Food Contact Notification (FCN) News in November
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:
|
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: |
REACH24H has rich experience in dealing with United States food contact materials (FDA /FCN / 21 CFR) and EU food contact materials (EU 10/2011/BfR) and can make custom-made compliance service for enterprises. If you have further questions, please consult
+86-571-87103815