Details of AMS Proposed Rule to Align Vitamin List for Organic Food, Infant Formula with FDA
The USDA's Agricultural Marketing Service issued a January 12, 2012 proposed rule to address the use of vitamins and minerals in organic food and organic infant formula. The proposed rule would align the organic standards for these products with Food and Drug Administration rules and provide a clear list of the essential synthetic nutrient vitamins and minerals that are allowed in organic food and infant formula. Comments on the proposed rule are due by March 12, 2012.
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(AMS is taking this action as part of its 2012 Sunset Review of the listing for nutrient vitamins and minerals on the U.S. Department of Agriculture’s National List of Allowed and Prohibited Substances (National List). As recommended by the National Organic Standards Board (NOSB), the proposed rule would continue the exemption (use) for nutrient vitamins and minerals for 5 years after the October 21, 2012 sunset date. In addition, the proposed rule would clarify what synthetic substances are allowed as nutrient vitamins and minerals in food and infant formula labeled as “organic” or “made with organic (specified ingredients or food group(s)),” as specified below.)
V&M proposed for organic foods. AMS states that this proposed rule would permit the following essential synthetic vitamins and minerals (V&M) to be used in organic foods (other than infant formula, and in accordance with FDA specifications for use): Vitamins A, C, K, D, E, thiamin, riboflavin, niacin, B6, B12, biotin, folate, pantothenic acid, calcium, iron, phosphorus, magnesium, zinc, iodine, copper, potassium, selenium, manganese, chromium, molybdenum, and chloride.
V&M proposed for organic infant formula. The proposed rule would also permit the following essential synthetic vitamins and minerals in organic infant formula: Vitamins A, C, K, D, E, thiamin, riboflavin, niacin, B6, B12, biotin, folic acid, pantothenic acid, choline, inositol, calcium, iron, phosphorus, magnesium, zinc, iodine, copper, sodium, potassium, selenium, manganese, and chloride.
Examples of banned V&M, unless on National List. AMS also provides examples of ingredients used in organic products that would be prohibited from use under this proposed rule, unless they are added to the National List: docosahexanoic acid (DHA) algal oil, arachidonic acid (ARA) single-cell oil, taurine, inositol, choline, ascorbyl palmitate, beta-carotene, L-carnitine, lycopene, nucleotides, lutein, and L-methionine.
Two years to implement. AMS proposes a two year implementation phase before any final rule would become effective. AMS believes that the National Organic Program's (NOP) advance disclosure of its intent with respect to nutrient vitamins and minerals, in combination with a proposed two year implementation phase, will minimize disruption to the organic industry.
(In a January 9, 2012 press release, AMS stated that the proposed rule would correct an inaccurate reference to FDA’s fortification policy and clearly delineate that only vitamins and minerals the FDA has classified as essential are permitted in products labeled as “organic” or “made with organic (specified ingredients or food group(s)).” Additionally, since current USDA organic regulations do not cover infant formula, the proposed rule would allow certain essential vitamins and minerals as additives to organic infant formula.)
AMS contact: Melissa Bailey (202) 720-3252
Press release on proposed rule available here, which was summarized in ITT's Online Archives 12011056. For initial summary of proposed rule, see 12011156.)