SIST EN ISO 18416:2016/A1:2023

Cosmetics - Microbiology - Detection of Candida albicans - Amendment 1 (ISO 18416:2015/Amd 1:2022)

Kosmetische Mittel - Mikrobiologie - Nachweis von Candida albicans - Änderung 1 (ISO 18416:2015/Amd 1:2022)

No scope available

Cosmétiques - Microbiologie - Détection de Candida albicans - Amendement 1 (ISO 18416:2015/Amd 1:2022)

Kozmetika - Mikrobiologija - Ugotavljanje prisotnosti kvasovke Candida albicans - Dopolnilo A1 (ISO 18416:2015/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 18416:2015/A1:2022 - Cosmetics - Microbiology - Detection of Candida albicans - Amendment 1 (ISO 18416:2015/Amd 1:2022)

Relations

• Amends: SIST EN ISO 18416:2016 - Cosmetics - Microbiology - Detection of Candida albicans (ISO 18416:2015)
• Effective Date: 01-Apr-2023

Overview

SIST EN ISO 18416:2016/A1:2023 is an important amendment to the international standard ISO 18416:2015, focusing on the microbiological detection of Candida albicans in cosmetics. Published by CEN and integrated into the European standards framework, this amendment updates the methodology used in cosmetics microbiology to ensure accurate detection of Candida albicans-a common yeast that can affect product safety and consumer health. Compliance with this standard is essential for cosmetic manufacturers and laboratories to maintain product quality, regulatory approval, and consumer safety.

Key Topics

• Scope of the Amendment
  This amendment introduces updated procedures and alternatives for enrichment media used in the detection of Candida albicans in cosmetic products.

• Modified Eugon LT Broth
  A significant addition in this update is the acceptance of Modified Eugon LT broth as an alternative enrichment medium. Its composition includes pancreatic digest of casein, papain digest of soybean meal, sodium chloride, L-cystine, sodium sulphite, glucose, egg lecithin, polysorbate 80, and sodium lauryl ether sulfate, dissolved in water and sterilized to maintain a neutral pH (7.0 ± 0.2).

• Preparation Details for Broth Media
  The amendment outlines precise preparation steps for Modified Eugon LT broth, including order of dissolving components, sterilization at 121 °C for 15 minutes, and mixing to ensure complete dissolution of substances, critical for reliable microbiological analysis.

• Compliance and Implementation
  CEN members, spanning numerous European countries, are mandated to adopt this amendment by April 2023, replacing any conflicting national standards.

Applications

• Cosmetic Product Safety Testing
  Laboratories conducting microbial testing of cosmetics use this standard to detect Candida albicans, a microorganism that could contaminate products causing spoilage or posing health risks to consumers.

• Quality Control in Manufacturing
  Cosmetic manufacturers incorporate this updated microbiological method into their quality control protocols, ensuring their products meet stringent safety guidelines.

• Regulatory Auditing and Certification
  Adherence to EN ISO 18416 and its amendments supports compliance with regulatory frameworks and facilitates certification processes for cosmetic products marketed internationally.

• Research and Development
  Microbiologists and product developers use this standard to refine and validate microbial detection methods during product formulation and stability testing.

Related Standards

• ISO 18416:2015 - The foundational standard that sets the original protocol for the microbiological detection of Candida albicans in cosmetics.

• CEN/CENELEC Internal Regulations - Governs the integration and enforcement of amendments like this across member countries.

• ISO/TC 217 “Cosmetics” - The technical committee responsible for cosmetics standards development, under which this amendment was prepared.

• Other Microbiological Standards for Cosmetics
  Includes standards for detection of bacteria, molds, and other pathogens relevant to cosmetic product safety.

---

Keywords: EN ISO 18416 amendment, cosmetics microbiology, detection of Candida albicans, Modified Eugon LT broth, cosmetic product safety testing, CEN standards, microbial contamination in cosmetics, cosmetic quality control, European cosmetic microbiology standard, cosmetic microbial testing methods.

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2023
Kozmetika - Mikrobiologija - Ugotavljanje prisotnosti kvasovke Candida albicans -
Dopolnilo A1 (ISO 18416:2015/Amd 1:2022)
Cosmetics - Microbiology - Detection of Candida albicans - Amendment 1 (ISO
18416:2015/Amd 1:2022)
Kosmetische Mittel - Mikrobiologie - Nachweis von Candida albicans - Änderung 1 (ISO
18416:2015/Amd 1:2022)
Cosmétiques - Microbiologie - Détection de Candida albicans - Amendement 1 (ISO
18416:2015/Amd 1:2022)
Ta slovenski standard je istoveten z: EN ISO 18416:2015/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 18416:2015/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2022
EUROPÄISCHE NORM
ICS 07.100.40
English Version
Cosmetics - Microbiology - Detection of Candida albicans -
Amendment 1 (ISO 18416:2015/Amd 1:2022)
Cosmétiques - Microbiologie - Détection de Candida Kosmetische Mittel - Mikrobiologie - Nachweis von
albicans - Amendement 1 (ISO 18416:2015/Amd Candida albicans - Änderung 1 (ISO 18416:2015/Amd
1:2022) 1:2022)
This amendment A1 modifies the European Standard EN ISO 18416:2015; it was approved by CEN on 17 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 18416:2015/A1:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 18416:2015/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 18416:2015 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by April 2023, and
conflicting national standards shall be withdrawn at the latest by April 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 18416:2015/Amd 1:2022 has been approved by CEN as EN ISO 18416:2015/A1:2022
without any modification.
...