A regulatory high-security zone
Toy Safety Directive 2009/48/EC applies to all products intended to be used in play by children under 14. The scoping question is not always trivial — the careful manufacturer assumes that anything attractive to children counts as a toy.
For children under 36 months the strictest requirements apply: no detachable parts smaller than a standard test cylinder, no cords with strangulation risk, particularly strict toxicological material limits.
The EN 71 standards family
EN 71-1 (mechanical and physical properties), EN 71-2 (flammability), EN 71-3 (migration of elements), EN 71-9 (organic chemical compounds) — for any given toy several apply at once.
A complex toy — wooden body with lacquered surface, rubber parts, textile components, plastic elements — has a test programme of 15 to 20 individual tests. Lab selection must align exactly with these requirements.
Chemical requirements
Phthalates (DEHP, DBP, BBP, DIBP, DINP, DIDP, DPHP) limited to 0.1 % by weight in materials that can be placed in the mouth.
EN 71-3 defines migration limits for eight elements — lead, antimony, arsenic, barium, chromium, mercury, selenium, tin — across three material categories (dry/brittle, scrapable, liquid/sticky). The limit varies by category.
The close link between toy law and REACH creates a double requirement. REACH compliance alone is not full toy compliance.
Notified Body and dossier
Self-declaration is possible for most categories where harmonised standards are fully applied. Annex V of the Toy Safety Directive lists the exceptions: chemical toys, activity toys, roller skates and inline skates, certain projectile toys. For these, Notified Body involvement is mandatory.
The technical file contains: full product description with all variants, analysis of all applicable EN 71 parts, all accredited test reports, risk analysis, Declaration of Conformity. Minimum retention: ten years from placing the last product on the market.
Switzerland applies the Toy Ordinance, identical in substance to the EU directive. The MRA enables mutual recognition of conformity assessments by SAS-accredited labs — where the required accreditation scope is in place.
Case: plush toy, small part, EUR 180,000
A German importer of plush toys for children under 36 months. Three years on the market. A parent reports to the authority that a button eye has come loose. The detached part is smaller than the standard EN 71-1 test cylinder. Safety Gate entry. Rewe delists within 48 hours.
Recall of all 12,000 units in trade. Direct damage EUR 180,000. What was missing: EN 71-1 testing specifically for the under-36-month age group. Cost of that testing: under EUR 3,000. Ratio to damage: 1 to 60.