An Inside Look at NOP National List
Allowed Processing Aids

By Kim Burton Dietz


When pursuing the organic label manufacturers need to pay close attention to the processing aids used in the development of a product. Even though processing aids don’t add significant ingredients to a product, they come into contact with that product and therefore impact the status of its organic makeup and ultimately, the labeling of the product.
The National Organic Program (NOP) National List of Allowed and Prohibited Substances (National List) section 205.600 includes descriptions of the criteria used to to allow a material, or processing aid, on the National List. Processing materials are placed in the handling section of the National List, sections 205.605 and 205.606. Section 205.605 is split into allowed nonsythentic materials and synthetic materials. Since the national law was put in place in 2002, the National List has been updated to include processing aids that have undergone review by the National Organic Standards Board (NOSB) and approved by the U.S. Department of Agriculture (USDA) NOP. The National List was updated on Nov. 4, 2003, and included all the materials that the NOSB recommended to be added to the National List from December 2000 through October 2003. So if a material is not on the National List, then it is not allowed for use in organic production.

According to the National Organic Program a processing aid is “(a) a 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; (b) 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 (c) 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.

The National Organic Program (NOP) publishes the National List of all processing aids allowed in organic foods. It is required that manufacturers use only those processing aids found on the list for their products to be certifiably organic. Manufacturers also need to realize that the use of non-organic processing aids, even those allowable by the NOP, prevents them from using the 100 percent organic label because the aids are not certified 100 percent organic. Those products can qualify for the “organic label,” because the processing aid, even if it only represents a miniscule percentage of the product’s make-up, puts the product into the less than 5 percent non-organic category.

Dairy cultures are a good example of a non-synthetic processing aid reviewed by the NOSB and approved for inclusion on the National List by the USDA NOP. Dairy cultures are used in the dairy industry to prepare foods for consumer use. It is understood that you need dairy cultures to make yogurt or cheese. Because it is only used for the technical function of the product and it is in insignificant levels, it is defined as a processing aid. It comes in contact with the food during processing but doesn’t constitute a significant ingredient. Even so, when a manufacturer uses dairy cultures the product can be certified organic but not certified as 100 percent organic.

Synthetics and The National List
The NOP standards require that synthetic processing aids are kept out of organic foods whenever possible. It is a goal for everyone in the organic industry but it can be challenging for manufacturers who require certain processing aids to produce their products that simply can’t be found in organic or natural forms. In those cases, synthetic alternatives can be approved but only after every effort is made to find an alternative.

For example, recently the synthetic form of malic acid was petitioned to the NOP. Malic acid is used as a processing aid in tea manufacturing to take out the cloudiness and make it clear. It was petitioned as a synthetic material for the National List. The NOSB reviewed the petition and also reviewed the Technical Advisory Paper (TAP), which mentioned that there was a nonsynthetic form of malic acid. The petitioner was requested to find a source of natural malic acid, which they did. The board approved the natural malic acid rather than the non-synthetic version. That was a win-win for everybody because the manufacturer got access to a product needed to complete a product without the use of synthetics.

If a natural alternative is not found, a synthetic processing aid may be recommended by the NOSB. The following criteria will be reviewed:

• It cannot be produced from a natural source and there are no organic substitutes.

• Its manufacture, use, and disposal do not have adverse effects on the environment and are done in a manner compatible with organic handling.

• 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.

• Its 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.

• It is listed as Generally Recognized As Safe (GRAS by the FDA when used in accordance with FDA’s Good Manufacturing Practices (GMPs) and contains no residues of heavy metals or other contaminants in excess of tolerances set by FDA.

• It is essential for the handling of organically produced agricultural products.

Asorbic acid is a common example of an allowable synthetic processing aid for organic products. Asorbic acid is a synthetic form of vitamin C used to reduce oxidation and hold color. If, for example, you are manufacturing apricot puree, you use asorbic acid because to prevent the oxidation process that turns the apricots brown when they hit the air. CO2 and Xanthan gum are other approved synthetic processing aids used for the carbonation of beverages as a thickener for organic products.

It’s critical that organic processors know what’s on the National List because it determines which non-organic ingredients they are allowed to use as they develop new products. If a manufacturer is developing a new product, they should make every effort to use processing aids on the National List. If that’s not possible, manufacturers can petition to have it added, however it is lengthy and complicated process. The average petition takes one to two years before it actually goes on the National List and is allowed for use.

