Statement on Current Infant Formula Recalls

Frequently Asked Questions

• Classification of the Current Situation Show Hide

  1. What are the current recalls about?
  In recent weeks, media outlets have reported on recalls of infant formula products from certain international manufacturers. According to publicly available information, the heat-stable toxin cereulide was associated with a specific issue during the fermentation of a raw material at the supplier level.
  
  2. Is Töpfer affected by these recalls?
  No. Our products are not affected. Our supply chains are independent of the publicly mentioned problematic supply chains. Safety and control are our top priorities from the very beginning.
  
  3. Has the safety of Töpfer products been reviewed?
  Töpfer products are subject to a multi-stage, strict control and verification process throughout the entire value chain. This process is an integral part of our quality promise and ensures the special Töpfer quality.
  
  In addition, Töpfer is monitored by the competent Bavarian food control authority. Our products and processes are regularly inspected by authorities.
  
  In connection with the current recalls, the responsible Bavarian Authority for Food Safety and Veterinary Affairs reviewed our supplier declarations, analytical data, and our testing and release procedures. The requested documentation was accepted.
  
  Based on our comprehensive testing and control systems, Töpfer products are not affected and can be used without restriction.
• Cause of the Recalls – Technical Classification Show Hide

  1. What exactly is cereulide?
  Cereulide is a heat-stable toxin.
  Cereulide is a heat-stable toxin. This means: once it has been formed, it cannot be destroyed by normal heating.
  
  2. When does cereulide form?
  Cereulide does not automatically form due to the presence of the bacterium itself. It only develops under very specific conditions, especially:
  
  ✓ certain temperature ranges
  ✓ sufficient moisture
  ✓ suitable nutrient conditions
  ✓ extended growth time
  
  Typically, this occurs in improperly stored starchy foods or, as discussed in the current case, under specific fermentation conditions of a raw material.
  
  3. Does cereulide form in dry infant formula?
  No. Dry infant formula does not provide the conditions required for cereulide formation. The toxin can only develop if it has already been formed previously under moist conditions.
  
  4. Why is cereulide relevant?
  In higher amounts, cereulide can cause nausea and vomiting. For this reason, raw materials are strictly controlled before being used in food products.
• Production and Independence Show Hide

  1. Does Töpfer produce together with other brands?
  No. Töpfer manufactures exclusively at its own production facility in the Allgäu region of Germany. We do not share production lines or facilities with other manufacturers. This independence is a central component of our quality strategy.
  
  2.Are there overlaps in the supply chain with affected brands?
  No. Our regulatory reviews and supplier audits show no connections to the publicly mentioned problematic supply chains. Each raw material at Töpfer is independently qualified, tested, and approved, regardless of the supply chains used by other manufacturers.
  
  3. Where do Töpfer’s raw materials come from?
  Our focus is on organic quality as well as regional and European sourcing. The majority of our raw materials originate from the Allgäu region, from Germany, or from Europe. This proximity ensures quality, transparency, and traceability.
  
  4. Are raw materials from outside the EU used?
  Certain raw materials are unfortunately only available in limited quantities worldwide. Even if such raw materials are used occasionally, our strict EU-based quality and control standards apply without exception. Procurement is carried out exclusively through qualified, long-standing, and continuously audited partners within the DACH region.
  
  5. Has Töpfer sourced raw materials from Cabio Biotech?
  No. Töpfer has never sourced raw materials from Cabio Biotech for its production.
• Quality Assurance Show Hide

  1. How does Töpfer ensure the quality of its raw materials?
  At Töpfer, quality begins with the raw materials. We work exclusively with long-standing qualified partners based on clearly defined specifications. Each relevant batch is tested before being used.
  
  2. Are microbiological tests conducted?
  Yes. Both raw materials and intermediate and finished products are comprehensively tested microbiologically, in our own laboratories and additionally by external accredited institutes.
  
  3. Are chemical and contaminant analyses conducted?
  Yes. Our quality control includes comprehensive chemical testing in accordance with legal requirements and internal quality standards.
  
  4. Is there a release procedure before products are placed on the market?
  Yes. No product leaves our facility without a complete quality inspection and formal release.
  
  5. Have testing procedures been adjusted to new limit values?
  Yes. Our analytical procedures have been aligned with updated scientific evaluation standards. New limit values do not indicate new risks but rather provide additional safety.
  
  6. Have there been any recalls of Töpfer products in recent years?
  No. In recent years, there have been no recalls or official quality warnings due to contamination or non-compliant ingredients.