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Application A566 – L-5-Methyltetrahydrofolate, Calcium as a Permitted form of Folate – Draft Assessment Report

07 February 2008

Dear Sir/Madam

Thank you for the opportunity to comment on this application. The New Zealand Food Safety Authority (NZFSA) has the following comments to make.

NZFSA supports the application to list L-5-methyltetrahydrofolate, calcium salt (L-MTHF) as an alternative form of folate in foods where voluntary fortification with folate is permitted.

NZFSA supports the proposed amendment to Standard 1.1A.2 that would disallow the making of health claims when L-MTHF is the form of folate added to fortified foods.

NZFSA supports the removal of folic acid/folate from column 3 and additionally from column 4 of the Schedule to Standard 1.1.1 of the Food Standards Code.

In addition NZFSA makes the following comment in relation to the making of health claims when L-MTHF is the form of folate added to fortified foods.

- We understand that FSANZ’s rationale for not allowing health claims when L-MTHF is the form of folate being added to foods is because all the current evidence links folic acid to a reduced risk of a Neural Tube Defect (NTD) affected pregnancy. However we would point out that there is evidence that L-MTHF is just as effective as folic acid in increasing red blood cell folate levels and increased red blood cell folate levels have been linked to a reduction in NTDs. We also believe that it would now be impossible (ethically at least) to conduct double blind randomised human trials to produce the clinical evidence required to prove that L-MTHF is effective in reducing the risk of NTDs. In our view this would then make it impossible under the current high level health claims assessment structure for L-MTHF to ever be approved to make a high level health claim and consequently be approved for mandatory fortification.

- Subsequently we believe that if there is perceived to be no direct link between L-MTHF and a reduction in the risk of NTDs it will be important to factor this into the monitoring of mandatory fortification. We understand that it is almost impossible to identify the different forms of folate within a total red blood cell folate level so any increase in red blood cell folate will be due to all forms of folate consumed by the individual. It will therefore be necessary to monitor the uptake of voluntary permissions using this form of folate (L-MTHF) so that any reduction in NTDs is only attributed to folic acid fortification or folic acid supplement use.

NZFSA also considers this would be an opportune time to align the recommended dietary intakes of folate listed in the Code with the recently published Nutrient Reference Values and to standardise the use of the terms folate and folic acid within the Code.

Yours sincerely