National Organic Program Proposes to Change Listing of Nutrients That Can be Added to Organic Food

By Riëtte van Laack –

USDA’s National Organic Program ("NOP") published a proposed rule that would amend the listing of vitamins and minerals in the National List of Allowed and Prohibited Substances (National List).  The National List identifies non-agricultural synthetic ingredients that may be used in or on “organic” and “made with organic” food.  See 7 C.F.R. § 205.605(b).  Since 2000, the National List has included “Nutrient vitamins and minerals, in accordance with 21 C.F.R. § 101.20, Nutritional Qualify Guidelines for Foods.”  The annotation referring to FDA’s fortification policy at § 101.20 has created confusion and controversy about which nutrients are permitted.  Specifically, it led to questions about whether “accessory nutrients” are permitted (NOP defines “accessory nutrients” as nutrients not specifically classified as a vitamin or mineral but found to promote health, such as DHA, ARA, lutein ester, and taurine).  It also led to questions about whether certain nutrients are permitted for use in or on organic infant formula.  Based on communications with FDA, the NOP learned that FDA’s fortification policy does not apply to infant formula.  Moreover, FDA clarified that so-called “accessory nutrients” are not within the scope of FDA’s fortification policy.   

To provide clarity as to which nutrients may be added to organic food and organic infant formula, NOP now proposes to amend the National List to state:  “Vitamins and minerals.  For food – vitamins and minerals identified as essential in 21 C.F.R. § 101.9.  For infant formula – vitamins and minerals as required by 21 C.F.R. § 107.100 or § 107.10.”  Thus, the proposed rule would permit use in organic food and infant formula of the essential vitamins A, C, K, D, E, thiamin, riboflavin, niacin, B6, B12, biotin, folic acid, and pantothenic acid, and the essential minerals calcium, iron, phosphorus, magnesium, zinc, iodine, copper, potassium, selenium, manganese, and chloride.  In addition, the essential minerals chromium and molybdenum would be permitted in organic food but not in organic infant formula, and the essential nutrients choline, inositol, and sodium would be permitted in organic infant formula but not in organic food.  Nutrients that do not fall within the identified categories of vitamins and minerals, e.g., EPA and DHA, would no longer be permitted in organic food and infant formula, unless these nutrients are specifically included in the National List.  To allow industry time to submit petitions for inclusion of these nutrients in the National List, NOP proposes a compliance date of two years after the rule is finalized.

The NOP is specifically seeking comments regarding the delayed compliance date and on the actual economic impacts of the proposed action on industry, including small entities.  Comments may be submitted until March 12, 2012.