Iron Fortification Ingredient accepted as GRAS

30/03/06 Akzo Nobel has announced that the self-affirmed GRAS (Generally Recognized As Safe) status of its iron fortification ingredient Ferrazone, has been accepted by the US FDA Center for Food Safety and Applied Nutrition, Office of Food Additive Safety.

The company noted that an independent panel of scientific experts determined that Ferrazone is safe and is GRAS for its intended use as a nutrient in soy, fish, teriyaki, hoisin and sweet and sour sauces.

Ferrazone (food-grade ferric sodium EDTA) is a superior iron source that is generally non-reactive in food and thereby provides a stable iron source for many foods without imparting taste or color changes. Ferrazone is water-soluble and stable against salt, pH, and oxidation. It is gentle on the stomach, does not promote constipation, and provides good absorption and bioavailability, even in high phytate diets.

Iron deficiency, including iron deficiency anemia (IDA), is one of the world’s most significant nutritional health problems, with an estimated 2 billion individuals suffering from some form of iron deficiencies. IDA undermines the health of 500 million women of reproductive age as well as leading to more than 60,000 childbirth deaths a year. Iron deficiency also causes a range of other problems in hundreds of millions of people, such as impaired cognitive development in children, fatigue, maternal mortality and low productivity in the workplace.

Ferrazone has been found to be efficacious in controlled, small-scale clinical studies and Ferrazone has also been proven to be effective in large-scale, real-life implementation trials. Reporting in the Journal of Nutrition in 2005, researchers at the Vietnamese National Institute of Nutrition (NIN) in Hanoi found Ferrazone highly effective in reducing iron deficiency in an effectiveness trial using Ferrazone added to fish sauce in a fortification program. In an earlier related study, researchers at the Swiss Federal Institute of Technology in Zurich together with the NIN found a high level of bioavailability of iron using Ferrazone.

Also, a recent study in China reported in the Food and Nutrition Bulletin (2005), showed the use of ferric sodium EDTA in soy sauce was highly effective in reducing iron deficiency in a trial of over 7000 subjects. In a comment on that study, Prof. Nevin Scrimshaw, President of the International Nutrition Foundation, noted that ferric sodium EDTA is “…a fortificant that is growing in recognition and use in efforts to create more food products that can deliver biologically effective amounts of iron to large population groups.” These studies confirm earlier research in Guatemala, South Africa and Thailand.

Ferrazone is intended for use as an iron fortificant in foods and beverages without producing bad tastes or colors and is under evaluation in a number of food fortification programs worldwide. Ferrazone is also used as an iron source for food and beverage fortification in developed countries.

Iron deficiency with anaemia affects about 10% to as high as 80% of children in some countries and more have iron deficiency without anaemia. Many poor and minority children in the developed countries are also affected.

Iron is used by the body to manufacture haemoglobin and myoglobin, the oxygen carrying component of blood and tissues, respectively. Insufficient iron in the body leads to a reduction of haemoglobin and myoglobin which in turn undermines the body’s capacity to generate and store energy. Iron is also involved in other vital cellular processes such as DNA replication and repair. Iron also plays an essential role in the
cognitive development in young children.

The World Bank has calculated that the cognitive damage done to children – iron deficiency has been found to negatively affect IQ scores by as much as 5 to 7 IQ points – is severely hampering GDP growth in some countries, which in turn contributes further to the cycle of under-development. The Copenhagen Consensus, a group of international economists, concluded that micronutrient fortification in one of the best investments for developing countries.

Akzo Nobel is working with a number of ministries of health worldwide to reduce iron deficiency with Ferrazone, as well as being a partner to a number of non-Governmental Organizations (NGOs) including the Flour Fortification Alliance (FFI) and the Global Alliance for Improved Nutrition (GAIN). Akzo Nobel is a member of the International Life Sciences Institute (ILSI), a private scientific foundation which has been active in addressing iron deficiency via its Project IDEA (Iron Deficiency Elimination Action). An application is pending for approval of Ferrazone at the European Food Safety Authority (EFSA).