Open AccessSafety evaluation of crosslinked polyacrylic acid polymers (carbomer) as a new food additive
Author(s) -
Younes Maged,
Aquilina Gabriele,
Engel KarlHeinz,
Fowler Paul,
Frutos Fernandez Maria Jose,
Fürst Peter,
Gürtler Rainer,
GundertRemy Ursula,
Husøy Trine,
Manco Melania,
Mennes Wim,
Passamonti Sabina,
Moldeus Peter,
Shah Romina,
WaalkensBerendsen Ine,
Wölfle Detlef,
Wright Matthew,
Barat Baviera José Manuel,
Degen Gisela,
Leblanc JeanCharles,
Herman Lieve,
Civitella Consuelo,
Giarola Alessandra,
Smeraldi Camilla,
Tard Alexandra,
Vianello Giorgia,
Castle Laurence
Publication year - 2021
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.2021.6693
Subject(s) - food additive , polyacrylic acid , food science , chemistry , organic chemistry , polymer
The EFSA Panel on Food Additives and Flavourings ( FAF ) provides a scientific opinion on the safety of crosslinked polyacrylic acid polymers (carbomer) proposed for use as food additive in solid and liquid food supplements. Carbomer is formed from the monomer, acrylic acid, which is polymerised and crosslinked with allyl pentaerythritol ( APE ). The polymers are synthesised in ethyl acetate using as free‐radical polymerisation initiator. In vivo data showed no evidence for systemic availability or biotransformation of carbomer. Carbomer does not raise a concern regarding genotoxicity. Considering the available data set, the Panel derived an acceptable daily intake ( ADI ) of 190 mg/kg body weight (bw) per day based on a no observed adverse effect level ( NOAEL ) of 1,500 mg/kg bw per day from a sub‐chronic 13‐week study in rat, applying a compound specific uncertainty factor ( UF ) of 8. At the proposed maximum use levels, the exposure estimates ranged at the mean from 1.1 to 90.2 mg/kg bw per day and at the p95 from 12.5 to 237.4 mg/kg bw per day. At the proposed typical use level, the exposure estimates ranged at the mean from 0.7 to 60.2 mg/kg bw per day and at the p95 from 10.3 to 159.5 mg/kg bw per day. The Panel noted that the maximum proposed use levels would result in exposure estimates close to or above the ADI . The Panel also noted that level of exposure to carbomer from its proposed use is likely to be an overestimation. Taking a conservative approach, the Panel considered that exposure to carbomer would not give rise to a safety concern if the proposed maximum use level for solid food supplements is lowered to the typical use level reported by the applicant.