Organ effects in animal toxicology studies
Repeated-dose animal studies found effects on the liver, spleen and mesenteric lymph nodes, including lymphoid hyperplasia and granulomas, at doses above a threshold. No effects were seen at or below 3 mg per kilogram of body weight per day, which became the reference point used to set a provisional safety limit for animal feed. No genotoxic activity was detected in standard tests.
Repeat-dose toxicity studies and a two-generation reproduction study in animals showed adverse effects on the liver, spleen and mesenteric lymph nodes at doses above the NOAEL of 3 mg/kg body weight per day.
2016AnimalEFSA FEEDAP Panel, EFSA Journal 4439
The substance was devoid of genotoxic potential in standard battery tests.
2016LabEFSA FEEDAP Panel, EFSA Journal 4439
A 34-week rat study at 500 mg/kg daily found reduced testicular weights and pigment deposits in liver and kidney; a 2-year dietary study at 1% found no adverse effects, though individual study data were limited.
1974AnimalJECFA, WHO Food Additives Series 6, Monograph 369
Withdrawn acceptable daily intake
An acceptable daily intake (ADI) for the group of synthetic carotenoids including E160f was set at 0 to 5 mg per kilogram of body weight in 1974, based on rat studies. In 2019 the international food safety body JECFA withdrew this figure entirely, concluding that rats are not a suitable model for carotenoid safety in humans because their gut absorbs these compounds very differently. No new human safety data were submitted, so no replacement ADI could be set.
JECFA withdrew the group ADI of 0-5 mg/kg body weight for synthetic carotenoids including beta-apo-8'-carotenoic acid methyl and ethyl esters, ruling that rat models are not appropriate for carotenoid safety evaluation in humans due to different bioavailability.
2019Regulatory reviewJECFA, 87th meeting, WHO/FAO food additives database, chemical ID 375
Removed from UK and EU food use
E160f was excluded from the EU's approved food additives list in November 2011 under the regulation that consolidated the Union list of permitted additives. The stated reason was that the sole manufacturer had stopped production and industry operators withdrew support for its safety re-evaluation by EFSA. The UK carried over this exclusion after Brexit. E160f is therefore not a permitted food additive in Great Britain, Northern Ireland, or the remaining EU member states.
Commission Regulation (EU) No 1129/2011, recital 13, states that E160f 'is not offered anymore by the manufacturer and re-evaluation of this substance by the Authority is no longer supported by the business operators' and therefore must not be included in the Union list.
2011RegulatoryCommission Regulation (EU) No 1129/2011, recital 13
E160f does not appear in the UK FSA approved additives and E-numbers guidance or the assimilated Regulation 1333/2008 Annex II as retained in UK law.
2024RegulatoryUK Food Standards Agency, Approved additives and E-numbers guidance