FCN No. 1733

LANXESS Corporation

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: 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 2682-20-4).
• Notifier: LANXESS Corporation
• Manufacturer/Supplier: LANXESS Corporation
• Intended Use: As:
  1. a preservative in aqueous formulations of adhesives that will be used under use conditions defined in 21 CFR 175.105;
  2. a preservative in aqueous coating formulations to be used on paper under use conditions defined in 21 CFR 176.170;
  3. a preservative in aqueous additive formulations (latex emulsions, fillers, binders, pigment slurries, and sizing solutions) used in paper and paperboard manufacturing to produce paper in compliance with 21 CFR 176.170 and 176.180; and
  4. as a slimicide in the wet end of paper manufacturing to produce paper in compliance with 21 CFR 176.170 and 176.180.
  The FCS is not for use in contact with infant formula and human milk (see Limitations/Specifications).
• Limitations/Specifications: The FCS may be used in contact with all food types under Conditions of Use A through H, as described in Table 2. The maximum level of the FCS:
  1. in adhesives is 150 ppm;
  2. in paper coating formulations is 150 ppm, with the exception of latex coatings where the maximum level is 250 ppm;
  3. in aqueous additive formulations for use in paper is 150 ppm;
  4. as a slimicide used in the wet end of paper manufacture is 150 ppm in the process water.
  The FCS is not for use in contact with infant formula or human milk. Such uses were not included as part of the intended use of the substance in the FCN.
• Effective Date: Jul 7, 2017
• National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 601 kB)
• FDA Decision: Finding of No Significant Impact (FONSI) and EA Revision Sheet

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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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