EFSA Keeps Aspartame ADI at 40 mg/kg, Finds 3 Sweeteners 'Safe at Current Use Levels'

The European Food Safety Authority (EFSA) issued a scientific opinion that the sweeteners aspartame (E 951), acesulfame K (E 950) and aspartame-acesulfame salt (E 962), which combines the two, raise no safety concern at currently authorised uses and use levels. The re-evaluation was requested by the European Commission. The Panel on Food Additives and Flavourings (FAF) pulled together the human and animal evidence it had assessed systematically. Intake estimates drew on 46 dietary surveys from 23 European countries.

Because E 962 splits into aspartame and acesulfame ions after ingestion, the panel evaluated the two components separately. No genotoxicity concern was identified for aspartame or its main breakdown product, DKP. No new studies were available to set a new reference point, so the existing acceptable daily intake (ADI) of 40 mg per kg of body weight was kept. For acesulfame K, the ADI of 15 mg/kg set in an earlier re-evaluation was applied. Estimated dietary exposure was generally below the ADI for both components. The panel recommended tidying up the specifications for E 962 and revisiting the arsenic and lead limits in the aspartame specifications.

'Hazard identification' versus 'risk assessment'

Confusion has persisted because IARC classified aspartame as 'possibly carcinogenic to humans (Group 2B)'. EFSA explains that IARC's hazard identification and the risk assessments by JECFA and EFSA differ in purpose and method. IARC looks at whether something can cause cancer, while a risk assessment asks whether health effects occur at actual intake levels. This conclusion, too, applies when intake is within the ADI. People with phenylketonuria need extra caution because of the phenylalanine released from aspartame.