EFSA Update. Seppo Salminen Func.onal Foods Forum Faculty of medicine University of Turku

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1 EFSA Update Seppo Salminen Func.onal Foods Forum Faculty of medicine University of Turku

2 Need for New Tools? Current probio.cs/prebio.cs are useful for several clinical condi.ons Health messages only to prebio.cs in EU For general healthy microbiota maintenance Member states discussing Novel food regula.on updated concerns new probio.cs

3 IN SEARCH OF NOVEL MODULATORS Examples: Clostridium butyricum* Bacteroides xylanisolvens* Akkermansia muciniphila Bacillus cereus Enterobacterium halleii Faecalibacterium prausnizii Fructophilic lac7c acid bacteria Butyricicoccus pullicaecorum

4 Novel food: Clostridium butyricum Probio7c from Japan History of safe use as a human probio7c Used in Europe for fa@ening chicken (feeds) Member states ques7oned safety Reasonable answers no more objec7ons No EFSA assessment: safe for human use Only novel food approval, health claim yet to be established?

5 Novel food: Clostridium butyricum

6 Bacteria assessed by EFSA/Commission Bacteroides xylanisolvens* Approved only with 1 hour pasteuriza@on of product No viable bacteria in product Clostridium butyricum Approved by member states (no EFSA assessment)

7 Qualified Presumption of Safety

8 Novel food: human milk oligosaccharides Human milk oligosaccharides Over 200 different structures Composi.ons vary between mother Can be produced using D- lactose

9 Novel food: Lacto-N-neotetraose Human milk oligosaccharide Tetrasaccharide naturally occurring in human breast milk Novel food is a synthe.c oligosaccharide produced 11 using D- lactose Ini.al Assessment by the Food Safety Authority of Ireland No safety concerns iden.fied Approved by EFSA

10 Novel food: Lacto-N-neotetraose and 2 -O-fucosyllactose Human milk oligosaccharides for supplements Toddlers 1-3 years lacto- N- neotetraose and 2'- O- fucosyllactose as novel food ingredients in food supplements for children Approved by EFSA 11

11 Novel food new guidance 11

12 Novel probiotics & prebiotics safety & health claims QPS Qualified of Safety Safety Novel & with health claims Health benefits claims Efficacy

13 Akkermansia muciniphila? Resides in the intes.nal mucus layer Uses mucus/mucin as substrate Viable Akkermansia muciniphila counteracts metabolic endotoxemia, diet- induced obesity, and devia.ons gut barrier func.on in diet- induced obese mice Safety studies available Human studies ongoing

14 Akkermansia muciniphila? Safety assessment model

15 Health Claims

16 Health claims where to go

17 Chicory inulin and stool frequency? Relevance to general population The Panel considers that maintenance of normal defeca7on by increasing stool frequency (provided that it does not result in diarrhoea) is a beneficial physiological effect. 6 per 8 human studies - > increase in stool frequency with the consump7on of na7ve chicory inulins or chicory inulin

18 Assessment Human interven7on studies = heterogeneous regarding the dose of chicory inulin used the form in which was administered (powder in sachets, in bakery products, breakfast cereals, chocolate drinks), the dura7on of the interven7on (from one to four weeks), the sample size (4 to 44 subjects), the type of subjects recruited (healthy volunteers, subjects with cons7pa7ons), the age of par7cipants (23 to 76 years) the study seangs (free- living individuals, hospitalised subjects, subjects in a metabolic room).

19 Assessment The Panel considers that these studies provide evidence for an increase in stool frequency with the consump7on of na7ve chicory inulin at doses of 12g/day.

20 Assessment Microbiota Studies Genome Med May 10;8(1):52.

21 Assessment Medical Devises Ar7cle 1 The group of products whose principal intended ac7on, depending on proanthocyanidins (PAC) present in cranberry (Vaccinium Macrocarpon) extract, is to prevent or treat cys77s, are not medical devices in the meaning of Ar7cle 1 (2) (a) of Council Direc7ve 93/42/ EEC of 14 June 1993 concerning medical devices, Ar7cle 2 This Decision shall enter into force on the twen7eth day following that of its publica7on in the Official Journal of the European Union. Ar7cle 3 This Decision is addressed to the Member States.