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  • I

    European Commission Directorate General for Health and Consumers

    Evaluation of the EU Legislative Framework in the Field of Medicated Feed

    Framework Contract for evaluation and evaluation related services - Lot 3: Food Chain

    (awarded through tender no 2004/S 243-208899)

    Final Report

    Submitted by:

    Food Chain Evaluation Consortium (FCEC)

    Civic Consulting - Agra CEAS Consulting -

    Van Dijk Management Consultants - Arcadia International

    Project Leader: Civic Consulting

    European CommissionDG SANCO

    Rue de la Loi 2001049 Brussels

    24.02.2010

  • Contact for this assignment: Dr Frank Alleweldt

    Civic Consulting

    Evaluation of the EU Legislative Framework in the Field of Medicated Feed

    Final Report

    Prepared by the Food Chain Evaluation Consortium (FCEC)

    Civic Consulting Agra CEAS Consulting Van Dijk Management Consultants Arcadia International

    Project Leader: Civic Consulting

    Food Chain Evaluation Consortium

    c/o Civic Consulting Potsdamer Strasse 150

    D-10783 Berlin-Germany Telephone: +49-30-2196-2297

    Fax: +49-30-2196-2298 E-mail: alleweldt@civic-consulting.de

  • Expert Team

    Civic Consulting:

    Dr Frank Alleweldt (Project director) Prof Dr Ludwig Theuvsen

    Dr Senda Kara Mr Rmi Bteille

    Mr Philipp von Gall

    fcec Food Chain Evaluation Consortium

    Civic Consulting Agra CEAS Consulting Van Dijk Management Consultants Arcadia International

  • Evaluation of the EU legislative framework in the field of medicated feed DG SANCO Evaluation Framework Contract Lot 3 (Food Chain)

    Food Chain Evaluation Consortium 1

    Contents

    ACRONYMS.............................................................................................................................................. 3

    EXECUTIVE SUMMARY ....................................................................................................................... 4

    1. INTRODUCTION ................................................................................................................................. 6

    1.1. AIM OF THE STUDY............................................................................................................................ 6

    1.2. ACKNOWLEDGEMENTS...................................................................................................................... 6

    2. BACKGROUND - ANIMAL HUSBANDRY IN THE EUROPEAN UNION.................................. 7

    2.1. HOLDING OF ANIMALS....................................................................................................................... 7

    2.2. PRODUCTION OF ANIMAL PRODUCTS ................................................................................................. 9

    2.3. PRODUCTION SYSTEMS...................................................................................................................... 9

    2.4. FARM INPUTS .................................................................................................................................. 11

    2.4.1. Sales of compound feed........................................................................................................... 11

    2.4.2. Sales of veterinary medicinal products ................................................................................... 13

    3. PRODUCTION OF MEDICATED FEED IN THE EUROPEAN UNION .................................... 16

    3.1. ANNUAL PRODUCTION..................................................................................................................... 16

    3.2. RULES OF GOOD MANUFACTURING PRACTICE.................................................................................. 19

    3.3. MEDICATED PRE-MIXES................................................................................................................... 21

    3.3.1. VMPs used for the production of medicated feed.....................................................................21

    3.3.2. Authorisation of medicated premixes .......................................................................................23

    3.4. ADDITIONAL COSTS OF PRODUCING MEDICATED FEED FOR FEED MANUFACTURERS ........................ 26

    3.5. ON-FARM PRODUCTION OF MEDICATED FEED .................................................................................. 30

    4. USE OF MEDICATED FEED IN THE EUROPEAN UNION ....................................................... 31

    4.1. USE OF MEDICATED FEED FOR DIFFERENT PRODUCTION SYSTEMS AND ANIMAL SPECIES................. 31

    4.2. CONTROL SYSTEMS FOR THE USE OF MEDICATED FEED IN THE MS.................................................. 34

    4.3. IMPORTANCE OF MEDICATED FEED COMPARED TO ALTERNATIVE WAYS OF ADMINISTRATION ........ 34

    4.4. ADDITIONAL COSTS OF USING MEDICATED FEED ............................................................................. 38

