Do you want to know about the simplified ways for US FDA notifications to speed-up your food contact product approvals? Prior to 1995 the only route available to a company wishing to notify a new food contact substance in the USA was a Food Additive Petition. This was a long process, generally taking 2 to 4 years to get clearance from FDA, followed by another 12 months before the relevant new regulation appeared in Chapter 21 of the Code of Federal Regulations. However, since 1995 two faster routes have been introduced, Threshold of Regulation Exemptions and Food Contact Notifications. Also, because FDA is better resourced in the food contact area a Food Additive Petition submitted now would be much faster than was historically the case. This training looks at these three routes in depth, their advantages and disadvantages and how, in certain circumstances additional exemptions mean that there is no need to notify FDA at all.

The existence of multiple submission routes makes the task of notifying a new food contact substance a complex one. Additionally, there are significant data requirements which must be complied with if FDA are going to clear the substance. The complexity is increased again by the things that are not explicitly stated, the exemptions that exist and how to make use of these to ensure that food contact materials are sold legally with minimal regulatory effort. Anyone involved in the supply of food contact materials and substances who does not feel fully informed on how to notify new substances would benefit from this training session.

Who should attend this training?

Anyone involved in notifying a new food contact substance to FDA, or making use of the various exemptions;

•  - Scientists in testing laboratories
•  - Regulatory affairs professionals
•  - Quality managers and quality department employees
•  - Technical directors
•  - Other technical managers, executives and consultants

Training Outline

During this training following topics will be covered:

• A brief history of the notification routes
• What is a food additive and why this is important
• FDA data requirements for clearance of new food contact substances
• - Chemistry Requirements
• - Determination of Migration
• - Exposure Calculations
• - Toxicology Requirements
• - Environmental Requirements
• How and when to use a Food Addition Petition
• How and when to use a Food Contact Notification
• How and when to use a Threshold of Regulation Exemption
• Exemptions from the need to notify FDA and how to use them
• - GRAS
• - The Basic Resin Doctrine
• - The Mixture Doctrine
• - No Migration Exemption
• - The Housewares Exemption
• Summary of Notification Options