Scientific Opinion on the re-evaluation of boric acid (E 284) and sodium tetraborate (borax) (E 285) as food additives

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Article
Panel on Food Additives and Nutrient Sources Added to Food
Acknowledgements

The Panel wishes to thank the members of the Working Group B on Food Additives and Nutrient Sources added to Food: Fernando Aguilar, Riccardo Crebelli, Birgit Dusemund, David Gott, Torben Hallas-Møller, Jürgen König, Oliver Lindtner, Daniel Marzin, Inge Meyland, Alicja Mortensen, Iona Pratt, Paul Tobback, Ine Waalkens-Berendsen, Ruud Woutersen for the preparatory work on this scientific opinion and EFSA staff: Joanne Gartlon for the support provided to this scientific opinion.

EFSA Journal
EFSA Journal 2013;11(10):3407 [52 pp.].
doi
10.2903/j.efsa.2013.3407
Panel members at the time of adoption
Fernando Aguilar, Riccardo Crebelli, Birgit Dusemund, Pierre Galtier, David Gott, Ursula Gundert-Remy, Jürgen König, Claude Lambré, Jean-Charles Leblanc, Pasquale Mosesso, Alicja Mortensen, Agneta Oskarsson, Dominique Parent-Massin, Martin Rose, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Ruud Woutersen and Matthew Wright
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2011-00468
EFSA-Q-2011-00469
Adopted
3 October 2013
Published
24 October 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of boric acid (E 284) and sodium tetraborate (borax) (E 285) as food additives in the EU. These additives are authorised in EU for use as preservatives of sturgeon eggs (caviar) up to a maximum concentration of 4 g boric acid/kg. Previous evaluations have been performed by the Scientific Committee for Food (SCF) in 1979, 1988 and 1992, Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1962, EFSA (2004, 2005a, b, 2012) and TemaNord (2002). The Panel concluded that boric acid and sodium tetraborate do not raise concern for genotoxicity. Feeding studies in rats, mice and dogs have demonstrated that the male reproductive system is adversely affected by boric acid and sodium tetraborate. The adverse effects found with boric acid are similar to those obtained from other borates indicating that the boron is the toxicologically active species. The data on toxicokinetics do not indicate differences between laboratory animals and humans. The Panel concluded that based on the NOAEL of 9.6 mg boron/kg bw/day, derived from a developmental toxicity study in rats, and application of an uncertainty factor of 60, a group ADI of 0.16 mg boron/kg bw/day can be established. Exposure to boron from its use as food additive at the highest is 0.04 mg boron/kg bw/day for children, 0.01 mg boron/kg bw/day for adolescents, 0.01 mg boron/kg bw/day for adults, and 0.01 mg boron/kg bw/day for the elderly. Exposure estimates to boron from its use as food additive at the highest 95th percentile for consumers only, for children, adolescents, adults and the elderly would be 0.56, 0.37, 0.13 and 0.15 mg/kg bw/day, respectively. The Panel concluded that it is unlikely that a regular exceedance of the ADI occurs.

Keywords
boric acid, E 284 (CAS Registry Number 10043-35-3), sodium tetraborate, borax, E 285 (CAS Registry Number 1330-43-4), food preservatives
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Number of Pages
52