31. 12. 85 Official Journal of the European Communities No C 351/13 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
Article 17 
The laws of the Member State shall determine the 
procedure for registration and for invalidation of trade­
marks and the effects of invalidation. They may further 
provide that a trade-mark to which one of the grounds for 
invalidation mentioned in this Directive applies shall not be 
capable of defeating the claims of third parties. Article 17 
Article 18 
1. The Member States shall bring into force the laws, 
regulations and administrative provisions necessary to 
comply with this Directive not later than... They shall 
immediately inform the Commission thereof. 
2. The Member States shall communicate to the 
Commission the text of the main provisions of national law 
which they adopt in the field governed by this Directive. 
Article 19 
This Directive is addressed to the Member States. Unchanged. 
Article 17a 
The symbol composed of a capital letter R contained 
within a circle, thus ®, may be used to indicate a registered 
trade-mark. 
Article 18 
1. Unchanged. 
Unchanged. 
Unchanged. Article 19 
Amended proposal for a Council Directive prohibiting the use in livestock farming of certain 
substances having a hormonal action (}) 
COM(85) 832 final 
(Submitted by the Commission to the Council pursuant to the second paragraph of 
Article 149 of the EEC Treaty on 18 December 1985) 
(85/C 351/06) 
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 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 administration to farm animals of certain 
substances having a hormonal action is at present regulated 
in different ways in the Member States; whereas while their 
immediate effect on animals from the farmer's point of 
view is clear, assessments of their effect on human health 
vary and this is reflected in the regulations governing their 
use; whereas this divergence distorts the conditions of 
competition in products that are the subject of common 
(!) OJ No C 313, 4. 12. 1985, p. 4. market organizations and is a serious barrier to intra-
Community trade; 
Whereas this distortion of competition and barrier to trade 
should be removed by ensuring that all consumers should 
be able to buy the products in question under identical 
conditions of supply and these products should, to meet 
their anxieties and expectations, be in the best possible 
state; whereas such a course of action is bound to bring 
about an increase in consumption of the product in 
question; 
Whereas the use of hormonal substances for fattening 
purposes should therefore be prohibited; where the use of 
certain substances for therapeutic purposes may be 
authorized but must be strictly controlled in order to 
prevent any misuse of them; 
Whereas, since it would be difficult to be certain of correct 
operation of the scheme as a whole if animals so treated and 
the meat from such animals were to be traded, this should 
No C 351/14 Official Journal of the European Communities 31. 12. 85 
as a general rule be prohibited; whereas derogations from 
this rule may be allowed where satisfactory guarantees can 
be provided; 
Whereas, as part of the adoption of harmonized rules in the 
Community, arrangements for importation from third 
countries that offer equivalent guarantees should be 
introduced; whereas these guarantees can be required 
under Directives 72/462/EEC (*) and 85/358/EEC (2), 
Whereas, in order to ensure that the provisions of this 
Directive can be implemented effectively, the latest date for 
introduction of the provisions of Directive 85/358/EEC 
should be made to fall before that for introduction of the 
provisions of this Directive; whereas Community control 
measures should be involved in order to ensure uniform 
application in the Member States of the rules applicable on 
administration of substances having a hormonal or 
thyrostatic action, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
For the purposes of implementation of this Directive the 
definitions of meats and of farm animals given in Article 1 
of Directive 81/602/EEC shall apply. 
For the purposes of implementation of this Directive and of 
Directive 81/602/EEC 'therapeutic treatment' shall mean 
the administering to an individual farm animal of any of the 
substances referred to in Article 3 to treat a fertility 
problem diagnosed, on examination, by a veterinarian. 
Such treatment shall remain prohibited for animals 
intended for fattening. 
Article 2 
Without prejudice to the provisions of Article 4 of 
Directive 81/602/EEC, Member States may not authorize 
any derogation from the provisions of the abovementioned 
Directive. 
Article 3 
For the purposes of implementation of Article 4 of 
Directive 81/602/EEC 
(a) there shall be established, after the Committee on 
Veterinary Medicines has given its opinion on the 
measures provided for in the first two indents, and in 
accordance with the procedure laid down in Article 8, 
— a list of the products satisfying the relevant 
principles and criteria of Directives 81/851/EEC 
and 81/852 EEC that may be authorized by the 
Member States for the treatments mentioned in 
Article 4 of Directive 81/602/EEC, 
— the conditions of use of these products, in 
particular, the delay period necessary and detailed 
provisions concerning the control of these con­
ditions of use, 
(!) OJ No L 302, 31. 12. 1972, p. 28. 
(2) OJ No L 191, 23. 7. 1985, p. 46. — the means of identification of animals. 
