Proposal for a Regulation of the European Parliament and of the Council on maximum residue levels of pesticides in products of plant and animal origin
Date: 2003-03-14
Institutions: European Commission
Subjects: European Food Safety Authority, consumer protection, food standard, foodstuffs legislation, pesticide residue

EN

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 14.3.2003
COM(2003) 117 final

2003/0052 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on maximum residue levels of pesticides in products of plant and animal origin

(presented by the Commission)

 
EXPLANATORY MEMORANDUM

SUMMARY 

This proposed draft Regulation of the European Parliament and the Council replaces the four
Council Directives on Maximum Residue Levels (MRLs) for plant protection products.

The consequence of this draft Regulation entering into force will be that all MRLs for plant
protection  products  will  become  harmonised  after  a  transitional  ‘phase-in’  period,  and  will
thenceforth only be set at the European level. It removes all trade barriers that were the result
of  the  current  situation  whereby  Member  States  can  set  their  own  national  MRLs  in  the
absence of Community MRLs.

It  provides  for  the  role  of  the  European  Food  Safety  Authority  (EFSA)  and  of  the
Commission in the process of setting MRLs. Risk assessment will become a responsibility of
EFSA acting with its network of experts and institutes in the Member States and where EFSA
will  have  the  responsibility  for  giving  an  opinion  on  the  safety  of  each  MRL.  The
Commission will be responsible for the risk management, by deciding on the setting of MRLs
based on the opinion of EFSA.

Member States authorities will provide EFSA with data on national diets,  the authorisations
and  their  agricultural  practices.  EFSA  will  base  its  opinions  on  assessments  of  these  data,
other  data  obtained  in  the  process  of  evaluation  of  active  substances  under  Directive
91/414/EEC and additional data to be supplied by applicants. 

MRLs not yet harmonised both for existing and new substances, previously set at the national
level will be compiled by EFSA, screened for their safety based on the data available and set
as  temporary  MRLs.  These  MRLs  will  be  revisited  on  a  substance-by-substance  basis  after
the final conclusions on each of the 91/414/EEC evaluations.

In all cases where there is no use of a pesticide on a commodity or when no data are available
to demonstrate that residues do not endanger consumer health, no residues may be permitted
at levels higher than 0.01 mg/kg which is an enforceable default for zero. Exceptions will be
made for substances where a level of 0.01 is not safe for the consumer by setting MRLs at a
lower level

OBJECTIVES OF PROPOSAL:

The  primary  objectives  of  the  proposal  are  to  consolidate  and  to  simplify  the  existing
legislation in this area and to define the  roles  of  the different  actors,  particularly  that  of  the
EFSA  in  the  process.  To  this  end,  existing  legislation  was  examined  in  the  fifth  Simpler
Legislation  for  the  Internal  Market  (SLIM  V)  exercise  of  the  Commission  during  2001,  the
recommendations of which are incorporated in the proposal. A secondary objective is to solve
existing practical, Single Market and third-country trade problems.

MAIN ISSUES ADDRESSED IN PROPOSAL:

The proposal:

1.

Takes  into  account  problems  encountered  in  the  practical  implementation  of  the
existing directives.

2

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

Acts  on  the  issues  raised  in  the  Report  of  the  Commission  to  the  Council  on  the
implementation  of  Articles  7  and  4  respectively  of  Council  Directives  86/362/EEC
and  90/642/EEC,  concerning  the  monitoring  of  pesticides  residues  (COM/2000/98
final).

Is in line with the conclusions of the Agriculture Council of 20 November 2001 and
the  Environment  Council  of  12  December  2001  in  response  to  the  Report  of  the
Commission  on  progress  in  evaluating  active  substances  under  Council  Directive
91/414/EEC  (COM/2001/444  final),  both  of  which  call  on  the  Commission  to
propose amendments the residues directives. It also responds to the resolution of the
European Parliament of 30 May 2002 and also adopted in response to the Report of
the Commission.

Sets the groundwork to prepare the Commission and the Member States to deal more
effectively with the extensive workload expected in and after 2003 in the framework
of  Council  Directive  91/414/EEC  when  several  hundreds  of  active  substances  of
plant protection products will be withdrawn from the market and where MRLs will
need to be set for food commodities in the absence of the all of information required
to  guarantee  an  adequate  protection  of  the  consumer  (use  of  default  MRL  of  0.01
mg/kg).

Uses the new comitology procedures.

Takes  note  of  developments  outlined  in  the  White  Paper  on  Food  Safety  including
but not limited to those regarding the European Food Safety Authority established by
Regulation 178/2002 of the Parliament and the Council as well as its competence in
matters of risk assessment and the provision of independent scientific advice.

Establishes a framework within which Member States can set fees for the evaluation
of  dossiers.  The  resources  needed  for  this  area  of  work  are  expected  to  increase
dramatically  in  the  future  and  the  current  legislation  does  not  provide  a  basis  to
recover the costs incurred.

Establishes a framework within  which the Commission  and the  Member States can
work  with  the  European  Food  Safety  Authority  in  this  area  -  separating  risk
assessment from risk management.

Takes account of the provisions of the Commission proposal for a Regulation of the
Council and the European Parliament on official feed and food controls.

Takes into account the recommendations of the SLIM V exercise of 2001.

Allows  for  the  possibility  that  in  some  cases  MRLs  can  be  set  on  the  basis  of
monitoring data.

Allows for the possibility that in some cases, the normal shelf-life of products should
be considered in fixing dates of entry-into-force of MRLs

Allows  for  the  possibility  to  set  import  tolerances  where  different  agricultural
practices  outside  the  European  Union  lead  to  different  residue  levels  on  imported
products.

14.

Repeals the original 4 Directives and replaces them with a single Regulation.

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15.

Establishes  transitional  measures  for  setting  temporary  MRLs  of  active  substances
that have not yet been evaluated in the framework of Council Directive 91/414/EEC
on the placing of plant protection products on the market and in doing so, removes
the competence of Member States to act unilaterally in this area of food safety.

OVERVIEW OF LEGISLATION ON PESTICIDES MRLS:

Legislation  on  pesticide  residues  in  food  and  feed  includes  provisions  for  the  setting  of
maximum  residue  levels,  for  sampling  as  well  as  for  monitoring,  control  and  reporting.
Residues in babyfood are covered by separate legislation and using a different approach.

Setting of MRLs:

Pesticides  MRLs  are  currently  set  in  four  Council  Directives:  76/895/EEC  (for  some  crops
and  categorised  by  customs  codes  -  not  a  satisfactory  directive  by  today's  standards),
86/362/EEC (cereals), 86/363/EEC (products of animal origin) and 90/642/EEC (products of
plant origin other than cereals).

With about 160 crops and up to 1,000 pesticides in or out of use, then up to 160,000 MRLs
are  possible  for  raw  commodities  (including  animal  feed).  The  Community  is  gradually
harmonising all of these (see status below). The directives also permit Member States to act at
national level pending Community decisions on individual MRLs. The  directives  also  allow
MRLs  to  be  set  for  processed  and  for  composite  foods.  In  practice  this  is  not  done  at
Community level for logistics reasons although the Community does step in where there are
problems.  Processing  factors  for  individual  substances  are  normally  agreed  during  the
evaluation  of  a  91/414/EEC  dossier  and  are  used  in  the  consumer  intake  assessments
performed to check the acceptability of a MRL.

Matters are complicated by the fact that Council Directive 91/414/EEC on the placing of plant
protection  products  on  the  market  also  permits  Member  States  to  set  MRLs  when  granting
national authorisations of plant protection products. It includes a procedure to ensure that the
residues  directives  take  account  of  such  MRLs.  Furthermore,  under  WTO  rules  introduced
late in the 1990's, Codex MRLs should be respected. Many Codex MRLs are not acceptable
to the Community,  particularly those set prior to  the  late  1990's  but  where  the  Commission
did  not  formally  object  to  them  at  the  time.  Therefore  the  Authority  will  have  to  critically
examine on a case-by-case basis whether Codex MRLs ensure the same high level of sanitary
protection that would be expected from Community MRLs.

1.1.1. Objective of setting an MRL:

Extract from Foreward to 'FAO Guidelines on Pesticide Residue Trials to provide Data for the Registration of
Pesticides and the Establishment of Maximum Residue Levels'

Adequate data from properly conducted trials involving agricultural plants or farm animals intended for the production of food
are  needed  to  establish  the  parameters  of  "good  agricultural  practices  in  the  use  of  pesticides".  The  levels  of  residues  of
pesticides remaining unavoidably in food products entering trade following such practices, form the basis for setting maximum
residue levels. It is important that the results of residue analysis in supervised trials relate to those chemical species in the residue
which are relevant for the purpose of setting maximum residue levels. It is equally important that the food products examined, as
well as portions thereof examined, be relevant to the commodity moving in trade. Other aspects should also be borne in mind
during  pesticide  residue  trials,  which  have  a  bearing  on  the  usefulness  of  the  residue  data  used  in  setting  maximum  residue
levels.

4

MRLs for pesticides used in plant protection products have been set by the Community since
1976  to  facilitate  trade.  Unusually  by  the  standards  of  today,  the  1976  Directive  permits
Member States to set MRLs at higher levels than the Community ones but not at lower levels.
In  this  respect,  these  older  pesticides  MRLs  differ  from  the  more  recent  directives  where
MRLs  are  primarily  set  to  protect  the  consumer.  however,  the  MRL  is  normally  set  for  the
product moving in trade and not for the product as consumed by the consumer e.g. dried tea
leaves vs. the liquid beverage.

1.1.2. How MRLs are set:

Generally, an authorisation for use of a pesticide will only be given on the basis of submitted
scientific data showing that the  use  is  safe  for  the  user,  the  environment  and  the  consumer.
The consumer assessment part of the procedure relates to data on the residues in the crop from
'supervised trials' data. If, inter alia, the proposed conditions of use result in residue levels that
are  safe  for  the  consumer,  then  (i)  an  authorisation  for  use  specifying  the  use  conditions
('good agricultural practice' - GAP) can be issued and (ii) a MRL can be set and the product
can move in trade.

The  mechanisms and methods  used  to  fix MRLs  are  fairly  well-standardised  at  Community
level  and  well-developed  data  requirements  exist.  Various  authorised  uses  in  one  or  more
countries  or  regions  on  a  given  crop  may  give  rise  to  various  levels  of  residues.  The  GAP
giving  rise  to  the  highest  levels  (the  so-called  'critical'  GAP)  is  used  to  set  the  MRL  as  all
other authorised uses should be covered by it. If the residues arising from the critical GAP are
not  safe  for  the  consumer,  then  that  use  is  not  authorised  and  the  next  critical  GAP  is
examined.

In  a  minority  of  cases  where  residues  might  be  expected  but  where  there  are  no  authorised
uses  e.g.  from  environmentally  persistent  substances  such  as  DDT,  then  MRLs  can  be  set
(provided  they  are  safe  for  the  consumer)  using  monitoring  data  that  is  regularly  reviewed.
There  have  also  been  calls  for  the  Commission  to  set  MRLs  using  monitoring  data  for
substances  still  in  use  for  minor  commodities  e.g.  spices  and  where  residues  arise  as
adventitious contamination e.g. honey. This proposal opens up this possibility.

Since risk is a combination of hazard and exposure, then due to differences in national eating
habits, an acceptable consumer assessment in one country may not be acceptable in another.
In the Community, diets in all Member States are examined when setting MRLs and intakes
by  adults,  children  and  toddlers  are  assessed.  Total  intake  of  a  substance  from  all  dietary
sources  is  examined  every  time  a  MRL  is  set  for  a  substance  on  a  crop.  Acceptable
methodologies are not yet available to systematically look at aggregate exposure (from other
sources such as home and workplace) or cumulative exposure (intake from all dietary sources
of similarly-acting substances). These are being developed.

1.1.3. What the setting of a MRL at the Limit of Determination (LOD) signifies:

The  LOD  is  the  lower  limit  of  analytical  determination  i.e.  the  limit  below  which  residues
cannot be detected using suitable analytical methods in accredited laboratories and following
agreed  quality  assurance  guidelines  and  criteria.  The  LOD  is  therefore  dependent  on  the
substance, the method and the matrix. For example, LODs for substances in oily crops such as
nuts or oilseeds are often higher than those in 'watery crops' because of analytical difficulties.
The LOD needs to be carefully defined to ensure that legal enforcement measures seen to be
neither arbitrary nor capricious.

5

Setting a MRL at the LOD is not equivalent to banning a substance and conversely, banning a
substance does not mean that the MRL is set at the LOD. For many of the cases where MRLs
are set at LOD, the MRLs could be increased without compromising consumer safety. There
are eight cases where MRLs would normally be set at the LOD.

(a)  No  residue  expected  because  obsolete:  The  substance  is  obsolete  and  is  no  longer  used
anywhere. This would also normally preclude that residues would be present on products but
illegal  uses  cannot  be  excluded  nor  that  contamination  may  occur  from  old  stocks.  No
judgement  needs  to  be  made  in  such  cases  on  the  consumer-protection  aspects  of  the
acceptability of residues.

(b)  No  residue  expected  and  no  residue  wanted:  Following  an  evaluation,  the  use  of  the
substance  is  banned  in  the  Community  because  e.g.  its  residues  are  genotoxic.  Residues  on
imported products would also be unwelcome.

(c)  No  residues  expected  because  of  use  pattern:  Following  an  evaluation,  it  has  been
demonstrated that the authorised uses of the substance do not leave residues in the harvested
crop e.g. it is used as a soil or seed dressing or if residues degrade quickly. This could also
apply to animal-origin products if a substance is used on crops that are not fed to animals.

(d)  No  residues  expected  because  not  (yet)  used  on  certain  crops:  Particularly  for  new
substances, in early years only a few major crops e.g. cereals would be treated. For untreated
crops, no residues would be expected. As new uses are developed, the LODs for those latter
crops  would  have  to  be  reviewed.  This  will  also  be  true  in  future  for  existing  substances
because,  with  the  loss  of  half  of  all  existing  substances  in  2003,  the  others  will  find  wider
uses.

