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SSfcï" .4' COMMISSION OF THE EUROPEAN COMMUNITIES 
ll^j".:-:;^';;';?" COM(93) 441 final 
Brussels, 22 September 1993 
Proposal for a 
COUNCIL REGULATION (EEC) 
concerning the prohibition on the use in stockfarming of certain substances 
having a hormonal or thyrostatic action and of p-agonists 
CSSiiSiS'^P 
Proposal for a 
COUNCIL REGULATION (EEC) 
on measures to monitor certain substances and residues thereof 
in live animals and animal products 
li^fe Proposal for a 
COUNCIL REGULATION (EEC) 
amending Regulation (EEC) No 805/68 on the common organization 
of the market in beef and veal 
.*f^7 (presented by the Commission) 
Explanatory Memorandum 
1. In its communication (COM(93) 167 final) of 21 April 1993 to the Council and to the 
European Parliament on control of residues in meat (hormones-beta-agonists and other 
substances) the Commission announced its intention to present proposals to remedy the 
principal defects in existing control arrangements, and thereby remove the potential threat to 
human health, and the distortion of competition, that arises from the non-observance of the 
rules. That communication set out the results of an enquiry into the situation in the Member 
States, and emphasized the Community-wide dimension of the problems in relation to the 
misuse of these substances. It is clear that effective measures at the Community level are an 
essential prerequisite to attaining the objectives of established policy in this sector. 
2. The following proposals are presented in conformity with the conclusions in the Commission's 
communication: 
(a) for a Council Regulation concerning the prohibition on the use, in livestock production, 
of beta-agonists substances and of certain substances having a hormonal action, and a 
thyrostatic action, and revoking Directives 81/602/EEC, 88/146/EEC and 88/299/EEC; 
(b) for a Council Regulation concerning the control measures in relation to certain 
substances and their residues in live animals and in animal products, and revoking 
Directives 85/358/EEC and 86/469/EEC; 
(c) for a Council Regulation modifying Council Regulation 805/68 on the common 
organization of the market in the beefmeat sector. 
3. The purpose of the measures proposed is to improve the technical controls so as to make more 
effective the existing rules designed to prevent the misuse of certain growth promoters and 
other substances in livestock production; to combat in particular the growing misuse of beta-
agonists substances for fattening purposes; to streamline and focus control procedures in 
order to enable the campaigns conducted by the competent authorities in the Member States 
to better detect residues; and to create the conditions for more effective administrative 
sanctions by way of refusal of premiums to certain producers. 
(a) The proposed Council Regulation on the prohibition of certain substances, clarifies and 
consolidates the requirements in the existing Directives, and prohibits the use of beta-
agonists for all purposes other than the therapeutic treatment of horses and of pet 
animals. 
(b) The proposed Council Regulation on the control measures, clarifies and improves 
existing procedures for the detection of residues. It requires that controls be based 
essentially on targetted and unannounced inspections, with less emphasis on the present 
system of random sampling. Central to this approach continues to be the drawing-up by 
Member States of annual plans for the detection of residues; plans must cover a 
minimum level of sampling but a certain flexibility is provided in order to reflect local 
conditions and experience. The proposal prescribes the procedures to apply in the 
investigation and confirmation of suspected cases of fraud, including destruction of the 
batch of animals concerned where at least 10% of animals have been found to have 
residues of illegal substances. Member States would be required also to take the 
necessary measures to ensure that abattoirs cooperate in the investigation of suspected 
breaches of the regulations. This draft includes the Council decisions relating to the 
powers and the designation of the Community reference laboratories for residues, which 
designation shall be amended in the future to allow for the inclusion of substances or 
residues not yet covered. 
(c) The proposed amendment to the beefmeat market organization removes the existing 
provision - considered insufficient by the Commission - that individual animals found 
to have been treated with prohibited substances should not be eligible for the male beef 
premium. The withdrawal of this provision will enable the Commission, acting under 
its own competence (recently confirmed by the Court in Case C-240/90) to provide for 
forfeiture of aid in the product sectors concerned (beefmeat and sheepmeat) in the case 
of a producer who fails to observe the regulations or who obstructs investigations. The 
Commission would intend to propose to the Management Committee that a producer be 
initially debarred from aid for the year in which the infringement first arose; debarment 
for a longer period, for example, a total of five years would be proposed in the case of 
a subsequent infringement. 
The proposals do not have any impact on the Community budget, or involve additional 
burdens for SMEs. 
Proposal for a 
COUNCIL REGULATION (EEC) 
concerning the prohibition on the use in stockfarming of certain substances 
having a hormonal or thyrostatic action and of P-agonists 
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 Council Directive 81/602/EEC(1) prohibits certain substances having a hormonal action and 
any substances having a thyrostatic action and whereas Council Directive 88/146/EEC(2) prohibits 
the use in stockfarming of certain substances having a hormonal action, whilst conceding 
derogations; 
Whereas Council Directive 88/299/EEC(3) lays down the conditions for applying the derogations 
provided for in Article 7 of Directive 88/146/EEC from the prohibition on trade in certain categories 
of animals and their meat; 
Whereas, on account of the residues they leave in meat and other foodstuffs of animal origin, certain 
substances having a thyrostatic, oestrogenic, androgenic or gestagenic action may be dangerous for 
consumers and may also affect the quality of foodstuffs of animal origin; 
Whereas new substances having an anabolizing action such as beta-agonists are used illegally in 
livestock rearing with a view to stimulating the growth and yield of animals; 
Whereas the results of an enquiry conducted by the Commission in the Member States from 1990 
to 1992 show that beta-agonists are widely available in the livestock rearing sector, leading to their 
illegal use; whereas the improper use of beta-agonists can be a serious risk to human health; 
Whereas, in the interests of the consumer, the holding, administering to any animal and placing on 
the market for that purpose of stilbenes, thyrostatics and beta-agonists should be prohibited and the 
use of the other substances should be regulated; 
Whereas, however, the administering of beta-agonists for therapeutic purposes to equidae and 
carnivorous pets may be authorized; 
(1) OJNoL222, 7.8.1981, p. 32. 
(2) OJ No L 70, 16.3.1988, p. 16. 
(3) OJ No L 128, 21.5.1988, p. 36. 
