Notifier

Effective Date

Name of The Substance

Intended Use

Limitations/Specifications

Henkel, Inc.

Apr 15, 2017

Polyester-polyurethane adhesive formulated from the following:

Polyurethane component prepared from allophanate-modified methane diphenyl diisocyanate, 4,4′-diphenylmethane diisocyanate (CAS Reg. No. 101-68-8), propylene oxide, ethylene oxide, 1,2-propanediol, hexamethylene diisocyanate homopolymer (CAS Reg. No. 28182-81-2), and hexamethylene diisocyanate (CAS Reg. No. 8222-06-0) and

Polyester/polyether/polyol component prepared from adipic acid (CAS Reg. No. 124-04-0), 1,3-benzenedicarboxylic acid (CAS Reg. No. 121-91-5), diethylene glycol (CAS Reg. No. 111-46-6), 1,2-propanediol (CAS Reg. No. 57-55-6), polypropylene glycol (CAS Reg. No. 25322-69-4), and 1,2,3-propanetriol (CAS Reg. No. 56-81-5).

The FCS Is intended to be used as an adhesive in laminate structures intended for contact with food, except for use in contact with infant formula and human milk (see Limitations/Specifications).

The adhesive may be applied at a maximum rate of 1.25 pounds per 3000 square feet of food-contact surface. A food-contact layer will separate the adhesive from food and will consist of low density polyethylene with a minimum thickness of 1 mil or other material with equivalent or greater barrier properties under the intended conditions of use. Laminate structures using the FCS as an adhesive may be used in contact with 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.

Eastman Chemical Company

Apr 18, 2017

2,2,4,4-Tetramethylcyclobutane-1,3-diol (CAS Reg. No. 3010-96-6).

As a monomer, alone or in combination with the polyhydric alcohols listed in 21 CFR 175.300(b)(3)(vii)(c), in the production of polyester resins used as coatings for (1) metal substrates, used in the manufacture of single‐use food‐contact articles or components of such articles; and (2) any suitable substrate used in the manufacture of repeated-use food‐contact articles or components of such articles; except for use in contact with infant formula and human milk (see Limitations/Specifications).

For use at levels not to exceed 29 mole% of the final coating. The polyester resins and the final coatings will otherwise comply with FDA regulations for their intended use. The FCS-containingcoatings may be used in contact with all food types, except for high alcohol (>15 volume % ethanol) foods, under Conditions of Use A through H, as described in Tables 1 and 2. The FCS is not for use in the contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.

Addivant

Apr 21, 2017

Phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters (CAS Reg. No. 939402-02-5).

As an antioxidant in all polymers, except low density polyethylene (LDPE), that are used to form repeat use articles in contact with infant formula and human milk, as well as in polymers used as packaging for powdered infant formula.

The FCS may be used at levels up to 2000 parts per million (ppm) in (1) all polymers, except LDPE, in repeat use articles intended for the feeding of infant formula and human milk; and (2) all polymers intended for use as packaging for powdered infant formula. The FCS may be used in conjunction with triisopropanolamine (CAS Reg. No. 122-20-3) at a maximum use level of 0.75 percent by weight of the FCS.