The EFSA Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of paprika extract (E 160c). Paprika extract (E 160c) is a natural dye allowed as a food additive in the EU.
Paprika extract (E 160c) is a natural dye with capsanthin and capsorubin being the principle colouring compounds. Paprika extract (E 160c) is authorised as a food additive in the European Union (EU), according to Annex II to Regulation (EC) No 1333/2008 on food additives. Specifications for paprika extract (E 160c) are defined in Commission Regulation (EU) No 231/212 laying down specifications for food additives. Paprika extract (E 160c) is permitted quantum satis (QS) in food except for meat preparations and processed meat, in which it is allowed up to 10 mg/kg product, and foodstuffs in which the use of colours is specifically prohibited.
Paprika extract (E 160c) has been evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1970, 1989, 2000 and 2008, but no acceptable daily intake (ADI) was ever allocated. In the 2008 evaluation, no ADI was allocated, due to concerns as to whether the material tested in the 90-day study and the long-term study was representative of all commercial paprika extracts used as a food colour. Furthermore, JECFA requested information on the concentrations of capsaicin present in the extracts and additional information about the composition of batches of extract produced by a variety of manufacturers. At the 77th JECFA meeting in 2013, following receipt of additional analytical data, the specifications were revised, and the tentative status was removed. At its 79th meeting, JECFA reconsidered the toxicological data and the dietary exposure and established an ADI for paprika extract for use as a food colour of 0–1.51 mg/kg body weight (bw), expressed as total carotenoids.
The use of paprika extract (E 160c) as a food colour has not been evaluated previously by the Scientific Committee on Food (SCF) or EFSA. Capsaicin was evaluated as a flavouring substance by the SCF in 2002. As a limit of 250 mg/kg has been set for the content of capsaicin in paprika extract (E 160c) (Commission Regulation (EU) No 231/2012), studies dealing with capsaicin toxicity are of limited relevance to paprika extracts used as a food colour (E 160c) and are therefore not described in this opinion.
The bioavailability of capsanthin and capsorubin from paprika extract is very low. The Panel agreed with the conclusion of JECFA in 2008, that there are no indications that carotenoids from paprika extract (E 160c) would behave differently from other oxygenated carotenoids with respect to their low bioavailability. When capsanthin is absorbed, it is transported by plasma lipoproteins. The half-life for capsanthin in plasma is approximately 20 hours in man. Capsanthin can be oxidised to capsanthone and its geometrical isomer 11-cis-capsanthin in man.
Toxicological data on a paprika extract (E 160c), including capsanthin and capsorubin, were limited to a 13-week oral toxicity study and one chronic toxicity and carcinogenicity study in rats on a specified paprika extract (DN-933). The no-observed-adverse-effect level (NOAEL) in the 13-week oral toxicity study was 5.0% paprika extract/kg bw/day, equivalent to 2948 mg paprika extract/kg bw/day for males and 3197 mg paprika extract/kg bw/day for females.
Paprika extract (E 160c) was not carcinogenic to male and female F344 rats according to a two-year combined chronic toxicity and carcinogenicity study on a specified paprika extract (DN-933). Slight histopathological changes were observed in livers of males exposed to 5% paprika extract in their feed (the highest dose tested, equivalent to approximately 2 500 mg paprika extract/kg bw/day).
Several studies in rats and mice show the carcinogenic or tumour promoting potential of capsaicin or chilli extract, although no carcinogenic effects were observed in other studies. However, as paprika extracts used as a food colour contain a very low amount of capsaicin, the relevance of the studies using chilli pepper or capsaicin for the assessment of chronic toxicity or carcinogenic effects of paprika extract as a food colour is limited.
Mixed results are reported in the literature from a few, relatively old, limited in vitro genotoxicity studies with paprika extracts of different purity and composition. Therefore, upon request of EFSA, two new good laboratory practice (GLP) compliant genotoxicity studies using a specified paprika extract (DN-933), representative of commercially available paprika extracts used as the food additive (E 160c), were submitted by the Natural Food Colours Association (NATCOL) in 2014. These studies, which fulfil the requirements for genotoxicity assessment according to the EFSA guidelines on food additives (EFSA ANS Panel, 2012), were negative and the Panel concluded that there was no evidence of genotoxic potential for paprika extract.
