31. 5. 85 Official Journal of the European Communities No C 132/5 
II 
(Preparatory Acts) 
COMMISSION 
Proposal for a Council Directive concerning the examination of animals and fresh meat for the 
presence of residues 
COM(85) 192 final 
(Submitted by the Commission to the Council on 8 May 1985) 
(85/C 132/05) 
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 64/433/EEC of 
26 June 1964 on health problems affecting intra -
Community trade in fresh meat ('), as last amended by 
Directive 83/90/EEC (2), and in particular Article 4 
thereof, 
Having regard to Council Directive 81/602/EEC of 
31 July 1981 concerning the prohibition of certain sub­
stances having a hormonal action and of any substance 
having a thyrostatic action (3), and in particular Article 7 
thereof, 
Having regard to the proposal from the Commission, 
Having regard to the opinion of the European Par­
liament, 
Having regard to the opinion of the Economic and 
Social Committee, 
Whereas Article 4(2) of Directive 64/433/EEC lays 
down as regards examination of animals or meat for 
residues that the Council shall adopt: 
— the detailed arrangements for controls, 
— the tolerances for the substances referred to in the 
second subparagraph of Article 4 (1) (b) of that 
Directive, 
— the frequently of sampling; 
Whereas Article 7 of Directive 81/602/EEC requires 
Member States to ensure that farm animals, the meat of 
such animals and the meat products obtained therefrom 
are subjected to controls and provides that detailed rules 
for carrying out such controls be laid down by the 
Council; 
(*) OJ No 121, 29. 7. 1964, p. 2012/64. 
O OJ No L 59, 5. 3. 1983, p. 10. 
(») OJ No L 222, 7. 8. 1981, p. 32. Whereas the adoption of Community provisions 
concerning the detailed arrangements for controls of 
animals and fresh meat for residues, for the frequency of 
sampling of animals or meat, for examination for 
residues, and for the establishment of maximum permitted 
limits of residues of substances having a pharmacological 
action and of the conversion products thereof and other 
substances transmitted to meat which are likely to be 
dangerous to human health have the object of protecting 
human health and of removing barriers to intra-
Community trade in animals, meat and meat products 
resulting from differences between the health 
requirements of Member States; 
Whereas it is necessary to adopt a general solution 
concerning controls in the Community of farm animals 
and meat and meat products obtained therefrom for the 
presence of residues; 
Whereas it is appropriate to provide that sampling be 
carried out officially in the Member States in accordance 
with common criteria for the different groups of sub­
stances of concern; whereas it is appropriate that samples 
are subject to examination at officially authorized labora­
tories ; 
Whereas it is appropriate that the national reference 
laboratories designated in accordance with Article 
4 (1) (b) of Directive 64/433/EEC should coordinate the 
standards and methods of analysis used in their 
respective territories; whereas it is appropriate that for 
each residue or group of residues of concern a 
Community laboratory should be designated for liaison 
with the national reference laboratories; 
Whereas further details of the criteria of operation of 
laboratories should be established later; 
Whereas, when an examination reveals the presence of 
residues, it is necessary that common control measures 
are taken to ascertain and eliminate the cause of the 
residue, and which ensure that meat showing residues 
which exceed the permitted level is excluded from 
human consumption; 
Whereas measures should be taken to facilitate 
cooperation between Member States in the application of 
these controls and where necessary for the adoption of 
coordinated measures in accordance with the procedure 
No C 132/6 Official Journal of the European Communities 31.5.85 
of the Standing Veterinary Committee set up by Council 
Decision 68/361/EEC (x); 
Whereas it is necessary to keep under review the details 
of the controls carried out in particular as a function of 
the results which are found; 
Whereas it is necessary to provide for the amendment 
and, where necessary, supplementation of technical 
provisions concerning controls and frequency of 
sampling to take account of new knowledge and 
scientific and technical developments; whereas it is 
necessary to provide for the adoption of the necessary 
adjustments in accordance with the procedure of the 
Standing Veterinary Committee; 
Whereas Community control arrangements should be 
introduced to ensure that the requirements of this 
Directive are applied uniformly in all Member States, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Member States shall ensure that examination of animals 
and fresh meat for the presence of residues is carried out 
in accordance with the requirements of this Directive. 