(e)  No  residue  expected  because  no  longer  authorised  for  use  in  the  Community:  In  2003,
about 400 substances will have been withdrawn from the market and most withdrawals will
have been for economical reasons (and without any prior evaluations) rather than because of
concerns.  They  might  still  be  used  in  third  countries  and  residues  could  be  present  on
imported produce.

(f)  Existing  high  residue  levels  are  possibly  unsafe  (although  lower  levels  would  be
acceptable):  Often  new  data  becomes  available  showing  that  a  substance  is  not  as  safe  as
formerly  thought  and  that  existing  MRLs  for  some  crops  are  too  high.  In  these  cases,  the
MRLs need to be reduced to safe levels. If a good agricultural practice exists giving rise to the
lower  safe  levels  then  the  MRL  can  be  reduced.  If  not,  then  the  MRL  is  set  at  LOD  as  a
precautionary  measure.  If  afterwards,  a  new  GAP  is  developed  giving  rise  to  low,  but  safe,
residue levels then the MRL can be increased again.

(g)  Where  a  substance  is  banned  because  of  environmental  or  worker  safety  considerations
then  MRLs  would  also  normally  be  set  at  the  LOD.  However,  there  may  be  safe  consumer
exposure levels and residues could be accepted on (i) imported produce and (ii) domestic or
imported  produce  where  soil  is  contaminated  and  persistent  residues  are  taken  up  by  crops
e.g. DDT. In both cases a consumer safety assessment would be required. In addition, in the
former  case,  one  cannot  under  WTO  rules  use  MRLs  to  block  trade  where  an  assessment
shows  that  allowing  the  imports  would  protect  the  consumer.  In  the  latter  case  the  MRLs
would be set using monitoring data that is regularly reviewed.

(h) Insufficient data: Where the minimum data requirements to set a MRL are not met for a
substance/crop combination, then a policy decision can be taken to set the MRL at LOD (see

6

below).  When  additional  data  becomes  available,  the  need  to  set  a  higher  MRL  can  be
reconsidered.

1.1.4. Use of default LOD:

Various approaches exist around the  world on the  use  of  a  default  MRL  for  non-authorised
uses.

One approach e.g. U.S.A., Codex, sees MRLs being set (whether at LOD or at a higher level)
only where adequate data is available. In its absence, there  is no MRL and no possibility of
trade.  It  supposes  that  in  all  cases  where  any  residues  are  detected  and  where  there  is  no
MRL,  the  result  will  be  confiscation  of  the  consignment.  In  the  absence  of  agreed  certified
analytical methods for each substance/matrix combination, this approach is open to capricious
use and a strong risk of trade problems. A variation of this policy approach is to allow trade in
the absence of a MRL with the intention of eventually setting a MRL.

A  second  approach  e.g.  Germany,  sees  a  default  MRL  of  0.01  mg/kg  being  applied  to
everything unless a specific higher MRL has been established for a particular crop/substance
combination. This has the advantage of protecting against the unforeseen but also gives rise to
trade problems for imported produce - especially for produce treated with new pesticides that
have  not  been  used  and  not  yet  evaluated  in  the  country  of  destination.  Canada  currently
applies this approach with a default of 0.1 mg/kg but is currently considering moving to the
U.S.A. approach.

The Community approach up to now has been to gradually set MRLs for every substance and
once  these  MRLs  have  been  set  for  a  substance  then  these  Community  MRLs  apply
everywhere. This approach allows national policies and MRLs to apply for the substances not
yet harmonised at Community level. A drawback of this is that it means different policies and
different MRLs in each Member State for many substances and this results in continuing trade
problems in the Internal Market. When setting MRLs for a substance, the current Commission
approach  is  to  explicitly  set  MRLs  at  the  LOD  for  those  crops  for  which  there  is  no  or
insufficient  data.  This  approach  in  itself  requires  data  (on  the  definition  of  the  residues,  on
analytical  methods  etc)  but  such  data  is  normally  available  from  the  dossiers  on  the  other
crops  for  which  MRLs  are  being  set.  Setting  a  default  MRL  at  or  near  the  LOD  also  gives
Member  States  an  additional  legal  instrument  with  which  illegal  uses  of  pesticides  can  be
controlled.

The  approach  initially  proposed  for  the  future  was  based  on  the  U.S.A.  one.  This  was
supported by SLIM but rejected by the Member States. The approach now proposed is similar
to the Canada/Germany one. The new 'default' approach is necessary because of the hundreds
of  substances  being  withdrawn  from  the  market  in  2003  for  which  we  do  not  have  the
necessary residue and analytical data to set explicit MRLs. However, the use of a Community
default MRL is not compatible with the practice of letting Member States set national MRLs
for those substances still in use but for which Community MRLs have not yet been set. The
proposal includes provisions for temporary MRLs  in these cases (see  'Single  Market  Issues'
below).

Why choose 0.01 mg/kg as a default MRL?

Since many residues can be detected with modern sophisticated methods at levels lower than
0.01  mg/kg,  the  question  is  often  asked  as  to  why  this  level  is  conventionally  set  at  0.01
mg/kg.

7

Firstly,  it  is  not  possible  to  set  MRLs  at  zero  because  there  is  no  analytical  method  that  is
capable of detecting 'zero' levels of residues and background analytical noise and uncertainty
increase  as  zero  is  approached.  Actual  detection  limits  are  dependent  on  the  matrix,  the
substance  and  the  analytical  method.  It  is  not  practical  to  determine  and  to  certify  these
individually for the more than 160,000 possible combinations. Therefore a default needs to be
selected  and  from  practical  experience  this  is  0.01  mg/kg.  A  lower  value  may  not  be
attainable  for  certain  substance/matrix  combinations  and  a  higher  default  value  is  not
necessary.

Secondly,  for  almost  all  cases  investigated  of  pesticides  in  use,  a  MRL  at  0.01  mg/kg  is
protective  of  the  consumer.  In  exceptional  case  where  this  may  not  be  true,  a  lower  level
could be explicitly set.

Thirdly,  monitoring  laboratories  do  not  have  the  resources  to  routinely  examine  every
possible crop/substance combination and they have to prioritise  their  efforts.  They normally
use certified multi-residue methods for screening levels of more than a hundred substances at
a time in any  one  commodity  and can  look  at  e.g.  up  to  50  samples  in  any  one  run.  Multi-
residue methods are not as sensitive as targeted methods that can only detect one substance at
a time but at much lower levels than the multi-residue methods which  are  generally  able to
detect levels down to 0.01 mg/kg. It is considered that screening 50 samples for more than a
hundred  substances  each  is  more  protective  of  the  consumer  than  spending  the  same  time
analysing  10  samples  for  one  substance.  An  exception  is  where  there  is  a  suspected
infringement or a rapid alert - in which cases a more targeted sampling  and analysis can be
made.

Sampling:

Sampling  for  pesticides  residues  in  products  of  plant  origin  was  covered  by  Commission
Directive  79/700/EEC.  This  was  recently  repealed  and  replaced  by  Commission  Directive
2002/63/EC  which  (i)  extended  sampling  provisions  to  include  pesticides  in  products  of
animal origin and (ii) incorporated into EC legislation the sampling provisions of Codex that
the Community agreed to in 2000. Article 33 of the proposal addresses sampling.

Monitoring, reporting and control:

The objectives of monitoring are two-fold. Firstly, monitoring is done to permit an estimation
to be made of the real exposure of consumers to pesticides residues. The second objective of
monitoring to ensure compliance (i) with existing Community and national MRLs and (ii) to
guard against  illegal use of pesticides. MRLs are set on the basis of data arising  from  legal
authorised uses and, as a corollary, in this sense the legally permitted residues should not be
considered as contaminants.

In  the  Community,  national  monitoring  programmes  are  complemented  by  a  co-ordinated
Community monitoring programme which has as its first objective to estimate the exposure of
consumers to pesticides residues. Monitoring is done at all points in the food production and
distribution chain. To cover all major pesticides and crop groupings, monitoring programmes
have  been  organised  over  a  five-year  period.  The  first  such  period  has  just  expired  and  a
contract is being prepared to analyse the results. 

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MRLs for babyfood:

The above-mentioned existing Community legislation on MRLs applies without prejudice to
the 'babyfood' directives (Directives 91/321/EEC and 96/5/EC)  where  MRLs  are  also  set.  It
differs from them in several respects.

1.

2.

3.

4.

The basic intention of the legislation on Baby Food is to control the production chain
in order that no pesticides are used in the manufacturing process. In absence of ways
to  directly  control  this  MRLs  are  set  at  such  levels  that  do  not  permit  the  use  of
pesticides. 

Babyfood  legislation  applies  a  default  MRL  of  0.01  mg/kg  unless  other  (higher  or
lower)  MRLs  are  explicitly  set  (this  is  the  approach  proposed  in  the  current
proposal);

Babyfood MRLs apply to a specific sector rather than to all of the population;

Since  babyfoods  are  often  composite,  processed  foods,  the  MRLs  are  set  and  are
applicable for the food to be eaten and calculated as the whole diet. The toxicological
endpoint (acceptable daily intake) is the starting point. In the MRL directives, GAP
is  the  starting  point  and  the  MRLs  apply  to  the  raw  commodity  (or  part  thereof).
Processing/composition factors are applied for the consumer intake assessment. 

This different approach is justification not to include babyfood MRLs in the current proposal.

OBJECTIVES TO BE ATTAINED BY PROPOSED MEASURES:

Consolidation:

Four  Council  Directives  and  most  of  their  provisions  are  being  replaced  with  a  single
Regulation of the European Parliament and the Council.

Simplification:

The SLIM recommendations are taken up in the proposal which is a Regulation rather than a
Directive.  Many  of  the  procedures  in  the  existing  directives  have  been  simplified  in  the
proposal.

Legal basis for expenditure: 

The  current  directives  do  not  contain  any  legal  basis  for  expenditure  and,  in  2002,  it  was
considered appropriate to use the 'veterinary model' as a basis for drafting new text.

In the area of pesticides residues there are two types of Community expenditure. One relates
to  monitoring,  enforcement  and  control  and  the  second  is  related  to  the  development  of
technical guidelines, data requirements and methods to set MRLs. Although the second type
of work should be transferred to the EFSA as soon as it becomes operational, a legal basis is
still required for the first category and expenditure in the second category will still be required
during the transition period during which EFSA becomes operational. Therefore, the proposal
covers both types, recognising that the second type could be removed in the medium-term.

Single Market issues:

9

The  biggest  Single  Market  problem  is  related  to  the  non-harmonised  substances  and  the
different national policies and MRLs governing them. In addition, uses of 461 substances will
be  withdrawn  in  2003  and  a  harmonised  approach  to  setting  their  MRLs  in  the  absence  of
specific data, as well as to dealing with imports from third countries will be necessary. It can
be seen from the Table below (penultimate row in rightmost column) that at the end of 2003,
there  will  be  a  withdrawal  from  the  market  of  about  386  substances  for  which  there  are  no
Community  MRLs.  Since  most  will  be  withdrawn  because  of  lack  of  data,  it  will  be
impossible to set explicit MRLs for them on a substance by substance basis. A default 'MRL
at LOD' approach together with the setting of import tolerances where appropriate, is the only
realistic  way  to  control  them.  This  approach  would  also  apply  to  75  substances  to  be
withdrawn for which we currently have harmonised Community MRLs.

The  problem  with  applying  the  default  LOD  approach  will  lie  with  the  388  substances  that
will remain on the market but for which MRLs are not yet harmonised (middle row, rightmost
column).  Their  uses,  currently  covered  by  national  MRLs,  would  be  blocked  by  the
application of a default LOD. Therefore, the proposal includes an annex of temporary MRLs
that  will  be  based  on  the  existing  national  MRLs.  Filling  this  annex  is  not  a  trivial  task
(screening of MRLs in 15 Member States times up to 388 substances times up to 160 crops)
and it could be one of the  first tasks given to the EFSA.  Since there  are not  yet  any agreed
Community  (or  even  Codex  in  almost  all  cases)  toxicological  endpoints  for  the  substances,
then national (or JMPR or OECD) data would have to apply in the first instance. The setting
of temporary  Community  MRLs  carries  a  risk  that  some  of  the  national  MRLs  upon  which
they are based may be unsafe. However, it should be recalled that (i) 91/414/EC dossiers will
be available or forthcoming for all of them, (ii) unsafe MRLs will be identified by EFSA, the
Commission or the Member States and will be reduced accordingly and (iii) since the MRLs
already apply then the situation for the consumer will not be any worse than at present during
the  temporary  transition  period  and  (iv)  this  proposal  includes  a  safeguard  clause.  The
proposal foresees that as soon as a substance is evaluated under 91/414/EEC and Community
toxicological endpoints are agreed, then the temporary 'national-based' MRLs will be deleted
from that annex and new Community MRLs will be fixed based  on  the agreed  91/414/EEC
endpoints. Under this  scheme,  all  Community  MRLs  will  be  harmonised  in  one  way  or  the
other and there should be no more trade problems in the Community due to this issue.

MRL status on 9/1/2003 of substances under evaluation under Directive 91/414/EEC

Number of
substances

of which
harmonised (or
about to be)

and of which not
yet harmonised

Substances  likely  to  stay  on  the  EC  market  for
the foreseeable future (best-case scenario)
Existing Already in Annex I
List 1
List 2
List 3
List 41
New

Sub-total

25
42
52
163
136
89
507

22
25
20
23
4
23
117

3
17
32
140
1322
66
3903

1

2

3

Preliminary  data  from  the  ongoing  notification  procedure  set  up  for  this  stage  by  Commission
Regulation (EC) N° 1112/2002.
MRLs may not applicable to most of the substances.
National MRLs apply under current legislation. The proposal foresees temporary Community MRLs for
most of these pending 91/414/EEC evaluations and decisions.

