COMMISSION OF THE EUROPEAN COMMUNITIES 
C0M(92) 207 final 
Brussels, 20 May 1992 
Amendment to the proposal for a 
COUNCIL DIRECTIVE 
amending Directive 81/602/EEC and 88/146/EEC 
as regards the prohibition of certain substances having 
a hormonal action and of any substances 
having a thyrostatic action 
(presented by the Commission pursuant to Article 149(3) 
of the EEC-Treaty) 
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EXPLANATORY MEMORANDUM 
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On 14th September 1990 the Commission submitted a modified proposal to the 
Council for a Directive amending Directives 81/602/EEC and 88/146/EEC as 
regards the prohibition of certain substances having a hormonal action and of 
any substance having a thyrostatic act ion*1). 
Following the opinion given by the European Parliament at its session of 9th -
13th December 1991, the Commission agreed to modify its proposal. 
The modification establishes more precise details in relation to the 
authorization for use of testosterone for the prevention and treatment of 
ovine balonoposthitis and in relation to the controls to be carried out. 
(1) O.J. C 245, 29.09.1990 
AMENDMENT TO THE PROPOSAL FOR A COUNCIL DIRECTIVE 
amending Directive 81/602/EEC and 88/146/EEC 
as regards the prohibition of certain substances having 
a hormonal action and of any substances 
having a thyrostatic action *1). 
The Commission presented the above mentioned Proposal to the Council on 14th 
September 1990. As a result of the opinion given by the European Parliament 
during its session of 9th - 13th December 1991 the initial Proposal is 
amended as follows : 
1. The following recitals are added : 
'whereas, in certain regions of the Community and under certain climatic 
conditions, sheep, in particular extensively reared castrated male 
sheep, are susceptible to the disease known as 'ovine balanoposthitis', 
which causes the animals considerable stress, suffering and loss of 
condition; whereas the least painful and most effective method of 
prevention and control of this disease known at present is the 
administration of testosterone; whereas it is therefore desirable to 
authorize the administration of this substance for therapeutic and 
preventive purposes to animals affected by the disease; whereas such 
authorization must, however, be subject to strict controls to ensure 
that this substance is not used for fattening purposes; whereas 
Directives 81/602/EEC and 88/146/EEC must be amended accordingly;' 
'whereas the very existence, let alone the treatment, of ovine 
balanoposthi t is on a farm may result in heavy losses for the producer; 
whereas this factor must always be taken into account;' 
(1) O.J. C 245, 29.09.1990 
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2. In Article 1, paragraph 4a is replaced by the following : 
'the veterinary medicinal products used for treatment and prevention 
must be administered only by a veterinarian to castrated male sheep 
which are clearly identified;' 
3. In Article 1, paragraph 4b is replaced by the following : 
'the disease must have been diagnosed on the basis of examination of the 
animal by a veterinarian; preventive treatment must be authorized by the 
competent authorities. In the latter case, the competent veterinary 
authorities must establish the meteorological and environmental factors 
necessitate preventive treatment against ovine balanoposthitis, 
providing that some proved cases have occurred previous to the decision 
to authorize preventive treatment. The competent authorities must 
specify the particular characteristics and location of the farms 
concerned, and the period and frequency of treatment;' 
4. In Article 1, paragraph 4c is replaced by the following : 
'both in the case of therapeutic treatment and preventive action, the 
veterinarian must keep a record of the following : 
- the nature of the treatment 
the nature of the medicinal product authorized 
the date of treatment 
the identity of the animals treated 
the date when slaughter is authorized 
This information must be made available at the request of the competent 
authorities who must ensure that the information accompanies the animals 
until the time of slaughter and in particular that the official 
veterinarian responsible for ante and post mortem inspection is informed 
prior to making a decision concerning the fitness of the carcass for 
consumpt ion;' 
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5. Article 2 is replaced by the following : 
'The Council, acting by a qualified majority on a proposal from the 
Commission, may adopt derogations from Articles 5 and 6 in respect of 
trade in animals intended for reproduction and reproductive animals at 
the end of their career, and sheep which have been treated for ovine 
balanoposthitis, which, in the course of their existence, have been 
treated under the provisions of Article 4 (1) (2) (3) and (4) of 
Directive 81/602/EEC and in respect of meat from these various animals, 
taking into account the guarantees given and provided that the waiting 
period has expired.' 
'Notwithstanding Article 6(1) for the purpose of Article 7(2) of 
Directive 86/469/EEC, guarantees at least equivalent to those required 
under paragraph 1 shall be established in accordance with the procedure 
laid down in Article 8, and must be provided in respect of imports from 
third countries of sheep as referred to in Article 4(3) of Directive 
81/602/EEC and meat derived therefrom. Guarantees that the waiting 
period has expired must also be given.' 
6. Article 3 is replaced by the following : 
'Before 1 January 1993 the Commission will submit a report to the 
Council and the European Parliament on the experience gained, together 
with proposals for possible amendments to the provisions in force.' 
7. Article 4 is replaced by 
'Member States shall bring into force the laws, regulations and 
administrative provisions necessary to comply with this Directive before 
'When Member States adopt these measures, the latter shall contain a 
reference to this Directive or shall be accompanied by such reference on 
the occasion of their official publication. The methods of making such 
a reference shall be laid down by the Member States.' 
'Member States shall communicate to the Commission the provisions of 
national law which they adopt in the field governed by this Directive.' 

U ISSN 0254-1475 
COM (92) 207 final 
DOCUMENTS 
EN 03 
Catalogue number: CB-CO-92-220-EN-C 
ISBN 92-77-44285-9 
Office for Official Publications of the European Communities 
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