Call for food additives usage level and/or concentration data in food and beverages intended for human consumption - Batch 7

Deadline
1 October 2018
Document (326.16 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 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 7) is 1 October 2018, 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.

Table 1: List of food additives (sweeteners) for which usage levels and/or concentration data are requested (Batch 7)

E number

Substance

E 420(i)

Sorbitol

E 420(ii)

Sorbitol syrup

E 421

Mannitol

E 950

Acesulfame K

E 952(i)

Cyclamic acid

E 952(ii)

Sodium cyclamate

E 952(iii)

Calcium cyclamate

E 953

Isomalt

E 954(i)

Saccharin

E 954(ii)

Sodium saccharin

E 954(iii)

Calcium saccharin

E 954(iv)

Potassium saccharin

E 955

Sucralose

E 957

Thaumatin

E 959

Neohesperidine DC

E 961

Neotame

E 962

Salt of aspartame-acesulfame

E 965(i)

Maltitol

E 965(ii)

Maltitol syrup

E 966

Lactitol

E 967

Xylitol

E 968

Erythritol

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.

Further calls for data in relation to the remaining food additives to be re-evaluated according to Regulation (EU) No 257/2010 will be launched. Though not part of this call for data an indicative list of these food additives is given at the end of this call (Table 2).

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 [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. In particular, data providers shall ensure that the same data are not sent several times to EFSA: for example sent by both the food manufacturer and also by the association to which the food manufacturer belongs.

If an interested party has information that a food additive is not used for one or several food categories, this information is highly relevant for EFSA. Such information will be of course cross-checked with information sent by all interested parties.

Data providers should be aware that EFSA may need to contact them once the initial submission is received. The aim is to clarify foods not well characterised/identified or to check any possible mistakes (e.g. on MPLs) or not plausible data (e.g. on reported levels, proposed dilution factors). Replies to these requests are strongly encouraged as EFSA reserves the right to discard these data if feedback is not received.

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 [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 additive usage 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  Please be aware that the data collection for the submission of additive analytical results will open in the DCF from 15 May 2018 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 [at] efsa.europa.eu .

For reporting in SSD1,specific reporting requirements apply for food additives detailed in the document ‘Specific reporting requirements for contaminants and food additives occurrence data submission’ available at: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2017.EN-1262/full For data  reported using SSD version 2 the guidance ‘Specific reporting requirements for contaminants and food additives occurrence data submission in SSD2’ should be used available at http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2017.EN-1261/full. For the collection of concentration data (analytical results), the general recommendations and mandatory fields apply as specified in these documents

In case data are compiled using the simplified excel file 'MS Excel® GenericReportingFormat.xls' (available at: http://www.efsa.europa.eu/en/data/toolbox, 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 .

Table 2: Remaining food additives to be re-evaluated according to Regulation (EU) No 257/2010

E-number

Name of the food additive

E 260

Acetic acid

E 261

Potassium acetates

E 262

Sodium acetates

E 263

Calcium acetate

E 270

Lactic acid

E 290

Carbon dioxide

E 296

Malic acid

E 297

Fumaric acid

E 325

Sodium lactate

E 326

Potassium lactate

E 327

Calcium lactate

E 330

Citric acid

E 331

Sodium citrates

E 332

Potassium citrates

E 333

Calcium citrates

E 350

Sodium malates

E 351

Potassium malate

E 352

Calcium malates

E 355

Adipic acid

E 356

Sodium adipate

E 357

Potassium adipate

E 363

Succinic acid

E 380

Triammonium citrate

E 385

Calcium disodium ethylene diamine tetra-acetate (Calcium disodium EDTA)

E 500

Sodium carbonates

E 501

Potassium carbonates

E 503

Ammonium carbonates

E 504

Magnesium carbonates

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 oxide

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 585

Ferrous lactate

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 650

Zinc acetate

E 920

L-cysteine

E 927b

Carbamide

E 938

Argon

E 939

Helium

E 941

Nitrogen

E 942

Nitrous oxide

E 943a

Butane

E 943b

Isobutane

E 944

Propane

E 948

Oxygen

E 949

Hydrogen

E 1505

Triethyl citrate

E 1517

Glyceryl diacetate (diacetin)

E 1518

Glyceryl triacetate (triacetin)


[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.]. http://www.efsa.europa.eu/en/efsajournal/doc/1457.pdf

Published
22 January 2018