02-pdf-Eddy Piron-EN-New feed additive legislation-2 · green image replace antimicriobial growth...
Transcript of 02-pdf-Eddy Piron-EN-New feed additive legislation-2 · green image replace antimicriobial growth...
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New EU - feed additive legislation
Impact for poultry production and
feed additives
Eddy Piron
Ankara, 10th February 2005
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• New Feed additive Regulation– History
– Novelties in the new Regulation
• Future AGP (Antimicrobial Growth Promoters)
• Long term future anticoccidials in the EU
• BSA - Brand Specific Approvals– What is BSA
– Impact BSA
– Approved BSA products
• Future outlook – poultry production/feed additives
New EU feed additive Regulation
TOPICS FOR TODAY :
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• 1995 - 2000 : Multiple food scares !
– Escalating BSE - crises
– Salmonella eggs / poultry
– Resistance debate
– Dioxin crises,
– GMO, clenbuturol, hormones
– …
New EU feed additive Regulation
History
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• 1995 - 2000 : Multiple food scares !
• Uncoordinated reactions from Member States & food chain
– unilateral bans
– Import and trade restrictions
– Media hypes
– opportunistic behaviour retail chains
New EU feed additive Regulation
History
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• 1995 - 2000 : Multiple food scares !
– Escalating BSE - crises
– Salmonella eggs / poultry
– Growth promoter bans
– Dioxin crises, – GMO, clenbuturol, hormones,
– …
• Uncoordinated reactions from Member States & food chain
– unilateral bans
– Import and trade restrictions
– Media hypes– opportunistic behaviour retail chains
New EU feed additive Regulation
History
Consumer
Confidence
crises in
food safety
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• Old legislation : (Dir 70/524/EEC)
– 5 major amendments since 1970
– Numerous modifications of annexes, never consolidated
– no flexibility in categories of additives + mode of administration (drinking water, …)
– procedure for dossier evaluation : confusing, not “user friendly” and time consuming
– different types of authorizations
– certain derogations at national level were still possible
– ...
New EU feed additive Regulation
History
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EU COMMISSION : White paper on food safety (12.01.2000)
• Creation of EFSA
Parma, Italy
• New feed legislation
Feed additives Reg 1831/2003
New EU feed additive Regulation
History
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EFSA European Food Safety Authority
• Functioning since May 2003
New Location : Italy, Parma
• All scientific advisory EU panels
• Best possible scientific expertise & advise.
“European FDA”
New EU feed additive Regulation
History
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New feed legislation : Feed additive Reg 1831/2003
New EU feed additive Regulation
History
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BASIC (modified) PRINCIPLES in the new feed additive Directive 1831/2003:
1. Definitions and categories of feed additives
2. Procedure for dossier evaluation - EFSA
3. Authorizations subject to renewals for all additives
4. Supervision and post-market monitoring
5. Introduction of precautionary principle in feed legislation
6. Phasing out growth promoters + Status anticoccidials
New EU feed additive Regulation
Novelties
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1. Definitions and categories of feed additives
– Drinking water included
– Possibility to create new categories
– 5 main categories of feed additives : – Technological additives
– Sensory additives
– Nutritional additives
– Zootechnical additives
– Coccidiostats and histomonostats
New EU feed additive Regulation
Novelties
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2. Procedure for dossier evaluation - EFSA
New EU feed additive Regulation
Novelties
Old procedure (70/524/EEC)Old procedure (70/524/EEC)
Applicant
Rapporteur (MS)
87/153/EEC1
E.C. + other
Member States2
Formal check : 60 d.
3
STOP
not OK
Full evaluation :320 d.
OK 4SCAN/
EFSA
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Authorisation
6
7
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- new procedure EFSA
New EU feed additive Regulation
Novelties
Applicant
EFSA (European Food Safety Authority)
E.C. (European Commission)
Opinion within 6 + x months
Authorisation (or not)
3 months (comitology = Voting by Member States)
Scientific body’s
in member states
via E.C. (inform MS)
confirm receipt <15d
submit info to MS/EC
summary: public
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3. Authorizations subject to renewals for all additives- Duration of authorisation : 10 years
- Possibility to modify, suspend or revoke an authorisation at any time based on opinion from EFSA (on own initiative, or following request of E.C. or MS). Opinion shall be made public
- Existing products : re-evaluation or new dossier within 7 years
New EU feed additive Regulation
Novelties
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4. Supervision and post-market monitoring
→E.C. : conditions for supervision / post-market
monitoring may be imposed by authorisation (art.
9(4)c)
(additive specific)
New EU feed additive Regulation
Novelties
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New EU feed additive Regulation
Novelties
5. Introduction of precautionary principle in feed legislation
The Precautionary Principle – origin :
‘… Where there are threats of serious or irreversible
damage, lack of full scientific certainty shall not be
used as a reason for postponing cost-effective
measures to prevent environmental degradation ’(Principle 15 of the Rio Declaration, 1992)
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New EU feed additive Regulation
Novelties
Precautionary Principle introduced in legislation :
(17) It is recognised that scientific risk assessment alone
cannot, in some cases, provide all the information on which a
risk management decision should be based, and that other
factors relevant to the matter under consideration should
legitimately be taken into account, including societal, economic
or environmental factors, feasibility of controls and the benefit
for the animal or for the consumer of animal products.
