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 adopted by the Council with a view to the adoption of a Regulation of the European Parliament and of the Council on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC
Date: 2004-09-08
Institutions: European Commission
Subjects: European standard, animal nutrition, animal product, crop production, food safety, foodstuff, pesticide

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 8.9.2004 
COM(2004) 587 final 

2003/0052 (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 adopted by the Council with a view to the adoption of a Regulation of 
the European Parliament and of the Council on maximum residue levels of pesticides in 
or on food and feed of plant and animal origin and amending Council 
Directive 91/414/EEC  

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2003/0052 (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 adopted by the Council with a view to the adoption of a Regulation of 
the European Parliament and of the Council on maximum residue levels of pesticides in 
or on food and feed of plant and animal origin and amending Council 
Directive 91/414/EEC  

1- 

BACKGROUND 

Date of forwarding of the proposal to the EP and Council 
(document COM(2003)117 final – 2003/0052 COD): 

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

14 March 2003 

16 July 2003 

Date of the opinion of the European Parliament (First Reading) 

20 April 2004 

Date of forwarding of the amended proposal 

Date of adoption of the Common Position 

26 April 2004* 

19 July 2004. 

* 

2- 

1. 

2. 

In view of the tight timelines, with political agreement being reached in Council six 
days after the 1st Reading, - the Commission did not have time to adopt an amended 
proposal based on the final version of the EP opinion. The Commission accepted the 
text on which political agreement was reached and expresses in this Communication 
its considered views on the EP amendments. 

AIM OF THE COMMISSION’S PROPOSAL 

The aim of the proposed draft Regulation is to replace, codify and simplify the four 
existing  Council  Directives  on  Maximum  Residue  Levels  (MRLs)  for  plant 
protection  products 
(Directives  76/895/EEC,  86/362/EEC,  86/363/EEC  and 
90/642/EEC),  to  harmonise  all  MRLs  at  EU  level  and  to  define  the  roles  of  the 
Member  States,  the  Commission,  the  European  Food  Safety  Authority  (EFSA)  and 
other parties in the process of setting MRLs.  

The Regulation provides for MRLs to be directly applicable and enforceable in the 
Member  States,  underpinned  by  publicly  available  consumer  risk  assessments  for 
which  EFSA  has  overall  responsibility.  Where  plant  protection  products  are  not 
authorised  for  use  in  the  Community,  where  uses  outside  the  Community  are 

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unacceptable in terms of consumer intake of residues, or where data are insufficient 
to complete a risk assessment, a default value of 0.01 mg/kg shall apply. 

3. 

The Regulation defines the obligations of the Member States with regard to control 
and enforcement of MRLs and reporting data concerning control and enforcement to 
EFSA and the publication of these data in an annual report by EFSA. 

3- 

COMMENTS ON THE COMMON POSITION 

3.1. GENERAL REMARKS 

The  common  position  adopted  by  the  Council  by  unanimity  represents  a  balanced 
further elaboration of the Commission proposal, where various provisions requested 
by the Council were included, and in which several of the 1st Reading amendments 
of the European Parliament have been taken into account. The roles and tasks of the 
Member States and the EFSA in the evaluation processes before MRL-setting by the 
Commission  have  been  modified  in  the  revised  proposal.  As  the  possibility  is  left 
open  that,  in  a  later  stage  –  based  on  a  report  by  the  Commission  and  appropriate 
further  proposals  -  this  division  of  roles  and  tasks  could  revert  to  the  original 
Commission  proposal,  the  Commission  can  accept  the  changes.  At  the  time  of 
reaching the political agreement on the text, the Commission and the Council made 
declarations  (see  Annex)  to  ensure  that  EFSAs  role  is  respected  and  that  in  a  later 
stage the co-ordination of the work will be reviewed. 

Other provisions included at the request of the Council were: the possibility that the 
default  MRL  could  be  replaced  by  the  lowest  effective  limit  of  analytical 
determination  (LOD)  for  substances  where  the  data  are  available,  derogations 
concerning  emergency  MRLs  and  fumigation  treatments,  the  introduction  of  the 
administrative  review  clause  and  the  changing  of  reporting  dates  regarding  the 
annual report. The Commission questions the appropriateness for the administrative 
review  clause  and  stresses  that  it  should  not  interfere  with  the  independence  of  the 
EFSA in providing scientific advice and technical assistance. The remaining changes 
are  acceptable  to  the  Commission.  Several  other  requests  by  the  Council  were 
identical  to  amendments  proposed  by  the  EP  and  are  discussed  in  the  next 
paragraphs. 

3.2. SPECIFIC REMARK  

In article 14(1) the wording “submitted for adoption” should be replaced by “to be 
adopted” to reflect the correct wording for a comitology procedure. 

