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Home > Master Publication List > Organic Standards for Handling (Processing)

Organic Standards for Handling (Processing)

Highlights of the USDA's National Organic Program Regulations


Ann H. Baier
NCAT Agriculture Specialist
© NCAT 2008
IP333


Abstract

This collection of excerpts from the U.S. Department of Agriculture's National Organic Program provides the reader with key standards relevant to handlers of organic crops. This publication should be used together with excerpts for all certified organic operations, livestock production and crop production, as applicable.

Highlights of the USDA's National Organic Program Regulations include key standards for:

1) All certified organic operations
2) Crop production
3) Livestock production
4) Handling (including processing)

Please use this publication in combination with the ATTRA publication Organic Standards for All Organic Operations, and others, if relevant to your organic operations.

Table of Contents

Introduction

This publication provides easy reference to the standards relevant to handlers of organic products. This set of excerpts from the USDA's National Organic Program Final Rule contains the general requirements for handling (including processing) organic products, including facility pest management, prevention of commingling and contamination, lists of allowed and prohibited agricultural and non-agricultural materials, product composition, labeling and use of the term "organic." While this includes the key standards that directly address handling, it is not a complete collection of all the standards that organic handlers must comply with. It must be used in conjunction with standards for all organic operations and organic crop and livestock production, as applicable.

This set of excerpts is not a substitute for reading the entire set of standards. The regulatory texts of the National Organic Program standards are available on USDA's National Organic Program Web site. To view the production and handling standards, click on "Regulations" under General Information. Under Regulatory Text, click on "Electronic Code of Federal Regulations."

This set of excerpts should also not be used as a substitute for verifying points of compliance for organic production and handling activities with an accredited organic certifier. For a list of certifiers, click on Certifiers under "I Want Information On" in the NOP Web site index (above).

Using this guide:

This is a collection of verbatim excerpts from key parts of the National Organic Program's Final Rule. Organic regulations are found under the USDA's Agricultural Marketing Service 7 CFR Part 205. CFR stands for Code of Federal Regulations. Part 205, the National Organic Program, is found under Title 7: Agriculture, one of 50 broad subject areas that are subject to federal regulation.

The Organic Foods Production Act was enacted under the 1990 Farm Bill. The Act, as it is referred to in the text, authorized creation of the USDA National Organic Program to set national standards for the production, handling and processing of organically grown agricultural products. The NOP oversees mandatory certification of organic production. Producers who meet NOP standards may label their products as "USDA Certified Organic." The subparts reference organization levels in each excerpt.

The following sections of Part 205 of the National Organic Program are excerpted below:

  • § 205.270 Organic handling requirements
  • § 205.271 Facility pest management practice standard
  • § 205.272 Commingling and contact with prohibited substance prevention practice standard
Subpart D—Labels, labeling and market information
  • § 205.300 Use of the term "organic"

  • § 205.301 Product composition

  • § 205.302 Calculating the percentage of organically produced ingredients

  • § 205.303 Packaged products labeled "100-percent organic" or "organic"

  • § 205.304 Packaged products labeled "made with organic (specified ingredients or food groups)"

  • § 205.305 Multi-ingredient packaged products with less than 70 percent organically produced ingredients

  • § 205.306 Labeling of livestock feed

  • § 205.307 Labeling of non-retail containers used for only shipping or storage of raw or processed agricultural products labeled as "100-percent organic," "organic" or "made with organic (specified ingredients or food groups)"

  • § 205.308 Agricultural products in other than packaged form at the point of retail sale that are sold, labeled or represented as "100-percent organic" or "organic"

  • § 205.309 Agricultural products in other than packaged form at the point of retail sale that are sold, labeled or represented as "made with organic (specified ingredients or food groups)"

  • § 205.310 Agricultural products produced on an exempt or excluded operation
  • § 205.311 USDA Seal
The National List of Allowed and Prohibited Substances
  • § 205.605 Nonagricultural (non-organic) substances allowed as ingredients in or on processed products labeled as "organic" or "made with organic (specified ingredients or food groups)"

  • § 205.606 Non-organically produced agricultural products allowed as ingredients in or on processed products labeled as "organic" or "made with organic (specified ingredients or food groups)"

  • § 205.2 Terms defined [selected terms for handling operations]
Note: e-CFR Data used in this publication is current as of July 23, 2008.

Amendment dates are noted at the end of certain sections, such as Defined terms, the National List and also in some aspects of livestock production. Changes may be the result of legal actions, petitions to add or remove materials or technical corrections. Most other sections of the Rule have not changed since their original version. To find the most current version available, please go the electronic code of federal regulations. See instructions in paragraph two of the Introduction.

