Common Position (EC) No 2/2009 of 18 December 2008 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 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, and repealing Regulation (EEC) No 2377/90 (Text with EEA relevance)
Date: 2008-12-18
Institutions: Council of the European Union
Subjects: animal product, consumer protection, food safety, foodstuff, health legislation, human nutrition, veterinary drug

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COMMON POSITION (EC) No 2/2009

adopted by the Council on 18 December 2008

with a view to the adoption of Regulation (EC) No …/2009 of the European Parliament and of the
Council of … laying down Community procedures for the establishment of residue limits of
pharmacologically active substances in foodstuffs of animal origin, and repealing Regulation (EEC)
No 2377/90

(Text with EEA relevance)

(2009/C 33 E/02)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

(4)

Having regard to the Treaty establishing the European Com-
munity, and in particular Article 37 and Article 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,

(5)

Acting in accordance with the procedure referred to in
Article 251 of the Treaty (2),

Whereas:

(1)

(2)

(3)

As a result of scientific and technical progress it
is
possible to detect the presence of residues of veterinary
medicinal products in foodstuffs at ever lower levels.

In order
to protect public health, maximum residue
limits should be established in accordance with generally
recognised principles of safety assessment, taking into
account toxicological risks, environmental contamination,
as well as
the microbiological and pharmacological
effects of residues. Account should also be taken of other
scientific
substances
concerned which may have been undertaken by interna-
tional organisations or scientific bodies established within
the Community.

assessments of

safety of

the

This Regulation directly concerns public health and is
relevant to the functioning of
the internal market in
products of animal origin included in Annex I to the
Treaty. It is therefore necessary to establish maximum
residue limits for pharmacologically active substances in
respect of various foodstuffs of animal origin, including
meat, fish, milk, eggs and honey.

(6)

(7)

Council Regulation (EEC) No 2377/90 of 26 June 1990
laying down a Community procedure for the establish-
ment of maximum residue limits of veterinary medicinal
products in foodstuffs of animal origin (3)
introduced
Community procedures to evaluate the safety of residues
of pharmacologically active substances in accordance
with human food safety requirements. A pharmacologi-
cally active substance may be used in food-producing
animals only if evaluated favourably. Maximum residue
limits are established for such substances where they are
considered necessary for the protection of human health.

relating

Directive 2001/82/EC of the European Parliament and of
the Council of 6 November 2001 on the Community
to veterinary medicinal products (4)
Code
provides
that veterinary medicinal products may be
authorised or used in food-producing animals only if
pharmacologically active substances contained therein
have been assessed as safe according to Regulation (EEC)
that Directive contains rules
No 2377/90. Moreover
concerning the documentation of use, re-designation (‘off
label use’), prescription and distribution of veterinary
medicinal products intended for use in food-producing
animals.

In the light of the European Parliament's resolution of
3 May 2001 (5) on the availability of veterinary medicinal
products, the Commission's public consultation under-
taken in 2004 and its assessment of
the experience
gained, it has proved necessary to modify the procedures
for setting maximum residue limits while maintaining the
overall system for setting such limits.

in

establishment,

Maximum residue limits are the points of reference for
the
accordance with Directive
2001/82/EC, of withdrawal periods in marketing authori-
sations for veterinary medicinal products to be used in
food-producing animals as well as for the control of resi-
dues in food of animal origin in the Member States and
at border inspection posts.

(1) OJ C 10, 15.1.2008, p. 51.
(2) Opinion of

the European Parliament of 17 June 2008 (not yet
published in the OJ) and Council Common Position of 18 December
2008.

(3) OJ L 224, 18.8.1990, p. 1.
(4) OJ L 311, 28.11.2001, p. 1.
(5) OJ C 27 E, 31.1.2002, p. 80.

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(8)

(9)

(10)

(11)

(12)

Council Directive 96/22/EC of 29 April 1996 concerning
the prohibition on the use in stockfarming of certain
substances having a hormonal or thyrostatic action and
of beta-agonists (1) prohibits the use of certain substances
for specific purposes in food-producing animals. This
Regulation should apply without prejudice to any Com-
munity legislation prohibiting the use in food-producing
animals of certain substances having a hormonal action.

Council Regulation (EEC) No 315/93 of 8 February 1993
laying down Community procedures for contaminants in
food (2)
lays down specific rules for substances not
resulting
Those
substances
to legislation on
maximum residue limits.

from intentional
should not be subject

administration.

the

Regulation (EC) No 178/2002 of
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 (3) lays
down the framework for food legislation at Community
level and provides for definitions in that area. It is appro-
priate that those definitions apply for the purposes of
legislation on maximum residue limits.

the

European
Regulation (EC) No 882/2004 of
Parliament and of the Council of 29 April 2004 on offi-
cial controls performed to ensure the verification of
compliance with feed and food law, animal health and
animal welfare rules (4) lays down general rules for the
control of food in the Community and provides for defi-
nitions in that area. It is appropriate that those rules and
definitions apply for
legislation on
maximum residue limits. Priority should be given to the
detection of the illegal use of substances and part of the
samples should be selected according to a risk-based
approach.

the purposes of

the

Regulation (EC) No 726/2004 of
European
Parliament and of the Council of 31 March 2004 laying
down Community procedures for the authorisation and
supervision of medicinal products for human and veter-
a European Medicines
inary use
Agency (5) entrusts the European Medicines Agency (‘the
Agency’) with the task of advising on the maximum
residue limits for veterinary medicinal products which
may be accepted in food of animal origin.

and establishing

(13) Maximum residue limits should be set for pharmacologi-
cally active substances used or intended to be used in
veterinary medicinal products placed on the market in
the Community.

