Regulation (EC) No 299/2008 of the European Parliament and of the Council of 11 March 2008 amending Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin, as regards the implementing powers conferred on the Commission
Date: 2008-03-11
Institutions: Council of the European Union, European Parliament
Subjects: animal nutrition, animal product, crop production, food safety, foodstuff, foodstuffs legislation, pesticide residue, plant health legislation

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REGULATION (EC) No 299/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 11 March 2008

amending Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed
of plant and animal origin, as regards the implementing powers conferred on the Commission

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

(3)

Having regard to the Treaty establishing the European Commu-
nity, 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),

After consulting the Committee of the Regions,

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

Whereas:

(4)

(5)

Regulation (EC) No 396/2005 of the European Parliament
and of the Council (3) provides that certain measures are to
adopted in accordance with Council Decision
be
1999/468/EC of 28 June 1999 laying down the proce-
dures for the exercise of implementing powers conferred
on the Commission (4).

(1)

(2)

In accordance with the statement by the European Parlia-
ment, the Council and the Commission (5) concerning
Decision 2006/512/EC, for the regulatory procedure with
scrutiny to be applicable to instruments adopted in accor-
dance with the procedure referred to in Article 251 of the
Treaty which are already in force, those instruments must
be adjusted in accordance with the applicable procedures.

The Commission should be empowered to define the scope
of Regulation (EC) No 396/2005 and the criteria necessary
for the establishment of certain maximum residue levels
(MRLs) of pesticides in or on food and feed of plant and
animal origin listed in its relevant annexes. Since those
measures are of general scope and are designed to amend
non-essential elements of Regulation (EC) No 396/2005,
inter alia by supplementing it with new non-essential ele-
ments, they must be adopted in accordance with the regu-
latory procedure with scrutiny provided for in Article 5a of
Decision 1999/468/EC.

On grounds of efficiency and in order to guarantee eco-
nomic operators a rapid decision-making process, whilst
ensuring a high level of consumer protection, the normal
time limits for the regulatory procedure with scrutiny
should be curtailed for the adoption of measures setting,
including, implementing, modifying or deleting MRLs and
establishing a list of active substances for which no MRLs
are required, as well as a list of active substance/product
combinations where active substances are used as fumi-
gant for post-harvest treatment.

Decision 1999/468/EC has been amended by Decision
2006/512/EC, which introduced the regulatory procedure
with scrutiny for the adoption of measures of general scope
and designed to amend non-essential elements of a basic
instrument adopted in accordance with the procedure
referred to in Article 251 of the Treaty, inter alia by delet-
ing some of those elements or by supplementing the
instrument with new non-essential elements.

(6) When, on imperative grounds of urgency, and in particu-
lar where a risk to human or animal health exists, the nor-
mal time limits for the regulatory procedure with scrutiny
cannot be complied with, the Commission should be able
to apply the urgency procedure provided for
in
Article 5a(6) of Decision 1999/468/EC for the adoption of
measures setting, including, implementing, modifying or
deleting MRLs.

(1) OJ C 161, 13.7.2007, p. 45.
(2) Opinion of the European Parliament of 29 November 2007 (not yet
published in the Official Journal) and Council Decision of 3 March
2008.

(3) OJ L 70, 16.3.2005, p. 1. Regulation as amended by Commission

Regulation (EC) No 178/2006 (OJ L 29, 2.2.2006, p. 3).

(4) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision

(7)

Regulation (EC) No 396/2005 should therefore be
amended accordingly,

2006/512/EC (OJ L 200, 22.7.2006, p. 11).

(5) OJ C 255, 21.10.2006, p. 1.

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HAVE ADOPTED THIS REGULATION:

Article 1

Amendments

Regulation (EC) No 396/2005 is hereby amended as follows:

1. Article 4(1) shall be replaced by the following:

‘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. That mea-
sure, designed to amend non-essential elements of this Regu-
lation, shall be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 45(3). Annex I
shall include all products for which MRLs are set, as well as
the other products for which it is appropriate to apply har-
monised 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. Article 5(1) shall be replaced by the following:

‘1.
Active substances of plant protection products evalu-
ated under Directive 91/414/EEC for which no MRLs are
required shall be defined and listed in Annex IV to this Regu-
lation, taking into account the uses of those active substances
and the matters referred to in points (a), (c) and (d) of
Article 14(2). Those measures, designed to amend non-
essential elements of this Regulation, shall be adopted in
accordance with the regulatory procedure with scrutiny
referred to in Article 45(4).’;

