平成 25 年度 農山漁村 6 次産業化対策事業 食品産業グローバル革新支援事業 FY 2013 Financial Supports for Promoting the “Sixth Industry” in Agriculture, Forestry and Fisheries in Rural Areas Global Innovation Support Project for Food Industry 「東アジアにおける栄養表示、 栄養機能及び健康強調表示」調査報告書（V） "Investigation of Nutrition Labelling, Nutrition and Health Claims in East Asia"（V） 平成 26（2014）年 3 月 特定非営利活動法人 国際生命科学研究機構（ILSI Japan） March 2014 International Life Sciences Institute (ILSI) Japan 目 次 1. 調査事業の目的・・・・・・・・・・・・・・・・・・・・・・・2 2. 事業の概要・・・・・・・・・・・・・・・・・・・・・・・・・2 2.1 調査対象国 2.2 調査対象食品・項目 2.3 実施方法 2.4 実施体制 2.5 実施スケジュール 2.6 ワークショップ/国際会議 2.7 まとめ 3. 調査結果・・・・・・・・・・・・・・・・・・・・・・・・・・7 3.1 コーデックス食品規格委員会及び日本 (7) 3.2 大韓民国 (15) 3.3 中華人民共和国 (23) 3.4 台湾 (33) 3.5 アセアン諸国 3.5.1 インドネシア共和国 (41) 3.5.2 カンボジア王国 (53) 3.5.3 シンガポール共和国 (63) 3.5.4 タイ王国 (73) 3.5.5 フィリピン共和国 (83) 3.5.6 ブルネイ・ダルサラーム国 (93) 3.5.7 ベトナム社会主義共和国 (103) 3.5.8 マレーシア (113) 3.5.9 ミャンマー連邦共和国 (123) 3.5.10 ラオス人民民主共和国 (131) 3.6 インド近隣諸国 3.6.1 インド共和国 (141) 3.6.2 スリランカ民主社会主義共和国 (149) 3.6.3 ネパール連邦民主共和国 (157) 3.6.4 バングラデシュ人民共和国 (165) 4．ワークショップ「食品の安全と基準」及びラウンドテーブル ディスカッション「食品安全に関わる課題と挑戦」 ・・・・・・・173 平成 25 年度 農山漁村 6 次産業化対策事業 食品産業グローバル革新支援事業 「東アジアにおける栄養表示、栄養機能及び健康強調表示」調査報告書（V） 調査報告者： 浜野弘昭 特定非営利活動法人国際生命科学研究機構（ILSI Japan） 調査協力者： 赤羽丈明 浅田由美 今城 敏 岩本 洋 大島道史 梅木陽一郎 大木嘉子 太田俊久 太田裕見 荻原葉子 柿木康宏 片嶋充弘 金子清久 香村正徳 篠原久実 瀬川修一 関谷史子 高橋智子 立脇久寛 土屋大輔 滑川啓介 西山泰孝 二上 彩 長谷川浩司 細野秀和 吉村千秋 （株）ADEKA ユニリーバ・ジャパン（株） 花王（株） 森永乳業（株） 森永乳業（株） ダニスコジャパン（株） 長谷川香料（株） （株）ヤクルト本社 サントリーウエルネス（株） 味の素（株）ASEAN Regional HQs アサヒホールディングス（株） 花王（株） 日本コカ・コーラ（株） 味の素（株） 日清オイリオグループ（株） サッポロビール（株） 高砂香料工業（株） ネスレ日本（株） キリンホールディングス（株） （株）ヤクルト本社 長瀬産業（株） 日本ハム（株） （株）ヤクルト本社 キッコーマン（株） サントリービジネスエキスパート（株） カルピス（株） ILSI ILSI ILSI ILSI ILSI 韓国支部 中国事務所 台湾支部 東南アジア地域支部 インド支部 山口隆司 杉崎祐司 平川 忠 ILSI Japan 事務局 ILSI Japan 事務局 ILSI Japan 事務局 -1- 1. 調査事業の目的 食品産業グローバル革新支援事業 「東アジアにおける栄養表示、栄養機能及び健康強調表示」 Global Innovation Support Project for Food Industry Investigation of Nutrition Labelling, Nutrition and Health Claims in East Asia For the purpose of supporting the food industry to expand overseas businesses in the fast-growing markets of emerging countries, ILSI Japan planned to investigate, in this fiscal year project, the system of so-called “Functional Foods” or high value-added foods at which the Japanese food industry is excel, such as nutrition labelling system, foods with nutrient function claims, foods for specified health uses, and dietary or food supplements. Target countries investigated were Korea, China, Taiwan, ASEAN countries (Indonesia, Cambodia, Singapore, Thailand, the Philippines, Brunei, Vietnam, Malaysia, Myanmar and Lao) as well as India, Sri Lanka, Nepal and Bangladesh, taking Codex Alimentarius Commission and Japan as references. The investigations were conducted through the international network of International Life Sciences Institute (ILSI) with the cooperation of research experts in these countries. Since the investigations included Cambodia, Lao, Myanmar and Vietnam in the project, ILSI Japan held Workshop & Roundtable Discussion on Food Safety and Standards in Yangon, Myanmar on March 3 & 4, 2014 especially for administrative and/or rule making officers in these countries for the purpose of exchanging views on the issues of Food Safety Challenges and Capacity Building Needs in the region. 1. 調査事業の目的： 我が国経済の急速なグローバル化の流れに食品産業が対応し、持続的に発展していく ためには、諸外国における食品に係わる法的枠組み、当該国内食品規格・基準、食品添 加物の使用基準等に関する情報が不可欠であり、国際的に通用する食品規格・品質ばか りでなく当該国における法的、社会的枠組みの理解と遵守を含めた食品産業の基盤の強 化を図る必要がある。 本事業は、現在急成長しつつある新興国市場への海外展開の支援を目的として、これ ら諸国における食品の法的枠組み、国内食品規格・基準、食品添加物の使用基準等に関 する情報を調査するものである。調査は、ILSI 組織の国際ネットワークを通じ、調査対 象とする当該国の調査専門家の協力を得ながら実施し、今後、調和或いは統一を図るた めの課題を抽出、その結果をワークショップ/国際会議等で共有する。 -2- 2. 事業の概要 2. 事業の概要： 2.1 調査対象国： ILSI Japanでは、平成21年度から24年度まで、東アジア食品産業海外展開支援事業に おいて、「東アジアの食品等の規格基準、分析方法の調査と結果の共有化」事業を受託 し、これまでの事業においては、コーデックス委員会、韓国、中国、ASEAN諸国の内マ レーシア、シンガポール、フィリピン、インドネシア、タイ、ベトナム、更にはインド、 スリランカ、ネパール、バングラデシュについて調査を実施した。 平成25年度事業では、これまでの調査対象国（組織）であるコーデックス委員会、韓 国、中国、ASEAN主要国（インドネシア、シンガポール、タイ、フィリピン、ベトナ ム、マレーシア）、インド及び近隣諸国（スリランカ、ネパール、バングラデシュ）に 加えて、これまで未調査のASEAN諸国の内カンボジア、ブルネイ、ミャンマー、ラオス も新たにを対象とし、更には台湾についても調査を行った。 2.2 調査対象食品・項目： 平成21年度から24年度までの調査においては、食品の法的枠組み、即席めん、炭酸飲 料、調理冷凍食品及び乳・乳製品（牛乳）の規格基準及びその分析方法、食品添加物に 関わる法体系、使用基準等に関する調査を実施してきた。 本事業ではこれらの調査項目に加えて、我が国食品産業が得意とされる高付加価値型 食品である、栄養機能食品、特定保健用食品、サプリメント等、いわゆる“機能性食品 （栄養表示、栄養機能強調表示、健康強調表示及びサプリメント）”の制度についての 調査を行った。 2.3 実施方法： 本事業は、特定非営利活動法人 国際生命科学研究機構（ILSI Japan）が中心となり、 ILSI の国際的ネットワーク特に ILSI 韓国支部、ILSI 中国事務所、ILSI 東南アジア地 域支部（ASEAN 諸国担当） 、ILSI インド支部（インド及び近隣諸国担当） 、更に ILSI 台湾支部（平成 25 年 7 月に新規設立）に参加を求め、次の手順で調査を進めた。 1．ILSI Japan が調査国、調査項目を決定し、調査票（Investigation Format for Nutrition Labelling and Nutrition/Health Claims: 本報告書「コーデックス食品規 格委員会及び日本」の項参照）を設計、作成した。 2．ILSI Japan は調査プログラムと調査票を関連 ILSI 支部に送付。必要に応じ現地で の会議を実施し、当該国の条件によっては調査票を部分的に修正した。 3．調査国担当の各 ILSI 支部は、調査結果を英語で調査票に記入、調査報告書を作成し た。 4．ILSI Japan は調査票を集計、解析し、必要に応じ（できる限り）日本語に翻訳した。 5．ミャンマー、ヤンゴンにおいて、調査結果の報告と情報の共有化を目的としたワーク ショップ「食品の安全と基準」及びラウンドテーブルディスカッション「食品安全に 関わる課題と挑戦」を開催した（平成 26 年 3 月 4、5 日） 。 6．調査結果を報告書として作成し、同時に ILSI Japan ホームページ上に公開した。 -3- 2. 事業の概要 2.4 実施体制： ILSI Japan の一組織である「国際協力委員会」内に調査対象とするそれぞれの地域/ 組織（コーデックス委員会、韓国、中国、アセアン諸国、インド地域、台湾）を担当す る会員からなるプロジェクトチームを立ち上げ、調査プログラム設計、調査項目を提案、 協力 ILSI 支部（韓国、中国、東南アジア地域、インド及び台湾各支部）との調整の後、 最終決定する。プロジェクトチームは下記 ILSI支部/事務所のネットワークを利用し、 調査事業を進める。 事業統括 ILSI支部/事務所 調査担当国 ILSI 東南アジア地域支部 カンボジア、ブルネイ、ミャンマー、ラオス を含むアセアン10か国 ILSI 台湾支部 台湾 （日本及びコーデック ILSI 韓国支部 韓国 スを担当、調査全体の ILSI 中国事務所 中国（香港、台湾を除く） 統括） インド地域（スリランカ、ネパール、バング ILSI Japan ILSI インド支部 ラデシュを含む） 2.5 実施スケジュール： 本事業は、概略次のスケジュールに沿って進めた。 予備調査、調査プログラム設計、調査票開発：2 か月（平成 2 年 9 月～10 月） （委員会開催：9 月北京、10 月シンガポール、東京） 調査対象国における調査、調査票の作成：3 か月（平成 25 年 11 月～平成 26 年 1 月） （委員会開催：11 月、12 月、1 月東京） 調査票の集計、課題の抽出：1 か月（平成 26 年 2 月） （委員会開催：2 月東京） ワークショップ/国際会議の開催： 平成 26 年 3 月 4、5 日（ミャンマー、ヤンゴン） 報告書及びデータベースの作成： 1 か月（平成 26 年 3 月） （委員会開催：3 月東京） プログラム全体の期間 ： 7 か月 2.6 ワークショップ/国際会議： これまで（平成 21 年度から 24 年度）の調査結果については、 「東アジアの食品等の規 格基準の調査と結果の共有化」 （平成 22 年 3 月、東京） 、 「アジア・太平洋地域の食品規 格基準、資源・環境対策に係る情報の共有化」 （平成 23 年 3 月、バンコク） 、 「アジア地 域の食品規格基準に係る情報の共有化」 （平成 24 年 2 月、ジャカルタ） 、 「インド、バン グラデシュ、ネパール、スリランカにおける食品及び食品添加物の法的枠組みと事例研 究」 （平成 25 年 2 月、東京）という形で公表、情報を共有化した。 本年度の事業においては、新たな調査対象国がカンボジア、ブルネイ、ミャンマー、 ラオス及び台湾であることから、今後、食品規格等の調和或いは統一を図るための課題 を検討することを目的として、これらの国々の行政官を中心としたワークショップ「食 品の安全と基準」と、ASEAN 地域内ではよりグローバル化が急がれる CLMV 諸国（カ ンボジア、ラオス、ミャンマー、べトナム）の行政官によるラウンドテーブルディスカ ッション「食品安全に関わる課題と挑戦」を、それぞれ平成 26 年 3 月 4 日及び 5 日に、 ミャンマー、ヤンゴンにおいて開催した。 -4- 2. 事業の概要 2.7 まとめ： 以下にこれまでの調査（平成 21 年度から 24 年度）および本年度の調査をまとめ一覧 にまとめた。 事業年度 調査内容 調査対象国 ワークショップ / 国際会議 日時 開催場所 参加者 数 食品関連法規の体系、 コーデックス、韓国、 平成 21 年 即席めん、炭酸飲料、 中国、マレーシア、 度（I） 調 理 冷 凍 食 品 の 規 シンガポール、フィ 格・基準 リピン 「東アジアの食 平成 22 年 品等の規格基準 3 月 29 日 163 名 の調査と結果の 東京（日本） 共有化」 食品関連法規の体系、 即席めん、炭酸飲料、 平成 22 年 調理冷凍食品、牛乳の 度（II） 規格基準及び分析方 法 コーデックス、韓国、 中国、マレーシア、 シンガポール、フィ リピン、インドネシ ア、タイ、ベトナム 「アジア・太平 洋地域の食品規 格基準、資源・ 環境対策に係る 情報の共有化」 食品添加物の法体系、 即席めん、炭酸飲料、 平成 23 年 調理冷凍食品、牛乳に 度（III） おける食品添加物使 用基準、ハラル制度、 コーデックス、韓国、 中国、マレーシア、 シンガポール、フィ リピン、インドネシ ア、タイ、ベトナム、 平成 24 年 「アジア地域の 2 月 21 日 食品規格基準に 127 名 ジャカルタ 係る情報の共有 （インドネ 化」 シア） 食品関連法規の体系、 即席めん、炭酸飲料、 平成 24 年 調理冷凍食品、牛乳の 度（IV） 規格基準・分析方法、 食品添加物の法体 系・使用基準 インド、バングラデ シュ、ネパール、ス リランカおよびコー デックス、韓国、中 国、ASEAN 諸国 「インド、バン グラデシュ、ネ 平成 25 年 パール、スリラ 2 月 22 日 ンカにおける食 東京 品及び食品添加 物の法的枠組み と事例研究」 コーデックス、韓国、 中国、ASEAN（イン ドネシア、シンガポ ール、タイ、フィリ 栄養表示、栄養機能強 ピン、ベトナム、マ 平成 25 年 調表示、健康強調表示 レーシア、カンボジ 度（V） 及びサプリメントの ア、ブルネイ、ミャ 制度 ンマー、ラオス） 、イ ンド及び近隣諸国 （スリランカ、ネパ ール、バングラデシ ュ） 、台湾 -5- ワークショップ 「食品の安全と 基準」及びラウ ンドテーブルデ ィスカッション 「食品安全に関 わる課題と挑 戦」 平成 23 年 3月4日 バンコク （タイ） 115 名 80 名 平成 26 年 3 月 4、5 日 ヤ ン ゴ ン 60 名 （ミャンマ ー） -6- 3.1 Codex & Japan Nutrition Labelling and Nutrition/Health Claims ᰤ㣴⾲♧ཬ䜃ᰤ㣴/ᗣᙉㄪ⾲♧ 3.1 Codex Alimentarius Commission and Japan 䝁䞊䝕䝑䜽䝇㣗ရつ᱁ጤဨ ཬ䜃 ᪥ᮏ Investigation Format for Nutrition Labelling Regulations-1.1 Nutrition Labelling Codex 㛵㐃ἲつ䠋つ๎ CODEX STAN 1-1985 CAC/GL 2-1985 Nutrient Reference Values (Definitions, NRVs-R/-NCD) ᰤ㣴ཧ↷㔞䠄ᐃ⩏, NRVs-R/-NCD䠅 CAC/GL 2-1985 Article 2.6, 3.4.4 Relevant Laws/Regulations Nutrient Declaration (Application: Mandatory or Voluntary) ᰤ㣴⾲♧䠄㐺⏝䠖 ⩏ົ䜒䛧䛟䛿௵ព䠅 Food Categories Applied 㐺⏝䛥䜜䜛㣗ရ䜹䝔䝂䝸䞊 CAC/GL 2-1985 Article 3.1 Mandatory All Prepackaged Foods -7- Japan Food Sanitation Act (1947) Health Promotion Act (2002) Food Labelling Act (2013) 㣗ရ⾨⏕ἲ䠄1947䠅 ᗣቑ㐍ἲ䠄2002䠅 㣗ရ⾲♧ἲ䠄2013䠅 Definitions for NRVs 㣗➼ᦤྲྀᇶ‽ Voluntary, Mandatory when nutrition/health claims made ௵ព䚸ᰤ㣴䠋ᗣᙉㄪ⾲♧䜢⾜䛖ሙྜ ᚲ㡲 All prepackaged foods 䛶䛾ໟ῭䜏㣗ရ 3.1 Codex & Japan Investigation Format for Nutrition Labelling Regulations-1.1 Nutrition Labelling Codex Exemptions (Food Categories) 㐺⏝㝖እ䠄㣗ရ䜹䝔䝂䝸䞊䠅 National Authority (Size of Food Business Operators) 䠄㣗ရᴗ⪅䛾つᶍ䠅 National Authority Listing of Nutrients (Nutrients, Order) ᰤ㣴ᡂศ䝸䝇䝖 䠄ᰤ㣴ᡂศ䚸 グ㍕㡰䠅 Optional Ingredients 䛭䛾䛾ᰤ㣴ᡂศ CAC/GL 2-1985 Article 3.2 Japan Not applicable 㐺⏝↓䛧 Not applicable 㐺⏝↓䛧 Energy, Protein, Fat, Carbohydrate (Available Carbohydrate and D.F.) and Sodium ⇕㔞䚸䛯䜣䜁䛟㉁䚸⬡⫫䚸ⅣỈ≀䠄⢾ ㉁䛸㣗≀⧄⥔䛾⾲♧ྍ䠅䚸䝘䝖䝸䜴䝮 CAC/GL 2-1985 Article 3.2.2 Any other nutritional constituent 䛭䛾䛾䛶䛾ᰤせᡂศ Investigation Format for Nutrition Labelling Regulations-1.2 Nutrition Labelling Presentation of Nutrient Content (Expression per 100g/ml or serving or package) ᰤ㣴ᡂศ㔞䛾⾲♧᪉ἲ 䠄⾲♧᪉ἲ 100g/ml 䚸1䝃䞊䝡䞁䜾䚸 ཪ䛿1ໟศ䛒䛯䜚䠅 (Expression in Exact values or Ranges) 䠄⾲♧䛩䜛್䠖୍ᐃ್䜒䛧䛟䛿ᖜ⾲♧䠅 (Analysis or Calculation Basis) 䠄ศᯒ್䜒䛧䛟䛿ィ⟬್䠅 Codex Japan Per 100g/ml, per serving, per package CAC/GL 2-1985 Article 3.4 CAC/GL 2-1985 Article 3.5.2 CAC/GL 2-1985 Article 3.5.2 Use of Food Composition Table/ Database for Presentation of Nutrients 100g/ml ᙜ䛯䜚䚸1䝃䞊䝡䞁䜾ᙜ䛯䜚䚸 1ໟᙜ䛯䜚 Exact values / Range ୍ᐃ್䠋ᖜ⾲♧ Analysis or Calculation basis allowed ศᯒ್䚸ィ⟬್ྍ Allowed ㄆ䜑䜙䜜䜛 ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲䠋 䝕䞊䝍䝧䞊䝇 䛾⏝ Food Composition Table/Database for Presentation of Nutrients Japanese Food Composition Table ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲䠋 