Cosmetics - Microbiological limits (ISO 17516:2014)

This International Standard is applicable for all cosmetics and assists interested parties in the assessment
of the microbiological quality of the products. Microbiological testing does not need to be performed on
those products considered to be microbiologically low risk (see ISO 29621).

Kosmetische Mittel - Mikrobiologische Grenzwerte (ISO 17516:2014)

Diese Internationale Norm gilt für alle kosmetischen Mittel und unterstützt interessierte Parteien bei der Beurteilung der mikrobiologischen Qualität der Produkte. An Produkten, die als mikrobiologisch risikoarm gelten (siehe ISO 29621), braucht keine mikrobiologische Prüfung durchgeführt zu werden.

Cosmétiques - Microbiologie - Limites microbiologiques (ISO 17516:2014)

L'ISO 17516:2014 s'applique à tous les produits cosmétiques et aide les parties concernées à évaluer la qualité microbiologique des produits. Il n'est pas nécessaire que les produits considérés comme présentant un faible risque microbiologique soient soumis à des essais microbiologiques.

Kozmetika - Mikrobiološke mejne vrednosti (ISO 17516:2014)

Ta mednarodni standard se uporablja za vse kozmetične izdelke in pomaga zainteresiranim stranem pri ocenjevanju mikrobiološke kakovosti izdelkov. Tistih izdelkov, ki predstavljajo nizko mikrobiološko tveganje (glejte ISO 29621), ni treba mikrobiološko testirati.

General Information

Status
Published
Public Enquiry End Date
30-Sep-2013
Publication Date
07-Dec-2014
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
18-Nov-2014
Due Date
23-Jan-2015
Completion Date
08-Dec-2014

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Kozmetika - Mikrobiološke mejne vrednosti (ISO 17516:2014)Kosmetische Mittel - Mikrobiologische Grenzwerte (ISO 17516:2014)Cosmétiques - Microbiologie - Limites microbiologiques (ISO 17516:2014)Cosmetics - Microbiological limits (ISO 17516:2014)07.100.40Kozmetika - mikrobiologijaCosmetics microbiologyICS:Ta slovenski standard je istoveten z:EN ISO 17516:2014SIST EN ISO 17516:2015en01-januar-2015SIST EN ISO 17516:2015SLOVENSKI
STANDARD



SIST EN ISO 17516:2015



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 17516
October 2014 ICS 07.100.99; 71.100.99 English Version
Cosmetics - Microbiology - Microbiological limits (ISO 17516:2014)
Cosmétiques - Microbiologie - Limites microbiologiques (ISO 17516:2014)
Kosmetische Mittel - Mikrobiologie - Mikrobiologische Grenzwerte (ISO 17516:2014) This European Standard was approved by CEN on 9 August 2014.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a 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 European Standard 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, 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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 17516:2014 ESIST EN ISO 17516:2015



EN ISO 17516:2014 (E) 2 Contents Page Foreword .3
SIST EN ISO 17516:2015



EN ISO 17516:2014 (E) 3 Foreword This document (EN ISO 17516:2014) 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 European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2015, and conflicting national standards shall be withdrawn at the latest by April 2015. 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. 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, 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 the United Kingdom. Endorsement notice The text of ISO 17516:2014 has been approved by CEN as EN ISO 17516:2014 without any modification. SIST EN ISO 17516:2015



SIST EN ISO 17516:2015



© ISO 2014Cosmetics — Microbiology — Microbiological limitsCosmétiques — Microbiologie — Limites microbiologiquesINTERNATIONAL STANDARDISO17516First edition2014-10-01Reference numberISO 17516:2014(E)SIST EN ISO 17516:2015



ISO 17516:2014(E) ii © ISO 2014 – All rights reservedCOPYRIGHT PROTECTED DOCUMENT©
ISO 2014All rights reservedä Unless otherwise speci Ðiedá no part of this publication may be reproduced or utilized otherwise in any form or by any meansá electronic or mechanicalá including photocopyingá or posting on the internet or an intranetá without prior written permissionä Permission can be requested from either ISO at the address below or ISOïs member body in the country of the requesteräISO copyright of ÐiceTel. + 41 22 749 01 11Fax
ª
v s
t t
y v {
r {
v yEæmail copyright 7isoäorgWeb www.iso.orgPublished in SwitzerlandSIST EN ISO 17516:2015



