Date: July 21, 2023
To: NOP Organic Operations and Certifiers
Subject: Produce coatings comprised of mono and diacylglycerides and citric acid marketed by Apeel Sciences – additional considerations for certification.
Background: Apeel Sciences is marketing produce coatings containing glycerides under the names Apeel, Edipeel, Organipeel, and others. Mono and diacylglycerides (“glycerides”) such as those in Apeel coatings are approved for use in post-harvest processing but restricted to drum drying applications. The listing appears on the National List under §205.605(b) and was effective April 21, 2001.
Apeel Sciences submitted a notice to the FDA supporting these ingredients’ status as Generally Recognized as Safe (GRAS) for use as an edible food coating in the United States. In the notice, Apeel Sciences claims the final product contains only glycerides and citric acid, except for some residual heavy metals and other minor contaminants. As is often the case for self-affirmed GRAS notices, the FDA did not grant GRAS status or review any other regulatory issues related to the resulting product. The FDA only stated is has no questions about the final submission.
Among other disclosures, the GRAS submission describes in detail the plant material from which the glycerides are extracted, and the solvents used in the manufacturing process. The GRAS submission is based on the use of grape seed oil extracted using glycol and treated with heptane and/or ethyl acetate. Furthermore, the resulting powder product is subsequently dissolved in ethanol to create a liquid solution for dipping and spraying individual pieces of produce. No part of the GRAS submission discusses how an Apeel coating could be manufactured using methods and materials that comply with the Organic Food Production Act and USDA organic rules created through the National Organic Program. This Notice to Organic Operations has been drafted to provide a comprehensive list of potential non-compliance issues and where to look for them.
1. Source Materials Apeel Sciences has applied for over eighty patents related to these and similar coating products. The patents are broadly written, as is customary, and assert claims about extracting glycerides from nearly every conceivable agricultural waste stream. Apeel Sciences makes no mention of organic sources of grape seed in any of its publicly available communications. Moreover, Apeel Sciences is not required to use grape seeds, or any other specific plant stock, to continue to claim self-affirmed GRAS status for similar products containing the same ingredients. Any produce coatings applied to certified organic produce must be derived from certified organic plant material, including skins, pulp, seeds, stems, leaves, flower, etc., to ensure the plant stock is grown without prohibited materials and is not contaminated during processing, storage, or transportation. It is imperative that certified organic handlers using the Apeel Sciences glyceride food coating products on organic produce provide the certifier with a complete chain of custody of the plant stock used to make it, including, for instance, NOP certificates from organic grape growers supplying the seeds.
2. Other Ingredients. The Apeel Science patents also claim the right to incorporate colorings, flavors, aromas, and antibiotics into Apeel coatings for various purposes. Organic certifiers should therefore confirm that any additives to Apeel coatings be disclosed and their compliance with organic rules confirmed, including the source materials and processing methods of the additives.
3. Storage and Transport Apeel does not hold an organic certificate and may not be compliant with organic regulations. Storage and transport containers and conveyances must be verified to ensure they comply with organic rules such as:
- Trucks, trailers, rail cars, and aircraft freight areas are clean and contain no residues that can cross-contaminate.
- Totes, cases, bags, tanks, and other containers are made of organic-compliant materials.
- Containers are sealed when transported with non-organic materials to prevent cross- contamination.
- Spilled or spoiled materials surrendered for destruction.
- Manifests and invoices accurately represent product identity, source, and certification.
4. Good Manufacturing Practices Organic inspectors are not directly charged with food safety oversight beyond pest control and sanitation. However, in regard to the handling/manufacturing or products that claim to be compliant with organic standards, inspectors must confirm that proper controls are in place to maintain the organic status of the base material during processing. Apeel Sciences uses a number of toxic solvents and other materials to make its conventional product line, which may be present in the facility and create the conditions for cross-contamination. Here is a representative list of the issues to be addressed when a facility handles both organic and non-organic materials.
- Incoming shipments inspected for proper storage and handling in transit.
- Incoming materials verified by invoice, labeling, source, identity, and certifier statement.
- Organic materials properly labeled and stored apart from or above conventional materials.
- Pest control and cleaning materials and processes do not contaminate organic materials.
- cGMP verified process controls to purge and clean equipment prior to use with organic materials.
