Beeswax (E 901) - Scientific Opinion

Following a request from the European Commission, the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) was asked to update the opinion of the Scientific Committee on Food of the European Commission (SCF) on the safety in use of beeswax and to consider, within the same opinion, the additional use of beeswax as a carrier of flavours.

Beeswax was evaluated by the SCF in 1990. At that time, the Committee concluded that, due to the paucity of experimental toxicological data, it was unable to establish the full safety of this compound. Nevertheless, its use as a glazing agent was considered temporarily acceptable.

Beeswax is an authorised food additive in the European Union. It is permitted as a glazing agent on confectionery (excluding chocolate), small products of fine bakery wares coated with chocolate, snacks, nuts and coffee beans, and for surface treatment only of certain fruits (fresh citrus fruits, melons, apples, pears, peaches and pineapples). It is also permitted for use in food supplements and as a carrier for colours.

Beeswax is a complex mixture of saturated and unsaturated linear and complex monoesters, hydrocarbons, free fatty acids, free fatty alcohols, and other minor substances produced by the worker honeybee.

The Panel noted that experimental biochemical and toxicological studies carried out specifically on beeswax were still lacking and considered that the data on beeswax itself were insufficient to establish an acceptable daily intake (ADI). However, the Panel concluded that the safety of beeswax could be assessed based on the available scientific literature on the main constituents of beeswax and on plant waxes showing chemical structural similarities to beeswax, published since the last SCF evaluation.

The conservative exposure estimate of 1,290 mg of beeswax per person per day calculated in this opinion corresponds to an exposure approaching 22 mg beeswax per kg body weight per day for a 60 kg individual. The Panel considered this estimate to be very conservative, as it was based on the assumptions that a person would consume all the proposed foods and tablets or capsules at the 95th percentile and that beeswax would be used in the proposed applications at the maximum usage level.

In addition, the data on soft drink consumption used for the exposure assessment were obtained from a two-day survey, which may overestimate higher percentiles compared with a more realistic seven-day survey.

The Panel concluded that the use of beeswax as a food additive for the existing uses and the proposed new use is not of safety concern.

The Panel noted that NOAELs identified in toxicological studies on the main constituents of beeswax and on plant waxes showing chemical structural similarities were 10 to 50 times higher than the very conservative exposure estimate of 22 mg/kg body weight per day and were generally the highest doses tested. Such margins of safety were considered adequate for the assessment of beeswax, which consists of components that are poorly absorbed from the gastrointestinal tract and, if absorbed to any extent, would be metabolised to compounds that also occur endogenously.

The Panel examined information on the presence of varroacide residues in beeswax and found that the active varroacide substances most often detected in European samples of beeswax are fluvalinate, coumaphos and bromopropylate. The Panel noted that veterinary medicinal residues and contaminants found in foodstuffs of animal origin are regulated by specific European legislation.

The Panel also noted that beeswax specifications for lead are set at 5 mg/kg in European legislation and at 2 mg/kg by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). The Panel considers that the specification for lead levels should be set as low as possible.