EN 71: toy safety in the European Union
Guide · EU toys
Toys placed on the European Union market fall under Directive 2009/48/EC, the Toy Safety Directive (TSD), which makes CE marking mandatory and sets in Annex II a body of essential safety requirements (mechanical, flammability, chemical, electrical, hygiene, radioactivity). Presumption of conformity is obtained by applying the harmonised EN 71 series, supplemented by EN 62115 for electric toys. This page covers the directive's scope, the structure of the EN 71 series part by part, the detail of EN 71-3 on migration of 19 elements, the adjacent texts (RoHS, REACH, EMC, RED for connected toys), marking and traceability, and the cases that trigger Notified Body involvement.
Scope of Directive 2009/48/EC
Section titled “Scope of Directive 2009/48/EC”Article 2 defines a toy as a product designed or intended, whether or not exclusively, for use in play by children under 14 years of age. The intended-use criterion prevails over the commercial one: a product marketed as decoration but obviously intended for play (plush toys sold in pharmacies, figurines given out by fast-food chains) falls in scope.
Annex I lists 19 categories of product that look like toys but are not toys for the purposes of the directive. The most useful to know during product framing:
- public playground equipment for collective use (covered by EN 1176);
- sports equipment and sport bicycles (excluding small learner bikes);
- faithful replicas of firearms;
- puzzles of more than 500 pieces;
- precision scale models for adult collectors, clearly labelled as such;
- festive decorations and professional fashion items;
- aquatic equipment intended for use in deep water;
- video games, books, school badges;
- educational construction kits aimed at advanced teenagers (under conditions).
This filter is the first step in product framing. A product that is not a toy may still fall under another directive (playground equipment under EN 1176, PPE under 2016/425, and others) but falls outside 2009/48/EC.
How the directive and the EN 71 series fit together
Section titled “How the directive and the EN 71 series fit together”Directive 2009/48/EC sets essential requirements in Annex II across eight families:
| Annex II part | Essential requirement |
|---|---|
| I | Physical and mechanical properties |
| II | Flammability |
| III | Chemical properties |
| IV | Electrical properties |
| V | Hygiene |
| VI | Radioactivity |
| VII (Annex V) | Warnings |
| VIII (article 11) | Specific requirements for toys intended for use in water |
The harmonised EN 71 standards spell out the test methods and thresholds that demonstrate conformity with those requirements. A harmonised standard cited in the Official Journal of the European Union carries presumption of conformity for the essential requirement it covers, within the scope of the standard. For electrical requirements (Annex II part IV), the reference standard is not in the EN 71 series but is named EN 62115.
EN 71 series at a glance
Section titled “EN 71 series at a glance”Fourteen main parts, each dedicated to one risk family or to a category of toy.
| Part | Scope | Method |
|---|---|---|
| EN 71-1 | Mechanical and physical properties | Small parts, sharp edges, projectiles, choking hazards, ride-ons, toys for children under 36 months |
| EN 71-2 | Flammability | Fire behaviour of the material, propagation speed, set-back distance for headgear and disguises |
| EN 71-3 | Migration of certain elements | 19 elements, three material categories, dosing in an acid simulating gastric fluid |
| EN 71-4 | Experimental sets for chemistry and related activities | Specification of substances, maximum dose, instructions and safety data sheet |
| EN 71-5 | Chemical toys other than experimental sets | Modelling pastes, non-finger paints, casting kits |
| EN 71-6 | Graphical symbol for age warning | The crossed-out 0-3 years pictogram, dimensions and legibility |
| EN 71-7 | Finger paints | Requirements and test methods specific to finger paints |
| EN 71-8 | Activity toys for domestic use | Slides, swings, playframes for private use |
| EN 71-9 | Organic chemical compounds, requirements | Migration limits for solvents, monomers, preservatives |
| EN 71-10 | Organic chemical compounds, sample preparation | Extraction and preparation procedures |
| EN 71-11 | Organic chemical compounds, analytical methods | Chromatography, spectrometry, quantification |
| EN 71-12 | N-nitrosamines and N-nitrosatable substances | Elastomers in mouth contact (toy teats, balloons) |
| EN 71-13 | Olfactory games, cosmetic kits, gustative games | Ingredient safety, labelling, doses |
| EN 71-14 | Trampolines for domestic use | Construction, stability, fall height, safety net |
The exact list of versions cited in the OJEU evolves by Commission implementing decision. The reflex to keep is to verify the in-force version at the time of the EU declaration of conformity (DoC), via the Commission's consolidated page or EUR-Lex.
EN 71-3: migration of 19 elements
Section titled “EN 71-3: migration of 19 elements”EN 71-3 is the most discussed part in practice because it drives raw-material selection (plastics, paints, inks, textiles, metal alloys) and is the subject of systematic analytical testing.
