Call for expression of interest to use certain food additives in foods for infants below 16 weeks of age

22 May 2018
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EFSA-Q-number: EFSA-Q-2018-00317


According to Regulation (EC) No 1333/2008[1], food additives which were permitted for use in the European Union before 20 January 2009 need to be re-evaluated by the European Food Safety Authority (EFSA). The programme for this re-evaluation is defined by Regulation (EU) No 257/2010[2].

EFSA is currently issuing scientific opinions on the safety of these food additives when used in food as per Annexes II to Regulation (EC) No 1333/2008. The risk assessment approach followed until now by the ANS Panel in the re-evaluation of food additives does not cover their use in food for infants below 12 weeks of age[3]. The ANS Panel has, therefore, issued scientific opinions on food additives (listed in table 1) excluding the re-evaluation of uses for this particular age.

On 31 May 2017, EFSA published a guidance document[4] on the risk assessment of substances present in food intended for infants below 16 weeks of age, enabling the ANS Panel to assess the safety of food additives uses for this population.

In addition, in the ANS Panel opinions on the food additives listed in table 1, there are conclusions and recommendations on data gaps in the risk assessment, concerning food categories for all population groups. These will need to be addressed by additional data to be provided and will need additional evaluation in accordance with the European Commission’s (EC) approach for the follow-up of EFSA’s scientific opinions on the re-evaluation of the safety of permitted food additives[5]. For the sake of efficiency, EC asked EFSA to address the above lack of data in the EFSA calls for data to be launched during its assessment for infants below 16 weeks of age.

In order to ensure efficiency in the process for the completion of the re-evaluation, it is important that EFSA retrieves from interested parties all relevant data for the re-evaluation of these food additives regarding the specific uses. To this end, and in accordance with article 6(3) of Regulation (EU) No 257/2010, EFSA is launching public calls for data.

As a first step interested parties should confirm their interest for the use of the food additives indicated in the table 1 in foods for infants below 16 weeks of age.

As a second step, EFSA will communicate the information needed for each additive and the final deadline to provide the data through specific calls for data for the individual additives.

According to Article 6(5) of Regulation (EU) No 257/2010 where the requested information has not been submitted to EFSA within the set deadlines, the food additive may be removed from the Union list in accordance with the procedure laid down in Article 10.3 of Regulation (EC) No 1333/2008.

Overall objective

The purpose of this call is to offer interested parties (IPs) the opportunity to express their interest to use the food additives listed in table 1 in foods for infants below 16 weeks of age.

Deadline for registering an interest

By 22/05/2018 please send a confirmation in writing to EFSA that you are registering your interest on one or more of the food additives listed in Table 1 for uses in foods for infants below 16 weeks of age. By registering an interest you are confirming that the food additive is in use in food category 13.1.1 or or section B of part 5 of Annex III;

Table 1. List of food additives to be re-evaluated for use in foods for their use in foods for infants below 16 weeks of age.



Name of the food additive

E 170

Calcium carbonate

E 304i

Ascorbyl palmitate

E 306

Tocopherol-rich extract

E 307


E 308


E 309


E 322


E 407


E 410

Locust bean gum

E 412

Guar gum

E 415

Xanthan gum

E 440


E 466

Sodium carboxy methyl cellulose, Cellulose gum

E 471

Mono-and diglycerides of fatty acids

E 472c

Citric acid esters of mono- and diglycerides of fatty acids

E 473

Sucrose esters of fatty acids

E 1450

Starch sodium octenyl succinate


Submission of information

The confirmation that these additives are in use mentioning the respective category(ies) shall be submitted to EFSA in electronic form and paper version, by letter containing:

  • Reference to the current call and its specific EFSA question number: EFSA-Q-2018-00317
  • Name and E number of the food additive(s) for which you are registering an interest
  • Contact details[6] (name of contact person, name of company/organisation, postal address, e-mail address and telephone number) of the person responsible for the data submission and,
  • if applicable, the list of interested business operators and/or interested parties represented together with their contact details;


Please send all electronic correspondence, including enquiries to: fip [at]

Submissions should be sent to the following address:

European Food Safety Authority

FIP Unit

Via Carlo Magno 1/a

I-43126 Parma



[1] Regulation (EC) No 1333/2008 on food additives, OJ L 354, 31.12.2008

[2] Regulation (EU) No 257/2010, 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.

[3] Opinion of the Scientific Committee on Food on the applicability of the ADI (Acceptable Daily Intake) for food additives to infants (expressed on 17/09/1998)

[4] EFSA Scientific Committee. Guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age. EFSA Journal 2017;15(5):4849, 58 pp.

[6] The interested parties shall notify EFSA of any change in the contact details by sending an e-mail to the FIP mailbox (fip [at]

24 April 2018