#32026R0459Commission Implementing Regulation (EU) 2026/459 amending rules on increased official controls for arachidonic acid oil from China due to cereulide toxin risk
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This regulation adds arachidonic acid oil from China to the list of products subject to heightened border controls because of contamination with cereulide toxin produced by Bacillus cereus. The toxin was found in infant formula, leading to recalls and investigations into infant illnesses and two suspected deaths. All consignments must now be accompanied by an official certificate confirming the absence of cereulide toxin (below 0.1 μg/kg LOQ) with attached laboratory results. Identity and physical checks are required on 50 % of incoming shipments. A two-month transitional period until 26 April 2026 allows previously dispatched consignments to enter without the new documentation.
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Key Changes
- Arachidonic acid oil from China added to Annex II of Regulation 2019/1793 with 50% frequency of identity and physical checks
- Mandatory official certificate required stating absence of cereulide toxin, with sampling and analysis results attached
- Cereulide toxin must be absent (analytical result ≤ 0.1 μg/kg LOQ) using ISO 18465 LC-MS/MS method
+ 3 more changes with Pro
Obligations
What this law requires
All consignments of arachidonic acid oil originating from China must be accompanied by an official certificate confirming the absence of cereulide toxin at levels below 0.1 μg/kg LOQ, with attached laboratory results of sampling and analyses
Conduct identity and physical checks on 50% of all incoming consignments of arachidonic acid oil from China at EU borders
Consignments of arachidonic acid oil from China dispatched before the regulation's entry into force may enter the Union without the official certificate and laboratory results only until 26 April 2026
Laboratory analyses for arachidonic acid oil from China must include sampling and testing to demonstrate absence of cereulide toxin with results attached to the official certificate
Add arachidonic acid oil originating in China to point 1 of Annex II to Implementing Regulation (EU) 2019/1793 as a product subject to heightened controls due to cereulide toxin contamination risk