The final ruling recently issued by the FDA on “Gluten Free” claims for fermented and hydrolyzed foods has restricted the choice of enzymes that can meet this claim. As a result of this regulation change companies are being forced to search for alternatives for enzymes used for decades for specific applications such as flavor production.
The FDA decision mandates that any ingredient, regardless of how far back in the production chain, must meet the definition of “Gluten Free.” This means that even if the use of that ingredient would result in a possible exposure in the parts per billion level (which is below the threshold for a product to be considered gluten-free), the final consumer product could not claim to be “gluten-free.” The FDA is the only global regulatory body that is pursuing this topic, other countries including the EU and Japan accept the use of wheat and other allergens in the fermentation media.
Many of the enzymes affected by this regulation change are produced from koji style fermentation on wheat bran, where the intact wheat protein is consumed during the fermentation process. ELISA testing proves that there is no intact gluten in the purified enzyme. The enzyme is separated from the remaining biomass and purified through various filtration and size exclusion processes. Currently, no validated analytical method exists to prove that similar size proteins are not residual peptides from wheat. As there is no method to confirm the absence of gluten peptides, the FDA mandates the assumption of their presence, adopting a zero-risk approach. As a result of change, no enzyme produced by surface culture method on wheat bran can be considered “gluten-free”.
One of EDC’s most popular fungal proteases for the flavor modification and enzyme modified cheese, EMC, industry is our ENZECO® Fungal Protease 400. It does not meet the FDA standard for use in products that are marketed as “gluten-free” product, necessitating rapid development of an alternative product.
To assist companies in finding alternative proteases to meet the new gluten-free claim requirements, EDC is now offering ENZECO® Protease 400 WF. This is a wheat free version achieving equivalent to superior cheese flavors. It is suggested to be evaluated at a 1:1 replacement for the regular Protease 400. WF replacement dosages vary based on the products formulation, ranging from 1:1 to about +/-35% of the original dosage.
Enzymes for use in gluten free consumer products are not limited to just the Enzeco Protease 400 WF. Our extensive enzyme catalogue includes options meeting gluten-free requirements, such as Papain, Ficin, Bromelain, bacterial proteases, Esterases, and Lipases. Please contact your EDC representative to discuss options that will work for your products and request samples at info@EnzymeDevelopment.com