Nylon-MXD6 FDA Information

FDA Status

The FDA has approved the use of Nylon-MXD6 for direct and indirect food packaging applications, subject to certain limitations. Please refer to 21 CFR (Code of Federal Regulations), for details and exact information.

a) For direct contact applications to food
177.1500 (a) (10) (ii), (b) 10.1
177.1630 (e) (4) (v), as a modifier of PET

b) For indirect contact applications to food
177.1390 (c) (1) (i) (e)
177.1500 (b) 10.3
"no objection letter" for PET/Nylon-MXD6 multilayer bottles, where PET is the food contact surface

European Regulation Status

Nylon-MXD6, which is a polymer of 1,3-benzenedimethanamine (metaxylenediamine, MXDA) and adipic acid, meets the directive of Commission of European Communities, Directive 90/128/EEC, concerning the plastics materials and articles intended to come into contact with foodstuffs.
1,3-benzenedimethanamine and adipic acid are listed in section A of the monomer list of EEC directive. PM/REF No. of these monomers are 12130 and 13000.
1,3-benzenedimethanamine is restricted with Specific Migration Limit (SML) in food or in food simulant, and the SML is 0.05 mg/kg.

For your information, the monomer contents in Nylon-MXD6 monolayer films and food simulating solvent in out laboratory are shown below:

Content of MXDA in Nylon-MXD6
Content of adipic acid in Nylon-MXD6 less than 1 ppm (detected value: 0.25ppm)
less than 100ppm (detected value: 60ppm)

According to these results, the migration of MDXA in food or food simulant thought to be lower than 0.05 mg/kg in practical use. This results, however, are no guarantee that the final product using Nylon-MXD6 meets the EEC directive. The final product should be checked my the manufacturer of the product.

Japanese Regualtion Status

In Japan, the standards of equiptment and packaging for food are regulated in Japanese food sanitaion law. Concerning this law, Ministry of Health and Welfare notification No.20 regulates the standards of materials for packaging practically. Nylon-MXD6 meets general standards for nylon plastics regulated in the notification. The general standards regulate the extractives of heavy metals from the packaging material. The standards for nylon plastics regualte the extractive of nonvolatiles and caprolactam in various conditions.

The extractives from Nylon-MXD6 produced by Mitsubishi Gas Chemical Comapny have been confirmed to be lower than these standards in each condition regulated in the notification, by Japan Food Research Laboratories who authorized by the Japanese government. Therefor, we think that Nylon-MXD6 manufactured by Mitsubishi Gas Chemical Comapny is suitable for food packaging in Japan.


FDA Status The FDA has approved the use of Nylon-MXD6 for direct and indirect food packaging applications, subject to certain limitations. Please refer to 21 CFR (Code of Federal Regulations), for details and exact information. a) For direct contact applications to food 177.1500 (a) (10) (ii), (b) 10.1 177.1630 (e) (4) (v), as a modifier of PET b) For indirect contact applications to food 177.1390 (c) (1) (i) (e) 177.1500 (b) 10.3 "no objection letter" for PET/Nylon-MXD6 multilayer bottles, where PET is the food contact surface
European Regulation Status Nylon-MXD6, which is a polymer of 1,3-benzenedimethanamine (metaxylenediamine, MXDA) and adipic acid, meets the directive of Commission of European Communities, Directive 90/128/EEC, concerning the plastics materials and articles intended to come into contact with foodstuffs. 1,3-benzenedimethanamine and adipic acid are listed in section A of the monomer list of EEC directive. PM/REF No. of these monomers are 12130 and 13000. 1,3-benzenedimethanamine is restricted with Specific Migration Limit (SML) in food or in food simulant, and the SML is 0.05 mg/kg. For your information, the monomer contents in Nylon-MXD6 monolayer films and food simulating solvent in out laboratory are shown below:
	Content of MXDA in Nylon-MXD6 Content of adipic acid in Nylon-MXD6	less than 1 ppm (detected value: 0.25ppm) less than 100ppm (detected value: 60ppm)
According to these results, the migration of MDXA in food or food simulant thought to be lower than 0.05 mg/kg in practical use. This results, however, are no guarantee that the final product using Nylon-MXD6 meets the EEC directive. The final product should be checked my the manufacturer of the product.
Japanese Regualtion Status In Japan, the standards of equiptment and packaging for food are regulated in Japanese food sanitaion law. Concerning this law, Ministry of Health and Welfare notification No.20 regulates the standards of materials for packaging practically. Nylon-MXD6 meets general standards for nylon plastics regulated in the notification. The general standards regulate the extractives of heavy metals from the packaging material. The standards for nylon plastics regualte the extractive of nonvolatiles and caprolactam in various conditions. The extractives from Nylon-MXD6 produced by Mitsubishi Gas Chemical Comapny have been confirmed to be lower than these standards in each condition regulated in the notification, by Japan Food Research Laboratories who authorized by the Japanese government. Therefor, we think that Nylon-MXD6 manufactured by Mitsubishi Gas Chemical Comapny is suitable for food packaging in Japan.