Sponsor Day on animal feeding: The post-antibiotic era – innovation & regulation of feed additives in the EU

Dr. Elinor McCartney 1

The post-antibiotic era – innovation & regulation of feed additives in the EU

Dr Elinor McCartney President

Pen & Tec Consulting Group


Content

•  Antimicrobial resistance (AMR) – a driver of regulation & innovation

•  EU/EFSA feed additive approval process in context ²  Reg. 1831/2003 – definition of a feed additive

²  Reg. 429/2008 guidelines, EURL/EFSA guidance – “toolkits”

²  Reg. 767/2009 – feed materials

²  Dir. 2011/82 – veterinary medicines

•  Designing for EU/EFSA success ²  Pioneer feed additives, post-AGP ban

²  Novelty & EFSA challenges on quality, safety & efficacy

²  EFSA-compliant efficacy data & meta-analysis

²  Examples of innovation in botanical zootechnical additives

²  Horizon 2020 additives & support teams/services

2


0

10

20

30

40

50

60

70

80

90

100

1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006

Avilamycin

Broilers

Pigs

Humans

resistant strains (%)

DANMAP 2006

3000

1500

Active substance (kg)

Resistance to avilamycin in Enterococcus faecium

3


0

50

100

150

200

250

1990 1992 1994 1996 1998 2000 2001 2002 2003 2004 2005 2006

AGPs

Veterinary

Total

Consumption (Tm actives)

Animal antimicrobial consumption (Tm): -15% 1990-2006 (DANMAP 2006)

DANMAP 2006

4


EURL Antimicrobial Resistance Newsletter Nº 2 2007

resistant sensitive

non- wildtype

inter-mediate

5


Heavy emphasis on AMRs in animals

6


*ECDC/EMEA Joint Technical Report: The bacterial challenge: time to react 2009 http://ec.europa.eu/transport/road_safety/specialist/statistics/trends/index_en.htm

Most human AMR problems arise in çhospitals & the

çcommunity

AMR is reponsible for ≈25,000 EU deaths per annum*

7


EFSA Journal 2014;12(3):3590

Suggested citation: EFSA (European Food Safety Authority) and ECDC (European Centre for Disease Prevention and Control), 2014. The European Union Summary Report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2012. EFSA Journal 2014;12(3):3590, 336 pp., doi:10.2903/j.efsa.2014.3590

Available online: www.efsa.europa.eu/efsajournal

© European Food Safety Authority, 2014

SCIENTIFIC REPORT OF EFSA AND ECDC

The European Union Summary Report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 20121

European Food Safety Authority2,3 European Centre for Disease Prevention and Control2,3

European Food Safety Authority (EFSA), Parma, Italy

European Centre for Disease Prevention and Control (ECDC), Stockholm, Sweden

ABSTRACT The antimicrobial resistance data among zoonotic and indicator bacteria in 2012, submitted by 26 European Union Member States, were jointly analysed by the EFSA and the ECDC. Resistance in zoonotic Salmonella and Campylobacter isolates from humans, animals and food and resistance in indicator Escherichia coli, as well as data on methicillin-resistant Staphylococcus aureus, in animals and food were addressed. Resistance in human isolates was mainly interpreted using clinical breakpoints, while microbiological resistance in animal and food isolates was assessed using epidemiological cut-off values. Resistance was commonly found in isolates from humans, animals and food, although marked disparities in resistance were frequently observed between Member States. In Salmonella from humans, high resistance levels were recorded to ampicillin, sulfonamides and tetracyclines, while resistance to third-generation cephalosporins and fluoroquinolones remained low. In Salmonella and Escherichia coli isolates from fowl, pigs, cattle and meat thereof, microbiological resistance to ampicillin, tetracyclines and sulfonamides was commonly detected, while microbiological resistance to third-generation cephalosporins was generally low. High to very high microbiological resistance to (fluoro)quinolones was observed in Salmonella isolates from turkeys, fowl and broiler meat. In Campylobacter from humans, resistance to ampicillin, ciprofloxacin, nalidixic acid and tetracyclines was high, while resistance to erythromycin was low to moderate. High to extremely high microbiological resistance to ciprofloxacin, nalidixic acid and tetracyclines was observed in Campylobacter isolates from fowl, broiler meat, pigs and cattle, whereas much lower levels were observed for erythromycin and gentamicin. Increasing trends for ciprofloxacin resistance was observed in Campylobacter isolates from humans, broilers and/or pigs in several Member States. Multi-resistance and co-resistance to critically important antimicrobials in both human and animal isolates were presented, and for the first time, multi-resistance patterns in Salmonella serovars. Very few isolates from animals were co-resistant to critically important antimicrobials. A minority of isolates from animals belonging to a few Salmonella serovars (notably Kentucky and Infantis) were resistant to high levels of ciprofloxacin.

