초록

본 과제의 최종목표는 원료의 특성상 독성이있거나 약리작용이 강하여 건강기능식품원료로 적합하지 않은 원료를 건강기능식품공전에 추가 고시하기 위한 근거를 마련하는데 있음. 이를 위한 주요 연구내용으로는 1) 건강기능식품에 사용할 수 없는 원료 (78개 품목)에 대한 상세 모노그래프를 작성하고, 2) 건강기능식품에 사용할 수 없는 원료로 확대 고시되어야 할 품목을 제안하는 것임.

Abstract ▼

This study was undertaken to expand the list of herbs, medicinal foods, or oriental medicines which are prohibited in the health functional food ingredients. This goal could be attained by conducting the following two objectives: 1) providing detailed monographs for the 78 items announced as the neg

This study was undertaken to expand the list of herbs, medicinal foods, or oriental medicines which are prohibited in the health functional food ingredients. This goal could be attained by conducting the following two objectives: 1) providing detailed monographs for the 78 items announced as the negative list for health functional food ingredients; 2) suggesting new items which shoud be additionally added in the negative list for the health functional food ingredients.
1. Preparation of the detailed monographs for the 78 items announced as the negative list for health functional food ingredients
1) Established the components ((1) identity: (2) toxicity/ safety information: (3) references) for the detailed monographs for the negative list for the health functional food ingredients.
2) The computer program for monograph preparation and database accumulation was designed.
3) Detailed monographs for the 78 items already announced as the negative list for health functional food ingredients were printed out from the computer program made in the present study.
2. Suggestion of new items which should be additionally added in the negative list for health functional food ingredients
1) Selected 92 items which need to be reviewed for the extension of the negive list for health functional food ingredients.
2) Designed the computer program for assessing the severeness of adverse reactions (or health risks) of individual herbs or health functional food ingredients by incorporating the basic toxicity/safety component and relevant score systems, and decided the cut-off point for the inclusion.
3) Suggested the 64 items of ingredients as the herbs or medicinal plants and materials which need to be additionally added in the negative list for health functional food ingredients.

목차 Contents

• 용역연구사업 연구결과보고서...1
• 표지...3
• 제출문 ...5
• 목차 ...7
• I. 연구개발결과 요약문...9
• 연구개발결과 요약문...9
• Summary...11
• II. 최종 연구개발과제 연구결과...13
• 제1장 최종 연구개발 목표...14
• 1.1 연구개발과제의 목표...14
• 1.2 연구개발과제의 목표달성도...20
• 1.3 국내.외 기술개발 현황...21
• 제2장 연구개발 내용 및 방법...33
• 2.1 연구개발 내용...33
• 2.2 연구방법...35
• 제3장 연구개발 결과...67
• 3.1 건강기능식품에 사용할 수 없는 원료에 대한 모노그래프 작성...67
• 3.2 ‘건강기능식품에 사용할 수 없는 원료’로 확대고시되어야 할 품목들에 대한 제안...132
• 제4장 연구결과 고찰 및 결론...152
• 4.1 검토대상 품목(92종)의 위해도 평가점수 히스토그램...152
• 4.2 평가점수에 따른 검토대상 원료의 단계별 위해도 분류...153
• 4.3 검토대상 품목(총 92종)의 평가문항 별 점수추이...154
• 4.4 위해도점수 cut-off 포인트의 적절성 검토...156
• 4.5 ‘건강기능식품에 사용할 수 없는 원료’로 추가 고시되어야 할 품목 제안...158
• 제5장 연구개발과제의 연구성과...159
• 5.1 활용성과...159
• 5.2 활용계획...160
• 제6장 기타 중요 변경사항...162
• 제7장 참고문헌...163
• 제8장 첨부서류...166