Proposal for a COUNCIL REGULATION (EEC) on measures to monitor certain substances and residues thereof in live animals and animal products
Date: 1993-09-22
Institutions: European Commission
Subjects: animal product, application of EU law, health risk, hormone, live animal, veterinary legislation

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COMMISSION  OF  THE  EUROPEAN  COMMUNITIES 

COM(93)  441  final 
Brussels,  22  September  1993 

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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 

Proposal  for  a 
COUNCIL  REGULATION  (EEC) 

on  measures  to  monitor  certain  substances  and residues  thereof 
in  live  animals  and animal  products 

Proposal  for  a 
COUNCIL  REGULATION  (EEC) 

li^fe 

amending  Regulation  (EEC)  No  805/68  on  the  common  organization 
of  the  market in  beef  and veal 

(presented  by  the  Commission) 

.*f^7 

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) 

(b) 

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; 

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-
to  streamline  and  focus  control  procedures  in 
agonists  substances  for  fattening  purposes; 
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. 

Subject to Article 4, the following  are also prohibited: 

Article 3 

(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. 

Notwithstanding  Articles  2  and  3,  the  following  may  be  allowed: 

Article  4 

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  meaning  of  Article  2(b)  of  Council 
to  equidae  within 
The  administering 
Directive  90/426/EEC(7)  of  beta-agonists 
treat  cardio-respiratory  disorders.  Such 
to 
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. 

2. 

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. 

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. 

Detailed  rules  for  the  application  of  this  Regulation  shall  be  adopted  in  accordance  with  the 
procedure  laid  down  in  Article  12. 

Article  11 

(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. 

Directives  81/602/EEC,  88/146/EEC  and  88/299/EEC  are  hereby  repealed. 

Article  13 

Member  States  shall  inform  the  Commission  of  the  national  measures  adopted  pursuant  to  this 
Regulation. 

Article  14 

This  Regulation  shall  enter  into  force  on  1 January  1994. 

Article  15 

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) 

O J N oL  191, 23.7.1985,  p.  46. 
O J No  L 7 0,  16.3.1988, p.  16. 
OJ  No  L  275,  26.9.1986,  p.  36. 
O J N 0 L 6 6,  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) 

O J N oL  55,  8.3.1971, p. 23. 
O J N o L 6 2,  15.3.1993, p.  1. 
OJ  No  L  268, 24.9.1991, p.  15. 
O J N o L 2 6 8,  14.9.1992,  p.  1. 
O J N o L 6 2,  15.3.1993, p.  49. 
OJ  No  L  212,  22.7.1989,  p.  87. 
O J N oL  376,  31.12.1991, p.  38. 
O J N o L 2 6 8,  14.9.1992,  p.  35. 
O J N oL  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. 

For  the  purposes  of  this  Regulation: 

Article  2 

(a) 

(b) 

(c) 

(d) 

(e) 

"prohibited  substances  or  products"  means  substances  or  products  the  administering  of  which 
to  animals  is  prohibited  under  Community  legislation; 

"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; 

"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; 

"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; 

"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) 

O J N oL  66,  10.3.1989,  p.  37. 
O J N oL  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. 

3. 

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. 

The  checks  provided  for  in  paragraph  1  must  be  conducted  by  the  competent  national 
authorities  without  prior notice. 

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  4 

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. 

2. 

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. 

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; 

farmed  fish  and  shellfish,  aquaculture  products  and  feed; 

(b)  poultry,  poultrymeat  and poultry  feed; 
(c) 
(d)  milk  and milk  products; 
(e) 
(f)  meat  of  rabbits,  wild  game  and farmed  game; 
(g)  honey. 

egg  products; 

The  plans  shall  cover  the  detection  of  groups  of  residues  by  type  of  animal,  feedingstuffs  and 
products  in  accordance  with  Annex II. 

Article  12 

The plans  must  comply  with  the  rules  on  sampling  laid  down  in  Annex III. 

Article  13 

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 

The  plans  shall  take  into  account  the  specific  situation  of  each  Member  State  and  specify  in 
particular: 

Article  15 

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. 

2. 

3. 

