REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the functioning of 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
Date: 2015-02-16
Institutions: European Commission
Subjects: animal product, consumer protection, drug surveillance, food inspection, food safety, foodstuff, health control, health risk, human nutrition, marketing standard, medicinal product, veterinary drug, waste disposal













EUR-Lex - 52015DC0056 - EN











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52015DC0056

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the functioning of 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 /* COM/2015/056 final */









REPORT FROM THE
COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL
on the functioning of 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

 INTRODUCTION

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 (hereinafter: ‘Regulation (EC) No 470/2009’)[1] establishes maximum
residue limits and reference values (‘reference points for action’) for pharmacologically
active substances present in food obtained from animals.
A maximum residue
limit (MRL) is the maximum concentration of a residue of a pharmacologically
active substance which may be permitted in food of animal origin. A reference
point for action (RPA) is the level of residue of a pharmacologically active
substance established for monitoring purposes in the case of certain substances
for which a maximum residue limit has not been laid down.
Regulation (EC) No
470/2009 entered into force on 6 July 2009. Article 28 thereof requires the
Commission to report to the European Parliament and the Council on the
experience gained from applying the Regulation by 6 July 2014, i.e. after it
has been in force for five years.

 BACKGROUND
     AND DATA COLLECTION

1.      Background
The use of veterinary medicines
on food-producing animals may leave residues in food derived from those animals
that can be harmful to humans. While the pharmacological effects of medicinal
products are necessary for the effective treatment of animals, consumers should
be protected from them. 
The process for
establishing a maximum residue limit begins with an application to the European Medicines Agency
(EMA). The
EMA’s Committee for Medicinal Products for Veterinary Use
(CVMP) assesses the data in the application and prepares the
EMA’s opinion. On the basis of this opinion, the Commission drafts an
implementing act in consultation with Member States.  
Since the mid-1960s,
national authorities in the Member States have imposed safety requirements on
veterinary medicinal products intended for food-producing animals to ensure
that food derived from treated animals is safe for human consumption. In order
to facilitate a harmonised approach to the scientific assessment of residues
and to avoid barriers to the free movement of food of animal origin, the
Council adopted Regulation (EEC) No 2377/90 of 26 June 1990 laying down a
Community procedure for the establishment of maximum residue limits of
veterinary medicinal products in food of animal origin.[2] That
Regulation was subsequently repealed and replaced by Regulation (EC) No 470/2009.
Regulation (EC) No 470/2009 was
established with the aim of tackling the following problems which were
identified as
a result of applying Regulation (EEC) No 2377/90:

 the legislation was difficult
     to understand owing to its complex system for categorising  substances;
 substances used safely for
     many years in veterinary medicines for food-producing animals were suddenly
     banned;
 the detailed scientific data
     required for establishing  MRLs created a high cost burden for industry and
     contributed to a decrease in applications for authorisations for new
     veterinary medicines;
 international standards
     supported by the EU could not be included in EU legislation without further
     scientific assessment by the EMA;
 the monitoring authorities
     in the Member States had no reference values for many substances, in
     particular those detected in food from outside the EU. In such cases, it
     was difficult for regulatory authorities to establish compliance and there
     was no EU-level procedure for conducting a scientific evaluation that
     could lead to harmonised residue limits and controls.

