A total of 50 strains are now considered not novel and do not require formal pre-market Novel Food authorization, due to the strains having a history of consumption in the EU prior to May 15, 1997.
Updated on Dec. 17, the list provides regulatory clarity and simplified market access for manufacturers and distributors in Europe.
Companies already using these strains can confidently market products across the EU and new entrants can leverage these strains for innovation without regulatory delays, according to Jerome Le Bloch, head of scientific department at Nutraveris.
He pointed out several of the strains were already well established and previously recognized as non-novel, including Lactobacillus fermentum, Lactobacillus johnsonii, Lactobacillus reuteri, and Bacillus clausii, one of the most studied probiotics of the past two years.
To cover just a few of their reported benefits, L.fermentum has been linked to cognitive performance and reduce cold symptoms, L. reuteri has been linked to oral health and gut insulin metabolism, while Lactobacillus johnsonii has been found to support skin health.
The update also assigns an official non-novel status to species that previously had no formal designation, including Kluyveromycesmarxianus, Enterococcusfaecalis, Rhizopusoryzae, Hafniaalvei, and Corynebacteriumflavescens, Le Bloch noted.
Luca Bucchini, European regulation expert and managing director at Hylobates Consulting Srl, told NutraIngredients the increased inclusion of bacterial strains within this register will put more emphasis on the relevance and importance of Novel Food status within the probiotics category.
“Up to a few years ago, there was little interest in applying novel food legislation to bacteria used in food or food supplements. Indeed, although novel food legislation in theory applied, a novel food assessment was requested only in specific cases, and Member States were satisfied with their own assessment of safety or relied on EFSA’s list of micro-organisms with QPS (Qualified Presumption of Safety).”
Bucchini said the update was needed as people started to question the novel food status of probiotics used in supplements.
“Every time a new species is listed as not novel in the catalogue there is a sigh of relief for the species itself, but also more questions arise about what is not listed and why.”
He further noted that some species have been assigned the “not novel in food supplement” status, meaning that such species, unless new evidence is provided, cannot be used in foods.
For the complete list and specific conditions of use, businesses and stakeholders should consult the official EU Novel Food Status Catalogue.
Newly listed not novel strains
The bacterial species updated with a not novel status, categorized by their permissible use.
Not novel in food:
• Acetobacter aceti• Arthrobacter globiformis • Bifidobacterium pseudolongum • Bifidobacterium thermophilum• Brevibacterium casei• Carnobacterium divergens • Carnobacterium maltaromaticum • Carnobacterium piscicola• Corynebacterium flavescens• Fructilactobacillus lindneri • Hafnia alvei• Kocuria varians • Lactobacillus fermentum• Lactobacillus johnsonii• Lactobacillus lindneri• Leuconostoc citreum • Leuconostoc pseudomesenteroides• Ligilactobacillus salivarius • Limosilactobacillus fermentum • Limosilactobacillus reuteri • Oenococcus oeni • Propionibacterium acidipropionici • Staphylococcus warneri• Streptomyces griseus
Not novel in food supplements:
• Bacillus clausii• Bacillus subtilis subsp. natto• Enterococcus faecalis• Escherichia coli strain Nissle 1917 (DSM 6601)• Lactobacillus gasseri• Lactobacillus reuteri• Lactobacillus salivarius• Streptococcus oralis• Streptococcus rattus • Streptococcus uberis
