EFSA set open data call deadline for infant formula food additives

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The European Food and Safety Authority (EFSA) has set a number of deadlines to register interest and submit data for a range of common food additives found in infant formula products and foods.

The deadlines are a response to the Authority's plans to re-evaluate the list of additives that were previously permitted for use in the European Union before 20 January 2009.

Additives undergoing re-evaluation include acacia gum (E 414), ascorbyl palmitate (E 304(i)), calcium carbonate (E 170), carrageenan (E 407), silicon dioxide (E 551), tocopherol-rich extract (E 306), α-tocopherol (E 307), γ-tocopherol (E 308) and δ- tocopherol (E 309).

Other food additives under investigation include starch sodium octenyl succinate (E 1450), xanthan gum (E 415), guar gum (E 412), lecithins (E 322), locust bean gum (E 410), pectin (E440i), amidated pectin (E 440ii) and sodium carboxymethylcellulose (E 466).

Questions raised for the majority of these additives’ safety profiles originate from guidelines published on 31 May 2017.

Here, EFSA’s Scientific Committee (SC) made available a document detailing the risk assessment of substances present in food intended for infants below 16 weeks of age.

ANS Panel recommendations

In addition, the EFSA’s Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) identified in the conclusions and recommendations of its published opinion on the additives’ data gaps in the risk assessment, relevant for all population groups.

“For the sake of efficiency, the European Commission asked EFSA to address the above lack of data (data gaps) during its risk assessment of food additives for uses in food for young infants,” the Authority stated.

“Therefore specific data requirements for all uses of [the additive] are included in this call for data.”

EFSA added that it would consider the relevance of the information provided for the risk assessment of the additive in question. The submission of the requested information is without prejudice to the final opinion of the Panel.

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.

Interest and data deadlines

EFSA has set the deadline for registering interest for the additives, acacia gum (E 414), ascorbyl palmitate (E 304(i)), calcium carbonate (E 170), carrageenan (E 407), silicon dioxide (E 551), tocopherol-rich extract (E 306), α-tocopherol (E 307), γ-tocopherol (E 308) and δ- tocopherol (E 309) for the 21 November 2018.

The deadline for submission of data and disclosure of contact details has been set for the 28 February 2019.

The remaining additives, starch sodium octenyl succinate (E 1450), xanthan gum (E 415) have been given the deadline for the submission of data of 31 December 2018.

Interested parties have until 31 December 2019 to submit technical and toxicological data on guar gum (E 412), lecithins (E 322), locust bean gum (E 410) pectin (E440i), amidated pectin (E 440ii) and sodium carboxymethylcellulose (E 466).