In addition, one of the main
problems in the veterinary sector at the time of drafting Regulation (EC) No 470/2009 was the lack of availability
of authorised veterinary medicines.
Regulation (EC) No
470/2009 ensures that substances intended for use on food-producing animals are
assessed for their harmful potential and that consumers of food of animal
origin are adequately protected. It helps to determine ‘withdrawal periods’ when
granting marketing authorisations for veterinary medicinal products. A
withdrawal period is a period after treatment during which an animal must not
be slaughtered or during which milk, eggs or honey must not be taken for human
consumption, to ensure that maximum residue limits are not exceeded. Under Directive
2001/82/EC[3],
pharmacologically active substances intended for use on food‑producing
animals must have MRLs before a marketing authorisation for the related
veterinary medicinal product can be granted. A lack of MRLs which apply to certain
animal species will lead to a lack of authorised veterinary medicines for treating
those species. It is therefore vital that as many pharmacologically active
substances as possible are evaluated in accordance with Regulation (EC) No 470/2009.
All the
pharmacologically active substances that have been assessed in accordance with
Regulation (EC) No 470/2009 are listed and classified in alphabetical order in
Commission Regulation (EU) No 37/2010[4],
which was adopted on the basis of Article 27 of Regulation (EC) No 470/2009.
This Regulation contains two separate tables: one for authorised substances,
and one for prohibited substances.
Commission Regulation
(EU) No 37/2010 has been amended over 40 times by Commission implementing
regulations amending or adding MRLs. Currently, 641 pharmacologically active
substances are listed in Table 1 and nine pharmacologically active
substances are listed in Table 2 (prohibited substances). In addition,
food additives with a valid E number which are approved for human
consumption are classified as ‘No MRL required’.[5] 
2.      Data collection
In May 2014, a
questionnaire about Regulation (EC) No 470/2009 was published on the ‘Your
Voice in Europe’ website and paper versions were sent to the EMA, national
public authorities, businesses and non-business stakeholders.
The number of responses
received is indicated in the table below (respondents declared themselves to be
‘business’ or ‘non-business’):
 THE ‘YOUR VOICE IN EUROPE’ SURVEY SAMPLE 
 PUBLIC AUTHORITIES || BUSINESSES || NON-BUSINESS 
 32 (67 %) || 11 (23 %) || 5 (10 %) 
The
responses received came from a broad cross-section of the various stakeholders involved
in MRL policy:         

·       Public authorities – from
24 Member States (i.e. 86 % of the Member States) and from some  non-EU
countries;
·       Businesses;
·       Non-business.  

A
full list of respondents can be found in Annex I.
The
findings of the questionnaire
were
presented to stakeholders and Member States and they were given the opportunity
to comment on the following occasions:  

·       27 June 2014: at
the Animal Health Advisory Committee – for stakeholders (industry,
veterinarians and consumers).
·       2 July 2014: at
the Standing Committee on Veterinary Medicinal Products – for Member States and the EMA.

