Notifier

Effective Date

Name of The Substance

Intended Use

Limitations/Specifications

Perstorp Holdings AB

Jul 5, 2017

Polycaprolactone (CAS Reg. No. 24980‐41‐4).

For use in blends with authorized polylactide polymers and thermoplastic starch polymers intended for use as components of articles in contact with food, except for use in contact with infant formula and human milk (see Limitations and Specifications).

The FCS may be used in blends with the identified polymers at levels up to 35%. Finished articles may contact all food types under Conditions of Use B through H, as described in Tables 1 and 2, respectively. 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.

SABIC Innovative Plastics

Jul 7, 2017

Carbonic dichloride, polymer with 2,3-dihydro-3,3-bis(4-hydroxyphenyl)-2-phenyl-1-H-isoindol-1-one and 4,4’-(1-methylethylidene)bis[phenol], bis[4-(1-methyl-1-phenylethyl)phenyl] ester (CAS Reg. No. 503834-43-3).

As a component in the manufacture of articles intended to contact food, except for use in contact with infant formula and human milk (see Limitations/Specifications).

The FCS may be used under conditions of use A through H and J, as described in Table 2. Adjuvant substances permitted for use in polycarbonate resin complying with 21 CFR 177.1580 may be used in the polymer that is the subject of this notification, subject to any limitations in the authorizing regulation or notification. 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.

LANXESS Corporation

Jul 7, 2017

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

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).

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:

in adhesives is 150 ppm;

in paper coating formulations is 150 ppm, with the exception of latex coatings where the maximum level is 250 ppm;

in aqueous additive formulations for use in paper is 150 ppm;

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.

Dow Chemical Company

Jul 11, 2017

Benzene, diethenyl-, polymer with ethenylbenzene and ethenylethylbenzene, chloromethylated (CAS Reg. No. 69011-14-9).

The FCS is used to remove organic substances from aqueous and acidic food types I, II, and VI, excluding bottled water and alcoholic beverages containing over 30% alcohol, as described in Table 1. The FCS may not be used to filter ingredients used in the preparation of infant formula (see Limitations/Specifications).

The finished resin is intended for repeated use in the processing of food at stream temperatures not to exceed 40 °C. The finished resin should be treated with water to remove the process solvent in accordance with good manufacturing practice (GMP). 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.

BASF SE

Jul 18, 2017

Hexanedioic acid, polymer with hexahydro-2H-azepin-2-one and 1,6-hexanediamine (CAS Reg. No. 24993-04-2).

As a component in multi-layer films intended to contact food, except for use in contact with infant formula and human milk (see Limitations/Specifications).

The multi-layer films containing the FCS may be used for single and repeated use in contact with all food types under Conditions of Use A through H, as described in Tables 1 and 2. The films will have a maximum thickness of 2 mil (0.002 inch) of the FCS. Adjuvant substances permitted for use in Nylon 6/66 polymers may be used in the FCS, subject to any limitations regarding conditions of use, food types, or any other limitation in the authorizing regulation or notification. 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.

Newlight Technologies, Inc.

Jul 22, 2017

Butanoic acid, 3-hydroxy-, (R)-, homopolymer (CAS Reg. No. 29435-48-1).

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

Finished articles that contain the FCS may contact all food types under Conditions of Use B 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.