azodicarbonamide chemicals

Plastic materials and articles were the first materials to be covered by EU harmonisation. Even if this harmonization is not yet complete, there are several regulations at national and EU level.
The Plastics Directive 2002/72/EC covers single and multi-layer plastic structures. Multi-layer structures made from non-plastic materials, such as composite paperboard for beverage packaging, are not covered by this directive. In these cases, national legislation applies, generally requiring that each layer conforms to specific material regulations and the overall construction conforms to Regulation (EC) 1935/2004. Nevertheless, Directive 2007/19/EC allows the use of plastic layers formulated with unauthorized substances that do not comply with the specific restrictions if they are separated from the food by a functional plastic barrier in such a way that the material or the finished article meets these requirements meets the specific and total migration limits. The substances mentioned above must not be carcinogenic, mutagenic or toxic to reproduction
Shortly after discovering this incident, the industry reported the case to European and national authorities and informed them that they would take action to replace azodicarbonamide with alternative foam concentrates. The European Commission has asked EFSA to carry out a risk assessment and inform the Commission about the risk of the active substance. EFSA carried out an initial azodicarbonamide in 2003 and found in July 2003 that the risk to consumers was very low, if any. It was found that SEM was a very weak carcinogen in mice and had weak genotoxic activity. While acknowledging the minor safety concerns, she recommended removing SEM from baby food as rapidly as technical progress allows (EFSA, 2003a,b). The European Commission banned the use of azodicarbonamide in food contact materials in August 2005, giving industry time to replace it. EFSA also reassured the general public that, given the low SEM concentration and safety risk, consumers would not need to change their diet and could continue to use all affected foods, including baby food.

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