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European Food Safety Authority Confirms the Threshold for Stage 1 Infant Formula Used by the Ministry of Health for Risk Assessment

EFSA confirms infant formula toxin threshold used by Israel's Health Ministry, impacting Nutrilon product safety after cereulide detection.

وزارت بهداشتPublic

After the toxin was found last week in Israel in infant food products from the Nutrilon company, imported by Teva, the Ministry contacted all importers and the manufacturer, including Teva, requesting an immediate response regarding risk management for the possible presence of cereulide in batches currently in Israel. It is clarified that as of this date, no indications have been received from hospitals or health maintenance organizations that infants were harmed by use of the product.

The European Food Safety Authority (EFSA) yesterday published a scientific risk assessment in response to global recalls following the detection of the cereulide toxin in a raw material used to produce infant food, dated February 2, 2026. EFSA confirmed the health-based threshold set by the Irish authority for stage 1 infant food products (from birth to six months), on which the food regulatory framework of the Ministry of Health is based. In addition, the European Food Safety Authority decided to establish a higher action threshold for stage 2 infant food products (from 6 to 12 months). As a result, in Israel as well as worldwide, binding regulation on the matter will be formulated.

As recalled, the toxin was found last week in Israel in infant food products from the Nutrilon company imported by Teva. At the same time, professional teams at the Ministry of Health contacted all importers and the manufacturer of infant food products, including Teva, requesting an immediate response regarding risk management related to the presence of cereulide in batches currently in Israel.
In December–January of this year, a broad global recall began, including hundreds of products in dozens of countries worldwide, during which the global Nestlé company announced that many infant formula products manufactured at several production sites in Europe were not safe for infant consumption due to the presence of certain levels of the cereulide toxin in the raw material used to manufacture the formula.

The toxin is produced by the bacterium Bacillus cereus and is not destroyed by heat or acidic conditions. Exposure to this toxin at certain doses may cause vomiting, nausea, abdominal pain and cramps, diarrhea, and in rare cases weakness, primarily among infants. As of this date, there is no specific regulation worldwide for this toxin; existing legislation addresses only the bacterium Bacillus cereus.

As part of the Ministry of Health’s handling of the issue, on Sunday a Ministry sampling team went out to marketing channels and to the warehouses of importers and the local manufacturer in order to test approximately 20 types of products from all companies, which were sent for testing at a certified laboratory in Germany.
As recalled, the Ministry of Health also instructed Teva, the importer of Nutrilon infant formula, to conduct laboratory testing on all products to ensure they are safe for use. Last week, immediately after it was discovered that three batches contained the toxin at levels above the threshold approved by regulatory authorities, the Ministry instructed a recall of those batches.
The Ministry also instructed Teva to submit within 14 days the findings of the comprehensive review regarding the company’s conduct on this matter.

The Ministry of Health continues to act on an ongoing basis to ensure the safety of infant foods marketed in Israel.
Although a comprehensive review conducted with importers and manufacturers did not indicate use of the suspected raw material by additional companies, the Ministry of Health continues, as customary in events of this type, to operate continuously and monitor global developments, sample additional products in Israel, analyze results in real time, and require companies to present risk management and supporting documentation in accordance with requirements. As needed, the Ministry will also update and expand existing tests and procedures to ensure a high level of safety and transparency.

  • Questions and Answers – Infant Food Products (Infant Formula)
    30.01.2026 Following the voluntary recall of several Nutrilon products
  • Questions and answers on the subject (PDF)
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