EFSA issues statement on 4-methylbenzophenone in some breakfast cereals

Riitta Maijala, EFSA’s Director of Risk Assessment, said: “Although the migration of
4-methylbenzophenone from packaging into foods is not desirable, only in the highest 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. scenario considered[2] – regular consumption of products contaminated at the highest levels reported so far – could some children possibly be at risk. However, there are important limitations in our knowledge and understanding of 4-methylbenzophenone and further data and analysis would be needed to be able to fully assess its safety.”

Based on the limited exposure data available and applying knowledge on the toxicity The potential of a substance to cause harm to a living organism. of a similar substance, benzophenone, EFSA concluded that short term consumption of contaminated breakfast cereals should not pose a risk to most people. However, if the contamination of food through the use of
4-methylbenzophenone in printing inks for food packaging were to continue, more data would be needed in order to carry out a full risk assessment A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation..

Due to the lack of data available, EFSA was not able to fully assess consumer exposure to
4-methylbenzophenone or its toxicological effects in humans. However, given its chemical structure and toxicity studies on benzophenone, EFSA concluded that 4-methylbenzophenone is likely to be a carcinogen but should not raise concerns with regard to genotoxicity When a substance is capable of damaging the DNA in cells. (i.e. should not cause damage to DNA A complex chain-like molecule that carries the genetic material, present in living organisms and some viruses. DNA (deoxyribonucleic acid) is capable of copying itself and carries the instructions for all the proteins used to create and sustain life., the genetic material of cells).

The similarities between 4-methylbenzophenone and benzophenone did enable EFSA to do a preliminary risk assessment. This looked at the lowest levels at which benzophenone caused adverse effects in animal experiments and took into account uncertainties such as the lack of data on
4-methylbenzophenone and differences between animals and humans.

In response to a specific question from the Commission, EFSA concluded that there was not enough scientific evidence to be able to apply the previously established group TDI The tolerable daily intake (TDI) is an estimate of the amount of a substance in food or drinking water which is not added deliberately (e.g contaminants) and which can be consumed over a lifetime without presenting an appreciable risk to health.  (Tolerable Daily Intake The amount of a substance (e.g. nutrient or chemical) that is ingested by a person or animal via the diet.) for benzophenone and hydroxybenzophenone to 4-methylbenzophenone. EFSA is due to review the TDI for benzophenone and hydroxybenzophenone by the end of May 2009.

• EFSA statement on the presence of 4-methylbenzophenone found in breakfast cereals