In June, the Council of the European Union approved the new Toy Safety Regulation, which will replace Directive 2009/48/EC. This legislation marks a significant advancement, introducing stricter requirements and broader responsibilities for all stakeholders in the toy industry—manufacturers, importers, and distributors. The regulation will enter into force 30 months after its publication.
Key Highlights of the Regulation
The primary objective of the new regulation is to strengthen toy safety, with a particular focus on two critical areas:
1. Chemical Safety Requirements
The regulation introduces stricter and automatic bans on hazardous substances:
- Prohibited Substances: Automatic bans will apply to substances classified as:
- CMR (carcinogenic, mutagenic, or toxic to reproduction)
- Endocrine disruptors
- Respiratory sensitizers
- Neurotoxic or toxic to specific organs: These prohibitions will take effect as soon as a substance receives the relevant classification under the CLP Regulation (Reg. 1272/2008).
- Tolerated Traces: The presence of trace amounts of these substances is permitted only when technically unavoidable, provided that good manufacturing practices are followed and in compliance with the ALARA principle (As Low As Reasonably Achievable).
- PFAS Ban: A total ban will be introduced for all per- and polyfluoroalkyl substances (PFAS) in toys.
- Bisphenols: A group of 34 bisphenols identified as hazardous by the ECHA will be explicitly banned, even if not yet formally classified.
- Stricter Migration Limits: Tighter limits will be enforced for the migration of substances such as lead, mercury, chromium VI, arsenic, and bisphenol A (BPA).
2. New Requirements for Connected and Digital Toys
In response to the growing market of “smart” toys, the regulation introduces new provisions for digital safety and data privacy:
- Compliance with Specific Laws: Toys incorporating high-risk artificial intelligence components must comply with the AI Act (Reg. 2024/1689).
- Compliance is also required with:
- the Cyber Resilience Act (CRA, in force as of 10 December 2024, applicable from 11 December 2027), and
- the Radio Equipment Directive (2014/53/EU) for privacy and data protection.
- Stricter Conformity Assessments: Toys equipped with microphones, cameras, or geolocation features will undergo more rigorous conformity assessment procedures.
3. Mandatory Digital Product Passport (DPP)
One of the most significant innovations is the introduction of a Digital Product Passport (DPP), which will replace the traditional EU Declaration of Conformity.
- Content: The DPP must include essential information such as CE marking, chemical safety data, and references to relevant testing.
- Digital Access: The DPP must be digitally accessible through a data medium (e.g., a QR code) displayed on the toy or its packaging.
- Automated Verification: The DPP will be automatically checked at EU borders via customs IT systems, streamlining controls and ensuring compliance.
4. Other Notable Updates
- Stricter noise level limits
- Provisions for second-hand toys
- Updated warning requirements
What Steps Should Be Taken Now for Compliance
- Update Chemical Risk Assessments
- Prepare the Digital Product Passport
- Anticipate AI and Cybersecurity Requirements
- Complete Any Missing Testing Procedures
Early and proactive preparation is essential to successfully navigate these regulatory changes and ensure that products remain compliant and market-ready in an evolving legislative landscape.
