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.
