The New Health Claims Process

In its first round of evaluations, EFSA refuses eight of nine health claim submissions.

By Joerg Gruenwald

The European Food Safety Authority (EFSA) has initiated the health claims assessment process by rejecting eight of nine new claims. The latest rejection was an omega 3 health claim for infant brain and eye development. The reason for the rejections, in most cases, relates to a failure to demonstrate causality bet­ween consumption of the ingredients or foods and the intended health benefits.

EFSA made it clear that it is not rejecting the ingredient, but rather the science, which it said was incomplete and needed to be touched up.

So far, only Unilever’s stanol/ sterol claim has passed muster. That submission was backed by a multimillion-dollar research project with solid documentation. But what about small to medium enterprises? Will they be able to match that level of substantiation?

Like FDA, EFSA seems to have adopted similarly stringent standards with regard to its review process. In this environment, it seems, only strong, placebo-controlled, double-blind studies will be sufficient for a food claim. As a result, many experts argue that these unworkably high standards will threaten R&D, not to mention investments.

Among the requirements for claim substantiation, the ingredient or food in question must be well defined in the claim, and a cause-effect relationship must be clearly demonstrated.

Of the 43,000 originally submitted claims (many were doubles), many were badly prepared and documented. This has reduced the list of claims waiting for assessment to 2800. Still, if EFSA continues to apply its high standards, the list of accepted claims will be far shorter by 2010. Also, manufacturers wishing to apply for proprietary claims may think twice before submitting a claim, considering instead whether their efforts are worth the gamble. As a result, they will probably turn to safer brand marketing strategies.

Further, without more diversity, food and beverages using claims from the “short” positive list will be quite uniform, resulting in little innovation and differentiation in the market. To alter this outcome, manufacturers have no choice but to rise to this challenge and submit good claims backed by solid scientific evidence.

The question is, in the end, whether this effort will improve the credibility of the food and supplement industry in Europe. In every industry there are some “black sheep” that tarnish the reputation of the whole group. But applying pharma-like requirements serves only the interests of the large multinational food companies, while at the same time re­ducing the health claim prospects of small and medium-sized players in the industry. These smaller firms deserve the chance to document their claims at reasonable costs.

Building consumer trust is always on the agenda when designing a new product or product line. So from this perspective, good, solid science behind a claim is an investment that will pay off in the long run, even if the manufacturer has to accept a few setbacks along the way.NW