Call for data for the re-evaluation of malic acid and malates (E 296; E 350-352) as food additives

Deadline for registering interest: 28 July 2024
Deadline for submission of data: 31 December 2024

Background

According to Regulation (EC) No 1333/2008[1], food additives that 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]. This programme 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 malic acid and malates (E 296; E 350-352).

In order to ensure an effective re-evaluation, it is important that EFSA retrieves from the interested parties all the relevant data for the re-evaluation of the selected food additives.

Therefore, in accordance with 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(EU) No 257/2010, EFSA launches a public call for data, in order to acquire documented information (published and/or unpublished) on malic acid and malates (E 296; E 350-352).

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institutions, academia) and/or other stakeholders, the opportunity to submit documented information (published and/or unpublished) relevant to the re-evaluation of the following food additives:

_{TABLE 1. List of the food additives included in this call for data}

These food additives were already included in a previous ‘Call for data on miscellaneous food additives’ published by EFSA in 2010 [3] 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 (RAL[at]efsa[dot]europa[dot]eu)) on the following topics:

1. Identity and characterisation of the food additives 

2. Confirmation of adequacy of conventional risk assessment 

3.      a) Information on manufacturing process and related specifications
         b) Information on production organism(s) 
         c) Presence of toxicologically relevant impurities and related specifications

4.       Information on natural occurrence

5.       Additional data on uses and use levels (submit to:data.collection [at] efsa.europa.eu (data[dot]collection[at]efsa[dot]europa[dot]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 tool by 28/07/2024. 

EU Survey Malic acid and malates 

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 257/20102 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 and 4.2. 

Interested business operators 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 attachment is not allowed) with:

• The heading of the email to RAL indicating: Call for data for Malic acid and malates
•  A cover letter that should contain:
  o    Reference to the specific call Reference to the substance(s) concerned and its E numbers and its EFSA question number.
  o    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.
  o    A 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.
• Please create separate folders with the confidential and with the non-confidential parts.

Submission of information sought at point n. 4.1

Interested parties should submit the information to EFSA, data.collection [at] efsa.europa.eu (data[dot]collection[at]efsa[dot]europa[dot]eu). 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)[4] 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 

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.

Correspondence

Once internet-based software chosen please kindly send the link and login to RAL [at] efsa.europa.eu. You may provide the password by phone, if so, you are kindly asked to call the following phone no +39 0521 036 246 as soon as email with the links is sent. Alternatively, it can be sent in a separate email to RAL [at] efsa.europa.eu (RAL[at]efsa[dot]europa[dot]eu).

Data providers of uses and use levels (information sought n.4.1) 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.

For additional questions on this process the following functional mailboxes can be used: