Proper substantiation of health claims necessary: these claims disapproved

Health claims are strictly regulated in the European Union. A new health claim may not simply be used before it has been approved. Among other things, evidence must be provided for this. Recently, a number of submitted health claims have been rejected. Why were these health claims rejected?

Regulation 1924/2006 regulates nutrition and health claims on foods in the European Union (EU). A health claim is defined herein as a claim that states, suggests or implies that a relationship exists between a food category, a food or a food ingredient and health.

Regulation 1924/2006 distinguishes between 3 types of health claims. Namely: health claims about disease risk reduction, health claims about children's development and health, and health claims about the normal role of a nutrient in growth and development and functions of the body.

Health claims may not be used unless they are included in the Community List of Approved Health Claims. The claims in this list may only be used if the aforementioned condition is met.

New health claim?

And what if you want to use a health claim that is not on the list? Then you as a company can submit a request for a new health claim. Article 15 of Regulation 1924/2006 lists what exactly an application must contain. For example, the application must contain the independent studies conducted that demonstrate that the health claim is true. It must also contain a proposal for the wording of the health claim.

The application is forwarded by the national competent authority to the European Food Safety Authority (EFSA), which evaluates the application. EFSA then issues an opinion on this and shares this opinion with the European Commission (EC), the Member States and the applicant. The EC ultimately makes the final decision on inclusion in the Community List based on EFSA's opinion and other factors.

Health claim organic foods

The Technical University of Cyprus submitted the health claim "Organic foods (lower levels of pesticide residues than in conventional foods) contribute to the protection of body cells and molecules (lipid and DNA) from oxidation damage" with the target population being healthy children aged 3 to 15 years.

EFSA subsequently recommended that these health claims about children's development and health not be included in the Community list. Based on this advice, the EC decided not to use the claim.

Indeed, EFSA found that a specification of the pesticide residue content that makes a food "organic" was lacking. This fact was lacking even in the studies provided to support the health claim. Since the health claim focuses on 'organic food' and is not well specified, no causal relationship can be established, according to EFSA. Thus, the claim does not meet the requirements of the claims regulation.

Health claim beta-glucans from oats and/or barley

Nestlé additionally submitted a health claim related to pressure-cooked beta-glucans from oats and/or barley. The submitted health claim reads as follows "The consumption of beta-glucans from oats and/or barley in breakfast cereals contributes to the reduction of blood glucose rise after meals. EFSA also issued a negative opinion for this health claim.

EFSA indicated that there is actually an effect of beta-glucans on reducing postrandial glycemic response based on the evidence. However, a dose-response relationship was not tested. Therefore, a reduction at a dose of 1.3g of beta-glucans per 25g of available carbohydrate, which applies to breakfast cereals, could not be concluded.

In addition, evidence was lacking that beta-glucans processed and cooked under pressure in breakfast cereals have a greater effect on the postrandial glycemic response, than when added to other carbohydrate-containing products. Based on the EFSA opinion, the EC therefore decided not to include this claim in the EU list either.

Insufficient scientific evidence

Insufficient scientific evidence regularly plays a role in the rejection of health claims. For example, Sensus B.V. submitted the claim "Frutalose® oligofructose from chicory contributes to regular bowel function by increasing the frequency of bowel movements. This claim was rejected because this effect has been demonstrated by only 1 study and has not been replicated in other studies. The same reason resulted in a disapproval of the claim "Affron® contributes to maintaining a healthy state of mind by reducing the negative attributes of depressive and anxious feelings" from Pharmaactive Biotech Products. Finally, Praline i Cokolada j.d.o.o 's submitted claim 'MegaNatural®-BP helps maintain healthy blood pressure' was rejected because out of 2 studies, only 1 study showed a positive effect of MegaNatural®-BP.

Good substantiation essential

So it is very important to make sure that a health claim is well supported by generally accepted scientific data. Make sure there are enough studies available that prove the claim and that the evidence is specific enough to support your claim. For example, it is important that the amount the consumer ingests from a "normal serving" has a proven effect according to the studies. Finally, it is very important to define all terms in the health claim as specifically as possible and make sure that these terms match the terms used in the evidence.