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2023 US FDA Announces US Food Exposure Notice FCN Adding 4 Substances (July)

Time：

2023-09-20

2023 US FDA Announces US Food Exposure Notice FCN Adding 4 Substances (July)

According to the official website of the US Food and Drug Administration (FDA), in July 2023, the FDA approved four food contact notification (FCN) applications.

◆ Food contact substance name: 2,5-Furandione, dihydro -, mono C15-20 alkenyl derivatives (CAS Reg. No. 68784-12-3)
Effective date: March 27, 2022
Intended use: As a surface treatment agent for calcium carbonate, used as a pigment and/or filler in food contact materials and products, except for use in contact with infant formula and breast milk (see restrictions/usage specifications)
Restriction/Use Specification: The calcium carbonate contained in this substance shall not exceed 0.85 weight percentage in PETG, PET, and polyester food contact materials and products in contact with all types of food. It is applicable to use conditions A to H, as detailed in Tables 1 and 2. Not suitable for use in contact with infant formula and breast milk, such use is not included in the expected use of the substance in the FCN

◆ Name of food contact substance:An aqueous mixture of peroxyacetic acid (PAA) (CAS Reg No. 79-21-0), hydrogen peroxide (HP) (CAS Reg. No. 7722-84-1), acetic acid (AA) (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No.2809-21-4), and optionally sulfuric acid (SA) (CAS Reg. No. 7664-93-9). REPLACES FCNs 887, 1132, 1738, and 1806
Effective date: March 25, 2022
Intended use: As an antibacterial agent, it is used in the production, processing, and preparation of process water or ice, involving food contact as follows:
1. All or cut meat, including animal skins, corpses, parts, trimmings, and organs;
2. All or cut poultry, including corpses, parts, trimmings, and organs;
3. Fruits and vegetables.
Except for use in contact with infant formula and breast milk (see restrictions/usage specifications)
Restriction/Usage Specification: The substance will not be used beyond the following levels:
1. In process water or ice used for cleaning, rinsing, or cooling all or cut meat (including animal skins, corpses, parts, trimmings, and organs), the concentration of PAA shall not exceed 2000 ppm, the concentration of HP shall not exceed 800 ppm, and the concentration of HEDP shall not exceed 80 ppm;
2. In the process water or ice used for cleaning, washing or cooling all or cut poultry (including carcasses, parts, trimming and organs), in the form of spray, washing, washing, soaking, cooling water, low temperature (such as below 40 ° F) soaking tank or scalding water, the concentration of PAA shall not exceed 2000 ppm, the concentration of HP shall not exceed 770 ppm, and the concentration of HEDP shall not exceed 100 ppm;
3. In process water or ice used for cleaning or cooling fruits and vegetables in food processing facilities, the concentration of PAA shall not exceed 500 ppm, the concentration of HP shall not exceed 115 ppm, and the concentration of HEDP shall not exceed 14 ppm.
Not suitable for use in contact with infant formula and breast milk, such use is not included in the expected use of the substance in the FCN

◆ Name of food contact substance: 1,2-Bis (3,5-di-tert-butyl-4 hydroxyhydrocinnamoyl) hydrazine (CAS Reg. No. 32687-78-8)
Effective date: March 22, 2022
Intended use: Used as an antioxidant in polyolefin polymers and copolymers, except for use in contact with infant formula and breast milk (see restrictions/usage specifications)
Restriction/Usage Specification: This substance can be used under the following conditions:
1. In contact with all types of food, the amount of high-density polyethylene (HDPE) used shall not exceed 0.12% of the weight of the finished product, suitable for conditions of use (COU) B to H, as detailed in Tables 1 and 2;
2. According to the polyethylene copolymer described in item 3.2a of 21 CFR 177.1520 (c), when in contact with water-based and acidic foods, the amount used shall not exceed 0.18% of the weight of the finished product, applicable to conditions B to H;
3. The amount of polyolefin used shall not exceed 0.12% of the weight of the finished reusable product, and is suitable for contact with all types of food.
Not suitable for use in contact with infant formula and breast milk, such use is not included in the expected use of the substance in the FCN

◆ Food contact substance name: Glycidyl metacrylate (CAS Reg. No. 106-91-2)
Effective date: March 23, 2022
Intended use: As a monomer for manufacturing acrylic copolymers that meet the requirements of 21 CFR 175.300 (b) (3) (xx), as a component of resin and polymer coatings, except for use in contact with infant formula and breast milk (see limitations/usage specifications)
Restriction/Usage Specification: This substance can be used in finished polymer coatings that come into contact with food types I, II, IV-B, VI (up to 15% alcohol), VII-B, and VIII at a maximum level of 0.4 milligrams per square inch according to usage conditions A to H (see Tables 1 and 2), and 0.18 milligrams per square inch in finished polymer coatings that come into contact with food types VI (up to 20% alcohol) under usage conditions C to G, In the finished polymer coating in contact with food type VI (up to 50% alcohol) under usage conditions E to G, the maximum level is 0.18 milligrams per square inch (see Annex 1 for details). Not suitable for use in contact with infant formula and breast milk, such use is not included in the expected use of the substance in the FCN