REGULATION (EC) No 470/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  
of 6 May 2009  
laying down Community procedures for the establishment of residue limits of pharmacologically 
active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and 
amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation 
(EC) No 726/2004 of the European Parliament and of the Council  
(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 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,  
Acting in accordance with the procedure referred to in 
Article 251 of the Treaty (  2 ), 
Whereas:  
(1) 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.  
(2) 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 contamina ­
tion, as well as the microbiological and pharmacological 
effects of residues. Account should also be taken of other 
scientific assessments of the safety of substances 
concerned which may have been undertaken by inter ­
national organisations or scientific bodies established 
within the Community.  (3) 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.  
(4) Council Regulation (EEC) No 2377/90 of 26 June 1990 
laying down a Community procedure for the estab ­
lishment 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 
pharmacologically 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.  
(5) Directive 2001/82/EC of the European Parliament and of 
the Council of 6 November 2001 on the Community 
Code relating to veterinary medicinal products (  4 ) 
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) No 2377/90. Moreover that Directive contains 
rules concerning the documentation of use, re-desig ­
nation (off label use), prescription and distribution of 
veterinary medicinal products intended for use in food- 
producing animals.  
(6) 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 
undertaken 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.EN 16.6.2009 Official Journal of the European Union L 152/11  
( 1 ) OJ C 10, 15.1.2008, p. 51.  
( 2 ) Opinion of the European Parliament of 17 June 2008 (not yet 
published in the Official Journal), Council Common Position of 
18 December 2008 (OJ C 33 E, 10.2.2009, p. 30) and Position 
of the European Parliament of 2 April 2009 (not yet published in 
the Official Journal).  ( 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.(7) Maximum residue limits are the points of reference for 
the establishment, in accordance with Directive 
2001/82/EC, of withdrawal periods in marketing author ­
isations for veterinary medicinal products to be used in 
food-producing animals as well as for the control of 
residues in food of animal origin in the Member States 
and at border inspection posts.  
(8) Council Directive 96/22/EC of 29 April 1996 concerning 
the prohibition on the use in stock-farming of certain 
substances having a hormonal or thyrostatic action and 
of β-agonists (  1 ) prohibits the use of certain substances 
for specific purposes in food-producing animals. This 
Regulation should apply without prejudice to any 
Community legislation prohibiting the use in food- 
producing animals of certain substances having a 
hormonal action.  
(9) 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 from intentional administration. Those 
substances should not be subject to legislation on 
maximum residue limits.  
(10) Regulation (EC) No 178/2002 of the European 
Parliament and of the Council of 28 January 2002 
laying down the general principles and requirements of 
food law, establishing the European Food Safety 
Authority and laying down procedures in matters of 
food safety (  3 ) lays down the framework for food legis ­
lation at Community level and provides for definitions in 
that area. It is appropriate that those definitions apply for 
the purposes of legislation on maximum residue limits.  
(11) 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 (  4 ) lays down general rules for the 
control of food in the Community and provides for 
definitions in that area. It is appropriate that those 
rules and definitions apply for the purposes of 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.  
(12) Regulation (EC) No 726/2004 of the European 
Parliament and of the Council of 31 March 2004 
laying down Community procedures for the authoris ­
ation and supervision of medicinal products for human and veterinary use and establishing a European Medicines 
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.  
(13) Maximum residue limits should be set for pharmacolo ­
gically active substances used or intended to be used in 
veterinary medicinal products placed on the market in 
the Community.  
(14) It appears from the public consultation and from the fact 
that only a small number of veterinary medicinal 
products for food-producing animals have been 
authorised in recent years that Regulation (EEC) 
No 2377/90 has resulted in such medicinal products 
being less readily available.  
(15) In order to ensure animal health and welfare, it is 
necessary 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 contribute to the misuse or illegal use of substances.  
(16) 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, 
provision should be made for the systematic consider ­
ation by the Agency of the use of a maximum residue 
limit established 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.  