© European Food Safety Authority, European Centre for Disease Prevention and Control, 2014

KEY WORDS antimicrobial resistance, zoonotic bacteria, indicator bacteria

1 On request from EFSA, Question No EFSA-Q-2013-00214, approved on 24 February 2014. 2 Correspondence: in EFSA: [email protected]; in ECDC: [email protected] 3 Acknowledgements: EFSA and ECDC wish to thank the members of the Scientific Network for Zoonoses Monitoring Data,

former Task Force on Zoonoses Data Collection (EFSA) and the Food and Waterborne Diseases and Zoonoses Network (ECDC) who provided the data and reviewed the report. Also, the contribution of EFSA’s staff members: Pierre-Alexandre Belœil, Pia Mäkelä, Anca Stoicescu, Valentina Rizzi, Anne-Laure Moufle, Roisin Rooney, Kenneth Mulligan, Francesca Riolo, Mario Monguidi, Saghir Bashir, Angela Cohen, Gina Cioacata and Klaudia Chrzastek, the contributions of ECDC’s staff members: Therese Westrell, Johanna Takkinen and Liselott Diaz Högberg, and the contributions of EFSA’s contractors: the Animal Health and Veterinary Laboratory Agency of the United Kingdom: Sarah Easthope, Catherine Tallentire and Christopher Teale, and the University of Hasselt: Stijn Jaspers and Marc Aerts, for the support provided to this scientific output.

Scientific support & advice EFSA and ECDC provide independent scientific support and advice to risk managers and decision makers on the possible emergence, spread and transfer of antimicrobial resistance, EFSA collects data on AMR in food-producing animals, while ECDC collects data on AMR in humans.

Integrated approach EFSA and ECDC monitor AMR in animals and humans, using data reported by Member States. The two agencies cooperate with the European Medicines Agency to analyse the relationship between antimicrobial use and the emergence of resistance in food-producing animals and in humans.

Europe’s fight against ANTIMICROBIAL RESISTANCE How do EFSA and ECDC fight AMR?

8


AMR crisis (WHO 2014)

2

Antimicrobial resistance – global report on surveillance

WHO 2014

Fatal scrapes & scratches in children Fatal bladder infections in elderly Fatal sequelae to routine hip replacements

Dr Keiji Fukuda WHO Director-General

End of safe medicine Funding needed for new antibiotics

UK experts

AMR travels with infectious disease Infectious diseases travels globally

Dr Daniel Lo Fo Wong Senior advisor AMR, WHO

AMR is a global threat Little is being done to tackle it AMR turns common infections into untreatable diseases. Every antibiotic will become useless

Lord Darzi, former UL health minister

UK funding inadequate (<1% R&D funds) Worse than 1980s AIDS crisis

Professor Laura Piddock University of Birmingham

UK AMR is less than elsewhere but we see patients with infections resistant to antibiotics

