The European Food Safety Authority (EFSA) has released its first reports from its Panel on dietetic products, nutrition and allergies (NDA), a series of opinions regarding claims referring to the reduction of disease risk, and children's development and health.
Companies that submit research and information to EFSA submit it into one of three categories, or Articles. Article 13 deals with “function” health food, such as claims like “calcium is good for your bones.” Article 13/5 handles new function health claims that are based on newly developed scientific evidence and/or for which protection of proprietary data is requested. The third article, Article 14, deals with claims regarding child disease, risk reduction and child development or health.
EFSA has begun with 220 claims in the Article 14 category, and an additional 2,500 in the Article 13 category.
Of the initial eight claims posted a few weeks ago, five were related to children’s health and the other three were related to disease risk reduction. Of these, seven were rejected for “insufficiently demonstrating causality between use of the product and the proclaimed health benefit.” This, however, does not mean that they were necessarily proclaimed a fraud or failure.
One of the reports, regarding a-linolenic acid (ALA) and linolenic acid (LA) and growth and development in children, was rejected for the reason that the quantities in the report were already reported as consumed by children as a part of their recommended balanced diet, according to the panel. The report did not show an established benefit that had not already been known, therefore it did not fail based on lack of information, but rather because it had no new benefits or information to offer.
Particular interest rests on what levels of claims the panel will allow. If companies find the requirements too difficult (and too expensive), they may avoid going to the panel with a submission and could end up omitting the claim statement in their marketing and communication. In this case, not only are companies unable to provide any health messaging, but consumers do not receive health messaging, meaning many potentially beneficial products will either not be differentiated from commodities that are less beneficial, but also that consumer behavior may not change to support more healthful practices and policies.
While the cost of submitting a dossier to the panel, on top of the cost pertaining to all the research already committed to their products, is another frustration for companies, it is still an important area to ensure is done properly – even if the cost seems steep. In regards to submissions to the EFSA NDA panel, it would be wise to remember the old saying ‘you’ve got to spend money to make money.’
Nigel Baldwin, Senior Scientific and Regulatory Consultant of Cantox’s European office spoke with NPIcenter and explained that “You really should not underestimate the work involved before making a submission. Nor should you underestimate the risk involved in making a submission, because if you mess it up, you’re going to get worse than not being able to make a claim, you’re actually going to have to say that you cannot make the claims.”
“In a lot of cases the dossiers just aren’t up to scratch. So if [EFSA] review them, they’re forced to give them a negative opinion,” Baldwin added.
If companies decide that the benefits of the evaluation process (with even a slight chance of a positive outcome) are appropriate to the cost of the process, then they will continue to follow the submission process, and may even enhance research programs. Not only would this benefit companies going through the process, ultimately, as levels of substantiation increased and dossiers got richer, but then the consumer would also benefit from not only consumption, but also from the communication of truthful claims to raise baseline education.
Stefanie Geiser, regulatory claims manager for Belgium-based EAS, in conversation with NPIcenter, commented. “It seems that some of the applicants that received a 'negative' opinion from EFSA have asked to withdraw their dossier before it will be discussed in the Standing Committee in order to avoid being mentioned in the public register of approved/rejected claims. This request was rejected. It will not be possible to withdraw a dossier after EFSA's opinion is given.”
Geiser went on to explain that “smaller companies are obviously more affected than larger companies, since the human studies required to obtain the scientific evidence to achieve approval for specific ingredient claims take time and money.”
“Article 13 claims on the list can be used by all, once approved,” Geiser added.
The rest of the world will surely be watching to see just how well this claims evaluation process works out in the EU, for jurisdictions creating new regulations, as well as those revisiting existing claims. Ingredient companies around the world will be evaluating the cost/benefit of product specific research programs. Finished goods manufacturers will be critically evaluating the benefits of the higher cost of goods that typically go into functional products, wondering if at the other end, they’ll be able to say anything meaningful that will translate into new sales in the EU.