Importing Toys from China: Directive 2009/48 and Standard EN 71

Directive 2009/48/EC, adopted on 18 June 2009, governs toy safety in the European Union. It replaces Directive 88/378/EEC and covers any product designed or intended to be used in play by children under 14. The manufacturer, meaning the factory, bears responsibility for compliance. If it is established outside the Union, the importer takes on its own obligations: checking the CE marking, ensuring the technical file exists and supplying instructions. Since 13 December 2024, Regulation (EU) 2023/988 also requires that an economic operator established in the Union be responsible for the product.

In practice, you must have a safety assessment carried out before placing on the market, a technical file, an EC declaration of conformity and CE marking affixed to the product. The manufacturer keeps these records for ten years after placing on the market. Warnings, such as "Not suitable for children under 36 months", must be written in the language(s) required by the country of sale. In France, that is French. The name and address of the manufacturer, then of the importer, must appear on the toy or its packaging.

The EN 71 series brings together the harmonised European standards applicable to toys. The directive does not name them specifically, but applying them creates a presumption of conformity. In practice, importers follow this route. Three parts form the core: EN 71-1, EN 71-2 and EN 71-3.

The other parts cover specific product families. Chemistry sets fall under EN 71-4 and EN 71-5, finger paints under EN 71-7. Part 12 limits nitrosamines in toys for under-36-months and those intended to be put in the mouth. Electric toys combine EN 71-14 and standard EN IEC 62115. Parts 9 to 11, devoted to organic compounds, have never been harmonised at European level.

For most toys, the directive allows self-assessment. The manufacturer applies the harmonised standards, compiles its file and affixes the CE marking without going through a third party. This regime, called internal production control, is the general-law regime. It exempts no one from proof: market surveillance authorities can request test reports at any time.

Some categories are exempt from self-assessment. For toys intended for children under 36 months, for those intended to be put in the mouth, for chemistry sets and for toys containing hazardous substances or mixtures, the directive requires an EC type-examination carried out by a notified body. Production must then match the examined type. Baby plush toys, teething rings, developmental toys: this step through a third party should be planned from the outset, in both budget and schedule.

A Chinese factory generally tests its products against the national GB 6675 standard, which does not cover European requirements. EN 71 compliance must therefore be requested explicitly and included in the specification. Many factories subcontract these tests to laboratories present in China. You can also send your samples directly to an accredited laboratory, which keeps you in control of the report.

The cost depends on the number of materials and colours: each material may require separate tests. Budget a few hundred to a few thousand euros and several weeks' lead time for a complete toy. These costs weigh at the outset, then even out over the product's lifetime.

CE marking must be affixed to the toy, or failing that to its packaging, visibly, legibly and indelibly. It attests to regulatory compliance, not a quality level, and it binds whoever affixes it. Before releasing the balance payment, check its presence and appearance on actual production, not just on the sample.

The EN 71 standard does not cover everything. The REACH Regulation (EC) No 1907/2006 adds chemical restrictions, notably on phthalates in plasticised materials. In the event of non-compliance, customs can refuse release for free circulation and authorities can order a withdrawal or recall. Toys are among the products regularly flagged on Safety Gate, the Union's rapid alert system.

Sorva is a brokerage and sourcing house working between Europe and China. Our Chinese-speaking team in Guangzhou negotiates your toys with factories, writes the compliance requirement into the specification and has the EN 71 tests, marking and documentation written into the proforma, before any deposit. We check the authenticity of the reports supplied, order a regulatory compliance study when needed and organize the pre-shipment inspection to compare production against the reference sample.

In most cases, you pay no fees: you open a file, we negotiate the goods for you, and we take a commission on their ex-factory value.