7 C.F.R. § 205.605

Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic (specified ingredients or food group(s)).”

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The following nonagricultural substances may be used as ingredients in or on processed products labeled as “organic” or “made with organic (specified ingredients or food group(s))” only in accordance with any restrictions specified in this section.

(a) Nonsynthetics allowed.

(1) Acids (Citric—produced by microbial fermentation of carbohydrate substances; and Lactic).

(2) Agar-agar.

(3) Animal enzymes—(Rennet—animals derived; Catalase—bovine liver; Animal lipase; Pancreatin; Pepsin; and Trypsin).

(4) Attapulgite—as a processing aid in the handling of plant and animal oils.

(5) Bentonite.

(6) Calcium carbonate.

(7) Calcium chloride.

(8) Calcium sulfate—mined.

(9) Carrageenan.

(10) Diatomaceous earth—food filtering aid only.

(11) Enzymes—must be derived from edible, nontoxic plants, nonpathogenic fungi, or nonpathogenic bacteria.

(12) Flavors—nonsynthetic flavors may be used when organic flavors are not commercially available. All flavors must be derived from organic or nonsynthetic sources only and must not be produced using synthetic solvents and carrier systems or any artificial preservative.

(13) Gellan gum (CAS # 71010-52-1)—high-acyl form only.

(14) Glucono delta-lactone—production by the oxidation of D-glucose with bromine water is prohibited.

(15) Kaolin.

(16) L-Malic acid (CAS # 97-67-6).

(17) Magnesium chloride.

(18) Magnesium sulfate, nonsynthetic sources only.

(19) Microorganisms—any food grade bacteria, fungi, and other microorganism.

(20) Nitrogen—oil-free grades.

(21) Oxygen—oil-free grades.

(22) Perlite—for use only as a filter aid in food processing.

(23) Potassium chloride.

(24) Potassium iodide.

(25) Pullulan—for use only in tablets and capsules for dietary supplements labeled “made with organic (specified ingredients or food group(s)).

(26) Sodium bicarbonate.

(27) Sodium carbonate.

(28) Tartaric acid—made from grape wine.

(29) Waxes—nonsynthetic (Wood rosin).

(30) Yeast—When used as food or a fermentation agent in products labeled as “organic,” yeast must be organic if its end use is for human consumption; nonorganic yeast may be used when organic yeast is not commercially available. Growth on petrochemical substrate and sulfite waste liquor is prohibited. For smoked yeast, nonsynthetic smoke flavoring process must be documented.

(b) Synthetics allowed.

(1) Acidified sodium chlorite—Secondary direct antimicrobial food treatment and indirect food contact surface sanitizing. Acidified with citric acid only.

(2) Activated charcoal (CAS #s 7440-44-0; 64365-11-3)—only from vegetative sources; for use only as a filtering aid.

(3) Alginates.

(4) Ammonium bicarbonate—for use only as a leavening agent.

(5) Ammonium carbonate—for use only as a leavening agent.

(6) Ascorbic acid.

(7) Calcium citrate.

(8) Calcium hydroxide.

(9) Calcium phosphates (monobasic, dibasic, and tribasic).

(10) Carbon dioxide.

(11) Cellulose (CAS #9004-34-6)—for use in regenerative casings, powdered cellulose as an anti-caking agent (non-chlorine bleached) and filtering aid. Microcrystalline cellulose is prohibited.

(12) Chlorine materials—disinfecting and sanitizing food contact surfaces, equipment and facilities may be used up to maximum labeled rates. Chlorine materials in water used in direct crop or food contact are permitted at levels approved by the FDA or EPA for such purpose, provided the use is followed by a rinse with potable water at or below the maximum residual disinfectant limit for the chlorine material under the Safe Drinking Water Act. Chlorine in water used as an ingredient in organic food handling must not exceed the maximum residual disinfectant limit for the chlorine material under the Safe Drinking Water Act.

(i) Calcium hypochlorite.

(ii) Chlorine dioxide.

(iii) Hypochlorous acid—generated from electrolyzed water.

(iv) Sodium hypochlorite.

(13) Collagen gel—as casing, may be used only when organic collagen gel is not commercially available.

(14) Ethylene—allowed for postharvest ripening of tropical fruit and degreening of citrus.

(15) Ferrous sulfate—for iron enrichment or fortification of foods when required by regulation or recommended (independent organization).

(16) Glycerides (mono and di)—for use only in drum drying of food.

(17) Hydrogen peroxide.

(18) Low-acyl gellan gum.

(19) Magnesium stearate—for use only in agricultural products labeled “made with organic (specified ingredients or food group(s)),” prohibited in agricultural products labeled “organic”.