(1) OJ L 125, 23.5.1996, p. 3.
(2) OJ L 37, 13.2.1993, p. 1.
(3) OJ L 31, 1.2.2002, p. 1.
(4) OJ L 165, 30.4.2004, p. 1. Corrected version in OJ L 191, 28.5.2004,

p. 1.

(5) OJ L 136, 30.4.2004, p. 1.

(14)

(15)

(16)

(17)

It appears from the public consultation and from the fact
that only a small number of veterinary medicinal
products
been
for
that Regulation (EEC)
years
authorised in recent
No 2377/90 has resulted in such medicinal products
being less readily available.

food-producing

animals

have

In order to ensure animal health and welfare, it is neces-
sary that veterinary medicinal products are available to
treat specific disease conditions. Furthermore, the lack of
availability of appropriate veterinary medicinal products
for a specific treatment for a specific species may contri-
bute to the misuse or illegal use of substances.

The system established by Regulation (EEC) No 2377/90
should therefore be modified with a view to increasing
the availability of veterinary medicinal products for food-
producing animals. In order to serve that objective, provi-
sion should be made for the systematic consideration by
the Agency of the use of a maximum residue limit estab-
lished for one species or foodstuff for another species or
another foodstuff. In this respect, the adequacy of the
safety factors already inherent in the system should be
taken into account in order to ensure that food safety
and animal welfare are not compromised.

It is recognised that, in certain cases, scientific risk assess-
ments alone cannot provide all the information on which
risk management decisions should be based and that
other factors relevant to the matter under consideration
should legitimately be taken into account, including the
technological aspects of food production and the feasi-
bility of controls. The Agency should therefore provide
an opinion consisting of a scientific risk assessment and
risk management recommendations on residues of phar-
macologically active substances.

(18) Detailed rules on the format and content of applications
for the establishment of maximum residue limits and on
methodological principles of risk assessment and of risk
management
the
smooth functioning of
framework of
maximum residue limits.

recommendations are necessary for
the whole

(19)

the European Parliament and of

Besides veterinary medicinal products, other products
which are not subject to specific legislation on residues,
such as biocidal products, are used in animal husbandry.
These biocidal products are defined in Directive 98/8/EC
of
the Council of
16 February 1998 concerning the placing of biocidal
products on the market (6). Furthermore, veterinary
medicinal products not having a marketing authorisation
in the Community may be authorised in countries
outside the Community. That may be because in other
target species are more
regions different diseases or
to
prevalent or because companies have chosen not

(6) OJ L 123, 24.4.1998, p. 1.

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such products,

market a product in the Community. The fact that a
product is not authorised in the Community does not
necessarily indicate that its use is unsafe. For the pharma-
the
cologically active substances of
Commission should be enabled to set a maximum
residue limit
following an opinion by the
Agency, in accordance with the principles set for pharma-
cologically active substances intended for use in veter-
inary medicinal products. It is also necessary to amend
Regulation (EC) No 726/2004 to include, within the
tasks of the Agency, advising on the maximum levels of
residues of active substances in biocidal products.

food,

for

(20) Under

the system established by Directive 98/8/EC,
operators having placed or seeking to place biocidal
products on the market are obliged to pay charges for
the evaluations carried out pursuant to different proce-
dures associated with that Directive. This Regulation
provides that
the Agency is to carry out evaluations
the maximum residue
related to the establishment of
limit for pharmacologically active substances intended to
be used in biocidal products. As a consequence,
this
Regulation should clarify how those evaluations are
financed,
in order to take due account of fees already
collected for evaluations carried out, or to be carried out,
under that Directive.

controls, and Commission Decision 2005/34/EC of
11 January 2005 (2) lays down harmonised standards for
the testing for certain residues in products of animal
origin imported from third countries. It is appropriate to
extend the provisions of Decision 2005/34/EC to all
products of animal origin placed on the Community
market.

(24) A number of pharmacologically active substances are
prohibited or currently not authorised under Regulation
(EC) No 2377/90, Directive 96/22/EC or Regulation (EC)
No 1831/2003 of the European Parliament and of the
Council of 22 September 2003 on additives for use in
animal nutrition (3). The residues of pharmacologically
active substances in products of animal origin arising, in
particular,
from environmental
contamination should be carefully controlled and moni-
tored in accordance with Council Directive 96/23/EC of
certain
to monitor
29 April 1996 on measures
in live animals and
substances and residues thereof
animal products (4),
the
product.

from illegal use or

the origin of

regardless of

(25)

(26)

The Community contributes, in the context of the Codex
Alimentarius, to the development of international stan-
dards on maximum residue limits, while ensuring that
the high level of protection of human health maintained
in the Community is not
reduced. The Community
should therefore take over without a further risk assess-
ment those Codex Alimentarius maximum residue limits
it has supported in the relevant Codex Alimentarius
Commission meetings. Consistency between international
standards and Community legislation on residue limits in
food will thereby be further enhanced.

Foodstuffs are subject to controls on residues of pharma-
cologically active substances in accordance with Regu-
lation (EC) No 882/2004. Even if residue limits are not
set for such substances pursuant to this Regulation, resi-
dues of such substances might occur due to environ-
mental contamination or the occurrence of a natural
metabolite in the animal. Laboratory methods are capable
of finding such residues at ever lower levels. Such resi-
dues have caused different control practices in Member
States.

It is appropriate for the Community to provide for proce-
dures to set reference points for action at concentrations
of the residues for which laboratory analysis is technically
feasible in order to facilitate intra-Community trade and
imports, without undermining a high level of protection
of human health in the Community. However, the setting
of reference points for action should in no way serve as a
pretext for condoning the illegal use of prohibited or
non-authorised
food-producing
animals. Therefore, any residues of those substances in
food of animal origin should be considered undesirable.

substances

to treat

It is also appropriate for the Community to establish a
harmonised approach for situations where Member States
find evidence of a recurrent problem, since such a
finding could suggest a pattern of misuse of a particular
substance or a disregard for guarantees provided by third
countries concerning the production of food intended for
import
should
into the Community. Member States
notify the Commission of recurring problems, and appro-
priate follow-up measures should be taken.