ISO 17516:2014(E) Contents PageForeword .ivIntroduction .v1 Scope .1tTermsanddeÐinitions .13 Principle .14 Microbiological limits for cosmetics .2Annex A
Flowchart for interpretation of test results .3Bibliography .4© ISO 2014 – All rights reserved iiiSIST EN ISO 17516:2015



ISO 17516:2014(E)Forewordthrough ISO technical committeesä Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committeeä International organizationsá governmental and nonægovernmentalá in liaison with ISOá also take part in the workä electrotechnical standardizationäThe procedures used to develop this document and those intended for its further maintenance are different types of ISO documents should be notedä This document was drafted in accordance with the
Directivesá Part
tä www.iso.org/directivesAttention is drawn to the possibility that some of the elements of this document may be the subject of patent rightsä ISO shall not be held responsible for identifying any or all such patent rightsä Details of any the ISO list of patent declarations receivedä www.iso.Any trade name used in this document is information given for the convenience of users and does not constitute an endorsementäFor an explanation on the meaning of ISO speci Ðic terms and expressions related to conformity assessmentá as well as information about ISOïs adherence to the WTO principles in the Technical Barriers Foreword æ Supplementary information
t s yá Cosmetics. iv © ISO 2014 – All rights reservedSIST EN ISO 17516:2015



ISO 17516:2014(E)IntroductionEvery cosmetic manufacturer has a responsibility relative to the microbiological safety and quality of its products to ensure that they have been produced under hygienic conditionsä Cosmetic products are
...

SLOVENSKI STANDARD
oSIST prEN ISO 17516:2013
01-september-2013
Kozmetika - Mikrobiološke mejne vrednosti (ISO/DIS 17516:2013)
Cosmetics - Microbiological limits (ISO/DIS 17516:2013)
Kosmetische Mittel - Mikrobiologische Grenzwerte (ISO/DIS 17516:2013)
Ta slovenski standard je istoveten z: prEN ISO 17516
ICS:
07.100.99 Drugi standardi v zvezi z Other standards related to
mikrobiologijo microbiology
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
oSIST prEN ISO 17516:2013 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 17516:2013

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oSIST prEN ISO 17516:2013

DRAFT INTERNATIONAL STANDARD ISO/DIS 17516
ISO/TC 217 Secretariat: ISIRI
Voting begins on Voting terminates on

2013-07-25 2013-10-25
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION  •  МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ  •  ORGANISATION INTERNATIONALE DE NORMALISATION


Cosmetics — Microbiology — Microbiological limits
Cosmétiques — Microbiologie — Limites microbiologiques

ICS 07.100.99; 71.100.99





ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.

To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.



THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION.
©  International Organization for Standardization, 2013

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oSIST prEN ISO 17516:2013
ISO/DIS 17516

COPYRIGHT PROTECTED DOCUMENT


©  ISO 2013
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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland

ii © ISO 2013 – All rights reserved

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oSIST prEN ISO 17516:2013
ISO/DIS 17516
Contents Page
1 Scope . 1
2 Terms and definitions . 1
3 Principle . 2
4 Microbiological limits for cosmetics . 3
Annex A (Flow chart for interpretation of test results) . 4
Bibliography . 5






© ISO 2002 – All rights reserved iii

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oSIST prEN ISO 17516:2013
ISO/DIS 17516
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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 17516 was prepared by Technical Committee ISO/TC 217 Cosmetics.

















iv © ISO 2002 – All rights reserved

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oSIST prEN ISO 17516:2013
ISO/DIS 17516
Introduction
Every cosmetic manufacturer has a responsibility relative to the microbiological safety and quality of its
products to ensure that they have been produced under hygienic conditions. Cosmetic products are not
expected to be sterile, however they shall not contain excessive amounts of microorganisms nor specific
microorganisms that have the potential to affect the product quality or consumer safety . Moreover, some
cosmetic products which are considered to have low microbiological risk (see ISO 29621) may not be
subjected to routine microbiological testing and manufactures can decide not to test if they can assure
products meet this standard.
The manufacturer should follow the Good Manufacturing Practices (ISO 22716) and take the necessary
precautions to limit the introduction of microorganisms from raw materials, processing and packaging. When
necessary, microbiological testing may be performed using ISO 21148, ISO 21149, ISO 16212, ISO 18415,
ISO 18416, ISO 21150, ISO 22717, and ISO 22718.
The objective of this International Standard is to develop acceptable quantitative and qualitative limits for
cosmetic finished products.


