Proposal for a Regulation of the European Parliament and of the Council laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, and repealing Regulation (EEC) No 2377/90 {SEC(2007)484} {SEC(2007)485}
Date: 2007-04-17
Institutions: European Commission
Subjects: animal product, consumer protection, food safety, foodstuff, health legislation, human nutrition, veterinary drug

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 17.4.2007 
COM(2007) 194 final 

2007/0064 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

laying down Community procedures for the establishment of residue limits of 
pharmacologically active substances in foodstuffs of animal origin, and repealing 
Regulation (EEC) No 2377/90 

{SEC(2007)484} 
{SEC(2007)485} 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

•  Grounds for and objectives of the proposal 

The general policy objective is to continue to limit consumer exposure to pharmacologically 
active  substances  intended  to  be  used  in  veterinary  medicinal  products  for  food  producing 
animals and residues  thereof in foodstuffs of animal origin through  Community procedures. 
Nevertheless  the  proposal  should  ensure  maintenance  of  a  high  level  of  consumer  health 
protection  while  not  compromising  availability  of  veterinary  medicinal  products  in  the 
Community. At the same time, the proposal should contribute to simplification of legislation 
by  improving  the  readability  and  clarity  of  the  Regulation  in  line  with  the  better  regulation 
strategy of the Commission. 

In order to achieve the aim pursued, the following specific objectives have to be born in mind: 

•  Improve availability of veterinary medicinal products for food producing animals 
in order to ensure animal health and welfare and avoid illegal use of substances; 

•  Simplify  the  existing  legislation  by  enhancing  readability  of  the  provisions  on 
established  MRLs  for  the  end-users  (i.e.  animal  health  professionals,  control 
competent authorities in Member states and third countries);  

•  Provide  clear  references  for  the  control  of  residues  of  pharmacologically  active 
substances  in  foodstuffs  to  improve  consumer  health  protection  and  the 
functioning of the Single Market; 

•  Clarify  the  Community  procedures  establishing  Maximum  Residues  Limits 

(MRLs) by ensuring consistency with international standards. 

•  General context 

The current legal framework for MRLs has lead to particular problems: 

(a) 

(b) 

(c) 

Availability  of  veterinary  medicines  has  decreased  to  an  extent  that  creates 
adverse effects for public and animal health and animal welfare. 

International standards supported by the EU cannot be included in Community 
legislation  without  a  new  scientific  assessment  by  the  European  Medicines 
Agency. 

Control services of Member States have no points of reference in particular for 
substances detected in food from third countries.  

(d) 

The current legislation is difficult to understand. 

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In the absence of a change of existing legislation, a further deterioration of the availability of 
veterinary  medicinal  products  can  be  expected  with  a  negative  impact  on  human  health, 
animal  health  and  animal  welfare.  Furthermore,  the  negative  impact  on  the  animal  health 
industry and food industry would be increased over time. 

•  Existing provisions in the area of the proposal 

Regulation (EEC) No 2377/90 

The main changes proposed are the following: 

•  make  the  assessment  of  possibilities  for  extrapolation  a  compulsory  part  of  the 
overall  scientific  assessment  and  create  a  legal  basis  for  the  Commission  to  lay 
down the principles for applying extrapolation; 

•  introduce  an  obligation  to  adapt  Community  legislation  to  include  MRLs  set  by 

Codex with the support of the EU; 

•  create  a  specific 

limits  for 
pharmacologically  active  substances  not  intended  to  be  authorised  as  veterinary 
medicines in particular for control purposes and for imported food; 

to  set  maximum  residue 

legal  framework 

•  Consistency with the other policies and objectives of the Union 

Not applicable. 

2. 

CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

•  Consultation of interested parties 

Consultation methods, main sectors targeted and general profile of respondents 

The Commission published a Reflection Paper in December 2003 requesting comments on the 
various  points  raised  for  the  reconsideration and  modification  of  the  Community  legislation 
concerning residues of veterinary medicinal products. This paper analysed the reasons for the 
difficulties  encountered  in  the  application  of  the  existing  legislation  and  sought  to  propose 
alternative  ways  to  achieve  a  high  level  of  consumer  protection  coupled  with  continued 
availability  and  development  of  veterinary  medicinal  products  for  the  European  market  and 
good functioning of the intra- and extra Community trade in food of animal origin. Comments 
on ten main questions were solicited in the Reflection Paper. 

The  Reflection  Paper  was  published  on  the  websites  of  Directorate  General  Enterprises  and 
Industry  and  Directorate  General  Health  and  Consumer  Protection  of  the  European 
Commission. 

Two  Member  States  meetings  took  place  on  13  December  2004  and  11  July  2005.  At  the 
meeting on 13 December 2004 on the follow-up of the Reflection Paper on residues in food 
conceptual ideas for legislative amendments were discussed and it was agreed to continue the 
discussion in six expert Working Groups during spring 2005. 

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At  the  meeting  with  the  Member  States  on  11  July  2005,  proposals  for  changes  in  the 
legislation on residues of pharmacologically active substances used in food producing animals 
identified  by  the  six  Working  Groups  were  presented  in  a  Discussion  Paper  for  discussion 
with Member States representatives. 

European  bodies  which  sent  comments  on  the  Reflection  Paper  on  residues  in  food  were 
invited  to  a  meeting  on  18th  July  2005.  Twenty  one  European  organizations  attended  the 
meeting.  Proposals  for  changes  in  the  legislation  on  residues  of  pharmacologically  active 
substances  used  in  food  producing  animals  identified  by  six  Working  Group  of  Member 
States'  experts  were  presented  in  the  same  Discussion  Paper  than  the  one  presented  to  the 
Member States representatives.  

In  order  to  assess  the  impact  of  the  different  possible  options,  the  Commission  consulted 
stakeholders  with  questionnaires.  They  were  requested  to  complete  a  specific  questionnaire 
ranking  the  different  potential  solutions  identified  by  the  six  expert  working  Groups.  The 
questionnaire  was  sent  to  the  working  groups'  experts  and  to  professional  organizations' 
representatives. They were asked to provide their assessment on the key areas of interest. 

The  impacts  were  evaluated  with  a  distinction  between  a  positive  or  a  negative  impact.  A 
semi-quantitative assessment was provided.212 

Summary of responses and how they have been taken into account 

Public  consultation  on  the  Reflection  Paper  closed  end  of  March  2003.  Comments  were 
received from over 40 sources including 12 Member States, the European Medicines Agency, 
one  European  association  for  the  veterinary  profession,  the  pharmaceutical  animal  health 
industry and its European asssociation, the organisations of primary producers of foodstuff of 
animal  origin,  umbrella  organisations  of  the  European  food  industry  as  well  as  European 
organisations for particular types of food production (dairy, meat and sausages, fish, honey, 
dried fruit, nuts and spices), two countries outside the EU and a few individual persons.  

