Food Contact Notification (FCN) News in November

Jan. 11th, 2017
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According to FDA official website, 8 food contact notifications (FCN) have been approved by FDA in November, and their information is shown in the table below:

Notifier

Effective Date

Name of The Substance

Intended Use

Limitations/Specifications

Clordisys Solutions, Inc

Nov 2, 2016

Chlorine dioxide (CAS Reg. No. 10049-04-4)

As an antimicrobial agent used to fumigate fruits and vegetables, including raw agricultural commodities

The FCS will be applied only in unlit areas and shall not exceed 3 ppm residual in the air. In raw agricultural commodities, the FCS will be applied in the preparing, packing, or holding of the food for commercial purposes, consistent with the FD&C Act section 201(q)(l)(B)(i) but not applied for use under 201(q)(l)(B)(i)(I), (q)(l)(B)(i)(II), or (q)(I)(B)(i)(III)

Rock Paint Co., Ltd

Nov 2, 2016

Styrene-maleic anhydride copolymer, end-capped with cumene (CAS Reg. No. 26762-29-8)

As a component of adhesives otherwise complying with FCN No. 448 and intended to be used in laminate structures at retort temperatures, except for use in contact with infant formula and human milk (see Limitations/Specifications)

The FCS may be used at levels up to 4.3 weight % of adhesives otherwise complying with FCN No. 448. The adhesives may be used in contact with all types of food, except those containing more than 8% alcohol, under retort packaging conditions at temperatures not to exceed 275°F. Laminate structures containing the adhesive will meet all applicable provisions and test specifications in 21 CFR 177.1390, including 177.1390(c)(3)(i)(b)(3) and 177.1390(c)(3)(ii). 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

Buckman Laboratories, Inc

Nov 15, 2016

Monochloramine (CAS Reg. No. 10599-90-3)

As an antimicrobial agent in process water used in poultry processing, including primary and secondary processing of whole or cut poultry

The FCS will be used in an amount not to exceed 50 ppm. The FCS will be generated by the reaction between ammonia and sodium hypochlorite using the oxamine generation process

Asahi Kasei Corporation

Nov 17, 2016

2-Propenoic acid, 2-methyl-, polymer with ethenylbenzene and methyl 2-methyl-2-propenoate (CAS Reg. No. 25035-81-8)

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

For use at a maximum thickness of 50 μm in contact with dry foods with surface containing no fat or oil (i.e., Food Type VIII) under Conditions of Use E and F, 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

The Valspar Corporation

Nov 18, 2016

1,6-Hexanediol (CAS Reg. No. 629-11-8)

For use as a monomer in the manufacture of polyester or polyester/polyurethane resins for use as components of coatings on metal substrates for food-contact articles, except for use in contact with infant formula and human milk (see Limitations/ Specifications)

The FCS may be used at a maximum level not to exceed 13.1 percent by weight of the final coating. The polyester and polyester/urethane resins and the final coatings will otherwise comply with 175.300(b)(3)(vii) for their intended use. The FCS may be used in contact with all food types, except alcoholic foods, under Conditions of Use A through H, as described in Tables 1 and 2. The FCS will not be used 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

Aquagenics Technologies

Nov 25, 2016

An aqueous mixture of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (HP) (CAS Reg. No.7722-84- l), acetic acid (CAS Reg. No. 64-1 9-7), 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and optionally sulfuric acid (CAS Reg. No. 7664-93-9)

As an antimicrobial agent in process water or ice

Components of the FCS mixture in process water or ice will not exceed:

  1. 400 parts per million (ppm) PAA, 100 ppm HP, and 5 ppm HEDP in spray, wash, rinse, dip, chiller water, or scald water for meat carcasses, parts, trim, and organs;
  2. 2000 ppm PAA, 500 ppm HP, and 27 ppm HEDP in spray, wash, rinse, chiller water, or scald water for poultry carcasses, parts, trim, and organs;
  3. 230 ppm PAA, 57 ppm HP, and 3 ppm HEDP for washing, rinsing, or cooling of processed and pre-formed meat and poultry products;
  4. 230 ppm PAA, 57 ppm HP, and 3 ppm HEDP to commercially prepare fish and seafood; and
  5. 350 ppm PAA, 88 ppm HP, and 5 ppm HEDP for fruits and vegetables in a processing facility.

Fuji Silysia Chemical Ltd

Nov 25, 2016

Siloxanes and silicones, di-Me, hydroxyl-terminated, reaction products with silica (CAS Reg. No. 102782-80-9)

As an anti-blocking agent or slip agent in films and sheets manufactured from polypropylene (PP), and linear low density polyethylene (LLDPE) polymers, complying with applicable authorizations

For use at levels not exceeding 2 weight percent of the finished films and sheets in contact with food containing > 8% alcohol content, under Conditions of Use A through H (for PP) or B through H (for LLDPE), as described in Table 2

PeroxyChem, LLC

Nov 30, 2016

An aqueous mixture containing peroxyacetic acid (PAA, CAS Reg. No. 79-21-0), hydrogen peroxide (HP, CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP, CAS Reg. No. 2809-21-4), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9)

As an antimicrobial agent in process water and ice used in the production and preparation of meat including processed and pre-formed meat

The components of the FCS mixture will not exceed:
(1) for washing, rinsing, or cooling whole or cut meat including carcasses, parts, trim and organs: 1800 ppm PAA, 1215 ppm HP, and 121.5 ppm HEDP; and
(2) for washing, rinsing, storing, or cooling processed and preformed meat: 495 ppm PAA, 335 ppm HP, and 33.5 ppm HEDP

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