Whereas, moreover, it is necessary to ensure that all consumers are able to purchase meat and 
foodstuffs derived therefrom under the same conditions of supply and that those products correspond 
more closely to their concerns and expectations; whereas, given consumer sensitivity, this can only 
bring about an increase in the consumption of the products in question; 
Whereas the prohibition on the use of hormonal substances for fattening purposes should continue 
to apply; whereas the use of certain substances for therapeutic or zootechnical purposes may be 
authorized but must be strictly controlled in order to prevent any misuse; 
Whereas current scientific knowledge does not permit the normal physiological concentrations of 
endogenous hormones to be determined or the withdrawal period for products containing hormonal 
substances to be defined, with the result that it has not been possible to draw up a list of products 
which may be used for therapeutic or zootechnical purposes and which meet the requirements laid 
down by law; 
Whereas, furthermore, live animals so treated for therapeutic or zootechnical purposes and the meat 
from such animals should not as a general rule be traded, since this could impair the effectiveness 
of the control arrangements of the scheme as a whole; whereas, however, derogations from the 
prohibition may, subject to certain conditions, be provided for in respect of intra-Community trade 
and imports from third countries of animals intended for breeding and breeding animals at the end 
of their reproductive life; 
Whereas such derogations may be authorized where adequate guarantees are provided so as to 
prevent distortion of trade; whereas such guarantees must cover the products which may be used, 
the conditions governing their use and the checks to ensure that the conditions are complied with, 
especially with regard to the necessary withdrawal period; 
Whereas equivalent guarantees must be accepted, in accordance with a Community procedure, in 
respect of imports from third countries, taking account of the guarantees given by the third countries 
concerned; 
Whereas provision should be made for the effective verification of application of the provisions 
deriving from this Regulation; 
Whereas, if the illegal use of growth and productivity promoters in stockfarming is to be combated 
effectively in all Member States, action will have to be organized at Community level; 
Whereas, in order to ensure the immediate and uniform application of the prohibitions and 
obligations envisaged, a regulation should be adopted; whereas Directives 81/602/EEC, 88/146/EEC 
and 88/299/EEC sould therefore be repealed, 
HAS ADOPTED THIS REGULATION: 
Article 1 
For the purposes of this Regulation, the definitions of meat and meat products given in Council 
Directives 64/433/EEC(4), 71/118/EEC(5) and 77/99/EEC(6) shall apply. 
In addition, the following definitions shall apply: 
"farm animals" means domestic animals of the bovine, porcine, ovine and caprine species, 
solipeds and poultry, wild animals of those species and wild ruminants which have been raised 
on a holding; 
"therapeutic treatment" means the administering to an individual farm animal of any substance 
authorized under Article 4(1) to treat a fertility problem diagnosed, on examination, by a 
veterinarian; 
"zootechnical treatment" means the administering to an individual farm animal of any 
substance authorized under Article 4(2) for synchronizing oestrus, terminating unwanted 
gestation, improving fertility and preparing donors and recipients for the implantation of 
embryos, after examination by a veterinarian. 
Article 2 
1. The placing on the market of stilbenes, stilbene derivatives, their salts and esters and 
thyrostatic substances for administering to animals of all species is hereby prohibited. 
2. The placing on the market of beta-agonists for administering to animals of all species, with 
the exception of equidae and domestic carnivorous animals, is hereby prohibited. 
Article 3 
Subject to Article 4, the following are also prohibited: 
(a) the administering to a farm or aquaculture animal, by any means whatsoever, of substances 
having a thyrostatic, oestrogenic, androgenic or gestagenic action and beta-agonists; 
(b) the holding, placing on the market or slaughtering for consumption of farm animals and 
aquaculture animals which contain or have contained the substances mentioned in (a); 
(c) the placing on the market of meat of the farm animals or aquaculture products referred to in 
0>); 
(4) OJ No 121, 29.7.1964, p. 2012/64. 
(5) OJNoL55, 8.3.1971, p. 23. 
(6) OJ No L 26, 31.1.1977, p. 85. 
(d) the processing of the meat or products referred to in (c) and the placing on the market of meat 
products prepared from or with such meat and of products processed or prepared from such 
aquaculture animals. 
Article 4 
Notwithstanding Articles 2 and 3, the following may be allowed: 
1. The administering to farm animals, for therapeutic purposes, of oestradiol 17 B, testosterone 
and progesterone and derivatives which readily yield the parent compound on hydrolysis after 
absorption at the site of application. Products used for therapeutic treatment may be 
administered only by a veterinarian, by injection and not by implant, to farm animals which 
have been clearly identified. Treatment of identified animals must be registered by the 
veterinarian directly responsible. The latter must record at least the following details in a 
register, to be made available to the competent authority at its request: 
the type of treatment, 
the type of products authorized, 
the date of treatment, 
the identity of the animals treated. 
Therapeutic treatment of animals intended for fattening and, during the fattening period, of 
breeding animals at the end of their reproductive life shall, however, be prohibited. 
2. The administering to farm animals of substances having an oestrogenic, androgenic or 
gestagenic action other than the substances referred to in Article 2 for the purpose of 
zootechnical treatment. Such substances must be administered by a veterinarian to clearly 
identified animals, and the treatment must be recorded by the veterinarian directly responsible 
in accordance with point 1. 
However, the Member States may allow the synchronization of oestrus and the preparation of 
donors and recipients for the implantation of embryos to be effected not by the veterinarian 
but on his direct responsibility. In that event, the veterinarian shall make out a non-renewable 
prescription, specifying the treatment in question and the quantity of the product required and 
shall record the products prescribed. 
Zootechnical treatment of animals intended for fattening and, during the fattening period, of 
breeding animals at the end of their reproductive life shall, however, be prohibited. 
3. The administering to equidae within the meaning of Article 2(b) of Council 
Directive 90/426/EEC(7) of beta-agonists to treat cardio-respiratory disorders. Such 
administering must be carried out by a veterinarian or on his direct responsibility. Such 
treatment must be recorded by the veterinarian directly responsible, giving at least the details 
referred to in point 1. 
(7) OJ No L 224, 18.8.1990, p. 42. 
Article 5 
The Commission, acting in accordance with the procedure laid down in Article 12, may decide to 
include any new substance in the group of substances referred to in Article 4(1) having a direct or 
indirect oestrogenic, androgenic or gestagenic action. To be included therein, any new substances 
must satisfy the relevant principles and criteria laid down in Council Directives 81/851/EEC(8) and 
81/852/EEC(9). 
Article 6 
Hormonal products and products having an anabolic effect, whose administration to farm animals 
is permitted in accordance with Article 4, must also meet the criteria and requirements of Directives 
81/851/EEC and 81/852/EEC. 
Furthermore, the following shall not be authorized: 
(a) sustained-release products or salts or esters with a long half-life where the therapeutic or 
zootechnical objective can be achieved by using products with a shorter half-life which, by 
reason of their composition, do not act as a deposit; 
(b) products the withdrawal period of which is not known and those with a withdrawal period of 
more than 15 days; 
(c) products the conditions governing the use of which are not known; 
(d) products for which there are no available reagents or equipment for the analytical techniques 
for detecting the presence of residues exceeding the permitted limits. 
Article 7 
1. Animals, or meat or products from animals, to which substances having a thyrostatic, 
oestrogenic, androgenic or gestagenic action or beta-agonists have been administered in any 
way whatsoever may not be despatched from the territory of one Member State to that of 
another. 
2. Notwithstanding paragraph 1, Member States may authorize trade in animals for breeding and 
breeding animals at the end of their reproductive life which, during the latter period, have 
undergone a treatment referred to in Article 4(1) and (2), and in equidae which have 
undergone a treatment as referred to in Article 4(3) or shall authorize the affixing of the 
Community stamp to meat from such animals where the conditions laid down in Articles 4 
and 6 are complied with, particularly with regard to observance of the withdrawal period. 
(8) 
(9) OJ No L 317, 6.11.1981, p. 1. 
OJ No L 317, 6.11.1981, p. 16. 
