Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 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.
Date: 2005-02-23
Institutions: Council of the European Union, European Parliament
Subjects: animal feedingstuffs, animal product, crop production, food inspection, food safety, foodstuff, pesticide, pesticide residue

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I

(Acts whose publication is obligatory)

REGULATION (EC) NO 396/2005 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 23 February 2005

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)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community, 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
Directive 86/362/EEC of 24 July 1986 on the fixing of
maximum levels for pesticide residues in and on

(1) OJ C 234, 30.9.2003, p. 33.
(2) Opinion of the European Parliament of 20 April 2004 (not yet
published in the Official Journal), Council Common Position of
19 July 2004 (OJ C 25 E, 1.2.2005, p. 1) and Position of the
European Parliament of 15 December 2004 (not yet published
in the Official Journal) and Council Decision of 24 January
2005.

cereals (4), Council Directive 86/363/EEC of 24 July 1986
on the fixing of maximum levels for pesticide 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 and on
products of plant origin,
including fruit and vegeta-
bles (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should be repealed and replaced by a single act.

to the functioning of

(2) This Regulation directly concerns public health and is
relevant
the internal market.
Differences in national maximum residue levels for
pesticides 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
countries and the Community. Accordingly,
in the
interest of free movement of goods, equal competition
conditions among the Member States, as well as a high
level of consumer protection,
is appropriate that
maximum residue levels (MRLs) for products of plant and
animal origin be set at Community level, taking into
account good agricultural practice.

it

(3) A Regulation establishing MRLs does not

require
transposition into national law in the Member States. It
is therefore the most appropriate legal instrument with

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

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

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

Directive 2004/61/EC.

(4) OJ L 221, 7.8.1986, p. 37. Directive as last amended by
Commission Directive 2004/61/EC (OJ L 127, 29.4.2004,
p. 81).

(6) OJ L 350, 14.12.1990, p. 71. Directive as last amended by
Commission Directive 2004/95/EC (OJ L 301, 28.9.2004,
p. 42).

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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.

(4) 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 in
order to prevent a reduction in yield or damage to them,
and ensure both the quality of the products harvested
and high agricultural productivity. To this end, different
methods are available, including non-chemical methods,
practices such as using resistant varieties, crop rotation,
mechanical weeding, biological control and chemical
methods such as the use of plant protection products.

(5) One of the most common 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 products,
in animals feeding on those products and in honey
produced by bees exposed to those substances. Accord-
ing to Council Directive 91/414/EEC of 15 July 1991
concerning the placing of plant protection products on
the market (1), public health should be given priority over
the interests of crop protection, thus it is necessary to
ensure that such residues should not be present at levels
presenting an unacceptable risk to humans and, where
relevant, to animals. MRLs should be set at the lowest
achievable level consistent with good agricultural practice
for each pesticide with a view to protecting vulnerable
groups such as children and the unborn.

(7) 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
agricultural 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 the use of amounts of pesticides at
levels consistent with efficient pest control.

(8) 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 substances (3). At the
same time, many other active substances are not
currently authorised under Directive 91/414/EEC. The
residues of active substances in products of plant and
animal origin arising from unauthorised use or from
from use in third
environmental contamination or
countries should be carefully controlled and monitored.

(9) The basic rules with regard to food and feed law are laid

down in Regulation (EC) No 178/2002.

(6)

It is also important to carry out further work to develop
a methodology to take into account cumulative and
synergistic effects.
In view of human exposure to
combinations of active substances and their cumulative
and possible aggregate and synergistic effects on human
health, MRLs should be set after consultation of the
European Food Safety Authority established by Regula-
tion (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 safety (2)
(hereinafter the Authority).

(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/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 protection 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.

(1) OJ L 230, 19.8.1991, p. 1. Directive as last amended by
Commission Directive 2004/99/EC (OJ L 309, 6.10.2004, p. 6).
(2) OJ L 31, 1.2.2002, p. 1. Regulation as amended by

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

(3) OJ L 33, 8.2.1979, p. 36. Directive as last amended by
Regulation (EC) No 850/2004 of the European Parliament and
(OJ L 158, 30.4.2004, p. 7. Regulation as
of the Council
corrected in OJ L 229, 29.6.2004, p. 5).

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(11) 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 Regulation, it is
appropriate to apply them also to feed which is not
intended for
this
Regulation should not be an obstacle to the tests which
are necessary in order to assess pesticides.

food-producing animals. However,

(12) 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.
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 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 establishment of MRLs under
this Regulation.
Pursuant
to that Directive, a Member State may be
designated 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.