Council Directive 97/78/EC of 18 December 1997 laying
down the principles governing the organisation of veter-
inary checks on products entering the Community from
third countries (1)
each consignment
imported from a third country is subject to veterinary

requires

that

(1) OJ L 24, 30.1.1998, p. 9.

(27)

The current
legislation on maximum residue limits
should be simplified by placing together in one single
Commission regulation all decisions classifying pharma-
cologically active substances as regards residues.

(2) OJ L 16, 20.1.2005, p. 61.
(3) OJ L 268, 18.10.2003, p. 29.
(4) OJ L 125, 23.5.1996, p. 10.

(21)

(22)

(23)

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(28)

(29)

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).

In particular, the Commission should be empowered to
adopt methodological principles for the risk assessment
and risk management recommendations regarding the
establishment of maximum residue limits, rules on the
conditions for extrapolation, measures setting reference
points for action,
including measures reviewing those
reference points, as well as methodological principles and
the establishment of reference
scientific methods for
points for action. Since those measures are of general
scope and are designed to amend non-essential elements
of this Regulation by supplementing it with new non-
essential elements, they must be adopted in accordance
with the regulatory procedure with scrutiny provided for
in Article 5a of Decision 1999/468/EC.

(30) When, on imperative grounds of urgency, the normal
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 reference points for action and
measures reviewing those reference points.

(31)

Since the objectives of
this Regulation, namely the
protection of human and animal health and ensuring the
availability of appropriate veterinary medicinal products,
cannot be sufficiently achieved by the Member States and
can therefore, by reason of the scale and effects of this
Regulation, be better achieved at Community level, the
Community may adopt measures, in accordance with the
principle of subsidiarity as set out in Article 5 of the
Treaty. In accordance with the principle of proportion-
ality, as set out in that Article, this Regulation does not
go beyond what is necessary in order to achieve those
objectives.

(32)

In the interests of clarity,
it is therefore necessary to
replace Regulation (EEC) No 2377/90 with a new
regulation.

(33) A transitional period should be provided for in order to
allow the Commission to prepare and adopt a regulation
incorporating the pharmacologically active substances
and their classification regarding maximum residue limits
as laid down in Annexes I to IV to Regulation (EEC)
No 2377/90, as well as certain implementing provisions
for that new regulation,

HAVE ADOPTED THIS REGULATION:

TITLE I

GENERAL PROVISIONS

Article 1

Subject matter and scope

This Regulation shall apply without prejudice to Com-
3.
munity legislation prohibiting the use
in food-producing
animals of certain substances having a hormonal or thyrostatic
action and of beta-agonists, as provided for by Directive
96/22/EC.

For the purposes of ensuring food safety, this Regulation

1.
lays down rules and procedures in order to establish:

(a) the maximum concentration of a residue of a pharmacologi-
cally active substance which may be permitted in food of
animal origin (‘maximum residue limit’);

(b) the level of a residue of a pharmacologically active substance
established for control
in the case of certain
reasons
substances for which a maximum residue limit has not been
laid down in accordance with this Regulation (‘reference
point for action’).

2.

This Regulation shall not apply:

(a) to active principles of biological origin intended to produce
active or passive immunity or to diagnose a state of immu-
nity, used in immunological veterinary medicinal products;

Article 2

Definitions

In addition to the definitions laid down in Article 1 of Directive
2001/82/EC, Article 2 of Regulation (EC) No 882/2004 and
Articles 2 and 3 of Regulation (EC) No 178/2002, the following
definitions shall apply for the purposes of this Regulation:

(a) ‘residues of pharmacologically active substances’ means all
pharmacologically active substances, expressed in mg/kg or
μg/kg on a fresh weight basis, whether active substances,
excipients or degradation products, and their metabolites
which remain in food obtained from animals;

(b) to substances falling within the scope of Regulation (EEC)

No 315/93.

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

(b) ‘food-producing animals’ means animals bred, raised, kept,
slaughtered or harvested for the purposes of producing
food.

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TITLE II

MAXIMUM RESIDUE LIMITS

CHAPTER I

Risk assessment and risk management

S e c t i o n 1

pharmacologically active substance in a particular foodstuff for
another foodstuff derived from the same species, or maximum
residue
active
established for
substance in one or more species for other species.

a pharmacologically

limits

i n t e n d e d
P h a r m a c o l o g i c a l l y a c t i ve
f o r u s e i n ve t e r i n a r y m e d i c i n a l p r o d u c t s i n t h e
C o m m u n i t y

s u b s t a n c e s

Article 6

Scientific risk assessment

Article 3

Application for an opinion of the Agency

in cases where the Codex Alimentarius procedure
Except
referred to in Article 14(3) of this Regulation applies, any phar-
macologically active substance intended for use in the Com-
munity in veterinary medicinal products which are to be admi-
nistered to food-producing animals shall be subject
to an
opinion of the European Medicines Agency (‘the Agency’) estab-
lished by Article 55 of Regulation (EC) No 726/2004 on the
maximum residue limit,
formulated by the Committee for
Medicinal Products for Veterinary Use (‘the Committee’) estab-
lished by Article 30 of that Regulation.

To that end, the applicant for a marketing authorisation for a
veterinary medicinal product in which such a substance is used,
a person intending to apply for such a marketing authorisation
or, where appropriate, the holder of such a marketing authorisa-
tion, shall submit an application to the Agency.

