ICS 07.100.99, 71.100.

70 TECHNICKÁ NORMALIZAČNÁ INFORMÁCIA Október 2016

Mikrobiológia kozmetických výrobkov. TNI

Usmernenie na používanie noriem ISO na CEN ISO/TR
mikrobiologické skúšanie kozmetických 19838
výrobkov (ISO/TR 19838: 2016). 68 1720

Microbiology - Cosmetics - Guidelines for the application of ISO standards on Cosmetic Microbiology (ISO/TR 19838:2016)

Táto technická normalizačná informácia obsahuje anglickú verziu CEN ISO/TR 19838:2016, ISO/TR 19838:2016.
This Technical standard information includes the English version of CEN ISO/TR 19838:2016, ISO/TR
19838:2016.

Táto technická normalizačná informácia bola oznámená vo Vestníku ÚNMS SR č. 09/16

123541

Úrad pre normalizáciu, metrológiu a skúšobníctvo SR, 2016

Tento dokument a ani jeho časti sa nesmú rozmnožovať a rozširovať v akejkoľvek podobe
a akýmikoľvek prostriedkami bez písomného povolenia ÚNMS SR.
 TNI CEN ISO/TR 19838: 2016

TECHNICAL REPORT CEN ISO/TR 19838

RAPPORT TECHNIQUE
TECHNISCHER BERICHT May2010

ICS 07.100.99; 71.100.70

English Version
Microbiology - Cosmetics - Guidelines for the application of
ISO standards on Cosmetic Microbiology (ISO/TR
19838:2016)
Microbiologie - Cosmétique - Lignes directrices pour
l'application des Normes ISO à la microbiologie
cosmétique (ISO/TR 19838:2016)

This Technical Report was approved by CEN on 18 April 2016. It has been drawn up by the Technical Committee CEN/TC 392.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.

EUROPEANCOMMITTEEFORSTANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TR 19838:2016 E
worldwide for CEN national Members.
 TNI CEN ISO/TR 19838: 2016
CEN ISO/TR 19838:2016 (E)

Contents Page

European foreword .......................................................................................................................................... 3

2
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CEN ISO/TR 19838:2016 (E)

European foreword
This document (CEN ISO/TS 19838:2016) 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.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

Endorsement notice
The text of ISO/TR 19838:2016 has been approved by CEN as CEN ISO/TR 19838:2016 without any
modification.

3
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TECHNICAL ISO/TR
REPORT 19838
First
edition
2016-05-15

Microbiology — Cosmetics — Guidelines

for the application of ISO standards on
Cosmetic Microbiology
Microbiologie — Cosmétique — Lignes directrices pour l’application
des normes ISO relatives à la microbiologie cosmétique

Reference number
=/53ffi$*\= ISO/TR 19838:2016[E]
ISO
© ISO 2016
 TNI CEN ISO/TR 19838: 2016
ISO/TR 19838:2016(E)

A COPYRIGHT PROTECTED DOCUMENT

© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by
any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written
permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of the requester.
ISO copyright office
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CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org

ii © ISO 2016 - All rights reserved

 TNI CEN ISO/TR 19838: 2016
ISO/TR 19838:2016(E)

Contents page
Foreword ........................................................................................................................................................... iv
Introduction ........................................................................................................................................................v
1 Scope....................................................................................................................................................... 1
2 Termsand definitions ............................................................................................................................ 1
3 Microbial content .................................................................................................................................. 2
3.1 Generál requirements.................................................................................................................. 2
3.2 Enumeration of mesophilic microorganisms (bacteria, yeasts and moulds) .............................. 3
3.3 Detection of specified microorganisms ...................................................................................... 3
3.4 Detection of specified and non-specified microorganisms ......................................................... 4
4 Antimicrobial preservation .................................................................................................................. 5
4.1 Generál requirements.................................................................................................................. 5
4.2 Evaluation of the preservation of a cosmetic formulation .......................................................... 5
4.3 Evaluation of the preservation of a cosmetic product ................................................................ 6
5 Examples of microbial content results ................................................................................................ 6
5.1 Generál ....................................................................................................................................... 6
5.2 Eye make-up remover................................................................................................................. 6
5.3 Mascara....................................................................................................................................... 6
5.4 Face cream .................................................................................................................................. 7
5.5 Shampoo ..................................................................................................................................... 8
6 Examples of interpretation of preservation efficacy test results ....................................................... 8
Annex A (informative) Relationship between the ISO cosmetic microbiology standards ......................... 11
Annex B (informative) Relationship between the ISO standards dealing with the microbial
content of cosmetics ............................................................................................................................ 12
Annex C (informative) Evaluation of the microbial content of a cosmetic product ................................... 13
Annex D (informative) Interpretation of test results ..................................................................................... 14
Bibliography .................................................................................................................................................... 15
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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 through
ISO technical committees. Each member body interested in a subject for which a technical committee has
been established has the right to be represented on that committee. International organizations, governmental
and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
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 different types of
ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of 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 on the ISO list of
patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as
well as information about ISO’s adherence to the WTO principles in the Technical Barriers to Trade (TBT)
see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 217, Cosmetics.