Therefore, the authorisation of an additive should be
granted by the Commission.
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New EU feed additive Regulation
Novelties
Different approach to products approvals
EU versus US :
US : FDA approval (science based)
market decides on use
EU : EU-commission approves based on :
scientific advice
other societal, environmental, economic
benefit for the animal or the consumer(e.g. hormonal or antibiotic growth promoters)
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6. Phasing out growth promoters + Status
anticoccidials (art 11)
Antibiotic growth promoters :
phase out by Dec 31, 2005
New EU feed additive Regulation
Novelties
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New EU feed additive Regulation
Novelties
Antibiotic growth promoters :
Art. 11 : “… antibiotics, other than coccidiostats and histomonostats, may be marketed and used as feed additives only until 31 December 2005; as of 1 January 2006, those substances shall be deleted from the Register”
= Ban on all antibiotic growth promoters as from Jan 2006
Maxus (avilamycin), (broiles – pigs)
Romensin (monensin-sodium), (cattle)
Salocin (salinomycin-sodium), (pigs)
Flavomycin (flavophospholipol), (broilers, pigs, cattle)
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New EU feed additive Regulation
Novelties
Long term future anticoccidials in the EU
art 11 : “… with a view on the phasing out of the use of coccidiostats and histomonostats as feed additives by 31 December 2012, the Commission shall submit to the European Parliament and the Council before 1 January 2008 a report on the use of these substances as feed additives and available alternatives, accompanied, where appropriate, by legislative proposals.”
Conclusions for anticoccidials :
• report by 2008 advising on the further use.
• New legislation on anticoccidials by 2012
– possible by 2012 : transition of anticoccidials to a new veterinary product status or maintain feed additive status
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• New Feed additive Regulation– History
– Novelties in the new Regulation
• Future AGP (Antimicrobial Growth Promoters)
• Long term future anticoccidials in the EU
• BSA - Brand Specific Approvals– What is BSA
– Impact BSA
– Approved BSA products
• Future outlook – poultry production/feed additives
New EU feed additive Regulation
TOPICS FOR TODAY :
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BSA BSA -- Brand Specific ApprovalsBrand Specific Approvals
– What is BSA
– Business Impact BSA by product
– Approved BSA products
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BSA BSA -- Brand Specific ApprovalsBrand Specific Approvals
• Directive 96/51 installed BSA regime for anticoccidials and growth promoters
• Old situation : approval at generic molecule level.
– Robenidine, maduramycin, lasalocid, salinomycin, monensin, …
– approvals per species
• BSA : approval at brand level for 10 years
– CYCOSTAT, CYGRO, AVATEC, DECCOX, BIOCOX
– approval per species
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BSA BSA -- Brand Specific ApprovalsBrand Specific Approvals
• - Requires complete registration file
- Quality
- Efficacy
- Toxicity – human and animal safety
- Ecotox – environmental safety
- Additive is approved – not the molecule
Additive definition includes composition, brand, producer.
- Producer linked to approval
- Increased treacebality
- Increased product responsibility
- Multiple BSA possible for one molecule :
e.g. : Sacox®: BSA approved salinomycin from Intervet
Salinomax® : salinomycin from Alpharma (BSA pending)
Each approved based on a complete registration file.
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BSA : ImpactBSA : Impact
• Removal of all generics from the market– increased market potential for branded products – stop to generic driven quality erosion
• BSA approvals :– Alpharma : Avatec®, Cygro®, Cycostat®, Deccox®,
Salinomax® (pending)– Elanco : Elancoban®, Monteban®, Maxiban®
– Intervet : Sacox®
– Janssen : Clinacox®
– Phibro : Aviax®
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BSA : ImpactBSA : Impact
• Remain approved as generic molecules
– Until Dec 31, 2005 : monensin, salinomycin, avilamycin and flavomycin as antimicrobial growth promoter
– Untill 2014 : halofuginone as anticoccidial
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BSA ImpactBSA Impact : : banned in EUbanned in EU
• Generic copies : – salinomycin, monensin, robenidine, ... : banned as from 2005
• Banned during the BSA process :– dinitolamide (DOT) per 1.10.99 (Zoalene®)
– ipronidazole per 1.10.99
– aprinocide per 1.10.99 (Arpocox®)
– ronidazol per 18.3.98, Dir 98/19/EC
• Banned May 2002 (Monographs not accepted)– amprolium, – amprolium/ethopabate (Amprolmix®)
– meticlorpindol (Clopidol® - Coyden®)
– meticlorpindol/methylbenzoquate (Lerbek®) – dimetridazole (Emtryl®)
– nicarbazin (Carbigran®, Cycarb®, Nicrazin® ..)
