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第1章 健康機能食品産業及び製品動向
1. 健康機能食品をめぐる概要 ······················································································3
1-1. 概要 ·····················································································································31) 健康機能食品市場の環境変化 ··················································································32) 健康機能食品管理の政策課題 ··················································································3
1-2. 健康機能食品の原料認定および基準 ········································································41) 機能性原料認定のための評価原則 ··········································································122) 健康機能食品の品目拡大 ······················································································133) 健康機能食品の情報提供 ······················································································144) 副作用モニタリングシステム ··············································································14

2. 健康機能食品産業の動向および展望 ·······································································16
2-1. 概要 ···················································································································161) 市場概要 ·············································································································162) 製造業者の現況 ···································································································172-2. 韓国の健康機能食品市場動向 ················································································20
1) 2005年の市場現況 ································································································20
2) 2006年の市場現況 ································································································27
3) 2007年以降のの展望 ···························································································29
2-3. 健康機能食品専門店の現況 ···················································································30
1) 東遠F&B ···············································································································31
2) 韓国人参公社 ·······································································································323) プルムウォン健康生活 ··························································································324) ヒュロム ·············································································································325) ビタミンハウス ···································································································32

韓国健康食品産業総覧 2008/10 --------------------------------------------------------------------------

6) ウェルライフ ·······································································································32
7) 三養ジェネックス ································································································32

3. 主要健康機能食品の製品動向 ·················································································34
3-1. グルコサミン(Glucosamine) ··················································································341) 市場現況 ············································································································342) 原料および製品規格 ···························································································343) 市場展望 ············································································································34
3-2. γ-リノレン酸(Gamma Linolenic Acid) ··································································351) 市場現況 ············································································································352) 原料および製品規格 ···························································································363) 市場展望 ············································································································36
3-3. オメガ3(DHA/EPA) ································································································361) 市場現況 ············································································································362) 原料および製品規格 ···························································································373) 市場展望 ············································································································37
3-4. クロレラ(Chlorella) ····························································································371) 市場現況 ············································································································382) 原料および製品規格 ···························································································38
3) 市場展望 ············································································································38
3-5. スピルリナ(Spirulina) ························································································391) 市場現況 ············································································································392) 原料および製品規格 ···························································································393) 市場展望 ············································································································39
3-6. コエンザイムQ-10(Coenzyme Q-10) ········································································401) 市場現況 ············································································································402) 原料および製品規格 ···························································································40
3) 市場展望 ············································································································40

4. 主要国の健康機能食品市場 ····················································································42
4-1. 世界の機能性食品市場の現況と展望 ·····································································421) 製品動向 ·············································································································42

目次2) 外国の健康機能食品管理の動向 ·············································································43
4-2. アメリカの機能性食品市場の現況と展望 ································································451) 概要 ·················································································································452) 品目別の市場規模 ······························································································453) 市場展望 ···········································································································464) 企業動向 ···········································································································47
5) 進出可能分野 ·······································································································48
4-3. 中国の機能食品市場展望 ·······················································································48
1) 中国政府の健康食品政策 ······················································································49
2) メタボリック症候群 ·····························································································50
3) 外国企業の機能食品 ·····························································································50
4-4. シンガポールの健康補助食品市場の現況 ································································51
1) 概念および一般動向 ·····························································································512) 輸出入の現況 ·······································································································51
3) 市場規模および競争現況 ······················································································534) 企業別市場占有率 ································································································53
4-5. タイの機能性食品市場の現況と展望 ·······································································541) 概要 ···················································································································542) 市場現況 ·············································································································543) 市場展望 ············································································································56<表1-1> 製品別告示型健康機能食品の分類 ···································································6<表1-2> 市道別健康機能食品製造事業所の現況(2005) ·················································18<表1-3> 健康機能食品製造及び販売業の現況 ······························································18<表1-4> 健康機能食品業の事業所数現況(2005.12) ······················································18<表1-5> 市道別健康機能食品の販売事業所数(2005) ····················································19<表1-6> 地方庁別健康機能食品輸入業者の現況(2005) ·················································19<表1-7> 市道別健康機能食品輸入業者の現況(2005) ····················································19<表1-8> 健康機能食品の生産実績推移 ········································································20<表1-9> 2005年度売上額上位10事業所現況 ·································································21<表1-10> 品目類型別健康機能食品売上現況(2005) ······················································22<表1-11> 市道別・類型別健康機能食品の品目数現況(2005) ·········································23

