Communication from the Commission to the European Parliament pursuant to the second subparagraph of Article 251 (2) of the EC Treaty concerning the common position of the Council on the adoption of a 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
Date: 2009-01-08
Institutions: European Commission
Subjects: European Medicines Agency, European standard, animal product, foodstuff, human nutrition, veterinary drug

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 8.1.2009 
COM(2008) 912 final 

2007/0064 (COD) 

COMMUNICATION FROM THE COMMISSION 
TO THE EUROPEAN PARLIAMENT 

pursuant to the second subparagraph of Article 251 (2) of the EC Treaty 

concerning the 

common position of the Council on the adoption of a 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 

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2007/0064 (COD) 

COMMUNICATION FROM THE COMMISSION 
TO THE EUROPEAN PARLIAMENT 

pursuant to the second subparagraph of Article 251 (2) of the EC Treaty 

concerning the 

common position of the Council on the adoption of a 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 

1. 

BACKGROUND 

Date of transmission of the proposal to the EP and the Council 
(document COM(2007)194 final – 2007/0064 (COD): 

17 April 2007 

Date  of  the  opinion  of  the  European  Economic  and  Social 
Committee: 

26 September 2007 

Date of the opinion of the European Parliament, first reading: 

17 June 2008 

Scheduled date of adoption of the common position: 

18 December 2008 

2. 

OBJECTIVE OF THE COMMISSION PROPOSAL 

The  proposal's  aim  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. 

The Commission proposal has four key objectives: 
1.  To  improve  availability  of  veterinary  medicinal  products  for  food  producing  animals  in 
order to ensure animal health and welfare and avoid illegal use of substances; 
2.  To  simplify  the  existing  legislation  by  enhancing  readability  of  the  provisions  on 
established  Maximum  Residue  Limits  (MRLs)  for  the  end-users  (i.e.  animal  health 
professionals, control competent authorities in Member States and third countries); 
3.  To  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; 

4.  To  clarify  the  Community  procedures  establishing  MRLs  by  ensuring  consistency  with 
international standards. 

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3. 

3.1 

COMMENTS ON THE COMMON POSITION 

Overall remarks on the common position 

The political agreement found by the European Parliament, the Council and the Commission 
in Trilogue discussions was endorsed by COREPER in its meeting on 29 October 2008. The 
adoption of the  Common Position is  scheduled for 18/19 December 2008. It addresses both 
amendments  and  modification  proposals  in  a  satisfactory  way  and  in  the  spirit  of  the  initial 
proposal. A number of changes to the proposal improve the text while maintaining its initial 
objectives. Amendments and modification proposals often relate to the same provisions of the 
proposal.  Several  amendments  and  modifications  constitute  editorial 
improvements. 
Modifications proposed by the Council have led to a slight restructuring and renumbering. 

Key amendments proposed by the European Parliament in the first reading relating to: 

•  the availability of veterinary medicinal products, 

•  the provisions on reference points for action, such as the inclusion of control measures, the 
clarification relating to the residue levels triggering sanctions by competent authorities and 
equal treatment of Third country imports and intra-Community trade, 

•  the clarification of the conditions under which a further scientific assessment by the EMEA 
is  not  required  when  an  MRL  has  been  set  in  the  framework  of  Codex  Alimentarius 
Commission of FAO/WHO, 

are  addressed  in  the  political  agreement.  In  order  to  respond  to  specific  availability  related 
amendments, two minor changes to Directive 2001/82/EC on the Community code relating to 
veterinary  medicinal  products  are  included.  Furthermore,  the  Commission  has  agreed  to  a 
Declaration on an assessment of options for a future review of Directive 2001/82/EC. 

Amendments aiming at the introduction of the regulatory procedure with scrutiny (PRAC) are 
not  present  in  the  political  agreement  with  the  exception  of  PRAC  for  the  adoption  of 
methodological principles for risk assessment and risk management recommendations. 

