ISO 18416:2015/Amd 1:2022
(Amendment)Cosmetics - Microbiology - Detection of Candida albicans - Amendment 1
Cosmetics - Microbiology - Detection of Candida albicans - Amendment 1
Cosmétiques — Microbiologie — Détection de Candida albicans — Amendement 1
General Information
- Status
- Published
- Publication Date
- 12-Sep-2022
- Technical Committee
- ISO/TC 217 - Cosmetics
- Drafting Committee
- ISO/TC 217/WG 1 - Microbiological standards and limits
- Current Stage
- 6060 - International Standard published
- Start Date
- 13-Sep-2022
- Due Date
- 22-Nov-2022
- Completion Date
- 13-Sep-2022
Relations
- Consolidates
ISO 7961:2021 - Aerospace — Bolts — Test methods - Effective Date
- 06-Jun-2022
- Effective Date
- 27-Nov-2021
Overview
ISO 18416:2015/Amd 1:2022 is an essential amendment to the international standard focused on the microbiological detection of Candida albicans in cosmetics. Issued by ISO (International Organization for Standardization), this update refines procedures and media compositions used to ensure the microbiological safety and quality of cosmetic products by effectively detecting this yeast species. The amendment provides an alternative enrichment broth formulation, enhancing flexibility and accuracy in microbiological testing environments.
Key Topics
- Detection of Candida albicans: This standard specifies microbiological methods to identify the presence of the yeast Candida albicans in cosmetic products, a critical microorganism affecting product safety and consumer health.
- Enrichment Broth Alternatives: Amendment 1 introduces the use of Modified Eugon LT broth as an alternative to the previously specified Eugon LT 100 liquid broth for enrichment purposes.
- Modified Eugon LT Broth Composition:
- Pancreatic digest of casein: 15 g
- Papain 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: 1000 ml
- Preparation Method: Detailed heating and sterilization instructions ensure broth integrity, including dissolving components in boiling water, autoclaving at 121 °C for 15 minutes, and maintaining a pH of 7.0 ± 0.2 at room temperature.
- Standardization and Quality: The amendment aligns with ISO's rigorous development procedures and international cooperation, including joint task force participation by ISO/TC 217 (Cosmetics) and CEN/TC 392 under the Vienna Agreement.
Applications
- Cosmetic Microbiological Testing Laboratories: Employing the alternative Modified Eugon LT broth allows laboratories to maintain testing flexibility, ensuring reliable detection of Candida albicans in various cosmetic matrices.
- Quality Assurance for Cosmetic Manufacturers: Implementing this standard helps manufacturers maintain compliance with global microbiological safety requirements, safeguarding consumers from fungal contamination risks.
- Regulatory Compliance and Product Certification: Using the updated methodology supports adherence to international guidelines, facilitating certification and market access across multiple regions.
- Research and Development: The amendment enables formulation scientists and microbiologists to optimize microbial control strategies during product development with validated testing protocols.
Related Standards
- ISO 22716 – Cosmetics: Good Manufacturing Practices (GMP): Provides guidance on quality management and control, complementing microbiological standards.
- ISO 21149 – Cosmetics: Microbiology Testing Methods: Focuses on detection and enumeration of various microorganisms in cosmetics, supporting comprehensive microbial safety assessments.
- ISO 19007 – Cosmetics: Enumeration of Microorganisms: Details methods for assessing microbial counts, useful alongside Candida albicans detection.
- European Pharmacopoeia and USP antimicrobial testing standards: Relevant for laboratories seeking harmonization between cosmetic and pharmaceutical microbiology testing.
By adhering to ISO 18416:2015/Amd 1:2022, cosmetic industry stakeholders can enhance microbiological control activities, supporting product integrity, consumer safety, and regulatory compliance worldwide. The amendment's focus on practical, validated alternatives in culture media makes it invaluable in modern cosmetic microbiology laboratories.
ISO 18416:2015/Amd 1:2022 - Cosmetics — Microbiology — Detection of Candida albicans — Amendment 1 Released:13. 09. 2022
ISO 18416:2015/Amd 1:2022 - Cosmetics — Microbiology — Detection of Candida albicans — Amendment 1 Released:13. 09. 2022
Frequently Asked Questions
ISO 18416:2015/Amd 1:2022 is a standard published by the International Organization for Standardization (ISO). Its full title is "Cosmetics - Microbiology - Detection of Candida albicans - Amendment 1". This standard covers: Cosmetics - Microbiology - Detection of Candida albicans - Amendment 1
Cosmetics - Microbiology - Detection of Candida albicans - Amendment 1
ISO 18416:2015/Amd 1:2022 is classified under the following ICS (International Classification for Standards) categories: 07.100.40 - Cosmetics microbiology. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 18416:2015/Amd 1:2022 has the following relationships with other standards: It is inter standard links to ISO 7961:2021, ISO 18416:2015. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO 18416:2015/Amd 1:2022 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 18416
Second edition
2015-12-01
AMENDMENT 1
2022-09
Cosmetics — Microbiology —
Detection of Candida albicans
AMENDMENT 1
Cosmétiques — Microbiologie — Détection de Candida albicans
AMENDEMENT 1
Reference number
ISO 18416:2015/Amd.1:2022(E)
ISO 18416:2015/Amd.1:2022(E)
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 18416:2015/Amd.1:2022(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
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The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
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patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
...
NORME ISO
INTERNATIONALE 18416
Deuxième édition
2015-12-01
AMENDEMENT 1
2022-09
Cosmétiques — Microbiologie —
Détection de Candida albicans
AMENDEMENT 1
Cosmetics — Microbiology — Detection of Candida albicans
AMENDMENT 1
Numéro de référence
ISO 18416:2015/Amd.1:2022(F)
ISO 18416:2015/Amd.1:2022(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2022
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publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
ii
ISO 18416:2015/Amd.1:2022(F)
Avant-propos
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nationaux de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est
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concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents
critères d'approbation requis pour les différents types de documents ISO. Le présent document a
été rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir
www.iso.org/directives).
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les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de
l'élaboration du document sont indiqués dans l'Introduction et/ou dans la liste des déclarations de
brevets reçues par l
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