No C 170/4 Official Journal of the European Communities 29.6. 84 
Proposal for a Council Directive amending Directive 81/602/EEC concerning the 
prohibition of certain substances having a hormonal action and of any substances having a 
thyrostatic action 
COM(84) 295 final 
(Submitted by the Commission to the Council on 13 June 1984) 
(84/C 170/03) 
THE COUNCIL OF THE EUROPEAN 
COMMUNITIES, 
Having regard to the Treaty establishing the 
European Economic Community, and in particular 
Article 43 thereof, 
Having regard to Council Directive 81/602/EEC of 
31 July 1981 concerning the prohibition of certain 
substances having a hormonal action and of any 
substances having a thyrostatic action ('), and in 
particular Articles 5 and 7 thereof, 
Having regard to Council Directive 64/433/EEC of 
26 June 1964 on health problems affecting intra -
Community trade in fresh meat (2), as last amended 
by Directive 83/90/EEC (3), and in particular Article 
4 (2) thereof, 
Having regard to the proposal from the Commission, 
Having regard to the opinion of the European 
Parliament, 
Having regard to the opinion of the Economic and 
Social Committee, 
Whereas the adoption of Community provisions 
concerning the absorption by farm animals of sub­
stances having a hormonal action or thyrostatic action 
have the object, in the interest of consumers, of 
protecting human health and of removing barriers to 
intra-Community trade of animals, meat and meat 
products resulting from differences between the 
health requirements of Member States; 
Whereas it is therefore necessary to supplement the 
provisions already laid down on the matter by the 
aforementioned Directive 64/433/EEC and Council 
Directive 71/118/EEC of 15 February 1971 
concerning health problems of trade in fresh poul-
trymeat (4), as last amended by Directive ..., and by 
the aforementioned Directive 81/602/EEC; 
Whereas, in accordance with Article 5 of Directive 
81/602/EEC, it is necessary to take a decision as 
(') OJ No L 222, 7. 8. 1981, p. 32. 
(2) OJ No 121, 29. 7. 1964, p. 2012/64. 
(») OJ No L 59, 5. 3. 1983, p. 10. 
(4) OJ No L 55, 8. 3. 1971, p. 23. soon as possible on the administering to farm animals 
of Oestradiol 176, Progesterone, Testosterone, 
Trenbolone and Zeranol for fattening purposes; 
Whereas it is important to authorize only substances 
which have a favourable effect on farm animal 
production and whose administration will neither 
present harmful effects on human health nor harm the 
consumer by altering the characteristics of meat; 
Whereas the Scientific Veterinary Committee, the 
Scientific Committee for Animal Nutrition and the 
Scientific Committee for Food have studied this 
problem on the basis of a report of a Commission 
scientific group on anabolic agents in animal 
production; whereas the Commission has declared its 
intention to continue to consult these Committees 
and the numerous interested parties, in particular the 
consumers, on these questions; 
Whereas it appears that some data necessary on the 
toxicology of Trenbolone and Zeranol and their 
metabolites are still lacking; whereas, in consequence, 
their use for fattening purposes must in the present 
circumstances be prohibited; 
Whereas, on scientific grounds, it appears that the use 
of Oestradiol 176, Testosterone and Progesterone, 
and those derivatives which readily yield the parent 
compound on hydrolysis after absorption from the 
site of application, would not present any harmful 
effects to the health of the consumer nor harm the 
consumer by altering the characteristics of meat when 
used under the appropriate conditions as growth 
promoters in farm animals; whereas, in consequence, 
Member States may authorize their use for fattening 
purposes; 
Whereas approval of products containing authorized 
substances must comply with the relevant principles 
and criteria set out in Council Directive 81/851/EEC 
of 28 September 1981 on the approximation of the 
laws of the Member States relating to veterinary 
medicinal products (s), and Council Directive 
81/852/EEC of 28 September 1981 on the approxi­
mation of the laws of Member States relating to 
analytical, pharmaco-toxicological and clinical 
(s) OJ No L 317, 6. 11. 1981, p. 1. 
