Call for Aspartame (E 951) use level and/or analytical data in food and beverages intended for human consumption
Background
Regulation (EC) No 1331/2008[1] establishes a common procedure for the assessment and authorisation of food additives, which shall be subject to a safety evaluation by the European Food Safety Authority (EFSA) before they are permitted for use in the European Union. In addition, it is foreseen that food additives must be kept under continuous observation and must be re-evaluated by EFSA.
For this purpose, a programme for the re-evaluation of food additives that were already permitted in the European Union before 20 January 2009 has been set up under Regulation (EU) No 257/2010.[2] This Regulation also foresees that food additives are re-evaluated whenever necessary in the light of changing conditions of use and new scientific information. For efficiency and practical purposes, the re-evaluation should, as far as possible, be conducted by grouping food additives according to the main functional class to which they belong. The order of specific priorities for the re-evaluation of the currently approved food additives is listed in Annex II of Regulation (EU) No 257/2010.
In the context of the ongoing re-evaluation of the food additive salt of aspartame-acesulfame (E 962), the Panel on Food Additives and Flavourings (FAF Panel) was consulted during its 9th plenary meeting[3] with respect to the data to be used to estimate total exposure to the two moieties of the food additive E 962. The FAF Panel recommended the launch of a public call for concentration data (use and use levels) for aspartame (E 951) that could complement the data already received for the salt of aspartame acesulfame (E 962) in response to the previous call issued in 2018.
Deadline for submission of data
This call for data is requesting use levels and/or analytical data for aspartame (E 951). The deadline for the submission of data is 1 October 2020.
Interested business operators and any other interested parties shall submit the data related to the re-evaluation of a food additive within the period set by the call for data according to Article 6(1) of Regulation (EU) No 257/2010. In addition, in accordance with Article 6(4), the information not submitted within the final deadline will only exceptionally be considered and EFSA can finalise its opinions on the basis of information already provided.
The mode for data submission is described below. Data provided may be used in the EFSA opinions depending on their quality, and exclusion criteria will be indicated in the respective document. In addition, only the data provider organisation will be cited in the EFSA opinions.
Further calls for data in relation to the remaining food additives to be re-evaluated according to Regulation (EU) No 257/2010 will be launched.
Confidentiality
According to Article 8 of Regulation (EU) No 257/2010 setting up a re-evaluation programme of approved food additives, confidential treatment may be given to information the disclosure of which might significantly harm the competitive position of business operators or other interested parties.
Therefore, the business operators and/or the interested parties should indicate which information they wish to be treated as confidential and provide verifiable justification supporting this request.
Contact details
Please address any technical inquiries regarding the reporting of data to: data.collection [at] efsa.europa.eu.
Submission of use level data
Individual food manufacturers and food manufacturer associations are invited to submit data on use levels of additives in food and beverages for human consumption for aspartame (E 951). In order to streamline the data collection exercise, food manufacturers are invited to liaise with the relevant food manufacturer associations for the data submission. In particular, data providers shall ensure that the same data are not sent several times to EFSA: for example, sent by both the food manufacturer and also by the association to which the food manufacturer belongs.
If an interested party has information that aspartame (E 951) is not used for one or several food categories, this information is highly relevant for EFSA. Such information will be of course cross-checked with information sent by all interested parties.
Data providers should be aware that EFSA may need to contact them once the initial submission is received. The aim is to clarify foods not well characterised/identified or to check any possible mistakes (e.g. on MPLs) or data that is not plausible (e.g. on reported levels, proposed dilution factors). Replies to these requests are strongly encouraged as EFSA reserves the right to discard these data if feedback is not received.
Data submission of use levels of aspartame (E 951) in food and beverages intended for human consumption should be reported in the template specifically developed for this call and published on Zenodo together with a short guide https://zenodo.org/record/3859927#.XvDP8WgzbIU
Should you need any support in filling in the reporting template, please contact data.collection [at] efsa.europa.eu (data[dot]collection[at]efsa[dot]europa[dot]eu)
Data should be submitted directly to EFSA using the dedicated e-mail address for this service: data.collection [at] efsa.europa.eu (data[dot]collection[at]efsa[dot]europa[dot]eu)
Submission of analytical/results
Food manufacturers, national food authorities, research institutions, academia, food business operators and other stakeholders are invited to submit analytical data on concentration levels in food and beverages intended for human consumption for aspartame (E 951) .
Data should be transmitted in electronic format (XML) using the EFSA web interface 'Data Collection Framework (DCF)' (https://dcf.efsa.europa.eu/dcf-war) in the data collection folder CHEM_MON_SSD2_WF2.2020. The guidance 'Chemical monitoring reporting Guidance: 2020 data collection' should also be consulted for reporting requirements and is available at https://www.efsa.europa.eu/en/supporting/pub/en-1796
In order to receive access to the DCF web interface please contact: data.collection [at] efsa.europa.eu
[1] Regulation (EC) No 1331/2008 establishing a common authorisation procedure on food additives, food enzymes and food flavourings. OJ L 354, 31.12.2008, p.1.
[2] Regulation (EU) No 257/2010 of 25 March 2010 setting up a programme for the re-evaluation of approved food additives in accordance with Regulation (EC) No 1333/2008. OJ L 80, 26.03.2010, p. 19.
[3] https://www.efsa.europa.eu/sites/default/files/event/190924-m.pdf