䝕䞊䝍䝧䞊䝇 ᪥ᮏ㣗ရᡂศ⾲ -8- 3.1 Codex & Japan Investigation Format for Nutrition Labelling Regulations-1.2 Nutrition Labelling Calculation of Nutrients (Energy/Protein/ Carbohydrate/Fat) ᰤ㣴ᡂศ䛾ィ⟬ 䠄䜶䝛䝹䜼䞊䠋䛯 䜣䜁䛟㉁䠋ⅣỈ≀䠋⬡㉁) Tolerances and Compliances (Tolerance Limits) බᕪ䛸㐺ྜᛶ䠄ㄗᕪ⠊ᅖ䠅 Specific Features of Presentation (Format, %NRV Labelling) ⾲♧᪉ἲ䛾≉Ⰽ 䠄䝣䜷䞊䝬䝑 䝖䚸%NRV䚸⾲♧䠅 (Front of Package Labelling, FOP) 䠄䝟䝑䜿䞊䝆ṇ㠃䛾⾲♧䚸FOP䠅 Codex CAC/GL 2-1985 Article 3.3 CAC/GL 2-1985 Article 3.5 CAC/GL 2-1985 Article 3.4.4, 4.2 CAC/GL 2-1985 Article 3.4.4, 4.2 Japan Identical to Codex Guidelines 䝁䞊䝕䝑䜽䝇䛸ྠ䛨 Values plus/minus 20%, Specific tolerations defined for certain nutrients ⾲♧್䠇/䠉20䠂䚸ᰤ㣴⣲䛻䜘䜚䛾ㄗ ᕪ⠊ᅖ䛒䜚 Tabular format No %NRV labelling applied ⾲ᙧᘧ %NRV ⾲♧䛿㐺⏝↓䛧 No FOP labelling applied FOP⾲♧䛾つᐃ↓䛧 Investigation Format for Nutrition Labelling Regulations-1.3 Nutrition Labelling Administrations/Compliances for Nutrition Labelling (Governing Authorities/Agencies) Codex Consumer Affairs Agency Local Governments Competent Authorities ᰤ㣴⾲♧䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ⟶ᙜ ᒁ䠋ᐁᗇ䠅 Inspections and Penalties ᰝᐹ䛸⨩๎ Japan ᾘ㈝⪅ᗇ 㒔㐨ᗓ┴ Periodical inspections Penalties defined Competent Authorities -9- ᰝᐹ䚸ཤ䛒䜚 ⨩๎つᐃ䛒䜚 3.1 Codex & Japan Investigation Format for Nutrition Claims Regulations-2 Nutrition Claims Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ Definitions (Nutrient Content/Comparative Claims) ᐃ⩏䠄ᰤ㣴⣲ྵ᭷㔞/ẚ㍑ᙉㄪ⾲♧䠅 Nutrient Content Claims ᰤ㣴⣲ྵ᭷㔞ᙉㄪ⾲♧ Nutrient Comparative Claims ᰤ㣴⣲ẚ㍑ᙉㄪ⾲♧ Non-addition Claims 䠄Non-addition of Sugars/Sodium Salts䠅 ↓ῧຍ⾲♧䠄⢾㢮䠋䝘䝖䝸䜴䝮ሷ䛾 ↓ῧຍ䠅 Codex CODEX STAN 1-1985 CAC/GL 1-1979 CAC/GL 23-1997 CAC/GL 23-1997 Article 2 Japan Food Sanitation Act (1947) Health Promotion Act (2002) Food Labelling Act (2013) 㣗ရ⾨⏕ἲ䠄1947䠅 ᗣቑ㐍ἲ䠄2002䠅 㣗ရ⾲♧ἲ䠄2013䠅 Identical to Codex Guidelines 䝁䞊䝕䝑䜽䝇䛸ྠ䛨 CAC/GL 23-1997 Article 5 Conditions defined CAC/GL 23-1997 Article 6 Conditions defined ᙉㄪ⾲♧䛾ᇶ‽䛜ᐃ䜑䜙䜜䛶䛔䜛 ᙉㄪ⾲♧䛾ᇶ‽䛜ᐃ䜑䜙䜜䛶䛔䜛 Conditions defined CAC/GL 23-1997 Article 7 ᙉㄪ⾲♧䛾ᇶ‽䛜ᐃ䜑䜙䜜䛶䛔䜛 Investigation Format for Nutrition Claims Regulations-2 Nutrition Claims Administrations/Compliances for Nutrition Claims䠄Governing Authorities/Agencies䠅 Codex Competent Authorities ᰤ㣴ᙉㄪ⾲♧䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ ⟶ᙜᒁ䠋ᐁᗇ) Consumer Affairs Agency Local Governments ᾘ㈝⪅ᗇ 㒔㐨ᗓ┴ Periodical Inspections Penalties defined Inspections and Penalties ᰝᐹ䛸⨩๎ Japan Competent Authorities - 10 - ᰝᐹ䚸ཤ䛒䜚 ⨩๎つᐃ䛒䜚 3.1 Codex & Japan Investigation Format for Health Claims Regulations-3.1 Health Claims Codex Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ Definitions 䠄Collective Name of Foods with Health Claims, if applicable䠅 ᐃ⩏䠄ᗣᙉㄪ⾲♧䜢䛧䛯㣗ရ䜢ᣦ 䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾ྡ⛠䠅 CODEX STAN 1-1985 CAC/GL 1-1979 CAC/GL 23-1997 Japan Food Sanitation Act (1947) Health Promotion Act (2002) Food Labelling Act (2013) 㣗ရ⾨⏕ἲ䠄1947䠅 ᗣቑ㐍ἲ䠄2002䠅 㣗ရ⾲♧ἲ䠄2013䠅 Foods with Health Claims (FHC) CAC/GL 23-1997 Article 2 Nutrient Function Claims 䠄Collective Name of the Foods, if applicable䠅 CAC/GL 23-1997 ᰤ㣴ᶵ⬟ᙉㄪ⾲♧䠄ᰤ㣴ᶵ⬟⾲♧䜢 Article 2 䛧䛯㣗ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭 䛾ྡ⛠䠅 Other Function Claims䠄Collective Name of the Foods, if applicable䠅 CAC/GL 23-1997 䛭䛾䛾ᶵ⬟ᙉㄪ⾲♧䠄䛾ᶵ⬟⾲ Article 2 ♧䜢䛧䛯㣗ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ 䛿䛭䛾ྡ⛠) ಖᶵ⬟㣗ရ䠄ᰤ㣴ᶵ⬟㣗ရ䛚䜘䜃≉ ᐃಖ⏝㣗ရ䠅 Foods with Nutrient Function Claims (FNFC), applicable to all prepackaged foods including Tablet or Capsule type of products ᰤ㣴ᶵ⬟㣗ရ䠖㘄䚸䝍䝤䝺䝑䝖ᆺ䜢ྵ 䜐䛩䜉䛶䛾㣗ရ Foods for Specified Health Uses (FOSHU), applicable to all prepackaged foods ≉ᐃಖ⏝㣗ရ䠖䛶䛾ໟ῭䜏㣗ရ Investigation Format for Health Claims Regulations-3.1 Health Claims Reduction of Disease Risk Claims 䠄Collective Name of Foods Applied䠅 䝸䝇䜽పῶᙉㄪ⾲♧䠄㐺⏝䛥䜜 䜛㣗ရ䜢ᣦ䛩ྡ⛠䠅 Types of Approval/Certification 䠄Standardized/ Pre-authorized Claims䠅 Codex CAC/GL 23-1997 Article 2 Japan Foods for Specified Health Uses (FOSHU), applicable to all prepackaged foods ≉ᐃಖ⏝㣗ရ䠖䛶䛾ໟ῭䜏㣗ရ CAC/GL 23-1997 Article 8.1.2, 8.2 FNFC: Pre-authorized Claims/Selfdetermined ᰤ㣴ᶵ⬟㣗ရ䠖つ᱁ᇶ‽䚸⮬ᕫㄆドᆺ ᢎㄆ䠋ㄆド䛾✀㢮䠄つ᱁ᇶ‽ᆺ䠋 ๓ᢎㄆᆺ䠅 䠄Food Product/Constituent Specific Approval䠅 FOSHU: Product Specific CAC/GL 23-1997 䠄㣗ရ䠋≉ᐃ䛾⤌ᡂᡂศ䛻ᑐ䛩䜛ᢎ Article 8.1.2, 8.2 ㄆ䠅 - 11 - ≉ᐃಖ⏝㣗ရ䠖ಶู⏦ㄳ䚸⾲♧チྍ 3.1 Codex & Japan Investigation Format for Health Claims Regulations-3.2 Health Claims Scientific Substantiation of Health Claims ᗣᙉㄪ⾲♧䛻㛵䛩䜛⛉Ꮫⓗᐇド Codex CAC/GL 23-1997 Article 8, Process for the Substantiation (Organizational Systems, Governing CAC/GL 23-1997 Authority/Agency/Commission) Annex Article 3.1 ᐇド䛾䝥䝻䝉䝇䠄ᑂᰝ⤌⧊䛾ᵓ㐀䚸 ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠋ጤဨ䠅 Criteria for the Substantiation and/or Consideration of the Evidence ᐇド䛾ᇶ‽䛚䜘䜃䠋䜎䛯䛿ຠᯝ䛾 ホ౯ Specific Safety Concerns ≉ᐃ䛾Ᏻᛶ䛻㛵䛩䜛㡯 Re-evaluation Documentation required ドᣐ᭩㢮䠄⏦ㄳ䠅䛜ᚲせ Consumer Affairs Agencyĺ Consumer Commission (substantiation)ĺ Food Safety Commission (safety assessment)ĺ Ministry of Health, Labour and Welfare ĺ CAA ᾘ㈝⪅ᗇэᾘ㈝⪅ጤဨ䠄ᗣຠᯝ䠅 э㣗ရᏳጤဨ䠄Ᏻᛶ䠅эཌ⏕ປ ാ┬䠄⾲♧/⸆ἲ䠅эᾘ㈝⪅ᗇ Documentation required CAC/GL 23-1997 Annex Article 3.2, 3.3 CAC/GL 23-1997 Annex Article 4 CAC/GL 23-1997 Annex Article 5 ホ౯ Japan ドᣐ᭩㢮䠄⏦ㄳ䠅䛜ᚲせ Documentation required ドᣐ᭩㢮䠄⏦ㄳ䠅䛜ᚲせ Not specified つᐃ↓䛧 Investigation Format for Health Claims Regulations-3.2 Health Claims Codex Product Quality Concerns䠄GMP, ISO, HACCP or Other Measures䠅 Documentation required 〇ရရ㉁䛻㛵䛩䜛㡯䠄GMP, ISO, HACCP 䜎䛯䛿䛾ホ౯ᑻᗘ䠅 ドᣐ᭩㢮䠄⏦ㄳ䠅䛜ᚲせ Foods for Specified Health Uses (FOSHU) Adverse Event Reporting System 䠄Mandatory/ Voluntary䠅 ᭷ᐖ㇟䛻㛵䛩䜛ሗ࿌䝅䝇䝔䝮䠄⩏ ົ䠋௵ព䠅 Administrations/Compliances for Health Claims䠄Governing Authorities/Agencies䠅 Competent Authorities ≉ᐃಖ⏝㣗ရ䛻䛴䛔䛶ሗ࿌⩏ົ Consumer Affairs Agency Local Governments Competent Authorities ᗣᙉㄪ⾲♧䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ ⟶ᙜᒁ䠋ᐁᗇ䠅 Inspections and Penalties ᰝᐹ䛸⨩๎ Japan ᾘ㈝⪅ᗇ 㒔㐨ᗓ┴ Periodical Inspections Penalties defined Competent Authorities - 12 - ᰝᐹ䚸ཤ䛒䜚 ⨩๎つᐃ䛒䜚 3.1 Codex & Japan Investigation Format for Health Claims Regulations-3.3 Health Claims Relevant Laws/Regulations for Dietary/Food/Health Supplements 䝎䜲䜶䝍䝸䞊䠋䝣䞊䝗䠋䝦䝹䝇 䝃䝥䝸 䝯䞁䝖䛻㛵䛩䜛㛵㐃ἲつ䠋つ๎ Definitions㸦Dietary Supplements, and/or Food Supplements, and/or Health Supplements㸧 ᐃ⩏㸦ࢲ࢚ࢱ࣮ࣜࢧࣉ࣓ࣜࣥࢺ ࠾ࡼࡧ㸭ࡲࡓࡣࣇ࣮ࢻࢧࣉ࣓ࣜࣥ ࢺ࠾ࡼࡧ㸭ࡲࡓࡣ࣊ࣝࢫࢧࣉ࣓ࣜ ࣥࢺ㸧 Administrations/Compliances for the Supplements 䠄Governing Authorities/Agencies䠅 Codex Japan Not specifically defined, Treated in the same manner as foods CAC/GL 55-2005 ≉ᐃ䛾つᐃ䛿↓䛔䚸㏻ᖖ䛾㣗ရ䛸䛧䛶 ྲྀ䜚ᢅ䜟䜜䜛 Not specifically defined Treated in the same manner as foods CAC/GL 55-2005 Article 2 ≉ᐃ䛾つᐃ䛿↓䛔䚸㏻ᖖ䛾㣗ရ䛸䛧䛶 ྲྀ䜚ᢅ䜟䜜䜛 Not specifically defined Treated in the same manner as foods Competent Authorities 䝃䝥䝸䝯䞁䝖䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ⟶ ᙜᒁ䠋ᐁᗇ䠅 - 13 - ≉ᐃ䛾つᐃ䛿↓䛔䚸㏻ᖖ䛾㣗ရ䛸䛧䛶 ྲྀ䜚ᢅ䜟䜜䜛䠄ᾘ㈝⪅ᗇ䚸ཌ⏕ປാ┬䠅 - 14 - 3.2 Korea Nutrition Labelling and Nutrition/Health Claims ᰤ㣴⾲♧ཬ䜃ᰤ㣴/ᗣᙉㄪ⾲♧ 3.2 Republic of Korea 㡑Ẹᅜ Korea Nutrition Labelling Regulations-1.1 㡑ᅜ 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ 㡑ᅜ Health Functional Foods Act(2002; March 2010) Food Sanitation Act (1962; Latest Amend. June 2011) Livestock Product Hygiene Management Act(1962) Special Act on Safety Control of Children’s Dietary Life(2008; June 2011) ᗣᶵ⬟㣗ရἲ (2002;᭱᪂ᨵṇ2010ᖺ3᭶) 㣗ရ⾨⏕ἲ (1962; ᭱᪂ᨵṇ2011 ᖺ6᭶) ᐙ␆〇ရ⾨⏕⟶⌮ἲ(1962) Ꮚ౪㣗⏕άᏳ⟶⌮≉ูἲ(2008; 2011ᖺ6᭶ᨵṇ) Nutrient Reference Values (Definitions, Defined and Listed in Food Labeling Standards Table 2 NRVs-R/-NCD) ᰤ㣴ཧ↷㔞䠄ᐃ⩏, 㣗ရ⾲♧ᇶ‽䛷ᐃ⩏䚸ྠ⾲2䛻ᥖ㍕ NRVs-R/-NCD䠅 - 15 - 3.2 Korea Korea Nutrition Labelling Regulations-1.1 㡑ᅜ 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ Nutrient Declaration (Application: Mandatory or Voluntary) 㡑ᅜ Generally Voluntary, But Mandatory in case as follows: 1) Some Foods defined in Food Sanitation Act Enforcement Rule Article 6(Long term storage foods(retort food only), Biscuit, Candy, Ice Candy, Breads, Dumpling, Cocoa Products or Chocolates, Jams, Edible Oils and Fats, Noodles, Beverages, Foods for Special Dietary Uses, Fish Sausage, gimbap, hamburger, sandwich) 2) Some Foods defined in Livestock Product Labeling Standards(modified milks, milks, fermanted milks, processed milks, Ice creams, powdered milk, natural cheese, processed cheese, sausages) 3) when nutrition/health claims made 4) franchise more than 100 restaurants, cafe, bakery, etc. to mainly provide children’s preferred foods ᰤ㣴⾲♧䠄㐺⏝䠖 ⩏ ົ 䜒䛧䛟䛿 ௵ព䠅 ཎ๎௵ព䛰䛜ୗグ䛾ሙྜ䛿⩏ົ⾲♧䛸䛺䜛㻦 㻝㻕㻌㣗ရ⾨ἲ⾜つ๎➨㻢᮲䛻ᐃ䜑䜙䜜䛯㣗ရ䠄㛗ᮇಖᏑ㣗ရ㻔䝺䝖䝹䝖㣗ရ䛻㝈䜛䠅䚸䝡 䝇䜿䝑䝖䚸䜻䝱䞁䝕䜱㢮䚸ịⳫ㢮䚸䝟䞁㢮䚸㤝㢌㢮䚸䝁䝁䜰〇ရ䛒䜛䛔䛿䝏䝵䝁䝺䞊䝖㢮䚸 䝆䝱䝮㢮䚸㣗⏝Ἔ⬡㢮䚸㯝㢮䚸㣧ᩱ㢮䚸≉ᐃ⏝㏵㣗ရ䚸㨶⫗䝋䞊䝉䞊䝆䚸 gimbap 㻔䛾䜚 ᕳ䛝䠅䚸䝝䞁䝞䞊䜺䞊䚸䝃䞁䝗䜲䝑䝏 㻞㻕㻌␆⏘≀䞉␆⏘ຍᕤရ⾲♧ᇶ‽䛷ᐃ䜑䜙䜜䛶䛔䜛㣗ရ䠄ㄪ〇ங䚸ங䚸Ⓨ㓝ங䚸ຍᕤங䚸 䜰䜲䝇䜽䝸䞊䝮䚸⢊ங䚸䝘䝏䝳䝷䝹䝏䞊䝈䚸䝥䝻䝉䝇䝏䞊䝈䚸䝋䞊䝉䞊䝆䠅 㻟㻕㻌ᰤ㣴䠋ᗣᙉㄪ⾲♧䛜䛺䛥䜜䛯䛸䛝 㻠㻕䝺䝇䝖䝷䞁䚸䜹䝣䜵䚸䝧䞊䜹䝸䞊➼Ꮚ౪䛾Ⴔዲ㣗ရ䜢䛻㈍䛧䚸100௨ୖ䛾ᨭᗑ䜢ᣢ䛴 䝣䝷䞁䝏䝱䜲䝈ᗑ Korea Nutrition Labelling Regulations-1.1 㡑ᅜ 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ Food Categories Applied 㐺⏝䛥䜜䜛㣗ရ䜹䝔䝂䝸䞊 㡑ᅜ All prepackaged foods and some franchise restaurant, cafe, bakery 䛩䜉䛶䛾ໟ῭䜏㣗ရཬ䜃୍㒊䛾䝣䝷䞁䝏䝱䜲䝈䝺䝇䝖䝷䞁䚸䜹䝣䜵䚸䝧䞊䜹䝸䞊 Applicable to specified cases for example, when the size of main labeling is Exemptions (Food Categories) smaller than 30 ੌ ⾲♧㠃✚䛜30 ੌ 䜘䜚ᑠ䛥䛔ሙྜ䛺䛹≉ᐃ䛾ሙྜ䛻እつᐃ䛜㐺⏝䛥䜜䜛 㐺⏝㝖እ䠄㣗ရ䜹䝔䝂䝸䞊䠅 (Size of Food Business Operators) 䠄㣗ရᴗ⪅䛾つᶍ䠅 Not applicable processed foods, but applicable to restaurants, etc. Listing of Nutrients (Nutrients, Order) Energy, Carbohydrate : sugars, Protein, Fat : saturated, tran-fatty acid, Cholesterol, Sodium ᰤ㣴ᡂศ䝸䝇䝖 䠄ᰤ㣴ᡂศ䚸 グ㍕㡰䠅 Optional Ingredients 䛭䛾䛾ᰤ㣴ᡂศ ຍᕤ㣗ရ䛷䛿㐺⏝䛥䜜䛺䛔䛜䚸䝺䝇䝖䝷䞁➼䛻䛿㐺⏝䛜䛒䜛 ⇕㔞䚸ⅣỈ≀䠖⢾㢮䚸䛯䜣䜁䛟㉁䚸⬡㉁䠖㣬ཬ䜃䝖䝷䞁䝇⬡⫫㓟䚸䝁䝺䝇䝔 䝻䞊䝹䚸䝘䝖䝸䜴䝮 Any other nutritional constituent 䛭䛾䛾ᰤ㣴ᡂศ - 16 - 3.2 Korea Korea Nutrition Labelling Regulations-1.2 㡑ᅜ 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ 㡑ᅜ Presentation of Nutrient Content (Expression per 100g/ml or serving or package) per serving size or per 100 g or per 100 ml or per package ୍㣗䛒䛯䜚䚸100g䠋100m l䛒䛯䜚䚸䜒䛧䛟䛿1ໟ䛒䛯䜚 ᰤ㣴ᡂศ㔞䛾⾲♧᪉ἲ 䠄⾲♧᪉ ἲ 100g/ml 䚸1䝃䞊䝡䞁䜾䚸ཪ䛿1 ໟศ䛒䛯䜚䠅 (Expression in Exact values or Expressed in specified manners Ranges) 䠄⾲♧䛩䜛್䠖୍ᐃ್䜒䛧䛟䛿ᖜ ⾲♧䠅 (Analysis or Calculation Basis) ᐃ䜑䜙䜜䛯᪉ἲ䛷⾲♧ Analyzed and Calculated in specified manners ᐃ䜑䜙䜜䛯᪉ἲ䛷ศᯒཬ䜃ィ⟬ 䠄ศᯒ್䜒䛧䛟䛿ィ⟬್䠅 Use of Food Composition Table/ Database for Presentation of Nutrients Allowed ㄆ䜑䜙䜜䛶䛔䜛 ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲ 䠋䝕䞊䝍䝧䞊䝇 䛾⏝ Food Composition Table/Database for Presentation Korean Food Composition Table of Nutrients ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲ 䠋䝕䞊䝍䝧䞊䝇 㡑ᅜ㣗ရᡂศ⾲ Korea Nutrition Labelling Regulations-1.2 㡑ᅜ 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ Calculation of Nutrients (Energy/Protein/ Carbohydrate/Fat) ᰤ㣴ᡂศ䛾ィ⟬ 䠄䜶䝛䝹䜼䞊 䠋䛯䜣䜁䛟㉁䠋ⅣỈ≀䠋⬡㉁) Tolerances and Compliances (Tolerance Limits) බᕪ䛸㐺ྜᛶ䠄ㄗᕪ⠊ᅖ䠅 Specific Features of Presentation (Format, %NRV Labelling) ⾲♧᪉ἲ䛾≉Ⰽ 䠄䝣䜷䞊䝬䝑 䝖䚸%NRV䚸⾲♧䠅 (Front of Package Labelling, FOP) 䠄䝟䝑䜿䞊䝆ṇ㠃䛾⾲♧䚸FOP䠅 㡑ᅜ Identical to Codex Guidelines 䝁䞊䝕䝑䜽䝇䜺䜲䝗䝷䜲䞁䛸ྠ䛨 Values plus/minus 20%, Specific tolerations defined for certain nutrients 䠇/䠉20%䚸୍㒊䛾ᰤ㣴ᡂศ䛷䛿≉ᐃ䛾チᐜ⠊ᅖ䛜Ỵ䜑䜙䜜䛶䛔䜛 Tabular format No % NRV labelling applied ⾲ᙧᘧ ᰤ㣴ཧ↷㔞䠄NRV䠅䛻ᑐ䛩䜛ẚ⋡䠄䠂䠅䛻䜘䜛⾲♧䛜㐺⏝䛥䜜䜛 No FOP labelling legally applied, Recommended ⩏ົ䛷䛿䛺䛔䛜䚸௵ព⾲♧䛜᥎ዡ䛥䜜䛶䛔䜛 - 17 - 3.2 Korea Korea Nutrition Labelling Regulations-1.2 㡑ᅜ 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ 㡑ᅜ Ministry of Food and Drug Safety Administrations/Compl Local Governments iances for Nutrition Labelling (Governing Authorities/Agencies) Ministry of Food and Drug Safety (㣗ရ་⸆ရᏳ┬䠅 ᰤ㣴⾲♧䛾⾜ᨻ䠋㡰Ᏺ 䠄ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠅 Inspections and Penalties ᆅ᪉⮬య Periodical inspections Penalties defined ᐃᮇⓗᰝᐹ䛒䜚 ⨩๎つᐃ䛒䜚 ᰝᐹ䛸⨩๎ Korea Nutrition Claim Regulations-2 㡑ᅜ 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ Definitions (Nutrient Content/Comparative Claims) ᐃ⩏䠄ᰤ㣴⣲ྵ᭷㔞䠋ẚ㍑ᙉ ㄪ⾲♧䠅 Nutrient Content Claims ᰤ㣴⣲ྵ᭷㔞ᙉㄪ⾲♧ Nutrient Comparative Claims ᰤ㣴⣲ẚ㍑ᙉㄪ⾲♧ Non-addition Claims 䠄Non-addition of Sugars/Sodium Salts䠅 ↓ῧຍ⾲♧䠄⢾㢮䠋䝘䝖䝸䜴䝮 ሷ䛾↓ῧຍ䠅 㡑ᅜ Health Functional Foods Act(2002) Food Sanitation Act (1962) Livestock Product Hygiene Management Act(1962) ᗣᶵ⬟㣗ရἲ (2002; 2010ᖺ3᭶ᨵṇ) 㣗ရ⾨⏕ἲ(1962; ᭱᪂ᨵṇ2011ᖺ6᭶䠅ᐙ␆〇ရ⾨⏕⟶⌮ἲ (1962) Identical to Codex Guidelines 䝁䞊䝕䝑䜽䝇䜺䜲䝗䝷䜲䞁䛸ྠ䛨 Conditions defined 䠄⾲♧䠅᮲௳䛜つᐃ䛥䜜䛶䛔䜛 Conditions defined 䠄⾲♧䠅᮲௳䛜つᐃ䛥䜜䛶䛔䜛 Conditions defined 䠄⾲♧䠅᮲௳䛜つᐃ䛥䜜䛶䛔䜛 - 18 - 3.2 Korea Korea Nutrition Claim Regulations-2 㡑ᅜ 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ Administrations/Complian ces for Nutrition Claims 䠄Governing Authorities/Agencies䠅 㡑ᅜ Ministry of Food and Drug Safety Local Governments Ministry of Food and Drug Safety (㣗ရ་⸆ရᏳ┬) ᰤ㣴ᙉㄪ⾲♧䛾⾜ᨻ䠋㡰 Ᏺ䠄ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ) Inspections and Penalties ᆅ᪉⮬య Periodical Inspections Penalties defined ᰝᐹ䛸⨩๎ ᐃᮇⓗ䛺ᰝᐹ ⨩๎つᐃ䛜ᐃ䜑䜙䜜䛶䛔䜛 Korea Health Claim Regulations-3.1 㡑ᅜ 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 ᗣᙉㄪ⾲♧ Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ Definitions 䠄Collective Name of Foods with Health Claims, if applicable䠅 ᐃ⩏䠄ᗣᙉㄪ⾲♧䜢䛧䛯㣗ရ䜢 ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾ྡ⛠䠅 Nutrient Function Claims 䠄Collective Name of the Foods, if applicable䠅 ᰤ㣴ᶵ⬟ᙉㄪ⾲♧䠄ᰤ㣴ᶵ⬟⾲♧ 䜢䛧䛯㣗ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ 䛿䛭䛾ྡ⛠䠅 Other Function Claims䠄Collective Name of the Foods, if applicable䠅 䛭䛾䛾ᶵ⬟ᙉㄪ⾲♧䠄䛾ᶵ⬟ ⾲♧䜢䛧䛯㣗ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛 ሙྜ䛿䛭䛾ྡ⛠) 㡑ᅜ Health Functional Foods Act (2002) ᗣᶵ⬟㣗ရἲ(2002) Foods with Health Claims (FHC) ᗣᙉㄪ⾲♧䛾䛒䜛㣗ရ(FHC) Foods with Nutrient Function Claims (All Processed Foods) ᰤ㣴ᶵ⬟ᙉㄪ⾲♧䛾䛒䜛㣗ရ䠄䛩䜉䛶䛾ຍᕤ㣗ရ䠅 Foods for Other Function Claims (All Processed Foods) 䛭䛾䛾ᶵ⬟ᙉㄪ⾲♧䛾䛒䜛㣗ရ䠄䛩䜉䛶䛾ຍᕤ㣗ရ䠅 - 19 - 3.2 Korea Korea Health Claim Regulations-3.1 㡑ᅜ 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 ᗣᙉㄪ⾲♧ 㡑ᅜ Reduction of Disease Risk Claims 䠄Collective Name of Foods Applied䠅 Foods for Reduction of Disease Risk Claims (All Processed Foods) 䝸䝇䜽పῶᙉㄪ⾲♧䠄㐺⏝䛥䜜 䜛㣗ရ䜢ᣦ䛩ྡ⛠䠅 Types of Approval/Certification 䠄Standardized/ Pre-authorized Claims䠅 ᢎㄆ䠋ㄆド䛾✀㢮䠄つ᱁ᇶ‽ᆺ䠋 ๓ᢎㄆᆺ䠅 䝸䝇䜽పῶᙉㄪ⾲♧䛾䛒䜛㣗ရ䠄䛩䜉䛶䛾ຍᕤ㣗ရ䠅 Pre-authorized claims ๓䛻ㄆྍ䛜ᚲせ Specified in Health Functional Food Code for Generic Claims Listed for Product Specified Claims 䠄Food Product/Constituent Specific Approval䠅 䠄㣗ရ䠋≉ᐃ䛾⤌ᡂᡂศ䛻ᑐ䛩䜛 ᢎㄆ䠅 ᇶ‽࿌♧ᆺ⾲♧䠄Generic Claims)䛻䛴䛔䛶䛿ᗣᶵ⬟㣗ရබ 䛻䠄つ᱁ᇶ‽䛜䠅つᐃ䚹ಶูㄆᐃᆺ⾲♧䠄Product Specified Claims)䛻䛴䛔䛶䛿䝸䝇䝖䛥䜜䛶䛔䜛 Korea Health Claim Regulations-3.2 㡑ᅜ 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ 㡑ᅜ Specified in Regulation on Approval of Functional ingredient and Scientific Substantiation of Health of Standard/Specification for Health Functional Food Claims ᗣᙉㄪ⾲♧䛻㛵䛩䜛⛉Ꮫⓗᐇド ᗣᶵ⬟㣗ရ䛾ᶵ⬟ᛶᡂศཬ䜃つ᱁䠋ᇶ‽䛾ㄆᐃ䛻㛵䛩䜛つ๎ 䛻ᐃ䜑䜙䜜䛶䛔䜛 Process for the Substantiation (Organizational Systems, Governing Authority/Agency/Commission) Ministry of Food and Drug Safety Ministry of Food and Drug Safety (㣗ရ་⸆ရᏳ┬) ᐇド䛾䝥䝻䝉䝇䠄ᑂᰝ⤌⧊䛾ᵓ㐀䚸 ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠋ጤဨ䠅 Criteria for the Substantiation and/or Consideration of the Evidence ᐇド䛾ᇶ‽䛚䜘䜃䠋䜎䛯䛿ຠᯝ䛾 ホ౯ Specified in Regulation on Approval of Functional ingredient and of Standard/Specification for Health Functional Food ᗣᶵ⬟㣗ရ䛾ᶵ⬟ᛶᡂศཬ䜃つ᱁䠋ᇶ‽䛾ㄆᐃ䛻㛵䛩䜛つ๎ 䛻ᐃ䜑䜙䜜䛶䛔䜛 - 20 - 3.2 Korea Korea Health Claim Regulations-3.2 㡑ᅜ 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ 㡑ᅜ Specified in Regulation on Approval of Functional ingredient and of Standard/Specification for Health Functional Food Specific Safety Concerns ≉ᐃ䛾Ᏻᛶ䛻㛵䛩䜛㡯 ᗣᶵ⬟㣗ရ䛾ᶵ⬟ᛶᡂศཬ䜃つ᱁䠋ᇶ‽䛾ㄆᐃ䛻㛵䛩䜛つ๎ 䛻ᐃ䜑䜙䜜䛶䛔䜛 Specified in Regulation on Approval of Functional ingredient and of Standard/Specification for Health Functional Food Re-evaluation ホ౯ ᗣᶵ⬟㣗ရ䛾ᶵ⬟ᛶᡂศཬ䜃つ᱁䠋ᇶ‽䛾ㄆᐃ䛻㛵䛩䜛つ๎ 䛻ᐃ䜑䜙䜜䛶䛔䜛 Product Quality Concerns䠄GMP, ISO, HACCP or Other Measures䠅 〇ရရ㉁䛻㛵䛩䜛㡯䠄GMP, ISO, HACCP 䜎䛯䛿䛾ホ౯ᑻᗘ䠅 Adverse Event Reporting System 䠄Mandatory/ Voluntary䠅 ᭷ᐖ㇟䛻㛵䛩䜛ሗ࿌䝅䝇䝔䝮 䠄⩏ົ䠋௵ព䠅 ᗣᙉㄪ⾲♧ Voluntary, but GMP required for OEM producer ⮬⟶⌮䛰䛜䚸OEM〇㐀⪅䛻䛿GMP䛜せồ䛥䜜䜛 Specified in Health Functional Foods Act Enforcement Rule ᗣᶵ⬟㣗ရἲ⾜つ๎䛻ᐃ䜑䜙䜜䛶䛔䜛 Korea Health Claim Regulations-3.2 㡑ᅜ 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 㡑ᅜ Administrations/Compliances for Health Claims䠄Governing Authorities/Agencies䠅 ᗣᙉㄪ⾲♧䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓ ᡤ⟶ᙜᒁ䠋ᐁᗇ䠅 Ministry of Food and Drug Safety Local Governments Ministry of Food and Drug Safety (㣗ရ་⸆ရᏳ┬) ᆅ᪉⮬య Periodical Inspections / Penalties defined Inspections and Penalties ᰝᐹ䛸⨩๎ ᐃᮇⓗ䛺ᰝᐹ ⨩๎つᐃ䛜ᐃ䜑䜙䜜䛶䛔䜛 - 21 - 3.2 Korea Korea Health Claim Regulations-3.3 㡑ᅜ 䠖 ᗣᙉㄪ⾲♧つ๎-3.3 ᗣᙉㄪ⾲♧ 㡑ᅜ Health Functional Foods Act is applied into all the food with health Relevant Laws/Regulations for Dietary/Food/Health Supplements claims regardless of form. 䝎䜲䜶䝍䝸䞊䠋䝣䞊䝗䠋䝦䝹䝇 䝃䝥 䝸䝯䞁䝖䛻㛵䛩䜛㛵㐃ἲつ䠋つ๎ ᗣᶵ⬟㣗ရἲ䛜䚸〇ရ䛾ᙧែ䛻㛵䜟䜙䛪ᗣᙉㄪ⾲♧䜢⾜䛖䛩 䜉䛶䛾㣗ရ䛻㐺⏝䛥䜜䜛 Health functional food is only legally defined term. It is defined as Definitions㸦Dietary Supplements, and/or Food Supplements, and/or “foods manufactured (including processed foods) with functional Health Supplements㸧 raw materials or ingredients useful for the human body” ᐃ⩏㸦ࢲ࢚ࢱ࣮ࣜࢧࣉ࣓ࣜࣥ ࢺ࠾ࡼࡧ㸭ࡲࡓࡣࣇ࣮ࢻࢧࣉࣜ ࣓ࣥࢺ࠾ࡼࡧ㸭ࡲࡓࡣ࣊ࣝࢫࢧ ࣉ࣓ࣜࣥࢺ㸧 ἲⓗ䛻ᐃ⩏䛥䜜䛶䛔䜛䛾䛿ᗣᶵ⬟㣗ရ䛾䜏䛷䛒䜛䚹䇾ேయ䛻᭷ຠ 䛺ᶵ⬟ᛶ䜢ᣢ䛳䛯⣲ᮦ䜔ᡂศ䜢⏝䛧䛶〇㐀䠄ຍᕤ䜢ྵ䜐䠅䛧䛯㣗 ရ䇿䛸ᐃ⩏䛥䜜䛶䛔䜛 Administrations/Compliances for the Supplements 䠄Governing Authorities/Agencies䠅 Health Functional Foods Act is applied into all the food with health claims regardless of form. 䝃䝥䝸䝯䞁䝖䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ ⟶ᙜᒁ䠋ᐁᗇ䠅 ᗣᶵ⬟㣗ရἲ䛜䚸〇ရ䛾ᙧែ䛻㛵䜟䜙䛪ᗣᙉㄪ⾲♧䜢⾜䛖䛩 䜉䛶䛾㣗ရ䛻㐺⏝䛥䜜䜛 - 22 - 3.3 China Nutrition Labelling and Nutrition/Health Claims ᰤ㣴⾲♧ཬ䜃ᰤ㣴/ᗣᙉㄪ⾲♧ 3.3 People’s Republic of China ୰⳹ேẸඹᅜ China Nutrition Labelling Regulations-1.1 ୰ᅜ 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ ୰ᅜ GB 28050-2011 General Standard for the Nutrition Labeling of Prepackaged Foods. GB28050-2011ໟ㣗ရ䛾ᰤ㣴⾲♧䛾䛯䜑䛾୍⯡つ᱁ NRV is a reference standard of nutrition which is especially for food labeling Nutrient Reference purpose, and to compare the content levels of nutrients. NRV provides a reference Values (Definitions, scale to consumer when choosing foods. NRVs-R/-NCD) ᰤ㣴ཧ↷㔞䠄ᐃ⩏, NRV䛿ᰤ㣴⣲䛾ཧ↷つ᱁䛷䛒䜚䚸≉䛻㣗ရ䛾⾲♧┠ⓗ䛾䛯䜑䛻タᐃ䛥䜜䚸ᰤ㣴⣲ NRVs-R/-NCD䠅 䛾ྵ᭷㔞䜢ẚ㍑䛷䛝䜛䚹NRV䛿ᾘ㈝⪅䛜㣗ရ䜢㑅䜆䛸䛝䛾ᑻᗘ(つ᱁)䜢ᥦ౪䛩䜛 Nutrient Declaration (Application: Mandatory or Voluntary) Mandatory ᰤ㣴⾲♧䛿⩏ົ ᰤ㣴⾲♧䠄㐺⏝䠖 ⩏ ົ 䜒䛧䛟䛿 ௵ព䠅 Food Categories Applied 㐺⏝䛥䜜䜛㣗ရ䜹䝔 䝂䝸䞊 Almost all prepackaged food. Refer to GB 2760 Annex F food categories. 䜋䜌䛶䛾ໟ㣗ရ䛜ᑐ㇟䚹GB2760㝃ᒓ᭩F䛾㣗ရ䜹䝔䝂䝸䞊䜢ཧ↷ - 23 - 3.3 China China Nutrition Labelling Regulations-1.1 ୰ᅜ 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ Exemptions (Food Categories) 㐺⏝㝖እ䠄㣗ရ䜹䝔䝂 䝸䞊䠅 ୰ᅜ Fresh food; Alcoholic beverages with less than 0.5% of alcohol content; Packaged food with total surface area of no more than 100 cm2 or the largest surfaces area of the package is no more than 20 cm2; Non-pre-packed food sold on the site; Bottled drinking water; the daily intake amount shall be no more than 10g or 10ml; And other regulation exemptions. ⏕㩭㣗ရ䚸䜰䝹䝁䞊䝹ྵ᭷㔞䛜0.5䠂ᮍ‶䛾䜰䝹䝁䞊䝹㣧ᩱ䚸⾲㠃✚䛜100 ੌ ᮍ‶䛛䚸䜎䛯䛿䝟䝑䜿䞊䝆䛾᭱㠃䛾㠃✚䛜20 ੌ ᮍ‶䛾ໟ㣗ရ䚸ᗑ㢌㈍䛾 㠀ໟ㣗ရ䚸䝪䝖䝹ධ䜚㣧ᩱỈ䚸ẖ᪥䛾ᦤྲྀ㔞䛜10g 䛒䜛䛔䛿10ml 䜢㉸䛘䛺䛔㣗 ရ䚸䛭䛾䛾㐺⏝㝖እ䛾㣗ရ (Size of Food Business Operators) N/A 䠄㣗ရᴗ⪅䛾つᶍ䠅 Listing of Nutrients (Nutrients, Order) つᐃ↓䛧 Energy; Protein; Fat; Trans fat (if add HO); Carbohydrate; Sodium; And any other nutrients we claim. ᰤ㣴ᡂศ䝸䝇䝖 䠄ᰤ㣴 ᡂศ䚸 グ㍕㡰䠅 䜶䝛䝹䜼䞊䚸䛯䜣䜁䛟㉁䚸䝖䝷䞁䝇⬡⫫䠄㑏ඖ䛥䜜䛶䛔䜛ሙྜ䠅䚸ⅣỈ≀䚸䝘䝖䝸䜴 䝮䚸䛭䛾䛾⾲♧䛧䛯䛔ᰤ㣴⣲ Optional Ingredients Besides nutrients listed in GB28050, when label nutrients that GB14880 and MOH Announcement allowed to fortified, the nutrient ingredients should list following in order; Like DHA 䛭䛾䛾ᰤ㣴ᡂศ ᰤ㣴⾲♧ GB28050䛾䝸䝇䝖௨እ䛾ᰤ㣴⣲䚸GB14880ཬ䜃MOH䛜ᙉ䛩䜛䛣䛸䜢ㄆ䜑䛯ᰤ 㣴⣲䚹ᰤ㣴⣲䛿DHA䛾䜘䛖䛻䝸䝇䝖䛩䜛ᚲせ䛜䛒䜛 China Nutrition Labelling Regulations-1.2 ୰ᅜ 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ୰ᅜ Presentation of Nutrient Content (Expression per 100g/ml or serving or package) ᰤ㣴ᡂศ㔞䛾⾲♧᪉ἲ 䠄⾲♧᪉ἲ 100g/ml 䚸1䝃䞊䝡䞁䜾䚸 ཪ䛿1ໟศ䛒䛯䜚䠅 (Expression in Exact values or Ranges) Per 100g/ml or Per serving is acceptable 100g/ml ᙜ䛯䜚䜎䛯䛿䝃䞊䝡䞁䜾ᙜ䛯䜚 Exact values ୍ᐃ್ Both is acceptable ศᯒ್䚸ィ⟬್ඹ䛻チᐜ䛥䜜䜛 Yes, nutrition table. 