Cargill’s ARA-Rich Oil Achieves EU Novel Foods Approval

This action represents the second approval for Cargill’s ARA granted by a major food regulatory jurisdiction, the first being the U.S. FDA´s letter of Feb. 16, 2011.

Jan 4 2012 --- Cargill’s arachidonic acid-rich oil (ARA) has been authorized as a novel food (NF) by the European Commission for use in infant formula and follow-on formula (formula for older children) under Commission Directive 2006/141/EC, commonly know as the infant formula directive. Cargill officially received the European Commission’s letter of authorization on Dec. 19, 2011. This action represents the second approval for Cargill’s ARA granted by a major food regulatory jurisdiction, the first being the U.S. Food and Drug Administration’s (FDA) letter of Feb. 16, 2011, in which the FDA stated having no questions regarding Cargill’s conclusion that ARA derived by fermentation with the common fungal organism, Mortierella alpine, is Generally Recognized As Safe (GRAS) under the conditions of intended use. Such FDA communications are commonly called “no objection” letters.

ARA, an omega-6 long-chain polyunsaturated fatty acid (LCPUFA), is a natural component of human mother’s milk. It is considered important to infant brain and vision development when supplemented in infant formula along with the omega-3 LCPUFA, docosahexaenoic-rich oil (DHA) at an approximate ARA:DHA ratio of 2:1. Both substances are currently used in virtually all infant formulas sold worldwide.

In 2010, a state-of-the-art ARA facility was opened in Gedian, China, through Cargill’s joint venture, Cargill Alking Bioengineering. Cargill Alking Bioengineering has been in business since 2004 and, in partnership with Cargill, is capable of serving the global marketplace. The facility has greatly increased capacity, providing customers with a reliable option for high-quality ARA.

“Cargill is pleased that we now have the opportunity to help our European customers develop premium infant formulas using Cargill’s ARA,” said David Henstrom, vice president, Cargill Health & Nutrition. “This approval is the culmination of a series of regulatory efforts that, coupled with our increased capacity, now enables us to fulfill the needs of our infant formula customers in Europe.”