6. 5. 82 Official Journal of the European Communities No C 114/17 
Opinion on the proposal for a Council Directive on the manufacture, putting into 
circulation and supply of medicated feedingstuffs in the Community 
The text referred to the Committee has been published in Official Journal of the 
European Communities No C 41 of 16 February 1982, page 3. 
A. LEGAL BASIS FOR THE OPINION 
On 29 January 1982 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 
196th plenary session held in Brussels on 24 March 1982. 
The full text of the opinion is a 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 made by the Council of 
the European Communities on 29 January 1982 for 
an opinion on the proposal for a Council Directive 
on the manufacture, putting into circulation and 
supply of medicated feedingstuffs in the 
Community, 
Having regard to the decision taken by its Bureau on 
26 January 1982, instructing the Section for 
Agriculture to draw up an opinion on the matter, 
Having regard to its previous work on the matter, 
Having regard to the opinion adopted by the above 
Section at its 233rd meeting held on 18 March 
1982, 
Having regard to the oral report made by the 
rapporteur, Mr Wick, 
Having regard to its discussions at the 196th plenary 
session held on 24 March 1982, 
HAS ADOPTED THE FOLLOWING OPINION 
unanimously: 1. General comments 
1.1. The Committee approves the proposed 
Directive subject to the following comments. 
When discussing, as long ago as 1976, the draft 
Directive on the approximation of the laws of the 
Member States relating to veterinary medicinal 
products (a Directive not adopted by the Council 
until autumn 1981), the Committee urged that rules 
on medicated feedingstuffs be adopted as rapidly as 
possible. 
1.2. Medicated feedingstuffs, i.e. specific mixtures 
of veterinary medicinal products and feedingstuffs 
which are prepared under special conditions prior to 
being put into circulation, have proved to be an 
extremely important, indispensable and at the same 
time economic way to prevent and cure diseases — 
which in certain cases are even caused by modern 
livestock farming methods. 
The Committee therefore considers that the 
protection of human health necessitates Community 
rules to ensure that medicated feedingstuffs are 
manufactured under the same, effectively controlled, 
conditions in all the Member States and are supplied 
on the prescription of a veterinarian who is 
responsible for seeing that their use in treating 
animals is justified on veterinary grounds. 
No C 114/18 Official Journal of the European Communities 6. 5. 82 
1.3. The Directive's scope is confined to medicated 
feedingstuffs which must be manufactured from 
officially authorized pre-mixes of veterinary 
medicinal products and from feedingstuffs that 
comply with Community law. 
The Committee notes that the supply of other 
veterinary medicinal products is not covered. In its 
view it would be advisable to follow up the draft 
Directive by extending the approximation of laws to 
provide Community rules for this sector too. 
1.4. The draft Directive is linked to Directive 81/ 
851 /EEC which deals in particular with the 
authorization and manufacture of veterinary 
medicinal product pre-mixes. Under Article 2 (3) of 
this Directive the Council has until October 1983 to 
decide on an approved list of pharmacological 
molecules which may be used for preparing 
veterinary medicinal product pre-mixes. 
The Committee hopes that this and other provisions 
in the Directive on veterinary medicinal products are 
implemented on time so as to ensure that the rules on 
medicated feedingstuffs are applied rapidly, 
correctly and uniformly throughout the 
Community. 
2. Specific comments 
2.1. Article 2 (m) 
The term 'standard prescription' is not precise 
enough. The basic requirements which must be met in 
preparing such prescriptions should be spelt out. 
2.2. Article 3 (1) 
Paragraph 1 should state explicitly that this Directive 
does not apply to the additives in animal 
feedingstuffs. 
At present Article 3 (1) of the draft Council Directive 
states that: 'This Directive shall be without prejudice 
to other Community provisions on feedingstuffs.' 
2.3. Article 3 (2) 
The Committee assumes that export authorization 
will only be given in the case of medicated 
feedingstuffs which comply with the requirements of 
the recipient country and with the Community's 
consumer protection requirements. 
2.4. Article 5 (2) and (4) 
The Committee believes that manufacturing firms 
must also be required to provide adequate health protection for workers engaged in the manufacture of 
medicated feedingstuffs. 
2.5. Third sentence of Article 5 (3) 
Authorization procedures for pre-mixes and for 
manufacturers of veterinary medicinal products are a 
sine qua non if this particular provision is to be 
complied with. The Committee also believes that any 
restrictions should be clearly indicated on the 
standard prescription or prescription. (The fourth 
'whereas' of the preamble states that 'precise 
instructions' are to be given in a prescription or 
standard prescription). 
2.6. Article 5 (6) 
The Directive stipulates that manufacturers' records 
must be kept for one year and the Committee 
wonders whether this period is long enough to enable 
the necessary inspections to be carried out. 
2.7. Fifth paragraph of Article 12 (1) 
The Committee likewise wonders whether the 
stipulated period of one year for the preservation of 
veterinarians' prescriptions will be long enough to 
allow the necessary checks to be carried out. 
2.8. Article 12 (2) 
The Committee is aware that this Directive cannot 
indicate in greater detail what is meant by animals 
treated by or in the care of a veterinarian. The 
Committee would like to see clarification of this 
matter in an explanatory memorandum which would 
also make it clear that animals need to be under the 
direct supervision of the veterinarian. The 
Committee also believes that the date and type of 
treatment should be recorded in some appropriate 
manner. 
2.9. Article 12 
In this connection the Committee also sees a need for 
precautionary measures to ensure that the health of 
stockfarmers and their employees is adequately 
protected when medicated feedingstuffs are used. 
2.10. Article 13 
The draft Directive states that medicated 
feedingstuffs may also be supplied to the livestock-
farmer by the merchant. If this additional retail 
channel — not previously available in some EEC 
countries — is now to be opened up, adequate 
measures will have to be taken to ensure that 
Community regulations are still stringently complied 
with. 
6. 5. 82 Official Journal of the European Communities No C 114/19 
2.11. The Committee realizes that uniform 
sanctions are precluded in view of the fact that 
criminal law has not been harmonized. It 
nevertheless trusts that Member States will take into consideration the deterrent effect, when drawing up 
their legislation, and that distortions of competition 
caused by varying threats of sanctions will be 
avoided. 
Done at Brussels, 24 March 1982. 
The Chairman of the Economic and 
Social Committee 
Tomas ROSEINGRAVE