EN ISO 15213-2:2023 PDF

Overview

EN ISO 15213-2:2023 (CEN adoption) is the international horizontal method for the enumeration of Clostridium perfringens by colony-count technique in the food chain. The standard specifies procedures for sample preparation, dilution, inoculation, incubation, colony counting and confirmation to determine C. perfringens levels in products for human consumption, animal feed, environmental samples from food/feed production and samples from primary production. It replaces ISO 7937:2004 and is intended for routine food microbiology and food safety testing.

Key Topics and Requirements

• Scope and applicability: Validated for multiple food categories including ready-to-eat/meat products, eggs and egg products, processed fruits and vegetables, infant formula and cereals, multi-component foods; also applicable to pet food, animal feed and environmental samples. Primary production samples are included in scope but were not part of the interlaboratory validation.
• Principle: Enumeration by colony-count on selective agar after appropriate dilutions; technique suited to samples yielding at least 10 colonies per plate (≈ >10 cfu/mL liquid or >100 cfu/g solid).
• Selective medium: Use of tryptose sulfite cycloserine (TSC) agar (formerly sulfite-cycloserine, no formulation change).
• Heat treatment: Optional heat shock (historically 10 min at 80 °C) to select for spores-now optional when high background flora is present or when spores-only enumeration is required.
• Confirmation: Procedures updated in line with ISO 14189; includes biochemical tests (acid phosphatase, SIM agar) and optional molecular differentiation between pathogenic and non‑pathogenic strains (Annex D).
• Validation and performance: Method validated by interlaboratory study; performance characteristics and validation data provided in Clause 11 and Annex C. Annex B includes culture media performance criteria.
• Reporting and QA: Requirements for expression of results, test reporting and quality assurance suitable for laboratory SOPs and accreditation.

Applications and Users

Who uses EN ISO 15213-2:2023:

• Food microbiology laboratories and QC/analytical labs
• Food and feed manufacturers (HACCP and shelf-life testing)
• Public health and regulatory laboratories (surveillance, outbreak investigation)
• Environmental monitoring teams in production and processing sites
• Research labs studying Clostridium perfringens contamination and spore survival

Practical uses:

• Routine enumeration of C. perfringens for food safety compliance
• Environmental swabbing and process hygiene monitoring
• Support for risk assessments and corrective actions in production
• Differentiation of pathogenic strains where required for epidemiology

Related Standards

• ISO 15213 series (other parts)
• ISO 14189 (confirmation methods)
• Supersedes ISO 7937:2004

This standard is essential for accurate, standardized colony-count enumeration of C. perfringens in the food chain, enabling consistent results across laboratories and supporting food safety management and regulatory compliance.