Open AccessRe‐evaluation of ammonium phosphatides (E 442) as a food additive
Author(s) -
Mortensen Alicja,
Aguilar Fernando,
Crebelli Riccardo,
Domenico Alessandro Di,
Dusemund Birgit,
Frutos Maria Jose,
Galtier Pierre,
Gott David,
GundertRemy Ursula,
Leblanc JeanCharles,
Lindtner Oliver,
Moldeus Peter,
Mosesso Pasquale,
ParentMassin Dominique,
Oskarsson Agneta,
Stankovic Ivan,
WaalkensBerendsen Ine,
Woutersen Rudolf Antonius,
Wright Matthew,
Younes Maged,
Boon Polly,
Chrysafidis Dimitrios,
Gürtler Rainer,
Tobback Paul,
Rincon Ana Maria,
Tard Alexandra,
Lambré Claude
Publication year - 2016
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2016.4597
Subject(s) - acceptable daily intake , genotoxicity , toxicity , toxicology , food additive , tolerable daily intake , developmental toxicity , reproductive toxicity , adverse effect , dosing , zoology , body weight , no observed adverse effect level , reference dose , carcinogen , pesticide , physiology , chemistry , medicine , food science , pregnancy , biology , pharmacology , gestation , risk assessment , biochemistry , genetics , computer security , computer science , agronomy
The EFSA Panel on Food Additives and Nutrient Sources added to Food ( ANS ) provides a scientific opinion re‐evaluating the safety of ammonium phosphatides (E 442) as a food additive. The Scientific Committee on Food ( SCF ) and the Joint FAO / WHO Expert Committee on Food Additives ( JECFA ) allocated an acceptable daily intake ( ADI ) of 30 mg/kg body weight (bw) per day in 1978 and 1974, respectively. The Panel noted that after oral administration of E 442 ([ 32 P] YN ), a proportion of the radioactivity passed through the gastrointestinal tract and was excreted via faeces and also a quantity of radioactivity was absorbed rapidly after dosing as indicated by its presence in the skeletal tissue and liver. Acute oral toxicity of ammonium phosphatides is low and no adverse effects were observed in a 90‐day rats study. The Panel considered that ammonium phosphatides did not raise concern for genotoxicity. The Panel identified no observed adverse effect levels ( NOAEL s) of 8,500 and 3,000 mg/kg bw per day, the highest doses tested, from dietary chronic and carcinogenicity studies with ammonium phosphatides in mice and rats, respectively. No effects on reproduction and development were observed in a dietary two‐generation reproductive toxicity study at the only dose tested of 3,000 mg/kg bw per day, and in addition, no maternal or developmental effects were recognised in a dietary prenatal developmental toxicity study up to a dose of 4,774 mg/kg bw per day. Based on the available toxicological database, the Panel concluded that there is no reason to revise the current ADI for ammonium phosphatides of 30 mg/kg bw per day. Considering that the ADI is not exceeded in any population group, the Panel also concluded that the use of ammonium phosphatides (E 442) as a food additive, at the permitted or reported use and use levels, would not be of safety concern.