EFSA sets upper intake level for LC-PUFA

October 2012

In July 2012, the European Food Safety Authority (EFSA) published a Scientific Opinion on the tolerable upper intake level (UL) for eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and docosapentaenoic acid omega-3 fatty acids. The opinion stated that available data are insufficient to establish a UL for the omega-3 long-chain polyunsaturated fatty acids (LC–PUFA), individually or combined, for any population group.

IngredientsNetwork.com noted that the decision came after a 2011 study by the German Federal Institute for Risk Assessment (BfR) reported that high consumption of omega-3 fortified foods could exceed the 1.5g recommended daily intake of DHA and EPA. BfR estimated that between 3.7% and 16.7% of Germans could consume potentially health-damaging levels of DHA and EPA through excessive consumption of omega-3-fortified foods.

The EFSA panel noted: “At observed intake levels, consumption of omega-3 LC–PUFA has not been associated with adverse affects in healthy children or adults.” The panel specified that there was no significant risk with long-term supplemental intakes of EPA and DHA combined up to about 5 g/day; it also qualified that supplemental intakes up to 1.8 g/day of EPA alone do not raise safety concerns for the adult population and up to 1 g/day for DHA alone does not raise any safety concerns for the general population.

In related news, the Swiss government acted in June 2012 via SR 817.022.104 (Regulation on Special Food) to adopt an upper limit of 250 mg of EPA and DHA intake for the general population and up to 400 mg EPA and DHA for pregnant and lactating women. The Global Organization for EPA and DHA, a trade association based in Salt Lake City, Utah, USA, said it will approach the Swiss government with the EFSA opinion to ask them to reconsider their position, according to a report by NaturalProductsInsider.com.

July 2012 also marked the end of EFSA’s massive review of the almost 3,000 potential health claims submitted by industry. In the final group of five opinions, EFSA rejected the application regarding soy isoflavones and positive outcomes in a number of health conditions including menopause, reducing low-density lipoprotein cholesterol, and the delivery of antioxidant benefits.

A month earlier, EFSA upheld its scientific opinion that evidence was lacking that consumption of olive oil polyphenols (standardized by the content of hydroxytyrosol and its derivatives) maintained normal blood HDL (high-density lipoprotein) concentrations.

Also in June 2012, EFSA approved a health claim related to the consumption of cocoa flavanols and maintenance of normal endothelium-dependent vasodilation. EFSA established the following wording as reflecting the scientific data: “Cocoa flavanols help maintain endothelium-dependent vasodilation, which contributes to normal blood flow.” The agency also noted that “in order to obtain the claimed effect, 200 mg of cocoa flavanols should be consumed daily. This amount could be provided by 2.5 g of high-flavanol cocoa powder or 10 g of high-flavanol dark chocolate, both of which can be consumed in the context of a balanced diet. The target population is the general population.