Common Position (EC) No 1/2005 of 19 July 2004 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to the adoption of a Regulation of the European Parliament and of the Council on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC
Date: 2004-07-19
Institutions: Council of the European Union
Subjects: European Food Safety Authority, animal nutrition, animal product, approximation of laws, crop production, foodstuff, foodstuffs legislation, human nutrition, pesticide residue

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I

(Information)

COUNCIL

COMMON POSITION (EC) No 1/2005

adopted by the Council on 19 July 2004

with a view to the adoption of Regulation (EC) No.../2005 of the European Parliament and of the
Council of... on maximum residue levels of pesticides in or on food and feed of plant and animal
origin and amending Council Directive 91/414/EEC

(Text with EEA relevance)

(2005/C 25E/01)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-
PEAN UNION,

Having regard to the Treaty establishing the European Com-
munity, and in particular Articles 37 and 152(4)(b) thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and
Social Committee (1),

Having consulted the Committee of the Regions,

Acting in accordance with the procedure laid down in Article
251 of the Treaty (2),

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 vegetables (3), Council Direc-
tive 86/362/EEC of 24 July 1986 on the fixing of
maximum levels
in and on
cereals (4), Council Directive 86/363/EEC of 24 July
1986 on the fixing of maximum levels for pesticide

for pesticide residues

(1) OJ C 234, 30.9.2003, p. 33.
(2) Opinion of the European Parliament of 20 April 2004 (OJ C 104 E,
30.4.2004), Council Common Position of 19 July 2004 and posi-
tion of the European Parliament of ………. (not yet published in
the Official Journal).

(3) OJ L 340, 9.12.1976, p. 26. Directive as last amended by Regu-

lation (EC) No 807/2003, (OJ L 122, 16.5.2003, p. 36).

residues in and on foodstuffs of animal origin (5), and
Council Directive 90/642/EEC of 27 November 1990 on
the fixing of maximum levels for pesticide residues in
including fruit and
and on products of plant origin,
vegetables (6), 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)

(3)

Differences in national maximum residue levels for pesti-
cides can pose barriers to trade in products included in
Annex I to the Treaty and products derived therefrom
between Member States and trade between third coun-
tries and the Community. Accordingly, in the interest of
free movement of goods and equal competition condi-
tions 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 trans-
law in the Member States. It is
position into national
therefore the most appropriate legal
instrument with
which to set MRLs for pesticides in products of plant
and animal origin, as its precise requirements are to be
applied at
the same time and in the same manner
throughout the Community and accordingly permit a
more efficient use of national resources.

(5) OJ L 221, 7.8.1986, p. 43. Directive as last amended by Directive

2004/61/EC.

(4) OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commis-

(6) OJ L 350, 14.12.1990, p. 71. Directive as last amended by Direc-

sion Directive 2004/61/EC, (OJ L 127, 29.4.2004, p. 81).

tive 2004/61/EC.

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(4)

(5)

(6)

(7)

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 organ-
isms 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 products,
in animals feeding on those products and in honey
produced by bees exposed to those substances.
It is
necessary to ensure that such residues should not be
levels presenting an unacceptable risk to
present at
humans and, where relevant, to animals.

Council Directive 91/414/EEC of 15 July 1991
concerning the placing of plant protection products on
the market (1) provides that Member States, when issuing
authorisations, are to prescribe that plant protection
products be used properly. Proper use includes the appli-
cation of the principles of good plant protection practice
as well as the principles of integrated control. 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.

products

containing

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
active
substances (2). At
the same time, many other active
substances are not currently authorised under Directive
91/414/EEC. The
in
products of plant and animal origin arising from
unauthorised use or from environmental contamination
from use in third countries should be carefully
or
controlled and monitored.

residues of active

substances

certain

2002 laying down the general principles and require-
ments of
food law, establishing the European Food
Safety Authority and laying down procedures in matters
of food safety (3).

(9)

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/or composite plant and animal
products intended for human consumption or animal
feed in which pesticide residues may be present, whilst
providing the basis for securing a high level of protec-
tion for human and animal health and the interests of
consumers. Such rules should include the establishment
of specific MRLs for each pesticide in food and feed
products and the quality of the data underlying these
MRLs.

(10) Notwithstanding the fact

that

the principles of

the
general food law laid down in Regulation (EC) No 178/
2002 apply only to feed for food-producing animals, in
view of the difficulty of segregating products to be used
as feed intended for animals which are not destined for
food production and in order to facilitate the control
and the enforcement of the provisions of this Regu-
lation, it is appropriate to apply them also to feed which
is not intended for food-producing animals. However,
this Regulation should not be an obstacle to the tests
which are necessary in order to assess pesticides.

It

(11) Directive 91/414/EEC lays down 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 humans or on animals. Pesti-
cide residues resulting from uses of plant protection
products may have harmful effects on the health of
consumers.
is therefore appropriate that rules for
MRLs for products intended for human consumption be
defined that are linked to the authorisation for use of
plant protection products as defined under Directive 91/
414/EEC. Similarly that Directive needs to be adapted in
order to take into account the Community procedure for
the
this Regulation.
Pursuant to that Directive, a Member State may be desig-
nated as rapporteur for the evaluation of an active
substance. It is appropriate to use the expertise in that
Member State for the purposes of this Regulation.

establishment of MRLs under

(8)

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

and of

(1) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commis-

sion Directive 2004/71/EC (OJ L 127, 29.4.2004, p. 14).

(12)

It
is appropriate that specific rules concerning the
control of pesticide residues be introduced to comple-
ment the general Community provisions on the control
of food and feed.

(2) OJ L 33, 8.2.1979, p. 36. Directive as last amended by Regulation

(3) OJ L 31, 1.2.2002, p. 1. Regulation as amended by Regulation (EC)

(EC) No 807/2003.

No 1642/2003 (OJ L 245, 29.9.2003, p. 4).

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(13)

for animal

Specific rules
feed including marketing,
storage of feed and feeding of animals are provided for
in Directive 2002/32/EC of the European Parliament and
of the Council of 7 May 2002 on undesirable substances
in animal feed (1). For certain products it is not possible
to determine whether they will be transformed into food
or animal feed. Therefore the pesticide residues in such
products should be safe both for human and, where rele-
vant, for animal consumption. Accordingly it is appro-
priate that the rules set out in this Regulation also apply
to those products in addition to the specific rules for
animal nutrition.

