare.  

(9) 

A  temporary  exemption  was  provided  for  the  use  of  oestradiol17ß  for  oestrus 
induction  in  cattle,  horses,  sheep  or  goats  until  14  October  2006.  Since  effective 
alternative products exist and are already used and in order to ensure the high level of 
health protection chosen in the Community, that exemption should not be renewed. 

Directive 96/22/EC should therefore be amended accordingly, 

12 

See  the  "Report  concerning  the  availability  of  alternative  veterinary  medicinal  products  to  those 
containing  oestradiol  17β  or  its  ester-like  derivatives  for  the  treatment  of  fetal  maceration  or 
mummification in cattle, and for the treatment of pyometra", available at: 
http://ec.europa.eu/food/animal/resources/comm_staff_work_doc11102005_en.pdf 

EN 

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HAVE ADOPTED THIS DIRECTIVE: 

Article 1 

Directive 96/22/EC is hereby amended as follows: 

(1) 

Article 2 is replaced by the following: 

"Article 2 

Member  States  shall  prohibit  the  placing  on  the  market  of  the  substances  listed  in 
Annex  II  for  administering  to  any  animals,  the  meat  and  products  of  which  are 
intended for human consumption, for purposes other than those provided for in point 
2 of Article 4." 

(2) 

(3) 

(4) 

Article 5a is deleted. 

In Articles 3, 6, 7, 8, 11 and 14 a, the references to Article 5a are deleted. 

In Article 11, paragraph 1 is replaced by the following: 

“1.  Third  countries  whose  legislation  authorizes  the  placing  on  the  market  and 
administration  of  stilbenes,  stilbene  derivatives,  their  salts  and  esters,  or  of 
thyrostatic substances for administering to all species of animals the meat and 
products of which are intended for human consumption may not appear on any 
of the lists of countries provided for under Community legislation from which 
Member States are authorized to import farm or aquaculture animals or meat or 
products obtained from such animals. ” 

(5) 

Article 11a is replaced by the following: 

“Article 11a 

With  regard  to  the  substances  listed  in  Annex  III,  the  Commission  shall  seek 
additional  information,  taking  into  account  recent  scientific  data  from  all  possible 
sources, and keep the measures applied under regular review with a view to timely 
presentation  to  the  European  Parliament  and  to  the  Council  of  any  necessary 
proposals.” 

(6) 

Annex II is replaced by the text in the Annex to this Directive. 

Article 2 

Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative  provisions 
necessary  to  comply  with  this  Directive  by  [1  July  2007]  at  the  latest.  They  shall  forthwith 
communicate to the Commission the text of those provisions and a correlation table between 
those provisions and this Directive. 

EN 

11 

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When Member States adopt those provisions, they shall contain a reference to this Directive 
or be accompanied by such a reference on the occasion of their official publication. Member 
States shall determine how such reference is to be made. 

This Directive shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 3 

Article 4 

This Directive is addressed to the Member States. 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

EN 

12 

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ANNEX 

“ANNEX II 

List of prohibited substances: 

List A: 

– 

– 

– 

List B:  

Thyrostatic substances, 

Stilbenes, stilbene derivatives, their salts and esters, 

Oestradiol 17β and its ester-like derivatives.  

– 

Beta-agonists” 

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13 

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LEGISLATIVE FINANCIAL STATEMENT 

This  document  is  intended  to  accompany  and  complement  the  Explanatory  Memorandum.  As  such,  when  completing  this  Legislative  Financial 
Statement,  and  without  prejudice  to  its  legibility,  an  attempt  should  be  made  to  avoid  repeating  information  contained  in  the  Explanatory 
Memorandum. Before filling in this template, please refer to the specific Guidelines that have been drafted to provide guidance and clarification for 
the items below.  

1. 

NAME OF THE PROPOSAL : 

Directive  of  the  European  Parliament  and  of  the  Council  amending  Council  Directive  96/22/EC  concerning  the  prohibition  on  the  use  in 
stockfarming of certain substances having a hormonal or thyreostatic action and of beta-agonists 

2. 

ABM / ABB FRAMEWORK 

Policy Area(s) concerned and associated Activity/Activities: Food safety, veterinary medicinal products 

3. 

