Aspartame, also known as E 951, is an artificial sweetener that has been approved for use in foods and beverages in the European Union (EU), and as a flavour enhancer or sweetening agent for non-medicinal purposes in natural health products (NHPs) in Canada. In both the EU and Canada, aspartame has been allowed as an additive in foods/beverages or NHPs, respectively, at an upper limit of 40 mg/kg body weight per day for oral consumption for its acceptable daily limit (ADI)1 or toxicity restriction2.
Currently, the European Food Safety Authority (EFSA) is conducting new risk assessments for food additives that have been permitted prior to January 20, 2009, as per the European Commission (EC) Regulation No. 1333/2008 [Article 32]3. For approved sweeteners, risk assessments are scheduled to be completed by December 31, 2020. However, the European Commission has requested that the risk assessment for aspartame be prioritized by EFSA with an earlier evaluation deadline of July 31, 2012 due to concerns over the presence of degradation products, in particular DKP (5-Benzyl-3,6-dioxo-2-piperazine acetic acid).
Due to limitations in the available data for DKP and other primary and secondary degradation products of aspartame when the evaluation commenced in September 2011, EFSA has requested and was granted an extension for the full re-evaluation until May 2013 by the European Commission4. For its full review of aspartame, EFSA is seeking data on degradation products of aspartame that may arise under certain storage conditions of foods and/or beverages. Storage conditions may include:
EFSA is also seeking data to better understand the formation of DKP and other degradation products of aspartame, and other possible food sources of DKP and their respective levels. As such, EFSA is requesting analytical data on levels of degradation products of aspartame in various products on the market in order to characterize the extent of exposure to these compounds.
Although extensive reviews on the use and safety of aspartame have been conducted for many years, recently published articles have given rise to safety concerns5. In 2010, two studies were conducted to investigate possible health effects from consumption of artificial sweeteners. One study was a carcinogenicity study conducted in mice6, and the second study was an epidemiological study investigating an association between the consumption of soft drinks with artificial sweetener and preterm deliveries7. EFSA’s scientific experts questioned the validity of both studies by a) indicating methodological limitations in the mouse study (i.e. mouse strain used, and the influence on the length of the study and b) indicating a lack of a causal effect for preterm births and artificial sweeteners in the Halldorsson study (i.e. preterm deliveries were medically induced rather than occurring spontaneously). As such, EFSA has noted that these studies provide sufficient cause to reconsider previous safety assessments of aspartame or other sweeteners that are authorized in the EU5.
With respect to the degradation product DKP, extensive animal studies have been examined and summarized by The Joint FAO/WHO Expert Committee on Food Additives (JECFA). JECFA’s summary has indicated that an estimated DKP ADI for men was 7.5 mg/kg body weight per day, based on 750 mg/kg body weight, the dose at which no toxicological effects occurred in a 115 week rat study. DKP data were considered alongside aspartame in JECFA’s safety conclusion of aspartame8.
For interested parties and stake holders, the deadline to submit data to EFSA for aspartame and its degradation products (including DKP) has been extended until September 30, 20123. EFSA has requested that information be submitted electronically or on physical media such as CD or DVD. For further details on submitting information to EFSA on aspartame degradation products please refer here. The extension will allow stakeholders and all interested parties to submit not only published data, but any unpublished or newly generated data for DKP and primary and secondary degradation products of aspartame to EFSA. Furthermore, the May 2013 extension for completing a re-evaluation of aspartame will provide EFSA ample time to review the most up-to-date information in order to form their final opinion of this particular food additive.
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