Recalls due to the presence of excessive levels of ethylene oxide in food have regularly taken place in the Netherlands these last few years. Ethylene oxide is a pesticide that kills bacteria, fungi and viruses. It is carcinogenic, mutagenic and toxic to reproduction. Ingestion of ethylene oxide can be harmful to health if consumed over a long period of time, on a regular basis and in large quantities. A recall can have major consequences for a business. In addition to possible loss of value, a recall may lead to the imposition of fines by the Netherlands Food and Consumer Product Safety Authority (NVWA), claims for damages, and reputational damage. It is therefore essential that businesses are aware of the rules governing the use of ethylene oxide and the NVWA supervision of that use. In this blog, we address the main points of attention for businesses when ethylene oxide is used or found in food.
Ethylene oxide — in which food is it found?
Ethylene oxide is often used in countries outside the EU as a disinfectant to kill bacteria and fungi. The sterilizing agent is mainly found in food additives. These are substances that are intentionally added to food in order to achieve a certain technological objective. Additives permitted by the EU are known as ‘E numbers’. A food additive in which ethylene oxide is relatively common is the locust bean gum binder (E410). Ethylene oxide is also sometimes found in sesame seeds. Since 2020, excessive levels of ethylene oxide have been found in the Netherlands in baby milk, ice cream, crackers, sauces, condiment products, vegetarian snacks (croquettes and bitterballen), vegetarian cheese, cream cheese, canned fish, soy milk and noodles, among other products.
Ethylene oxide level below 0.1 mg/kg is permitted
The use of ethylene oxide for sterilisation purposes in food additives is prohibited within the European Union (EU) (Regulation 231/2012). Regulation 2022/1396 furthermore provides that since 1 September 2022 food additives, including mixtures of food additives, may not contain more ethylene oxide than the maximum residue limit (MRL) of 0.1 mg/kg. The reason why the EU introduced this general rule is that it is difficult to determine whether the presence of ethylene oxide is due to its use in the sterilisation of food additives, or whether there is some other reason for its presence. Some countries outside the EU, such as India, do allow the use of ethylene oxide as a disinfectant in food.
Sample testing
Article 17 of the General Food Law Regulation (GFLR) provides that the food business operator is primarily responsible for food safety. Businesses that import, produce, process, manufacture or distribute foods that may contain ethylene oxide (such as locust bean gum or sesame seeds) must therefore regularly monitor the presence of ethylene oxide. The ethylene oxide content in food can be checked by means of sample testing. There are several companies in the Netherlands that carry out such sample testing. The NVWA may also check ethylene oxide levels in food during inspections. If excessive levels of ethylene oxide are found in food, the NVWA may take enforcement measures against the businesses in question, for instance by destroying or seizing products and by imposing fines and orders subject to a penalty.
Obligation for businesses to notify NVWA
If a food business’s own investigation shows that products contain a level of ethylene oxide higher than the MRL, it must notify the NVWA, using a form on the NVWA website. This is known as a GFLR notification. This notification obligation applies to all parties that have imported, processed, manufactured or distributed the product and that are or should be aware that the food does not meet the food safety requirements. This notification must be made also if the product has not yet left the immediate control of the food business operator. The NVWA has published a notification guide to clarify when a notification must be made to the NVWA or not. The NVWA may impose a fine for failure to submit a timely GFLR notification. A notification obligation does not automatically give rise to a recall obligation. That may be the case only if the food in question has left the direct control of the food business operator.
A recall: making the right assessment
Food business operators that believe or have reason to assume that they have imported, processed, manufactured or distributed a food in which the ethylene oxide MRL is exceeded must withdraw the food in question from the market. If the product may have reached consumers, the food business operator must effectively and accurately inform consumers accordingly. In some cases, food business operators that have placed products with excessive levels of ethylene oxide on the market must also carry out a public recall. That is the case if the product may have reached consumers and there are no other means of achieving a high level of health protection (Article 19(1) of the GFLR). Businesses themselves must primarily assess whether a public recall is necessary.
If the NVWA believes that a public recall must take place and the food business refuses to do so, the NVWA may force a producer to do so by imposing an order subject to a penalty. It may then also impose a fine at a later time. The maximum fine is €900,000 or 1% of the annual turnover, whichever is higher, if the food business intentionally fails to carry out a recall. Such intent is assumed, for instance, if the food business intentionally ignores instructions from the NVWA. In the event of gross negligence rather than intent, the NVWA may impose a fine of up to 0.5% of the annual turnover of the business involved. That is the case, for instance, if the food business involved takes inadequate precautions, such as having insufficient traceability systems in place. If the food business involved fails to act, the NVWA itself may furthermore inform the food business’s buyers and consumers.
Click here for the main points to consider in recalls and NVWA enforcement.
More information on NVWA raids can be found at invalnvwa.nl or in this video briefing with practical tips.
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