Digestive- and Immune-Health Scientists Start Petition to Protest EU Health Claims Process

Scientists in the digestive- and immune-health sector have initiated a new petition, protesting what they say is an “illogical” process of approving health claims in the European Union. This moves stems largely from the widespread negative opinions the European Food Safety Authority (EFSA) has so far delivered, across the board, to proposed health claims involving probiotics benefits to digestive and immune health.

The petition is asking for the signatures of digestive-health scientists. On the website, a letter signed by three EU scientists (Ger T. Rijkers from The Netherlands, Stephan Bischoff of Germany, and Bruno Pot of France) describes the need for petitioners to get involved:

To Whom It Concerns:

"It may not always make scientific sense but that is what is in the regulation and that is what we must follow," professor Albert Flynn, chairman of the NDA panel of EFSA said on December 2nd 2010 during the summing up of a workshop on the scientific requirements for health claims of probiotics related to gut and immune function. Probiotics (and prebiotics for that matter) aim at improving health and preventing disease of the consumer. In that context, the WHO has asked, in 2001, the scientific community to do more research in the field of probiotics because probiotics were expected to contribute positively to several health issues. The FAO made a similar appeal for prebiotics in 2007. Since then research has developed rapidly and since 2002 more than 5700 papers have been published on the (beneficial) effects of probiotics. As a consequence awareness of probiotic efficacy and mechanisms has increased tremendously, both in the public and in the scientific and medical community, and, most logically, applications for selected, well-documented strains have been proposed.

In order to bridge probiotic research and marketing, many health claim applications for pro- and prebiotics have been submitted over the last 2 years for approval by EFSA. Thus far, however, all these applications have resulted in negative opinions from the NDA panel of EFSA.

During the above mentioned workshop, the NDA panel and industry stakeholders exchanged ideas on the Guidelines for assessment of health claims on pre- and probiotics. While the discussion was open, the outcome, from a scientific perspective, was very limited. We, as scientists appreciate the wish of industry stakeholders to get detailed guidance from EFSA on health claim applications, including the possibility of pre-submission advice. This will help them and us at the scientific community, to structure and plan even better the necessary applied and fundamental research for claim substantiation and guarantee a continued long-term development and improvement of the research efforts in this field. Europe has developed a very strong leadership in this field and we all hope to continue to do so in the future.

If, because of regulatory issues, the design and execution of fundamental and clinical research into the beneficial effects of pre- and probiotics would need additional requirements, the corresponding  guidelines for those regulatory issues should be made very clear. The statement made during the workshop by the NDA panel that "this (i.e. the health claims assessment procedure) is a learning process for all of us" does not do justice to the hundreds of top quality research papers related to health benefits of probiotics. In that context, the Regulation (EC) No 1924/2006 states that health claims can only be authorized after a scientific assessment of the highest possible standard. For the evaluation of peer-reviewed published research papers which were the basis of rejected health claim dossiers, it would be helpful, if not crucial, to know which standards were and will be used in the evaluation. If future research would be limited to those aspects that are considered by the current Regulation, we fear that a substantial number of promising health applications, using well-documented pre- and probiotic products, will not even be considered for proper assessment.

Although we all encourage the use of the most strict scientific standards for judging health claims, there is a general feeling that when food is concerned, other criteria than strictly pharmaceutical should be used and that in the benefit of the consumer and general public health, it is important that healthy food products can easily be discriminated from those that are not generally regarded as ‘healthy’ , even may be harmful on a longer term.

One of the major obstacles is the regulatory ban on clinical endpoints, such as diarrhoea, e.g. in case of studies on prevention of traveller’s diarrhoea, and the requirement of validated biomarkers and risk reduction factors. Regulatory issues thus would form an obstacle for research aimed at substantiation of the beneficial effects of pre- and probiotics. The Regulation has been set up, amongst other reasons, to protect the consumer, an aim we couldn’t agree more with. As we have indicated above, the rigidity of the regulation may withhold the consumer products with benefits that could provide health advantages. Therefore we believe that for pre- and probiotics, we need an amendment within the regulation to bring these points back within the scope that can and will be considered by EFSA through a broader mandate. The availability of crystal clear guidelines will not only facilitate the design of research flows, it will also allow to make claim evaluation much more consistent, transparent and efficient. This in the benefit of all stackeholders, the producers, the scientific community involved, the EFSA committees involved and, above all, the European consumer. We all agree, however, that in the end, any regulation, but certainly a Health Claim Regulation on pro- and prebiotics, as well as other food products, MUST make scientific sense.

We hope that politics will pay attention to these matters and ask the commission and DG Sanco to take appropriate measures.

Ger T. Rijkers, Utrecht and Nijmegen, The Netherlands
Stephan Bischoff, Stuttgart, Germany
Bruno Pot, Lille, France

View the petition here