㣗ရ䠄ᰤ㣴䠅ᡂศ⾲䛾⏝䛿チᐜ䛥䜜䜛 Yes, nutrition table. 㣗ရ䠄ᰤ㣴䠅ᡂศ⾲䛾⏝䛿チᐜ䛥䜜䜛 䠄⾲♧䛩䜛್䠖୍ᐃ್䜒䛧䛟䛿ᖜ⾲♧䠅 (Analysis or Calculation Basis) 䠄ศᯒ್䜒䛧䛟䛿ィ⟬್䠅 Use of Food Composition Table/ Database for Presentation of Nutrients ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲䠋 䝕䞊䝍䝧䞊䝇 䛾⏝ Food Composition Table/Database for Presentation of Nutrients ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲䠋 䝕䞊䝍䝧䞊䝇 - 24 - 3.3 China ᰤ㣴⾲♧ China Nutrition Labelling Regulations-1.2 ୰ᅜ 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ୰ᅜ Calculation of Nutrients (Energy/Protein/ Carbohydrate/Fat) Energy (kJ) = Protein (17) + Carbohydrate (17) + Fat (37) ᰤ㣴ᡂศ䛾ィ⟬ 䠄䜶䝛䝹䜼䞊 䠋䛯䜣䜁䛟㉁䠋ⅣỈ≀䠋⬡㉁) Tolerances and Compliances (Tolerance Limits) 䜶䝛䝹䜼䞊 䠄KJ䠅 = 䝍䞁䝟䜽㉁ (17) + ⅣỈ≀ (17) + ⬡⫫ (37) Protein, Polyunsaturated fat, Monounsaturated fat, Carbohydrates, Lactose, Total dietary fiber (soluble fibre, insoluble fibre), individual component of fibre, Vitamins (other than VD,VA), Minerals (exclude Na) 80% declared value; Energy, Fat, Saturated fat, Trans fat, Cholesterol, Sodium, Sugars120% declared value; VA & VD 80%~120% declared value 䛯䜣䜁䛟㉁䚸ከ౯㣬⬡⫫䚸୍౯㣬⬡⫫䚸ⅣỈ≀䚸ங⢾䚸⥲ 㣗≀⧄⥔䠄Ỉ⁐ᛶ㣗≀⧄⥔䚸⁐ᛶ⧄⥔䠅䚸⧄⥔䛾ಶ䚻䛾ᡂศ䚸䝡䝍䝭 䞁㢮䠄VD䚸VA௨እ䠅䚸䝭䝛䝷䝹(䝘䝖䝸䜴䝮䜢㝖䛟)䛷䛿⾲♧䛥䜜䛯್䛾 80䠂௨ୖ䚸䜶䝛䝹䜼䞊䚸⬡⫫䚸㣬⬡⫫䚸䝖䝷䞁䝇⬡⫫䚸䝁䝺䝇䝔䝻䞊 䝹䚸䝘䝖䝸䜴䝮䚸⢾䠖䛷䛿⾲♧䛥䜜䛯್䛾120䠂௨ୗ බᕪ䛸㐺ྜᛶ䠄ㄗᕪ⠊ᅖ䠅 Specific Features of Presentation (Format, %NRV Labelling) ⾲♧᪉ἲ䛾≉Ⰽ 䠄䝣䜷䞊䝬䝑 䝖䚸%NRV䚸⾲♧䠅 (Front of Package Labelling, FOP) Table format with NRV% and Character format for foods whose total area of package less than 100cm2 without NRV% NRV䠂䛷⾲♧䛩䜛ሙྜ䛿⾲ᙧᘧ䚸䜎䛯䚸䝟䝑䜿䞊䝆䛾㠃✚䛜100 ੌ ᮍ‶䛾㣗ရ䛷䛿NRV䠂䜢⏝䛫䛪ᩥᏐᙧᘧ つᐃ↓䛧 No provision 䠄䝟䝑䜿䞊䝆ṇ㠃䛾⾲♧䚸FOP䠅 China Nutrition Labelling Regulations-1.3 ୰ᅜ 䠖 ᰤ㣴⾲♧ᇶ‽-1.3 ᰤ㣴⾲♧ ୰ᅜ CFDA, AQSIQ, Administration of Industry & Commerce(AIC) and its local department Administrations/Compl and CIQ (for import products), the biggest concern is all of them have right to random iances for Nutrition inspection; Their right are not clear in fact. Labelling (Governing Authorities/Agencies) CFDA(୰ᅜ㣗ရ⸆ရ⟶⌮ᒁ)䚸AQSIQ(ᅜᐙရ㉁⟶⌮᳨ᰝ᳨ᒁ)䚸AIC(ᕤၟ⟶ ᰤ㣴⾲♧䛾⾜ᨻ䠋㡰Ᏺ 䠄ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠅 Inspections and Penalties ᰝᐹ䛸⨩๎ ⌮ᒁ)䚸䛭䛾䝻䞊䜹䝹㒊㛛䛸CIQ(ฟධቃ᳨ᰝ᳨㒊䠗㍺ධရ䛾ሙྜ)䛜⟶㎄䛩䜛䚹 ၥ㢟Ⅼ䛿䚸䛭䜜䜙䛶䛜䝷䞁䝎䝮䛻᳨ᰝ䜢⾜䛖ᶒ㝈䜢䜒䛴䛜䚸䛭䛾ᶒ㝈䛿ᐇ㝿䛻 䛿᫂☜䛷䛿䛺䛔 Food safety law: Article 86 Under any of the following circumstances, any food producer or trader in violation of the Law, shall have any and all illegal benefits, including foods or food additives illegally produced or traded, and tools, equipment and food raw material, used for illegal production or trading confiscated by the relevant authorities according to their respective duties and responsibilities, and be subject to a fine of RMB2,000 - 50,000 if the total value of the commodity is less than RMB 10,000; and subject to a fine between 5 and 10 times the total value of the commodity if the total value of the commodity exceeds RMB10,000; and for the serious cases, be ordered to stop production or business till revoked the business license. 㣗ရᏳἲ➨86᮲䛻䛚䛔䛶䚸௨ୗ䛾≧ἣ䛿㐪䛸䛺䜛䚹㐪ἲ䛻⏕⏘䛥䜜䛯ᡈ䛔䛿 ྲྀᘬ䛥䜜䛯㣗ရ䚸㣗ရῧຍ≀䚸㛵ಀᙜᒁ䛾⩏ົ䛸㈐௵䛾䜒䛸䛷ᢲ䛥䜜䛯ᕤල䚸 ᶵჾ䚸㣗ရཎᩱ䜢⏝䛧䛶〇㐀䛥䜜䛯〇ရ䛷䚸䛭䛾ᙜ䛺ྲྀᘬ䛻䜘䜚୍㒊䛒䜛䛔 䛿䛶䛾ṇ┈䜢ᚓ䜛㣗ရ䝯䞊䜹䞊䜔䝖䝺䞊䝎䞊䛿⨩㔠䛾ᑐ㇟䛸䛺䜛䚹ၟရ䛾 ྜィ౯್䛜10,000ேẸඖᮍ‶䛾ሙྜ䚸2,000 - 50,000ேẸඖ䚹ၟရ䛾ྜィ౯್䛜 10,000ேẸඖ䜢㉸䛘䜛ሙྜ䚸䛭䛾5䡚10ಸ䛾⨩㔠䛾ᑐ㇟䛸䛺䜛䚹䜎䛯䚸᭱ᝏ䛾ሙྜ 䛻䛿䚸⏕⏘䜔ᴗ䛾Ṇᡈ䛔䛿Ⴀᴗチྍド䛾ྲྀᾘ䛧䜢䛨䜙䜜䜛 - 25 - 3.3 China China Nutrition Claim Regulations-2 ୰ᅜ 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ Relevant Laws/Regulations ୰ᅜ GB 28050 ᅜᐙᶆ‽ GB28050 㛵㐃ἲつ䠋つ๎ Definitions (Nutrient Content/Comparati ve Claims) ᐃ⩏䠄ᰤ㣴⣲ྵ᭷㔞 䠋ẚ㍑ᙉㄪ⾲♧䠅 Nutrient Content Claims ᰤ㣴⣲ྵ᭷㔞ᙉㄪ ⾲♧ Nutrient Comparative Claims ᰤ㣴⣲ẚ㍑ᙉㄪ⾲ ♧ Nutrient content claim means a nutrition claim that describes the energy value or the content level of a nutrient contained in a food. Nutrient comparative claim means a nutrition claim that compares the energy value or the content level of a nutrient in a food with other known foods of the same type. ᰤ㣴⣲ྵ᭷㔞⾲♧䛿䚸䜶䝛䝹䜼䞊್䜔㣗ရ䛻ྵ䜎䜜䜛ᰤ㣴⣲䛾ྵ᭷㔞䜢グ㏙䛩䜛 ᰤ㣴ᙉㄪ⾲♧䜢ព䛩䜛䚹ᰤ㣴⣲ẚ㍑⾲♧䛿䚸䜶䝛䝹䜼䞊್䛒䜛䛔䛿㣗ရ୰䛾ᰤ 㣴⣲䛾ྵ᭷㔞䜢ྠ䛨䝍䜲䝥䛾䛾㣗ရ䛸ẚ㍑䛧ᰤ㣴ᙉㄪ⾲♧䛩䜛䛣䛸䜢ព䛩䜛 The terminology for nutrient content claim includes "contains", "high", "low" or "no", etc. ᰤ㣴⣲ྵ᭷⾲♧䛾ᑓ㛛⏝ㄒ䛸䛧䛶䚸䛂ྵ䜣䛷䛔䜛䛃䚸䛂㧗䛃䚸䛂ప䛃䜎䛯䛿䛂ྵ䜣䛷䛔䛺 䛔䛃䛜䛒䜛 The terminology for nutrient comparative claims includes "add", "reduce", etc. Enhanced or reduced by 25% or more, Compared to reference food/normal food. ẚ㍑䛾䛯䜑䛾ᰤ㣴⣲ྵ᭷⾲♧䛾ᑓ㛛⏝ㄒ䛸䛧䛶䚸䛂ῧຍ䛃䛒䜛䛔䛿䛂㍍ῶ䛃䚸䛂25䠂௨ ୖᙉ䛧䛯䛃䛒䜛䛔䛿䛂25䠂௨ୖ㍍ῶ䛧䛯䛃䚸䛂ཧ↷㣗ရ/㏻ᖖ䛾㣗ရ䛸ẚ㍑䛧䛶䛃➼䛜 䛒䜛 China Nutrition Claim Regulations-2 ୰ᅜ 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ Non-addition Claims 䠄Non-addition of Sugars/Sodium Salts䠅 ↓ῧຍ⾲♧䠄⢾㢮䠋䝘䝖䝸䜴 䝮ሷ䛾↓ῧຍ䠅 Administrations/Complianc es for Nutrition Claims 䠄Governing Authorities/Agencies䠅 ᰤ㣴ᙉㄪ⾲♧䛾⾜ᨻ䠋㡰Ᏺ 䠄ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ) Inspections and Penalties ᰝᐹ䛸⨩๎ ୰ᅜ Not permit in principle. All nutrients content claim is based on GB 28050. ཎ๎ⓗ䛻チྍ䛧䛶䛔䛺䛔䚹 䛶䛾ᰤ㣴⣲ྵ᭷㔞⾲♧䛿GB28050 䛻ᇶ䛵䛟 See previous page, Nutrition Labelling Regulations-1.3 ᰤ㣴⾲♧ᇶ‽-1.3 䛾ྠ㡯䛸ྠ䛨 See previous page, Nutrition Labelling Regulations-1.3 ᰤ㣴⾲♧ᇶ‽-1.3 䛾ྠ㡯䛸ྠ䛨 - 26 - 3.3 China China Health Claim Regulations-3.1a (Nutrient Function Claim) ୰ᅜ 䠖 ᗣᙉㄪ⾲♧つ๎-3.1a䠄ᰤ㣴ᶵ⬟⾲♧䠅 ᗣᙉㄪ⾲♧ ୰ᅜ Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ Definitions 䠄Collective Name of Foods with Health Claims, if applicable䠅 GB 28050 ᅜᐙᶆ‽ GB28050 Not applicable ヱᙜ䛧䛺䛔 ᐃ⩏䠄ᗣᙉㄪ⾲♧䜢䛧䛯㣗ရ䜢 ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾ྡ⛠䠅 Nutrient Function Claims 䠄Collective Name of the Foods, if applicable䠅 Nutrient function claim means a nutrition claim that describes the physiological role of a nutrient in growth, development and normal function of the body. The list of nutrient function claims see Annex D ᰤ㣴ᶵ⬟ᙉㄪ⾲♧䠄ᰤ㣴ᶵ⬟⾲ ♧䜢䛧䛯㣗ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙ ྜ䛿䛭䛾ྡ⛠䠅 ᰤ㣴ᶵ⬟⾲♧䛿䚸య䛾ᡂ㛗䚸Ⓨ㐩䛒䜛䛔䛿ṇᖖ䛺ᶵ⬟䛻䛚䛡䜛 ᰤ㣴⣲䛾⏕⌮ⓗᙺ䛻䛴䛔䛶ㄝ᫂䛩䜛䛣䛸䜢ព䛩䜛 ᰤ㣴ᶵ⬟⾲♧䛾䝸䝇䝖䛻䛴䛔䛶䛿䚸㝃ᒓ᭩D䜢ཧ↷ China Health Claim Regulations-3.1a (Nutrient Function Claim) ୰ᅜ 䠖 ᗣᙉㄪ⾲♧つ๎-3.1a䠄ᰤ㣴ᶵ⬟⾲♧䠅 ᗣᙉㄪ⾲♧ ୰ᅜ Other Function Claims䠄Collective Name of the Foods, if applicable䠅 Not allowed for the nutrients other than those listed in 䛭䛾䛾ᶵ⬟ᙉㄪ⾲♧䠄䛾ᶵ⬟⾲♧䜢 Annex D 䛧䛯㣗ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾 㝃ᒓ᭩D௨እ䛾ᰤ㣴⣲䛿チྍ䛥䜜䛶䛔䛺䛔 ྡ⛠) Reduction of Disease Risk Claims 䠄Collective Name of Foods Applied䠅 䝸䝇䜽పῶᙉㄪ⾲♧䠄㐺⏝䛥䜜䜛㣗 ရ䜢ᣦ䛩ྡ⛠䠅 Not allowed チྍ䛥䜜䛶䛔䛺䛔 Not applicable ヱᙜ䛧䛺䛔 Not applicable ヱᙜ䛧䛺䛔 Types of Approval/Certification 䠄Standardized/ Pre-authorized Claims䠅 ᢎㄆ䠋ㄆド䛾✀㢮䠄つ᱁ᇶ‽ᆺ䠋 ๓ ᢎㄆᆺ䠅 䠄Food Product/Constituent Specific Approval䠅 䠄㣗ရ䠋≉ᐃ䛾⤌ᡂᡂศ䛻ᑐ䛩䜛ᢎㄆ䠅 - 27 - 3.3 China China Health Claim Regulations-3.1b (Health Function Claim) ୰ᅜ 䠖 ᗣᙉㄪ⾲♧つ๎-3.1b䠄ᗣᶵ⬟⾲♧䠅 ᗣᙉㄪ⾲♧ Relevant Laws/Regulations ୰ᅜ Food Safety Law Provisions for Health Food Registration (interim) 㛵㐃ἲつ䠋つ๎ Definitions 䠄Collective Name of Foods with Health Claims, if applicable䠅 ᐃ⩏䠄ᗣᙉㄪ⾲♧䜢䛧䛯㣗ရ䜢 ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾ྡ⛠䠅 ᗣ㣗ရⓏ㘓䛻㛵䛩䜛㣗ရᏳἲつᐃ(ᬻᐃ) Health food, refers to those foods which claim to have certain health functions or aim at supplementing vitamins and minerals, namely, those foods which are used for certain groups of people with the aim to adjust organic function instead of curing diseases and will not cause any acute, sub-acute or chronic damages to human body. ᗣ㣗ရ䛸䛿䚸䛒䜛ᗣᶵ⬟䜢ᣢ䛳䛶䛔䜛䛣䛸䜢ッồ䛩䜛䛛䚸䝡䝍䝭䞁 䜔䝭䝛䝷䝹䜢⿵䛖䛣䛸䜢┠ⓗ䛸䛩䜛䚸䛩䛺䜟䛱䚸㌟య䛾ᶵ⬟䜢ㄪᩚ䛩䜛 䛣䛸䜢┠ⓗ䛻≉ᐃ䛾䜾䝹䞊䝥䛾ே䚻䛻⏝䛥䜜䜛㣗ရ䜢ゝ䛖䜒䛾䛷 䛒䛳䛶䚸䜢⒪䛩䜛┠ⓗ䛷⏝䛥䜜䜛䜒䛾䛷䛿䛺䛟䚸䛛䛴䚸ேయ䜈 䛾ᛴᛶ䚸ளᛴᛶ䜎䛯䛿៏ᛶ䛾᭷ᐖᛶ䜢ច㉳䛧䛶䛿䛺䜙䛺䛔 China Health Claim Regulations-3.1b (Health Function Claim) ୰ᅜ 䠖 ᗣᙉㄪ⾲♧つ๎-3.1b䠄ᗣᶵ⬟⾲♧䠅 ᗣᙉㄪ⾲♧ ୰ᅜ Health Function Claims 䠄Collective Name of the Foods, if applicable䠅 ᰤ㣴ᶵ⬟ᙉㄪ⾲♧䠄ᰤ㣴ᶵ⬟⾲ ♧䜢䛧䛯㣗ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙ ྜ䛿䛭䛾ྡ⛠䠅 Functional health food can claim 27 functions: Enhancing Immune Function, Antioxidative function, Assisting Memory Improvement , Alleviating Physical Fatigue, Weight Control, Improving Child Growth, Enhancing Anoxia Endurance, Assisting Blood Lipids Reduction, Assisting Blood Sugar Reduction, Assisting Blood Pressure Reduction, Sleep Improvement, Eliminating Acne, Eliminating Chloasma, Improving Skin Water Content, Improving Skin Oil Content, Increasing Bone Density, Facilitating Milk Secretion, Clear the Throat, Alleviating Lead Excretion, Assisting the Protection of Gastric Mucosa, Regulating Gastrointestinal Tract Flora, Facilitating Digestion, Facilitating Feces Excretion, Assisting Irradiation Hazard Protection, Alleviating Eye Fatigue, Assisting the Protection Against Chemical Injury to Liver, Improving iron-deficiency Anaemia ᶵ⬟ᛶᗣ㣗ရ䛿௨ୗ䛾27䛾ᶵ⬟䜢ッồ䛷䛝䜛䚹 චᶵ⬟䛾ᙉ䚸ᢠ㓟ᶵ⬟䚸グ᠈ຊ䛾ᨵၿ䚸⫗య⑂ປ䛾ᨵၿ䚸య 㔜⟶⌮䛾ᨭ䚸Ꮚ౪䛾ᡂ㛗䛾ಁ㐍䚸↓㓟⣲ᣢஂຊ䛾ᙉ䚸⾑୰⬡㉁ 䛾పῶ䜢ಁ㐍䚸⾑⢾್పῶ䜢ಁ㐍䚸⾑ᅽపୗ䜢ᨭ䚸╧╀䛾ᨵၿ䚸䛻 䛝䜃䛾㝖ཤ䚸⫢ᩬ䛾㝖ཤ䚸⫙Ỉศ㔞䛾ᨵၿ䚸⓶Ἔศ䛾ᨵၿ䚸㦵ᐦ ᗘ䛾ቑຍ䚸䝭䝹䜽ศἪ䛾ಁ㐍䚸ႃ䛾Ύί䚸㖄ἥ䛾ಁ㐍䚸⫶⢓⭷ಖㆤ 䛾ಁ㐍䚸⭠ෆ䝣䝻䞊䝷䛾ᨵၿ䚸ᾘᶵ⬟䛾ஹ㐍䚸ἥ䛾ஹ㐍䚸↷ᑕ䝝 䝄䞊䝗䛾ಖㆤ䚸║ᛶ⑂ປ䛾⦆䚸Ꮫ≀㉁䛻䜘䜛⫢㞀ᐖ䛾⦆䚸㕲Ḟ ஈᛶ㈋⾑䛾ᨵၿ - 28 - 3.3 China China Health Claim Regulations-3.1b (Health Function Claim) ୰ᅜ 䠖 ᗣᙉㄪ⾲♧つ๎-3.1b䠄ᗣᶵ⬟⾲♧䠅 ᗣᙉㄪ⾲♧ ୰ᅜ Other Function Claims䠄Collective Name of the Foods, if applicable䠅 䛭䛾䛾ᶵ⬟ᙉㄪ⾲♧䠄䛾ᶵ⬟⾲♧䜢 Not applicable 䛧䛯㣗ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾 ྡ⛠) Reduction of Disease Risk Claims 䠄Collective Name of Foods Applied䠅 䝸䝇䜽పῶᙉㄪ⾲♧䠄㐺⏝䛥䜜䜛㣗 ရ䜢ᣦ䛩ྡ⛠䠅 Types of Approval/Certification 䠄Standardized/ Pre-authorized Claims䠅 ᢎㄆ䠋ㄆド䛾✀㢮䠄つ᱁ᇶ‽ᆺ䠋 ๓ ᢎㄆᆺ䠅 䠄Food Product/Constituent Specific Approval䠅 Not applicable ヱᙜ䛧䛺䛔 ヱᙜ䛧䛺䛔 Health food registration (Pre-marketing administrative approval) ᗣ㣗ရ䛾Ⓩ㘓䠄๓䝬䞊䜿䝔䜱䞁䜾⟶⌮⪅䛾ᢎㄆ䠅 Simultaneous assessment of health food and ingredients contained 㣗ရཬ䜃⣲ᮦ䛜ྠ䛻ホ౯䛥䜜䜛 䠄㣗ရ䠋≉ᐃ䛾⤌ᡂᡂศ䛻ᑐ䛩䜛ᢎㄆ䠅 China Health Claim Regulations-3.2 (Health Function Claim) ୰ᅜ 䠖 ᗣᙉㄪ⾲♧つ๎-3.2䠄ᗣᶵ⬟⾲♧䠅 ᗣᙉㄪ⾲♧ ୰ᅜ Scientific Substantiation of Health Function tests (animal and/or human) Claims ᶵ⬟ヨ㦂䠄ື≀䛚䜘䜃/䜎䛯䛿䝠䝖䠅 ᗣᙉㄪ⾲♧䛻㛵䛩䜛⛉Ꮫⓗᐇ ド Process for the Substantiation (Organizational Systems, Governing Authority/Agency/Commission) ᐇド䛾䝥䝻䝉䝇䠄ᑂᰝ⤌⧊䛾ᵓ㐀䚸 ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠋ጤဨ䠅 Criteria for the Substantiation and/or Consideration of the Evidence ᐇド䛾ᇶ‽䛚䜘䜃䠋䜎䛯䛿ຠᯝ䛾 ホ౯ Three continuous batches of samples are tested in designated labs for hygiene, active ingredient, stability, toxicology and health function. Validation tests are mandatory. 