(17) It is recognised that, in certain cases, scientific risk 
assessments alone cannot provide all the information 
on which risk management decisions should be based 
and that other factors relevant to the matter under con ­
sideration should legitimately be taken into account, 
including the technological aspects of food production 
and the feasibility of controls. The Agency should 
therefore provide an opinion consisting of a scientific 
risk assessment and risk management recommendations 
on residues of pharmacologically 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 recommendations are necessary for the 
smooth functioning of the whole framework of 
maximum residue limits.EN L 152/12 Official Journal of the European Union 16.6.2009  
( 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 by OJ L 191, 28.5.2004, p. 1.  (  5 ) OJ L 136, 30.4.2004, p. 1.(19) 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 European Parliament and of the Council of 
16 February 1998 concerning the placing of biocidal 
products on the market (  1 ). 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 
regions different diseases or target species are more 
prevalent or because companies have chosen not to 
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 phar ­
macologically active substances of such products, the 
Commission should be enabled to set a maximum 
residue limit for food, following an opinion by the 
Agency, in accordance with the principles set for phar ­
macologically active substances intended for use in 
veterinary 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.  
(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 
procedures associated with that Directive. This Regulation 
provides that the Agency is to carry out evaluations 
related to the establishment of the maximum residue 
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.  
(21) The Community contributes, in the context of the Codex 
Alimentarius, to the development of international 
standards on maximum residue limits, while ensuring 
that the high level of protection of human health main ­
tained in the Community is not reduced. The 
Community should therefore take over without a 
further risk assessment 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.  
(22) 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, residues 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 residues have caused different control practices in 
Member States.  
(23) Council Directive 97/78/EC of 18 December 1997 laying 
down the principles governing the organisation of 
veterinary checks on products entering the Community 
from third countries (  2 ) requires that each consignment 
imported from a third country is subject to veterinary 
controls, and Commission Decision 2005/34/EC (  3 ) 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 (  4 ). The residues of pharmacologically 
active substances in products of animal origin arising, 
in particular, from illegal use or from environmental 
contamination should be carefully controlled and 
monitored in accordance with Council Directive 
96/23/EC of 29 April 1996 on measures to monitor 
certain substances and residues thereof in live animals 
and animal products (  5 ), regardless of the origin of the 
product.  
(25) It is appropriate for the Community to provide for 
procedures to set reference points for action at concen ­
trations 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 substances to treat food- 
producing animals. Therefore, any residues of those 
substances in food of animal origin should be considered 
undesirable.  
(26) 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 providedEN 16.6.2009 Official Journal of the European Union L 152/13  
( 1 ) OJ L 123, 24.4.1998, p. 1.  ( 2 ) OJ L 24, 30.1.1998, p. 9.  
( 3 ) OJ L 16, 20.1.2005, p. 61.  
( 4 ) OJ L 268, 18.10.2003, p. 29.  
( 5 ) OJ L 125, 23.5.1996, p. 10.by third countries concerning the production of food 
intended for import into the Community. Member 
States should notify the Commission of recurring 
problems, and appropriate follow-up measures should 
be taken.  
(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.  
(28) 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 ). 
(29) 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 scientific methods for the establishment of 
reference 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 proportionality, 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 regu ­
lation.  (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  
1. For the purposes of ensuring food safety, this Regulation 
lays down rules and procedures in order to establish:  
(a) the maximum concentration of a residue of a pharmacolo ­
gically 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 reasons in the case of 
certain 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 
immunity, used in immunological veterinary medicinal 
products;  
(b) to substances falling within the scope of Regulation (EEC) 
No 315/93.  
3. This Regulation shall apply without prejudice to 
Community 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.  
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 Regu ­
lation:EN L 152/14 Official Journal of the European Union 16.6.2009  
( 1 ) OJ L 184, 17.7.1999, p. 23.(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) ‘food-producing animals’ means animals bred, raised, kept, 
slaughtered or harvested for the purposes of producing 
food.  
TITLE II  
MAXIMUM RESIDUE LIMITS  
CHAPTER I  
Risk assessment and risk management  
S e c t i o n 1  
P h a r m a c o l o g i c a l l y a c t i v e s u b s t a n c e s 
i n t e n d e d f o r u s e i n v e 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  
Article 3  
Application for an opinion of the Agency  
Except in cases where the Codex Alimentarius procedure 
referred to in Article 14(3) of this Regulation applies, any phar ­
macologically active substance intended for use in the 
Community in veterinary medicinal products which are to be 
administered 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 author ­
isation, shall submit an application to the Agency.  
