SIST EN ISO 18415:2017/A1:2023 PDF

Overview

EN ISO 18415:2017/A1:2022 - Cosmetics - Microbiology - Detection of specified and non‑specified microorganisms (Amendment 1) is a CEN-endorsed amendment to ISO 18415:2017. It updates the microbiological testing guidance for cosmetics by adding an alternative enrichment medium - the Modified Eugon LT broth - and clarifies numbering of subclauses. The amendment was approved by CEN in September 2022 and transposed into national standards.

Key topics and technical requirements

• Scope: Detection methods for specified and non‑specified microorganisms in cosmetic products (amendment to the original ISO 18415:2017).
• New enrichment medium: The amendment adds Modified Eugon LT broth as an alternative to Eugon LT 100 liquid broth.
• Composition of Modified Eugon LT broth (per 1 000 ml):
  • Pancreatic digest of casein 15 g
  • Papaic digest of soybean meal 5 g
  • Sodium chloride 4 g
  • L‑cystine 0.7 g
  • Sodium sulphite 0.2 g
  • Glucose 5.5 g
  • Egg lecithin 1 g
  • Polysorbate 80 15 g
  • Sodium lauryl ether sulfate 1.56 g
  • Water to 1 000 ml
• Preparation and processing:
  • Dissolve polysorbate 80 and egg lecithin into boiling water first; dissolve other components with heating and mixing.
  • Dispense into suitable containers and sterilize at 121 °C for 15 minutes (autoclave).
  • Mix while still hot to re-dissolve settled substances.
  • Final pH after sterilization: 7.0 ± 0.2 (measured at room temperature).
• Document housekeeping: Affected subclauses are renumbered (the original 5.3.2.2 becomes 5.3.2.3 for other enrichment broths).

Applications and users

This amendment is directly relevant for:

• Cosmetic microbiologists and QC laboratories performing microbial detection and enrichment for cosmetic products.
• Manufacturers and contract testing labs implementing routine microbial limits testing, contamination investigations, product-release testing, and stability/microbial challenge assessments.
• Regulatory and compliance professionals who align testing protocols with CEN/ISO requirements.
• Use cases include detection of specified contaminants, screening for non‑specified microorganisms, and providing validated enrichment procedures for complex cosmetic matrices.

Related standards and context

• This amendment modifies EN ISO 18415:2017 (the original standard for detection of microorganisms in cosmetics) and was developed by ISO/TC 217 in collaboration with CEN/TC 392.
• It should be implemented alongside an organization’s broader cosmetic microbiology program and applicable national regulatory requirements.

Keywords: ISO 18415, cosmetics microbiology, Modified Eugon LT broth, enrichment broth, microbial detection, cosmetic safety testing, CEN amendment.