(20) Nutrient vitamins and minerals, in accordance with 21 CFR 104.20, Nutritional Quality Guidelines For Foods.

(21) Ozone.

(22) Peracetic acid/Peroxyacetic acid (CAS # 79-21-0)—for use in wash and/or rinse water according to FDA limitations. For use as a sanitizer on food contact surfaces.

(23) Phosphoric acid—cleaning of food-contact surfaces and equipment only.

(24) Potassium carbonate.

(25) Potassium citrate.

(26) Potassium hydroxide—prohibited for use in lye peeling of fruits and vegetables except when used for peeling peaches.

(27) Potassium lactate—for use as an antimicrobial agent and pH regulator only.

(28) Potassium phosphate—for use only in agricultural products labeled “made with organic (specific ingredients or food group(s)),” prohibited in agricultural products labeled “organic”.

(29) Silicon dioxide—Permitted as a defoamer. Allowed for other uses when organic rice hulls are not commercially available.

(30) Sodium acid pyrophosphate (CAS # 7758-16-9)—for use only as a leavening agent.

(31) Sodium citrate.

(32) Sodium hydroxide—prohibited for use in lye peeling of fruits and vegetables.

(33) Sodium lactate—for use as an antimicrobial agent and pH regulator only.

(34) Sodium phosphates—for use only in dairy foods.

(35) Sulfur dioxide—for use only in wine labeled “made with organic grapes,” Provided, That, total sulfite concentration does not exceed 100 ppm.

(36) Taurine—for use only in pet food.

(37) Tocopherols—derived from vegetable oil when rosemary extracts are not a suitable alternative.

(38) Xanthan gum.

(c)-(z) [Reserved]

[68 FR 61993, Oct. 31, 2003] Editorial Note:For Federal Register citations affecting § 205.605, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

Notes of Decisions

Cited in 10 cases (1 in the last 5 years), 2002–2021 · leading case: Ham v. Hain Celestial Grp., Inc., 70 F. Supp. 3d 1188 (N.D. Cal. 2014).

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Ham v. Hain Celestial Grp., Inc., 70 F. Supp. 3d 1188 (N.D. Cal. 2014). · cites it 2× “” See 7 C.F.R. § 205.605 . Hain asserts that adding an organic ingredient to an “All Natural” product does not mislead a reasonable consumer.”

Marentette v. Abbott Labs., Inc., 886 F.3d 112 (2d Cir. 2018). “Because only those synthetic substances which are included on the National List may be used in organic-labeled products, certifying agents must consider whether any of the ingredients a producer or handler intends to include are synthetic, and must deny certification if they are…”

Pelayo v. Nestle USA, Inc., 989 F. Supp. 2d 973 (C.D. Cal. 2013). “” See 7 C.F.R. § 205.605 (b) (identifying synthetic substances allowed in products labeled as “organic”).”

Naegele v. R.J. Reynolds Tobacco Co., 50 P.3d 769 (Cal. 2002). “, 7 C.F.R. § 205.605 (2002) [listing several dozen nonsynthetic and synthetic substances that “may be used as ingredients in or on processed products labeled as ‘organic’ ”])-—but it does not result in products that would fall outside the immunity of section 1714.”

Silber v. Barbara's Bakery, Inc., 950 F. Supp. 2d 432 (E.D.N.Y 2013). “at ¶ 37 (citing 7 C.F.R. § 205.605 (b) (categorizing ascorbic acid as “synthetic”); 21 C.”

Harvey v. Veneman, 396 F.3d 28 (1st Cir. 2005). “We note that in his brief, Harvey admits that he has withdrawn his challenge as to some of the thirty-eight substances listed in 7 C.F.R. § 205.605 (b) because use of the substances is required by other statutes.”

Organic Consumers Ass'n v. Hain Celestial Grp., Inc., 285 F. Supp. 3d 100 (D.C. Cir. 2018). “20," 7 C.F.R. § 205.605 (a), as "nutrient(s) [that] may appropriately be added to a food that replaces traditional food in the diet to avoid nutritional inferiority," 21 C.”

Harvey v. Johanns, 462 F. Supp. 2d 69 (D. Me. 2006). “7 C.F.R. § 205.605 (b). The First Circuit invalidated the regulations because of statutory language appearing in 7 U.”

Marenette v. Abbott Labs. (2d Cir. 2018). “§§ 6510(a)(1), 6517; 7 C.F.R. § 205.605 (b). Because only those 6 synthetic substances which are included on the National List may be used in 7 organic‐labeled products, certifying agents must consider whether any of the 8 ingredients a producer or handler intends to include are…”

Mason v. Reed's Inc. (S.D.N.Y. 2021). “See 7 C.F.R. § 205.605 . The USDA also issued guidance listing citric acid as non-synthetic.”

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