(2) 
However, trade in high-value horses, and in particular racehorses, competition horses, circus 
horses or horses intended for stud purposes or for exhibitions, including horses in these 
categories to which oral preparations containing allyl trenbolone or beta-agonists have been 
administered for the purposes mentioned in Article 4, may take place before the end of the 
withdrawal period, provided that the conditions governing administration are fulfilled and that 
the type and date of treatment are mentioned on the certificate accompanying the horses. 
Article 8 
1. The importation from third countries of farm or aquaculture animals and of meat from animals 
to which substances having a thyrostatic, oestrogenic, androgenic or gestagenic action have 
been administered in any way whatsoever is hereby prohibited. 
However, animals intended for breeding, breeding animals at the end of their reproductive life, 
or meat therefrom, from third countries may be imported subject to their satisfying guarantees 
at least equivalent to those laid down herein which have been established in accordance with 
the procedure laid down in Article 12 for the purpose of giving effect to Article 30 of Council 
Regulation (EEC) No ..../93(10) on measures to monitor certain substances and residues thereof 
in live animals and animal products. 
2. Controls on imports from third countries shall be carried out in accordance with Article 4(2)(c) 
of Council Directive 91/496/EEC(1,) and Article 8(2) of Directive 90/675/EEC(,2). 
Article 9 
Undertakings producing substances having a thyrostatic, oestrogenic, androgenic or gestagenic action 
and beta-agonists, undertakings authorized in any capacity to market such substances and 
undertakings producing pharmaceutical and veterinary medicinal products from such substances shall 
be required to keep registers detailing, in chronological order, quantities produced or acquired and 
those sold or used for the production of pharmaceutical products or veterinary medicines. 
Article 10 
Farm animals, their feed, the meat of such animals, the meat products obtained therefrom and all 
other products of animal origin shall be subject to checks in accordance with Regulation 
(EEC) No ...793 on measures to monitor certain substances and residues thereof in live animals and 
animal products. 
Article 11 
Detailed rules for the application of this Regulation shall be adopted in accordance with the 
procedure laid down in Article 12. 
(10) OJ No L 
(,,) OJ No L 268, 24.9.1991, p. 56. 
(12) OJ No L 373, 31.12.1990, p. 1. 
Article 12 
The Commission shall be assisted by the Standing Veterinary Committee (hereinafter referred to as 
"the Committee"). 
The representative of the Commission shall submit to the Committee a draft of the measures to be 
taken. The 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 the majority laid down in Article 148(2) of the Treaty in the case 
of decisions which the Council is required to adopt on a proposal from the Commission. The votes 
of the representatives of the Member States within the Committee shall be weighted in the manner 
set out in that Article. The Chairman shall not vote. 
The Commission shall adopt the measures envisaged if they are in accordance with the opinion of 
the Committee. If the measures envisaged 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 
relating to the measures to be taken. The Council shall act by a qualified majority. If within three 
months of the date of referral the Council has not acted, the proposed measures shall be adopted 
by the Commission. 
Article 13 
Directives 81/602/EEC, 88/146/EEC and 88/299/EEC are hereby repealed. 
Article 14 
Member States shall inform the Commission of the national measures adopted pursuant to this 
Regulation. 
Article 15 
This Regulation shall enter into force on 1 January 1994. 
This Regulation shall be binding in its entirety and directly applicable in all Member States. 
Done at Brussels, For the Council 
The President 
10 
Proposal for a 
COUNCIL REGULATION (EEC) 
on measures to monitor certain substances and residues thereof 
in live animals and animal products 
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 by Directive 85/358/EEC(1), as last amended by Directive 88/146/EEC(2), the Council 
introduced certain rules on the detection and monitoring of substances having a hormonal or a 
thyrostatic action; whereas those rules should be extended to cover other substances which are used 
in stockfarming to promote growth and productivity in livestock or for therapeutic purposes and 
which may prove dangerous to the consumer on account of their residues; 
Whereas by Directive 86/469/EEC(3), as amended by Decision 89/187/EEC(4), the Council introduced 
certain rules on the monitoring of a certain number of residues of pharmacological substances and 
of environmental contaminants in farm animals and in the fresh meat obtained from such animals; 
whereas such monitoring should be extended to cover other animal species and all animal products 
for human consumption; 
Whereas there is insufficient clarity in the Community legislation on monitoring residues in meat, 
giving rise to varying interpretations in the different Member States; 
Whereas there is a need to reinforce the controls carried out by and in the Member States; 
Whereas producers and other actors in the stockfarming industry should take greater responsibility 
in future for the quality and harmlessness of meat for human consumption; 
a) 
(2) 
(3) 
(4) OJNoL 191, 23.7.1985, p. 46. 
OJNo L70, 16.3.1988, p. 16. 
OJ No L 275, 26.9.1986, p. 36. 
OJN0L66, 10.3.1989, p. 37. 
11 
Whereas the specific penalties in respect of stockfarmers not complying with Community legislation 
prohibiting the use of certain hormonal and anabolic substances in stockfarming are to be 
incorporated in the separate provisions governing particular product groups; 
Whereas Article 4 of Council Directive 71/118/EEC(5), as last amended by Directive 92/116/EEC(6), 
requires the Member States to ensure that checks are conducted to detect residues of substances 
having a pharmacological action, their derivatives and other substances which may be transmitted 
to poultrymeat and which may make the consumption of fresh poultrymeat dangerous or harmful 
to human health; 
Whereas Council Directive 91/493/EEC(7) requires a monitoring system to be established by the 
Member States to detect contaminants present in the aquatic environment; 
Whereas Council Directive 92/46/EEC-(8), as amended by Directive 92/118/EEC(9), provides that by 
30 June 1993 at the latest, national measures for the detection of residues in raw milk, heat-treated 
milk and milk-based products shall have been submitted to the Commission by the Member States; 
whereas the residues to be detected are those in Part A, group III and Part B, group II of Annex I 
to Directive 86/469/EEC; 
Whereas Council Directive 89/437/EEC(10), as last amended by Directive 91/684/EEC(n), requires 
the Member States to ensure that checks are conducted to detect residues of substances having a 
pharmacological or hormonal action, antibiotics, pesticides, detergents and other substances harmful 
or likely to alter the organoleptic characteristics of egg products or make the consumption of such 
products dangerous or harmful to human health; 
Whereas Council Directive 92/45/EEC(12), as amended by Directive 92/116/EEC, requires the 
Member States to extend their residue detection plans in order to make wild-game meat subject, 
where necessary, to sampling checks with a view to detecting the presence of contaminants from 
the environment; 
Whereas Council Directive 91/495/EEC(13), as last amended by the aforesaid Directive 92/116/EEC, 
requires the Member States to supplement their residue detection plans to make rabbits and farmed 
game subject to monitoring of residues; 
(5) 
(6) 
(7) 
(8) 
(9) 
(10) 
(11) 
(12) 
(13) OJNoL 55, 8.3.1971, p. 23. 
OJNoL62, 15.3.1993, p. 1. 
OJ No L 268, 24.9.1991, p. 15. 
OJNoL268, 14.9.1992, p. 1. 
OJNoL62, 15.3.1993, p. 49. 
OJ No L 212, 22.7.1989, p. 87. 
OJNoL 376, 31.12.1991, p. 38. 
OJNoL268, 14.9.1992, p. 35. 
