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2 EU

3 GRAS NDI

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4 GRAS Novel Food Novel Food

Food ---------------------------------------------------------122 Novel Food

5 EU EU FDA FSA FFSA 1

6 () () () 2

7 FDA-CFSAN FICC() DANISCO.USA() Masaoka & Associates, Inc. EU EFSA FSA Coutrelis & Associates () Ajinomoto Pharmaceuticals Europe Ltd() 3

8 substance labeling,claim,declaration ingredient (product) conventional food 4

9 Novel Food NDI Dietary Supplement GRAS Conventional food EU Novel Food PARNUTS Food Supplement CoQ10 5

10 NDINew Dietary Ingredient GRAS Novel Food() 2 3 6

11 (Food Additives Amendment, Section 409, Federal Food Drug and Cosmetic Act ) FDA (Delaney Clause) (Substances Generally Recognized As Safe, GRAS )GRAS GRAS Food Additives 21CFR170.3 Definitions GRAS FDA Guidance for Industry: Summary Table of Recommended Toxicological Testing for Additives Used in Food Low Toxicological Potential, Intermediate Toxicological Potential, High Toxicological Potential,12 ppb1000 ppb Concern Levels 2 Low(I)Intermediate(II)High(III) concernconcern Level 7

3 Definitions GRAS FDA Guidance for Industry: Summary Table of Recommended Toxicological Testing for Additives Used in Food

12 ppb 500 ppb 250 ppb 50 ppb 25 ppb 12 ppb A B C 2-1 8

13 Concern Levels Redbook 2000: Toxicological Principles for the Safety Assessment of Food Ingredients Chapter III. Concern Levels and Recommended Toxicity Studies GRAS (Generally Recognized as Safe) GRAS (Generally Recognized as Safe) 21CFR (a)(1) GRAS (a)(2)gras the views of experts qualified by scientific training and experiences (b) 21CFR 2-2 PART 170 FOOD ADDITIVES Subpart BFood Additive Safety Eligibility for classification as generally recognized as safe (GRAS). (a) General recognition of safety may be based only on the views of experts qualified by scientific training and experiences to evaluate the safety of substances directly or indirectly added to food: The basis of such views may be either (1) scientific procedures or (2) in the case of a substance used in food prior to January 1, 1958, through experience based on common use in food. General recognition of safety requires common knowledge about the substance throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food (b) General recognition of safety based upon scientific procedures shall require the same quantity and quality of scientific evidence as is required to obtain approval of a food additive regulation for the ingredient. General recognition of safety through scientific procedures shall ordinary be based upon published studies which may be corroborated by unpublished studies and other data and information. 9

30 (a)(1) 1958 1 1 GRAS (a)(2)gras the views of experts qualified by scientific training and experiences (b) 21CFR 2-2 PART 170 FOOD ADDITIVES Subpart BFood Additive Safety 170.

14 GRAS GRAS FDA FDA GRAS (GRAS Affirmation) GRAS GRASGRAS Notification GRASSelf determined GRAS Self affirmed GRAS GRAS GRAS GRAS Petition GRAS GRAS Notification GRAS GRAS Self determined GRAS 2-3 GRAS 1958 FDA GRAS 1969 FDA GRAS GRAS 1997 GRAS CAS GRAS NDINew Dietary Ingredient 1994 Dietary Supplement Health and Education Act: DSHEA 10

Self determined GRAS 2-3 GRAS 1958 FDA GRAS 1969 FDA GRAS 370 1972-1980 1997 25 GRAS 1997

15 NDINew Dietary IngredientFDA 1994 Grandfathered substance FDA NDI NDI GRAS 21CFR190.6 Requirement for premarket notification NDI will reasonably be expected to be safe GRAS GRAS NDI CFR PART 190DIETARY SUPPLEMENTS Subpart BNew Dietary Ingredient Notification Requirement for premarket notification. (b)(4) The history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe, including any citation to published articles or other evidence that is the basis on which the distributor or manufacturer of the new dietary supplement will reasonably be expected to be safe. Any reference to published information offered in support of the notification shall be accompanied by reprints or photostatic copies of such references. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation; and 11

16 NDI FDA GRAS (New Dietary Ingredient, NDI) GRAS GRAS (1997 ) FDA 1990 Nutrition Labeling and Education ActNLEA) Health Claims Dietary Supplement Health, and Education Act (DSHEA) / Structure/Function Claims Grandfather 30 FDA / 1997 FDA FDA Modernization Act National Academy of Science (NAS) Authoritative Statement Qualified Health Claims 3 1 / / NDI 12

