05.03.10
The European Food Safety Authority (EFSA) has instituted a new regulatory process to ensure that all claims made on food labels in the EU are “clear and substantiated by scientific evidence.” With two-thirds of the initial batch of claims rejected, the impact of this on the health and wellness food and beverage market in the region and beyond could be profound. With some claims due to be outlawed very soon, manufacturers are scrambling to reformulate and resubmit their claims. To address these and other issues, Euromonitor has put together a report that touches on the following points.
Disease reduction now accounts for more than half of all H&W claims: In recent years, health claims on health and wellness food became more tightly focused, shifting away from general functionality and nutritional benefit and toward very specific disease reduction claims.
Increased regulation—a disincentive to invest…: Increased regulation could act as a disincentive to invest in research and development for EU-based manufacturers and place them at a disadvantage to their peers in other major health and wellness markets, especially the U.S. and Japan.
…But also a barrier to entry: For incumbent players in some mature categories, this regulatory tightening may actually prove to be beneficial as it could act as a barrier to entry, making it more difficult for new and potentially disruptive fortified/functional ingredients—and rivals—to come to market.
Approved claims equal to significant rewards: With annual sales of health and wellness food and beverages in the EU forecast to be worth almost $203 billion by 2012, manufacturers that succeed in getting their specific health and wellness product claims approved are likely to reap significant rewards.
Goodbye Article 13.1, hello to Article 13.5: The mass rejection of claims under Article 13.1 was unsurprising, due to the tightness of EFSA’s criteria and the fact that the scientific criteria were not clear when many of the dossiers were initially submitted.
Learning process: Many manufacturers perceive the initial rejection of their claims as part of a learning process and do not consider it to be a major setback. Re-evaluation of both claims and clinical evidence—as well as ongoing dialogue with EFSA—are becoming the norm.
Heart health—one of the winners: The approval of plant sterol claims from McNeil and Unilever provides some hope to the rest of the industry that submissions of proprietary claims under Article 13.5 may be viewed more favorably by EFSA regulators.
FDA getting in on the act…: The impact of this regulatory tightening has the potential to affect markets well beyond the EU, including the U.S. and even the BRIC economies (Brazil, Russia, India and China). It may also have specific relevance to Japan and its FOSHU regulatory framework.