The meetings with Member States' experts and stakeholders on the Discussion Paper resulted 
in important guidance for the Commission on major items. The main ideas of this consultation 
were  taken  on  board  by  the  Commission  in  the  drafting  of  the  legal  proposal.  The  semi-
quantitative  assessment  based  on  stakelholders  interviews  was  used  for  the  impact 
assessment.213 

An  open  consultation  was  conducted  over  the  internet  from  18/12/2003  to  20/03/2004.  The 
on 
available 
Commission 
http://europa.eu.int/common/entreprise/pharmaceuticals/pharmacos/archives 2004.htm. 

response(s). 

received 

results 

The 

are 

40 

•  Collection and use of expertise 

There was no need for external expertise.230 

•  Impact assessment 

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•  Option 1 - To maintain the current legal framework. Maintaining the current legal 
framework would mean that existing availability problems would be unresolved. 
The  existing  practice  of  only  limited  use  of  extrapolation  one  residue  limit  to 
different  tissues  and  species  would  continue.  Consistency  with  international 
standards could not be promoted as the current legislation requires new scientific 
assessment.  Moreover,  the  lack  of  harmonisation  in  the  area  of  control  would 
persist  with  different  control  levels  of  Member  States  without  a  clear  scientific 
basis.  The  general  lack  of  clarity  of  the  legislation  would  not  be  overcome  and 
risks of erroneous application would continue. 

•  Option  2  -  To  review  the  existing  regulation  by  incorporating  specific  legal 
provisions  and  amending  existing  rules  to  address  the  specific  objectives.  A 
review  provides  the  chance  to  overcome  the  existing  shortage  of  veterinary 
medicines  in  the  medium  and  long  term  by  establishing  a  clear  legal  basis  for 
extended  use  of  one  residue  limit  for  other  tissues  and  species.  International 
standards  supported  by  the  European  Union  could  directly  be  incorporated  in 
European  Union  legislation.  Furthermore,  the  food  industry  and  third  countries 
would  be  provided  with  a  clear  science-based  European  Union  reference  for 
residues  of  substances  not  intended  for  use  in  veterinary  medicines  in  the 
Community.  Finally,  improved  clarity  could  be  achieved  with  the  review  of  the 
legislation, in particular by creating one consolidated list of substances with their 
different  classifications.  This  should  result  in  improved  compliance.  Overall  the 
administrative burden would be reduced. 

•  Option  3  -  To  replace  the  existing  legislation  by  guidelines.  The  option  of 
replacing  the  existing  legislation  by  guidelines  would  create  public  health  risks 
Deregulation of the internal market and different levels of food safety could lead 
to  crisis  in  consumer  confidence  with  major  economic  losses.  Self-regulation 
would result in a reduced administrative burden, but this effect would be offset by 
enforcement mechanisms to be created under such system. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

•  Summary of the proposed action 

The  legal  proposal  addresses  the  shortcomings  of  the  current  situation  by  amending  on 
substance the existing legal framework on maximum residue limits while leaving the overall 
system  of  setting  maximum  residue  limits  based  on  scientific  assessment  intact.  The  main 
changes proposed are the following: 

•  make  the  assessment  of  possibilies  for  extrapolation  a  compulsory  part  of  the 
overall  scientific  assessment  and  create  a  legal  basis  for  the  Commission  to  lay 
down the principles for applying extrapolation; 

•  introduce  an  obligation  to  adapt  Community  legislation  to  include  MRLs  set  by 

Codex with the support of the EU; 

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•  create  a  specific 

limits  for 
pharmacologically  active  substances  not  intended  to  be  authorised  as  veterinary 
medicines in particular for control purposes and for imported food; 

to  set  maximum  residue 

legal  framework 

•  rearrange  the  sequence  of  articles  in  order  to  create  a  logical  structure, 

differentiating in particular risk assessment and risk management provisions; 

•  integrate in a separate Commission regulation the rules (MRLs, conditions of use, 
prohibitions) relating to individual substances, which are currently in 4 annexes of 
the current basic act. 

•  Legal basis 

Article 37, Article 152 (4) (b) of the Treaty329 

•  Subsidiarity principle 

The  proposal  falls  under  the  exclusive  competence  of  the  Community.  The  subsidiarity 
principle therefore does not apply. 

•  Proportionality principle 

The proposal complies with the proportionality principle for the following reason(s). 

The setting of residue limits is an integral part of the Community system of authorisations for 
veterinary medicinal product and of food controls in the EU. While controls are carried out by 
Member  States,  there  is  no  choice  than  fixing the  same  residue  limits  for  the  benefit  of  the 
free circulation of goods in the EU. 

The  objective  is  to  reduce  the  administrative  burden  for  economic  operators  compared  with 
the burden caused by the existing legal framework. 

The administrative burden would be reduced by three factors: 

–  the  absence  of  the  need  for  a  separate  scientific  assessment  of  active  substances  which 
have been assessed by Codex. The reduction would result on the one hand from the non-
delivery of a full file including all requested data and on the other hand from the speeding-
up of the process of authorising the veterinary medicine in question. 

–  the  reduction  of  scientific  data  to  be  provided,  if  the  scientific  committee  extends  the 
application of extrapolation. Actually, as the new regulation would require the committee 
to consider extrapolation and to balance their decision on setting maximum residue limits 
with  the  need  to  ensure  availability  of  medicines,  broader  use  of  extrapolation  can  be 
expected. 

–  The  harmonisation  of  control  standards  for  certain  residues  in  food.  Industry  currently 
faces  an  unjustified  burden  by  divergent  control  reference  points  in  different  Member 
States. The benefits of the common market can not be fully realised for this reason and also 
imports from third countries face unnecessary obstacles. Refusal of consignments or even 
destruction  of  goods  cause  drastic  economic  consequences  for  producers  and  traders, 
which  could  be  avoided  to  a  large  extent  with  one  single  transparent  reference  point 
applied by competent authorities in all Member States.  

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•  Choice of instruments 

Proposed instruments: regulation.342 

Other means would not be adequate for the following reason(s). 