10

                                                
Substances  withdrawn  or  likely  be  withdrawn  in
the foreseeable future
Existing List 1
List 2
List 3
List 4
New

Other banned substances (Dir. 79/117/EEC)

Sub-total

TOTAL

Coherence with Directive 91/414/EEC:

23
97
225
96
7

17
465

972

23
29
11
0
1

17
81

198

0
68
214
96
6

0
3844

774

Directive 91/414/EEC on the placing of plant protection products on the market is the primary
piece  of  Community  legislation  for  plant  protection  products  and  their  active  substances.  It
provides  for  a  Community  evaluation  of  the  active  substance  and  for  Member  States  to
evaluate and authorise the uses of products containing them - using agreed hazard endpoints
and  risk  assessment  criteria.  The  Commission  cannot  authorise  uses  (it  can  oblige  Member
States  to  withdraw  uses  however)  and  Member  States  consistently  invoke  the  principle  of
subsidiarity on every occasion that they feel their competence to authorise uses is threatened.
In the 1990's, the Community assessment of active substances almost ground to a halt while
trying to evaluate all uses of each substance. The scope of the assessments went beyond what
was  foreseen  in  the  directive  but  it  was  felt  that  as  much  as  possible  should  be  done  at
Community  level.  This  view  and  approach  has  changed  as  a  result  of  experience.  More
recently,  the  focus  is  on  a  limited  range  of  representative  uses  when  assessing  active
substances at Community level.

Directive 91/414/EEC allows Member States full control of all authorisations e.g. whether for
use of an insecticide on an edible crop, a herbicide along railway tracks and motorways, or as
a  growth  regulator  in  parks  and  sports  arenas.  In  allowing  any  use,  Member  States  have  to
ensure  that  users,  bystanders,  soil,  non-target  terrestrial  and  aquatic  animals  and  plants,
succeeding  crops,  water,  air,  and  consumers  are  protected.  In  the  latter  case,  MRLs  are
required  and,  for  new  active  substances  and  for  substances  in  its  Annex  I,  the  Directive
permits Member  States to set provisional  MRLs  pending  a  notification  to  EFSA  and  a  later
endorsement from the Commission after comitology.

The  current  proposal  takes  account  of  this  possibility  but  modifies  the  current  procedure  -
recognising  that  an  amendment  of  Directive  91/414/EEC  is  also  necessary.  In  addition,  the
proposal blocks the Member States from setting MRLs in future.

The proposal also recognises the need for coherent timing of  decisions on  substances  in the
two sets of legislation. Annex I inclusion decisions under Directive 91/414/EEC often include
risk mitigation measures and in any case always oblige Member States to review all existing
authorisations in the light of the new agreed 91/414/EEC endpoints and the uniform principles
for risk  assessment  in  Annex  VI  of  that  Directive. The proposal provides that MRLs would
normally be set for active substances after their inclusion in Annex I to the Directive because
full assessment reports would then be available (excluded substances would have MRLs set at
the LOD after allowing for sell-out or phase-out periods).

4

Almost no data will be available. A significant number of 'import tolerance' requests is expected.

11

                                                
On  a  related  matter,  the  proposal  also  recognises  that,  under  the  current  legislation,  when
MRLs are reduced for reasons other than health concerns, then produce on the market could
become illegal from one day to the next. This is particularly problematic for produce which
has a long shelf-life  and the proposal provides for 'phase-in' dates to resolve the problem in
cases where there are no health concerns.

Key dates:

The key date for Directive 91/414/EEC is 2003 (withdrawal of about 400 substances from the
market).  Another  key  date  is  2008  (finalisation  of  review  programme  and  start  of  re-
evaluations).

The  key  date  for  residues  legislation  is  2004.  At  this  time,  decisions  have  to  be  made  on
MRLs for about 400 substances used on crops during 2003 but that in 2004 are no longer on
the  market.  Decisions  also  have  to  be  made  on  MRLs  for  up  to  388  substances  still  on  the
market but with national MRLs. Since at least one Member State has stated that it would ban,
in  2004,  all  trade  in  commodities  containing  residues  of  the  388  substances,  a  Community
solution before that time would be desirable.

ROLES AND PROCEDURES:

Role of the European Food Safety Authority (EFSA):

EFSA should take on those tasks related to risk assessment of plant protection products under
Directive  91/414/EEC  and  the  risk  assessment  of  pesticides  residues  under  the  pesticides
residues legislation. 

Given  the  fact  that  EFSA  is  not  yet  operational,  the  approach  taken  in  drafting  the  current
proposal was to ensure that the present work continues and that the transition to EFSA be as
smooth  as  possible.  Therefore,  the  text  is  as  specific  as  possible  about  the  role  of  EFSA
without  always  explicitly  detailing  the  exact  procedures  and  timelines  under  which  EFSA
should  work  in  this  area.  Although  these  details  will  eventually  be  necessary,  the  proposal
provides  that  they  can  be  adopted  as  implementing  measures  through  comitology  at  a  later
stage. The proposal foresees two additional tasks for EFSA.

Firstly, it should  be  recalled  that  one  of  the  objectives  of  pesticide  residue  monitoring  is  to
assess  actual  consumer  exposure  to  residues.  Since  this  exposure,  coupled  to  the  hazard
profile of a  substance, is what determines  risk, then  it  is considered proper  that this task be
handled  by  the  EFSA  which  will  be  well-placed  to  modify  the  design  and  requirements  of
monitoring programmes so as to improve its risk estimates. The task of compiling, analysing
and  publishing  the  monitoring  data  and  reports,  currently  managed  by  the  Commission,  is
proposed to be transferred to EFSA and this is also considered to be consistent with the risk
communication remit of EFSA.

Secondly,  risk  can  only  be  properly  assessed  if  all  the  data  elements  are  available.  On  the
exposure side of the risk equation, detailed data on dietary intakes from all sources (all food
types - including portion sizes - as well as water and other sources) are required. Therefore,
the  Regulation  proposes  that  EFSA  maintain  a  database  of  all  uses  of  plant  protection
products in the Community to complement a second database on dietary intakes of each type
of  food  among  various  population  subgroups.  It  will  be  well-placed  to  maintain  this

12

information  through  its  complementary  activities  on  the  assessment  of  plant  protection
products under Council Directive 91/414/EEC and on intakes of other substances in food.

Role of the Commission :

The  Commission  will  be  responsible  for  risk  management,  by  deciding  on  the  setting  of
MRLs taking into account the opinion of EFSA. This will not be an automatism relying fully
on EFSA’s judgement. The Commission has its own responsibility will have to verify the risk
assessment  and  the  opinion  of  EFSA.  Apart  from  setting  MRLs  the  Commission  shall  also
make  proposals  for  Monitoring  Decisions  and  publish  guidelines  for  submission  of  data,
methods of sampling etc.

Under what circumstances can and should MRLs be deleted?

Normally MRLs would be deleted (i) where there are no authorised uses or (ii) where there is
insufficient data on which to set a MRL, or (c) where there is evidence that a MRL is not safe
for  the  consumer  (see  also  the  discussion  on  default  MRLs  above).  Under  all  these
circumstances,  the  default  MRL  of  0.01  mg/kg  would  apply.  However,  there  may  be
circumstances where an assessment shows that a MRL of 0.01 mg/kg would not be protective
of the consumer. In such cases, a specific, lower MRL could be set.

Under what circumstances can and should MRLs be set?

The proposal foresees two types of MRL - fixed and temporary. Fixed MRLs are foreseen for
all existing MRLs in Directives 86/362/EEC,  86/363/EEC and  90/642/EEC - irrespective of
their 91/414/EEC inclusion status and of whether the substances are considered as existing or
new  in  the  context  of  Directive  91/414/EEC.  These  MRLs  can  actually  be  modified  at  any
time  and  all  would  be  reviewed  case-by-case  after  91/414/EEC  inclusion  or  exclusion
decisions.  To  avoid  continuing  trade  problems  in  the  Single  Market,  temporary  MRLs  are
foreseen to be created in a one-off exercise for all existing substances for which there is not
yet a Community MRL as well as for substances with MRLs in Directive 76/895/EEC. These
would be reviewed and either transferred to the 'fixed-MRL' annex after a 91/414/EEC Annex
I inclusion decision, or deleted after an exclusion decision. Temporary MRLs would also be
set for new active substances prior to a 91/414/EEC Annex I decision where Member States
have  issued  provisional  authorisations  under  that  directive.  These  would  also  be  reviewed,
and either transferred to the 'fixed-MRL' annex after an Annex I inclusion decision, or deleted
after an exclusion decision

The existing legislation provides for a number of circumstances under which the Commission
or  the  Member  States  can  set  MRLs.  That  number  is  reduced  in  this  proposal,  as  is  the
competence  of  Member  States  to  set  MRLs.  Assuming  that  'default  LOD'  approach  of  the
proposal  is  adopted,  then  there  are  five  (eventually  to  be  reduced  to  four)  sets  of
circumstances under  which  MRLs  are  required  and which  are  foreseen in the proposal.  The
five  sets  of  circumstances  are,  as  well  as  the  proposed  approaches  to  deal  with  them,
illustrated  graphically  on  the  following  pages  in  the  diagrams  accompanying  the  text.  They
are:

1.

2.

3.

New or changed use for a substance (Article 22).

Import tolerances (Article 29).

One-off creation of an annex of Temporary MRLs (Article 24).

13

4.

Cases of concern (Article 42).

1.         New or changed use for a substance:

This  is  foreseen  as  the  normal  or  standard  procedure  for  setting  MRLs.  Where  a  new  or
changed  use  for  a  substance  is  developed  (Article  22  of  proposal),  MRLs  often  need  to  be
modified.  Annex  I  inclusion  decisions  under  Directive  91/414/EEC  often  include  risk
mitigation  measures  and  in  any  case  always  oblige  Member  States  to  review  all  existing
authorisations  in  the  light  of  the  newly-agreed  91/414/EEC  endpoints  and  the  uniform
principles  for  risk  assessment  in  Annex  VI  of  that  Directive.  Hence,  many  such  cases  are
foreseen.  In  these  cases,  a  91/414/EEC  dossier  and  assessment  report  would  be  available
already  and  the  extra  workload  for  any  one  individual  use  would  normally  be  marginal.  In
addition,  due  to  the  withdrawal  of  so  many  substances,  new  extensions  of  uses  of  the
remaining existing substances should become a very common practice - even before annex I
decisions are taken. Since a default LOD will be already in place for a new use, an upwards
revision of the MRL would be necessary.

For  a  changed  use  of  a  new  or  existing  substance  after  Annex  I  inclusion,  the  MRL  could
need  changing  in  either  direction.  Article  4.1.f  of  Directive  91/414/EEC  already  allows
Member  States  to  do  this  nationally  but  on  a  provisional  basis.  This  possibility  will  be
removed by the proposed Regulation and the normal procedure will have to be followed. It is
anticipated that Member States will object strongly to this but their concerns can be allayed if
there are guarantees that such MRLs can be set quickly at Community level.

Where  a  new  use  for  a  new  substance  is  developed  in  a  Member  State,  this  procedure  also
applies. Most new substances are developed and assessed initially for one or two major crop
types and in the first instance  are only  introduced into one  Member  State.  The  91/414/EEC
assessment process takes several years and during this period the substance can be introduced
into  other  Member States with  different  growing  conditions  or  pest  pressures.  Articles  4.1.f
and  8.1  of  Directive  91/414/EEC  provide  that  Member  States  may  issue  provisional
authorisations and, where appropriate, provisional MRLs (this possibility has to be removed
in the amendment of Directive 91/414/EEC). In addition, as experience is gained, extension to
other crops is common and even expected. Since a default LOD will be in place, an upwards
revision of the MRL would be necessary - in many cases even before Annex I inclusion. In
such cases, temporary MRLs would be set pending Annex I decisions under 91/414/EEC.

Currently, where there is no harmonised  MRL  at Community level, Article 8.2 of Directive
91/414/EEC  permits  Member  States  to  authorise  new  or  extended  uses  of  existing  active
substances  and  to  set  national  MRLs  pending  the  eventual  harmonisation  of  MRLs  for  the
substance  at  Community  level.  This  proposal  will  not  permit  this  in  future  as  the  national
MRLs will be replaced by temporary Community MRLs  (see case  3 below). The procedure
outlined here would also apply to the modification of temporary Community MRLs.

2.         Import tolerances:

There are three cases where 'import tolerances' would be required (Article 29 of proposal).

(a) Where an importer wants to import a commodity containing residues of a substance used
in the Community but where the commodity is not produced in the Community e.g. papayas.
In  this  case  there  would  usually  be  expertise  (Rapporteur  Member  State)  and  91/414/EEC
data in the Community and the additional workload would be slight-to-moderate.

14

(b) Where an importer wants to import a commodity treated with a substance no longer or not
yet  used  in  the  Community.  In  this  case,  there  would  normally  not  be  expertise  in  the
Community  and  full  toxicological  and  residues  data  would  be  required.  A  significant
workload would be expected for each individual evaluation - for which there could be many
due  to  our  withdrawal  of  461  substances  from  the  market.  An  exception  would  be  for
substances  that  had  been  evaluated  at  Community  level  and  which  were  withdrawn  for
reasons  of  consumer  protection  e.g.  because  they  were  genotoxic.  For  the  small  number  of
cases where this has happened, no import tolerance could be considered.

(c)  Where  an  importer  wants  to  import  a  commodity  treated  with  a  substance  in  use  in  the
Community  but  where  the  foreign  GAP  gives  higher  residues  than  the  Community  critical
GAP.  In this  case, marginal data specific to the GAP  for  the  crop  would  be  needed  since  a
dossier and Rapporteur Member State would be available. The additional workload would be
slight.

3.         Temporary MRLs:

Temporary  MRLs  (Article  24  of  proposal)  are  required  for  non-harmonised  substances  that
are still in use in the Community as a pre-requisite to applying a default LOD policy for the
up  to  500  substances  that  will  be  withdrawn  from  the  market.  Their  use  is  discussed  more
fully in the main body of the text in the context of the Single Market. It is envisaged that such
MRLs  be  deleted  after  91/414/EEC  Annex  I  inclusion  decisions  are  taken  and  that  they  be
then replaced with fixed MRLs.

