Get the free Threshold of Regulation (tor) Exemptions

This document provides a list of exemptions issued under 21 CFR 170.39, related to substances used in food-contact articles. It includes information about the companies that made requests, the chemical names of substances, their specific uses, and any limitations on their use. It emphasizes that these exemptions are typically applicable regardless of manufacturer or supplier and outlines the process for inquiries and searching the database.

How to fill out threshold of regulation tor

How to fill out threshold of regulation tor

1. Identify the substance or food additive for which you need to establish a threshold of regulation.
2. Gather toxicological data, including exposure assessments and safety evaluations.
3. Determine the Maximum Tolerated Dose (MTD) based on the available studies.
4. Calculate the acceptable daily intake (ADI) for the substance using safety factors.
5. Consider the existing environmental and dietary exposure levels to determine cumulative exposure.
6. Prepare submission materials that document the above findings and calculations.
7. Submit the compiled data and assessment to the appropriate regulatory agency for review.

Who needs threshold of regulation tor?

1. Food manufacturers who use food additives or substances in their products.
2. Regulatory bodies overseeing food safety and standards.
3. Researchers working in food science and toxicology.
4. Companies involved in the production of food contact materials.

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What is threshold of regulation tor?

The Threshold of Regulation (TOR) refers to a regulatory framework under the U.S. Food and Drug Administration (FDA) that provides guidance on the use of food contact substances (FCS) that are not expected to migrate into food at significant levels.

Who is required to file threshold of regulation tor?

Manufacturers or suppliers of food contact substances who wish to determine if a substance is exempt from premarket notification requirements under the Food, Drug, and Cosmetic Act are required to file a Threshold of Regulation exemption request.

How to fill out threshold of regulation tor?

Filing a TOR request involves completing the prescribed form by providing specific details about the substance, its intended use, and data supporting the claim that the substance will not migrate into food at significant levels.

What is the purpose of threshold of regulation tor?

The purpose of the TOR is to facilitate the use of safe food contact substances by easing regulatory burdens on manufacturers, thereby encouraging innovation while ensuring food safety.

What information must be reported on threshold of regulation tor?

The information required includes the identity of the substance, its intended use, the conditions of food contact, migration data, and any relevant safety assessments demonstrating that the substance will not migrate into food at significant levels.