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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000491

Date: April 26, 2005

From: Environmental Review Group (ERG)/Supervisor
Division of Chemistry Research and Environmental Review (HFS-246)

Subject: FCN No. 491 - Poly(oxy-1,2-ethanediyl), alpha-sulfo-omega-(undecyloxy)-, sodium salt, branched and linear for use as an emulsifier in adhesives.

Notifier: Clariant GmbH
Division Functional Chemicals
Frankfurt, GERMANY

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

We have reviewed the claim of categorical exclusion for the above referenced notification and have concluded that categorical exclusion is warranted. The claim of categorical exclusion cites the section under which categorical exclusion is warranted, 21 CFR 25.32 (i), states compliance with the categorical exclusion criteria, and states that no extraordinary circumstances exist that require the submission of an environmental assessment.

We conclude that the notifier's claim of categorical exclusion is warranted even though we had initially asked for an EA for this action. The basis for our conclusion on this action is provided in the attached document entitled, "Supplement to the Environmental Information for Food Contact Notification No. 491."

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

Annette M. McCarthy, Ph.D.

Attachment





Supplement to the Environmental Information
for Food Contact Notification No. 491

The notifier for Food Contact Notification (FCN) 491 submitted a claim of categorical exclusion under 21 CFR 25.32(i). The food contact substance (FCS) that is the subject of this FCN is an emulsifier that will be used as a component of pressure-sensitive adhesives that are applied to stickers, labels, and tapes, in direct contact with food. After an initial review of the information contained in the FCN, the Environmental Review Group (ERG) determined that the claim of categorical exclusion was not warranted because it questioned the applicability of § 25.32(i) to stickers, tapes, and labels as food packaging material under such section. The notifier, subsequently, submitted an environmental assessment (EA), dated February 25, 2005, with a letter that reiterated their views on the applicability of the categorical exclusion to the proposed use.

After further review, we have determined that food contact substances, used in the manufacture of pressure-sensitive adhesives that are present in finished food packaging material, e.g., as stickers, labels, and tapes applied to food, when such substances are present at not greater than 5 percent-by-weight of the sticker, label or tape, are subject to the categorical exclusion in § 25.32(i). Such substances are similar to those that were used as a basis for the categorical exclusion in § 25.32(i). In addition, the use and disposal of these substances are consistent with the factors that the agency used as a basis for the exclusion in § 25.32(i) (62 FR 40570 at 40579-81; July 29, 1997). Such factors include: 1) only very small quantities of the substances are expected to enter the environment at sites where the substances are used in the manufacture of food-packaging materials; 2) only extremely low levels of substances, if any, could be expected to enter the environment as a result of disposal of food-packaging materials; and 3) virtually no change in the use of natural resources and energy would be expected because the substances would be replacing other, currently regulated substances, and would not affect the uses of the packaging materials to which they were added.

Prepared by ____________________________________________ Date: April 26, 2005
Annette M. McCarthy, 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: April 26, 2005
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