BUDGET LINES 

3.1.  Budget lines (operational lines and related technical and administrative assistance lines (ex- B..A lines)) including headings : 

No financial implications 

3.2.  Duration of the action and of the financial impact: not applicable (n.a.) 

Until modified or revoked 

EN 

14 

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3.3.  Budgetary characteristics (add rows if necessary) : 

Budget 
line 

Type of expenditure 

New 

EFTA 
contribution 

Contributions 
from applicant 
countries 

Heading in 
financial 
perspective 

Comp/ 
Non-comp 

Diff13/ 
Non-
diff14 

Comp/ 
Non-comp 

Diff/ 
Non-diff 

YES/ NO 

YES/NO 

YES/NO 

No [n.a.] 

YES/ NO 

YES/NO 

YES/NO 

No [n.a.] 

4. 

SUMMARY OF RESOURCES 

4.1.  Financial Resources 

4.1.1. Summary of commitment appropriations (CA) and payment appropriations (PA) 

Expenditure type 

Section 
no. 

Year 
n 

n + 1 

n + 2 

n + 3 

n + 4 

Total 

n + 5 
and 
later 

EUR million (to 3 decimal places) 

Operational expenditure15 

Commitment 
Appropriations (CA) 

8.1 

Payment  Appropriations 
(PA) 

a 

b 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

13 
14 
15 

Differentiated appropriations. 
Non-differentiated appropriations hereafter referred to as NDA. 
Expenditure that does not fall under Chapter xx 01 of the Title xx concerned. 

EN 

15 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Administrative expenditure within reference amount16 

Technical 
& 
administrative  assistance 
(NDA) 

8.2.4 

c 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

TTOOTTAALL  RREEFFEERREENNCCEE  AAMMOOUUNNTT  

Commitment 
Appropriations 

a+c 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

Payment 
Appropriations 
Administrative expenditure not included in reference amount17 

n.a. 

n.a. 

n.a. 

b+c 

n.a. 

n.a. 

n.a. 

n.a. 

Human 
associated 
(NDA) 

resources 

and 
expenditure 

Administrative  costs,  other 
than  human  resources  and 
associated 
not 
included in reference amount 
(NDA) 

costs, 

8.2.5 

d 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

8.2.6 

e 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

Total indicative financial cost of intervention  

TOTAL  CA 
cost 
Resources 

of 

TOTAL  PA 
cost 
Resources 

of 

including 
Human 

including 
Human 

a+c
+d+
e 

b+c
+d+
e 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

16 
17 

Expenditure within article xx 01 04 of Title xx. 
Expenditure within chapter xx 01 other than articles xx 01 04 or xx 01 05. 

EN 

16 

EN 

 
  
 
 
 
 
  
  
  
  
  
  
  
 
 
 
 
 
 
                                                 
Co-financing details 

If the proposal involves co-financing by Member States, or other bodies (please specify which), an estimate of the level of this co-financing 
should be indicated in the table below (additional lines may be added if different bodies are foreseen for the provision of the co-financing): not 
applicable 

Co-financing body 

EUR million (to 3 decimal places) 

n + 1 

n + 2 

n + 3 

n + 4 

Year 
n 

Total 

n + 5 
and 
later 

…………………… 

f 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

TOTAL CA including co-
financing 

a+c
+d+
e+f 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

4.1.2. Compatibility with Financial Programming 

⌧  Proposal is compatible with existing financial programming. 

(cid:133) 

(cid:133) 

Proposal will entail reprogramming of the relevant heading in the financial perspective. 

Proposal  may  require  application  of  the  provisions  of  the  Interinstitutional  Agreement18  (i.e.  flexibility  instrument  or 
revision of the financial perspective). 

18 

See points 19 and 24 of the Interinstitutional agreement. 

EN 

17 

EN 

 
  
 
 
 
                                                 
4.1.3. Financial impact on Revenue 

⌧  Proposal has no financial implications on revenue 

(cid:133) 

Proposal has financial impact – the effect on revenue is as follows: 

NB: All details and observations relating to the method of calculating the effect on revenue should be shown in a separate annex. 

Budget line

Revenue 

EUR million (to one decimal place) 

Situation following action 

[n+1]

[n+2]

[n+3]

[n+4]

[Year 
n] 

[n+5]
19 

Prior 
to 
action 
[Year 
n-1] 

a) Revenue in absolute terms 

n.a.  

n.a.  

n.a.  

n.a.  

n.a.  

n.a.  

b) Change in revenue 

 Δ 

n.a.  

n.a.  

n.a.  

n.a.  

n.a.  

n.a.  

(Please specify each revenue budget line involved, adding the appropriate number of rows to the table if there is an effect on more than 
one budget line.) 