No data on reproductive and developmental toxicity of paprika extract (E 160c) are available. Nevertheless, the Panel noted that in 2014, JECFA based on the results of a dietary, GLP compliant developmental toxicity study that had been performed with lutein, a carotenoid of similar structure to capsanthin, concluded by a read-across, that paprika extracts meeting the specifications for use as a food colour are unlikely to pose a reproductive/developmental hazard. The Panel agreed that this read‑across was appropriate and agreed with this conclusion.
Considering the widespread consumption of paprika extract (E 160c) and the absence of reports on allergic and intolerance reactions, the Panel concluded that the food additive paprika extract (E 160c) is unlikely to represent a safety concern as regards allergenicity and immunotoxicity.
Based on the lack of genotoxic potential, the Panel considered that the NOAEL for histopathological changes from the combined chronic toxicity and carcinogenicity study by Inoue et al. (2008) could be used for establishing an ADI. For males, this was equivalent to 2388 mg/kg bw/day, and for females equivalent to 2826 mg/kg bw/day. On this basis and using the default uncertainty factor of 100, the Panel established an ADI of 24 mg/kg bw/day for paprika extract (E 160c).
Based on the analytical data on paprika extract N1, which is reported by NATCOL to be comparable to the specified paprika extract DN-933 used in these studies, the total carotenoid content was 7.1%. Using this value, the NOAELs expressed on a carotenoid basis would be equivalent to 170 mg carotenoids/kg bw/day for males and to 200 mg carotenoids/kg bw/day for females, respectively. On this basis and using the default uncertainty factor of 100, the Panel established an ADI of 1.7 mg carotenoids/kg bw/day for paprika extract (E 160c).
According to the EC specifications, concentrations up to 250 mg capsaicin/kg, i.e. 0.25% are allowed. The paprika extract generally contains less than 0.01% capsaicin.
For the maximum level exposure assessment scenario, mean estimates ranged from 0.1 to 1.8 mg carotenoids/kg bw/day across all population groups. Estimates based on the high percentile (95th percentile) ranged from 0.3 to 2.7 mg carotenoids/kg bw/day across all population groups.
For the refined exposure assessment scenario, in the brand-loyal scenario, mean exposure to paprika extract (E 160c) from its use as a food additive ranged from 0.1 mg carotenoids/kg bw/day to 1.1 mg carotenoids/kg bw/day. The high exposure to paprika extract (E 160c) ranged from 0.2 mg carotenoids/kg bw/day to 1.7 mg carotenoids/kg bw/day. In the non-brand-loyal scenario, mean exposure to paprika extract (E 160c) ranged from < 0.1 mg carotenoids/kg bw/day to 0.5 mg carotenoids/kg bw/day in children. The high exposure ranged from 0.1 mg carotenoids/kg bw/day to 0.8 mg carotenoids/kg bw/day. Dietary exposure from the food additive and the regular diet would lead to a mean intake for children of 0.2 to 0.5 mg/kg bw/day (non‑brand-loyal scenario). On average, dietary exposure from the natural diet would represent around 1% of the dietary exposure.
Exposures to paprika extract (E 160c) in the refined exposure assessment scenarios were below the ADI established by the Panel.
The Panel recommended that:
- In the EC specifications, the term ‘paprika oleoresin’ as a synonym of ‘paprika extract’ should not be used.
- Limits for pesticides and mycotoxins could be considered in the specifications to avoid any potential adverse effects.
- The maximum limits for toxic elements (arsenic, lead, mercury and cadmium) present as impurities in the EC specification for paprika extract (E 160c) should be revised to ensure that paprika extract (E 160c) as a food additive will not be a significant source of exposure to these toxic elements in food.
- The EC specifications could be based on total capsaicinoids rather than on capsaicin only.
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