Article 4  
Opinion of the Agency  
1. The opinion of the Agency shall consist of a scientific risk 
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 
scientific findings of the European Food Safety Authority 
(EFSA) established by Article 22 of Regulation (EC) 
No 178/2002.  
Article 5  
Extrapolation  
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 
assessments and when drawing up risk management recommen ­
dations, consider using maximum residue limits established for 
a pharmacologically active substance in a particular foodstuff 
for another foodstuff derived from the same species, or 
maximum residue limits established for a pharmacologically 
active substance in one or more species for other species.  
Article 6  
Scientific risk assessment  
1. The scientific risk assessment shall consider the meta ­
bolism 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 acceptable daily intake (ADI). Alternative approaches to ADI 
may be used, if they have been laid down by the Commission as 
provided for in Article 13(2).  
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.  
3. If the metabolism and depletion of the substance cannot 
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 
evaluated in order to avoid unnecessary suffering for 
animals or to ensure the safety of those treating them;EN 16.6.2009 Official Journal of the European Union L 152/15(b) other legitimate factors, such as the technological aspects of 
food and feed production, the feasibility of controls, 
conditions of use and application of the substances in 
veterinary medicinal products, good practice in the use of 
veterinary medicinal and biocidal products and the like ­
lihood of misuse or illegal use;  
(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 appropriate, any conditions or restrictions for the 
use of the substance concerned;  
(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.  
Article 8  
Applications and procedures  
1. The application referred to in Article 3 shall comply with 
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.  
2. The Agency shall ensure that the opinion of 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.  
3. The Agency shall 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 v e 
s u b s t a n c e s f o r w h i c h a n o p i n i o n o f t h e 
A g e n c y m a y b e r e q u e s t e d  
Article 9  
Opinion of the Agency requested by the Commission or a 
Member State  
1. The Commission or a Member State may submit to the 
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;  
(b) where the substance in question is included in a medicinal 
product intended to be used pursuant to Article 11 of 
Directive 2001/82/EC and no application for the estab ­
lishment 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.  
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 
organisation.  
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 
requirements laid down by the Commission pursuant to 
Article 13(1).  
2. The Agency shall ensure that the opinion of the 
Committee is given within 210 days of receipt of the request 
by the Commission, a Member State or an interested party or 
organisation. 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.EN L 152/16 Official Journal of the European Union 16.6.20093. 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 
Regulation 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 
Directive before 6 July 2009;  
(b) following the procedure referred to in Article 8 of this 
Regulation 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 necessary by the Member States or the Commission.  
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.  
However, any specific provisions relating to the conditions of 
use of the substances classified in accordance with the first 
subparagraph of this paragraph shall be laid down pursuant 
to Article 10(2) of Directive 98/8/EC.  
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 amount of the fees for evaluations carried out by the 
Agency and the rapporteur following an application made in 
accordance with paragraph 1(b) of this Article shall be estab ­
lished 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 o v 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 
accordance with this Regulation for specific foodstuffs or 
species, Articles 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  
The Agency shall publish the opinions referred to in Articles 4, 
9 and 11 after deleting any information of a commercially 
confidential nature.EN 16.6.2009 Official Journal of the European Union L 152/17  
( 1 ) OJ L 35, 15.2.1995, p. 1.Article 13  
Implementing measures  
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.  
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 
foodstuff for another foodstuff derived from the same 
species, or a maximum residue limit established for a phar ­
macologically 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 
residues 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 
accordance 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;  
(c) the absence of the need to establish a maximum residue 
limit;  
(d) a prohibition on the administration of a substance.  
3. A maximum residue limit shall be laid down where it 
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 
Commission, without objection from the Community Dele ­
gation, in favour of a maximum residue limit for a pharma ­
cologically active substance intended for use in a veterinary 
medicinal product, provided that the scientific data taken 
into consideration have been made available to the 
Community Delegation prior to the decision of the Codex 
Alimentarius Commission. In this case, an additional 
assessment by the Agency shall not be required.  
