Why is there a 20 ppm limit for gluten-free products?

The 20 ppm (parts per million) limit for gluten-free products is crucial to ensure the safety of people with celiac disease. Let me explain why this threshold was established.

In Europe, the current regulations for “gluten-free” products are governed by European Regulation (EU) No. 828/2014. This regulation, published in 2014 and in force since 2016, states that foods labeled as “gluten-free” must contain less than 20 mg/kg (20 ppm) of gluten in the final product.

The reason behind this limit is based on scientific research. In 2007, Dr. Carlo Catassi conducted a study entitled “Prospective, double-blind, placebo-controlled trial to establish a safe gluten threshold for patients with celiac disease.” The objective was to determine the maximum amount of gluten that a person with celiac disease can ingest without triggering an immune response. The experiment involved 49 adults with celiac disease, divided into three groups. Each group was given a different amount of gluten daily: 10 mg, 50 mg or placebo (no gluten). The results showed significant variability in the patients’ response to gluten. However, it was concluded that 50 mg of gluten per day is the minimum dose required to damage the intestine of the patients.

Since people with celiac disease may consume several products labeled “gluten-free” in a single day, the safe threshold of 20 ppm was established. This is equivalent to 20 mg of gluten per kilogram of product. Although the study has limitations due to the small number of participants and the duration of the experiment, further studies cannot be conducted with risk to the health of celiac patients.

In summary, the 20 ppm limit ensures that “gluten-free” products are safe for people with celiac disease, allowing them to enjoy a risk-free diet. And at Adpan we comply with the regulation and all our products contain even less than 20 ppm, thus guaranteeing safe consumption for coeliacs.