Opinion of the Commission pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendments to the Council's common position regarding the proposal for a Regulation of the European Parliament and of the Council on additives for use in animal nutrition amending the proposal of the Commission pursuant to Article 250 (2) of the EC Treaty
Date: 2003-07-16
Institutions: European Commission
Subjects: animal nutrition, antibiotic, food additive, food safety, withdrawal from the market

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 16.7.2003
COM(2003) 447 final

2002/0073 (COD)

OPINION OF THE COMMISSION

pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty,
on the European Parliament’s amendments
to the Council’s common position regarding the
proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

on additives for use in animal nutrition

AMENDING THE PROPOSAL OF THE COMMISSION
pursuant to Article 250 (2) of the EC Treaty

2002/0073 (COD)

OPINION OF THE COMMISSION

pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty,
on the European Parliament’s amendments
to the Council’s common position regarding the
proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

on additives for use in animal nutrition

1.

INTRODUCTION

Article  251(2),  third  subparagraph,  point  (c)  of  the  EC  Treaty  provides  that  the
Commission is to deliver an opinion on the amendments proposed by the European
Parliament  at  second  reading.  The  Commission  sets  out  its  opinion  on  the
amendments proposed by Parliament.

2.

BACKGROUND

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Adoption of the proposal by the Commission: 

22 March 20021

Opinion of the European Economic 
and Social Committee: 

18 September 20022

Opinion of the European Parliament at first reading: 21 November 2002

Date of political agreement in Council:

16 December 2002

Date of adoption of the amended proposal: 

18 December 2002

Date of adoption of the common position: 

17 March 20033

Adoption by Parliament of the Recommendation 
for a second reading :

19 June 2003

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COM(2002) 153 final-2002/0073(COD) .
OJ C 61, 14.03.2003 p. 43.
OJ C 113E, 13.05.2003, p. 1.

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3.

PURPOSE OF THE PROPOSAL

With a view to bringing coherence to Community legislation in  a  “farm  to  table”  approach,
the objectives of the proposal, which results from the White Paper on Food Safety, are:

–  To distinguish clearly between the risk evaluation (to take into account the entry into force
of the European Food Safety Authority (hereunder called “the Authority” - EFSA) and the
risk management (Comitology)

–  To  simplify  the  existing  rules  regarding  the  authorisation  procedure  of  additives  in

feedingstuffs

–  To lay down provisions for the phasing out of antibiotics used as growth promoters.

–  To maintain the use of coccidiostats as feed additives.

–  To consolidate EU provisions on additives for use in animal nutrition.

The European Food Safety Authority (EFSA) will have the competence and the responsibility
to provide a single framework for dossier evaluation for all feed additives. It will bring clarity
(guidelines will be updated and adapted to the various types of additives), efficiency (a single
evaluation) and transparency (adoption of an assessment report and public consultation) to the
process.

A definition of feed additives is provided by this Regulation. The list of authorised additives
will  be  divided  into  a  restricted  number  of  broad  additive  categories.  Processing  aids  and
veterinary medicines are not covered within the scope of this regulation.

Except for coccidiostats fed to healthy animals during their entire productive life, compounds
used in disease prevention, namely antibiotics, are not authorised as feed additives.

In  its  opinion  adopted  on  28  May  1999,  the  Scientific  Steering  Committee  (SSC)
recommended that the use of antimicrobials as growth promoting agents, belonging to classes
that  are  or  may  be  used  in  human  or  veterinary  medicine,  should  be  phased  out  as  soon  as
possible and ultimately abolished.

A  second  opinion  of  the  SSC  on  anti-microbial  resistance  adopted  on  10-11  May  2001
confirmed  the  need  to  plan  and  co-ordinate  the  phase-out  process  and  to  make  efforts  to
replace those anti microbials by alternative products.

In order to comply with the SSC recommendation, the following steps are now being taken:

–  exclusion of the antibiotics from the scope of the new legislation on feed additives, i.e. the

request for authorisation of antibiotic feed additives will no longer be permitted;

–  Adoption of a transitional period  for  the  phasing  out  of  the  four  remaining  antibiotics  in
order  to  allow  animal  production  practices  to  be  adapted.  These  substances  will  be
prohibited from 1.1.2006.

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4.

OPINION  OF  THE  COMMISSION  ON  THE  AMENDMENTS  BY  THE  EUROPEAN
PARLIAMENT

The Commission considers that the amendments improve the text of its proposal and
therefore it accepts all the amendments voted by the Parliament:

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Amendment 7 provides that the opinion of the European Food Safety Authority
is made public.

Amendment 9 on the renewal of authorisations for feed additives considers that
efficacy studies are not necessary to obtain a renewal of the authorisation.

Amendments 14 to 20 are compromise amendments previously discussed and
accepted by COREPER.

They concern:

a reference to the General Food Law(Regulation 178/2002) in a recital ,

a priority order for the re-evaluation of additives ,

a report from the Commission before 2008 on the use of coccidiostats as feed
additives and available alternatives ,

specific rules for the labelling of flavours ,

provisional authorisation of an additive by the Commission .

5.

CONCLUSIONS

Pursuant to Article 250 (2) of the Treaty, the Commission amends its proposal as set
out above.

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