Medicated Feed: The Belgian context 05/06/2014 Erik Hoeven Policy Advisor Technical & Scientific Issues BEMEFA - APFACA | All rights reserved.

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Transcript Medicated Feed: The Belgian context 05/06/2014 Erik Hoeven Policy Advisor Technical & Scientific Issues BEMEFA - APFACA | All rights reserved.

Medicated Feed: The Belgian context

Erik Hoeven

Index

Introduction • Veterinary AMP’s : some statistics • What is Medicated Feed?

• •

Introduction

Veterinary AMP’s : some statistics What is Medicated Feed?

Veterinary AMP’s

Veterinary AMP’s VMP administration • Treatment of animals  different pathways: • • “individual” versus “group” Injection versus oral VETERINARIAN PRESCRIPTION • Feed versus water • Medicated feed versus other in-feed medication 5 05/06/2014 BEMEFA - APFACA | All rights reserved

Veterinary AMP’s Third ESVAC report • Distribution of sales, in mg/PCU, of the various pharmaceutical forms of veterinary antimicrobial agents for food-producing animals (including horses) aggregated by the 25 EU/EEA countries for 2011 6 05/06/2014 BEMEFA - APFACA | All rights reserved

Veterinary AMP’s 7 Third ESVAC report • Distribution of sales of veterinary antimicrobial agents for food-producing animals (including horses), in mg per population correction unit (mg/PCU), by pharmaceutical form, by country, for 2011 05/06/2014 BEMEFA - APFACA | All rights reserved

EU statistics Third ESVAC report The 2011 report shows a general reduction in most countries ranging from -0.4% to -28% expressed in mg/population correction unit (PCU) between 2010 and 2011. The largest decrease per type of delivery route was with premixes (-16%), whereas oral powders decreased by 7% and oral solutions by 4%.

• • • •

What is Medicated Feed?

10 Definitions • • “medicated feedingstuffs”: any mixture of a VMP or products and feed or feeds which is ready prepared for marketing and intended to be fed to animals without further processing, because of its curative or preventive properties or other properties as a medicinal product covered by Article 1 (2) of Directive 65/65/EEC

(definition in Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products)

Directive 90/167 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs • “medicated feedingstuffs may be manufactured from [1 or more] authorized medicated pre-mixes only” • “authorized medicated pre-mix”: any pre-mix for the manufacture of medicated feedingstuffs as defined in Article 1 (2) of Directive 81/851/EEC which has been granted an authorization in accordance with Article 4 of that Directive; 05/06/2014 BEMEFA - APFACA | All rights reserved

What is Medicated Feed?

11 Medicated feedingstuff (Directive 90/167) Adequate [approved] premises, storage, facilities, staff,… Labeling Regular check Conditions of authorized premix Storage, Sealing & Cleaning GHP & GMP

Medicated Feed

What is Medicated Feed?

12 • • • • Medicated feed is ….

… a compound feed (complete or complementary) … • • not only with antibiotics Anthelmintic medicinal products (vermifuges) ZnO … a service to farmers • CFP’s main business is to produce high-quality and safe feed for healthy animals and to meet nutritional demands in order to keep animals healthy … not a convenience (from the CFP point of view) Infrastructure + transport Management of the VMP stock Registrations, prescription Qualified personnel Management of carry-over Occupational health Periodical test for homogeneity Recovery analysis Traceability ….

What is Medicated Feed?

13 • • • • • • • Medicated feed : some advantages Prescribed dose is correctly delivered as the VMP is incorporated and homogeneously dispersed in the feed (key legal requirement); Correct dosage leads to efficient treatment and less risk of non-compliant residues to the benefit of consumers / public Completion of treatment period; Less stress compared to injection or individual oral dosing; Appropriate for a vast majority of types of farm animal species and production systems; Easily traceable (within applied traceability systems in Feed) Safe route of administration for the farmer. 05/06/2014 BEMEFA - APFACA | All rights reserved

Belgian Case Medicated Feed Convention Data Collection Center of expertise “AMCRA” Zinc Innovation

Medicated Feed Convention

Medicated Feed Convention Medicated Feed Convention •

30/01/2013

Medicated Feed Convention 17 Background  Awareness of sector to produce “MF” in optimal conditions with respect to “ALARA” reduction of carry-over of active substances in subsequent feed & acknowledgement of authorities of efforts conducted by sector to that respect;  Availability of technological solutions for mash “AB-MF” feed such as end-of-line mixer and FDS; defined management practices for production with main mixer.  Awareness of sector and authorities that separate approach is justifiable for (mash) “AB-MF” and other MF (deworming, ZnO); 05/06/2014 BEMEFA - APFACA | All rights reserved

