1995S-0316
RPT 242
Volume 176-177

Volume 176

Cover Letter

Letter from CFSAN to Ingredia

Letter from Ingredia to CFSAN

Declarative Statement

New Dietary Ingredient Notification for Lactium

Letter from Ingredia to CFSAN

New Dietary Ingredient Notification for Lactium

Appendix 1 - Lactium’s specifications

Appendix 2 - Lactium’s analysis certificates

Appendix 3 - Gomond, P. (Study Director); Miermon, M. (Technician). 2003. Acute Oral Toxicity Test in the Rat. Acute Toxic Class Method: Test Substance: ING 911 - DRAFT. [Test Facility] EVIC; France. [Sponsor] INGREDIA; France (July 17, 2003). Study: Tj 290 / 03-2070.

Appendix 4 - OECD. 1997. In vitro Mammalian Cell Gene Mutation Test (Guideline No. 476). In: Guidelines for the Testing of Chemicals. Organisation for Economic Co-Operation and Development (OECD); Paris, Vol. 2.

Appendix 5 - Dufour, P. (Study Director); Miermon, M. (Responsible Technician); Urbaniak, R. (Anatomopatholigist). 2003. Oral Toxicity Test After 28-Day Repeated Administration in the Rat of a Food Supplement ING 911 - DRAFT. [Test Facility] EVIC; France. [Sponsor] INGREDIA; France (Oct. 10, 2003). Study: Tj 289 / 03-2070.

Appendix 6 - Forichon, A. (Study Director); Aujoulat, M. (Deputy Study Director); Withers, P. (Quality Assurance); Demagny, B. (Study Monitor). 2001. ING 911 - In Vitro Mammalian Cell Gene Mutation Test on L5178Y Mouse Lymphoma Cells TK+/- (Microtitre Method). [Test Facility] MDS Pharma Services; France. [Sponsor] INGREDIA; France (Jan. 24, 2001). Study Number: 755/002.

Appendix 7 - Forichon, A. (Study Director); Aujoulat, M. (Deputy Study Director); Withers, P. (Quality Assurance); Demagny, B. (Study Monitor). 2000. ING 911 - Bacteria Reverse Mutation Test (Plate Incorporation and Preincubation Methods). [Test Facility] Pheonix International Preclinical Services Europe; France. [Sponsor] INGREDIA; France (June 16, 2000). Pheonix International Study Number: 755/001; Sponsor Study Number: ING 911/AMTE/E COLI, continued

Volume 177

Appendix 8 - Cover sheet

Appendix 8 - GB : Messaoudi, M.; Nejdi, A.; Marchand, T. 2001. Study Report Version 1.0. Study of the Effects of “ING 911” Hydrolysate, Given at a 150 mg/kg Daily Dose Throughout Pregnancy, on the Maternal Behaviour and the Physical, Neurmotor and Behavioural Development of Youngs Between Birth and Adulthood in Wistar Rat. [Investigator] Centre de Recherche ETAP - Applied Ethology; France. [Sponsor]
INGREDIA; France (Nov., 2001). Protocol Code: INGREDIA - 18/1100/ING 911 - Behavioural Toxicology (Experimental Period: Jan. - July 2001).

Appendix 8 - F : Original in French

Appendix 9 - GB : Plenat, F. 2001a. Study Report: Study of the Effects of the “ING 911” Hydrolysate, Given Orally to Wistar Mother Rats Throughout Pregnancy. [Test Facility] Laboratoire d’Anatomie Pathologique - Faculte de Medecine; France. [Sponsor] INGREDIA; France (May, 2001). Protocol Code: INGREDIA-8/100/Pathoanatomy (Experimental Period: Feb. - Apr. 2001).

