prEN 71-20

Safety of toys - Part 20: Microbiological safety of toys containing accessible aqueous media

This document specifies microbiological cleanliness and preservative efficacy requirements for accessible aqueous media in toys.
The requirements in this document apply to all toys that are, contain or are supplied with accessible aqueous materials (e.g. paste, putty, liquid or gel).
The cleanliness and preservation effectiveness requirements are applicable to a toy as it is initially received by the consumer, in an unopened and undamaged container. This document does not apply to a toy that has been used, has had its packaging opened or is otherwise compromised in a way that would introduce microbiological contamination.
This document does not cover products and samples which are post-consumer use, since the microbiological limits are inappropriate given there is no way to establish what conditions the toys have been subject to before testing.
The following are specifically excluded from the scope of this document:
-   materials that are inaccessible during normal use or reasonably foreseeable abuse;
-   food;
-   cosmetics;
-   components of toys covered by EN 71-13 where;
-   the component is in scope of the Cosmetic Products Regulation (i.e. Regulation (EC) No 1223/2009 [13]; and
-   the component comprises only recognized food flavours and food ingredients (see relevant legislation, for example Regulation (EC) No 178/2002 [16] ("general food law"), Regulation (EC) No 1334/2008 [15] (flavours), Regulation (EC) No 1333/2008 [14], Commission Regulation (EU) No 231/2012 [18] (food additives) and Regulation (EU) No 1169/2011 (food information to consumers)[17]);
-   experimental sets covered by EN 71-4.
NOTE   Play cosmetics, that are only for use on the toy (e.g. makeup products only for a doll), are not excluded.

Sicherheit von Spielzeug - Teil 20: Mikrobiologische Sicherheit von Spielzeug, das zugängliche wässrige Medien enthält

Dieses Dokument legt Anforderungen an die mikrobiologische Reinheit und Wirksamkeit von Konservierungsstoffen für zugängliche wässrige Medien in Spielzeug fest.
Die Anforderungen in diesem Dokument gelten für sämtliches Spielzeug, bei dem es sich um zugängliche wässrige Materialien (z. B. Paste, Knetmasse, Flüssigkeit oder Gel) handelt, sowie für sämtliches Spielzeug, das diese Materialien enthält oder mit diesen geliefert wird.
Die Anforderungen an die Sauberkeit und Wirksamkeit der Konservierung gelten für ein Spielzeug im Anlieferungszustand beim Verbraucher, das sich in einem ungeöffneten und unbeschädigten Behältnis befindet. Dieses Dokument gilt nicht für Spielzeug, das bereits benutzt wurde, dessen Verpackung geöffnet wurde oder das auf andere Weise so beeinträchtigt ist, dass eine mikrobiologische Verunreinigung eingebracht werden würde.
Dieses Dokument deckt keine Produkte und Proben nach der Nutzung durch Verbraucher ab, da die mikrobiologischen Grenzwerte in Anbetracht dessen, dass es keine Möglichkeit gibt festzustellen, welchen Bedingungen das Spielzeug vor der Prüfung ausgesetzt war, ungeeignet sind.
Folgendes ist eigens vom Anwendungsbereich dieses Dokuments ausgenommen:
-   Materialien, die während der üblichen Nutzung oder des vernünftigerweise vorhersehbaren Fehlgebrauchs unzugänglich sind;
-   Lebensmittel;
-   Kosmetik;
-   Teile von Spielzeug, das von EN 71-13 abgedeckt wird, wenn:
-   das Teil in den Anwendungsbereich der Kosmetikprodukte-Verordnung fällt [d. h. Verordnung (EG) Nr. 1223/2009 [13]); und
-   das Teil ausschließlich aus anerkannten Lebensmittelaromen und Lebensmittelzutaten besteht (siehe maßgebende Gesetzgebung, zum Beispiel Verordnung (EG) Nr. 178/2002 [16] ("Allgemeine Grundsätze und Anforderungen des Lebensmittelrechts"), Verordnung (EG) Nr. 1334/2008 [15] (Aromen), Verordnung (EG) Nr. 1333/2008 [14], Verordnung (EU) Nr. 231/2012 der Kommission [18] (Lebensmittelzusatzstoffe) und Verordnung (EU) Nr. 1169/2011 (Information der Verbraucher über Lebensmittel) [17];
-   von EN 71-4 abgedeckte Experimentierkästen.
ANMERKUNG   Spiel-Kosmetik, die ausschließlich für die Verwendung auf dem Spielzeug vorgesehen ist (z. B. Makeup-Produkte nur für Puppen), ist nicht ausgenommen.

