Regulation (EC) No 1333/2008 of the European Parliament and the Council on food additives requires that food additives are 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 Commission Regulation (EU) No 257/2010 of 25 March 2010. This Regulation also foresees that food additives are re-evaluated whenever necessary in 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 group of 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 Commission Regulation (EU) No 257/2010. In addition, the Panel on Food Additives and Nutrient Sources added to Food (ANS) discussed and agreed on a draft work programme for the re-evaluation of food additives for 2014 during its 48th plenary meeting.
Moreover, the European Commission has asked EFSA to carry out refined exposure assessments for tertiary-butyl hydroquinone (TBHQ) (E 319) and sucrose esters of fatty acids (E 473) further to the evaluations carried out by the EFSA Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) in 2004.
Deadline for submission of data
The deadline for the submission of data (Batch 3) is 30 September 2014, and details are listed in Table 1.
Further calls for data in relation to the food additives re-evaluation work programme for 2015 onwards will be published at a later stage.
Table 1: List of food additives for which usage levels and/or concentration data are requested in relation to the 2014 draft work programme (Batch 3)
|E number||Substance||Mandate number/Question number|
|M-2011-0160 / EFSA-Q-2011-00346|
|M-2011-0160 / EFSA-Q-2011-00345|
|M-2011-0160 / EFSA-Q-2011-00482|
|M-2011-0160 / EFSA-Q-2011-00483|
Tertiary-butyl hydroquinone (TBHQ)
|M-2013-0248 / EFSA-Q-2013-00690|
|M-2011-0160 / EFSA-Q-2011-00500|
|M-2011-0160 / EFSA-Q-2011-00507|
|M-2011-0160 / EFSA-Q-2011-00508|
Processed eucheuma seaweed
|M-2011-0160 / EFSA-Q-2011-00509|
Locust bean gum
|M-2011-0160 / EFSA-Q-2011-00510|
|M-2011-0160 / EFSA-Q-2011-00511|
|M-2011-0160 / EFSA-Q-2011-00512|
|M-2011-0160 / EFSA-Q-2011-00513|
|M-2011-0160 / EFSA-Q-2011-00514|
|M-2011-0160 / EFSA-Q-2011-00515|
|M-2011-0160 / EFSA-Q-2011-00516|
|M-2011-0160 / EFSA-Q-2011-00517|
|M-2011-0160 / EFSA-Q-2011-00520|
|M-2011-0160 / EFSA-Q-2010-00733|
|M-2013-0248 / EFSA-Q-2013-00693|
|M-2011-0160 / EFSA-Q-2011-00544|
Sucrose esters of fatty acids
|M-2013-0248 / EFSA-Q-2013-00692|
[a] E 316 is authorised individually or in combination with E 315, maximum limits are expressed as erythorbic acid
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 EFSA opinions. Only the data provider organisation will be cited in the EFSA opinions. Data provider organisations wishing to remain anonymous in the publications should indicate it in the email they will use to submit data to EFSA.
Please address any technical inquiries regarding the reporting of data to: data.collection [at] efsa.europa.eu.
Submission of usage level data
Food manufacturers eventually coordinated by the food manufacturers associations are invited to submit data on usage levels of additives in food and beverages for human consumption listed in Table 1.
Data submission on usage level 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 Description3 (SSD Guidance) and provides features that support manual data entry.
To submit usage level data please download the zip file “Additive_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 and to avoid compromising its functionalities.
Should you need any support in filling in the reporting format, please contact data.collection [at] efsa.europa.eu.
In order to streamline the data collection exercise, food manufacturers are invited to liaise with the relevant food manufacturer associations.
Food manufacturers should submit data directly to EFSA via e-mail using the dedicated e-mail address for this service: data.collection [at] efsa.europa.eu.
Data providers are encouraged to provide information also in the cases where food additives included in the call are not longer used in some of the food categories in which these are authorised. This information can be submitted either by e-mail at the dedicated e-mail address data.collection [at] efsa.europa.eu or in the fields R.A1 to R.A3 of the template (MS Excel® AddUseLevTemplate.xls).
The documentation needed to support the data collection on food additives usage levels is summarised below:
Table 1a: Mandatory, recommended or optional information to be reported related to food additives usage level data in food and beverages intended for human consumption.
ADD_usage_data_submission.zip including the following files:
MS Excel® AddUseLevTemplate.xls
MS Excel® StandardSampleDescription.xls
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 food additives listed in Table 1.
Data submission of concentration data (analytical results) on food additives should follow the requirements identical to those described in the call for continuous collection of chemical contaminants occurrence data in food and feed and reported in Table 2a of the Annex. Please be aware, that it is also mandatory to provide the additive food category number in the field of “Product Comment (S.21)” as listed in the excel file “MS Excel® ADD_Food_Categories.xls”.
Data should be transmitted using the EFSA web interface “Data Collection Framework (DCF)” (https://dcf.efsa.europa.eu/dcf-war). The data collection group “OCC_GROUP5.2012” is to be selected when submitting data on these substances through the DCF. In order to receive access to the DCF web interface please contact: data.collection [at] efsa.europa.eu.
In case data are compiled using the simplified excel file “MS Excel® GenericReportingFormat.xls” (available at http://www.efsa.europa.eu/en/datexdata/docs/GenericReportingFormat.xls), they cannot be transmitted using the DCF web interface. In this case data should be sent to the e-mail address: data.collection [at] efsa.europa.eu.
For the collection of this type of data the general recommendations and mandatory fields apply as specified in the Guidance on Standard Sample Description.
It should be noted that the present call is not aiming at collecting compliance sample information but the actual concentration level of additives in the analysed food.
The documentation needed to support the data collection on food additives concentration levels is summarised below:
Table 2a: Call for concentration data of food additives in food and beverages intended for human consumption - Mandatory or recommended information to be reported.
The documentation listed below is needed to support the data collection on food additives is summarised below:
MS Excel® file “ADD_Food_Categories.xls”. Food classification related to additives, exceptions and restrictions.
MS Excel® file “MPLs_ADD_Batch3.xls”. Food additive’s authorised uses and use levels in Batch 3.