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Excerpts

§ 205.270 Organic handling requirements

  1. Mechanical or biological methods, including but not limited to cooking, baking, curing, heating, drying, mixing, grinding, churning, separating, distilling, extracting, slaughtering, cutting, fermenting, eviscerating, preserving, dehydrating, freezing, chilling or otherwise manufacturing, and the packaging, canning, jarring or otherwise enclosing food in a container may be used to process an organically produced agricultural product for the purpose of retarding spoilage or otherwise preparing the agricultural product for market.

  2. Nonagricultural substances allowed under §205.605 and non-organically produced agricultural products allowed under §205.606 may be used:

    1. In or on a processed agricultural product intended to be sold, labeled or represented as "organic," pursuant to §205.301(b), if not commercially available in organic form.

    2. In or on a processed agricultural product intended to be sold, labeled or represented as "made with organic (specified ingredients or food groups)," pursuant to §205.301(c).

  3. The handler of an organic handling operation must not use in or on agricultural products intended to be sold, labeled or represented as "100-percent organic," "organic" or "made with organic (specified ingredients or food groups)," or in or on any ingredients labeled as organic:

    1. Practices prohibited under paragraphs (e) and (f) of §205.105.

    2. A volatile synthetic solvent or other synthetic processing aid not allowed under §205.605, except that non-organic ingredients in products labeled "made with organic (specified ingredients or food groups)" are not subject to this requirement.

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§ 205.271 Facility pest management practice standard

  1. The producer or handler of an organic facility must use management practices to prevent pests, including but not limited to:

    1. Removal of pest habitat, food sources and breeding areas;

    2. Prevention of access to handling facilities; and

    3. Management of environmental factors, such as temperature, light, humidity, atmosphere and air circulation to prevent pest reproduction.

  2. Pests may be controlled through:
    1. Mechanical or physical controls including but not limited to traps, light or sound; or

    2. Lures and repellents using non-synthetic or synthetic substances consistent with the National List.

  3. If the practices provided for in paragraphs (a) and (b) of this section are not effective to prevent or control pests, a non-synthetic or synthetic substance consistent with the National List may be applied.

  4. If the practices provided for in paragraphs (a), (b) and (c) of this section are not effective to prevent or control facility pests, a synthetic substance not on the National List may be applied, provided that the handler and certifying agent agree on the substance, method of application and measures to be taken to prevent contact of the organically produced products or ingredients with the substance used.

  5. The handler of an organic handling operation who applies a non-synthetic or synthetic substance to prevent or control pests must update the operation's organic handling plan to reflect the use of such substances and methods of application. The updated organic plan must include a list of all measures taken to prevent contact of the organically produced products or ingredients with the substance used.

  6. Notwithstanding the practices provided for in paragraphs (a), (b), (c) and (d) of this section, a handler may otherwise use substances to prevent or control pests as required by federal, state or local laws and regulations, provided that measures are taken to prevent contact of the organically produced products or ingredients with the substance used.

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§ 205.272 Commingling and contact with prohibited substance prevention practice standard

  1. The handler of an organic handling operation must implement measures necessary to prevent the commingling of organic and non-organic products and protect organic products from contact with prohibited substances.

  2. The following are prohibited for use in the handling of any organically produced agricultural product or ingredient labeled in accordance with subpart D of this part:

    1. Packaging materials and storage containers or bins that contain a synthetic fungicide, preservative or fumigant;

    2. The use or reuse of any bag or container that has been in contact with any substance in such a manner as to compromise the organic integrity of any organically produced product or ingredient placed in those containers, unless such reusable bag or container has been thoroughly cleaned and poses no risk of contact of the organically produced product or ingredient with the substance used.

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Subpart D—Labels, labeling and market information

§ 205.300 Use of the term "organic"

  1. The term "organic" may only be used on labels and in labeling of raw or processed agricultural products, including ingredients, that have been produced and handled in accordance with the regulations in this part. The term "organic" may not be used in a product name to modify a non-organic ingredient in the product.

  2. Products for export, produced and certified to foreign national organic standards or foreign contract buyer requirements, may be labeled in accordance with the organic labeling requirements of the receiving country or contract buyer, provided that the shipping containers and shipping documents meet the labeling requirements
    specified in §205.307(c).

  3. Products produced in a foreign country and exported for sale in the United States must be certified pursuant to subpart E of this part and labeled pursuant to this subpart D.

  4. Livestock feeds produced in accordance with the requirements of this part must be labeled in accordance with the requirements of §205.306.

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§ 205.301 Product composition

  1. Products sold, labeled or represented as "100-percent organic" A raw or processed agricultural product sold labeled or represented as "100-percent organic" must contain (by weight or fluid volume, excluding water and salt) 100 percent organically produced ingredients. If labeled as organically produced, such product must be labeled pursuant to §205.303.

