Proposal for a COUNCIL REGULATION (EC) amending 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
Date: 1996-11-19
Institutions: European Commission
Subjects: animal product, food inspection, health policy, veterinary drug, veterinary legislation

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 19.11.1996 
COM(96)  584  final 

96/0279  (CNS) 

Proposal for a 

COUNCIL REGULATION (EC) 

amending 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 

(presented by the Commission) 

K  I K'  ? 

1i 

f.  .»' 

EXPLANATORY MEMORANDUM 

I.  COUNCIL REGULATION (EEC) NO 2377/90 

On  26  June  1990, the  Council  adopted  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  (OJ  NoL  224,  18.8.1990,  p.  1), 
hereinafter referred to as "the Regulation".  The aim of this Regulation is to protect public 
health and to prevent the establishment of maximum residue limit at national level  from 
hindering the free  movement of veterinary medicinal products and foodstuffs  within the 
European Union. 

The  effect  of  the  combined  provisions  of  the  Regulation  and  of  Article 4  of 
Directive 81/851/EEC on the approximation of the laws of the Member States relating to 
veterinary  medicinal  products  (OJ  NoL  317,  6.11.1981,  p.  1),  as  amended  by 
Directive 90/676/EEC of  13 December  1990 (OJ No L 373, 31.12.1990, p.  15), has been 
as follows: 

since  1  January  1992, the date on which the Regulation entered into force, it has not 
been possible to authorize the placing of a veterinary medicinal product on the market 
unless a maximum residue limit has been established beforehand  at Community level 
(new substance); 

substances  whose  use  was  authorized  on  that  date  have  had  to  be  progressively 
evaluated,  so  that  from  1 January  1997  the  use  of  substances  for  which  maximum 
residue limits had not been established  would be prohibited  in the Community  (old 
substances). 

Pursuant  to the Regulation, on the basis of  the scientific  opinion  of  the  Committee  for 
Veterinary  Medicinal  Products  (hereinafter  referred  to  as  CVMP),  it  falls  to  the 
Commission to adopt, in accordance with the procedure of the Regulatory Committee, a 
legally binding decision classifying  the substance in question in one of the four annexes 
to the Regulation: 

-  Annex I, restricted  to substances  for  which  a maximum  residue  level  may be  fixed 
after an evaluation of the toxicological risks that substance presents for human health; 

-  Annex II contains substances not subject to maximum residue levels; 

-  Annex HI covers  substances  for  which  in the absence of  adequate scientific  data it  is 

not  possible  to  establish  a  definitive  maximum  residue  limit  but  which  without 

presenting  a hazard for the health of the consumer may be the subject  of  a maximum 

residue limit for a specified  period required for the completion of scientific  studies; 

Annex  IV  is  for  substances  for  which  no  maximum  residue  limit  can  be  established 

because the substances concerned  constitute, at whatever limit, a hazard to the health 

of the consumer. 

The  Commission  has  then  classified  some  282  of  the  most  widely  used  substances  in 

veterinary  medicine  in  one  of  the  Annexes  to  the  Regulation  by  adopting  the  following 

Regulations: 

