In the March edition of P&F magazine, Quality Assurance International’s (QAI) Jessica Walden answered some of your top questions regarding organic certification for flavors. After publication—in late February—the USDA’s National Organic Program (NOP) published a guidance document regarding flavors and whether or not flavor ingredients need to be sourced organically. You may refer to this document on the NOP website.
In light of this clarification, QAI has amended its stance on how flavor ingredients are evaluated; specifically, QAI is no longer making a distinction between “agricultural” vs. “nonagricultural” flavors. All flavoring ingredients are now assessed according to the NOP requirements for the use of nonagricultural, non-synthetic flavors, which are covered under 205.605(a) of the NOP’s National List of Allowed and Prohibited Substances.
Therefore, QAI's response to several questions posed by Perfumer & Flavorist magazine has been amended. The questions and revised answers can be seen below. (The red text is the revised text.)
P&F: What flavor ingredients are considered “agricultural” vs. “nonagricultural” and how are they assessed for compliance under the NOP Rule?
Walden: Further to the NOP’s clarification, the distinction between “agricultural” and “nonagricultural” flavor ingredients is no longer being enforced by QAI. Now, nonsynthetic flavors, whether agricultural or nonagricultural, may be used in organic products according to the National List, 205.605, and do not need to be sourced organically nor petitioned to be placed on 205.606. As long as flavors meet the definition of a natural flavor, according to the FDA in 21 CFR Part 101.22(a)(3), are from nonsynthetic sources, and are not produced using synthetic solvents and carrier systems or any artificial preservatives, they may be used. They also must be produced without the use of genetically-modified organisms or irradiation. Please note: this does not apply to essences or oils that are added-back to organic juices during processing. “Add-backs” in organic juices must be sourced organically.
The FDA definition of natural flavor is as follows: “The term natural flavor or natural flavoring means the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose significant function in food is flavoring rather than nutritional. Natural flavors include the natural essence or extractives obtained from plants listed in 182.10, 182.20, 182.40, and 182.50 and part 184 of this chapter, and the substances listed in 172.510 of this chapter.” FDA 21 CFR Part 101.22(a)(3)
P&F: What are the organic requirements for flavor ingredients?
Walden: All ingredients in the flavor, including carriers or solvents, must be organically produced, approved non-organic agricultural materials, or approved nonagricultural ingredients, which are listed in the NOP Regulation, section 205.605. For products making a 100% organic claim, all ingredients in the product must be certified 100% organic, and any processing aids used must be organic. For the organic claim, all organic ingredients must equal 95% of the product’s formulation (excluding water and salt). The remaining 5% either must be ingredients listed in section 205.605 or, beginning June 2007, listed in section 205.606.
For products making a “made with organic (specified ingredients or food groups)” claim, at least 70% of the product (excluding water and salt) must be composed of organic ingredients. The remaining 30% may be from nonorganic agricultural ingredients or nonagricultural ingredients listed in section 205.605 of the NOP Regulation. All nonorganic ingredients in an organic or made with organic product must be produced without genetically modified organisms, irradiation or sewage sludge. All certified organic flavors and flavor ingredients must be nonsynthetic and produced without synthetic solvents, carriers or preservatives.
P&F: How will the commercial availability changes that will be enforced starting June 9, 2007 affect ingredients used in organic flavors?
Walden: Beginning June 9, 2007, all nonorganic agricultural ingredients in products labeled as organic must be listed on 205.606 and must be demonstrated as commercially unavailable. If these ingredients are not listed on 205.606 by June 9, 2007, the company will be required to either source the organic version or change the labels to a “made with organic” claim. As a certified flavor manufacturer, you are required to follow this commercial availability requirement for all agricultural ingredients, e.g., fruit purees, sugar, ethyl alcohol, maltodextrin. To have ingredients reviewed for inclusion on 205.606, you must petition the USDA NOP. For information on the NOP Petition process, please visit www.ams.usda.gov/nop/petition/petitionhome.html.
Again, due to the recent NOP clarification on flavors, all flavor ingredients are currently covered under the allowed nonagricultural ingredients that may be used in “organic” and “made with organic” products, so long as they meet the NOP restriction regarding synthetic solvents, carriers and preservatives, are not produced with genetically modified organisms or irradiation and meet the FDA definition of natural flavor. Therefore, any flavor ingredients that you source to use in your organic flavors (e.g., citral, delta-lactone, orange oil, bergamot oil) do not need to be organically produced.
P&F: For those of us already manufacturing and selling certified organic flavors, how will the upcoming changes (sunset, definitions of “agricultural” and “nonsynthetic”) affect our current certified organic flavors and the ingredients we use to make them?
Walden: Sunsetting, which occurs once every five years, is when all materials on the National List of Allowed and Prohibited Substances are reviewed and either voted to stay on the list or to be removed. We have just completed our first sunset period and the only item removed from the National List (205.605) was colors. Flavors are still allowed, but will be reassessed in five years. Regarding the current NOP definitions of agricultural, nonagricultural, nonsynthetic and synthetic, they are currently being considered and will possibly be amended by the National Organic Standards Board (NOSB). At this time, it is unclear how the definitions will change or if and how they will affect our certified clients. It is important to note that once the NOSB makes its recommendations, it will open for public comment. In any case, if the definition changes will affect certified operators, then there will be a phase-in time to allow for changes to products, if applicable.
Regarding the NOP’s recent clarification on flavors, it is important to note that for those flavor manufacturers who are already using organic flavor ingredients, or who are in the process of obtaining organic flavor ingredients (e.g., organic essential oils), they may want to continue to follow that path. The outcome of the NOSB’s recommended definitions of “agricultural” and “nonagricultural” may impact the NOP’s guidance on flavors; additionally, the NOSB may recommend changes to the National List with regard to flavors. Using certified organic flavor ingredients now is perhaps the safest approach, and will buffer organic flavor products against any changes regarding flavors in the future.