Dr Paul Cosford Public Health England


Lies, Damn Lies, Statistics and …

(Consumer) Politics

9


EU votes Population (M) Nº votes

Germany 83 29

UK 60 29

France 60 29

Italy 60 29

Spain 40 27

Poland 40 27

Romania 23 14

Netherlands 16 13

Greece 11 12

Czech Republic 10 12

Belgium 10 12

Hungary 10 12

Portugal 10 12


Sweden 9 10

Bugaria 8 10

Austria 8 10

Slovakia 5 7

Denmark 5 7

Finland 5 7

Ireland 4 7

Croatia 4 7

Lithuania 4 7

Latvia 2 4

Slovenia 2 4

Estonia 1 4

Cyprus (4), Lxburg (4) Malta (3)

2 11

EU 28 500 M 452

500 M demanding consumers!

10


EU legislative response to AMR & other “food” issues •  White Paper on Food Safety (2000) •  European Food Safety Authority (EFSA, 2002)

•  Rapid Alert System for Food and Feed (RASFF, 2003)

•  New Regulations on “Novel” Foods/Feeds (GMOs, 2003)

•  Traceability/HACCP “From Farm to Fork” (2006)

•  New Regulations on undesirable substances, feed additives, feed hygiene, official controls in the food chain (2003-2006)

•  New Regulations on food enzymes, additives, & flavours (2008)

•  New feed regulation (2009)

•  Application of the new laws to food and feed imported to the EU

•  EU bans antibiotic growth promotors (AGPs) – completed in 2006

•  Increased pressure to reduce use of veterinary & human antibiotics

11


But, every cloud has a silver lining…

12


Innovation – post-AGP ban

•  Probiotics – gut flora stabilisers, immune stimulators •  Feed enzymes – digestibility enhancers •  Chelated minerals – better animal welfare & nutrition •  Selenium yeasts – better nutrition for animals & humans •  Organic acids/salts – help combat enteropathogens •  Botanical preparations (herbs, spices, exotic & edible plants) •  Innovative feed materials •  Better quality feeds •  Improved or creative delivery systems •  TLC è animal health & hygiene •  Horizon 2020 products? •  Horizon 2020 teams! 13


A Horizon 2020 team at work ….


Dream teams for EC/EFSA dossiers ü  Committed sponsor (cost & time)

ü  ISO-17025 accredited analytical labs

ü  R&D sites with EFSA “knowhow”

ü  Dedicated & modern R&D feed mill

ü  Life scientists – used to working with animals, people & data

ü  Computer-literacy & statistical skills

ü  Passion & perfectionism for work in technical & legal areas

ü  Communication skills – written & team-working

ü  Fluency in English & attention to detail 26


Being a pioneer…. the price of innovation

15


EC/EFSA feed additives – innovation index? Type EC listed –

current legal status

EFSA listed as under (re)evaluation

Comment

Feed enzymes Zootechnical Digestibility

50 90 ≅ 100, regulated since 1990s

Feed probiotics Zootechnical Gut flora

40 90 ≅ 100, regulated since 1990s

Feed flavours Sensory

600 NICs (nature identical components) 200 Botanicals

70 grouped: 50 NICs 70 botanicals

“Flavours” = most feed additives!

Zootechnical Mostly “Other”

≅ 5 NICs ≅ 1 Botanical

< 10 NICs <10 botanicals

Room for innovation?


Building EU success Main dossier reference material

Commercial objectives – how to achieve within legal framework? ü  EU regulations 1831/2003 & 429/2008

ü  EFSA guidance (adminstrative, zootechnical, tolerance/efficacy …)

ü  EURL guidance (method validations & verifications)

ü  SCAN/recent EFSA opinions on similar products?

ü  Previous SCF reports/opinions (e.g. use in foods)

ü  EFSA, JECFA, EMEA, CoE reports & literature searches

ü  GOOGLE: EFSA, DGSanCo, US FDA/EPA, etc

ü  In-house & external research – EFSA-compliant?

