Food Contact Notification(FCN) News in May

Jun. 19th, 2017
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According to FDA official website, 6 food contact notifications (FCN) have been approved by FDA in May, and their information is shown in the table below:

Notifier

Effective Date

Name of The Substance

Intended Use

Limitations/Specifications

Zhejiang Transfar Whyyon Chemical Co. Ltd.

May 3, 2017

Benzenesulfonic acid, 2,2′-(1,2-ethenediyl)bis(5-((4-(bis(2-hydroxyethyl)amino)-6-((4-sulfophenyl)amino)-1,3,5-triazin-2-yl)amino)-, tetrasodium salt (CAS Reg. No. 16470-24-9).

As an optical brightener in paper and paperboard, except for use in contact with infant formula and human milk (see Limitations/Specifications).

For use in paper and paperboard complying with 21 CFR 176.170 in contact with all food types at levels not to exceed that necessary to achieve the desired technical effect, except for the following:

When the substance is used in uncoated paper and paperboard intended for contact with Food Types I, II, IV-B, VI and VII-B, the brightener is limited to use at levels not to exceed 0.5 pound per ton of paper; and

When the substance is used in clay coatings for paper and paperboard intended for use in contact with Food Types I, II, IV-B, VI and VII-B, the brightener is limited to use at levels not to exceed 0.25 pound per ton of coated paper.

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.

Kuraray Company, Ltd.

May 5, 2017

2-Methylene-1,3-propanediol (MPDiol) modified ethylene-vinyl alcohol (EVOH) copolymers (CAS Reg. No. 1485481-35-3).

As a component of films, bottles, and molded articles that contact food, except for use in contact with infant formula and human milk (see Limitations/Specifications).

The FCS may contain up to 3 mole percent of MPDiol. The finished food-contact article containing the FCS may contact all food types 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.

Pure Bioscience, Inc.

May 18, 2017

A solution of silver dihydrogen citrate stabilized with sodium lauryl sulfate and citric acid.

As an antimicrobial solution applied by spray or dip to reduce the pathogen populations on poultry carcasses, parts, and organs. (See Limitations/Specifications).

For use at levels up to 160 ppm silver dihydrogen citrate (as silver) in the spray or dip applied to poultry carcasses parts and organs. The FCS is not for use in combination with any other silver containing antimicrobial and is not intended to be used in chiller baths.

Dover Chemical Corporation

May 24, 2017

Phosphorous acid, triphenyl ester, polymer with α-hydro-ω-hydroxypoly[oxy(methyl-1,2-ethanediyl)], C10-16 alkyl esters (CAS Reg. No. 1227937-46-3)

As a thermal stabilizer in polymeric food contact articles. The FCS is not intended for use in substances in contact with infant formula and human milk (see Limitations/Specifications).

For use at levels not to exceed 0.20% by weight in linear low density polyethylene (LLDPE), high density polyethylene (HDPE), polypropylene (PP), and high impact polystyrene (HIPS) used as components of polymeric food contact articles in contact with all types of food under Conditions of Use A through H. The FCS may be used in conjunction with triisopropanolamine (CAS Reg. No. 122-20-3) at a maximum use level of 1.5% by weight of the FCS. The FCS is not for use in contact with infant formula and human milk because such uses were not included as part of the intended use of the substance in the FCN.

Diam Bouchage SAS

May 26, 2017

Polyurethane resin produced by reacting a mixture of 2,4-toluene diisocyanate (CAS Reg. No. 584-84-9) and 2,6-toluene diisocyanate (CAS Reg. No. 91-08-7) with polyoxyethylene-polyoxypropylene glyceryl ether (CAS Reg. No. 9082-00-2) and 1,4-butanediol (CAS Reg. No. 110-63-4).

As a binder or adhesive in the manufacture of agglomerated cork stoppers that contact alcoholic beverages. The stoppers will function as closures for alcoholic beverage containers, i.e., Food Types VI-A and VI-C, under Conditions of Use D through G, as described in Tables 1 and 2.

The FCS is subject to the maximum use level in agglomerated cork stoppers described in the notification.

BASF Corporation

May 26, 2017

Tris(2-ethylhexyl) trimellitate (CAS Reg. No. 3319-31-1).

The FCS is intended for use as a plasticizer in repeated-use, food-contact vinyl chloride polymers, except for use in contact with infant formula and breast milk (see Limitations/Specifications).

The FCS is intended to be used as a plasticizer at levels not to exceed 50% by weight in repeated-use food-contact vinyl chloride polymers intended to contact all types of food. The finished product is not for use in contact with infant formula and breast milk. Such uses are not included as part of the intended use of the substance in the FCN.

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