Following its Call for data, EFSA was given access to over 600 datasets for use in its full re-evaluation of aspartame, which is scheduled for completion in 2012. As is standard following a call for data, some of the submissions requested by EFSA have not yet been received.
Reaffirming its commitment to openness and transparency, the Authority has published the full list of studies that were made available to EFSA. The Authority has also made publicly available previously unpublished scientific data including the 112 original studies on aspartame which were submitted to support the request for authorisation of aspartame in Europe in the early 1980s. (These studies are individually numbered and available in batches for ease of access.)
When the pending submissions have been received and any related issue (e.g. confidentiality) clarified, EFSA will update these lists with the additional scientific information in due course.
Summary of the Call for data
Launched: 1 June 2011. Closed: 30 September 2011
The purpose of this Call for data was to offer interested parties and/or all stakeholders the opportunity to submit any available documented information, published or unpublished, including also original raw data on Aspartame (E951). The information of interest to EFSA consists in any scientific or technical data that could contribute to the safety assessment of this food additive.
Confidentiality and unpublished data
Specific issues relating to confidentiality of the data provided are discussed between the owners of the data and EFSA. In application of Article 8.4 of Regulation 257/2010, following a proposal from EFSA, the European Commission decides after consulting the interested business operator and/or the other interested parties which information may remain confidential and shall notify EFSA and the Member States accordingly.