SIST EN ISO 21150:2016/A1:2023

Cosmetics - Microbiology - Detection of Escherichia coli - Amendment 1 (ISO 21150:2015/Amd 1:2022)

Kosmetische Mittel - Mikrobiologie - Nachweis von Escherichia coli - Änderung 1 (ISO 21150:2015/Amd 1:2022)

No scope available

Cosmétiques - Microbiologie - Détection d'Escherichia coli - Amendement 1 (ISO 21150:2015/Amd 1:2022)

Kozmetika - Mikrobiologija - Ugotavljanje prisotnosti bakterije Escherichia coli - Dopolnilo A1 (ISO 21150:2015/Amd 1:2022)

General Information

• Status: Published
• Public Enquiry End Date: 02-Feb-2022
• Publication Date: 14-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: 15-Mar-2023
• Ref Project: EN ISO 21150:2015/A1:2022 - Cosmetics - Microbiology - Detection of Escherichia coli - Amendment 1 (ISO 21150:2015/Amd 1:2022)

Relations

• Amends: SIST EN ISO 21150:2016 - Cosmetics - Microbiology - Detection of Escherichia coli (ISO 21150:2015)
• Effective Date: 01-Apr-2023

Overview

SIST EN ISO 21150:2016/A1:2023 is an essential amendment to the international standard for microbiological testing in the cosmetics industry, specifically focusing on the detection of Escherichia coli (E. coli). Developed by ISO/TC 217 and CEN/TC 392, this standard ensures consistent, reliable microbiological safety assessments in cosmetic products. Published by CEN in September 2022, it modifies the original EN ISO 21150:2015 standard to refine testing procedures and media compositions for improved detection accuracy.

The amendment introduces the Modified Eugon LT broth as an alternative enrichment medium to enhance the microbiological screening process, ensuring that cosmetic products meet stringent safety requirements regarding E. coli contamination.

Key Topics

• Scope: Focus on microbiological detection methods for E. coli in cosmetics to ensure product safety.
• Amendment Highlights: Introduction of Modified Eugon LT broth as an alternative to the original Eugon LT 100 liquid broth, accompanied by detailed composition and preparation guidelines.
• Medium Composition:
  • 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 1000 ml
• Preparation Instructions: Detailed steps for dissolving components, sterilization at 121 °C for 15 minutes, and pH adjustment to 7.0 ± 0.2 after sterilization.
• Standard Implementation: Mandated by CEN members across Europe, with national standards bodies required to adopt this amendment promptly.

Applications

SIST EN ISO 21150:2016/A1:2023 serves a vital role in:

• Cosmetics Manufacturing: Assists producers in validating the microbiological safety of products by detecting E. coli contamination during production and final quality control.
• Quality Assurance Laboratories: Provides standardized testing procedures ensuring reproducible, accurate results across different testing facilities worldwide.
• Regulatory Compliance: Supports cosmetics companies in meeting EU and international safety regulations, facilitating market access and consumer protection.
• Research and Development: Assists R&D teams in evaluating preservative efficacy and microbial resistance in cosmetic formulations.

By adopting this amendment, cosmetic manufacturers and testing laboratories can enhance safety monitoring, reduce contamination risks, and maintain high product quality standards.

Related Standards

• EN ISO 22716 – Cosmetics - Good Manufacturing Practices (GMP) - Guidelines on quality management and hygiene.
• ISO 21149 – Cosmetics - Microbiology - Detection of Candida albicans.
• ISO 16212 – Cosmetics - Microbiology - Detection of Staphylococcus aureus.
• ISO 17516 – Cosmetics - Microbiology - Limits for microbial contamination.
• ISO/IEC 17025 – General requirements for the competence of testing laboratories, underpinning reliable microbiological testing.

These complementary standards ensure a comprehensive approach to microbiological safety and quality management in the cosmetics sector.

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Keywords: EN ISO 21150 amendment, cosmetics microbiology, E. coli detection, Modified Eugon LT broth, microbiological testing cosmetics, cosmetic safety standards, CEN cosmetic standards, ISO 21150:2015/A1:2022, microbial contamination cosmetics, cosmetic product testing

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2023
Kozmetika - Mikrobiologija - Ugotavljanje prisotnosti bakterije Escherichia coli -
Dopolnilo A1 (ISO 21150:2015/Amd 1:2022)
Cosmetics - Microbiology - Detection of Escherichia coli - Amendment 1 (ISO
21150:2015/Amd 1:2022)
Kosmetische Mittel - Mikrobiologie - Nachweis von Escherichia coli - Änderung 1 (ISO
21150:2015/Amd 1:2022)
Cosmétiques - Microbiologie - Détection d'Escherichia coli - Amendement 1 (ISO
21150:2015/Amd 1:2022)
Ta slovenski standard je istoveten z: EN ISO 21150:2015/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 21150:2015/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2022
EUROPÄISCHE NORM
ICS 07.100.40
English Version
Cosmetics - Microbiology - Detection of Escherichia coli -
Amendment 1 (ISO 21150:2015/Amd 1:2022)
Cosmétiques - Microbiologie - Détection d'Escherichia Kosmetische Mittel - Mikrobiologie - Nachweis von
coli - Amendement 1 (ISO 21150:2015/Amd 1:2022) Escherichia coli - Änderung 1 (ISO 21150:2015/Amd
1:2022)
This amendment A1 modifies the European Standard EN ISO 21150:2015; it was approved by CEN on 10 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 21150:2015/A1:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 21150:2015/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 21150:2015 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 21150:2015/Amd 1:2022 has been approved by CEN as EN ISO 21150:2015/A1:2022
without any modification.
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