Processing Aids and Food Contact Substances: Understanding The Controversy of What’s What

By Jessica Walden and Emily Brown Rosen

Q: As a certified handler of organic products I understand that all non-agricultural ingredients and processing aids used in organic production must be on the National List of Allowed and Prohibited Substances, section 205.605. However, what about those other materials that may contact the organic product, like boiler chemicals, sanitizers, anti-microbials, modified atmosphere and components of packaging or equipment? Do these types of materials also have to be on the National List in order to be used in organic production? My certifier says “yes”; my competitor’s certifier says “no”. What is the answer?

A: Good question, but unfortunately the answer is not black and white. In fact, this subject has been one of the most highly controversial and debated subjects in the organic industry. To try to come to an answer requires that one first understand the background to the question.

The Policy With Good Intentions, But Many Interpretations
The National Organic Program (NOP) often creates policies to help further define the organic regulation and provide clarity, but sometimes these create more questions than they answer. That is the case with the policy released December 12, 2002, regarding the issue of food contact substances.

The NOP’s National List of Allowed Substances, 205.605 covers a wide range of materials from ingredients/additives and processing and packaging aids to sanitizers (for no-rinse and direct food contact application) and even boiler chemicals. According to the organic regulation, when looking to incorporate non-agricultural substances in processing, a handler must only use items from this list. Although the list is extensive, there are still some indirect substances that may come into contact with foods in processing (i.e., packaging plastics, equipment sanitizers, machine lubricants, etc.) that were not addressed by the list and many handlers and certifiers came to the NOP with questions.

In an attempt to provide some answers, the NOP released the 2002 policy stating that only substances on the NOP’s National List can be used in the production of “organic” and “made with organic” products… unless the substance is classified by the Food and Drug Administration (FDA) as a “Food Contact Substance.” The FDA defines a food contact substance as “any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting or holding food if such use is not intended to have any technical effect in such food.”

This broad category includes a plethora of substances including many that could be classified as processing aids, sanitizers and preservatives—materials that have been reviewed by the National Organic Standards Board (NOSB) and added (or not added) to the National List. This raises a conflict about the classification a substance falls under. Is it a FDA food contact substance, which doesn’t need to be on the National List or is it something that falls under the realm of substances addressed by the National List (i.e., processing aids) and thus must be included on the list? Many materials that are considered food contact substances are prohibited under the NOP regulation, so one cannot just go by the FDA classification. Overall, this is a policy that is not well understood, supported or uniformly applied by organic certifiers and organic operators.

The Big Question
As stated above, there are many types of materials that qualify as food contact substances under the FDA. Examples of food contact substances and indirect additives include, but are not limited to: coatings, plastics, paper, adhesives, ingredients used in packaging such as colorants, antioxidants, antimicrobials, as well as substances that are used in the manufacturing of foods such as boiler-water additives for steam, ion-exchange resins (considered secondary direct additives), chemicals used in peeling vegetables, defoaming agents and extractants like hexane, methylene chloride, acetone and trichlorethylene. NOSB has previously ruled on a number of these and allowed a few, while specifically prohibiting others. For example, NOSB specifically rejected morpholine as a boiler chemical (considered a food contact substance under the FDA) since it is a known carcinogen.

The NOP’s National List, 205.605 includes materials that would also qualify as food contact substances. This includes substances such as activated carbon; volatile boiler chemicals (with the restriction that such materials may only be used in boilers where steam is used for packaging sterilization); and sanitizers/antimicrobials like chlorine, peracetic acid and hydrogen peroxide (indirect additives). The National List, however, does not include materials like non-volatile boiler additives that are allowed for use in boilers where steam contacts food directly, ion-exchange resins and persistent sanitizers like quaternary ammonium compounds (historically prohibited by most certifiers). So the question is: what takes precedence over what? Do organic certifiers and operators consult the National List when deciding on which processing aids and indirect additives to use during organic processing or can operators use a whole gamut of other materials that are not on the National List, but that are approved food contact substances?

The Big Headache: What About Processing Aids?
One of the biggest areas of confusion is the fact that the NOP policy does not explicitly mention processing aids; it only indicates that ingredients must be reviewed and approved by the NOSB and listed on the National List in order to be used. Processing aids are not classified as ingredients by the NOP because they are not “still present” in the end product. Although processing aids are, for the most part, not considered “still present” in the end product, the NOP regulation at 205.301(f)(4) does require that products making an “organic” or “made with organic” claim may not be processed with processing aids not approved on the National List.

What makes this all more complicated is the fact that some processing aids have been deemed by the FDA to be food contact substances if they have no “ongoing technical effect” in the finished food. Because some materials can be considered both a processing aid (as regulated by the National List) and a food contact substance (governed by the FDA) there is bound to be confusion. The organic regulation may say “No, sorry, you can’t use this processing aid because it is not on the list,” while at the same time the NOP policy on food contact substances is saying, “The FDA defines this as a food contact substance, so it’s OK.”

What Do Certifiers Say?
There is a general discomfort when this topic is brought up among the accredited certifiers. The overall feeling is that the NOP’s food contact substances policy in many ways undermines the NOP regulation and the National List. It is also noted that policy statements do not have the same legal weight as regulations. Therefore, the standard line is that any non-agricultural ingredient, processing aid or other substance such as a no-rinse sanitizer, antimicrobial or boiler chemical that is in direct contact with organic ingredients or products must be listed on the National List of Allowed and Prohibited Substances, 205.605, and meet the specific annotation as applicable.

