Pivotal and emerging issues in FDAs approach to safety assessment

5 Pivotal and emerging issues in FDA s approach to safety assessment 

The exclusive nature of the FCN process allows for a safety assessment for the FCS and its constituents in each and every FCN submitted by each and every notifier. The safety assessment may be for a new FCS or constituent or may be an updated assessment for a FCS or constituent that the FDA has evaluated previously. Thus, the FDA can monitor all safety information on FCSs and their constituents on a continuing basis and quickly address any safety concerns in the process. Moreover, as noted above, this process allows the FDA to acquire and maintain knowledge of the manufacturers/suppliers of the FCS or articles manufactured from the FCS. In addition, because the 

Another important aspect of the safety assessment is the evaluation of constituents of food additives, which include impurities and byproducts, as well as the low molecular weight oligomeric fraction of polymeric substances. For example, the safety evaluation for every FCN encompasses all components that would be expected to migrate to food, including the FCS, the food additive, and constituents of the food additive. This assessment is complex and the lack of proper evaluation and supporting documentation on all substances is the most common deficiency. 

Polymerization aids constitute one specific class of substances that is frequently the subject of a constituent safety evaluation. Polymer manufacture necessarily requires the use of various substances, such as catalysts, initiators, and chain transfer agents, to aid in the polymerization process but that are not essential in the final polymer. These substances are used at low levels and are typically incorporated into the polymer during polymerization or are removed during the final manufacturing steps. Solvents are also generally used in the manufacturing process and are removed during the final steps. 

Under the FCN process, polymerization aids and solvents are also subjected to an independent safety assessment along with the monomers and polymer and are also typically not included in the language in the notification letters. However, as the FCN is exclusive to the notifier, the identity and manufacturing information contained in the FCN apply to the FCS whether or not such information is included in the language in the notification letter or website listing of effective notifications. FCNs have been submitted for catalysts as an FCS. 

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