Seminar on Food and Feed AdditivesTokyo, JAPAN 2 July 2013

Innovative Biotechnology in Feed Additives: Improvements for a Sustainable Environment, Animal Welfare and Productivity Enhancement

Dr. Gerhard GansSenior Director Global Regulatory Affairs DSM Nutritional Products

Challenge IProtein - a mounting global concern

World demand for quality protein from animal sources is increasing - driven by 2 major factors:

More peopleBefore 2050 the human population is expected to reach 9 billion people

More disposable incomeFamilies with higher income will eat more meat

More animal protein = increased demand for feed ingredients, increased cost and more pressure on the environment

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Soybeans US Soybean meal 44%

Challenge IIRegulatory & Consumer Pressure Increase

Regulators seek to protect consumer, animals and environment

Decision making criteria of consumer are changing

Increasing pressure on broiler producers to:

Improve animal welfare

Reduce use of antibiotics

Protect the environment

Improve food safety

More efficient utilization of protein can help meet all these criteria

Crop

Proventriculus

Gizzard

Duodenum

Pancreas

Diet proteins

Polypeptides

Oligopeptides+ free AAs

Free AAs

Proteolytic enzymes

Pepsin (+ HCl)

TrypsinChymotrypsinElastase

AminopeptidasesCarboxypeptidasesDipeptidases

One Potential Solution:Improve Protein Digestion in Poultry

Characteristics of RONOZYME® ProAct

Is a preparation of serine protease, with broad specificity and high stability at low pH

Is produced by fermentation of a genetically modified Bacillus licheniformis strain containing a synthetic gene mimetic to the gene coding for a serine protease.

The production strain does not contain genes coding for antibiotic resistance

Absence of toxin formation in Bacillus licheniformis was shown by genome analysis and in vitro cytotoxicity studies

The production strain is absent in the preparation and the level of recombinant DNA is below the limit of detection of the PCR method

Extensive safety data package provides evidence on the safe use for consumer, workers and target animals

Decrease quantity of excreta

Decrease excreta moisture

Decrease of water intake

Decrease litter moisture/nitrogen content

Reduce levels in the diet

Decrease nitrogen excretion

Improve digestibility

Environmental Impact: Mode of action Dietary protein: water intake and litter quality

Dietary crude protein

-1% of crudeprotein in the

diet will reducewater in-take

by 2.7%

Animal Welfare Impact

Improved litter dry matter and nitrogen level can help decrease incidence of footpad dermatitis, breast blisters and hock burns

Lower protein diets supplemented with RONOZYME ProAct allow improved welfare without loss in animal performance

Improve litter quality

Improve animal welfare

AID 75.6%

AID82.6%

N input22.5% CP

WithoutProAct

WithProAct

Consumpt. of feed

N input 20.5% CP

N output

N content of manure

N output

Feed Manure

35% Reduction

AID = Apparent Ileal Digestibility of CP

Environmental Impact:Reduction of N excretion

Nitrogen is a major pollutant

Global warming

Nutrient enrichment

Algal bloomsoxygen depletion

Acidification

Acid rain

Emission of Greenhouse Gases:• CO2 - from fertilizer production from use of energy• N2O - from application of N-fertilizers and manure• CH4 - from ruminants, from paddies

Agriculture is responsible for 60% of global N2O emissions and 50% of global methane emissions

Emission of Greenhouse Gases:• CO2 - from fertilizer production from use of energy• N2O - from application of N-fertilizers and manure• CH4 - from ruminants, from paddies

Agriculture is responsible for 60% of global N2O emissions and 50% of global methane emissions

Emission of nitrate: NO3÷:

• from use of fertilizers• from manure

Agriculture is main source of nitrate pollutionNitrate pollution of ground water is also a health issue

Emission of nitrate: NO3÷:

• from use of fertilizers• from manure

Agriculture is main source of nitrate pollutionNitrate pollution of ground water is also a health issue

Emission of ammonia: NH3+:

• from use of fertilizers• from manure

In W Europe 92% of ammonia emissions are agriculturalAmmonia is also an animal health issue

Emission of ammonia: NH3+:

• from use of fertilizers• from manure

In W Europe 92% of ammonia emissions are agriculturalAmmonia is also an animal health issue

Minimise environmental impact, maximise profitability

Europe:

6.357 billion broilers or~ 15.9 mil ton broilers

NH3 emission reduction:

Per ton broilers: -1.68 kg NH3

Total potential: -26712 ton NH3

Reduced N-excretion:

Per ton broilers: - 2.79 kg N

Total potential: - 44018 t N

which means*:

157,500ha less land is needed for manure application

612M more broilers can be reared without need for extra land

Source: Food and Agriculture Organization of the United Nations* Assumes maximum application of 17kg N/ha

RONOZYM ® ProAct Regulatory Approval Times

BRAZIL•4 months for approval

AUSTRALIA•13 months for approval

EU-27•18 months for approval in EFSA & EU

USA•19 month for approval by CVM

CANADA•29 month for approval

CANADA

BRAZIL

AUS

EU-27USA

7

Innovative Product Development Needs:

Convergence in the National Approaches for Premarket Approval

Acceptance of OECD test guidelines instead of national specific test guidelines

Respect and utilize the evaluation results of the counterpart (FSC / EFSA) to accelerate the evaluation process

Rigid and transparent evaluation lead times

Number of expert groups with frequent meetings

Timelines for evaluation process

Active dialogue between authority/expert group and industry to develop further the current approval process.

Thank you for your attention!