Appendix 9 - F : Original in French

Appendix 10 - Cover Sheet

Appendix 10 - GB : Plenat, F. 2001 b. Study Report: Study of the Effects of the “ING 911” Hydrolysate, Given to Female Rats Throughout Pregnancy, on Internal and External Malformations in Young Second-Generation Wistar Rats. [Test Facility] Laboratoire d’Anatomie Pathologique - Faculte de Medecine; France. [Sponsor] INGREDIA; France (Oct., 2001). Protocol Code: INGREDIA-13-2/0501/Pathoanatomy-F2 (Experimental Period: July-Aug. 2001).

Appendix 10 - F: Original in French

Appendix 11 - Miclo, L., Perrin, E., Driou, A., Papadopoulos, V., Boujrad, N., Vandresse, R., Boudier, J., Desor, D., Linden, G., and Gaillard, J.; Characterization of a-Casozepine, a Tryptic Peptide from Bovine alpha-s1 Casein with Benzodiazepine-like Activity. The FASEB Journal express article 10.1096/fj.00-0685fje. Published online June 8, 2001.

Appendix 12 - Cover Page

Appendix 12 - Messaoudi, M, Jung P, Grasmuck V, Desor F, Desor, D. Addictive effect of the product <<ING 912>> intraperitonally administered in the Conditioned Place Reference in the male Wistar Rat. [Investigator] Centre de Recherche ETAP - Applied Ethology; France. [Sponsor] INGREDIA; France (Oct., 1998). Protocol Code: INGREDIA - 3/02980/ING 912 - (Experimental Period: April - May 1998).

Appendix 13 - Cover Page

Appendix 13 - Messaoudi, M, Desor F, Desor, D. Assessment of behavioral effects of <<ING 913>> peptide. Centre de Recherche ETAP - Applied Ethology; France. [Sponsor] INGREDIA; France (Dec., 1999). Protocol Code : INGREDIA 01/0399- (Experimental Period : April 1999)

Appendix 14 - Cover Page

Appendix 14 - Messaoudi, M, Grasmuck V, Desor F, Desor, D. Tolerance to the anxiolytic effect of the product <<ING 913>> intraperitoneally administered on conditioned defensive burying in the male Wistar Rat. [Investigator] Centre de Recherche ETAP - Applied Ethology; France. [Sponsor] INGREDIA; France (October, 1998). Protocol Code : INGREDIA-7/0698 - (Experimental Period: July 1998).

Appendix 15 - Cover Page

Appendix 15 - GB: Bresson, JL; Elghozi, JL; Desor, D; Messaoudi, M. [Sponsor] INGREDIA; France (July 2000). Protocol Code: INGREDIA-04/0799 - (Experimental Period: September 1999 -February 2000).

Appendix 15 - F : Original in French

Appendix 16 - Cover Page

Appendix 16 - GB : Bourdon, L. (Main Investigator); Canini, F.; Lanoir, D.; Martin, S.; Fidier, N.; d’Aleo, P.; Roux, A.; Denis, J.; Chapotot, F.; Becq, G.; Lanoir, D. (Author). 2003. Analysis of the Chronic Psychophysiological Effects of ING 911. [Sponsor INGREDIA; France] (Mar., 2003). Study: Tj 289/03-2070.

Appendix 16 - F : Original in French

Appendix 17 - U.S. EPA. 1997. Exposure Factors Handbook. U.S. Environmental Protection Agency (U.S. EPA); Washington, DC. [PB98-124217].

Appendix 18 - Fennema, O.R. (Ed.). 1996. Food Chemistry (3rd Ed.). Marcel Dekker; New York, pp. 847.

Appendix 19 - Holland, B., Welch, A.A., Unwin, I.D., Buss, D.H., Paul, A.A., and Southgate, D.A.T. (Eds.). 1996. Milk and Milk Products. &-I: McCance and Widdowson’s The Composition of Foods (5th Ed.). The Royal Society of Chemistry; Cambridge, pp. 73-74.

Appendix 20 - U.S. EPA. 2002. Child-Specific Exposure Factors Handbook (Interim Report). U.S. Environmental Protection Agency (U.S. EPA), National Center for Environmental Assessment; Washington, DC. [EPA-600-P-00-002B].