Ionising radiation of more than 10kGy for the manufacture of materials

Regulatory framework

The framework regulation for plastics requires their components to be assessed and approved before being placed on the market. Certain manufacturing processes however are liable to alter the composition of the final material, leading to the formation of new potentially dangerous substances; this is the case with ionising radiation. ANSES is responsible for assessing applications for approval to use ionising radiation of more than 10kGyfor the manufacture of plastics.

Plastics, and the substances that may be used to manufacture them, are regulated at European level. However, certain treatments used to manufacture these materials may cause the formation of  “neoformed” compounds, which were absent from the initial material but formed during the manufacturing process.

Physical ionisation treatments are used in the manufacture of multi-layer plastics, and may cause the formation of neoformed substances. In the context of applications in France for approval to use plastics treated by ionising radiation of more than 10 kGy, particular attention is paid to the potential formation of neoformed substances.

In order to facilitate the compilation of assessment dossiers and enable a more stringent risk assessment, it became necessary to update the guidelines dating from 2001. The recommendations on compiling applications for approval to use plastics for food contact treated by ionising radiation were updated, and these updated guidelines were put online in February 2006. The additional necessity of assessing materials ionised at doses of less than or equal to 10 kGywas also examined and recommendations were made on 26 September 2007.