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Organic/Natural Regulations: Reader Follow-Up Questions

P&F magazine's March article "FAQ: Top 10 Organic Questions Answered" and P&Fnow's March 21 article on the National Organic Program's (NOP) clarification helped clear up some questions that you had regarding organic/natural and the certification process. With the continuous changes in organic regulations, it is hard to keep track of what's coming next and how it affects you. Here, Jessica Walden (Quality Assurance International technical specialist) answers some follow-up questions that P&Fnow received from you—our readers.

Reader Question 1: How is an extraction solvent like hexane regarded? We have always considered it a prohibited “synthetic solvent” and it is very limiting not to have use of it.

Walden: The NOP Rule allows the use of flavors in products making an “organic” claim (e.g., at least 95% organic ingredients) and “made with organic” (specified ingredients and food groups) claim (e.g., at least 70% organic ingredients) so long as the flavors are nonsynthetic (i.e., natural) and are not produced using synthetic solvents, artificial preservatives and synthetic carrier systems. The NOP defines nonsynthetic/natural as “a substance that is derived from mineral, plant, or animal matter and does not undergo a synthetic process.” Hexane is a hydrocarbon derived from petroleum. It is, therefore, a synthetic solvent and is not allowed in flavors used in “organic” and “made with organic” products, nor is it allowed for use in the production of “organic” and “made with organic” flavors.

Reader Question 2: Is there any allowance for process aids (like catalysts)?

Walden: I am assuming that this question pertains to processing aids used in the manufacturing of a (nonorganic) natural flavor that will be used in a certified “organic”/“made with organic” product. The answer is that as long as the flavor meets the NOP restriction, which is that flavors are nonsynthetic and are not produced using synthetic solvents, artificial preservatives and synthetic carrier systems, processing aids/catalysts are okay.1 For “organic” and “made with organic” flavors, all nonagricultural processing aids/catalysts must be listed on the NOPs National List of Allowed Substances, 205.605. Agricultural processing aids may be used so long as they are not produced from and with genetically modified organisms, irradiation or sewage sludge.

Reader Question 3: How would a chemical like ammoniated glyccyrizan (USA-FDA natural, but EU-artificial) fit into the organic-compliant paradigm? What about butyl butyryllactate (natural ingredients, Maillard reaction, but BBL does not exist in nature, although this type ‘gammish’ is viewed as US-natural)?

Walden: Unfortunately, most certifiers do not have flavor chemists on staff, so we rely largely on signed affidavits from suppliers of natural flavor materials to indicate whether or not the flavor material is compliant with the NOP regulation. Please find QAI’s Flavor Affidavit by clicking here

However, during the certification process for flavors, we do review all flavor ingredients added to the product and if we have reason to believe that an ingredient may not meet the NOP regulation (even if we have received an acceptable flavor affidavit for said ingredient) we ask for further information on how the material is produced. Currently, the NOP Rule requires that flavors are nonsynthetic. Synthetic is defined in the NOP Rule as “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.”2

The NOP recently clarified that flavors used in “organic”/“made with organic” products must meet the FDA’s Natural Flavor definition, 21 CFR Part 101.22(a)(3) and be produced without the use of synthetic solvents, carrier systems or artificial preservatives. The FDAs Natural Flavor definition includes all flavors that are derived from natural substances and are processed using biological and mechanical methods, as opposed to chemical methods. In light of this, QAI would inquire further into how the above mentioned flavor materials—ammoniated glycyrrhizin and butyl butyryllactate—are produced in order to determine if they met the NOP requirements.

Reader Question 4: Can you explain without using the NOP to describe what natural FEMA GRAS approved ingredients are allowable in an organic flavor formulation at 100%, 95% and 70%?

Walden: 100% = all ingredients must be certified 100% organic. Under this classification, there can be no nonorganic ingredients in the product and all multi-ingredient ingredients must be certified at the 100% claim. All processing aids must at least be organic (95%). So, any FEMA GRAS approved ingredients must also be certified 100% organic.

95% = at least 95% of the ingredients must be organic and the remaining ingredients must be on the NOPs National List, 205.605 and 205.606. Any FEMA GRAS approved ingredients must either be organically certified, listed on the National List, or be classed as a natural flavor that meets the NOPs requirements.

70% = at least 70% of the ingredients must be organic and the remaining ingredients must be on the NOPs National List, 205.605, or must be approved agricultural ingredients. Any FEMA GRAS approved ingredients must either be listed on the National List, 205.605, be classed as a natural flavor that meets the NOPs requirements, be organically certified, or be “agricultural” and produced without GMOs, irradiation or sewage sludge.

Reader Question 5: If I use a peppermint oil that has been specially distilled, which creates specific flavor characters that no one else has, can I use it as an organic ingredient?

Walden: You can’t use the peppermint oil as an organic ingredient unless it has been organically produced and organically processed (example, organically grown and certified peppermint that is distilled in an organically-certified facility). However, since this ingredient meets the FDA Natural Flavor definition, you can use it in an “organic” (at least 95% organic ingredients) and a “made with organic” (at least 70% organic ingredients) product as long as it meets the NOPs restriction regarding synthetic solvents, carriers and preservatives. Nonorganic peppermint oil may not be used in a product making a 100% organic claim.

1Please note, all ingredients used in “organic” and “made with organic” products cannot be produced with genetically modified organisms and irradiation.
2This definition is currently under review by the National Organic Standards Board.

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