29.6. 84 Official Journal of 
standards and protocols in respect of the testing of 
veterinary medicinal products (*); whereas additional 
requirements as regards carrier substances, conditions 
of use and withdrawal periods must also be complied 
with; whereas a Community procedure within the 
Standing Veterinary Committee, set up by Council 
Decision 68/361/EEC of 15 October 1968 (2)> should 
be used to establish a list of products which may be 
approved and the conditions of their use, as well as to 
modify the list of authorized substances in the light of 
progress in scientific and technical knowledge; 
Whereas Member States may choose not to allow in 
their territory the marketing and administration to 
farm animals, for fattening purposes, of substances 
and products which may be authorized under the 
present Community rules, but must not raise any 
obstacle for human health reasons to the importation 
of animals, meat and meat products from other 
Member States where such substances and products 
have been authorized in accordance with Community 
rules; 
Whereas it is suitable to prescribe, in accordance with 
Article 7 of Directive 81/602/EEC and Article 4 (2) 
of Directive 64/433/EEC, the measures necessary for 
the control of farm animals, of meat and meat 
products in relation to the use of substances having a 
hormonal action or thyrostatic action, as well as 
tolerances for these substances and the frequency of 
sampling; and that these measures must also facilitate 
the cooperation between Member States in the 
application of these controls and, where necessary, 
provide for the adoption, in accordance with the 
procedure of the Standing Veterinary Committee, of 
measures necessary to ensure the coordination and 
uniform application of these controls, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Directive 81/602/EEC is hereby amended as follows: 
1. Article 5 is replaced by the following: 
'Article 5 
1. By way of derogation from Article 2, 
Member States may authorize the administering to 
farm animals, for fattening purposes, of Oestradiol 
176 Testosterone and Progesterone and those deri­
vatives which readily yield the parent compound 
on hydrolysis after absorption from the site of 
application. 
OOJNoL317, 6. 11. 1981, p. 16. 
(2) OJ No L 255, 18. 10. 1968, p. 23. European Communities No C 170/5 
2. Member States shall ensure that the 
aforementioned substances are: 
— only administered to farm animals by implan­
tation which is located in a part of the animal 
which must be discarded at slaughter, 
— only administered to animals which are 
identified at the time of implantation and that 
these animals are not slaughtered before the 
expiry of the delay period laid down in 
application of subparagraph (3a), 
— administered by a veterinarian. 
3. (a) Before 1 April 1986, in accordance with the 
procedure laid down in Article 16 and 
following the relevant principles and criteria 
of Directives 81/851/EEC and 81/852/ 
EEC, there shall be established: 
— a list of products containing as active 
substances the substances referred to in 
paragraph 1 which may be approved for 
marketing and use in the Community, 
— the conditions of use of products 
contained in the abovementioned list in 
application of paragraph 2, in particular 
the delay period necessary and detailed 
provisions concerning the control of 
these conditions of use, 
-r- the means of identification of animals. 
(b) Member States shall ensure that the 
products mentioned under subparagraph (a) 
are subject to the rules of Articles 24 to 50 
of Directive 81/851/EEC except for those 
rules which relate to the national author­
ization for marketing. 
4. In order to take account of scientific and 
technical progress, the list of substances referred to 
in paragraph 1 which may be administered to 
animals for fattening purposes may be completed 
or amended in accordance with the procedure laid 
down in Article 16. 
Any substance which may be authorized: 
— must have a favourable effect on farm animal 
production, 
— must not endanger human or animal health nor 
harm the consumer by altering the charac­
teristics of farm animal products, 
— must comply with the relevant principles and 
criteria of Directives 81/851/EEC and 
81/852/EEC. 
No C 170/6 Official Journal of the European Communities 29. 6. 84 
5. However, any decision concerning the 
possible inclusion of Trenbolone or Zeranol on the 
list shall be made by the Council, acting by a 
qualified majority on a proposal from the 
Commission, and in conformity with the other 
conditions laid down in paragraph 4.' 