(13) It is appropriate that specific rules concerning the control
of pesticide residues be introduced to complement the
general Community provisions on the control of food
and feed.

(14) Whilst considering MRLs of pesticides, it should also be
recognised that few consumers are aware of the risks
arising from pesticides. It would be valuable to fully
explain such risks to the public.

(15) Member States should look into the possibility of
publishing the names of companies whose products
contain higher pesticide residues than the maximum
permitted levels.

(16) Specific rules for animal

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
relevant,
is
appropriate that the rules set out in this Regulation also
apply to those products in addition to the specific rules
for animal nutrition.

for animal consumption. Accordingly it

(17) It is necessary to define at Community level certain terms
used for the setting, control and reporting on controls of
MRLs for products of plant and animal origin.
It is
important that the Member States apply proper sanctions
in accordance with Regulation (EC) No 882/2004 of the
European Parliament and of the Council of 29 April
2004 on official controls performed to ensure the
verification of compliance with feed and food law, animal
health and animal welfare rules (2).

(18) Directive 76/895/EEC provides that Member States may
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.

(19) The determination of MRLs for pesticides 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
for
currently regulated by Directive 76/895/EEC or
pesticides for which Community MRLs have not yet
been set.

(20) 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.

(21) In exceptional circumstances and in particular
unauthorised pesticides that may be present
environment,
monitoring data in setting MRLs.

it is appropriate to permit

for
in the
the use of

(22) 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
appropriately low level to protect the consumer from the
intake of unauthorised or excessive levels of pesticides

(1) OJ L 140, 30.5.2002, p. 10. Directive as last amended by
Commission Directive 2003/100/EC (OJ L 285, 1.11.2003,
p. 33).

(2) OJ L 165, 30.4.2004, p. 1. Regulation as corrected in OJ L 191,

28.5.2004, p. 1.

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In order to facilitate control of residues of
residues.
for pesticide
pesticides, a default value is to be set
in products or groups of products
residues present
for which no MRLs have been
covered by Annex I
III, unless the active
established in Annexes II or
is
substance in question is listed in Annex IV.
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.

It

(28) 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.

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

the Community in certain cases

(23) 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 Authority.

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

(25) Through the World Trade Organisation, the Commu-
nity'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 Commu-
nity MRLs are being set,
the
corresponding good agricultural practices.

taking into account

(26) 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 are set 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.

(30) It

is good administrative practice and technically
desirable to coordinate 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.

(31) 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.

(32) 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
authorisations and, on completion of
re-evaluation,
should be made definitive if
they are supported by
dossiers which satisfy Annex III to Directive 91/414/EEC,
or be set to a default level if they are not so supported.

(33) This Regulation establishes MRLs for the control of
pesticide residues in food and feed.
is therefore
appropriate that Member States establish national
programmes to control these residues. The results of
the national control programmes are to be submitted to
the Commission, the Authority and the other Member
States and included in the Community annual report.

It

(27) It is necessary that the Authority assess MRL applications
and evaluation reports prepared by the Member States,
taking into account the full range of toxicological effects
such as immunotoxicity, endocrine disruption and
developmental toxicity, with a view to determining the
associated risks to consumers and, where relevant, to
animals.

(34) To ensure that consumers are kept adequately informed,
Member States should,
in accordance with Regulation
(EC) No 882/2004, publish the results of national
monitoring residues annually on the Internet, providing
all individual data, including the place of collection and
the names of retailers, traders and/or producers.

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(35) 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).

(36) 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
to achieve the
is necessary in order
objectives pursued in accordance with the third para-
graph of Article 5 of the Treaty,

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,
in
particular the need to ensure a high level of consumer
protection and harmonised 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.

2. This Regulation shall not apply to the products covered
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)

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

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
introduction of harmful organisms into its territory.

4. This Regulation shall apply without prejudice to
Directives 98/8/EC (2), 2002/32/EC and Regulation (EEC)
No 2377/90 (3).

Article 3

Definitions

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

2. The following definitions shall also apply:

(a)

(b)

(c)

‘good agricultural practice’ (GAP) means the nationally
recommended, authorised or registered safe use of plant
protection products under actual conditions at any stage
transport, distribution and
of production, storage,
processing of
It also implies the
in conformity with Directive 91/414/EEC,
application,
of the principles of integrated pest control in a given
climate zone, as well as using the minimum quantity of
pesticides and setting MRLs/temporary MRLs at
the
lowest
to be
obtained;

level which allows the desired effect

food and feed.