OJNoL 268, 24.9.1991, p. 41. 
12 
Whereas, if the illegal use of growth and productivity promoters in stockfarming is to be combated 
effectively in all Member States, action will have to be organized at Community level; 
Whereas a certain number of provisions of Directives 86/469/EEC and 85/358/EEC, and of Council 
Decisions 89/187/EEC(14) and 91/664/EEC(15), require clarification and amendment in the interests 
of the effective application of controls and residue detection in the Community; whereas, with a 
view to immediate and uniform application of the controls currently provided for, the present rules 
and amendments to them should be assembled in a single text in the form of a Regulation repealing 
the aforesaid instruments, 
HAS ADOPTED THIS REGULATION: 
CHAPTER I 
Scope and definitions 
Article 1 
This Directive lays down measures to monitor: 
the substances listed in Part A and group I of Part B of Annex I hereto; 
the groups of residues in Annex I hereto. 
Article 2 
For the purposes of this Regulation: 
(a) "prohibited substances or products" means substances or products the administering of which 
to animals is prohibited under Community legislation; 
(b) "authorized substances or products, used illegally" means substances or products authorized 
under Community legislation but used for purposes other than those laid down in the existing 
legislation; 
(c) "residue" means a residue of substances having a pharmacological action, of their metabolites 
and other substances transmitted to animal products and likely to be harmful to human health; 
(d) "competent authority" means the central authority of a Member State competent in veterinary 
matters or any authority to which such central authority has delegated such competence; 
(e) "official sample" means a sample taken by the competent authority which bears, for the 
purposes of examinination of the residue in question, a reference to the species, the type, the 
quantity concerned, the method of collection and particulars identifying the origin of the 
animal or of the animal product; 
(14) 
(15) OJNoL 66, 10.3.1989, p. 37. 
OJNoL 368, 31.12.1991, p. 17. 
13 
(f) "approved laboratory" means a laboratory approved by the competent authorities of a Member 
State for the purposes of examining an official sample in order to detect the presence of 
residues; 
(g) "batch of animals" means a group of animals of the same species and age, reared on the same 
holding, at the same time and under the same conditions of rearing; 
(h) "beta-agonist" means a beta adrenoceptor agonist. 
CHAPTER II 
Monitoring of certain substances 
Article 3 
1. With a view to the correct application of the Community legislation on certain substances, 
official on-the-spot checks by samplinjg shall be conducted during manufacture on the 
substances listed in Part A and group I of Part B of Annex I and during their handling, 
storage, transport, distribution and sale. Where fraud is suspected, these checks must cover the 
entire production and distribution chain. 
2. The checks provided for in paragraph 1 must be conducted with a view in particular to 
detecting the presence of prohibited substances or products which it is intended to administer 
to animals for the purposes of fattening. 
3. The checks provided for in paragraph 1 must be conducted by the competent national 
authorities without prior notice. 
Article 4 
Possession of the substances listed in Part A and group I of Part B of Annex I shall be restricted 
to authorized persons during importing, manufacture, storage, distribution, sale and utilization. 
Article 5 
Without prejudice to criminal penalties, or penalties imposed by professional bodies, suitable 
penalties of an administrative nature shall be imposed where a veterinarian or a pharmacist is 
responsible, as the case may be, for the transfer or administering of prohibited substances or 
products or for the administering of authorized substances or products for purposes other than those 
laid down in the current legislation. 
Article 6 
Where the checks provided for in this Chapter show that prohibited substances or products are 
present, such substances or products shall be placed under offical supervision until the requisite 
measures been applied. 
14 
Article 7 
Where there are reasons for suspecting that an infringement has taken place, the competent authority 
shall conduct or have conducted: 
spot checks on animals on their farms of origin, in particular with a view to detecting traces 
of implants; 
checks to detect substances the use of which is prohibited on the farms where the animals are 
being reared, kept or fattened; 
spot checks on feedingstuffs for the animals at their farms of origin and on their drinking 
water. 
The checks may include the taking of an official sample. 
Article 8 
1. Where the results of checks conducted in a Member State show the need for an investigation 
in one or more Member States or in one or more third countries, the Member State concerned 
shall inform the other Member States and the Commission. The Commission shall take the 
measures necessary for such an investigation. 
2. The measures to implement paragraph 1 shall be adopted, where required, in accordance with 
the procedure provided for in Article 34. 
CHAPTER m 
Monitoring plans to detect residues 
Article 9 
The examination of live animals, their excrement and body fluids and of tissue, animal products, 
animal feed and drinking water for the presence of residues of the substances listed in Annex I 
hereto shall be carried out in accordance with this Chapter. 
Article 10 
1. Member States shall assign the task of coordinating the implementation of the inspections 
provided for in this Chapter to a central department or body. 
2. The department or body referred to in paragraph 1 shall be responsible for: 
(a) drawing up the plan provided for in Article 11 to enable the competent departments to 
carry out the required inspections; 
(b) coordinating the activities of the central and regional departments responsible for 
monitoring the various residues. Such coordination shall extend to all departments 
working to prevent the fraudulent use of substances or products on stock farms; 
15 
(c) collecting the results and other data to be forwarded to the Commission before 1 March 
each year. 
Article 11 
1. By 31 January at the latest each year, the Member States shall submit plans to the 
Commission setting out the national measures to be implemented during the current year. 
2. The plans provided for in paragraph 1 shall specify in particular the measures to detect 
residues in: 
(a) animals of the bovine, porcine, ovine, caprine and equine species, their meat and 
feedingstuffs; 
(b) poultry, poultrymeat and poultry feed; 
(c) farmed fish and shellfish, aquaculture products and feed; 
(d) milk and milk products; 
(e) egg products; 
(f) meat of rabbits, wild game and farmed game; 
(g) honey. 
Article 12 
The plans shall cover the detection of groups of residues by type of animal, feedingstuffs and 
products in accordance with Annex II. 
Article 13 
The plans must comply with the rules on sampling laid down in Annex III. 
Article 14 
The plans must conform to the sampling levels and frequencies laid down in Annex IV. 
However, at the request of a Member State the Commission may, in accordance with the 
procedure provided for in Article 34, adjust the minimum requirements as regards checks laid 
down in Annex IV provided it is clearly established that such adjustments increase the overall 
effectiveness of the plans in respect of the Member State concerned and in no way reduces 
their freedom in identifying residues or cases of illegal use of substances as listed in Annex I. 
The sampling levels and frequencies covering the animals and products referred to in 
Article ll(2)(c), (d), (e), (f) and (g) shall be established in accordance with the procedure 
provided for in Article 34; in doing so, account shall be taken of experience gained under 
existing national measures and information forwarded to the Commission under existing 
Community requirements making such specific product groups subject to the search for 
residues. 
