Scientific Opinion on the reconsideration of the ADI and a refined exposure assessment of β-apo-8′-carotenal (E 160e)

Autor(en)

, Fernando Aguilar, Riccardo Crebelli, Birgit Dusemund, Pierre Galtier, David Gott, Ursula Gundert-Remy, Juergen Koenig, Claude lambre, Jean-Charles Leblanc, Pasquale Mosesso, Alicja Mortensen, Agneta Oskarsson, Dominique Parent-Massin, Martin Rose, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Ruud Woutersen, Matthew Wright

Abstrakt

The Panel on Food Additives and Nutrient Sources added to Food (ANS) has previously provided a scientific opinion re-evaluating the safety of β-apo-8′-carotenal (E 160e) as a food additive in the EU and establishing an acceptable daily intake (ADI) of 0.05 mg/kg body weight (bw)/day (EFSA ANS Panel, 2012). Following a request by the European Commission, the ANS Panel was asked to consider newly submitted information on the interpretation of the 13-week study in rats used as a basis to establish the ADI, to clarify its impact on that ADI and to carry out the refined exposure assessment of β-apo-8′-carotenal. The new information comprised an evaluation of all of the original kidney section slides from the 13-week toxicological study under improved visualisation conditions. The ANS Panel has considered that the supplementary information provided by the Commission and the present toxicological database on β-apo-8′-carotenal provides a basis to revise the established ADI and concluded that, based on the NOAEL of 30 mg/kg bw/day from the 13-week study in rats and an uncertainty factor of 100, a new ADI for β-apo-8′-carotenal of 0.3 mg/kg bw/day can be established. The Panel concluded that using data provided by the food industry, which are based only on a limited number of regulated categories, the reported uses and use levels of β-apo-8’-carotenal (E 160e) would not be of safety concern.

Organisation(en)

Department für Ernährungswissenschaften

Externe Organisation(en)

European Food Safety Authority

Journal

EFSA Journal

Band

12

Anzahl der Seiten

30

ISSN

1831-4732

DOI

https://doi.org/10.2903/j.efsa.2014.3492

Publikationsdatum

01-2014

Peer-reviewed

Ja

ÖFOS 2012

303009 Ernährungswissenschaften

Schlagwörter

ASJC Scopus Sachgebiete

Food Science, Animal Science and Zoology, Veterinary Medicine(miscalleneous), Plant Science, Parasitology, Microbiology

Link zum Portal

https://ucris.univie.ac.at/portal/de/publications/scientific-opinion-on-the-reconsideration-of-the-adi-and-a-refined-exposure-assessment-of-apo8carotenal-e-160e(23aeba76-d2cf-42bc-b189-8933da826aa5).html