Self regulation would result in the total deregulation of the single market and most probably 
major discrepancies in veterinary medicinal products availability as well as discrepancies in 
level of safety of food of animal origin within the Community. Consumer confidence on meat 
and meat products is currently built on a single harmonised set of rules applied under the strict 
supervision of competent authorities. Self regulation could not assure a comparable level of 
harmonisation and enforcement. Clearly, risks for consumer health would increase as a result 
of  self  regulation  because  there  would  be  no  comparable  enforcement  mechanism  available 
ensuring the respect of adequate residue limits.  

A  directive  would  not  be  adequate,  because  the  residue  limits  are  directly  applicable. 
Furthermore,  uniform  administrative  or  scientific  procedures  have  to  apply  for  the 
applications for setting residue limits to the European Medicines Agency (EMEA), scientific 
assessments by the EMEA and the scientific opinions issued by the EMEA. 

4. 

BUDGETARY IMPLICATION 

409The proposal has no implication for the Community budget. 

5. 

ADDITIONAL INFORMATION 

•  Simplification 

511The proposal provides for simplification of legislation. 

512The proposal intends 

•  to  rearrange  the  sequence  of  articles  in  order  to  create  a  logical  structure, 

differentiating in particular risk assessment and risk management provisions; 

•  integrate  in  one  single  annex  of  a  separate  Commission  regulation  the  rules 
(MRLs,  conditions  of  use,  prohibitions)  relating  to  individual  substances,  which 
are currently in 4 different annexes. 

•  the  public  authorities  profit  from  the  improved  readibility  of  the  residue 
legislation.  In  particular  the  consolidation  in  one  single  regulation  of  all  residue 
limits makes the work of enforcement by control authorities easier. 

•  timelines  for  procedural  management  would  be  clearly  fixed  for  all  parties 
involved.  International  standards  supported  by  the  Community  would  be 
automatically  recognised  without  the  need  to  submit  any  specific  application  at 
Community level, and thus avoiding duplication of work. The development time 
and  cost  for  new  products  should  be  accordingly  reduced.  Animal  health  and 
welfare  and  consumer  health  shall  benefit  significantly  by  making  legislation 
clearer and thus potentially improving compliance with legislative requirements. 

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•  furthermore,  the  review  of  the  MRL  Regulation  would  also  introduce  more 
transparency for all end users. The compilation of all substances and their MRL 
related  provisions  in  one  Commission  regulation  replacing  the  existing  four 
annexes would improve the readability and comprehension, in particular if sorted 
to the alphabet. Veterinarians should have access to a unique document collating 
all  the  necessary  information  on  all  substances  evaluated  as  they  are  allowed  to 
use in exceptional circumstances products for a food producing species without an 
explicit  authorisation  of  this  product  (article  11  of  Directive  2001/82/EC). 
Thereby simplification would help to improve availability of veterinary medicine 
for  certain  animal  species  or  conditions.  Equally  third  countries  exporting 
foodstuffs  of  animal  origin  in  the  Community  would  benefit  from  that 
simplification  and  clarification  of  the  Community  requirements  as  compliance 
should get easier.  

•  The proposal is included in the Commission's rolling programme for up-date and 

simplification of the acquis communautaire. 

•  Repeal of existing legislation 

The adoption of the proposal will lead to the repeal of existing legislation. 

•  Recasting 

The proposal involves recasting. 

•  European Economic Area 

The proposed act concerns an EEA matter and should therefore extend to the European 
Economic Area.

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2007/0064 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

laying down Community procedures for the establishment of residue limits of 
pharmacologically active substances in foodstuffs of animal origin, and repealing 
Regulation (EEC) No 2377/90 

(Text with EAA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, and in particular Article 
37 and Article 152(4)(b) thereof, 

Having regard to the proposal from the Commission1, 

Having regard to the opinion of the European Economic and Social Committee2, 

Having regard to the opinion of the Committee of the Regions3, 

Acting in accordance with the procedure referred to in Article 251 of the Treaty4, 

Whereas: 

(1) 

(2) 

(3) 

As a result of scientific and technical progress it is possible to detect the presence of 
residues of veterinary medicines in foodstuffs at ever lower levels.  

It  is  necessary  to  establish  maximum  residue  limits  for  pharmacologically  active 
substances in respect of various foodstuffs of animal origin, including meat, fish, milk, 
eggs and honey. 

Council  Regulation  (EEC)  No  2377/90  of  26  June  1990  laying  down  a  Community 
procedure  for  the  establishment  of  maximum  residue  limits  of  veterinary  medicinal 
products in foodstuffs of animal origin5 introduced Community procedures to evaluate 
the safety of residues of pharmacologically active substances according to human food 
safety  requirements.  A  pharmacologically  active  substance  may  be  used  in  food-
producing  animals  only  if  evaluated  favourably.  Maximum  residue  limits  are 
established  for  such  a  substance  if  that  is  considered  necessary  for  the  protection  of 
human health.  

1 
2 
3 
4 
5 

OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 
OJ L 224, 18.8.1990, p. 1. Regulation as last amended by Commission Regulation (EC) No 1831/2006 
(OJ L 354. 14.12.2006, p. 5). 

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(4) 

Directive 2001/82/EC of the European Parliament and of the Council of 6 November 
2001 on the Community Code relating to veterinary medicinal products6 provides that 
veterinary  medicinal  products  may  be  authorised  or  used  in  food-producing  animals 
only  if  pharmacologically  active  substances  contained  therein  have  been  assessed  as 
safe  according  to  Regulation  (EEC)  No  2377/90.  Moreover  it  contains  rules 
concerning the documentation of use, re-designation (‘off label use’), prescription and 
distribution  of  veterinary  medicinal  products  intended  for  use  in  food-producing 
animals. 

(5) 

In  the  light  of  the  Commission's  public  consultation  undertaken  in  2004  and  the 
Commission’s assessment of the experience gained, it has proved necessary to modify 
the  procedures  for  setting  maximum  residue  limits  while  maintaining  the  overall 
system for setting such limits.  

(6)  Maximum  residue  limits  are  the  points  of  reference  for  the  establishment,  in 
in  marketing 
accordance  with  Directive  2001/82/EC,  of  withdrawal  periods 
authorisations for veterinary medicinal products to be used in food-producing animals 
as well as for the control of residues in food of animal origin in the Member States and 
at border inspection posts.  

(7) 

(8) 

(9) 

Council Directive 96/22/EC concerning the prohibition on the use in stockfarming of 
certain  substances  having  a  hormonal  or  thyrostatic  action  and  of  beta-agonists  and 
repealing  Directive  81/602/EEC,  88/146/EEC  and  88/229/EEC7  prohibits  the  use  of 
certain  substances  for  specific  purposes  in  food-producing  animals.  This  regulation 
should  apply  without  prejudice  to  any  Community  legislation  prohibiting  the  use  in 
food producing animals of certain substances having a hormonal action. 