韓国健康食品産業総覧 2008/10 --------------------------------------------------------------------------<表1-12> 市道別健康機能食品のGMP指定事業所の現況(2005) ·······································26<表1-13> 健康機能食品専門売場の出店現況 ·······························································31<表1-14> 世界の機能食品市場現況 ············································································43<表1-15> 国別の機能性食品関連制度および法令 ·························································44<表1-16> アメリカの機能食品市場現況 ······································································46<表1-17> 大企業の市場占有率 ···················································································48<表1-18> シンガポール のその他の調製食品類の輸入現況 ··········································52<表1-19> シンガポールのその他の調製食品類の輸出現況 ············································52<表1-20> 企業別市場占有率(2005年) ·········································································53<表1-21> 国別市場占有率(2005年) ············································································54

第2章 健康機能食品管理
1. 健康機能食品の管理 ······························································································59
1-1. 健康機能食品製造業の事業許可および管理 ·····························································591) 健康機能食品専門製造業の事業許可 ······································································592) ベンチャー健康機能食品製造業の事業許可 ·····························································60
3) 事業許可事項の変更許可 ·····················································································61
4) 事業許可事項の変更申告 ·····················································································595) 品目製造申告 ·······································································································626) 品目製造申告事項の変更申告 ················································································637) 品目製造申告証の再交付(2006.11.20新設) ·····························································638) 健康機能食品委託製造の運営管理 ··········································································639) 生産実績の報告管理 ·····························································································6410) 輸出健康機能食品の英文証明書発給 ·····································································65
1-2. 健康機能食品輸入業・販売業の事業申告および管理 ················································66
1) 健康機能食品輸入業の事業申告の受理 ···································································66
2) 健康機能食品一般(流通専門)販売業の事業申告の受理 ·············································66
3) 事業申告の変更申告 ·····························································································68
1-3. 優秀健康機能食品製造基準(GMP)の運営管理および活性化 ········································68
1) 目的 ···················································································································68
2) 根拠法令 ·············································································································69

目次3) 必要性および期待効果 ··························································································694) 適用範囲 ···········································································································69
5) 健康機能食品GMP指定の申請手続き ········································································696) 機関別の推進業務 ································································································707) 指定変更申請 ·······································································································708) 教育・訓練 ··········································································································709) 処分基準 ·············································································································7110) 参考事項 ···········································································································71
1-4. 健康機能食品の品質管理 ·····················································································72
1) 品質管理人の選任 ······························································································72
2) 自家品質検査管理 ······························································································733) 検査方法 ·············································································································74
1-5. 医薬品製造施設の健康機能食品製造のための利用および管理 ···································76
1) 根拠法令 ···········································································································762) 認定基準 ···········································································································76
3) 対象医薬品製造施設 ·····························································································764) 認定手続き ··········································································································76
5) 事業許可(変更)申請 ·····························································································776) 医薬品製造施設利用事業所に対する事後管理 ··························································777) 違反事業所に対する措置 ······················································································77
1-6. 事業者および品質管理のための教育管理 ································································78
1) 事業者等の教育 ···································································································78
2) 教育実施機関 ·······································································································79
3) 教育時間 ·············································································································79
4) 行政制裁 ·············································································································79
5) 行政事項 ·············································································································80
1-7. 機能性表示および広告管理 ···················································································80
1) 健康機能食品の表示基準の管理 ·············································································80
1-8. 消費者認識改善のための教育・広報 ·······································································90
1) 教育 ···················································································································90
2) 広報 ···················································································································91
3) 情報公開 ·············································································································91

韓国健康食品産業総覧 2008/10 --------------------------------------------------------------------------

2. 健康機能食品管理の推進実績 ·················································································92
2-1. 健康機能食品管理体系の改善および教育・広報の強化 ·············································92
1) 健康機能食品製造業事業許可および管理 ································································92
2) 健康機能食品の教育・広報 ···················································································94
2-2. 安全で優秀な健康機能食品製造基盤の構築 ····························································961) 優秀健康機能食品製造基準(健康機能食品GMP)制度 ·················································962) 健康機能食品GMP制度の活性化 ··············································································96
2-3. 健康機能食品の流通・販売秩序の確立 ···································································971) 健康機能食品の表示基準管理 ················································································972) 機能性表示及び広告の事前審議 ·············································································97
2-4. 健康機能食品産業の支援及び育成 ··········································································971) 優秀健康機能食品製造管理の標準化および電算化(GMS普及) ·····································972) 健康機能食品の製品情報登録 ················································································98

