EFSA’s expert Panel on food contact materials (the CEF Panel) considers there to be no health risks from the short-term consumption of breakfast cereals contaminated with
4-methylbenzophenone at levels reported earlier this year. The Panel reached its conclusions after re-assessing the toxicological data on the similar substance, benzophenone. However, the Panel confirmed that should the use of 4-methylbenzophenone continue, more data would be needed for a full risk assessment.
Benzophenone and 4-methylbenzophenone are chemicals used in printing inks for food packaging. In February 2009, the European Commission asked EFSA for urgent advice on the risks to human health following the discovery of 4-methylbenzophenone in certain breakfast cereals. The Commission also asked EFSA to evaluate whether the existing Tolerable Daily Intake (TDI) for benzophenone and hydroxybenzophenone could also be applied to 4-methylbenzophenone, and to re-assess the TDI for benzophenone and hydroxybenzophenone by the end of May 2009.
The Panel considered the safety threshold for benzophenone which was used as the basis of EFSA’s urgent advice to the Commission in March to be very cautious, as it was based upon adaptive (i.e. reversible) changes reported in experimental animals as a result of their exposure to benzophenone rather than adverse effects as such. However, the Panel considered that this approach was reasonable given the lack of data available and the short deadline.
Based on a higher threshold which the Panel considered to represent the intake level beyond which benzophenone may cause adverse health effects, the Panel determined a new TDI for benzophenone of 0.03mg per kilogram of bodyweight. The Panel agreed with the previous EFSA statement that the TDI for benzophenone could not be applied to 4-methylbenzophenone, and also stated that hydroxybenzophenone should not be included in the same TDI as benzophenone due to the absence of supporting data.
 The CEF Panel’s conclusions and the earlier EFSA Statement were both largely based on scientific knowledge on benzophenone, due to the very limited data available on 4-methylbenzophenone and the chemical similarities between the two substances. The urgent EFSA statement published in March had indicated that a health concern could not be excluded for some children who regularly ate breakfast cereals contaminated with 4-methylbenzophenone at the highest levels reported.
 The previous TDI, set by the EU’s former Scientific Committee on Food in 1992, was 0.01mg/kg bw.