 FINDINGS
     OF THE QUESTIONNAIRE

The following conclusions can be drawn
from the findings of the questionnaire. The responses to the questionnaire are provided
in graph form in Annex II.
1.     
Scope
For the purpose of ensuring food
safety, Article 1 of Regulation (EC) No 470/2009 states that the Regulation
lays down rules and procedures in order to establish (i) the maximum
concentration of a residue of a pharmacologically active substance permitted in
food of animal origin (MRL – maximum residue limit), and (ii) the level of a residue
of a pharmacologically active substance for which an MRL has not been laid down
(RPA – reference point for action).
When stakeholders and Member
States were asked if the scope of Regulation (EC) No 470/2009 was appropriate,
80 % responded positively. As regards possible improvements to the scope
of the Regulation, a minority of respondents said that the scope may need to be
adjusted with regard to scientific assessment and to risk management, e.g. in
relation to the development of new biological products.
2.     
Scientific
risk assessment and risk management procedures
An
organisation wishing to have an MRL established or amended must submit an
application to the EMA along with sufficient data to demonstrate the safety of
the pharmacologically active substance, including the depletion of its residues
in animals, and the details of analytical methods for detecting the substance
and its metabolites.
The
basic principle for setting MRLs is that the residue of the substance consumed
in food of animal origin must not exceed the acceptable daily intake (ADI). The
ADI is established by the EMA on the basis of the scientific information
available and indicates the level of the substance or its metabolites which
would not affect human health. On the basis of the CVMP’s opinion, a Commission
regulation establishing the MRL is adopted, supplementing or amending the
classification contained in Regulation (EU) No 37/2010.
The scientific risk assessment examines
the metabolism 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 ADI.
The
scientific risk assessment is a key element of Regulation (EC) No 470/2009
and so it is essential that it achieves its purpose. The Commission has received
positive feedback regarding this provision and the current methods of establishing
MRLs and ADIs, with 80 % of respondents stating that there was an adequate
balance between food safety and the availability of veterinary medicines.
In addition, the scientific risk
assessment may take into account monitoring and exposure data if the metabolism
and depletion of the substance cannot be assessed. This specific provision in Article
6(3) of Regulation (EC) No 470/2009 is considered useful (75 % of
respondents).
EMA opinions must include a
scientific risk assessment and risk management recommendations. Article
13(2)(a) of Regulation (EC) No 470/2009 requires the Commission to adopt
measures regarding the methodology of the risk assessment and the risk management
recommendations. Respondents to the questionnaire said that it would be beneficial
if the Commission were to adopt further legal measures to implement this
requirement.
3.      Classification of
pharmacologically active substances: special cases
Where scientific data are
incomplete, Regulation
(EC) No 470/2009 allows for the
possibility of establishing a provisional MRL classification. This is laid down
in Article 14(2)(b) and (4) and is considered to be one of the most useful elements
of the Regulation
(90 %
of respondents). The provisions of Article 14(2)(b) and (4) are used in
situations where there is no health risk associated with the lack of data, e.g.
the analytical method proposed by the applicant for monitoring of residues does
not fulfil the criteria for a confirmatory method but is appropriate for monitoring
purposes. This provisional MRL classification is particularly appreciated as it
does not delay the filing of an application for a marketing authorisation of a
veterinary medicinal product.
Article 14(2)(c) allows
pharmacologically active substances to be classified as ‘No MRL required’. Under
Regulation
(EC) No 470/2009 there
is no need to establish an MRL if the substance is considered safe at the residue
level to be expected in food of animal origin. This classification is
considered useful since it explicitly acknowledges the absence of consumer
safety concerns associated with a specific substance.
4.      Number of applications
A 2011 survey, Benchmarking
the Competitiveness of the Global Animal Health Industry,[6] showed
that since Regulation (EC)
No 470/2009 entered
into force in 2009, the negative impact of MRL legislation on companies has
slightly decreased. 
Between 2009 and 2013, the number
of applications for establishment of MRLs submitted to the EMA increased by
over 20% compared to the five years preceding the Regulation’s entry into
force, with the number of applications rising from 33 to 40. Furthermore, since
the entry into force of Regulation
(EC) No 470/2009, almost
20 % of the applications submitted have come from SMEs.
Overall, the increase in the
number of applications is encouraging, as it shows that there is a certain amount
of innovation in veterinary medicinal products and confirms that SMEs are willing
and able to place veterinary medicines on the market in the EU.
The diagram below illustrates
the number of applications for an EMA opinion submitted under the Council Regulation
(EEC) No 2377/90 (between
2004 and 2008) and under the Regulation
(EC) No 470/2009 (between
2009 and 2013):
•         
Number of applications for an EMA opinion submitted from
2004–2008 and from 2009–2013 
(Article 3 of Regulation (EC) No 470/2009)
              2004-2008                                                      2009-2013
   No applications from SMEs (Data breakdown for SMEs and non-SMEs only available from 2006) ||   ||   Almost 1/5 of applications from SMEs   
5.      Extrapolation
In order to address concerns about
the lack of availability of veterinary medicines for food‑producing
animals, an extrapolation principle was included in Article 5 of Regulation
(EC) No 470/2009. It stipulates that a maximum residue limit established
for substances in a particular food can be used for establishing the MRL for
another food obtained from the same or another species. For every MRL
application, the EMA will consider whether an established MRL can be
extrapolated, without additional data, to other foods or other species.
Since 2009, the EMA has
recommended the extrapolation of 13 substances to additional animal species or foods
(e.g. fin fish, goats and poultry species). About 70 % of the extrapolations
occurred between 2012 and 2013. Moreover, each time extrapolation was
recommended, it included minor species.
Member States, veterinarians and
industry representatives have stated that the extrapolation principle has a
good impact on the availability of authorised veterinary medicinal products – especially
when it results in MRLs for minor species. It has reduced the research, expenditure
and risks associated with developing new products as the applicant does not
need to provide additional data.
The adoption of an implementing
measure by the Commission would provide additional clarity to the EMA and
businesses and may promote the use of this provision.
The table below summarises MRL
extrapolation between 2009 and 2013:
 Year || Substance(s) for which extrapolation was recommended || Animal species || Minor species 
 2009 || Tildipirosin || From bovine, pigs to goats || Yes 
 2010 || Isoeugenol || From salmon to (other) fin fish || Yes 
 2011 || Fenbendazole || Fom all ruminants, pigs, horses and chicken to all (other) food producing species, except fish || Yes 
 Monepantel || From sheep milk to goats milk || Yes 
 2012 || Eprinomectin || From cattle and sheep to goats || Yes 
 Diclazuril || From chicken to all (other) poultry species || Yes 
 Managanese carbonate || From bovine to all (other) food producing species || Yes 
 Neomycin || Modification to bovine MRLs to all (other) food producing species || Yes 
 Phoxim || From bovine, sheep, pigs and chicken to (all other full food producing species) || Yes 
 2013 || Butafosfan || From cattle  and porcine to all (other )mammalian food producing species || Yes 
 Chloroform || All ruminants , porcine to all (other) mammalian food producing species || Yes 
 Triptorelin acetate || Porcine to all (other) food producing species || Yes 
 Lufenuron || Atlantic salmon and rainbow trout to other Fin fish || Yes 
 2014 (January - April) || Barium selenate || Bovine/ovine to all (other) food producing species || Yes 
6.      Codex Alimentarius 