3. 健康機能食品管理の今後の計画 ·············································································· 99
3-1. 基本方向 ·············································································································99
3-2. 細部計画 ·············································································································99
1) 健康機能食品の製造基盤の構築 ·············································································99
2) 健康機能食品GMPの適用拡大 ··················································································99
3) 中小事業所の衛生水準向上のための技術支援 ························································100
4) 健康機能食品を消費者に正しく広める ·································································100

第3章 機能性原料
1. 機能性原料 ·········································································································105
1-1. γ-リノレン酸 ···································································································1051) 概要 ·················································································································1052) 機能性原料の特徴 ·····························································································1053) 機能内容および効能効果 ···················································································1054) 摂取対象および摂取量 ······················································································106

目次5) その他 ··············································································································106
1-2. 難消化性デキストリン ························································································1061) 概要 ·················································································································1062) 機能性原料の特徴 ·····························································································1063) 機能内容および効能効果 ···················································································107
4) 摂取対象および摂取量 ······················································································107
5) その他 ··············································································································107
1-3. 緑茶抽出物 ········································································································107
1) 概要 ·················································································································1072) 機能性原料の特徴 ·····························································································1073) 機能内容および効能効果 ···················································································108
4) 摂取対象および摂取量···················································································108

5) その他 ··············································································································108
1-4. 大豆タンパク ·····································································································109
1) 概要 ·················································································································109
2) 機能性原料の特徴 ·····························································································109
3) 機能内容および効能効果 ·················································································109
4) 摂取対象および摂取量 ······················································································109
5) その他 ··············································································································109
1-5. MSM ···················································································································1101) 概要 ·················································································································1102) 機能性原料の特徴 ·····························································································1103) 機能内容および効能効果 ···················································································1104) 摂取対象および摂取量 ······················································································110
5) その他 ··············································································································110
1-6. キクラゲ ············································································································1111) 概要 ·················································································································1112) 機能性原料の特徴 ·····························································································1113) 機能内容および効能効果 ···················································································111
4) 摂取対象および摂取量 ······················································································111
5) その他 ··············································································································112
1-7. バナバ酒精抽出物 ·······························································································112韓国健康食品産業総覧 2008/10 --------------------------------------------------------------------------

1) 概要 ·················································································································1122) 機能性原料の特徴 ·····························································································1123) 機能内容および効能効果 ···················································································112
4) 摂取対象および摂取量 ······················································································113
5) その他 ··············································································································113
1-8. ベータ-カロチン ································································································113
1) 概要 ················································································································1132) 機能性原料の特徴 ···························································································1133) 機能内容および効能効果 ···················································································114
4) 摂取対象および摂取量 ······················································································114
5) その他 ··············································································································114
1-9. 植物ステロール ··································································································114
1) 概要 ·················································································································1142) 機能性原料の特徴 ·····························································································1153) 機能内容および効能効果 ···················································································1154) 摂取対象および摂取量 ······················································································115
5) その他 ··············································································································115
1-10. アロエ ·············································································································116
1) 概要 ·················································································································1162) 機能性原料の特徴 ·····························································································1163) 機能内容および効能効果 ···················································································116
4) 摂取対象および摂取量···················································································116

5) その他 ··············································································································116
1-11. EPA/DHA ···········································································································117
1) 概要 ·················································································································1172) 機能性原料の特徴 ·····························································································1183) 機能内容および効能効果 ···················································································118
4) 摂取対象および摂取量 ······················································································118
5) その他 ··············································································································118
1-12. 乳酸菌 ·············································································································119
1) 概要 ·················································································································1192) 機能性原料の特徴 ·····························································································119

目次3) 機能内容および効能効果 ···················································································119
4) 摂取対象および摂取量 ······················································································120
5) その他 ··············································································································120
1-13. 高麗人参 ··········································································································1201) 概要 ·················································································································1202) 機能性原料の特徴 ·····························································································1203) 機能内容および効能効果 ···················································································121
4) 摂取対象および摂取量 ······················································································121
5) その他 ··············································································································121
1-14. キシリトール ···································································································122
1) 概要 ·················································································································1222) 機能性原料の特徴 ·····························································································1223) 機能内容および効能効果 ···················································································122
4) 摂取対象および摂取量 ······················································································122
5) その他 ············································································································122
1-15. イワシペプタイド ·····························································································123
1) 概要 ·················································································································1232) 機能性原料の特徴 ·····························································································1233) 機能内容および効能効果 ···················································································123
4) 摂取対象および摂取量 ····················································································124
5) その他 ··············································································································124
1-16. オニノダケ根酒精抽出粉末 ················································································124
1) 概要 ·················································································································1242) 機能性原料の特徴 ·····························································································1243) 機能内容および効能効果 ···················································································1254) 摂取対象および摂取量 ······················································································125
5) その他 ··············································································································125
1-17. 緑イガイ抽出オイル複合物 ················································································1251) 概要 ·················································································································1252) 機能性原料の特徴 ·····························································································1263) 機能内容および効能効果 ···················································································126
4) 摂取対象および摂取量 ······················································································126韓国健康食品産業総覧 2008/10 --------------------------------------------------------------------------