© ISO 2002 – All rights reserved v

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oSIST prEN ISO 17516:2013

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oSIST prEN ISO 17516:2013
DRAFT INTERNATIONAL STANDARD ISO/DIS 17516

Cosmetics – Microbiology - Microbiological limits
1  Scope
This International Standard is applicable for all cosmetics and assists interest
...

SLOVENSKI STANDARD
oSIST prEN ISO 17516:2013
01-september-2013
Kozmetika - Mikrobiološke mejne vrednosti (ISO/DIS 17516:2013)
Cosmetics - Microbiological limits (ISO/DIS 17516:2013)
Kosmetische Mittel - Mikrobiologische Grenzwerte (ISO/DIS 17516:2013)
Ta slovenski standard je istoveten z: prEN ISO 17516
ICS:
07.100.99 Drugi standardi v zvezi z Other standards related to
mikrobiologijo microbiology
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
oSIST prEN ISO 17516:2013 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 17516:2013

---------------------- Page: 2 ----------------------
oSIST prEN ISO 17516:2013


EUROPÄISCHE NORM
ENTWURF
prEN ISO 17516
EUROPEAN STANDARD

NORME EUROPÉENNE

Juli 2013
ICS 07.100.99; 71.100.70
Deutsche Fassung
Kosmetische Mittel - Mikrobiologische Grenzwerte (ISO/DIS
17516:2013)
Cosmetics - Microbiology - Microbiological limits (ISO/DIS Cosmétiques - Microbiologie - Limites microbiologiques
17516:2013) (ISO/DIS 17516:2013)
Dieser Europäische Norm-Entwurf wird den CEN-Mitgliedern zur parallelen Umfrage vorgelegt. Er wurde vom Technischen Komitee
CEN/TC 392 erstellt.

Wenn aus diesem Norm-Entwurf eine Europäische Norm wird, sind die CEN-Mitglieder gehalten, die CEN-Geschäftsordnung zu erfüllen, in
der die Bedingungen festgelegt sind, unter denen dieser Europäischen Norm ohne jede Änderung der Status einer nationalen Norm zu
geben ist.

Dieser Europäische Norm-Entwurf wurde vom CEN in drei offiziellen Fassungen (Deutsch, Englisch, Französisch) erstellt. Eine Fassung in
einer anderen Sprache, die von einem CEN-Mitglied in eigener Verantwortung durch Übersetzung in seine Landessprache gemacht und
dem Management-Zentrum des CEN-CENELEC mitgeteilt worden ist, hat den gleichen Status wie die offiziellen Fassungen.

CEN-Mitglieder sind die nationalen Normungsinstitute von Belgien, Bulgarien, Dänemark, Deutschland, der ehemaligen jugoslawischen
Republik Mazedonien, Estland, Finnland, Frankreich, Griechenland, Irland, Island, Italien, Kroatien, Lettland, Litauen, Luxemburg, Malta,
den Niederlanden, Norwegen, Österreich, Polen, Portugal, Rumänien, Schweden, der Schweiz, der Slowakei, Slowenien, Spanien, der
Tschechischen Republik, der Türkei, Ungarn, dem Vereinigten Königreich und Zypern.

Die Empfänger dieses Norm-Entwurfs werden gebeten, mit ihren Kommentaren jegliche relevante Patentrechte, die sie kennen, mitzuteilen
und unterstützende Dokumentationen zur Verfügung zu stellen.

Warnvermerk : Dieses Schriftstück hat noch nicht den Status einer Europäischen Norm. Es wird zur Prüfung und Stellungnahme
vorgelegt. Es kann sich noch ohne Ankündigung ändern und darf nicht als Europäischen Norm in Bezug genommen werden.