16


Building successful feed additive dossiers Consider strategic options - additive groups

1.   Technological: Act on feed & feedingstuffs, e.g. preservatives, anti-oxidants, emulsifiers,stabilisers, thickeners, gelling agents, binders, anti-radionucleotides, anticakers, acidifiers, silage additives, denaturants, mycotoxin de-activators

2.   Sensory: Add colour to feed/animals or flavour to feeds 3.   Nutritional: Vitamins, pro-vitamins, trace elements, amino

acids, urea 4.   Zootechnical: a. Improve feed digestibility, b. gut flora

equilibrium, c. the environment, or d. “other“ (performance enhancers, animal welfare, food quality ….)

5.   Coccidiostats & Histomonostats

17


Building successful feed additive dossiers Planning & data audit

ü  Who, what, why, where, when, which, how? ü  Do we need/want a feed additive approval? If yes, why? ü  Which category/functional group/s & why? ü  What do current guidelines/guidance require? ü  What data are available & do they meet current standards? ü  What data must be generated? ü  Time & cost of data generation? ü  What problems will arise & how do we solve them? ü  Can we protect our investment? ü  Iterate until project strategy & plan is clear

18


Building a successful feed additive dossier What is it and what does it do?

•  Product specification?

•  Administered in feed, water or other route?

•  Improve feed, animal products or animal colour?

•  Satisfy nutritional needs?

•  Improve the environment?

•  Improve animal production, performance, welfare?

•  Coccidiostat/histomonostat?

•  Something else? ( → Comitology)

•  Options to market as a feed material, premixture or complementary feed?

19


Planning DATA AUDIT EXPERT ADVICE ITERATE KEY ISSUES

1. Safety e.g. use in foods e.g. calculate relative exposure

e.g. assemble supporting

literature (CoE/EMEA/JECFA)

e.g. do we need residue studies?

2. Efficacy e.g. optimum range & “claims”?

e.g. EFSA-compliant studies

e.g. select study sites

e.g. justify minimum dose?

3. Quality i.e. analytical

method validation & verification

e.g. product specification

e.g. role & legal status of coating

agents & excipient/s

e.g. stability & compatibility

4. Generate data SAFETYè EFFICACYè QUALITYè e.g. EFSA/EURL compliance

5. Reports Review in detail Check raw data Check & rerun statistics e.g. meta-analysis

6. Annexes Safety Annexes Efficacy Annexes Quality Annexes Bibliography

7. Text Safety Text Efficacy Text Quality Text Summary Text (coherence)

8. Administration EURL EU EFSA SUBMIT

Building EU success Best practice – planning ahead

20


EURL EU EFSA: (1 paper copy, 2 CDs)

Cover letter & declaration form &

EU Annex I

Cover letter & application form

(EU Annex I)

Part 1 Administrative

Part 2 Technical

Part 3 Confidential

3 ref. samples (same lot)

3 ref. standards Administrative data Cover letter

Section I PubSum, ScSum, List.Doc, ConfInfo

Confidential parts

Certificate of ID/analysis

Section I Public summary

Application form (EU Annex I)

Section II Quality II Annexes From Section II

Pay EURL fees EU MSDS

Section I Scientific summary

Contact details (Annex E)

Section III Safety

III Annexes From Section III

PubSum & ScSum

Section I Dossier Index

Descript. Add Annex A

(Register entry)

Section IV Efficacy IV Annexes

From Section IV

Obtain proof of payment or fee waiver

Section I Confidential Parts

Completeness Checklist (Annex

B)

Section V PMMP

Notes ê

English

NB: Multi-tasking dossiers OK!

EURL fee proof of payment or fee

waiver

Declaration E-copy = paper

NB Bibliography to Sections II, III, IV.

PDFs <20 MB


Building successful feed additive dossiers Best practice: EFSA completeness check list

22


Austria Bulgaria Belgium Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Hungary Ireland Italy Latvia Lithuania Luxembourg Malta Netherlands Poland Portugal Romania Slovakia Slovenia Spain Sweden UK

Natugro Inc.