㐃⥆䛩䜛3䝞䝑䝏䛾䝃䞁䝥䝹䛻䛴䛔䛶䚸⾨⏕≧ែ䚸άᛶᡂศ䚸Ᏻᐃ ᛶ䚸ẘ≀Ꮫཬ䜃ᗣᶵ⬟䜢䚸ᣦᐃ䛥䜜䛯ᐇ㦂ᐊ䛷ヨ㦂䛩䜛䚹᳨ド ヨ㦂䛿ᚲ㡲䛷䛒䜛 Technical Standards for Testing & Assessment of Health Food (2003) (Nine of them were revised in 2012) ᗣ㣗ရ䛾᳨ᰝ·ホ౯䛾䛯䜑䛾ᢏ⾡つ᱁(2003)(䛭䛾䛖䛱䛾9つ᱁ 䛿2012ᖺ䛻ᨵᐃ䛥䜜䛯) - 29 - 3.3 China China Health Claim Regulations-3.2 (Health Function Claim) ୰ᅜ 䠖 ᗣᙉㄪ⾲♧つ๎-3.2䠄ᗣᶵ⬟⾲♧䠅 ᗣᙉㄪ⾲♧ ୰ᅜ The safety toxicology test report, the hygiene test report, the other inspection reports (the appraisal report of raw materials, the vaccine virulence test report) Specific Safety Concerns ≉ᐃ䛾Ᏻᛶ䛻㛵䛩䜛㡯 Ᏻᛶẘᛶヨ㦂ሗ࿌᭩䚸⾨⏕ヨ㦂ሗ࿌᭩䚸䛭䛾䛾᳨ᰝሗ࿌᭩䠄ཎ ᮦᩱ䛾㚷ᐃホ౯᭩䚸䝽䜽䝏䞁ཎᛶヨ㦂ሗ࿌᭩䠅 Extending the valid period of the health food license, reducing the range of suitable users, expanding the range of unsuitable users, precautions and function Articles, and alter dosage, product specifications, storage life and quality standard. Re-evaluation ホ౯ ᗣ㣗ရ䛾〇㐀チྍᮇ㛫䛾ᘏ㛗䚸㐺ษ䛺䝴䞊䝄䞊䛾⠊ᅖ䛾⦰ᑠ䚸 㐺ᙜ䛺䝴䞊䝄䞊䛾⠊ᅖ䞉ὀព㡯䞉ᶵ⬟グ㍕䛾ᣑ䚸ᢞ㔞䞉〇ရ ᵝ䞉㈹ᮇ㝈䛒䜛䛔䛿ရ㉁つ᱁䛾ኚ᭦ Product Quality Concerns䠄GMP, ISO, HACCP or Other Measures䠅 〇ရရ㉁䛻㛵䛩䜛㡯䠄GMP, ISO, HACCP 䜎䛯䛿䛾ホ౯ᑻ ᗘ䠅 Health food GMP ᗣ㣗ရ GMP N/A つᐃ↓䛧 Adverse Event Reporting System 䠄Mandatory/ Voluntary䠅 ᭷ᐖ㇟䛻㛵䛩䜛ሗ࿌䝅䝇䝔䝮 䠄⩏ົ䠋௵ព䠅 China Health Claim Regulations-3.2 (Health Function Claim) ୰ᅜ 䠖 ᗣᙉㄪ⾲♧つ๎-3.2䠄ᗣᶵ⬟⾲♧䠅 ᗣᙉㄪ⾲♧ Administrations/Complia nces for Health Claims 䠄Governing Authorities/Agencies䠅 ᗣᙉㄪ⾲♧䛾⾜ᨻ䠋㡰 Ᏺ䠄ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠅 Inspections and Penalties China Food and Drug Administration (CFDA) ୰ᅜ㣗ရ་⸆ရᒁ 䠄CFDA䠅 CFDA and AIC (Administration for Industry & Commerce) According to Provisions for Health Food Registration (interim), Advertising regulations of health food (interim) and Advertising Law, the penalties can be canceling the health food license, canceling the advertisement license of health food and fining. ᰝᐹ䛸⨩๎ CFDA(୰ᅜ㣗ရ⸆ရ⟶⌮ᒁ)ཬ䜃AIC(ᕤၟ⟶⌮ᒁ)ᗣ㣗ရⓏ㘓つᐃ(ᬻᐃ)䚸 ᗣ㣗ရᗈ࿌つไ(ᬻᐃ)ཬ䜃ᗈ࿌ἲ䛻ᇶ䛵䛝䚸⨩๎䛿䚸ᗣ㣗ရ䛾〇㐀㈍ チྍ䛾ྲྀᾘ䛧䚸ᗣ㣗ရᗈ࿌䛾チྍ䛾ྲྀᾘ䛧ཬ䜃⨩㔠䛸䛺䜛 - 30 - 3.3 China China Health Claim Regulations-3.3 ୰ᅜ 䠖 ᗣᙉㄪ⾲♧つ๎-3.3 ᗣᙉㄪ⾲♧ Relevant Laws/Regulations for Dietary/Food/Health Supplements 䝎䜲䜶䝍䝸䞊䠋䝣䞊䝗䠋䝦䝹䝇 䝃䝥䝸 䝯䞁䝖䛻㛵䛩䜛㛵㐃ἲつ䠋つ๎ Definitions㸦Dietary Supplements, and/or Food Supplements, and/or Health Supplements㸧 ᐃ⩏㸦ࢲ࢚ࢱ࣮ࣜࢧࣉ࣓ࣜࣥࢺ ࠾ࡼࡧ㸭ࡲࡓࡣࣇ࣮ࢻࢧࣉ࣓ࣜࣥ ࢺ࠾ࡼࡧ㸭ࡲࡓࡣ࣊ࣝࢫࢧࣉ࣓ࣜ ࣥࢺ㸧 Administrations/Compliances for the Supplements 䠄Governing Authorities/Agencies䠅 䝃䝥䝸䝯䞁䝖䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ⟶ ᙜᒁ䠋ᐁᗇ䠅 Food Safety Law Provisions for Health Food Registration (interim) Regulations of nutrient supplements ᗣ㣗ရ䛾Ⓩ㘓䛻㛵䛩䜛㣗ရᏳἲ䛾つᐃ(ᬻᐃ) Nutrient supplements, aiming at supplementing vitamins and minerals ᰤ㣴⣲䝃䝥䝸䝯䞁䝖䚸䝡䝍䝭䞁䜔䝭䝛䝷䝹䜢⿵㊊䛩䜛┠ⓗ䛷䛒䜛 CFDA ୰ᅜ㣗ရ⸆ရ⟶⌮ᒁ - 31 - - 32 - 3.4 Taiwan Nutrition Labelling and Nutrition/Health Claims ᰤ㣴⾲♧ཬ䜃ᰤ㣴/ᗣᙉㄪ⾲♧ 3.4 Taiwan ྎ ‴ Taiwan Nutrition Labelling Regulations-1.1 ྎ‴ 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ ྎ ‴ Act Governing Food Sanitation (2013); Draft: Nutrition Labelling Standard for Packaged Food (8/19/2013, 2nd notice for comments; 7/1/2015, scheduled effective date) 㣗ရ⾨⏕ἲ(2013); 䝗䝷䝣䝖: ໟ῭䜏㣗ရ䛾䛯䜑䛾ᰤ㣴⾲♧ᇶ‽(2013ᖺ8᭶19᪥䚸䝁䝯䞁䝖䛻 ᑐ䛩䜛➨2ᅇ㏻▱䠗2015ᖺ7᭶1᪥ ⾜ணᐃ) Nutrient Reference Values (Definitions, NRVs-R/Definitions for DNIVs/ DVs NCD) DNIVs/ DVs 䛾ᐃ⩏; DNIVs/ DVs䠖୍᪥ᙜ䛯䜚ᰤ㣴ᦤྲྀ㔞 ᰤ㣴ཧ↷㔞䠄ᐃ⩏, NRVsR/-NCD䠅 Nutrient Declaration (Application: Mandatory or Voluntary) ᰤ㣴⾲♧䠄㐺⏝䠖 ⩏ົ 䜒 䛧䛟䛿 ௵ព䠅 Food Categories Applied 㐺⏝䛥䜜䜛㣗ရ䜹䝔䝂䝸䞊 Mandatory ⩏ົ All prepackaged foods 䛩䜉䛶䛾ໟ῭䜏㣗ရ - 33 - 3.4 Taiwan Taiwan Nutrition Labelling Regulations-1.1 ྎ‴ 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ ྎ ‴ Ready to eat food (Separately regulated: Vitamins/ minerals packaged in tablet/ capsule format, health food, special dietary food) Exemptions (Food Categories) ㄪ⌮῭䜏㣗ရ(䝍䝤䝺䝑䝖/䜹䝥䝉䝹ᙧ≧䛾 䝡䝍䝭䞁㢮/ 䝭䝛䝷䝹㢮䚸ᗣ㣗ရ䚸 㐺⏝㝖እ䠄㣗ရ䜹䝔䝂䝸䞊䠅 ≉ᐃ⏝㏵㣗ရ䛿ู㏵つᐃ䛒䜚) (Size of Food Business Operators) 䠄㣗ရᴗ⪅䛾つᶍ䠅 Not applicable 㐺ᛂ↓䛧 Energy, Protein, Fat, Saturated Fat, Trans Fat, Carbohydrate (including D.F.), Sugars and Sodium Listing of Nutrients (Nutrients, Order) ᰤ㣴ᡂศ䝸䝇䝖 䠄ᰤ㣴ᡂศ䚸 グ㍕㡰䠅 Optional Ingredients 䜶䝛䝹䜼䞊䚸 䛯䜣䜁䛟㉁䚸 ⬡㉁䚸㣬⬡⫫㓟䚸䝖䝷䞁䝇⬡⫫㓟䚸ⅣỈ≀䠄㣗 ≀⧄⥔䜢ྵ䜐䠅䚸⢾㢮䚸䛚䜘䜃䝘䝖䝸䜴䝮 Any other nutritional constituent, declared in the nutrition and health claim or labelled by the manufacture voluntarily 䛭䛾䛾ᰤ㣴ᡂศ 〇㐀⪅䛻䜘䜛ᰤ㣴ᗣッồ䜒䛧䛟䛿ᰤ㣴⾲♧䛻䜘䜛䛭䛾䛾ᰤ㣴ᡂศ䛿௵ព Taiwan Nutrition Labelling Regulations-1.2 ྎ‴ 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ Presentation of Nutrient Content (Expression per 100g/ml or serving or package) ᰤ㣴ᡂศ㔞䛾⾲♧᪉ἲ 䠄⾲♧᪉ἲ 100g/ml 䚸1䝃䞊䝡䞁䜾䚸 ཪ䛿1ໟศ䛒䛯䜚䠅 (Expression in Exact values or Ranges) 䠄⾲♧䛩䜛್䠖୍ᐃ್䜒䛧䛟䛿ᖜ⾲ ♧䠅 (Analysis or Calculation Basis) 䠄ศᯒ್䜒䛧䛟䛿ィ⟬್䠅 Use of Food Composition Table/ Database for Presentation of Nutrients ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲䠋 䝕䞊䝍䝧䞊䝇 䛾⏝ Food Composition Table/Database for Presentation of Nutrients ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲䠋 䝕䞊䝍䝧䞊䝇 ྎ ‴ Per serving, per 100g/ml, or Per serving, DNIV% or DV% 1㣗ศ䚸100g/ml䛒䛯䜚䚸ཪ䛿 1㣗ศ䚸 DNIV% ཪ䛿 DV% Exact values ୍ᐃ್ Both analysis and calculation basis are allowed ศᯒ್䚸ィ⟬್䛾䛔䛪䜜䜒ྍ Allowed ྍ Taiwanese Food Composition Table (https://consumer.fda.gov.tw/Food/TFND.aspx?nodeID=178) ྎ‴㣗ရᡂศ⾲ (https://consumer.fda.gov.tw/Food/TFND.aspx?nodeID=178) - 34 - 3.4 Taiwan Taiwan Nutrition Labelling Regulations-1.2 ྎ‴ 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ ྎ ‴ Calculation of Nutrients (Energy/Protein/ Carbohydrate/Fat) Similar to Codex Guidelines, except for Dietary fiber (2 Kcal/g), Erythritol (0 Kcal/g) and other Sugar alcohols (2.4 Kcal/g). ᰤ㣴ᡂศ䛾ィ⟬ 䠄䜶䝛䝹䜼䞊 䠋䛯䜣䜁䛟㉁䠋ⅣỈ≀䠋⬡㉁) Codex 䜺䜲䝗䝷䜲䞁䛸ྠ➼䚸ణ䛧㣗≀⧄⥔(2 Kcal/g)䚸 䜶䝸䝇䝸䝖䞊䝹(0 Kcal/g) 䚸䛭䛾䛾⢾䜰䝹䝁䞊䝹 (2.4 Kcal/g) 䜢㝖䛟 Specific tolerations defined for different nutrients (80%, 120%, 180%䠅 Tolerances and Compliances (Tolerance Limits) බᕪ䛸㐺ྜᛶ䠄ㄗᕪ⠊ᅖ䠅 ᰤ㣴ᡂศู䛻ᐃ䜑䜙䜜䛶䛔䜛 䠄80%. 120%, 180%䠅 Tabular format; linear format for small packaging %DV labelling applied Specific Features of Presentation (Format, %NRV Labelling) ⾲ᙧᘧ; ᑠᐜჾ䛻䛴䛔䛶䛿ิグᙧᘧ %DV ⾲♧䜢㐺⏝ ⾲♧᪉ἲ䛾≉Ⰽ 䠄䝣䜷䞊䝬䝑 䝖䚸%NRV䚸⾲♧䠅 (Front of Package Labelling, FOP) No FOP labelling applied 䠄䝟䝑䜿䞊䝆ṇ㠃䛾⾲♧䚸FOP䠅 FOP⾲♧䛿㐺⏝እ Taiwan Nutrition Labelling Regulations-1.3 ྎ‴ 䠖 ᰤ㣴⾲♧ᇶ‽-1.3 ᰤ㣴⾲♧ ྎ ‴ Administrations/Compl (Taiwan) Food and Drug Administration and local governments iances for Nutrition Labelling (Governing Authorities/Agencies) 㻔ྎ‴㻕㻌་⸆㣗ရᒁ䛸ᆅ᪉ᆅ⮬య ᰤ㣴⾲♧䛾⾜ᨻ䠋㡰Ᏺ 䠄ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠅 Inspections and Penalties ᰝᐹ䛸⨩๎ Periodical inspections; penalties defined ᐃᮇⓗ䛺ᰝᐹ㻧 ⨩๎䛾つᐃ䛒䜚 - 35 - 3.4 Taiwan Taiwan Nutrition Claim Regulations-2 ྎ‴ 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ Definitions (Nutrient Content/Comparative Claims) ᐃ⩏䠄ᰤ㣴⣲ྵ᭷㔞䠋ẚ㍑ ᙉㄪ⾲♧䠅 Nutrient Content Claims ᰤ㣴⣲ྵ᭷㔞ᙉㄪ⾲♧ Nutrient Comparative Claims ᰤ㣴⣲ẚ㍑ᙉㄪ⾲♧ ྎ ‴ Act Governing Food Sanitation (2013); Regulation on Nutrition Claims of Conventional Foods (2003) 㣗ရ⾨⏕ἲ(2013) ୍⯡㣗ရ䛾ᙉㄪ⾲♧つไ(2003) Identical to Codex Guidelines Codex䜺䜲䝗䝷䜲䞁䛸ྠ୍ Similar conditions defined (no nutrition claim on carbohydrate and protein, no very low sodium claim, limited number of vitamins and minerals for claims) 䝁䞊䝕䝑䜽䝇ྠᵝ䛾᮲௳䜢つᐃ (ⅣỈ≀䛸䛯䜣䜁䛟㉁䜈䛾ᙉㄪ⾲⌧䛺䛧䚸㉸ప䝘䝖䝸䜴䝮⾲⌧䛺䛧䚸䝡䝍 䝭䞁㢮䛸䝭䝛䝷䝹㢮䛾⾲⌧ᩘ䛻䛿ไ㝈䛒䜚 Similar conditions defined (< 15% DVs, 100g solid for vitamins A, C and E, calcium due to the latest increase revision of the DVs) 䝁䞊䝕䝑䜽䝇ྠᵝ䛾᮲௳䜢つᐃ (< 15% DVs䚸䝡䝍䝭䞁A䚸C ཬ䜃 E䚸 䜹䝹䝅䜴䝮䛿100gᅛᙧ䛒䛯䜚䚸DVsቑ ຍ䛾᭱᪂䛾ᨵゞ䛻䜘䜛) Taiwan Nutrition Claim Regulations-2 ྎ‴ 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ Non-addition Claims 䠄Non-addition of Sugars/Sodium Salts䠅 ↓ῧຍ⾲♧䠄⢾㢮䠋䝘䝖䝸䜴 䝮ሷ䛾↓ῧຍ䠅 Administrations/Complianc es for Nutrition Claims 䠄Governing Authorities/Agencies䠅 ᰤ㣴ᙉㄪ⾲♧䛾⾜ᨻ䠋㡰Ᏺ 䠄ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ) Inspections and Penalties ᰝᐹ䛸⨩๎ ྎ ‴ Not applicable 㐺ᛂ↓䛧 (Taiwan) Food and Drug Administration; local governments (ྎ‴) ་⸆㣗ရᒁ䛸ᆅ᪉ᆅ⮬య Periodical inspections; penalties defined ᐃᮇⓗ䛺ᰝᐹ㻧 ⨩๎䛾つᐃ䛒䜚 - 36 - 3.4 Taiwan Taiwan Health Claim Regulations-3.1 ྎ‴ 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 ᗣᙉㄪ⾲♧ ྎ ‴ Act Governing Food Sanitation (2013); Health Food Control Act (2006); Enforced Rules of Health Food Control Act (2006); Regulations for Application of Health Food Permit (2012) Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ 㣗ရ⾨⏕⟶⌮ἲ(2013); ᗣ㣗ရ⟶⌮ἲ(2006); ᗣ㣗ရ⟶⌮ ἲ⾜⣽๎ (2006䠅; ᗣ㣗ရ⏦ㄳチྍ㎨ἲ(2012) Definitions 䠄Collective Name of Foods with Health Claims, if applicable䠅 ᐃ⩏䠄ᗣᙉㄪ⾲♧䜢䛧䛯㣗ရ䜢ᣦ 䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾ྡ⛠䠅 Nutrient Function Claims 䠄Collective Name of the Foods, if applicable䠅 ᰤ㣴ᶵ⬟ᙉㄪ⾲♧䠄ᰤ㣴ᶵ⬟⾲♧䜢 䛧䛯㣗ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭 䛾ྡ⛠䠅 Health Food; applicable to all prepackaged foods ᗣ㣗ရ Health Food; 䛶䛾ໟ䛥䜜䛯㣗ရ䛻㐺⏝ྍ⬟ Health Food; no distinction ᗣ㣗ရ Health Food; ≉䛻༊ู↓䛧 Taiwan Health Claim Regulations-3.1 ྎ‴ 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 ᗣᙉㄪ⾲♧ Other Function Claims䠄Collective Name of the Foods, if applicable䠅 䛭䛾䛾ᶵ⬟ᙉㄪ⾲♧䠄䛾ᶵ⬟⾲ ♧䜢䛧䛯㣗ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ 䛿䛭䛾ྡ⛠) ྎ ‴ Health Food; no distinction ᗣ㣗ရ Health Food; ≉䛻༊ู↓䛧 Reduction of Disease Risk Claims 䠄Collective Name of Foods Applied䠅 Health Food; no distinction 䝸䝇䜽పῶᙉㄪ⾲♧䠄㐺⏝䛥䜜 䜛㣗ရ䜢ᣦ䛩ྡ⛠䠅 Types of Approval/Certification 䠄Standardized/ Pre-authorized Claims䠅 ᢎㄆ䠋ㄆド䛾✀㢮䠄つ᱁ᇶ‽ᆺ䠋 ๓ᢎㄆᆺ䠅 䠄Food Product/Constituent Specific Approval䠅 䠄㣗ရ䠋≉ᐃ䛾⤌ᡂᡂศ䛻ᑐ䛩䜛ᢎ ㄆ䠅 ᗣ㣗ရ Health Food; ≉䛻༊ู↓䛧 Not Applicable 㐺⏝↓䛧 Health Food ᗣ㣗ရ Health Food - 37 - 3.4 Taiwan Taiwan Health Claim Regulations-3.2 ྎ‴ 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ ྎ ‴ Scientific Substantiation of Health Similar to Codex; documentation required Claims Codex䛸㢮ఝ䚹ドᣐ᭩㢮䛾ᥦฟ䛜ᚲせ ᗣᙉㄪ⾲♧䛻㛵䛩䜛⛉Ꮫⓗᐇド