9. 6. 81 Official Journal of the European Communities No C 138/29 
Opinion 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 
The text referred to the Committee has been published in Official Journal of the 
European Communities No C 305 of 22 November 1980, page 2. 
A. LEGAL BASIS FOR THE OPINION 
On 10 November 1980 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 decision taken by the Council of 
the European Communities on 10 November 1980 
asking it to deliver an opinion 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, 
Having regard to the decision taken by the ESC 
Bureau on 18 December 1980, instructing the Section 
for Agriculture to draw up an opinion on the 
matter, 
Having regard to the report presented by the 
rapporteur, Mr Jaschick, 
Having regard to its discussions at its 185th plenary 
session, held on 25 and 26 February 1981 (meeting of 
25 February 1981), 
HAS ADOPTED THE FOLLOWING OPINION 
by 70 votes to three, with 20 abstentions: 
1. General comments 
1.1. The Committee welcomes the Commission's 
intention to regulate the use of substances with a hormonal or thyrostatic action on animals to be used 
as human food. Its approval is qualified by the 
following comments. 
1.2. The Committee recognizes that there is an 
urgent need to draw up Community provisions in 
order to protect human health and offer agricultural 
producers equal opportunities. 
1.3. The Committee considers that although some 
aspects of the problem might lend themselves more to 
a Directive, the arguments in favour of a Regulation 
(e.g. the possibility of immediate application) are 
more powerful. However, under no circumstances 
should the abolition of existing national provisions 
be allowed to create a 'gap in the law'. The 
simultaneous adjustment of existing provisions in 
individual Member States would be facilitated by a 
Regulation. 
1.4. In view of the existence of a 'grey' market, it is 
imperative that control should be exercised on the 
production, import, storage and distribution of such 
substances. The Commission has therefore made a 
proposal for a separate Regulation (COM(80)922 
final) in implementation of Article 4, and the system 
outlined could be conveniently applied to all such 
substances. This must not, however, be allowed in 
any way to retard the entry into force of the present 
Regulation. 
No C 138/30 Official Journal of the European Communities 9. 6. 81 
2. Specific comments 
2.1. The Committee points out that according to the 
first recital of the preamble there is still no conclusive 
evidence of whether such substances are dangerous 
irrespective of dose, so there should be no relaxation 
of the requirement that producers must prove such 
substances to be harmless before putting them on the 
market. In this context the Committee also considers 
it essential to take account of the products formed 
when such substances are broken down or involved 
in a reaction. The title of the Regulation should also 
speak of 'productive' rather than 'domestic' animals, 
in line with the comments made hereafter on 
Article 2. 
The Committee would like the Commission to 
consider whether implants of specific hormonal 
substances for fattening could be allowed, provided 
such substances are safe from a health point of view 
and provided the quality of the meat is not in any 
way impaired. 
Article 1 
2.2. The proposed Regulation applies only to 
certain substances with a pharmacological action. 
The Commission's 1976 proposal on veterinary 
medicines in general should therefore also be 
adopted as soon as possible. 
2.3. The Committee considers that the absence of 
residues in animals or fresh meat is no proof that 
such substances have not been used. Controls should 
therefore be carried out primarily on holdings. The 
Committee points out, however, that there would be 
practical difficulties in carrying out such controls. 
Article 2 
2.4. The proposed Regulation should also generally 
apply to animals used in food production, and that 
includes rabbits, game in enclosures, fish, etc. 
Paragraph (a) should therefore read: 
'Productive animals: Animals used in food 
production.' 
The Regulation should therefore be redrafted in the 
appropriate places. 
2.5. Frozen meat should also be included in 
paragraphs (b) and (c) through reference to certain 
Directives. Article 3 
2.6. The first words 'Notwithstanding Article 4' 
should not apply to Article 3 (b) and should therefore 
be deleted. Article 3 should then read: 
'(a) The use on ... affect is prohibited (with the 
exception of Article 4(1). 
(b) The putting into trade ... is prohibited.' 
2.7. The Committee is strongly in favour of third-
country imports being treated with the same 
stringency as intra-Community products. It draws 
attention, however, to the difficulties of exercising 
satisfactory control over the use of natural hormonal 
substances in third countries. The Committee 
emphasizes the need to find an appropriate solution 
to this problem. 
2.8. The Committee warns against the danger of 
abusing this control system in order to create barriers 
to trade. 
Article 4 
2.9. The Committee wonders whether it is possible 
to distinguish between natural and artificial 
hormonal substances in every case. It therefore 
strongly urges that no opportunities should be 
created for circumventing the law, especially through 
synchronization of the oestrous cycle. 
