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Environmental Decision Memo for Food Contact Notification No. 000419

Date: May 20, 2004

 

From; Environmental Toxicologist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)

 

Subject: FCN No. 419 - n-Octyl-phophonic acid (NOPA)- modified titanium dioxide for use as a colorant in all types of food-contact polymers

 

Notifier: Tioxide Group
86 Morris A1 rue des Garennes BP 89
62102 Calais Cedex, FRANCE

 

To: Division of Food Contact Notifications (HFS-275)
Attention: Elizabeth R. Sanchez, Ph.D.
Through: Layla I. Batarseh, Ph.D., Supervisor, ERG

 

 

Attached are the Finding of No Significant Impact (FONSI) and our supplement to the notifier's environmental assessment (EA) for FCN 419. When this notification becomes effective, these documents and the notifier's EA, dated March 30, 2004, may be made available to the public.

 

Please let us know if there is any change in the identity or use of the food-contact substance.

 

 

 

Tong Zhou, Ph.D.

 

2 Attachments

 





Finding of No Significant Impact

A food contact notification (FCN No. 419), submitted by Huntsman Tioxide/ Tioxide Europe S.A.S./ Tioxide Europe S.L., to provide for the safe use of n-octyl phosphonic acid (NOPA)- modified titanium dioxide, produced by chemically reacting 0.8% by weight of NOPA (CAS Reg. No. 4724-48-5) with titanium dioxide, for use as a colorant in all types of food-contact polymers.

 

The Environmental Review Group has determined that allowing this notification to become effective will not significantly affect the quality of the human environment and therefore will not require the preparation of an environmental impact statement. This finding is based on information submitted by the notifier in an environmental assessment (EA) dated March 30, 2004, and on our supplement to that EA.

 

 

 

Prepared by__________________________________________ Date: May 20, 2004
Tong Zhou, Ph.D., Environmental Toxicologist
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

 

 

 

Approved by_________________________________________ Date: May 20, 2004
Layla I. Batarseh, Ph.D., Supervisor
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

 





Supplement to the Environmental Information
for Food Contact Notification No. 419

This document incorporates by reference the notifier's environmental assessment (EA) dated March 30, 2004.

 

The purpose of this supplement is to clarify an inaccuracy in the notifier's EA regarding the proposed use of the food-contact substance (FCS). In addition, we are providing up-to-date information for municipal solid waste disposal in the United States.

Under Intended Use on page 7 (see Section D.1. of FDA Form 3480), the notifier stated, "Up to a maximum of 20 percent by weight of the polymer under Condition of Use A through H, except that when used under Conditions of Use C and less severe conditions, the pigment may be used at levels up to 30%."

This statement agrees with what FDA allows regarding limitations/specifications for the intended use of the FCS.

However, the notifier stated in the first paragraph under Format Item 4 of the EA, "The action requested in this submission is the notification of the use of n-octyl phosphonic acid (NOPA)-modified titanium dioxide as a colorant in food-contact polymers at levels not to exceed 20 percent by weight of the polymer under the Food and Drug Administration's (FDA) Condition of Use A ('High temperature heat-sterilized (e.g., over 212 °F)') through H ('Frozen or refrigerated storage: Ready prepared foods intended to be reheated in container at time of use')."

This statement is not clear, because it does not say that the FCS also may be used at levels up to 30 percent when used under Conditions of Use C and less severe conditions.

The notifier stated under Format Item 4 on page 2 of the EA, ". . . it is anticipated that disposal will occur nationwide, with about 76% of the materials being deposited in land disposal sites, and about 24% combusted."

These figures are based on the EPA 1997 update of municipal solid waste in the United States. The most recently EPA report on municipal solid waste disposal suggests about 79% land disposal and 21% combustion.

 

 

Prepared by ___________________________________________ Date: May 20, 2004

Tong Zhou, Ph.D., Environmental Toxicologist

Environmental Review Group

Division of Chemistry Research and Environmental Review