EFSA has until the end of the year to give opinions on all nutrients currently on-market by right of derogation under the remit of the 2002 Food Supplements Directive (FSD). It received hundreds of dossiers backing the safety of nutrient forms. Derogations will remain in place if EFSA does not reach opinion on all nutrient forms by year’s end.
A positive opinion from EFSA, if ratified by the EC and member states, means nutrients can be added to Annex 2 positive list of the FSD, as is the case for the boron form, boric acid, which has been proven safe for use and is employed widely by supplement manufacturers usually in relation to bone health.
Calcium, magnesium caprylate
EFSA said the safety of calcium caprylate and magnesium caprylate, added to food supplements at the usage levels proposed by the petitioner could not be demonstrated.
Caprylic acid is a natural component of the diet, found in the fat content of dairy products such as milk (0.3 per cent) and butter (0.8 per cent), and also in palm kernel oil (3-4 per cent) and coconut oil (9-10 per cent). The average dietary exposure to caprylate is considered to be in the range of 330 to 410 mg/day, and at high percentile dietary exposure up to 992 mg/day.
However, the usage levels proposed in the petition to EFSA would result in exposures to caprylic acid around 10- to 30-fold higher than the estimated exposure to caprylate from the diet, said EFSA. Intake of caprylate from food supplements might amount to nearly 9 g caprylate/day which is equivalent to 145 mg/kg bw/day for a 60 kg person.
The Panel concluded that the amounts of caprylic acid from the proposed use levels are far greater than dietary exposures and it is therefore not possible to base a safety evaluation on the normal metabolism of dietary caprylic acid.
The opinion can be found here.
Iron, chromium, selenium in humifulvate
Particular sources of chromium iron and selenium also did not pass EFSA’s bioavailability and safety test.
The panel examined iron(II)- chromium(III)- and selenium present in supplemented humifulvate intended for the general population, to be used in food supplements.
It found that the bioavailability of iron, chromium, selenium and other minerals from the humic acid/fulvic acid chelates (HFC) sources tested might be lower than that of other sources, and therefore concluded that the bioavailability might be “limited or even absent”.
EFSA also concluded that the submitted data were insufficient to demonstrate the safety of the proposed use and use levels of the minerals, based on a NOAEL (no-observed-adverse-effect-level) for supplemented potassium humate powder of 15 mg/kg bw/day, equivalent to 7 mg HFC/kg bw/day.
The opinion can be found here.
Positive opinions
EFSA has also recently published a number of positive safety opinions for certain forms of nutrients. NutraIngredients.com will report on those next week.