Scientific Opinion on the safety evaluation of the active substances, sodium borohydride and palladium acetate for use in active food contact materials

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 , reduced to palladium 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 The CEF Panel considered that a low exposure to palladium resulting from a concentration up to 0.05 mg/kg food is not of toxicological concern. In migration tests in various food simulants, there was no detectable migration of palladium (detection limit = 0.0005 mg/kg). In migration tests in various food simulants, the migration of boron from the use of sodium borohydride was up to 0.09 mg/kg. Samples tested were composed of two polymer layers, boron being in the layer not in direct contact with food simulant as it is the intended use of the substance.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 that the UL set by the NDA.The CEF Panel after having considered the above-mentioned data concluded that there is no safety concern for the consumer from the intended use of sodium borohydride and of palladium acetate and its reduction product, palladium, in oxygen absorbing systems in active food contact materials.The sodium borohydride should only be used behind a plastic layer to prevent direct contact with the packaged food and the palladium species should also be behind a barrier layer or should be incorporated into the plastic of the primary packaging material in order to minimise direct contact of palladium with the food and thereby keep its migration within acceptable levels.The Commission may wish to take note of the different sources of exposure to boron and palladium, other than FCM, if setting a restriction for these substances. 4 Commission Regulation (EC) No 450

Scientific Opinion on safety assessment of the active substance, iron (0) modified bentonite as oxygen absorber, for use in active food contact materials

“…Sodium borohydride was also evaluated as active FCM substance (EFSA CEF Panel, 2012b). In that case, the CEF Panel concluded that there is no safety concern for the consumer when the sodium borohydride is only used behind a plastic layer to prevent direct contact with the packaged food.…”

“…Boric acid is authorised as a monomer and additive for plastic materials and articles in contact with foods (Regulation (EU) No 10/2011) with a combined specific migration limit (SML) with other substances containing boron of 6mg/kg (expressed as boron) (FCM Substance No 584). Sodium borohydride was also evaluated as active FCM substance (EFSA CEF Panel, 2012b). In that case, the CEF Panel concluded that there is no safety concern for the consumer when the sodium borohydride is only used behind a plastic layer to prevent direct contact with the packaged food.…”

Scientific Opinion on the safety assessment of the active substances, palladium metal and hydrogen gas, for use in active food contact materials

“…Palladium was considered to be non genotoxic and of no toxicological concern under a low exposure level resulting from a concentration up to 50 µg/kg food in a previous evaluation (EFSA CEF Panel, 2012). The active article is designed as a gas permeable but liquid impermeable laminated pad, which is placed within a cap or closure or as an adhesive label on tray lids.…”

“…The specific migration of palladium metal into conventional food simulants was not detected at the limit of quantification of 0.6 µg/kg. Palladium was considered to be non genotoxic and of no toxicological concern under a low exposure level resulting from a concentration up to 50 µg/kg food in a previous evaluation (EFSA CEF Panel, 2012). Based on these previously drawn conclusions and given the intended conditions of use leading to non-detectable migration, the CEF Panel concluded that the active substances palladium and hydrogen do not raise a safety concern for the consumer when used as an oxygen scavenger in packages for foods and beverages at room temperatures or below.…”

Nanotecnologías ecocompatibles para aplicaciones en biomateriales de titanio

“…La forma más tradicional de sintetizar NPa de plata (NPaAg) es a través de la reducción o síntesis química, donde los iones Ag + se reducen para nuclearse y formar nanoestructuras de Ag o . El agente reductor más utilizado en las síntesis químicas es el borohidruro de sodio, el cual es tóxico para el medio ambiente y un agente considerado peligroso para el personal que lo manipula [81]. Por otra parte, para que las NPa se mantengan estables en suspensión y no precipiten, es necesario utilizar algún agente estabilizante que las recubra (capping).…”