Article 4

Opinion of the Agency

The opinion of the Agency shall consist of a scientific risk

1.
assessment and risk management recommendations.

2.
The scientific risk assessment and the risk management
recommendations shall aim to ensure a high level of human
health protection, whilst also ensuring that human health,
animal health and animal welfare are not negatively affected by
the lack of availability of appropriate veterinary medicinal
products. The opinion shall take account of any relevant scien-
tific findings of the European Food Safety Authority (‘EFSA’)
established by Article 22 of Regulation (EC) No 178/2002.

Article 5

Extrapolation

1.
The scientific risk assessment shall consider the metabo-
lism and depletion of pharmacologically active substances in
relevant animal species, the type of residues and the amount
thereof, that may be ingested by human beings over a lifetime
without an appreciable health risk expressed in terms of accep-
table daily intake (‘ADI’). Alternative approaches to ADI may be
they have been laid down by the Commission as
used,
provided for in Article 13(2).

if

2.

The scientific risk assessment shall concern the following:

(a) the type and amount of residue considered not to present a

safety concern for human health;

(b) the risk of toxicological, pharmacological or microbiological

effects in human beings;

(c) residues that occur in food of plant origin or that come

from the environment.

If the metabolism and depletion of the substance cannot
3.
be assessed, the scientific risk assessment may take into account
monitoring data or exposure data.

Article 7

Risk management recommendations

The risk management recommendations shall be based on the
scientific risk assessment performed in accordance with Article 6
and shall consist of an assessment of the following:

(a) the availability of alternative substances for the treatment of
the relevant species or the necessity of the substance evalu-
ated in order to avoid unnecessary suffering for animals or
to ensure the safety of those treating them;

(b) other legitimate factors, such as the technological aspects of
food and feed production, the feasibility of controls, condi-
tions of use and application of the substances in veterinary
medicinal products, good practice in the use of veterinary
medicinal and biocidal products and the likelihood of
misuse or illegal use;

With a view to ensuring the availability of authorised veterinary
medicinal products
for conditions affecting food-producing
animals, the Agency, while ensuring a high level of protection
of human health, shall, when carrying out scientific risk assess-
ments and when drawing up risk management recommenda-
tions, consider using maximum residue limits established for a

(c) whether or not a maximum residue limit or a provisional
maximum residue limit should be established for a pharma-
cologically active substance in veterinary medicinal products,
the level of that maximum residue limit and, where appro-
priate, any conditions or restrictions for the use of
the
substance concerned;

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(d) whether the data provided are not sufficient to allow a safe
limit
to be identified, or whether a final conclusion
concerning human health with regard to residues of a
substance cannot be established given the lack of scientific
information. In either case, no maximum residue limit may
be recommended.

(b) where the substance in question is included in a medicinal
product intended to be used pursuant to Article 11 of Direc-
tive 2001/82/EC and no application for the establishment
of a maximum residue limit for that substance in respect of
the foodstuff or species concerned has been submitted
pursuant to Article 3 of this Regulation.

Article 8

Applications and procedures

The application referred to in Article 3 shall comply with
1.
the format and content
laid down by the Commission as
provided for in Article 13(1) and shall be accompanied by the
fee payable to the Agency.

that

ensure

the opinion of

The Agency shall

2.
the
Committee is given within 210 days of receipt of a valid appli-
cation in accordance with Article 3 and paragraph 1 of this
Article. This time limit shall be suspended where the Agency
requests the submission of supplementary information on the
given substance within a specific time period, and shall remain
suspended until such time as the requested supplementary infor-
mation has been provided.

The Agency shall

3.
forward the opinion referred to in
Article 4 to the applicant. Within 15 days of receipt of the
opinion, the applicant may provide written notice to the Agency
that he wishes to request a re-examination of the opinion. In
that case the applicant shall submit the detailed grounds for his
request to the Agency within 60 days of receipt of the opinion.

Within 60 days of receipt of
the applicant's grounds for a
re-examination request, the Committee shall consider whether
its opinion should be revised and adopt the final opinion. The
reasons for the conclusion reached on the request shall be
annexed to the final opinion.

4. Within 15 days of the adoption of the final opinion, the
Agency shall forward it to the Commission and the applicant,
stating the grounds for its conclusions.

S e c t i o n 2

O t h e r p h a r m a c o l o g i c a l l y a c t i ve s u b s t a n c e s f o r
b e
w h i c h

t h e A g e n c y m a y

o p i n i o n

a n

o f

r e q u e s t e d

Article 9

Opinion of the Agency requested by the Commission or a
Member State

The Commission or a Member State may submit to the
1.
Agency a request for an opinion on maximum residue limits in
either of the following circumstances:

(a) where the substance in question is authorised for use in a
veterinary medicinal product in a third country and no
application for the establishment of a maximum residue
limit for that substance in respect of the foodstuff or species
concerned has been submitted pursuant to Article 3;

In the circumstances of point (b) of the first subparagraph,
where minor species or minor uses are concerned, the request
may be submitted to the Agency by an interested party or orga-
nisation.

Articles 4 to 7 shall apply.

A request for an opinion referred to in the first subparagraph of
this paragraph shall comply with the format and content
to
requirements
Article 13(1).

laid down by the Commission pursuant

that

ensure

the opinion of

The Agency shall

2.
the
Committee is given within 210 days of receipt of the request by
the Commission, a Member State or an interested party or orga-
nisation. This time limit shall be suspended if
the Agency
requests the submission of supplementary information on the
given substance within a specific time period and until such
time as the requested supplementary information has been
provided.

3. Within 15 days of the adoption of the final opinion, the
Agency shall forward it to the Commission and, as applicable,
to the Member State or the interested party or organisation
which made the request, stating the grounds for its conclusions.