Regulation  (EEC) No 675/92, OJ L 73, 19.3.1992, p. 8 

Regulation  (EEC) No 3093/92, OJ L 311, 28.10.1992, p. 18 

Regulation (EEC) No 895/93, OJ L 93,  17.4.1992, p. 10 

Regulation  (EC) No 3425/93, OJ L 312, 15.12.1993, p. 12 

Regulation  (EC) No 3426/93, OJ L 312,  15.12.1993, p. 15 

Regulation  (EC) No 955/94, OJ L  108, 29.4.1994, p. 8 

Regulation  (EC) No  1430/94, OJ L  156, 23.6.1994, p. 6 

Regulation (EC) No 2703/94, OJ L 287, 8.11.1994, p. 19 

Regulation  (EC) No 3059/94, OJ L 323, 16.12.1994, p. 15 

Regulation  (EC) No  1102/95, OJL  110, 17.5.1995, p. 9 

Regulation  (EC) No  1441/95, OJ L  143, 27.6.1995, p. 22 

Regulation  (EC) No  1442/95, OJ L  143, 27.6.1995, p. 26 

Regulation  (EC) No  1798/95, OJ L 174, 26.7.1995, p. 20 

Regulation  (EC) No 2796/95, OJ L 290, 5.12.1995, p. 1 

Regulation  (EC) No 2804/95, OJ L 291, 6.12.1995, p. 8 

Regulation  (EC) No 281/96, OJ L 37, 15.5.1996, p. 9 

Regulation  (EC) No 282/96, OJ L 37, 15.2.1996, p. 12 

Regulation  (EC) No  1140/96, OJ L  151, 26.6.1996, p. 6 

Regulation  (EC) No  1147/96, OJ L  151, 26.6.1996, p. 26 

The  harmonization  thus  achieved  has enabled  the  Community  to play  a more  active  and 
coordinated  role  in  the  international  harmonization  work  undertaken  within  the  Codex 
Alimentarius  Committee  for  residues  of  veterinary  medicinal  products  in  foodstuffs  and 
the JECFA (Joint FAO/WHO Expert Committee on Food Additives). 

n.  ADAPTATION  OF  COUNCIL  REGULATION  (EEC)  No  2377/90  TO  THE  NEW 

COMMUNITY SYSTEM OF MARKETING  AUTHORIZATIONS 

Since  the  Regulation  was  adopted,  the  regulatory  environment  for  veterinary  medicinal 

products  has  been  radically  altered  following  the  entry  into  force  of  the  Community 

system of marketing authorizations resulting from  Council Regulation  (EEC) No 2309/93 

laying  down  Community  procedures  for  the  authorization  and  supervision  of  medicinal 

products  for  human  and  veterinary  use  and  establishing  a  European  Agency  for  the 
Evaluation of Medicinal Products1 and Council Directives 93/40/EEC2 and 93/41/EEC.3 

The  CVMP  is  henceforth  responsible  to  the  European  Agency  for  the  Evaluation  of 

Medicinal  Products  (hereafter  referred  to as "the Agency") which  deals with  requests  for 

authorization  to  place  human  and  veterinary  medicinal  products  on  the  market  in 

accordance  with  the  so-called  centralized  procedure  and  to  which  it  falls,  under 

Regulation  (EEC)  No  2309/93, to  issue  an  opinion  on  the  maximum  residue  limits  of 

veterinary medicinal products which are acceptable in foodstuffs  of animal origin. With a 

view  to  legal  consistency,  the  Regulation  should  therefore  be  adapted  by  conferring  on 

the  Agency  the  task  of  dealing  with  applications  for  the  establishment,  amendment  and 

extension  of  maximum  residue  limits  and by  aligning  the  decision  making  process  with 

that  of  the  centralized  procedure  (role  of  Agency  Secretariat,  time  limits,  appeals). 

Account  should  also be taken  of  Council  Regulation  (EC) No 297/95  on  fees  payable  to 
the  European  Agency  for  the  evaluation  of  medicinal  products4  which  lays  down  inter 
alia that fees are charged by the Agency for examining  applications for the  establishment, 

amendment and extension of maximum residue limits. 

Moreover,  it  is  necessary  to  adapt  the  period  for  submitting  draft  measures  to  the 

regulatory  committee  to  allow  the  Community  to  meet  its  obligations  under  the 

Agreements  on  the  application  of  sanitary  and  phytosanitary  measures  which  emerged 

from  the  multilateral  negotiations  of  the  Uruguay Round,  approved  on  behalf  of  the 
European  Community  by  Council  Decision  94/800/EC  of  22 December  1994.5  This 
agreement  creates  a  transparency  obligation  as  regards  health  measures  which 

necessitates  the  introduction  of reasonable  periods  for  consulting  members  of  the  World 

Trade Organization. 

1 
2 
3 
4 
5 

OJ L 214, 24.8.93, p. 1. 
OJL214,  24.8.93, p.  31. 
OJL214,  24.8.93, p. 40. 
OJ L 35, 15.2.9.95, p. 1. 
OJL  336, 23.12.94. p. 1 

III.  EXTENSION OF THE DEADLINE OF 1 JANUARY  1997 FOR THE REVISION 

OF OLD SUBSTANCES 

Article 7(2) of the Regulation provides for the gradual evaluation of old substances and 
Article  14 lays down that, with effect  from  1 January  1997, "the administration  to food 
producing animals of veterinary medicinal products containing pharmacologically  active 
substances which are not mentioned in Annexes I, II or HI shall be prohibited within the 
Community". 

