Technical Documentation: Requirements of the New EU Toy Directive
On June 30th, 2009, the European Toy Safety Directive 2009/48/EC was published in the Official Journal of the European Union. The New Toy Safety Directive sets new requirement for Technical documentation. The provisions of the Toy Safety Directive will come into force on 20 July 2011. For chemical requirements there is an additional transitional period ending on 20 July 2013.
The technical documentation must contain all data to ensure that toys placed on the market comply with the requirements of the Toy Safety Directive. The manufacturer of the toy must be able to provide the following information:
- a detailed description of the design and manufacture, including a list of components and materials used in the toy as well as the safety data sheets on chemicals used, to be obtained from the chemical suppliers.
- documentation regarding the safety assessment(s) carried out.
- a description of the conformity assessment procedure followed.
- a copy of the EC declaration of conformity.
- the addresses of the places of manufacture and storage.
- Test reports
- copies of documents that the manufacturer has submitted to a notified body, if involved.
- If applicable: copy EC type examination certificate.
- Keep for 10 years.
- The manufacturer is responsible to draft the Technical Documentation. Importers and distributors must ensure that the Technical Documentation can be made available to surveillance authorities, upon reasoned request.
- The Technical Documentation must be drafted in one of the official EU languages.
DETAILED DESCRIPTION OF THE DESIGN AND MANUFACTURE:
the description should include a detailed description of the toy including all parts and components, clear and detailed colour pictures, design and manufacturing drawings and schemes etc. and details of the manufacturing process.
Additional important information is:
- The intended use of the toy.
- The suitable age of children for which the toy is intended, 玩具有意愿的适用年龄
• A list of components and materials used in the toy as well as the safety data sheets on chemicals used, to be obtained from the chemical suppliers.
- A list of components and materials used in the toy as well as the safety data sheets on chemicals used, to be obtained from the chemical suppliers.
- Safety assessment: Manufacturers shall carry out an analysis of chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards that a toy may present, as well as an assessment of the potential exposure to such hazards. This all in order to minimize risks. The assessment will help the manufacturer to identify what harmonized standards need to be used and if EC type examination is needed.
CONFORMITY ASSESSMENT PROCEDURE.
There are two options:
1. Self assessment:
- use harmonized standards as the standards cover all safety aspects of the toy.
- internal production control in accordance with Module A of Annex II to Decision No. 768/2008/EC.
2. Third party verification:
- EC type examination by a Notified Body.
- Module B + C of Annex II to Decision No. 768/2008/EC.
EC declaration of conformity
1. No … (unique identification of the toy(s))
2. Name and address of the manufacturer or his authorised representative.
3. This declaration of conformity is issued under the sole responsibility of the manufacturer.
4. Object of the declaration (identification of toy allowing traceability). It shall include a colour image of sufficient clarity to enable the identification of the toy.
5. The object of the declaration described in point 4 is in conformity with the relevant Community harmonization legislation.
6. References to the relevant harmonized standards used, or references to the specifications in relation to which conformity is declared.
7. Where applicable: the notified body … (name, number) … performed … (description of intervention) … and issued the certificate.
8. Additional information.
Signed for and on behalf of: (place and date of issue) (name, function) (signature)
EC TYPE EXAMINATION is required in the following cases.
- harmonised standards do not exist.
- harmonised standards have not or only partly been applied by a manufacturer.
- one or more harmonized standards have been published with a restriction.
- the manufacturer considers that the nature, design, construction or purpose of the toy requires
third party verification.
Remark:
Obligations of Economic Operators
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Manufacturers |
Authorised Representatives |
Importers |
Distributor |
Drafted technical documentation |
Yes |
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--- |
--- |
Keep the technical documentation |
Keep a period of 10 years after the toy has been placed on the market |
Keep a period of 10 years after the toy has been placed on the market |
--- |
--- |
Technical documentation can be made available |
--- |
--- |
Keep a period of 10 years after the toy has been placed on the market |
Base on reasonable request |
Drafted EC declaration of conformity |
Yes |
Yes |
--- |
--- |
Keep EC declaration of conformity |
Keep a period of 10 years after the toy has been placed on the market |
Keep a period of 10 years after the toy has been placed on the market |
Keep a period of 10 years after the toy has been placed on the market |
Base on reasonable request |
Address |
Yes |
--- |
Yes |
--- |
Bear identification on their toys |
Yes |
--- |
--- |
--- |
CE marker |
Yes |
--- |
--- |
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Learn more:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:170:0001:0037:en:PDF
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Solution
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