  2. Products sold, labeled or represented as "organic"

    A raw or processed agricultural product sold, labeled or represented as "organic" must contain (by weight or fluid volume, excluding water and salt) not less than 95 percent organically produced raw or processed agricultural products. Any remaining product ingredients must be organically produced, unless not commercially available in organic form, or must be nonagricultural substances or non-organically produced agricultural products produced consistent with the National List in subpart G of this part. If labeled as organically produced, such product must be labeled pursuant to §205.303.

  3. Products sold, labeled or represented as "made with organic (specified ingredients or food groups)."

    Multi-ingredient agricultural product sold, labeled or represented as "made with organic (specified ingredients or food groups)" must contain (by weight or fluid volume, excluding water and salt) at least 70 percent organically produced ingredients which are produced and handled pursuant to requirements in subpart C of this part. No ingredients may be produced using prohibited practices specified in paragraphs (f)(1), (2) and (3) of §205.301. Non-organic ingredients may be produced without regard to paragraphs (f)(4), (5), (6) and (7) of §205.301. If labeled as containing organically produced ingredients or food groups, such product must be labeled pursuant to §205.304.

  4. Products with less than 70 percent organically produced ingredients.

    The organic ingredients in multi-ingredient agricultural product containing less than 70 percent organically produced ingredients (by weight or fluid volume, excluding water and salt) must be produced and handled pursuant to requirements in subpart C of this part. The non-organic ingredients may be produced and handled without regard to the requirements of this part. Multi-ingredient agricultural product containing less than 70 percent organically produced ingredients may represent the organic nature of the product only as provided in §205.305.

  5. Livestock feed

    1. A raw or processed livestock feed product sold, labeled or represented as "100-percent organic" must contain (by weight or fluid volume, excluding water and salt) not less than 100 percent organically produced raw or processed agricultural product.

    2. A raw or processed livestock feed product sold, labeled or represented as "organic" must be produced in conformance with §205.237.

  6. All products labeled as "100-percent organic" or "organic" and all ingredients identified as "organic" in the ingredient statement of any product must not:

    1. Be produced using excluded methods, pursuant to §201.105(e) of this chapter;

    2. Be produced using sewage sludge, pursuant to §201.105(f) of this chapter;

    3. Be processed using ionizing radiation, pursuant to §201.105(g) of this chapter;

    4. Be processed using processing aids not approved on the National List of Allowed and Prohibited Substances in subpart G of this part, except that products labeled as "100-percent organic," if processed, must be processed using organically produced processing aids;

    5. Contain sulfites, nitrates or nitrites added during the production or handling process, except that wine containing added sulfites may be labeled "made with organic grapes";

    6. Be produced using non-organic ingredients when organic ingredients are available; or

    7. Include organic and non-organic forms of the same ingredient.

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§ 205.302 Calculating the percentage of organically produced ingredients

  1. The percentage of all organically produced ingredients in an agricultural product sold, labeled or represented as "100-percent organic," "organic" or "made with organic (specified ingredients or food groups)" or that include organic ingredients must be calculated by:

    1. Dividing the total net weight (excluding water and salt) of combined organic ingredients at formulation by the total weight (excluding water and salt) of the finished product.

    2. Dividing the fluid volume of all organic ingredients (excluding water and salt) by the fluid volume of the finished product (excluding water and salt) if the product and ingredients are liquid. If the liquid product is identified on the principal display panel or information panel as being reconstituted from concentrates, the calculation should be made on the basis of single- strength concentrations of the ingredients and finished product.

    3. For products containing organically produced ingredients in both solid and liquid form, dividing the combined weight of the solid ingredients and the weight of the liquid ingredients (excluding water and salt) by the total weight (excluding water and salt) of the finished product.

  2. The percentage of all organically produced ingredients in an agricultural product must be rounded down to the nearest whole number.

  3. The percentage must be determined by the handler who affixes the label on the consumer package and verified by the certifying agent of the handler. The handler may use information provided by the certified operation in determining the percentage.

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§ 205.303 Packaged products labeled "100-percent organic" or "organic"

  1. Agricultural products in packages described in §205.301(a) and (b) may display, on the principal display panel, information panel and any other panel of the package and on any labeling or market information concerning the product, the following:

    1. The term "100-percent organic" or "organic" as applicable, to modify the name of the product;

    2. For products labeled "organic," the percentage of organic ingredients in the product; (The size of the percentage statement must not exceed one-half the size of the largest type size on the panel on which the statement is displayed and must appear in its entirety in the same type size, style and color without highlighting.)