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Introduction
Every cosmetic manufacturer has a dual responsibility relative to the microbiological quality of its products.
— The first is to ensure that the product, as purchased, is free from the numbers and types of
microorganisms that could affect product quality and consumer health. This is generally ensured by
applying cosmetic good manufacturing practice (GMP) (see ISO 22716) during the manufacturing and
packaging operations and, if necessary by using microbial content tests on finished products.
— The second is to ensure that microorganisms introduced during normál product use will not adversely
affect the quality or safety of the product. This is generally ensured by conducting preservation efficacy
tests (or challenge tests) during the development stage of the new product.
In order to ensure product quality and safety for consumers, it is advisable that an appropriate microbiological
risk analysis be performed to determine the types of cosmetic products to which this Technical Report would
be applicable.
— Products considered to present a low microbiological risk are described in ISO 29621. These products
identified as “hostile” and produced in compliance with GMP pose a very low overall risk to the user.
Therefore, products that comply with the characteristics outlined in ISO 29621 do not require
microbiological testing including both challenge test and end product testing.
— For those products which are not considered “hostile” the microbiological quality has to be assessed by
conducting tests with appropriate methods. ISO TC 217 provides a comprehensive set of standards to
assess the antimicrobial preservation of cosmetic products and the microbiological quality of finished
products (methods and limits). Manufacturers can decide not to test if they can demonstrate that their
products comply with those requirements specified in ISO 17516 and/or ISO 11930.

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TECHNICAL REPORT ISO/TR 19838:2016(E)

Microbiology — Cosmetics — Guidelines for the

application of ISO standards on Cosmetic Microbiology

1 Scope
This Technical Report gives generál guidelines to explain the use of ISO cosmetic microbiological standards
depending on the objective (in-market control, product development, etc.) and the product to be tested.
This Technical Report can be used to fulfil the requirements of the ISO štandard on microbiological limits
(ISO 17516).

2 Terms and definitions

For the purposes of this document, the following terms and definitions apply.
2.1
cosmetic formulation
preparation of raw materials with a qualitatively and quantitatively defined composition
2.2
cosmetic product
finished cosmetic product that has undergone all stages of production, including packaging in its final
container for shipment
2.3 sample
one or more representative elements selected from a set to obtain information about that set
2.4.1
microbial content
<quantitative> estimated number of viable aerobic mesophilic microorganisms (bacteria, yeasts and moulds)
within a cosmetic
2.4.2
microbial content
<qualitatative> detectable specified or non-specified microorganisms within a cosmetic sample
2.5
preservation of a cosmetic formulation
set of means used to avoid microbial proliferation in a cosmetic formulation
EXAMPLE Preservatives, multifunctional compounds, hostile raw materials, extréme pH, low water activity
values, etc.
2.6
antimicrobial protection of a cosmetic product
ability of a cosmetic product to overcome microbial contamination that might present a potential risk to the
user
Note 1 to entry: The overall antimicrobial protection includes preservation of the formulation, the specific
manufacturing process and protective packaging.