Article 10

Pharmacologically active substances contained in biocidal
products used in animal husbandry

1.
For the purposes of Article 10(2)(ii) of Directive 98/8/EC,
for pharmacologically active substances intended to be used in a
biocidal product used in animal husbandry,
the maximum
residue limit shall be established:

(a) following the procedure referred to in Article 9 of this Regu-

lation for:

(i) active substances/product type combinations included in
the 10-year programme of work referred to in
Article 16(2) of Directive 98/8/EC;

(ii) active substances/product

type combinations

to be
included in Annexes I, IA or IB to Directive 98/8/EC for
which a dossier has been accepted by the competent
authority as referred to in Article 11(1)(b) of that Direc-
tive before … (*);

(b) following the procedure referred to in Article 8 of this Regu-
lation and on the basis of an application submitted in
accordance with Article 3 of this Regulation for all other
active substances/product type combinations to be included
in Annexes I, IA or IB to Directive 98/8/EC for which the
establishment of a maximum residue limit is deemed neces-
sary by the Member States or the Commission.

(*) The date of entry into force of this Regulation.

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2.
The Commission shall classify the pharmacologically
active substances referred to in paragraph 1 in accordance with
Article 14. For the purposes of classification, a regulation as
referred to in Article 17(1) shall be adopted by the Commission.

Article 13

Implementing measures

However, any specific provisions relating to the conditions of
use of the substances classified in accordance with the first sub-
paragraph of this paragraph shall be laid down pursuant to
Article 10(2) of Directive 98/8/EC.

1.
In accordance with the regulatory procedure referred to in
Article 25(2), the Commission shall, in consultation with the
Agency, adopt measures regarding the form and content of the
applications and requests referred to in Articles 3 and 9.

3.
The costs of evaluations carried out by the Agency
following a request made in accordance with paragraph 1(a) of
this Article shall be covered by the budget of the Agency as
referred to in Article 67 of Regulation (EC) No 726/2004.
However,
this shall not apply to the evaluation costs of a
rapporteur designated, in accordance with Article 62(1) of that
Regulation, for the establishment of a maximum residue limit
where that rapporteur has been appointed by a Member State
that has already received a fee for that evaluation on the basis of
Article 25 of Directive 98/8/EC.

the fees for evaluations carried out by the
The amount of
Agency and the rapporteur following an application made in
accordance with paragraph 1(b) of
this Article shall be
established in accordance with Article 70 of Regulation (EC)
No 726/2004. Council Regulation (EC) No 297/95 of
10 February 1995 on fees payable to the European Agency for
the Evaluation of Medicinal Products (1) shall apply.

S e c t i o n 3

C o m m o n p r ov i s i o n s

Article 11

Review of an opinion

Where the Commission, the applicant under Article 3 or a
Member State, as a result of new information, considers that a
review of an opinion is necessary in order to protect human or
animal health, it may request the Agency to issue a new opinion
on the substances in question.

Where a maximum residue limit has been established in accord-
ance with this Regulation for specific foodstuffs or species, Arti-
cles 3 and 9 shall apply for the establishment of a maximum
residue limit for that substance for other foodstuffs or species.

The request referred to in the first subparagraph shall be accom-
panied by information explaining the issue to be addressed.
Article 8(2) to (4) or Article 9(2) and (3),as appropriate, shall
apply to the new opinion.

Article 12

Publication of opinions

2.
The Commission shall, in consultation with the Agency,
Member States and interested parties, adopt measures regarding:

(a) the methodological principles for the risk assessment and
risk management recommendations referred to in Articles 6
and 7, including technical requirements in accordance with
internationally agreed standards;

(b) rules on the use of a maximum residue limit established for
a pharmacologically active substance in a particular food-
stuff for another foodstuff derived from the same species, or
a maximum residue limit established for a pharmacologi-
cally active substance in one or more species for other
species, as referred to in Article 5. Those rules shall specify
how and under what circumstances scientific data on resi-
dues in a particular foodstuff or in a species or more species
may be used for setting a maximum residue limit in other
foodstuffs, or other species.

Those measures, designed to amend non-essential elements of
this Regulation by supplementing it, shall be adopted in accord-
ance with the regulatory procedure with scrutiny referred to in
Article 25(3).

CHAPTER II

Classification

Article 14

Classification of pharmacologically active substances

1.
The Commission shall classify the pharmacologically
active substances subject to an opinion of the Agency on the
maximum residue limit in accordance with Article 4, 9 or 11,
as appropriate.

2.
The classification shall include a list of pharmacologically
active substances and the therapeutic classes to which they
belong. The classification shall also establish, in relation to each
such substance, and, where appropriate, specific foodstuffs or
species, one of the following:

(a) a maximum residue limit;

(b) a provisional maximum residue limit;

The Agency shall publish the opinions referred to in Articles 4,
9 and 11 after deleting any information of a commercially
confidential nature.

(c) the absence of the need to establish a maximum residue

limit;

(1) OJ L 35, 15.2.1995, p. 1.

(d) a prohibition on the administration of a substance.

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A maximum residue limit shall be laid down where it

3.
appears necessary for the protection of human health:

(a) pursuant to an opinion of the Agency in accordance with

Article 4, 9 or 11, as appropriate; or

(b) pursuant to a decision of the Codex Alimentarius Commis-
sion, without objection from the Community Delegation, in
favour of a maximum residue limit for a pharmacologically
active substance intended for use in a veterinary medicinal
product, provided that the scientific data taken into consid-
eration have been made available to the Community Delega-
the Codex Alimentarius
tion prior
Commission. In this case, an additional assessment by the
Agency shall not be required.

to the decision of

A provisional maximum residue limit may be established
4.
in cases where scientific data are incomplete, provided that there
are no grounds for supposing that residues of that substance at
the level proposed constitute a hazard to human health.