    3. The term "organic" to identify the organic ingredients in multi-ingredient products labeled "100-percent organic";

    4. The USDA seal; and/or

    5. The seal, logo or other identifying mark of the certifying agent which certified the production or handling operation producing the finished product and any other certifying agent which certified production or handling operations producing raw organic product or organic ingredients used in the finished product, provided that the handler producing the finished product maintain records, pursuant to this part, verifying organic certification of the operations producing such ingredients, and provided further that such seals or marks are not individually displayed more prominently than the USDA seal.

  2. Agricultural products in packages described in §205.301(a) and (b) must:

    1. For products labeled "organic," identify each organic ingredient in the ingredient statement with the word "organic" or with an asterisk or other reference mark which is defined below the ingredient statement to indicate the ingredient is organically produced. Water or salt included as ingredients cannot be identified as organic.

    2. On the information panel, below the information identifying the handler or distributor of the product and preceded by the statement "Certified organic by * * *," or similar phrase, identify the name of the certifying agent that certified the handler of the finished product and may display the business address, Internet address or telephone number of the certifying agent in such label.

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§ 205.304 Packaged products labeled "made with organic (specified ingredients or food groups)"

  1. Agricultural products in packages described in §205.301(c) may display on the principal display panel, information panel and any other panel and on any labeling or market information concerning the product:

    1. The statement:

      1. "Made with organic (specified ingredients)," provided that the statement does not list more than three organically produced ingredients; or

      2. "Made with organic (specified food groups)," provided that the statement does not list more than three of the following food groups: beans, fish, fruits, grains, herbs, meats, nuts, oils, poultry, seeds, spices, sweeteners and vegetables or processed milk products; and, provided further that all ingredients of each listed food group in the product must be organically produced; and

      3. Which appears in letters that do not exceed one-half the size of the largest type size on the panel and which appears in its entirety in the same type size, style and color without highlighting.

    2. The percentage of organic ingredients in the product. The size of the percentage statement must not exceed one-half the size of the largest type size on the panel on which the statement is displayed and must appear in its entirety in the same type size, style and color without highlighting.

    3. The seal, logo or other identifying mark of the certifying agent that certified the handler of the finished product.

  2. Agricultural products in packages described in §205.301(c) must:

    1. In the ingredient statement, identify each organic ingredient with the word "organic" or with an asterisk or other reference mark which is defined below the ingredient statement to indicate the ingredient is organically produced. Water or salt included as ingredients cannot be identified as organic.

    2. On the information panel, below the information identifying the handler or distributor of the product and preceded by the statement "Certified organic by * * *" or similar phrase, identify the name of the certifying agent that certified the handler of the finished product, except that the business address, Internet address or telephone number of the certifying agent may be included in such label.

  3. Agricultural products in packages described in §205.301(c) must not display the USDA seal.

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§ 205.305 Multi-ingredient packaged products with less than 70 percent organically produced ingredients

  1. An agricultural product with less than 70 percent organically produced ingredients may only identify the organic content of the product by:

    1. Identifying each organically produced ingredient in the ingredient statement with the word "organic" or with an asterisk or other reference mark which is defined below the ingredient statement to indicate the ingredient is organically produced, and

    2. If the organically produced ingredients are identified in the ingredient statement, displaying the product's percentage of organic contents on the information panel.

  2. Agricultural products with less than 70 percent organically produced ingredients must not display:

    1. The USDA seal; and

    2. Any certifying agent seal, logo or other identifying mark which represents organic certification of a product or product ingredients.

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§ 205.306 Labeling of livestock feed

  1. Livestock feed products described in §205.301(e)(1) and (e)(2) may display on any package panel the following terms:

    1. The statement "100-percent organic" or "organic," as applicable, to modify the name of the feed product;

    2. The USDA seal;

    3. The seal, logo or other identifying mark of the certifying agent which certified the production or handling operation producing the raw or processed organic ingredients used in the finished product, provided that such seals or marks are not displayed more prominently than the USDA seal;

    4. The word "organic" or an asterisk or other reference mark which is defined on the package to identify ingredients that are organically produced. Water or salt included as ingredients cannot be identified as organic.

  2. Livestock feed products described in §205.301(e)(1) and (e)(2) must:

    1. On the information panel, below the information identifying the handler or distributor of the product and preceded by the statement "Certified organic by * * *" or similar phrase, display the name of the certifying agent that certified the handler of the finished product. The business address, Internet address or telephone number of the certifying agent may be included in such label.

    2. Comply with other federal agency or state feed labeling requirements as applicable.

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§ 205.307 Labeling of non-retail containers used for only shipping or storage of raw or processed agricultural products labeled as "100-percent organic," "organic" or "made with organic (specified ingredients or food groups)"

  1. Non-retail containers used only to ship or store raw or processed agricultural product labeled as containing organic ingredients may display the following terms or marks:

    1. The name and contact information of the certifying agent which certified the handler that assembled the final product;

    2. Identification of the product as organic;

    3. Special handling instructions needed to maintain the organic integrity of the product;

    4. The USDA seal;

    5. The seal, logo or other identifying mark of the certifying agent that certified the organic production or handling operation that produced or handled the finished product.