Council Regulation (EEC) No 315/93 of the European Parliament and of the Council 
of 8 February 1993 laying down community procedures for contaminants in food8 lays 
down specific rules for substances not resulting from intentional administration. Those 
substances should not be subject to the legislation on maximum residue limits.  

Regulation (EC) No 178/2002 laying down the general principles and requirements of 
food  law,  establishing  the  European  Food  Safety  Authority  and  laying  down 
procedures in matters of food safety9 lays down the framework for food legislation on 
a Community level and provides for definitions in that area. It is appropriate that those 
definitions should apply for the purposes of the legislation on maximum residue limits.  

(10)  Regulation  (EC)  No  882/2004  of  the  European  Parliament  and  of  the  Council  of  29 
April 2004 on official controls performed to ensure the verification of compliance with 
feed and food law, animal health and animal welfare rules10 lays down general rules 

6 

7 

8 

9 

10 

OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive 2004/28/EC (OJ L 136, 30.4.2004, 
p. 58). 
OJ  L  125,  23.5.1996,  p.  3.  Directive  as  last  amended  by  Directive  2003/74/EC  of  the  European 
Parliament and of the Council (OJ L 262, 14.10.2003, p. 17). 
OJ  L  37,  13.2.1993,  p.  1.  Regulation  as  last  amended  by  Regulation  (EC)  No  1882/2003  of  the 
European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). 
OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 575/2006 (OJ 
L 100, 8.4.2006, p. 3). 
OJ  L  165,  30.4.2004,  p.  1.  Regulation  as  last  amended  by  Regulation  (EC)  No  854/2004  (OJ  L  139, 
30.4.2004, p. 206).  

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for the control of food in the European Community and provides for definitions in that 
area.  It  is  appropriate  that  those  definitions  should  apply  for  the  purposes  of  the 
legislation on maximum residue limits.  

(11)  Article  57  of  Regulation  (EC)  No  726/2004  of  the  European  Parliament  and  of  the 
Council of 31 March 2004 laying down Community procedures for the authorisation 
and supervision of medicinal products for human and veterinary use and establishing a 
European Medicines Agency11 entrusts to the European Medicines Agency, hereinafter 
"the Agency", the task of advising on the maximum limits for residues of veterinary 
medicinal products which may be accepted in food of animal origin. 

(12)  Maximum residue limits should be set for pharmacologically active substances used or 
intended  to  be  used  in  veterinary  medicinal  products  placed  on  the  market  in  the 
Community. 

(13) 

(14) 

It appears from the public consultation and from the fact that only a small number of 
veterinary  medicinal  products  for  food-producing  animals  have  been  authorised  in 
recent  years  that  the  obligation  to  comply  with  Regulation  (EEC)  No  2377/90  has 
meant that such medicinal products have been less readily available. 

In  order  to  ensure  animal  health  and  animal  welfare,  it  is  necessary  that  medicinal 
products  are  available  to  treat  specific  disease  conditions.  Furthermore,  the  lack  of 
availability of appropriate veterinary medicinal products for a specific treatment for a 
specific species may contribute to the misuse or illegal use of substances. 

(15)  The system established by Regulation (EEC) No 2377/90 should therefore be modified 
with  a  view  to  increasing  the  availability  of  veterinary  medicinal  products  for  food-
producing animals. In order to serve that objective, provision should be made for the 
systematic  consideration  by  the  Agency  of  the  use  of  a  maximum  residue  limit 
established for one species or foodstuff for another species or another foodstuff. 

(16) 

(17) 

In  order  to  protect  human  health,  maximum  residue  limits  should  be  established  in 
accordance  with  generally  recognised  principles  of  safety  assessment,  taking  into 
account  toxicological  risks,  environmental  contamination,  as  well  as  unintended 
microbiological and pharmacological effects of residues. 

It is recognised that, in certain cases, scientific risk assessment alone cannot provide 
all  the  information  on  which  a  risk  management  decision  should  be  based  and  that 
other  factors  relevant  to  the  matter  under  consideration  should  legitimately  be  taken 
into account including technological aspects of food production and the feasibility of 
controls;  the  Agency  should  therefore  provide  an  opinion  on  the  scientific  risk 
assessment and risk management recommendations on residues of pharmacologically 
active substances. 

(18)  Detailed  rules  on  the  format  and  content  of  applications  for  the  establishment  of 
maximum residue limits and on methodological principles of risk assessment and risk 
management recommendations are necessary for the smooth functioning of the overall 
framework of maximum residue limits.  

11 

OJ L 136, 30.04.2006, p. 1. Regulation as last amended by Regulation (EC) No 1901/2006 (OJ L 378, 
27.12.2006, p. 1). 

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(19)  Besides  veterinary  medicines,  other  products  which  are  not  subject  to  specific 
legislation  on  residues  are  used  in  animal  husbandry,  such  as  disinfectants.  Further, 
veterinary medicinal products not having a marketing authorisation in the Community 
may be authorised in countries outside the Community. That may be because in other 
regions  different  diseases  or  target  species  are  more  prevalent  or  because  companies 
have chosen not to market a product in the Community. The fact that a product is not 
authorised in the Community does not necessarily indicate that its use is unsafe. For 
the pharmacologically active substances of such products, the Commission should be 
enabled to set a maximum residue limit for food, following an opinion by the Agency 
in accordance with the principles set for pharmacologically active substances intended 
for use in veterinary medicinal products.  

(20)  The  Community  contributes  in  the  context  of  the  Codex  Alimentarius  to  the 
development  of  international  standards  on  maximum  residue  limits,  while  ensuring 
that  the  high  level  of  human  health  protection  adopted  in  the  Community  is  not 
reduced. The Community should therefore take over without a further risk assessment 
those  Codex  maximum  residue  limits  it  has  supported  in  the  relevant  Codex 
Alimentarius  Commission  meeting.  Consistency  between  international  standards  and 
Community legislation on residue limits in food will thereby be further enhanced. 

(21)  Foodstuffs are subject to controls on residues of pharmacologically active substances 
in accordance with Regulation (EC) No 882/2004. Even if residue limits are not set for 
such substances pursuant to this Regulation, residues of such substances might occur 
due  to  environmental  contamination  or  occurrence  of  a  natural  metabolite  in  the 
animal. Laboratory methods are capable of finding such residues at ever lower levels. 
Such residues have caused different control practices in Member States. 