(14)

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

(15) Directive 76/895/EEC provides that Member States may
levels of MRLs than are currently
authorise higher
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.

(16)

for pesticides

The determination of MRLs
requires
lengthy technical consideration and includes an assess-
ment 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 pesti-
cides for which Community MRLs have not yet been set.

(17)

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

(18)

In exceptional circumstances, and in particular
for
unauthorised pesticides that may be present in the envir-
onment,
it is appropriate to permit the use of moni-
toring data in setting MRLs.

(19) MRLs for pesticides should be continually monitored
and should be changed to take account of new informa-
tion 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 appropriately low level to protect the consumer from
the intake of unauthorised or excessive levels of pesti-
cides residues. In order to facilitate control of residues of
pesticides, a default value is to be set for pesticide resi-
dues present in products or groups of products covered
by Annex I for which no MRLs have been established in
Annexes II or III, unless the active substance in question

(1) OJ L 140, 30.5.2002, p. 10. Directive as last amended by Commis-

sion Directive 2003/100/EC (OJ L 285, 1.11.2003, p. 33).

is listed in Annex IV. It is appropriate to set the default
value at 0,01 mg/kg and to provide for the possibility of
setting it at a different level for active substances covered
by Annex V, taking into account the routine analytical
methods available and/or consumer protection.

For food and feed produced outside the Community,
different agricultural practices as regards the use of plant
protection products may be legally applied, sometimes
resulting in pesticide residues differing from those
resulting from uses legally applied in the Community. It
is therefore appropriate that MRLs be 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.

Regulation (EC) No 178/2002 establishes procedures for
taking emergency measures in relation to food and feed
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 humans and, where relevant, animals be
assessed by the European Food Safety Authority ('the
Authority').

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

Through the World Trade Organisation, the Communi-
ty'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 Commis-
sion should also be considered when Community MRLs
are being set.

(20)

(21)

(22)

(23)

(24)

It is necessary that the Authority assess MRL applications
and evaluation reports prepared by the Member States
with a view to determining the associated risks to consu-
mers and, where relevant, to animals.

(25) Member States should lay down rules on sanctions
applicable to infringements of
this Regulation and
ensure that they are implemented. Those sanctions are
to be effective, proportionate and dissuasive.

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

(32)

In accordance with the principle 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 for products of
plant and animal origin. This Regulation does not go
beyond what is necessary in order to achieve the objec-
tives pursued in accordance with the third paragraph of
Article 5 of the Treaty,

(26)

(27)

(28)

(29)

substances with decisions

It is good administrative practice and technically desir-
able to coordinate the timing of decisions on MRLs for
active
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 Regu-
lation.

taken for

It is therefore necessary to adopt separate rules providing
for temporary but mandatory harmonised MRLs, with a
view to setting MRLs progressively as decisions are taken
on individual active substances as part of the evaluations
under Directive 91/414/EEC. Such temporary harmo-
nised MRLs should be based, in particular, on existing
national MRLs established by the Member States and
should respect the national arrangements by which they
were established, provided that the MRLs do not present
an unacceptable risk to consumers.

Following the inclusion of existing active substances in
Annex I to Directive 91/414/EEC, Member States are to
re-evaluate each plant protection product containing
those active substances within four years of the date of
inclusion. The MRLs concerned should be retained for a
period of up to four years to provide for continuity of
re-evaluation,
authorisations and, on completion of
they are supported by
should be made definitive if
dossiers which
to Directive
satisfy Annex
91/414/EEC, or be set to a default level if they are not
so supported.

III

(30)

This Regulation establishes MRLs for the control of
pesticide residues in food and feed. It is therefore appro-
priate that Member States establish national programmes
to control these residues. The results of the national
control programmes are to be submitted to the Commis-
sion, the Authority and the other Member States and
included in the Community annual report.

(31)

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 Commission (1).

(1) OJ L 184, 17.7.1999, p. 23.

HAVE ADOPTED THIS REGULATION:

CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter

This Regulation establishes,
in accordance with the general
principles laid down in Regulation (EC) No 178/2002, harmo-
nised Community provisions relating to maximum levels of
pesticide residues in or on food and feed of plant and animal
origin.

Article 2

Scope

1.
This Regulation shall apply to products of plant and
animal origin or parts thereof covered by Annex I to be used as
fresh, processed and/or composite food or feed in or on which
pesticide residues may be present.

This Regulation shall not apply to the products covered
2.
by Annex I where it may be established by appropriate
evidence that they are intended for:

(a) the manufacture of products other than food or feed; or

(b) sowing or planting; or

(c) activities authorised by national law for the testing of active

substances.

3. Maximum residue levels for pesticides set in accordance
with this Regulation shall not apply to products covered by
Annex I intended for export to third countries and treated
before export, where it has been established by appropriate
evidence that the third country of destination requires or agrees
with that particular treatment in order to prevent the introduc-
tion of harmful organisms into its territory.

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4.
This Regulation shall apply without prejudice to Direc-
tives 98/8/EC (1) and 2002/32/EC and Regulation (EEC) No
2377/90 (2).

(g) ‘import tolerance’: means an MRL set for imported products

where:

Article 3

Definitions

1.
For the purpose of this Regulation, the definitions in
Regulation (EC) No 178/2002 and in Article 2(1) and (4) of
Directive 91/414/EEC shall apply.

2.

