Seminar on Food and Feed Additives Tokyo, JAPAN 2 July 2013

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1 Seminar on Food and Feed Additives Tokyo, JAPAN 2 July 2013 Innovative Biotechnology in Feed Additives: Improvements for a Sustainable Environment, Animal Welfare and Productivity Enhancement Dr. Gerhard Gans Senior Director Global Regulatory Affairs DSM Nutritional Products

2 Challenge I Protein - a mounting global concern World demand for quality protein from animal sources is increasing - driven by 2 major factors: More people Before 2050 the human population is expected to reach 9 billion people More disposable income Families with higher income will eat more meat More animal protein = increased demand for feed ingredients, increased cost and more pressure on the environment $/tonne Population (Billions) Year Year Soybeans US Soybean meal 44%

3 Challenge II Regulatory & 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

4 One Potential Solution: Improve Protein Digestion in Poultry Crop Proteolytic enzymes Proventriculus Pepsin (+ HCl) Diet proteins Gizzard Pancreas Trypsin Chymotrypsin Elastase Polypeptides Duodenum Aminopeptidases Carboxypeptidases Dipeptidases Oligopeptides + free AAs Free AAs

5 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

6 Environmental Impact: Mode of action Dietary protein: water intake and litter quality Dietary crude protein Improve digestibility Reduce levels in the diet Decrease nitrogen excretion Decrease of water intake -1% of crude protein in the diet will reduce water in-take by 2.7% Decrease quantity of excreta Decrease excreta moisture Decrease litter moisture/nitrogen content

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

8 Environmental Impact: Reduction of N excretion Consumpt. of feed N content of manure Without ProAct N input 22.5% CP AID 75.6 % N output Feed Manure With ProAct N input 20.5% CP AID 82.6 % N output 35% Reduction AID = Apparent Ileal Digestibility of CP

9 Nitrogen is a major pollutant Emission of Greenhouse Gases: CO 2 - from fertilizer production from use of energy N 2 O - from application of N-fertilizers and manure CH 4 - from ruminants, from paddies Global warming Agriculture is responsible for 60% of global N 2 O emissions and 50% of global methane emissions Emission of nitrate: NO 3 : from use of fertilizers from manure Agriculture is main source of nitrate pollution Nitrate pollution of ground water is also a health issue Emission of ammonia: NH 3+ : from use of fertilizers from manure In W Europe 92% of ammonia emissions are agricultural Ammonia is also an animal health issue Nutrient enrichment Algal blooms oxygen depletion Acidification Acid rain

10 Minimise environmental impact, maximise profitability Europe: billion broilers or ~ 15.9 mil ton broilers NH 3 emission reduction: which means*: 157,500ha less land is needed for manure application 612M more broilers can be reared without need for extra land Per ton broilers: kg NH 3 Total potential: ton NH 3 Reduced N-excretion: Per ton broilers: kg N Total potential: t N Source: Food and Agriculture Organization of the United Nations * Assumes maximum application of 17kg N/ha

11 RONOZYM ProAct Regulatory Approval Times BRAZIL BRAZIL 4 months for approval AUSTRALIA 13 months for approval CANADA 29 month for approval AUS CANADA EU-27 USA EU months for approval in EFSA & EU USA 19 month for approval by CVM 7

12 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.

13 Thank you for your attention!

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