EFSA’s Scientific Opinion on the safety evaluation of the active substances, sodium borohydride and palladium acetate for use in active food contact materials voiced support for the use of the chemicals in plastic during the manufacturing process - giving the European Commission (EC) the green light to approve the chemicals for food contact applications.
The document, which was based on a dossier submitted by UK-based ColorMatrix Group, followed a request from the UK Food Standards Agency (FSA).
Despite the overall approval, which was delivered by EFSA’s Panel of food contact materials, enzymes, flavourings and processing aids (CEF), the agency suggested that measures be implemented to prevent direct contact between the chemicals and food.
“No safety concerns”
“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,” said the document.
According to the report, the migration of palladium into food was not detectable.
“The CEF Panel considered that a low exposure to palladium resulting from a concentration up to 0.05mg/kg food is not of toxicological concern. In migration tests in various food simulants, there was no detectable migration of palladium (detection limit = 0.0005mg/kg).”
The migration of boron into food was measured up to 0.009mg/kg – well below the tolerable upper intake level (UL) of 0.16mg/kg per day.
“In migration tests in various food simulants, the migration of boron from the use of sodium borohydride was up to 0.09mg/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,” the opinion added.
“Prevent direct contact”
The scientific opinion was undertaken in accordance with the European Commission Regulation No450/2009 – under which active and intelligent materials, articles intended to come into contact with food and substances responsible for the active or intelligent function need to be evaluated by EFSA before EC-approval.
The opinion added that measures should still be implemented to minimise direct contact between the evaluated substances and food.
“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 EFSA document added.
It added that the EC may wish to examine different sources of exposure to the chemicals, other than food contact materials, if it decides to set restrictions.