‘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;

‘pesticide residues’ means residues,
including 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, point

(2) 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
amended by Regulation (EC) No 1882/2003 (OJ L 284,
31.10.2003, p. 1).
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 1875/2004 (OJ L 326, 29.10.2004, p. 19).

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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 a concentration for a pesticide residue in or on
food or feed set in accordance with this Regulation, based
on good agricultural practice and the lowest consumer
exposure necessary to protect vulnerable consumers;

(e)

‘CXL’ means an MRL set by the Codex Alimentarius
Commission;

(f)

(g)

(h)

(i)

(j)

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

‘import
imported
products to meet the needs of international trade where:

tolerance’ means an MRL set

for

— the use of the active substance in a plant protection
product on a given product is not authorised in the
Community for reasons other than public health
reasons for the specific product and specific use; or

— a different level is appropriate because the existing
Community MRL was set for reasons other than
public health reasons for the specific product and
specific use;

‘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;

‘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 day, without appreciable risk to the consumer
on the basis of the data produced by appropriate studies
and taking into account sensitive groups within the
population (e.g. children and the unborn);

‘acceptable daily intake’ means the estimate of
the
amount of substances in food expressed on a body
weight basis, that can be ingested daily over a lifetime,
without appreciable risk to any consumer on the basis of
all known facts at the time of evaluation, taking into
account sensitive groups within the population (e.g.
children and the unborn).

Article 4

List of groups of products for which harmonised MRLs
shall apply

1. The products, product groups and/or parts of products
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.

2. Annex I shall be first established within three months
from the entry into force of this Regulation and shall be
revised when appropriate, in particular, at the request of a
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 Regulation.

2. Annex IV shall be first established within 12 months from
the entry into force of this Regulation.

CHAPTER II

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
protection 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 authorisation to submit an application in
accordance with Article 7.

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2. All parties demonstrating, through adequate evidence, a
legitimate interest in health, including civil society organisa-
tions, as well as commercially interested parties such as
manufacturers, growers, importers and producers of products
covered by Annex I may also submit an application to a
Member State in accordance with Article 7.

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. In no event may this
period exceed two years.

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

4. Applications for import tolerances shall be submitted to
rapporteur Member States designated pursuant to Directive
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 the 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

1. The applicant shall include in an application for an MRL
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;

(c)

(d)

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

use of that active substance;

a comprehensive overview of relevant concerns raised in
the available scientific literature about the plant protec-
tion product and/or its residue;

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, toxicological
data and data on routine analytical methods for use in
control
laboratories, as well as plant and animal
metabolism 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.

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 Authority and the Commission and
draw up an evaluation report without undue delay.

the Uniform Principles for

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

3. By way of derogation from paragraph 1 and by agreement
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 evaluat-
ing 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.

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
the application and the
state the date of
accompanying documents.

receipt of

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SECTION 2

Consideration of applications concerning MRLs by the
authority

the time limit

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

Article 10

Article 12

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
particular, 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
combination;

the pesticide/product

(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 intake
due to the residues in the product for which the MRLs
was requested;

(d)

any other element relevant to the risk assessment.

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

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

Assessment of existing MRLs by the Authority

1. 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 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
Annex II or III to this Regulation;

that active substance set out

in

(b)

the necessity of setting new MRLs for
that active
substance, or its inclusion in Annex IV to this Regulation;

(c)

specific processing factors as referred to in Article 20(2)
of this Regulation that may be needed for that active
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 to Directive 91/414/
2.
EEC before the entry into force of
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.

this Regulation,

Article 13

Administrative review

Article 11

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

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.

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.

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

In exceptional cases where more detailed evaluations need to
be carried out,
laid down in the first
subparagraph may be extended to six months from the date
of receipt of the valid application.

the time limit

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

if appropriate,

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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

1. Upon receipt of the opinion of the Authority and taking
into account
that opinion, a Regulation on the setting,
modification or deletion of an MRL or a Decision rejecting the
application 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).

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

(a)

the scientific and technical knowledge available;

(b)

(c)

(d)

(e)

(f)

the possible presence of pesticide residues arising from
sources other than current plant protection uses of active
substances, and their known cumulative and synergistic
effects, when the methods to assess such effects are
available;

the results of an assessment of any potential risks to
consumers with a high intake and high vulnerability and,
where appropriate, to animals;

the results of any evaluations and decisions to modify the
uses of plant protection products;

a CXL or a GAP implemented in a third country for the
legal use of an active substance in that country;

other legitimate factors relevant to the matter under
consideration.

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
supplementary 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

2. Where a temporary MRL is set as provided for in
it shall be deleted from Annex III by a
paragraph 1(b),
Regulation one year after the date of the inclusion or non-
inclusion in Annex I to Directive 91/414/EEC of the active
in accordance with the procedure
substance concerned,
referred to in Article 45(2) of
this Regulation. However,
it may be
where one or more Member States so request,
maintained for an additional year pending confirmation that
any scientific studies necessary for supporting an application
for setting a MRL have been undertaken. In cases where such
the temporary MRL shall be
confirmation is provided,
maintained for a further
two years, provided that no
unacceptable safety concerns for the consumer have been
identified.

Article 16

Procedure for setting temporary MRLs in certain
circumstances

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
contamination 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
component of
the diet of consumers, and do not
constitute a major part of the diet of relevant subgroups,
and, where relevant, of animals; or

(c)

for honey; or

(d)

for herbal infusions; or

(e) 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 Directive 91/414/EEC; or

(f) where new products, product groups and/or parts of
products have been included in Annex I, and one or
more Member States so request, in order to allow any
scientific studies necessary for supporting an MRL to be
undertaken and evaluated, provided that no unacceptable
safety concerns for the consumer have been identified.

(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
Regulation; or

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

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

The MRLs referred to in paragraph 1(e) shall be reassessed at
the expiry of the period for which the essential use was
authorised. The MRLs referred to in paragraph 1(f) shall be
reassessed when the scientific studies have been completed
and evaluated, but no later than four years after their inclusion
in Annex III.

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

(a)

such products are not
consumption;

intended for

immediate

Article 17

Modifications of MRLs following revocation of
authorisations 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:

(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;

(c)

the other Member States and the Commission have been
informed of the measures taken.

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 unacceptable 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.

(a)

such products comply with paragraph 1 and Article 20;
or

(1)

(b)

the active substance is listed in Annex IV.

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 Regulation (EC) No 882/2004.

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Article 20

Article 23

MRLs applicable to processed and/or composite products

Information to be provided by the Member States on
national MRLs

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

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

CHAPTER IV

(a)

the GAP;

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

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

Article 21

First establishment of MRLs

(c)

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.

1. MRLs for products covered by Annex I shall be first
established and listed in Annex II in accordance with the
procedure referred to in Article 45(2), incorporating the MRLs
provided for under Directives 86/362/EEC, 86/363/EEC and
90/642/EEC, taking into account the criteria mentioned in
Article 14(2) of this Regulation.

2. Annex II shall be established within 12 months from the
entry into force of this Regulation.

Article 24

Opinion of the Authority on data underlying national
MRLs

1. The Authority shall provide a reasoned opinion to the
Commission on potential risks to consumer health arising
from:

Article 22

(a)

temporary MRLs that may be included in Annex III;

First establishment of temporary MRLs

(b)

active substances that may be included in Annex IV.

1. Temporary MRLs for active substances for which a
decision 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
to in Article 45(2),
the information
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
this Regulation in accordance with
entry into force of
Articles 23, 24 and 25.

the Authority shall

In preparing the reasoned opinion referred to in
2.
paragraph 1,
the
scientific and technical knowledge available, and in particular,
information provided by the Member States as required by
Article 23.

take into account

Article 25

Setting of temporary MRLs

Taking into account the opinion of the Authority, if such an
opinion is necessary, 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). Temporary MRLs shall be set at the lowest level that can be
achieved in all Member States on the basis of good agricultural
practice.

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CHAPTER V

OFFICIAL CONTROLS, REPORTS AND SANCTIONS

SECTION 1

Official controls of MRLs

Article 26

Official controls

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

3. All laboratories analysing samples for the official controls
on pesticide residues shall participate in the Community
proficiency tests for pesticide residues organised by the
Commission.

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

to enforce compliance with this Regulation,

2.
Such controls on pesticide residues shall, in particular,
consist of sampling and subsequent analysis of the samples
and identification of the pesticides present and their respective
residue levels. Such controls shall also be carried out at the
point of supply to the consumer.

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

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

(1)

(2)

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 882/2004.
Commission Directive 2002/63/EC of 11 July 2002 establish-
ing 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).

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

National control programmes for pesticide residues

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

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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;

(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;

(b)

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

(c)

the pesticides to be analysed;

(d)

the criteria applied in drawing up such programmes,
including:

(i)

the pesticide-product combinations to be selected;

(d) details of

the accreditation status of

the analytical
laboratories involved in the controls referred to in point
(a);

(e) where permitted by national
enforcement measures taken.

legislation, details of

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.

