In an 8-page Q&A document published recently in regard to article 13.5 (proprietary and emerging science) and article 14 (children’s and disease reduction claims), EFSA briefly details what it considers important for probiotic strain characterisation.
“For microorganisms (e.g. bacteria, yeast), as well as species identification, there should be sufficient characterisation (genetic typing) at strain level by internationally accepted molecular methods and strains should be named according to the International Code of Nomenclature,” EFSA writes.
“Although not required for substantiation of a claim, it is in the interests of the applicant that strains are deposited in an internationally recognized culture collection (with access number) for control purposes. For manufacturing processes, information should be provided to show consistency in the final product for those characteristics considered pertinent to the claimed effect.”
EFSA’s advice was published the day before its Panel on Dietetic Products, Nutrition and Allergies (NDA) recently rejected 171 of 181 generic article 13.1 probiotic dossiers, including some relating to strains developed by some the world’s biggest probiotic suppliers.
A spokesperson for one major supplier said she hadn’t seen EFSA’s guidance and had no comment to make about the fact some of its strains had been rejected in the batch of 523 opinions published on October 1.
The Q&A
The Q&A affirmed EFSA’s preference for human studies.“While studies in animals or in vitro may provide supportive evidence, human data are central for the substantiation of the claim,” it said.
“There is no pre-established formula as to how many or what type of studies are needed to substantiate a claim. However, the NDA panel considers what the accepted norms are in the relevant research fields and EFSA consults experts from various disciplines, as appropriate.”
In regard to characterization, it added that, “characterisation should also be sufficient to allow control authorities to verify that the food/constituent which bears a claim is the same one that was the subject of a community authorisation.”
EFSA emphasised that claims needed to be “sufficiently defined” which may result in several claims being submitted for one nutrient or product.
“The claimed effect needs to be specific enough to be testable and measurable by generally accepted methods. For example, ‘gut health’ is too general (unclear what measure can be used) but ‘transit time’ is specific (measurable by generally accepted methods).”
EFSA said it was being more communicative with applicants.
“Specifically, EFSA intends to use the ‘stop the clock’ procedure to request, when the NDA experts consider appropriate, supplementary information from applicants related to the definition of the claim, e.g. the proposed food/constituent, the claimed effect, risk factors for disease, and conditions of use,” it said.
“Up to now these issues were addressed with applicants only before the application was accepted by EFSA and before evaluation started.”
The Q&A can be found here.