EFSA has conducted a full re-evaluation of this artificial sweetener, covering data made available up until November 2012. From the available laboratory animal database EFSA identified chronic, reproductive and developmental toxicity endpoints as critical. Its subsequent risk assessment was based on developmental toxicity, thought to result from aspartame’s metabolism to phenylalanine. Relevant human data on the developmental toxicity of phenylalanine came from phenylketonuria (PKU) patients, homozygous for phenylalanine hydroxylase mutations, who have a markedly reduced capacity for metabolising this amino acid. PKU patients and their offspring (exposed during pregnancy) can exhibit developmental effects if phenylalanine intake is poorly controlled. Clinical guidelines recommend that plasma phenylalanine should be kept below 360 μM. Realistically, dietary intake of aspartame is not expected to result in peak phenylalanine levels above 240 μM. An administration of 40 mg aspartame/kg bw (the current acceptable daily intake) would not exceed 360 μM plasma phenylalanine in high consuming healthy, and PKU heterozygous (with a slightly reduced capacity to metabolise phenylalanine), individuals. EFSA therefore supported the current ADI. The safety of the aspartame metabolites phenylalanine, methanol and aspartic acid, and the degradation product 5-benzyl-3,6-dioxo-2-piperazine acetic acid (DKP), were additionally reviewed. Interested parties are invited to comment on this draft document by 15 February.

European Food Safety Authority. Panel on Food Additives and Nutrient Sources added to Food (ANS). Draft opinion on the re-evaluation of aspartame (E951) as a food additive.


The above item was taken from the January–February 2013 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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