Overview
EN ISO 19343:2017 (ISO 19343:2017) is an international/European standard for the detection and quantification of histamine in fish and fishery products using a validated HPLC method. It applies to fresh and processed seafood (including fish sauces and products matured in brine) intended for human consumption and supports regulatory food safety control, notably in relation to scombroid (histamine) poisoning.
Key topics and technical requirements
- Scope and principle: Specifies a high performance liquid chromatography (HPLC) procedure that separates histamine from other biogenic amines. Samples are extracted with perchloric acid, pre-column derivatized with dansyl chloride, and analyzed by HPLC with UV detection.
- Reagents and materials: Lists required solvents and reagents (e.g., acetone, acetonitrile, toluene, perchloric acid, dansyl chloride) and recommends laboratory-grade water complying with ISO 3696.
- Internal standard and calibration: Uses an internal standard (recommended: 1,7-diaminoheptane) and calibration curves for histamine quantification based on peak-area ratios.
- Apparatus and LC conditions: Defines typical equipment (grinder/homogenizer, refrigerated centrifuge, nitrogen evaporator, 0.2 µm filters) and an LC system (column oven, UV detector at λ = 254 nm). An example column is Kromasil® C18 5 µm, 25 cm × 4.6 mm.
- Procedure steps: Covers sample preparation, extraction, derivatization, purification, LC separation, and calculation methods.
- Performance and precision: Includes annexes with recommended HPLC separation and method performance characteristics, reporting repeatability, reproducibility and interlaboratory study results (method validation).
Practical applications
- Food testing laboratories: Routine monitoring of histamine levels in raw, processed and fermented fish products.
- Quality control for seafood producers and processors: Ensures products meet safety criteria and limits set by regulatory authorities.
- Regulatory and public health agencies: Enforces compliance with microbiological food safety regulations (e.g., EU Regulation 2073/2005) and investigates scombroid poisoning incidents.
- Research and method development: Reference method for comparative studies on biogenic amines in seafood.
Who should use this standard
- Analytical chemists and microbiologists in food testing labs
- Seafood quality assurance teams
- National reference laboratories and regulatory bodies
- Accreditation bodies assessing laboratory competence in histamine testing
Related standards
This standard is essential for consistent, reproducible histamine detection and quantification in the seafood sector and supports food safety risk management for histamine-related poisoning.