Histamine levels in fish are strictly regulated worldwide to prevent scombroid poisoning, a foodborne illness caused by the consumption of decomposed fish. In the European Union, Commission Regulation (EC) No 2073/2005 requires testing of nine samples from each batch of high-risk species (e.g., tuna, mackerel, sardines). The batch is acceptable if the mean histamine content is ≤100 ppm, with no more than two samples between 100–200 ppm and none exceeding 200 ppm. These thresholds aim to protect public health while maintaining the quality and safety of seafood entering the European market.

In the United States, the Food and Drug Administration (FDA) enforces even stricter standards. According to the latest Compliance Policy Guide, fish are considered adulterated if any sample contains histamine levels at or above 35 ppm—down from the previous 50 ppm threshold. Additionally, fish with histamine concentrations of 200 ppm or more are classified as injurious to health. These limits underscore the importance of rapid and accurate histamine testing. ProGnosis Biotech’s validated ELISA and lateral flow kits are designed to help producers meet both EU and U.S. standards with confidence.

Both the European Union (EU) and the United States (U.S.) enforce stringent regulations to ensure that seafood, meat and honey products are free from harmful antibiotic residues. In the EU, substances like chloramphenicol and nitrofurans are prohibited in food-producing animals. To monitor compliance, the EU has established Reference Points for Action (RPAs), which are the lowest concentrations that can be reliably detected using validated analytical methods. As per Commission Regulation (EU) 2019/1871, the RPAs are set at 0.15 µg/kg (ppb) for chloramphenicol and 0.5 µg/kg for nitrofuran metabolites (including AOZ, AMOZ, AHD, and SEM). Food products containing residues at or above these levels are considered non-compliant and are barred from entering the food chain

In the U.S., the Food and Drug Administration (FDA) maintains a zero-tolerance policy for chloramphenicol and nitrofurans in food products. Any detectable presence of these substances renders the product adulterated under the Federal Food, Drug, and Cosmetic Act. To facilitate enforcement, the FDA has established minimum detection levels: 0.15 ppb for chloramphenicol and 0.5 ppb for nitrofuran metabolites. These thresholds are not permissible limits but are the lowest levels at which these substances can be reliably identified using current analytical methods. Consequently, producers must ensure that their products are entirely free from these prohibited antibiotics to meet both EU and U.S. regulatory standards.

Detecting antibiotic residues and histamine in food products requires high analytical precision due to the complexity of matrices like seafood, honey, and processed fish. Antibiotics such as nitrofurans are metabolized into trace compounds that must be identified at extremely low concentrations. This demands matrix-specific kits with ultra-low detection limits. Without such tools, it’s easy to miss residues or generate false positives. ProGnosis Biotech’s Bio-Shield series includes targeted ELISA kits for both banned and permitted antibiotics, ensuring reliable, fast detection across multiple sample types.

Histamine poses different challenges. It forms rapidly in fish post-harvest if temperature control fails, and once present, it cannot be removed by cooking or processing. Because its formation depends on handling conditions rather than intentional contamination, histamine testing must be both frequent and fast. ProGnosis Biotech offers rapid ELISA and lateral flow kits that require no acylation, delivering accurate results in minutes—making them ideal for routine quality control and safety assurance.