SIST EN ISO 16212:2017/A1:2023

Cosmetics - Microbiology - Enumeration of yeast and mould - Amendment 1 (ISO 16212:2017/Amd 1:2022)

Kosmetische Mittel - Mikrobiologie - Zählung von Hefen und Schimmelpilzen - Änderung 1 (ISO 16212:2017/Amd 1:2022)

No scope available

Cosmétiques - Microbiologie - Dénombrement des levures et des moisissures - Amendement 1 (ISO 16212:2017/Amd 1:2022)

Kozmetika - Mikrobiologija - Ugotavljanje števila kvasovk in plesni - Dopolnilo A1 (ISO 16212:2017/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 16212:2017/A1:2022 - Cosmetics - Microbiology - Enumeration of yeast and mould - Amendment 1 (ISO 16212:2017/Amd 1:2022)

Relations

• Amends: SIST EN ISO 16212:2017 - Cosmetics - Microbiology - Enumeration of yeast and mould (ISO 16212:2017)
• Effective Date: 01-Apr-2023

Overview

EN ISO 16212:2017/A1:2022 is the CEN-endorsed amendment to ISO 16212:2017, an international standard for cosmetics microbiology addressing the enumeration of yeast and mould in cosmetic products. Amendment 1 (A1) introduces a new medium formulation - the Modified Eugon LT liquid broth - and its preparation details to support reliable yeast and mould testing in cosmetic quality control laboratories.

Key topics and technical requirements

• New Annex A subclause (A.4): Adds the composition and preparation procedure for the Modified Eugon LT liquid broth.
• Medium composition (per 1 000 ml water):
  • 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
• Preparation steps:
  • Dissolve polysorbate 80 and egg lecithin successively into boiling water until fully dissolved.
  • Dissolve remaining components by mixing while heating.
  • Dispense into suitable containers and sterilize in an autoclave at 121 °C for 15 minutes.
  • Mix while still hot to redissolve any settled substances.
  • After sterilization, the medium pH at room temperature shall be 7.0 ± 0.2.

Note: This amendment modifies EN ISO 16212:2017 as adopted by CEN; full procedural and validation details remain in the base standard and should be consulted for complete test methods and quality requirements.

Applications and users

• Who uses this standard:
  • Cosmetic manufacturers and formulators
  • Quality control and microbiology laboratories
  • Regulatory bodies and conformity assessors
  • Contract testing labs and suppliers of culture media
• Practical uses:
  • Routine microbial quality control to enumerate yeast and mould in finished cosmetic products and raw materials
  • Shelf-life and stability testing where fungal contamination is a concern
  • Method standardization across laboratories to ensure comparability of yeast/mould counts
  • Development and validation of in-house test procedures using the specified medium

Related standards and context

• EN ISO 16212:2017 (base standard) - method for enumeration of yeast and mould in cosmetics.
• Prepared by ISO/TC 217 and CEN/TC 392 under the Vienna Agreement; consult national adoption documents for implementation dates and any national guidance.

For compliance and laboratory implementation, obtain the full EN ISO 16212:2017 and Amendment 1 documents to ensure adherence to all method, validation and reporting requirements.

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2023
Kozmetika - Mikrobiologija - Ugotavljanje števila kvasovk in plesni - Dopolnilo A1
(ISO 16212:2017/Amd 1:2022)
Cosmetics - Microbiology - Enumeration of yeast and mould - Amendment 1 (ISO
16212:2017/Amd 1:2022)
Kosmetische Mittel - Mikrobiologie - Zählung von Hefen und Schimmelpilzen - Änderung
1 (ISO 16212:2017/Amd 1:2022)
Cosmétiques - Microbiologie - Dénombrement des levures et des moisissures -
Amendement 1 (ISO 16212:2017/Amd 1:2022)
Ta slovenski standard je istoveten z: EN ISO 16212:2017/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 16212:2017/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2022
EUROPÄISCHE NORM
ICS 07.100.40
English Version
Cosmetics - Microbiology - Enumeration of yeast and
mould - Amendment 1 (ISO 16212:2017/Amd 1:2022)
Cosmétiques - Microbiologie - Dénombrement des Kosmetische Mittel - Mikrobiologie - Zählung von
levures et des moisissures - Amendement 1 (ISO Hefen und Schimmelpilzen - Änderung 1 (ISO
16212:2017/Amd 1:2022) 16212:2017/Amd 1:2022)
This amendment A1 modifies the European Standard EN ISO 16212:2017; 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 16212:2017/A1:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 16212:2017/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 16212:2017 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 16212:2017/Amd 1:2022 has been approved by CEN as EN ISO 16212:2017/A1:2022
without any modi
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