2. Article 7 is replaced by the following Articles: 
'Article 7 
Without prejudice to the provisions of Directive 
64/433/EEC, Member States shall ensure that 
checks on compliance with the prohibitions as laid 
down in Articles 2 and 3, checks on farm animals, 
the meat of such animals, the meat products 
obtained therefrom for the presence of residues of 
hormonal substances referred to in Article 2 (a) 
and checks on compliance with the conditions of 
use of products provided for in Article 5 are 
carried out in their territory in accordance with 
the provisions of this Directive. 
Article 8 
Member States shall ensure that on-the-spot 
random checks for the presence of prohibited sub­
stances as referred to in Articles 2 and 3 are made 
officially at the levels of manufacturing, handling, 
storage, transport, distribution and sale. 
Article 9 
1. Member States shall ensure that on-the-spot 
random checks are made officially for the presence 
of prohibited substances as referred to in Articles 2 
and 3 at agricultural holdings where animals are 
reared, held or fattened for slaughter. 
2. The checks shall include taking random 
samples from animals for examination for the 
presence of residues. 
Article 10 
1. Member States shall ensure that random 
checks are taken officially from animals and meat, 
including meat destined for the production of meat 
products, at the slaughterhouse of production for 
examination for the presence of residues of sub­
stances mentioned in Article 2 (a). 
2. In particular, random samples shall be taken 
of animals and meat from holdings submitting 
regularly calves and fattened bovine animals for 
slaughter. Article 11 
1. The samples referred to in Article 9 (2) and 
Article 10 shall be taken officially and examined 
by an authorized laboratory for the presence of 
residues. 
2. The examination for residues referred to in 
paragraph 1 must be carried out in accordance 
with proven methods which are scientifically 
recognized, in particular those laid down by 
Community provisions. 
It must be possible to assess the examination for 
residues using the reference methods established in 
accordance with Article 4 (1) (b) of Directive 
64/433/EEC. 
3. All positive findings shall be confirmed by an 
official laboratory using the reference method 
referred to above in paragraph 2. 
Article 12 
1. Where examination as referred to in Article 
11 (3) has confirmed the presence of prohibited 
substances or of residues exceeding the maximum 
natural physiological levels of authorized sub­
stances, the competent authorities shall be 
informed without delay of: 
(a) all information needed to identify the origin of 
the animals; 
(b) the result of the examination. 
2. The competent authorities shall thereupon 
ensure that: 
(a) an investigation is made at the farm of origin 
to determine the reason for the presence of 
residues; 
(b) an investigation of the source or sources of the 
substance concerned is made as necessary at 
the levels of distribution, sale, transport, 
handling, storage and manufacture. 
3. The competent authorities shall also ensure 
that: 
(a) the herd or animals at the farm of origin and 
herds which, as a result of the investigations 
referred to in paragraph 2 may be assumed to 
contain the residue in question, are provided 
with official marking and subject to appro­
priate examinations; 
(b) if the examination reveals the presence of 
prohibited substances, the animals shall be 
confiscated or destroyed; 
(c) if the examination reveals the presence of 
residues of authorized substances above the 
limits mentioned in paragraph 1, the slaughter 
29.6.84 Official Journal of the European Communities No C 170/7 
of the animals concerned for human 
consumption shall be prohibited until it can be 
ensured that the amount of residue no longer 
exceeds the permitted levels. This period may 
in no case be shorter than the delay period 
fixed for the substance in application of Article 
5 (3) (a). However, where it is ascertained that 
the conditions of use laid down have not been 
complied with, the animals concerned shall be 
confiscated or destroyed; 
(d) during the period of examination, the animals 
must not be disposed of to other parties: 
4. By way of derogation from paragraph 3 (c), 
animals whose slaughter is prohibited may be 
slaughtered before the end of the prohibition 
period if the competent authority is informed at 
least one week before the proposed slaughter date, 
stating the place of slaughter. The officially 
marked animals must be accompanied to the place 
of slaughter by an official veterinary certificate 
containing the information required under 
paragraph 1 (a). 
The carcase of each animal whose slaughter is 
notified pursuant to the above subparagraph shall 
be officially examined for the residue concerned 
and shall be detained until the result of the exami­
nation is known. 
