Call for food additives usage level and/or concentration data in food and beverages intended for human consumption (Batch 5)
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 (data[dot]collection[at]efsa[dot]europa[dot]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 (data[dot]collection[at]efsa[dot]europa[dot]eu)
Should you need any support in filling in the reporting format, please contact data.collection [at] efsa.europa.eu (data[dot]collection[at]efsa[dot]europa[dot]eu)
Data should be submitted directly to EFSA using the dedicated e-mail address for this service: data.collection [at] efsa.europa.eu (data[dot]collection[at]efsa[dot]europa[dot]eu)
The documentation needed to support the data collection on food additivesusage 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
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