The following definitions shall also apply:

(a) ‘good agricultural practice’

(GAP): means the nationally
recommended, authorised or registered safe use of plant
protection products under actual conditions at any stage of
production, storage, transport, distribution and processing
of food and feed;

(b) ‘critical GAP’: means the GAP, where there is more than
one GAP for an active substance/product combination,
which gives rise to the highest acceptable level of pesticide
residue in a treated crop and is the basis for establishing
the MRL;

(c) ‘pesticide

residues,

including

residues’: means

active
substances, metabolites and/or breakdown or
reaction
products of active substances currently or formerly used in
plant protection products as defined in Article 2(1) of
Directive 91/414/EEC, which are present
in or on the
products covered by Annex I to this Regulation, including
in particular those which may arise as a result of use in
plant protection, in veterinary medicine and as a biocide;

(d) ‘maximum residue level’ (MRL): means the upper legal level
of concentration for a pesticide residue in or on food or
feed;

(e) ‘CXL’: means an MRL set by the Codex Alimentarius

Commission;

(f) ‘limit of determination’ (LOD): means the validated lowest
residue concentration which can be quantified and reported
by routine monitoring with validated control methods;

(1) Directive 98/8/EC of the European Parliament and of the Council of
16 February 1998 concerning the placing of biocidal products on
the market (OJ L 123, 24.4.1998, p. 1). Directive as last amended
by Regulation (EC) No 1882/2003, (OJ L 284, 31.10.2003, p. 1).
(2) Council Regulation (EEC) No 2377/90 of 26 June 1990 laying
down a Community procedure for the establishment of maximum
residue limits of veterinary medicinal products in foodstuffs of
animal origin (OJ L 224, 18.8.1990, p. 1). Regulation as last
amended by Commission Regulation (EC) No 546/2004 (OJ L 87,
25.3.2004, p. 13).

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

— an existing Community MRL is not sufficient to meet

the needs of international trade;

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

(i) ‘acute reference dose’: means the estimate of the amount of
substance in food, 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;

(j) ‘acceptable daily intake’: means the estimate of the amount
of substance in food expressed on a body weight basis, that
can be ingested daily over a lifetime, without appreciable
health risk to the consumer on the basis of all known facts
at the time of evaluation.

Article 4

List of groups of products for which harmonised MRLs
shall apply

The products, product groups and/or parts of products
1.
referred to in Article 2(1) to which harmonised MRLs shall
apply shall be defined in and covered by Annex I in accordance
with the procedure referred to in Article 45(2). Annex I shall
include all products for which MRLs are set, as well as the
other products for which it is appropriate to apply harmonised
MRLs in particular in view of their relevance in the diet of
consumers or in trade. Products shall be grouped in such a way
that MRLs may as far as possible be set for a group of similar
or related products.

Annex I shall be first established within three months
this Regulation and shall be
in particular at the request of a

2.
from the entry into force of
revised when appropriate,
Member State.

Article 5

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

1.
Active substances of plant protection products evaluated
under Directive 91/414/EEC for which no MRLs are required
shall be defined in accordance with the procedure referred to in
Article 45(2) of this Regulation and listed in Annex IV hereto,
taking into account the uses of those active substances and the
matters referred to in Article 14(2), (a), (c) and (d) of this Regu-
lation.

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Annex IV shall be first established within 12 months

2.
from the entry into force of this Regulation.

(iv) a copy of the relevant GAP applying to the specific use

of that active substance;

CHAPTER II

concern;

(c) where appropriate, scientifically substantiated reasons for

PROCEDURE FOR APPLICATIONS FOR MRLS

SECTION 1

SUBMISSION OF APPLICATIONS FOR MRLS

Article 6

Applications

1. Where a Member State envisages granting an authorisa-
tion or a provisional authorisation for the use of a plant protec-
tion product in accordance with Directive 91/414/EEC, that
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, whether it is necessary to set a new MRL,
or whether the active substance should be included in Annex
IV. If necessary it shall require the party requesting the authori-
sation to submit an application in accordance with Article 7.

Parties demonstrating, through adequate evidence, a legiti-
2.
mate interest, including manufacturers, growers and producers
of products covered by Annex I may also submit an application
to a Member State in accordance with Article 7.

3. Where a Member State considers that the setting, modifi-
cation or deletion of an MRL is necessary, that Member State
may also compile and evaluate an application for setting, modi-
fying or deleting the MRL in accordance with Article 7.

Applications for import tolerances shall be submitted to
4.
to Directive
rapporteur Member States designated pursuant
91/414/EEC or,
if no such rapporteur has been designated,
applications shall be made to Member States designated by the
Commission in accordance with procedure referred to in
Article 45(2) of this Regulation at the request of the applicant.
Such applications shall be made in accordance with Article 7
of this Regulation.

Article 7

Requirements relating to applications for MRLs

The applicant shall include in an application for an MRL

1.
the following particulars and documents:

(a) the name and address of the applicant;

(b) a presentation of the application dossier including:

(i) a summary of the application;

(ii) the main substantive arguments;

(iii) an index of the documentation;

(d) the data listed in Annexes

II and III

to Directive
91/414/EEC relating to data requirements for the setting of
MRLs for pesticides including, where appropriate, toxicolo-
gical data and data on routine analytical methods for use in
control laboratories, as well as plant and animal metabo-
lism data.

However, where relevant data are already publicly available,
in particular when an active substance has already been
evaluated under Directive 91/414/EEC or when a CXL
exists and such data are submitted by the applicant, a
Member State may also use such information in evaluating
an application. In such cases, the evaluation report shall
include a justification for using or not using such data.

2.
The evaluating Member State may, where appropriate,
request the applicant to provide supplementary information in
addition to information required under paragraph 1 within a
time limit specified by the Member State.

Article 8

Evaluation of applications

1.
A Member State to which an application complying with
Article 7 is submitted pursuant to Article 6 shall immediately
forward a copy to the European Food Safety Authority estab-
lished by Regulation (EC) No 178/2002 (hereinafter referred to
as 'the Authority') and the Commission and draw up an evalua-
tion report without undue delay.

2.
Applications shall be evaluated in accordance with the
relevant provisions of the Uniform Principles for the Evaluation
and Authorisation of Plant Protection Products set out
in
Annex VI to Directive 91/414/EEC or specific evaluation prin-
ciples to be laid down in a Commission Regulation in accord-
ance with the procedure referred to in Article 45(2) of this
Regulation.

3.
By way of derogation from paragraph 1 and by agree-
ment between the Member States concerned, evaluation of the
application may be carried out by the rapporteur Member State
designated pursuant to Directive 91/414/EEC for that active
substance.

4. Where a Member State encounters difficulties in evalu-
ating an application or in order to avoid duplication of work, it
may be decided in accordance with the procedure referred to in
Article 45(2) which Member State shall evaluate particular
applications.

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Article 9

Submission of evaluated applications to the Commission
and the Authority

1.
After completion of the evaluation report, the Member
State shall forward it to the Commission. The Commission
shall without delay inform the Member States and forward the
application, the evaluation report and the supporting dossier to
the Authority.