Article 2 
For the purpose of this Directive, the definitions given in 
Article 2 of Directive 64/433/EEC shall apply. 
In addition: 
(a) Approved sample means a sample taken by the 
competent authority and which consists for the 
examination of the residue concerned of a reference 
to the species, the tissue, the amount, the method of 
collection, package and dispatch, and the iden­
tification of origin; 
(b) Approved laboratory means a laboratory approved by 
the competent authorities of a Member State to 
make an examination of an approved sample for the 
presence of residues; 
(c) Residue means residue of substances having a phar­
macological action and of conversion products 
thereof and other substances transmitted to meat 
which are likely to be dangerous to human health. 
Article 3 
1. Member States shall ensure that: 
(a) approved samples are taken from animals and fresh 
meat for examination at approved laboratories for 
residues in accordance with the Annex. 
(b) the national reference laboratories designated in 
accordance with Article 4 (1) (b) of Directive 
C) OJ No L 255, 18. 10. 1968, p. 23. 64/433/EEC coordinate standards and methods of 
analysis for each residue or group of residues 
concerned, in particular as regards the specifications 
for an approved sample and methods of analysis, 
including the arrangement of periodic comparative 
tests of split samples by approved laboratories, and 
the respect of the tolerances laid down. 
(c) for each residue or group of residues a Community 
laboratory designated pursuant to paragraph 2 liaises 
between the national reference laboratories referred 
to in (b). 
2. The Council, acting on a proposal from the 
Commission, shall determine the criteria for the authori­
zation of approved laboratories, shall designate the 
laboratories referred to in paragraph 1 (c), and shall 
determine the powers and conditions of operation of the 
latter. 
3. 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. 
All positive findings shall be confirmed by an official 
laboratory using the reference method referred to above. 
Article 4 
1. Where an examination of an approved sample 
taken in accordance with the Annex reveals the presence 
of residues of prohibited substances or of authorized 
substances exceeding the maximum permitted levels, or 
where the problems referred to in Article 6 (1) and (2) 
are demonstrated, the Member State shall ensure that the 
competent authorities are 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. 
31.5.85 Official Journal of the European Communities No C 132/7 
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 appropriate 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 maximum permitted 
levels, the slaughter 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. 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 first subparagraph shall be officially 
examined for the residue concerned and shall be 
detained until the result of the examination is known. 
5. The competent authorities shall also ensure that at 
the establishment of production, or animal holdings in 
the same region or locality supplying the establishment, 
additional samples are examined for the substance 
concerned in accordance with the intensive surveillance 
system laid down in the Annex. 
Article 5 
Notwithstanding Article 4, the competent authority shall, 
if information suggests the presence of residues, examine 
the animals or the fresh meat involved for the presence 
of these residues. 
Article 6 
1. Where examination in its territory demonstrates in 
animals of fresh meat a widespread presence of residues, 
the Member State concerned shall intensify the sampling 
and investigation measures for the residue concerned in 
accordance with the Annex. 2. 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. 
3. In accordance with the procedure of Article 10, 
measures may be taken to ensure the coordination of the 
investigations necessary. 
Article 7 
The Member States shall annually inform the 
Commission and the other Member States of the details 
of the examinations made and of the results. 
Article 8 
1. The provisions of the Annex may be amended or 
supplemented in accordance with the procedure laid 
down in Article 10. 
2. By way of derogation from Article 3 (1) (a) and 
Article 6 (1), in accordance with the procedure laid 
down in Article 9, other sampling examination fre­
quencies may be applied on application and presentation 
of alternative strategies for those Member States: 
— with small animal populations, or 
— with less than 10 % holdings with more than 20 
animals. 
