9. 6. 81 Official Journal of the European Communities No C 138/21 
Opinion on the proposal for a Council Regulation laying down conditions for controlling 
the possession, distribution and administration to animals of certain substances with a 
hormonal action 
The text referred to the Committee has not yet been published in the Official Journal of 
the European Communities. 
A. LEGAL BASIS FOR THE OPINION 
On 14 January 1981 the Council referred the abovementioned proposal to the Economic 
and Social Committee in accordance with Article 43 of the Treaty establishing the 
European Economic Community. 
B. OPINION OF THE ECONOMIC AND SOCIAL COMMITTEE 
The Economic and Social Committee prepared its opinion on the above matter at its 
185th plenary session held in Brussels on 25 and 26 February 1981. 
The full text of the opinion is as follows: 
THE ECONOMIC AND SOCIAL COMMITTEE, 
Having regard to the Treaty establishing the 
European Economic Community, and in particular 
Article 43 thereof, 
Having regard to the request from the Council of the 
European Communities on 14 January 1981 for an 
opinion on the proposal for a Council Regulation 
laying down conditions for controlling the 
possession, distribution and administration to 
animals of certain substances with a hormonal 
action, 
Having regard to the decision of its chairman on 
12 January 1981 instructing the Section for 
Agriculture to do the preparatory work on the matter 
(Article 46 (2) of the Rules of Procedure — Urgency 
Procedure), 
Having regard to its opinions on the proposal for a 
Council Regulation concerning the use of substances 
with a hormonal action and those having a 
thyrostatic action in domestic animals and the 
proposal for a Council Regulation concerning the 
control and examination of animals and meat in the 
Community for the presence of residues of 
substances with oestrogenic, endrogenic, gestagenic 
and thyrostatic effect, 
Having regard to the oral report of the rapporteur, 
Mr Jaschick, 
Having regard to its discussions on 25 February 
1981, during the 185th plenary session, held on 25 
and 26 February 1981, HAS ADOPTED THE FOLLOWING OPINION 
by 65 votes to one, with 20 abstentions: 
1. General comments 
1.1. The Committee welcomes the Commission's 
concern to introduce comprehensive rules for the use 
of substances with a hormonal action. Recent 
problems with such substances make it imperative to 
take immediate steps to protect consumers. 
2. Specific comments 
Article 2 
2.1. The Committee feels that the definition of 
'domestic animals' should be extended to cover all 
animals from which food is obtained. 
2.2. The Committee proposes the insertion of a new 
subparagraph (d) defining regulation of the oestrus 
cycle. 
(d) Regulation of the oestrus cycle 
action, which for zootechnical purposes, 
makes it possible to synchronize the oestrus in 
non-cyclical and cyclical female animals. 
No C 138/22 Official Journal of the European Communities 9. 6. 81 
Article 3 
2.3. The Committee wonders how the term 
'properly' (Article 3(1)) can be construed 
uniformly. 
2.4. It assumes that the imports and distribution 
will be dealt with on a case-by-case basis. 
2.5. As regards Article 3 (4) it would refer to its 
comments in 2.2. 
Article 4 
2.6. The Committee feels that the period for which 
registers are to be kept should be stated clearly. 
Article 5 
2.7. The Committee recommends that the 
procedure provided for in Article 10 should be used 
for authorizing substances for therapeutic use or 
synchronization of the oestrus. It also stresses that 
each specific substance must be checked to see if it is 
really necessary in the light of the substances which 
have been authorized previously. It assumes that the 
substances listed under Article 5 will be authorized 
for therapeutic use under the procedure provided for 
in Article 10. The Committee would refer to the 
possibility of a legal vacuum between the entry into 
force of the Regulation and the authorization of 
substances under Article 10. 
2.8. The first indent should refer to the 
synchronization of the oestrus. 
2.9. The second indent should also state that 
substances which are being considered for 
authorization should be vetted for interaction with 
other substances. 
Done at Brussels, 25 February 1981. Article 6 
2.10. The Committee points out that under Article 6 
medicinal products banned in the Community may 
be manufactured for export. This would not only 
increase health hazards for non-Community 
consumers but could also promote a black market in 
the Community. 
Article 7 
2.11. Prescriptions should have to be kept for six 
months (Article 7 (2)). 
Article 8 
2.12. Steps must be taken to make bans water­
tight. 
Article 9 
2.13. In view of the fact that the Regulation is 
directly applicable in the Member States, the 
Committee feels that the check procedures must be 
regulated. As regards the location for the checks the 
Committee would refer to its comments on the parent 
Regulation (Doc. COM(80) 614 fin). 
Article 11 
2.14. This Regulation and the parent Regulation 
should enter into force simultaneously. 
The Chairman 
of the Economic and Social Committee 
Tomas ROSEINGRAVE 
9. 6. 81 Official Journal of the European Communities No C 138/23 
ANNEX 
to the Economic and Social Committee's opinion 
Amendment rejected 
The following amendment, tabled in accordance with the Rules of Procedure, was rejected during 
the discussions: 
Page 22 
Article 11, paragraph 2.14 
Substitute the following conclusion: 
"This Regulation is supplemental to the basic draft Regulation (COM(80) 614 fin) and 
essential to the implementation of the provisions of Article 4 thereof. The control of approved 
substances as outlined in this Regulation could be conveniently applied to those other 
substances which might be registered or approved in amending the basic Regulation as 
recommended.' 
Result of the voting 
For: 10, Against: 52, Abstentions: 15