Process for the Substantiation (Organizational Systems, Governing Authority/Agency/Commission) ᐇド䛾䝥䝻䝉䝇䠄ᑂᰝ⤌⧊䛾ᵓ㐀䚸 ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠋ጤဨ䠅 Criteria for the Substantiation and/or Consideration of the Evidence ᐇド䛾ᇶ‽䛚䜘䜃䠋䜎䛯䛿ຠᯝ䛾 ホ౯ Similar to Codex, but with a dual track system; Ministry of Health and Welfare (MOHW)* ĺHealth Food Advisory Committee (effect substantiation and safety assessment)ĺ (MOHW)* *With the assistance of PITDC (Pharmaceutical Industry Technology and Development Center) 㻯㼛㼐㼑㼤䛸㢮ఝ䚹䛧䛛䛧䚸୪⾜༠㆟䝅䝇䝔䝮䜢䛸䜛䚹 ⾨⏕⚟㒊 (MOHW)* ĺ ᗣ㣗ရㅎၥጤဨHealth Food Advisory Committee (ຠᯝࡢᐇドᏳᛶホ౯) ĺ (MOHW) *PITDC (㈈ᅰἲே㓾⸩ᕤᴗᢏ⾡ⓐᒎ୰ᚰ:Pharmaceutical Industry Technology and Development Center)䛾ຓ䜢ཷ䛡䛶 Similar to Codex for Track 1 (regular product); documentation required Track1 =ᕤ⛬䠍䠄㏻ᖖ/᪂つ〇ရ䠅䛿Codex䛻㢮ఝ; ドᣐ᭩㢮䛾ᥦฟ 䛜ᚲせ Documentations required for Classes 2 to 4 (other than conventional processing food) Specific Safety Concerns ≉ᐃ䛾Ᏻᛶ䛻㛵䛩䜛㡯 Class 2䛛䜙4䠄㏻ᖖ/〇㐀㣗ရ௨እ䠅䛷䛿ドᣐ᭩㢮䛾ᥦฟ䛜ᚲせ Taiwan Health Claim Regulations-3.2 ྎ‴ 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ Re-evaluation ホ౯ Product Quality Concerns䠄GMP, ISO, HACCP or Other Measures䠅 〇ရရ㉁䛻㛵䛩䜛㡯䠄GMP, ISO, HACCP 䜎䛯䛿䛾ホ౯ᑻᗘ䠅 ྎ ‴ When in doubt with new scientific study or with product composition, formulation or manufacturing method; or when considered necessary ᪂䛯䛺⛉Ꮫⓗ▱ぢ䛜ᚓ䜙䜜䛶⩏䛜⏕䛨䛯䚸䛒䜛䛔䛿〇ရ䛾⤌ᡂ䚸 㓄ྜ䚸〇㐀ᕤ⛬䛻ኚ᭦䛜⏕䛨䛯ሙྜ䚸䜎䛯䛿ᚲせ䛻ᛂ䛨䛶ホ౯ Documentation required ドᣐ᭩㢮䛾ᥦฟ䛜ᚲせ Voluntary; via “Unexpected Adverse Reaction to Health Food and Adverse Event Reporting System 䠄Mandatory/ Voluntary䠅 ᭷ᐖ㇟䛻㛵䛩䜛ሗ࿌䝅䝇䝔䝮 䠄⩏ົ䠋௵ព䠅 Tablets Reporting System” thru Drug Relief Foundation (outsourcing) ௵ព; 䛂㈈ᅰἲே⸩ᐖᩆᇶ㔠᭳䛃 “Drug Relief Foundation” (እ 㒊ጤク䠅䛾 䛂䝦䝹䝇䝣䞊䝗䞉㘄䛻ᑐ䛩䜛ணᮇ䛫䛼᭷ᐖ㇟ሗ࿌䝅 䝇䝔䝮“Unexpected Adverse Reaction to Health Food and Tablets Reporting System”䛃䜢㏻䛧䛶 ሗ࿌ - 38 - 3.4 Taiwan Taiwan Health Claim Regulations-3.2 ྎ‴ 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ ྎ ‴ Administrations/Compliances for Health Claims䠄Governing Authorities/Agencies䠅 ᗣᙉㄪ⾲♧䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ ⟶ᙜᒁ䠋ᐁᗇ䠅 (Taiwan) Food and Drug Administration; local Governments 䠄ྎ‴䠅⾨⏕⚟㒊㣗ရ⸩≀⟶⌮⨫; ᆅ᪉⮬య Periodical inspections; penalties defined Inspections and Penalties ᰝᐹ䛸⨩๎ ᐃᮇᰝᐹ; ⨩๎䛾つᐃ䛒䜚 Taiwan Health Claim Regulations-3.3 ྎ‴ 䠖 ᗣᙉㄪ⾲♧つ๎-3.3 ᗣᙉㄪ⾲♧ Relevant Laws/Regulations for Dietary/Food/Health Supplements 䝎䜲䜶䝍䝸䞊䠋䝣䞊䝗䠋䝦䝹䝇 䝃䝥䝸 䝯䞁䝖䛻㛵䛩䜛㛵㐃ἲつ䠋つ๎ Definitions㸦Dietary Supplements, and/or Food Supplements, and/or Health Supplements㸧 ᐃ⩏㸦ࢲ࢚ࢱ࣮ࣜࢧࣉ࣓ࣜࣥࢺ ࠾ࡼࡧ㸭ࡲࡓࡣࣇ࣮ࢻࢧࣉ࣓ࣜࣥ ࢺ࠾ࡼࡧ㸭ࡲࡓࡣ࣊ࣝࢫࢧࣉ࣓ࣜ ࣥࢺ㸧 Administrations/Compliances for the Supplements 䠄Governing Authorities/Agencies䠅 䝃䝥䝸䝯䞁䝖䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ⟶ ᙜᒁ䠋ᐁᗇ䠅 ྎ ‴ Not specifically defined; treated in the same manner as foods ≉䛻つᐃ䛫䛪䚸㣗ရ䛸ྠᵝ䛻ᢅ䛖 Not specifically defined; treated in the same manner as foods ≉䛻つᐃ䛫䛪䚸㣗ရ䛸ྠᵝ䛻ᢅ䛖 Not specifically defined; treated in the same manner as foods ≉䛻つᐃ䛫䛪䚸㣗ရ䛸ྠᵝ䛻ᢅ䛖 - 39 - - 40 - 3.5.1 Indonesia Nutrition Labelling and Nutrition/Health Claims ᰤ㣴⾲♧ཬ䜃ᰤ㣴/ᗣᙉㄪ⾲♧ 3.5.1 Republic of Indonesia 䜲䞁䝗䝛䝅䜰ඹᅜ ᰤ㣴⾲♧ Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ Indonesia Nutrition Labelling Regulations-1.1 䜲䞁䝗䝛䝅䜰 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 䜲䞁䝗䝛䝅䜰 • Act no. 18 Year 2012 on Food • Ministry of Health Regulation Number 30 Year 2013 on inclusion of the information content of sugar, salt, and fat and health information to processed food and fast food • Head of NADFC Regulation No: HK.03.1.23.11.11.09605 (2011) on Amendment to Head of NADFC Decree No: HK.00.06.51.0475 on Guidelines on Nutrition Information Uses on Food Label • Head of NADFC Regulation Number HK.03.1.23.11.11.09909 Year 2011 on Controlling of Claims on Label and Advertisement of Processed Food Regulation: • Government Regulation No. 69/1999 on Food labelling and Advertisement. http://jdih.pom.go.id/ x 㣗⣊ἲ➨18ྕ䠄2012䠅 x ◁⢾䜔ሷ䚸⬡㉁䛾ሗ䜔䚸ຍᕤ㣗ရ䜔䝣䜯䞊䝇䝖䞉䝣䞊䝗䛻㛵䛩䜛䛥䜎䛦䜎䛺ᗣሗ䜢 ໟᣓ䛩䜛ಖ┬つ๎➨30ྕ䠄2013䠅 x 㣗ရ䛻⾲♧䛥䜜䜛ᰤ㣴ሗ䛾⏝䛻㛵䛩䜛䜺䜲䝗䝷䜲䞁䛻㛵䛩䜛ᅜᐙ་⸆ရ㣗ရ┘╩ ᗇ㛗ᐁHK.00.06.51.0475䛾ಟṇ䛷䛒䜛ᅜᐙ་⸆ရ㣗ရ┘╩ᗇ㛗ᐁ௧ HK.03.1.23.11.11.09605 (2011) x ຍᕤ㣗ရ䛾⾲♧䛸ᗈ࿌䛻䛚䛡䜛ᙉㄪ⾲♧䛾⟶⌮䛻㛵䛩䜛ᅜᐙ་⸆ရ㣗ရ┘╩ᗇ㛗ᐁ ௧HK.03.1.23.11.11.09909䠄2011䠅 つ๎䠖 x 㣗ရ䛾⾲♧䛚䜘䜃ᗈ࿌䛻㛵䛩䜛ᨻᗓつᐃ➨69ྕ䠄1999䠅 http://jdih.pom.go.id/ - 41 - 3.5.1 Indonesia Indonesia Nutrition Labelling Regulations-1.1 䜲䞁䝗䝛䝅䜰 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ 䜲䞁䝗䝛䝅䜰 Nutrient Reference Values NRV Indonesia 䜲䞁䝗䝛䝅䜰ᰤ㣴ཧ↷㔞 (Definitions, NRVs-R/Regulation: NCD) Head of NADFC Decree No: HK. つ๎ (2007) on NRV 㣗ရ䛾ᰤ㣴ཧ↷㔞䛻㛵䛩䜛ᅜᐙ་⸆ရ㣗ရ ᰤ㣴ཧ↷㔞䠄ᐃ⩏, NRVs- 00.05.52.6291 for Food Product. ┘╩ᗇ㛗ᐁ௧HK.00.05.52.6291 (2007) R /-NCD䠅 -Voluntary -Nutrition labelling mandatory ࡲ ௵ព only for food: ࡲ ௨ୗ䛾㣗ရ䛻䛴䛔䛶䛿ᰤ㣴ᡂศ⾲♧䛿⩏ົ a. accompanied by statement Nutrient Declaration a.䝡䝍䝭䞁䚸䝭䝛䝷䝹䚸䛾ᰤ㣴⣲䜢ῧຍ䛧䛯᪨ that the food contains vitamin, (Application: Mandatory 䛾ᩥ᭩䛜ῧ䛥䜜䛯㣗ရ mineral, and other nutrients or Voluntary) added to it; or b.㣗ရရ㉁䛾ศ㔝䛷㐺⏝䛥䜜䜛䝹䞊䝹䜔つ๎ ᰤ㣴⾲♧䠄㐺⏝䠖 ⩏ົ 䜒 b. required by virtue of the 䜢タ䛡䛯䛣䛸䛻䜘䜚䝡䝍䝭䞁䚸䝭䝛䝷䝹ⱝ䛧䛟䛿 provisions in applicable rules 䛾ᰤ㣴⣲䛜ᙉ䛥䜜䛯㣗ရ 䛧䛟䛿 ௵ព䠅 and regulations in the field of food quality any food nutrition, shall be enriched with vitamin, mineral and or any other nutrients. Food Categories Applied All prepackaged foods 䛶䛾ໟ῭䜏㣗ရ 㐺⏝䛥䜜䜛㣗ရ䜹䝔䝂䝸䞊 Exemptions (Food Categories) Not applicable 㐺⏝↓䛧 㐺⏝㝖እ䠄㣗ရ䜹䝔䝂 䝸䞊䠅 (Size of Food Business Operators) 㐺⏝↓䛧 Not applicable 䠄㣗ရᴗ⪅䛾つᶍ䠅 Indonesia Nutrition Labelling Regulations-1.1 䜲䞁䝗䝛䝅䜰 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ 䜲䞁䝗䝛䝅䜰 Core nutrients: •Total Energy •Total Fat. •Protein. •Total Carbohydrate(including dietary fibre) •Sodium. Mandatory with Specific Requirement due to : - food products contain nutrients in certain amounts or せᰤ㣴⣲䠖 - the required nutrients to be Listing of 䞉⥲䜶䝛䝹䜼䞊 added or fortified into food or Nutrients 䞉⥲⬡㉁ - food with claims (Nutrients, 䞉䛯䜣䜁䛟㉁ The nutrients are: Order) 䞉⥲ⅣỈ≀䠄㣗≀⧄⥔䜢ྵ䜐䠅 • Energy from Fat. ᰤ㣴ᡂศ䝸䝇䝖 • Saturated Fat. 䞉䝘䝖䝸䜴䝮 䠄ᰤ㣴ᡂศ䚸 • Trans Fat. ௨ୗ䛾⌮⏤䛻䜘䜚≉ู䛺つ๎䛷⩏ົ䛸䛺䛳䛶䛔䜛䜒䛾䠖 グ㍕㡰䠅 • Cholesterol. ࡲ ᰤ㣴⣲䜢≉ᐃ䛺㔞ྵ᭷䛩䜛㣗ရ • Dietary Fibre. ࡲ ᚲせ䛸䛥䜜䜛ᰤ㣴⣲䛜ῧຍⱝ䛧䛟䛿ᙉ䛥䜜䛯㣗ရ ࡲ ᙉㄪ⾲♧䛾䛒䜛㣗ရ ᰤ㣴⣲䠖 䞉⬡㉁⏤᮶䛾䜶䝛䝹䜼䞊 䞉㣬⬡⫫㓟 䞉䝖䝷䞁䝇⬡⫫㓟 䞉䝁䝺䝇䝔䝻䞊䝹 䞉㣗≀⧄⥔ - 42 - 3.5.1 Indonesia Indonesia Nutrition Labelling Regulations-1.1 䜲䞁䝗䝛䝅䜰 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ 䜲䞁䝗䝛䝅䜰 • Sugar. • Vitamin A. • Vitamin C. • Calcium. • Iron. Listing of • Other nutrients that are added/fortified in accordance with the regulations. Nutrients (Nutrients, Order) •Other nutrients with claims on the label ᰤ㣴ᡂศ䝸䝇䝖䠄ᰤ 㣴ᡂศ䚸 グ㍕㡰䠅 䞉⢾㢮 䞉䝡䝍䝭䞁A 䞉䝡䝍䝭䞁C 䞉䜹䝹䝅䜴䝮 䞉㕲 䞉つ๎䛻ᚑ䛳䛶ῧຍ䛥䜜䛯/ᙉ䛥䜜䛯䛾ᰤ㣴⣲ 䞉䝷䝧䝹䛻ᙉㄪ⾲♧䛥䜜䛯䛾ᰤ㣴⣲ Indonesia Nutrition Labelling Regulations-1.1 䜲䞁䝗䝛䝅䜰 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ 䜲䞁䝗䝛䝅䜰 Voluntary: Optional Ingredients 䛭䛾䛾ᰤ㣴ᡂศ ௵ព䠖 • Energy from Saturated Fat. • Mono Unsaturated Fat. • Poly Unsaturated Fat. • Potassium. • Soluble Dietary Fibre. • Insoluble Dietary Fibre. • Sugar Alcohol. • Other Carbohydrate. • Vitamin, Mineral and Other Nutrients. - 43 - 䞉㣬⬡⫫㓟䛾䜶䝛䝹䜼䞊 䞉1౯䛾㣬⬡⫫㓟 䞉ከ౯㣬⬡⫫㓟 䞉䜹䝸䜴䝮 䞉Ỉ⁐ᛶ㣗≀⧄⥔ 䞉⁐ᛶ㣗≀⧄⥔ 䞉⢾䜰䝹䝁䞊䝹 䞉䛾ⅣỈ≀ 䞉䝡䝍䝭䞁䚸䝭䝛䝷䝹䛸䛾ᰤ㣴⣲ 3.5.1 Indonesia Indonesia Nutrition Labelling Regulations-1.2 䜲䞁䝗䝛䝅䜰 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ 䜲䞁䝗䝛䝅䜰 䞉Per 100 g, per 100 ml and per 100 kcal only for infant formula Presentation of Nutrient Content (Expression per 100g/ml or serving or 䞉Per serving for other foods package) x ஙᗂඣ⏝ㄪᩚங䛻䛴䛔䛶䛾䜏100g 䛒䛯䜚䚸100ml 䛒䛯䜚䚸 ᰤ㣴ᡂศ㔞䛾⾲♧᪉ἲ 100kcal 䛒䛯䜚 䠄⾲♧᪉ἲ 100g/ml 䚸1䝃䞊䝡䞁䜾䚸ཪ x 䛾㣗ရ䛿䝃䞊䝡䞁䜾䠄1㣗䠅䛒䛯䜚 䛿1ໟศ䛒䛯䜚䠅 (Expression in Exact values or Ranges) Exact values ୍ᐃ್ 䠄⾲♧䛩䜛್䠖୍ᐃ್䜒䛧䛟䛿ᖜ⾲♧䠅 Should be based on actual analysis of the product (Analysis or Calculation Basis) 〇ရ䛾ᐇ㝿䛾ศᯒ䛻ᇶ䛵䛟䜉䛝 䠄ศᯒ್䜒䛧䛟䛿ィ⟬್䠅 Use of Food Composition Table/ Database for Presentation of Nutrients Not allowed チྍ ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲䠋䝕䞊 䝍䝧䞊䝇 䛾⏝ Food Composition Table/Database for Presentation of Nutrients 㐺⏝↓䛧 Not applicable ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲䠋䝕䞊 䝍䝧䞊䝇 Energy is calculated from macronutrients. Calculation of Nutrients The formula used is: (amount of carbohydrate x 4 kcal) + (Energy/Protein/ (amount of protein x 4 kcal) + (amount of fat x 9 kcal) Carbohydrate/Fat) ᰤ㣴ᡂศ䛾ィ⟬ 䠄䜶䝛䝹䜼䞊䠋䛯䜣 䜁䛟㉁䠋ⅣỈ≀䠋⬡㉁) 䜶䝛䝹䜼䞊䛿」ᩘ䛾ᰤ㣴⣲䛛䜙⟬ฟ䛥䜜䜛 ௨ୗ䛾ᘧ䜢⏝䠖 䠄ⅣỈ≀㔞㽢4kcal䠅+䠄䛯䜣䜁䛟㉁㔞㽢4kcal 䠅+䠄⬡㉁㔞㽢9kcal 䠅 Indonesia Nutrition Labelling Regulations-1.2 䜲䞁䝗䝛䝅䜰 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ 䜲䞁䝗䝛䝅䜰 For mandatory fortified food and food with nutrition and health claim, the result of analysis should be at least 100% of declared nutrients. For voluntary nutrition labelling, the result of analysis should be at least 80% of the declared nutrients For certain nutrient(energy, fat, saturated fat, cholesterol, trans fatty acid, Tolerances and Compliances sugar and sodium), the result of analysis should be no more than 120% (Tolerance Limits) of declared nutrients බᕪ䛸㐺ྜᛶ䠄ㄗᕪ⠊ᅖ䠅 ⩏ົⓗ䛻ᙉ䛥䜜䛯㣗ရ䜔ᰤ㣴ᙉㄪ⾲♧䚸ᗣᙉㄪ⾲♧䛥䜜䛯㣗ရ䛻 䛴䛔䛶䛿䚸ศᯒ⤖ᯝ䛿⏦࿌䛧䛯ᰤ㣴⣲䛾100%䛷䛺䛟䛶䛿䛺䜙䛺䛔 ௵ព䛾ᰤ㣴⾲♧䛻䛴䛔䛶䛿䚸ศᯒ⤖ᯝ䛿⏦࿌䛧䛯ᰤ㣴⣲䛾ᑡ䛺䛟䛸䜒 80%䛷䛺䛟䛶䛿䛺䜙䛺䛔 ≉ᐃ䛾ᰤ㣴⣲䠄䜶䝛䝹䜼䞊䚸⬡⫫䚸㣬⬡⫫䚸䝁䝺䝇䝔䝻䞊䝹䚸䝖䝷䞁䝇⬡ ⫫㓟䚸⢾㢮䚸䝘䝖䝸䜴䝮䠅䛻䛴䛔䛶䛿䚸ศᯒ⤖ᯝ䛿⏦࿌䛧䛯ᰤ㣴⣲䛾120% ௨ୗ䛷䛺䛟䛶䛿䛺䜙䛺䛔 - 44 - 3.5.1 Indonesia Indonesia Nutrition Labelling Regulations-1.2 䜲䞁䝗䝛䝅䜰 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ 䜲䞁䝗䝛䝅䜰 Specific Features of Presentation (Format, %NRV Labelling) ⾲♧᪉ἲ䛾≉Ⰽ 䠄䝣䜷䞊䝬䝑 䝖䚸%NRV䚸⾲♧䠅 (Front of Package Labelling, FOP) 䠄䝟䝑䜿䞊䝆ṇ㠃䛾⾲♧䚸FOP䠅 In tabular format -Mandatory to include % against Indonesian NRV ⾲ᙧᘧ - 䜲䞁䝗䝛䝅䜰䛾ᰤ㣴ཧ↷㔞䛻ᑐ䛩䜛ẚ⋡䜢ྵ䜑䜛䛣䛸䛿⩏ົ Voluntary: Allow some of the products to include it on the label. Components that should be included are energy, fat, saturated fat and sodium. The four components must be included together, in a neutral color (not in traffic light color). ௵ព䠖 ᗄ䛴䛛䛾〇ရ䛻䛴䛔䛶䛿䚸䝷䝧䝹䛻♧䛧䛶䜘䛔䚹ྵ䜐䜉䛝⾲♧ 㡯┠䛿䚸䜶䝛䝹䜼䞊䚸⬡⫫䚸㣬⬡⫫䛚䜘䜃䝘䝖䝸䜴䝮䚹䛣䛾4 䛴䛾ᰤ㣴⣲䛿䛶୍⥴䛻୰㛫Ⰽ䛷䠄ಙྕ䛾Ⰽ䛷䛿䛺䛟䠅♧䛥䛺䛟 䛶䛿䛺䜙䛺䛔䚹 Indonesia Nutrition Labelling Regulations-1.3 䜲䞁䝗䝛䝅䜰 䠖 ᰤ㣴⾲♧ᇶ‽-1.3 ᰤ㣴⾲♧ Administrations/Compliances