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인사말 / 1

제 1 장. 기능성 식품의 정의

기능성 식품이란? ·························································· 2

과학적 근거에 대한 이해 ················································ 3

과학적 근거가 될 수 있는 임상시험은? ····························· 4

과학적 근거가 될 수 있는 선행 연구는? ··························· 5

제 2 장. 왜 기능성 식품에 주목해야 하는가?

한국의 기능성 식품시장 동향 ··········································· 8

일본의 기능성 식품시장 동향 ········································· 11

한국과 일본의 기능성 식품제도 비교 ······························ 14

일본의 기능성표시식품제도에 주목해야 하는 이유 ············ 15

제 3 장. 일본의 기능성표시식품 신고 가이드라인

기능성표시식품으로서의 충족 기본요건 ···························· 18

기능성 표시의 범위 ······················································· 19

저작권법 상의 유의사항 ················································· 20

안전성에 관한 평가방법 ················································· 21

생산･제조 및 품질관리에 관한 사항 ································ 24

건강피해 정보수집에 관한 사항 ······································ 27

기능성에 관한 사항 ······················································· 27

포장 표시 및 정보공개 방법 ··········································· 28

신고 방법에 관한 사항 ·················································· 32

제 4 장. 기능성 관여성분에 대한 분석

기능성 관여성분이란 ······················································ 36

기능성에 관한 작용기서에 대해 ······································ 37

기능성 관여성분의 정량･정성 확인에 대해 ······················· 38

제도 대상에서 제외되는 성분에 대해 ······························ 41

추출물(엑기스)의 취급 ···················································· 43

제 5 장. 기능성의 근거 1 - 임상시험

최종 제품을 이용한 임상시험에 대해 ······························ 46

임상시험 대상자 ···························································· 47

기타 임상시험 대상자에 관한 규정 ································· 50

기능성 근거로서 주관적인 지표를 이용하는 경우 ············· 51

제 6 장. 기능성의 근거 2 - 연구리뷰

연구리뷰란 ···································································· 54

연구 리뷰의 특성 ·························································· 56

연구 리뷰의 유의 사항에 대해 ········································ 58

제 7 장. 일본 기능성표시식품의 신고현황

기능성표시식품 신고 현황 ·············································· 60

기능성표시식품 종류별 현황 ··········································· 62

기능성 용도별 현황 ······················································· 64

관여성분별 현황 ···························································· 65

신고 기업의 현황 ·························································· 67

제 8 장. 한국산 기능성표시식품 사례 (당조고추)

① 당조고추의 기능성에 대한 가설 설정 ·························· 70

② 가능성 조사 실시 ····················································· 71

③ 성분 분석 ································································ 73

④ 임상 시험 실시 ························································ 74

⑤ 학술 논문화 ····························································· 78

⑥ 연구 리뷰 ································································ 80

⑦ 기능성표시식품 신고 ················································· 80

제 9 장. 한국산 식품의 기능성표시식품화 가능성

김치 ············································································· 86

인삼 (홍삼) ··································································· 88

제 10 장. 기능성표시식품제도를 활용한 상품 설계

식품의 형태별 생산 조건 ··············································· 92

상품 설계를 위한 리서치 ··············································· 94

상품 형상 ····································································· 95

기능성 어필과 원료 혼합 시 유의 사항 ··························· 96

신고 상품의 포장 표시 내용 ··········································· 97

실제 매장에서 판매 환경의 변화 ···································· 99

광고 시 유의점 ··························································· 101