IPA Europe believes that this public consultation is a great opportunity for EFSA and the NDA Panel to clarify many aspects of health claim substantiation in the territory of gut and immune function within which Probiotics fall.
The objective of such a guidance being to improve dossier submissions and guide research targeted to substantiate claims. Toward this end and after a preliminary reading of this second draft, IPA Europe is happy to notice that various of the comments submitted by Probiotic sector have been considered and this new draft clarifies several important points (e.g. criteria for judging validity of questionnaires, characterisation of the food constituent, acceptance of changes in outcome variable(s) measured in vivo in humans as health claims under particular conditions...).
IPA Europe however regrets that uncertainties remain, such as regarding study populations that are acceptable to substantiate a health claim on food.
We would also have expected EFSA to recognize the new possible beneficial effects and/or outcome measures that could be acceptable beyond those evaluated so far or stipulated in the 2011 guidance.
IPA Europe will carefully review and consolidate comments from its members and submit further detailed contribution by 23 March 2015 to this new opportunity.