EUROPÄISCHES KOMITEE FÜR NORMUNG
EUROPEAN COMMITTEE FOR STANDARDIZATION

COMITÉ EUROPÉEN DE NORMALISATION

Management-Zentrum: Avenue Marnix 17, B-1000 Brüssel
© 2013 CEN Alle Rechte der Verwertung, gleich in welcher Form und in welchem Ref. Nr. prEN ISO 17516:2013 D
Verfahren, sind weltweit den nationalen Mitgliedern von CEN vorbehalten.

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oSIST prEN ISO 17516:2013
prEN ISO 17516:2013 (D)
Inhalt
Seite
Vorwort .3
Einleitung .4
1 Anwendungsbereich .5
2 Begriffe .5
3 Kurzbeschreibung .6
4 Mikrobiologische Grenzwerte für kosmetische Mittel .6
Anhang A (normativ) Flussdiagramm für die Auswertung von Prüfergebnissen.7
Literaturhinweise .8


2

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oSIST prEN ISO 17516:2013
prEN ISO 17516:2013 (D)
Vorwort
Dieses Dokument (prEN ISO 17516:2013) wurde vom Technischen Komitee ISO/TC 217 „Kosmetische Mittel“
in Zusammenarbeit mit dem Technischen Komitee CEN/TC 392 „Kosmetische Mittel“ erarbeitet, dessen
Sekretariat vom AFNOR gehalten wird.
Dieses Dokument ist derzeit zur parallelen Umfrage vorgelegt.
Anerkennungsnotiz
Der Text von ISO/DIS 17516:2013 wurde vom CEN als prEN ISO 17516:2013 ohne irgendeine Abänderung
genehmigt.
3

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oSIST prEN ISO 17516:2013
prEN ISO 17516:2013 (D)
Einleitung
Jeder Hersteller von kosmetischen Mitteln muss in Bezug auf die mikrobiologische Sicherheit und Qualität
seiner Produkte dafür Sorge tragen, dass diese unter hygienischen Bedingungen hergestellt werden. Es wird
nicht erwartet, dass kosmetische Produkte steril sind, dennoch dürfen sie weder übermäßigen Mengen an
Mikroorganismen noch spezifische Mikroorganismen enthalten, die das Potential haben, die Produktqualität
oder die Sicherheit der Verbraucher zu beeinträchtigen. Außerdem brauchen einige kosmetische Produkte,
die als mikrobiologisch risikoarm gelten (siehe ISO 29621), nicht einer routinemäßigen mikrobiologischen
Prüfung unterzogen zu werden und die Hersteller können sich gegen eine Prüfung entscheiden, wenn sie
sicherstellen können, dass die vorliegende Norm eingehalten wird.
Der Hersteller sollte die gute Herstellungspraxis (ISO 22716) beachten und die notwendigen Vorkehrungen
treffen, um das Einbringen von Mikroorganismen aus Rohmaterialien, der Verarbeitung und Verpackung zu
begrenzen. Falls notwendig, darf eine mikrobiologische Prüfung unter Anwendung von ISO 21148,
ISO 21149, ISO 16212, ISO 18415, ISO 18416, ISO 21150, ISO 22717 und ISO 22718 durchgeführt werden.
Das Ziel der vorliegenden Internationalen Norm besteht in der Entwicklung annehmbarer quantitativer und
qualitativer Grenzwerte für kosmetische Endprodukte.
4

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oSIST prEN ISO 17516:2013
prEN ISO 17516:2013 (D)
1 Anwendungsbereich
Diese Internationale Norm gilt für alle kosmetischen Mittel und unterstützt interessierte Parteien bei der
Beurteilung der mikrobiologischen Qualität der Produkte. An Produkten, die als mikrobiologisch risikoarm
gelten (siehe ISO 29621), braucht keine mikrobiologische Prüfung durchgeführt zu werden.
2 Begriffe
Für die Anwendung dieses Dokuments gelten die folgenden Begriffe.
2.1
Produkt
Anteil eines identifizierten kosmetischen Produkts, das im Labor zur Untersuchung entgegengenommen wird
2.2
aerobe mesophile M
...

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