Open call for food additives/food flavourings analytical, use level and presence data during the first pilot under the monitoring programme in food and beverages intended for human consumption

Deadline for submission: 30/06/2025
Deadline for validation and acceptance of data: 31/08/2025

Background

Regulation (EC) No 1333/2008 and Regulation (EC) No 1334/2008 lay down rules on food additives (FA) and food flavourings (FF) used in foods with a view to ensure the effective functioning of the internal market whilst ensuring a high level of protection of human health. These regulations aim to protect consumer interests and fair practices in food trade, protecting the environment where feasible, also providing a list of FA/FF and source materials approved for use in and on foods, conditions of use of such substances and rules on the labelling of FA/FF sold as such.

The objective of the monitoring of the consumption and the use of FA/FF is to gather data on their intake and to assess that their use does not raise a health concern. This monitoring helps in verifying the dietary intakes estimated at the time of establishment of the authorisation or re-evaluation. The monitoring is also a relevant information source for future risk management measures. Finally, the data collected during the monitoring could be used for future risk assessment purposes, e.g., to assess the combined exposure to multiple chemicals. To achieve this objective, a common terminology and methodology need to be implemented. 

For such purpose, EFSA has developed a new data collection allowing direct data submission of monitoring data on FA/FF by interested stakeholders, and collection of analytical data, use levels and presence data (M-2022-00210). The new data collection will be piloted in 2025 and 2026.

Following the Commission Recommendation (EU) 2023/965 on the methodology for the monitoring of FA/FF intake, MS should collect at least one of the following types of data:

(a)    Analytical data: concentration of FA/FF measured in food.
(b)    Use level data: concentration of FA/FF reported by business operators to be added to food.

MS may also collect (c) presence data, i.e., data on the presence or the absence of a specific FA/FF in a foodstuff. Since the collected data should allow for the calculation of the FA/FF intake, the collection of presence data alone is not sufficient, and MS should collect at least one type of occurrence data (analytical or use level data). However, it is recommended to also collect presence data to identify whether a FA/FF is used or not used in a particular foodstuff. 

Submission of data

National food authorities, research institutions, academia, food business operators and other stakeholders are invited to submit analytical, use level and presence data on FA and FF. The full list of FA and FF that can be reported and their corresponding codes are published with this call in the excel file ‘PARAM_addAnalysis_flavAnalysis.xlsx’. The preparation of this excel was based on version 16.2 of PARAM catalogue. The full list of restrictions and exceptions that can be reported and their corresponding codes are published with this call in the excel file ‘ADDFOOD_Restrictions_Exceptions.xlsx’. The preparation of this excel was based on version 7.1 of ADDFOOD catalogue.

Priority list of food additives and food flavourings under the monitoring programme:

SubstanceDeadline for data submission
Green S (E 142)30 June 2025
Tartrazine (E 102)30 June 2025
Ponceau 4R/Cochineal Red A (E 124)30 June 2025
Caffeine (16.016)30 June 2025
Pulegone (Annex III)30 June 2025

How to submit data

Data must be submitted in electronic format (XML) to the EFSA Data Collection Framework (DCF) https://dcf.efsa.europa.eu/dcf-war/dc. User credentials are required to access the DCF web interface. Please, contact data.collection [at] efsa.europa.eu to obtain the credentials.

The annual major release of the catalogues (31/01/2025) can be downloaded from https://doi.org/10.5281/zenodo.779880.
Guidance on the installation and use of the EFSA Catalogue browser can be found at http://www.efsa.europa.eu/en/supporting/pub/en-1726.

The DCF will open for the reporting of FA and FF analytical, use level and presence data on 1 April 2025. The deadline for the complete transmission of all data through DCF is 30 June 2025. The last two months, period of 1 July – 31 August is set for the data validation and data acceptance in EFSA Scientific Data Warehouse (sDWH). 

Analytical data

EFSA will only accept data in SSD2 (Standard Sample Description version 2) format. Analytical data will be reported under the Chemical Monitoring Data Collection. In case data are compiled manually using the EFSA tools available at https://zenodo.org/records/10886138, the XML file must be generated for direct submission to the DCF. The guidance ‘Chemical monitoring reporting guidance: 2025 data collection’ should also be consulted for reporting requirements and is available at https://doi.org/10.2903/sp.efsa.2025.EN-9245

Use level data

Use level data will be reported under the new data collection on use levels. EFSA will only accept data using the new data model format. In case data are compiled manually using the EFSA tools available at https://doi.org/10.5281/zenodo.14893177, the XML file must be generated for direct submission to the DCF. The ‘Reporting guidance for use level data on food additives and food flavourings – 2025’ should also be consulted for reporting requirements and is available at https://doi.org/10.2903/sp.efsa.2025.EN-9285.

Presence data 

Presence data together with analytical data should be submitted to EFSA using SSD2. Presence data together with use levels should be submitted to EFSA using the new data collection on use levels. The reporting of no presence data alone at sample level should be reported using the new data model for no presence. In case data are compiled manually using the EFSA tools available at https://doi.org/10.5281/zenodo.14893698,  the XML file must be generated for direct submission to the DCF. The ‘Reporting guidance for no presence data on food additives and food flavourings at sample level – 2025’ should also be consulted for reporting requirements and is available at https://doi.org/10.2903/sp.efsa.2025.EN-9284

Confidentiality

The communication below is not applicable to Member State competent authorities.

Please note that all confidentiality requests related to datasets submitted within the frame of this call for data must be submitted exclusively via Portalino. Submission of data in any other form (email, third party e-submission platforms, etc.) will not be accepted.

Guidance about the confidentiality assessment process and information on how to submit confidentiality requests are available here and here. In addition, instructions on how to use Portalino are available here. Whenever a confidentiality request is submitted, a non-confidential version (in which the data claimed confidential has been redacted/blackened) and a confidential version (in which the data claimed confidential has been earmarked but remains visible) must be submitted.

Data providers should clearly indicate the data collection in which the dataset of concern was transmitted (e.g. Chemical Monitoring data collection 2025; Data Collection Framework (DCF) folder: CHEM_MON_SSD2_W2.2025) and dataset-ID as found in DCF.

Please note that confidentiality requests must be submitted via Portalino if information should be kept confidential since EFSA is required to proactively publish all data on which it bases its Scientific Output pursuant to Article 38(1)(d) of the GFL and Article 6(1) of EFSA’s Practical Arrangements concerning transparency and confidentiality after the adoption of the relevant scientific output/opinions.

Contact details

Please address any technical enquiries regarding the reporting of data to data.collection [at] efsa.europa.eu (data[dot]collection[at]efsa[dot]europa[dot]eu)