This  temporary  category  would  include  MRLs  that  have  already  been  set  in  Directive
76/895/EEC since Member States are allowed to set higher MRLs arnd therefore they are not
fully harmonized MRLs. When they were set these MRLs were not always backed up by data
meeting the quality standards required today.

4.         Cases of concern:

In  cases of concern  (Article  42  of  proposal), where  a  Member  State  or  other  party  has  new
information  indicating  that  an  existing  MRL  may  not  be  safe  and  needs  to  be  revised
downwards (with or without triggering  a  safeguard  clause).  For  example,  new  toxicological
data may require that the acceptable daily intake (ADI) or the acute reference dose (ARfD) be
revised downwards or new dietary information may become available indicating that people
are eating more of a certain commodity than was estimated during the intake assessment. As a
temporary  risk  management  measure,  the  MRL  could  be  reduced  downwards  pending  an
assessment of the data and a final decision on a new MRL.

15

2003/0052 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on maximum residue levels of pesticides in products of plant and animal origin

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular the third
subparagraph of Article 37(2), Article 95(1) 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 laid down in Article 251 of the Treaty4,

Whereas:

(1)

Council  Directive  76/895/EEC  of  23  November  1976  relating  to  the  fixing  of
maximum  levels  for  pesticide  residues  in  and  on  fruit  and  vegetables5,  Council
Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide
residues  in  and  on  cereals6,  Council  Directive  86/363/EEC  of  24  July  1986  on  the
fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin7,
and Council Directive 90/642/EEC of 27 November 1990 on the  fixing of maximum
levels  for  pesticide  residues  in  and  on  products  of  plant  origin,  including  fruit  and
vegetables8, have been substantially amended several times. In the interests of clarity
and simplicity, those Directives should be repealed and replaced by a single act. 

(2)

This  Regulation  directly  concerns  public  health  and  is  relevant  to  the  functioning  of
the internal market. It covers products which are included in Annex I to the Treaty as

1

2

3

4

5

6

7

8

OJ C , , p. .
OJ C , , p. .
OJ C , , p. .
OJ C , , p. .
OJ L 340, 9.12.1976, p. 26. Directive as last amended by Commission Directive 2002/79/EC, OJ L 291,
28.10.2002, p. 1
OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commission Directive 2002/97/EC, OJ L 343,
18.12.2002, p. 23
OJ L 221, 7.8.1986, p. 43. Directive as last amended by Commission Directive 2002/97/EC, OJ L 343,
18.12.2002, p. 23
OJ L 350, 14.12.1990, p. 71. Directive as last amended by Commission Directive 2002/100/EC, OJ L 2,
7.1.2003, p. 33

16

                                                
(3)

(4)

(5)

(6)

(7)

(8)

9

10

11

well  as  products  which  are  not.  Consequently,  it  is  appropriate  to  choose  the  third
subparagraph of Article 37(2), Article 95(1) and Article 152(4)(b) as the legal basis.

Differences  in  national  maximum  residue  levels  for  pesticides  can  pose  barriers  to
trade between Member States and trade between third countries and the Community.
Accordingly, in the interest of free movement of goods, equal competition conditions
among  the  Member  States,  as  well  as  consumer  protection,  it  is  appropriate  that
maximum  residue  levels  (MRLs)  for  products  of  plant  and  animal  origin  be  set  at
Community level.

A regulation establishing MRLs does not require transposition into national law in the
Member States. It is therefore the most appropriate legal instrument to set MRLs for
pesticides in products of plant and animal origin, as its precise requirements should be
applied  at  the  same  time  and  in  the  same  manner  throughout  the  Community  and
accordingly permit a more efficient use of national resources.

The production and consumption of plant and animal products play a very important
role in the Community. The yield from plant production is continually being affected
by harmful organisms. It is essential to protect plants and plant products against such
organisms, not only to prevent a reduction in yield or damage to them but also in order
to  ensure  the  quality  of  the  products  harvested,  to  increase  agricultural  productivity,
and  to  protect  the  natural  environment  by  limiting  the  surface  area  needed  for
agricultural production.

One of the most important methods of  protecting plants and  plant  products  from  the
effects  of  harmful  organisms  is  the  use  of  active  substances  in  plant  protection
products.  However,  a  possible  consequence  of  their  use  may  be  the  presence  of
residues in the treated commodities, in animals feeding on those  commodities and in
honey produced by bees exposed to them. It is necessary to ensure that such residues
should  not  be  present  at  levels  presenting  an  unacceptable  risk  to  human  or  animal
health.

A number of active substances are banned under Council Directive 79/117/EEC of 21
December  1978  prohibiting  the  placing  on  the  market  and  use  of  plant  protection
products  containing  certain  active  substances9.  At  the  same  time,  many  other  active
substances  are  not  currently  authorised  under  Council  Directive  91/414/EEC  of  15
July  1991  concerning  the  placing  of  plant  protection  products  on  the  market10.  The
residues  of  active  substances  in  products  of  plant  and  animal  origin  arising  from
unauthorised use or from environmental contamination or from use in third countries
should be carefully controlled and monitored.

The  basic  rules  with  regard  to  feed  and  food  law  are  laid  down  in  Regulation  (EC)
No 178/2002 of the European Parliament and of the Council of 28 January 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 safety11.

OJ L 33, 8.2.1979, p. 36. Directive as last  amended  by  the  Act  of  Accession  of  Austria,  Finland  and
Sweden.
OJ  L  230,  19.8.1991,  p.  1.  Directive  as  last  amended  by  Commission  Directive  2003/5/EC  (OJ  L  8,
14.1.2003, p. 7).
OJ L 31, 1.2.2002, p. 1.

17

                                                
(9)

(10)

In addition to those basic rules, more specific rules are needed to ensure the effective
functioning  of  the  internal  market  and  trade  with  third  countries  in  relation  to  fresh,
processed and composite plant and animal products intended for human consumption
or animal feed on which pesticide residues may be present, whilst providing the basis
for securing a high level of protection for human and animal health and the interests of
consumers. Such rules should include the specification of MRLs for each pesticide on
all food and feed products and the quality of the data underlying these MRLs.

Specific  rules  for  animal  feed  including  marketing,  storage  of  feed  and  feeding  of
animals are provided for in Directive 2002/32 of the European Parliament and of the
Council  of  7  May  2002  on  undesirable  substances  in  animal  feed12.  For  certain
products it is not possible to determine whether they will be transformed into food or
animal feed. Therefore the Pesticide Residues on such products should be safe both for
human and animal consumption. Accordingly it is appropriate that the rules set out in
this Regulation also apply to those products in addition to the specific rules for animal
nutrition. 

(11)

The basic rules with regard to official control of food and feed controls are laid down
in Regulation (EC) No XXX/2003 of the European Parliament and of the  Council of
xx. 200313.  It  is  appropriate  that  specific  rules  concerning  monitoring  and  control  of
pesticide residues be introduced.

(12) Council Directive 91/414/EEC provides basic rules with respect to the use and placing
on  the  market  of  plant  protection  products.  In  particular  the  use  of  those  products
should have no harmful effects on human or animal health. Pesticide residues resulting
from  uses  of  plant  protection  products  may  have  harmful  effects  on  the  health  of
consumers.  It  is  therefore  appropriate  that  rules  for  the  M  R  Ls  on  the  products
intended  for  human  consumption  are  defined  that  are  linked  to  the  authorisation  for
use of the pesticides as defined in the framework of Council Directive 91/414/EEC.

(13) Directive 91/414/EEC provides that  Member States, when issuing  authorisations, are
to  prescribe  that  plant  protection  products  be  used  properly.  Proper  use  includes  the
application of the principles of good plant protection practice as well as the principles
of integrated control so that whenever possible and practicable, the use and the choice
of pesticides does not interfere with the use of biological control methods. The MRLs
should be set as low as is consistent with such biological control methods. Where the
MRLs  arising  from  an  authorised  use  of  a  pesticide  under  Directive  91/414/EEC
present  a  risk  to  the  consumer  such  use  should  be  revised  to  decrease  the  levels  of
pesticide residues. The Community should encourage the use of methods or products
favouring  a  reduction  in  risk,  and  a  reduction  in  the  amounts  of  pesticides  used  to
levels consistent with efficient pest control.

(14)

It  is  necessary  to  define  at  Community  level  certain  terms  used  for  the  setting,
monitoring and control of MRLs in and on products of plant and animal origin.

(15) Directive 76/895/EEC provides for the possibility for the Member States to authorise
higher  levels  of  MRLs  than  are  currently  authorised  at  Community  level.  That
possibility  should  cease  to  exist  as,  in  view  of  the  internal  market,  it  could  create
obstacles to intra-Community trade. 

12

13

OJ L140, 30.5.2002, p.10
OJ LXXX, XX.YY.2002, p. Z – proposal submitted to Council (COM (2003) 52 final)

18

                                                
(16)

(17)

(18)

The determination of MRLs for pesticides requires lengthy technical consideration and
includes an assessment of potential risks to consumers. Therefore, MRLs cannot be set
immediately  for 
the  residues  of  pesticides  currently  regulated  by  Directive
76/895/EEC or for pesticides for which Community levels have not yet been set.

It is appropriate that the minimum data requirements to be used when considering the
setting of MRLs for pesticides be laid down at Community level. 

In  exceptional  circumstances,  for  unauthorised  pesticides  that  may  be  present  in  the
environment as contaminants, it is appropriate to permit the use of monitoring data in
setting MRLs for pesticides.

(19) MRLs for pesticides should be continually monitored and should  be  changed  to take
account  of  new  information  and  data.  MRLs  should  be  set  at  the  lower  level  of
analytical  determination  where  authorised  uses  of  plant  protection  products  do  not
result  in  detectable  levels  of  pesticide  residues.  Where  uses  of  pesticides  are  not
authorised  at  Community  level,  MRLs  should  be  set  at  an  appropriate  low  level  to
protect  the  consumer  from  the  intake  of  unauthorised  or  excess  levels  of  pesticides
residues.  That  level  is  conventionally  set  at  0.01  mg/kg  although  in  the  exceptional
cases where such a level does not guarantee consumer protection, lower levels should
be set.

(20)

For feed and food produced outside the Community, different agricultural practices as
regards  the  use  of  plant  protection  products  may  be  legally  applied,  resulting  in
pesticide  residues  differing  from  those  resulting  from  uses  legally  applied  in  the
Community. It is therefore appropriate that MRLs are fixed for imported products that
take these uses and the resulting residues into account provided that the safety of the
products can be demonstrated using the same criteria as for domestic produce. 

(21) Regulation  (EC)  No  178/2002  of  the  European  Parliament  and  of  the  Council
establishes  procedures  for  taking  emergency  measures  in  relation  to  food  of
Community  origin  or  imported  from  a  third  country.  Those  procedures  allow  the
Commission to adopt such measures in situations where food is likely to constitute a
serious  risk  to  human  health,  animal  health  or  the  environment  and  where  such  risk
cannot  be  contained  satisfactorily  by  measures  taken  by  the  Member  State(s)
concerned. It is appropriate that these measures and their effect on human and animal
health are evaluated by the European Food Safety Authority without delay.

(22)

(23)

(24)

The  lifetime  exposure,  and  where  appropriate  the  acute  exposure  of  consumers  to
pesticide  residues  via  food  products  should  be  assessed  and  evaluated  in  accordance
with Community procedures and practices, taking account of guidelines published by
the World Health Organisation.

Through the  World Trade Organisation,  the Community’s trading partners should be
consulted  about  the  MRLs  proposed,  and  their  observations  should  be  taken  into
account,  before  the  MRLs  are  adopted.  MRLs  set  at  the  international  level  by  the
Codex Alimentarius Commission should also be considered when Community MRLs
are being set.

The  European  Food  Safety  Authority  established  by  Regulation  (EC)  No  178/2002,
has  a  key  role  to  play  in  the  assessment  of  risks  to  the  consumer  and  should  be
involved in the scientific evaluation of applications to set MRLs and in the assessment
of risks to consumers from pesticide residues. 

19

(25)

(26)

(27)

(28)

(29)

(30)

The Member States should lay down rules on penalties applicable to infringements of
the  provisions  of  this  Regulation  and  ensure  that  they  are  implemented.  Those
penalties must be effective, proportionate and dissuasive.

The  development  of  a  Community  harmonised  system  for  MRLs  entails  the
development  of  guidelines,  databases  and  other  activities  with  costs  associated.  It  is
appropriate for the Community in certain cases to make a contribution to those costs.

It is good administrative practice and is technically desirable to co-ordinate the timing
of decisions on MRLs for active substances with decisions taken for those substances
under Directive 91/414/EEC. For many substances for which Community MRLs have
not yet been set, decisions are not due to be taken under that Directive before the date
of entry into force of this Regulation.

It is therefore necessary to adopt separate rules providing for temporary but mandatory
MRLs, with a view to setting MRLs progressively as decisions are taken on individual
active substances in the framework of the evaluations under Directive 91/414/EEC.

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 Commission14, 

In accordance with the principal of proportionality, it is necessary and appropriate for
the  achievement  of  the  basic  objectives  of  facilitating  trade  whilst  protecting  the
consumer  to  lay  down  rules  on  MRLs  in  products  of  plant  and  animal  origin.  This
Regulation  does  not  go  beyond  what  is  necessary  in  order  to  achieve  the  objectives
pursued in accordance with the third paragraph of Article 5 of the Treaty,

HAVE ADOPTED THIS REGULATION:

Chapter I
Subject matter, scope and definitions

Article 1
Subject matter

This Regulation shall apply to fresh, processed and  composite plant  and animal products  or
parts  thereof  listed  in  Annex  I,  intended  for  human  consumption  or  animal  feed  on  which
pesticide residues may be present due to:

(a)

the  use  of  plant  protection  products  falling  within  the  scope  of  Directive
91/414/EEC; 

(b)

plant protection products applied outside the Community; or

(c)

environmental  contamination  by  substances  formerly  used  as  plant  protection
products.

