The European Committee for Standardization (CEN) has introduced two updated testing standards, EN 71-18:2024 and EN 71-19:2024, which will become mandatory across the EU starting June 30, 2024. These new protocols significantly revise how toy manufacturers must test for:
- Phenol content in water-based materials and phenol migration in polymer materials
- Bisphenol A (BPA) migration in all applicable toy components
The standards enforce compliance with strict limits set by the EU Toy Safety Directive 2009/48/EC, specifically Annex II, Appendix C.
Key Changes in Testing Methodology
The new standards replace previous testing methods (EN 71-10:2005 and EN 71-11:2005) with more rigorous requirements:
1. Testing Conditions:
- Samples must now be agitated at body temperature (37±2°C) using a horizontal shaker at 150±10 rpm for 180-187 minutes
- This replaces previous room-temperature (20±2°C) testing with slower rotation (60±5 rpm for 60±5 minutes)
2. Potential Impact:
The more aggressive testing conditions may result in higher measured migration values for both phenol and BPA compared to previous methods.
Compliance Timeline and Geographic Scope
- EU Implementation: Mandatory from June 30, 2024
- Legacy Standard Phase-out: Conflicting national standards must be withdrawn by June 2025
- Global Implications: While immediately effective in the EU, these standards may influence regulations in:
- United Kingdom (Toy Safety Regulations 2011)
- Switzerland (Toy Ordinance)
- Turkey (Toy Safety Regulations)
Critical Actions for Toy Manufacturers
1. Immediate Testing Review:
- Conduct comparative tests using both old and new methods to assess potential compliance gaps
- Identify materials most likely to be affected by the stricter conditions
2. Production Process Optimization:
- Re-evaluate curing times, temperature controls, and material formulations
- Consider alternative materials with lower migration potential
3. Documentation Updates:
- Ensure Technical Documentation reflects the new testing standards
- Update compliance certificates and supplier agreements
Why These Changes Matter
- Health Protection: Phenol and BPA are known endocrine disruptors with potential developmental effects
- Market Access: Non-compliant products risk being pulled from EU markets
- Competitive Advantage: Early adopters can use compliance as a market differentiator
Next Steps:
- Engage with accredited testing laboratories familiar with the new protocols
- Review all product lines for potential compliance issues
- Monitor for regulatory updates in non-EU markets that may adopt these standards