Toy Safety: New Rules in the European Market

The new EU Toy Safety Regulation was proposed to respond to emerging challenges, such as risks relating to digital toys and the surge in online shopping. Read more.

The European Toy Safety Regulation

The proposed EU Toy Safety Regulation, which repeals the EU Toy Safety Directive 2009/48/EC, introduces stricter rules on harmful chemicals and strengthens safety requirements. It also highlights the importance of children’s psychological and mental health and cognitive development, particularly for digitally connected toys.
The regulation emphasizes the need for clear warnings and requires manufacturers to implement a digital product passport (DPP).

The purpose of this regulation is to reduce the high number of unsafe toys in the EU market, including those sold online or imported from outside the EU. It bans per-and polyfluoroalkyl substances (PFAS) and bisphenols and expands the generic ban on carcinogenic, mutagenic and reprotoxic (CMR) substances. It also covers other hazardous substances, including endocrine disruptors and skin sensitizers. The introduction of a DPP can help accelerate customs checks and allow consumers to access safety information more easily.

Main chemical requirements

The proposed regulation includes significant updates to chemical safety. Key changes include:

Ban on bisphenols
Ban on PFAS
Expansion of former Appendix C restrictions to all toys
Expansion of applicability for nitrosamine limits to all toys
Additional bans and lowered limits for fragrances
Restrictions on other hazardous substances such as endocrine disruptors

PFAS and bisphenols

Ban beyond carcinogenic, mutagenic and reprotoxic (CMR)

Nitrosamines

Fragrances

Former
Appendix C

The use in toys, components of toys or micro-structurally distinct parts of toys, PFAS and bisphenols is prohibited.

Endocrine disruption: Category 1 or 2, for human health and the environment
Specific target organ toxicity: Category 1, either in single exposure or in repeated exposure
Respiratory sensitization: Category 1
Skin sensitization: Category 1
Persistent, bioaccumulative and toxic
Very persistent and bioaccumulative
Persistent, mobile and toxic
Very persistent and mobile

Now applicable to ALL toys
Nitrosamines and nitrosatable substances are prohibited in all toys
The migration of those substances from toys, components of toys or micro-structurally distinct parts of toys shall not exceed 0,01 mg/kg for nitrosamines and 0,1 mg/kg for nitrosatable substances

Toys intended for use by children under 36 months or other toys intended to be placed in the mouth shall not contain any fragrances

Other toys:

Shall not contain certain fragrance allergens unless their presence in the toy is technically unavoidable under good manufacturing practice and does not exceed 10 mg/kg
The names of certain fragrance allergens shall be listed on the toy, on an affixed label on the packaging or in an accompanying leaflet, as well as in the DPP; if those allergens are added to a toy, where they are present in the toy or any component thereof at concentrations exceeding 10 mg/kg

The new regulation proposes applying Appendix C requirements in the current Toy Safety Directive (TSD) to all toys, whereas the TSD limits these only to toys intended for children under 36 months or those designed to be placed in the mouth.

TCEP,¹ TCPP,² TDCP³
Formamide
Formaldehyde
Phenol
Certain preservatives (CIT,⁴ MIT,⁵ BIT,⁶ CIT/MIT⁷)
Aniline

Table note:

¹Tris(2-chloroethyl) phosphate (TCEP),
²Tris(1-chloro-2-propyl) phosphate (TCPP),
³Tris(1,3-dichloroisopropyl)phosphate (TDCP)
⁴Chloromethyl (CIT),
⁵Methylisothiazolinone (MIT),
⁶Benzisothiazolinone (BIT),
⁷Chloromethyl-methylisothiazolone (CIT/MIT)

Labeling toys: What will change?

Key changes for labeling toys sold on the EU market include:

New requirements regarding size, visibility and legibility of labels
Mandate for manufacturers to make communication channels publicly available, allowing consumers to submit any safety-related complaint via appropriate channels (e.g., email address, telephone number, contact page)
Requirement to display the DPP data carrier on the toy or its packaging

Digital product passport for toys

The DPP shall replace the traditional declaration of conformity and must include safety and compliance information. Requirements for the DPP align with the Ecodesign for Sustainable Products Regulation (ESPR), making safety data immediately available for authorities and consumers.

Digitally connected toys and artificial intelligence (AI) integration

When a safety assessment is performed, risks related to mental health must be taken into consideration. Toys using AI covered by the Artificial Intelligence Act¹ must comply with the requirements of cybersecurity, privacy and personal data protection.

How UL Solutions can help

UL Solutions technical experts can help you stay on top of regulatory changes in every market you target and support you in the transition from the European Toy Safety Directive 2009/48/EC to the EU Toy Safety Regulation.

Our global chemical laboratories test thousands of toys and children’s products every day to evaluate compliance with regulations impacting the toy industry, including the European, U.S., Chinese and Brazilian markets.

At UL Solutions, we are also committed to helping you navigate the complexities of smart toys and connected children’s product compliance with the applicable EU, U.S. and other international standard consumer safety specifications. Our experts are familiar with regulatory requirements for digital connectivity, Internet of Things (IoT) integration and global safety expectations.

¹ https://artificialintelligenceact.eu/