14

OJ L 184, 17.7.1999, p. 23.

20

                                                
This  Regulation  shall  be  subject  to  the  rules  on  food  and  feed  provided  for  by  Regulation
(EC) No 178/2002. 

Article 2
Scope

1.

2.

3.

This Regulation shall apply without prejudice to Council Directive 2002/32/EC

This Regulation shall not apply to the products referred to in Article 1 where it may
be established by appropriate evidence that they are intended for:

(a)

the manufacture of products other than food intended for human consumption
or animal feed; or

(b)

sowing or planting.

Maximum residue levels  for  pesticides  set in  accordance with this  Regulation  shall
not apply in the case of products referred to in Article 1 intended for export to third
countries  and  treated  before  export,  where  it  may  be  established  by  appropriate
evidence that the third country of destination requires or agrees with that particular
treatment in order to prevent the introduction of harmful organisms into its territory.

Article 3
Definitions

For  the  purpose  of  this  Regulation,  the  definitions  in  Regulation  (EC)  No  178/2002  shall
apply.

The following definitions shall also apply: 

(1)

(2)

(3)

(4)

(5)

‘pesticide residues’: means residues of plant protection products as defined in Article
2(2) of Directive 91/414/EEC which are present in or on the products referred to in
Article 1 of this Regulation and which may arise as a result of use in plant protection,
in veterinary medicine and as a biocide; 

‘Maximum Residue Level’ (MRL): means the upper legal level of concentration for
a  pesticide  residue,  in  excess  of  which  measures  are  to  be  taken  to  withdraw  a
product from the market; 

‘Limit  of  Determination’  (LOD):  means  the  lowest  level  achieved  and  reported  by
routine  monitoring  with  validated  methods  in  accredited  laboratories  as  defined  in
Regulation (EC) No XXX/200313;

‘good  agricultural  practice’  (GAP):  means  the  nationally  recommended,  authorised
or registered safe use of pesticides under actual conditions at any stage of production,
storage, transport, distribution and processing of food commodities and animal feed
necessary for effective and reliable pest control;

‘import tolerance’: means a MRL based on a Codex Alimentarius Commission MRL
or on a GAP implemented in a third country for the legal use of an active substance
in that third country where:

21

(a)

the use of the active substance in a plant protection product on a commodity is
not authorised in the Community; or

(b)

an existing MRL is not sufficient to meet the needs of international trade;

(6)

(7)

(8)

‘proficiency  test’:  means  a  comparative  test  in  which  several  laboratories  perform
analyses on identical  samples,  allowing  an evaluation of  the  quality  of  the  analysis
by each laboratory;

‘acute  reference  dose:  means  the  estimate  of  the  amount  of  substance  in  food  or
drinking-water  expressed on a body weight basis, that  can be ingested over  a  short
period of time, usually during one meal or one day, without appreciable health risk to
the consumer on the basis of all known facts at the time of evaluation;

‘acceptable daily intake’: means the estimate of the amount of substance in food or
drinking-water  expressed on a body weight basis,  that  can be ingested daily  over  a
life time, without appreciable health risk to the consumer on the basis of all known
facts at the time of evaluation;

(9)

‘composite food stuffs’: means food containing a mixture of ingredients.

Chapter II
Community procedure for applications for MRLs

SECTION 1
SUBMISSION OF APPLICATIONS FOR MRLS

Article 4
Applicants for MRLs

An application to set, modify or delete an MRL may be made by:

(a)

(b)

(c)

1.

2.

a Member State authorising the use of a plant protection product on its territory;

interested  parties,  including  manufacturers,  growers,  importers  and  producers  of
products referred to in Article 1;

any party identifying an appropriate and scientifically substantiated possible concern
for human or animal health due to the intake of pesticide residues.

Article 5
Applications to be submitted to the European Food Safety Authority

The application to set, modify or delete an MRL shall be submitted for an opinion to
the  European  Food  Safety  Authority  established  by  Regulation  (EC)  No  178/2002
(hereinafter referred to as “the Authority”). 

The Authority shall acknowledge in writing receipt of the application to the applicant
without delay. The acknowledgement shall state the date of receipt of the application.

22

3.

The Authority shall notify the Commission of the application.

Article 6
Requirements relating to applications for MRLs

1.

(a)

(b)

(c)

(d)

2.

The  application  to  set,  modify  or  delete  an  MRL  shall  be  accompanied  by  the
following information:

the name and address of the applicant;

a presentation of the application dossier including:

(i)

a summary of the application; 

(ii)

the main substantive arguments;

(iii) an index of the documentation;

where appropriate, scientifically substantiated reasons for concern.

the  data  listed  in  Annexes  II  and  III  to  Directive  91/414/EEC  relating  to  data
requirements  for  the  setting  of  MRLs  for  pesticide  residues,  including,  where
appropriate, toxicological data as well as plant and animal metabolism data.

However,  where  an  active  substance  has  already  been  authorised  for  use  in  the
Community  under  Directive  91/414/EEC  or  where  a  Codex  Alimentarius
Commission  MRL  exists,  the  Authority  may  consider  that  the  applicant  may  be
exempted  from  the  submission  of  certain  requirements  for  data,  particularly  as
regards  the  toxicology.  In  such  cases,  the  reasoned  opinion  of  the  Authority  as
referred to Article 9 shall include a justification for any such waivers granted.

The  Authority  may,  where  appropriate,  request 
to  provide
supplementary  information  in  addition  to  information  required  under  paragraph  1
within  a  time  limit  specified  by  the  Authority  which  in  no  event  shall  exceed  six
months.

the  applicant 

Article 7
Guidelines relating to submission of data

The data as referred to in Article 6(1)(d) shall comply with the guidelines set out in
Annex VI.

The  Authority  shall  regularly  make  proposals  for  updating  those  guidelines  to  take
account of scientific and technical progress. 

23

SECTION 2
CONSIDERATION OF APPLICATIONS CONCERNING MRLS BY THE AUTHORITY

Article 8
Receipt of application concerning MRLs by the Authority

Upon receipt of an application to set, modify or delete an MRL, the Authority shall:

(a)

(b)

(c)

verify that the application complies with Article 6;

inform the  applicant,  the  Commission  and the Member States  where  an application
does not comply with Article 6;

make  available  to  the  Member  States  and  the  Commission  a  summary  of  each
application, and, at the request of  a  Member State or the Commission,  transmit the
application dossier and any supplementary information supplied by the applicant.

Article 9
The Authority’s opinion on applications concerning MRLs 

1.

The Authority shall give a reasoned opinion on applications complying with Article
6, on the setting, modification or deletion of an MRL. That opinion shall include: 

(a)

an  assessment  on  whether  the  analytical  method  for  routine  monitoring
proposed in the application is appropriate for the intended control purposes;

(b)

the anticipated LOD for the pesticide commodity combination;

(c)

an assessment of the risks of the acceptable daily intake or acute reference dose
being exceeded as a result of the modification of the MRL; the contribution to
the total intake due to the residues on the commodity for which the MRLs was
requested. 

The Authority shall forward its reasoned opinion to the applicant, the Commission,
and the Member States.

Without prejudice to Article 39 of Regulation (EC) No 178/2002, the Authority shall
make its reasoned opinion public.

Article 10
Time limits for the Authority’s opinion on applications concerning MRLs

The Authority shall give its reasoned opinion as provided for in Article 9(1) within
the following time limits from the date of receipt of the application : 

(a)

(b)

three  months  where  the  toxicology  of  the  active  substance  has  already  been
evaluated at Community level;

twelve  months  where  the  toxicology  of  the  active  substance  has  not  been
evaluated at Community level.

2.

3.

1.

24

2.

Where the Authority requests  supplementary  information  as  provided  for  in  Article
6(2), the time limits laid down in  paragraph  1  are  suspended  until  that  information
has been provided.

SECTION 3
SETTING, MODIFYING OR DELETION RELATED TO APPLICATIONS FOR MRLS 

Article 11
 Decisions on applications concerning MRLs

Upon  receipt  of  a  reasoned  opinion  of  the  Authority  as  provided  for  in  Article  9(1),  a
reasoned  decision  shall  be  adopted  on  the  setting,  modification  or  deletion  of  an  MRL,  in
accordance with the procedure referred to in Article 49 (2). 

The decision shall take into account the opinion of the Authority. 

The Commission may request at any time that supplementary information be provided by the
applicant.

Article 12
Opinion of the Authority not required

Where  amending  Annexes  II  or  III,  in  order  to  delete  or  to  reduce  to  0.01  mg/kg  an  MRL
following  the  revocation  of  an  existing  authorisation  for  a  plant  protection  product  under
Directive 91/414/EC.an opinion of the Authority shall not be required. 

Chapter III
MRLs applicable to products of plant and animal origin and
active substances

Article 13
Compliance with maximum residue levels

1.

2.

The products referred to in Article 1 shall not contain, from the time they are placed
on the market any pesticide residue exceeding:

(a)

the MRLs for those products set out in Annexes II and III; 

(b)

0.01 mg/kg for active substances not listed in Annex IV for those products for
which no specific MRL is set out in Annexes II or III;

Member  States  may  not  prohibit  or  impede  the  placing  on  the  market  within  their
territories  of  the  products  referred  to  in  Article  1  on  the  grounds  that  they  contain
pesticide residues provided that:

(a)

the  concentration  of  the  pesticide  residues  does  not  exceed  the  appropriate
MRLs set out in Annexes II or III; or

25

(b)

the active substance is listed in Annex IV.

Article 14
Prohibited uses of processed and composite products

In the case of processed and composite products as referred to in Article 1, the following shall
be prohibited:

(a)

(b)

to dilute products not complying with the MRLs set out in Annexes II or III so
as to reduce the pesticide residue levels below those MRLs ;

to  mix  products  which  are  to  be  subjected  to  a  sorting  technique  or  physical
treatment  with  products  intended  for  direct  human  consumption  or  as  an
ingredient in food or feed;

(c)

to use products not complying with the  MRLs set out in Annexes  II or  III  as
ingredients in the manufacture of other food or feed;

(d)

to detoxify those products by chemical treatments.

Article 15
MRLs applicable to dried and other processed products 

1.

2.

Where  MRLs  are  not  set  out  in  Annexes  II  or  III  for  dried  and  other  processed
products  referred  to  in  Article  1,  the  MRLs  applicable  shall  be  those  set  out  in
Annexes II or  III  for the appropriate commodity  referred to in Annex I, taking into
account:

(a)

changes in the levels of pesticide residues caused by the drying process; or 

(b)

changes in the levels of pesticide residues caused by processing. 

Specific  concentration  or  dilution  factors  for  certain  drying  or  other  processing
operations  or  for  certain  dried  or  otherwise  processed  products  may  be  included  in
the list in Annex V in accordance with the procedure referred to in Article 49(2).

Article 16
MRLs applicable to composite food and feed

The  MRL  to  be  applied  to  composite  food  and  feed  shall  correspond  to  the  MRLs  of  their
ingredients as set out in Annexes II or III taking into account the relative concentrations of the
ingredients in their composition and the provisions of Articles 13, 14 and 15. 

26

Chapter IV
Establishing lists of commodities, MRLs and active substances

SECTION 1
PROCEDURE FOR THE ESTABLISHMENT OF LISTS OF GROUPS OF COMMODITIES,
MRLS, ACTIVE SUBSTANCES AND ASSESSMENT OF MRLS

Article 17
Establishment of lists of groups of commodities of plant and animal origin

Lists of groups of commodities of plant and animal origin with examples of products in those
groups and the parts of those products to which MRLs apply, to be set out in Annex I shall be
established  in  accordance  with  the  procedure  referred  to  in  Article  49(2).  Those  lists  shall
include  animal  feed  as  referred  to  in  Article  1.  Annex  I  shall  include  all  commodities  for
which MRLs are explicitly set, grouped in such a way that MRLs may be set for a group of
similar or related commodities.

Article 18
Establishment of lists of MRLs 

The lists of MRLs for products of plant and animal origin to be set out in Annex II shall be
established in accordance with the procedure referred to in Article 49(2), taking into account:

(a)

the scientific and technical knowledge available; 

(b)

(c)

(d)

the  possible  presence  of  pesticide  residues  arising  from  other  uses  of  active
substances;

the results of an assessment of any potential risks to the consumer and, where
appropriate, to animal health;

the  results  of  any  evaluations  undertaken  in  accordance  with  Directive
91/414/EEC;

(e) modifications  to  the  uses  of  products  containing  active  substances  that  have

arisen as a result of decisions under Directive 91/414/EEC;

(f)

the following MRLs:

(i) MRLs  provided  for  under  Directives  86/362/EEC,  86/363/EEC  and

90/642/EEC;

(ii) MRLs set by the Codex Alimentarius Commission;

27

(iii) Maximum  residues  limits  (MRLs)  listed  in  annexes  I,  II  and  III  of

Council Regulation (EEC) No 2377/9015

Article 19
Establishment of a list of temporary MRLs 

The lists of temporary MRLs for active substances for which a decision on inclusion or non-
inclusion in  Annex I to Directive  91/414/EC  has  not  yet  been  taken,  shall  be  established  in
accordance with the procedure referred to in Article 49(2), taking into account the information
provided by the Member States and the matters referred to in points (a)(b) and (c) of Article
18.

Such temporary MRLs shall include:

(a)

remaining MRLs in the Annex to Directive 76/895/EEC; 

(b)

hitherto unharmonised national MRLs, as referred to in Article 24; and 

(c) MRLs set according to the simplified procedure referred to in Article 27, to be

set out in Annex III.