2.10. The Commission has made provisions in a 
supplementary Regulation for the implementation of 
Article 4 and a list of the substances which may be 
administered to 'productive' animals in the 
circumstances specified. 
The lack of additional provisions on the application 
of paragraph 1 would have particularly deleterious 
effects when the Regulation comes into force. The 
Committee therefore urges the simultaneous 
adoption of the relevant provisions. The Committee 
is particularly anxious that there should be no 'gap in 
the law' pending adoption of the Community list of 
approved products. 
Article 5 
2.11. Owing to the rapid breakdown of certain 
substances, tests to detect residues should preferably 
be carried out on living animals in pens at the 
holding of origin or transit, or on freshly slaughtered 
animals (with viscera) at the slaughterhouse. 
Additional tests are also needed in the case of meat 
and meat products (e. g. baby food) brought onto the 
market in the Community. This is particularly true of 
third-country imports. 
9. 6. 81 Official Journal of the European Communities No C 138/31 
banned) in order to cover the costs of controls and 
examinations. Consideration should be given to 
whether public health funds should not be made 
available for this purpose. 
Article 8 
2.15. The Council, Commission and Member States 
should take great care to make sure that when the 
present Regulation is brought into force there should 
be no period of grace during which sanctions cannot 
be applied. 
Article 11 
2.16. The Committee recommends that the 
proposed Regulation should enter into force as soon 
as possible. 
The Chairman 
of the Economic and Social Committee 
Tomas ROSEINGRAVE 
ANNEX 
to the Economic and Social Committee's opinion 
Amendments rejected 
The following amendments, tabled in accordance with the Rules of Procedures, were rejected 
during the discussions: 
Insert new paragraph, between 1.3 and 1.4 and adjust numbers accordingly, as follows: 
'The Committee regrets that the Commission has not relied on an appropriate consultative 
procedure to support the proposals and before preparing the Draft Regulation.' 
Reason 
It is normal procedure, particularly in such a complicated matter, for the Commission to 
emphasize the recommendations of experts in the field. There exists a Standing Veterinary 
Committee set up by Council Decision of 15 October 1968 (see Article 10 of this Regulation) and 
there is no reference to its consultation in the Explanatory Note attached to the Regulation. There 
also exists the Commission's Advisory Veterinary Committee which rejected the Commission's 
proposals at its meeting on 27 November 1980 (paragraph 4.1 page 14 of the report) and made 
alternative recommendations which were supported by COPA, COGECA, FVE, Commerce, 
Industry and Workers representatives. The draft Regulation is dated 31 October, i. e. prior to this 
particular recommendation. 
Result of the voting 2.12. Methods of analysis used to detect residues 
must be the same in third countries as in the 
Community. Experience has shown that certificates 
produced by veterinary authorities in third countries 
are not sufficient. The problem of tolerances is 
especially thorny and so calls for careful and early 
consideration by the Commission. The Committee 
emphasizes that tolerances for the residues of 
prohibited artificial substances used in fattening 
should be set at zero. 
Article 6 
2.13. The Committee wonders to what extent these 
provisions can actually be put into practice. 
Article 7 
2.14. The Committee is against the automatic 
levying of a tax on products (even when they are not 
Done at Brussels, 25 February 1981. 
For: 14, Against: 50, Abstentions: 16 
No C 138/32 Official Journal of the European Communities 9. 6. 81 
Page 29, paragraph 1.4: 
Delete last sentence. 
Reason 
This sentence was not in the text of the draft opinion nor the relative amendment of the paragraph 
at the section meeting. It implies the urgent adoption of the whole draft Regulation which would be 
an erroneous interpretation of this opinion. 
Result of the voting 
For: 13, Against: 61, Abstentions: 16 
Page 30, second paragraph of 2.1 (specific comments): 
Insert after the first line the words: 
'the strong recommendation of the Advisory Veterinary Committee and'. 
The paragraph will therefore read: 
'The Committee would like the Commission to consider the strong recommendation of the 
Advisory Veterinary Committee and whether implants ...' 
Reason 
The rapporteur has condensed a more specific amendment at the section meeting and which 
quoted paragraph 5.3. Page 23 of his written report (CES 1429/80). The amendment envisaged the 
registration of approved products. 
Result of the voting 
For: 18, Against: 60, Abstentions: 11 
Page 31, paragraph 2.16, Article 11: 
Delete this comment. 
Reason 
It is unnecessary and implies full approval of the proposals by the Committee. In fact, elsewhere in 
the opinion difficulties in the implementation of the proposals are foreseen (e.g. 2.3 last sentence; 
2.7 last two sentences and 2.13). However, some regulation is required and suitable amendments 
would meet with approval from all interested in this serious problem. 
Result of the voting 
For: 8, Against: 63, Abstentions: 14