(22) 

It is therefore appropriate for the Community to provide for procedures to set reference 
points for control action at concentrations of the  residues for which scientific advice 
indicates  that  consumer  exposure  is  negligible  and  laboratory  analysis  is  technically 
feasible in order to facilitate intra-Community trade and imports.  

(23)  The legislation on maximum residue limits should be simplified by placing together in 
one single Commission Regulation all decisions classifying pharmacologically active 
substances as regards residues, and setting reference points for action.  

(24)  The measures necessary for the implementation of this Regulation should be adopted 
in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the 
procedures for the exercise of implementing powers conferred on the Commission12. 

(25) 

In  particular,  power  should  be  conferred  on  the  Commission  to  adopt  rules  on  the 
conditions  for  extrapolation  and  on  the  establishment  of  reference  points  for  action. 
Since  those  measures  are  of  general  scope  and  are  designed  to  amend  non-essential 
elements of this Regulation, and to supplement this Regulation by the addition of new 
non-essential  elements,  they  should  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.  

12 

OJ  L  184,  17.7.1999,  p.  23.  Decision  as  amended  by  Council  Decision  2006/512/EC  (OJ  L  200, 
22.7.2006, p. 11). 

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(26)  Since the objectives of the action to be taken, namely to protect human health as well 
as  animal  health,  and  to  ensure  the  availability  of  appropriate  veterinary  medicinal 
products, cannot be sufficiently achieved by the Member States and can therefore, by 
reason of the scale and effects of the action, be better achieved at Community level, 
the Community may adopt measures, in accordance with the principle of subsidiarity 
as  set  out  in  Article  5  of  the  Treaty.  In  accordance  with  the  principle  of 
proportionality, as set out in that Article, this Regulation does not go beyond what is 
necessary in order to achieve those objectives. 

(27)  For  the  sake  of  clarity,  it  is  therefore  necessary  to  replace  Regulation  (EEC)  No 

2377/90 with a new Regulation. 

(28)  A  transitional  period  should  be  provided  for  in  order  to  allow  the  Commission  to 
prepare  and  adopt  a  regulation  which  contains  all  applicable  decisions  pursuant  to 
Regulation 2377/90 and implementing provisions for this new regulation, 

HAVE ADOPTED THIS REGULATION: 

TITLE I 
GENERAL PROVISIONS 

Article 1 
Subject matter and scope 

1. 

This Regulation lays down rules and procedures in order to establish the following: 

(a) 

(b) 

the maximum concentration of a residue of a pharmacologically active 
substance  which  may  be  permitted  in  food  of  animal  origin 
("maximum residue limit"); 

the  tolerance  level  of  a  residue  of  a  pharmacologically  active 
substance below which human exposure to that residue through food 
containing the substance is considered negligible ("reference point for 
action"). 

2. 

This Regulation shall not apply to the following: 

(a) 

active  principles  of  biological  origin  intended  to  produce  active  or 
passive  immunity  or  to  diagnose  a  state  of  immunity,  used  in 
immunological veterinary medicinal products; 

(b) 

substances falling within the scope of Regulation (ECC) No 315/93;  

3. 

This  regulation  shall  apply  without  prejudice  to  Community  legislation  prohibiting 
the use in food producing animals of certain substances having a hormonal action as 
provided by Directive 96/22/EC. 

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Article 2 
Definitions 

In  addition  to  the  definitions  laid  down  in  Article  1  of  Directive  2001/82/EC,  Article  2  of 
Regulation  (EC)  No  882/2004  and  Articles  2  and  3  of  Regulation  (EC)  No  178/2002,  the 
following definitions shall apply for the purposes of this Regulation: 

(a)  ‘residues  of  pharmacologically  active  substances’  means  all  pharmacologically  active 
substances, expressed in mg/kg or μg/kg on a fresh weight basis, whether active substances, 
excipients or degradation products, and their metabolites which remain in food obtained from 
animals; 

(b)  “food-producing  animals”:  means  animals  bred,  raised,  kept,  slaughtered  or  harvested 
specifically for the purpose of producing food. 

TITLE II 
MAXIMUM RESIDUE LIMITS 

CHAPTER 1 RISK ASSESSMENT AND RISK MANAGEMENT 

Section 1 Pharmacologically active substances intended for use in veterinary medicinal 

products 

Article 3 
Application for an opinion of the Agency 

Any pharmacologically active substance intended for use in veterinary medicinal products for 
administration  to  food-producing  animals  shall  be  subject  to  an  opinion  of  the  European 
Medicines  Agency  ("the  Agency")  on  the  maximum  residue  limit,  formulated  by  the 
Committee for Medicinal Products for Veterinary Use ( ‘the Committee’). 

To  that  end,  the  holder  of  a  marketing  authorisation  for  a  veterinary  medicinal  product  in 
which such a substance is used, the applicant for such a marketing authorisation or a person 
intending  to  apply  for  such  a  marketing  authorisation,  shall  submit  an  application  to  the 
Agency.  

Article 4 
Opinion of the Agency 

1.  The  opinion  of  the  Agency  shall  consist  in  a  scientific  risk  assessment  and  risk 
management recommendations. 

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2.  The  scientific  risk  assessment  and  the  risk  management  recommendations  shall  aim  to 
ensure a high level of human health protection, whilst also ensuring that human health, animal 
health and animal welfare are not negatively affected by the lack of availability of appropriate 
veterinary medicinal products.  

Article 5 
Extrapolation 

With  a  view  to  ensuring  the  availability  of  authorised  veterinary  medicinal  products  for 
conditions  affecting  food-producing  species,  the  Committee  shall,  when  carrying  out 
scientific risk assessments and when drawing up risk management recommendations, consider 
using  maximum  residue  limits  established  for  a  pharmacologically  active  substance  in  a 
particular  foodstuff  for  another  foodstuff  derived  from  the  same  species,  or  in  one  or  more 
species for other species. 

Article 6 
Scientific risk assessment 

1.  The  scientific  risk  assessment  shall  consider  the  metabolism  and  depletion  of 
pharmacologically active substances in relevant animal species and the type of residues, and 
the  amount  thereof,  that  may  be  ingested  by  human  beings  over  a  lifetime  without  an 
appreciable  health  risk  expressed  in  terms  of  acceptable  daily  intake  (ADI).  Alternative 
approaches to ADI may be used, if they have been laid down by the Commission as provided 
for in Article 12(1).  

