Call for data for the re-evaluation of fumaric acid (E 297) and succinic acid (E 363) as food additives

These food additives were already included in previous calls for data published by EFSA in 2010^[3] and in 2012^[4], however no data were received.

The purpose of this call for data is to collect information (data to be submitted to RAL [at] efsa.europa.eu) on the following topics:

1. Confirmation of adequacy of the conventional risk assessment for fumaric acid E 297
2. a) Information on manufacturing process and related specification
   b) Information on production organism(s)
   c) Presence of toxicologically relevant impurities and related specifications
3. Information on natural occurrence
4. Additional data on uses and use levels (submit to: data.collection [at] efsa.europa.eu)

Please refer to documents at the bottom of this webpage for full information on the data requirements.

Deadline for submission of interest via EU survey

Interested parties and stakeholders should express their interest to submit data via EU Survey EU Survey Fumaric and Succinic Acid by 28/07/2024.

Deadline for submission of data

Interested parties and stakeholders should provide by 31/12/2024 the information described below.

In accordance with Article 6(4) of the Regulation (EU) No 257/2010^[2] 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.

In order to facilitate the collaboration of all interested parties to provide the data needed, we are seeking your consent to disclose the name and address of your organisation/business to the other parties that has expressed an interest to provide the requested information. If you do not wish to make these contact details available, clearly indicate it in your first communication.

Confidentiality

In accordance with Article 8 of Regulation (EU) No 257/2010, in the version of the text in force prior to 27 March 2021, 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, data providers should indicate any information they wish to be treated as confidential and provide verifiable justification supporting this request. Please also note that the information described in Article 8(2) of Regulation (EU) No 257/2010, in the version of the text in force prior to 27 March 2021, cannot be regarded as confidential in any circumstances.

In application of Article 8(4) of Regulation (EU) 257/2010, in the version of the text in force prior to 27 March 2021, following a proposal from EFSA, the Commission will decide after consulting the interested business operator and/or the other interested parties, which information may remain confidential.

Submission of information

Submission of information sought at points n. 1- 3.

Interested business operators and/or interested parties should submit the information to EFSA, RAL [at] efsa.europa.eu (RAL[at]efsa[dot]europa[dot]eu), through their chosen internet-based software (submission by email is not allowed) with:

• a cover letter that should contain:
  • Reference to the specific call Reference to the substance(s) concerned and its E numbers and its EFSA question number.
  • The contact details (name of contact person, name of company/organisation, e-mail address and telephone number) of the person responsible for the data submission and, if applicable, the list of interested business operators and/or interested parties represented and their contact details.
• statement of the submitter that they hold all the necessary rights to grant EFSA permission to use and, where appropriate, to disclose the submitted information, data, document, paper, or study for the purposes better defined in this call. In case the submitter does not enjoy such rights for the submitted subject matter, they should share the contact details of the respective owner(s) of data and/or the holder(s) of any relevant intellectual property rights, so that EFSA may seek their approval directly.
• separate folders with the confidential and with the non-confidential parts.

Submission of information sought at point n. 4

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 (SSD Guidance) ^[5] 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 contact data.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 levels is summarised below: 

ADD_use_data_submission.zip including the following files:

• MS Excel^® AddUseLevTemplate.xlsm
• Guidance on using addUseLevTemplate.pdf
• Annex Food Category Description

Possibility for EFSA to use the data for the safety assessment of the same or other substance under the same or other legal or regulatory frameworks.
In case future mutual interests arise in exchanging any relevant information (i.e., technical, or toxicological data) with the Joint FAO/WHO Expert Committee on Food Additives (JECFA) for the re-evaluation of food additives or with other EU agencies (such as the European Medicines Agency (EMA)), we would appreciate your written consent for data sharing between EFSA and other EU agencies or JECFA on this additive.

Please note that EFSA may, where legally possible, use or re-use relevant information or data (i.e., technical, toxicological data) for the evaluation of the same or another substance under the same or a different legal or regulatory framework from the one mentioned above.