3. Article 8(2) shall be replaced by the following:

‘2.
Applications shall be evaluated in accordance with the
relevant provisions of the Uniform Principles for the Evalu-
ation 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. That
regulation, designed to amend non-essential elements of this
Regulation by supplementing it, shall be adopted in accor-
dance with the regulatory procedure with scrutiny referred to
in Article 45(3).’;

(a) a regulation on the setting, modification or deletion of
an MRL. That regulation, designed to amend non-
essential elements of this Regulation, shall be adopted in
accordance with the regulatory procedure with scrutiny
referred to in Article 45(4). On imperative grounds of
urgency, the Commission may have recourse to the
urgency procedure referred to in Article 45(5) in order
to ensure a high level of consumer protection;

(b) a decision rejecting the application, which shall be
adopted in accordance with the regulatory procedure
referred to in Article 45(2).’;

5. Article 15(2) shall be replaced by the following:

‘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 to Directive 91/414/EEC of the active substance con-
cerned. That regulation, designed to amend non-essential ele-
ments of this Regulation, shall be adopted in accordance with
the regulatory procedure with scrutiny referred to in
Article 45(4). On imperative grounds of urgency, the Com-
mission may have recourse to the urgency procedure referred
to in Article 45(5) in order to ensure a high level of consumer
protection.

However, where one or more Member States so request, the
temporary MRL may be maintained for an additional year
pending confirmation that any scientific studies necessary for
supporting an application for setting a MRL have been under-
taken. In cases where such confirmation is provided, the tem-
porary MRL shall be maintained for a further two years,
provided that no unacceptable safety concerns for consum-
ers have been identified.’;

6. Article 18 shall be replaced by the following:

‘Article 18

Compliance with MRLs

4. Article 14(1) shall be replaced by the following:

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:

‘1.
Upon receipt of the opinion of the Authority and tak-
ing account of that opinion, one of the following shall be
prepared by the Commission without delay and at the latest
within three months:

(a)

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

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(b) 0,01 mg/kg for those products for which no specific
MRL is set out in Annexes II or III, or for active sub-
stances not listed in Annex IV unless different default
values are fixed for an active substance while taking into
account the routine analytical methods available. Such
default values shall be listed in Annex V. That measure,
designed to amend non-essential elements of this Regu-
lation, shall be adopted in accordance with the regula-
tory procedure with scrutiny referred to in Article 45(4).
On imperative grounds of urgency, the Commission
may have recourse to the urgency procedure referred to
in Article 45(5) in order to ensure a high level of con-
sumer protection.

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 paragraph 1 and Article 20;
or

In exceptional circumstances, and in particular further
4.
to the use of plant protection products in accordance with
Article 8(4) of Directive 91/414/EEC or pursuant to obliga-
tions set out in Directive 2000/29/EC (*), 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 appropri-
ate risk assessment for consideration without undue delay
with a view to setting a temporary MRL for a specified period
or taking any other necessary measure in relation to such
products. Those measures, designed to amend non-essential
elements of this Regulation by supplementing it, shall be
adopted in accordance with the regulatory procedure with
scrutiny referred to in Article 45(4). On imperative grounds
of urgency, the Commission may have recourse to the
urgency procedure referred to in Article 45(5) in order to
ensure a high level of consumer protection.

(*) Council Directive 2000/29/EC of 8 May 2000 on protec-
tive measures against the introduction into the Commu-
nity 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 Commis-
sion Directive 2007/41/EC (OJ L 169, 29.6.2007, p. 51).’;

(b)

the active substance is listed in Annex IV.

7. Article 20(2) shall be replaced by the following:

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 pro-
vided that:

‘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. That measure, designed to amend non-essential
elements of this Regulation, shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in
Article 45(3).’;

(a)

such products
consumption;

are not

intended for

immediate

8. Article 21(1) shall be replaced by the following:

(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 speci-
fied in Annexes II or III;

(c)

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

‘1. MRLs for products covered by Annex I shall be first
established and listed in Annex II, incorporating the MRLs
provided for under Directives 86/362/EEC, 86/363/EEC
and 90/642/EEC, taking into account the criteria listed in
Article 14(2) of this Regulation. Those measures, designed to
amend non-essential elements of this Regulation, shall be
adopted in accordance with the regulatory procedure with
scrutiny referred to in Article 45(3).’;

9. Article 22(1) shall be replaced by the following:

Measures designed to amend non-essential elements of this
Regulation and defining the active substance/product com-
binations listed in Annex VII shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in
Article 45(3).

