EFSA to Interact Further with Health Claims Applicants

EFSA has decided to further develop procedures for communication with applicants while claims are being evaluated including greater use of the “stop the clock” procedure when NDA experts consider it necessary to request additional information regarding an application.

17/06/09 Experts from EFSA’s Panel on Dietetic products, nutrition and allergies (NDA) met health claims applicants and industry experts in Brussels on 15 June for an exchange of views on the presentation of applications for health claim authorisations.

The meeting was an opportunity to further explain the claims evaluation process to applicants and provide additional guidance in the light of experiences gained so far with the assessment of claim applications related to Article 14 and 13(5) claims of the Regulation on nutrition and health claims.

Professor Albert Flynn, Chair of EFSA’s NDA Panel said: “This has been a very successful public consultation on EFSA’s evaluation of health claims. Our discussions with industry on guidance and new communications procedures will help applicants for the authorisation of claims and will also benefit the overall efficiency of EFSA’s evaluation process.”

EFSA has decided to further develop procedures for communication with applicants while claims are being evaluated including greater use of the “stop the clock” procedure when NDA experts consider it necessary to request additional information regarding an application. This will help ensure that there is a shared, mutual understanding between the panel and the applicant of the claim to be evaluated prior to adoption of the final opinion. The NDA Panel may request supplementary information from applicants to clarify in particular the object of the claim (e.g. whether it relates to a component of the foodstuff or the product itself) or the claimed health relationship.

Up to now, these issues would be addressed with applicants only before the application was accepted by EFSA and before evaluation started. Experience has shown that some of these questions only become apparent during the assessment of the application and this can have a significant bearing on the evaluation.

Participants discussed various aspects of the process such as how the Panel decides whether a claim is substantiated and how the evidence is weighted, what are the data requirements and pertinent studies to be included, and on what basis EFSA proposes for the wordings of claims. EFSA will review and seek to improve transparency of the opinions with respect to these aspects.

Before the meeting, EFSA published on its website a document, in the form of Frequently Asked Questions (FAQ), highlighting the areas needing further clarification. Participants were asked to comment on the document ahead of the meeting. The NDA Panel will take into account comments received through this consultation, and those expressed during the meeting, with a view to finalising an FAQ document to complement the guidance document. This is a living document which will be updated regularly in the light of experience gained.

EFSA aims to publish the revised version of the FAQ, an overview of comments received during the consultation and a report of the technical meeting on its website in the autumn.

Earlier this month responding to a presentation by the renowned Max Planck Institute on the stifling of innovation, patient representatives, food industries, politicians and regulatory experts agreed that a "period of reflection" – a time-out – of the current implementation of the European Health Claims legislation is urgently needed. Stakeholders from various different societal angles convened in Brussels on 2nd of June and agreed that the innovation element of (EC) Regulation 1924/2006 on nutrition and health claims does not function.

Furthermore, the stakeholders present called for an urgent economic and regulatory impact assessment to be undertaken as well as the introduction of a Gold, Silver and Bronze grading for the supporting science. It should be avoided that in July 2009 promising products are forced from the market whilst less effective products stay in, pending their EFSA evaluation at a later date.

The event, chaired by Members of European Parliament Jules Maaten and Karin Riis-Jorgensen, focused on a presentation by Dr. Ivan Baines of the German Max Planck Institute, who demonstrated that there is a considerable risk of further technology and R&D investment outflow from Europe comparable to recent negative trends of the pharmaceutical sector. According to Dr. Baines, "the regulation in its current form is acting as a deterrent of food R&D in Europe. This may pre-empt the development of important nutraceuticals as well as closing the door on European competitiveness in nutrition, wellness and health".

Commenting on Dr. Baines' presentation, representatives from Danisco and Sudzucker voiced concerns that the current implementation is unclear and unpredictable. Also, the staggering of the publication of EFSA health claim opinions would lead to an unfair level-playing field. Nigel Baldwin, regulatory consultant at CANTOX, confirmed that these are industry-wide concerns which are particularly true for Small and Medium-sized Enterprises (SMEs).

Another concern with the implementation of the health claims legislation is the lack of a proper and complete economic and regulatory impact assessment – according to the Max Planck Institute the data is not available to make effective policy. According to the European Patent Office, there is a clear link between patent applications and innovation and investment. However, it is not only the number of patent applications that should be considered when assessing the impact on innovation but also the origin of the patent application.

Ysbrand Poortman, Vice President of the World Alliance of Organisations for the Prevention and Treatment of Genetic Conditions, stressed that nutrition plays a key role in the prevention of disease and that the door should not be closed for the development of food ingredients that provide consumers and patients with healthier choices. To this end, the implementation of the Regulation should not solely be limited to the 'Gold' standard but should also encourage 'Silver' and 'Bronze' to develop their healthy ingredients – leading to a 'race to the top' among food companies and a renewed incentive to innovate.

In concluding the event, Dutch MEP Jules Maaten stated that “the lack of an impact assessment for this piece of legislation - particularly with regard to R&D, technology and innovation -, the confirmation of the European Commission that the January 2010 deadline will not be met, and the postponement of the nutrient profiling and food labelling debates raise the need for a time-out to reflect on the implementation of the health claims legislation.” As an immediate step he noted that there should be “no staggering of the publication of the EFSA health claim opinions as these would lead to a market distortion and are not in the interest of society or industry.”