Article 13 
Where the checks and investigations referred to in 
Articles 8 to 12 disclose the presence of prohibited 
substances referred to in Articles 2 and 3, Member 
States shall ensure that the substances concerned 
are placed under official control until the 
necessary sanctions are taken. 
Article 14 
1. Where the findings in one Member State 
indicate the need for investigation in one or more 
other Member States, the Member State concerned 
shall inform the other Member States and the 
Commission thereof. 
2. In accordance with the procedure of Article 
17, measures may be taken to ensure the coordi­
nation of the investigations necessary in relation to 
the presence of prohibited substances. 
Article 15 
1. Member States shall inform the Commission 
annually of the details of the result of sampling, 
examinations and investigations made for the 
presence of residues of substances referred to in 
Article 2 (a). 2. On the basis of this information, the 
Commission shall report to the Member States 
meeting in the Standing Veterinary Committee set 
up by the Council Decision of 15 October 1968 
(hereinafter called 'the Committee'); if necessary, 
in accordance with the procedure laid down in 
Article 16, measures may be taken to ensure the 
uniform application of the controls laid down by 
this Directive. 
Article 16 
1. Where the procedure laid down in this 
Article is to be used, matters shall, without delay, 
be referred by the chairman, either on his initiative 
or at the request of a Member State, to the 
Committee. 
2. Within the Committee, the votes of Member 
States shall be weighted as provided in Article 148 
of the Treaty. The chairman shall not vote. 
3. The representative of the Commission shall 
submit a draft of the measures to be adopted. The 
Committee shall deliver its opinion on such 
measures within a period to be determined by the 
chairman in keeping with the urgency of the 
question submitted for examination. Opinions shall 
be delivered by a majority of 45 votes. 
4. The Commission shall adopt the measures 
and implement them immediately where they are 
in accordance with the opinion of the Committee. 
Where they are not in accordance with the opinion 
of the Committee or if no opinion is delivered, the 
Commission shall, without delay, propose to the 
Council the measures to be adopted. The Council 
shall adopt the measures by a qualified majority. 
If, within three months from the date on which a 
matter was referred to it the Council has not 
adopted any measures, the Commission shall adopt 
the proposed measures and implement them 
immediately, save where the Council has decided 
against these measures by a simple majority. 
Article 17 
1. Where the procedure laid down in this 
Article is to be followed, the chairman shall, 
without delay, refer the matter, either on his own 
initiative or at the request of a Member State, to 
the Committee. 
2. Within the Committee, the votes of Member 
States shall be weighted as provided in Article 148 
of the Treaty. The chairman shall not vote. 
3. The Commission representative shall submit a 
draft of the measures to be adopted. The 
Committee shall deliver its opinion on such 
measures within a period of two days. Opinions 
shall be delivered by a majority of 45 votes. 
No C 170/8 Official Journal of the European Communities 29.6. 84 
4. The Commission shall adopt the measures 
and shall apply them immediately where they are 
in accordance with the opinion of the Committee. 
Where they are not in accordance with the opinion 
of the Committee or if no opinion is delivered, the 
Commission shall, without delay, propose to the 
Council the measures to be adopted. The Council 
shall adopt the measures by a qualified majority. 
If, within 15 working days from the date on which 
the proposal was submitted to it, the Council has 
not adopted any measures, the Commission shall 
adopt the proposed measures and apply them 
immediately, save where the Council has decided 
against these measures by a simple majority.' 
3. Articles 8, 9 and 10 shall become Articles 18, 19 
and 20. Article 2 
Member States shall bring into force the laws, regu­
lations and administrative provisions necessary to 
comply with this Directive: 
— not later than 1 July 1985 as regards the 
prohibition of the administration of Trenbolone 
and Zeranol to farm animals for fattening 
purposes, in application of Articles 2 and 5 of 
Directive 81/602/EEC, as amended by Article 1 
(1) of this Directive, 
— not later than 1 July 1986 for the remaining 
provisions. They shall forthwith inform the 
Commission thereof. 
Article 3 
This Directive is addressed to the Member States.