The European Food Safety Authority (EFSA) has published a scientific opinion on a novel amidase food enzyme that reduces acrylamide in coffee extracts used to manufacture instant coffee and coffee substitutes.

The risk assessment was conducted as part of the novel food approval process for Acrylerase, submitted by the applicant Kerry Group. EFSA found no safety concerns with Acrylerase.

The opinion comes at a time of increased EU focus on acrylamide in coffee products. Acrylamide is a process-related contaminant formed naturally during high-temperature processing such as roasting, and it is a substance of growing concern due to its genotoxic and carcinogenic properties. Under Regulation (EU) 2017/2158, food business operators are required to apply mitigation measures in line with the “As Low As Reasonably Achievable” (ALARA) principle and monitor acrylamide levels against benchmark values.

According to Kerry Group, Acrylerase is the first commercially available food enzyme designed to directly decompose acrylamide after it has formed, rather than reducing its formation indirectly through process modifications. It can reportedly achieve up to a 90 percent reduction in acrylamide levels without affecting organoleptic properties or yield.

EFSA’s new opinion represents the first scientific assessment of an amidase for hydrolyzing acrylamide in coffee extracts and coffee substitutes.

EFSA Finds No Food Safety Concerns with Acrylerase

EFSA’s scientific opinion confirms the safety of Acrylerase for its intended use in coffee extracts for instant coffee and coffee substitutes.

The enzyme is produced using the genetically modified Escherichia coli strain SP-a by c-LEcta GmbH. EFSA did not find safety concerns with the genetic modifications, as the enzyme was considered free from viable cells of the production organism and its DNA.

Dietary exposure to Acrylerase was estimated to be up to 0.478 milligrams (mg) total organic solids (TOS) per kilogram (kg) of body weight (BW) per day in European populations.

Toxicity studies were carried out with a trehalose phosphorylase, produced by E. coli strain PK-a, as a surrogate subject for toxicological studies. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. EFSA identified a no observed adverse effect level (NOAEL) of 1,149 mg TOS/kg BW per day, the highest dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 2,404.

The enzyme’s amino acid sequence was compared to known allergens and no match was found. Therefore, EFSA considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that the likelihood is low.