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2.7
microbiologically low-risk products
products whose environment denies microorganisms the physical and chemical requirements for growth
and/or survival (hostile products)
Note 1 to entry: This category of low-risk products applies to microbiological contamination which may occur
during manufacturing and/or use by the consumer.
Note 2 to entry: A product whose packaging prevents the ingress of microorganisms is considered a
microbiological low-risk product during its use.
Note 3 to entry: The inclusion of preservatives or other antimicrobial compounds in a formulation by itself would
not necessarily constitute a low-risk product.
2.8
microbiological Risk Assessment (low risk products)
evaluation of product characteristics to determine if that product may be subject to microbial contamination
Note 1 to entry: These characteristics include the composition of the product, the production conditions,
packaging and a combination of these factors (see ISO 29621).

3 Microbial content

3.1 General requirements

There are eight International Standards dealing with the microbial content of cosmetic samples (see Annex A).
— ISO 16212
— ISO 17516
— ISO 18415
— ISO 18416
— ISO 21149
— ISO 21150
— ISO 22717
— ISO 22718
Additionally, ISO 21148 gives general instructions for carrying out microbiological examinations of cosmetic
products.
Because of the large variety of cosmetic products within this field of application, the methods described in
these International Standards may not be appropriate for some products in every detail (e.g. certain water
immiscible products).
Other methods (e.g. automated) may be substituted for the tests presented here provided that their equivalence
has been demonstrated or the method has been otherwise verified.
The possible inhibition of microbial growth by the sample should be neutralized to allow the detection of
viable microorganisms. In all cases and whatever the methodology, the neutralization of the antimicrobial
properties of the product should be checked and demonstrated.
The study of the neutralization of the antimicrobial activity should be performed when the tests have to be
carried out on new products and whenever there is a change in the experimental conditions of the test.

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The given International Standards will allow the following:

— the enumeration and detection of mesophilic microorganisms which may grow under aerobic conditions;
— the determination of the absence of specified microorganisms that are of interest for cosmetic products;
and, therefore, to estimate if the product under test complies with the requirements of the International
Štandard on microbiological limits (ISO 17516).
The test methods are described in the individual standards. The choice of a specific method, or combination of
methods, will depend on the purpose for performing the test. It is up to the user to decide which approach is
best for each application.
Depending on the expected level of contamination of the sample to be tested, two different approaches can be
used (see Annex A).
— Quantitative tests (enumeration) are to be used when there is no information on the microbiological
quality of the sample or if it is expected to be contaminated.
— Qualitative tests (detection) can be used if the sample is presumably free from microbial contamination
(e.g. based on product history) and can be very useful from an economical and production time
standpoint.
In the event where microorganisms are detected, the presence of specified microorganisms should be checked
according to 3Ji or 3A

3.2 Enumeration of mesophilic microorganisms (bacteria, yeasts and moulds)

For bacteria, the enumeration method described in ISO 21149 involves enumeration of colonies on a
non-selective agar médium. Enumeration of colonies can be performed by a plate count method or a filtration
method using a specified culture médium incubated under defined conditions.
The results are expressed as follows:
“[number of] aerobic mesophilic bacteria per gram or per millilitre of product, expressed as cfu/g or
cfu/ml”.
For yeasts and moulds, the method described in ISO 16212 involves enumeration of colonies by a plate count
method or a filtration method using a specified culture médium with antibiotic incubated under defined
conditions.
An alternative condition using the culture médium without antibiotic is proposed in ISO 16212.
The results are expressed as follows:
“[number of] yeast and mould per gram or per millilitre of product expressed, as cfu/g or cfu/ml”

3.3 Detection of specified microorganisms

The detection of skin pathogens šuch as Staphylococcus aureus, Pseudomonas aeruginosa and Candida
albicans may be relevant. The detection of other kinds of microorganisms might be of interest since these
microorganisms (including indicators of fecal contamination e.g. Escherichia coli) suggest hygienic failure
during the manufacturing process.
The methods are described in ISO 18416 (C. albicans), ISO 21150 [E. coli) ISO 22717 [P. aeruginosa), and
ISO 22718 (S. aureus).

