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

Deadline
31 January 2017
Document (348.18 KB)

Background
Regulation (EC) No 1331/2008 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. 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.

Deadline for submission of data

The deadline for the submission of data (Batch 5) is 31 January 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 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.

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 5)

E number Substance

E 330

Citric acid

E 331(i)

Monosodium citrate

E 331(ii)

Disodium citrate

E 331(iii)

Trisodium citrate

E 332(i)

Monopotassium citrate

E 332(ii)

Tripotassium citrate

E 333(i)

Monocalcium citrate

E 333(ii)

Dicalcium citrate

E 333(iii)

Tricalcium citrate

E 334

Tartaric acid

E 335(i)

Monosodium tartrate

E 335(ii)

Disodium tartrate

E 336(i)

Monopotassium tartrate

E 336(ii)

Dipotassium tartrate

E 337

Potassium sodium tartrate

E 353

Metatartaric acid

E 354

Calcium tartrate

E 380

Triammonium citrate

E 445

Glyerol esters of wood rosin

E 507

Hydrochloric acid

E 508

Potassium chloride

E 509

Calcium chloride

E 511

Magnesium chloride

E 513

Sulphuric acid

E 514(i)

Sodium sulphate

E 514(ii)

Sodium hydrogen sulphate

E 515(i)

Potassium sulphate

E 515(ii)

Potassium hydrogen sulphate

E 516

Calcium sulphate

E 517

Ammonium sulphate

E 524

Sodium hydroxide

E 525

Potassium hydroxide

E 526

Calcium hydroxide

E 527

Ammonium hydroxide

E 528

Magnesium hydroxide

E 529

Calcium oxide

E 530

Magnesium oxides

E 552

Calcium silicate

E 553a(i)

Magnesium silicate

E 553a(ii)

Magnesium trisilicate

E 553b

Talc

E 554

Sodium aluminium silicate

E 555

Potassium aluminium silicate

E 574

Gluconic acid

E 575

Glucono-delta-lactone

E 576

Sodium gluconate

E 577

Potassium gluconate

E 578

Calcium gluconate

E 579

Ferrous gluconate

E 626

Guanylic acid

E 627

Disodium guanylate

E 628

Dipotassium guanylate

E 629

Calcium guanylate

E 630

Inosinic acid

E 631

Disodium inosinate

E 632

Dipotassium inosinate

E 633

Calcium inosinate

E 634

Calcium 5’-ribonucleotides

E 635

Disodium 5’-ribonucleotides

E 640

Glycine and its sodium salt

E 900

Dimethyl polysiloxane

E 999

Quillaia extract

E 1505

Triethyl citrate

 

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 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 (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

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 (the actual reporting template, where the data should be entered)
  • MS Excel® StandardSampleDescription.xls (SSD catalogues)
  • Guide_using_Reporting_format_additives.doc
  • Folder of macros (Excel® Visual Basic macros, which links the template with the SSD catalogues
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 submission of concentration data (analytical results) on food additives should follow the identical requirements described in the call for continuous collection of chemical contaminants occurrence data in food and feed. Please be aware that it is also mandatory to provide the additive food category number in the field of “Product Comment (S.21)” as described in the “Specific requirements for chemical contaminant and food additive occurrence data submission” .

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. 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/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 [at] efsa.europa.eu.

For the collection of concentration data (analytical results) the general recommendations and mandatory fields apply as specified in the “Specific requirements for chemical contaminant and food additive occurrence data submission”.

Last updated: 10 January 2017

Published
24 May 2016