SIST EN ISO 18415:2017/A1:2023

Cosmetics - Microbiology - Detection of specified and non-specified microorganisms - Amendment 1 (ISO 18415:2017/Amd 1:2022)

Kosmetische Mittel - Mikrobiologie - Nachweis von spezifizierten und nichtspezifizierten Mikroorganismen - Änderung 1 (ISO 18415:2017/Amd 1:2022)

No scope available

Cosmétiques - Microbiologie - Détection des micro-organismes spécifiés et non spécifiés - Amendement 1 (ISO 18415:2017/Amd 1:2022)

Kozmetika - Mikrobiologija - Ugotavljanje prisotnosti specifičnih in nespecifičnih mikroorganizmov - Dopolnilo A1 (ISO 18415:2017/Amd 1:2022)

General Information

• Status: Published
• Public Enquiry End Date: 02-Feb-2022
• Publication Date: 13-Mar-2023
• ICS: 07.100.40 - Cosmetics microbiology
• Technical Committee: KDS - Cosmetics, chemical disinfectants and surface active agents
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 26-Oct-2022
• Due Date: 31-Dec-2022
• Completion Date: 14-Mar-2023
• Ref Project: EN ISO 18415:2017/A1:2022 - Cosmetics - Microbiology - Detection of specified and non-specified microorganisms - Amendment 1 (ISO 18415:2017/Amd 1:2022)

Relations

• Amends: SIST EN ISO 18415:2017 - Cosmetics - Microbiology - Detection of specified and non-specified microorganisms (ISO 18415:2017)
• Effective Date: 01-Apr-2023

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.

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2023
Kozmetika - Mikrobiologija - Ugotavljanje prisotnosti specifičnih in nespecifičnih
mikroorganizmov - Dopolnilo A1 (ISO 18415:2017/Amd 1:2022)
Cosmetics - Microbiology - Detection of specified and non-specified microorganisms -
Amendment 1 (ISO 18415:2017/Amd 1:2022)
Kosmetische Mittel - Mikrobiologie - Nachweis von spezifizierten und nichtspezifizierten
Mikroorganismen - Änderung 1 (ISO 18415:2017/Amd 1:2022)
Cosmétiques - Microbiologie - Détection des micro-organismes spécifiés et non spécifiés
- Amendement 1 (ISO 18415:2017/Amd 1:2022)
Ta slovenski standard je istoveten z: EN ISO 18415:2017/A1:2022
ICS:
07.100.40 Kozmetika - mikrobiologija Cosmetics microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 18415:2017/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2022
EUROPÄISCHE NORM
ICS 07.100.40
English Version
Cosmetics - Microbiology - Detection of specified and non-
specified microorganisms - Amendment 1 (ISO
18415:2017/Amd 1:2022)
Cosmétiques - Microbiologie - Détection des micro- Kosmetische Mittel - Mikrobiologie - Nachweis von
organismes spécifiés et non spécifiés - Amendement 1 spezifizierten und nichtspezifizierten
(ISO 18415:2017/Amd 1:2022) Mikroorganismen - Änderung 1 (ISO 18415:2017/Amd
1:2022)
This amendment A1 modifies the European Standard EN ISO 18415:2017; it was approved by CEN on 9 September 2022.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18415:2017/A1:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 18415:2017/A1:2022) has been prepared by Technical Committee ISO/TC 217
"Cosmetics" in collaboration with Technical Committee CEN/TC 392 “Cosmetics” the secretariat of
which is held by AFNOR.
This Amendment to the European Standard EN ISO 18415:2017 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by March 2023, and
conflicting national standards shall be withdrawn at the latest by March 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 18415:2017/Amd 1:2022 has been approved by CEN as EN ISO 18415:2017/A1:2022
without any modification.
SIST E
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