2.
The Authority shall acknowledge in writing receipt of the
application to the applicant, the evaluating Member State and
the Commission without delay. The acknowledgement shall
state the date of receipt of the application and the accompa-
nying documents.

SECTION 2

CONSIDERATION OF APPLICATIONS CONCERNING MRLS BY THE
AUTHORITY

2. Where the Authority requests supplementary information,
the time limit laid down in paragraph 1 shall be suspended
until that information has been provided. Such suspensions are
subject to Article 13.

Article 12

Assessment of existing MRLs by the Authority

The Authority shall, within a period of 12 months from
1.
the date of
the inclusion or non-inclusion of an active
substance in Annex I to Directive 91/414/EEC after the entry
into force of this Regulation, submit a reasoned opinion based
in particular on the relevant assessment report prepared under
Directive 91/414/EEC to the Commission and the Member
States on:

(a) existing MRLs for that active substance set out in Annex II

or III to this Regulation;

Article 10

(b) the necessity of setting new MRLs for that active substance,

or its inclusion in Annex IV to this Regulation;

The Authority's opinion on applications concerning MRLs

1.
The Authority shall assess the applications and the
evaluation reports and give a reasoned opinion on, in particu-
lar, the risks to the consumer and where relevant to animals
associated with the setting, modification or deletion of an MRL.
That opinion shall include:

(a) an assessment of 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/product combination;

(c) an assessment of the risks of the acceptable daily intake or
acute reference dose being exceeded as a result of the modi-
fication of the MRL; the contribution to the intake due to
the residues in the product
for which the MRLs was
requested;

(c) specific processing factors as referred to in Article 20(2) of
that active

this Regulation that may be needed for
substance;

(d) MRLs which the Commission may consider including in
Annex II and/or Annex III to this Regulation and on those
MRLs which may be deleted related to that active
substance.

For

substances

included in Annex I

2.
to Directive
91/414/EEC before the entry into force of this Regulation, the
reasoned opinion referred to in paragraph 1 of this Article
shall be delivered within 12 months of the entry into force of
this Regulation.

(d) any other element relevant to the risk assessment.

Article 13

The Authority shall forward its reasoned opinion to the
2.
the Commission and the Member States. The
applicant,
reasoned opinion shall clearly define the basis for each conclu-
sion reached.

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

Article 11

Time limits for the Authority's opinion on applications
concerning MRLs

Administrative review

Any decision taken under, or failure to exercise, the powers
vested in the Authority by this Regulation may be reviewed by
the Commission on its own initiative or in response to a
request from a Member State or from any person directly and
individually concerned.

For that purpose, a request shall be submitted to the Commis-
sion within two months after the day on which the party
concerned became aware of the act or omission in question.

1.
The Authority shall give its reasoned opinion as provided
for in Article 10 as soon as possible and at the latest within
three months from the date of receipt of the application.

The Commission shall
take a decision within two months
requiring, if appropriate, the Authority to withdraw its decision
or to remedy its failure to act within a set time-limit.

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SECTION 3

(c) in the cases mentioned in Article 16, set temporary MRLs

and list them in Annex III to this Regulation.

SETTING, MODIFYING OR DELETION OF MRLS

Article 14

Decisions on applications concerning MRLs

Upon receipt of the opinion of the Authority and taking
1.
into account that opinion, a Regulation on the setting, modifi-
cation or deletion of an MRL or a Decision rejecting the appli-
cation shall be prepared by the Commission without delay and
at the latest within three months, and submitted for adoption
in accordance with the procedure referred to in Article 45(2).

to Directive 91/414/EEC of

2. Where a temporary MRL is set as provided for in para-
graph 1(b), it shall be deleted from Annex III by a Regulation
one year after the date of the inclusion or non-inclusion in
Annex I
the active substance
in accordance with the procedure referred to in
concerned,
Article 45(2) of this Regulation. However, where one or more
Member States so requests, it may be maintained for an addi-
tional year pending confirmation that any scientific studies
necessary for supporting an application for setting a MRL have
been undertaken. In cases where such confirmation is provided,
the temporary MRL shall be maintained for a further two years,
provided that no unacceptable
the
consumer have been identified.

safety concerns

for

2. With regard to the acts referred to in paragraph 1,
account shall be taken of:

Article 16

(a) the scientific and technical knowledge available;

(b) the possible presence of pesticide residues arising from
sources other than current plant protection uses of active
substances;

(c) the results of an assessment of any potential risks to the

consumer and, where appropriate, to animals;

(d) the results of any evaluations and decisions to modify the

uses of plant protection products;

(e) a CXL or a GAP implemented in a third country for the

legal use of an active substance in that country;

(f) other legitimate factors relevant to the matter under consid-

eration.

3.
The Commission may request at any time that supple-
mentary information be provided by the applicant or by the
Authority. The Commission shall make available any supple-
mentary information received to the Member States and the
Authority.

Article 15

Inclusion of new or modified MRLs in Annexes II and III

1.

The Regulation referred in Article 14(1) shall:

(a) set new or modified MRLs and list them in Annex II to this
Regulation where the active substances have been included
in Annex I to Directive 91/414/EEC; or

(b) where the active substances have not been included in
Annex I to Directive 91/414/EEC and where they are not
included in Annex II to this Regulation, set or modify
temporary MRLs and list them in Annex III to this Regu-
lation; or

Procedure for setting temporary MRLs in certain circum-
stances

1.
The Regulation referred to in Article 14(1) may also set a
temporary MRL to be included in Annex III in the following
circumstances:

(a) in exceptional cases, in particular where pesticide residues
may arise as a result of environmental or other contamina-
tion or from uses of plant protection products pursuant to
Article 8(4) of Directive 91/414/EEC; or

(b) where the products concerned constitute a minor compo-
the diet of consumers and, where relevant, of

nent of
animals; or

(c) for honey; or

(d) where essential uses of plant protection products have been
identified by a Decision to delete an active substance from,
or not to include an active substance in, Annex I to Direc-
tive 91/414/EEC.

2.
The inclusion of temporary MRLs as referred to in para-
graph 1 shall be based on the opinion of the Authority, moni-
toring data and an assessment demonstrating that there are no
unacceptable risks to consumers or animals.