5) その他 ············································································································126
1-18. キトサンおよびキトオリゴ糖 ·············································································126
1) 概要 ·················································································································1262) 機能性原料の特徴 ·····························································································1273) 機能内容および効能効果 ···················································································127
4) 摂取対象および摂取量 ······················································································127
5) その他 ············································································································127
1-19. フラクトオリゴ糖 ·····························································································128
1) 概要 ·················································································································1282) 機能性原料の特徴 ·····························································································1283) 機能内容および効能効果 ···················································································128
4) 摂取対象および摂取量 ······················································································129
5) その他 ··············································································································129
1-20. 紅麹 ················································································································129
1) 概要 ·················································································································1292) 機能性原料の特徴 ·····························································································1293) 機能内容および効能効果 ···················································································1304) 摂取対象および摂取量 ······················································································130
5) その他 ··············································································································130
1-21. ハイビスカス等の複合抽出物 ·············································································130
1) 概要 ·················································································································1312) 機能性原料の特徴 ·····························································································131
3) 機能内容および効能効果 ···················································································131
4) 摂取対象および摂取量 ······················································································131
5) その他 ··············································································································131

第4章 統計
1. 健康機能食品統計 ·······························································································135<表4-1> 健康機能食品の輸入検査の現況(2005) ·························································135<表4-2> 健康機能食品製造事業所に対する行政処分 ···················································139<表4-3> 類型別・機関別健康機能食品輸入現況(2005) ···············································141

目

次<表4-4> 健康機能食品の適合/非適合現況(2005) ·······················································145<表4-5> 上位10ヵ国の健康機能食品の適合/非適合現況(2005) ····································146<表4-6> 品目別・国別健康食品輸入現況(2005) ·························································147<表4-7> 国別・品目別健康食品輸入現況(2005) ·························································153<表4-8> 高麗人参類の製造業者現況(2006.12.31) ······················································167<表4-9> 市道別高麗人参の栽培面積(2006) ·······························································167<表4-10> 高麗人参の栽培推移 ·················································································168<表4-11> 全農産物対比高麗人参産業の位置 ···························································168<表4-12> 年度別高麗人参生産量 ··············································································169<表4-13> 市道別高麗人参耕作現況（2006） ···························································169<表4-14> 高麗人参生産量および生産額（2006） ······················································170<表4-15> 組合別高麗人参耕作現況（2006） ···························································170<表4-16> 高麗人参耕作農家の現況（2006） ······························································171<表4-17> 年度別高麗人参栽培面積推移 ··································································171<表4-18> 高麗人参生産額推移 ·················································································172<表4-19> 高麗人参新規耕作面積推移 ·······································································172<表4-20> 年根別高麗人参耕作面積及び組合員数動向·········································173<表4-21> 年度別高麗人参需給動向 ··········································································173<表4-22> 年度別・月別生人参価格動向 ····································································174<表4-23> 年度別・月別直参価格動向 ·······································································174<表4-24> 年度別・月別曲参価格動向 ·······································································175<表4-25> 年度別・月別生乾参価格動向 ····································································175<表4-26> 年度別・月別細根価格動向 ·······································································176<表4-27> 年度別生人参買入動向 ··············································································176<表4-28> 年度別・等級別生人参買入推移 ······························································177<表4-29> 買入等級別の価格推移 ··············································································177<表4-30> 年度別高麗人参輸出額 ··············································································178<表4-31> 地域別高麗人参輸出実績 ···········································································178<表4-32> 農産物輸出対比高麗人参類の比重 ······························································179<表4-33> 品目別高麗人参輸出現況 ···········································································179<表4-34> 類型別高麗人参輸出実績 ···········································································180<表4-35> 年度別高麗人参輸入動向 ···········································································180

韓国健康食品産業総覧 2008/10 --------------------------------------------------------------------------<表4-36> 主要国別高麗人参輸出実績 ·······································································181

第5章 企業リスト
1. 健康機能食品企業リスト ·····················································································188
2．市道別索引····································································································256

3．市道別・規模別索引
4．製品別索引·······················································································265····································································································274