U.S – The timeline given by the U.S. Food and Drug Administration (FDA) for manufacturers to establish compliance requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and bear the “gluten-free” claim is finally past.

The authority drew up the Final Rule on gluten-free labelling of fermented and hydrolyzed foods on August 13, 2020 and set the compliance deadline to August 13, 2021.

In both fermented and hydrolyzed foods, protein strands have been broken down into smaller strands or individual amino acids. The rule is designed to protect individuals with celiac disease — a hereditary, chronic inflammatory disorder of the small intestine — who are advised to avoid all sources of gluten in their diet to protect against adverse health effects associated with consumption of gluten for those with the disease.

The final rule, titled “Gluten-Free Labeling of Fermented or Hydrolyzed Foods,” pertains to foods such as yogurt, sauerkraut, pickles, cheese, green olives, vinegar, beers, wine and hydrolyzed plant proteins used to improve flavor or texture in processed foods such as soups, sauces, and seasonings. Distilled foods, such as distilled vinegars, are also discussed in the final rule.

The final rule does not change the definition of “gluten-free” established in 2013, but only adds compliance requirements for hydrolyzed or fermented foods and compliance information for distilled foods.

Currently available test methods cannot reliably detect and quantify gluten in fermented or hydrolyzed foods because gluten proteins are no longer intact as a result of these processes. Thus, the final rule provides alternative means for the agency to verify compliance with the requirements for fermented or hydrolyzed foods labeled “gluten-free” based on records that are made and kept by the manufacturer.

“Once we identify that a scientifically valid method has been developed that can accurately detect and quantify gluten in fermented or hydrolyzed foods or ingredients, it would no longer be necessary for the manufacturer of foods bearing the “gluten-free” claim to make and keep these records,” the FDA informed.

It also requires the manufacturer of these kinds of foods bearing the “gluten-free” claim to document that it has adequately evaluated the potential for gluten cross-contact and, if identified, that the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process.

Further, the rule gives FDA the mandate to use scientifically valid analytical methods to verify the absence of gluten in distilled foods, as appropriate.