Article 9 
1. Where the procedure laid down in this Article is to 
be used, the matter shall be referred without delay to the 
Standing Veterinary Committee (hereinafter referred to 
as 'the Committee'), by the chairman, either on his own 
initiative or at the request of a Member State. 
2. Within the Committee, the voters of the Member 
States shall be weighted as provided in Article 148 (2) 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 the measures within a period to be 
determined by the chairman in keeping with the urgency 
of the question submitted for examination. Opinion 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. 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 
No C 132/8 Official Journal of the European Communities 31. 5. 85 
submitted to it, the Commission shall adopt the proposed 
measures and apply them immediately save where the 
Council has decided against them by a simple majority. 
Article 10 
1. Where the procedure laid down in this Article is to 
be used, the matter shall be referred without delay to the 
Committee by the chairman, either on his own initiative 
or at the request of a Member State. 
2. Within the Committee, the votes of the Member 
States shall be weighted as provided in Article 148 (2) 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 two days. 
Opinions shall be delivered by a majority of 45 votes. 
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 
ANNEX 
RESIDUE SAMPLING 
CHAPTER 1 
1. Sampling frequency will be based on the following general groups of substances, animal populations 
and variable criteria. 
Residue groups substances 
Group I (a) Stilbenes, stilbene derivatives, their salts and esters 
(b) Thyrostatic substances 
Group II Other substances with oestrogenic, androgenic or gestagenic action used for fattening 
Group III Chloramphenicol, antibiotics, sulphonamides and other antimicrobial substances 
Group IV Pesticides 
— Organochlorine compounds — including PCBs 
Group V Heavy metals 
— Lead — Antimony 
— Cadmium — Copper 
— Mercury — Zinc 
— Arsenic — Nickel 
— Selenium — Chromium 
Group VI Endo- and ectoporasitic substances 
Group VII Tranquilizers and beta blockers 
Group VIII (a) Other veterinary medicines 
(b) Other substances 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 15 
days from the date on which the proposal was submitted 
to it, the Commission shall adopt the proposed measures 
and shall apply them immediately save where the Council 
has decided against them by a simple majority. 
Article 11 
The Member States shall bring into force the laws, regu­
lations and administrative provisions necessary to comply 
with this Directive not later than 1 April 1986 and shall 
forthwith inform the Commission thereof. 
Article 12 
This Directive is addressed to the Member States. 
31.5.85 Official Journal of the European Communities No C 132/9 
2. Population species groups 
Group I Bovine animals 
Group II Porcine animals 
Group III Sheep and goats 
Group IV Solipeds 
3. Sampling conditions and randomization 
(a) Member States shall ensure that official samples are taken for official examination from animals 
and meat in accordance with the appropriate sampling system, and the following variable criteria. 
Samples shall be taken in confidence and on a statistically random basis. 
(b) Variable criteria 
Account shall be taken of: 
(i) Legislation in force regarding the use of the substances referred to in the residue groups 
mentioned above, in particular the prohibition of use, authorization of use. 
(ii) Factors liable to encourage fraud or misuse. 
(iii) The animal population concerned as regards: 
— total size of population; 
— homogeneity of population groups; 
— age of animals in particular in respect of Group IV and V substances; 
— sex of animals in particular as regards Group I substances. 
(iv) The environment of farms as regards: 
— regional differences; 
— the relation to industrial activity, in particular for Group IV and V substances; 
— relation to arable farming in particular for Group IV substances. 
(v) The farm production systems including: 
— intensive farming units; 
— fattening systems, in particular as regards Group I and II substances; 
— husbandry systems, in particular feeding regime, and animal health care measures. 
(vi) The expectation of problems, known on account of past history and other indications of the 
existence of problems. 
(vii) The required degree of consumer protection, according to the nature and toxicity of the 
substance in question. 
4. Sampling system 
Member States shall apply for each group of substances, and according to the appropriate status level 
and variable criteria appropriate to their territory, a sampling and examination system in accordance 
with the provision of the following chapter. 