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The main steps of the methods are the following:

— an enrichment using a non-selective broth médium incubated under defined conditions to increase the
number of microorganisms while avoiding the risk of inhibition by the selective ingredients present in
selective/differential growth média;
— then, if growth is detected, an isolation on a selective médium followed by identification tests.
If the identification of the colonies confirms the presence of the specified microorganism [Staphylococcus
aureus, Pseudomonas aeruginosa, Candida albicans or Escherichia coli) the result is expressed as follows:
“Presence of the specified microorganism [name of the species) in the sample S.”
If no growth after enrichment is observed and/or if the identification of the colonies does not confirm the
presence of the specified microorganism [Staphylococcus aureus, Pseudomonas aeruginosa, Candida
albicans or Escherichia coli), the result is expressed as follows:
“Absence of the specified microorganism [name of the species) in the sample, S.”

3.4 Detection of specified and non-specified microorganisms

Two International Standards describe how to detect specified and non-specified microorganisms.
— The principle of ISO 18415 is to perform an enrichment by using a non-selective broth incubated under
defined conditions to increase the number of microorganisms without the risk of inhibition by the
selective ingredients that are present in selective/differential growth média followed by isolation on
a non-selective médium incubated under defined conditions and identification conducted according
to need by using appropriate incubation conditions and suitable identification tests.
For each species of specified microorganism, and if the identification of the colonies confirms the
presence of this species, the result is expressed as follows:
“Presence of [name of the species) in the sample, S”.
If growth is observed after enrichment and if the colonies are isolated and recognized as non-specified
microorganisms, the result is expressed as follows:
“Presence of [name of the species or main morphological characteristics) in the sample, S, and
absence of specified microorganisms”.
If no growth after enrichment is observed, the result is expressed as follows:
“Absence of aerobic mesophilic bacteria and yeast (specified microorganisms included) in the
sample, S”.
— I SO 21149 describes a method for the detection of aerobic mesophilic bacteria.
The enrichment method described in ISO 21149 consists of incubation under defined conditions of a
defined quantity of the sample (S) in a non-selective broth containing suitable neutralizers and/or
dispersing agents followed by a transfer of a defined quantity of the previous suspension on non-selective
solid agar médium under defined conditions. The difference between ISO 18415 and ISO 21149 is that
the neutralization of the antimicrobial activity in ISO 21149 is only checked for bacteria, while ISO
18415 refers to both bacteria and yeast.
Therefore, if no growth after enrichment is observed, the results are expressed as follows:
“Absence of aerobic mesophilic bacteria (specified bacteria included) in the sample S”.
If growth is observed after enrichment, the results are expressed as:
“Presence of aerobic mesophilic bacteria in the sample S”.

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NOTE Enrichment methods are not appropriate (temperature, culture media) to detect moulds.
Therefore, even if no growth after enrichment is observed, it is necessary to look for moulds using
appropriate culture conditions (see ISO 16212).

4 Antimicrobial preservation

4.1 General requirements

The antimicrobial protection of a cosmetic product (cosmetic formulation in its final container) can come from
many sources, such as the following:
— chemical preservation;
— inherent characteristics of the formulation;
— package design;
— manufacturing process
When evaluating the overall antimicrobial protection of a cosmetic product, these different sources should be
taken into account in a microbiological risk assessment.
ISO 11930 describes a procedure for the interpretation of data generated by the preservation efficacy test (if
appropriate) and by the microbiological risk assessment
4.2 Evaluation of the preservation of a cosmetic formulation
A preservation efficacy test or challenge test is commonly used to evaluate the preservation of a cosmetic
formulation. This test is not required for those cosmetic products for which the microbiological risk has been
determined to be low (see ISO 29621).
This test is primarily designed for water-soluble or water-miscible cosmetic products and can require
adaptation, for example, to test products in which water is the internal phase. The test described in ISO 11930
involves, for each test microorganism, placing the formulation in contact with a calibrated inoculum, and then
measuring the changes in the microorganism count at set time intervals for a set period and at a set
temperature.
As for the microbial content tests, the possible inhibition of microbial growth by the sample should be
neutralized to allow the detection of viable microorganism. In all cases and whatever the methodology, the
neutralization of the antimicrobial properties of the product should be checked and demonstrated.
The microorganism counts are converted in log reduction values and compared with 2 sets of criteria
expressed as minimum log reduction.
— Criteria A, whereby the formulation is protected against microbial proliferation that may present a
potential risk for the user and no additional factors are considered.
— Criteria B, whereby the level of protection is acceptable if the risk analysis demonstrates the existence of
control factors not related to the formulation indicating that the microbiological risk is tolerable for the
cosmetic product.
The inherent variability in microbial counts should be taken into consideration when comparing the obtained
values and the preset criteria A or B. A deviation of 0,5 log units from the preset criteria is considered
acceptable.

