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GRAS Notice (GRN) No GRAS Notice (GRN) No. 596 http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/default.htm ORIGINAL SUBMISSION August 9, 2015 Dr. Leah Rosenfeld Consumer Safety Officer Division of Biotechnology and GRAS Notice Review Office of Food Additive Safety U.S. Food and Drug Administration Tel: 240-402-1386 Email:[email protected] Dear Dr. Rosenfeld Attached please find our revised GRAS notice for breadfruit. We are very grateful for all of the comments and suggestions from your team. We have incorporated all of the information and i t has improved our application considerably. Thank you for all of your help and we are happy to provide additional information as needed. Kind Regards, (b) (6) Susan J. Murch, PhD Professor & Canada Research Chair Chemistry Department, Room 350, Fipke Centre 3247 University Way, University of British Columbia Kelowna, British Columbia, Canada, V1V 1V7 Tel: 250-807-9566 \ UBC a place of mind G ~ N 00D5Cfb T H E U N I V E R S I TY 0 F B R I T I S H C 0 l U M B I A August• 9, 20 15 Dr. Leah Rosenfeld Consumer Safety Officer Division of Biotechnology and GRAS Notice Review Office of Food Additive Safety U.S. Food and Drug Administrat ion Tel: 240-402 -1386 Emai i: [email protected] Dear Dr. Rosenfeld Attached please find our revi sed GRAS notice for breadfruit . We are very grateful for all of the comments and suggestions fr om your team . We have incorporated all of the information and it has improved our application consi derably. Thank you for all of your help and we are happy to provide additional information as needed. Kind Regards, (b) (6) Susan J. Murch, PhD Professor & Canada Research Chair Chemistry Departm ent, Room 350, Fipke Centre 3247 Universit y Way, University of British Columbia Kelowna, British Col um bia, Canada, VlV 1V7 Tel: 250-807-9566 [R1 ~(C[Ell~~[Q) AUG 1'8 20\5 OFFICE OF FOO D ADDITIVE SAFElY UBC a place of mind ~ T H E U N I V E R S I TY 0 F B R I T I S H C 0 L U M B I A August- 9, 2015 Dr. leah Rosenfeld Consumer Safety Officer Division of Biotechnology and GRAS Notice Review Office of Food Additive Safety U.S. Food and Drug Administration Tel : 240-402-1386 Email:[email protected] Dear Dr. Rosenfeld The enclosed DVD is virus free by Sophos Endpoint Security and Control. Kind Regards, (b) (6) Susan J. Murch, PhD Professor & Canada Research Chair Chemistry Department, Room 350, Fipke Centre 3247 University Way, University of British Columbia Kelowna, British Columbia, Canada, VlV 1V7 Tel: 250-807-9566 lPd~CG~DW~[Q) AUG I '8 2015 OFFICE OF FOODADDITIVE SAFETY GRAS EXEMPTION CLAIM The PlantSMART Labs at the University of British Columbia (UBC), hereby notifies the U.S. Food and Drug Administration that the uses of breadfruit (Artocarpus altilis Parkinson (Fos) and hybrids) flours described below are exempt from the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act because PlantSMART has determined that such uses are generally recognized as safe (GRAS). PlantSMART made this GRAS determination based on scientific procedures, a comprehensive search of the scientific literature, meta -analysis of the scientific nutritional literature and government databases as well as laboratory testing to establish safety and a lack of toxicity. These findings are described in the following sections, and the evaluation accurately reflects the conditions of the intended use of this substance in foods. 1.1 Name and Address of Notifier PlantSMART Labs University of British Columbia Kelowna, British Columbia, Canada, V1V 1V7 Contact Name: Susan J. Murch Professor & Canada Research Chair Chemistry, Room 350 Fipke Centre 3247 University Way Telephone: (250) 807-9566 e-mail: [email protected] As the notifier, PlantSMART, University of British Columbia accepts responsibility for the GRAS determination that has been made for breadfruit (Artocarpus altilis and hybrids) flours as described in the subject notification; consequently breadfruit flour described herein is exempt from pre-market approval requirements for food ingredients. 1.2 Name of GRAS Substance The tropical tree species Artocarpus altilis Parkinson (Fos) and hybrids of Artocarpus altilis x Artocarpus mariannensis are most commonly known as breadfruit in English or ‘ulu’ in the Pacific but may also be known as: árbol de pan, fruta de pan, pan, panapen, (Spanish), arbre à pain, fruit à pain (French), beta (Vanuatu), bia, bulo, nimbalu (Solomon Islands), blèfoutou, yovotévi (Bénin), brotfruchtbaum (German), broodvrucht, broodboom (Dutch), cow, panbwa, pain bois, frutapan, and fruta de pan (Caribbean), fruta pao, pao de massa (Portuguese), kapiak (Papua New Guinea), kuru (Cook Islands), lemai, lemae (Guam, Mariana Islands), mazapan (Guatemala, Honduras), meduu (Palau), mei, mai (Federated States of Micronesia, Kiribati, Marshall Islands, Marquesas, Tonga, Tuvalu), mos (Kosrae), rata del (Sri Lanka), rimas (Philippines), shelisheli (Tanzania), sukun (Indonesia, Malaysia), ‘ulu (Hawai‘i, Samoa, Rotuma, Tuvalu), ‘uru (Society Islands), uto, buco (Fiji). Breadfruit has a long traditional use as fresh food but dried and ground breadfruit will be sold as a food ingredient. The common name for dried, ground breadfruit will be “breadfruit flour”. 