Scientific Opinion on the safety evaluation of the active substances, sodium borohydride and palladium acetate for use in active food contact materials
Meta data
Competing interests: One member of the Panel declared an interest as his laboratory carried out experimental migration testing used for the evaluation of the substance. This was considered as a conflict of interest and he was asked to leave the room during discussion and vote. One member of the Panel declared an interest as he prepared part of the summary of the toxicological data on the substance under contract of his Institute with the EFSA. This was considered as a conflict of interest because he could not act at the same time as a representative of the contractor and a member of the Panel with voting rights. He was allowed to stay in the room to answer questions specifically addressed to him but did not participate in the discussion of the opinion.
Abstract
This scientific opinion of EFSA deals with the risk assessment of sodium borohydride (CAS No 16940-66-2 and FCM substance No 981), and palladium acetate (CAS No 3375-31-3 and FCM substance No 982), reduced to palladium (CAS No 7440-05-3; FCM substance No 993) in the plastic during the manufacturing process, when used in combination as an oxygen absorbing system in food contact materials. The CEF Panel considers that palladium is non genotoxic and a low exposure to palladium resulting from a concentration up to 0.05 mg/kg food is not of toxicological concern.
In addition, the CEF Panel used the tolerable upper intake level (UL) of 0.16 mg boron/kg bw per day equivalent to 10 mg boron/person per day in adults established by the EFSA NDA Panel in 2004, instead of the previously derived TDI of 0.1 mg boron/kg bw (SCF, 2001a).
Migration of palladium into food was not detectable (detection limit = 0.0005 mg/kg) while the migration of boron into food was up to 0.09 mg/kg.
Based on the default assumption for food contact materials that an adult may consume daily up to 1 kg of food in contact with food contact materials containing boron, the migration of 0.09 mg/kg food would correspond to an intake of 0.09 mg boron/adult/day which is 111 times lower than the UL set by the NDA.
The CEF Panel concluded that there is no safety concern for the consumer from the use of these substances in oxygen absorbing systems in food contact materials.