New EU restrictions on Chinese ARA oil imports: summary
- New EU restrictions target Chinese ARA oil following toxin contamination risks
- Cereulide toxin traced to a Chinese supplier prompted widespread global recalls
- EU now requires strict certification proving ARA oil is entirely cereulide free
- Half of all incoming shipments will undergo enhanced inspections at EU borders
- EFSA established new cereulide safety limits to reduce infant exposure risks
From tomorrow, new restrictions on Chinese imports of a common infant formula ingredient are coming into effect.
Member states have agreed that all arachidonic acid (ARA) oil made in China, intended for Europe, will be subject to much stricter checks. ARA oil is added to infant formula to support eye and brain development, but it’s also been linked to a widespread toxin contamination, triggering global recalls for some of the biggest names in the business, like Nestlé and Danone.
How ARA oil triggered global infant formula recalls
The toxin in question is cereulide, which can cause severe nausea, vomiting, or in extreme cases, more serious illness. The source of the contamination has been identified as a third-party supplier in China, hence these newfound restrictions.
Cereulide is produced by certain bacteria of the Bacillus cereus group. In very specific environmental conditions, the bacteria can multiply and lead to the development of cereulide in food. Oil doesn’t typically provide optimal conditions for the bacteria to grow, and so it’s been suggested that during, or even before the oil was produced, the organism had been growing and producing the toxin.
That’s why contamination concerns took industry by surprise. Cereulide testing procedures for ARA oil hadn’t previously been in place, because cereulide contamination in oil was an unknown risk.
Emergency checks for Chinese ARA oil
All ARA oil producers in China will need to show member state authorities an official certificate proving that testing has been conducted, including lab results confirming that no cereulide was detected.
High inspection rates are also being enforced, meaning that about half of ARA oil shipments entering the EU region will undergo identity checks, physical inspections and testing.
According to the European Commission, there is a zero-tolerance policy; ARA oil must be completely devoid of the toxin in order to enter the EU market.
Member states are responsible for enforcing these measures, but shipments already sent before this new rule takes effect can still enter the bloc until 26 April 2026 – even without certifications. However, they’ll still face inspections.
Global recalls prompt European action
The new food safety measures follow the fast-tracked development of cereulide safety thresholds for infants and formula in the EU.
In response to a request from the Commission, the European Food Safety Authority (EFSA) has determined how much cereulide babies can safely consume in a short period of time.
It has been decided that infants should not consume more than 0.014 micrograms of cereulide per kilogram of body weight. In infant formula, cereulide above 0.054 micrograms per litre could exceed the safe limit. In follow-on formula, the threshold is 0.1 micrograms per litre.
It’s thought anything above these levels poses a risk of acute effects, such as vomiting, in infants.
According to EFSA, in conjunction with the European Centre for Disease Prevention and Control (ECDC), current contamination risk is low, thanks to large-scale recalls already underway across multiple countries.
