Environmental Decision Memo for Food Contact Notification No. 001224

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the Inventory of Effective Food Contact Substance Notifications.

See also Environmental Decisions.

October 17, 2012                  

From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
Through: Annette M. McCarthy, Ph.D, Senior Science and Policy Staff____

To: Division of Food Contact Notifications (HFS-275)
Attention: Anita Chang, Ph.D.

Subject: FCN 1224 – Sodium borohydride (SBH) (CAS # 16940-66-2) used in conjunction with palladium acetate (2+) salt (CAS # 3375-31-3) (referred to by the trade name HyGuardTM) as an oxygen scavenging system in polyethylene terephthalate (PET) packaging systems. For palladium acetate only, the proposed use is to expand the use to include the liner of a bottle closure (which is in direct contact with the food), at a level up to 50ppm. This use is in addition to what is authorized for use in FCN 1160 (bottle closure and bottle as opposed to only the bottle wall); such that when this notification becomes effective it will replace FCN 1160.

Notifier: ColorMatrix Group

Attached is the Finding of No Significant Impact (FONSI) for FCN 1224.  After this notification becomes effective, copies of this FONSI and the notifier’s environmental assessment, dated August 7, 2012, may be made available to the public. We will post digital transcriptions of the FONSI and the environmental assessment on the agency's public website.

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

Talia A. Lindheimer

Attachment:       Finding of No Significant Impact


A food-contact notification (FCN No. 1224), submitted by ColorMatrix Group, to provide for the safe use of sodium borohydride used in conjunction with palladium acetate (2+) salt (referred to by the trade name HyGuardTM) as an oxygen scavenging system in polyethylene terephthalate (PET) packaging systems.   Palladium may be incorporated into the liner layer at a level up to 50ppm. This FCS system is intended for use in contact with Food Types I, II, IVA-B, and VIA-C under Use Conditions E-G. 

The Office of Food Additive Safety 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, dated August 7, 2012.

In the course of the review, it was noted that the EA contains several non-substantive errors, primarily related to the numbering and listing of attachments.   Format item 15 of the EA lists non-confidential attachments, Attachments 1-3, 5, 7-11.   The numbering of these attachments is accurate. Format item 16 lists confidential Attachments 4, 6, 12, 13 and 14. Attachment 6 is not cited within the EA, so this attachment was not considered as supporting documentation to this FONSI. 

The notifier submitted a confidential version of the EA, which is listed as being Attachment 14; however the document was submitted as a second attachment 10. This appears to be a typographical error. Separate confidential and non-confidential versions of the EA are not permitted. The EA is a public document and thus the confidential EA was not considered during the course of the review. This FONSI is based only on the non-confidential EA. 

Beverage container closures are routinely recycled; therefore OFAS focused its evaluation on the potential impacts that may result on recycling streams as a result of consumer use and disposal of closures containing the FCS. The FCS is currently used in PET packaging systems and has not been shown to adversely impact recycling streams. The addition of palladium to the bottle cap liner is not expected to alter the contribution of the FCS to recycling streams. The results of this FCN becoming effective for the uses of sodium borohydride in conjunction with palladium acetate (2+) salt are not expected to be significant.

The resources/energy to produce a closure utilizing the FCS will at most be the same as a conventional closure containing other polymer additives. In many cases, the overall use of resources/energy when using the FCS to produce a packaging will be substantially less, because of the light-weighting opportunities offered. Therefore, the replacement of other additives or other packaging types by the FCS technology is not expected to have any adverse effect on the use of natural resources and energy in the production of packaging systems, and most likely will offer significant improvements.

Prepared by     __________________________________________Date: October 17, 2012
Talia A. Lindheimer
Office of Food Additive Safety        
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by   __________________________________________Date: October 17, 2012
Annette M. McCarthy, Ph.D.
Senior Science and Policy Staff
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

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