To this end, the Commission published as an annex to Volume VI of the Regulations on 
medicinal  products  in  the  European  Community  a  timetable  for  the  evaluation  of  old 
substances.  The number of substances to be evaluated between  1992 and  1997 was then 
estimated at 400. In view of the difficulties  encountered by the industry in collecting the 
data necessary  to establish  dossiers  and by the  national  authorities  in evaluating  them, 
this timetable was changed and published in the form of a Commission communication in 
the Official  Journal of the European Communities on 29 September 1993.6 

The  Member  States  bearing  most  of  the  burden  of  the  evaluation  work  through  the 
CVMP were unable, however, to allocate sufficient  resources for the revision work to be 
completed by the deadline originally laid down by the Council.  For its part, the industry 
became involved in a major process of réévaluation and updating of dossiers. 

There  is  no  doubt  that  as  a result  of  this  exercise,  the  market  in  veterinary  medicinal 
products will have become more transparent, thus improving consumer protection.  It is, 
however, clear that the scale of the task far exceeded available resources and that, in spite 
of  the  considerable  efforts  of  the  Agency  since  commencing  its  activities  on 
1 January  1995,  the  evaluation  currently  underway  will  not  be  completed  by 
1 January 1997. 

Therefore, in order to allow this Community procedure to continue on a sound  scientific 
basis  and  not  to  deprive  veterinary  surgeons  and  other  users  of  substances  needed  to 
protect  animal  health,  the  time  limit  originally  laid  down  should  be  extended  by two 
years.  However,  for  obvious  reasons  of  consumer  protection  and  transparency,  this 
extension  should  be restricted  to those substances for  which dossiers were presented to 
the Agency before  1 January 1996. 

OJ C 263, 29.9.93, p. 5. 

The figures below give an overview of the situation on 1 March 1996: 

Annex I 

Annex II 

Total 

Substances undergoing evaluation in 
the Agency 

Substances undergoing evaluation for 
which further data has been requested 
from the firms concerned 

Substances whose evaluation has not 
yet begun 

Total 

32 

22 

35 

89 

69 

10 

101 

32 

78 

113 

157 

246 

The evaluation of prospective Annex I substances is estimated to involve 250 hours of 
work and prospective Annex JJ substances around 30 hours of work. Therefore,  11090 
hours of work are still needed to complete the evaluation of old substances. 

Given an 8-hour working day, 1 386 working days are then still needed for this activity. 
However, the Member States do not allocate the same resources to this work. The table 
below  shows the time that the national experts  spend on this activity, based on a 240 
working-day year: 

France (two experts) 
Netherlands (two experts) 
United Kingdom 

I Germany 

Italy 
Sweden 
Denmark 

I Ireland 
Austria 
Finland 
Portugal 
Spain 
Belgium 
Total 

100% 
50% 
70% 
25% 
25% 
25% 
25% 
25% 
10% 
10% 
10% 
10% 
10% 

I 
I 
1 

480 days 
240 days 
168 days 
120 days 
60 days 
60 days 
60 days 
60 days 
24 days 
24 days 
24 days 
24 days 
24 days 
1368 days 

However,  this  calculation  does  not  take  account  of  the  time  needed  for  industry  to 
respond  to  requests  for  additional  information  (around  6  months),  meetings  and  the 
delays inherent in the decision making process. It is therefore reasonable that, to complete 
the evaluation  of  old  substances  under conditions  which  are satisfactory  from  both the 
scientific  and  public  health  protection  point  of  view,  the  time  limit  laid  down  by  the 
Regulation should be extended to 1 January 1999. 

IV.  ESTABLISHMENT  OF  MAXIMUM  RESIDUE  LIMITS  FOR  SUBSTANCES 

UNDERGOING CLINICAL TRIALS 

Article 4(2) of Directive 81/851/EEC lays down that "from  1  January  1977 the Member 
States shall not permit foodstuffs  for human consumption to be taken from  test animals 
unless maximum residue limits have been established by the Community  in accordance 
with  the  provisions  of  Regulation  (EEC)  No  2377/90  and  an  appropriate  withdrawal 
period has been established to ensure that this maximum limit will not be exceeded in the 
foodstuffs". 

This  means  that,  from  1 January  1997,  unless  a maximum  residue  limit  is  established 
before â clinical trial is carried out, foodstuffs  from animals used in the clinical trial and 
possibly  the animals themselves  (regardless of the time that has elapsed  since the trial) 
would have to be destroyed. 