3.2 

European Parliament amendments included in full, in part or in principle in the 
amended  proposal  and  incorporated  in  full,  in  part  or  in  principle  in  the 
common position  

The  following  amendments  are  included  in  the  political  agreement  either  fully,  partly  or  in 
principle: 

2 on the future review of the veterinary pharmaceutical legislation, 3, 4, 6 and 45 on the aim 
of the regulation, 5 on food control, 8 on reference points for action, 9 and 10 on the subject 
matter and scope of the regulation, 11, 14, 15 and 16 on the contents of the EMEA opinion in 
the establishment of an MRL, 17 and 18 on the availability of veterinary medicinal products 
for horses, 20, 31 and 34 on an accelerated procedure for the establishment of MRLs, 21 on 
the  possibility  for  the  Commission,  Member  States  or  an  interested  party  or  organisation  to 
request an EMEA opinion on an MRL, 23 on the review of an opinion, 24, 25 and 26 on the 
implementing  measures,  28  and  32  on  transparency  when  accepting  MRL  set  in  the 
framework of Codex Alimentarius, 35 on the analytical methods, 37 and 40 on the methods 
for establishing reference points for action, 38 on the establishment and review of reference 
points for action, 39 and 41 on the placing of the market of foodstuffs containing residues of a 
pharmacologically  active  substance,  42  on  action  to  be  taken  in  the  case  of  confirmed 
presence  of  a  prohibited  or  non-authorised  substance,  44  on  a  report  to  the  European 
Parliament and the Council. 

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3.3 

European  Parliament  amendments  not  included  in  the  amended  proposal  and 
not incorporated in the common position 

1  on  the  legal  base  of  the  regulation,  25  on  the  implementing  measures  as  regards  to  the 
proposed change to the Standing Committee on the Food Chain and Animal Health, 27 on the 
classification  of  pharmacologically  active  substances,  30  on  the  prohibition  of  the 
administration of a substance to food-producing animals, 33 on the proposed change to PRAC 
when fixing individual MRLs, 36 on the circulation of foodstuff. 

3.4 

Changes to the original proposal introduced by the Commission in the amended 
proposal and incorporated in the common position 

There was no amended proposal. 

3.5 

Other modifications introduced by the Council common position compared with 
the original proposal 

In general terms, some modifications to the initial proposal have led to a restructuring of the 
initial  text;  thus,  Article  15  dealing  with  analytical  methods  has  been  included  in  Title  IV. 
Furthermore, modifications related to Titles III and IV of the initial proposal have led in parts 
to  a  renumbering  of  these  Titles  without,  however,  bringing  change  to  the  key  elements 
included in the initial text. 

The following specific modifications have been introduced: 

Recital 19 is amended to clarify the inclusion of biocidal products used in animal husbandry 
into  the  proposal.  Furthermore,  it  is  stated  that  Regulation  (EC)  No  726/2004  shall  be 
amended  to  include  the  advising  on  MRLs  of  residues  of  active  substances  in  biocidal 
products within the tasks of the EMEA.  

A new Recital 19a on the financing modalities of the evaluation related to the establishment 
of the maximum residue limit for pharmacologically active substances to be used in biocidal 
products used in animal husbandry is added.  

New  Recitals  21a,  21b  and  22a  are  added  in  order  to  take  account  of  the  inclusion  of  food 
control management measures in the proposal.  

Recital 25 is amended to clarify the conferment of powers to the Commission.  

A new Recital 25a is introduced to take account of the inclusion of an urgency procedure in 
the  framework  of  the  comitology  procedure  for  the  establishment  of  reference  points  for 
action.  

Recital 28 is amended to clarify the incorporation of pharmacologically active substances and 
their  classification  regarding  MRLs  as  laid  down  in  the  annexes  of  the  current  MRL-
regulation.  

Article 1 paragraph 3 is modified to include a complete reference to Directive 96/22/EC.  

In Article 2 (b) the word "specifically" is deleted.  

The title of Section 1 in Title II of the initial proposal is amended for reasons of clarity.  

The wording of Article 3 is amended for reasons of clarity.  

The wording of Article 5 is amended to include a reference to human health protection in the 
extrapolation process.  