4.2.  Human Resources FTE (including officials, temporary and external staff) – see detail under point 8.2.1. 

Annual requirements 

Year n 

n + 1 

n + 2 

n + 3 

n + 4 

n + 5 
and 
later 

Total  number  of  human 
resources 

0.2 

0.2 

0.2 

0.2 

0.2 

0.2 

19 

Additional columns should be added if necessary i.e. if the duration of the action exceeds 6 years. 

EN 

18 

EN 

 
  
 
 
 
 
                                                 
5. 

CHARACTERISTICS AND OBJECTIVES 

Details  of  the  context  of  the  proposal  are  required  in  the  Explanatory  Memorandum.  This  section  of  the  Legislative  Financial 
Statement should include the following specific complementary information: 

5.1.  Need to be met in the short or long term 

Availability of veterinary medicinal products containing thyrostatic substances in order to treat hyperthyroidism in dogs and cats, non 
use  of  oestradiol  17β  in  animal  production  in  order  prevent  long  term  increased  exposure  to  oestradiol  17  and  associated  possible 
increased related cancer rates. 

5.2.  Value-added  of  Community  involvement  and  coherence  of  the  proposal  with  other  financial  instruments  and  possible  synergy:  Not 

applicable  

5.3.  Objectives, expected results and related indicators of the proposal in the context of the ABM framework 

Financial objectives are not applicable 

5.4.  Method of Implementation (indicative)  

Show below the method(s)20 chosen for the implementation of the action. 

20 

If more than one method is indicated please provide additional details in the "Relevant comments" section of this point. 

EN 

19 

EN 

 
  
 
 
 
                                                 
(cid:133)  Centralised Management 

(cid:133)  Directly by the Commission 

(cid:133) 

Indirectly by delegation to: 

(cid:133) 

Executive Agencies 

(cid:133)  Bodies set up by the Communities as referred to in art. 185 of the Financial Regulation 

(cid:133)  National public-sector bodies/bodies with public-service mission 

(cid:133)ٱ  Shared or decentralised management 

X  With Member States 

X  With third countries 

(cid:133) 

Joint management with international organisations (please specify) 

Relevant comments: Marketing authorisations for thyrostatic substances and oestradiol 17β will have to be modified by Member States. 
Control of non use of oestradiol 17β is the task of Member States. Third counties will have to ensure that animals or animal products 
imported into the Community will not have been treated with oestradiol 17β. 

EN 

20 

EN 

 
  
 
6. 

MONITORING AND EVALUATION 

6.1.  Monitoring system 

Not foreseen 

6.2.  Evaluation 

6.2.1. Ex-ante evaluation 

Not foreseen 

6.2.2. Measures taken following an intermediate/ex-post evaluation (lessons learned from similar experiences in the past) 

Not foreseen 

6.2.3. Terms and frequency of future evaluation 

Not foreseen 

7. 

ANTI-FRAUD MEASURES  

Not applicable 

EN 

21 

EN 

 
  
8. 

DETAILS OF RESOURCES 

8.1.  Objectives of the proposal in terms of their financial cost: Not applicable 

Commitment appropriations in EUR million (to 3 decimal places) 

(Headings  of  Objectives,  actions 
and outputs should be provided) 

Type of 
output 

Av. 
cost 

Year 
n 

Year 
n+1 

Year 
n+2 

Year 
n+3 

Year 
n+4 

Year n+5 and 
later 

TOTAL 

No. outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

OPERATIONAL  OBJECTIVE  No.1 
21……… 
Action 1 thyrostatic subst. 

- Output 1 

- Output 2 

Action 2 Oestradiol  
- Output 1 

Sub-total Objective 1 

OPERATIONAL  OBJECTIVE  No.2 
1……… 
Action 1………………. 

- Output 1 

Sub-total Objective 2 

OPERATIONAL OBJECTIVE 
No.n 1 

Sub-total Objective n 

TOTAL COST 

n.a. 

n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 

n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 

n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 

n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

21 

As described under Section 5.3. 

EN 

n.a. 

n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

22 

n.a. 

n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 

n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 

n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 

n.a. 

n.a. 
n.a. 

n.a. 

n.a. 

n.a. 
n.a. 

n.a. 

n.a. 

n.a. 
n.a. 

n.a. 

n.a. 

n.a. 
n.a. 

n.a. 

n.a. 

n.a. 
n.a. 

n.a. 

n.a. 

n.a. 
n.a. 

n.a. 

n.a. 

n.a. 
n.a. 

n.a. 

n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

n.a. 
n.a. 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
8.2.  Administrative Expenditure 

8.2.1. Number and type of human resources 

Types of 
post 

Staff to be assigned to management of the action using existing and/or additional 
resources (number of posts/FTEs) 

A*/AD 

B*, 
C*/AST 

Officials 
or 
temporary 
staff22 
(XX 01 
01) 

Staff  financed23  by 
art. XX 01 02 

staff24 
Other 
financed  by  art.  XX 
01 04/05 

TOTAL 

Year n 

Year n+1 

Year n+2 

Year n+3 

Year n+4 

Year n+5 

0.1 

0.1 

n.a. 

n.a. 