for Nutrition Labelling (Governing Authorities/Agencies) ᰤ㣴⾲♧䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ⟶ ᙜᒁ䠋ᐁᗇ䠅 Inspections and Penalties ᰝᐹ䛸⨩๎ 䜲䞁䝗䝛䝅䜰 National Agency for Drug and Food Control of the Republic of Indonesia (NADFC or BPOM) 䜲䞁䝗䝛䝅䜰ඹᅜ䛾ᅜᐙ་⸆ရ㣗ရ┘╩ᗇ䠄NADFC䛒䜛䛔䛿 BPOM䠅 -Monitoring and surveillance programme is in place - 䝰䝙䝍䝸䞁䜾䜔┘ど䝥䝻䜾䝷䝮᭷䜚 - 45 - 3.5.1 Indonesia Indonesia Nutrition Claim Regulations-2 䜲䞁䝗䝛䝅䜰 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ Relevant Laws/Regulations 䜲䞁䝗䝛䝅䜰 • Act no. 18 Year 2012 on Food • Ministry of Health Regulation Number 30 Year 2013 on inclusion of the information content of sugar, salt, and fat and health information to processed food and fast food • Head of NADFC Regulation No: HK.03.1.23.11.11.09605 (2011) on Amendment to Head of NADFC Decree No: HK.00.06.51.0475 on Guidelines on Nutrition Information Uses on Food Label • Head of NADFC Regulation Number HK.03.1.23.11.11.09909 Year 2011 on Controlling of Claims on Label and Advertisement of Processed Food Regulation: • Government Regulation No. 69/1999 on Food labelling and Advertisement. http://jdih.pom.go.id/ 㛵㐃ἲつ䠋つ๎ x 㣗⣊ἲ➨18ྕ䠄2012䠅 x ◁⢾䜔ሷ䚸⬡㉁䛾ሗ䜔䚸ຍᕤ㣗ရ䜔䝣䜯䞊䝇䝖䞉䝣䞊䝗䛻㛵䛩䜛䛥䜎䛦䜎䛺ᗣሗ 㛵䛩䜛ಖ┬つ๎➨30ྕ䠄2013䠅 x 㣗ရ䛻⾲♧䛥䜜䜛ᰤ㣴ሗ䛾⏝䛻䛴䛔䛶䛾䜺䜲䝗䝷䜲䞁䛻㛵䛩䜛ᅜᐙ་⸆ရ㣗ရ┘ ╩ᗇ㛗ᐁHK.00.06.51.0475䛾ಟṇ䛷䛒䜛ᅜᐙ་⸆ရ㣗ရ┘╩ᗇ㛗ᐁ௧ HK.03.1.23.11.11.09605 (2011) x ຍᕤ㣗ရ䛾⾲♧䛸ᗈ࿌䛻䛚䛡䜛ᙉㄪ⾲♧䛾⟶⌮䛻㛵䛩䜛ᅜᐙ་⸆ရ㣗ရ┘╩ᗇ㛗 ᐁ௧HK.03.1.23.11.11.09909䠄2011䠅 つ๎䠖 x 㣗ရ䛾⾲♧䛚䜘䜃ᗈ࿌䛻㛵䛩䜛ᨻᗓつᐃ➨69ྕ䠄1999䠅 http://jdih.pom.go.id/ Indonesia Nutrition Claim Regulations-2 䜲䞁䝗䝛䝅䜰 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ Definitions (Nutrient Content/Comparative Claims) ᐃ⩏䠄ᰤ㣴⣲ྵ᭷㔞䠋 ẚ㍑ᙉㄪ⾲♧䠅 Nutrient Content Claims ᰤ㣴⣲ྵ᭷㔞ᙉㄪ⾲♧ 䜲䞁䝗䝛䝅䜰 Same as Codex -Nutrient Content Claim -Nutrient Comparative Claim 䝁䞊䝕䝑䜽䝇䛸ྠᵝ - ᰤ㣴⣲ྵ᭷㔞ᙉㄪ⾲♧ - ᰤ㣴⣲ẚ㍑ᙉㄪ⾲♧ Conditions defined - Relevant regulation: •Head of NADFC Decree No: HK.00.05.52.6291 (2007) on NRV for Food Product. http://www.pom.go.id/search/query2.asp?qs_materi=semua&qs_search=acua n+label+gizi&qs_TX=1 •Head of NADFC Regulation No: HK.03.1.23.11.11.09909 (2011) on Controlling Claims on Processed Food labelling and Advertisement http://www.pom.go.id/search/query2.asp?qs_materi=t_hukumPerundangan& qs_search=pengawasan+klaim&qs_TX=1 つᐃ᮲௳ - 㛵㐃つ๎ x 㣗ရ䛾ᰤ㣴⣲ཧ↷㔞䛻㛵䛩䜛ᅜᐙ་⸆ရ㣗ရ┘╩ᗇ㛗ᐁ HK.00.05.52.6291 (2007) http://www.pom.go.id/search/query2.asp?qs_materi=semua&qs_search=acuan+ label+gizi&qs_TX=1 x ຍᕤ㣗ရ䛾⾲♧䛸ᗈ࿌䛻䛚䛡䜛ᙉㄪ⾲♧䛾⟶⌮䛻㛵䛩䜛ᅜᐙ་⸆ရ㣗ရ┘ ╩ᗇ㛗ᐁ௧HK.03.1.23.11.11.09909䠄2011䠅 http://www.pom.go.id/search/query2.asp?qs_materi=t_hukumPerundangan&qs _search=pengawasan+klaim&qs_TX=1 - 46 - 3.5.1 Indonesia Indonesia Nutrition Claim Regulations-2 䜲䞁䝗䝛䝅䜰 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ Nutrient Comparative Claims ᰤ㣴⣲ẚ㍑ᙉㄪ⾲♧ 䜲䞁䝗䝛䝅䜰 Conditions defined -Regulation: •Head of NADFC Decree No: HK.00.05.52.6291 (2007) on NRV for Food Product. http://www.pom.go.id/search/query2.asp?qs_materi=semua&qs_search=acuan +label+gizi&qs_TX=1 •Head of NADFC Regulation No: HK.03.1.23.11.11.09909 (2011) on Controlling Claims on Processed Food labelling and Advertisement http://www.pom.go.id/search/query2.asp?qs_materi=t_hukumPerundangan&qs _search=pengawasan+klaim&qs_TX=1 つᐃ᮲௳ - つ๎ 䡡㣗ရ䛾ᰤ㣴⣲ཧ↷㔞䛻㛵䛩䜛ᅜᐙ་⸆ရ㣗ရ┘╩ᗇ㛗ᐁHK.00.05.52.6291 (2007) http://www.pom.go.id/search/query2.asp?qs_materi=semua&qs_search=acuan+label +gizi&qs_TX=1 䡡ຍᕤ㣗ရ䛾⾲♧䛸ᗈ࿌䛻䛚䛡䜛ᙉㄪ⾲♧䛾⟶⌮䛻㛵䛩䜛ᅜᐙ་⸆ရ㣗ရ┘╩ᗇ 㛗ᐁ௧HK.03.1.23.11.11.09909䠄2011䠅 http://www.pom.go.id/search/query2.asp?qs_materi=t_hukumPerundangan&qs_sear ch=pengawasan+klaim&qs_TX=1 Indonesia Nutrition Claim Regulations-2 䜲䞁䝗䝛䝅䜰 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ Non-addition Claims 䠄Non-addition of Sugars/Sodium Salts䠅 䜲䞁䝗䝛䝅䜰 “no sugar added” claim ↓ῧຍ⾲♧䠄⢾㢮䠋䝘䝖䝸䜴 䝮ሷ䛾↓ῧຍ䠅 “◁⢾↓ῧຍ䇿⾲♧ Administrations/Compliance s for Nutrition Claims National Agency for Drug and Food Control of the Republic of Indonesia 䠄Governing (NADFC or BPOM) Authorities/Agencies䠅 ᰤ㣴ᙉㄪ⾲♧䛾⾜ᨻ䠋㡰Ᏺ 䠄ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ) Inspections and Penalties ᰝᐹ䛸⨩๎ 䜲䞁䝗䝛䝅䜰ඹᅜ䛾ᅜᐙ་⸆ရ㣗ရ┘╩ᗇ䠄NADFC䛒䜛䛔䛿BPOM䠅 Monitoring and surveillance programme is in place 䝰䝙䝍䝸䞁䜾䜔┘ど䝥䝻䜾䝷䝮᭷䜚 - 47 - 3.5.1 Indonesia Indonesia Health Claim Regulations-3.1 䜲䞁䝗䝛䝅䜰 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 ᗣᙉㄪ⾲♧ Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ 䜲䞁䝗䝛䝅䜰 Act no. 18 Year 2012 on Food • Ministry of Health Regulation Number 30 Year 2013 on inclusion of the information content of sugar, salt, and fat and health information to processed food and fast food • Head of NADFC Regulation No: HK.03.1.23.11.11.09605 (2011) on Amendment to Head of NADFC Decree No: HK.00.06.51.0475 on Guidelines on Nutrition Information Uses on Food Label • Head of NADFC Regulation Number HK.03.1.23.11.11.09909 Year 2011 on Controlling of Claims on Label and Advertisement of Processed Food Regulation: • Government Regulation No. 69/1999 on Food labelling and Advertisement. http://jdih.pom.go.id/ x 㣗⣊ἲ➨18ྕ䠄2012䠅 x ◁⢾䜔ሷ䚸⬡㉁䛾ሗ䜔䚸ຍᕤ㣗ရ䜔䝣䜯䞊䝇䝖䞉䝣䞊䝗䛻㛵䛩䜛䛥䜎䛦䜎䛺ᗣሗ 㛵䛩䜛ಖ┬つ๎➨30ྕ䠄2013䠅 x 㣗ရ䛻⾲♧䛥䜜䜛ᰤ㣴ሗ䛾⏝䛻㛵䛩䜛䜺䜲䝗䝷䜲䞁䛻㛵䛩䜛ᅜᐙ་⸆ရ㣗ရ┘ ╩ᗇ㛗ᐁHK.00.06.51.0475䛾ಟṇ䛷䛒䜛ᅜᐙ་⸆ရ㣗ရ┘╩ᗇ㛗ᐁ௧ HK.03.1.23.11.11.09605 (2011) x ຍᕤ㣗ရ䛾⾲♧䛸ᗈ࿌䛻䛚䛡䜛ᙉㄪ⾲♧䛾⟶⌮䛻㛵䛩䜛ᅜᐙ་⸆ရ㣗ရ┘╩ᗇ㛗 ᐁ௧HK.03.1.23.11.11.09909䠄2011䠅 つ๎䠖 䡡㣗ရ䛾⾲♧䛚䜘䜃ᗈ࿌䛻㛵䛩䜛ᨻᗓつᐃ➨69ྕ䠄1999䠅 http://jdih.pom.go.id/ Indonesia Health Claim Regulations-3.1 䜲䞁䝗䝛䝅䜰 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 ᗣᙉㄪ⾲♧ 䜲䞁䝗䝛䝅䜰 Same as Codex: Health claims - Nutrient Function Claims - Other function claims - Reduction of Disease Risk claims Definitions 䠄Collective Name of Foods with Health Claims, if applicable䠅 ᐃ⩏䠄ᗣᙉㄪ⾲♧䜢䛧䛯㣗ရ䜢 ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾ྡ⛠䠅 *But for food intended for young children (1-3 years old) only allowed to include nutrient function claim. 䝁䞊䝕䝑䜽䝇䛸ྠᵝ䠖ಖ⾲♧ - ᰤ㣴ᶵ⬟ᙉㄪ⾲♧ - 䛭䛾䛾ᶵ⬟ᙉㄪ⾲♧ - 䝸䝇䜽పῶᙉㄪ⾲♧ *1-3ᡯ䛾ᗂඣ⏝㣗ရ䛿ᰤ㣴ᶵ⬟ᙉㄪ⾲♧䛾䜏ྍ - 48 - 3.5.1 Indonesia Indonesia Health Claim Regulations-3.1 䜲䞁䝗䝛䝅䜰 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 ᗣᙉㄪ⾲♧ 䜲䞁䝗䝛䝅䜰 Nutrient Function Claims䠄Collective Name of the Foods, if applicable䠅 ᰤ㣴ᶵ⬟ᙉㄪ⾲♧䠄ᰤ㣴ᶵ⬟⾲♧䜢䛧䛯 㣗ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾ྡ⛠䠅 Nutrient Function Claims ᰤ㣴ᶵ⬟ᙉㄪ⾲♧ Other Function Claims䠄Collective Name of the Foods, if applicable䠅 䛭䛾䛾ᶵ⬟ᙉㄪ⾲♧䠄䛾ᶵ⬟⾲♧䜢 Other Function Claims 䛧䛯㣗ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾 ྡ⛠) Reduction of Disease Risk Claims 䠄Collective Name of Foods Applied䠅 䝸䝇䜽పῶᙉㄪ⾲♧䠄㐺⏝䛥䜜䜛㣗 ရ䜢ᣦ䛩ྡ⛠䠅 Reduction of Disease Risk Claims 䝸䝇䜽పῶᙉㄪ⾲♧ Types of Approval/Certification 䠄Standardized/ Pre-authorized Claims䠅 ᢎㄆ䠋ㄆド䛾✀㢮䠄つ᱁ᇶ‽ᆺ䠋 ๓ ᢎㄆᆺ䠅 䠄Food Product/Constituent Specific Approval䠅 䛭䛾䛾ᶵ⬟ᙉㄪ⾲♧ Pre-authorized Claims ๓ㄆド䛻䜘䜛ᙉㄪ⾲♧ No product specific claims 䠄㣗ရ䠋≉ᐃ䛾⤌ᡂᡂศ䛻ᑐ䛩䜛ᢎㄆ䠅 ≉ᐃ䛾〇ရ䛻ᑐ䛩䜛ᙉㄪ⾲♧䠄product specific claims䠅䛷䛿䛺䛔 Indonesia Health Claim Regulations-3.2 䜲䞁䝗䝛䝅䜰 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ 䜲䞁䝗䝛䝅䜰 Scientific Substantiation of Health Claims ᗣᙉㄪ⾲♧䛻㛵䛩䜛⛉Ꮫⓗᐇ ド Documentation required ドᣐ᭩㢮䛜ᚲせ •Must submit scientific substantiations of claim. •All substantiations are reviewed by an evaluator group and expert group (if needed). Process for the Substantiation (Organizational Systems, •Based on the result of the review, evaluator and expert give Governing Authority/Agency/Commission) recommendation for BPOM •Based on such recommendation, BPOM publishes the ᐇド䛾䝥䝻䝉䝇䠄ᑂᰝ⤌⧊䛾ᵓ approval/reject letter. 㐀䚸ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠋ጤဨ 䠅 䞉 ᙉㄪ⾲♧䜢⛉Ꮫⓗ䛻ᐇド䛩䜛䜒䛾䜢ᥦฟ䛩䜛 䞉 䛶䛾ᐇド䛿ᶒጾ䜎䛯䛿ᑓ㛛ᐙ䛻䜘䜚ホ౯䛥䜜䜛䠄ᚲせ䛷䛒䜜䜀䠅 䞉 ホ౯⤖ᯝ䛻ᇶ䛵䛝䚸ᶒጾ䜎䛯䛿ᑓ㛛ᐙ䛜BPOM䛻᥎⸀䛩䜛 䞉 ᥎⸀䛻ᇶ䛵䛝䚸BPOM䛜ྠព/༷ୗ䛾᭩⡆䜢Ⓨ⾜䛩䜛 - 49 - 3.5.1 Indonesia Indonesia Health Claim Regulations-3.2 䜲䞁䝗䝛䝅䜰 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ 䜲䞁䝗䝛䝅䜰 Criteria for the Substantiation and/or Consideration of the Evidence ᐇド䛾ᇶ‽䛚䜘䜃䠋䜎䛯䛿ຠᯝ䛾ホ౯ •Scientific evidence data, especially clinical study that published in peer reviewer scientific journal. x ⛉Ꮫⓗ䛺᰿ᣐ䛸䛺䜛䝕䞊䝍䚸≉䛻ᰝㄞ䛥䜜䛯䝆䝱䞊䝘䝹 䛻බ㛤䛥䜜䛯⮫ᗋ◊✲ Specific Safety Concerns ≉ᐃ䛾Ᏻᛶ䛻㛵䛩䜛㡯 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Re-evaluation ホ౯ Product Quality Concerns䠄GMP, ISO, HACCP or Other Measures䠅 〇ရရ㉁䛻㛵䛩䜛㡯䠄GMP, ISO, HACCP 䜎䛯䛿䛾ホ౯ᑻᗘ䠅 Adverse Event Reporting System 䠄Mandatory/ Voluntary䠅 ᭷ᐖ㇟䛻㛵䛩䜛ሗ࿌䝅䝇䝔䝮䠄⩏ົ䠋 ௵ព䠅 Indonesia Health Claim Regulations-3.2 䜲䞁䝗䝛䝅䜰 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ 䜲䞁䝗䝛䝅䜰 Administrations/Compliance s for Health Claims National Agency for Drug and Food Control of the Republic of Indonesia 䠄Governing (NADFC or BPOM) Authorities/Agencies䠅 ᗣᙉㄪ⾲♧䛾⾜ᨻ䠋㡰Ᏺ 䠄ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠅 Inspections and Penalties ᰝᐹ䛸⨩๎ 䜲䞁䝗䝛䝅䜰ඹᅜ䛾ᅜᐙ་⸆ရ㣗ရ┘╩ᗇ䠄NADFC䛒䜛䛔䛿BPOM䠅 Monitoring and surveillance programme is in place 䝰䝙䝍䝸䞁䜾䜔┘ど䝥䝻䜾䝷䝮᭷䜚 - 50 - 3.5.1 Indonesia Indonesia Health Claim Regulations-3.3 䜲䞁䝗䝛䝅䜰 䠖 ᗣᙉㄪ⾲♧つ๎-3.3 ᗣᙉㄪ⾲♧ 䜲䞁䝗䝛䝅䜰 Dietary supplement is regulated as health supplement. Relevant Laws/Regulations for Dietary/Food/Health Supplements 䝎䜲䜶䝍䝸䞊䠋䝣䞊䝗䠋 䝦䝹䝇 䝃䝥䝸䝯䞁䝖䛻㛵 䛩䜛㛵㐃ἲつ䠋つ๎ Health supplement is regulated under Deputy of Traditional Medicine, Cosmetic and Complement Product Control, National Agency of Drug and Food Control. Head of NADF Decree Number HK.00.05.23.3644 Year 2004 on Food Supplement Control (Ketentuan Pokok Pengawasan Suplemen Makanan) 䝎䜲䜶䝍䝸䞊䝃䝥䝸䝯䞁䝖䛿䝦䝹䝇䝃䝥䝸䝯䞁䝖䛸䛧䛶つไ䛥䜜䛶䛔䜛䚹 䝦䝹䝇䝃䝥䝸䝯䞁䝖䛿䚸ᅜᐙ་⸆ရ㣗ရ┘╩ᗇ䛾Deputy of Traditional Medicine, Cosmetic and Complement Product Control䛾ୗ䛷つไ䛥䜜䛶䛔䜛䚹 㣗ရ⿵ຓ㣗ရ䛾⟶⌮䛻㛵䛩䜛ᅜᐙ་⸆ရ㣗ရ┘╩ᗇ㛗ᐁ௧ HK.00.05.23.3644䠄2004䠅 (Ketentuan Pokok Pengawasan Suplemen Makanan) Indonesia Health Claim Regulations-3.3 䜲䞁䝗䝛䝅䜰 䠖 ᗣᙉㄪ⾲♧つ๎-3.3 ᗣᙉㄪ⾲♧ 䜲䞁䝗䝛䝅䜰 Food supplements are products intended to supplement the nutritional needs of food, containing one or more ingredients such Definitions㸦Dietary Supplements, and/or Food Supplements, and/or as vitamins, minerals, amino acids, or other materials (plant or not Health Supplements㸧 plant) which have nutritional value and/or physiological effects in