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4.3 Evaluation of the preservation of a cosmetic product

The evaluation of the antimicrobial protection of a cosmetic product combines the following elements:
a) the characteristics of its formulation (see ISO 29621) or the results of the preservation efficacy test (if
performed), or both;
b) the characteristics of the cosmetic product in conjunction with the production condition (see ISO 22716
and ISO 29621), the packaging type and, if justified, recommendations for use of the product (see ISO
29621).

5 Examples of microbial content results

5.1 General
Depending on the expected level of contamination of the sample to be tested, different approaches can be used
(see Annex C).
5.2 Eye make-up remover
A water-based preserved product, however with a risk of contamination during manufacturing considered low,
based on product history.
— Neutralization of the antimicrobial properties demonstrated to be suitable for a product dilution of 1/10.
— Enrichment in non-selective media according to ISO 18415 (1 ml sample): no detection. Result: absence
of aerobic mesophilic bacteria and yeast (specified microorganisms included) in 1 ml.
— Enumeration of yeast and mould according to ISO 16212: no recovery (1/10 dilution factor).
Result: <10 cfu of yeast and mould/ml.
The microbiological limit for products specifically intended for the eye area are as follows (see ISO 17516):
— total aerobic mesophilic microorganisms (bacteria plus yeast and mould) <1 × 102 cfu per g or ml;
— absence of specified microorganisms in 1 g or ml.
Interpretation of results: → Product meets ISO 17516, provided that the microbiological risk is controlled
according to ISO 11930 or ISO 29621 (no ability to proliferate in the product).
5.3 Mascara
A preserved oil in water emulsion with raw materials of natural origin (mineral pigments): likelihood of
low-level of contamination (bacterial and fungal spores).
— Neutralization of the antimicrobial properties demonstrated to be suitable for a product dilution of 1/10.
— Enumeration of bacteria according to ISO 21149. Count obtained for the 1/10 dilution: plate 1: 14
colonies, plate 2: 16 colonies, mean: 15 colonies. Results: estimated number (see ISO 21149) 150 cfu of
aerobic mesophilic bacteria/g.
— Enumeration of yeast and mould according to ISO 16212: no recovery (1/10 dilution factor). Result:
<10 cfu of yeast and mould/g.
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— Detection of specified microorganisms according to ISO 18415 or according to ISO 21150, ISO 22717,
ISO 22718 and ISO 18416 (1 g sample): no detection.
Result: absence of specified microorganisms in 1 g.
The microbiological limit for products specifically intended for the eye area are as follows (see ISO 17516):
— total aerobic mesophilic microorganisms (bacteria plus yeast and mould) <1 × 102 cfu per g or ml;
— absence of specified microorganisms in 1g or ml. The
interpretation of results are as follows:
— total aerobic mesophilic microorganisms (bacteria plus yeast and mould): 150 cfu/g;
— due to inherent variability of the plate count method (see ISO 17516), result is considered out of limit if
>200 cfu/g or ml;
— absence of specified microorganisms in 1 g or ml.
→ Product meets ISO 17516, provided that the microbiological risk is controlled according to ISO 11930 or
ISO 29621 (no ability to proliferate in the product).
5.4 Face cream
A water-based preserved product with no product history.
— Neutralization of the antimicrobial properties demonstrated to be suitable for a product dilution of 1/10.
— Enumeration of bacteria according to ISO 21149 for 1/10 dilution: no recovery. Result:
<10 cfu of bacteria/g.
— Enumeration of yeast and mould according to ISO 16212 for the 1/10 dilution (1 g sample): no recovery
(1/10 dilution factor).
Result: <10 cfu of yeast and mould/g.
— Detection of specified microorganisms according to ISO 18415 or according to ISO 21150, ISO 22717,
ISO 22718 and ISO 18416: detection of Pseudomonas aeruginosa.
Result: presence of Pseudomonas aeruginosa in 1 g.
Microbiological limit for products non-specifically intended for under three year old children and eye area or
mucous membranes are as follows (see ISO 17516):
— total aerobic mesophilic microorganisms (bacteria plus yeast and mould) <1 × 103 cfu per g or ml;
— absence of specified microorganisms in 1g or ml.
Interpretation of results are as follows:
— total aerobic mesophilic microorganisms (bacteria plus yeast and mould): <10 cfu/g;
— presence of Pseudomonas aeruginosa in 1 g.
→ Product does not meet ISO 17516.

