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New York Bill Would Establish GRAS Substances Reporting Requirement

Stacks of binders of regulations

A bill recently introduced in the New York legislature, S08615/A9295, would establish reporting requirements for generally recognized as safe (GRAS) substances that are added to food. Specifically, the bill would require a report to be submitted to the Commissioner of the New York Department of Agriculture and Markets on the use of GRAS substances in food.

Information that would be required in the report includes:

  • Name and address of the reporter or reporting organization;
  • The name of any GRAS substances discussed in the report;
  • Intended conditions for the use, level of use, and purposes for use of the GRAS substance(s);
  • Statutory basis for conclusion of GRAS status; and
  • Dietary exposure to the notified substance.

A report would not have to be submitted for certain exempted GRAS substances. These include: 1) Substances for which FDA issued a letter stating it has no question regarding the conclusion that the substance is GRAS under its intended conditions of use; 2) Any substances recognized in federal regulations as prior sanctioned or GRAS substances for use in food or food packaging; AND 3) food-contact substances with an effective premarket notification. In addition, small businesses would be exempt from the reporting requirement.

The bill also specifies that the commissioner shall make the GRAS reports available to the public in a searchable database and that reporters may be charged a fee to recover the costs incurred in listing a substance and maintaining the database. Information designated by the submitter as a trade secret would be redacted from the report.