2026年7月FDA食品接触物质清单（FCS）更新

FCN No

Notifier

Food contact substance

Intended use

Limitations/specifications

2525

Billions Europe Ltd.

Octyltriethoxysilane-modified titanium dioxide

As a pigment for food-contact polymers, except for use in contact with infant formula and human milk (see Limitations/Specifications).

The level of octyltriethoxysilane will not exceed 1.6 percent by weight of the FCS. The FCS will be used at levels not to exceed 25 percent by weight of the food-contact article under Conditions of Use A through H, as described in Table 2. 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.

2519

Advancion Corporation

3-Amino-3-methyl-2-butanol (AMB; CAS Reg. No. 13325-14-9)

As a dispersant for mineral pigment suspensions used as a component of fillers or coatings for paper and paperboard, except for use in contact with infant formula and human milk (see Limitations/Specifications).

The FCS will be used as a component of:

1. coatings at a level not to exceed 0.25% by weight of the mineral pigment

2. fillers at a level not to exceed 0.05% by weight of the mineral pigment.

The finished paper and paperboard may contact all food types under Conditions of Use A through H, and J (microwave-only, excluding susceptor applications).
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.

 2511

Cotek Specialties (Taicang) Co., Ltd.

2-methyl-4-isothiazolin-3-one (CAS Reg. No. 2682-20-4).

As an antimicrobial in uncured liquid rubber latex used to manufacture repeat-use rubber gloves, except for use in contact with infant formula and human milk. (see Limitations/Specifications).

The FCS may be used in contact with all food types. The maximum level of the FCS in latex emulsions is 250 ppm. The FCS is not for use in contact with infant formula and human milk. Such uses were not part of the intended use of the substance in the FCN.

2510

Seta? Kimya Sanayi A.?.

Tricyclodecanedimethanol (CAS Reg. No. 26160-83-8 and 26896-48-0).

As a monomer in the manufacture of (1) polyester or polyester/polyurethane resins for use as components of coatings for use on metal substrates and repeated-use food-contact surfaces, or (2) polyester resins for use in adhesives, except for use in contact with infant formula and human milk (see Limitations/Specifications).

1. The level of the FCS in the final coating may not exceed 46.1 percent by weight. Coatings containing the FCS may contact all food types under Conditions of Use A through H, as described in Tables 1 and 2.

2. Polyester-based adhesives containing the FCS shall comply with 21 CFR 175.105 or 21 CFR 175.125 and will be used at room temperature or below.

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.

2506

Enviro Tech Chemical Services, Inc.

1,3-Dibromo-5,5-dimethylhydantoin (CAS Reg. No. 77-48-5) optionally containing up to 0.5 weight percent 1,3-dibromo-5-ethyl-5-methylhydantoin (CAS Reg. No. 82925-96-0)

As an antimicrobial agent in process water and ice for meat products.

For use at a level not to exceed that needed to provide 900 ppm available bromine in water or ice applied to meat products.

2505

International Flavors & Fragrances

α-1,3-Glucan (CAS Reg. No. 9051-95-0)

1. For use as a base resin or a component of articles and films;

2. as a coating on film (non-paper substrate);

3. as a coating on paper and paperboard; and

4. as a wet strength agent added prior to the sheet forming process in the manufacture of paper and paperboard, except for use in contact with infant formula and human milk (see Limitations/Specifications).

The FCS may be used in single and repeat use applications. The FCS may be used at levels up to 75 g/m2 when used as a coating on paper and paperboard. The FCS may be used as a wet strength agent at levels up to 5% by weight of finished paper and paperboard. The FCS may be used in contact with all food types under Conditions of Use A through H and J, as described in Tables 1 and 2. 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.

2502

Cargill, Incorporated

Fatty acids, C18-unsaturated, dimers, hydrogenated, polymers with hexamethylenediamine (CAS Reg. No. 800392-64-7)

As a processing aid in the production of polyethylene films, except for use in contact with infant formula and human milk (see Limitations/Specifications).

The FCS may be used in food packaging at levels not to exceed 2000 ppm by weight in finished polyethylene films with a thickness not to exceed 6 mil, or at levels not to exceed 1000 ppm by weight in finished polyethylene films with a thickness not to exceed 12 mil, in contact with all food types under Conditions of Use A through H, as described in Tables 1 and 2. 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.