    4.5. CONSEQUENCES OF THE USE OF READY-TO-USE ORAL VETERINARY MEDICINES.............................. 42

    4.5.1. Consequences on the competitiveness of livestock farmers..................................................... 42

  • Evaluation of the EU legislative framework in the field of medicated feed DG SANCO Evaluation Framework Contract Lot 3 (Food Chain)

    Food Chain Evaluation Consortium 2

    4.5.2. Consequences for occupational safety .................................................................................... 43

    4.5.3. Consequences for public health .............................................................................................. 44

    4.5.4. Environmental consequences .................................................................................................. 46

    4.6. MEDICATED FEED FOR NON-FOOD PRODUCING ANIMALS................................................................. 47

    ANNEX 1: GLOSSARY

    ANNEX 2: METHODOLOGICAL APPROACH

    ANNEX 3: ANIMAL HUSBANDRY WITHIN THE EU

    ANNEX 4: PRODUCTION OF FEED

    ANNEX 5: DATA ON SALES OF VETERINARY MEDICINAL PRODUCTS

    ANNEX 6: EC QUESTIONNAIRE

    ANNEX 7: RESPONSES OF COMPETENT AUTHORITIES TO EC QUESTIONNAIRE

    ANNEX 8: QUESTIONNAIRE TO FEED MANUFACTURERS/FARMERS

    ANNEX 9: QUESTIONNAIRE TO MANUFACTURERS OF VMPS

    ANNEX 10: RESULTS OF SURVEY

    ANNEX 11: CASE STUDIES

    ANNEX 12: REFERENCES

    ANNEX 13: TERMS OF REFERENCE

  • Evaluation of the EU legislative framework in the field of medicated feed DG SANCO Evaluation Framework Contract Lot 3 (Food Chain)

    Food Chain Evaluation Consortium 3

    Acronyms

    COPA-COGECA: Committee of Professional Agricultural Organisations and General Confederation of Agricultural Co-operatives in the European Union

    DG: Directorate General

    EMEA: European Medicines Agency

    FCEC: Food Chain Evaluation Consortium

    FEDIAF: European Pet Food Industry Federation

    FEFAC: European Feed Manufacturers Federation

    FVE: Federation of Veterinarians of Europe

    IFAH: International Federation for Animal Health

    LSU: Livestock units

    MS: Member State/s

    PCV: Porcine Circovirus

    PMWS: Postweaning Multisystemic Wasting Syndrome

    PRRS: Porcine Reproductive and Respiratory Syndrome Virus

    ToR: Terms of Reference

    VMP: Veterinary Medicinal Product

  • Evaluation of the EU legislative framework in the field of medicated feed DG SANCO Evaluation Framework Contract Lot 3 (Food Chain)

    Food Chain Evaluation Consortium 4

    Executive Summary

    The European Commission is in the process of revising Directive 90/167/EEC which sets out the conditions under which medicated animal feeds may be prepared, placed on the market and used within the Community. DG Health and Consumers commissioned Civic Consulting of the FCEC this study to evaluate the production and use of medicated feed in the EU. Key conclusions of the study include:

    Size and recent evolution of the medicated feed market vary drastically amongst Member States. Production trends vary by country, with three Member States reporting a decrease in use of medicated feed over the last 5 years, four reporting an increase in use and two reporting no change. All in all, there is considerable uncertainty with regard to production of medicated feed since official statistics are rare.

    The number of authorised medicated pre-mixes varies significantly across countries. Innovation in the market for medicated pre-mixes seems to be limited and treatments via medicated feed appear to be based on pre-mixes containing rather old active substances. This is reflected in the small number of medicated pre-mixes newly authorised per year in many countries. Antimicrobials are by far the most important VMPs currently used for the production of medicated feed. This strong emphasis on antimicrobials is reflected in the number of authorised medicated pre-mixes: In many countries around three quarters of all authorised pre-mixes are antimicrobials.

    Whereas the share of oral application of antimicrobials remains relatively stable, the importance of medicated feed compared to other routes of oral application is decreasing. Medicated feed is still the most common way of oral administration of antimicrobials for animals in some Member States for which detailed data is available, and possibly also in the EU as a whole, according to sales data from a sample of seven VMP producers (when measured as share of total tonnage of active substances). However, medicated feed loses

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