4. A provisional maximum residue limit may be established 
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 
accordance 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.EN L 152/18 Official Journal of the European Union 16.6.20097. 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 accelerated 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 
Commission 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 clas ­
sified in accordance with Article 14(2)(a), (b) or (c) may be 
administered to food-producing animals within the 
Community, provided that such administration is in accordance 
with Directive 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  
1. For the purposes of 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 
Commission shall also prepare a draft regulation within 30 
days of receipt of the decision of the Codex Alimentarius 
Commission, without objection from the Community Dele ­
gation, 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 
regulation 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).  
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 
residues 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 regu ­
latory 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).EN 16.6.2009 Official Journal of the European Union L 152/19Article 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 accordance with Community requirements. 
The Commission shall be advised on the performance of 
analytical methods by the relevant Community reference 
laboratory.  
2. Without prejudice to the second subparagraph of 
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.  
3. The principles of risk assessment shall be applied in order 
to guarantee a high level of protection of health. The risk 
assessment shall be based on methodological principles as 
well as scientific methods to be adopted by the Commission 
in consultation with EFSA.  
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 26(3).  
Article 20  
Community contribution to the support measures for 
reference points for action  
If the application of 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  
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 
Community 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 where this Regulation and its implementing measures 
have been complied with.  
Article 23  
Placing on the market  
Food of animal origin containing residues of a pharmacolo ­
gically 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.  
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 Regu ­
lation.  
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 
reference points for action, the competent authority shall 
carry out the investigations provided for by Directive 
96/23/EC to determine whether there has been illegal adminis ­
tration of a prohibited or non-authorised pharmacologically 
active substance and, where relevant, shall apply the penalty 
provided for.  
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.EN L 152/20 Official Journal of the European Union 16.6.20093. Where appropriate, the Commission shall submit 
proposals, 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.  
4. Detailed rules on the application of this Article shall be 
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 
scrutiny referred to in Article 26(3).  
TITLE V  
FINAL PROVISIONS  
Article 25  
Standing Committee on Veterinary Medicinal Products  
1. The Commission shall be assisted by the Standing 
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.  
Article 26  
Standing Committee on the Food Chain and Animal Health  
1. The Commission shall be assisted by the Standing 
Committee on the Food Chain and Animal Health.  
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.  
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.  
Article 27  
Classification of pharmacologically active substances under 
Regulation (EEC) No 2377/90  
1. By 4 September 2009, the Commission shall adopt, in 
accordance with the regulatory procedure referred to in 
Article 25(2), a regulation 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 extra ­
polation to other species or tissues in accordance with Article 5.  
Article 17 shall apply.  
Article 28  
Reporting  
1. By 6 July 2014, the Commission shall submit a report to 
the European Parliament and to the Council.  
2. The report shall, in particular, review the experience 
gained from the application of this Regulation, including 
experience with substances classified under this Regulation 
which have a multiple use.  
3. The report shall, if appropriate, be accompanied by 
relevant proposals.  
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 regu ­
lation referred to in Article 27(1) of this Regulation.EN 16.6.2009 Official Journal of the European Union L 152/21Article 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:  
‘3. By way of derogation from Article 11, the 
Commission 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:  ‘The Commission may modify these withdrawal periods or 
establish other withdrawal periods. In so doing, the 
Commission may differentiate between foodstuffs, species, 
routes of administration and annexes to Regulation (EEC) 
No 2377/90. Those measures, designed to amend non- 
essential 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 Regulation (EC) No 470/2009 of 
the European Parliament and of the Council of 6 May 2009 
laying down Community procedures for the establishment 
of residue limits of pharmacologically active substances in 
foodstuffs of animal origin (*).  
___________  
(*) OJ L 152, 16.6.2009, p. 11’.  
Article 32  
Entry into force  
This Regulation shall enter into force on the 20th day following 
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, 6 May 2009.  
For the European Parliament 
The President  
H.-G. PÖTTERING  For the Council 
The President  
J. KOHOUTEN L 152/22 Official Journal of the European Union 16.6.2009