Registration deadline: 15 September 2023
Submission deadline: 31 March 2024
Re-evaluation of gluconic acid (E 574) and related food additives (e 575-579)
Under the programme for the re-evaluation of food additives set in Regulation (EU) No 257/2010.
Background
According to Regulation (EC) No 1333/2008[1], food additives which were permitted for use in the European Union before 20 January 2009 need to be re-evaluated by the European Food Safety Authority (EFSA). The programme for this re-evaluation is defined by Regulation (EU) No 257/2010[2]. The programme for the re-evaluation of food additives should have been completed by the end of December 2020, however this deadline could not be achieved and a number of food additives remain to be re-evaluated.
Among the food additives that remain to be re-evaluated in accordance with the above regulations, EFSA is interested in collecting any documented information that could support the re-evaluation of gluconic acid (E 574) and related food additives (E 575-579).
In order to ensure an effective re-evaluation, it is important that EFSA retrieves from interested parties all relevant data for the re-evaluation of the selected food additives.
Therefore, in accordance to article 6(3) of the Regulation (EU) No 257/2010, EFSA launches a public call for data in order to acquire documented information (published and/or unpublished) on gluconic acid (E 574) and related food additives (E 575-579).
The submission of the requested information is without prejudice to the final opinion of the FAF Panel.
Overall objective
The purpose of this call for data is to offer interested parties (e.g. food business operators, national food authorities, research institutions, academia) and/or other stakeholders, the opportunity to submit documented information (published and/or unpublished) relevant to the re-evaluation of the following food additives:
| Name | E number | Synonyms/ Chemical name | EFSA-Q-Number |
| GLUCONIC ACID | E 574 | D-gluconic acid; Dextronic acid / Gluconic acid | 2011-00684 |
| GLUCONO-DELTA-LACTONE | E 575 | Gluconolactone; GDL; D-Gluconic acid delta-lactone; Delta-gluconolactone / D-Glucono-1,5-lactone; | 2011-00685 |
| SODIUM GLUCONATE | E576 | Sodium D-gluconate / Sodium salt of D-gluconic acid | 2011-00686 |
| POTASSIUM GLUCONATE | E 577 | Potassium salt of D-gluconic acid / Potassium D-gluconate | 2011-00687 |
| CALCIUM GLUCONATE | E 578 | Calcium salt of D-gluconic acid/ Calcium di-D-gluconate | 2011-00688 |
| FERROUS GLUCONATE | E 579 | Ferrous di-D-gluconate dihydrate; Iron(II) di-gluconate dihydrate | 2011-00689 |
These food additives were already included in a previous call for data published by EFSA in 2012[3].
Submission of use level data
Data on uses and use levels in food were also already collected by EFSA by means of a “Call for food additives usage level and/or concentration data in food and beverages intended for human consumption (Batch 5)”[4]published in 2016 and closed in 2017.
Individual food manufacturers and food manufacturer associations are invited to submit data on use levels of food additives in food and beverages for human consumption for the food additives listed above. 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 (e.g. by both the food manufacturer and also by the association to which the food manufacturer belongs to).
If an interested party has information that a food additive is not used for one or several food categories, this information is highly relevant for EFSA. Such information will be 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 not plausible data (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 approved food additives in food and beverages intended for human consumption should be reported in the template developed for this purpose (MS Excel AddUseLevTemplate.xlsm). This format is structured in accordance with the Guidance on Standard Sample Description [1] (SSD Guidance) and includes features that support manual data entry.
- To submit use level data please download the zip file 'ADD_use_data_submission.zip', which also contains a technical guidance on the use of the reporting template (‘Guidance on using addUseLevTemplate.pdf’). Please follow the instructions described in the first work sheet of the Template, and more extensively within the technical guidance for the correct use of the reporting format to avoid compromising its functionalities.
Should you need any support in filling in the reporting format, please contactdata.collection [at] efsa.europa.eu (data[dot]collection[at]efsa[dot]europa[dot]eu)
Use levels datasets should be saved and 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)
The documentation needed to support the data collection on food additive use levelsis summarised below:
ADD_use_data_submission.zipincluding the following files:
- MS Excel®AddUseLevTemplate.xlsm
- Guidance on using addUseLevTemplate.pdf
- Annex Food Category Description
[1] European Food Safety Authority; Standard sample description for food and feed.EFSA Journal 2010;8(1):1457 [54 pp.].
https://www.efsa.europa.eu/en/efsajournal/pub/1457
Data on uses and use levels in food were also already collected by EFSA by means of a “Call for food additives usage level and/or concentration data in food and beverages intended for human consumption (Batch 5)”[4] published in 2016 and closed in 2017.
Interested parties that have already submitted information in response to the above calls do not need to reply again to the present call, unless they can contribute with additional information not previously provided to EFSA.
Deadlines for submission of data and disclosure of contact details
Interested parties and stakeholders should provide by 31/03/2024 the information described below, except for the information requested under point 3.A.
Please communicate in writing by e-mail to: RAL [at] efsa.europa.eu, your availability to submit the requested information by the timeline specified above or any proposal for a new deadline providing justified reasons.
In accordance with Article 6(4) of the Regulation (EU) No 257/2010, the information not submitted within the final deadline will only exceptionally be considered and EFSA can finalise its opinions on the basis of the information already provided.
[1] Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives, OJ L 354, 31.12.2008. Available here:https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32008R1333
[2] Commission 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. Available here:
[3] https://www.efsa.europa.eu/sites/default/files/consultation/120706a.pdf
[4] https://www.efsa.europa.eu/it/data/call/160524