Article 20
Establishment of a list of active substances for which no MRLs are required

The  list  of  active  substances  of  plant  protection  products,  evaluated  under  Directive
91/414/EEC  and  for  which  it  is  agreed  by  the  Committee  referred  to  in  Article  49(1)  that
MRLs are not required , to be set out in Annex IV shall be established in accordance with the
procedure referred to in Article 49(2), taking into account the uses of those active substances
and the matters referred to in points (a) and (c) of Article 18.

Article 21
Assessment of existing MRLs by the Authority

The  Authority  shall,  within  a  period  of  12  months  from  the  date  of  the  inclusion  or  non-
inclusion  of  an  active  substance  in  Annex  I  to  Directive  91/414/EEC,  submit  a  reasoned
opinion to the Commission and the Member States on that active substance and on:

(a)

existing  MRLs  for  that  active  substance  set  out  in  Annex  II  or  III  to  this
Regulation;

(b)

the necessity of setting new MRLs for that active substance;

(c)

specific  drying  and  processing  factors  for  that  active  substance  that  may  be
included in Annex V;

15

OJ L 224, 18.8.1990, p.1 - Council Regulation (EEC) N° 2377/90 of the 26 June 1990 laying down a
Community procedure for establishment of maximum residue limits of veterinary medicinal products in
foodstuffs of animal origin as last amended by  Commission  Regulation  (EEC)  N  °61/2003,  OJ  L  11,
16.1.2003, p.12

28

                                                
(d) MRLs which the Commission may consider including in Annex II and on those
MRLs which may be deleted  or  reduced  to  0.01  mg/kg,  related  to  that  active
substance. 

SECTION 2
MRLS AND APPLICATIONS FOR AUTHORISATION OF PLANT PRODUCTION
PRODUCTS UNDER DIRECTIVE 91/414/EEC

Article 22
MRLs corresponding to applications for authorisation and provisional authorisation of plant
protection products under Directive 91/414/EEC

Where a Member State, in accordance with Directive 91/414/EEC, receives an application to
grant an authorisation or a provisional authorisation for the use of a plant protection product,
the Member State shall consider whether as a result of such use, an existing MRL set out in
Annex II or III to this Regulation needs to be modified or whether it is necessary to set a new
MRL. 

Where  a  Member  State  considers  that  the  setting,  modification  or  deletion  of  an  MRL  is
necessary,  that  Member  State  shall  submit  an  application  for  setting,  modifying  or  deleting
the MRL under Chapter II of this Regulation.

Article 23
Inclusion of new or modified MRLs in Annexes II and III

Where a new or modified MRL is set following an application by a Member State as

1.
provided for in Article 22, the new or modified MRL shall be listed:

(a)

in Annex II to this Regulation where the substance has been included in Annex
I to Directive 91/414/EEC; or

(b)

in other cases, as a temporary MRL, in Annex III to this Regulation.

2.
Where a temporary MRL is included in Annex III to this Regulation as provided for in
paragraph 1(b), it shall not be maintained in that Annex for a period exceeding one year from
the  date  of  the  inclusion  or  non-inclusion  in  Annex  I  to  Directive  91/414/EEC  of  the  active
substance concerned.

SECTION 3
 SETTING TEMPORARY MRLS 

Article 24
Information to be provided by the Member States on national MRLs

Where for an  active substance of  a plant protection product, not  yet included in Annex  I  to
Directive 91/414/EEC:

29

(a)

(b)

an MRL is not set out in Annex II to this Regulation for a certain commodity
set out in Annex I to this Regulation and

a Member State has set, by 30 June 2004 at the latest, a national MRL for an
active  substance  on  the  commodity  referred  to  in  (a),  based  on  the  use  of  a
plant protection product on its territory

the  Member  State  concerned  as  referred  to  under  (b)  shall  notify  the  Commission  and  the
Authority,  in  a  format  and  by  a  date  to  be  established  in  accordance  with  the  procedure
referred to in Article 49(2) of the following:

(c)

the national MRL referred to under (b);

(d)

the GAP; 

(e)

data on supervised trials;

(f)

the  acceptable  daily  intake  and,  if  relevant,  the  acute  reference  dose  used  for
the national risk assessment, as well as the outcome of the assessment.

Article 25
Opinion of the Authority on data underlying national MRLs

The  Authority  shall  compile  lists  of  the  national  MRLs  notified  in  accordance  with

1.
Article 24and use them as a basis to provide a reasoned opinion to the Commission on:

(a)

a list of temporary MRLs that may be included in Annex III;

(b)

a list of active substances that may be included in Annex IV.

In  preparing  the  opinion  referred  to  in  paragraph  1,  the  Authority  shall  take  into

2.
account:

(a)

the following MRLs:

(i) MRLs set out in Annex II to Directive 76/895/EEC;

(ii)

national  MRLs  set  by  Member  States  by  30  June  2004  at  the  latest,  as
referred to in Article 24;

(iii) MRLs adopted by the Codex Alimentarius Commission;

(b) MRLs listed in Annexes I, II and III of Regulation (EEC) N° 2377/9015;

(c)

the  scientific  and  technical  knowledge  available,  and  in  particular  data
submitted by the Member States on:

(i)

the toxicological assessment, including potential excess of the acceptable
daily intake and, if applicable, of the acute reference dose;

(ii)

the GAP;

30

(iii)

the  data  on  supervised  trials  used  by  Member  States  to  establish  the
national MRL.

Article 26
Setting of temporary MRLs

Taking  into  account  the  opinion  of  the  Authority,  and  in  accordance  with  the  procedure
referred to in Article 49(2), temporary MRLs for the active substances referred to in Article
24 may be included in Annex III, or, as appropriate the active substance may be included in
Annex IV. 

Article 27
Simplified procedure for setting temporary MRLs in certain circumstances

Temporary  MRLs  may  be  included  in  Annex  III  in  accordance  with  the  procedure

1.
referred to in Article 49(2) in the following circumstances: 

(a)

in exceptional cases, in particular where pesticide residues may arise as a result
of environmental or other contamination; 

(b) where the products concerned constitute a very minor component of the diet of

European consumers or

(c) where  the  products  concerned  constitute  a  minor  component  of  international

trade.

The inclusion of temporary MRLs as referred to in paragraph 1, shall take into account
2.
the opinion of the Authority, monitoring data and an assessment demonstrating that there are
no unacceptable risks to consumers or animals. 

The continued validity of those temporary MRLs shall be re-assessed at least once every 10
years and any such MRLs shall be modified or deleted from Annex III as appropriate.

SECTION 4
HONEY

Article 28
Setting MRLs for pesticide residues in honey

MRLs may be set for pesticide residues in honey, as defined in Annex I of Council Directive
2001/110/EC16, and included in Annex III of this Regulation on the basis of monitoring data
and taking into account a reasoned opinion of the Authority, in accordance with the procedure
referred to in Article 49(2).

The continued validity of those MRLs shall  be  re-assessed  at least once  every  10  years and
any such MRLs shall be modified or deleted from Annex III, as appropriate. 

16

OJ L 10, 12.1.2002, p. 47.

31

                                                
SECTION 5
IMPORT TOLERANCES

Article 29
Setting import tolerances 

Applications for import tolerances may be made by the Member States or the parties referred
to in points (b) and (c) of  Article  4 and shall be made  in accordance with the provisions of
Chapter II.

SECTION 6
INFORMATION TO BE SUBMITTED BY MEMBER STATES AND DATABASE

Article 30
Information to be submitted by the Member States 

Member  States  shall  submit  to  the  Authority  details  of  the  GAPs  and  any  dietary  intake
information necessary for the assessment of the safety of an MRL.

Article 31
Database of the Authority on MRLs

Without prejudice to the applicable provisions of Community and  national  law on  access to
documents,  the  Authority  shall  develop  and  maintain  a  database,  accessible  to  the
Commission and to the competent  authorities  of  the  Member  States,  containing  the  relevant
scientific  information  and  GAPs  relating  to  the  MRLs,  the  active  substances  and  the
processing factors set  out in Annexes  II,  III,  IV  and  V.  In  particular  it  shall  contain  dietary
intake assessments, processing factors and toxicological endpoints.

Chapter V
Official controls, monitoring, fees, reports and penalties

SECTION 1
OFFICIAL CONTROLS AND MONITORING OF MRLS AND ACTIVE SUBSTANCES

Article 32
Official controls, monitoring and fees 

1.
Member  States  shall  carry  out  official  controls  on  pesticide  residues  in  order  to
enforce  compliance  with  this  Regulation,  in  accordance  with  the  provisions  of  Regulation
(EC) No XXX/2003 of the European Parliament and of the Council 13. 

32

The official controls on pesticide residues shall consist of sampling at the point of supply and
subsequent  chemical  analysis  of  the  samples  and  identification  of  the  pesticides  in  the
samples. The point chosen should allow for potential enforcement action.

2.
Member  States  shall  carry  out  monitoring  on  pesticide  residues  in  particular,  at  the
point  of  supply  to  the  consumer.  Such  monitoring  shall  be  in  addition  to  any  similar
monitoring required under Council Directive 96/23/EC17. 

3.
Member States shall establish fees to cover the costs of the official controls referred to
in  paragraph  1  in  accordance  with  the  principles  established  under  Regulation  (EC)  No
XXX/200313. 

Article 33
Sampling 

Each  Member  State  shall  take  samples  in  a  sufficient  number  and  across  a  range  of
1.
products and  geographical  areas  to assure  that  the results  are  representative  of their  market,
reflecting  as  appropriate,  the  respective  contributions  of  national,  Community  and  third
country produce to its market. 

2.
The sampling methods necessary for carrying out such monitoring of products, other
than  those  provided  for  in  Commission  Directive  2002/63/EC18,  shall  be  determined  in
accordance with the procedure referred to in Article 49(2).

Article 34
Methods of Analysis

1.
Detailed  rules  on  methods  of  analysis  for  pesticide  residues  including  specific
validation criteria and quality control procedures may be adopted and set out in Annex VII in
accordance with the procedure referred to in Article 49(2). 

The methods of analysis of pesticide residues shall comply with the criteria set out in

2.
Annex II to Regulation (EC) No 200313/XXX. 

All laboratories analysing samples for the official controls and monitoring on pesticide

3.
residues shall participate in the Community Proficiency Test. 

SECTION 2
NATIONAL CONTROL AND MONITORING PROGRAMMES

Article 35
The obligations of Member States relating to national control and monitoring programmes
for pesticide residues

Member  States  shall  establish  annually  national  control  and  monitoring  programmes

1.
for pesticide residues for the following calendar year.

17

18

OJ L 125, 23.5.1996, p. 10.
OJ L 187, 16.7.2002, p. 30.

33

                                                
Those  annual  national  control  and  monitoring  programmes  shall  comply  with  Article  43  of
Regulation (EC) No XXX/200313 on multi-annual control plans for pesticide residues. 

Those programmes shall specify at least the following:

(a)

the products to be sampled;

(b)

the number of samples to be taken and analyses to be carried out;

(c)

the pesticide residues to be analysed;

(d)

the criteria applied in drawing up such programmes, including:

(i)

the pesticide-product combinations to be selected; 

(ii)

the number of samples to be taken in relation to the domestic production;
and

(iii) consumption of the products.

Member States shall submit their annual national control and monitoring programmes

2.
for pesticide residues, to the Commission and to the Authority by 31 December each year.

Member States shall participate in the Community Monitoring Programme as provided

3.
for in Article 36.

SECTION 3
COMMUNITY MONITORING PROGRAMME

Article 36
Community Monitoring Programme

1.
The  Commission  and  the  Authority  shall  prepare  a  co-ordinated  Community
monitoring programme, identifying specific samples to be included in the national control and
monitoring programmes, and taking into account problems that have been identified regarding
compliance with the MRLs set out in this Regulation.

The  Authority  shall  submit  to  the  Commission  by  1  May  each  year,  an  opinion
2.
concerning  the  co-ordinated  Community  monitoring  programme  for  the  following  calendar
year,  including  its  opinion  on  the  specific  samples  which  shall  be  included  in  the  national
control and monitoring programmes. 

3.
The  Community  monitoring  programme  shall  be  adopted  in  accordance  with  the
procedure referred to in Article 49(2), and shall be presented to the Committee referred to in
Article 49(1), by 1 July each year for the following calendar year . 

34

SECTION 4
INFORMATION BY THE MEMBER STATES AND COMMUNITY ANNUAL REPORT 

Article 37
Information by the Member States

In addition to the information to be submitted by the Member States to the Authority and the
Commission  in  the  annual  reports  provided  for  in  Article  44  of  Regulation  (EC)  No
XXX/200313, Member States shall submit the following information to the Commission, the
Authority and the other Member States by 31 December each year:

(a)

(b)

(c)

(d)

the  results  of  the  official  controls  and  monitoring  as  provided  for  in  Article
32(1) and (2); 

the  results  of  the  analyses  of  the  samples  taken  during  the  current  year  for
pesticide  residues  in  products  of  plant  origin  under  their  national  control  and
monitoring programmes as referred to in Article 35 and under the Community
monitoring programme as referred to in Article 36; 

the  LODs  applied  in  the  national  control  and  monitoring  programme  as
referred to in Article 35 and under the Community monitoring programme  as
referred to in Article 36;

details  of  the  participation  of  the  analytical  laboratories  in  the  Community
proficiency  tests  and  other  proficiency  tests  relevant  to  the  pesticide-product
combinations sampled in the national control and monitoring programme; 

(e)

details  of  the  accreditation  of  the  analytical  laboratories  as  provided  for  in
Regulation (EC) No XXX/200313.

Article 38
Format for the submission of information to the Authority 

The  Authority  may  designate  a  format  for  the  submission  of  information  to  be
submitted by the Member States as provided for in Article 37.

The Authority shall collate and combine the information referred to in Article 37. 

Article 39
 The Community Annual Report

The Authority shall complete a Community Annual Report. 

The Authority shall include information on the following in the Community Annual
Report:

(a)

an  analysis  of  any  possible  significance  of  discrepancies  in  the  results  of  the
monitoring provided for in Article 32 (2);

1.

2.

1.

2.