  2. Non-retail containers used to ship or store raw or processed agricultural product labeled as containing organic ingredients must display the production lot number of the product if applicable.

  3. Shipping containers of domestically produced product labeled as organic intended for export to international markets may be labeled in accordance with any shipping container labeling requirements of the foreign country of destination or the container labeling specifications of a foreign contract buyer, provided that the shipping containers and shipping documents accompanying such organic products are clearly marked "For Export Only" and provided further that proof of such container marking and export must be maintained by the handler in accordance with recordkeeping requirements for exempt and excluded operations under §205.101.

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§ 205.308 Agricultural products in other than packaged form at the point of retail sale that are sold, labeled or represented as "100-percent organic" or "organic"

  1. Agricultural products in other than packaged form may use the term "100-percent organic" or "organic," as applicable, to modify the name of the product in retail display, labeling and display containers, provided that the term "organic" is used to identify the organic ingredients listed in the ingredient statement.

  2. If the product is prepared in a certified facility, the retail display, labeling and display containers may use:

    1. The USDA seal; and

    2. The seal, logo or other identifying mark of the certifying agent that certified the production or handling operation producing the finished product and any other certifying agent which certified operations producing raw organic product or organic ingredients used in the finished product, provided that such seals or marks are not individually displayed more prominently than the USDA seal.

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§ 205.309 Agricultural products in other than packaged form at the point of retail sale that are sold, labeled or represented as "made with organic (specified ingredients or food groups)"

  1. Agricultural products in other than packaged form containing between 70 and 95 percent organically produced ingredients may use the phrase "made with organic (specified ingredients or food groups)" to modify the name of the product in retail display, labeling and display containers.

    1. Such statement must not list more than three organic ingredients or food groups, and

    2. In any such display of the product's ingredient statement, the organic ingredients are identified as "organic."

  2. If prepared in a certified facility, such agricultural products labeled as "made with organic (specified ingredients or food groups)" in retail displays, display containers and market information may display the certifying agent's seal, logo or other identifying mark.

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§ 205.310 Agricultural products produced on an exempt or excluded operation

  1. An agricultural product organically produced or handled on an exempt or excluded operation must not:

    1. Display the USDA seal or any certifying agent's seal or other identifying mark which represents the exempt or excluded operation as a certified organic operation, or

    2. Be represented as a certified organic product or certified organic ingredient to any buyer.

  2. An agricultural product organically produced or handled on an exempt or excluded operation may be identified as an organic product or organic ingredient in a multi-ingredient product produced by the exempt or excluded operation. Such product or ingredient must not be identified or represented as "organic" in a product processed by others.

  3. Such product is subject to requirements specified in paragraph (a) of §205.300 and paragraphs (f)(1) through (f)(7) of §205.301.

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§ 205.311 USDA Seal

USDA Organic Seal.
Figure 1.
USDA Organic Seal
  1. The USDA seal described in paragraphs (b) and c) of this section may be used only for raw or processed agricultural products described in paragraphs (a), (b), (e)(1) and (e)(2) of §205.301.

  2. The USDA seal must replicate the form and design of the example in Figure 1 and must be printed legibly and conspicuously:
    1. On a white background with a brown outer circle and with the term "USDA" in green overlaying a white upper semicircle and with the term "organic" in white overlaying the green lower half circle; or

    2. On a white or transparent background with black outer circle and black "USDA" on a white or transparent upper half of the circle with a contrasting white or transparent "organic" on the black lower half circle.

    3. The green or black lower half circle may have four light lines running from left to right and disappearing at the point on the right horizon to resemble a cultivated field. A downloadable image of the USDA seal is available as a PDF file on the NOP Web site.

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The National List of Allowed and Prohibited Substances

§ 205.605 Nonagricultural (non-organic) substances allowed as ingredients in or on processed products labeled as "organic" or "made with organic (specified ingredients or food groups)"

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 groups)" only in accordance with any restrictions specified in this section.

  1. Non-synthetics allowed:

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

    Agar-agar.

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

    Bentonite.

    Calcium carbonate.

    Calcium chloride.

    Calcium sulfate—mined.

    Carageenan.

    Dairy cultures.

    Diatomaceous earth—food filtering aid only.

    Egg white lysozyme (CAS # 9001-63-2) Enzymes—must be derived from edible, nontoxic plants, nonpathogenic fungi or nonpathogenic bacteria.

    Flavors, non-synthetic sources only and must not be produced using synthetic solvents and carrier systems or any artificial preservative.

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

    Kaolin.

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

    Magnesium sulfate, non-synthetic sources only.