Test principle
Section titled “Test principle”The test simulates contact between a child and the toy by mouthing or ingestion. A sample is immersed in a hydrochloric acid solution simulating gastric juice for a defined duration, at 37 degrees C. The concentration of released elements is then measured by spectrometry (most often ICP-MS). The result is compared with a limit expressed in mg of migration per kg of material.
Three material categories
Section titled “Three material categories”Annex II Part III point 13 of the directive distinguishes three material categories, with different limits because the plausible ingested quantity differs.
| Category | Description | Examples |
|---|---|---|
| Category 1 | Dry, brittle, powder-like or pliable material | Chalk, hard modelling clay, wooden toys, dry paints |
| Category 2 | Liquid or sticky material | Liquid paints, inks, slime, finger paints |
| Category 3 | Scraped-off material | Scraped film from a surface coating |
The category 2 (liquid) migration limits are roughly four times lower than category 1 (dry), and category 3 (scraped) limits roughly fifty times lower, because the exposure per cm-squared is very different.
The 19 elements in scope
Section titled “The 19 elements in scope”| Element | Form(s) | Why it is in scope |
|---|---|---|
| Aluminium | Al | Found in pigments, additives, alloys |
| Antimony | Sb | Flame retardant, catalyst in PET |
| Arsenic | As | Known carcinogen, old pigments |
| Barium | Ba | Pigments (yellow, white), PVC stabilisers |
| Boron | B | Borax, slime, fluxes |
| Cadmium | Cd | Red and yellow pigments, PVC stabilisers |
| Chromium (III) | Cr(III) | Leather tanning, green pigments |
| Chromium (VI) | Cr(VI) | Carcinogen, anti-corrosion treatments |
| Cobalt | Co | Blue pigments, inks |
| Copper | Cu | Alloys (brass, bronze), pigments |
| Lead | Pb | Old paints, PVC stabilisers, solder |
| Manganese | Mn | Pigments, steel alloys |
| Mercury | Hg | Preservatives, old fungicides |
| Nickel | Ni | Skin allergen, alloys |
| Selenium | Se | Deep red pigments, semiconductors |
| Strontium | Sr | Pigments, alloys |
| Tin (total) | Sn | Solder, alloys, PVC stabilisers |
| Tin (organic) | organotin compounds | Biocides, PVC stabilisers, neurotoxic |
| Zinc | Zn | Pigments, alloys, galvanising |
Numerical migration values (in mg/kg of material) are set in Annex II Part III point 13 of 2009/48/EC, as a three-column table (category 1, 2, 3). The values have been revised by successive delegated acts (notably for lead, chromium VI, aluminium, cobalt), and the consolidated table must be read on the EUR-Lex consolidated version at the date of assessment.
By way of example, lead's category 1 limit went from 13.5 mg/kg in the original 2009 text to 2.0 mg/kg under Commission Delegated Regulation (EU) 2017/738. The EUR-Lex consolidation is the only enforceable document.
Three uses of the table
Section titled “Three uses of the table”| Use | Who does it |
|---|---|
| Specify raw materials upstream | Design office, material supplier, manufacturer |
| Validate a batch via accredited laboratory testing | Test laboratory, manufacturer |
| Document the technical file and the DoC | Manufacturer, importer |
For the structure of the technical file and the EU declaration of conformity that apply to a toy, see the CE technical file and the CE procedure, which still apply here (2009/48/EC sits within the new legislative framework).
Flammability (EN 71-2)
Section titled “Flammability (EN 71-2)”EN 71-2 covers the fire behaviour of the materials used in toys and sets thresholds on flame propagation speed. The categories warranting the closest attention:
- disguises and headgear likely to be worn near candles (with a maximum propagation speed specified);
- plush toys, whose long pile presents a fast-spread risk;
- play tents and igloos, whose walls must be self-extinguishing;
- masks in foam or cellulose, worn close to the face.
The standard explicitly excludes materials that are non-flammable by nature (metals, ceramics, glass). The relevant test methods include a vertical flame test, a surface flash test for raised-pile materials, and a propagation test on textile samples cut to fixed dimensions. Results are compared to the burning rate ceilings set in EN 71-2 for the category at hand. A common failure mode on cheap costume textiles is exceeding the burning rate on the surface flash test, which can be remedied by treating the fabric or by changing the fibre blend.
Electrical requirements (EN 62115)
Section titled “Electrical requirements (EN 62115)”Toys powered by battery, accumulator or an external transformer fall under Annex II part IV (electrical properties) of the directive. The associated harmonised standard is EN 62115 (formerly EN 50088), not a part of the EN 71 series.
EN 62115 covers:
- insulation and dielectric strength;
- temperature rise in normal and fault conditions;
- mechanical strength of connectors;
- prevention of tipping and entrapment;
- battery safety (accessibility, polarity, short circuit).
