FCN News in July

Aug. 25th, 2016
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According to FDA official website, 3 food contact notifications (FCN) have been approved by FDA in July, and their information is shown in the table below

Notifier

Effective Date

Name of The Substance

Intended Use

Limitations/Specifications

ZEON Corporation
ZEON Chemicals(Thailand) Co., Ltd.

Jul 7,2016

Cyclopentene, polymer with 1-butene, (2E)-2-butene, (2Z)-2-butene, 2-methyl-1-propene, and 1,3-pentadiene

As a component of pressure-sensitive adhesives used as the food-contact surface of labels and/or tapes.

The FCS-containing pressure-sensitive adhesives are applied to food as described in 21 CFR 175.125.

Henkel Adhesive Technologies

Jul20,2016

D-Glucitol, 1-deoxy-1-(methylamino)-, reaction products with 4-ethenylphenol homopolymer and formaldehyde, 1-hydroxyethylidene-1,1-diphosphonic acid, manganous oxide, phosphate, fluorotitanic and fluorozirconic salts. REPLACES FCN 1472

For use as a stabilizer to prevent oxidation of tinplated steel containers (cans) with or without a polymeric topcoat, except for use in contact with liquid infant formula and breast milk.

The maximum coating weight is 20 mg/m2 (dry basis). The finished steel may be used in contact with: (1) all foods as described in Table 1, under Conditions of Use A through H as described in Table 2; (2) powdered infant formula under Conditions of Use E through G as described in Table 2. The FCS is not for use in contact with liquid infant formula and breast milk. Such uses were not included as part of the intended use of the substance in the FCN.

Notifier

Effective Date

Name of The Substance

Intended Use

Limitations/Specifications

Chitec Technology Co., Ltd.

Jul29,2016

Amines, bis(hydrogenated palm-oil alkyl)hydroxy (CAS Reg. No. 1374859-51-4).

For use as an antioxidant to stabilize polypropylene (PP) polymers complying with 21 CFR 177.1520(c) as well as high density polyethylene polymers (HDPE) and copolymers complying with 21 CFR 177.1520(c); intended for single and repeat food contact use, except for use in contact with infant formula and breast milk (see Limitations/Specifications).

1. At levels not to exceed 0.1 percent by weight of PP polymers complying with 21 CFR 177.1520(c), item 1.1, 1.2, 1.3, 3.1a (with a density of 0.85-0.91 gram per cubic centimeter), 3.2b, and 3.4. The finished polymers may be used in contact with:
(a) food types I, II, IV-B, VI-A, VI-B, VII-B and VIII under Conditions of Use A through H and,
(b) types III, IV-A, V, VI-C, VII-A, and IX under Conditions of Use B through H.
2. At levels not to exceed 0.1 percent by weight of PP polymers complying with 21 CFR 177.1520(c), item 3.5. The finished polymers may be used in contact with food types I, II, IV-B, VI, VII-B and VIII described under Condition of Use D through H.
3. At levels not to exceed 0.1 percent by weight of HDPE polymers and copolymers complying with 21 CFR 177.1520(c), item 2.1, 2.3, 3.1a, 3.1b, 3.6 (with a density not less than 0.94 gram per cubic centimeter) and 5. The finished polymers may be used in contact with:
(a) food types I, II, IV-B, VI-A, VI-B, VII-B and VIII under Conditions of Use A through H, and
(b) food types III, IV-A, V, VI-C, VII-A, and IX under Conditions of Use B through H.