Food Contact Notification (FCN) News in January 2018
According to FDA official website, 4 food contact notifications (FCN) have been approved by FDA in January, and the details are shown in the table below:
| Notifier | Effective Date | Name of The Substance | Intended Use | Limitations/Specifications |
| Oerlikon Balzers Coating AG | Jan 4, 2018 | Chromium (III) oxide (CAS Reg. No.1308-38-9). | As a surface coating on repeat-use food processing and food packaging equipment to prevent abrasive wear to the components of the equipment, except for use in contact with infant formula and human milk. (see Limitations/Specifications). | For use at a thickness not to exceed 200 nanometers. The coating may contact all food types under Conditions of Use A through H, as described in Tables 1 and 2. The FCS is not for use in contact with infant formula and human milk. Such use was not included as part of the intended use of the substance in the FCN. |
| SK Chemicals Co., Ltd. | Jan 9, 2018 | 1,4-Benzenedicarboxylic acid, polymer with 1,4-cyclohexanedimethanol,1,2-ethanediol,[4-(hydroxymethyl) cyclohexyl]methyl 4-(hydroxymethyl)cyclohexanecarboxylate, 2,2′-oxybis[ethanol] and 4,4′-[oxybis(methylene)]bis[cyclohexanemethanol] (CAS Reg. No. 1632972-01-0). | As a polymeric component of food-contact articles, except for use in contact with infant formula and human milk (see Limitations/Specifications). | The polymer will be used under Conditions of Use C through G in contact with all types of food. 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. |
| Valley Chemical Solutions | Jan19, 2018 | An aqueous mixture of 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), water, and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9) | As an antimicrobial agent used during the processing of meat and poultry carcasses, parts, and organs, and preformed and/or processed poultry and meat products. | The components of the FCS mixture will not exceed:
1.2000 ppm PAA, 892 ppm HP, and 7 ppm HEDP for use in all process water that contacts poultry carcasses, parts, trim, and organs during production, including water applied by wash, rinse, dip, chill, scald, spray, and mist; 2.495 ppm PAA, 221 ppm HP, and 1.7 ppm HEDP for use in brine and ice that may contact poultry carcasses, parts, trim, and organs, and in process water, brine, and ice for washing, rinsing, or cooling processed and preformed poultry products; 3.2000 ppm PAA, 892 ppm HP, and 7 ppm HEDP for use in all process water that contacts meat carcasses, parts, trim, and organs during production, including water applied by wash, rinse, dip, chill, spray, and mist; and 4.495 ppm PAA, 221 ppm HP, and 1.7 ppm HEDP for use in brine and ice that may contact meat carcasses, parts, trim, and organs, and in process water, brine, or ice for washing, rinsing, or cooling processed and preformed meat products. |
| BASF SE | Jan23, 2018 | Sodium salt of (2-propenoic acid, polymers with acrylic acid-isopropanol reaction products (CAS Reg. No. 113133-74-7)) | As a mineral pigment dispersant used in the manufacture of food-contact paper and paperboard, except for use in contact with infant formula and human milk (see Limitations/Specifications). | The FCS may be used in coatings at a level not to exceed 0.36 weight percent of solid pigment. 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. |
REACH24H has extensive experience in United States food contact materials (FDA /FCN / 21 CFR), EU food contact materials (EU 10/2011/BfR)and China food contact materials (GB 9685, GB 4806.X). We have the capability to advise and identify a regulatory strategy for successful registration.. If you require any further information, please contact
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