EFSA provides advice on the safety of ITX: ITX considered of low health concern

Following reports of the presence of ITX in foods packed in cartons, the European Commission requested that EFSA provide scientific advice with respect to possible health risks associated with this substance by April 2006. In view of the level of public concern, EFSA’s AFC Panel has adopted its final opinion on 7 December.

The Panel’s work focused on the assessment of possible exposure Concentration or amount of a particular substance that is taken in by an individual, population or ecosystem in a specific frequency over a certain amount of time. to this substance as well as on its genotoxic potential. In carrying out the exposure assessment One of the key steps in risk assessment, this relates to a thorough evaluation of who, or what, has been exposed to a hazard and a quantification of the amounts involved., the Panel referred primarily to data available on the levels of ITX found by industry in foodstuffs packed in cartons printed with ITX containing inks. The food products analysed in these studies comprise four types of milk-based products, including infant formula, milk and soy beverages as well as fruit juices, fruit nectars and other drinks. It appeared that the composition of the food itself influenced the levels found. According to the reports, the ITX levels in fat-containing foods were higher than in water-based products. Highest levels of ITX were found in milk-based products, followed by “cloudy” products such as orange juice and tomato juice (due to the presence of pulp). ITX was not detectable in ‘clear’ fruit juices such as apple juice nor was it detectable in water. The pack size appears also to be a factor as levels found in smaller cartons were relatively higher than those in bigger cartons.

The Panel gave special attention to the exposure of infants and young children. Infants who are not exclusively breastfed may be fed with ready-to-feed formulae packed in cartons. A large number of beverages consumed by young children are likely to be packed in cartons, particularly milk-based products and fruit juice in small volume packages. The potential dietary exposure For the purposes of risk assessment, measurement of the amount of a substance consumed by a person or animal in their diet that is intentionally added or unintentionally present (e.g. a nutrient, additive or pesticide). of infants and young children could therefore be higher than that of adults.

Following review of available genotoxicity When a substance is capable of damaging the DNA in cells. studies, the Panel concluded that the findings from animal studies did not indicate a genotoxic potential for ITX. EFSA therefore advises that ITX does not give cause for health concern at the levels reported. There are no data available at present on aspects other than genotoxicity. If contamination of foods with ITX was to continue, the Panel would wish to make recommendations about further studies that may be needed.

Following a request of the European Commission, EFSA has also provided scientific advice in the same opinion on another substance also used in inks, 2-ethylhexyl-4-dimethylaminobenzoate (EHDAB). This substance was also found in liquid products such as milk packed in printed carton packaging, but at lower levels than ITX. The Panel concluded that the occurrence The fact or frequency of something (e.g. a disease or deficiency in a population) happening. of EHDAB in food from its use in inks applied to food packaging materials is of no safety concern.