(ii)

the number of samples taken for domestic and non-
domestic products respectively;

Article 32

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

national diet;

(iv)

the Community control programme; and

The Annual Report on Pesticide Residues

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.

(v)

the results of previous control programmes.

2. The Authority shall include information on at least the
following in the Annual Report:

their updated national
2. Member States shall submit
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 shall participate in the Community control
programme as provided for in Article 29. They shall, on an
annual basis, publish all results of national residue monitoring
on the Internet. Where MRLs are exceeded, Member States
may name the retailers, traders or producers concerned.

SECTION 4

Information by the Member States and annual report

(a)

(b)

(c)

(d)

an analysis of the results of the controls provided for in
Article 26(2);

a statement of the possible reasons why the MRLs were
exceeded, together with any appropriate observations
regarding risk management options;

an analysis of chronic and acute risks to the health of
consumers from pesticide residues;

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

Article 31

Information by the Member States

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.

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 results of
Article 26(1);

the official controls provided for

in

4. The format of the Annual Report may be decided in
accordance with the procedure referred to in Article 45(2).

5. The Authority shall submit the Annual Report to the
Commission by the last day of February each year.

6. The Annual Report may include an opinion on the
pesticides to be covered in future programmes.

the LODs applied in the national control programmes
referred to in Article 30 and under the Community
control programme referred to in Article 29;

7. The Authority shall make public the Annual Report, as
well as any comments by the Commission or Member States.

(a)

(b)

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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.

SECTION 5

Sanctions

Article 34

Sanctions

lay down rules on the sanctions
The Member States shall
applicable to infringements 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 provisions of

(a)

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

(b) Community proficiency tests as

referred to in

Article 28(3);

(c)

(d)

(e)

studies and other measures necessary for the preparation
and development of legislation and of technical guide-
lines on pesticide residues, aimed,
in particular, at
developing and using methods of assessing aggregate,
cumulative and synergistic effects;

studies necessary for estimating the exposure of
consumers and animals to pesticide residues;

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

Article 37

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

Community contribution to the support measures for
harmonised pesticide MRLs

CHAPTER VI

EMERGENCY MEASURES

Article 35

Emergency measures

Articles 53 and 54 of Regulation (EC) No 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. The time limit
within which the Commission must take its decision shall be
reduced to seven days in the case of fresh produce.

CHAPTER VII

SUPPORT MEASURES RELATING TO HARMONISED
PESTICIDE 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:

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

the cost of

2. The appropriations shall be authorised each financial year
as part of the budgetary procedure.

CHAPTER VIII

COORDINATION OF APPLICATIONS FOR MRLS

Article 38

Designation of national authorities

Each Member State shall designate one or more national
authorities 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

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Article 39

Coordination by the Authority of information on MRLs

The Authority shall:

(a)

(b)

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

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

CHAPTER IX

IMPLEMENTATION

Article 43

Scientific opinion of the Authority

The Commission or the Member States may request from the
Authority 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.

Article 44

Article 40

Procedure for the adoption of the Authority's opinions

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 Commis-
sion 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 VII. In particular it
shall contain dietary intake assessments, processing factors
and toxicological 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.

1. When the Authority's opinions pursuant to this Regula-
tion require only scientific or technical work involving the
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 of this Article 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)

(b)

implementing measures to ensure the uniform applica-
tion of this Regulation;

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

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(c)

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

(d) detailed rules concerning the scientific data required for

the setting of MRLs.

Article 47

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.

CHAPTER X

FINAL PROVISIONS

Article 48

Repeal and adaptation of legislation

1. Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/
642/EEC are hereby repealed with effect from the date referred
to in the second paragraph of Article 50.

2. Article 4(1)(f) of Directive 91/414/EEC shall be replaced
by the following:

‘(f) where appropriate,

the MRLs for

the agricultural
products affected by the use referred to in the
authorisation have been set or modified in accordance
with Regulation (EC) No 396/2005 (*)’

(*) OJ L 70, 16.3.2005, p. 1.

Article 49

Transitional measures

1. The requirements of Chapter 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.

in order

However,
to ensure a high level of consumer
protection 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 implementa-
tion of certain MRLs provided for in Articles 15, 16, 21, 22,
and 25.

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 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
the Regulations establishing
publication of
Annexes I, II, III and IV.

the last of

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

Done at Strasbourg, 23 February 2005.

For the European Parliament
The President
J.P. BORRELL FONTELLES

For the Council
The President
N. SCHMIT