The Panel considers that since the exposures from the proposed use levels for calcium caprylate and magnesium caprylate are not comparable to the estimated dietary exposures for caprylic acid, and would result from a single bolus dose, it is not possible to assume that there would be sufficient capacity to handle this load of caprylic acid using normal metabolic pathways. However, the Panel notes that the nutrients are only 7-12 % by weight of the caprylate, so if calcium and magnesium were administered at the UL, exposure to caprylic acid from the sources would be significant, both in absolute weight and in calorific terms. The Panel concludes that there are insufficient toxicological data on caprylic acid itself to allow conclusions on the safety of the proposed use and use levels of calcium caprylate and magnesium caprylate. The Panel notes that read across from the tricaprylin data would result in inadequate safety margins but concludes that such a read across is inappropriate since the forestomach effect may result from tricaprylin and not caprylic acid. Nevertheless, the caprylin data could indicate possible concerns about caprylic acid. Also, the Panel highlights the paucity of toxicological data on caprylic acid, and considers that long term toxicity data on caprylic acid would be needed for an adequate assessment. The Panel concludes that the Calcium caprylate and magnesium caprylate added for nutritional purposes as sources of calcium and magnesium to food supplements amounts of cap rylic 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 Panel therefore concludes that the safety of calcium caprylate and magnesium caprylate, as sources of calcium and magnesium respectively, at the proposed use levels cannot be established based on the available information.
Calcium caprylate and magnesium caprylate added for nutritional purposes as sources of calcium and magnesium to food supplements
GRILLI, SANDRO;
2009
Abstract
The Panel considers that since the exposures from the proposed use levels for calcium caprylate and magnesium caprylate are not comparable to the estimated dietary exposures for caprylic acid, and would result from a single bolus dose, it is not possible to assume that there would be sufficient capacity to handle this load of caprylic acid using normal metabolic pathways. However, the Panel notes that the nutrients are only 7-12 % by weight of the caprylate, so if calcium and magnesium were administered at the UL, exposure to caprylic acid from the sources would be significant, both in absolute weight and in calorific terms. The Panel concludes that there are insufficient toxicological data on caprylic acid itself to allow conclusions on the safety of the proposed use and use levels of calcium caprylate and magnesium caprylate. The Panel notes that read across from the tricaprylin data would result in inadequate safety margins but concludes that such a read across is inappropriate since the forestomach effect may result from tricaprylin and not caprylic acid. Nevertheless, the caprylin data could indicate possible concerns about caprylic acid. Also, the Panel highlights the paucity of toxicological data on caprylic acid, and considers that long term toxicity data on caprylic acid would be needed for an adequate assessment. The Panel concludes that the Calcium caprylate and magnesium caprylate added for nutritional purposes as sources of calcium and magnesium to food supplements amounts of cap rylic 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 Panel therefore concludes that the safety of calcium caprylate and magnesium caprylate, as sources of calcium and magnesium respectively, at the proposed use levels cannot be established based on the available information.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
