The Food Safety Division of the Swiss Federal Office of Public Health has decided on an improved Specific Migration Limit (SML) for Ketjenflex® 8 after its full evaluation. A modification with this scope to the list of Additives of the Annex 6 of the ordinance of the FDHA on articles and Materials (SR 817.023.21) was officially announced on the 10th of May 2010.
On the request of Axcentive SARL, producer of Ketjenflex® 8, the Swiss authorities evaluated this plasticizer and concluded that an SML of 5 mg/kg was justified. Axcentive provided existing and new data to show the safety of their product in this application. The new SML is valid per its decision and will be published with the next update of the list. Parallel to the Swiss work, toxicologists from the German authorities evaluated Ketjenflex® 8 and with the Swiss came to this unanimous conclusion. Consequently also Germany confirms this SML for Ketjenflex® 8. Axcentive technical manager Jean de Barbeyrac comments: “this improved SML , coming from a level of 10 ppb as unevaluated substance, enables printers and food packaging manufacturers to continue using Ketjenflex® 8 based inks. Ketjenflex 8 is an important ingredient for its versatile functionalities as plasticizer and adhesion promoter in packaging inks”.