35

(b)

a report to the Commission on the the MRLs that were exceeded, together with
any  appropriate  observations  regarding  the  need  to  modify  such  MRLs,  in
relation to the underlying GAPs;

(c)

a report on any acute or chronic risks to the health of consumers.

Where  a  Member  State  has  not  provided  complete  information  by  31  December  in
accordance  with  Article  37,  the  Authority  may  disregard  the  information  from  that
Member State when compiling the Community Annual Report.

The Authority shall submit the Community Annual Report to the Commission by 30
April of the following year.

The  Commission  may  designate  a  format  for  the  submission  of  the  Community
Annual Report by the Authority.

The Authority shall publish the Community Annual Report.

3.

4.

5.

6.

Article 40
Submission of the Community Annual Report to the Committee

The Commission shall submit the Community Annual Report to the Committee referred to in
Article 49(1) before 31 January each year, for review and recommendations on any necessary
measures  to  be  taken  regarding  reported  possible  infringements  of  the  MRLs  set  out  in
Annexes II and III.

SECTION 5
PENALTIES

Article 41
Penalties

The Member  States shall lay down the rules on  penalties  applicable  to  infringements  of  the
provisions  of  this  Regulation  and  shall  take  all  measures  necessary  to  ensure  that  they  are
implemented. The penalties provided for must be effective, proportionate and dissuasive. The
Member  States  shall  notify  those  provisions  and  any  subsequent  amendment  to  the
Commission without delay.

Chapter VI
Emergency measures

Article 42
Emergency measures and opinion by the Authority 

1.

Articles 53 and 54 of Regulation (EC) 178/2002 shall apply where as a result of new
information or of a reassessment of existing information, pesticide residues or MRLs
covered  by  this  Regulation  may  endanger  human  or  animal  health  requiring
immediate action.

36

2.

3.

The  Commission  shall  notify  without  delay  the  Authority  of  any  emergency
measures taken.

The  Authority  shall  complete  a  full  assessment  of  the  risks  and  shall  provide  its
opinion to the Commission on those risks within 15 days of the date of notification
by the Commission.

Chapter VII
Community harmonised system on MRLs

Article 43
Harmonised system on MRLs for pesticide residues

A  harmonised  system  for  MRLs  in  the  field  of  pesticide  residues  shall  be  established  at
Community level, including:

(a)

(b)

(c)

(d)

a database for Community legislation on MRLs of pesticide residues and for making
such information publicly available;

Community proficiency tests as referred to in Article 34 (3) and 37(d);

studies necessary for the preparation of legislation on pesticide residues;

studies  necessary  for  the  estimation  of  the  exposure  of  consumers  and  animals  to
pesticides residues.

Article 44
Community contribution to the harmonised system on MRLs for pesticide residues

The Community may make a financial contribution up to 100% of the cost of the harmonised
system as provided for in Article 43.

The  appropriations  for  that  system  shall  be  decided  each  year  as  part  of  the  budgetary
procedure.

Chapter VIII
Co-ordination of applications for MRLs

Article 45
Designation of national authorities

Each  Member  State  shall  designate  an  authority  to  co-ordinate  co-operation  with  the
Commission, the Authority, other Member States, manufacturers, producers, and growers for
the purposes of this Regulation. 

Each Member State shall inform the Commission and the Authority of the name and address
of the designated authority.

37

Article 46
Co-ordination by the Authority of applications for MRLs

The Authority shall:

co-ordinate with the rapporteur Member State designated in accordance with Directive

(a)
91/414/EEC for an active substance;

(b)
co-ordinate  with  applicants  referred  to  in  Article  4  and  the  Member  States  and  the
Commission  regarding  applications  on  MRLs  and  import  tolerances  covered  by  this
Regulation;

(c)

ensure all necessary contacts with interested parties as referred to in Article 4(b);

complete  the  scientific  evaluations  of  dossiers  and  applications  for  the  inclusion  of

(d)
MRLs in the lists in Annexes II and III.

Article 47
Rapporteur Member State and fees for applications for MRLs

Rapporteur  Member  States  may  establish  a  regime  containing  an  obligation  for

1.
applicants to pay a fee for the administrative costs for the evaluation of their applications.

2.

(a)

The Rapporteur Member States shall ensure that the fee referred to in paragraph 1:

is established in a transparent manner;

corresponds  to  the  real  cost  of  the  examination  and  administrative  treatment  of  the

(b)
applications;

is  received  by  the  designated  authority  in  the  Rapporteur  Member  State  as  provided

(c)
for in Article 45;

is  used  to  finance  exclusively  the  costs  actually  incurred  for  the  evaluation  and

(d)
administrative treatment of the application.

However,  a  scale  of  fixed  charges  based  on  average  costs  for  the  treatment  of  applications
referred to in paragraph 1, may be established by Rapporteur Member States.

Chapter IX
Implementation

Article 48
Scientific opinion of the Authority

The Commission may consult the Authority for a scientific opinion on any measure related to
the  assessment  of  risks  in  the  framework  of  the  implementation  of  this  Regulation.  The
Commission may specify the time limit within which such an opinion shall be provided.

38

Article 49
Committee Procedure

1.
The Commission shall be assisted by the Standing Committee on the Food Chain and
Animal Health, instituted by Article 58 of Regulation No 178/2002 (hereinafter referred to as
“the Committee”.)

Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC

2.
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 three months.

Article 50
Implementing measures

In  accordance  with  the  procedure  referred  to  in  Article  49  (2)  the  following  shall  be
established or may be amended:

(a)

implementing measures to ensure the uniform application of this Regulation;

(b)

the  dates  in  Article  24(1)(b),  Article  25(2)(a)(ii),  Article  35(2),  Article  36(2)
and (3), Article 37, Article 39(3) and Article 40 

(c) Annexes  I  to  VII,  as  a  result  of  developments  in  scientific  or  technical

knowledge;

(d)

technical guidance documents to assist in the application of this Regulation ;

(e) methods for analysis and assessment;

(f)

quality control procedures;

(g)

detailed rules concerning the scientific data  required for the setting of MRLs;
the  opinion  of  the  Authority  shall  be  taken  into  account  when  adopting  such
rules.

Article 51
Report on implementation of this Regulation

Not  later  than  10  years  after  the  entry  into  force  of  this  Regulation,  the  Commission  shall
forward to the European Parliament and to the Council a report on its implementation and any
appropriate proposals.

39

Chapter X
Final Provisions

Article 52
Repeal

Directives  76/895/EEC,  86/362/EEC,  86/363/EEC  and  90/642/EEC  are  repealed  with  effect
from 1 January 2005.

References to the repealed Directives shall be construed as references to this Regulation and
shall be read in accordance with the correlation table in Annex VIII.

Article 53
Transitional Measures

Where it is necessary in order to allow for the normal marketing, processing and consumption
of  the  harvested  products,  taking  their  normal  shelf  life  into  account,  in  order  to  safeguard
legitimate  expectations,  transitional  measures  may  be  laid  down  for  the  implementation  of
certain MRLs provided for in Articles 18, 19, 23, 26, 27, 28 and 29. 

Those measures which shall be without prejudice to the obligation to ensure a high level of
consumer protection shall be adopted in accordance with the procedure referred to in Article
49(2).

Article 54
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 

It  shall  apply  from  1  January  2005  for  fresh  products  and  from  1  July  2005  for  stored
products. 

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

40

ANNEXES (I-VII to be established by comitology procedure) 

ANNEX I:
Groups of commodities of plant and animal origin with examples of products
in  those  groups  and  the  parts  of  those  products  to  which  MRLs  apply  -  including  animal
feedstuffs as referred to in Article 1. This annex comprises the existing commodities listed in
the annexes to the original four directives but also includes a new commodity - honey.

41

ANNEX II: MRLs for products of plant and animal origin, (in the first instance transferred)
from the Annexes of 86/362/EEC, 86/363/EEC and 90/642/EEC as referred to in Article 18.

42

ANNEX III: Temporary MRLs for active substances for which a decision on inclusion in or
exclusion from Annex I to Directive 91/414/EC has not yet been taken, including remaining
MRLs  in  the  Annex  to  Directive  76/895/EEC  as  well  as  hitherto  unharmonised  national
MRLs,  as  referred  to  in  Article  24  and  MRLs  set  according  to  the  simplified  procedure
referred to in Article 27.

43

ANNEX IV: List  of  active  substances  of  plant  protection  products,  evaluated  under
Directive 91/414/EEC and for which it is agreed by the Standing Committee that MRLs are
not required (as referred to in Article 20).

44

ANNEX V:
Specific concentration and dilution factors fixed after an evaluation as part of
the  91/414/EEC  dossier  or  developed  after  a  91/414/EEC  decision  has  been  adopted  by  the
Commission (as referred to in Article 14).

45

ANNEX VI: Guidelines for the generation of data concerning residues as provided in Annex
II part A, section 6 and Annex III, part A, section 8 of Directive 91/414/EEC concerning the
placing of plant protection products on the market 

46

ANNEX VII: Analytical methods, quality control procedures (as referred to in Article 35).

47

ANNEX VIII: Correlation Table

This Regulation Directive76/895 Directive 86/362 Directive 86/363 Directive 90/642

Article 1

Article1(2)

Article 1(1)

Article 1(1)

Article 1(1)

Article 2(2) 

Article 9(2)

Article 1(4)

Article 1(4)

Article 1(4)

Article 2(3)

Article 9(1)

Article 1(3)

Article 1(3)

Article 1(3)

Article 3

Article 2

Article 2

Article 2

Article 2

Article 4

Article 5

Article 6

Article 7

Article 8

Article 9

Article 10

Article 11

Article 12

Article 13(1)

Article 4(1)

Article 4(1)

Article 3(1)

Article 13(2 a) Article 3(1)

Article 3(2)

Article 3(2)

Article 5

Article 13(2 b)

Article 3(1)

Article 3(1)

Article 3(1)

Article 14

Article 15

Article 16

Article 17

Article 18

Article 19

Article 20

Article 21

Article 4 (2)

Article 4 (2)

Article 3(2)

Article 4(3)

Article 4(3)

Article 3(3)

48

Article 22

Article 23

Article 24(2)

Article 5

Article 10

Article 10

Article 7

Article 25

Article 26

Article 27

Article 28

Article 29

Article 30

Article 31

Article 32(1)

Article 6(1)

Article 4(4)

Article 4(4)

Article 3(4)

Article 33(2)

Article 6(2)

Article 8(1)

Article 8(1)

Article 6(1)

Article 34(1)

Article 6(1)

Article 34(2)

Article 6(2)

Article 8(1)

Article 8(1)

Article 6(2)

Article 7(1)

Article 7(2a)

Article 7(2b)

Article 4(1)

Article 4(2a)

Article 4(2b)

Article 7(3)

Article 7(1)

Article 4(3)

Article 7(3)

Article 7(2)

Article 4(3)

Article 7(3)

Article 7(3)

Article 7(5)

Article 7(3)

Article 4(3)

Article 4(3)

Article 4(5)

Article 4(3)

Article 3(2)
Article 4(1)

Article 9(1)

Article 9(1)

Article 8

Article 35(1)

Article 35(2)

Article 36(1)

Article 37

Article 38

Article 39(2b)

Article 39(6)

Article 40

Article 41

Article 42(1)

Article 43

Article 44

49

Article 7

Article 7
Article 8

Article 9(2)(3)
Article 11
Article 12
Article 13

Article 9(2)
Article 11
Article 12
Article 13

Article 8(2)(3)
Article 9
Article 10

Article 45

Article 46

Article 47

Article 48

Article 49

Article 50

Article 51

Article 52

Article 53

50

LEGISLATIVE FINANCIAL STATEMENT

Policy area(s): Health an consumer protection

Activities:  Setting  and  controlling  maximum  levels  of  pesticides  residues  in  products  of
plant and animal origin, monitoring the residue levels in food and feed. 

Title of action: Regulation of the European Parliament and of the Council on maximum levels of
pesticides residues in products of plant and animal origin

1.

BUDGET LINE(S) + HEADING(S)

B-1-333  and  B-1333A  Phytosanitary  measures.  This  budget  line  deals  with  plant
health  and  phytosanitary  issues.  Pesticides  residues  measures  form  a  part  of  the
overall expenditure of this budget line.

2.

OVERALL FIGURES 

2.1.

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

To be fixed annually - generally about 0.3M€, reducing to 0.2M€ by 2008.

2.2.

Period of application:

The activity will start in January 2003

2.3.

Overall multiannual estimate of expenditure:

(a)

Schedule  of  commitment  appropriations/payment  appropriations 
intervention) (see point 6.1.1)

(financial

Not applicable.

(b)

Technical  and  administrative  assistance  and  support  expenditure  (see  point  6.1.2);
€ million (to three decimal places)

Commitments

0.300

0.300

0.250

0.200

0.200

0.200

1.450

Payments

0.300

0.300

0.250

0.200

0.200

0.200

1.450

Subtotal a+b

Commitments

Payments

0.300

0.300

0.250

0.200

0.200

0.200

1.450

0.300

0.300

0.250

0.200

0.200

0.200

1.450

(c)

Overall  financial  impact  of  human  resources  and  other  administrative  expenditure
(see points 7.2 and 7.3)

51

Commitments/
payments

0.738

0.738

0.738

0.738

0.738

0.738

0.738

TOTAL a+b+c

0.768

0.768

0.768

0.768

0.768

0.768

0.768

Commitments

0.768

0.768

0.768

0.768

0.768

0.768

0.768

Payments

0.768

0.768

0.768

0.768

0.768

0.768

0.768

2.4.

Compatibility with financial programming and financial perspective

[X] Proposal is compatible with existing financial programming.

2.5.

Financial impact on revenue:i

[X] Proposal  has  no  financial  implications  (involves  technical  aspects  regarding

implementation of a measure)

3.

BUDGET CHARACTERISTICS

Type of expenditure

New

EFTA
contribution

Contributions
from applicant
countries

Comp

Non-diff

NO

NO

NO

Heading in
financial
perspective

Part A, B-
1333

4.

