The document followed on from the stakeholders’ meeting on the subject in Amsterdam last December, as well as 170+ pages of comments from stakeholders in the convening period, but has garnered a lukewarm response.
“The document, to my opinion, does not make any substantial progress at all despite the very active debates at the December meeting,” a spokesperson for a leading probiotic company told NutraIngredients.com.
She said the guidance ducked questions raised in Amsterdam and in the consultation period about matters such as which kinds of questionnaires were suitable for validation of stool consistency and common colds.
A typical common cold questionnaire used in clinical trials (WURSS-21) had been confirmed as valid at the Amsterdam meeting but it had not appeared in the guidance.
She noted another potential biomarker, secretory IgA, had been recognised in a previous article 14 opinion as having a potentially, “beneficial physiological effect in the context of reducing the risk of influenza and common cold” but it too was absent from the guidance in relation to colds and flus, although another biomarker, IgE, is mentioned for certain allergies.
In the guidance, EFSA acknowledges that, “It is not intended that the document should include an exhaustive list of beneficial effects and studies/outcome measures which are acceptable. Rather, it presents examples drawn from evaluations already carried out to illustrate the approach of the Panel, as well as some examples which are currently under consideration within ongoing evaluations.”
But Ger Rijkers, PhD, from the University Medical Center in Utrecht, in the Netherlands, said the case-by-case approach being adopted by EFSA was not working.
“Scientists as well as industry have asked and asked again for a (detailed) list of acceptable outcome measures,” he said. “’ Examples drawn from evaluations’” are not very useful in case of probiotics because all evaluations have been negative.”