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 carnauba wax (E 903) 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.
Carnauba wax is authorised in the EU as a food additive only as glazing agent (Directive 95/2/CE; Regulation 2008). Carnauba wax is authorised to food supplements, small products of fine bakery wares coated with chocolate, snacks, nuts and coffee beans. Maximum permitted use is 200 mg/kg food. It is also permitted as surface treatment on fresh citrus fruits, melons, apples and pears, as well as on peaches and pineapples up to 200 mg/kg food. In confectionary it may be used up to 500 mg/kg and on chewing gum up to 1200 mg/kg.
Carnauba wax has been evaluated by the Scientific Committee on Food (SCF, 1992; 1997; 2001; 2002) and by the Joint FAO/WHO Expert Committee on Food Additives (JECFA, 1993). JECFA allocated an Acceptable Daily Intake (ADI) of 0-7 mg/kg bw/day (JECFA, 1993). The SCF did not establish an ADI but did not object the use of carnauba wax as a glazing agent (SCF, 2002).
Carnauba wax is a complex mixture of compounds consisting of aliphatic esters (wax esters), α-hydroxyl esters and cinnamic aliphatic diesters. It also contains free acids, free alcohols, hydrocarbons and resins. It is obtained from the leaves of the Brazilian Mart wax palm, Copernicia cerifera (EU, 2008). The average composition of the highest quality carnauba wax has been reported as consisting primarily of 40% (w/w) aliphatic esters, 21% (w/w) diesters of 4-hydroxycinnamic acid, 13% (w/w) esters of ω-hydroxycarboxylic acids and 12% (w/w) free alcohols (Wolfmeier et al., 2005).
Specifications have been defined in the 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 and elimination were available for this revaluation. One modified 90-day toxicity feeding study carried out to investigate “bioaccumulation” of carnauba wax in Fischer F-344 rats indirectly suggested that the lipid like components from the wax are not accumulated in the tissues (Edwards, 1998). Overall, taking also into consideration the chemical composition of carnauba wax, the Panel considered, as with other natural waxes, that absorption of carnauba wax is expected to be low, if any.
The Panel noted that toxicological studies were conducted on carnauba wax itself and therefore the components of carnauba wax have been tested in those studies.
From a 13-weeks study with Wistar rats fed diets containing 0, 1, 5 or 10% carnauba wax, or 10% cellulose powder for 13 weeks corresponding to 0, 800, 4200 and 8800 mg/kg bw/day for males and 0, 900, 4600 and 10 200 mg/kg bw/day for females (Rowland et al., 1982) the Panel could derive a No Observed Adverse Effect Level (NOAEL) of 8800 mg/kg bw/day, the highest dose tested in male rats.
From a 90-day toxicity study with Fischer F-344 rats fed diets containing carnauba wax corresponding to daily intakes of 0, 15, 150 and 1500 mg/kg bw, respectively, continuously for 90 days (Edwards, 1998), the Panel could derive a NOAEL of 1500 mg/kg bw/day, the highest dose tested.
The Panel considered that based on the available data and the lack of structural alerts on carnauba wax it can be concluded that there is no concern for genotoxicity for carnauba wax.
No chronic toxicity or carcinogenicity studies were available on carnauba wax.
From a reproductive toxicity study of carnauba wax with Wistar rats administered 0, 0.1, 0.3, or 1% carnauba wax in the diet, the Panel could derive a NOAEL of approximately 670 mg carnauba wax/kg bw/day, the highest dose tested in female rats.
Refined estimates reported for carnauba wax, when considering Maximum Permitted Levels (MPLs), resulted in a mean dietary exposure of European toddlers (aged 12-35 months and weighing an average of 15 kg) ranged from 2.6-4.6 mg/kg bw/day, and from 3.1-8.1 mg/kg bw/day at the 95th percentile. The mean dietary exposure of European children (aged 3-9 years and weighing an average of 30 kg) ranged from 1.6-4.5 mg/kg bw/day, and from 3.2-7.6 mg/kg bw/day at the 95th percentile. The main contributors to the total anticipated mean exposure to carnauba wax for these populations were fruits and confectionary.
The mean dietary exposure of European adolescents (aged 10-17 years and weighing an average of 50 kg) ranged from 0.9-2.1 mg/kg bw/day, and from 1.9-3.8 mg/kg bw/day at the 95th percentile. The main contributors to the total anticipated mean exposure to carnauba wax for this population were fruits and confectionary. Whereas the mean dietary exposure of the European adult population give a mean dietary exposure in the range of 0.7-1.7 mg/kg bw/day and 1.5-3.0 mg/kg bw/day for high level consumers. The main contributors to the total anticipated mean exposure to carnauba wax for this population were fruits. For the elderly, mean exposure to carnauba wax was 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. Main contributors for these populations were fruits. From the highest consumers of these populations (95th percentile) these exposures estimates would result in margins of safety from 83 to 447 when compared to the NOAEL of 670 mg/kg bw/day identified in a reproductive toxicity study with rats by Parent (Parent et al., 1983), from 31 to 67 when compared to the NOAEL of 250 mg/kg bw/day identified in a subchronic toxicity study with dogs by Parent (Parent et al., 1983b), from 185 to 1000 when compared to the NOAEL of 1500 mg/kg bw/day identified in a subchronic toxicity study with rats by Edwards (Edwards et al., 1998), and from 1086 to 5867 when compared to the NOAEL of 8800 mg/kg bw/day identified in a subchronic toxicity study with rats by Rowland (Rowland et al., 1982). These margins of safety are considered sufficient by the Panel taking into consideration that the NOAEL’s identified are the highest dose tested not showing any effect in their respective studies, and that the exposure estimates to carnauba wax carried out in this opinion are very conservative.
Overall, the Panel concluded that long-term toxicity data on carnauba wax were lacking and therefore did not establish an ADI.
However, the Panel noted that available toxicity studies consistently reported no findings associated with carnauba wax intake. Furthermore, consideration of the conservative exposure estimates to carnauba wax from the currently authorised uses indicated sufficient margins of safety, which allowed the Panel to consider that the use of carnauba wax as a food additive with the currently authorised uses would not be of safety concern.