The Ministry of Health announces a public consultation to amend Article 518 of the Food Sanitary Regulations. The purpose of the proposed amendment is to stipulate that, for foods that have undergone fermentation and/or protein hydrolysis processes or that contain hydrolyzed ingredients, the limit for using the term “gluten-free” will be 10 ppm.

The health authority deems it necessary to amend Article 518 of the RSA, since gluten in hydrolyzed and fermented foods can only be quantified using the competitive ELISA method, which measures gluten at levels of 10 mg/kg or higher. This technique will not accurately determine gluten levels below 10 mg/kg with acceptable precision, and it will be impossible to meet the requirements set forth in the article. And if the sandwich ELISA technique were applied to these foods, small peptides would not be detected and the gluten content would be underestimated.

Article 518 of the RSA, since gluten in hydrolyzed foods as well as in fermented foods Fermented foods can only be quantified using the competitive ELISA method, but this method it quantifies gluten from 10 mg/kg. This technique will not determine gluten with acceptable accuracy gluten levels below 10 mg/kg cannot be accurately determined, and it will be impossible to meet the established requirements. in the article. And if the sandwich ELISA technique were applied to these foods, small peptides would not be detected and the gluten content would be underestimated. Small-sized peptides will not be detected, and the gluten content will be underestimated.

The Attorney General’s Office (AGU) ensured the enforcement of legislation mandating the labeling of processed food products sold in the country with “contains gluten” or “does not contain gluten.” It also confirmed the regulatory authority of the National Health Surveillance Agency (ANVISA in Portuguese) regarding such labeling.

A consumer association has filed a lawsuit against a food company, requesting that the packaging of processed food products include the message: “contains gluten: gluten is harmful to the health of individuals with celiac disease.” The lower court accepted this request.

Subsequently, the AGU, through the Federal Regional Attorney’s Office for the 3rd Region, representing Anvisa, appealed the ruling. The appeal emphasized that this decision overlooked health regulations and the specific technical and regulatory aspects of food labeling.

In its appeal, the AGU argued that if the association’s claim were accepted, the information on the packaging would be incomplete and could mislead consumers into believing that only individuals with celiac disease are intolerant to gluten.

According to information from ANVISA presented during the proceedings, gluten “is also harmful to consumers with other conditions, not just those with celiac disease.” Therefore, “current regulations require labels to indicate the presence or absence of this substance without additional specifications, while providing significantly more informative content,” states an excerpt from the agency’s technical communication.

Thus, the clear indication of gluten presence or absence on processed food labels, as mandated by Law No. 10,674 of 2003, is deemed sufficient to alert individuals with celiac disease about the risks associated with consuming gluten-containing foods.