‘1.
Temporary MRLs for active substances for which a
decision on inclusion or non-inclusion in Annex I to Direc-
tive 91/414/EEC has not yet been taken shall be first estab-
lished and listed in Annex III to this Regulation, unless

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already listed in Annex II, taking into account the informa-
tion provided by the Member States, where relevant the rea-
soned opinion referred to in Article 24, the factors referred
to in Article 14(2) and the following MRLs:

The time limits laid down in Article 5a(3)(c) and (4)(b) and (e)
of Decision 1999/468/EC shall be set at two months, one
month and two months respectively.

(a)

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

(b) hitherto unharmonised national MRLs.

Those measures, designed to amend non-essential elements
of this Regulation, shall be adopted in accordance with the
regulatory procedure with scrutiny
to in
Article 45(3).’;

referred

10. Article 27(2) shall be replaced by the following:

‘2. Measures designed to amend non-essential elements of
this Regulation by supplementing it and determining the
sampling methods necessary for carrying out such controls
of pesticide residues in products other than those provided
for in Directive 2002/63/EC (*) shall be adopted in accor-
dance with the regulatory procedure with scrutiny referred to
in Article 45(3) of this Regulation.

(*) Commission Directive 2002/63/EC of 11 July 2002 estab-
lishing 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).’;

11. Article 45 shall be replaced by the following:

‘Article 45

Committee procedure

reference

5. Where
to this paragraph,
Article 5a(1), (2), (4) and (6) and Article 7 of Decision
1999/468/EC shall apply, having regard to the provisions of
Article 8 thereof.’;

is made

12. Article 46 shall be replaced by the following:

‘Article 46

Implementing measures

1.
Implementing measures to ensure the uniform applica-
tion of this Regulation, technical guidance documents to
assist in its application and detailed rules concerning the sci-
entific data required for the setting of MRLs shall be estab-
lished or may be amended in accordance with the regulatory
procedure referred to in Article 45(2), taking into account,
where appropriate, the opinion of the Authority.

2. Measures designed to amend non-essential elements of
this Regulation and relating to the establishment or amend-
ment of the dates referred to in Article 23, Article 29(2),
Article 30(2), Article 31(1) and Article 32(5) shall be adopted
in accordance with the regulatory procedure with scrutiny
referred to in Article 45(3), taking into account, where appro-
priate, the opinion of the Authority.’;

13. Article 49 shall be replaced by the following:

1.
The Commission shall be assisted by the Standing
Committee on the Food Chain and Animal Health established
by Article 58 of Regulation (EC) No 178/2002.

‘Article 49

Transitional measures

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.

1.
The requirements of Chapter III shall not apply to prod-
ucts lawfully produced or imported into the Community
before the date referred to in the second paragraph of
Article 50.

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

3. Where reference is made to this paragraph, Article 5a(1)
to (4) and Article 7 of Decision 1999/468/EC shall apply,
having regard to the provisions of Article 8 thereof.

However, in order to ensure a high level of consumer pro-
tection, appropriate measures concerning those products
may be taken. Those measures, designed to amend non-
essential elements of this Regulation by supplementing it,
shall be adopted in accordance with the regulatory procedure
with scrutiny referred to in Article 45(5).

4. Where reference is made to this paragraph, Article 5a(1)
to (4) and (5)(b), and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.

2. Where necessary to allow for the normal marketing,
processing and consumption of products, further transitional
measures may be laid down for the implementation of

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certain MRLs provided for in Articles 15, 16, 21, 22, and 25.
Those measures, designed to amend non-essential elements
of this Regulation by supplementing it, and without preju-
dice to the obligation to ensure a high level of consumer pro-
tection, shall be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 45(4).’

Article 2

Entry into force

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

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

Done at Strasbourg, 11 March 2008.

For the European Parliament
The President
H.-G. PÖTTERING

For the Council
The President
J. LENARČIČ