Sécurité des jouets - Partie 20 : Sécurité microbiologique des jouets contenant des milieux aqueux accessibles

Le présent document spécifie les exigences en matière de propreté microbiologique et d’efficacité des conservateurs pour les milieux aqueux accessibles dans les jouets.
Les exigences du présent document s’appliquent à tous les jouets qui sont, contiennent ou sont fournis avec des matériaux aqueux accessibles (par exemple, pâte, mastic, liquide ou gel).
Les exigences en matière de propreté et d’efficacité de conservation s’appliquent au jouet tel qu’il est reçu initialement par le consommateur, dans un contenant non ouvert et non endommagé. Le présent document ne s’applique pas à un jouet qui a été utilisé, dont l’emballage a été ouvert ou qui est compromis d’une autre manière susceptible d’introduire une contamination microbiologique.
Le présent document ne couvre pas les produits et échantillons utilisés post-consommation, car les limites microbiologiques sont inappropriées étant donné qu’il n’existe aucun moyen d’établir les conditions auxquelles les jouets ont été soumis avant les essais.
Les éléments suivants sont spécifiquement exclus du domaine d’application du présent document :
-   les matériaux inaccessibles dans le cadre d’une utilisation normale ou d’un abus raisonnablement prévisible ;
-   les denrées alimentaires ;
-   les cosmétiques ;
-   les composants de jouets couverts par l’EN 71-13 lorsque :
-   le composant entre dans le domaine d’application du règlement relatif aux produits cosmétiques (c’est-à-dire le règlement (CE) n° 1223/2009 [13] ; et
-   le composant ne comprend que des arômes et des ingrédients alimentaires reconnus (voir la législation pertinente, par exemple le règlement (CE) no 178/2002 [16] (« principes généraux de la législation alimentaire »), le règlement (CE) no 1334/2008 [15] (arômes), le règlement (CE) no 1333/2008 [14], le règlement (UE) no 231/2012 de la Commission [18] (additifs alimentaires) et le règlement (UE) no 1169/2011 (information des consommateurs sur les denrées alimentaires) [17]) ;
-   les coffrets d’expériences couverts par l’EN 71-4.
NOTE   Les jeux cosmétiques, qui sont uniquement destinés à être utilisés sur le jouet (par exemple, les produits de maquillage réservés à une poupée), ne sont pas exclus.

[Not translated]

General Information

• Status: Not Published
• Publication Date: 30-Oct-2025
• ICS: 97.200.50 - Toys
• Technical Committee: CEN/TC 52 - Safety of toys
• Drafting Committee: CEN/TC 52/WG 3 - Safety of toys - Mechanical, physical and general properties
• Current Stage: 4020 - Submission to enquiry - Enquiry
• Start Date: 23-Jan-2025
• Due Date: 23-Jan-2025
• Completion Date: 23-Jan-2025
• Directive: 2009/48/EC - DIRECTIVE 2009/48/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 June 2009 on the safety of toys
• Mandate: M/589 - Safety of toys in support of Directive 2009/48/EC
• Ref Project: oSIST prEN 71-20:2025 - Safety of toys - Part 20: Microbiological safety of toys containing accessible aqueous media

