14 September 2004
Thank you for the opportunity to comment on this application. The New Zealand Food Safety Authority (NZFSA) has the following comments to make, concerning the toxicological data and risk assessment.
We note that the toxicity testing for the Ulkenia oil was done at a somewhat less than ideal level of testing (just three tests). These showed a lack of toxicity up to 900 mg/kg/day in a 90-day feeding study, no effect at 2000 mg/kg dose in an acute toxicity study, and nothing of toxicological importance in a one-generation reproduction toxicity study (normally the latter are performed over two generations). There was no evidence of mutagenicity in properly conducted mutagenicity tests also.
NZFSA notes however that the data from other oils and food sources of DHA-rich oil confirms the lack of risks from the normal and high consumption of these oils. The evidence of safety relies on both sets of data – the specific tests done on the Ulkenia oil, and the data (both animal and human) on other similar oils.
However, because this database is more limited than ideal, the NZFSA suggests that it would be wise to consider the same restrictions imposed by the US FDA – namely that the average level of DHA per person should not exceed 0.5 g/day for children up to the age of 9. We note that the potential intakes for children were estimated, and that the high consumption figure of nearly 800 mg/day may not be very robust, and may be overestimates as conservative estimates of intakes were used. NZFSA do not think it is likely to pose a real health risk as this is still well below the no-observed-effect level of 900 mg/kg/day seen in the 90-day rat feeding study.
Our suggestion is that in the Final Assessment Report, FSANZ provides comment on:
• The reason why the US FDA figure for the maximum intake of DHA for children has not been recommended, and
• The high consumption figure for children being about 50% higher than the US FDA figure. The New Zealand intake figures are all higher than the Australian figures, so the issue of an upper limit should at least be addressed.