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U.S. Department of Health and Human Services

Food

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Environmental Decision Memo for Food Contact Notification No. 000772

Date:January 16, 2008
From:Chemist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject:FCN No. 772 - Acrylate monomers in formulations, containing an optional photoinitiator, intended for use in radiation cured coatings and adhesives.
Notifier:RadTech International North America
Food Packaging Alliance
 
To:Division of Food Contact Notifications (HFS-275)
Attention: Kenneth McAdams
Through: Layla I. Batarseh, Ph.D., Supervisor, ERT

The food contact substance (FCS) is a mixture of one or more of tripropylene glycol diacrylate, trimethylolpropane triacrylate, trimethylolpropane ethoxylate triacrylate, and bisphenol A diglycidyl ether diacrylate as monomer(s) and the difunctional alpha-hydroxy ketone, described in the notification, as an optional photoinitiator. The mixture is cured by either ultraviolet (UV) or electron beam (EB) irradiation.

The above referenced notification contains two proposed uses, which are coatings and adhesives, for the FCS under both single and repeated use conditions. The notifier submitted a claim of categorical exclusion under 21 CFR 25.32(i) for the proposed use of the FCS as a component of a coating of single use, finished, food packaging material. Also, the notifier submitted a claim of categorical exclusion under 21 CFR 25.32(j) for the proposed use of the FCS as a component of a food contact surface intended for repeated use.

We have reviewed the claims of categorical exclusion and have concluded that categorical exclusion is warranted for the proposed use of the FCS as a coating or a component of a coating intended for single and repeated use. The claims of categorical exclusion cite the sections—21 CFR 25.32(i) and (j)—under which categorical exclusion is warranted, state compliance with the categorical exclusion criteria, and state that no extraordinary circumstances exist that require the submission of an environmental assessment.

The notifier submitted an environmental assessment (EA) for the proposed use of the FCS as a component of adhesives. Adhesives are not coatings, and adhesives are not, in general, categorically excluded from the need to prepare an EA. Correspondingly, uses of adhesives or components of adhesives in finished food packaging materials at more than five percent require preparation of an EA. Therefore, the need to submit an EA was appropriate in this instance because the notification, FCN 772, does not place a specific limitation on the FCS, when intended for use in adhesives, to contribute with certainty always less than five percent by weight to a finished food contact article.

We have reviewed the EA. The EA contains a discussion of the potential impact posed by use and disposal from use of the FCS on use of resources and energy. In the penultimate statement of that discussion, a reference was made to plasticizers. We regard the reference to plasticizers as being an unintentional misidentification of the resins that are the explicit topic of the concluding paragraph. Held in that regard, the introduction of the word "plasticizers" into the discussion was due to a trivial editing error having no important effect on the validity of the final environmental conclusion ending the discussion.

We have prepared the attached Finding of No Significant Impact (FONSI) for the use, proposed in FCN 772, of the FCS as an adhesive in articles or as a component of articles that contact food. After this notification becomes effective, this FONSI and the notifier's environmental assessment, dated November 8, 2007, may be made available to the public in response to a FOIA request, and we will post redacted copies of them on the internet at http://www.cfsan.fda.gov/~rdb/opa-envt.html.*

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

 

William H. Lamont

 

Attachment:
Finding of No Significant Impact


Finding of No Significant Impact

A food contact notification (FCN No. 772), submitted by Food Packaging Alliance of RadTech International NA, to provide for the safe use of a mixture of one or more of tripropylene glycol diacrylate, trimethylolpropane triacrylate, trimethylolpropane ethoxylate triacrylate, and bisphenol A diglycidyl ether diacrylate as monomer(s) and the difunctional alpha-hydroxy ketone, described in the notification, as an optional photoinitiator. The mixture is intended for use in coatings and adhesives and is cured by either ultraviolet (UV) or electron beam (EB) irradiation.

The Environmental Review Team 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 November 8, 2007.

 

Prepared by __________________________________________Date: January 16, 2008
William H. Lamont, Chemist
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: January 16, 2008
Layla I. Batarseh, Ph.D., Supervisor
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration


*The FDA web links cited in this article are now out of date. The new FDA websites can be accessed from the Food Ingredients and Packaging section under the Food topic of www.fda.gov.