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://ucrisportal.univie.ac.at/de/publications/23aeba76-d2cf-42bc-b189-8933da826aa5