The EU Toy Safety Directive 2009/48/EC enforces strict chemical safety rules for toys, including limits on heavy metals, phthalates, nitrosamines, allergenic fragrances, and hazardous chemicals. Accredited testing ensures toys meet these requirements, safeguarding children’s health and enabling market access within the EU.
The European Union has established stringent regulations to safeguard young consumers, particularly through the Toy Safety Directive 2009/48/EC. The directive lays down the safety criteria that toys must meet before they can be marketed in the EU, including certain strict chemical requirements.
Toys must also comply with other applicable EU legislation to meet chemical safety requirements, such as REACH Annex XVII, Entry 51 & 52 for phthalates, and Entry 50 for PAH.
Key Chemical Safety Provisions covered by Toys Directive 2009/48/EC:
Restriction on Heavy Elements
Limits migration of 19 'heavy elements', including lead, mercury, and cadmium in accessible parts of toys.
Restriction on Specific Chemicals:
Controls 12 chemicals restricted in toys for children under 36 months or toys intended to be placed in the mouth, as given in Appendix C of the directive. Examples of chemicals include, Bisphenol A (BPA), formamide in foam toy materials, and preservatives (MIT, CIT, BIT) in aqueous toy materials such as bubble solution.
Nitrosamines
N-nitrosamines and N-nitrosatable substances are restricted for use in toys intended for children under 36 months or in other toys intended to be placed in the mouth, e.g., balloons, finger paints.
Allergenic Fragrances
58 allergenic fragrances are banned, while some of them and another 71, may be used in certain toys provided they are indicated on the label and comply with additional requirements.
Prohibition of Hazardous Chemicals
Chemicals classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) are prohibited in toys unless deemed safe following rigorous scientific evaluation.
Relevant EN 71 Standards Covering Chemical Risks
The EN 71 series consist of standards that cover different aspects of toy safety. The standards related to the aforementioned chemical risks are:
EN 71-3: Migration of Certain Elements
It provides detailed test methods to measure the migration of heavy metals and other elements from toy materials. These methods ensure accurate and reliable testing to verify compliance with the safety limits.
- EN 71-4: Experimental Sets for Chemistry and Related Activities
- This standard covers safety requirements for chemistry sets and similar experimental toys.
- EN 71-5: Chemical Toys (Sets) Other Than Experimental Sets
- This part addresses safety requirements for chemical toys, such as modeling clay and other sets that involve chemical reactions.
- EN 71-7: Finger Paints
- This part sets requirements for the safety of finger paints, including limits on toxic substances.
- EN 71-12: N-Nitrosamines and N-Nitrosatable Substances
- This standard specifies the requirements and test methods for N-nitrosamines and N-nitrosatable substances in toys made from elastomers, such as balloons and teethers, as well as in finger paints.
- EN 71-13: Olfactory Board Games, Cosmetic Kits, and Gustative Games
- This part covers safety requirements for toys that involve scents, cosmetics, and taste.
- EN 71-15: Formamide in foam toy materials (content)
- It provides a test method to determine the formamide content in foam toy materials .
- EN 71-16: Certain chlorinated phosphorus flame retardants (TCEP, TCPP, TDCP) in toy materials
- This standard provides a test method to determine the content of these flame retardants in toy materials.
- EN 71-17: Certain isothiazolinones (MIT, CIT, BIT) in aqueous toy materials
- It provides a test method to determine the content of these isothiazolinones in aqueous toy materials.
- EN 71-18: Phenol in aqueous (content) and polymeric (migration) toy materials
- This standard provides detailed test methods to measure the concentration and migration of phenol from toy materials.
- EN 71-19: Migration of bisphenol A from toy materials
- It provides a detailed test method to measure the migration of bisphenol A from toy materials.
Conformity Assessment and Market Access
Toys must undergo conformity assessments to demonstrate compliance with the Toy Safety Directive and associated chemical safety standards. This can be done through methods such as self-verification using the EN 71 standards listed above for chemical requirements. Only toys meeting these requirements are permitted to be sold within the EU market.
Ensure Compliance with Us
Navigating the complex chemical safety requirements of the EU Toy Safety Directive and associated EN 71 standards can be challenging. Our accredited laboratory offers comprehensive chemical testing services tailored specifically for toys and children’s products. From heavy metal migration to nitrosamine analysis and phthalate testing , we provide accurate, reliable, and timely testing to help manufacturers, importers, and retailers ensure full compliance. Contact us today to learn more about our tailored testing solutions.