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

    Nitrogen—oil-free grades.

    Oxygen—oil-free grades.

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

    Potassium chloride.

    Potassium iodide.

    Sodium bicarbonate.

    Sodium carbonate.

    Tartaric acid.

    Waxes—non-synthetic (Carnauba wax and Wood resin).

    Yeast—non-synthetic, growth on petrochemical substrate and sulfite waste liquor is prohibited (Autolysate; Bakers; Brewers; Nutritional and Smoked—non-synthetic smoke flavoring process must be documented).

  2. Synthetics allowed:

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

    Alginates.

    Ammonium bicarbonate—for use only as a leavening agent.

    Ammonium carbonate—for use only as a leavening agent.

    Ascorbic acid.

    Calcium citrate.

    Calcium hydroxide.

    Calcium phosphates (monobasic, dibasic and tribasic).

    Carbon dioxide.

    Cellulose—for use in regenerative casings, as an anti-caking agent (non-chlorine bleached) and filtering aid.

    Chlorine materials—disinfecting and sanitizing food contact surfaces, except that residual chlorine levels in the water shall not exceed the maximum residual disinfectant limit under the Safe Drinking Water Act (Calcium hypochlorite; Chlorine dioxide and Sodium hypochlorite).

    Cyclohexylamine (CAS # 108-91-8)—for use only as a boiler water additive for packaging sterilization.

    Diethylaminoethanol (CAS # 100-37-8)—for use only as a boiler water additive for packaging sterilization.

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

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

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

    Glycerin—produced by hydrolysis of fats and oils.

    Hydrogen peroxide.

    Lecithin—bleached.

    Magnesium carbonate—for use only in agricultural products labeled "made with organic (specified ingredients or food groups)," prohibited in agricultural products labeled "organic."

    Magnesium chloride—derived from sea water.

    Magnesium stearate—for use only in agricultural products labeled "made with organic (specified ingredients or food groups)," prohibited in agricultural products labeled "organic."

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

    Octadecylamine (CAS # 124-30-1)—for use only as a boiler water additive for packaging sterilization.

    Ozone.

    Pectin (low-methoxy).

    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.

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

    Potassium acid tartrate.

    Potassium carbonate.

    Potassium citrate.

    Potassium hydroxide—prohibited for use in lye peeling of fruits and vegetables except when used for peeling peaches during the Individually Quick Frozen (IQF) production process.

    Potassium iodide—for use only in agricultural products labeled "made with organic (specified ingredients or food groups)," prohibited in agricultural products labeled "organic."

    Potassium phosphate—for use only in agricultural products labeled "made with organic (specific ingredients or food groups)," prohibited in agricultural products labeled "organic."

    Silicon dioxide.

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

    Sodium citrate.

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

    Sodium phosphates—for use only in dairy foods.

    Sulfur dioxide—for use only in wine labeled "made with organic grapes," provided that total sulfite concentration does not exceed 100 ppm.

    Tartaric acid. Tetrasodium pyrophosphate (CAS # 7722-88-5)—for use only in meat analog products.

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

    Xanthan gum.

  3. -  z. [Reserved]

[68 FR 61993, Oct. 31, 2003, as amended as 68 FR 62217, Nov. 3, 2003; 71 FR 53302, Sept. 11, 2006; 72 FR 58473, Oct. 16, 2007]

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§ 205.606 Non-organically produced agricultural products allowed as ingredients in or on processed products labeled as "organic"

Only the following non-organically produced agricultural products may be used as ingredients in or on processed products labeled as "organic" only in accordance with any restrictions specified in this section and only when the product is not commercially available in organic form.