- Finished product properly labeled and stored apart from conventional products.
- Thoroughly auditable recordkeeping performed.
- Records maintained for five years.
- Mass balance of incoming organic materials and finished product.
5. Manufacturing Solvents and Catalysts Heptane or ethyl acetate are the solvents disclosed by Apeel Science in the GRAS notice to the FDA. Heptane and ethyl acetate are synthetic materials not allowed in organic processing and handling. Glycol is disclosed as the catalyst to help separate the grape seed oil from the seed. Glycol is not listed as an approved synthetic in organic processing. Certifiers should remain aware the Apeel Sciences patents claim the right to use any number of exotic, toxic, synthetic, and non-organic solvents, catalysts, and processing aids in the preparation of their products. The GRAS notice focused on only a handful of materials. Certifiers should require disclosure of all solvents, catalysts and processing aids used to produce the lot of coating powder being mixed and applied to produce under consideration for organic certification.
6. Labeling Apeel Sciences currently does not hold a USDA NOP Organic Certificate for any product. Since the coatings are applied prior to sale, and are self-affirmed as GRAS, Apeel Sciences claims no notice to consumers is required that additional ingredients have been added to the produce. Note, however, knowledge of the presence of glycerides, citric acid, and heavy metals and solvent residues may be important to many consumers, and to organic consumers especially. Citric Acid is known to cause mild negative effects in part of the general population, with some people reporting significant adverse events even from small amounts.
Citric acid is required by the FDA to be listed as an ingredient on Nutrition Facts and Supplement Facts on-package panels for this reason, and produce sold with Apeel coatings may be required to provide these point-of-sale disclosures in the future. Retailers and other produce purveyors should be aware that adverse events associated with undisclosed ingredients may trigger civil and criminal liability.
The Apeel Science patents also claim the right to incorporate colorings, flavors, aromas, and antibiotics into Apeel coatings for various purposes. Organic certifiers should therefore confirm that any additives to Apeel coatings be disclosed and their compliance with organic rules confirmed, including source materials and processing methods.
The USDA summarizes labeling of raw unpackaged agricultural products as follows:
§ 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.”
(a) 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.
(b) 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.
Thus, certifiers should take care to determine if the application of Apeel coatings is undertaken “in a certified facility” or handling operation before approving the use of the USDA seal on stickers, labels and placards used to sell coated products. Similar to other processing equipment used at seasonally at harvest, produce growers may elect to use a contractor to apply Apeel coatings; that contractor must be certified handler to maintain organic status.
7. Ethanol solution Apeel Sciences states their product is delivered to coating facilities in dry powder form that must be dissolved in ethanol to create a solution suitable for dipping or spraying produce. The most common source of ethanol is corn, specifically GMO corn. Organic certifiers should confirm the use of ethanol from organic sources produced non-synthetically using fermentation. Synthetic ethanol is not allowed in organic handling.
Many fresh produce processors handle both conventional and organic produce, so certifiers should confirm that adequate cGMP verified controls are in place to segregate organic and conventional ethanol and ethanol/glyceride coating solutions. In a spray-coating operation, the certifier should confirm that overspray from a conventional line does not cross-contaminate organic produce, organic processing equipment, or stored produce. The certifier should note how the ethanol and ethanol solutions are released, recovered and/or disposed of after use to maintain environmental integrity or soil, air, and water.
Ethanol even in low solution is flammable. Ethanol is considered a flammable liquid (Class 3 Hazardous Material) in concentrations above 2.35% by mass (3.0% by volume; 6 proof) and ethanol mixtures can ignite below average room temperature. In addition, acute effects of solvent inhalation, including ethanol, in both humans and animals include narcosis, anesthesia, CNS depression, respiratory arrest, unconsciousness, and death. [NIOSH. Organic Solvent Neurotoxicity; DHHS (NIOSH) PUBLICATION NUMBER 87-104; Current Intelligence Bulletin 48]. Certifiers should take appropriate safety precautions when near to or exposed to Apeel coating solutions.
Certifiers should remain aware the Apeel Science patents claim the right to use any number of synthetic and non-organic solvents, catalysts, and processing aids in the preparation of the final spray or dipping solution used to apply the product to produce. The Apeel Sciences GRAS notice focused only on ethanol. Certifiers should require disclosure of all solvents, catalysts and processing aids used to produce the final coating solution that is or may be applied to produce under consideration for organic certification.
