Scope
Commission Regulation (EU) No 10/2011 governs plastic materials and articles intended to come into contact with food. Annex II sets specific migration limits (SML) for metals that may migrate from the plastic into the food it holds. The measured quantity is migration into food (or a food simulant), expressed in mg/kg of food — a different basis from toy-material migration (mg/kg of material) and from total-content limits (mg/kg of article). For infant food-contact articles — bottles, nipples, sippy cups, milk-storage bags, feeding accessories — this is the governing instrument.
Metals with a positive specific migration limit (Annex II point 1)
Values in mg/kg food, current after Regulation (EU) 2016/1416 (aluminium, zinc) and Regulation (EU) 2020/1245 (lanthanides, not-detectable regime).
| Metal | SML (mg/kg food) |
|---|---|
| Aluminium | 1 |
| Antimony | 0.04 |
| Barium | 1 |
| Cobalt | 0.05 |
| Copper | 5 |
| Iron | 48 |
| Lithium | 0.6 |
| Manganese | 0.6 |
| Nickel | 0.02 |
| Zinc | 5 |
| Lanthanides (Eu, Gd, La, Tb — sum) | 0.05 |
Metals with no positive SML — “not detectable” regime (Annex II point 2)
Lead, cadmium, mercury, and arsenic are not authorised substances and have no positive migration limit; their migration must be not detectable, at the detection limits the Regulation states. This is the strictest possible ceiling — below the limit of detection.
| Metal | Treatment | Detection limit (mg/kg food) |
|---|---|---|
| Lead | Not detectable | 0.01 |
| Cadmium | Not detectable | 0.002 |
| Mercury | Not detectable | 0.01 |
| Arsenic | Not detectable | 0.01 |
| Chromium | Not detectable | 0.01 (relaxed to 3.6 for total chromium where documented Cr(VI) exclusion applies) |
How the limits are used in the Heavy Metal Tested & Certified standard
For HMTc Category 9, this Regulation is the governing basis for the food-contact rows (bottles, nipples/spouts, sippy cups, food-storage items, feeding accessories). The certification limit for lead, cadmium, mercury, and total arsenic is the Regulation’s not-detectable ceiling at the stated detection limit; for nickel and aluminium it is the positive SML (0.02 and 1 mg/kg food). Hexavalent chromium is bounded by the not-detectable total-chromium limit. Total-content limits from children’s-product law (US CPSIA, Washington Children’s Safe Product Act) apply in addition, as a separate ceiling in a different basis. Stainless-steel drinkware components are additionally controlled for nickel release under the former EU Nickel Directive 94/27/EC (now REACH Annex XVII entry 27).
Related pages
- Nickel, Aluminum, Lead, Cadmium, Mercury, Total, Arsenic, Total, Chromium
- EU Nickel Directive 94/27/EC
- Bottles (plastic, glass, stainless steel), Bottle nipples and spouts, Sippy cups and toddler drinkware components, Infant food-storage items (milk storage bags/containers), Feeding accessories (spoons, plates, bowls — child-sized)
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