2. The scientific risk assessment shall concern the following: 

(a) 

(b) 

(c) 

the  type  and  amount  of  residue  considered  not  to  present  a  safety 
concern for human health; 

the  risk  of  unintended  pharmacological  or  microbiological  effects  in 
human beings; 

residues  that  occur  in  food  of  plant  origin  or  come  from  the 
environment.  

3.  If  the  metabolism  and  depletion  of  the  substance  cannot  be  assessed  and  the  use  of  the 
substance  is  designed  to  promote  animal  health  and  welfare,  the  scientific  risk  assessment 
may take into account monitoring data or exposure data.  

Article 7 
Risk management recommendations 

The  risk  management  recommendations  shall  be  based  on  the  scientific  risk  assessment 
performed in accordance with Article 6 and shall consist in an assessment of the following: 

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(a) 

(b) 

(c) 

(d) 

the  availability  of  alternative  substances  for  the  treatment  of  the  relevant 
species  or  the  necessity  of  the  substance  evaluated  in  order  to  avoid 
unnecessary suffering for animals or to ensure the safety of those treating them;  

other  legitimate  factors  such  as  the  technological  aspects  of  food  production, 
the feasibility of controls, conditions of use and application of the substances in 
veterinary medicinal products and the likelihood of misuse or illegal use; 

whether  or  not  a  maximum  residue  limit  or  a  provisional  maximum  residue 
limit  should  be  established  for  a  pharmacologically  active  substance  in 
veterinary  medicinal  products,  residues  of  which  have  been  found  in  a 
particular  foodstuff  of  animal  origin,  the  level  of  that  maximum  residue  limit 
and,  where  appropriate,  any  conditions  or  restrictions  for  the  use  of  the 
substance concerned;  

whether  it  is  feasible  to  establish  a  maximum  residue  limit  when  the  data 
provided do not allow a safe limit to be identified, or when no final conclusion 
concerning human health with regard to residues of a substance can be drawn 
owing to the lack of scientific information. 

Article 8 
Applications and procedures 

1. The application referred to in Article 3 shall comply with the format and content laid down 
by  the  Commission  as  provided  for  in  Article  12(1)  and  shall  be  accompanied  by  the  fee 
payable to the Agency.  

2.  The  Agency  shall  ensure  that  the  opinion  of  the  Committee  is  given  within  210  days 
following the receipt of a valid application in accordance with Article 3 and paragraph 1 of 
this Article. This time limit shall be suspended when the Agency requests the submission of 
supplementary  information  on  the  given  substance  within  a  specific  time  period,  and  until 
such time as the supplementary information requested has been provided.  

3. The Agency shall forward the opinion referred to in Article 4 to the applicant. Within 15 
days of receipt of the opinion, the applicant may provide written notice to the Agency that he 
wishes to request a re-examination of the opinion. In that case the applicant shall forward the 
detailed grounds for his request to the Agency within 60 days of receipt of the opinion.  

Within  60  days  of  the  receipt  of  the  grounds  for  the  request,  the  Committee  shall  consider 
whether its opinion should be revised. The reasons for the conclusion reached on the request 
shall be annexed to the final opinion referred to in paragraph 4. 

4. Within 15 days of the adoption of the final opinion, the Agency shall forward it both to the 
Commission and to the applicant, stating the grounds for its conclusions. 

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Section  2  Pharmacologically  active  substances  not  intended  for  use  in  veterinary 

medicinal products 

Article 9 
Agency's opinion requested by the Commission or the Member States 

1.  For  substances  not  intended  for  use  in  veterinary  medicinal  products  to  be  placed  on  the 
market  in  the  Community  and  where  no  application  for  such  substances  has  been  made  in 
accordance  with  Article  3,  the  Commission  or  Member  States  may  forward  to  the  Agency 
requests for an opinion on maximum residue limits.  

Articles 4 to 8 shall apply. 

2.  The  Agency  shall  ensure  that  the  opinion  of  the  Committee  is  given  within  210  days 
following  the  receipt  of  the  request  by  the  Commission.  This  time  limit  shall  be  suspended 
when the Agency requests submission of supplementary information on the given substance 
within a specific time period, and until such time as the supplementary information requested 
has been provided. 

3.  Within  15  days  of  the  adoption  of  the  final  opinion,  the  Agency  shall  forward  it  to  the 
Commission and, as the case may be, to the Member State or party which made the request, 
stating the grounds for its conclusions. 

Section 3 Common provisions 

Article 10 
Review of an opinion 

Where the Commission, the applicant under Article 3, or a Member State under Article 9, as a 
result  of  new  information,  considers  that  a  review  of  an  opinion  is  necessary  in  order  to 
protect  human  or  animal  health,  it  may  request  the  Agency  to  issue  a  new  opinion  on  the 
substances in question. 

That  request  shall  be  accompanied  by  information  explaining  the  issue  to  be  addressed. 
Article 8(2) and (4) or Article 9(2) and (3) respectively shall apply to the new opinion. 

Article 11 
Publication of opinions 

The Agency shall publish the opinions referred to in Articles 4, 9 and 10, after deleting any 
information of a commercially confidential nature. 

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Article 12 
Implementing Measures 

1. In accordance with the regulatory procedure referred to in Article 20(2), the Commission 
shall, in consultation with the Agency, adopt the following: 

(a) 

(b) 

the  form  in  which  applications  referred  to  in  Article  3  and  requests 
referred  to  in  Article  9  are  to  be  presented,  and  the  content  of  these 
applications; 

the  methodological  principles  of  the  risk  assessment  and  risk 
management  recommendations  referred  to  in  Articles  6  and  7, 
including  technical  requirements  in  accordance  with  internationally 
agreed standards.  

2.  The  Commission  shall,  in  consultation  with  the  Agency,  adopt  rules  on  the  use  of  a 
maximum residue level of a particular foodstuff for another foodstuff of the same species, or 
of one or more species for other species as referred to in Article 5. Those rules shall specify 
how and under what circumstances scientific data on residues in a particular foodstuff or in a 
species or more species may be used for setting a maximum residue limit in other foodstuffs, 
or other species. 

Those  measures,  designed  to  amend  non-essential  elements  of  this  Regulation  by 
supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny 
referred to in Article 20(3). 

CHAPTER II CLASSIFICATION 

Article 13 
Classification of pharmacologically active substances 

1.  The  Commission  shall  classify  the  pharmacologically  active  substances  subject  to  an 
opinion of the Agency on the maximum residue limit in accordance with Articles 4, 9 or 10.  

