Scientific Opinion on the safety evaluation of the active substances, sodium carbonate peroxyhydrate coated with sodium carbonate and sodium silicate, bentonite, sodium chloride, sodium carbonate for use in active food contact materials
This scientific opinion of the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of the powder mixture of the active substances sodium carbonate peroxyhydrate coated with sodium carbonate and sodium silicate (FCM substance No 1009), bentonite (CAS No 1302-78-9, FCM No 393), sodium chloride (CAS No 7647-14-5, FCM No 985), sodium carbonate (CAS No 497-19-8, FCM No 1008) which are intended to be used as combined oxygen generator and carbon dioxide absorber in packaging containing whole fresh fruits. The powder mixture is placed in a nonwoven polyethylene sachet separated from the food by a pad. In the presence of moisture, sodium carbonate peroxyhydrate first decomposes into sodium carbonate and hydrogen peroxide which decomposes into water and oxygen. Sodium carbonate reacts with carbon dioxide to form sodium bicarbonate. Because the sachet is not placed in direct contact with the food or food exudates, only hydrogen peroxide which decomposes to water and oxygen may be released with no other potential migration of volatile compounds. Based on the conclusion drawn in the EU Risk Assessment Report that hydrogen peroxide is not classified as a mutagen and the results from a subchronic toxicity study with hydrogen peroxide, the Panel concluded that hydrogen peroxide does not raise a safety concern under the intended conditions of use. Therefore the CEF Panel concluded that sodium carbonate peroxyhydrate coated with sodium carbonate and sodium silicate, bentonite, sodium chloride and sodium carbonate do not raise a safety concern for the consumer when used as combined oxygen generator and carbon dioxide absorber, for packaging of whole fruits. The substances should be used in sachets which prevent the release of the powder mixture into the food. Sachets should not be in direct contact with food or food exudates.