The letter criticises EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) for failing to address points of concern Danone raised during three separate stop-the-clock procedures and says the NDA found trial faults including blinding procedures that had passed peer review procedures.
“We believe our comments can be an opportunity for risk assessors (EFSA) and risk managers (Commission and Member States) to clarify their respective positions,” wrote Danone Dairy vice president of research and development, Frederic René, and Pierre-Hubert Cuijpers, the division’s general counsel in food law, in their letter to Basil Mathioudakis, the EC’s unit head in Food Law, Nutrition and Labelling.
Key points raised in Danone’s letter include:
- demand to see Assessment Methodology Unit (AMU) reports that are designed to guarantee transparency in the process
- demand to see minority opinions that may have existed among some NDA panel members as mandated in article 38(1)(B) of EU regulation 178/2002
- stop-the-clock not used by EFSA to air genuine concerns
- inconsistent application of requirement to demonstrate “mechanisms of action”
In regard to minority opinions Danone said it understood, “that the opinions are adopted in quorum and by a majority of the NDA Panel members. However, in the published opinion, it remains unclear whether there are or not members of the Panel who had different minority opinions.”
“Danone would like to know how the opinions of the members of the AMU are considered at this stage in light of [article 38(1)(B) of EU regulation 178/2002].”
Danone said it was “deplorable” that the NDA Panel had not raised issues it published in its final opinion at the stop-the-clock phase as Danone, “believed it could have brought the appropriate answers to the Panel”.
Mechanisms of action
The French dairy player said the requirement to demonstrate mechanisms of action, something which is only just emerging in probiotic science, had not been required in positive opinions for some vitamins and minerals.
More generally it said there was a necessity for, “regular open dialogue between applicants and EFSA” so applicants could better, “understand EFSA’s expectations and specific aspects of their health claim dossiers”.
The maker of Actimel and Activia challenged why the Panel:
- was not clear about whether the reduction of C. Difficile toxins was beneficial or not
- took issue with transparent blinding measures the British Medical Journal did not and which were not raised in stop-the-clock exchanges
- dismissed toxin assessment procedures as weakening the central trial in the dossier
- deemed weak a chosen data imputation scenario for the same trial
- dismissed supporting data on bioavailability and probiotic properties because it did not demonstrate effects on C. Difficile or effects in humans when it was intended and marked as ‘supporting data’ only
Danone had proposed the claim wording: “Fermented milk containing the probiotic Lactobacillus casei DN-114001 and yogurt symbiosis decreases presence of Clostridium difficile toxins in the gut (of susceptible ageing people). Presence of Clostridium difficile toxins is associated with the incidence of acute diarrhoea.”