How to Get On the National List
Before submitting a petition to the NOP to add a processing aid to the National List, petitioners must complete an extensive series of paperwork that includes material safety data sheets (MSDS), and descriptions of how they intend to use the use the material, why they need it, whether it comes in a natural form, and what, if any, alternatives are available. They also need to prove it has GRAS status.

Once the paperwork is completed it is submitted to the NOP, the minimum timeframe for National List Material Review is 145 days during which time the following communications and expectations take place between NOP staff, Materials Committee, and TAP contractors:

• Day 1 through 14:
The petition for request of a material to be added or deleted from the National List is received by NOP. The NOP staff reviews the petition to see if all of the requirements, as described by the petition process, are complete. If the petition has all the required information then a copy of the petition is sent to the NOSB Materials Committee Chairperson.

• Day 14 through 30:
The Materials Chairperson sends a copy of the petition to the Vice-Chair of the Materials Committee and Vice-Chair of the designated NOSB committee (Crops, Livestock or Handling). The Vice-Chair of the designated committee will review the entire document and convene a meeting with his/her committee to discuss a recommendation. The designated committee will vote on the recommendation and forward it (in writing) to the Materials Chair. The Materials Chair acts on their direction. For example, a TAP report is requested, the petition is returned to NOP with specific reasons as to why the material is being returned, or further direction is given regarding the material.

• No later than 115 days prior to a NOSB meeting:
All TAP review requests that are sent to contractors 115 days prior to the next NOSB meeting will be guaranteed completed TAP reviews. Petitioners should see the Statement of Work for specific tasks and responsibilities that fall under this time frame. In Phase I the contractor must notify NOP in writing of any substance(s) they feel are not appropriate for National List evaluation. Contractors must not directly correspond with the petitioner. All requests for additional information or clarification should be sent via e-mail to NOP Staff.

• Sixty (60) days prior to the NOSB meeting:
Copies of the completed TAP review must be received by NOP. One copy must be overnight express mailed along with a copy sent via e-mail.

• Thirty (30) days prior to the NOSB meeting:
TAP reviews are posted on the NOP website for review and public comment. TAP report copies are sent to petitioners.

Organic processors can find more information and updates to the National List by accessing www.ams.usda.gov/nop/NOP/ standards/ListReg.html. Keeping abreast of the current list of allowed and prohibited substances in the National List will aid in the efficient development of new organic products while protecting the integrity of the organic labeling claim.

Kim Burton Dietz is human resource and regulatory compliance manager with J.M. Smucker Quality Beverages, a wholly owned subsidiary of J.M. Smucker Co. Burton Dietz is currently appointed as secretary of and serves as a handler/processor representative to the NOSB. She can be reached at kim.dietz@jmsmucker.com.

 
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NOSB Petitioned Processing Aids in Review

The NOSB is presently considering several products for addition to the National List, including the following processing aids:

NPCAPS
(Empty capsules composed of pullulan, carageenan and potassium chloride)
Manufacturer: Capsugel Division of Pfizer, Inc.
Application: For use in pharmaceuticals or dietary supplements
Status: Under NOP Review

Nitrous Oxide
Manufacturer: Nitrous Oxide Corp.
Application: As a whipping propellant in products labeled as “organic” and “made w/organic.”
Status: Deferred: Under NOSB Review

L-Malic Acid
Manufacturers: A.E. Staley, and Barick Ingredients, Inc.
Application: As a PH adjuster in processing operations.
Status: NOSB recommended this Nonsynthetic –Add to 205.605(a) from the microbial fermentation of carbohydrate substances. NOP returned this recommendation to the NOSB for further documentation.

Sodium Acid Pyrophosphate
Manufacturer: International Food Additives Council company members
Application: As a leavening agent in baked goods.
Status: NOSB recommended this Synthetic–Add to 205.605(b) for use only as a leavening agent. NOP returned this recommendation to the NOSB for further documentation.

Microorganisms
Manufacturer: Kikkoman Corp.
Application: For spore powder; seed mold (dry mash culturing starter) used as yeast for bread or fermentation.
Status: NOSB recommended this Non–Synthetic – Add to 205.605(a) as “any food-grade bacteria, fungi, and other microorganisms.” NOP returned this recommendation to the NOSB for further documentation.