Omega-3 industry prepared if German concerns gain EU traction
While dismissing the German Federal Institute for Risk Assessment (BfR) omega-3 overconsumption concerns as "unfounded", the Global Organization for EPA and DHA Omega-3 (GOED) said it would provide safe maximum permitted level (MPL) data if needed.
There currently exists no official European Union MPL for omega-3s but a BfR report found consumption of docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA) and docosapentaenic acid (DPA) could exceed MPLs of 1.5g per day set by the BfR due to the consumption of DHA-fortified foods.
Article 8, EU Regulation 1925/2006
Based on this, the BfR has requested that an untested article of EU Regulation 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods, be invoked so that DHA, EPA and DPA are added to a list of nutrients over which overconsumption concerns exist.
"While GOED believes the concerns expressed in the German report to be unfounded, Article 8 of EC Regulation 1925/2006 allows for substances of concern to be brought to the attention of the Commission for assessment," GOED's Harry Rice told NutraIngredients.
"That said, regardless of our opinion, in general, it would be inappropriate to dismiss the German report without first considering its merit. The evidence will speak for itself."
BfR representatives presented their report and called for the article 8 action at a February 21, 2011, meeting of the EC Standing Committee Meeting on the Food Chain and Animal Health (SCOFCAH).
"Not necessarily achieved in reality"
Minutes from that meeting show BfR omega-3 consumption modelling backed its functional food derived consumption forecast intakes of 2-3 times higher than might, "reasonably expected to be ingested under normal conditions in a balanced and varied diet."
Using different scenarios the BfR found between 3.7 and 16.7 per cent of the German population would exceed 1.5g of EPA/DHA/DPA per day.
But the agency acknowledged its opinion was, "a conservative procedure with a high degree of certainty which nonetheless is not necessarily achieved in reality".
At the SCOFCAH meeting, two member states backed the BfR position, two others said there was no safety concern about overconsumption of omega-3s, with others calling for further data from the BfR.
EC delegates reminded member state attendees that the European Food Safety Authority (EFSA) had observed typical EU-wide consumption of EPA and DHA of between 80-420mg per day - lower than EFSA recommended levels to gain cardiovascular benefits.
"It was concluded that there is a need to reflect on the request by Germany in relation to EPA/DHA/DPA and that any decision would take into account the views presented by the delegations and the elements mentioned during the Committee meeting," the SCOFCAH minutes noted.
Article 8 of the regulation states nutrients should be added to an annex where: "a substance other than vitamins or minerals, or an ingredient containing a substance other than vitamins or minerals, is added to foods or used in the manufacture of foods under conditions that would result in the ingestion of amounts of this substance greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or would otherwise represent a potential risk to consumers."
But Rice observed: "Article 8 is untested in the EU and no defined procedures exist for how to compile scientific safety dossiers".
Post-publication addition: The BfR report (in German) can be found here. It suggests harmful effects could include increased cholesterol levels, risk of cardiovascular mortality among long term users with cardiovascular disease, inhibited immune systems in the elderly, and anaemic effects.