Celiac disease is an autoimmune disease where the consumption of gluten triggers an immune response targeting and damaging the small intestine in predisposed individuals. It is estimated that celiac disease affects 1 in 100 people worldwide (Celiac Disease Foundation). The damage caused by the production of antibodies attacking the small intestine limits individuals ability to absorb nutrients which can lead to other serious health problems.
The US Food & Drug Administration (FDA) issued a rule defining the term “gluten-free” which food manufacturers can voluntarily use in labelling their foods. The term gluten-free refers to foods that do not contain an ingredient that results in the presence of 20 parts per million (ppm) or more, of gluten in the food. This regulation applies to packaged foods, including digestive aids, distilled, fermented, and hydrolysed foods. In 2020, the FDA issued a final rule on gluten-free labelling for foods that are fermented or hydrolysed, or that contain fermented or hydrolysed ingredients. Questions were raised where enzymes produced via fermentation would be included in this ruling, as certain fermentation methods for producing enzymes use growth media that contains gluten. Because gluten proteins in hydrolysed and fermented foods are no longer intact and, currently, cannot be adequately detected and quantified through testing, enzymes fall under the scope of the regulation. This meant that where enzymes are used in the manufacture of food ingredients, if the manufacturer wished to label their final food product as gluten-free the enzyme must also comply with the FDA ruling. For an enzyme to comply to the FDA ruling, this means that any of the fermentation inputs used in the enzyme production must be gluten-free, or have lower than 20 ppm of gluten present, prior to fermentation of the enzyme.
As a processing aid, enzymes carry out a reaction to modify a food ingredient but have no function in the end product. Enzymes can deliver such a range of enhancements to food ingredients that it is highly likely that many prepared food products are produced using an ingredient that has been modified using an enzyme as a processing aid.
nearly all commercially prepared foods contain at least one ingredient that has been made with enzymes
With enzymes being so widely used in the food industry, and understanding the importance of labelling for our customers, Biocatalysts Ltd set out to produce a range of customised enzymes that would comply with the FDA gluten-free ruling criteria to continue to ensure our customers can manufacture their food products with the benefit of being able to label their final product as gluten-free.
For a list of Biocatalysts’ enzyme products that comply with the FDA gluten-free ruling, click below, or if you are currently looking to replace an enzyme product that contains, or is manufactured using a fermentation input containing 20ppm or more gluten and want to be able to label your final food product as gluten-free reach out to our team below to discuss your needs and we can work together to find a solution for your product.