Following a request from the European Commission, the Panel on Food Additives and Nutrient Sources added to Food (ANS) of the European Food Safety Authority (EFSA) was asked to deliver a scientific opinion on the re-evaluation of candelilla wax (E 902) as a food additive.
The Panel was not provided with a newly submitted dossier and based its evaluation on previous evaluations, additional literature that became available since then and the data available following a public call for data. The Panel noted that not all original studies on which previous evaluations were based were available for re-evaluation by the Panel.
Candelilla wax is authorised in the European Union as a glazing agent on confectionery (including chocolate) and other products, and for the surface treatment of certain fruits. It is also authorised in food supplements. Candelilla wax is also used in cosmetics to give structure to solid and stick-like preparations or in formulations like fragrance and hair care preparations and pharmaceuticals.
Candelilla wax has been evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1993 and 2005 which concluded that at the predicted dietary exposure there was no safety concern. The Scientific Committee for Food (SCF) evaluated the safety of candelilla wax in 1990 and did not establish an ADI but considered its use as glazing agent temporarily acceptable.
Candelilla wax is obtained from the leaves of candelilla plants Euphorbia antisyphilitica found in semi-desert regions. It is described as a hard, yellowish-brown, opaque to translucent wax. The chemical composition and physical properties of the wax vary with climate, time and region of harvest and with the age of the plant. The average composition of candelilla wax has been reported as consisting of hydrocarbons (42% w/w), wax, resin, and sitosteroyl esters (39% w/w), lactones (6% w/w) and free wax resin acids (8% w/w) and free wax and resin alcohols (5% w/w).
Specifications have been defined in Directive 2008/84/EC and new specifications according to Commission Regulation (EU) No 231/2012 will apply from 1st December 2012.
No new data on absorption, distribution, metabolism or excretion (ADME) of candelilla wax were available to the Panel for this evaluation. However, the Panel also considered the results of ADME studies conducted with its main constituents. Overall, the Panel considered that absorption of candelilla wax is expected to be low, and that upon absorption the components would be incorporated into normal metabolic pathways.
Overall, the Panel considered that the available data suggest that candelilla wax is not genotoxic. Although the database is very limited and does not include studies in mammalian cells, the Panel, taking account of the lack of structural alerts for genotoxicity in addition to available data, considered that candelilla wax is not genotoxic. The lactones present in candelilla wax are considered to be stable and not to belong to the category of reactive genotoxic lactones characterized by a low number of carbons in the heterocycle.
Available in vivo toxicological studies, including short-term and subchronic studies conducted on candelilla wax mixtures, short-term, subchronic, chronic toxicity and carcinogenicity studies as well as reproductive and developmental toxicity studies conducted on its main components, did not report adverse effects. No-observed adverse effect levels (NOAEL) from these studies range from 600 mg/kg bw/day to 2400 mg/kg bw/day.
The Panel noted that there were limited data comparing the composition of the candelilla wax tested with the specification of the food additive. However the Panel considered that the materials tested were likely to be broadly similar in composition to the food additive.
Exposure estimates for all age groups (toddlers, children, adolescents, adults, and the elderly) performed by the Panel show that the mean dietary exposure of European toddlers (aged 12-35 months) ranged from 2.6 to 4.6 mg/kg bw/day, and from 3.1 to 8.1 mg/kg bw/day at the 95th percentile. The mean dietary exposure of European children (aged 3-9 years) ranged from 1.6 to 4.5 mg/kg bw/day, and from 3.2 to 7.6 mg/kg bw/day at the 95th percentile. For European adolescents (aged 10-17 years) the mean dietary exposure ranged from 0.9 to 2.1 mg/kg bw/day, and from 1.9 to 3.8 mg/kg bw/day at the 95th percentile. For the European adult population a mean dietary exposure in the range of 0.7-1.7 mg/kg bw/day was estimated and 1.5-3.0 mg/kg bw/day for high level consumers. For the elderly mean exposure estimates were in the range of 0.8-1.5 mg/kg bw/day and in the range of 1.9-2.7 mg/kg bw/day at the 95th percentile. The main contributors to the total anticipated mean exposure to candelilla wax (> 10%) were fruits and confectionary in most population groups.
For the highest consumer populations (95th percentile) these exposures estimates would result in margins of safety between 74 and 400 when compared to the lowest NOAEL (600 mg/kg bw/day) and between 296 and 1600 when compared the highest NOAEL (2400 mg/kg bw/day) identified in the toxicity studies.
Overall, the Panel considered that long-term toxicity data on candelilla wax was lacking and therefore did not establish an Acceptable Daily Intake (ADI).
However, the Panel noted that available toxicity studies consistently reported no findings associated with intake of the main components constituting candelilla wax. Furthermore, consideration of the exposure estimates to candelilla wax, using the maximum permitted levels of carnauba wax, indicated sufficient margin of safety, which allowed the Panel to conclude that the use of candelilla wax as a food additive with the currently authorised uses would not be of safety concern.