Natugro

25 kg

WhizzGro® Dossier

EFSA “6-month

evaluation”

Public Summary

WGs & Plenary/s

EFSA opinion published

28 Member States:

Comitology, QMV (≥3 m) → Regulation (+2-3m)

Building successful feed additive dossiers The evaluation & authorisation process



Germany 83 29

UK 60 29

France 60 29

Italy 60 29

Spain 40 27

Poland 40 27

Romania 23 14

Netherlands 16 13

Greece 11 12

Czech Republic 10 12

Belgium 10 12

Hungary 10 12

Portugal 10 12


Sweden 9 10

Bulgaria 8 10

Austria 8 10

Slovakia 5 7

Denmark 5 7

Finland 5 7

Ireland 4 7

Croatia 4 7

Lithuania 4 7

Latvia 2 4

Slovenia 2 4

Estonia 1 4

Cyprus (4), Lxburg (4) Malta (3)

2 11

EU 28 500 M 452

Building successful feed additive dossiers QMV, EU 28, ≥50% Member States (> 60% EU population), 74% votes

24


Building a successful feed additive dossier Being a pioneer….

25


Building successful feed additive dossiers Best practices – learning from experience

ü  Start at the beginning – if possible

ü  Collect all relevant & current

EURL/EU/EFSA documents

ü  Focus on key EFSA documents (e.g. sensory guidance for botanicals)

ü  Check (& challenge?) product positioning & claims with the client/marketing department

ü  PLAN the dossier – problems, solutions, budgets, & time to market

26


Building successful feed additive dossiers Do’s

ü  If in doubt, consult the EU Commission &/or EFSA by e-mail/telecon

ü  Follow EU guidelines to the letter (!) (Reg 429/2008)

ü  Follow relevant EFSA guidance/s to the letter (!), BUT è

ü  Check legal loopholes for opportunities to reduce costs/time (read the small print in Reg. 429/2008)

ü  Be ruthless with studies that are not EFSA-compliant

ü  Use standard templates for efficacy & tolerance study protocols & reports

ü  Monitor all studies – visit & communicate with study directors & barn crews

ü  Check all study raw data & statistics!

ü  Blood samples (& tissues?) in all tolerance studies! (store spare sets?) 27


2. TOC (Table of Contents) Item Page 1. Title page 2. Table of Contents 3. Summary (insert in final report) 4. Quality statement 5. Target dates/reporting requirements 6. Materials & methods (inc. statistical technique/s) 7. Results (tables) 8. Discussion & conclusions (text/bullet points) 9. References 10. Appendices: CVs, CoAs., external laboratory reports, raw data, statistical outputs 11. Addenda (e.g. late additions to report) 12. EFSA Annex C (tolerance/efficacy)

Building successful feed additive dossiers Do use standard templates for study protocols & reports

28


Building successful feed additive dossiers Don’ts

x  Assume that commercial trials from 1985 will meet current EFSA standards

x  Run studies without an EFSA-compliant, written protocol x  Finalise reports without a careful review against EFSA

requirements x  Submit a dossier without double-checking both e-copies &

paper copies against each other x  Assume that EURL/EFSA/EU guidance/guidelines will be the

same as for the last dossier submitted, hence è do not:

x  Copy & paste from the previous dossier to the current dossier (e.g. species extension) without checking & updating to fit new EURL/EFSA/EU requirements

29


EFSA Evaluations GUILTY UNTIL PROVEN INNOCENT

30


EFSA FEEDAP evaluations

EFSA feed additive dossier validation process

²  Informal/formal letter of receipt

²  EFSA completeness check (30 working days)

²  EFSA MiP – Missing Information Parts

²  EFSA validation letter è Clock Zero (6 months evaluation)

²  EFSA circulates dossier to EURL, EU & Member States

²  EFSA requests confirmation that the Public Summary does not contain confidential information

²  EFSA publishes the Public Summary of the dossier

²  All this will be managed by the EFSA Applications Help Desk

31


EFSA FEEDAP evaluations

EFSA working groups (WG) & plenary meetings

²  Dossier evaluation is mainly undertaken by WG of independent experts – listed on EFSA web page – not all are FEEDAP panel members

²  EFSA Sins!

