27.09.2021

Ethylene oxide

 Ethylene oxide is a plant protection agent that is not permitted in the EU and has been used, among other things, to sterilise spices. In Germany, its use in the food sector has been banned since 1981, as ethylene oxide is classified as mutagenic. Since the end of 2020, numerous warnings with positive findings in sesame seeds can be found in the European rapid alert system. The background to this is that ethylene oxide is very suitable for antimicrobial treatment and is also approved for the US market, for example.

 Since the beginning of the year, however, more and more rapid alerts have been appearing for herbs and spices, and there are also increasing reports of findings in thickeners (including guar gum and locust bean gum) from Turkey. In recent weeks and months, more and more affected products, both raw materials and finished goods, have been identified.

The legal assessment of the products is often difficult. On the one hand, there are maximum residue levels in Regulation (EC) No. 396/2005  (Pesticide Maximum Residue Levels Regulation). If a raw material is included in this regulation, the corresponding MRL can be used for evaluation. On the other hand, the assessment of processed products is sometimes problematic, as it is sometimes not clear whether fumigation with ethylene oxide has taken place in the fresh product or only in the already processed goods.

For the evaluation of food additives, the first sentence of the Annex to Regulation (EU) No 231/2012 must be observed. According to this, ethylene oxide may not be used for the sterilisation of food additives. This means that there must be no active use. Here, the question of how the entry occurred must also be taken into account in the assessment. On the one hand, a deliberate sterilisation of the products may have taken place, but on the other hand it is also possible that contamination has occurred through treated storage rooms, containers or the like. In the case of contamination, there would then be no violation of Regulation (EU) No. 231/2012.

However, the question of marketability is only one aspect of the assessment of ethylene oxide findings. More difficult to answer is the assessment of whether the food is safe in the sense of Article 14 of Regulation (EC) 178/2002. 

In the vast majority of samples, only the degradation product of ethylene oxide, 2-chloroethanol, is detected and there is hardly any toxicological data available on this compound. The BfR (Federal Institute for Risk Assessment) suggests assuming a similar toxicity here as for ethylene oxide. However, there are justified doubts about this approach, as the chemical structures of the two compounds are very different.

All in all, it remains to be said that we have numerous affected products and that a clear assessment is often difficult.

We will be happy to advise you. Contact us for more information.