16 
Article 15 
The plans shall take into account the specific situation of each Member State and specify in 
particular: 
the legislation on the use of the substances listed in Annex I, and in particular on their 
prohibition or authorization, distribution and placing on the market and the rules governing 
their administration; 
the infrastructure of the relevant departments (in particular giving details of the type and size 
of the bodies involved in implementation of the plans); 
a list of approved laboratories with details of their capacity for processing samples; 
national tolerances for authorized substances where no maximum Community residue levels 
have been set under Council Regulation (EEC) No 2377/90 laying down a Community 
procedure for the establishment of maximum residue limits of veterinary medicinal products 
in foodstuffs of animal origin(16); 
a list of the substances to be detected, the methods of analysis, standards for interpreting the 
findings and, in the case of the substances listed in group B of Annex I, the number of 
samples to be taken, giving reasons for this number; 
the number of official samples to be taken in relation to the number of animals of the species 
concerned slaughtered in preceding years in accordance with the sampling levels and 
frequency laid down in Annex IV; 
details of the rules governing the collection of official samples, and in particular the rules 
concerning the particulars to appear on such official samples; 
the type of measures laid down by the competent authorities with regard to products in 
which residues have been detected. 
Article 16 
1. The Commission shall examine the plans forwarded under Article 11(1) to ascertain whether 
they conform to this Regulation. 
2. The Commission shall approve the plans in accordance with the procedure provided for in 
Article 34. Under the same procedure, the Commission may decide that a Member State must 
amend or supplement the plan which it has submitted. 
3. At the request of the Member State concerned and in order to take account of changes in the 
situation in that Member State or in a region thereof, the Commission may decide, in 
accordance with the procedure provided for in Article 33, to approve an amendment or 
addition to a plan previously approved pursuant to paragraph 2. 
4. In accordance with the procedure provided for in Article 33, the Commission may decide that 
a Member State must amend or supplement a plan previously approved pursuant to 
paragraph 2 in order to take account of changes in the situation in that Member State or of 
findings gathered under Articles 25 and 26. 
(16) OJNoL 224, 18.8.1990, p. 1. 
17 
5. Every six months, Member States shall inform the Commission and the other Member States 
within the Standing Veterinary Committee of their implementation of plans approved pursuant 
to paragraph 2. Where necessary, paragraph 4 shall apply. Each year before 1 March the 
Member States shall forward to the Commission the results of their residue detection plans and 
of their measures to implement controls. 
6. At regular intervals, and at all events whenever it deems it necessary on public health grounds, 
the Commission shall inform the Member States within the Standing Veterinary Committee 
of developments in the situation in the various regions of the Community. 
7. Each year the Commission shall inform the Member States meeting within the Standing 
Veterinary Committee about: 
the implementation of national plans, 
developments in the situation in the various regions of the Community. 
8. Each year the Member States shall publish the results of their national plans for monitoring 
residues. 
CHAPTER IV 
Rules concerning checks on residues 
| Article 17 
j 
.$$ As provided for in Annexes I to IV, official samples shall be taken from animals, their excrement 
and body fluids, including the contents of the slurry pit, from their tissues and drinking water, from 
products of animal origin and from animal feed for examination at approved laboratories for 
residues. 
Article 18 
1. In each Member State at least one national reference laboratory shall be designated in 
accordance with the procedure provided for in Article 34. A given residue or residue group 
may not be assigned to more than one national reference laboratory. 
2. The laboratories referred to in paragraph 1 shall be responsible for: 
coordinating the work of the other national laboratories responsible for residue analysis, 
in particular by coordinating the standards and methods of analysis for each residue or 
residue group concerned; 
assisting the competent authority in organizing the plan for monitoring residues; 
periodically organizing comparative tests for each residue or residue group assigned to 
them; 
ensuring that national laboratories observe the limits laid down; 
disseminating information supplied by Community reference laboratories. 
18 
Article 19 
The Community reference laboratories shall be those designated in Chapter 1 of Annex V. 
The powers and working conditions of the laboratories shall be as defined in Chapter 2 of Annex V. 
Article 20 
1. The official samples shall be analysed in accordance with the methodological routines 
determined in accordance with the procedure provided for in Article 34. 
2. All positive findings resulting from the analyses referred to in paragraph 1 must, if challenged, 
be confirmed by the national reference laboratory designated in accordance with Article 18(1) 
for the substance or residues in question, using the reference methods laid down in accordance 
with the procedure under Article 34. 
Article 21 
Where examination of an official sample reveals the presence of residues of prohibited substances 
or of authorized substances used illegally or in quantities exceeding either the levels set by 
Community legislation or, pending the adoption of such provisions, the levels fixed by national 
legislation, Articles 22 to 26 shall apply. 
Article 22 
1. The competent authority shall obtain without delay: 
(a) all the information required to identify the animal and farm of origin; 
(b) full details of the examination and its result. If the controls carried out in a Member 
State demonstrate the need for an investigation or other action in one or more Member 
States or third countries, the Member State concerned shall inform the other Member 
States and the Commission. The Commission shall coordinate the appropriate measures 
taken in Member States where an investigation or other action proves necessary. 
2. The appropriate authority shall thereupon carry out: 
(a) an investigation on the farm of origin to determine the reasons for the presence of 
residues; 
(b) an investigation of the source or sources of the substance concerned at the stage of 
manufacture, handling, storage, transport, administration, distribution or sale, as 
appropriate; 
(c) any other further investigations which they consider necessary. 
19 
3. The competent authority shall ensure that 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 regarded as 
containing the residues in question, are marked with an official marking and subjected to the 
collection of official samples. The samples shall be taken from all the animals present on the 
inspected farm which are likely to be suspect. In the case of poultry and fish, the samples 
shall be taken from a significant number of individuals. 
Article 23 
1. Where examination of the samples taken pursuant to Article 22 reveals the presence of 
prohibited substances or of authorized substances used illegally, animals which have given 
positive test results shall be slaughtered immediately, either on the spot or at the nearest 
slaughterhouse and their carcases sent to a high-risk processing plant as defined in Article 2(5) 
of Council Directive 90/667/EEC(17), without prejudice to the penalties imposed by Community 
legislation in the sector. 
If 10% or more of the animals tested prove positive, the whole batch of animals shall be 
slaughtered under the conditions provided for in the first subparagraph. For a further period 
of at least twelve months, any animal from that farm or owned by the same owner or supplied 
by the same supplier shall be systematically tested for residues. 
2. Where the samples taken pursuant to Article 22 reveal residues of authorized substances 
exceeding the levels set by Community rules or, in the absence of such rules, the levels set 
by national law, slaughter of the animals for human consumption shall be prohibited until it 
can be ensured that the residues no longer exceed the permissible levels. 
This period may under no circumstances be shorter than the withdrawal period prescribed for 
the substances in question. 
However, if the presence of residues of authorized substances proves to be due to failure to 
observe the terms and conditions for using authorized substances other than the withdrawal 
period, the animals and their meat shall be destroyed as provided for in paragraph 1. 
3. During the period of examination, the animals may be disposed of to other persons only under 
the supervision of an official veterinarian. 
4. Notwithstanding the first subparagraph of paragraph 2, animals whose slaughter is prohibited 
may be slaughtered in emergencies before the end of the prohibition period only with the 
approval of the competent authority, which must have been informed before the proposed 
slaughter date and have designated the place of slaughter. The animals, officially marked, 
must be accompanied to the place of slaughter by an official veterinary certificate containing 
the information required under Article 22(1 )(a). 
The meat of each animal whose slaughter is notified pursuant to the first subparagraph shall 
be officially sampled for the residue concerned and shall be detained until the result of the 
examination is known. 
