Call for food additives usage level and/or concentration data in food and beverages intended for human consumption (Batch 6)

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.

Deadline for submission of data

The deadline for the submission of data (Batch 6) is 30 November 2017, and details are listed in Table 1.

The interested business operators and any other interested party 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 the information already provided.

Further calls for data in relation to the food additives re-evaluation work programme will be published according to the deadlines laid down in Regulation (EU) No 257/2010.

Table 1: List of food additives for which usage levels and/or concentration data are requested (Batch 6)

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.

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@efsa.europa.eu.

Submission of usage level data

Individual food manufacturers and food manufacturer associations are invited to submit data on usage levels of additives in food and beverages for human consumption for the food additives listed in Table 1. In order to streamline the data collection exercise, food manufacturers are invited to liaise with the relevant food manufacturer associations for the data submission.

Data submission of usage 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.xls). This format is structured in accordance with the Guidance on Standard Sample Description[3] (SSD Guidance) and includes features that support manual data entry.

To submit usage level data please download the zip file 'ADD_usage_data_submission.zip', which also contains a technical guidance on the use of the reporting template ('Guide_using_Reporting_format_additives.doc'). Please follow the instructions described in 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@efsa.europa.eu

Data should be submitted directly to EFSA using the dedicated e-mail address for this service: data.collection@efsa.europa.eu

The documentation needed to support the data collection on food additiveusage levels is summarised below:

ADD_usage_data_submission.zip including the following files:

• MS Excel^® AddUseLevTemplate.xls
• MS Excel^® StandardSampleDescription_ADD.xls
• Guide_using_Reporting_format_additives.doc

Submission of concentration data (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 the food additives listed in Table 1.

Data should be transmitted using the EFSA web interface 'Data Collection Framework (DCF)' (https://dcf.efsa.europa.eu/dcf-war) in the relevant data collection folder Additives_2017_WF2.  Please be aware that the data collection for the submission of additive analytical results will open in the DCF from 15 May 2017 in line with the opening of the data collection on chemical contaminants. In order to receive access to the DCF web interface please contact: data.collection@efsa.europa.eu.

The revised ‘Specific requirements for chemical contaminant and food additive occurrence data submission’ will be published before the Additives_2017_WF2 data collection is open. For the collection of concentration data (analytical results), the general recommendations and mandatory fields apply as specified in this document

In case data are compiled using the simplified excel file 'MS Excel^® genericreportingformat.xls' (available at: http://www.efsa.europa.eu/sites/default/files/assets/genericreportingformat.xls), they cannot be directly transmitted using the DCF web interface. In this case, data should be sent to the e-mail address: data.collection@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] European Food Safety Authority; Standard sample description for food and feed. EFSA Journal 2010;8(1):1457 [54 pp.]. https://efsa.onlinelibrary.wiley.com/doi/abs/10.2903/j.efsa.2010.1457