²  WGs supported by EFSA FEEDAP scientific officers (Secretariat)

²  Plenary meetings consist of 21 EFSA FEEDAP scientific panel members – also listed on EFSA web page

²  EFSA opinion is first drafted by WG, then discussed & adopted at EFSA plenary meetings

²  EFSA plenary may request reworking of WG draft or raise additional questions for the applicant (!)

²  Hence dossier usually appears at least twice on EFSA FEEDAP agenda

32


EFSA FEEDAP Evaluations

EFSA SIns – Supplementary Information requests

²  = “Clock-Stop”

²  30 working days to reply or

²  Applicant requests time extension/s

²  In theory only 1 EFSA clock-stop (SIn) with all questions from WG

²  In practice, several SIns are more common è

²  (Depends on applicant’s answers & EFSA plenary)

33


EFSA FEEDAP Evaluations

Best practices, must do’s, recipes for success:

ü  Answer all EFSA questions to the letter

ü  Be realistic about time frames & request time

extension/s as necessary

ü  Stick to sound technical arguments & avoid anecdotal data

ü  EFSA want DATA not fairy tales!

ü  Use legal arguments if necessary (Reg. 429/2008!)

ü  Be prepared to yield on less important points (e.g. minimum effective dose)

ü  Generate essential additional data (DTW!)

ü  Keep EFSA secretariat informed by e-mail 34


A few botanical examples

44


Non-antibiotic feed additives – e.g. zootechnical “botanicals”

•  Pioneer feed additives, post-AGP ban •  Plant-derived, well-researched, & deliver consistent performance

•  Patent protection

•  Innovative delivery to target gut sites

•  Proven quality, purity, stability & guaranteed batch uniformity

•  Safe for animals, consumers, users, & the environment

•  EU/EFSA-approved (2 products in piglets, 1 product in broilers) •  Under evaluation (≈6 dossiers - 3 broiler, 2 piglet, 1 pig)

•  Several regulatory failures – withdrawn, insufficient safety & efficacy data

•  Many listed as feed “flavours”, but EFSA tough stance on safety – e.g. botanical residues of toxicological concern

14


Botanical NICs in weaned piglets: coated thymol, citric/sorbic acids, vanillin

Study, duration & parameters

Control Product at 3 kg/Tm feed Probability Improvement

Study 1, 49d Growth

Feed:gain

437 g/d

1.81

462 g/d

1.76

P<0.05 P<0.05

25 g/d (6%) -0.05 (3%)

Study 2, 42 d Growth

Feed:gain

494 g/d

1.75

516 g/d

1.66

P<0.01 P<0.05

22 g/d (4%) -0.09 (5%)

Study 3, 42d Growth

Feed:gain

307 g/d

1.86

334 g/d

1.68

P<0.01 P<0.05

27 g/d (9%) -0.18 (10%)


Botanical NICs in broilers: coated thymol, citric/sorbic acids, vanillin

35

Parameter T1 Control (0 g/Tm)

T2 NICs (200 g/Tm)

P value

AWG (g) 1,932a 1,970b 0.0013 AFI (g) 3,260 3,271 0.6316 FCR 1.688b 1.661a 0.0006 AWG – mean weight gain; AFI – mean feed intake; abDifferent superscripts within a row indicate significant differences (P≤0.05).

