Calcium, zinc, chromium forms safe, says EFSA

EFSA’s Scientific Panel on Additives and Nutrient Sources added to Food (ANS) analysed safety and usage data contained in six dossiers and found no safety issues in any of them.

Forms given the OK by the ANS include calcium silicate, chromium and zinc picolinate, chromium(III) lactate trihydrate, four magnesium forms and potassium molybdate and mean the nutrient forms can be added to the positive list of approved nutrients contained within the 2002 Food Supplements Directive (FSD).

Picolinates​

In an opinion on chromium and zinc picolinate, combined estimated exposure of 96mg or 1.6mg picolinate/kg body weight per day, was deemed of no safety concern.

“The Panel also concluded that the use of chromium (III) picolinate, as a source of chromium, is of no safety concern provided that the amount of supplemental chromium does not exceed the level of 250μg/day, the value set by the World Health Organization,”​ the ANS said.

The ANS noted genotoxicity concerns in regard to chromium picolinate had emerged recently and said a reevaluation may be required at a later date.

Manganese forms ​

For the four manganese forms the ANS noted that while no particular studies had been completed on the specific forms, science for manganese was relevant. It said there were no safety concerns at the highest proposed fortification levels of 5mg which would give an average total intake across the general population of 12.2mg, less for older people.

These levels were in line with earlier UK recommendations of 4mg for manganese supplements.

The four forms were manganese aspartate, manganese L-ascorbate, manganese pidolate and manganese bisglycinate.

Potassium molybdate​

In an opinion on potassium molybdate, the panel highlighted the fact sodium molybdate and ammonium molybdate were already approved and listed on the FSD positive annex and again found so safety issue with the potassium form.

“Based on the highest proposed use level, an anticipated exposure to potassium from the food supplements is 16μg/day,”​ it said. “The Panel considered this amount as being negligible compared to the average daily dietary intake of potassium defined by EFSA in 2005, which ranges from 2.7-4 g/day.​

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Again though it noted​new in vitro ​and in vivo ​testing had revealed genotoxicity issue and that molybdenum might need further investigation.

Chromium nitrate ​

An opinion on chromium nitrate found no safety issues up to 250μg/day​but again stated reservations about recent genotoxicity studies and the fact the UK Expert Group on Vitamins and Minerals (EVM) had failed to establish an upper safe level for chromium.

Silicates​

Calcium silicate, silicon dioxide, silicic acid gel were all deemed safe, with the petitioner seeking fortification that would result in bioavailability of 700mg silicon per day – the same level recommended by the EVM.

That meant silicon dioxide at 2500mg/day and silicic acid gel at 200mg.

However EFSA’s Panel on Dietetic products, Nutrition and Allergies (NDA), had been unable to set a safe upper level for the nutrient but estimated average intakes of 20-50mg per day were unlikely to cause adverse effects.

Chromium ​lactate trihydrate​

For chromium(III) lactate trihydrate, data on approved forms, chromium(III) chloride and chromium(III) sulphate, was used to support a claim for 200μg/day supplementation, below the Who level of 200μg/day.

The opinions can be found here​.