2.  The  classification  shall  include  a  list  of  pharmacologically  active  substances  and  the 
therapeutic classes to which they belong. The classification shall also entail the establishment, 
in relation to each such substance, of one of the following: 

(a) 

a maximum residue limit;  

(b) 

a provisional maximum residue limit; 

(c) 

the absence of a maximum residue limit;  

(d) 

a prohibition on the administration of a substance.  

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3. A maximum residue limit shall be laid down where it appears necessary for the protection 
of human health pursuant to an opinion of the Agency in accordance with Articles 4, 9 or 10 
or pursuant to a vote by the Community in favour of the establishment of a maximum residue 
limit  for  a  pharmacologically  active  substance  intended  for  use  in  a  veterinary  medicinal 
product in the Codex Alimentarius. In the latter case an additional assessment by the Agency 
is not required.  

4.  A  provisional  maximum  residue  limit  may  be  established  for  a  pharmacologically  active 
substance in cases where scientific data are incomplete, provided that there are no grounds for 
supposing that residues of the substance concerned at the level proposed present a hazard for 
human health. 

The provisional maximum residue limit shall apply for a defined period of time, which shall 
not exceed five years. That period may be extended once for a period not exceeding two years 
where it is demonstrated that such an extension would allow scientific studies in progress to 
be completed. 

5. No maximum residue limit shall be established where, pursuant to an opinion in accordance 
with Articles 4, 9 or 10, it is not necessary for the protection of human health.  

6. The administration of a substance to food-producing animals shall be prohibited, pursuant 
to an opinion in accordance with Articles 4, 9 or 10, in either of the following circumstances: 

(a) 

(b) 

where  any  use  of  a  pharmacologically  active  substance  in  food-
producing animals constitutes a hazard to human health; 

where  no  final  conclusion  concerning  human  health  with  regard  to 
residues of a substance can be drawn. 

7.  Where  it  appears  necessary  for  the  protection  of  human  health,  the  classification  shall 
include  conditions  and  restrictions  for  the  use  or  application  of  a  pharmacologically  active 
substance used in veterinary medicinal products which is subject to a maximum residue limit, 
or for which no maximum residue limit has been set.  

Article 14 
Procedure  

1.  For  the  purpose  of  the  classification  provided  for  in  Article  13,  the  Commission  shall 
prepare a draft Regulation within 30 days after receipt of the Agency's opinion referred to in 
Articles 4, 9(1) or 10. The Commission shall also prepare a draft Regulation within 30 days 
after  receipt  of  the  result  of  a  vote  by  the  Community  in  favour  of  the  establishment  of  a 
maximum residue limit in the Codex Alimentarius as referred to in Article 13(3).  

Where  the  draft  Regulation  is  not  in  accordance  with  the  opinion  of  the  Agency,  the 
Commission shall provide a detailed explanation of the reasons for the differences. 

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2.  The  Regulation  referred  to  in  paragraph  1  shall  be  adopted  by  the  Commission  in 
accordance with, and within 30 days after the end of the regulatory procedure referred to in 
Article 20(2).  

Article 15 
Analytical methods 

The  Agency  shall  consult  Community  reference  laboratories  for  laboratory  analysis  of 
residues designated by the Commission in accordance with Regulation (EC) No 882/2004, on 
appropriate analytical methods for detecting residues of pharmacologically active substances 
for which maximum residue limits have been determined in accordance with Article 13. The 
Agency  shall  provide  the  Community  reference  laboratories  and  national  reference 
laboratories designated in accordance with Regulation (EC) No 882/2004 with those methods. 

Article 16 
Circulation of foodstuff 

Member States may not prohibit or impede the import and placing on the market of food of 
animal  origin  on  grounds  related  to  maximum  residue  limits  where  the  provisions  of  this 
Regulation and its implementing measures have been complied with. 

TITLE III 
REFERENCE POINTS FOR ACTION 

Article 17 
Establishment and review 

1.  When  it  is  appropriate  in  order  to  ensure  the  functioning  of  controls  of  food  of  animal 
origin imported or placed on the market, in accordance with Regulation (EC) No 882/2004, 
from 
reference  points 
the  Commission  may  establish 
pharmacologically  active  substances  which  are  not  subject  to  a  classification  in  accordance 
with Article 13(2)(a), (b) or (c). 

for  action 

residues 

for 

Those  measures,  designed  to  amend  non-essential  elements  of  this  Regulation,  shall  be 
adopted in accordance with the regulatory procedure with scrutiny referred to in Article 21(3).  

The  reference  points  for  action  shall  be  reviewed  regularly  in  the  light  of  technological 
progress. 

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Article 18 
Methods for establishing reference points for action 

1.  The  reference  points  for  action  shall  be  based  on  the  content  of  an  analyte  in  a  sample, 
which  can  be  detected  and  confirmed  by  a  reference  control  laboratories  designated  in 
accordance with Regulation (EC) No 882/2004 with an analytical method validated according 
to  Community  requirements.  In  this,  the  Commission  shall  be  advised  by  the  relevant 
Community reference laboratory on the performance of analytical methods. 

2. The Commission may forward a request to the European Food Safety Authority for a risk 
assessment as to whether the reference points for action are adequate to protect human health. 
In those cases the European Food Safety Authority shall ensure that the opinion is given to the 
Commission within 210 days after receipt of the request.  

3.  The  risk  assessment  shall  take  account  of  rules  to  be  adopted  by  the  Commission  in 
consultation with the European Food Safety Authority.  

Those rules, designed to amend non-essential elements of this Regulation by supplementing 
it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in 
Article 21(3). 

Article 19 
Community contribution to the support measures for reference points for action 

If the application of this Title requires the Community to finance measures in support of the 
establishment  and  functioning  of  the  reference  points  for  action,  Article  66(1)(c)  of 
Regulation (EC) No 882/2004 shall apply. 

TITLE IV 
FINAL PROVISIONS 

Article 20 
Standing Committee on Veterinary Medicinal Products 

1.  The  Commission  shall  be  assisted  by  the  Standing  Committee  on  Veterinary  Medicinal 
Products.  

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall 
apply, having regard to the provisions of Article 8 thereof. 

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at one month. 

3. Where reference is made to this paragraph, Article 5a (1) to (4) and Article 7 of Decision 
1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

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Article 21 
Standing Committee on the Food Chain and Animal Health 

1.  The  Commission  shall  be  assisted  by  the  Standing  Committee  on  the  Food  Chain  and 
Animal Health. 

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall 
apply, having regard to the provisions of Article 8 thereof. 

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at one month. 