The Low Voltage Directive (LVD) 2014/35/EU does not apply to the toy itself when its internal supply stays below 75 V DC or 50 V AC, which covers nearly all battery-powered toys. The external transformer, on the other hand, falls under the LVD and the harmonised standard EN 61558-2-7 (safety isolating transformers for toys).
EMC and radio (electronic and connected toys)
Section titled “EMC and radio (electronic and connected toys)”Every toy containing an active electronic circuit is subject to the EMC Directive 2014/30/EU. The generic harmonised standards (EN 55014-1 for emissions, EN 55014-2 for immunity, both for household and similar appliances including toys) apply first.
If the toy embeds a radio transmitter (Wi-Fi, Bluetooth, BLE, Thread, sub-GHz, active NFC), the applicable directive shifts to the Radio Equipment Directive 2014/53/EU, which then covers EMC (article 3.1(b)), spectrum (article 3.2) and cybersecurity (article 3.3, applicable since 1 August 2025). See the RED procedure and the RED harmonised standards table for radio-technology-driven standards selection.
Connected toys and RED article 3.3
Section titled “Connected toys and RED article 3.3”Since 1 August 2025, sub-articles 3.3(d) network protection, 3.3(e) personal data protection and 3.3(f) fraud protection are activated for radio equipment capable of exchanging data. Connected toys (interactive plush toys with voice recognition, educational robots, kids' smart watches with a radio module) fall in scope.
Harmonised standards:
- EN 18031-1 for 3.3(d), network resource protection;
- EN 18031-2 for 3.3(e), personal data protection (particularly relevant to a toy collecting voice, images or a user account);
- EN 18031-3 for 3.3(f), financial fraud protection (less common on a toy, except where the toy supports in-app purchases).
See the RED scope page for the decision grid between RED and EMC-only framing.
RoHS and REACH
Section titled “RoHS and REACH”RoHS 2011/65/EU
Section titled “RoHS 2011/65/EU”The RoHS 2 directive covers electrical and electronic equipment placed on the EU market and applies without ambiguity to electronic toys (category 7 of Annex I, "toys, leisure and sports equipment"). It restricts ten substances against a threshold expressed at the homogeneous material level, distinct from the EN 71-3 migration concept.
| Substance | Limit (% by mass, homogeneous material) |
|---|---|
| Lead | 0.1 |
| Mercury | 0.1 |
| Cadmium | 0.01 |
| Hexavalent chromium | 0.1 |
| PBB (polybrominated biphenyls) | 0.1 |
| PBDE (polybrominated diphenyl ethers) | 0.1 |
| DEHP (phthalate) | 0.1 |
| BBP (phthalate) | 0.1 |
| DBP (phthalate) | 0.1 |
| DIBP (phthalate) | 0.1 |
The four phthalates were added in 2015 (delegated act 2015/863) and have applied to toys and electronics since 22 July 2019. The thresholds are expressed per homogeneous material, that is a material that cannot be mechanically separated without being destroyed (a cable is an assembly of several homogeneous materials: copper core, PVC insulation, outer jacket, each subject to its own limit).
REACH (Regulation 1907/2006)
Section titled “REACH (Regulation 1907/2006)”The REACH regulation applies to every chemical substance produced or imported above 1 tonne per year. The opposable items for toy manufacturers:
- substances of very high concern (SVHC) on the candidate list (article 33), to be communicated within articles when present above 0.1 % by mass;
- Annex XVII restrictions, the best-known of which for toys covers six phthalates (DEHP, BBP, DBP, DINP, DIDP, DNOP) at 0.1 % by mass, with a stricter regime for toys or childcare articles likely to be placed in the mouth;
- restrictions on PAHs (polycyclic aromatic hydrocarbons) in rubbers and plastics with prolonged skin or mouth contact;
- restrictions on certain azo dyes in textiles, for example plush toys.
REACH sits alongside EN 71-3 rather than replacing it: the same toy must meet both EN 71-3 migration limits (what is released by oral contact) and REACH Annex XVII thresholds (what is present in the material).
Marking and traceability
Section titled “Marking and traceability”Article 17 of the directive mandates the CE marking, visible, legible and indelible, on the toy or, where technically impossible, on the packaging and the instructions. The minimum CE height is 5 mm unless a specific derogation applies.
The traceability information (article 4 for the manufacturer, article 6 for the importer) includes:
- name, registered trade name or registered trade mark;
- a single postal address at which the manufacturer can be contacted in the Union;
- type, batch or serial number, or any other element of identification;
- model number.
The warnings set in Annex V of the directive must be visible, legible and easily understandable in the language of the Member State of placing on the market. The crossed-out 0 to 3 years pictogram, standardised in EN 71-6, is mandatory for toys not intended for children under 36 months but that could appear attractive to them and present a risk (small parts, sharp points, and so on).