  1. Casings, from processed intestines.

  2. Celery powder.

  3. Chia (Salvia hispanica L.).

  4. Colors derived from agricultural products.

    1. Annatto extract color (pigment CAS # 1393-63-1)—water and oil soluble.

    2. Beet juice extract color (pigment CAS # 7659-95-2).

    3. Beta-carotene extract color, derived from carrots (CAS # 1393-63-1).

    4. Black currant juice color (pigment CAS #s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7 and 134-04-3).

    5. Black/purple carrot juice color (pigment CAS #s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7 and 134-04-3).

    6. Blueberry juice color (pigment CAS #s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7 and 134-04-3).

    7. Carrot juice color (pigment CAS # 1393-63-1).

    8. Cherry juice color (pigment CAS #s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7 and 134-04-3).

    9. Chokeberry—Aronia juice color (pigment CAS #s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7 and 134-04-3).

    10. Elderberry juice color (pigment CAS #s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7 and 134-04-3).

    11. Grape juice color (pigment CAS #s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7 and 134-04-3).

    12. Grape skin extract color (pigment CAS #s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7 and 134-04-3).

    13. Paprika color (CAS # 68917-78-2)—dried and oil extracted.

    14. Pumpkin juice color (pigment CAS # 127-40-2).

    15. Purple potato juice (pigment CAS #s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7 and 134-04-3).

    16. Red cabbage extract color (pigment CAS #s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7 and 134-04-3).

    17. Red radish extract color (pigment CAS #s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7 and 134-04-3).

    18. Saffron extract color (pigment CAS # 1393-63-1).

    19. Turmeric extract color (CAS # 458-37-7).

  5. Dillweed oil (CAS # 8006-75-5).

  6. Fish oil (Fatty acid CAS #s: 10417-94-4, and 25167-62-8)—stabilized with organic ingredients or only with ingredients on the National List, §205.605 and 205.606.

  7. Fructooligosaccharides (CAS # 308066-66-2).

  8. Galangal, frozen.

  9. Gelatin (CAS # 9000-70-8).

  10. Gums—water extracted only (Arabic; Guar; Locust bean; and Carob bean).

  11. Hops (Humulus luplus).

  12. Inulin—oligofructose enriched (CAS # 9005-80-5).

  13. Kelp—for use only as a thickener and dietary supplement.

  14. Konjac flour (CAS # 37220-17-0).

  15. Lecithin—unbleached.

  16. Lemongrass—frozen.

  17. Orange shellac—unbleached (CAS # 9000-59-3).

  18. Pectin (high-methoxy).

  19. Peppers (Chipotle chile).

  20. Starches.

    1. Cornstarch (native).

    2. Rice starch, unmodified (CAS # 977000-08-0)—for use in organic handling until June 21, 2009.

    3. Sweet potato starch—for bean thread production only.

  21. Turkish bay leaves.

  22. Wakame seaweed (Undaria pinnatifida).

  23. Whey protein concentrate.

    [72 FR 35140, June 27, 2007]

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§ 205.2 Terms defined [selected terms for handling operations] A

Act. The Organic Foods Production Act of 1990, as amended (7 U.S.C. 6501 et seq.).

Action level. The limit at or above which the Food and Drug Administration will take legal action against a product to remove it from the market. Action levels are based on unavoidability of the poisonous or deleterious substances and do not represent permissible levels of contamination where it is avoidable.

Agricultural product. Any agricultural commodity or product, whether raw or processed, including any commodity or product derived from livestock, that is marketed in the United States for human or livestock consumption.

Agricultural Marketing Service (AMS). The Agricultural Marketing Service of the USDA.

Allowed synthetic. A substance that is included on the National List of synthetic substances allowed for use in organic production or handling.

Audit trail. Documentation that is sufficient to determine the source, transfer of ownership and transportation of any agricultural product labeled as "100-percent organic," the organic ingredients of any agricultural product labeled as "organic" or "made with organic (specified ingredients)" or the organic ingredients of any agricultural product containing less than 70 percent organic ingredients identified as organic in an ingredients statement.

Bulk. The presentation to consumers at retail sale of an agricultural product in unpackaged, loose form, enabling the consumer to determine the individual pieces, amount or volume of the product purchased.

Certification or certified. A determination made by a certifying agent that a production or handling operation is in compliance with the Act and the regulations in this part, which is documented by a certificate of organic operation.

Certified operation. A crop or livestock production, wild-crop harvesting or handling operation or portion of such operation that is certified by an accredited certifying agent as utilizing a system of organic production or handling as described by the Act and the regulations in this part.

Claims. Oral, written, implied or symbolic representations, statements or advertising or other forms of communication presented to the public or buyers of agricultural products that relate to the organic certification process or the term "100-percent organic," "organic" or "made with organic (specified ingredients or food groups)" or, in the case of agricultural products containing less than 70 percent organic ingredients, the term "organic" on the ingredients panel.

Commercially available. The ability to obtain a production input in an appropriate form, quality or quantity to fulfill an essential function in a system of organic production or handling, as determined by the certifying agent in the course of reviewing the organic plan.

Commingling. Physical contact between unpackaged organically produced and non-organically produced agricultural products during production, processing, transportation, storage or handling, other than during the manufacture of a multi-ingredient product containing both types of ingredients.

Excluded methods. A variety of methods used to genetically modify organisms or influence their growth and development by means that are not possible under natural conditions or processes and are not considered compatible with organic production. Such methods include cell fusion, microencapsulation and macroencapsulation and recombinant DNA technology (including gene deletion, gene doubling, introducing a foreign gene and changing the positions of genes when achieved by recombinant DNA technology). Such methods do not include the use of traditional breeding, conjugation, fermentation, hybridization, in vitro fertilization or tissue culture.

Handle. To sell, process or package agricultural products, except such term shall not include the sale, transportation or delivery of crops or livestock by the producer thereof to a handler.