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5.5 Shampoo
A water-based preserved product with no product history.
— Neutralization of the antimicrobial properties demonstrated to be suitable for a product dilution of 1/100
for bacteria and 1/10 for yeast and mould.
— Enumeration of bacteria according to ISO 21149:
Count obtained for the 1/100 dilution: plate 1: 280 colonies, plate 2: 300 colonies, mean: 290 colonies.
Result: 2,9 x 104 cfu of aerobic mesophilic bacteria/g.
— Enumeration of yeast and moulds according to ISO 16212 for the 1/10 dilution (1 g sample): no
recovery (1/10 dilution factor).
Result: <10 cfu of yeast and mould/g.
— Detection of specified microorganisms according to ISO 18415 or according to ISO 18416, ISO 21150,
ISO 22717 and ISO 22718. Enrichment conducted with a dilution factor of 1/100 (1 g of sample into
100 ml of diluent): no detection.
Result: absence of specified microorganisms in 1 g.
Microbiological limit for products non-specifically intended for under three year old children and eye area or
mucous membranes (see ISO 17516):
— total aerobic mesophilic microorganisms (bacteria plus yeast and mould) <1 x 103 cfu per g or ml
— absence of specified microorganisms in 1 g or ml.
Interpretation of results:
— total aerobic mesophilic microorganisms (bacteria plus yeast and mould): 2,9 x 104 cfu/g.
— due to inherent variability of the plate count method (see ISO 17516), result is considered out of
limit if >2 000 cfu/g or ml
-> Product does not meetlSO 17516.
Manufacturers should follow an Out-of-Specification (OOS) procedúre to confirm or reject the OOS results.

6 Examples of interpretation of preservation efficacy test results

Antimicrobial protection is based on a combination of formulation characteristics, production conditions and
final packaging. The overall evaluation takes into account the microbiological risk assessment together with
the preservation efficacy test results, if relevant. The evaluation criteria for the preservation efficacy test
performed on the formulation are given in ISO 11930.

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Table 1 — Evaluation criteria

log reduction v alues (7?x = lgNo-lgNx) re quired3
Bacteria
Microorganisms C . albicans A. brasiliensis
Sampling time T7 T14 T7 T14 T28 T14 T28
T28
Criteria A >3 >1 >0c >1
≥3 and ≥3 and ≥1 and ≥1 and
NIb NI NI NI
Criteria B Not performed >3 Not performed >1 >0
≥3 and ≥1 and ≥0 and
NI NI NI
a In this test, an acceptable range of deviation of 0,5 log is accepted (see ISO b 11930).

NI: no increase in the count from the previous contact time. c Rx = 0 when lgN0
= lgNx (no increase from the initial count).

© ISO 2016 - All rights reserved 9

 Table 2 — Examples of preservation efficacy tests performed according ISO 11930 on various cosmetic formulations with conclusion on
the corresponding products
Examples Formulation Product
Challenge test results (log reduction values) Comments Conclusion on the Existence of control Conclusion on the antimicrobial
a formulation factors not related to protection of the product
Bacteria C.albicans A.brasiliensis the formulation?
T7 T14 T28 T7 T14 T28 T14 T28
1 3,1 3,4 3,8 1,0 1,1 1,4 0,0 1,0 Pass for criteria A Not required The product is protected against
mi-crobial proliferation that may present a
potential risk for the user.
2 2,6 3,4 3,8 0,6 1,1 1,4 -0,3 1,0 Deviation of 0,5 log is Pass for criteria A Not required The product is protected against
ac-ceptable (see ISO mi-crobial proliferation that may present a
11930) potential risk for the user.
3 3,1 3,5 1,1 1,3 0,1 0,5 Pass for criteria B The product complies with ISO 11930 on
Yes (e.g: package is a the basis of criterion B plus additional
pump) characteristics indicating that the
mi-crobial risk is tolerable.
4 3,1 3,8 1,0 1,1 -0,4 0,1 Deviation of 0,5 Pass for criteria B No The product does not meet the
logisac-ceptable (see ISO require-mentsof ISO 11930.
11930)
5 1,6 2,3 1,1 1,5 0,2 1,6 Fail criteria A and B Yes The product is considered a tolerable
(strengthened control microbiological risk provided that the
factors, e.g: single-dose microbiological quality of the finished
plus aseptic filling) product is ensured at the time of release.

