Scope
Directive 2009/48/EC on the safety of toys sets, in Annex II Part III point 13, maximum limits for the migration of chemical elements from toy material into the body when a child mouths, swallows, or contacts a toy. The limits apply to toys and to childcare articles with play value, and via the EN 1400 soother standard they govern the metal safety of pacifiers and teethers. The measured quantity is the migration of a soluble element from the toy material under simulated gastric conditions (0.07 M hydrochloric acid), expressed in mg/kg of toy material, tested by the harmonised standard EN 71-3.
The limits are split into three categories by the physical form of the accessible material, because a child ingests different amounts of each: Category I (dry, brittle, powder-like or pliable material), Category II (liquid or sticky material), and Category III (material that can be scraped off). A solid mouthable article — a pacifier, a teether, a hard-plastic or silicone component — is scraped-off material and is governed by the Category III limits.
Migration limits (current consolidated text, in force 2024)
Values in mg/kg of toy material. Amendments are noted where a value differs from the original 2009 text.
| Element | Category I (dry/brittle/powder/pliable) | Category II (liquid/sticky) | Category III (scraped-off) |
|---|---|---|---|
| Aluminium | 2250 | 560 | 28130 |
| Antimony | 45 | 11.3 | 560 |
| Arsenic | 3.8 | 0.9 | 47 |
| Barium | 1500 | 375 | 18750 |
| Boron | 1200 | 300 | 15000 |
| Cadmium | 1.3 | 0.3 | 17 |
| Chromium (III) | 37.5 | 9.4 | 460 |
| Chromium (VI) | 0.02 | 0.005 | 0.053 |
| Cobalt | 10.5 | 2.6 | 130 |
| Copper | 622.5 | 156 | 7700 |
| Lead | 2.0 | 0.5 | 23 |
| Manganese | 1200 | 300 | 15000 |
| Mercury | 7.5 | 1.9 | 94 |
| Nickel | 75 | 18.8 | 930 |
| Selenium | 37.5 | 9.4 | 460 |
| Strontium | 4500 | 1125 | 56000 |
| Tin | 15000 | 3750 | 180000 |
| Organic tin | 0.9 | 0.2 | 12 |
| Zinc | 3750 | 938 | 46000 |
Amendment history of the amended values
- Cadmium reduced to 1.3 / 0.3 / 17 mg/kg by Commission Directive 2012/7/EU (was 1.9 / 0.5 / 23).
- Lead reduced to 2.0 / 0.5 / 23 mg/kg by Commission Directive (EU) 2017/738 (was 13.5 / 3.4 / 160).
- Chromium (VI) Category III reduced to 0.053 mg/kg by Commission Regulation (EU) 2018/725 (was 0.2); Categories I and II unchanged at 0.02 and 0.005.
- Aluminium reduced to 2250 / 560 / 28130 mg/kg by Commission Directive (EU) 2019/1922 (was 5625 / 1406 / 70000). The superseded 70000 value still circulates on secondary lab pages and must not be used.
- Barium revised to 1500 / 375 / 18750 mg/kg by Commission Regulation (EU) 681/2013.
How the limits are used in the Heavy Metal Tested & Certified standard
For HMTc Category 9 (Infant and Child Contact Products), the Category III scraped-off migration limits are the governing basis for the mouthable-toy rows (pacifiers and sucking/teething aids; teething toys/teethers). The certification limit for each analyte is the strictest value across the comparable migration instruments — this Directive, the US ASTM F963 soluble-migration limits, and the Mexican NOM-252 bioavailable limits — because all three measure acid-soluble migratable element concentration in the same basis. Where a soluble-family instrument is stricter than this Directive (arsenic and mercury, at 25 and 60 mg/kg under ASTM/EN 71-3 versus 47 and 94 here), that stricter value binds. Speciation note: the arsenic and mercury limits here regulate the total element; inorganic arsenic and methylmercury have no migration counterpart.
Related pages
- Lead, Cadmium, Chromium, Arsenic, Total, Mercury, Total, Nickel, Aluminum, Tin
- en-71-3-element-migration
- Pacifiers and sucking/teething aids, Teething toys/teethers
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