Topics in Food Contact

Frequently Asked Questions on Food Contact Notifications

Mar 2001

Toxicology Requirements

• Are there any additional data requirements for biocides?
• Are there specific qualifications or credentials a lab should have?
• How is the estimated dietary intake calculated?
• How is the safe intake of an additive determined by FDA?
• We have done a lot of testing. Do we need to include all of our results?
• What substances must be tested for an FCN?
• What types of toxicity data must be submitted?

Chemical Requirements

• How should migration test results be validated?
• Should time and temperature conditions be considered?
• What chemistry information is required in a Food-Contact Notification?
• What food-simulating solvents should be used in a migration study?
• What should be considered in preparing test samples for migration studies?
• What should be included in a migration study report submitted with an FCN?
• Why does FDA require specifications and supporting analytical data?

Data Requirements

• What information is needed in an FCN regarding polymerization aids used to make a polymer?
• What is the impact of a positive (adverse) genotoxicity result where there are other studies and data available to support safety?
• Will FDA accept studies conducted under non-GLP conditions?
• Will submission of genotoxicity studies be necessary for polymeric substances, in addition to starting monomers used to make the polymer (where exposure is between 0.5 ppb and 50 ppb)?

Proprietary Rights

• Can a notifier license its FCN to a third party?
• Can a notifier transfer or assign its FCN to a third party?
• Can a notifier's proprietary right to an FCN expire?
• Does an effective FCN grant an exclusive proprietary right?

Who can File?

• Can a supplier rely on the FCN obtained by its customers to sell to other customers?
• Does an FCN cover a notifier's subsidiary or parent?
• Is there anything in the legislative history of FDAMA to indicate that the filing of an FCN can only be made by special classes of manufacturers or suppliers?

What products can be Covered?

• Can one file an FCN on components of packaging to hold food for irradiation?
• Can secondary directs be the subject of FCNs?
• How do recycling technologies fit into the FCN system?
• May an FCN be filed for building blocks of polymeric substances, and who is permitted to rely on the FCN?
• May notifications be filed for formulations?
• What kind of substance can be covered by an FCN?

The Logistics

• Are the existing Food Additive Regulations and Threshold of Regulation exemption letters still valid?
• How many products can a single FCN cover?
• Under what circumstances will FDA require the filing of a Food Additive Petition?
• Under what circumstances will FDA revoke an FCN?
• What information in an FCN is considered confidential?
• When does the review period begin to run?
• When is an FCN submission considered accepted by FDA?
• Where will FDA publish effective notifications?
• Will FDA issue a written letter indicating that the FCN is effective?
• Will FDA notify a submitter of language that will be used in an FCN?

The FCN Program in General

• What is the Food-Contact Notification program?
• What types of data are required for FCN filings?
• What types of toxicity data must be submitted?
• When is environmental impact data required?
• Where can I find information about data requirements?