The I talian approach to probiotics Bruno Scarpa Head of the - PowerPoint PPT Presentation

Prom oting com petitiveness for European SMEs Enabling I nnovation in Food/ Food supplem ents The I talian approach to probiotics Bruno Scarpa Head of the office of special foods, food supplem ents and novel foods Ministry of Health, I taly Brussels, Novem ber 7 , 2 0 1 7 1

GUI DELI NES ON PROBI OTI CS AND PREBI OTI CS Ministry of Health w w w .salute.gov.it I ndication for use in food and food supplem ents of probiotic m icroorganism s traditionally used for intestinal m icroflora balance

GUI DELI NES ON PROBI OTI CS 1 .1 Characteristics of m icroorganism s that m ay used in food and in food supplem ents 1 .2 I dentification of specie and strain 1 .3 Am ount of m icroorganism s ( usually at least 1 0 9 live cells per day ) 1 .4 Safety of probiotics 1 .4 I ndication for use ( intestinal m icroflora balance )

PROBI OTI CS I N FOOD SUPPLEMENTS The use of lactic bacteria in I taly in food supplem ent started about 3 5 years ago Even before the directive 8 9 / 3 9 8 / EC, these products w ere classified as « dietetics» and authorised in order to be m arketed

OLDEST « PROBI OTI CS» USED I N FOOD SUPPLEMENTS I N I TALY ( 1 ) Saccharom yces cerevisiae or lactic acid bacteria such as Streptococcus therm ophilus and Lactobacillus bulgaricus

OLDEST « PROBI OTI CS» USED I N FOOD SUPPLEMENTS I N I TALY ( 2 ) Allow ed: indication of the favourable effect related to the equilibrium of intestinal bacterial m icroflora Presence of nutrients m inim um am ount ( m ostly group B vitam ins) of alive cells in order to justify their classification as dietetics because of the nutritional value

RATI ONALE OF ASSOCI ATI ON VI TAMI NS AND PROBI OTI CS The presence of vitam ins w as justified by the possibility of a dow nload of their synthesis due to the « unbalanced» intestinal m icroflora, for w hom these products w ere intended

DI RECTI VE 2 0 0 2 / 4 6 / EC ON FOOD SUPPLEMENTS Since 2 0 0 2 , products containing « probiotics» w ithout other nutrients in association can be legally m arketed as food supplem ents because of the FS definition as « concentrated sources» of nutrients or other substances w ith « physiological effect»

FOOD SUPPLEMENTS ROLE At national level the indication in the label of the nutritional or physiological effect attribuited to the food supplem ent has been alw ays considered as an appropriate and necessary w ay to help consum ers to m ake inform ed choices

PROBI OTI CS FOOD SUPPLEMENTS ROLE I n line w ith this approach since the 8 0 s product containing « probiotics» m icroorganism s m ay bear the indication: « Prom oting the balance of intestinal m icroflora » This effect w as supposed to be beneficial for the hum an health justifying per se the use of the term « probiotic»

EU COMMI SSI ON 1 4 Decem ber 2 0 0 7 GUI DANCE ON THE I MPLEMENTATI ON OF REGULATI ON N° 1 9 2 4 / 2 0 0 6 ON NUTRI TI ON AND HEALTH CLAI MS MADE ON FOODS CONCLUSI ONS OF THE STANDI NG COMMI TTEE ON THE FOOD CHAI N AND ANI MAL HEALTH

GUI DANCE ON THE I MPLEMENTATI ON OF REGULATI ON ( EC) 1 9 2 4 / 2 0 0 6 ON NUTRI TI ON AND HEALTH CLAI MS MADE ON FOODS ( 1 ) A claim is a nutrition claim if in the nam ing of the substance or category of substances, there is only factual inform ation Nutrition claim s exam ples Contains lycopene Contains lutein

GUI DANCE ON THE I MPLEMENTATI ON OF REGULATI ON ( EC) 1 9 2 4 / 2 0 0 6 ON NUTRI TI ON AND HEALTH CLAI MS MADE ON FOODS ( 2 ) A claim is a health claim if in the nam ing of the substance, or category of substances, there is a description or indication of a functionality or an im plied effect on health Health claim exam ples Contains antioxidants ( the function is an antioxidant effect) Contains probiotics/ prebiotics ( the reference to probiotic/ prebiotic im plies a health benefit)

EFSA AND PROBI OTI CS ( 1 ) « Prom oting the balance of intestinal m icroflora » I T I S NOT A HEALTH CLAI M EFSA opinion  I ncreasing the num ber of any groups of bacteria is not in itself considered as beneficial.  …no evidency has been provided that … enhanced levels of beneficial m icroflora are beneficial to hum an health.  … « support a balanced/ beneficially affect» … intestinal m icroflora in the context of decreasing potentially pathogenic intestinal m icroorganism m ight be beneficial to hum an health

EFSA AND PROBI OTI CS ( 2 ) Usually EFSA refers to the presence of lactic bacteria as « probiotics» presence I n a sim ilar w ay EFSA refers to the vitam ins presence The term « PROBI OTI CS» is just a synonim ous of lactic bacteria. I t cannot be considered different from « VI TAMI NEs»

USE OF THE TERM PROBI OTI CS W hat is the best solution in the current regulatory fram ew ork ?

PROBI OTI CS AND CLAI MS REGULATI ON Article 1.4 Generic descriptor ? (denominations) which have traditionally been used to indicate a particularity of a class of foods or beverages which could imply an effect on human health …

CONTAI NS: HEALTH OR NUTRI TI ON CLAI MS ? “CONTAI NS… ” To be honest… any tim e a particular substance is underlined in the labelling preceded by the term “CONTAI NS” the consum er perceives it as a possible benefit, also if the substance doesn’t have an authorized health claim ? ? I s it thinkable to lim it the “CONTAI NS” to substances w ith authorized health claim s?

“ CONTAI NS PROBI OTI CS ”: THE BEST SOLUTI ON Nutrition claim