FDA Adds 10 New Substances to its Inventory of Effective FCS Notifications

The U.S. Food and Drug Administration (FDA) recently added ten new substances to its Inventory of Effective Food Contact Substances (FCS) Notifications. The newly listed FCN numbers, substances, manufacturers, and effective dates are listed below.

1. 1609; Agarose, polymer with 2‐(chloromethyl)oxirane, 2‐hydroxy‐3‐(2‐propen‐1‐yloxy)propyl ether, polymer with 1‐ethenyl‐2‐pyrrolidinone, graft (CAS Reg. No. 1613113‐98‐6); GE Healthcare Bio-Sciences AB; Jan 26, 2016.

2. 1605; Octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate (CAS Reg. No. 2082-79-3); BASF Corporation; Jan 9, 2016.

3. 1604; Isotridecanol phosphite condensation product with butylidenebis(2-(1,1-dimethylethyl)-5-methyl-4,1-phenylene); ADEKA Corporation; Jan 9, 2016.

4. 1600; A solution of silver dihydrogen citrate stabilized with sodium lauryl sulfate and citric acid; Pure Bioscience, Inc.; Jan 7, 2016.

5. 1599; 1-Propanaminium, N,N,N-trimethyl-3-[(1-oxo-2-propen-1-yl)amino]-, chloride (1:1), polymer with ethenamine and 2-propenamide, hydrochloride (CAS Reg. No. 1659307-53-5); Solenis LLC; Jan 6, 2016.

6. 1594; An aqueous mixture of peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (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); Valley Chemical Solutions; Jan 26, 2016.

7. 1587; Tris(2-ethylhexyl) trimellitate (CAS Reg. No. 3319-31-1); BASF Corporation; Jan. 27, 2016.

8. 1584; Polyester-polyurethane adhesive formulated from the following: (a) Polyurethane component prepared from polypropylene glycol, toluene diisocyanate, allophanate-modified methane diphenyl diisocyanate and 4,4'-diphenylmethane diisocyanate (CAS Reg. No. 101-68-8), and (b) Polyester/polyol component, prepared from adipic acid, diethylene glycol, methyloxirane polymer, and 1,1,1-tris(hydroxymethyl)propane; Henkel, Inc.; Jan. 15, 2016.

9. 1583; Polyester-polyurethane adhesive formulated from the following: (a) Polyurethane component prepared from allophanate-modified methane diphenyl diisocyanate, 4,4'-diphenylmethane diisocyanate (CAS Reg. No. 101-68-8), propylene oxide, ethylene oxide, 1,2-propanediol, hexamethylene diisocyanate homopolymer (CAS Reg. No. 28182-81-2) and hexamethylene diisocyanate (CAS Reg. No. 8222-06-0) and (b) Polyester/polyol component, prepared from adipic acid, diethylene glycol, methyloxirane polymer, and 1,1,1-tris(hydroxymethyl)propane; Henkel, Inc.; Jan. 15, 2016.

10. 1580; An aqueous mixture of peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), and 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4); Brainerd Chemical Company, Inc.; Jan. 26, 2016.

The Food and Drug Administration Modernization Act of 1997 amended the Federal Food, Drug, and Cosmetic Act to provide for the submission of food-contact notifications (FCNs). Under the FCN system, a manufacturer or supplier of a food-contact material may submit an FCN to FDA regarding the identity and use of a new food-contact substance (FCS), along with information supporting the conclusion that the substance is safe for the intended use.

If FDA does not object in writing within 120 days to the substance's use based on safety grounds, the submitter and its customers may market the substance. Once the notification becomes effective, FDA will add it to its Inventory of Effective FCS Notifications. For more background on submission of FCNs, please see the PackagingLaw.com article, "What is the Best Approach to Obtaining FDA Clearance for Food Contact Substances?"