1.3 Conditions of Use Breadfruit will be dried and ground into a milled product intended for use as an ingredient in various baked goods, breads, cereals, porridges, and pasta products. Breadfruit could also be used as a gluten-free substitute for other flours breads and snack foods. 1.4 Basis for GRAS Determination The GRAS determination for the intended uses of breadfruit flour is based on scientific procedures as described under 2 1 CFR§170.30. Information provided includes comprehensive searches of the literature through May 2015 conducted by PlantSMART served as the basis for preparation of a monograph summarizing the totality of the available information germane to determining the safety of the intended uses of breadfruit flour. Detailed analysis of the composition of macronutrients, micronutrients, and anti -nutritional factors demonstrated that breadfruit flour is similar to other commonly consumed flours. A comprehensive search and meta -analysis of the nutritional data was conducted along with compilation of scientific literature and government databases as well as laboratory testing of as well as studies of digestibility and responses in cell culture experiments. It may be concluded that breadfruit flour is safe under the intended conditions of use because the total exposure to breadfruit flour and its constituents resulting from these uses is well within levels shown to be safe by both current levels of consumption of other flours, which are compositionally very similar to breadfruit flour and the long history of use of fresh breadfruit by human populations. The estimated intakes of breadfruit flour, even for the highest users, are below the level shown to have no adverse effects or nutritional hazards, based on nutritional composition comparisons and human use. Therefore, the intended uses of breadfruit flour are determined to be safe and GRAS. Determination of the safety and GRAS status of breadfruit flour for dire ct addition to food under their intended conditions of use was made through evaluation of the scientific literature . Therefore, breadfruit flour is GRAS by scientific procedures under the conditions of use described. 1.5 Availability of Information The data and information that serve as the basis for this GRAS notification will be sent to the US Food and Drug Administration (FDA) upon request or will be available for review and copying at reasonable times at the offices of the PlantSMART, University of British Columbia. Notice to US Food and Drug Administration that the Use of Breadfruit (Artocarpus altilis and A. altilisൈA. mariannensis) Flour is Generally Recognized As Safe Submitted by the Notifier: Plant Secondary Metabolite Analytical Research Team (PlantSMART) Labs University of British Columbia Kelowna, British Columbia, Canada, V1V 1V7 Prepared by Susan J. Murch, PhD Department of Chemistry University of British Columbia 3247 University Way Kelowna, British Columbia, Canada, V1V 1V7 Tel: 250-807-9566 e-mail: [email protected] Table of Contents I. GENERAL INFORMATION .................................................................................................. 1 1.1. Submission Type ............................................................................................................... 1 1.2. Electronic Files .................................................................................................................. 1 1.3. Date of Most Recent Meeting with FDA .........................................................................1 1.4. Correspondence with FDA................................................................................................ 1 II. INFORMATION ABOUT THE NOTIFIER ....................................................................... 1 2.1. Notifier ............................................................................................................................... 1 2.2. Contact Person: .................................................................................................................. 2 2.3. Agent or Attorney Authorized to Act on Behalf of the Notifier .....................................2 III. GENERAL ADMINISTRATIVE INFORMATION ..........................................................2 3.1. Common or Usual Name of the Notified Substance
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