Food Contact Notification (FCN) News in February
According to FDA official website, 4 food contact notifications (FCN) have been approved by FDA in February, and their information is shown in the table below:
Notifier |
Effective Date |
Name of The Substance |
Intended Use |
Limitations/Specifications |
The Dow Chemical Company |
Feb 11, 2018 |
2-Propenoic acid, 2-methyl-, methyl ester, polymer with 1,3-butadiene, diethenylbenzene, ethenylbenzene, and butyl 2-propenoate (CAS. Reg. No. 39373-52-9) |
As articles or components of articles intended for repeat use in contact with food, except for use in contact with infant formula and human milk (see Limitations and Specifications). |
The FCS is composed of a minimum of 60 weight percent of the polymer consisting of styrene and butadiene with the balance of the polymer consisting of one or more of the following monomers: divinylbenzene <3 wt.-%; butyl acrylate 0-5 wt.-%; and methyl methacrylate <25 wt.-%. The FCS may be used in contact with all food types under Conditions of Use B through H as described in Table 2. The finished food contact articles containing the FCS are 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 |
Feb 24, 2018 |
An aqueous mixture of peroxyacetic acid (PAA; CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidine-1,1-diphosphonic acid (CAS Reg. No. 2809-21-4), and optionally sulfuric acid (CAS Reg. No. 7664-93-9) |
As an antimicrobial agent in: (1) brines, sauces, and marinades applied on the surface or injected into processed or unprocessed cooked or uncooked whole or cut meat or poultry, parts and pieces thereof; (2) brines, sauces, and marinades applied on the surface or injected into processed and preformed meat and poultry products. |
The FCS may be used in brines, sauces, and marinades at a level not to exceed 50 ppm PAA, 19 ppm hydrogen peroxide, and 8 ppm HEDP. |
PeroxyChem, LLC |
Feb 24, 2018 |
An aqueous solution of hydrogen peroxide (CAS Reg. No. 7722-84-1), aluminum nitrate, nonahydrate (CAS Reg. No. 7784-27-2), and phosphoric acid (CAS Reg. No. 7664-38-2) |
The FCS is intended for use as an antimicrobial additive that may be used alone or in combination with other processes for the commercial sterilization of aseptic filling systems and packaging prior to filling. The FCS may be used on equipment and food packaging materials intended to contact infant formula products. |
The FCS will be used as a 35 percent by weight aqueous hydrogen peroxide solution, with a maximum of 0.006 percent by weight aluminum nitrate, nonahydrate at the time of application. The concentration of hydrogen peroxide in distilled water packaged under production conditions (assay to be performed immediately after packaging) must not exceed 0.5 parts per million (ppm). The FCS may be used to sterilize polymeric packaging material (including packaging intended for contact with infant formula products) and the non-food contact surfaces of aseptic filling systems. FDA’s review of the use of the FCS to sterilize aseptic filling systems is limited to the extent that the FCS residues may transfer from the non-food contact surfaces of the aseptic filling system to food packaging materials. |
Dow Silicones Corporation |
Feb 24, 2018 |
Siloxanes and silicones, di-methyl, vinyl group-terminated, reaction products with polypropylene (CAS Reg. No. 1818406-81-3) |
As an additive in polypropylene polymers, except for use in contact with infant formula and human milk (see Limitations/Specifications) |
For use at levels not to exceed 3.0% by weight in finished polypropylene films with a maximum thickness of 25 microns that contact all food types under Conditions of Use A through H, as described in Table 2. 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
Ms. Mao
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