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2025
[Not translated]
Safety of toys - Part 20: Microbiological safety of toys containing accessible aqueous
media
Sicherheit von Spielzeug - Teil 20: Mikrobiologische Sicherheit von Spielzeug, das
zugängliche wässrige Medien enthält
Sécurité des jouets - Partie 20 : Sécurité microbiologique des jouets contenant des
milieux aqueux accessibles
Ta slovenski standard je istoveten z: prEN 71-20
ICS:
07.100.01 Mikrobiologija na splošno Microbiology in general
97.200.50 Igrače Toys
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2025
ICS 97.200.50
English Version
Safety of toys - Part 20: Microbiological safety of toys
containing accessible aqueous media
Sécurité des jouets - Partie 20 : Sécurité Sicherheit von Spielzeug - Teil 20: Mikrobiologische
microbiologique des jouets contenant des milieux Sicherheit von Spielzeug, das zugängliche wässrige
aqueux accessibles Medien enthält
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 52.
If this draft becomes a European Standard, 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.

This draft European Standard was established by CEN 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.
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.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 71-20:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 7
4 General. 8
5 Risk assessment and exemptions from testing . 9
5.1 Exemption from Clause 6 . 9
5.2 Exemption from Clause 7 . 9
6 Microbiological cleanliness . 9
6.1 Microbiological cleanliness requirements . 9
6.1.1 Total aerobic mesophilic count (TAMC), total yeast and mould count (TYMC) and bile-
tolerant gram-negative bacteria . 9
6.1.2 Specified organisms . 10
6.2 Microbiological cleanliness test methods . 11
7 Microbiological challenge (preservation effectiveness) . 12
7.1 Preservation effectiveness requirements . 12
7.2 Preservation effectiveness test method . 12
Annex A (informative) Explanatory rationale . 13
A.1 Scope . 13
A.2 Risk assessment and exemptions from testing . 13
A.3 Microbiological cleanliness . 13
A.4 Microbiological challenge (preservation effectiveness) . 14
Annex B (informative) Process water — Manufacturing aqueous toy materials . 15
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 2009/48/EC (OJ L 170, 30.6.2009, p. 1) aimed to be covered
................................................................................................................................................................... 16
Bibliography . 17
European foreword
This document prEN 71-20:2025 has been prepared by Technical Committee CEN/TC 52 “Safety of toys”,
the secretariat of which is held by DS.
This document is currently submitted to the CEN Enquiry.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
This document constitutes the twentieth part of the EN 71 series of standards on safety of toys.
EN 71, Safety of toys, consists of the following parts:
— Part 1: Mechanical and physical properties;
— Part 2: Flammability;
— Part 3: Migration of certain elements;
— Part 4: Experimental sets for chemistry and related activities;
— Part 5: Chemical toys (sets) other than experimental sets;
— Part 7: Finger paints — Requirements and test methods;
— Part 8: Activity toys for domestic use;
— Part 10: Organic chemical compounds — Sample preparation and extraction;
— Part 11: Organic chemical compounds — Methods of analysis;
— Part 12: N-Nitrosamines and N-nitrosatable substances;
— Part 13: Olfactory board games, cosmetic kits and gustative games;
— Part 14: Trampolines for domestic use;
— Part 15: Formamide in foam toy materials (content) (under development);
— Part 16: Certain chlorinated phosphorus flame retardants (TCEP, TCPP, TDCP) in toy materials (under
development);
— Part 17: Certain isothiazolinones (MIT, CIT, BIT) in aqueous toy materials (under development);
— Part 18: Phenol in aqueous (content) and polymeric (migration) toy materials;
— Part 19: Migration of bisphenol A from toy materials;
— Part 20: Microbiological safety of toys containing accessible aqueous media (this document).
It is up to the user of the standard to determine whether or not a toy is included in the scope of several of
the above parts of the EN 71 series, and to apply each applicable standard accordingly. Normative
references from one part of the EN 71 series to another, are therefore normally not provided in the
individual parts.
NOTE In addition to the above parts of EN 71, the following guidance documents have been published:
— CEN/TR 15071, Safety of toys — National translations of warnings and instructions for use in the EN 71