+2% AWG

-3 points FCR


Botanical “naturals” in weaned piglets: coated essential caraway/lemon oils

Zootechnical efficacy in weaned piglets – meta-analysis of 5 studies Product at 250 g/Tm feed Control Caraway &

lemon oils SEM P Difference

Mortality, 28-70 days (%) 6.21 4.57 1.16 0.299 ~ Live weight, 28 days (kg) 7.55 7.56 0.05 0.938 ~ Live weight, 70 days (kg) 23.41 24.24 0.19 0.002 +3.6% Daily gain, 28-70 days (g/day) 378.2 398.0 4.63 0.002 +5.2% Feed intake, 28-70 days (g/day) 553.2 575.3 6.22 0.009 +4.0% Feed:gain, 28-70 days 1.47 1.44 0.01 0.204 ~ SEM = standard error of the mean; P = probability

35


Botanical “naturals” in broilers (coated essential thyme/star anise oils): digestibility studies

Zootechnical efficacy in broilers – meta-analysis of 6 studies Product at 150 g/tm feed Control Thyme &

star anise oils SEM P Difference

Live weight (g), 21 days 793 819 35.55 0.014 +3.3% Daily gain (g/d), 1-21 days 35.7 36.9 1.65 0.014 +3.4% Feed intake (g/d), 1-21days 46.0 46.2 2.10 0.827 ~ Feed:gain, 1-21 days 1.30 1.26 0.03 0.101 ~ Nutrient digestibility Organic matter (%) 67.2 72.2 0.79 <0.001 +7.4% Crude protein (%) 77.3 81.5 1.22 <0.001 +5.4% Crude fat (%) 91.4 93.9 0.83 <0.001 +2.7% Crude ash (%) 37.5 42.2 2.26 <0.001 +12.5% Phosphorus (%) 38.4 45.7 2.51 0.002 +19.0% Calcium (%) 39.8 49.0 5.78 <0.001 +23.1% Dry matter (%) 78.6 81.2 0.21 <0.001 +3.3% SEM = standard error of the mean; P = probability

38


Botanicals in broilers è skeletal strength

OM (%) CP (%) CF (%) CA (%) P (%) Ca (%) DM (%)

67.2

72.2

77.3

81.5

91.4

93.9

37.5

42.2

38.4

45.7

39.8

49.0

78.6

81.2

* P<0.001 * P<0.001 * P<0.001

* P<0.001

* P<0.002

* P<0.001

* P<0.001

40

Control vs Coated essential thyme/star anise oils Botanical product at 150 g/Tm


Botanical “naturals” – broiler performance

Botanical performance in broilers – meta-analysis of 5 studies Coated product at 150 g/tm feed Control Thyme &

star anise oils

SEM P Difference

Mortality, 1-42 days (%) 5.91 6.32 3.13 0.788 ~ Live weight, 42 days (g) 2,710 2,750 113.28 0.316 ~ Daily gain, 1-42 days (g) 63.5 64.5 2.71 0.315 ~ Feed intake, 1-42 days (g) 100.2 98.5 4.12 0.288 ~ Feed:gain, 1-42 days 1.59 1.54 0.11 0.008 -3.1% SEM = standard error of the mean; P = probability

41


Kidney bean lectins in piglets for gut maturation

41

Oral lectins at 11, 12, 13 days of age

T1 Control

T2 Lectins

P value

%

change

ADG, 28-70 days of age g/day

378.4 412.5 0.004 +9%

ADFI, 28-70 days of age g/day

515.7 542.5 0.0149 +5%

Feed:gain, 28-70 days of age

1.367 1.319 0.186 -4%


Innovation - regulatory push or consumer pull?

Building Horizon 2020 products & teams!

43

• Education

• Resources

• Cutting edge science

• Passion for problem solving


Dr Elinor McCartney EU Food Chain Legislation Expert

Thank you – any questions?

President Pen & Tec Consulting Pl. Ausiàs March, 1, 4th floor D01 Mirasol, Sant Cugat del Vallès 08195 Barcelona, Spain E-mail: [email protected] Tel: +34 93 675 80 15 www.pentec-consulting.eu

Budapest 24th – 26th June 2014

Hotel InterContinental Budapest

Sponsor Day on animal feeding: The post-antibiotic era – innovation & regulation of feed additives in the EU

Technology

critically

indicator

broiler meat

nalidixic

generation

disease prevention

member states

microbiological