6 1,6 2,3 1,1 1,5 0,2 1,6 Fail criteria A and B No The product does not meet the
require-mentsof ISO 11930.
a
Among E. coli, P. aeruginosa and S. aureus, select the strain with the lowest log reduction value.
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Annex A
(informative)
Relationship between the ISO cosmetic microbiology standards

Figure A.1 — Microbiological risk assessment

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ISO/TR 19838:2016(E)

Annex B
(informative)
Relationship between the ISO standards dealing with the
microbial content of cosmetics

Table B.1 — Relationship between ISO standards dealing with the microbial content of
cosmetics
ISO 21149 ISO 16212 ISO 22718 ISO 22717 ISO 21150 ISO 18416 ISO 18415
Bacte-r Enumeration x
ia
Detection S.aureus P.aeruginosa E.coli x
Identifi-c Specified S. aureus x x
ation
P x x
aerug-ino
sa
E. coli x x
Non specified x
Yeast Enumeration x
Detection C.albicans x
Identifi-c Specified C . x x
ation albi-cans
Non x
specified
Mould Enumer-
ation

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 TNI CEN ISO/TR 19838: 2016
ISO/TR 19838:2016(E)

Annex C
(informative)
Evaluation of the microbial content of a cosmetic product

a If d, dilution factor corresponding to the dilution made for the preparation of the initial suspension (9.2) or
for the first counted dilution (see ISO 21149:2006, 12.1), is 1/10. If d 1/100, no recovery means <100 CFU/g
or ml.
b Enrichment methods are not appropriate (temperature, culture media) to detect moulds. Therefore, even if no
growth after enrichment is observed, it is necessary to look for moulds using appropriate cul-ture conditions
(see ISO 16212).
c Interpretation of « No detection » ISO 18415 is applied. If ISO 21149, which does not allow for the
de-tection of yeasts, is followed, the conclusion should be «Absence of aerobic mesophilic bacteria (specified
bacteria included)
in the sample.

Figure C.1 — Evaluation of the microbial content of a cosmetic product

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ISO/TR 19838:2016(E)

Annex D
(informative)
Interpretation of test results

Non microbiologically low-risk product

[see BO 29621)

Producttestingaccordingto ISO
standards (see Annex C)

Figure D.1 — Interpretation of test results

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 TNI CEN ISO/TR 19838: 2016
ISO/TR 19838:2016(E)

Bibliography

[I] ISO 11930, Cosmetics — Microbiology — Evaluation of the antimicrobial protection of a

cosmetic product
[2] ISO 16212, Cosmetics — Microbiology — Enumeration of yeast and mould
[3] ISO 17516, Cosmetics — Microbiology — Microbiological limits
[4] ISO 18415, Cosmetics — Microbiology — Detection of specified and non-specified microorganisms
[5] ISO 18416, Cosmetics — Microbiology — Detection of Candida albicans
[6] ISO 21148, Cosmetics — Microbiology — General instructions for microbiological examination
[7] ISO 21149:2006, Cosmetics — Microbiology — Enumeration and detection of aerobic mesophilic
bacteria
[8] ISO 21150, Cosmetics — Microbiology — Detection of Escherichia coli
[9] ISO 22716, Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good
Manufacturing Practices
[10] ISO 22717, Cosmetics — Microbiology — Detection of Pseudomonas aeruginosa
[II] ISO 22718, Cosmetics — Microbiology — Detection of Staphylococcus aureus
[12] ISO 29621, Cosmetics — Microbiology — Guidelines for the risk assessment and identification of
microbiologically low-risk products
[13] USP 37 <61> Interpretation of the results

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 TNI CEN ISO/TR 19838: 2016
ISO/TR 19838:2016(E)

ICS 07.100.99; 71.100.70

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