CHAPTER II 
Sampling levels and frequency 
5. Group I (a) (Stilbenes, stilbene derivatives, their salts and esters) 
Member States shall at least apply the frequency of Level II during the first year following the 
adoption of this Directive. 
Level I (Survey) 
(a) Member States shall ensure that the population of bovine animals for fattening is sampled annually 
at a frequency which gives at least a 95 % assurance that there will be residue in less than 1 % of 
the bovine fattening population if no positive findings are made. 
NoC 132/10 Official Journal of the European Communities 31.5.85 
(b) If, following the sampling mentioned above, one positive finding is officially confirmed, Member 
States shall monitor the extent of possible residues by the application of the sampling frequency of 
Level II. 
Level II (Monitoring) 
(a) Member States shall ensure that the population of bovine animals for fattening is sampled annually 
at a frequency which gives at least a 99,9 % assurance that there will be residue in less than 1 % of 
the bovine fattening population if no positive findings are made. 
(b) If, following the sampling mentioned above, one positive finding is officially confirmed, Member 
States shall measure the extent of possible residues by application of the sampling frequency of 
Level III. 
(c) If, following the application of the sampling frequency indicated in paragraph (a), no positive 
findings are officially confirmed during two sucessive years, Member States may apply the 
sampling frequency of Level I. 
Level HI (Measuring) 
(a) Member States shall ensure that the population of bovine fattening animals is sampled annually at a 
frequency which gives at least a 99,9 % assurance that there will be residues in less than 0,5 % of 
the bovine fattening population if no positive findings are made. 
(b) Following the annual sampling mentioned above: 
— if one positive finding is officially confirmed, Member States shall continue to sample at the 
frequency mentioned in paragraph (a); 
— if more than one positive finding is officially confirmed, Member States shall apply the 
sampling frequency of Level IV; 
— if no positive findings are officially confirmed, Member States may apply the sampling 
frequency of Level II. 
Level IV (Intensive) 
(a) Member States shall ensure that the population of bovine fattening animals is sampled annually 
at the frequency indicated in Level III paragraph (a). Member States shall also ensure that the 
non-fattening bovine population is sampled annually at the frequency indicated in Level II para­
graph (a). 
(b) In addition for each positive finding officially confirmed during the previous sampling at Level III, 
Member States shall ensure that in each case the population of bovine fattening animals in the 
same area of origin is also sampled annually at a frequency which gives at least a 99,9 % assurance 
that there will be residue in less than 1 % of the bovine fattening population of the area if no 
positive findings are made. 
(c) When positive findings have been officially confirmed in more than one area in the same region 
during the previous sampling at Level III, Member States shall ensure that, in addition to the 
sampling mentioned above, the population of bovine fattening animals of the region is sampled 
annually at the frequency referred to in paragraph (b). 
(d) The abovementioned sampling shall be continued until during one year not more than one positive 
finding is officially confirmed. In which case Member States may continue to sample at the 
frequency indicated in Level III. 
6. Group I (b) (Thyrostatics) 
Member States shall at least apply the sampling levels and frequency laid down for Group I (a) sub­
stances. However, during the first year following the adoption of this Directive, the frequency of Level 
I may be applied. 
7. Group II 
(a) Trenbolone and zeranol 
Member States shall at least apply the sampling levels and frequencies laid down for Group I (a) 
substances. 
(b) Oestradiol 17B, testosterone and progesterone 
Member States shall ensure that the population of bovine animals for fattening is sampled annually 
at the sampling frequency laid down for Group III substances. 
For each sample taken an examination shall be made at least for those substances which are 
atypical for the sex and physiological status of the animal concerned. 
31.5.85 Official Journal of the European Communities NoC 132/11 
8. Group III (Chloramphenicol, antibiotics, sulphonamides and similar antimicrobial substances) 
Member States shall ensure that at least the following sampling levels and frequencies are applied: 
Level I (Monitoring) 
(a) Member States shall ensure that the populations and species of animals in their territory which 
present the greatest expectation of residue problems, taking into account the variables mentioned 
in Chapter I, in particular, past-history, age, sex and farm production systems are subject to stat­
istically random sampling. The populations identified shall be sampled annually at a frequency 
which gives at least a 99,9 % assurance that there will be residue in less than 1 % of the population 
if no positive findings are made. 
