TY - JOUR
T1 - Scientific Opinion on the reconsideration of the ADI and a refined exposure assessment of β-apo-8′-carotenal (E 160e)
T2 - EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)
AU - EFSA Panel Food Additives
AU - Aguilar, Fernando
AU - Crebelli, Riccardo
AU - Dusemund, Birgit
AU - Galtier, Pierre
AU - Gott, David
AU - Gundert-Remy, Ursula
AU - Koenig, Juergen
AU - lambre, Claude
AU - Leblanc, Jean-Charles
AU - Mosesso, Pasquale
AU - Mortensen, Alicja
AU - Oskarsson, Agneta
AU - Parent-Massin, Dominique
AU - Rose, Martin
AU - Stankovic, Ivan
AU - Tobback, Paul
AU - Waalkens-Berendsen, Ine
AU - Woutersen, Ruud
AU - Wright, Matthew
PY - 2014/1
Y1 - 2014/1
N2 - 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.
AB - 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.
KW - beta-apo-8'-carotenal
KW - E 160e
KW - CAS Registry Number 1107-26-2
KW - food colour
KW - refined exposure
KW - ADI
KW - β-apo-8′-carotenal
UR - http://www.scopus.com/inward/record.url?scp=85078373344&partnerID=8YFLogxK
U2 - 10.2903/j.efsa.2014.3492
DO - 10.2903/j.efsa.2014.3492
M3 - Article
SN - 1831-4732
VL - 12
JO - EFSA Journal
JF - EFSA Journal
IS - 1
M1 - 3492
ER -