Safety evaluation of crosslinked polyacrylic acid polymers (carbomer) as a new food additive

Maged Younes, Gabriele Aquilina, Karl-Heinz Engel, Paul Fowler, Maria Jose Frutos Fernandez, Peter Furst, Rainer Gurtler, Ursula Gundert-Remy, Trine Husoy, Melania Manco, Wim Mennes, Sabina Passamonti, Peter Moldeus, Romina Shah, Ine Waalkens-Berendsen, Detlef Wolfle, Matthew Wright, Jose Manuel Barat Baviera, Gisela Degen, Jean-Charles LeblancLieve Herman, Consuelo Civitella, Alessandra Giarola, Camilla Smeraldi, Alexandra Tard, Giorgia Vianello, Laurence Castle

Onderzoeksoutput: Bijdrage aan tijdschriftArtikelpeer review

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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.
Oorspronkelijke taalEngels
TijdschriftEFSA Journal
Volume19
ISSN1831-4732
DOI's
PublicatiestatusGepubliceerd - aug-2021

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