CEN Issues EN 71-20:2025 for Microbiological Safety in Toys

SafeGuardSToys and Juvenile ProductsMar 03, 2026

SG 037/26

The European Committee for Standardization (Comité Européen de Normalisation, CEN) has published a new standard for microbiological safety in toys containing accessible aqueous media.

In December 2025, CEN published EN 71-20:2025 ‘Microbiological safety of toys containing accessible aqueous media’, a new standard that specifies microbiological cleanliness and preservative efficacy requirements for accessible aqueous media in toys.

This document is now part of the EN 71 series of standards for toy safety, which covers Parts 1-5, 7, 8 and 10-20.

Highlights of EN 71-20:2025 are summarized in Table 1.

Section to EN 71-20:2025	Highlights
Scope	Applies to toys that contain or are supplied with accessible aqueous materials as initially received by the consumer in an unopened and undamaged container (e.g. finger paints, gels, liquids, pastes and putties) Includes play cosmetics that are only for use on the toy (e.g. makeup products only for a doll) Exemptions: Toys and samples that are post-consumer use Materials that are inaccessible during normal use or after reasonably foreseeable abuse Cosmetics and food Toy components covered by EN 71-13 where these are under Regulation (EC) No 1223/2009 on cosmetics or comprise of only recognized food flavors and food ingredients Experimental sets within the scope of EN 71-4
6 ‘Microbiological cleanliness’	≤ 1 000 CFU/ml or 1 000 CFU/g total amount of bile-tolerant gram-positive bacteria ≤ 100 000 CFU/ml or 100 000 CFU/g TAMC Requires at least one of three checks if TAMC exceeds the following conditions: 1 000 CFU/ml or 1 000 CFU/g for toys intended for children under 36 months, or 10 000 CFU/ml or 10 000 CFU/g for all other toys Specifies requirements for a) TAMC and bile-tolerate gram-negative bacteria limit values (see Table 2 below) and b) TAMC action values (see Table 3 below), with certain considerations Requires the absence of five types of specified organisms in 1 ml or 1 g of accessible aqueous media Indicates test methods for assessing microbiological cleanliness
7 ‘Microbiological challenge (preservation effectiveness)’	Specifies methods and requirements for challenge testing
Annex A ‘Background and rationale for this European Standard’	Provides explanatory notes for: Scope Risk assessment and exemption from testing Microbiological cleanliness Microbiological challenge (preservation effectiveness)
Annex B ‘Process water – manufacturing aqueous toy materials’	Provides guidance for water used in the manufacture of toy materials

Table 1

Toy category	TAMC limit values (CFU/ml or CFU/g)	Bile-tolerate gram-negative bacteria limit values (CFU/ml or CFU/g)
All toys	< 100 000	< 1 000

Table 2

Toy category	TAMC values (CFU/ml or CFU/g)	Action
Toy intended for children under 36 months	≤ 1 000	Complies without additional checks
Toy intended for children under 36 months	> 1 000	Proceed to perform checks
Toys other than those intended for children under 36 months	≤ 10 000	Complies without additional checks
Toys other than those intended for children under 36 months	> 10 000	Proceed to perform checks

Table 3

According to EN 71-20:2025, this standard will be given the status of a national standard by June 2026. It is expected to be harmonized under Directive 2009/48/EC on toy safety upon official acceptance by the European Commission and publication in the Official Journal of the EU (OJEU).

Please note: we will keep you updated on changes to the EN 71-series of standards due to the Standardization Request; see SG 016/25.

Abbreviations

Abbreviation	Name
CFU	Colony forming unit
TAMC	Total aerobic microbial count

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