The continued validity of the temporary MRLs referred to in
(b) and (c) shall be reassessed at least once
paragraph 1(a),
every 10 years and any such MRLs shall be modified or deleted
as appropriate.

The MRLs referred to in paragraph 1(d) shall be reassessed at
the expiry of
the period for which the essential use was
authorised.

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Article 17

(c) the other Member States and the Commission have been

informed of the measures taken.

Modifications of MRL following revocation of authorisa-
tions of plant protection products

Amendments to Annexes II or III needed to delete an MRL
following the revocation of an existing authorisation for a plant
protection product may be adopted without
seeking the
opinion of the Authority.

CHAPTER III

MRLS APPLICABLE TO PRODUCTS OF PLANT AND ANIMAL
ORIGIN

Article 18

Compliance with MRLs

1.
The products covered by Annex I shall not contain, from
the time they are placed on the market as food or feed, or fed
to animals, any pesticide residue exceeding:

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

(b) 0,01 mg/kg for those products for which no specific MRL
is set out in Annexes II or III, or for active substances not
listed in Annex IV unless different default values are fixed
for an active substance in accordance with the procedure
referred to in Article 45(2) while taking into account the
routine analytical methods available. Such default values
shall be listed in Annex V.

2. Member States may not prohibit or impede the placing
on the market or the feeding to food-producing animals within
their territories of the products covered by Annex I on the
grounds that they contain pesticide residues provided that:

(a) such products comply with Articles 18(1) and 20; or

(b) the active substance is listed in Annex IV.

3.
By way of derogation from paragraph 1, Member States
may authorise, further to a post-harvest treatment with a fumi-
gant on their own territory,
residue levels for an active
substance which exceed the limits specified in Annexes II and
for a product covered by Annex I where the active
III
substance/product
listed in Annex VII
provided that:

combinations are

(a) such products are not intended for immediate consump-

tion;

The active substance/product combinations listed in Annex VII
shall be defined in accordance with the procedure referred to in
Article 45(2).

4.
In exceptional circumstances, and in particular further to
the use of plant protection products in accordance with Article
8(4) of Directive 91/414/EEC or in pursuance of obligations in
Directive 2000/29/EC (1), a Member State may authorise the
placing on the market and/or the feeding to animals within its
territory of treated food or feed not complying with paragraph
1, provided that such food or feed does not constitute an unac-
ceptable risk. Such authorisations shall immediately be notified
to the other Member States, the Commission and the Authority,
together with an appropriate risk assessment for consideration
without undue delay in accordance with the procedure referred
to in Article 45(2), with a view to setting a temporary MRL for
a specified period or taking any other necessary measure in
relation to such products.

Article 19

Prohibition concerning processed and/or

composite

products

The processing, and/or mixing for dilution purposes with the
same or other products, of the products covered by Annex I
not complying with Articles 18(1) or 20 with a view to placing
them on the market as food or feed or feeding them to animals
shall be prohibited.

Article 20

MRLs applicable to processed and/or composite products

1. Where MRLs are not set out in Annexes II or III for
processed and/or composite food or feed, the MRLs applicable
shall be those provided in Article 18(1)
for the relevant
product covered by Annex I, taking into account changes in
the levels of pesticide residues caused by processing and/or
mixing.

2.
Specific concentration or dilution factors for certain
processing and/or mixing operations or for certain processed
and/or composite products may be included in the list
in
in accordance with the procedure referred to in
Annex VI
Article 45(2).

(b) appropriate controls are in place to ensure that such
products cannot be made available to the end user or
consumer, if they are supplied directly to the latter, until
the residues no longer exceed the maximum levels specified
in Annexes II or III;

(1) Council Directive 2000/29/EC of 8 May 2000 on protective
measures against the introduction into the Community of organisms
harmful to plants or plant products and against their spread within
the Community (OJ L 169, 10.7.2000, p. 1). Directive as last
amended by Commission Directive 2004/70/EC (OJ L 127,
29.4.2004, p. 97).

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CHAPTER IV

SPECIAL PROVISIONS RELATING TO THE INCORPORATION
OF EXISTING MRLS INTO THIS REGULATION

the date of entry into force of Annex I to this Regulation at the
latest, a national MRL for that active substance for a product
covered by Annex I to this Regulation, or has decided that no
MRL is required for that active substance, the Member State
concerned shall notify the Commission, in a format and by a
date to be established in accordance with the procedure
referred to in Article 45(2) of the national MRL, or the fact that
no MRL is required for an active substance, and where relevant
and at the request of the Commission:

Article 21

First establishment of MRLs

(a) the GAP;

1. MRLs for products covered by Annex I shall be first estab-
lished and listed in Annex II in accordance with the procedure
referred to in Article 45(2), incorporating the MRLs provided
86/363/EEC
for
and
90/642/EEC,
the criteria mentioned in
Article 14(2) of this Regulation.

taking into account

under Directives

86/362/EEC,

(b) where the critical GAP is applied in the Member State and,
where available, summary data on supervised trials and/or
monitoring data;

(c) the acceptable daily intake and, if relevant, the acute refer-
ence dose used for the national risk assessment, as well as
the outcome of the assessment.

Annex II shall be established within 12 months from the

2.
entry into force of this Regulation.

Article 24

Article 22

Opinion of the Authority on data underlying national
MRLs

First establishment of temporary MRLs

Temporary MRLs for active substances for which a deci-
1.
sion on inclusion or non-inclusion in Annex I to Directive
91/414/EEC has not yet been taken shall be first established
and listed in Annex III to this Regulation, unless already listed
in Annex II hereto, in accordance with the procedure referred
the information
to in Article 45(2),
provided by the Member States, where relevant the reasoned
opinion mentioned in Article 24, the factors referred to in
Article 14(2) and the following MRLs:

taking into account

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

and

(b) hitherto unharmonised national MRLs.

2.
Annex III shall be established within 12 months from the
entry into force of this Regulation in accordance with Articles
23, 24 and 25.

1.
At the request of the Commission, the Authority shall
provide a reasoned opinion to the Commission on potential
risks to consumer health arising from:

(a) temporary MRLs that may be included in Annex III;

(b) active substances that may be included in Annex IV.

