FCN No. 2419
Dalian Bio-Chem Company Ltd.
Bester Trading Co., 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: |
2-Methyl-4-isothiazolin-3-one (CAS Reg. No. 2682-20-4)
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| Notifier: |
Dalian Bio-Chem Company Ltd.
Bester Trading Co., Ltd.
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| Manufacturer/Supplier: |
Dalian Bio-Chem Company Ltd.
Bester Trading Co., Ltd.
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| Intended Use: |
As:- an antimicrobial in uncured liquid rubber latex used to manufacture repeat-use rubber gloves.
- a preservative in coatings that comply with 21 CFR 175.300 and 175.320.
- a preservative in can-end and side-seam cements that comply with 21 CFR 175.300.
- a preservative in aqueous formulations of adhesives that will be used under use conditions defined in 21 CFR 175.105.
- a preservative in aqueous coating formulations to be used on paper under use conditions defined in 21 CFR 176.170.
- 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.
- 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).
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| Limitations/Specifications: |
The FCS may be used in contact with all food types. The intended uses 2 through 6 may be used under Conditions of Use A through H, as described in Tables 1 and 2. The maximum level of the FCS:- in latex emulsions for the manufacture of repeat-use gloves is 250 ppm;
- in aqueous emulsions for can coatings or polymeric coatings on polyolefin film is 100 ppm;>/li>
- in aqueous emulsions of can-end or side-seam cement is 150 ppm;
- in adhesives is 150 ppm;
- in paper coating formulations is 150 ppm, with the exception of latex emulsions in paper coatings, where the maximum level is 250 ppm;
- in aqueous additive formulations for use in paper is 150 ppm; and
- in the wet-end process water of paper manufacture is 150 ppm of dry weight fiber.
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.
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| Effective Date: |
May 24, 2025
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| National Environmental Policy Act (NEPA)** Submission: |
Environmental Assessment (in PDF, 261 kB)
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| FDA Decision: |
Finding of No Significant Impact (FONSI) (in PDF, 261 kB)
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