Handler. Any person engaged in the business of handling agricultural products, including producers who handle crops or livestock of their own production, except such term shall not include final retailers of agricultural products that do not process agricultural products.

Handling operation. Any operation or portion of an operation (except final retailers of agricultural products that do not process agricultural products) that receives or otherwise acquires agricultural products and processes, packages or stores such products.

Information panel. That part of the label of a packaged product that is immediately contiguous to and to the right of the principal display panel as observed by an individual facing the principal display panel, unless another section of the label is designated as the information panel because of package size or other package attributes (for example: irregular shape with one usable surface).

Ingredient. Any substance used in the preparation of an agricultural product that is still present in the final commercial product as consumed.

Ingredients statement. The list of ingredients contained in a product shown in their common and usual names in the descending order of predominance.

Label. A display of written, printed or graphic material on the immediate container of an agricultural product or any such material affixed to any agricultural product or affixed to a bulk container containing an agricultural product, except for package liners or a display of written, printed or graphic material which contains only information about the weight of the product.

Labeling. All written, printed or graphic material accompanying an agricultural product at any time or written, printed or graphic material about the agricultural product displayed at retail stores about the product.

Lot. Any number of containers which contain an agricultural product of the same kind located in the same conveyance, warehouse or packing house and which are available for inspection at the same time.

Market information. Any written, printed, audiovisual or graphic information, including advertising, pamphlets, flyers, catalogues, posters and signs, distributed, broadcast or made available outside of retail outlets that are used to assist in the sale or promotion of a product.

National List. A list of allowed and prohibited substances as provided for in the Act.

Nonagricultural substance. A substance that is not a product of agriculture, such as a mineral or a bacterial culture, that is used as an ingredient in an agricultural product. For the purposes of this part, a nonagricultural ingredient also includes any substance, such as gums, citric acid or pectin that is extracted from, isolated from or a fraction of an agricultural product so that the identity of the agricultural product is unrecognizable in the extract, isolate or fraction.

Non-synthetic (natural). A substance that is derived from mineral, plant or animal matter and does not undergo a synthetic process as defined in section 6502(21) of the Act (7 U.S.C. 6502(21)). For the purposes of this part, non-synthetic is used as a synonym for natural as the term is used in the Act.

Non-retail container. Any container used for shipping or storage of an agricultural product that is not used in the retail display or sale of the product.

Nontoxic. Not known to cause any adverse physiological effects in animals, plants, humans or the environment.

Organic. A labeling term that refers to an agricultural product produced in accordance with the Act and the regulations in this part.

Principal display panel. That part of a label that is most likely to be displayed, presented, shown or examined under customary conditions of display for sale.

Processing. Cooking, baking, curing, heating, drying, mixing, grinding, churning, separating, extracting, slaughtering, cutting, fermenting, distilling, eviscerating, preserving, dehydrating, freezing, chilling or otherwise manufacturing and includes the packaging, canning, jarring or otherwise enclosing food in a container.

Processing aid. (1) Substance that is added to a food during the processing of such food but is removed in some manner from the food before it is packaged in its finished form; (2) a substance that is added to a food during processing, is converted into constituents normally present in the food and does not significantly increase the amount of the constituents naturally found in the food; and (3) a substance that is added to a food for its technical or functional effect in the processing but is present in the finished food at insignificant levels and does not have any technical or functional effect in that food.

Producer. A person who engages in the business of growing or producing food, fiber, feed and other agricultural- based consumer products.

Production lot number/identifier. Identification of a product based on the production sequence of the product showing the date, time and place of production used for quality control purposes.

Prohibited substance. A substance the use of which in any aspect of organic production or handling is prohibited or not provided for in the Act or the regulations of this part.

Records. Any information in written, visual or electronic form that documents the activities undertaken by a producer, handler or certifying agent to comply with the Act and regulations in this part.

Retail food establishment. A restaurant, delicatessen, bakery, grocery store or any retail outlet with an in-store restaurant, delicatessen, bakery, salad bar or other eat-in or carry-out service of processed or prepared raw and ready-to-eat-food.

Split operation. An operation that produces or handles both organic and non-organic agricultural products.

Synthetic. A substance that is formulated or manufactured by a chemical process or by a process that chemically changes a substance extracted from naturally occurring plant, animal or mineral sources, except that such term shall not apply to substances created by naturally occurring biological processes.

[65 FR 80637, Dec. 21, 2000, as amended at 72 FR 70484, Dec. 12, 2007]


Organic Standards for Handling (Processing): Highlights of the USDA's National Organic Program Regulations
By Ann H. Baier
NCAT Agriculture Specialist
Holly Michels, Editor
Sherry Vogel, HTML Production
IP333
Slot 330
Version 112608

 

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This page was last updated on: April 26, 2012