3.3. AMENDMENTS MADE BY THE EUROPEAN PARLIAMENT AT FIRST READING 

Amendments incorporated in the Common Position: 

The  Council  has  included  in  the  common  position  several  amendments  adopted  at 
first  reading  by  the  European  Parliament  and  also  accepted  by  the  Commission. 
These amendments concern aspects of fees to be paid by applicants to fund control, 
enforcement  and  evaluation  activities,  the  timeframe  for  setting  final  MRLs  after 
evaluation of a substance under Directive 91/414/EEC, additions of commodities to 

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the list, such as herbal infusions, and providing extra protection of vulnerable groups 
such as children. 

Amendments  not  incorporated  in  the  Common  Position,  which  were  nevertheless 
found acceptable by the Commission as such or in a slightly reworded form or not in 
the exact place where the EP had wanted them.  

These amendments concern reporting information on the names of transgressors and 
requiring  EFSA  to  inform  the  general  public  about  the  risks  of  pesticides.  The 
Commission  has  also  a  positive  attitude  toward  the  idea  of  taking  into  account 
cumulative  exposure  and  has  the  intention  of  requesting  the  EFSA  to  develop 
methodology  to  permit  such  assessments  to  be  done.  Some  points  are  already 
legislation  concerning 
addressed  or  should  be  addressed 
authorisation of the use of pesticides (Council Directive 91/414/EEC) e.g. integrated 
pest management, immunotoxicity, endocrine disruptors etc. 

in  other  specific 

Amendments not acceptable  

Some amendments imposing restrictions on import tolerances are not accepted by the 
Commission  as  they  would  be  open  to  challenge  in  the  WTO  because  they 
discriminate  against  farmers  outside  the  EU  for  reasons  not  permitted  under  the 
WTO-SPS-agreement.  Conditions  for  import  tolerances  should  be  no  more  severe 
than  conditions  imposed  on  EU  farmers  and  should  be  in  line  with  specific  WTO 
rules. 

4- 

CONCLUSIONS 

For  the  above  reasons,  the  Commission  supports  the  Common  Position  adopted  by 
the Council. 

5- 

COMMISSION AND COUNCIL DECLARATIONS  

The following declarations by Council and Commission: 

– 

– 

– 

– 

– 

Commission statement concerning the expansion of the list of commodities for 
which MRLs are set. 

Commission  statement  on  the  intention  not  to  complicate  MRL  setting  by 
combining conflictual proposals in one package. 

Commission  statement  on  the  intention  to  consult  the  Member  States  with 
respect to financial resources 

Statement  by  Council  concerning  MRLs  for  emergency  measures  taken  by 
Member States 

Declarations by Commission and Council concerning the role of EFSA and the 
Member States in MRL evaluations; 

These declarations are attached to this Communication. 

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ANNEX  

COMMISSION AND COUNCIL DECLARATIONS 

Concerning Article 4: Statement by the Commission 

"The Commission will endeavour to ensure that the introduction of new products to 
Annex I will be timed in such a way as to minimise disruption to trade or to animal 
husbandry." 

Concerning Article 14: Statement by the Commission 

"The Commission will maintain its current practice of including more than one active 
substance in a proposal only when this is unlikely to slow down the adoption of the 
proposal." 

Concerning Article 18: Statement by the Council 

"The  Council  recalls  the  obligations  for  Member  States  to  control  the  use  of  plant 
protection products pursuant to Article 8(4) of Directive 91/414/EEC and to provide 
for effective official controls pursuant to Chapter V of this Regulation. Such controls 
should in particular apply to products put on the market pursuant to Article 18(4) and 
be aimed at assuring that they are only marketed in accordance with the provisions of 
that paragraph." 

Concerning Article 37: Statement by the Commission 

“The  Commission  will  maintain  its  current  practice  of  consulting  with  Member 
States  in  the  framework  of  the  Standing  Committee  with  respect  to  the  measures 
referred to in Article 36(1).” 

Concerning the Evaluation Arrangements and the Role of EFSA: Statements by the Council 
and the Commission 

"The Council considers that the evaluation arrangements provided by the Regulation 
reflect the need to ensure a smooth transition to the new fully harmonised procedure 
for  the  fixing  of  MRLs  while  respecting  the  current  arrangements  concerning 
national authorisations for plant protection products. 

The Council invites the Commission to present a report together with any appropriate 
proposal  concerning  improvements  which  will  appear  necessary  in  the  light  of  the 
experience in applying this Regulation." 

"The Commission notes that the Council has reached a unanimous consensus on this 
issue.  Nevertheless,  the  Commission  wishes  that  in  the  future  examination  of  this 
proposal further consideration be given to improving the coordination between EFSA 
and  Member  States'  national  authorities  so  that  requests  for  authorisation  can  be 
processed in the most effective manner 

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