How to Deal With the EU's Nutrition and Health Claims Regulation

As the EU began enforcing its nutrition and health claims regulation in 2013, we saw the first market trends and reactions to the regulation emerge. For many companies, the regulation prohibits the use of health claims previously allowed on the market. Companies seem to be coping with the regulations through a variety of strategies. In particular, two marketing trends are prevalent:

1. “Common” foods are now making increasing use of authorized nutrition and health claims for health ingredients that they already contain (e.g. vitamins/minerals in fruit juices, calcium in dairy products, omega-3 fatty acids in plant seed oils/nuts/fish products, fibers and beta-glucans in oat/barley bran cookies, and many more.)

2. An increased trend towards the addition of vitamins/minerals, fiber, or other ingredients to food products and food supplements to enable them to make more health claims.

The EU claims regulation has certainly promoted the use of nutrition claims and generic health claims for vitamins, minerals, omega-3, and fibers in common food products thanks to now-harmonized rules for these claims. Increasingly, many manufacturers of common foods that did not previously make use of nutrition and health claims are now including such claims in their marketing strategies.

However, regarding innovation and the use of health claims for other ingredients, the EU claims regulation has impeded this area of potential market growth. Many companies investing in research to produce innovative products with ingredients that have very specialized and targeted health benefits have seen applications for health claim authorizations turned down due to the tough scientific assessment requirements of the European Food Safety Authority (EFSA), whose requirements some say are more suitable to the assessment of medicines than food.

It is, therefore, logical to assume that the number of new EFSA health claim applications submitted will decrease, as many companies realize that the marketing advantage, based on the slim chance of claims approval, is minimal when one considers the cost to undertake very lengthy and expensive human clinical health claim trials required to meet EFSA’s substantiation standards.

At the same time, however, we have observed that the quality of submitted dossiers to EFSA to achieve additional, innovative health claim approvals is improving. Companies now have better awareness of EFSA’s standards for applications. These companies may still choose to submit applications-but often only after seeking advice and assistance from scientific experts on submitting claims applications and on whether the studies available for substantiation stand a chance of EFSA approval. To increase the chances of success-and since the EFSA standards are tough and often underestimated-companies are strongly advised to seek expert advice and undertake a gap-match analysis of their claims dossiers against EFSA standards before submission.

While the initial goals of the EU health claims regulation-consumer protection and fair competition-seems to make sense, in practice, the regulation has strongly curbed innovation. Nevertheless, companies can still devise creative solutions by taking advantage of the flexibility provided by EU Member States and/or the European Commission on certain aspects of the EU claims rules:

1. Make use of permitted alternative  health claim wording for the authorized claims included in the EU claims register, along the EU Member States’ guidelines and existing specific national guidelines.

2. Make use of product names or statements that express simplified health effects, as well as other general, non-specific health-benefit claims in combination with EU-authorized claims. For instance, a simplified product name could be “Vision,” which could then, on the label, be followed by a specific authorized health claim for a specific ingredient related to visual function. An easy, attractive statement could be “for mental well-being,” which could then be followed by an authorized health claim for a specific ingredient related to, for example, cognitive or psychological function.

This second approach is in line with European Commission rules, as long as the authorized health claim accompanying the general, non-specific health benefit statement is next to or following it on the product label. (If such statements are made in advertising-e.g., brochures-the same rules would apply. In television advertising, if claims are made verbally, they should also only be made if the verbal message is followed by the authorized health claim.) It is important to note, however, that what’s acceptable will always depend on what is deemed acceptable by authorities in each EU Member State.

It will be interesting to see how the marketplace continues to adapt to the new health claims environment. The market’s experience in 2013 will certainly pave the way for 2014 and beyond.