1. 10.81 Official Journal of the European Communities No C 251/7 
ANNEX I 
CCT heading 
No 
18.06 
19.03 
19.08 
21.07 
22.09 C 
35.02 A Description of goods 
Chocolate and other food preparations containing cocoa 
Macaroni, spaghetti and similar products 
A. Containing eggs 
Pastry, biscuits, cakes and other fine bakers' wares, whether or not containing 
cocoa in any proportion 
Food preparations not elsewhere specified or included: 
G. Other: 
I. containing no milkfats or containing less that 1 • 5 % by weight of such 
fats: 
(a) containing no sucrose or containing less than 5 % by weight of sucrose 
(including invert sugar expressed as sucrose): 
ex 1. containing no starch or containing less than 5 % by weight of 
starch: 
— Preparations known as 'long eggs', consisting in hens' eggs 
cooked in the form of cylinders; the centre consists of the 
egg yolks and is completely surrounded by the whites of the 
eggs-
Spirituous beverages: 
ex V. Other: 
— Containing egg or egg yolk 
Albumins: 
II. Other: 
ex a) Ovalbumin: 
1. Dried (for example, in sheets, scales, flakes, powder) 
2. Other 
Proposal for a Council Directive on health problems relating to residues of antibiotics in 
fresh meat of Community origin 
(Submitted by the Commission to the Council on 23 September 1981) 
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 opinion of the European 
Parliament, 
Having regard to the opinion of the Economic and 
Social Committee, 
Whereas, pursuant to Article 6 of Directive 
64/433/EEC (x), health problems relating to residues 
Having regard to the proposal from the Commission, (*) OJ No 121, 29. 7. 1964, p. 2012/64. 
No C 251/8 Official Journal of the European Communities 1. 10.81 
of antibiotics arising in intra-Community trade in 
fresh meat are subject to national law; whereas, in 
order to remove any barriers to trade thereby perpe­
tuated, the Member States' provisions in this respect 
should be replaced by Community provisions; 
Whereas a Community system of controls must be 
created to cover all meat produced and put into circu­
lation in the Community; 
Whereas for the uniform implementation of such a 
system of controls, the frequency of sampling, the 
permissible tolerances and the measures to be taken if 
these tolerances are exceeded must be laid down; 
Whereas, for laying down the methods of analysis to 
be used and amending the Annexes, a procedure 
should be chosen which ensures close cooperation 
between the Commission and the Member States; 
Whereas the purpose of all measures taken in cases of 
exceeding the tolerances, in particular the suspension 
of slaughterings, shall be that only slaughter animals 
free of residues of antibiotics are produced within the 
Community; 
Whereas it should be possible for owners of animals, 
in respect of which the suspension of slaughtering is 
ordered, to slaughter the animals before the expiry of 
the period of suspension on condition that each of the 
animals is inspected on slaughter to ensure that they 
are free of residues of antibiotics; 
Whereas a Community system of surveillance is 
necessary to monitor the application of this Directive; 
Whereas provision should be made for meeting the 
cost of examinations for residues; whereas appro­
priate details of these arrangements should be decided 
on in accordance with a procedure which permits 
close cooperation between the Commission and the 
Member States; 
Whereas the Member States should report to the 
Commission on their monitoring activities in 
application of the present Directive in order to 
provide a constant overall view of the inspections for 
residues of antibiotics out in the Member States, HAS ADOPTED THIS DIRECTIVE: 
Article 1 
In order to monitor the absence of residues of 
antibiotics in or on fresh meat produced within the 
Community and intended for human consumption the 
Member States shall ensure that the provisions of this 
Directive shall be applied. 
Article 2 
The definitions contained in Directive 64/433/EEC 
shall also apply in respect of this Directive. 
In addition, for the purposes of this Directive: 
(a) 'residues of antibiotics' shall mean detectable 
quantities of antibiotics and substances with a 
similar action or their metabolites in or on fresh 
meat; 
(b) 'tolerance' shall mean the quantity of residues of 
antibiotics in or on fresh meat corresponding to 
the limit of detection of the Community method 
of analysis. 
Article 3 
1. Member States shall ensure that fresh meat 
which has been produced in the Community and 
which is intended for human consumption is 
examined for residues of antibiotics in accordance 
with this Directive. 
2. The examination for residues of antibiotics shall 
be carried out during the slaughter procedure and in 
connection with meat inspection on a random basis in 
accordance with the frequency of sampling laid down 
in Annex I to this Directive. Care shall be taken to 
ensure that the sampling is evenly distributed as 
between the types of animals for slaughter and that it 
is carried out regularly. 
3. The technical details for sampling and the 
methods of analysis to be applied shall be drawn up 
in accordance with the procedure laid down in 
Article 9. 
4. Notwithstanding the provisions of paragraph 2 
the official veterinarian responsible for the exami­
nation of meat must, if he has information suggesting 
the presence of residues of antibiotics in the carcases 
presented for examination, examine each slaughtered 
animal for residues of antibiotics. 
1. 10.81 Official Journal of the European Communities No C 251/9 
5. Moreover, all slaughtered animals which are 
subjected to a bacteriological examination shall be 
examined for residues of antibiotics. 
6. Examinations under paragraphs 4 and 5 shall 
not count towards the number of random samples 
required in accordance with paragraph 2. 
Article 4 
1. Where examination for residues of antibiotics 
pursuant to Article 3 shows that the tolerances have 
been exceeded the inspection office in question shall 
inform the competent veterinary authorities without 
delay of: 
(a) the species of animal, its breed, age and sex, 
together with all information needed to identify 
with certainty the holding from which the animal 
came; and 
(b) the result of the examination. 
