Infant Formula Products

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1 Infant Formula Products Regulations and standards that apply to infant formula products for exporting to China Characteristics of current products and R&D Xueqin Du, August 2014 Farmland Dairy Pty Ltd

2 Breast milk is best for babies The World Health Organization (WHO) recommends that infants be exclusively breastfed for the first six months of life to achieve optimal growth, development and health (WHO2003). Infants who are not breast fed need a suitable breast-milk substitute, for example, infant formula (WHO2007). Infant formula is an option when it is available, affordable, can be used safely and provides a nutritional or other advantage over animal milk (WHO2005). Mothers should continue to breastfeed their children beyond the age of six months, until they are two years of age or older, at the same time providing them with safe and appropriate complementary foods to meet their evolving nutritional requirements(who2003).

3 Regulations and Standards that apply Australian regulations and standards Export Control Act 1982 Export Control (Orders) Regulations 1982 Export Control (Milk and Milk Products) Orders 2005 State and territory regulations NSW: Food Regulation 2010, Food Act2003

4 Regulations and Standards that apply Australian regulations and standards Food Standards Code Part 1.2 Labelling and other Information Requirements Mandatory Warning and Advisory Statement and declarations Nutrition Information Requirements Food Additives Vitamins and Minerals Part 1.4 Contaminants and Residues Microbiological Limits in Food Infant Formula Products infant formula (0-12 months) follow-on formula (6-12 months) infant formula products for special dietary use (e.g. metabolic and immunological conditions) Primary Production and Processing Standard for Dairy

5 Regulations and Standards that apply Importing Country Requirements China GB Good manufacturing practice for powdered formula for infants and young children GB Infant formula GB Older infants and young children GB Food additives GB Nutritional fortification GB General standard for the labelling of prepackaged foods for special dietary uses Administrative Measure on Inspection, Quarantine and Supervision of Imports and Exports of Dairy Products, implemented on 1 May 2013 Announcement No. 53 Order 62 All manufacturing and storage establishments involved in the export of dairy products, including infant formula to China must be registered with Chinese authorities by 1 May 2014.

6 Food Safety Programs in Place Approved Arrangement/Food Safety Program is approved by DAFF/AQIS and regularly audited by DAFF/FA NSW (every 6 months) The Food Safety Programs are also regularly audited by a professional organisation with RABQSA auditors are approved for regulatory audits (annually). Certification is provided for Codex HACCP standards. Key References Codex CAC/RCP , CODE OF HYGIENIC PRACTICE FOR POWDERED F ORMULAE FOR INFANTS AND YOUNG CHILDREN the Grocery Manufacturers Association USA 2009, CONTROL OF SALMONELLA IN LOW-MOISTURE FOODS

7 Product Characteristics Current products Value-added Ingredient DHA & AA Nucleotides Beta-carotene Alphalactalbumin Lactoferrin GOS & FOS Lutein Main functions/potential benefits Involved in growth and development of brain, vision and nerve. Lower number of first episodes of diarrhea, may be used by intestinal mucosal cells to make newborn s gut stronger. A precursor of vitamin A, antioxidant Obtain an amino acids profile closer to human milk: main source of tryptophan, good source of branched chained amino acids. Brings cystein. Prohibits growth of pathogenic microorganisms and help with immunity and gut health. Prebiotics, support the growth of healthy bacteria such as bifidus and acidophilus, produce softer and more regular bowel motions. Antioxidant found in the retina, to help support developing eyes.

8 Product Characteristics Current products Mica Infant Formula Protein Composition Protein Human milk Mica Infant Formula Commercial whey-dominant formulas Casein 40% 37% 40% 80% Whey 60% 63% 60% 20% α-lactalbumin β-lactoglubulin 2.4g/L* no 1.9g/L# Reduced *Approximate concentrations, Lien 2003 # α-lactalbumin enriched 1.2g/L* Main whey protein Bovine milk 0.5g/L* Main whey protein

9 Fattyacid Mica infant formula Australian (R.Yuhas Mica Infant fatty acid composition ( %TFAs) Human milk, et al, 2006) (%TFAs) Human milk, Chinese (R.Yuhas et al, 2006) (%TFAs) Bovine milk (%TFAs) Saturated C16:0 Palmitic C18:0 Stearic 3.4 Monounsaturated C16:1 Palmitoleic 0.1 C18:1 Oleic Polyunsaturated C18:2 n-6 Linoleic, LA C18:3 n-3 α- Linolenic, ALA 3.5* C20:4 n-6 AA C22:6 n-3 DHA LA:ALA AA:DHA *The higher lev el is us ed c ons idering DHA c onc entration being < 0.2% TFAs (SCF/CS/NUT/IF/6 Final, 2003)

10 R&D Modification of fatty acid composition of current infant formula to improve absorption of fat and calcium Dietary lipids are the predominant energy source for infants and play an important role in infant growth and development. While keeping the relatively lower total fat and energy per 100mL reconstituted milk unchanged the fatty acid composition will be improved to achieve better fat and calcium absorption by reducing palmitic acid and total saturated fatty acids (Steven et al, 1998) and Increasing monounsaturated fatty acids. Addressing further common nutritional insufficiencies of Chinese toddlers by increasing concentrations of certain micronutrients in the toddler formula (e.g. vitamin B2).

CODEX STANDARD FOR FOLLOW-UP FORMULA CODEX STAN 156-1987. This standard applies to the composition and labelling of follow-up formula.

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