Medicated Feed Convention 18 Background  Importance of a sustainable & rational reduction of consumption of all AB in livestock & reduction of AB resistance (public health). E.g. establishment of AMCRA (2012)  FIGURES : Importance of a detailed AB-DCS for the different animal species for all AB + annual BEMEFA survey for all MF;  Sensibilisation & Information !  Refine methods for the determination of levels of carry-over of the installation (measured with tracers)  Yearly evaluation BEMEFA / FASFC 05/06/2014 BEMEFA - APFACA | All rights reserved

Medicated Feed Convention Key Points of the Convention (carry-over) •

(1)

From 1/1/2014 no MF production through main mixer. Only use of end-of-line mixer and/or FDS. • Exceptions are :    MF for deworming MF with ZnO Pelleted MF with specific AB for rabbits • Choice per 1/1/2014 :    FDS : End-of-line mixer : Stop : 15 % 60 % 25 % 05/06/2014 BEMEFA - APFACA | All rights reserved 19

Medicated Feed Convention Key Points of the Convention (carry-over) •

(2)

Specifications for “end-of-line mixer” : evolution of the max. measured carry-over level (tracer) per 31/12/2016 31/12/2015 31/12/2014 max 2 % max 1,5 % max 1% 20 05/06/2014 BEMEFA - APFACA | All rights reserved

Medicated Feed Convention Key Points of the Convention (carry-over) •

(3)

Establishment of tolerances in non-MF for target animals (pigs + poultry), based on : • AB-resistance (public health) • Safety of animal • Residues in meat/eggs/milk (consumer safety) • LOD (FASFC) applies for all other non-MF (finisher feed for pigs, cattle feed, rabbit, …) • With respect to Zn : no tolerances or LOD, but carry-over considered as a feed additive (max. levels + labeling provisions) 05/06/2014 BEMEFA - APFACA | All rights reserved 21

Belgian Case

Medicated Feed Convention Data Collection AMCRA Zinc Innovation

•

Data collection

BEMEFA (AB and other substances) • • Evolution Medicated Feed Evolution Medicated premixes • Evolution Active Substances • BELVETSAC (only AB) • Active Substances medicated premix • Active Substances others • QUALITY SYSTEMS (only AB) 05/06/2014 BEMEFA - APFACA | All rights reserved 23

Evolution Medicated Feed in Belgium

MF production (2013)

•

Pig: 213,894 T

• • • • 220,161 T in 2012 227,472 T in 2011 230,493 T in 2010 215,633 T in 2009

(6,13 % = 2.30 % DW + Zn + 3.83 % AB) (6,35 % = 2.12 % DW + 4.23 % AB) (6,62 % = 2.21 % DW + 4.40 % AB) (6,72 % = 2.06 % DW + 4.66 % AB) (6,47 % = 2.08 % DW + 4.39 % AB)

25 05/06/2014 Overleg APIM BEMEFA

Evolution Medicated Feed in Belgium Results survey MF 250 000 200 000 150 000 100 000 50 000 -

215 633 146 417 69 216

2009

230 494 158 673 71 821 227 472 151 382 76 090

220 161 146 609 73 551

2012

213 894 133 529 80 366

2013 26

Evolution medicated premixtures in Belgium

Zn AB TOP - 6 TOP - 9 DW

TOTAL

Evolution medicated premixtures in Belgium

Use of premixtures (2013)

∆2009 ∆2010 ∆2011 ∆2012

∆2009 ∆2010 ∆2011 ∆2012

∆2009 ∆2010 ∆2011 ∆2012

2013 74% 87%

60.031 10,24%

3.401

6,01% -2.503

-5.570

-4,00% -8,49% -1.874

-3,03%

12.731 2,17% 513.716 87,59%

-83.459

-13,98% -106.196

-79.652

-60.962

586.479

-67.326

-17,13% -13,42% -10,61%

-10,30% -95.967

-72.490

-50.104

-14,06% -11,00% -7,87%

2012 636.583

85% 92%

61.905 9,72% 574.678 90,28%

2011 86% 93%

65.601 9,96% 593.368 90,04%

658.969

2010 86% 93%

62.534 9,16% 619.912 90,84%

682.446

2009 653.805

84% 91%

Evolution active substance in Belgium

Evolution active substance in Belgium 30

Active substance (kg)

AB DW 2013 ∆ 2012

53.077

2.598

-5,3 % -8,4 %

∆ 2011

-8,6 % -11,9 %

∆ 2010

-10,5 % -6,5 %

∆ 2009

-3,4 % 1,2 %

2012 2011 56.067

2.837

58.101

2.949

2010 2009 59.286

2.779

54.963

2.567

BELVETSAC

Total national consumption of antimicrobial compounds for veterinary use in Belgium for the years 2007-2012 (tons active substance)

BELVETSAC

Total mg of active substance used per kg biomass produced in Belgium for 2007-2012.

