Annexes to COM(2015)56 - Functioning of Regulation 470/2009 on Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin - Main contents
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| dossier | COM(2015)56 - Functioning of Regulation 470/2009 on Community procedures for the establishment of residue limits of pharmacologically ... |
|---|---|
| document | COM(2015)56  |
| date | February 16, 2015 |
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.