The Codex Alimentarius
Commission was created in 1963 by the Food and Agriculture Organisation of the
United Nations (FAO) and the World Health Organisation (WHO) to develop food
standards. Codex Alimentarius’s role is to protect the health of consumers, ensure
fair practices in the international food trade and promote the coordination of
all work on food standards undertaken by international governmental and
non-governmental organisations.
The EU and the Member States draw up EU position papers on issues discussed by the Codex Alimentarius
Commission. Consistency between international standards and EU legislation on residue
limits in food has been further enhanced by Regulation (EC) No 470/2009.
Under Article 14(3)(b)
of Regulation (EC) No 470/2009, MRLs can be laid down in the EU following
a Codex Alimentarius decision, provided that the scientific data taken into
consideration are made available to the EU Delegation before the Codex decision
is made. In this case, an additional assessment by the EMA is not required. Over
80 % of respondents to the questionnaire said this provision was useful as
it offers the veterinary pharmaceutical industry greater certainty that the EU
will adopt Codex MRLs and provides an incentive for developing new medicinal
products. However, it should be noted that this provision has not yet been used.
7.     
Controlling
and monitoring veterinary medicinal products from third countries
The Commission or a
Member State can request an opinion from the EMA on a substance used in a
veterinary medicine authorised in a third country but not in the EU. This facilitates
the harmonised approach to the control of residues in imported products of
animal origin. In the questionnaire, 90 % of respondents felt that
applying for an opinion was useful for monitoring and controlling residues in
animal products.
8.     
Rules
on placing food of animal origin on the market
Article 23 of the
Regulation (EC) No 470/2009 states that food of animal origin containing
residues of pharmacologically active substances can be placed on the market
only if it complies with an established MRL. 70 % of respondents consider
this provision appropriate. Although the provision works well in general,
respondents have argued that additional provisions, such as expanding MRLs to
other species or tissues and providing less stringent provisions for bulking
agents, could improve the legislation without adversely affecting consumer
safety.
9.     
Reference
points for action
Allocating MRLs for
pharmacologically active substances is one of the many measures taken to ensure
food safety. In addition, articles 18, 19 and 20 of Regulation (EC)
No 470/2009 lay down rules on establishing reference values for the
control of residues in food of animal origin for prohibited or non-authorised
substances.
The Commission can
establish RPAs under Regulation (EC) No 470/2009 for pharmacologically
active substances that are prohibited or currently not authorised under EU legislation.
The RPAs constitute, like MRLs, a reference value for monitoring residues in
food of animal origin. A food product cannot legally be placed on the EU market
if an RPA has been exceeded. The setting of RPAs should, however, in no way
serve as a pretext for allowing the illegal use of prohibited or non-authorised
substances to treat food-producing animals (cf. Recital 25 of Regulation (EC)
No 470/2009).
The respondents to the
survey were of the opinion that establishing RPAs would help to ensure the effectiveness of
checks on food of animal origin imported into or placed on the EU market as
they would have established reference values for potential action to be taken. So far, no RPAs have
been established by the Commission under the Regulation (EC) No 470/2009.

