EFSA Press Release, 10 July 2007

ADDITIVES - EFSA re-evaluates safety of food colours and adopts first opinion - Food colour Red 2G raises potential safety concerns

The Panel on food additives, flavourings, processing aids and materials in contact with food (the AFC Panel) of the European Food Safety Authority (EFSA) has adopted on the 5th of July an opinion on the food colour Red 2G (E 128). The use of this colour which is only permitted in certain breakfast sausages and burger meat raised potential health concerns. This is the first opinion in a series of re-evaluations EFSA is currently undertaking on the safety of food additives, including colours, authorised in the European Union (EU).

Red 2G has been shown to convert largely in the body into a substance, called aniline. Based on animal studies the Panel concluded that aniline should be considered as a carcinogen (i.e. it may cause cancer). Given new scientific evidence, it cannot be excluded that aniline's carcinogenic potential is due to damage to the genetic material of the cells. It is therefore not possible to determine a level of intake for aniline which may be regarded as safe for humans. The Panel therefore concluded that Red 2G should be regarded as being of safety concern.

EFSA has informed the European Commission of its conclusions on the safety of Red 2G.

The full opinion on Red 2G will be published shortly on the EFSA website at http://www.efsa.europa.eu/en/science/afc/afc_opinions.html. Please find the conclusions of the Panel attached to this press release [see below].

In the re-evaluation process of food additives currently authorised for use in the EU, priority has been given to food colours as they were among the first additives to be evaluated under European legislation. Since the first evaluations of additives, some 30 years ago, new studies have become available. Further to this evaluation, EFSA is continuing its work on the re-evaluation of colours and will look at all colours currently permitted in the EU on a case-by-case basis.

Additioanl information:

• For more information on EFSA's work on food additives please consult the EFSA webpage at In Focus http://www.efsa.europa.eu/en/in_focus/food_additives.html
• Red 2G (E128) is only permitted for use in breakfast sausages with a minimum cereal content of 6% and in burger meat with a minimum vegetable and/or cereal content of 4%. In both foodstuffs a maximum level of 20 mg/kg is permitted according to EU food law. (see: http://ec.europa.eu/food/fs/sfp/addit_flavor/flav08_en.pdf)

Parma , 9 July 2007

Excerpt from the opinion on Red 2G (E 128) adopted by the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) on July 5th, 2007

The AFC Panel concluded:

“For the current re-evaluation of Red 2G, the Panel has reconsidered several existing evaluations of Red 2G and its metabolite aniline supplemented by several studies which have been published since 1999.

The Panel based its evaluation on the conclusions of the EU Risk Assessment on aniline. This concluded that aniline should be considered as a carcinogen for which a genotoxic mechanism cannot be excluded, based on the following:

• aniline was genotoxic in vivo in rats and mice,
• there was insufficient mechanistic evidence to discount a genotoxic mechanism for the rodent carcinogenicity
• based on similar metabolism of aniline in animals and humans a carcinogenic risk for man cannot therefore be excluded.

Therefore the Panel concluded that it would be prudent to regard Red 2G as being of safety concern since it is extensively metabolised to aniline. Based on these considerations, the Panel withdrew the ADI1 for Red 2G.

The Panel considered that should the tumour inducing mechanism of aniline be further elucidated, shown to be thresholded and/or its relevance for man discounted, Red 2G could be re-evaluated once again.”