The absence of defined toxicological reference values has made the interpretation of findings complex for food business operators. Crucially, cereulide production is not directly correlated with bacterial counts<\/strong>; compliance with microbiological criteria does not necessarily guarantee the absence of toxin-related risk.<\/p>\n\n\n\n Recent detections of\u00a0cereulide in\u00a0<\/strong>baby formula<\/strong><\/a>\u00a0(infant formula)<\/strong>\u00a0have drawn increased attention to this regulatory gap. In response, the European Food Safety Authority (EFSA) published a\u00a0rapid risk assessment<\/strong><\/a>, establishing\u00a0science-based action thresholds to prevent cereulide poisoning<\/strong>\u00a0in infant formula, follow-on formula, and medical foods intended for young children.<\/p>\n\n\n\n Bacillus cereus<\/em> spores and the resulting cereulide toxin are highly heat-stable<\/strong>. They remain resistant to common food processing methods such as boiling and pasteurization. Consequently, conventional microbiological tests focusing solely on bacterial presence are insufficient: even when spores are inactivated, the toxin may persist in the food matrix.<\/p>\n\n\n\n The toxin\u2019s stability and its tendency to interact with specific food components complicate sampling. In some investigations, contaminated ingredients tested negative for the toxin until they were incorporated into finished products, illustrating how food matrices influence detectability. Because of these properties, analytical approaches must be specifically designed to identify and quantify the toxin itself<\/strong>.<\/p>\n\n\n\n As regulatory authorities move toward health-based guidance values\u2014with an acute reference dose (ARfD) of 0.014 \u00b5g\/kg body weight for infants\u2014highly sensitive analytical methods are required.<\/p>\n\n\n\n To address these challenges and meet the new thresholds defined by EFSA, M\u00e9rieux NutriSciences has developed\u00a0specific analytical solutions focused on the direct detection and quantification of cereulide in food<\/strong>\u2014specifically baby food (infant formula and follow-on formula), milk powder, ARA oil, ARA powder,\u00a0cereals<\/a>.<\/p>\n\n\n\n M\u00e9rieux NutriSciences has implemented dedicated methodologies based on ISO 18465<\/a><\/strong>, using LC-MS\/MS (liquid chromatography-tandem mass spectrometry)<\/strong>, providing the sensitivity and robustness needed to reach new EFSA recommendations.<\/p>\n<\/div>\n\n\n\n As cereulide is a lipophilic cyclic peptide, it is essential to use specific sample preparation protocols.<\/p>\n\n\n\n Analytical methods based on the well-established QuEChERS sample preparation protocol have been developed for selected matrices and raw ingredients, enhancing sensitivity and overall method robustness.<\/p>\n\n\n\n This approach is allowing us to reach lower LOQs compared to the ISO method.<\/p>\n<\/div>\n<\/div>\n\n\n\n Our network of laboratories can support you with aligned methodologies, ensuring analytical reliability and\u00a0result comparability across our global network of laboratories<\/a>. Contact our experts for more info on cereulide testing<\/p>\n\n\n\n Preventing toxin-related incidents requires a\u00a0risk assessment\u00a0that combines analytical precision with robust food safety management. Key strategies include:<\/p>\n\n\n\n![\"cereulide\"](\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/03\/Baby-Food-Featured-Image-1024x298.jpg\")
<\/figure>\n\n\n\nSpecific Analytical Challenges of the Cereulide Toxin<\/h2>\n\n\n\n
How M\u00e9rieux NutriSciences Addresses Cereulide Testing<\/h2>\n\n\n\n
LC-MS\/MS (Liquid Chromatography-tandem Mass Spectrometry)<\/h3>\n\n\n\n
QuEChERS Sample Preparation Protocol<\/h3>\n\n\n\n
Network of Laboratories to Ensure Results Comparability<\/h3>\n\n\n\n
Measures to Prevent Cereulide Poisoning<\/h2>\n\n\n\n
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