Aspartame: EFSA Launches Additional Call for Data

Previously planned for completion by 2020, the review of this sweetener is part of the systematic re-evaluation of all food additives authorised in the EU prior to 20 January 2009, as anticipated under Regulation EU 257/2010.

27 Jul 2012 --- In May 2011, EFSA was asked by the European Commission to bring forward the full re-evaluation of the safety of aspartame (E 951) to 2012. Previously planned for completion by 2020, the review of this sweetener is part of the systematic re-evaluation of all food additives authorised in the EU prior to 20 January 2009, as anticipated under Regulation EU 257/2010.

EFSA accepted this mandate and launched a public call for scientific data as well as a thorough literature review, enabling the Authority’s Panel on Food Additives and Nutrient Sources Added to Food (ANS) to start its risk assessment in early 2012.

In the course of its scientific deliberations, the Panel found that there were too little data available on 5-benzyl-3,6-dioxo-2-piperazine acetic acid (DKP) and other potential degradation products that can be formed from aspartame in food and beverages when stored under certain conditions. EFSA is therefore launching an additional call for data on DKP and other degradation products of aspartame.

To consider these additional data, coupled with a willingness to publicly consult on its draft opinion, means that EFSA’s ANS Panel will not finalise this work by end September 2012, as previously communicated.

EFSA is currently discussing with the European Commission the deadline for the final opinion and will continue to provide updates on the status of its work on aspartame.

The purpose of this call for data is to offer interested parties and all stakeholders the opportunity to submit any available documented information, published or unpublished, including also original raw data on the products which can be formed from aspartame (E 951) in the different types of foodstuffs taking into account the conditions of manufacturing and storage and the direct use as a table top sweetener.

The information of interest to EFSA consists in the following:
•  any data on the presence and levels of DKP found in aspartame-containing foodstuffs (including beverages) found on the market.
•  any data that could contribute to better specify the formation of DKP and other primary or secondary degradation products from aspartame and the amounts formed.
•  analytical data on the DKP (indication of stereoisomers included) and aspartame content in the different types of foodstuffs (including beverages) in which aspartame may be used: (i) immediately after addition of aspartame; (ii) following the food production (under all processing conditions); (iii) following storage under various conditions (e.g. temperature, light and time); (iv) following preparation for serving.
•  analytical data on other primary or secondary degradation products (indication of stereoisomers included) from aspartame and aspartame content in the different types of foodstuffs (including beverages) in which aspartame may be used: (i) immediately after addition of aspartame; (ii) following the food production (under all processing conditions); (iii) following storage under various conditions (e.g. temperature, light and time); (iv) following preparation for serving.
•  any information on the DKP stereoisomer used as test material in the biological and toxicological studies on DKP previously provided to EFSA4.
•  any data on the presence of DKP in foodstuffs from sources other than aspartame.