New York’s Food Safety and Chemical Disclosure Act: A State-Level Overhaul of GRAS Regulation

New York has passed sweeping food additive legislation that, if signed by the Governor, will fundamentally reshape how food manufacturers and suppliers operate in the state.

The Food Safety and Chemical Disclosure Act (S1239F) (the “Act”) would establish the first state-level disclosure and database regime for substances that companies have independently determined to be “Generally Recognized as Safe” (“GRAS”). The bill represents a significant escalation in state-level food safety regulation with far-reaching consequences for food manufacturers, ingredient suppliers, and consumer products companies operating in the New York market.

Takeaways

• Self-affirmed GRAS is one step closer to no longer being a private determination in New York State under the Act. If signed by Governor Kathy Hochul, New York would be the first state in the U.S. to require companies to publicly disclose the safety basis for substances they have self-affirmed as GRAS. What has been an internal, often opaque industry process would become a mandatory public filing subject to scrutiny.
• The core prohibition on the sale or use of GRAS substances without such public disclosure technically could encompass nearly every processed food product, since most additives rely on GRAS status. Whether this creates a manageable compliance regime or an administrative crisis depends entirely on how regulators interpret the exemptions, particularly the Food and Drug Administration (“FDA”)’s no-questions letter and pre-1958 ingredient carve-outs.
• Trade secret science can no longer anchor a GRAS conclusion. The Act expressly bars companies from redacting the data that forms the basis of their safety determination and requires that GRAS conclusions rest on publicly available information. Companies could no longer rely on proprietary toxicological studies to support self-affirmed status.
• Retailers would be narrowly shielded from liability, specifically for selling food containing an unreported GRAS substance, provided they maintain a written supply contract that affirmatively represents the product complies with the Act.

Background: The Federal GRAS Framework and Its Gaps

Under the Food, Drug, and Cosmetic Act (“FDCA”), substances that are “generally recognized as safe” are exempt from the premarket approval process required for food additives. Since 1997, the FDA has permitted companies to make these GRAS determinations independently or “self-affirmed,” without notifying the agency or the public. A manufacturer may simply rely on a qualified expert’s opinion and begin using the substance in food products, with no disclosure obligation whatsoever. The Act directly targets this gap by making the self-affirmation process visible for the first time.

The Outright Bans

Section 2 of the Act amends New York’s Agriculture and Markets Law § 199-a to prohibit the manufacture, sale, distribution, or use in food of three specific substances:

• FD&C Red No. 3 – a synthetic dye long used in maraschino cherries, candies, and certain medications, which FDA banned from cosmetics in 1990 but did not pull from food until January 2025 under federal law.
• Potassium bromate – a flour treatment agent banned in the EU, UK, Canada, and elsewhere, but still permitted federally in the U.S.
• Propylparaben – a preservative with alleged endocrine-disrupting properties, already banned in food in the EU.

Retailers that already have these products in stock would receive a transition period. They may continue selling such products until the earlier of the product’s expiration/“sell by” date, or three years after enactment. The New York Commissioner of Agriculture and Markets (the “Commissioner”) must amend the state exemption list at least 180 days before the ban’s effective date.

The GRAS Disclosure Regime

The Act creates a new Agriculture and Markets Law § 199-h, which establishes a mandatory reporting and public database system for GRAS substances used in food sold in New York.

The Core Prohibition

Unless a compliant GRAS report has been submitted to the Commissioner and is publicly available in a state-maintained database, it will be unlawful to sell or use any GRAS substance in or on food, make any new use of a GRAS substance in food, or sell any food product containing a GRAS substance. This is a sweeping prohibition. It could apply to virtually every processed food product on the market, because the overwhelming majority of food additives, flavoring agents, processing aids, and preservatives used today rely on GRAS status. The Act effectively converts what has been a voluntary federal notification system into a mandatory state disclosure regime backed by civil and injunctive enforcement.

What the Report Must Include

The required GRAS report under the Act is detailed. It must include:

• Identity information: chemical name, CAS or EC registry number, empirical and structural formula composition, and, for biological-source substances, full taxonomic identification, including any known toxicants in the source material.
• Manufacturing process and description: sufficient detail to evaluate safety as manufactured.
• Dietary exposure estimates: estimates covering the intended use, metabolites or reaction products, contaminants or by-products, all sources in the diet, and the assumptions underlying the estimates.
• Basis for GRAS conclusion: a narrative explaining why the substance is safe under its intended conditions of use, how it is generally recognized among qualified experts, and an identification of any data bearing on that conclusion.
• FDA history: any prior GRAS notices submitted to FDA and FDA’s responses.
• Certifications: signed statements from a responsible official certifying the report is complete, representative, and balanced.

