International Omega-3 Learning and Education Consortium for Health and Medicine

Scientists Make Push Against Nutrition Claims

The European Commission Standing Committee on the Food Chain and Animal Health has approved the controversial nutrition claims for omega-3s, despite vocal opposition from scientists opposed to the inclusion of ALA in the claims. The claims must be adopted by the European Parliament before becoming law, and the scientists have vowed to continue opposing the claims. They appeared to have convinced the UK's FSA to oppose the claims, with the UK abstaining in the Standing Committee vote and requesting a statement be inserted into the minutes voicing its opposition to claims that would imply the benefits of EPA and DHA could be obtained from any omega-3.

GOED has urged the Commission to approve the regulation, but only because a legal deadline would bar the claims from being used in any EU country if not approved by December, and would require hundreds of products in the EU to be re-labeled. Additionally, the Commission has indicated it would no longer work on omega-3 claims if the deadline was not met. So while the inclusion of ALA in the regulation on the basis of its heart health benefits as a precursor to EPA and DHA is not a position we would typically support, the damage to industry and consumers would be much greater if the regulation is not approved.

The nutrition claims will allow foods containing 80mg EPA+DHA per 100g/mL and kCal to claim they are "High in omega-3s" and those with 40mg to claim they are a "Source of omega-3s." The thresholds for ALA are 600mg and 300mg, respectively. However, the Commission removed the language that would have allowed the use of the claims on food supplements, because it wanted to address the issue of nutrition claims for all supplements rather than just omega-3s.

Two of GOED's Article 13 Claims Approved

Separately, the European Food Safety Agency (EFSA) issued its first batch of opinions for Article 13 Claims, including four different health areas related to omega-3s. The only two EPA and DHA claims that received positive opinions were submitted by GOED, for maintenance of normal triglyceride levels and maintenance of normal blood pressure. However, EFSA gave negative opinions to claims for the maintenance of normal HDL cholesterol levels and joint health.

For the triglyceride and blood pressure opinions, there is still significant uncertainty as to how they will be adopted by the Commission. Unlike the rest of EFSA's positive opinions, it set no conditions for using the claims. However, EFSA did say that high daily intakes would be required to obtain the effect, 2-4g/day for triglyceride reduction and 3g/day for blood pressure, but gave no indications on single serving requirements.

GOED specifically addressed the dosage issue for triglycerides and presented European member states with analysis that showed an effect at dosages as low as 500mg/day. However, this was a primary analysis and unpublished, so the European member states did not forward the information to EFSA. We are currently evaluating how to have this evidence considered, and publication of the data is in process. The chart below is from this manuscript and shows the dose response for triglyceride reductions, from multiple studies.

The HDL cholesterol claim received a negative opinion due to the simultaneous increases of LDL cholesterol in a few studies. Much of the joint health evidence centered on patients diagnosed with rheumatoid arthritis, which EFSA said was not representative of the general population to which the claim would have been applied.

Reviewed by: Adam Ismail