0.1 

0.1 

n.a. 

n.a. 

0.1 

0.1 

n.a. 

n.a. 

0.1 

0.1 

n.a. 

n.a. 

0.1 

0.1 

n.a. 

n.a. 

0.1 

0.1 

n.a. 

n.a. 

0.2 

0.2 

0.2 

0.2 

0.2 

0.2 

8.2.2. Description of tasks deriving from the action 

Interpretation  and  explanation  of  instrument  in  presentations,  letters, 
meeting also with respect to World Trade Organisation Panels 

8.2.3. Sources of human resources (statutory) 

(When  more  than  one  source  is  stated,  please  indicate  the  number  of 
posts originating from each of the sources) 

(cid:133) 

(cid:133) 

(cid:133) 

Posts  currently  allocated  to  the  management  of  the  programme  to 
be replaced or extended 

Posts pre-allocated within the APS/PDB exercise for year n 

Posts to be requested in the next APS/PDB procedure 

⌧  Posts  to  be  redeployed  using  existing  resources  within  the 
is  a 

redeployment) 

Instrument 

(internal 

managing  service 
modification of existing legislation. 

(cid:133) 

Posts  required  for  year  n  although  not  foreseen  in  the  APS/PDB 
exercise of the year in question 

22 
23 
24 

Cost of which is NOT covered by the reference amount. 
Cost of which is NOT covered by the reference amount. 
Cost of which is included within the reference amount. 

EN 

23 

   EN 

 
 
 
 
 
 
 
                                                 
8.2.4. Other  Administrative  expenditure  included  in  reference  amount  (XX  01 

04/05 – Expenditure on administrative management) 

Budget line 

(number and heading) 

1. 

Technical  and  administrative 
assistance  (including  related 
staff costs) 

Executive agencies25 

Other 
administrative assistance 

technical 

and 

– 

– 

intra muros  

extra muros 

Total  Technical  and  administrative 
assistance 

EUR million (to 3 decimal places) 

Year 
n 

Year 
n+1 

Year 
n+2 

Year 
n+3 

Year 
n+4 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

Year 
n+5 
and 
later 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

TOTAL 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

8.2.5. Financial  cost  of  human  resources  and  associated  costs  not  included  in 

the reference amount 

Type of human resources 

Year n 

Year n+1  Year n+2  Year n+3  Year n+4 

Year n+5 

and later 

EUR million (to 3 decimal places) 

Officials and temporary staff (XX 01 
01) 

Staff  financed  by  Art  XX  01  02 
(auxiliary, END, contract staff, etc.) 

(specify budget line) 

Total cost of Human Resources 
and associated costs (NOT in 
reference amount) 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

Calculation – Officials and Temporary agents 

Reference should be made to Point 8.2.1, if applicable 

Not applicable 

25 

Reference should be made to the specific legislative financial statement for the Executive Agency(ies) 
concerned. 

EN 

24 

   EN 

 
 
 
                                                 
Calculation– Staff financed under art. XX 01 02 

Reference should be made to Point 8.2.1, if applicable 

Not applicable 

8.2.6  Other administrative expenditure not included in reference amount 

EUR million (to 3 decimal places) 

Year 
n 

Year 
n+1 

Year 
n+2 

Year 
n+3 

Year 
n+4 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

Year 
n+5 
and 
later 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

TOTAL 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

n.a. 

XX 01 02 11 01 – Missions 

XX 01 02 11 02 – Meetings & Conferences 

XX 01 02 11 03 – Committees26 

Committee 
Chain and Animal Health) 

for 

(Standing
the  Food

XX 01 02 11 04 – Studies & consultations 

XX 01 02 11 05 - Information systems 

2. 

3. 

Total  Other  Management 
Expenditure (XX 01 02 11) 

Other 
expenditure  of  an 
administrative  nature  (specify 
including reference to budget line) 

Total Administrative expenditure, other 
than human resources and associated 
costs (NOT included in reference 
amount) 

Calculation - Other administrative expenditure not included in reference amount 

Not applicable 

26 

Specify the type of committee and the group to which it belongs. 

EN 

25 

   EN