Critically, trade secret data cannot be the basis for a GRAS conclusion. The Act provides that data establishing general recognition of safety must be based on publicly available information. The Commissioner may redact trade secret information from public-facing reports but cannot redact data that forms the basis for the GRAS safety conclusion.

Exemptions

Not every GRAS substance would require a new state report. The following are exempt:

• Substances already reviewed by FDA and for which FDA has issued a “no questions” GRAS letter;
• Substances formally approved for use in food or food packaging by the FDA or the U.S. Department of Agriculture prior to January 1, 1958, and recognized as such in federal regulations as prior-sanctioned or GRAS substances;
• Food contact substances with effective premarket notifications;
• Substances approved by federal regulation for their intended food use;
• Ingredients widely consumed in the U.S. prior to January 1, 1958, subject only to conventional processing and without known safety hazards;
• New dietary ingredients for which FDA has acknowledged a notification without objection; and
• Substances the Commissioner determines are safe through rulemaking.

These exemptions are meaningful. Many commonly used substances have already gone through FDA’s voluntary GRAS notice program and received no-questions letters. Broad categories of historically established ingredients are also excluded. The practical scope of the new reporting requirement will turn on how many substances in current commercial use are genuinely “self-affirmed.”

The Public Database

The Commissioner must make all submitted reports publicly available in a searchable, downloadable database on the agency’s website. The database must be capable of handling anticipated public use and must be updated as new safety information is received. The Commissioner also has discretion to refuse to list a GRAS substance if the submitted report does not contain the required information, and may charge a listing fee to recover database maintenance costs. An interim progress report on the database’s development is required before implementation.

Enforcement

Section 7 of the Act extends the Commissioner’s existing enforcement authority, including the power to seek injunctive relief without proving inadequacy of legal remedies, to cover violations of new § 199-h. Manufacturers and suppliers face civil enforcement exposure for GRAS substances used without compliant reports on file.

Important Carve-Outs

Several limitations are worth noting:

• Retailers are protected if they have a valid written contract with their manufacturer, producer, distributor, or supplier certifying that the food or food product is compliant. Liability flows upstream to manufacturers and suppliers, not to the retailer who relies in good faith on supplier representations.
• Small businesses that are independently owned and operated with 100 or fewer employees are entirely exempt from the GRAS reporting requirements.
• No labeling obligations are created beyond what existing law already requires.

Effective Date and Implementation Timeline

The Act takes effect one year after becoming law, except that the Commissioner’s authority to begin rulemaking is effective immediately upon enactment. The Commissioner is authorized to promulgate rules and regulations necessary for implementation before the effective date.

The one-year timeline is tight. Building and deploying a searchable public database, establishing a filing process, and processing what could be a significant volume of GRAS reports for thousands of substances currently in commercial use will require substantial administrative infrastructure.

Broader Regulatory Trend

The Act complements recent efforts occurring at the federal level to reform the GRAS oversight process, as reported by EBG in September 2025 and December 2025: FDA’s exploration of potential rulemaking to eliminate the self-affirmation pathway, and a federal bill called The Better Food Disclosure Act of 2025 that would amend the FDCA to require notifications to the FDA regarding food substances generally recognized as safe. The Act is also part of a broader, accelerating state level movement to fill perceived gaps in federal food safety regulation. California, Illinois, and other states have enacted or are considering similar measures. If the federal GRAS notification program remains voluntary, further state-level legislative activity can be expected.

This trend reflects growing skepticism among state legislators about the adequacy of federal food safety regulation, particularly in light of the FDA’s limited resources for reviewing the thousands of substances currently in the food supply. Companies operating in multiple states should expect continued legislative activity in this space and should consider proactive compliance strategies that account for an increasingly fragmented state regulatory landscape.

Implications for Industry

The practical impact of the Act would be substantial. Companies that have relied on self-affirmed GRAS determinations would need to prepare and submit detailed reports or risk being unable to lawfully sell their products in New York.

The Governor’s signature and the subsequent administrative rulemaking process will be critical to watch. The Act signals that the era of truly “self-affirmed” GRAS determinations, made and maintained entirely outside the public view, is drawing to a close, at least in New York.