EU approves new probiotic strain as novel food / by Sebastian MELCHOR

The EU has recently authorized the marketing of heat-treated milk products fermented with probiotic strain Bacteroides xylanisolvens (DSM 23964), in what constitutes another probiotic approval as a novel food in the EU after Clostridium butyricum (CBM 588) was authorized last December 2014.

Whilst there is no positive list of individual strains which enjoy a probiotic status at EU level, EFSA  has adopted a “Qualified Presumption of Safety” concept which provides a generic assessment system for use within EFSA that, in principle, can be applied to all requests received for the safety assessments of microorganisms deliberately introduced into the food chain. QPS status informs on the safety of a microorganism and is used without prejudice to any other legal requirements. Therefore, the species granted with QPS status (e.g. L. acidophilus, L. brevis, L. casei, L. helveticus, L. plantarum, L. reuteri, L. rhamnosus, etc.) have been granted a presumption of safety[1].

According to the EU specifications, heat-treated fermented milk products are produced with Bacteroides xylanisolvens (DSM 23964) as starter culture. The description is “semi-skimmed milk (between 1,5 % and 1,8 % fat) or skimmed milk (0,5 % fat or less) is pasteurised or ultra-heat-treated before starting the fermentation with Bacteroides xylanisolvens (DSM 23964). The resulting fermented milk product is homogenised and then heat-treated to inactivate Bacteroides xylanisolvens”.

Some Member States have adopted positive lists of probiotics[2] and others have laid down certain conditions for naming specific strains as such[3].

There is no EU-wide definition of the terms “probiotic bacteria” or “probiotics”, nor has their use in food been regulated under EU regulations.

Ban on the use of “probiotics” still in place  

The use of the term “probiotics” for foods is currently subject to a de facto ban in the EU. The ban has its origin in the qualification of the term as a health claim in the Commission Guidance on Nutrition and Health Claims of December 14, 2007 as it is argued that the naming of this category of substances contains an implied health benefit. The ban has been severely criticized for the lack of a sound legal basis, and has had significant implications for the probiotic industry. In addition, it has been stated  the ban jeopardizes the right of consumers to access the necessary information to make choices in full knowledge of facts, by restricting the provision of information about the true nature of foods containing probiotics.

 - COMMISSION IMPLEMENTING DECISION (EU) 2015/1291 of 23 July 2015 authorising the placing on the market of heat-treated milk products fermented with Bacteroides xylanisolvens (DSM 23964) as a novel food under Regulation (EC) No 258/97 of the European Parliament and of the Council

[1]       Opinion of the Scientific Committee on a request from EFSA on the introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA. The EFSA Journal (2007) 587, 1-16.

[2]          See, inter alia, the publication of the Belgian Superior Health Council No. 8651: Probiotics and their implications for Belgian public health. Part 1: Microbiological characterization, of February 1, 2012.

[3]       See Italian Ministry of Health’s Guidelines on Probiotics (Linee guida sui probiotici, Ministero della Salute, Dipartimento Sanita Pubblica Veterinaria, Sicurezza alimentare e degli organi collegiali I direzione generale igiene e sicurezza degli alimenti e della nutrizione ufficio IV; Commissione unica per la dietetica e la nutrizione; Revisione 2011).