EFSA Publishes Long-Chain PUFA Upper Limit Opinion
In a much-anticipated decision, the European Food Safety Authority (EFSA) this week published a Scientific Opinion
on the tolerable upper intake level (UL) for EPA, DHA and DPA omega-3s. The Opinion stated that available data are insufficient to establish a UL for the n-3 LCPUFA (individually or combined) for any population group. The Panel noted, “at observed intake levels, consumption of n-3 LCPUFA has not been associated with adverse affects in healthy children or adults.” The Panel did specify that there was no significant risk with long-term supplemental intakes of EPA and DHA combined up to about 5g/day; it also qualified that supplemental intakes up to 1.8g/day of EPA alone do not raise safety concerns for the adult population and up to 1g/day for DHA alone does not raise any safety concerns for the general population.
The decision, which was published in the EFSA Journal
, was the result of a request from the European Commission (EC) to deliver a scientific opinion on the Tolerable Upper Intake Level of the n-3 LCPUFAs EPA, DHA and DPA.
In January 2011, Germany asked the EC to start a regulatory procedure to set an upper limit intake for EPA and DHA in the European Union. At that time, Germany recommended a limit of 1.5g per day from all food sources. In June 2011 the EC requested EFSA “review the existing scientific data on the possible link between the intake of omega-3 long chain polyunsaturated fatty acids, alone or combined (DHA and/or EPA and/or DPA) and adverse health effects, and to advise the Commission on a tolerable upper level of intake (UL) for omega-3 long-chain polyunsaturated fatty acids, alone or combined (DHA and/or EPA and/or DPA) for the general population and, if appropriate, for vulnerable subgroups of the population.” Concerns raised by Germany and possibly other Member States resulted in three Article 13 claims being put on hold due to intake levels > 2g/day. (See GOED's January 28, 2011
, March 28, 2011
and September 16, 2011
GOED, in an effort to aid EFSA in their review, commissioned both a comprehensive hazard characterization and intake assessment. Both were submitted to EFSA earlier this year (See GOED's February 17, 2012
and March 5 2012
GOED’s intake assessment included a complete evaluation of long-chain omega-3 intakes in the EU, with specific examination of background, current and potential future intakes. The final report supports the existence of low long-chain omega-3 intake from background diets and shows that the addition of supplements and fortified foods, while increasing intakes, would likely result in a maximum mean intake of 1g/day and not be greater than 2g/day for very high consumers.
In the safety assessment, which measured hazard characterization evidence of EPA, DHA and DPA, the conclusion was that no appropriate studies could be identified to define specific intake levels or intake/ response relationships that could be used to define a UL for the effects. These conclusions mirror those reached by the Norwegian Scientific Committee for Food Safety (VKM) last year (see GOED’s June 29, 2011 News Alert)
This week’s EFSA opinion concurs, stating that available data are insufficient to establish a UL for the n-3 LCPUFA (individually or combined) for any population group. The report states, “Long-term supplemental intakes of EPA and DHA combined up to about 5g/day do not appear to increase the risk of spontaneous bleeding episodes or bleeding complications or affect glucose homeostasis immune function or lipid peroxidation, provided the oxidative stability of the n-3 LCPUFA is guaranteed.”
As mentioned above, for EPA alone, the Panel stated supplemental intakes up to 1.8g/day do not raise safety concerns for the adult population. For DHA alone, the Panel said that up to 1g/day does not raise any safety concerns for the general population. GOED believes that the low 1g/day number is a result of what the Panel is quoting as “limited” data being available on the effects of long-term supplementation with DHA alone at higher doses. There is no reason to believe that the safety of DHA alone, and for that matter EPA alone, is any different than the safety of EPA + DHA. No dietary recommendations were made for DPA.
Finally, the report commented that limited data are available on the effects of long-term supplementation with omega-3s at higher doses. The Panel also noted that observed intakes of EPA and DHA from food and supplements in European populations are generally below these amounts. Finally, it is worth noting that the EFSA recommendation of 5g/day is significantly higher than the current 3g/day upper limit in the U.S.
As mentioned above, certain omega-3 claims were put on hold as a result of this pending upper limit decision. Now that the decision has been published, if necessary, GOED will continue to be proactive on moving those claims forward.
In addition, in June 2011, the Swiss government in SR 817.022.104 (Regulation on Special Food). Annex 13 adopted 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. GOED will approach the government with the EFSA opinion to ask them to reconsider their position.