In preparing the reasoned opinion referred to in para-
2.
graph 1, the Authority shall take into account the scientific and
technical knowledge available, and in particular,
information
provided by the Member States as required by Article 23.

Article 25

Article 23

Setting of temporary MRLs

Information to be provided by the Member States on
national MRLs

Where an active substance is not yet included in Annex I to
Directive 91/414/EEC and where a Member State has set, by

Taking into account the opinion of the Authority,
if such
opinion is requested, temporary MRLs for active substances
referred to in Article 23 may be set and listed in Annex III
pursuant
the active
to Article 22(1) or, as appropriate,
substance may be included in Annex IV pursuant to Article
5(1).

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CHAPTER V

adopted in accordance with the procedure referred to in Article
45(2).

OFFICIAL CONTROLS, REPORTS AND SANCTIONS

SECTION 1

OFFICIAL CONTROLS OF MRLS

Article 26

Official controls

1. Without prejudice to Directive 96/23/EC (1), Member
States shall carry out official controls on pesticide residues in
order to enforce compliance with this Regulation, in accord-
ance with the relevant provisions of Community law relating to
official controls for food and feed.

Such controls on pesticide residues shall,

in particular,
2.
consist of sampling and subsequent analysis of the samples and
identification of
the pesticides present and their respective
residue levels.

Article 27

Sampling

1.
Each Member State shall take a sufficient number and
range of samples to ensure that the results are representative of
the market, taking into account the results of previous control
programmes. Such sampling shall be carried out as close to the
point of supply as is reasonable, to allow for any subsequent
enforcement action to be taken.

2.
The sampling methods necessary for carrying out such
controls of pesticide residues in products other than those
provided for in Directive 2002/63/EC (2) shall be determined in
accordance with the procedure referred to in Article 45(2) of
this Regulation.

Article 28

Methods of Analysis

3.
All laboratories analysing samples for the official controls
on pesticide residues shall participate in the Community Profi-
ciency Tests for pesticide residues organised by the Commis-
sion.

SECTION 2

COMMUNITY CONTROL PROGRAMME

Article 29

Community Control Programme

1.
The Commission shall prepare a coordinated multiannual
Community control programme, identifying specific samples to
be included in the national control programmes and taking
into account problems that have been identified regarding
compliance with the MRLs set out in this Regulation, with a
view to assessing consumer exposure and the application of
current legislation.

2.
The Community control programme shall be adopted and
updated every year in accordance with the procedure referred
to in Article 45(2). The draft Community control programme
shall be presented to the Committee referred to in Article 45(1)
at least six months before the end of each calendar year.

SECTION 3

NATIONAL CONTROL PROGRAMMES

Article 30

1.
shall
The methods of analysis of pesticide residues
comply with the criteria set out in the relevant provisions of
Community law relating to official controls for food and feed.

2.
Technical guidelines dealing with the specific validation
criteria and quality control procedures in relation to methods
of analysis for the determination of pesticide residues may be

(1) Council Directive 96/23/EC of 29 April 1996 on measures to
monitor certain substances and residues thereof in live animals and
animal products
and repealing Directives 85/358/EEC and
86/469/EEC and Decisions 89/187/EEC and 91/664/EEC (OJ L 125,
23.5.1996, p. 10). Directive as last amended by Regulation (EC)
No 806/2003 (OJ L 122, 16.5.2003, p. 1).

(2) Commission Directive 2002/63/EC of 11 July 2002 establishing
Community methods of sampling for the official control of pesticide
residues in and on products of plant and animal origin and
repealing Directive 79/700/EEC (OJ L 187, 16.7.2002, p. 30).

National control programmes for pesticide residues

1. Member States
establish multiannual national
control programmes for pesticide residues. They shall update
their multiannual programme every year.

shall

Those programmes shall be risk-based and aimed in particular
at assessing consumer exposure and compliance with current
legislation. They 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 pesticides to be analysed;

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(d) the criteria applied in drawing up such programmes,

Article 32

including:

(i) the pesticide-product combinations to be selected;

The Annual Report on pesticide residues

(ii) the number of samples taken for domestic and non-

domestic products respectively;

(iii) consumption of the products as a share of the national

diet;

(iv) the Community Control Programme, and

(v) the results of previous control programmes.

2. Member States shall submit their updated national control
programmes for pesticide residues, as mentioned in paragraph
1,
to the Commission and to the Authority at least three
months before the end of each calendar year.

3. Member States
Control Programme as provided for in Article 29.

shall participate

in the Community

SECTION 4

INFORMATION BY THE MEMBER STATES AND ANNUAL REPORT

Article 31

1.
On the basis of the information provided by the Member
States under Article 31(1) the Authority shall draw up an
Annual Report on pesticide residues.

The Authority shall include information on at least the

2.
following in the Annual Report:

(a) an analysis of the results of the controls provided for in

Article 26(2);

(b) a statement of the possible reasons why the MRLs were
together with any appropriate observations

exceeded,
regarding risk management options;

(c) an analysis of chronic and acute risks to the health of

consumers from pesticide residues;

(d) an assessment of consumer exposure to pesticide residues
based on the information provided under point (a) and any
other
including reports
submitted under Directive 96/23/EC.

relevant available information,

3. Where a Member State has not provided information in
accordance with Article 31, the Authority may disregard the
information relating to that Member State when compiling the
Annual Report.

Information by the Member States

The format of the Annual Report may be decided in

4.
accordance with the procedure referred to in Article 45(2).

1. Member States shall submit the following information
concerning the previous calendar year to the Commission, the
Authority and the other Member States by 31 August each
year:

The Authority shall submit the Annual Report to the

5.
Commission by the last day of February each year.

(a) the results of the official controls provided for in Article

26(1);

The Annual Report may include an opinion on the pesti-

6.
cides to be covered in future programmes.

(b) the LODs applied in the national control programmes
referred to in Article 30 and under the Community Control
Programme referred to in Article 29;

(c) details of the participation of the analytical laboratories in
the Community proficiency tests referred to in Article 28(3)
and other proficiency tests relevant to the pesticide-product
combinations sampled in the national control programme;

(d) details of the accreditation status of the analytical labora-

tories involved in the controls referred to in point (a);

(e) where permitted by national legislation, details of enforce-

ment measures taken.