Mandatory warnings by toy type
Section titled “Mandatory warnings by toy type”| Type | Warning (Annex V part B) |
|---|---|
| Not for children under 36 months | Crossed-out 0-3 pictogram + statement of the risk (for example small parts) |
| Aquatic toys | "Warning. Only to be used in water in which the child is within its depth and under supervision." |
| Functional toys | "Warning. To be used under the direct supervision of an adult." |
| Chemical toys | "Warning. Only for children aged over [age]. To be used under adult supervision." |
| Skates, skateboards | "Warning. Protective equipment should be worn." |
| Toys inside food | "Warning. Toy inside. Adult supervision recommended." |
| Trampolines for domestic use | "Warning. For use by one child at a time. Somersaulting is dangerous." |
Conformity assessment procedure
Section titled “Conformity assessment procedure”Article 19 of 2009/48/EC draws two assessment modules from Decision 768/2008/EC.
| Case | Module | Notified Body |
|---|---|---|
| All Annex II essential requirements are covered by harmonised standards and the manufacturer applies them in full | Module A (internal production control, Annex II of 2009/48/EC) | Not required |
| At least one essential requirement is not covered by a harmonised standard, or the manufacturer applies them only in part | Module B (EU-type examination, Annex IV of 2009/48/EC) + internal follow-up | Yes |
EU-type examination involves submitting the technical file and a representative sample to a Notified Body, which verifies conformity with the essential requirements and issues an EU-type examination certificate. The Commission's NANDO database lists Notified Bodies for 2009/48/EC. The general module mechanics are explained in self-declaration vs Notified Body.
In practice, module B is triggered fairly often on innovative toys. Examples of situations where no fully covering harmonised standard exists:
- a new sensor or actuator type embedded in a soft toy (haptic feedback, microfluidic);
- a magnetic toy with unusually high pull force, where EN 71-1 small-magnet provisions need a complementary assessment;
- a chemistry kit that goes beyond the substance list in EN 71-4 or uses preparations not yet referenced;
- a connected toy whose radio link uses a technology not yet covered by a harmonised RED test standard.
In those cases, the Notified Body fills the standardisation gap with a custom assessment, often citing IEC, ISO or national standards as an alternative route to conformity.
Common pitfalls
Section titled “Common pitfalls”| Pitfall | Consequence |
|---|---|
| Assuming an "adult collector" product without a clear label escapes 2009/48/EC | Possible requalification as a toy by market surveillance, recall |
| Applying EN 71-3 without checking the consolidated limits in Annex II Part III point 13 | Conformity based on outdated values (the lead case, lowered to 2.0 mg/kg in 2017) |
| Confusing RoHS limits (homogeneous material) with EN 71-3 limits (migration into simulant) | Material specification miscalibrated, test failure |
| Omitting the crossed-out 0-3 warning on a product attractive to young children | Formal non-conformity, market surveillance finding, recall |
| Treating the LVD as applicable to a battery-powered toy | Useless over-specification; conversely, missing the LVD on the external transformer |
| Treating a connected toy under EMC only | RED framing missed, article 3.3 absent from the file since August 2025 |
| Skipping the REACH article 33 declaration for SVHC above 0.1 % | Liability on consumer report, ECHA may be involved |
| Mixing the EN 71-1 version cited in the OJEU with a later non-yet-harmonised version | Presumption of conformity invalid until the new version is cited |
Further reading
Section titled “Further reading”- CE procedure: assessment modules and placing on the market, common ground with 2009/48/EC
- Scope of CE directives: identifying applicable directives, including the Toy Safety Directive
- CE technical file: general structure applicable to a toy file
- CE harmonised standards: mechanics of the presumption of conformity
- RED procedure: framing connected toys
- RED harmonised standards: picking 3.3(d), (e), (f) standards for a connected toy
- Self-declaration vs Notified Body: decision grid for module A vs B
- Glossary: definitions for Toy Safety Directive, EN 71-3, SVHC, RoHS, RED 3.3
Sources & references
- Directive 2009/48/EC on the safety of toys , EUR-Lex eur-lex.europa.eu/eli/dir/2009/48/oj
- European Commission page, toy safety , European Commission single-market-economy.ec.europa.eu/sectors/toys_en
- List of harmonised standards under 2009/48/EC (implementing decision) , European Commission single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/toys_en
- CEN, technical committee CEN/TC 52 (safety of toys) , CEN www.cen.eu/
- Directive 2011/65/EU (RoHS 2) , EUR-Lex eur-lex.europa.eu/eli/dir/2011/65/oj
- Regulation (EC) No 1907/2006 (REACH) , EUR-Lex eur-lex.europa.eu/eli/reg/2006/1907/oj