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EU-2009/48/EC, EN71 series, REACH Annex 17
2009/48/EC is a directive that toy products exported to Europe must comply with. This directive establishes safety requirements for toys exported to Europe and rules for the free circulation of compliant toys in the European Economic Area, serving as a guiding framework.
The EN71 series, authorized by the European Commission, is a set of coordinated standards developed by the European Committee for Standardization (CEN) (responsible for developing the requirements of EN 62115 for electric toys). It is a way to verify product compliance with 2009/48/EC and is a technical detail. There are currently 13 parts in total.
·EN 71-1: Mechanical and Physical Properties
·EN 71-2: Flammability
·EN 71-3: Specification for migration of specific elements
·EN 71-4: Experimental apparatus for chemistry and related activities
·EN 71-5: Chemical toys (sets) other than laboratory kits
·EN 71-7: Finger painting pigments
·EN 71-8: Indoor and outdoor household swings, slides, and similar activity toys
·EN 71-9: Organic compounds - Requirements
·EN 71-10: Organic compounds - Sample preparation and extraction
·EN 71-11: Organic compounds - Analytical methods
·EN 71-12: N-nitrosamine and N-nitroso substances
·EN 71-13: Olfactory board games, cosmetic kits, and taste games
·EN 71-14: Home trampoline
Among them, 1, 2, and 3 are general requirements; 9, 10, and 11 are requirements for organic compounds in toys that meet specific conditions (note: 9, 10, and 11 are not included in the official gazette, but can be an important area of concern for toy product compliance, and many substances in Appendix C of the Toy Directive TSD also refer to this section)
The Toy Directive also requires toys to not only meet the EN71 series of requirements, but also comply with other parallel regulations. The requirements corresponding to REACH Annex 17 must also be met. This is also a requirement for CE marking.
The EU has very strict requirements for toy safety, mainly regulated through the 2009/48/EC (Toy Safety Directive), EN 71 series standards, and Annex 17 of REACH regulation. The following are detailed explanations of these regulations and standards:
1. 2009/48/EC (Toy Safety Directive)
2009/48/EC is the EU Toy Safety Directive, which applies to toys designed or intended for use by children under the age of 14 when playing.
Core content:
Safety requirements:
Physical and mechanical properties.
Combustion performance.
Chemical properties.
Electrical performance.
Hygiene requirements.
Radioactive requirements.
Chemical substance restrictions:
Limit the migration of 19 heavy metals (such as lead, cadmium, mercury, etc.).
Restrictions on 55 allergenic fragrances.
Restrictions on CMR (carcinogenic, mutagenic, reproductive toxic) substances.
CE mark:
Toys must comply with the requirements of 2009/48/EC and bear the CE mark.
Technical documents:
Manufacturers need to prepare technical documents, including design drawings, test reports, risk assessments, etc.
Declaration of conformity:
Manufacturers are required to sign a Declaration of Conformity (DoC) to demonstrate that their products comply with the requirements of the directive.
Scope of application:
All toys designed or reserved for children under 14 years old.
2. EN 71 series standards
The EN 71 series standards are toy safety standards of the European Union, specifically implementing the requirements of 2009/48/EC. It mainly includes the following parts:
EN 71-1: Mechanical and Physical Properties
Small parts: prevent small parts from falling off and causing children to accidentally swallow them.
Sharp edges and tips: Ensure that the toy has no sharp edges or tips.
Rope and elastic components: limit the design of rope length and elastic components.
Other mechanical hazards, such as folding mechanisms, springs, etc., must ensure their safety.
EN 71-2: Combustion performance
Material burning rate: Conduct a burning test on toy materials to ensure that they are not flammable or that the burning rate is within a safe range.
Specific material requirements: Plush toys, makeup clothing, etc. must meet additional combustion performance requirements.
EN 71-3: Migration of Specific Elements
Restricting elements: Restricting the migration of 19 heavy metals (such as lead, cadmium, mercury, etc.).
Testing method: Use simulated saliva, gastric juice and other liquids for migration testing.
EN 71-7: Finger painting pigments
Chemical properties: Limiting the chemical composition of finger painting pigments.
Label requirements: It is necessary to indicate applicable age, composition, and other information.
EN 71-12: Nitrosamines and Nitroso Substances
Restricted substances: Limit the content of nitrosamines and nitrosamines.
EN 71-13: Olfactory board games, taste toys, and sets
Chemical properties: Limit the chemical composition of olfactory and gustatory toys.
3. Annex 17 of REACH Regulation
Annex 17 of the REACH regulation is the EU's restriction requirements for chemical substances, applicable to all consumer goods, including toys.
Core content:
Restricted substances:
Limit the content of harmful chemicals such as lead, cadmium, and phthalates.
For example:
Lead: not exceeding 0.05% (500 ppm).
Cadmium: shall not exceed 0.01% (100 ppm).
Phthalates (DEHP, DBP, BBP): shall not exceed 0.1%.
Scope of application:
All consumer goods sold in the EU market.
How to meet EU toy safety requirements
Understand regulations and standards:
Familiar with the specific requirements of the 2009/48/EC, EN 71 series standards, and REACH Appendix 17.
Product Design:
Ensure that product design meets the requirements of physical, mechanical, and combustion performance.
Material selection:
Choose materials that comply with chemical substance restrictions.
Test certification:
Conduct testing in an accredited laboratory to ensure that the product complies with the EN 71 series standards.
Technical documents:
Prepare technical documents (including design drawings, test reports, risk assessments, etc.).
CE marking and declaration of conformity:
Attach the CE mark and sign a Declaration of Conformity (DoC).
summary
The EU's toy safety regulations and standard system are very strict, mainly including 2009/48/EC, EN 71 series standards, and REACH Appendix 17. Toy products exported to the EU must comply with these requirements and pass relevant tests and certifications to ensure product safety and smooth entry into the market.
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