Presented at a DSM customer event, Village Neuf , France on June 2013: Exploring the benefits of feed carotenoids for egg quality. -Feed additives for laying hens: Registration process in Europe Focus on carotenoids-M.Lutzow-2013

1. Feed additives for laying hens:
Registration process in Europe
Focus on carotenoids
Dr. Manfred L tzow
saqual GmbH, Switzerland

2. Content
• EU Feed legislation and additives - Introduction
• Registration and re-registration - Principles
• Vitamins, trace elements, amino acids,
enzymes
• Carotenoids
• Specific issues
• Conclusion and outlook
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3. EU Feed legislation
• Part of food chain (food safety, consumer concerns)
• EU "food law" (178/2002)
• Legislation covers all aspects in few pieces of legislation
• "Basic feed law" (767/2009)
• Feed material (catalogue, register)
• Feed hygiene (183/2005)
• Undesirable substances (2002/32)
• Feed additives (1831/2003, register)
• Analytical methods for official control
• Recall procedures
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4. Feed additives – positive list
• Technological additives
e.g. preservatives, antioxidants, binders
• Sensory additives
Flavourings, colours
• Nutritional additives
Vitamins, trace elements, amino acids,
urea
• Zootechnical additives
Digestibility enhancers, gut flora
stabilisers, favourably affect on the
environment, others
• Coccidiostats and histomonostats
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5. © M.Lützow 2012
Reevaluation of "old " additives
• Old legislation originated from 1970
• Many additives used/listed without
evaluation
• Generic listing (e.g. "all"
flavourings, "other" vitamins)
• 2003/04: all additives identified by
names and numbers
• Nov. 2010: submission of dossiers
for re-evaluation "Article 10(2)"
• ~ 400 dossiers & ~ 1’100
substances
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6. Reevaluation: key issues
• Many substances with no dossiers
already deleted
• Quality of additives – comprehensive
characterisation (up to 100%)
• Workers’ safety (dust formation)
• Update/new analytical methods
• Target animal safety: gaps closed
• Consumer safety: only for specific
classes & cases e.g. flavourings
• Significant data gaps result in
considerable delays of re-evaluation
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7. Reevaluation: vitamins
• Reauthorized: B6, E
• Finished EFSA dossiers: A, B1, C, Calpan, D3,
nicotinic acid, folic acid, biotin, choline, carnitine,
betaine, taurine, beta-carotene
• Pending EFSA dossiers: B2, B12, D3, K, Omega-6
• No big surprises – yet to come ?
• Pressure on "feed grade" ?
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8. Reevaluation: trace elements
• (Re)authorized: Se (organic), Zn, Mn
• Finished EFSA dossiers: I, Co, Cu, Mn, Zn, Se
• Pending EFSA dossiers: Fe, Cu, Mn, Zn, Se
• More detailed specifications (content, impurities)
• Safety instructions
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9. Reevaluation: enzymes
• Old: enzymes, now: digestibility
enhancers
• Zootechnical additive with holder
specific authorization
• New authorizations have been issued
• Competitive and innovative market
• Considerable target animal safety and
efficacy requirements, extrapolation to
additional categories
• Identity of producer organisms
(taxonomy)
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10. Reevaluation: carotenoids
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• Sensory additives
• Colouration of animal feed
• Colouration of human food
• For poultry and layers no new
products from a regulatory
point of view
• Limited number of molecules –
sufficient for yellow to
orange/red
• Recent EFSA assessments for
red and yellow (2006-09)
• "Food additive"

11. Reevaluation: canthaxanthin
• EFSA opinion from 2007
• Use in poultry and laying hens confirmed
(2008)
• “Maximum residue limits” (MRLs) of 30 mg
canthaxanthin/kg egg yolk
• MRLs for other poultry, salmon, trout
• Joint industry dossier (13.2.2009) – nine
companies
• EFSA status: “in progress”
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12. Reevaluation: ethyl ester of beta-
apo-8’-carotenoic acid
• Joint industry dossier (10.10.2010)
– two companies
• Poultry for fattening and poultry for
laying
• EFSA status: “additional data
requested” in April 2011
• Long "stand still" indicates no
critical safety issues
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13. Reevaluation: other carotenoids
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Carotenoid Status
Citranaxanthin
[Laying hens]
EFSA assessment from 2006
Dossier submitted, not yet
forwarded/requested
Capsanthin
[Poultry]
EFSA assessment from 2006
EFSA status: "additional data requested»
Lutein [Poultry] EFSA assessment from 2009
EFSA status: "additional data requested"

14. CAROPHYLL® Red 10%
• Application as zootechnical additive (holder: DSM)
• Recent EFSA opinion (12.12.12)
• Safe for breeder hens at the proposed dose of 6 mg/kg
complete feed
• Safe for the environment and consumers
• Recognized effects on the reproductive performance of
breeder hens as measured by hatchability and related
parameters
• Authorization being processed
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15. Other "quality" factors
• Food chain aspects
• EU rapid alert system for
food and feed
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16. RASFF: some recent cases
“dioxins in premixture with
carotenoids of Tagetes
erecta” (05/13)
“ochratoxin A in paprika
powder” (04/13)
“poor hygienic state of shell
dry peppers infested with
moulds and with insects”
(06/12)
“paprika powder from China
infested with moulds” (02/11)
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“dioxins and dioxin-like
polychlorobifenyls in ground
dried flowers of Tagetes
erecta” (06/09)

17. Conclusions and outlook
• Reevaluation of feed additives
ongoing
• Major feed additives &
carotenoids "on track"
• Completion by 2015/2016 ?
• No safety issues for layers
identified
• More detailed legislation re feed
additives, their quality and use
• More bureaucracy & paper work ?
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© M.Lützow 2004

18. Thank you very much!
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