Probiotics industry bodies have delivered a withering verdict on a technical workshop staged by the European Food Safety Authority (EFSA) to discuss gut health and immunity claims submitted under the EU’s Nutrition & Health Claims Regulation.
Four groups – the International Probiotics Association, the Yoghurt & Live Fermented Milks Association, the European Food & Feed Cultures Association and the Lactic Acid Bacteria Industrial Platform – issued a joint-statement in the wake of the meeting, which was held amid growing concern that to-date EFSA’s NDA panel has approved no claims for probiotic ingredients.
The bodies welcomed the workshop as “an opportunity to explore various solutions” but added that EFSA “did not totally meet the expectations of the participants.”
“Many procedural and scientific aspects remained unanswered,” they said. “In addition, the workshop revealed numerous discrepancies in the way the scientific community and the panel are evaluating evidence.
“There still remains considerable uncertainty regarding the level of scientific substantiation required and the method for applicants to deal with claims in emerging science. Further clarifications are needed on very basic elements such as, among others, recognized risk factors and beneficial physiological effects, ranking of different immune parameters, best study models and target populations to be used for claim substantiation for food and food supplements.
“The impact of EFSA’s negative opinions is deeply disconcerting for the industry, both in terms of the time and money invested in clinical trials, but also in terms of the damage to the industry’s credibility and the impact on public opinion. Therefore, we plead to the European Commission to understand that an improvement of the functioning of the claims approval process is necessary.”
The groups also joined calls for the European Food Safety Authority to hold ‘pre-submission meetings’ for companies applying for health claims.
“Increasing dialogue and clarity by establishing pre‐consultation meetings would be mutually beneficial to both EFSA and the applicants,” they argued. “Such consultations would not only benefit the quality of future applications but may also improve the efficiency of the process. Moreover, these consultations could – in the long run – lower the cost to EFSA, as the majority of the applications would improve and be properly presented and structured.”
However, there is no sign that such meetings will take place in the foreseeable future. At its management board meeting on December 16, EFSA set its budget for 2011 and confirmed there were no funds to pay for the resources necessary to hold pre-submission meetings.