 CONCLUSIONS

Regulation (EC) No 470/2009
has achieved its purpose of protecting public health and safeguarding animal
health and welfare.
Regulation
(EC) No 470/2009 has contributed to an increase in the number of MRL
applications and in the use of the extrapolation principle to extend existing
MRLs to other species. This was one of the main objectives of revising Council Regulation
(EEC) No 2377/90 and introducing Regulation (EC) No 470/2009. This in turn has
helped to safeguard public health as consumer exposure to pharmacologically
active substances is limited because clear reference values are provided for
the monitoring of residues in food. The increase in the number of established
MRLs has also helped to protect animal health, as a lack of MRLs for certain species
leads to a lack of authorised veterinary medicines to treat diseases in those
species. Recently,
accessibility was further improved by means of an online MRL database. 

Overall, Member States, businesses, non-business stakeholders and the EMA
regard their experience with Regulation (EC) No 470/2009 as positive. Nonetheless,
as it can be seen in Annex II, the views on particular issues may vary between
different stakeholders. This can be explained notably by their differing
perspectives when applying the Regulation No 470/2009 (e.g. competent
authorities versus pharmaceutical companies or veterinarians). 
Substantial
improvements have been made compared to the previous legislation on establishing
MRLs. The drafting of implementing measures as required by Article 13 of
Regulation (EC) No 470/2009 should bring further improvements.
At the same time, it is
important to note that the true impact of Regulation (EC) No 470/2009 will only
become clear as experience is gained in the longer term. Furthermore, it should
be pointed out that it would be wrong to expect Regulation (EC) No 470/2009 to
solve all the issues in the veterinary medicines sector. The lack of
availability of veterinary medicinal products in the EU is being addressed in the
amendments to the relevant legislation for which the Commission adopted a
proposal on 10 September 2014, and which are currently being discussed in
European Parliament and Council.
ANNEX I
List of respondents to the survey