The provisional maximum residue limit shall apply for a defined
period of time, which shall not exceed five years. That period
may be extended once for a period not exceeding two years
where it is demonstrated that such an extension would allow
completion of scientific studies in progress.

5.
No maximum residue limit shall be established where,
pursuant to an opinion in accordance with Article 4, 9 or 11,
as appropriate, it is not necessary for the protection of human
health.

6.
The administration of a substance to food-producing
animals shall be prohibited, pursuant to an opinion in accord-
ance with Article 4, 9 or 11, as appropriate, in either of the
following circumstances:

(a) where any presence of a pharmacologically active substance
or residues thereof in foods of animal origin may constitute
a hazard to human health;

(b) where no final conclusion concerning the effect on human

health of residues of a substance can be drawn.

7. Where it appears necessary for the protection of human
health, the classification shall include conditions and restrictions
for
the use or application of a pharmacologically active
substance used in veterinary medicinal products which is subject
to a maximum residue limit, or for which no maximum residue
limit has been set.

Article 15

Accelerated procedure for an opinion of the Agency

1.
In specific cases where a veterinary medicinal product or a
biocidal product needs to be authorised as a matter of urgency
for reasons relating to the protection of public health or of
animal health or welfare, the Commission, any person who has
submitted an application for an opinion pursuant to Article 3
or a Member State may ask the Agency to carry out an acceler-

ated procedure for the assessment of the maximum residue limit
of a pharmacologically active substance contained in those
products.

2.
The format and content of the application referred to in
paragraph 1 of this Article shall be laid down by the Commis-
sion pursuant to Article 13(1).

3.
By way of derogation from the time limits laid down in
Article 8(2) and Article 9(2), the Agency shall ensure that the
opinion of the Committee is given within 120 days of receipt of
the application.

Article 16

Administration of substances to food-producing animals

1.
Only pharmacologically active substances which are classi-
fied in accordance with Article 14(2)(a), (b) or (c) may be admi-
nistered to food-producing animals within the Community,
provided that such administration is in accordance with Direc-
tive 2001/82/EC.

2.
Paragraph 1 shall not apply in the case of clinical trials
which are accepted by the competent authorities following noti-
fication or authorisation in accordance with the legislation in
force and which do not cause foodstuffs obtained from livestock
participating in such trials to contain residues which constitute
a hazard to human health.

Article 17

Procedure

For the purposes of

1.
the classification provided for in
Article 14, the Commission shall prepare a draft regulation
within 30 days of receipt of an opinion of
the Agency as
referred to in Article 4, 9 or 11, as appropriate. The Commis-
sion shall also prepare a draft regulation within 30 days of
receipt of the decision of the Codex Alimentarius Commission,
without objection from the Community Delegation, in favour of
the establishment of a maximum residue limit as referred to in
Article 14(3).

Where the opinion of the Agency is required and the draft regu-
lation is not in accordance with this opinion, the Commission
shall provide a detailed explanation of
the reasons for the
divergence.

2.
The regulation referred to in paragraph 1 of this Article
shall be adopted by the Commission in accordance with, and
within 30 days of the end of, the regulatory procedure referred
to in Article 25(2).

3.
In the case of an accelerated procedure as referred to in
Article 15, the Commission shall adopt the regulation referred
to in paragraph 1 of this Article in accordance with, and within
15 days of the end of, the regulatory procedure referred to in
Article 25(2).

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TITLE III

REFERENCE POINTS FOR ACTION

Article 18

Establishment and review

When it is deemed necessary in order to ensure the functioning
of controls of food of animal origin imported or placed on the
market in accordance with Regulation (EC) No 882/2004, the
Commission may establish reference points for action for resi-
dues from pharmacologically active substances which are not
subject to a classification in accordance with Article 14(2)(a), (b)
or (c).

The reference points for action shall be reviewed regularly in the
light of new scientific data relating to food safety, the outcome
of the investigations and analytical tests referred to in Article 24
and technological progress.

Those measures, designed to amend non-essential elements of
this Regulation, shall be adopted in accordance with the regula-
tory procedure with scrutiny referred to in Article 26(3). On
imperative grounds of urgency,
the Commission may have
recourse to the urgency procedure referred to in Article 26(4).

Article 19

Methods for establishing reference points for action

1.
The reference points for action to be established pursuant
to Article 18 shall be based on the content of an analyte in a
sample, which can be detected and confirmed by official control
laboratories designated in accordance with Regulation (EC)
No 882/2004 with an analytical method validated in accordance
with Community requirements. The reference point for action
should take into account the lowest residue concentration which

can be quantified with an analytical method validated in accord-
ance with Community requirements. The Commission shall be
advised on the performance of analytical methods by the rele-
vant Community reference laboratory.

2. Without prejudice
second subparagraph of
to the
Article 29(1) of Regulation (EC) No 178/2002, the Commission
shall, where appropriate, submit a request to EFSA for a risk
assessment as to whether the reference points for action are
adequate to protect human health. In those cases, EFSA shall
ensure that the opinion is given to the Commission within
210 days of receipt of the request.

The principles of risk assessment shall be applied in order
3.
to guarantee a high level of protection of health. The risk assess-
ment shall be based on methodological principles as well as
scientific methods to be adopted by the Commission in consul-
tation with EFSA.

Those measures, designed to amend non-essential elements of
this Regulation by supplementing it, shall be adopted in accord-
ance with the regulatory procedure with scrutiny referred to in
Article 26(3).