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BSA : ImpactBSA : Impact
Other feed additives banned in the EU :
• Olaquindox, carbadox
• Avoparcin (1997)
• Tylosin, virginiamycin, spiramycin, zincbacitracin (June 1999)
• Nifursol (May 2003)
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• New Feed additive Regulation– History
– Novelties in the new Regulation
• Future AGP (Antimicrobial Growth Promoters)
• Long term future anticoccidials in the EU
• BSA - Brand Specific Approvals– What is BSA
– Impact BSA
– Approved BSA products
• Future outlook – poultry production/feed additives
New EU feed additive Regulation
TOPICS FOR TODAY :
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Future outlookFuture outlook
Importance for NonImportance for Non--EU produced meatEU produced meat
Rapid explosion of broiler meat imports from Brazil & Thailand
France = largest EU broiler producer
Brazil imports > > French production !!
BRAZIL = largests EU broiler producer
INCREASED VISIBILITY WITH : - AUTHORITIES
- PRODUCERS
- CONSUMERS31
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Future outlookFuture outlook
IncreasedIncreased visibilityvisibility withwith authoritiesauthorities –– producersproducers -- consumersconsumers
AUTHORIES :
Residue controls on boarders
Increased concern on quality of imported meat
EU production : generic quality gap closed oct 2004
EU imports : need for increased quality criteria & controls
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Future outlookFuture outlook
IncreasedIncreased visibilityvisibility withwith authoritiesauthorities –– producersproducers --
consumersconsumers
RETAILERS – CONSUMERS :
- Competitive strength = be more consumer friendly
= be more strict than legislators
(e.g.:labels, brands)
- Consumers : Need for risk free products
(e.g.: BSA approved)
- Retailers ‘solutions’
= Growing influence on integrated food chain
=Choice of products :
EU approved
Consumer accepted
Restrive lists of ingredients s for production (e.g.: no AGP)33
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Animal production in the EU
• Declining broiler numbers in EU � Regulatory constraints (precautionary principle)
� Lower productivity in EU: ban on hormones, AGP, GMO, repartioning agents; medicines availibility crisis, zeroresidue tolerance, environment legislation, …)
� Increased imports (WTO, Brazil, Thailand, …)
� Relocation of production to new memberstates or outside EU.
� Pressure on meat consumption
Future outlookFuture outlook
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Consumer confidence in meat :Consumer confidence in meat :
Still low and damaged by to many real and/or Still low and damaged by to many real and/or
perceived scandals :perceived scandals :
BSE, Dioxin, AGP, hormones, MPA, BSE, Dioxin, AGP, hormones, MPA,
BB--agonistssalmonellaagonistssalmonella, food poisoning, animal , food poisoning, animal
welfare, transport, manure, pollution, ..welfare, transport, manure, pollution, ..
Future outlookFuture outlook
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IncreasedIncreased importance importance consumerismconsumerism
= =
IncreasedIncreased importance importance retailersretailers in production in production chainchain* * RetailersRetailers imposingimposing production production methodsmethods
* Restricted list of feed additives by retailers* Restricted list of feed additives by retailers
��for EU productionfor EU production
��increased awareness to impose thisincreased awareness to impose this
for on imported meat as well.for on imported meat as well.
-- -- -- > more animal health problems> more animal health problems
(necrotic (necrotic entiritisentiritis, , coccidiosiscoccidiosis, …), …)
-- -- -- > lower > lower zootechnicalzootechnical performance performance
Future outlookFuture outlook
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DevelopmentDevelopment ofof new new feedfeed additives for additives for thethe EU :EU :
green imagegreen image
replace replace antimicriobialantimicriobial growthgrowth promoterspromoters
New New productsproducts : : prebioticsprebiotics ((mannansmannans, inuline, , inuline, otherother FOS)FOS)
immunostimulants immunostimulants ((BB--glucansglucans, …), …)
probioticsprobiotics
organicorganic acidsacids
herbsherbs
aromaticaromatic substancessubstances
….….
Future outlookFuture outlook
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‘‘Green consumer’ ?Green consumer’ ?
Who is he ?Who is he ?
Future outlookFuture outlook
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Monday Monday -- Friday :Friday : Convenience foodConvenience food
Objective criteria :Objective criteria :
* Safe* Safe
* Price* Price
* * TastTast
* Healthy* Healthy
* Convenience : easy to prepare * Convenience : easy to prepare -- consumeconsume
Future outlookFuture outlook
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Monday Monday -- Friday : Convenience foodFriday : Convenience food
Saturday Saturday -- Sunday ? Sunday ?
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Saturday Saturday –– Sunday = Sunday = BIOBIO--TIME !!!TIME !!!
Emotional criteriaEmotional criteria ::
EnvironmentEnvironment
Animal welfareAnimal welfare
Traditional productionTraditional production
Small scaleSmall scale
Premium priced luxury itemPremium priced luxury item
Consumers with higher incomeConsumers with higher income
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Restore consumer confidenceRestore consumer confidence
==
Everyone’s responsibility Everyone’s responsibility
* authorities : legislation, EFSA, controls, ...* authorities : legislation, EFSA, controls, ...
* production : ISO, GMP, HACCP, …* production : ISO, GMP, HACCP, …
+ communication with consumers, retailers, + communication with consumers, retailers, presspress
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Consumer confidence Consumer confidence
restorationrestoration
BE GOOD AND TELL IT !BE GOOD AND TELL IT !
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