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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications

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FCN No. 2475

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 2001
Notifier: Innospec Ltd.
Manufacturer/Supplier: Innospec Ltd.
Intended Use:
  1. As an antistatic agent in the production of polyethylene and polypropylene polymers and copolymers used in food-contact applications, including use in contact with infant formula and human milk.
  2. As an antistatic agent in the production of high-density polyethylene polymers used in repeat-use food-contact applications, except for use in contact with infant formula and human milk.
Limitations/Specifications:
  1. For use at levels not to exceed 12 parts per million (ppm) in articles in contact with infant formula and human milk under Conditions of Use A through H, as described in Table 2; and for use at levels not to exceed 60 parts per million (ppm) in articles in contact with all other food types under Conditions of Use A through H, as described in Tables 1 and 2.
  2. For use at levels not to exceed 280 parts per million (ppm) at a maximum use temperature of 175°C in repeat-use articles in contact with all food types, except for use in contact with infant formula and human milk.
The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Feb 7, 2026
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)
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