Moreover,  whereas  for  old  substances,  Article  4  of  the  Regulation  lays  down  that 

provisional  maximum  residue  limits  may  be  established  provided  that  there  are  no 

grounds  for  supposing  that  residues  of  the  substance  concerned  at  the  level  proposed 

present  a  hazard  for  the  health  of  the  consumer,  it  stipulates  that  as  regards  new 

substances, this possibility may be used only in "exceptional circumstances". 

Clinical  trials  are  carried  out  in  order  to  assess  the  effectiveness  of  the  substance, 

relatively early in the development process  and certainly  well  before  all the  information 

and data which has to be given in an application to establish a maximum residue limit for 

a pharmacologically active substance used in veterinary medicinal products in accordance 

with Annex V of Regulation (EEC) No 2377/90 is available. 

The  primary  objective  of  Regulation  (EEC)  No  2377/90  is  to  protect  the  health  of 

consumers  and it is  normal that such protection  should  apply  where  animals  have been 

the subject of clinical trials. However, notwithstanding this objective, it is also necessary 

to ensure that no undue damage is done to the research and development capacity of the 

pharmaceutical 

industry 

in  Europe  and  to  avoid  a  situation  where  European 

pharmaceutical companies are obliged to carry out their tests outside Europe. 

In the same way as with old substances, it is possible  to establish provisional  maximum 

residue  limits  for  substances  undergoing  clinical  trials. Annex  V  should be  amended  so 

that  initially  only  certain  data  is  provided,  which  nonetheless  constitutes  a  sound 

scientific  basis  for  the  evaluations.  To  this  end,  a  specific  annex  for  substances 

undergoing  clinical  trials which  are the  subject of  a provisional  maximum residue  limit 

and an appropriate withdrawal period guaranteeing protection of consumer health would 

have  to  be  added  to  Regulation  (EEC)  2377/90.  As  regards  the  fees  to  be  paid  to  the 
Agency,  a suitable solution should be applied under Regulation (EC) No  297/95,7 which 
could envisage the fee thus paid being  deducible  from that ultimately  due in connection 

with an application made under Article 6 of the Regulation. 

OJ NoL 35, 15.2.95, p. 1. 

Proposal  for a 

COUNCIL REGULATION (EC) 

amending 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 

THE COUNCIL OF THE EUROPEAN COMMUNITIES 

Having  regard  to  the  Treaty  establishing  the  European  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,  since  Council  Regulation  (EEC)  No  2377/90  was  adopted,  the  regulatory 
environment of veterinary medicinal products has been radically altered, in particular as a 
result  of  the  entry  into  force  of  Council  Regulation  (EEC)  No  2309/93  laying  down 
Community  procedures  for  the authorization  and supervision  of medicinal  products  for 
human  and  veterinary  use  and  establishing  a  European  Agency  for  the  Evaluation  of 
Medicinal  Products1  and  of  Council  Directive  93/40/EEC  amending  Directives 
81/851/EEC  and  81/852/EEC on  the  approximation  of  the  laws of  the  Member  States 
relating to veterinary medicinal products;2 

Whereas  the Committee  for  Veterinary  Medicinal  Products is henceforth  responsible to 
the European Agency for the Evaluation of Medicinal Products and whereas it falls to this 
Agency, through this Committee, to issue an opinion on the maximum residue limits of 
veterinary  medicinal  products  which  are  acceptable  in  foodstuffs  of  animal  origin  in 
accordance with Regulation (EEC) No 2377/90; 

Whereas Council Regulation (EC) No 297/95 of  10 February  1995 on fees payable to the 
European Agency for the Evaluation of Medicinal Products3 establishes the fees payable 
to  the  Agency  for  examining  applications  for  the  establishment,  amendment  and 
extension of maximum residue limits; 

Whereas it is necessary, consequently, to adapt Regulation (EEC) 2377/90 by conferring 
on the  Agency  the  task  of  dealing  with  applications  for  the establishment,  amendment 
and extension  of  maximum  residue  limits  and by aligning the decision-making  process 
with respect to the authorization and supervision of medicinal products for veterinary use 
with that introduced by Regulation (EEC) No 2309/93; 

Whereas the Agreement on the application of sanitary and phytosanitary measures which 
emerged from the multilateral negotiations of the Uruguay Round, approved on behalf of 
the  European  Community  by  Council  Decision  94/800/EC  of  22  December  1994 
concerning  the  conclusion  on  behalf  of  the  European  Community,  as  regards  matters 
within  its  competence,  of  the  agreements  reached  in  the  Uruguay  Round  multilateral 

