New EU Toy Regulations (EU) 2025/2509 and EN 71-1

On Dec. 12, 2025, the European Commission (EC) published Regulation (EU) 2025/2509 (Toy Safety Regulation) on the safety of toys, repealing Directive 2009/48/EC.

This regulation establishes new rules for children’s toys aimed at protecting children’s health and safety. This is aligned with the precautionary principle and rules on the free movement of toys within the European Union.

 

Timeline for the new regulation on EU toys

This regulation was published on Dec. 12, 2025 , and becomes applicable from Aug. 1, 2030. Until then, products may be placed on the EU market under the existing European Toy Safety Directive. Certain provisions, such as notification of conformity assessment bodies, delegated powers and committee procedures, confidentiality and penalties, apply from Jan. 1, 2026. This time gap  will allow the European Commission to adopt secondary delegated acts in support of the new Toy Safety Regulation.

The new law will be a regulation instead of a directive, which removes the need for any national transposition by EU Member States. The Toy Safety Regulation clarifies and introduces stronger requirements for economic operators, with additional dedicated articles outlining obligations for fulfillment service providers and online marketplaces.

 

Scope of the new toy regulation

Regulation (EU) 2025/2509 addresses a range of chemical and product types and introduces new restrictions and requirements.

Core changes include:

• Inclusion of adaptive toys for children with disabilities
• Ban of chemicals classified in one of any of the following categories:
  • Carcinogenicity, germ cell mutagenicity or reproductive toxicity (CMR) category 1A, 1B or 2
  • Endocrine disruption for human health category 1 or 2
  • Specific target organ toxicity category 1, either in single exposure or in repeated exposure
  • Respiratory sensitization category 1
  • Skin sensitization category 1A
• New limits or bans on other chemicals, including:
  • Bisphenols
  • Per- and polyfluoroalkyl substances (PFAS)
• Lowered the limits for Fragrances
• Expanded restrictions in the former Appendix C to all toys
• Expanded restriction for nitrosamines to slimes and putties
• Migration limits set for:
  • Acrylonitrile
  • Butadiene
  • Styrene
  • Vinyl chloride
• Toys must not be biocidal products or treated articles under the EU BPR Regulation (EU) 528/2012 (except for toys intended to be permanently placed outdoors).
• Outline of minimum letter height and contrast requirements to enhance legibility of warnings.
• New warning symbol to avoid having to translate to all languages of Member States.
• Requirement for a Digital Product Passport (DPP) for all toys that will replace the Declaration of Conformity aiming to enhance transparency for consumers, make safety information directly available, and simplify market surveillance checks.
• Requirement to assess all connected toys and toys using artificial intelligence (AI) with regard to mental health.
• Prohibited access to small batteries without the use of a tool.
• Where the size or nature of the toy so requires, a rechargeable battery may instead be made inaccessible, and removable or replaceable only by independent professionals.
• Request for an opinion from the European Chemicals Agency on the safety of these chemicals in toys:
  • Nitrosamines and nitrosatable substances
  • Lead
  • Cadmium
  • Mercury
  • Chromium VI (hexavalent chromium) 

 

Updates for the mechanical standard for toys: EN 71-1:2026 has been published

The new updated version of EN 71-1:2026 ‘Safety of Toys – Part 1: Mechanical and physical properties’ has been published on January 28, 2026.

The new version of the standard introduces, among other minor changes, some major updates for the following categories of toys:

• Expanding materials
• Food imitating toys
• Toys intended to bear the mass of a child

In particular, for expanding materials, the requirements have been revised to align with ASTM F963, taking into account that the risk of intestinal blockage is reduced if the toy can pass through a template representing the dimensions of the pyloric sphincter at the lower end of the stomach.

Requirements for food-imitating toys that are a realistic reproduction of food have been added to address the potential choking linked to a child confusing the toy with a real foodstuff. To help in defining which toys shall be considered as a realistic reproduction of foodstuff, a new Guideline has been published in December 2025: CEN/TR 18240 ‘Safety of Toys. Mechanical and physical properties – Guidance on the requirements for food-imitating toys in EN 71-1’.

Regarding toys intended to bear the mass of a child, a complete reorganization of the requirements, together with the introduction of new definitions, requirements and test methods.

The standard was published on Dec. 17, 2025, and outlines new requirements for microbiological safety of toys containing accessible aqueous media.

 

Microbiological safety updates for toys

The new EN 71-20:2025 standard, published on Dec. 17, 2025, outlines new requirements for microbiological safety of toys containing accessible aqueous media.

Specifically, this document specifies microbiological cleanliness and preservative efficacy requirements for accessible aqueous media in toys. It applies to all toys that are, contain, or are supplied with accessible aqueous materials, such as paste, putty, finger paint, 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. Microbiological limits are inappropriate for toys and samples used in a post-consumer context, as there is no way to establish what conditions the toys have been subject to before testing. 

This document does not apply to: 

• Materials that are inaccessible during normal use or after reasonably foreseeable abuse
• Food
• Cosmetics* 
• Components of toys covered by EN 71-13 
• Component in scope of the Cosmetic Products Regulation, i.e., Regulation (EC) No 1223/2009
• Experimental sets covered by EN 71-4
• Toy materials with water activities below 0.75 for microbiological cleanliness and microbiological challenge

*Play cosmetics that are only for use on the toy (e.g., makeup products only for a doll) are not excluded.

Test methods and acceptable levels

The test method requires the challenge according to EN ISO 11930:2019 or Ph. Eur. 11.5 (01/2023) Chapter 5.1.3. for preservative effectiveness.

The total amount of bile-tolerant gram-negative bacteria in accessible aqueous media shall not exceed 1,000 CFU/ml or 1,000 CFU/g for all toys. Total Aerobic Microbial Count (TAMC) shall not exceed 100,000 CFU/ml or 100,000 CFU/g in accessible aqueous media for all toys.

Additional testing shall be done when the TAMC exceeds one of the following:

1. 1,000 CFU/ml or 1,000 CFU/g for toys intended for children under 36 months or,
2. 10,000 CFU/ml or 10,000 CFU/g for all other toys

Definitions of terms

TAMC is equivalent to the sum of Total Aerobic Bacterial Count (TABC) and Total Yeast and Mold Count (TYMC).

TABC is the total number of bacterial colonies formed on culture media under aerobic conditions.

TYMC is the total number of yeast and mold colonies formed on culture media under aerobic conditions.

Information on good practices regarding the cleanliness of water used in the manufacturing process is provided in Annex B.

Once the standard is published in the Official Journal and is harmonized for the EU market, it will be the reference method to give the presumption of conformity.

 

Testing guidance from UL Solutions

As a leading provider of regulatory expertise and third-party testing services for toys for the EU market, UL Solutions is prepared to help you navigate compliance.  

For more details on how UL Solutions can help you tackle new toy requirements, please contact Katie.Ellen.Moore@ul.com or visit UL.com/toys.