New toy safety rules are not child's play
22.09.2011
life sciences | new provisions
Toy companies must now control product quality, register suppliers and purchasers of certain products, and warn consumers against improper use of products.
The Regulation of the Minister of Economy on Essential Requirements for Toys went into effect on 20 July 2011. The regulation transposes the EU’s Toy Safety Directive (2009/48) into Polish law and supersedes the prior regulation from 2003.
In addition to updating essential safety requirements, the Polish regulation imposes significant new obligations on businesses operating on the toy market. The most important obligations include checking whether suppliers meet basic requirements, and registering transactions and identifying counterparties in order to trace products and intervene effectively if a toy proves to be unsafe.
Essential safety requirements
The essential safety requirements, both general and particular, have been reviewed and updated. In terms of specific requirements, the regulation now addresses physical, mechanical, chemical and electrical properties of toys, flammability, hygiene and radioactivity.
Labelling
The regulation sets forth comprehensive rules for labelling of toys. The labelling must include the CE mark, product identification information (such as type, batch, serial or model number), and the trademark, name and address of the producer or importer. If the producer and the importer are both located outside Poland, the Polish distributor must also be identified. Annex 3 to the regulation defines in detail the rules for instructions for use of toys, as well as the mandatory wording for specific warnings. For example, skates, roller skates, online skates, skateboards, scooters and toy bicycles for children must contain the warning “Protective equipment should be worn. Not to be used in traffic.”
Manufacturer’s duties
The duty to assure that a toy complies with the essential safety requirements rests primarily on the manufacturer. The manufacturer must assure that a toy it designs and produces meets the essential requirements and that the toys manufactured within a single production series are of the same quality as the prototype. In order to document a toy’s conformity with the essential safety requirements, the manufacturer is required to prepare technical documentation depicting the process of construction, production and quality control for the toy, and to maintain the documentation for 10 years after placing the product on the market. Before placing a toy on the market, it is necessary to conduct a conformity assessment procedure, and if the toy passes, to issue a declaration of conformity. Only on the basis of a declaration of conformity may the toys be labelled with the CE mark.
Importer’s duties
In the case of toys from outside the EU introduced onto the Polish market, the importer plays the key role. An importer that does not produce a toy itself lacks the original source knowledge concerning product quality. It must rely on information supplied by the manufacturer. In order to verify the reliability of the product and the manufacturer, the importer is required to determine whether the manufacturer has conducted the proper conformity assessment and prepared the technical documentation. The importer is also required to confirm the completeness and accuracy of the labelling (including the proper wording of warnings and use of the Polish language) and to make up for any shortcomings in this respect. Finally, the importer is required to obtain a declaration of conformity for the product from the manufacturer, and maintain it for 10 years after placing the toy on the market, so that it may, for example, be presented to market surveillance authorities.
Distributor’s duties
Because the primary responsibility for conformity with essential safety requirements is imposed on the manufacturer and the importer (located within the EU), the formal duties of the distributor in this respect have been reduced accordingly. The distributor is required to ensure “with due care” that a toy it makes available on the market meets the applicable requirements. Clearly, as a minimum display of due care, the distributor will need to obtain a declaration of conformity for the product from the supplier. When the need arises, the distributor may, for example, be required to conduct product testing.
Traceability
Every economic operator on the toy market (i.e. manufacturer, authorised representative, importer or distributor) is required to record all of its own transactions involving purchase or supply of toys. The register should disclose the specific toys and identified counterparties (suppliers and buyers) participating in the transaction. The purpose of the register is to make it possible, if the need arises, to trace the route of an unsafe product and apply effective corrective measures (e.g. withdrawing the product from the market with the assistance of specific distributors). Transaction documentation must be maintained for 10 years.
Register of complaints and corrective measures
Producers and importers are required to address safety complaints by users with respect to specific toys. This implies an obligation to notify the complainant of the results of the analysis. In addition to a register of complaints, it is also necessary to record any instances of toys placed on the market that are not in conformity with the essential safety requirements, and the corrective measures taken.
Corrective measures
Producers and importers are required to take prompt corrective measures to assure that toys comply with the regulations, whenever they learn of an instance of non-conformity. Oftentimes the only way to eliminate a danger will be to withdraw products from the market and recall them from consumers. If a risk is identified, it is necessary to notify market surveillance authorities and cooperate with them in selecting and implementing the optimal corrective measures.
Sylwia Paszek, Life Science & Regulatory Law practice, Wardyński & Partners