Education ActNLEA) Health Claims 1994 10 Dietary Supplement Health, and Education Act (DSHEA) /

17 / 2-5 / Nutrition Labeling and Education Act, NLEA Significant Scientific Agreement FDA FDA FDA FDA

18 Dietary Supplement Health and Education Act, DSHEA (1) (2) (3) (4) / Structure/Function Claims FDA 14

19 health claims NLEA 2-8 DSHEA / Structure/Function ClaimsFDA FDA disease claimsfda health maintenance claims non-disease claims FDA claims for common, minor symptoms associated with life stages FDA express disease claims implied disease claims FDA 15

claims FDA claims for common, minor symptoms associated with

20 FDA FDA OMBOffice of Management and Budget Food and Drug Modernization Act, FDAMA 1997 FDA National Academy of Science (NAS) Authoritative Statement FDAMA Qualified Health Claims 2000 FDA Consumer Health Information for Better Nutrition (1990) Significant Scientific Agreement ( ) 16

Authoritative Statement FDAMA Qualified Health Claims 2000 FDA Consumer

21 5 FDA Significant Scientific Agreement 2-10 BB (Qualified Health Claims) QHC 2006 Dietary Supplement and Nonprescription Drug Consumer Protection act FDA

22 270 HHSHealth and Human Services Serious Adverse Event (a) Adverse Event Serious Adverse Event Serious Adverse Event Report FDA (b) (c) 15 New Medical Information 1 new medical information15 (d) MedWatch 18

23 (e) A B (f) (g) (h)preemption (g) (j) HHSHealth and Human Services 19

24 NDI FDA objection FDA FDA ///// androstenedione FDA NDIs androstenedione androstenedione FDA androstenedione DSHEA DSHEA NDIs 2004 Anabolic Steroid Control Act androstenedione Ephedra sinica /Ephedra sinica( )( )() Piper methysticum 20

25 Piper methysticum() 1 Piper methysticum 1 () NDI FDA 4 reasonably expected to be safe FDA reasonably expected to be safe FDA NDI FDA FDA sn-12-dag

26 DAG

27 EU EU 1 EU EU Novel FoodPARNUTS 3-1 Novel Food EU Novel Food 1997 GMO GMO 1829/2003/EC 1830/2003/EC GMO PARNUTS EFSA Commission EU Directive 3-1 EU 1 EAS

28 Novel Food Novel Food 1997/258/EC EU GMO /2003/EC 1830/2003/EC GMO EU EU EU EU EU EU EU Commission EFSAEFSA EU Commission EU Commission EU EUCommission 2007 EFSA EU 3-2 EU

29 EU Commission a cefsa EFSA d e Novel Food EU 2007 : a EUCommission b e c d EFSA 3-3 Novel Food EU

30 Novel Food Novel Food EU EU? A. EU Commission EU Commission Commission B. EU Commission Commission25 EU EU Novel Food EU Commission EFSA EFSA EU Novel Food 3-4 EU EAS2006 EU 1997/618/EC 26

31 PARNUTS PARNUTSfood for particular nutritional uses; EU 89/398/EEC 1998 PARNUTS EU PARNUTS PARNUTS PARNUTS EU 27

32 EU PARNUTS EU PARNUTS EU 2001/15/EC PARNUTS PARNUTS EU PARNUTS EU EFSA EFSA 2001 SCFEFSA EU PARNUTS 1989 EU 15 EU EU 5 28

33 EU EU PARNUTS EU EU EU EFSA EFSA EFSA EU EU EFSA EFSA EFSA EFSA

34 EU EUCommission C. EFSA 2007 a b : EFSA EU /2006/EC

35 a. RDA RDA RDA RDA b. 31

36 10% EU K DGCCRF EU EU A D BVL 32

37 EU MLX249MCA Boarder Substances MCA 2 Rapid Alert System for Food and FeedRASFFEC 178/2002/EC RASFF RASFF Alert notification

38 Information notification News notification RASFF Advisory Committee on Novel Food and Process(ACNFP) Web Mike Gasson FSA 20 EU 97/618/EC 34

39 OmegaTech FSA DHA DHA Gold 3 DHA gold - Application dossier Final Initial Opinion on DHA Gold Application for the Approval of DHA-rich Oil from OmegaTech(Germany) Schizochytrium sp. DHA-rich oil GRAS Schizochytrium sp GM Advisory Committee 1.Novel Food 2.Novel Food 3. source organism

40 3 DHA DHA 36

41 Novel Food in vitro in vivo FDA GRAS GRAS 37

42 FSA FDA Qualified Health Claim GRAS EU EU Novel Food EU EU 38

43 39

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