FCN No. 2001

Innospec Ltd.

According to Section 409(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act, food contact substance notifications (FCNs) are effective only for the listed manufacturer and its customers. Other manufacturers must submit their own FCN for the same food contact substance and intended use.

• Food Contact Substance: A mixture of 1-decene, polymer with sulfur dioxide (CAS Reg. No. 33990-98-6); 1,3-propanediamine, N1-(9Z)-9-octadecen-1-yl-, polymer with 2-(chloromethyl)oxirane (CAS Reg. No. 1010121-89-7); and dodecylbenzenesulfonic acid (CAS Reg. No. 27176-87-0). REPLACES FCN 1819
• Notifier: Innospec Ltd.
• Manufacturer/Supplier: Innospec Ltd.
• Intended Use: As an antistatic agent in the production of polyethylene and polypropylene polymers and copolymers used in food-contact applications.
• Limitations/Specifications:
  1. For use at levels not to exceed 20 parts per million (ppm) in polyethylene and polypropylene polymers and copolymers intended to be used in contact with all food types under all Conditions of Use, except for use in contact with infant formula and human milk.
  2. For use at levels not to exceed 4 parts per million (ppm) in high-density polyethylene and polypropylene polymers and copolymers intended for use in contact with infant formula and human milk under Conditions of Use A through H, as described in Table 2.
• Effective Date: Sep 14, 2019
• National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 568 kB)
• FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 117 kB)

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*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.

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