 PUBLIC
     AUTHORITIES
 AUSTRIA: Bundesministerium
     für Gesundheit (BMG);
 BELGIUM: Agence Fédérale des
     Médicaments et des Produits de Santé (AFMPS) / Agence Fédérale pour la
     Sécurité de la Chaîne Alimentaire (AFSCA);
 CROATIA: Ministarstvo
     Poljoprivrede;
 CYPRUS:
     Υπουργείο
     Γεωργίας, Φυσικών
     Πόρων και
     Περιβάλλοντος,
     Κτηνιατρικές
     Υπηρεσίες;
 CZECH REPUBLIC: Ústav pro Státní Kontrolu Veterinárních Biopreparátů a Léčiv (USKVBL) / Státní Veterinární Správa (SVS);
 DENMARK:
     Fødevarestyrelsen (FVST);
 EUROPEAN UNION: Committee
     for Medicinal Products for Veterinary Use (CVMP);
 FINLAND: Jord- och
     skogsbruksministeriet;
 FRANCE: Ministère de l’Agriculture;
 GERMANY: Bundesamt für
     Verbraucherschutz und Lebensmittelsicherheit (BVL) x2; 
 Institut für Hygiene und
     Umwelt; Bundesministerium für Ernährung und Landwirtschaft (BMEL);
 GREECE:
     Εθνικός
     Οργανισμός
     Φαρμάκων (EOF);
 IRELAND: Department of
     Agriculture Food & the Marine (DAFM) & The Irish Medicines Board
     (IMB);
 ITALY: Ministero della
     Sanità;
 LATVIA: Pārtikas
     un veterinārais dienests (PVD);
 LITHUANIA: Valstybinė
     Maisto ir Veterinarijos Tarnyba (VMVT);
 MALTA: Gvern ta’ Malta;
 NETHERLANDS: Ministerie van
     Economische Zaken;
 POLAND: Urząd
     Rejestracji Produktów Leczniczych (URPL);
 PORTUGAL: Direção-Geral de
     Alimentação e Veterinária (DGAV);
 ROMANIA: Institutul pentru
     Controlul Produselor Biologice si Medicamentelor de Uz Veterinar (ICBMV);
 SLOVAKIA: Štátna Veterinárna
     a Potravinová Správa (ŠVPS) / Ústav štátnej kontroly veterinárnych
     biopreparátov a liečiv (USKVBL);
 SLOVENIA: Vlada Republike
     Slovenije;
 SPAIN: Agencia Española de
     Medicamentos y Productos Sanitarios (AEMPS); Ministerio de Sanidad,
     Servicios Sociales e Igualdad (MSSSI);
 SWEDEN:
     Lakemedelsverket;
 TURKEY: T.C. Gıda
     Tarım ve Hayvancılık Bakanlığı;
 UNITED KINGDOM: Department for
     Environment Food & Rural Affairs (DEFRA);
 UNITED STATES OF AMERICA: Food and Drug
     Administration (FDA) Health and Human Services (HHS).


 BUSINESSES 
 Bayer
 CEVA
 Elanco Animal Health
 IFAH-Europe
 KLIFOVET AG
 Laboratoire Boiron
 Laboratoire TVM
 Novartis
 Sea Food Alliance
 The Danish Agriculture &
     Food Council
 TSGE Consulting Ltd


 NON-BUSINESS
 Bundestierärztekammer (BTK)
 Private veterinarian
 European Coalition on
     Veterinary Homeopathy (ECVH)
 European Federation of Honey
     Packers and Distributors (FEEDM)
 Federation of Veterinarians
     of Europe (FVE)