Many certifiers have chosen not to accept or even acknowledge the NOP policy on food contact substances. Others have developed their own framework/criteria for accepting materials that are not on the National List but that qualify as food contact substances under the FDA.

Below are examples of how some certifiers are doing their best to work within the current context of the NOP regulation versus the NOP policy. As each certifier has their own position on how to apply the NOP’s policy regarding food contact substances, it is important to contact your certifier to find out their position prior to using any material in or on organic ingredients and products, which is not on the National List 205.605.

The Hybrid NOP Policy/National List Approach
In this approach, the NOP regulation and the materials on the National List take precedence over the NOP’s policy on food contact substances and FDA categorization. However, the class of materials that have not been reviewed by the NOSB previously and that also qualify as food contact substances are considered and assessed according to the NOP’s policy. In other words, the types of materials that the NOSB and NOP have already specifically reviewed and approved/prohibited for use in organic handling must be on the National List in order to be used. Such materials include boiler chemicals that have direct food contact via steam, sanitizers/antimicrobials, preservatives and other additives. These might be deemed by the FDA to be food contact substances, but since the specific type of material has been assessed by the NOSB, the latter would trump the FDA classification. To illustrate: all amine boiler additives are approved as food contact substances by the FDA, but the NOSB/NOP has only approved three amines for use in organic handling, with specific restrictions, thus only these three would be approved for use by this certifier.

Materials that appear to be outside the scope of NOSB review (i.e., a select few indirect food additives or secondary food additives) that may contact the organic ingredients during manufacturing, storage, transport and display may be used in organic handing if they are categorized by the FDA as food contact substances. Such materials include ion-exchange resins, components of food grade packaging (other than synthetic fungicides, preservatives and fumigants, which are specifically prohibited under the NOP), components of conveyors that contact food, components of food grade equipment and contact surfaces (e.g., polyethylene filters, permanent coatings), and inert ingredients in NOP-listed sanitizers and hand sanitizers in food handling establishments. Any substance identified by a certified client or applicant as a food contact substance must be accompanied by documentation that substantiates the claim.

The “Must Be On The List If It Contacts Organic Food” Approach:
In this approach, any synthetic substance in direct contact with organic food must be on the National List, regardless if it is classified as a food contact substance by FDA or not. This includes sanitizers and inert ingredients in sanitizers that are used in direct contact with food, as well as ion exchange resins.

Equipment sanitizers, non-volatile boiler chemicals, that are not in contact with organic food, are not considered to be “in or on” organic food and are generally allowed. However, sanitizers used on food contact equipment must not be persistent in nature, and are subject to an intervening event such as thorough rinsing or purge of non-organic product before equipment is in contact with organic food. Boiler chemicals that are not carried into steam are permitted, as are systems that turn off injected volatile chemicals prior to runs of organic product. Packaging materials are not restricted, except as provided for in the regulation, with the prohibition on fumigants, preservatives and fungicides as specified in 205.272(b).

So, What Is the Best Way to Go About All of This?
There are no easy answers to this complex issue. Certifiers continue to use their best judgment and seek to work with the NOP for further clarification. Until then, the most fail-safe option, no matter what certifier you are working with, is to stick with products that are actually named on the National List. Going outside of the National List and using FDA food contact substances opens up the door for a variety of interpretations which may complicate the certification process and cause headaches.

If there is a material you really need to use that is not on the list, you may also want to consider drafting a petition to have that material reviewed by the NOSB. The board then can vote to recommend (or not recommend) to have the material you wish to use officially added to the National List.

To download a petition go to www.ams.usda.gov/NOP, and click on “National List of Allowed and Prohibited Substances” and follow the links.

Or be innovative and use something that has been developed as an alternative. Some of these minor ingredients are discussed in the Ingredients column in the January-February 2008 issue of Organic Processing Magazine.

As the NOP grows and learns more about the needs of handlers, consumers and the rest of the organic community, this area will surely develop and become better defined. Stay tuned and take a deep breath.

Jessica Walden is a technical specialist at Quality Assurance International, QAI, (www.qai-inc.com). She has been working in organic certification in the United States and abroad since 1995. She also serves as a member of the Processor Review Panel and Advisory Council with the Organic Materials Review Institute (OMRI) and is an invaluable member of the Organic Processing Editorial Advisory Board. You can reach her at jessica@qai-inc.com.

Emily Brown Rosen has been involved in organic certification, technical support to farmers, and materials review since 1992. She serves as policy director for Pennsylvania Certified Organic (www.paorganic.org) and also provides technical, educational and research services on a consulting basis for other organizations. She has also been the policy director for the Organic Materials Review Institute and was involved with the Technical Advisory Panel reviews for the NOSB. She serves on advisory boards for California Certified Organic Farmers, Northeast Organic Farming Assoc. of New Jersey and Midwest Organic Services Assoc. You can reach her at emily@paorganic.org.

Links For More Information:
• To view the NOP’s policy on food contact substances in full, go to: www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELDEV3099385&acct=nopgeninfo
Section 205.606 of the National List of Approved and Prohibited Substances (which includes a wide variety of processing aids and food contact substances) can be viewed on the NOP website at www.ams.usda.gov/NOP.