Safety of the proposed amendment of the specifications for microcrystalline cellulose (E 460(i)) as a food additive

Abstract

Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provided a scientific opinion regarding the safety of an amendment of the specifications for the food additive microcrystalline cellulose (E 460(i)). The scope of the current application was to amend the solubility of the food additive to 'practically insoluble or insoluble in sodium hydroxide solution'. Currently, the existing EU specifications describe microcrystalline cellulose as 'slightly soluble in sodium hydroxide'. In support of the request, the applicant carried out solubility tests on four batches of microcrystalline cellulose (E 460(i)). Because the concentration of sodium hydroxide solution to be used for the solubility tests is not indicated in the applicable JECFA testing procedures, the applicant performed the test using a concentration (50 g/L) as specified in the European Pharmacopeia. The tests indicated that the quantity of sodium hydroxide solution required to dissolve 1 g of the sample is more than 10,000 mL. The Panel noted that no analytical measurements of the solubility in a range of concentrations of sodium hydroxide solution were submitted in the application dossier and that, according to published information, the solubility of microcrystalline cellulose depends on the concentration of sodium hydroxide solution. The Panel also noted that in the current EU specifications for microcrystalline cellulose (E 460(i)) the concentration of sodium hydroxide solution to be used for testing solubility is not given. Therefore, the Panel concluded that the amendment to the specifications as regards the solubility of microcrystalline cellulose (E 460(i)) proposed by the applicant would not give rise to a safety concern. However, the Panel recommended that the concentration of sodium hydroxide solution to be used in the solubility test should be indicated in the EU specifications.