Call for usage level data on starch aluminium octenyl succinate (E 1452) in food intended for human consumption

Deadline
21 November 2016
Document (278.29 KB)

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 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.

In October 2015 EFSA launched a call[3] for usage level and/or concentration data in food and beverages intended for human consumption for certain food additives, including 11 modified starches. As an amendment of this call, EFSA invites food manufacturers, food manufacturer associations and any other interested parties to submit data on the usage and usage levels of starch aluminium octenyl succinate (E 1452).

Starch aluminium octenyl succinate (E 1452) is an authorised food additive in the EU according to Annex III, Part 5 of Regulation (EC) No 1333/2008[4] in food supplements as defined in Directive 2002/46/EC[5], due to its use in vitamin preparations for encapsulation purposes only.

Deadline for submission of data

The deadline for the submission of data is 21 November 2016.

The interested business operators and any other interested party shall submit the data related to the re-evaluation of starch aluminium octenyl succinate (E 1452) within the period set by the call for data according to Article 6(1) of the 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.

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 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 [at] efsa.europa.eu.

Submission of usage level data

Individual food manufacturers and food manufacturer associations are invited to submit data on usage levels of starch aluminium octenyl succinate (E 1452) in food supplements (encapsulated vitamin preparations). In order to streamline the data collection exercise, food manufacturers are invited to liaise with the relevant food manufacturer associations for the data submission.

Usage level data submitted by food additive manufacturers should preferably reflect the actual usage of the additive rather than levels recommended for use by the food industry. This should be clearly indicated during the submission of data.

Information in relation to the 'non-use' of starch aluminium octenyl succinate (E 1452) in the food category in which this food additive is authorised is also of high relevance for the re-evaluation.

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 [6] (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 [at] efsa.europa.eu

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

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

ADD_usage_data_submission.zip including the following files:

  • MS Excel® AddUseLevTemplate.xls
  • MS Excel® StandardSampleDescription.xls
  • Guide_using_Reporting_format_additives.doc

 


[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] Call for food additives usage level and/or concentration data in food and beverages intended for human consumption. Published on 12 October 2015. Available online: https://www.efsa.europa.eu/it/data/call/151012

[4] Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives. OJ L 354, 31.12.2008, p. 16–33.

[5] Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements. OJ L 183, 12.7.2002, p. 51.

[6] European Food Safety Authority; Standard sample description for food and feed. EFSA Journal 2010;8(1):1457 [54 pp]. http://www.efsa.europa.eu/en/efsajournal/doc/1457.pdf

Published
20 October 2016