1  OJ No L 214, 24.8.1993, p. 1. 
2  OJ  No L 214, 24.8.1993, p. 31. 
3  OJ No L 35, 15.2.1995, p. 1. 

negotiations  (1986-1994)4,  creates  transparency  obligations  as regards  health  measures; 
whereas Regulation  (EEC) No 2377/90  must therefore be adapted in order to enable the 
Community to fulfil  its obligations under this Agreement; 

Whereas  Council  Directive  81/851/EEC  as  amended  by  Directive  93/40/EEC  prohibits 
from  1st January  1997 foodstuffs  for human consumption being taken from animals used 
for  clinical  trials  unless"  maximum  residue  limits  have  been  established  by  the 
Community;  Whereas,  Regulation  (EEC)  No  2377/90  has  to  be  amended  in  order  to 
allow the use of this procedure for substances undergoing clinical trials; for this purpose, 
the  level  of  development  of  the  substance  concerned  should  be  taken  into  account; the 
information  and particulars  to  be  included  in  an  application  for  the  establishment  of  a 
MRL within the meaning of Annex V of this Regulation should be reviewed; 

Whereas  it  is  necessary  to  maintain  on  the  market  substances  the  use  of  which  was 
authorized  on  the  date  when  Regulation  (EEC)  No  2377/90  entered  into  force  and  for 
which  applications  were  submitted  to  the  Commission  or  to  the  Agency  before 
1 January  1996, in order to make it possible to continue their scientific  evaluation in the 
best possible conditions, given the resources available, 

HAS ADOPTED THIS REGULATION 

Article  1 

Regulation (EC) 2377/90 is amended as follows: 

1.  The following Article is inserted: 

"Article 4(a) 

A  provisional  maximum  residue  limit  may  be  established  for  a  pharmacologically 
active  substance  undergoing  clinical  trials,  provided  that  there  are  no  grounds  for 
supposing  that  residues  of  the  substance  concerned  at  the  level  proposed  present  a 
health hazard to consumers.  A suitable waiting period shall be fixed to guarantee that 
this  provisional  maximum  residue  limit  is  respected.  This  provisional  maximum 
residue  limit  shall  apply  for  a  defined  period  of  time,  which  shall  not  exceed  two 
years. 

The list of pharmacologically  active substances used in the context of clinical trials for 
which provisional  maximum residue limits have been established,  together with their 
appropriate time periods, shall be contained in Annex 111(a), which shall be adopted in 
accordance  with  the  procedure  laid  down  in  Article  8.  Except  as  provided  for  in 
Article  9,  any  amendments  to  Annex  IH(a)  shall  be  adopted  in  accordance  with  the 
same procedure." 

4  O.J. N°  L 336  of 23.12.94,  p.  1 

2.  Article 6 is replaced by the following text: 

"Article 6 

1. In order to obtain the inclusion in Annex I, II or HI of a pharmacologically  active 
substance  which  is  intended  for  use  in  veterinary  medicinal  products  for 
administration  to food- producing  animals, an application  to establish a maximum 
residue  limit  shall  be  submitted  to  the  European  Agency  for  the  Evaluation  of 
Medicinal  Products  set up by Council Regulation  (EEC) No 2309/93,  hereinafter 
referred to as the "Agency". 

This application shall contain the information  and particulars referred  to in Annex 
V and shall conform with the principles laid down in Directive 81/852/EEC.  When 
a provisional maximum residue limit as referred to in Article 4(a) of this Regulation 
has  been  established,  only  the  data  needed  to  complete  Annex  V  have  to  be 
supplied. 

2.  In  order  to  obtain  the  inclusion  in  Annex  111(a) of  a  pharmacologically  active 
substance  administered  to  food-producing  animals  and  used  in  the  context  of 
clinical trials, an application to establish a provisional maximum residue limit shall 
be  submitted  to  the  Agency.  This  application  shall  contain  the  information  and 
particulars referred to in Annex V, which shall be amended to that end. 

3.  The  application  shall  also  be  accompanied  by  the  fee  due  to  the  Agency  for 

examining the application fixed by Regulation (EC) No 297/95. 

