New York State Legislation: Self GRAS Ingredients Must Mandatorily Disclose Safety Data

The New York State Assembly passed the Food Safety and Chemical Disclosure Act (Bill No. S1239F/A1556G) on April 21, which has now been sent to Governor for signature. If the governor officially signs it, this will be the first state law in the United States requiring businesses to publicly disclose safety evidence for self-GRAS substances to the state government.

In simple terms, in the future, any food ingredients sold in New York State that are certified as “Self GRAS” substances must first submit a report to the state government and disclose data; otherwise, they cannot be sold. CIRS Group summarizes the core content of this bill as follows.

What Businesses Need to Do

The bill requires that, for any ingredient used in foods sold in New York State that is supported by a company’s self-GRAS determination without formal FDA review, the manufacturer must submit a complete GRAS dossier to the New York State Department of Agriculture and Markets. The data supporting a substance’s “GRAS” status must be based on publicly available information and must not rely on trade secrets.

At the same time, the bill directly bans three additives: Red Dye 3, potassium bromate, and propyl paraben, which cannot be used in food after one year.

The following substances are exempt from the reporting requirements

According to the bill, not all food ingredients need to go through this process. The following categories are exempt:

• any gras substance for which the federal food and drug administration has received a gras notice and issued a letter stating that the federal food and drug administration has no questions regarding the conclusion that the substance is generally recognized as safe under its intended conditions of use;
• any substance for which the federal food and drug administration has received a new dietary ingredient notification and issued a letter of acknowledgement without objection that the substance is safe under its notification's intended conditions of use; and
• any substances recognized in federal regulations as prior sanctioned or gras substances for use in food or food packaging;
• a small business, defined as a business that is independently owned and operated, and employs one hundred or fewer persons, shall be exempt from the requirements of this section.

State government's public database

The New York State government needs to propose an online public database for disclosing the content of business reports, allowing consumers to search and download at any time.

After receiving the business reports, the state government will review the completeness of the information. If the information is incomplete, they may refuse to include it in the database. Meanwhile, they may charge businesses a fee for inclusion and maintenance of the database.

When it takes effect

Once the bill is signed by the governor, it will officially take effect one year later. There is also a grace period for inventory held by retailers: food purchased before the bill takes effect can be sold until the expiration date, but no later than three years after the bill takes effect.

Summary by CIRS

This legislation in New York State targets the long-standing chaos of businesses’ self-GRAS, focusing on closing the regulatory loophole of data not being disclosed. It is worth noting that the bill does not require state governments to undertake substantive approval of material safety, but rather mandates companies to disclose safety data, with state governments performing the functions of data integrity review and information disclosure.

Given the highly integrated nature of the food supply chain in the United States, the introduction of this bill is likely to further narrow the practical acceptance of self-GRAS substances across the country. For companies seeking broad market access across the United States, beyond complying with reporting obligations to individual states, obtaining formal federal-level recognition through the FDA GRAS pathway remains a more effective and reliable strategy.

About CIRS Food Division

Established in 2012, the Food Business Division of CIRS Group has helped over 1,000 food companies globally in achieving one-stop compliance solutions. CIRS offers a full range of regulatory services, including but not limited to China novel food applications, synthetic biology-derived foods, U.S. GRAS notices, EU novel food applications, health food registration, and food for special medical purposes (FSMP).

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.