However, any decision on inclusion of products based 
on trenbolone and zeranol may be taken only on the 
basis of authorization by the Council acting by a 
qualified majority in response to a proposal from the 
Commission. 
Until each of the decisions provided for above has been 
applied, pharmaceutical specialities which have al­
ready received authorization to be placed on the 
market will continue to be authorized. 
Products on the list mentioned at (b) shall be subject to 
the rules of Articles 24 to 50 of Directive 81/851/EEC, 
excluding those rules dealing with national author­
izations on marketing. 
(b) Products used for therapeutic purposes must be 
injected by a veterinarian and the animal must be 
clearly identified. The dose must be recorded and the 
animal may not be slaughtered before expiry of the 
waiting period fixed in implementation of the provi­
sions set out at (a). 
Article 4 
The Member States will prescribe that undertakings 
producing substances having a thyrostatic action, oes­
trogen, androgen and gestagen and those authorized for 
whatever purpose to market those substances, and 
undertakings producing pharmaceutical and veterinary 
products based on those substances, must keep a register 
detailing, in chronological order, quantities produced or 
acquired and those sold or used for the production of 
pharmaceutical and veterinary products. 
Article 5 
Member States must ensure that no animals are dispatched 
from their territory to that of another Member State that 
have had administered to them in any way whatsoever 
substances with a thyrostatic or with an oestrogenic, 
androgenic or gestagenic action, and that no meat from 
such animals is dispatched. They shall reserve the 
Community stamp for meat from untreated animals. 
Until 31 December 1987 Member States prohibiting use of 
the substances mentioned in Article 5 of Directive 81/602/ 
EEC for fattening may restrict entry into their territory to 
untreated animals and meat from untreated animals. 
Article 6 
1. Member States shall prohibit importation from third 
countries of animals and of meat from animals to which 
have been administered in any way whatsoever substances 
with a thyrostatic or with an oestrogenic, androgenic or 
gestagenic action. 
2. To this end, the decisions to be taken for implemen­
tation of Directive 72/462/EEC, taking account of 
Article 13 of Directive 85/358/EEC in the case of meat, and 
31. 12. 85 Official Journal of the European Communities No C 351/15 
of the equivalent guarantee in the case of live animals, must 
be adopted before 1 January 1988. 
3. Member States shall ensure that imported fresh meat 
coming from approved slaughterhouses in third countries 
in respect of which a decision within the meaning of 
paragraph 2 has been taken is, without prejudice to animal 
health measures, circulated in the Community in accord­
ance with Article 25 of Directive 72/462/EEC. 
4. National rules on substances with a hormonal action 
dealing with imports from third countries shall remain 
applicable, subject to respect for the general provisions of 
the Treaty, until each of these decisions comes into 
application. 
5. As from 1 January 1988, Member States will suspend 
imports coming from third countries in respect of which no 
decision within the meaning of paragraph 2 has been taken. 
6. For the purposes of application of the above 
provisions, the Commission shall draw up a list of the 
products authorized by third countries for the treatments 
mentioned in Article 4 of Decision 81/602/EEC. 
Article 7 
The Council, acting by a qualified majority in response to a 
proposal from the Commission, may adopt derogations 
from Articles 5 and 6 in respect of trade in treated animals 
and meat of such animals in the framework of the 
provisions of Article 4 of Directive 81/602/EEC, where 
satisfactory guarantees are given. 
Article 8 
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 own initiative or at the request of a 
Member State, to the Standing Veterinary Committee 
(hereinafter called 'the Committee') set up by the Council 
Decision of 15 October 1968. Committee shall deliver its opinion on the draft within a 
time limit which the Chairman may lay down according to 
the urgency of the matter. The opinion shall be delivered by 
a majority of 45 votes, the votes of the Member States being 
weighted as provided for in Article 148 (2) of the Treaty. 
The Chairman shall not vote. 
3. 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 immediately 
submit to the Council a proposal on the measures to be 
taken. The Council shall act by a qualified majority. 
If within three months of 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 the measures by a simple majority. 
Article 9 
Measures necessary to ensure a smooth transition to the 
arrangements laid down in this Directive may be adopted in 
accordance with the procedure laid down in Article 8. 
Their maximum duration shall be one year. 
Article 10 
Member States shall bring into force the laws, regulations 
and administrative provisions necessary to comply: 
— with Directive 85/358/EEC, by 1 January 1987 at the 
latest, 
— with this Directive, by 1 January 1988 at the latest. 
They shall immediately inform the Commission thereof. 
Article 11 
2. The representative of the Commission shall submit to 
the Committee a draft of the measures to be adopted. The This Directive is addressed to the Member States.