Regulatory Affairs Directorate
Market Surveillance Directorate
The Safety of Toys Directive (Directive 2009/48/EC), which was transposed into Maltese Legislation by means of the Safety of Toys Regulations (S.L. 427.40) sets the essential safety requirements that toys placed on the market in the Community have to fulfil.
The Directive lays down the safety criteria or "essential requirements" which toys must meet during manufacture and before being placed on the market. The safety criteria cover general risks (protection against health hazards or physical injury) and particular risks (physical and mechanical, flammability, chemical properties, electrical properties, hygiene, radioactivity).
Technical details are left to be fixed by standardisation organisations, which mean that toys that comply with the harmonised standards are presumed to be in conformity with the essential safety requirements of the Directive. The list of harmonised standards under this Directive may be accessed through the following link: http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/toys/index_en.htm
All toys marketed in the EU must carry a CE mark, which is the manufacturer's declaration that the toy satisfies all essential safety requirements. Toys that are CE marked enjoy free circulation in the European Economic Area (EEA).
There are two different modules for conformity assessment that the manufacturers may apply:
Self-verification - the manufacturer applies the harmonised standards and describes the means whereby conformity of production is ensured; the manufacturer draws up a technical documentation and the EC declaration of conformity. Then, he affixes the CE marking, his name and address and an identification element (traceability) before placing the toy on the market.
Third party verification or certification - the manufacturer submits the model of the toy as well as a technical documentation to the notified body. The notified body issues an EC type examination certificate. The manufacturer has the means to ensure the conformity of his production with the approved model. He draws up a technical documentation and the EC declaration of conformity. Then, he affixes the CE marking, his name and address and an identification element (traceability) before placing the toy on the market.
The text of the Safety of Toys Regulations may be accessed through the following link: http://www.justiceservices.gov.mt/DownloadDocument.aspx?app=lom&itemid=10777&l=1