4. 

The Commission  shall  examine  the plans forwarded  under Article  11(1) to  ascertain  whether 
they  conform  to  this  Regulation. 

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. 

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. 

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. 

6. 

7. 

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. 

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. 

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 

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. 

| 
j 
.$$ 

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. 

2. 

The  official  samples  shall  be  analysed  in  accordance  with  the  methodological  routines 
determined  in  accordance  with  the  procedure  provided  for  in  Article  34. 

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. 

1. 

The  competent  authority  shall  obtain  without  delay: 

Article  22 

(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. 

3. 

4. 

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. 

During the period of examination, the animals may be disposed of to other persons only under 
the  supervision  of  an official  veterinarian. 

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. 

Annexes  I  to  V  may  be  amended  or  extended  in  accordance  with  the  procedure  provided  for  in 
Article  34. 

Article  31 

(20)  OJNoL  32, 5.2.1985, p. 14. 
(21)  OJ No  L  302,  31.12.1972,  p.  28. 

23 

Rules  for  the  application  of  this  Regulation  shall  be  drawn  up if  necessary  in  accordance  with  the 
procedure  laid  down  in  Article  34. 

Article  32 

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. 

The  Commission  shall  be  assisted  by  the  Committee. 

Article  34 

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. 

Directives  85/358/EEC  and  86/469/EEC  and  Decisions  89/187/EEC  and  91/664/EEC  are  hereby 
repealed. 

Article  35 

Member  States shall  inform  the Commission  of  the measures  taken  at national  level  to  implement 
this  Regulation. 

Article  36 

This  Regulation  shall  enter  into  force  on  1 January  1994. 

Article  37 

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 

Stilbenes,  stilbene  derivatives,  their  salts  and  esters 

(a) 
(b)  Thyrostatic  substances 
(c)  Other  substances  with  oestrogenic,  androgenic  or  gestagenic  action,  with  the 

exception  of  substances  in  Group  II 
beta-agonists,  with  the  exception  of  those  in  Group  II  (b) 

(d) 

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 

Residue  group  to be detected  by  type  of  animal,  their  feedingstuffs  and  products 

ANNEX  II 

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 

Type  of  animal, 
feedingstuffs 
or  animal 
products 
Substance 
groups 

Bovine,  ovine, 
caprine,  porcine, 
equine  animals, 
their meat  and 
feedingstuffs 

A  I a 

A  I b 

A  I c 

A  I d 

A  I a 

A  i b 

A  I c 

A  I d 

A  I a 

A  I b 

A  I c 

A l ia  and  b 

A l ia  and  b 

A l ia  and  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 

A  III  a 

A  III  b 

B  I a 

B  I b 

B  I c 

8  II a 

B  II  b 

B  II c 

A  III  a 

A  III  b 

B  I a 

B  I b 

B  I c 

B  II  a 

B  II  b 

B  II  c 

A  I a 

A  I d 

A  III  a 

A  III  b 

A  I a 

A  I b 

A  I c 

(**)  A  I a 

(**)  A  I c 

A l ia  and  b 

A  III  a 

A  III  b 

A  III  a 

A  III  a  (**) 

A  III  b 

A  III  b  <**) 

A  III  a 

A  III  b 

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 a 

B  I c  <**) 

B  II  a <**) 

B  II  b 

B  II  c 

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) 

(b) 

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; 
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) 

(f) 

(g) 

(h) 

(i) 

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; 

to  promote  and coordinate  research  into new  analytical  methods  and to  inform 
national  reference  laboratories  of  advances  in  analytical  methods  and  equipment; 

to  identify  residues  and determine  their  concentration  in  cases  where  the  results  of 
analysis  give  rise  to  a disagreement  between  Member  States; 

to  conduct  initial  and further  training  courses  for  the  benefit  of  analysts  from  national 
laboratories; 

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 4(j) of Regulation  (EEC) No  805/68  is hereby repealed. 

Article 1 

(1)  OJ No L  148, 28. 6.  1968, p. 24. 
(2)  OJ No L 77, 31.3.1993, p. 15. 

35 

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 

36 

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 

37