GOED Provides Safety Assessment to EFSA
GOED commissioned a safety assessment from Spherix Consulting
, which was submitted last week to the European Food Safety Authority (EFSA). The report was commissioned as part of GOED’s efforts to defend against the establishment of an unscientific upper limit (UL) in the European Union (EU).This report weighs the hazard characterization evidence of EPA, DHA and DPA.
Spherix reached the conclusion that, based on its weight of the evidence evaluation of the safety of ingestion of n-3 fatty acids on a number of safety end points and adverse effects (listed below), they could not identify any studies appropriate to define specific intake levels or intake/response relationships that could be used to define a UL for these 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
The thorough review consolidates available information and presents a critical analysis of the relevant pivotal information to address the hazard identification of EPA, DHA and DPA in general and with specific reference to fish- and algal-derived oils containing 20% or more of EPA+DHA+DPA as native triacylglycerides (TAGs), reconstituted TAGs or ethyl esters. The following safety end-points and adverse effects were considered:
Blood lipids, LDL-cholesterol levels; oxidative stress resulting in lipid peroxidation;
Inflammation and modulation of immune parameters;
Glucose homeostasis (blood glucose control in diabetes);
Gastrointestinal-and taste-related effects.
As with the Intertek Cantox intake assessment report
that was also forwarded to EFSA, the full version of this report is available only to the GOED members who contributed to funding this project in response to a member request last July. If your organization would like to contribute to obtain a full copy of this report, please contact Adam Ismail
The following past GOED News Alerts provide additional background information on the issue of upper limits.
February 17, 2012
September 16, 2011
March 28, 2011
January 28, 2011