EFSA finds mineral sources safe for food use

However it failed to deliver an opinion on the chromium source glycinate nicotinate for a lack of evidence.

EFSA's Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) found bisglycinate chelate pre-cursor forms for the four minerals were safe for use.

"As regards chromium glycinate nicotinate complex, due to lack of information on the specific identity of its components, the Panel is unable to reach a conclusion on the safety of this source and on the bioavailability of chromium from this source," AFC found.

The nutrients' use are governed by the Food Supplements Directive (FSD), the Foods For Particular Nutritional Uses Directive (PARNUTS) and baby foods and infant formula regulations.

Dosage and usage AFC gave opinion on the safety of the nutrients but did not recommend any safe maximum levels.

"No specific use levels for the mineral bisglycinates under consideration in this opinion have been given," AFC said.

"However, it is assumed that under the intended conditions of use, the daily intake would not exceed those levels anticipated through existing supplementation of the listed minerals and would be similar to other forms of copper, zinc, calcium, magnesium and chromium that are already approved for use in foods in the EU."

AFC found that actual forms (known as cations) of the five mineral per-cursors were bioavailable after oral administration.

It noted that it was not tasked with determining the safety of the cations themselves, only the pre-cursor forms.

While no genetic toxicity studies had been conducted it had no concerns in this area.

AFC noted that the glycinate forms under assessment were similar to ferrous forms AFC previously determined as being safe in 2006, and that this data was relevant to the current assessment.

"The Panel agrees that the sub-chronic studies on ferrous bisglycinate can be used to assess the subchronic toxicity of the glycinates."

While specific chronic, reproduvtive and developmental toxicity or carcinogenicity studies were unavailable, studies with female pigs receiving mineral glycinates dietary supplementation throughout a period covering multiple litters showed "no adverse effects on reproduction or on the resulting offspring were observed."

The Panel noted that these longer-term feeding studies are of limited value for the assessment of either chronic toxicity or carcinogenicity of the chelates, due to the relatively short duration of the studies relative to the life span of the pig and the small numbers of animals used in the studies.

Exposure Estimated exposure to the nutrients from all sources were: copper (5mg/day), zinc (25mg/day), calcium (2500mg/day) and magnesium (250mg/day).

The equivalent exposure was 12mg glycine per day for copper bisglycinate, 57mg glycine per day for zinc bisglycinate, 9239mg glycine per day for calcium bisglycinate and 1523mg glycine/day for magnesium bisglycinate.

The average intake of glycine in proteins from both food of animal origin, and vegetable origin was calculated to be about 26 mg/kg bw/day for adults and about 43 mg/kg bw/day for children.