(17) OJ No L 363, 27.12.1990, p. 51. 
20 
Meat in which the presence of residues is confirmed shall be sent to a high-risk processing 
plant within the meaning of the aforesaid Directive 90/667/EEC. 
5. The establishment or establishments supplying the farm of origin shall be subject to further 
checks for the substance in question. All farms and establishments in the same supply chain 
of animals and animal feed as the farm of origin shall be subject to similar checks. 
Article 24 
1. The costs of the investigations and checks referred to in Article 22(2) shall be borne by the 
owner or person having charge of the animals. 
The costs of analyses following the collection of official samples as provided for in 
Article 22(3) shall be borne by the owner or person having charge of the animals. 
2. Without prejudice to criminal or administrative penalties, the cost of destroying animals which 
have given a positive result or animals which have been deemed positive in accordance with 
Article 23 shall be borne by the owner of the animals without any financial compensation 
being paid. 
Article 25 
1. The Commission's veterinary experts may, in cooperation with the competent authorities of 
the Member States, make on-the-spot checks where this is necessary to ensure uniform 
application of this Regulation. 
A Member State within whose territory a check is being carried out shall give all necessary 
assistance to the experts in carrying out their duties. The Commission shall inform the 
Member State concerned of the results of the checks carried out. 
The Member State concerned shall take any measures which may prove necessary to take 
account of the results of the check. If the Member State does not take those measures, the 
Commission shall itself take appropriate measures in accordance with the procedure provided 
for in Article 34. 
2. The general rules for implementing this Article, especially as regards the frequency and 
method of carrying out the checks referred to in the first subparagraph of paragraph 1, shall 
be laid down in accordance with the procedure provided for in Article 34. 
Article 26 
1. The provisions of Council Directive 89/608/EEC of 21 November 1989 on mutual assistance 
between the administrative authorities of the Member States and cooperation between the latter 
and the Commission to ensure the correct application of legislation on veterinary and 
zootechnical matters08) shall apply. 
(18) OJNoL 351, 2.12.1989, p. 34. 
21 
Where a Member State considers that, in another Member State, the controls provided for in 
this Regulation are not being, or have ceased to be, carried out, it shall inform the competent 
central authority of that State accordingly. Following an investigation in accordance with 
Article 22(2), mat authority shall take all necessary measures and shall, at the earliest 
opportunity, notify the competent central authority of the first Member State of the decisions 
taken and the reasons for those decisions. 
If the former Member State fears that such measures are not being taken or are inadequate, 
it shall, together with the Member State which has been challenged, seek ways and means of 
remedying the situation; if appropriate, this may involve a visit on the spot. 
Member States shall inform the Commission of disputes and of solutions arrived at. 
If the Member States involved are unable to reach agreement, one of them shall bring the 
matter to the notice of the Commission within a reasonable period of time, and the latter shall 
instruct one or more experts to deliver an opinion. 
Pending those conclusions, the Member State of destination may carry out checks on products 
coming from the establishment or establishments or from one or more of the holdings 
challenged by the dispute and, if the result is positive, take measures similar to those provided 
for in Article 10(4) of Council Directive 64/433/EEC(,9). 
In the light of the experts' opinion, appropriate measures may be taken in accordance with the 
procedure provided for in Article 34. 
Those measures may be reviewed in accordance with the same procedure, in the light of a 
new expert opinion delivered within a period of 15 days. 
The general rules for the application of this Article shall be adopted in accordance with the 
procedure under Article 34. 
Article 27 
Slaughterhouse supervisors shall require a written statement from the owner or person having charge 
of the animals, certifying that he has complied with Community legislation on the prohibition on 
the use of substances having a hormonal or thyrostatic effect or of beta-agonists and that he takes 
full responsibility if prohibited substances are found in animals delivered to the slaughterhouse. 
Article 28 
Any failure to cooperate with the competent authority and any obstruction of slaughterhouse 
personnel or the slaughterhouse supervisor by the owner of the animals, or by persons having 
charge of them, during inspection and sampling as required for the implementation of national 
plans for monitoring residues and during inquiries and checks provided for in this Regulation 
shall result in criminal and/or administrative penalties. 
(19) OJ No 121, 29.7.1964, p. 2012/64. 
22 
Member States shall make every effort to ensure, within the limits of their national law, that 
judicial decisions regarding sentences for illegally holding or using prohibited substances or 
for illegally using authorized substances are published in the specialized agricultural press. 
Article 29 
The fees provided for in Council Directive 85/73/EEC of 29 January 1985 on the financing of health 
inspections and controls of fresh meat and poultrymeat(20) shall also be used for residue monitoring 
and control measures carried out under this Regulation, with the exception of those referred to in 
Article 22(1) and (2). Each year, Member States will send to the Commission the data relating to 
the allocation and the use of those fees. 
Article 30 
1. Inclusion and retention on the list referred to in Article 3 of Council Directive 72/462/EEC(21) 
shall be subject to submission by the third country concerned of an annual plan setting out the 
guarantees it offers as regards the monitoring of residues. This plan must be sent to the 
Commission no later than 31 January each year. 
The guarantees must have an effect at least equivalent to those provided for in this Regulation. 
The Commission shall approve the plan in accordance with the procedure provided for in 
Article 34 of this Regulation. Under the same procedure, guarantees alternative to those 
resulting from implementing this Regulation may be accepted. 
2. Where the requirements of paragraph 1 are not complied with, inclusion of a third country on 
the list referred to in Article 3 of Directive 72/462/EEC may be suspended in accordance with 
the procedure provided for in Article 34 hereof. 
3. Compliance with the plans submitted by third countries shall be verified by means of the 
checks referred to in Article 5 of Directive 72/462/EEC. 
4. Member States shall inform the Commission each year of the results of residue controls 
carried out on animals and animal products imported from third countries. 
Article 31 
Annexes I to V may be amended or extended in accordance with the procedure provided for in 
Article 34. 
(20) OJNoL 32, 5.2.1985, p. 14. 
(21) OJ No L 302, 31.12.1972, p. 28. 
23 
Article 32 
Rules for the application of this Regulation shall be drawn up if necessary in accordance with the 
procedure laid down in Article 34. 
CHAPTER V 
General provisions 
Article 33 
The Commission shall be assisted by the Standing Veterinary Committee (hereinafter referred to 
as 'the Committee'). 
The representative of the Commission shall submit to the Committee a draft of the measures to be 
taken. The 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 the 
majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is 
required to adopt on a proposal from the Commission. The votes of the representatives of the 
Member States within the Committee shall be weighted in the manner set out in that Article. The 
chairman shall not vote. 
The Commission shall adopt the measures envisaged if they are in accordance with the opinion of 
the Committee. 
If the measures envisaged 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 relating to the 
measures to be taken. The Council shall act by a qualified majority. 
If, fifteen days from the date of referral to the Council, the Council has not acted, the proposed 
measures shall be adopted by the Commission. 
Article 34 
The Commission shall be assisted by the Committee. 
The representative of the Commission shall submit to the Committee a draft of the measures to be 
taken. The 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 the 
majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is 
required to adopt on a proposal from the Commission. The votes of the representatives of the 
Member States within the Committee shall be weighted in the manner set out in that Article. The 
chairman shall not vote. 
