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EU Published EN 71-20:2025 on Microbiological Safety of Toys Containing Accessible Aqueous Media
 
Targeted audience EU/EEA manufacturers, EU/EEA importers and their upstream providers, EU/EEA distributors
Products concerned Toys that are, contain or are supplied with accessible aqueous materials (e.g., paste, putty, finger paint, liquid or gel).
[Excluding: (1) food, (2) cosmetics (for human), (3) components of toys covered by EN 71-13 where the component is in scope of EU Cosmetics Regulation (EC) No 1223/2009 or comprises only recognized food flavours and food ingredients, (4) experimental sets covered by EN 71-4]
Key industries concerned with this insight Toys
Application date 30 June 2026
Main content or requirements On 17 December 2025, the new European Standard EN 71-20:2025 on Microbiological safety of toys containing accessible aqueous media is published. The standard has set the requirements on microbiological cleanliness and preservation effectiveness. The standard will be given the status of a national standard at the latest by June 2026, and the conflicting national standards will be withdrawn at the latest by June 2027
Reference Link 1
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On 17 December 2025, the European Committee for Standardization (CEN) published a new European Standard EN 71-20, EN 71-20:2025 Safety of toys - Part 20: Microbiological safety of toys containing accessible aqueous media.

The standard EN 71-20:2025 applies to all toys that are, contain or are supplied with accessible aqueous materials (e.g., paste, putty, finger paint, liquid or gel). The microbiological cleanliness and preservation effectiveness tests shall be conducted on toys as initially received by the consumer, in an unopened and undamaged container.

The standard does not apply to (1) food, (2) cosmetics (for human), (3) components of toys covered by EN 71-13 where the component is in scope of EU Cosmetics Regulation (EC) No 1223/2009 or comprises only recognized food flavours and food ingredients, (4) experimental sets covered by EN 71-4.

Comparison of EN 71-20:2025 to EU NB Protocol No 2 (Rev 4) (NB-TOYS/2021-053) is as follows.

Comparison of EN 71-20:2025 to EU NB Protocol No 2 (Rev 4) (NB-TOYS/2021-053)

Test Item \ Limit (CFU/mL or CFU/g) EN 71-20:2025 NB-TOYS/2021-053
Microbiological cleanliness Total aerobic microbial count
(TAMC=TABC+TYMC)
100000
[Remark: Additional confirmation test shall be conducted when result is > 1000 (for toys < 36 m), or 10000 (for toys ≥ 36 m)]
1000
Total aerobic bacteria count
(TABC)
--
(Remark: Source of contamination is recommended be investigated when either result is > 1000)
--
Total yeast and mould count
(TYMC)
100
Bile-tolerant gram-negative bacteria 1000 100
Five kinds of pathogenic microorganisms:
(1) Pseudomonas aeruginosa
(2) Escherichia coli
(3) Staphylococcus aureus
(4) Salmonella spp.
(5) Candida albicans
Absent
Microbiological challenge
(Preservation effectiveness)
No increase in bacteria, yeasts or moulds at 7, 14 or 28 days (Depending on standard chosen)

Colony forming unit (CFU): Organism (or cluster of organisms) with the ability to form a colony under certain specified conditions. CFU is a measure of the number of viable bacteria or fungal cells in a sample.

The standard EN 71-20:2025 will be given the status of a national standard at the latest by June 2026, and the conflicting national standards will be withdrawn at the latest by June 2027. The standard is expected to become a harmonised standard under the EU Toy Safety Directive 2009/48/EC after it is accepted by the European Commission and is published in the Official Journal of the European Union (OJEU).

Intertek China Hardlines labs are capable of providing you with testing services and technical support in compliance with the EU toy regulations and standards.

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