Article 20

Community contribution to the support measures for
reference points for action

the application of

If
this Title requires the Community to
finance measures in support of the establishment and func-
tioning of reference points for action, Article 66(1)(c) of Regu-
lation (EC) No 882/2004 shall apply.

TITLE IV

MISCELLANEOUS PROVISIONS

Article 21

Analytical methods

where this Regulation and its implementing measures have been
complied with.

The Agency shall consult Community reference laboratories for
laboratory analysis of residues designated by the Commission in
accordance with Regulation (EC) No 882/2004 on appropriate
analytical methods for detecting residues of pharmacologically
active substances for which maximum residue limits have been
determined in accordance with Article 14 of this Regulation.
For the purposes of harmonised controls,
the Agency shall
provide information regarding those methods to the Com-
munity reference laboratories and national reference laboratories
designated in accordance with Regulation (EC) No 882/2004.

Article 22

Circulation of foodstuffs

Member States may not prohibit or impede the import or the
placing on the market of food of animal origin on grounds
related to maximum residue limits or reference points for action

Article 23

Placing on the market

Food of animal origin containing residues of a pharmacologi-
cally active substance:

(a) classified in accordance with Article 14(2)(a), (b) or (c) at a
level exceeding the maximum residue limit established
pursuant to this Regulation, or

(b) not classified in accordance with Article 14(2)(a), (b) or (c),
except where a reference point for action has been set for
that substance pursuant to this Regulation and the level of
residues does not equal or exceed that reference point for
action

shall be considered not to comply with Community legislation.

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Detailed rules on the maximum residue limit to be considered
for control purposes for foodstuffs derived from animals which
have been treated under Article 11 of Directive 2001/82/EC
shall be adopted by the Commission in accordance with the
regulatory procedure referred to in Article 26(2) of
this
Regulation.

2. Where the results of those investigations or analytical tests
on products of the same origin show a recurrent pattern indi-
cating a potential problem, the competent authority shall retain
a record of the findings and inform the Commission and the
other Member States in the Standing Committee on the Food
Chain and Animal Health referred to in Article 26.

Article 24

Action in case of confirmed presence of a prohibited or
non-authorised substance

1. Where the results of analytical tests are below the refer-
ence points for action, the competent authority shall carry out
the investigations provided for by Directive 96/23/EC to deter-
mine whether there has been illegal administration of a prohib-
ited or non-authorised pharmacologically active substance and,
where relevant, shall apply the penalty provided for.

3. Where appropriate, the Commission shall submit propo-
sals, and in the case of products of third country origin, bring
the matter to the attention of the competent authority of the
country or countries concerned requesting clarification as to the
recurrent presence of residues.

Detailed rules on the application of this Article shall be
4.
adopted. Those measures, designed to amend non-essential
elements of
this Regulation by supplementing it, shall be
adopted in accordance with the regulatory procedure with scru-
tiny referred to in Article 26(3).

TITLE V

FINAL PROVISIONS

Article 25

Article 27

Standing Committee on Veterinary Medicinal Products

The Commission shall be assisted by the Standing

1.
Committee on Veterinary Medicinal Products.

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 one month.

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.

Classification of pharmacologically active substances under
Regulation (EEC) No 2377/90

1.
By … (*), the Commission shall adopt, in accordance with
the regulatory procedure referred to in Article 25(2), a regu-
lation incorporating the pharmacologically active substances
and their classification regarding maximum residues limits as
laid down in Annexes I to IV to Regulation (EEC) No 2377/90
without any modification.

2.
For any substance referred to in paragraph 1 for which a
maximum residue limit has been established under Regulation
(EEC) No 2377/90, the Commission or a Member State may
also submit to the Agency a request for an opinion on extrapo-
lation to other species or tissues in accordance with Article 5.

Article 26

Article 17 shall apply.

Standing Committee on the Food Chain and Animal Health

The Commission shall be assisted by the Standing

1.
Committee on the Food Chain and Animal Health.

Article 28

Reporting

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.

By … (**), the Commission shall submit a report to the

1.
European Parliament and the Council.

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

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.

The report shall,

2.
review the experience
in particular,
gained from the application of this Regulation, including experi-
ence with substances classified under this Regulation which
have a multiple use.

The report shall, if appropriate, be accompanied by rele-

3.
vant proposals.

4. Where reference is made 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.

(*) 60 days after the entry into force of this Regulation.
(**) Five years after the entry into force of this Regulation.

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Article 29

Repeal

Regulation (EEC) No 2377/90 is hereby repealed.

Annexes I to IV to the repealed Regulation shall continue to
apply until the entry into force of the regulation referred to in
Article 27(1) of this Regulation, and Annex V to the repealed
Regulation shall continue to apply until the entry into force of
the measures referred to in Article 13(1) of this Regulation.

References to the repealed Regulation shall be construed as
references to this Regulation or, as appropriate, to the regulation
referred to in Article 27(1) of this Regulation.

Article 30

Amendments to Directive 2001/82/EC

Directive 2001/82/EC is hereby amended as follows:

1) Article 10(3) shall be replaced by the following:

By way of derogation from Article 11, the Commis-

‘3.
sion shall establish a list of substances:

— which are essential for the treatment of equidae, or

— which bring added clinical benefit compared to other

treatment options available for equidae

and for which the withdrawal period shall not be less than
six months according to the control mechanisms laid down
in Decisions 93/623/EEC and 2000/68/EC.

Those measures, designed to amend non-essential elements
of this Directive by supplementing it, shall be adopted in
accordance with the regulatory procedure with scrutiny
referred to in Article 89(2a).’;

2) in Article 11(2), the third subparagraph shall be replaced by

the following:

In so doing,

‘The Commission may modify these withdrawal periods or
establish other withdrawal periods.
the
Commission may differentiate between foodstuffs, species,
routes of administration and annexes to Regulation (EEC)
No 2377/90. Those measures, designed to amend non-essen-
tial elements of this Directive, shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in
Article 89(2a).’.