For reasons of clarity of the wording, Article 7 point (c) is modified by deleting the passage 
".., residues of which have been found in a particular foodstuff of animal origin,..". . 

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Article 7 point (d) is modified to clarify the situation where no MRL shall be recommended.  

The title of Section 2 in Title II of the initial proposal is amended for reasons of clarity.  

Article 9 paragraphs 2 and 3 are amended to include Member States and interested parties and 
organisation as possible requestors for an MRL in the framework of Article 9.  

In  line  with  Recital  19  and  19a,  a  new  Article  9a  is  introduced  to  clarify  the  proposal's 
intention  to  include  biocidal  products  used  in  animal  husbandry  in  the  proposal.  The 
Commission  agrees  to  this  clarification.  At  the  same  time  the  financing  modalities  of  the 
evaluation of this category of products are laid down.  

In  Article  10  a  new  second  paragraph  relating  to  the  extension  of  existing  MRLs  is 
introduced.  

Article  13  paragraph  2  is  modified  insofar  as  the  classification  of  pharmacologically  active 
substances shall also mention specific foodstuffs/ species where appropriate.  

A slight rewording of Article 13 paragraph 2, point (c) is undertaken for reasons of clarity.  

A  new  Article  13b  is  introduced,  relating  to  the  administration  of  substances  to  food 
producing  animals,  thus,  taking  up  the  contents  of  Article  14(1)  of  the  current  MRL-
regulation.  

The wording of Article 14 paragraph 1, subparagraph 2 is slightly amended.  

The wording of Article 17 paragraph 1, renumbered as Article 15 paragraph 1 in the political 
agreement, is slightly amended.  

The urgency procedure in the framework of the comitology procedure for the establishment of 
reference  points  for  action  has  been  added  to  Article  17,  renumbered  as  Article  15  in  the 
political agreement.  

Article 18 paragraphs 1 and 2, renumbered as Article 16 paragraphs 1 and 2 in the political 
agreement have been modified to clarify the procedure for the establishment of the reference 
points for action.  

A new paragraph 4 is added to Article 21, thus, aligning this provision with the introduction 
of the urgency procedure in the framework of the comitology procedure for the establishment 
of reference points for action.  

A  new  paragraph  2  is  added  to  Article  22  in  order  to  introduce  the  possibility  for  an 
extrapolation for substances already classified under the current MRL-regulation.  

A new Article 23a is added in line with Recital 19, foreseeing an amendment to Regulation 
(EC) No 726/2004 in order to include the advising on MRLs of residues of active substances 
in biocidal products within the tasks of the EMEA. 

4. 

CONCLUSION 

The Commission fully supports the common position. 

5. 

DECLARATION BY THE COMMISSION  

As  regards  a  future  revision  of  Directive  2001/82/EC  on  the  Community  code  relating  to 
veterinary  medicinal  products,  the  Commission  proposed  to  make  a  declaration,  thus, 
allowing addressing EP amendment 2 proposing a new Recital 1a. 

The wording of the proposed Commission Declaration is as follows: 

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“The Commission is aware of  concerns expressed by citizens, veterinarians,  Member States 
and  the  animal  health  industry  as  regards  the  directive  laying  down  the  rules  for  the 
authorization  of  veterinary  medicinal  products,  in  particular  the  importance  of  addressing 
existing problems linked to the availability of veterinary medicines and the use of medicinal 
products  in  species  for  which  they  are  not  authorized  and  any  disproportionate  regulatory 
burden hampering innovation, whilst ensuring a high level of consumer safety with respect to 
food of animal origin. The Commission points out that positive steps are being taken in this 
direction such as the simplification of the rules on variations of veterinary medicinal products 
and this review of the legislation on maximum residue limits in food. 

In  addition,  in  order  to  address  the  objectives  of  consumer  safety  and  animal  health 
protection,  competitiveness  of  the  veterinary  industry  including  SMEs  and  reduction  of 
administrative burden, the Commission will present in 2010 an assessment of the problems in 
the application of the veterinary medicinal products directive with a view to making, where 
appropriate, legal proposals.”  

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