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New Obligations for Manufacturers

Manufacturers will be required to ensure that documentation for all their new and existing products meets the new technical documentation requirements. A new requirement is that manufacturers will have to draft an EC Declaration of Conformity (DoC) for each product. This declaration, along with all technical documentation, must now be kept on file by the manufacturer for ten years after placing the product on the market. Along the DoC, product instructions and safety information must be included.
Additionally, products must be marked with the name and address of the manufacturer and the importer, as well as a relevant product type, batch or serial number, and CE mark.

For manufacturers to comply successfully with the new requirements, it is important that they understand all the requirements of the directive. To assist with compliance, the EU Commission has provided an EU Explanatory Guidance Document. Another guidance document specific to technical documentation is under development.

Technical Documentation

Manufacturers must necessarily ensure that products are designed and manufactured in accordance with safety requirements. Following this, a detailed description of product design and manufacture must be provided. This description must cover the manufacturing process, age suitability and grading and intended product use. A general description and color picture of the product must be included, along with product manufacturing and storage addresses. Furthermore, packaging and instructions must be provided, along with test reports and, if relevant, an EC type examination certificate.

Manufacturers will furthermore be expected to ensure that products continue to conform to the requirements of the directive, especially in the case of any changes in toy design.

Essential to compliance with the new technical documentation requirements will be the inclusion of a Bill of Materials (BOM) with the manufacturing documentation for each product. The BOM must specify relevant substances or components for each part or material included in the toy. It must also, where needed under REACH, include Safety Data Sheets (SDS).

Safety Assessment of All Toys

New is the requirement for a Safety Assessment Procedure. Manufacturers must identify chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards that a toy may present.

Importers Required to Verify Product Conformity and Marking

Importers will be required to ensure that appropriate conformity assessment procedures have been carried out by the manufactures of the toys they import. They must also verify that manufacturers have appropriate technical documentation for their products, as well as instructions, safety information and CE marking. Importers now need to ensure that each product carries their company details, including their registered name, trademarks and address, as well as those of the manufacturer. Importers must ensure that each product is marked with a type, batch or serial number.

Technical Documentation Validated by SGS

SGS provides a range of services that can assist toy manufacturers and importers to ensure that their products are compliant. These services include: BOM list review; preparation and review of CLP notification dossiers; preparation of safety data sheets (SDS), SVHC screening (REACH regulation); risk assessment and new toy directive factory audits. Along with these specific services, SGS can provide a full capacity product testing service (and report validation), along with provision of EC type examination certificates.

To register for the SGS webinar on Technical Documentation, on March 17,2011.please email us.

1 Except chemical requirements of the directive that will be implemented on July 20, 2013.

Sanda Stefanovic
Senior Toy Expert
SGS Nederland BV
t: +31 181 694517

The SGS Group is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With 64,000 employees, SGS operates a network of over 1,250 offices and laboratories around the world.