Are EU health claims dooming innovation – Your views

Below is a selection of attributed responses:

“It was necessary to regulate the market and help discriminate between quality products with some level of scientific back up and bogus supplements, but the actual health claims system has gone too far since we seem to have reached for food products the same level of requirement than for drugs, which have safety and adverse effects issues! We need to find a middle way.

“Regarding innovation and competition, only big companies will have access to health claims in the present system since EFSA only accepts drug-level scientific documentation. Medium and small size companies which don’t have structure and budgets to build clinical trials to substantiate health claims won’t be able to communicate on their products. Since EFSA prevents communication on food supplements, the whole industry is jeopardized.”

Célia Martin, regulatory affairs manager, Institut Rosell-Lallemand, France​

“Implemented improperly, as appears to be the case, the European Union health claims regulation will stifle innovation exactly where Europe (any economy really) needs it most: Among its small- to mid-sized enterprises. The rules are being bastardized so that only large multinationals, wielding teams of lawyers, have a fighting chance to worm their way through Brussels' regulatory maze.

“Stifle SME innovation and watch how quickly unemployment skyrockets. Europe is filled with brilliant food supplement experts; unleash, don't shackle, their potential.”

Matt Defosse, manager, Modern Plastics, Germany​

“The EFSA’s evaluation of scientific evidence is made under the highest standards, approaching those required for a drug but widely higher than those required for a ‘light’ dossier in case of medicinal plants.

“The EFSA methodology for health claim evaluation, widely based on anteriority and existing scientific consensus, is in opposition with innovation. We consider innovation is driven by the search for new functionalities. If the link between ingredient & functionality is already widely described in the scientific literature, where is the innovation?

“Imposing strict scientific wording for health claims makes them less understandable for consumers and less valuable for the industry.”

Elodie Linares, Quality/R&D director, BioSerae Laboratoires, France​

“EFSA may have doomed some claims in the past – but the future looks much brighter. EFSA should now be able to create clarity and transparency for manufacturers, retailers and consumers for future food research, marketing and claims. We strongly believe that health claims need to be backed by good science.

“Despite – or indeed because of - the initial controversy, EFSA is well-placed to provide valuable guidance and consultancy in the long term, providing a dialogue channel on how to set up research, clinical trials, protocols and phrasing of claim wordings. As such, food innovation will be bolstered rather than doomed because the entire process will become more predictable.”

Jens Bleiel, Chief executive officer, Food for Health Ireland. Ireland​

“Of course innovation is doomed! Especially in the food supplement industry. These companies and specialists are being restricted to researching more on the health benefits of natural sources such as fish oils and therefore putting restrictions on innovations of such products available to the consumer.

“I also envisage confusion at consumer level. The European Commission will also lose credibility if they allow a legislation to be approved with no scientific background. Do these legislations have different purposes? Who is going to profit from this?”

Hannah Cremona, marketing manager, Vivian Corporation, Malta​

“What is now going on between the EU Commission and EFSA regarding the assessment of the Article 13.1 submissions filed by the Member States has no bearing on innovation. After all, per the official text of the Regulation, the 13.1 claims now under consideration are the ones that are based on generally accepted scientific evidence. Whether EFSA is really assessing the 13.1 submissions with this criterion in mind is an interesting point, but it doesn’t change the fact that 13.1 claims are defined as the ones based on long-established and non-controversial scientific evidence.

“Innovation comes into play in the context of the Regulation’s Article 13.5, which opens the door for submissions based on “newly developed” scientific evidence. Per Article 18, such 13.5 claims should be filed by food business operators, not by the Member States. So, there is nothing in the Regulation that would stifle or inhibit innovation. To the contrary, Article 13.5 is an invitation for industry to support the development of new scientific evidence concerning the relationship between well characterised food (-ingredients) and health benefits.

“Whether such investments into innovative efforts are worthwhile in view of the fact that EFSA deals with 13.5 claims per the criteria set for Article 14 claims, is another matter. However, this is au fond​ a purely scientific issue that should be sorted out between the scientists commissioned by - working for - industry and their colleagues at EFSA. They will have to figure out whether the placebo controlled double blind trial is the best and most effective method to assess the effects of food on human health is really the gold standard that shall be met. As long as this debate is going on and EFSA sticks to its placebo-controlled double-blind golden guns, I think it is prudent not to invest in innovation.”

Bert Schwitters, director, The International Nutrition Company, the Netherlands​

Health claims will be discussed at the NutraIngredients Health Claims 2010​ conference to be held in Brussels on 10th December where the likes of Danone and Unilever will share their experiences with the process. For more information and to register, please click here​.