3. Where reference is made to this paragraph, Article 5a (1) to (4) and Article 7 of Decision 
1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

Article 22 
Classification of pharmacologically active substances under Regulation 2377/90(EEC) 

Within [60] days after the entry into force of this Regulation, the Commission shall adopt, in 
accordance with the regulatory procedure referred to in Article 20(2), a Regulation containing 
the pharmacologically active substances and their classification regarding maximum residues 
limits in accordance with Annexes I to IV of Regulation (EEC) No 2377/90.  

1. Regulation (EEC) N° 2377/90 is repealed.  

Article 23 
Repeal 

Annexes I to IV to the repealed Regulation shall continue to apply until the entry into force of 
the Regulation referred to in Article 22. Annex V to the repealed Regulation shall continue to 
apply until the entry into force of the measures referred to in Article 12(1).  

References to the repealed Regulation shall be construed as references to this Regulation and 
to the Regulation referred to in Article 22. 

Article 24 
Entry into Force 

This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

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

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President

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LEGISLATIVE FINANCIAL STATEMENT 

TITLE OF ACTION: Proposal for a Regulation of the European Parliament and of the 
Council  laying  down  Community  procedures  for  the  establishment  of  residue  limits  of 
pharmacologically active substances in foodstuffs of animal origin, repealing Regulation 
(EEC) No 2377/90 

Policy area(s): Internal Market (Article 95 TEC). 

Activit(y/ies): The following policies are concerned by the proposal: 

–  Review  of  the  Community  pharmaceutical  acquis  as  regards  residues  of  veterinary 

medicinal products 

–  Public health 

–  Internal market 

1. 

BUDGET LINE(S) + HEADING(S) 

02.030201 – European Medicines Agency — Subsidy under Titles 1 and 2 

02.030202 – European Medicines Agency — Subsidy under Title 3 

2. 

OVERALL FIGURES  

2.1. 

Total allocation for action (Part B): 0€ million for commitment 

Revenues: The proposed regulation’s financial impact on revenues is uncertain. An 
increase  in  applications  for  authorisations  of  veterinary  medicinal  products  could 
lead to an increase of fee revenues for the EMEA. 

Expenditure: The proposed review will not change the principle, that the system of 
residue  limits  is  operated  by  the  European  Medicines  Agency  (EMEA)  and  the 
Commission. Additional scientific assessments will be required for residue limits for 
control purposes while less assessments will result from the taking over of limits set 
by  Codex  alimentarius  and  from  extrapolation  requirements.  In  overall  terms  the 
review will thus have a very limited impact on resources which can not be quantified. 

2.2. 

Period of application: 

The assumption is that the proposed regulation would apply from the end of 2009. 

2.3. 

Overall multiannual estimate of expenditure: 

Costs for the Commission: None. 

Costs for the European Medicines Agency (EMEA): Negligible or none. 

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2.4. 

Compatibility with financial programming and financial perspective 

[X]  Proposal is compatible with existing financial programming. 

2.5. 

Financial impact on revenue: 

[X]  Proposal has a negligible financial impact 

3. 

BUDGET CHARACTERISTICS 

Type of expenditure 

New 

EFTA 
contribution 

Contributions 
form applicant 
countries 

Heading in 
financial 
perspective 

4. 

LEGAL BASIS  

–  Treaty establishing the European Community – Articles 37, and 152 (4) (b) 

5. 

DESCRIPTION AND GROUNDS 

5.1. 

Need for Community intervention 

The  need  for  the  review  stems  from  the  experience  with  the  existing  legal  framework  for 
residue limits which has lead to very complex legal provisions difficult to read and understand 
and to a lack of veterinary medicines for food producing animals. Consequently the specific 
objectives of the proposal are: 

•  To improve availability of veterinary medicinal products for food producing animals; 

•  To simplify the existing legislation; 

•  To provide clear references for the control of pharmacologically active substances in food; 

•  To ensure consistency with international standards. 

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5.2. 

Action envisaged and budget intervention arrangements 

Expected results with a budgetary implication can be measured in terms of: 

–  The number of marketing authorisations for veterinary medicinal products. 

5.3.  Methods of implementation 

Centralised Management, directly by the Commission and indirectly by delegation to a body 
set up by the Communities as referred to in Article 185 of the Financial Regulation (EMEA). 
The proposed regulation confirms the two  step procedure for the setting of residue limits: a 
first  step  (stage  of  scientific  assessment)  conducted  by  the  EMEA  and  a  second  step 
(decision-making stage) conducted by the Commission. 

6. 

FINANCIAL IMPACT 

See section 2. 

7. 

IMPACT ON STAFF AND ADMINISTRATIVE EXPENDITURE  

See section 2. 

8. 

FOLLOW-UP AND EVALUATION 

8.1. 

Follow-up arrangements 

Articles  67  to  70  of  Regulation  (EC)  No  726/2004  lay  down  financial  provisions  for  the 
annual preparation, execution, monitoring and reporting of the EMEA budget, including costs 
resulting  from  the  evaluation,  supervision  and  post-authorisation  vigilance  of  medicinal 
products.  Consequently,  adequate  monitoring  data  regarding  the  fee  revenues  under  the 
proposed regulation will be collected in the context of the implementation of these Articles. 

8.2. 

Arrangements and schedule for the planned evaluation 

After 4 years after entry into force, the Commission should evaluate the experience acquired 
as a result of the operation of the review of the system establishing maximum residue limits, 
and this will include details set up under its implementing provisions. 

EN 

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9. 

ANTI-FRAUD MEASURES 

The European Medicines Agency has specific budgetary control mechanisms and procedures. 
The  Management  Board,  which  comprises  representatives  of  the  Member  States,  the 
Commission  and  the  European  Parliament,  adopts  the  budget  (Article  66(f)  of  Regulation 
(EC) No 726/2004), as well as the internal financial provisions (Article 66(g)). The European 
Court of Auditors examines the execution of the budget each year (Article 68.3).  

Regarding fraud, corruption and other unlawful activities, the provisions of Regulation (EC) 
No  1073/1999  of  the  European  Parliament  and  of  the  Council  of  25  May  1999  concerning 
investigations  conducted  by  the  European  Anti-Fraud  Office  (OLAF)  apply  to  the  EMEA 
without restriction. Besides, a decision concerning co-operation with the OLAF was already 
adopted on 1 June 1999 (EMEA/D/15007/99). 

Finally,  the  Quality  Management  System  applied  by  the  Agency  supports  a  continuous 
review, whose objective  is  to  ensure  that the correct procedures  are  followed and  that these 
procedures and policies are pertinent and efficient. Several internal audits are undertaken each 
year as part of this process. 

EN 

27 

   EN