BELVETSAC Quality system • Certus (pigs) • 1/1/2014 • Data collection for all pig producers in scheme • Input (monthly): • • • Veterinarians MF producers Pharmacy • • 3 months : 35.000 registrations Data analysis : AMCRA scientific unit • Online feedback / Benchmarking veterinarian & farmer • • Sensibilization & communication ! Multi-animal / Multi-stakeholder platform 05/06/2014 BEMEFA - APFACA | All rights reserved 34

Belgian Case

Medicated Feed Convention Data Collection AMCRA Zinc Innovation

AMCRA

• Center of Expertise on

nti

icrobial

onsumption and

esistance in

nimals, founded in 2011 : • sector : associations representing compound feed sector (BEMEFA), farmers, veterinarians, pharmaceutical industry & academic world • authorities : FASFC & FAMHP • working groups • Animal specific : poultry, pigs, bovine, horse, pets … • Data collection, medicated feed • ZnO 05/06/2014 BEMEFA - APFACA | All rights reserved 36

AMCRA AMCRA

Plan 2020 : 10 points (May ‘14)

50% less AB utilization by 2020 2.

75% less utilization of the most critically important AB by 2020 3.

50% less AB MF by 2017 4.

All-embracing DCS by 2016 5.

Belgian Case

Medicated Feed Convention Data Collection AMCRA Zinc Innovation

Zinc

•

AMCRA Recommendation on ZnO

•

Medicated Feed (ZnO)

• Since 1/9/2013 • Prescription • 4 authorized medicated premixes (1000 ppm ZnO / 800 ppm Zn) • 2000 / 2500 ppm Zn in MF (zinc content of CF !!!) • First 14 days after weaning (piglets) 39 05/06/2014 BEMEFA - APFACA | All rights reserved

Zinc

•

Zinc Convention

• • • • • Sector + Ministry of Health / Ministry of Agriculture max. 110 ppm Zn instead of authorized max. level (150 ppm) : compensation ZnO-MF Feed for fattening pigs (> 23 kg) BE market 81 production units : > 95% feed concerned Sampling plan 40 05/06/2014 BEMEFA - APFACA | All rights reserved

Belgian Case

Medicated Feed Convention Data Collection AMCRA Zinc Innovation

Innovation 42 Fine dosage system • Alternative for production in factory : EXTENSION of factory • Medicated feed • License is needed • Only authorized veterinary premixes • Prescription • Procedure : www.favv.be/sp/pa/aliment-ani_nl.asp#dosage • Protocol homogeneity test • Approved by FASFC 05/06/2014 BEMEFA - APFACA | All rights reserved

Innovation

Evolution fine dosage system

Innovation Evolution electronic prescription • Making an MF prescription and digital sending (incl. printing and archiving) • RD of 20/12/2012 modifying the RD of 21/12/2006 • Conditions for the preparation, placing on the market and the use of medicated feed • Service provider dossier

PDA Laptop application New application?

•

Key principles for revision

Key principles for revision 47 FEFAC position (2012) • Higher degree of harmonization (e.g. requirements for production) • Prescription by a veterinarian is “sacred” – but more harmonized rules on nature and content of prescription • REGULATION preferable to a DIRECTIVE • Co-regulation : legislation + professional Codes & Guides • Possibilities for technological innovations • Medicated feedingstuffs are feed (legislation, taxation) • Take into account export to thirds countries (specific VMP’s) 05/06/2014 BEMEFA - APFACA | All rights reserved

Key principles for revision 48 • FEFAC position (2012) Reality of multi-purpose mills • Centralized EU procedure for authorization of premixes !!! • Same provision for production of MF in factory and on-farm • Carry-over : has to be measured, managed on order to minimize and verified. ML of residues of VMP’s in blank feed for different animal species & in animal products • Other • Pre-manufacturing • • Prescription by veterinarian of > 1 medicated pre-mix Sales through intermediate though preferably direct delivery from place of manufacturing to farm 05/06/2014 BEMEFA - APFACA | All rights reserved

Medicated Feed: The Belgian context Thank you!

Medicated Feed: The Belgian context 05/06/2014 Erik Hoeven Policy Advisor Technical & Scientific Issues BEMEFA - APFACA | All rights reserved.

Transcript Medicated Feed: The Belgian context 05/06/2014 Erik Hoeven Policy Advisor Technical & Scientific Issues BEMEFA - APFACA | All rights reserved.