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EU standards
type | Test items | Test standard |
rubber
| Full migration Special migration of aromatic amines | AP (2004)4 Rubber |
Nitrosamine and nitroso substance content | ||
Silicone Rubber | Full migration (deionized water, 3% acetic acid, 10% ethanol, olive oil substitute isooctane + 95% ethanol) | AP(2004)5 Silicone Rubber |
American standard
type | Test items | Test standard/test method |
Such as SBS, TPR, TPE, rubber, silicone, etc. | Distilled water extract N-hexane extract | 21CFR 177.2600 |
Silicone sealing ring | Water-extracted chloroform soluble extract Chloroform soluble extract of 8% ethanol extract Chloroform soluble extract extracted by n-heptane | 21CFR 177.1210 Closure with sealing gaskets |
France standard
type | Test items | Test standard |
rubber products | Total migration | Arrêté du 5 août 2020 |
Total volatile organic matter (VOC) | ||
Nitrosamine and nitroso substance content (pacifier) | ||
Migration of nitrosamines and nitroso substances | ||
Primary aromatic amine migration | ||
Total migration amount of primary aromatic amine and secondary aromatic amine | ||
Specific migration of formaldehyde | ||
Total specific migration of formaldehyde and hexamethylenetetramine | ||
POV | ||
Migration of heavy metals (barium, copper, aluminum, zinc) | ||
Heavy metal content (lead, cadmium, arsenic, antimony, mercury) | ||
Silicone products | Full migration | DM-4B-COM-003-v01 |
POV | ||
Total organic matter volatile | ||
Specific migration of organotin in 3% acetic acid |
Germany standard
type | Test items | Test standard |
Rubber, TPR, TPE | Sensory test | LFGB 30&31 |
Full migration | ||
Color migration | ||
Specific migration of primary aromatic amines | ||
Specific migration of nitrosamines | ||
Content of nitrosamines and nitroso substances (only for pacifiers, pacifiers, tooth rings, mouthguards) | ||
Total lead, total cadmium | ||
Silicone Rubber | Sensory test | LFGB 30&31 |
Color migration | ||
Full migration | ||
Peroxide value test | ||
Total organic volatile matter | ||
Total lead and total cadmium |
China standard
type | Test items | Test standard |
Rubber materials and products | Senses Total migration: -10% ethanol, 4% acetic acid 20% ethanol, 50% ethanol Potassium permanganate consumption Heavy metals (calculated as Pb) | GB 4806.11-2016 |
Rubber pacifier | Senses Total migration capacity distilled water, 4% acetic acid, 50% ethanol Potassium permanganate consumption Heavy metals (as lead) Zinc (Zn) migration 2,6-Di-tert-butyl p-cresol migration 2,2’-methylenebis-(4-methyl-6-tert-butylphenol) migration Remarks: The items in this column are only applicable to natural rubber and cis-1,4-polyisoprene rubber pacifiers (that is, latex pacifiers in daily use) N-nitrosamine release N-nitrosamine product release Volatile substances Remarks: The items in this column are only applicable to silicone rubber pacifiers (that is, silicone pacifiers in daily use). " | GB 4806.2-2015 |
The current EU regulation on food contact materials is a reg...
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