The Commission shall adopt the measures envisaged if they are in accordance with the opinion of 
the Committee. 
24 
If the measures envisaged 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 relating to the 
measures to be taken. The Council shall act by a qualified majority. 
If, three months from the date of referral to the Council, the Council has not acted, the proposed 
measures shall be adopted by the Commission. 
Article 35 
Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC are hereby 
repealed. 
Article 36 
Member States shall inform the Commission of the measures taken at national level to implement 
this Regulation. 
Article 37 
This Regulation shall enter into force on 1 January 1994. 
This Regulation shall be binding in its entirety and directly applicable in all Member States. 
Done at Brussels, For the Council 
The President 
25 
ANNEX I 
RESIDUE GROUPS 
GROUPS COMMON TO ALL MEMBER STATES 
Group I 
(a) Stilbenes, stilbene derivatives, their salts and esters 
(b) Thyrostatic substances 
(c) Other substances with oestrogenic, androgenic or gestagenic action, with the 
exception of substances in Group II 
(d) beta-agonists, with the exception of those in Group II (b) 
Group II 
(a) Substances authorized in accordance with Article 4(1) and (2) of Regulation (EEC) 
No ...793 concerning the prohibition on the use in stockfarming of certain substances 
having a hormonal action or a thyrostatic action and of beta-agonists 
(b) Substances of the beta-agonist group authorized in accordance with Article 4(3) of 
Regulation (EEC) No ..../93 concerning the prohibition on the use in stockfarming of 
certain substances having a hormonal action or a thyrostatic action and of beta-
agonists 
Group m 
(a) Inhibitors 
Antibiotics, sulphonamides and similar antimicrobial substances 
(b) Chloramphenicol 
B. SPECIFIC GROUPS 
Group I: Other medicines 
(a) Endo- and ectoparasitic substances 
(b) Tranquillizers and beta-blockers 
(c) Other veterinary medicines 
Group II: Other residues 
(a) Contaminants present in feedingstuffs 
(b) Contaminants present in the environment 
(c) Other substances 
26 
ANNEX II 
Residue group to be detected by type of animal, their feedingstuffs and products 
Type of animal, 
feedingstuffs 
or animal 
products 
Substance 
groups Bovine, ovine, 
caprine, porcine, 
equine animals, 
their meat and 
feedingstuffs Poultry(*)poultry 
meat and 
feedingstuffs Aquaculture 
animals and 
products, and 
their feedingstuffs Mi Ik and mi Ik-based 
products Egg products Rabbit meat and 
the meat of wild 
and farmed game Honey 
A I a 
A I b 
A I c 
A I d 
Alia and b 
A III a 
A III b A I a 
A i b 
A I c 
A I d 
Alia and b 
A III a 
A III b A I a 
A I b 
A I c 
Alia and b 
A III a 
A III b A I a 
A I d 
A III a 
A III b A III a 
A III b A I a 
A I b 
A I c 
Alia and b 
A III a 
A III b (**) A I a 
(**) A I c 
A III a (**) 
A III b <**) A III a 
A III b 
B I a 
B I b 
B I c 
B II a 
B II b 
B II c B I a 
B I b 
B I c 
8 II a 
B II b 
B II c B I a 
B I b 
B I c 
B II a 
B II b 
B II c green malachite 
B II b B I! a 
B II b 
B II c B I a 
B I b 
B I c 
B II a 
B II b 
B II c B I a (**> 
B I c <**) 
B II a <**) 
B II b 
B II c B I a 
B II b 
(*) Poultry = chickens, laying and breeding hens, turkeys, guinea fowl, ducks and geese. 
(**) Not applicable to wild game. 
27 
ANNEX III 
RULES ON SAMPLING 
A. SAMPLING CONDITIONS 
(a) Official samples are to be taken in accordance with the appropriate sampling system and the 
following principles: 
* Whether on the farm, at the slaughterhouse or in any other place where samples are 
taken, sampling must be unforeseen, unexpected, and effected at no fixed time and on 
no particular day of the week. The Member States must take all the precautions 
necessary to ensure that the element of surprise in the checks is constantly maintained. 
* In the case of the substances listed in Groups A I and A II of Annex I, sampling must 
be targeted so as to take account of the criteria set out in (b) below, especially as 
regards sex, age and fattening system, and must take account of all information in the 
Member State's possession. 
* In the case of the other substances listed in Annex I, the official samples shall be taken 
at random. 
Furthermore, the Member States shall be authorized to carry out checks on a basket of 
substances and to concentrate checks on those regions where species likely to be 
affected by such substances are produced. 
(b) Variable criteria to be taken into account when collecting targeted samples: 
(i) Legislation in force regarding the use of the substances listed in the residue groups 
(ii) Factors liable to encourage fraud or misuse. 
(iii) The animal population concerned as regards: 
total size of population, 
homogenity of population groups, 
age of animals, 
sex of animals. 
(iv) The environment of holdings as regards. 
regional differences, 
the relation to industrial activity, 
relation to arable farming. 
(v) Farm production systems including: 
intensive farming units, 
fattening systems, 
husbandry systems, in particular feeding regimes and animal health care measures 
28 
(vi) Problems liable to arise, in the light of known precedents and other indications. 
(vii) The required degree of consumer protection, according to the nature and toxicity of the 
substance in question. 
(viii) Where the provisions of Annex IV lay down that samples must be taken on the holding, 
such samples may be taken not only from the animals but also from their feedingstuffs 
and drinking water. 
B. SAMPLING SYSTEM 
Member States shall apply, for each type of substance and animal, and according to the health-
protection level, the above variable criteria and the special characteristics of their territory, a 
sampling and examination system in accordance with Annexes I, II and III to this Regulation. 
29 
ANNEX IV 
Sampling levels and frequency 
CHAPTER 1 
Cattle, pigs, sheep, goats, horses and the like 
Minimum annual requirements 
A. In the case of the residues and substances listed in Groups A I and A II of Annex I 
1. In the case of the following bovine animals for fattening: cows, young bulls, bulls, 
heifers and calves: 
the Member States shall ensure checks on a number of samples covering 
0.5% of the animals slaughtered in the previous year, 
the samples must be broken down as follows: 
(a) three-fifths are to be taken on the farm from live animals At least one 
third of these samples are to be tested for beta-agonists. Supplementary 
samples are to be taken from the animals' feedingstuffs and drinking 
water and slurry from the holding; 
(b) two-fifths are be taken in the slaughterhouse. 
2. In the case of sheep and pigs for fattening 
The Member States shall effect checks on a number of samples equal to 0.05% of 
the animals of each species slaughtered the previous year. 
3. Other animal types 
The number of samples shall be determined by the Member States on the basis of 
the problems identified for each animal category. 
B. In the case of the residues and substances listed in Group A HI of Annex I 
1. Group A IH(a) 
Samples equal to 0.1% of the animals slaughtered shall be tested. 
2. Group A 111(b) (Chloramphenicol) 
Samples equal to 0.02% of the animals slaughtered shall be tested. 
C. In the case of the residues listed in Groups B I and B II of Annex I: 
Monitoring shall cover 700 samples. However, instead of taking 700 samples, 
Luxembourg is authorized to effect checks on a number of samples equal to 0.2% 
of the animals slaughtered. 
