EU Regulatory Awareness Can Help Reduce U.S. Risk

The European Union has amended its import entry regulations for certain foods from certain countries related primarily to potential health risk the presence of ethylene oxide and aflatoxin. While the amendments did not change the regulatory limits, they did increase the frequency of identity and physical checks for consignments from a number of countries. The regulation, which was passed in late May, “temporarily changes the rate of official controls and puts emergency measures on entry into the EU of certain goods from some non-EU countries.” (FSN)

Following are overviews and TAG analysis of some of the most significant changes.

Ethylene oxide (ETO)

1. Because of the potential health risk from contamination, imports containing mixtures of food additives containing locust bean gum or guar gum from India, Malaysia and Turkey, the EU has increased the frequency identity and physical checks to 20% of consignments entering the Union.
2. Because no contamination by ethylene oxide was detected in spices from India, (e.g., roots, flowers and leaves, such as turmeric (curcuma) root) during official controls performed by Member States, these commodities can be excluded from increased official controls. Thus, only dried spices from India will be subject to official controls at border control posts, with a frequency of identity and physical checks set at 20% of consignments.

Discussion. It is the use of ethylene oxide as a fumigant that is the basis for the zero tolerance of its presence. According to EU regulations, ethylene oxide residue is defined as the sum of Ethylene oxide and 2-chloroethanol but is expressed as ethylene oxide. It has a 0.1 ppm limit of quantification, with any detection of ethylene oxide prohibited.

Because ethylene oxide is so unstable, it tends to breakdown into 2-chloroethanol which is much less toxic. Additionally, 2-chloroethanol can form from other sources that are used in food production (such as antifoaming agents). So simple detection of 2-chloroethanol does not necessarily mean that ETO was used as a fumigant. Additionally, guar gum, locust bean gum, and spices are used at very low percentages in finished product, so the level of 2-chloroethanol would have to be quite high to pose a risk. But the EU will continually take action on any detection even though it’s highly unlikely for free ETO to be present in finished products.

Aflatoxin and Ochratoxin A

1. Because a high frequency of non-compliance with the relevant requirements provided for in Union legislation with respect to contamination by aflatoxins was detected in hazelnuts from Georgia during official controls performed by Member States, the EU recommends the frequency of identity and physical checks for such consignments be increased to 30%.
2. To ensure efficient protection against potential health risks arising from contamination of rice from India and Pakistan by aflatoxins and ochratoxin A, the related regulation is extended to cover all types of rice. Doing so, however will significantly increases the administrative burden for Member States, so the frequency of controls is to be decreased to 5%. This frequency is expected to provide sufficient information for an assessment of risks associated with possible contamination of rice by aflatoxins and ochratoxin A.
3. Nutmeg from India has been subject to an increased level of official controls due to the risk of contamination by aflatoxins since July 2019. With both the official controls carried out by the Member States and available information showing improvements in compliance with the relevant legislation, there is evidence that the entry of this foodstuff into the Union no longer constitutes a serious risk to human health. Consequently, it is not necessary to continue to require that all consignments of nutmeg from India be accompanied by an official certificate showing compliance. However, Member States should continue to carry out controls to ensure that the current level of compliance is maintained. So nutmeg from India will now be subject to a frequency of identity and physical checks set at 30%.
4. Because a high frequency of contamination by aflatoxins was detected in nutmeg from Indonesia, the frequency of identity and physical checks to be performed on such consignments is to be increased to 30 % of consignments entering the Union.

Discussion. Compared with aflatoxin, ochratoxin A is not much of a risk in rice, so we are not sure as to why the EU is concerned about ochratoxin A in rice. We would see much greater risk in the increased results of aflatoxin in a number of other countries for groundnuts (peanuts) and ingredients derived from peanuts (flour, etc.). This isn’t surprising as aflatoxin is a big risk for peanuts, so we would recommend that any company receiving peanuts and/or peanut-derived ingredients request aflatoxin testing at some point in the supply chain – whether it is legislatively required or not.  In addition, a myriad of spices may be contaminated with aflatoxin, so this should be a common chemical of concern in spices as well, especially if the spices are bought on the open market

While these new controls are specifically focused toward imports into the EU, it is wise for food producers in the U.S. (and all other nations) to maintain awareness of such regulations and risk assessments, both as denoting potentially higher risk for ingredients they receive that are included in regulation and for foods they export to the EU. It is a global world, and there is very little that impacts one nation without affecting others.