ANNEX II
Findings of the questionnaire
 Legend to the graphics  
 Total ||   
 Public authority ||   
 Business ||   
 Non-business ||   
 Yes ||   
 No ||   
 N/A (not applicable) ||   
 Very adequate balance ||   
 Adequate balance ||   
 Somewhat adequate balance ||   
 No adequate balance ||   
 Very good impact ||   
 Good impact ||   
 Fairly good impact ||   
 Bad impact ||   
 Very useful ||   
 Useful ||   
 Somewhat useful ||   
 Not Useful ||   
1.                              
Impact of
extrapolation
Q1. Extrapolation is the principle of using MRLs established for
substances in a particular foodstuff for another foodstuff derived from the
same species or in one or more species for other species (Article 5 of
Regulation EC No 470/2009). 
In your view, what is the impact of extrapolation on the availability of
authorised veterinary medicinal products?
2.                              
List of
substances established for multiple purposes
 Substance(s) established for multiple purpose || PPP || Biocidal product || Feed additives 
   || Yes || No || Yes || No || Yes || No 
 Alphacypermethrin || X ||   ||   ||   ||   ||   
 Amitraz || X ||   ||   ||   ||   ||   
 Azamethiphos || X ||   ||   ||   ||   ||   
 Coumaphos || X ||   ||   ||   ||   ||   
 Cyfluthrin || X ||   ||   ||   ||   ||   
 Cyhalothrin || X ||   ||   ||   ||   ||   
 Cypermethrin || X ||   ||   ||   ||   ||   
 Deltamethrin || X ||   ||   ||   ||   ||   
 Diazinon || X ||   ||   ||   ||   ||   
 Diflubenzuron || X ||   || X ||   ||   ||   
 Permethrin || X ||   ||   ||   ||   ||   
 Phoxim || X ||   ||   ||   ||   ||   
 Teflubenzuron || X ||   ||   ||   ||   ||   
 Tau fluvalinate || X ||   ||   ||   ||   ||   
 Thiabendazole || X ||   ||   ||   ||   ||   
 Diclazuril ||   ||   ||   ||   || X ||   
 Halofuginone ||   ||   ||   ||   || X ||   
 Lasalocid ||   ||   ||   ||   || X ||   
 Monensin ||   ||   ||   ||   || X ||   
3.                              
Scope of
Regulation (EC) No 470/2009
Q18. Do you consider the scope of Regulation EC No 470/2009 as
defined in Article 1 appropriate?
4.                              
Food safety and
availability of veterinary medicinal products
Q5. Do you think
that the current methods to establish MRLs and Acceptable Daily Intakes (ADI)
achieve an adequate balance between food safety and the availability of
veterinary medicinal products (Article 6 of Regulation EC No 470/2009)?
5.                              
Scientific risk
assessment of pharmacologically active substances
Q3. The scientific risk assessment of pharmacologically active
substances may take into account monitoring data or exposure data, if the
metabolism and depletion of the substance cannot be assessed (Article 6(3) of
Regulation EC No 470/2009).
Do you consider these provisions in the Regulation useful?
6.                              
Scientific risk
assessment and risk management
Q4. An opinion of
the Agency shall consist of a scientific risk assessment and risk management
recommendations (Article 6 and 7 of Regulation EC No 470/2009). Do you consider
that the Commission should adopt an implementing measure (Article 13(2)(a) of
Regulation EC No 470/2009) providing further guidance for the implementation of
Article 6 and 7?
7.                              
Establishment of
provisional MRLs
Q9. A MRL must be established for pharmacologically active
substances (Article 14 of Regulation EC No 470/2009) intended for use in
veterinary medicinal products. Is the possibility of establishing provisional
MRL classification, where scientific data are incomplete, useful (Article
14(2)(b) of Regulation EC No 470/2009)?
8.                              
Establishment of
MRLs in the EU based on Codex Alimentarius
Q7. A MRL shall be laid down pursuant to a decision by Codex
Alimentarius Commission if the Union supported this decision (Article 14(3)(b)
of Regulation EC No 470/2009). Please indicate whether you consider the
establishment of MRLs in the Union based on a Codex Alimentarius decision a
useful procedure.
9.                              
Controlling and
monitoring residues in animal products
Q6. An opinion of the Agency may be requested by the Commission
or a Member State where a substance in a veterinary medicinal product is
authorised in a third country but not in the Union (Article 9(1)(a) of
Regulation EC No 470/2009). Do you consider this request for an opinion useful
in order to be able to control and monitor residues in animal products?
10.                          
Provisions
related to placing on the market
Q16. Article 23 of Regulation EC No 470/2009 specifies that food
of animal origin can be placed on the market if it complies with an established
MRL. Do you consider the provisions in Article 23 (a) and (b) related to the
placing on the market sufficient to cover all situations?
11.                          
Controls on food
of animal origin imported into or placed on the EU market
Q14. When it is deemed necessary to ensure the functioning of
controls of food of animal origin imported or placed on the EU market the
Commission may establish Reference Points for Action (RPA) for residues from
pharmacologically active substances (Article 18 of Regulation EC No 470/2009).
Are you aware of problems related to controls where the establishment of a RPA
would have been useful?
[1] OJ L 152, 16.6.2009, p.11.
[2] OJ L 224, 18.8.1990, p.1.
[3] 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 (OJ L 311, 28.11.2001, p.1).
[4] Commission Regulation (EU) No 37/2010 of 22 December 2009 on
pharmacologically active substances and their classification regarding maximum
residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p.1).
[5] See the ‘food additives’ section of Table 1 in the Annex to Regulation
(EU) No 37/2010.
[6] BioBridge Ltd., (2012) ‘Benchmarking the Competitiveness of the
Global Animal Health Industry’, 2011 Survey for IFAH-EUROPE.