EU and US health claims

Europe

In the European Union (EU) the health claims regulation is a turn-around for both the industry and the consumer. Health claims used to be applied for at national level for a particular product, whose effects and safety had to be shown by scientific studies.

This was a costly process for manufacturers, affordable only for very few (mainly multinational) food giants. For the consumer, the outcome was a variety of functional foods promising vague benefits for the 'natural defence system' or a 'healthy gut'.

Ingredient-based health claims

Under the new regulation, claims are granted based on ingredients. Any food containing a particular ingredient at the required level may use the approved claim. More importantly, any 'health' ingredient now needs to prove its actual effects within a consistent EU regulation system based on current science.

Claims will only be approved when sufficient scientific evidence can be presented, showing that the ingredient does what says it can to the age group in question and at the amount described.

Within the health claim regulation process, more than 4,000 claims were assessed by the European Food Safety Authority (EFSA). The vast majority were not approved; including almost all claims applied for probiotics, in most cases, this was due to a lack of scientific standards or evidence.

Omega-3 approvals

Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) omega-3 are two of the few ingredients that received positive "opinions" by the EFSA, which are expected to be converted into actual health claims.

For the general population:

•    EPA and DHA contribute to the normal function of the heart: 250 mg EPA+DHA / day.
•    DHA contributes to the maintenance of normal brain function: 250 mg DHA / serving(s)
•    DHA contributes to the maintenance of normal vision: 250 mg DHA / serving(s)

For adults:

 
•    DHA and EPA contribute to the maintenance of normal blood pressure: 3 g EPA+DHA / day
•    DHA and EPA contribute to the maintenance of normal triglyceride concentrations 2-4 g EPA+DHA
     / day

US

In 2004, the US Food and Drug Administration (FDA) gave 'qualified health claim' status to EPA and DHA, with respect to their effect on reducing the risk of coronary heart disease:

"Supportive but not conclusive research shows that consumption of EPA and DHA Omeag-3 fatty acids may reduce the risk of coronary heart disease."