Besides pollination, humans look to insects for other aspects of food production. Honey bees (Apis mellifera) and other bee species produce honey—the only available sweetener before industrial sugar production began in the 1800s (Alvarez-Suarez et al., 2010). Cochineal, a bright red dye, was first produced from the scale bug (Dactylopius coccus). Also referred to as carmine or cochineal extract, it is approved for use as a color additive in foods (21 CFR 73.100), drugs (21 CFR 73.1100), and cosmetics (21 CFR 73.2087).
Insects have always played an important role in food production. Pollinators, like bees, butterflies, and birds help ensure the successful reproduction of crops such as almonds, apples, blueberries, and chocolate. According to USDA, up to one third of the food we eat exists because of pollinators.
But what about the insects themselves? For thousands of years, some groups of people have turned to insects as an important nutritional source. Locusts, crickets, termites, larvae, and caterpillars are eaten in Africa, Asia, Australia, and North America. In fact, it is estimated that approximately 1,900 insect species are eaten worldwide (van Huis, 2012). Given recent worldwide food security and climate change concerns, international groups such as the Food and Agricultural Organization (FAO) of the United Nations (UN) have been investigating the potential role of insects as foods and feeds.
In the United States, there has been increased interest in alternative protein sources including cultured meat, seaweed, vegetables and fungi, and other meat-alternatives, as evidenced by a slew of Generally Recognized as Safe (GRAS) Notices filed by FDA since January 2017 for ingredients derived from these alternative protein sources (see table below). As manufacturers get bitten by the alternative-protein bug, the number of GRAS Notices filed by FDA for additional alternative-protein products is likely to increase.
To date, FDA has yet to file a GRAS Notice submission for cricket protein, though it has been marketed as a food ingredient in the US for approximately 5 years. While submitting a GRAS Notice to FDA is not a regulatory requirement, there don’t appear to be any press releases announcing that any cricket protein manufacturers have determined the GRAS status of their ingredient through an Independent (Self-Affirmed) GRAS process. A search of FDA’s warning letter database does not indicate that any enforcement action has been taken with regard to cricket-derived foods. This is likely due to FDA’s enforcement discretion, since insect-derived ingredients are subject to the Food, Drug, and Cosmetic Act (FD&C), and require either a GRAS conclusion or Food Additive Petition prior to use in foods. An introduction to GRAS can be found in a series of KemmelCal’s blog posts found here.
While no GRAS Notices have been filed for insect-derived protein preparations, GRAS Notice (GRN 930) was recently submitted to FDA for the use of silk fibroin derived from Bombyx mori cocoons as a coating to preserve fruits, vegetables, cheeses, and candy at levels of up to 880 mg per kg of food. GRN 930 is currently pending review.
Although international regulations don’t apply to food ingredients used in the US, they can often be indicative of growing interest in the US market. In a scientific opinion published in January 2021, the European Food Safety Authority (EFSA) evaluated the safety of dried yellow mealworm (Tenebrio molitor larva) as a novel food ingredient. After reviewing the manufacturing process, compositional data and specifications, stability, intake assessment, and safety and toxicity data provided—both publicly available and proprietary to the applicant), the EFSA Panel concluded that dried yellow mealworm is safe for use in snacks, sports protein, biscuits, legume-based dishes, and pasta-based dishes at maximum use levels ranging from 10 g to 100 g of dried yellow mealworm per 100 g. The EFSA Panel noted that “allergic reactions are likely to occur” in consumers with allergies to crustaceans and dust mites, and that additional research should be conducted on the potential allergenicity and cross-reactivity of the product.
In addition to allergenicity concerns, insect-derived products intended for human food consumption should also be assessed for contaminants. While it’s important to verify that the insect-derived product is nutritionally sound, it’s equally important to ensure that the product is free from undesirable substances, including but not limited to: heavy metals; pesticides; microbial contamination; and anti-nutritional factors or toxins.
As interest in alternative food sources increases, it will be important for manufacturers to avoid stirring up a regulatory hornet’s nest by establishing the safety of such ingredients by completing a GRAS determination. Please leave a comment below or contact KemmelCal directly if you have any questions or would like to learn more about KemmelCal’s GRAS evaluation consulting services.
References:
Alvarez-Suarez, Jose Miguel, et al. "Contribution of honey in nutrition and human health: a review." Mediterranean Journal of Nutrition and Metabolism 3.1 (2010): 15-23.
EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), et al. "Safety of dried yellow mealworm (Tenebrio molitor larva) as a novel food pursuant to Regulation (EU) 2015/2283." EFSA Journal 19.1 (2021): e06343.
van Huis, Arnold. "Potential of insects as food and feed in assuring food security." Annual review of entomology 58 (2013): 563-583.