C.F.R. » Title 7 » CHAPTER I—AGRICULTURAL MARKETING SERVICE (STANDARDS, INSPECTIONS, MARKETING PRACTICES), DEPARTMENT OF AGRICULTURE › SUBCHAPTER M—ORGANIC FOODS PRODUCTION ACT PROVISIONS › PART 205—NATIONAL ORGANIC PROGRAM › Subpart G—Administrative

7 C.F.R. § 205.600

Evaluation criteria for allowed and prohibited substances, methods, and ingredients

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The following criteria will be utilized in the evaluation of substances or ingredients for the organic production and handling sections of the National List:

(a) Synthetic and nonsynthetic substances considered for inclusion on or deletion from the National List of allowed and prohibited substances will be evaluated using the criteria specified in the Act (7 U.S.C. 6517 and 6518).

(b) In addition to the criteria set forth in the Act, any synthetic substance used as a processing aid or adjuvant will be evaluated against the following criteria:

(1) The substance cannot be produced from a natural source and there are no organic substitutes;

(2) The substance's manufacture, use, and disposal do not have adverse effects on the environment and are done in a manner compatible with organic handling;

(3) The nutritional quality of the food is maintained when the substance is used, and the substance, itself, or its breakdown products do not have an adverse effect on human health as defined by applicable Federal regulations;

(4) The substance's primary use is not as a preservative or to recreate or improve flavors, colors, textures, or nutritive value lost during processing, except where the replacement of nutrients is required by law;

(5) The substance is listed as generally recognized as safe (GRAS) by Food and Drug Administration (FDA) when used in accordance with FDA's good manufacturing practices (GMP) and contains no residues of heavy metals or other contaminants in excess of tolerances set by FDA; and

(6) The substance is essential for the handling of organically produced agricultural products.

(c) Nonsynthetics used in organic processing will be evaluated using the criteria specified in the Act (7 U.S.C. 6517 and 6518).

Notes of Decisions
Cited in 4 cases, 2005–2018 · leading case: Harvey v. Johanns, 494 F.3d 237 (1st Cir. 2007).
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Harvey v. Johanns, 494 F.3d 237 (1st Cir. 2007). · cites it 3× “That count alleged that two sections of the final rule, 7 C.F.R. §§ 205.600 (b) and 205.605(b), 1 contravened OFPA § 6510(a)(1) by too freely permitting the use of synthetic substances in the processing of organic foods.”
Harvey v. Veneman, 396 F.3d 28 (1st Cir. 2005). “7 C.F.R. §§ 205.600 (b), 205.605(b). Section 205.”
Organic Consumers Ass'n v. Hain Celestial Grp., Inc., 285 F. Supp. 3d 100 (D.C. Cir. 2018). “§ 6517 ; 7 C.F.R. § 205.600 - 607 (the National List).”
Harvey v. Johanns, 462 F. Supp. 2d 69 (D. Me. 2006). · cites it 4× “It declared that two USDA regulations, 7 C.F.R. §§ 205.600 (b) and 605(b), were “contrary to the plain language of OFPA and therefore exceed the Secretary’s statutory authority.”
— 7 C.F.R. § 205.600(b) — 1 case
Harvey v. Johanns, 462 F. Supp. 2d 69 (D. Me. 2006). “It declared that two USDA regulations, 7 C.F.R. §§ 205.600 (b) and 605(b), were “contrary to the plain language of OFPA and therefore exceed the Secretary’s statutory authority.”
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