Safety of the extension of use of sodium propionate (E 281) as a food additive

The present scientific opinion deals with the safety of the extension of use of sodium propionate (E 281) when used as antimicrobial agent in meat preparations, processed meat and processed fish up to 5,000 mg/kg. Sodium propionate is currently an authorised food additive in the European Union under Annex II of Regulation (EC) 1333/2008 for use in several food categories (bakery and cheese products) up to 3,000 mg/kg. The safety of propionic acid (E 280) and propionates (E 281–283) as a food additive has been re-evaluated in 2014 by the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), where no safety concerns for consumers were identified. The Panel considered that the available toxicological database for propionic acid and propionates remains valid and that in order to address the safety of the proposed extension of use the relevance of site of contact irritancy noted in the scientific opinion in 2014 is pivotal. It is also noted that the proposed extension of use concerns sodium propionate and the Panel would derive a conclusion for sodium propionate only. The concentration of propionic acid provoking site of contact effect in a 90-day study in dogs was three times higher than the concentration in food at the current highest permitted levels. The Panel noted that the concentration of sodium propionate at which no adverse effects were observed in a chronic study in dogs was around 10-fold higher than the concentration which could occur in food at the highest proposed permitted level in meat preparations, processed meat and fish. The Panel therefore considered that sodium propionate showed to be less irritating than propionic acid. The Panel concluded that the proposed extension of use of sodium propionate (E 281) as a food additive in meat preparations, processed meat and fish up to 5,000 mg/kg would not be of safety concern.