Substances which have genotoxic properties have the potential of interacting directly with the genetic material (DNA) found in cells.

Inks applied to food packaging materials are not covered by specific European legislation. However, materials and articles intended to come into contact with foods should comply with the general criteria laid down in Regulation (EC) No 1935/2004. This framework regulation specifies that food contact materials should be safe and should not transfer their components into foods in unacceptable quantities. Further information on the regulation of food contact materials.

FAQ on ITX

What is EFSA’s advice relative to the safety of ITX? Whilst ITX is an undesirable substance in foods, EFSA advised that ITX does not give cause for health concerns at the levels considered by the EFSA Panel on food additives, flavourings, processing aids and materials in contact with food [AFC] and reported in the  Opinion adopted on 7 December 2005.  

What was the basis for the conclusions drawn by the scientific experts of the AFC Panel concerning the safety of ITX? There were only limited data available for the safety assessment. In particular, no toxicity data other than those from genotoxicity[1] studies were available at the time the Panel evaluated the safety of ITX. Based on the genotoxicity studies available (in particular two animal studies), the Panel concluded that there is no indication for genotoxic effects.

Will EFSA publish another opinion on ITX in March or April 2006? EFSA delivered its final Opinion on ITX in December 2005, after having finalised the safety evaluation based on the data available at the time. The AFC Panel will not re-evaluate its Opinion or start a new risk assessment on ITX unless there is either new evidence to consider or EFSA is requested to do so by risk managers (the European Commission, the European Parliament or the EU Member States).

What is EFSA’s role concerning ITX – and what is not in EFSA’s remit? EFSA’s role is to provide scientific opinions on questions from risk managers related to food and feed safety and to communicate its advice to the public at large.

The Authority neither authorises nor bans the use of substances in foods but rather provides scientific advice with respect to their safety, at the request of risk managers. EFSA does not set upper limits with respect to the presence of substances found in foods; this is also the case for ITX. It is the responsibility of risk managers in the European Commission and EU Member States to define and agree such measures as and where required, taking into account scientific advice and other considerations.