series;
— the CEN/TR 15371 series, Safety of toys — Interpretations;
— CEN/TR 16918, Safety of toys — Children's mouthing behaviour in contact with toys;
— CEN/TR 17695, Safety of toys — Mechanical and physical properties — Guidance on categorization of
projectile toys within EN 71-1;
— CEN/TS 17973, Safety of toys — Categorization of slime type materials; and
— CEN ISO/TR 8124-8, Safety of toys — Part 8: Age determination — First age grade for the appropriate
play of toys (ISO/TR 8124-8).
Introduction
This document sets requirements to minimize the hazards of microbial contamination and growth in toys
containing accessible aqueous media.
This document is largely based upon the requirements in ISO 8124-12 [12] and ASTM F963 [2], with
some modifications to narrow the scope and facilitate use of the document. This document also takes into
account the Notified Bodies Toys protocol, EC-type approval protocol No. 2. Microbiological safety of toys
containing aqueous media REV 4 - NB-TOYS/2021-053 (January 2022) [4].
Conformity with the requirements of this document will minimize potential hazards associated with toys
due to lack of microbiological cleanliness or inadequate preservation. Either of which can result an
infectious disease resulting from use of the toy in its intended play modes (normal use) as well as
unintended play modes (reasonably foreseeable abuse).
This document will not, nor is it intended to, eliminate parental or supervisor responsibility in the
appropriate selection of toys. The requirements of this standard apply to toys in an as received state, it is
expected that parents and supervisors will exercise due care in ensuring toys are clean and not
contaminated after use. Nor will this document eliminate the need for parental supervision in situations
where children of various ages have access to the same toy(s).
1 Scope
This document specifies microbiological cleanliness and preservative efficacy requirements for accessible
aqueous media in toys.
The requirements in this document apply to all toys that are, contain or are supplied with accessible
aqueous materials (e.g. paste, putty, liquid or gel).
The cleanliness and preservation effectiveness requirements are applicable to a toy as it is initially
received by the consumer, in an unopened and undamaged container. This document does not apply to a
toy that has been used, has had its packaging opened or is otherwise compromised in a way that would
introduce microbiological contamination.
This document does not cover products and samples which are post-consumer use, since the
microbiological limits are inappropriate given there is no way to establish what conditions the toys have
been subject to before testing.
The following are specifically excluded from the scope of this document:
— materials that are inaccessible during normal use or reasonably foreseeable abuse;
— food;
— cosmetics;
— components of toys covered by EN 71-13 where;
— the component is in scope of the Cosmetic Products Regulation (i.e. Regulation (EC) No
1223/2009 [13]; and
— the component comprises only recognized food flavours and food ingredients (see relevant
legislation, for example Regulation (EC) No 178/2002 [16] (“general food law”), Regulation (EC)
No 1334/2008 [15] (flavours), Regulation (EC) No 1333/2008 [14], Commission Regulation
(EU) No 231/2012 [18] (food additives) and Regulation (EU) No 1169/2011 (food information
to consumers)[17]);
— experimental sets covered by EN 71-4.
NOTE Play cosmetics, that are only for use on the toy (e.g. makeup products only for a doll), are not excluded.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN 71-1:2014+A1:2018, Safety of toys — Part 1: Mechanical and physical properties
EN ISO 6222:1999, Water quality — Enumeration of culturable micro-organisms — Colony count by
inoculation in a nutrient agar culture medium (ISO 6222:1999)
EN ISO 9308-1:2014 , Water quality — Enumeration of Escherichia coli and coliform bacteria — Part 1:
Membrane filtration method for waters with low bacterial background flora (ISO 9308-1:2014)

As impacted by EN ISO 9308-1:2014/A1:2017
EN ISO 9308-2:2014, Water quality — Enumeration of Escherichia coli and coliform bacteria — Part 2:
Most probable number method (ISO 9308-2:2012)
EN ISO 9308-3:1998 , Water quality — Detection and enumeration of Escherichia coli and coliform
bacteria in surface and wastewater — Part 3: Miniaturized method (Most Probable Number) by inoculation
in liquid medium (ISO 9308-3:1998)
EN ISO 11930:2019 , Cosmetics — Microbiology — Evaluation of the antimicrobial prote
...