2. The Member States shall thereupon ensure that: 
1. the competent veterinary authorities investigate the 
livestock on the farm of origin to ascertain the 
cause of the tolerance being exceeded; 
2. the herd or animals which, as a result of the 
investigation referred to in subparagraph 1, may be 
assumed to contain residues of antibiotics are 
provided with official markings, 
3. their slaughter for human consumption is 
prohibited until it may be assumed that the 
residues present no longer exceed the tolerance, 
and in any case until the end of the withdrawal 
period fixed for each residue in Annex I to this 
Directive; 
4. the animals or herd whose slaughter is prohibited 
are not sold to third parties during the prohibition 
period. 
3. By way of derogation from paragraph 2, animals 
whose slaughter is prohibited may be slaughtered 
before the end of the suspension period if the owner 
informs the competent authority at least one week 
before the proposed slaughter date, stating the place 
of slaughter. The animals must be accompanied by an 
official veterinary certificate containing the infor­
mation required under paragraph 1 (a). 
4. The carcase of each animal whose slaughter is 
notified pursuant to paragraph 3 shall be examined 
for residues of antibiotics. The cost of any exami­
nation which shows that the tolerance has been 
exceeded shall be borne by the owner. These examinations shall not count towards the 
number of random samples referred to in Article 
3(2). 
Article 5 
1. Any slaughtered animal which is examined for 
residued of antibiotics shall be detained until the 
results of the examination are available. 
2. If the result of the examination for antibiotics 
shows that the tolerance has been exceeded, the 
whole slaughtered animal shall be deemed unfit for 
human consumption and shall be safely condemned. 
Article 6 
By 31 March of the year following that under review, 
the Member States shall provide the Commission with 
a summary annual report on the examinations made 
pursuant to this Directive, on the results of the 
examinations and on the measures taken, using the 
form at Annex II to this Directive. 
The Commission shall inform the Member States of 
the results of the abovementioned communications. 
Article 7 
The costs of analysis of samples for the detection of 
antibiotic residues shall be apportioned among the 
total of slaughtered animals and shall be borne by the 
persons having the power of disposition of the 
abovementioned animals. Nevertheless in the cases 
foreseen in Article 3 (5), as well as in the case where 
analysis reveals that the tolerance level has been 
exceeded, the costs of analysis of each sample shall be 
fully borne by the person having the power of 
disposition of animals concerned. 
Article 8 
1. The Commission shall make regular on-the-spot 
checks to verify from a veterinary viewpoint whether 
the provisions of this Directive are applied. 
Member States shall take the necessary steps to fa­
cilitate these checks and shall in particular ensure that 
the experts are supplied at their request with all infor­
mation and documentation needed for accessing the 
execution of the requirements of this Directive. 
2. The provision for implementing this Article, 
especially as regards the frequency and method of 
No C 251/10 Official Journal of the European Communities 1. 10.81 
carrying out the checks referred to in the first subpar­
agraph, the rules governing the appointment of 
veterinary experts and the rules which they must 
follow when drawing up their report, shall be laid 
down according to the procedure laid down in 
Article 9. 
Article 9 
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 Standing 
Veterinary Committee (hereinafter called 'the 
Committee') set up by the Council Decision of 15 
October 1968. 
2. Within the Committee, the votes of Member 
States shall be weighted as provided in Article 148 (2) 
of the Treaty. The Chairman shall not vote. Where they are not in accordance with the opinion of 
the Committee or if no opinion is delivered, the 
Commission shall without delay submit to the 
Council a proposal on the measures to be adopted. 
The Council shall adopt the measures by a qualified 
majority. 
If the Council has not adopted any measures within 
three months from the date on which the proposal 
was submitted to it, the Commission shall adopt the 
proposed measures and shall apply them immediately, 
save in the case where the Council has decided 
against these measures by a simple majority. 
Article 10 
Such amendments to the Annexes to this Directive as 
may be required by the progress of scientific research 
shall be made in accordance with the procedure laid 
down in Article 9. 
3. The Commission representative shall submit a 
draft of the measures to be adopted. The Committee 
shall deliver its opinion on the measures within a 
period to be determined by the Chairman in keeping 
with the urgency of the question submitted for exami­
nation. Opinions shall be delivered by a majority of 
45 votes. 
4. The Commission shall adopt the measures and 
shall implement them immediately, where they are in 
accordance with the opinion of the Committee. Article 11 
The Member States shall bring into force the legal 
provisions necessary to comply with this Directive 
and its Annexes on the 1 July 1982 and shall 
forthwith inform the Commission thereof. 
Article 12 
This Directive is addressed to the Member States. 
ANNEX I 
For every 100 slaughter animals an examination shall be carried out on: 
— at least two samples of meat from animals other than cattle aged less than six months, 
— at least five samples of meat from cattle aged less than six months. 
In the event of a suspension on slaughter, the withdrawal period: 
— for the substance responsible for the residue, in cases of proven oral administration, shall be at 
least one week, 
— fot the substance responsible for the residue, in cases of proven parenteral administration, shall 
be at least one month. 
1. 10.81 Official Journal of the European Communities No C 251/11 
ANNEX II 
Report on the examinations for residues of antibiotics in accordance with Directive .../.. ./EEC 
Member State: 
Year under review: 
Number of animals slaughtered 
(a) Number of samples 
examined 
(b) Number of samples 
which showed that 
tolerances were ex­
ceeded 
in accordance with / \ 
Article 3 (2) y ' 
(b) 
in accordance with / \ 
Article 3 (4) y ' 
(b) 
in accordance with / \ 
Article 3 (5) w 
(b) 
in accordance with / \ 
Article 4 (4) K ' 
(b) Cattle 
six months Cattle 
under 
six months Pigs Horses ruminants