(b) If, following the sampling mentioned above, positive findings are officially confirmed in more than 
0,5 % of the samples examined, Member States shall ensure that the frequency of sampling of the 
population concerned is increased by the application of the sampling frequency of Level II 
Level II (Measuring) 
(a) Member States shall ensure that each population concerned is sampled annually at a frequency 
which gives at least a 99,9 °/o assurance that there will be residue in less that 0,5 % of the popu­
lation if no positive findings are made. 
(b) Following the annual sampling mentioned above: 
— if positive findings are officially confirmed in more than 0,5 % of the samples examined, 
Member States shall apply the sampling frequency of Level III; 
— if positive findings are officially confirmed in less than 0,5 % of the samples examined in two 
successive years, Member States may apply the sampling frequency of Level I. 
Level HI (Intensive) 
(a) Member States shall ensure that the population concerned is sampled annually at the frequency 
indicated in Level II paragraph (a). 
(b) In addition for each positive finding officially confirmed during the previous sampling at Level II, 
Member States shall ensure that in each case the population of animals concerned in the same area 
of origin is also sampled annually at a frequency which gives at least a 99,9 % assurance that there 
will be residue in less that 1 % of the population of the area if no positive findings are made. 
(c) When positive findings have been officially confirmed in more than one area of the same region 
during the previous sampling at Level II, Member States shall ensure that in addition to the 
sampling mentioned above that the population concerned in the region is sampled annually at the 
frequency referred to in paragraph (b). 
(d) The abovementioned sampling shall be continued until during one year's positive findings are 
officially confirmed in less than 0,5 % of the population concerned. In which case Member States 
may continue to sample at the frequency indicated in Level II. 
Supplementary survey 
(a) Further to the sampling provided for in the levels indicated above, in addition Member States shall 
ensure that animal species populations not covered by the sampling of those levels are also sampled 
for residues. Each population identified shall be sampled annually at a frequency which gives at 
least a 99,9 % assurance that there will be residue in less than 1 % of the population if no positive 
findings are made. 
(b) If, during the course of the sampling mentioned above, positive findings are officially confirmed in 
a population group at a proportion higher than the level found in population groups already 
identified, the former is substituted for the latter unless the latter has shown positive findings in 
more than 0,5 % of the samples examined, in which case it is added to the latter. The population 
group shall also be added if, following the sampling, positive findings are officially confirmed in 
more than 0,5 % of the samples examined. 
No C 132/12 Official Journal of the European Communities 31. 5. 85 
9. Group IV (Pesticides) 
(a) Member States shall ensure that at least samples are taken annually from each of the species groups 
I, II and III at a frequency which gives at least 99,9 % assurance that there will be residue in less 
than 5 % of the population if no positive findings are made. 
(b) In addition to the application of Article 4, following the application of the annual sampling 
frequency, analysis shall be made of the laboratory findings of all the official samples examined. 
The analysis shall determine the distribution of the total levels found so that comparison may be 
made between at least four equal portions of the distribution area, and with levels found at 
previous annual sampling. 
If, following the above analysis, there is an indication of either a significant overall increase in 
relation to previous years, or a significant shift of levels found towards the tolerance levels, 
Member States shall ensure that all necessary action is taken to identify and reduce the levels 
found. 
10. Group V (Heavy metals) 
(a) Member States shall ensure that at least for: lead, cadmium, mercury, for arsenic, and for selenium 
when the latter are authorized for use in feedingstuffs samples are taken annually from the animal 
population at a frequency which gives at least 95 % assurance that there will be residue in less than 
1 % of the population if no positive findings are made. 
(b) Following the application of the annual sampling the provisions laid down for Group IV substances 
under paragraph (b) shall be applied.