Implementing measures relating to the submission of
2.
information by the Member States may be established in
accordance with the procedure referred to in Article 45(2) after
consultation with the Authority.

The Authority shall make public the Annual Report, as

7.
well as any comments by the Commission or Member States.

Article 33

Submission of the Annual Report on pesticide residues to
the Committee

The Commission shall submit the Annual Report on pesticide
residues to the Committee referred to in Article 45(1) without
delay,
for review and recommendations on any necessary
measures to be taken regarding reported infringements of the
MRLs set out in Annexes II and III.

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SECTION 5

SANCTIONS

Article 34

Sanctions

The Member States shall
lay down rules on the sanctions
applicable to infringements of the provisions of this Regulation
and shall take all measures necessary to ensure that they are
implemented. The sanctions provided for must be effective,
proportionate and dissuasive.

The Member States shall notify those rules and any subsequent
amendment to the Commission without delay.

CHAPTER VI

EMERGENCY MEASURES

(e) studies necessary to support control

laboratories where
analytical methods are not capable of controlling the MRLs
established.

2.
Any necessary implementing provisions concerning the
measures referred to in paragraph 1 may be adopted in accord-
ance with the procedure referred to in Article 45(2).

Article 37

Community contribution to the support measures for
harmonised pesticide MRLs

1.
The Community may make a financial contribution of up
to 100 % of the cost of the measures provided for in Article
36.

The appropriations shall be authorised each financial year

2.
as part of the budgetary procedure.

Article 35

COORDINATION OF APPLICATIONS FOR MRLS

CHAPTER VIII

Emergency measures

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.

CHAPTER VII

SUPPORT MEASURES RELATING TO HARMONISED PESTI-
CIDE MRLS

Article 36

Support measures relating to harmonised pesticide MRLs

Support measures relating to harmonised pesticide MRLs

1.
shall be established at Community level, including:

(a) a consolidated database for Community legislation on
MRLs of pesticide residues and for making such informa-
tion publicly available;

(b) Community proficiency tests as referred to in Article 28(3);

(c) studies and other measures necessary for the preparation
and development of legislation and of technical guidelines
on pesticide residues;

(d) studies necessary for estimating the exposure of consumers

and animals to pesticide residues;

Article 38

Designation of national authorities

Each Member State shall designate one or more national autho-
rities to coordinate cooperation with the Commission,
the
Authority, other Member States, manufacturers, producers and
growers for the purposes of this Regulation. Where more than
one authority is designated by a Member State, it shall indicate
which of the designated authorities shall act as a contact point.

The national authorities may delegate tasks to other bodies.

Each Member State shall
Authority of
national authorities.

the names and addresses of

inform the Commission and the
the designated

Article 39

Coordination by the Authority of information on MRLs

The Authority shall:

(a) coordinate with the rapporteur Member State designated in
accordance with Directive 91/414/EEC for an active
substance;

(b) coordinate with the Member States and the Commission
regarding MRLs, in particular for the purpose of fulfilling
the requirements of Article 41.

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Article 40

Information to be submitted by the Member States

Member States shall submit to the Authority, at its request, any
available information necessary for the assessment of the safety
of MRLs.

Article 41

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
the Member States,
and to the competent authorities of
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 VII. In particular it shall
contain dietary intake assessments, processing factors and toxi-
cological endpoints.

Article 42

Member States and Fees

1. Member States may recover the costs of work associated
with setting, modifying or deleting MRLs, or with any other
work arising from obligations under this Regulation, by means
of a fee or charge.

2. Member States shall ensure that the fee or charge referred
to in paragraph 1:

(a) is established in a transparent manner; and

(b) corresponds to the actual cost of the work involved.

It may include a scale of fixed charges based on average costs
for the work referred to in paragraph 1.

CHAPTER IX

IMPLEMENTATION

Article 43

application of well-established scientific or technical principles
they may, unless the Commission or a Member State objects,
be issued by the Authority without consulting the scientific
committee or the scientific panels mentioned in Article 28 of
Regulation (EC) No 178/2002.

2.
The implementing rules pursuant to Article 29(6)(a) of
Regulation (EC) No 178/2002 shall specify the cases in which
paragraph 1 above shall apply.

Article 45

Committee Procedure

1.
The Commission shall be assisted by the Standing
Committee on the Food Chain and Animal Health set up by
Article 58 of Regulation (EC) No 178/2002 (hereinafter
referred to as ‘the Committee’.)

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

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

3.

The Committee shall adopt its rules of procedure.

Article 46

Implementing measures

In accordance with the procedure referred to in Article 45(2)
and, where appropriate, taking into account the opinion of the
Authority,
the following shall be established or may be
amended:

(a) implementing measures to ensure the uniform application

of this Regulation;

(b) the dates in Articles 23, 29(2), 30(2), 31(1) and 32(5);

(c) technical guidance documents to assist in the application of

Scientific opinion of the Authority

this Regulation;

the Member States may request

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

(d) detailed rules concerning the scientific data required for the

setting of MRLs.

Article 47

Article 44

Report on implementation of this Regulation

Procedure for the adoption of the Authority's opinions

1. When the Authority's opinions pursuant to this Regu-
lation require only scientific or technical work involving the

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

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CHAPTER X

FINAL PROVISIONS

Article 48

Repeal and adaptation of legislation

Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and
from the date

1.
90/642/EEC are hereby repealed with effect
referred to in the second paragraph of Article 50.

Article 4(1)(f) of Directive 91/414/EEC shall be replaced

2.
by the following:

‘(f) where appropriate,

the agricultural
the MRLs
products affected by the use referred to in the authori-
sation have been set or modified in accordance with
Regulation (EC) No …/2004 (*).

for

(*) OJ L .... .’

Article 49

Transitional Measures

The requirements of Chapter

1.
III shall not apply to
products lawfully produced or imported into the Community
before the date referred to in the second paragraph of
Article 50.

However, in order to ensure a high level of consumer protec-
tion, appropriate measures concerning those products may be
taken in accordance with the procedure referred to in Article
45(2).

2. Where it is necessary in order to allow for the normal
marketing, processing and consumption of products, further
transitional measures may be laid down for the implementation
of certain MRLs provided for in Articles 15, 16, 21, 22, and
25.