30 
The annual results concerning environmental contaminants (heavy metals in 
particular) shall include a geographical map showing the distribution of the 
contamination. 
II. Follow-up 
Where an animal species or type of production of a given animal species has not tested 
positive for residues or substances of Groups A I, A II or A 111(b) of Annex I for two 
consecutive years, the Member States shall be authorized to test 300 samples a year for the 
residue group concerned and for the species or type of production of the species in question. 
CHAPTER 2 
Chickens, laying and breeding hens, turkeys, 
guinea fowl, ducks and geese 
Minimum annual requirements 
Samples must be taken from animals and their feedingstuffs and drinking water. 
A. In the case of the residues listed in Groups A I, A H, B I and B II, with the exception of the 
coccidiostats 
The number of samples taken must be at least 0.1% of the batches of the species in question 
slaughtered during the previous year. 
B. In the case of the residues listed in Group A III of Annex I: 
1. GroupAIII(a) 
Monitoring shall cover a number of samples equal to 1% or more of the batches, with 
a minimum of 100 samples in the case of turkeys, guinea fowl, ducks and geese. 
Group A EH (b) (chloramphenicol) 
Monitoring shall cover a number of samples equal to 1% of the batches of the species 
in question slaughtered during the previous year. 
C. In the case of the residues listed in Group B 1(a) (coccidiostats only) 
Monitoring shall cover a number of samples equal to 1% or more of the batches, with a 
minimum of 100 samples in the case of turkeys, guinea fowl, ducks and geese. 
31 
ANNEX V 
Chapter 1 
The following laboratories shall be designated Community reference laboratories for the 
detection of residues of certain substances: 
(a) For the residues listed in Groups A I and A II of Annex I to this Regulation, with the 
exception of beta-agonists 
Rijksinstituut voor de Volksgezondheid en Milieuhygiène 
A. van Leeuwenhoeklaan 9 
NL - 3720 BILTHOVEN 
(b) For the residues listed in Group A 111(a) of Annex I to this Regulation, with the exception 
of the sulphonamides 
Laboratoires des Médicaments vétérinaires 
(CNEVA - LMV) 
La Haute Marché, JAVENE 
F - 35133 FOUGERES 
(c) For the residues listed in Group A HI(b) of Annex I to this Regulation, plus beta-agonist 
and sulphonamide residues 
B undesgesundheitsamt 
Diedersdorfer Weg 1 
D - 12277 BERLIN 48 
(d) For the residues listed in Groups B 11(a) and B 11(b) of Annex I to this Regulation 
Istituto Superiore di Sanità 
Via Regina Elena 299 
I - 00161 ROMA 
Chapter 2 
The powers and operating conditions of the Community reference laboratories for the detection 
of residues in animals and foodstuffs of animal origin shall be as follows: 
1. The functions of Community reference laboratories shall be: 
(a) to coordinate the application, within the various national reference laboratories, of 
good laboratory practice in accordance with Directives 87/18/EEC(1) and 
S8/320/EEC(2); 
(b) to provide national reference laboratories with details of analytical methods and the 
comparative tests to be conducted, and to inform them of the results of such tests; 
(i) 
(2) OJNoL 15, 17.1.1987, p. 29. 
OJNoL 145, 11.6.1988, p. 35. 
32 
(c) to provide national reference laboratories, at their request, with technical advice on 
the analysis of the substances for which they have been designated the Community 
reference laboratory; 
(d) to distribute calibrated blank samples with and without residues to be analysed in 
comparative tests to be carried out by national reference laboratories; 
(e) to organize comparative tests between the various reference laboratories, the 
frequency of which shall be determined under the contracts to be concluded between 
the Commission and such laboratories and each time a new reference method is 
introduced under Community rules; 
(f) to promote and coordinate research into new analytical methods and to inform 
national reference laboratories of advances in analytical methods and equipment; 
(g) to identify residues and determine their concentration in cases where the results of 
analysis give rise to a disagreement between Member States; 
(h) to conduct initial and further training courses for the benefit of analysts from national 
laboratories; 
(i) to provide the Commission services, including the Community reference bureau, with 
technical and scientific assistance; 
(j) to compile a report on each year's work and transmit it to the Commission; 
(k) to liaise, in the field of analytical methods and equipment, with the national reference 
laboratories designated by third countries in the plans to be submitted in accordance 
with Article 34. 
2. In order to perform the functions specified in paragraph 1, Community reference 
laboratories must satisfy the following minimum requirements: 
(a) have suitably qualified staff who are adequately trained in analytical methods used 
for the residues for which they have been designated as the Community reference 
laboratory; 
(b) possess the equipment and substances needed to carry out the analyses for which they 
are responsible; 
(c) have an adequate administrative infrastructure; 
(d) have sufficient data-processing capacity to produce statistics based on their findings 
and to enable rapid communication of those statistics and other information to 
national reference laboratories and the Commission; 
(e) ensure that their staff respect the confidential nature of certain issues, results and 
communications; 
33 
(f) have sufficient knowledge of international standards and practices; 
(g) have available an up-to-date list of reference substances held by the Community 
reference bureau and an up-to-date list of manufacturers and vendors of such 
substances. 
34 
Proposal for a 
COUNCIL REGULATION (EEC) 
amending Regulation (EEC) No 805/68 on the common organization 
of the market in beef and veal 
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 of substances prohibited by Community veterinary regulations and in 
particular substances with a hormonal action and beta-agonists carries considerable risks to human 
health; whereas experience shows that, since the use of such substances can harm the reputation 
of beef and veal with consumers, it is also likely to disturb the balance on the market in beef and 
veal; whereas, given their effects on meat production, the illegal use of such substances is also 
likely to give the producers concerned economic advantages which could distort the market; 
whereas, therefore, Article 4(j) of Council Regulation (EEC) No 805/68(1), as last amended by 
Regulation (EEC) No 747/93(2>, lays down that the administration of prohibited substances renders 
the animals concerned ineligible for the premiums provided for in the beef and veal sector; 
whereas a thoroughgoing study of the current situation has shown that this measure is inadequate 
to ensure compliance with the prohibitions in force; whereas, therefore, the penalties should be 
strengthened; whereas the Commission intends to take appropriate measures as regards the detailed 
rules for the application of beef and veal premiums; whereas it is therefore necessary to delete the 
said Article 4(j), 
HAS ADOPTED THIS REGULATION: 
Article 1 
Article 4(j) of Regulation (EEC) No 805/68 is hereby repealed. 
(1) OJ No L 148, 28. 6. 1968, p. 24. 
(2) OJ No L 77, 31.3.1993, p. 15. 
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Article 2 
This Regulation shall enter into force on the seventh day following that of its publication in the 
Official Journal of the European Communities. 
This Regulation shall be binding in its entirety and directly applicable in all Member States. 
Done at Brussels, For the Council 
The President 
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ISSN 0254-1475 
COM (93) 441 final 
DOCUMENTS 
EN 03 
Catalogue number : CB-CO-93-485-EN-C 
ISBN 92-77-59409-8 
Office for Official Publications of the European Communities 
L-2985 Luxembourg 
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