Article 31

Amendment to Regulation (EC) No 726/2004

Article 57(1)(g) of Regulation (EC) No 726/2004 shall be
replaced by the following:

‘(g) advising on the maximum limits

for

residues of
veterinary medicinal products and biocidal products
used in animal husbandry which may be accepted in
foodstuffs of animal origin in accordance with Regu-
lation (EC) No …/2009 of the European Parliament and
of the Council of … laying down Community proce-
dures for the establishment of residue limits of pharma-
cologically active substances in foodstuffs of animal
origin (*).

(*) OJ L …’.

Article 32

Entry into force

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

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

Done at, …

For the European Parliament

The President

…

For the Council

The President

…

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STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. On 17 April 2007, the Commission submitted to the Council the abovementioned proposal based

on Article 152(4)(b) of the EC Treaty (codecision).

2. The European Parliament delivered its first reading opinion on 17 June 2008. The Economic and
Social Committee delivered its Opinion on 26 September 2007. The Committee of the Regions
decided not to deliver any opinion on this proposal.

3. The Council concluded its first reading and adopted its Common Position during its session of

18 December 2008, in accordance with the procedure laid down in Article 251 of the Treaty.

II. OBJECTIVES

1. The proposal aims at reviewing and completing existing provisions related to the establishment of
Maximum Residue Limits (MRLs) for pharmacologically active substances in foodstuffs of animal
origin. The main objectives foreseen are:

— to improve the availability of veterinary medicinal products for food producing animals whilst

ensuring a high level of human health protection;

— to create a specific legal framework to establish MRLs for pharmacologically active substances not

intended for use in veterinary medicinal products in the EU;

— to improve the consistency of EU legislation with international standards via the introduction of
the obligation to include MRLs set by the Codex Alimentarius in Community legislation, when
supported by the Community;

— to provide clear references for control purposes (i.e. Reference Points for Action) in some cases

where MRLs have not been set.

2. The proposal provides also for some improvements in terms of simplification and better regulation.

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
supported by the European Parliament;

the arrangements proposed by the Commission and

— includes a very large number of the amendments passed at first reading by the European

Parliament.

The Council also considered it was appropriate to introduce a number of amendments — in addition
to those made at the suggestion of the Parliament — either to clarify the scope of some provisions,
or to make the wording of the Regulation more explicit and guarantee legal certainty, or to increase
its consistency with other Community instruments.

B. Specific comments

1. Main amendments to the Commission proposal

(a) Improvement of the availability of veter inar y medicinal products

At the suggestion of the Parliament, amendments were made to a few provisions in order to
try to improve the availability of veterinary medicinal products for food producing animals, in
particular with regard to minor species and minor uses (e.g. Articles 9 and 30).

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More specifically, with regard to Article 9, the Council wanted to clarify the cases in which
Member States and the Commission may ask an opinion on MRLs to the Agency.
In
substance, identical coverage to that foreseen by the Parliament's opinion is proposed. In addi-
tion, the Council judged preferable to add provisions on the modalities of financing of MRL
evaluations for active substances included in biocidal products: the main reason was to differ-
entiate between substances included in products already on the market and new substances
and to take duly account of fees already collected for the evaluation having been or to be
carried out under Directive 98/8/EC.

Besides, the Council recalled the importance of ensuring a high degree of human health
protection and made some changes to insist on this aspect (e.g. Articles 5, 7(d) or 16).

(b) Establishment/review and functioning of reference points for action

Following a series of Parliament amendments, several provisions were adapted to clarify the
Commission proposal regarding in particular the definition of reference points for action and
conditions for their establishment and review. Further, the conditions for placing food of
animal origin on the market were specified. Likewise the measures to be taken when a
forbidden or non authorised substance is found were defined.

(c) Repor t to European Parliament and the Council

The Council also followed Parliament in asking the Commission to present a report on the
experience gained from the application of the regulation, not later than 5 years after its entry
into force. In addition, the Council requested that the report considers in particular substances
classified under the regulation and having a multiple use.

2. Council's position on the European Parliament's amendments

The Council has incorporated the following amendments without modification in its Common
Position:

— 4, 6, 9, 10, 14 and 16;

and incorporated part of, or retained the principle of amendments

— 2, 3, 5, 45, 8, 11, 15, 17, 18, 21, 23, 24, 25, 26, 28, 30, 31, 32, 34, 35, 37, 38, 39, 40, 41,

42, 43 and 44.

The Council, like the Commission, could not accept the following five amendments and did not
incorporate them:

— 1, 20, 27, 33, and 36.

On amendment 1, contrary to the Parliament the Council deemed essential to maintain a double
legal basis as the proposal is relevant to the functioning of the internal market for products of
animal origin included in Annex I to the Treaty.

To amendment 20, the Council preferred Amendment 31 which establishes also an urgent proce-
dure but still with an a priori evaluation by the Agency.

On amendment 27, the Council could not accept the wording proposed by the Parliament as a
prohibition of the presence of a pharmacologically active substance would not be possible to
enforce (e.g. occurrence of a natural metabolite in the animal).

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On amendment 33, the Council could not accept the comitology procedure with scrutiny consid-
ering the fixing of MRLs for specific substances to be a purely implementing measure with no
quasi-legislative character.

On amendment 36, the Council could not accept the complete deletion of the free circulation
clause. In addition, the wording proposed by the Parliament was judged unenforceable as at the
time of import control it is not possible to establish with certainty that the residue found results
from illegal administration. However the Council could agree on drafting improvements to make
the free circulation clause clearer.