LEGAL BASIS 

Treaty articles 37, 95 and 152.4(b) of the Treaty

5.

5.1.

DESCRIPTION AND GROUNDS

Need for Community intervention19

5.1.1. Objectives pursued

The  main  objective  of  the  proposal  is  to  ensure  that  the  presence  of  residues  of
pesticides in or on food or feed in the Community, whether domestically produced,
or imported:

– 

– 

does not present an unacceptable risk for human or animal health;

is not used a non-tariff trade barrier;

This will be ensured by setting, at Community level, acceptable maximum levels of
residues for each active substance and each product of plant or animal origin where
residues might be likely to occur and to set a default level at the limit of analytical

19

For further information, see separate explanatory note.

52

                                                
determination  for  all  other  combinations.  The  levels  shall  be  set  following  an
assessment of risks to the consumer. It also

– 

– 

brings  coherence  to  community  legislation  in  a  “farm  to  table”  approach”  by
clarifying certain procedural aspects, inter alia with the provisions  of Council
Directive  91/414/EEC  on  the  placing  of  plant  protection  products  on  the
market;

takes into account the entry into force of the European Food Safety Authority
(hereunder  called  “the  Authority”  which  will  be  responsible  for  the  risk
evaluation of residues.

The proposal lays down a procedure by which the Commission will set the maximum
levels  and  requires  that  the  Authority  will  have  a  key  role  in  forwarding  scientific
assessments and opinions to the Commission.

On  the  basis  of  opinions  forwarded  by  the  Authority,  the  Commission  will  take
decisions through a comitology procedure.

A  secondary  objective  of  the  proposal  is  to  consolidate  four  existing  Council
Directives  on  the  setting  of  maximum  levels  for  pesticides  residues  in  products  of
plant  and  animal  origin.  In  so  doing,  it  includes  the  existing  MRLs  fixed  in  those
directives  and,  for  the  currently-non-harmonised  MRLs,  it  sets  temporary  MRLs
based  on  those  currently  existing  at  national  level,  and  pending  the  outcomes  of
evaluations undertaken in the framework of Directive 91/414/EEC.

The proposal also provides for:

-
procedures for the monitoring and control of the levels of pesticides residues in
products  of  plant  and  animal  origin  in  the  Member  States  as  well  as  the  collation,
analysis and publication of the results of the monitoring;

5.1.2. Measures taken in connection with ex ante evaluation 

Not applicable.

5.1.3. Measures taken following ex post evaluation

The existing pesticides residues legislation formed part of the SLIM exercise in 2001
and the current proposal takes the SLIM recommendations into account.

5.2.

Action envisaged and budget intervention arrangements

General objectives: The general objective is to harmonise all MRLs at Community
level  whilst  ensuring  a  high  level  of  protection  of  the  health  of  consumers  and
minimising trade problems.

Performance indicators selected:

Output indicators: number of MRLs set, numbers of meetings held and applications
for  MRLs/renewal/  modification/  suspension/  revocation,  numbers  of  samples
analysed in the annual monitoring programmes.

53

Impact indicators: number of authorisations for individual crops (under 91/414/EEC)
granted,  renewed,  modified,  suspended  or  revoked;  number  of  interventions  by
trading partners in SPS;  numbers of trade  problems  signalled  by  Member  States  or
other stakeholders; rates of excedences of MRLs in annual monitoring programmes.

Details  and  frequency  of  planned  assessments:  Annual  assessments  of  compliance
and  consumer  exposure  will  be  made.  For  MRLs  based  on  monitoring  data,
assessments will be made at least once every ten years, All MRLs will be reassessed
based on the outcomes of evaluations under Directive 91/414/EEC and the changing
uses  of  substances  resulting  from  those  evaluations.  The  Regulation  itself  will  be
assessed after 10 years.

Assessment  of  the  results  obtained:  the  measures  procedure  provided  for  by  the
Regulation guarantee a high level of protection for human and animal health and the
environment while preventing distortion of trade in the single market.

Target population: consumers  are the  ultimate beneficiaries.  Other beneficiaries are
producers and traders.

5.3.

Methods of implementation

The  work  under  the  Regulation  will  be  shared,  as  under  Directive  91/414/EEC
between the Commission, the Authority and the Member States. For each individual
substance used  in the  Community,  a  Rapporteur  Member  has  or  will  be  nominated
under Directive 91/414/EEC. Having the 'Community expertise' for that substance, it
is envisaged that they will also act in this capacity in the area of residues and will be
permitted to recover costs by levying fees upon interested parties for their work. The
recommendations of the Rapporteur Member States will be assessed by the Authority
which will then deliver an opinion to the Commission. For substances not used in the
Community  but  where  residues  might  be  present  in  or  on  imported  products,  the
Authority should act as Rapporteur.

It  is  envisaged  that  the  work  of  the  Authority  in  this  area  will  require  12  full-time
staff. Because of the significant increase in workload in this area in the coming years,
it  is  not  expected  that  the  resource  needs  within  the  Commission  will  change  as  a
result of the additional support to be provided by the authority.

6.

FINANCIAL IMPACT

6.1.

Total financial impact on Part B - (over the entire programming period)

6.1.1.

Financial intervention

None

6.1.2.

Technical  and  administrative  assistance,  support  expenditure  and  IT  expenditure
(commitment appropriations)

2003

2004

2005

2006

2007

2008

Total

1) 
administrative assistance

Technical 

and

54

Technical 

a) 
offices

assistance

b)  Other 
administrative assistance:

technical 

and

- intra muros:

- extra muros:

of  which  for  construction
and 
of
maintenance 
computerised  management
systems

0.075

0.075

0.050

0.075

0.075

0.050

Subtotal 1

0.075

0.075

0.050

2) Support expenditure

0.200

0.200

0.200

a) Studies

0.165

0.165

0.140

0.140

0.140

0.140

0.890

b) Meetings of experts

0.060

0.060

0.060

0.060

0.060

0.060

0.360

c) Information and
publications

Subtotal 2

0.225

0.225

0.200

0.200

0.200

0.200

1.250

TOTAL 0.300

0.300

0.250

0.200

0.200

0.200

1.450

6.2.

Calculation  of  costs  by  measure  envisaged  in  Part  B  (over  the  entire
programming period)20

(Where  there  is  more  than  one  action,  give  sufficient  detail  of  the  specific  measures  to  be
taken for each one to allow the volume and costs of the outputs to be estimated.)

Breakdown 

Commitments (in € million to three decimal places)

Type
of outputs
(projects, files )

Number of
outputs

Average unit
cost

(total for years
1…n) 

Total cost

(total for years
1…n)

1

2

3

4=(2X3)

Action 1

- Measure 1

Action 2

- Measure 1

etc.

TOTAL COST

If necessary explain the method of calculation

20

For further information, see separate explanatory note.

55

                                                
7.

IMPACT ON STAFF AND ADMINISTRATIVE EXPENDITURE 

7.1.

Impact on human resources

Staff to be assigned to management of the
action using existing and/or additional
resources

Number of
permanent posts

Number of
temporary posts

3

1

1

5

Description of tasks deriving from the
action

Preparation of legislation,
development of policy, organisation of
meetings etc

Total

3

1

1

5

Types of post

Officials 
temporary staff

or

A

B

C

Other human resources

Total

7.2.

Overall financial impact of human resources

Type of human resources

Amount (€)

Method of calculation * 

Officials

Temporary staff

540,000€

5* 108,000€

Other human resources - (specify budget line)

The amounts are total expenditure for twelve months.

Total

540,000€

7.3.

Other administrative expenditure deriving from the action

Budget line - (number and heading)

Overall allocation (Title A7)

A0701 – Missions

A07030 – Meetings

A07031 
Committee on the Food Chain and Animal Health)1

–  Compulsory 

committees 

(Standing

Amount M€

Method of calculation

0.024

12 missions/year x 2 A-staff x 1000€ =

0.039

10 per year; 650€x6 experts = 3900€x10

0.059

Six meetings/yr x 15 delegates x 650€

Two  1-day  meetings  per  year;  20  delegates  x
650€ = 13000€x2

One every three years - cost spread over three
years. Typically 0.06M€/3

A07032  –  Non-compulsory  committees  (Consultative
committee) 1

A07040 – Conferences

A0705 – Studies and consultations

Other expenditure (specify)

Information systems (A-5001/A-4300)

Other expenditure - Part A (specify)

0.026

0.02

-

-

-

-

Total (M€)

0.198

56

The amounts are total expenditure for twelve months.

1 Specify the type of committee and the group to which it belongs.

I.

II.

III.

Annual total (7.2 + 7.3)

Duration of action

€ 738,000

Open, first six years 2003-2008 are costed

Total cost of action (I x II)

€ 4,428,000

The  needs  for  human  and  administrative  resources  shall  be  covered  within  the  allocation
granted to managing DG in the current allocation procedure

8.

FOLLOW-UP AND EVALUATION

8.1.

Follow-up arrangements

See also point 5.2.

Member States are also obliged to take appropriate legal or administrative measures in case of
non-compliance  with  MRLs  and  communicate  those  measures  to  the  Authority  and  the
Commission.

8.2.

Arrangements and schedule for the planned evaluation

Regular,  annual  and  multiannual  evaluations  of  consumer  exposure  are  planned.  See  also
point 5.

9.

ANTI-FRAUD MEASURES

Not applicable for the financial risks encountered.

57

IMPACT ASSESSMENT FORM

THE IMPACT OF THE PROPOSAL ON BUSINESS WITH SPECIAL REFERENCE
TO SMALL AND MEDIUM-SIZED ENTERPRISES (SMEs)

TITLE OF PROPOSAL

Regulation  of  the  European  Parliament  and  of  the  Council  on  maximum  residue  levels  of
pesticides in products of plant and animal origin

DOCUMENT REFERENCE NUMBER

SANCO/2003/2555 rev. 9

THE PROPOSAL

1.

Taking  account  of  the  principle  of  subsidiarity,  why  is  Community  legislation
necessary in this area and what are its main aims?

Pesticides  residues  in  food  and  feed  pose  a  risk  to  human  and  animal  health.
Maximum levels of residues need to set to ensure that any such risks remain within
acceptable limits. These maximum levels need to be set at Community level to avoid
trade problems that can and do arise due to differences in national levels. The main
objective is to protect consumers while facilitating trade.

THE IMPACT ON BUSINESS

2.

Who will be affected by the proposal?

–  which sectors of business

Agricultural  producers  of  food  and  feed,  importers  of  food  and  feed  into  the
Community.

–  which  sizes  of  business  (what  is  the  concentration  of  small  and  medium-sized

firms)

No information is available on this point.

–  are there particular geographical areas of the Community where these businesses

are found

No.

3.

What will business have to do to comply with the proposal?

Ensure that food and feed placed on the market has been produced using authorised
'Good agricultural practices' with respect to pesticides.

4.

What economic effects is the proposal likely to have?

58

–  on employment

None.

–  on investment and the creation of new businesses

None.

–  on the competitiveness of businesses

None

5.

Does the proposal contain measures to take account of the specific situation of small
and medium-sized firms (reduced or different requirements etc)?

No but it allows the possibility that data requirements could be reduced for food and
feed commodities that are minor in the diet and in trade.

IMPACT ON TRADING PARTNERS

Any  MRLs  being  adopted  under  the  Regulation  will  have  to  be  notified  under  the
SPS  procedures  of  the  World  Trade  Organisation.  The  Commission  proposes  to
notify, in general terms during the fiest semester of 2003, the measures provided for
in this regulation. In 2002 the Commission notified under the TBT procedures of the
WTO, a list of 325 substances that will be withdrawn from the market in 2003 and
where MRLs would be set at 0.01 mg/kg in 2005. It shall continue to notify any other
substances  to  be  withdrawn.  This  is  considered  sufficient  time  to  permit  trading
partners  to  either  change  their  agricultural  use  f  pesticides  or  to  generate  the  data
necessary to set a higher MRL.

No  impact  is  expected  on  trading  partners  from  developed  countries  because  the
provisions of the annexes will in the first instance, reflect current provisions and they
generally have the capacity to produce the data required for MRLs. There may be an
impact  on trading  partners  in  developing  countries  and  strenuous  efforts  have  been
made  since  1999  to  reduce  or  even  eliminate  these  impacts.  A  major  project  'The
Pesticides  Initiative  Programme'  has  been  established  by  the  Commission  to  help
ACP  trading  partners  develop  infrastructure,  review  and  if  necessary  adapt  their
GAPs and to work together to generate the data necessary to set MRLs.

CONSULTATION

6.

List the organisations which have been consulted about the proposal and outline their
main views.

The  revised  proposal  is  based  on  the  consensus  recommendations  of  the  SLIM
exercise of 2001 which involved extensive discussions of an original proposal with
stakeholders including industry, workers, consumers, Member States, environmental
organisations  and  COLEACP  which  manages  the  Pesticide  Initiative  Programme
with  ACP  countries  on  behalf  of  the  Commission.  One  environmental  organisation
(PAN)  does  not  support  the  proposal  since  it  considers  that  if  a  product  can  be
produced  in  one  country  or  region  without  leaving  pesticide  residues,  then  no

59

pesticides  residues  should  be  permitted  on  that  product  regardless  of  its  origin.  In
practice, this would prevent most countries from producing any  food or feed at all.
Industry  (ECPA) considered  that  those  elements of  the  babyfood  directives  dealing
with  pesticides  should  be  brought  within  the  scope  of  the  proposal  but  has  not
insisted on this point. Member States were also consulted on several occasions in the
residues working  group of the Standing  Committee on the  Food  Chain  and Animal
Health and stakeholders were again consulted in the Consultative Committee on Fruit
and Vegetables.

The (almost-) consensus view is that the existing legislation needs to be consolidated
and amended without delay and that a temporary solution needs to be found for the
as-yet unharmonised pesticides. In addition, flexibility has to be introduced to allow
for the marketing of products with long shelf lives.

i

For further information, see separate explanatory note.

60