Those measures, which shall be without prejudice to the obliga-
tion to ensure a high level of consumer protection, shall be
adopted in accordance with the procedure referred to in
Article 45(2).

Article 50

Entry into force

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

Chapters II, III and V shall apply as from six months from the
publication of the last of the Regulations establishing Annexes
I, II, III and IV.

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

Done at Brussels,

For the European Parliament

The President

For the Council

The President

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STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

On 14 March 2003 the Council received from the Commission a 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.

The European Parliament adopted its opinion at a first reading on 20 April 2004. The European
Economic and Social Committee adopted its opinion on 16 July 2003.

The Council adopted its common position on 19 July 2004, in accordance with the procedure laid
down in Article 251 of the Treaty.

II. OBJECTIVES

The proposal overhauls and streamlines European pesticides legislation by replacing four existing
Council Directives with a single Regulation. The aim of the new, harmonised provisions is twofold: to
facilitate trade within the Single Market and with third countries, import tolerances being granted to
exporters to the EU in certain cases, and to ensure a consistent level of consumer protection across the
Community. The proposal also provides for the role of the European Food Safety Authority (EFSA) in this
field. Under the new provisions, as amended by the Council, following a transitional period, MRLs
would only be set at Community level through a procedure where Member States assess the need for
an MRL and submit an evaluation report to the Commission. EFSA would be responsible for risk assess-
ment based on the Member State evaluation report and data received from applicants, while the
Commission would handle risk management by setting MRLs.

III. ANALYSIS OF THE COMMON POSITION

A. GENERAL OBSERVATIONS

The Council's common position broadly accords with the positions taken by the Commission and
the Parliament, inasmuch as it:

— confirms the objectives and most of the arrangements proposed by the Commission and

supported by the European Parliament;

— includes a large number of the amendments adopted at first reading by the European Parlia-

ment.

In particular, the Council agreed with a series of parliamentary amendments aiming to ensure the
smooth functioning of the new procedures and to increase consistency between the new Regulation
and other Community legislation. In addition, the Council felt that it was appropriate to introduce
further amendments, for example, to allow Member States the flexibility to deal with MRL excee-
dences that arise in certain exceptional cases. The Council also reordered and reformatted parts of
the text of the Regulation so as to clarify the roles of the Member States, EFSA and the Commission
and to separate transitional provisions from the standard procedures under the new regime. A
number of technical and editorial amendments were also introduced.

B. SPECIFIC COMMENTS

(a) Application procedure: the respective roles of the EFSA and the Member States

In its proposal, the Commission had foreseen an exclusive role for EFSA in scientific evaluation
work and the setting of MRLs. However, the Council agreed with the Parliament that Member
States should perform a preliminary analysis of MRL applications in line with established proce-
dures under Directive 91/414/EEC. In addition, the Council agreed that a copy of MRL applica-
tions received by Member States should immediately be sent to the Commission and to EFSA
(Article 8).

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(b) Procedure for routine work performed by EFSA

In the light of the substantial workload foreseen for EFSA, the Council introduced a new article
designed to avoid unnecessary consultation of scientific bodies on matters of routine, i.e. in
cases where EFSA issues opinions purely based on well-established scientific principles (Article
44). This provision is analogous to Article 31 of Regulation 178/2002/EC.

(c) Administrative review

A new article was added with a view to providing a form of legal redress regarding decisions
taken by EFSA and also in the event of non-action by EFSA (Article 13).

(d) Time scale and transition to the new procedures

To ensure a smooth transition to the new provisions, the Council followed the Parliament in
setting down specific deadlines for the completion of the principal technical annexes, which
will set out a list of harmonised MRLs (Annex II), a list of harmonised temporary MRLs (Annex
III) and a list of active substances for which no MRLs are required (Annex IV). In the same
spirit, the Council also introduced a deadline for drawing up the annex listing the products to
which harmonised MRLs will apply (Annex I). Like Parliament, the Council considered that the
Regulation should not apply in full until after the crucial annexes have been drawn up (Articles
4, 5, 21, 22 and 50).

(e) Possibility to extend the validity of temporary MRLs

In order to facilitate a smooth transition to a fully harmonised regime (e.g. where Member
States indicate that extra time is required to complete scientific studies on substances that have
been authorised nationally), the Council decided that it should be possible for temporary MRLs,
which will normally be valid for one year, to be maintained in Annex III for up to three addi-
tional years in certain cases (Article 15).

(f) The use of pesticides for post-harvest treatment

A derogation was introduced in order to provide for the practice of post-harvest fumigation of
products (e.g. with a view to protecting them against pests during storage and transport, which
can entail the temporary exceedence of MRLs while the product remains in storage or transit)
(Article 18(3)).

(g) The use of pesticides in exceptional circumstances

In order to provide for exceptional circumstances (e.g. when an emergency use of a plant
protection product is required to control pest(s) in accordance with Article 8(4) of Directive
91/414/EEC), emergency provisions were introduced allowing a Member State to authorise the
placing on the market and/or the feeding to animals within its territory of food or feed that is
not in compliance with the MRLs laid down in the Regulation. Such authorisations are to be
notified to the other Member States, the Commission and EFSA, with a view to setting
temporary MRLs and taking any other necessary actions. Such authorisations can only be
granted provided that the treated food or feed does not constitute an unacceptable risk to
consumers (Article 18(4)).

(h) Definitions

In redrafting the text to improve legal clarity, the Council added two new definitions, namely
‘critical GAP’ (i.e. the Good Agricultural Practice that forms the basis for a harmonised MRL
under the Regulation) and ‘CXL’ (i.e. an MRL set by the Codex Alimentarius Commission), and
deleted the definition of ‘composite foodstuffs’. In addition, the Council followed the European
Parliament in clarifying the definition of ‘pesticide residues’ (Article 3).

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(i) Technical and editorial amendments

A large number of other changes, including technical adjustments and clarifications, were also
made.

(j) Amendments not accepted by Council

Further discussion is needed, in particular, on issues associated with risk assessment, and on
provisions concerning the use of plant protection products, where Council was unable to agree to a
number of Parliament's amendments at this stage. Such items concern, in particular, approaches
to exposure assessment in the context of MRL-setting, considerations surrounding the most
appropriate way of providing information to the public, and the drafting of provisions
concerning good agricultural practice and pest management.