8. Status of Apeel ingredients and processing/handling aids on the NOP National List § 205.601 Synthetic substances allowed for use in organic crop production.https://www.ecfr.gov/current/title-7/subtitle-B/chapter-I/subchapter-M/part-205/subpart-G/subject-group-ECFR0ebc5d139b750cd
Alcohol Nonsynthetic Ethanol made by fermentation is permitted without restriction. For synthetic alcohol, see Ethanol or Isopropanol. Reference: 7 CFR 205.105 Ethanol made by fermentation. Permitted without restriction. For synthetic alcohol, see Ethanol or Isopropanol. Reference: 7 CFR 205.105
Ethanol, Synthetic. Also called “ethyl alcohol.” Permitted as algicide, disinfectants, and sanitizer, including irrigation system cleaning systems. For nonsynthetic ethanol, see Alcohol. Reference: 7 CFR 205.601(a)(1)
Fatty Acids. Fatty acids produced from plant or animal oils that have been hydrolyzed through heat, pressure, steam, or enzymes only. Reference: 7 CFR 205.105 Note that monoglycerides, diglycerides, and triglycerides are all forms of Fatty Acids.
Citric Acid. Nonsynthetic or Synthetic. Natural citric acid produced from microbial fermentation of carbohydrate substances (e.g., sugar) is permitted. Production process may not use genetically modified microorganisms. Synthetic forms of citric acid are prohibited except as specified at § 205.601. Reference: 7 CFR 205.105 & 205.601(j)(7)
Glycol The only reference to glycol is Propylene glycol (CAS #57–55–6)—only for treatment of ketosis in ruminant livestock production. Apeel Sciences is likely referring to ethylene glycol, a food grade de-icing compound. No glycol, including ethylene glycol, is an allowed synthetic.
205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic (specified ingredients or food group(s)).”https://www.ecfr.gov/current/title-7/subtitle-B/chapter-I/subchapter-M/part-205/subpart-G/subject-group-ECFR0ebc5d139b750cd
205.605 Nonsynthetics allowed.
Acids (Citric—produced by microbial fermentation of carbohydrate substances; and Lactic).
Synthetic Ethanol is not allowed in organic processing.
Flavors—nonsynthetic flavors may be used when organic flavors are not commercially available. All flavors must be derived from organic or nonsynthetic sources only and must not be produced using synthetic solvents and carrier systems or any artificial preservative.
205.605 Synthetics allowed. Glycerides (mono and di)—for use only in drum drying of food.
§ 205.606 Nonorganically produced agricultural products allowed as ingredients in or on processed products labeled as “organic.”https://www.ecfr.gov/current/title-7/subtitle-B/chapter-I/subchapter-M/part-205/subpart-G/subject-group-ECFR0ebc5d139b750cd
Ethanol, Citric Acid, and Glycerides are not listed as allowed in or on processed products.
Note on Food Safety The USDA organic program delegates food safety issues to the Food and Drug Administration and Food Safety Inspection Service. Organic system plans and organic inspections typically do not address food safety outside of basic sanitation and potential cross contamination from noncompliant materials. However, some certifiers have expressed interest in understanding potential safety issues, which are summarized below. Apeel coatings may be applied to produce with tough or thick skin that is not usually eaten by humans, such as bananas and avocados. They may also be applied to produce with thinner skin that is consumed completely, such as apples. Apeel Sciences has made no indication that there is any produce (or other fresh food) on which the coatings should not be applied to delay oxidation and desiccation. However, the GRAS notice contains an extensive section in which average or typical consumption rates of coated produce are calculated in relation to the potential adverse effects from excess consumption of monoacylglycerides and diacylglycerides (fatty acids) in the human diet. Apeel concludes that the expected intake of its coatings is sufficiently low, but with its lengthy discussion section the potential for harm is tacitly acknowledged. Operations may want to pay special attention to produce that is eaten whole, without peeling, or food made from coated peels, when considering all the factors supporting or not supporting certification. Note that the European Union allows the use of glycerides as food coatings without restrictions on how they are made or what they are made from. However, glycerides are not listed as allowed materials in EU organic rules. Concerns about adverse events related to undisclosed citric acid were discussed in the main document above.