3.  Article 7 is replaced by the following text: 

"Article 7 

1. The  Committee  for  Veterinary  Medicinal  Products  referred  to  in  Article  27  of 
Regulation (EEC) No 2309/93, hereinafter  referred  to as the "Committee", shall be 
responsible for formulating the Agency's opinion on the classification  of substances 
in Annexes I, H, HI, 111(a) or IV of this Regulation. 

2.  Articles  52  and  53  of  Regulation  (EEC)  No 2309/93  are  applicable  mutatis 

mutandis for the purposes of this Regulation. 

3.  The Agency shall ensure that the Committee's opinion is delivered within a period 
of  120  days  following  the  reception  of  a  valid  application.  If  the  information 
submitted  by  the  applicant  is  not  sufficient  to  enable  such  an  opinion  to  be 
prepared,  the  Committee  may  ask  the  applicant  to  supply  additional  information 
within  a specific  time limit.  The deadline  for  the opinion  shall  then  be  deferred 
until the additional information has been received. 

4.  The Agency shall forward the opinion to the applicant. Within  15 days of receipt of 
the opinion, the applicant may provide written notice to the Agency that he wishes 
to appeal.  In that case he shall forward  the detailed grounds for  his appeal to the 
Agency within 60 days of receipt of the opinion.  Within 60 days of the receipt of 
the grounds for appeal, the Committee shall consider whether its opinion should be 
revised and the reasons for the conclusion  reached on the appeal shall be annexed 
to the report referred to in paragraph 7. 

11 

5.  The Agency shall forward  the definitive  opinion of the Committee within 30 days 
of its adoption both to the Commission and to the applicant.  The opinion shall be 
accompanied  by a report describing the safety  evaluation  of  the  substance  by the 
Committee and which shall give the grounds for its conclusions. 

6.  The  Commission  shall  prepare  draft  measures  taking  account  of  Community 
legislation and shall start the procedure provided for in Article 8.  The Committee 
referred to in Article 8 shall adapt its rules of procedure in order to take account of 
the tasks conferred upon it by this Regulation. 

4.  In Article 8, paragraph 1 is replaced by the following text: 

"1.  Where the procedure laid down in this Article is to be followed,  the Commission 

shall be assisted by the Standing Committee for Veterinary Medicinal Products." 

5.  In Article 10, paragraph 1 is replaced by the following text: 

" 1.  Where the procedure laid down in this Article is to be followed, the Commission 
shall be assisted by the Standing Committee for Veterinary Medicinal Products." 

6.  Article 12 is replaced by the following text: 

"Article 12 

As soon as possible after  the amendment of Annexes I, H, IQ, Ilia or IV, the Agency 
shall publish a summary of the assessment of the safety  of the substances concerned 
that have been examined by the Committee. The Agency shall provide the competent 
authorities with appropriate methods of analysis for tracing residues. The  confidential 
nature of any proprietary data shall be respected. " 

7.  In Article 13, the terms "in Annex I or III" are replaced by "in Annex I, EQ or nia". 

8.  Article 14 is replaced by the following text: 

"Article 14 

With  effect  from  1 January  1997, the  administration  to  food-producing  animals  of 
veterinary  medicinal  products containing  pharmacologically  active  substances  which 
are not mentioned in Annexes I, II or III shall be prohibited within the Community. 

With regard to substances whose use was authorized in veterinary medicinal products 
before the date on which this Regulation entered into force and for which applications 
to establish  maximum residue limits were submitted  either to the  Commission.or to 
the  Agency  before  1 January  1996,  the  prohibition  date  indicated  in  the  previous 
subparagraph shall be deferred to 1 January  1999. Within three months of the adoption 
of this Regulation, the Agency will publish a list of these substances. 

As from  1 January  1997, the Member  States  shall  not  allow  foodstuffs  destined  fnr 
human  consumption  to  originate  from  animals  that  have  been  subjected  to  clinical 
trails unless the substance in question is mentioned in Annex Ilia." 

12 

Article 2 

This Regulation shall enter into force on 1 January 1997. 

This  Regulation  shall  be  binding  in  its  entirety  and  directly  applicable  in  all 
Member States. 

Done at 

For the Council 

The President 

13 

ISSN 0254-1475 

COM(96) 584 final 

DOCUMENTS 

EN 

03  15  05 

10 

Catalogue  number  :  CB-CO-96-581-EN-C 

ISBN 92-78-11557-6 

Office  for  Official  Publications of the European  Communities 

L-2985  Luxembourg