concentrated amounts. ᐃ⩏㸦ࢲ࢚ࢱ࣮ࣜࢧࣉ࣓ࣜࣥ ࢺ࠾ࡼࡧ㸭ࡲࡓࡣࣇ࣮ࢻࢧࣉࣜ ࣓ࣥࢺ࠾ࡼࡧ㸭ࡲࡓࡣ࣊ࣝࢫࢧ 䝣䞊䝗䝃䝥䝸䝯䞁䝖䛿㣗ရ䛾ᰤ㣴ⓗ䝙䞊䝈䜢⿵䛩䜛┠ⓗ䛷䚸௨ୗ ࣉ࣓ࣜࣥࢺ㸧 䛾ᡂศ䜢1✀㢮௨ୖྵ䜐〇ရ䠖䝡䝍䝭䞁䚸䝭䝛䝷䝹䚸䜰䝭䝜㓟䚸䜎䛯䛿 ⃰⦰䛥䜜䛯㔞䛷ᰤ㣴ⓗ౯್䛛䛴/䜎䛯䛿⏕⌮స⏝䜢ᣢ䛴䛾⣲ᮦ 䠄᳜≀ᛶ䜒䛧䛟䛿㠀᳜≀ᛶ䠅 Administrations/Compliances for the Supplements 䠄Governing Authorities/Agencies䠅 䝃䝥䝸䝯䞁䝖䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ ⟶ᙜᒁ䠋ᐁᗇ䠅 National Agency for Drug and Food Control of the Republic of Indonesia (NADFC or BPOM) 䜲䞁䝗䝛䝅䜰ඹᅜ䛾ᅜᐙ་⸆ရ㣗ရ┘╩ᗇ䠄NADFC䛒䜛䛔䛿 BPOM䠅 - 51 - - 52 - 3.5.2 Cambodia Nutrition Labelling and Nutrition/Health Claims ᰤ㣴⾲♧ཬ䜃ᰤ㣴/ᗣᙉㄪ⾲♧ 3.5.2 Kingdom of Cambodia 䜹䞁䝪䝆䜰⋤ᅜ Cambodia Nutrition Labelling Regulations-1.1 䜹䞁䝪䝆䜰 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ Relevant Laws/Regulations 䜹䞁䝪䝆䜰 Cambodian Food Standards: CS 126-2011: Nutrition Labelling (adopted, Khmer version) (Source GUIDELINES ON NUTRITION LABELLING, CAC/GL 21985) CS001-2000: Labelling of food product 㛵㐃ἲつ䠋つ๎ 䜹䞁䝪䝆䜰㣗ရつ᱁䠖 ̺CS126-2011䠖ᰤ㣴⾲♧䠄᥇⏝䚸䜽䝯䞊䝹ㄒ∧䠅 䠄ฟ䛿䝁䞊䝕䝑䜽䝇ᰤ㣴⾲♧䜺䜲䝗䝷䜲䞁CAC/GL2-1985䠅 ̺CS001-2000䠖ຍᕤ㣗ရ䛾⾲♧ - 53 - 3.5.2 Cambodia ᰤ㣴⾲♧ Cambodia Nutrition Labelling Regulations-1.1 䜹䞁䝪䝆䜰 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 䜹䞁䝪䝆䜰 Nutrient Reference Values (Definitions, NRVs-R/-NCD) NRV ᰤ㣴ཧ↷㔞䛜ᐃ䜑䜙䜜䛶䛔䜛 ᰤ㣴ཧ↷㔞䠄ᐃ⩏, NRVs-R/-NCD䠅 Nutrient declaration should be mandatory for all prepackaged foods for which nutrition or health claims, as defined in the Nutrient Declaration (Application: Guidelines for Use of Nutrition and Health Claims (CAC/GL 23Mandatory or Voluntary) 1997), are made. ᰤ㣴⾲♧䠄㐺⏝䠖 ⩏ົ 䜒䛧䛟䛿 ௵ ព䠅 ᗣ䞉ᰤ㣴ᙉㄪ⾲♧䛾⏝䛻㛵䛩䜛䝁䞊䝕䝑䜽䝇䜺䜲䝗䝷䜲䞁 䠄CAC/GL23-1997䠅䛻つᐃ䛥䜜䛯䛸䛚䜚䚸ᰤ㣴䞉ᗣᙉㄪ⾲♧䜢䛚 䛣䛺䛖䛶䛾ໟ῭䜏㣗ရ䛿䚸ᰤ㣴⾲♧䜢䛧䛺䛟䛶䛿䛺䜙䛺䛔 Food Categories Applied 㐺⏝䛥䜜䜛㣗ရ䜹䝔䝂䝸䞊 NA つᐃ↓䛧 NA つᐃ↓䛧 NA つᐃ↓䛧 Exemptions (Food Categories) 㐺⏝㝖እ䠄㣗ရ䜹䝔䝂䝸䞊䠅 (Size of Food Business Operators) 䠄㣗ရᴗ⪅䛾つᶍ䠅 Cambodia Nutrition Labelling Regulations-1.1 䜹䞁䝪䝆䜰 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ Listing of Nutrients (Nutrients, Order) ᰤ㣴ᡂศ䝸䝇䝖 䠄ᰤ㣴ᡂ ศ䚸 グ㍕㡰䠅 䜹䞁䝪䝆䜰 Where nutrient declaration is applied, the declaration of the following should be mandatory: -Energy value, the amounts of protein, available carbohydrate (i.e. dietary carbohydrate excluding dietary fibre), fat, saturated fat, sodium and total sugars; -The amount of any other nutrient for which a nutrition or health claim is made; and - The amount of any other nutrient considered to be relevant for maintaining a good nutritional status, as required by national legislation or national dietary guidelines. ᰤ㣴⾲♧䜢䛚䛣䛺䛖ሙྜ䚸௨ୗ䛿ᚲ䛪⾲♧䛩䜛䛣䛸䚹 ̺䜶䝛䝹䜼䞊್䚸䛯䜣䜁䛟㉁㔞䚸⏝ྍ⬟䛺ⅣỈ≀㔞䠄༶䛱䚸㣗≀⧄⥔䜢㝖 䛟㣗ရ୰䛾ⅣỈ≀䠅䚸⬡⫫䚸㣬⬡⫫㓟䚸䝘䝖䝸䜴䝮ཬ䜃䛶䛾⢾㢮䛾㔞 ̺ᰤ㣴䞉ᗣ⾲♧䜢䛚䛣䛺䛖ሙྜ䛿䛭䛾ᰤ㣴⣲䛾㔞 ̺ᅜ䛾ἲ௧䚸䛒䜛䛔䛿ᅜ䛾㣗䜺䜲䝗䝷䜲䞁䛻䜘䛳䛶ᐃ䜑䜙䜜䛯䚸Ⰻዲ䛺ᰤ㣴 ≧ែ䛾⥔ᣢ䛻㛵ಀ䛩䜛䛸⪃䛘䜙䜜䜛䛭䛾䛾ᰤ㣴⣲䛾㔞 Optional Ingredients 䛭䛾䛾ᰤ㣴ᡂศ NA つᐃ↓䛧 - 54 - 3.5.2 Cambodia Cambodia Nutrition Labelling Regulations-1.2 䜹䞁䝪䝆䜰 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ 䜹䞁䝪䝆䜰 Presentation of Nutrient Content (Expression per 100g/ml or serving or package) Energy and nutrients are expressed per 100 g/ml of the food ᰤ㣴ᡂศ㔞䛾⾲♧᪉ἲ 䠄⾲♧᪉ἲ 100g/ml 䚸1䝃䞊䝡䞁䜾䚸ཪ䛿1ໟ ศ䛒䛯䜚䠅 䜶䝛䝹䜼䞊ཬ䜃ᰤ㣴⣲䛿䛭䛾㣗ရ100g䛒䛯䜚䚸 ཪ䛿100ml䛒䛯䜚䛷⾲♧䛩䜛䛣䛸䚹 (Expression in Exact values or Ranges) 䠄⾲♧䛩䜛್䠖୍ᐃ್䜒䛧䛟䛿ᖜ⾲♧䠅 Not specified つᐃ↓䛧 It could be by calculation. ィ⟬್䛷䜒䜘䛔 (Analysis or Calculation Basis) 䠄ศᯒ್䜒䛧䛟䛿ィ⟬್䠅 Use of Food Composition Table/ Database for Presentation of Nutrients Updated ASEAN Food composition table/database ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲䠋䝕䞊䝍䝧䞊䝇 ASEAN㣗ရᡂศ⾲ཬ䜃䝕䞊䝍䝧䞊䝇䛾᭱᪂∧ 䛾⏝ Food Composition Table/Database for Presentation of Nutrients Not specified つᐃ↓䛧 ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲䠋䝕䞊䝍䝧䞊䝇 Cambodia Nutrition Labelling Regulations-1.2 䜹䞁䝪䝆䜰 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ Calculation of Nutrients (Energy/Protein/ Carbohydrate/Fat) ᰤ㣴ᡂศ䛾ィ⟬ 䠄䜶䝛䝹 䜼䞊䠋䝍䞁䝟䜽㉁䠋ⅣỈ ≀䠋⬡㉁) Tolerances and Compliances (Tolerance Limits) 䜹䞁䝪䝆䜰 The amount of energy to be listed should be calculated by using the following conversion factors: -Carbohydrates 4 kcal/g – 17 kJ -Protein 4 kcal/g – 17 kJ -Fat 9 kcal/g – 37 kJ -Alcohol (Ethanol) 7 kcal/g – 29 kJ -Organic acid 3 kcal/g – 13 kJ グ㍕䛥䜜䜛䜶䝛䝹䜼䞊㔞䛿௨ୗ䛾ኚಀᩘ䜢⏝䛔䛶ィ⟬䛧 䛯್䜢♧䛩䛣䛸䠖 ̺ⅣỈ≀ 4kcal/g䠉17kJ - 䛯䜣䜁䛟㉁ 4kcal/g䠉17kJ ̺⬡⫫ 9kcal/g䠉37kJ ̺ 䜰䝹䝁䞊䝹䠄䜶䝍䝜䞊䝹䠅 7kcal/g䠉29kJ ̺᭷ᶵ㓟 3kcal/g䠉13kJ Not specified つᐃ↓䛧 බᕪ䛸㐺ྜᛶ䠄ㄗᕪ⠊ᅖ䠅 - 55 - 3.5.2 Cambodia Cambodia Nutrition Labelling Regulations-1.2 䜹䞁䝪䝆䜰 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ Specific Features of Presentation (Format, %NRV Labelling) 䜹䞁䝪䝆䜰 Numerical information on vitamins and minerals should be expressed in metric units and/or as a percentage of the NRV per 100 g or per 100 ml or per package if the package contains only a single portion. In addition, this information may be given per serving as quantified on the label or per portion provided that the number of portions contained in the package is stated. In addition, information on protein and additional nutrients may also be expressed as percentages of the NRV where an NRV has been established. NRVs: Codex NRVs ⾲♧᪉ἲ䛾≉Ⰽ 䠄䝣䜷䞊 䝬䝑䝖䚸%NRV䚸⾲♧䠅 䝡䝍䝭䞁ཬ䜃䝭䝛䝷䝹䛾ᩘ್䛿䝯䞊䝖䝹ἲ䚸ཬ䜃/䛒䜛䛔䛿100g䛒䛯䜚䚸ཪ䛿 100ml䛒䛯䜚䚸ཪ䛿䜒䛧䛭䛾㣗ရ䛜1䝫䞊䝅䝵䞁ẖ䛻ໟ䛥䜜䛶䛔䜛ሙྜ䛻䛿1 ໟ䛒䛯䜚䛷䚸NRV䛻ᑐ䛩䜛䝟䞊䝉䞁䝖䛷⾲♧䛩䜛䛣䛸䚹 䛥䜙䛻䚸䛣䛾ሗ䛿⾲♧ୖ䛻グ㍕䛥䜜䛯1䝃䞊䝡䞁䜾㔞䛒䛯䜚䚸ཪ䛿ໟᐜჾ 䛻䝫䞊䝅䝵䞁ᩘ䛜᫂グ䛥䜜䛶䛔䜜䜀䛭䛾1䝫䞊䝅䝵䞁䛒䛯䜚䛷⾲♧䛧䛶䜒䜘䛔䚹 䛥䜙䛻䚸ᰤ㣴ཧ↷㔞䛜タᐃ䛥䜜䛶䛔䜛䛯䜣䜁䛟㉁䛸䛭䛾䛾ຍ䛧䛯ᰤ㣴⣲ 䛻䛴䛔䛶䛿䚸ᰤ㣴ཧ↷㔞䛻ᑐ䛩䜛䝟䞊䝉䞁䝖䛷⾲♧䛧䛶䜒䜘䛔䚹 NRVs䠖䝁䞊䝕䝑䜽䝇NRVs (Front of Package Labelling, FOP) 䠄䝟䝑䜿䞊䝆ṇ㠃䛾⾲♧䚸 FOP䠅 No つᐃ↓䛧 Cambodia Nutrition Labelling Regulations-1.3 䜹䞁䝪䝆䜰 䠖 ᰤ㣴⾲♧ᇶ‽-1.3 ᰤ㣴⾲♧ Administrations/Compliances for Nutrition Labelling (Governing Authorities/Agencies) 䜹䞁䝪䝆䜰 Ministry of industry, mine and energy (MIME) ᰤ㣴⾲♧䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ⟶ᙜᒁ 䠋ᐁᗇ䠅 Inspections and Penalties ᰝᐹ䛸⨩๎ ⏘ᴗ䚸㖔ᒣ䚸䜶䝛䝹䜼䞊┬䠄㻹㻵㻹㻱䠅 つᐃ↓䛧 NA - 56 - 3.5.2 Cambodia Cambodia Nutrition Claim Regulations-2 䜹䞁䝪䝆䜰 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ Relevant Laws/Regulations 䜹䞁䝪䝆䜰 Cambodian Food Standards: CS 126-2011: Nutrition Labelling (adopted, Khmer version) (Source GUIDELINES ON NUTRITION LABELLING, CAC/GL 2-1985) -CS001-2000: Labelling of food product 㛵㐃ἲつ䠋つ๎ 䜹䞁䝪䝆䜰㣗ရつ᱁䠖 ̺CS126-2011䠖ᰤ㣴⾲♧䠄᥇⏝䚸䜽䝯䞊䝹ㄒ∧䠅䠄ฟ䛿䝁䞊䝕䝑䜽 䝇ᰤ㣴⾲♧䜺䜲䝗䝷䜲䞁䚸CAC/GL2-1985䠅 ̺CS001-2000䠖㣗ရ〇ရ䛾⾲♧ Definitions (Nutrient Content/Comparative Claims) NA つᐃ↓䛧 ᐃ⩏䠄ᰤ㣴⣲ྵ᭷㔞䠋ẚ ㍑ᙉㄪ⾲♧䠅 Cambodia Nutrition Claim Regulations-2 䜹䞁䝪䝆䜰 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ 䜹䞁䝪䝆䜰 Nutrient Content Claims ᰤ㣴⣲ྵ᭷㔞ᙉㄪ⾲♧ Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Nutrient Comparative Claims ᰤ㣴⣲ẚ㍑ᙉㄪ⾲♧ Non-addition Claims 䠄Non-addition of Sugars/Sodium Salts䠅 ↓ῧຍ⾲♧䠄⢾㢮䠋䝘䝖䝸䜴䝮 ሷ䛾↓ῧຍ䠅 - 57 - 3.5.2 Cambodia Cambodia Nutrition Claim Regulations-2 䜹䞁䝪䝆䜰 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ 䜹䞁䝪䝆䜰 Administrations/Complian ces for Nutrition Claims Ministry of industry, mine and energy (MIME) 䠄Governing Authorities/Agencies䠅 ⏘ᴗ䚸㖔ᴗ䚸䜶䝛䝹䜼䞊┬䠄MIME䠅 ᰤ㣴ᙉㄪ⾲♧䛾⾜ᨻ䠋㡰 Ᏺ䠄ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ㻕 Inspections and Penalties ᰝᐹ䛸⨩๎ NA つᐃ↓䛧 Cambodia Health Claim Regulations-3.1 䜹䞁䝪䝆䜰 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 ᗣᙉㄪ⾲♧ Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ 䜹䞁䝪䝆䜰 Cambodian Food Standards: CS 126-2011: Nutrition Labelling (adopted, Khmer version) (Source GUIDELINES ON NUTRITION LABELLING, CAC/GL 2-1985) CS001-2000: Labelling of food product 䜹䞁䝪䝆䜰㣗ရつ᱁䠖 ̺CS126-2011䠖ᰤ㣴⾲♧䠄᥇⏝䚸䜽䝯䞊䝹ㄒ∧䠅䠄ฟ䛿䝁䞊䝕䝑䜽䝇 ᰤ㣴⾲♧䜺䜲䝗䝷䜲䞁䚸CAC/GL2-1985䠅 ̺CS001-2000䠖㣗ရ〇ရ䛾⾲♧ Definitions 䠄Collective Name of Foods with Health Claims, if applicable䠅 Not specified ᐃ⩏䠄ᗣᙉㄪ⾲♧䜢䛧䛯㣗ရ䜢 ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾ྡ⛠䠅 - 58 - つᐃ↓䛧 3.5.2 Cambodia Cambodia Health Claim Regulations-3.1 䜹䞁䝪䝆䜰 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 ᗣᙉㄪ⾲♧ 䜹䞁䝪䝆䜰 Nutrient Function Claims䠄Collective Name of the Foods, if applicable䠅 ᰤ㣴ᶵ⬟ᙉㄪ⾲♧䠄ᰤ㣴ᶵ⬟⾲♧䜢䛧䛯㣗ရ䜢ᣦ䛩ྡ⛠䛜 ᭷䜛ሙྜ䛿䛭䛾ྡ⛠䠅 Other Function Claims䠄Collective Name of the Foods, if applicable䠅 䛭䛾䛾ᶵ⬟ᙉㄪ⾲♧䠄䛾ᶵ⬟⾲♧䜢䛧䛯㣗ရ䜢ᣦ䛩ྡ ⛠䛜᭷䜛ሙྜ䛿䛭䛾ྡ⛠) Reduction of Disease Risk Claims䠄Collective Name of Foods Applied䠅 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 䝸䝇䜽పῶᙉㄪ⾲♧䠄㐺⏝䛥䜜䜛㣗ရ䜢ᣦ䛩ྡ⛠䠅 Types of Approval/Certification䠄Standardized/ Preauthorized Claims䠅 ᢎㄆ䠋ㄆド䛾✀㢮䠄つ᱁ᇶ‽ᆺ䠋 ๓ᢎㄆᆺ䠅 䠄Food Product/Constituent Specific Approval䠅 䠄㣗ရ䠋≉ᐃ䛾⤌ᡂᡂศ䛻ᑐ䛩䜛ᢎㄆ䠅 Cambodia Health Claim Regulations-3.1 䜹䞁䝪䝆䜰 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 ᗣᙉㄪ⾲♧ Scientific Substantiation of Health Claims 䜹䞁䝪䝆䜰 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 ᗣᙉㄪ⾲♧䛻㛵䛩䜛⛉Ꮫⓗᐇド Process for the Substantiation (Organizational Systems, Governing Authority/Agency/Commission) ᐇド䛾䝥䝻䝉䝇䠄ᑂᰝ⤌⧊䛾ᵓ㐀䚸ᨻ ᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠋ጤဨ䠅 Criteria for the Substantiation and/or Consideration of the Evidence ᐇド䛾ᇶ‽䛚䜘䜃䠋䜎䛯䛿ຠᯝ䛾ホ ౯ - 59 - 3.5.2 Cambodia Cambodia Health Claim Regulations-3.2 䜹䞁䝪䝆䜰 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ 䜹䞁䝪䝆䜰 Specific Safety Concerns ≉ᐃ䛾Ᏻᛶ䛻㛵䛩䜛㡯 Not specified ᣦᐃ䛺䛧 Not Specified ᣦᐃ䛺䛧 Re-evaluation ホ౯ Product Quality Concerns 䠄GMP, ISO, HACCP or Other Measures䠅 〇ရရ㉁䛻㛵䛩䜛㡯䠄GMP, ISO, HACCP 䜎䛯䛿䛾ホ౯ ᑻᗘ䠅 Adverse Event Reporting System䠄Mandatory/ Voluntary䠅 Not specified ᣦᐃ䛺䛧 Not Specified ᣦᐃ䛺䛧 ᭷ᐖ㇟䛻㛵䛩䜛ሗ࿌䝅䝇䝔䝮 䠄⩏ົ䠋௵ព䠅 Cambodia Health Claim Regulations-3.2 䜹䞁䝪䝆䜰 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ 䜹䞁䝪䝆䜰 Administrations/Compliances for Health Claims䠄Governing Authorities/Agencies䠅 Ministry of industry, mine and energy (MIME) ᗣᙉㄪ⾲♧䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓ ᡤ⟶ᙜᒁ䠋ᐁᗇ䠅 ⏘ᴗ䚸㖔ᒣ䚸䜶䝛䝹䜼䞊┬ Inspections and Penalties ᰝᐹ䛸⨩๎ NA つᐃ↓䛧 - 60 - 3.5.2 Cambodia Cambodia Health Claim Regulations-3.3 䜹䞁䝪䝆䜰 䠖 ᗣᙉㄪ⾲♧つ๎-3.3 ᗣᙉㄪ⾲♧ 䜹䞁䝪䝆䜰 Relevant Laws/Regulations for Dietary/Food/Health Supplements 䝎䜲䜶䝍䝸䞊䠋䝣䞊䝗䠋䝦䝹䝇 䝃䝥䝸䝯䞁䝖䛻㛵 䛩䜛㛵㐃ἲつ䠋つ๎ NA つᐃ↓䛧 NA つᐃ↓䛧 NA つᐃ↓䛧 Definitions䠄Dietary Supplements, and/or Food Supplements, and/or Health Supplements䠅 ᐃ⩏䠄䝎䜲䜶䝍䝸䞊䝃䝥䝸䝯䞁䝖䛚䜘䜃䠋䜎䛯䛿 䝣䞊䝗䝃䝥䝸䝯䞁䝖䛚䜘䜃䠋䜎䛯䛿䝦䝹䝇䝃䝥䝸 䝯䞁䝖䠅 Administrations/Compliances for the Supplements 䠄Governing Authorities/Agencies䠅 䝃䝥䝸䝯䞁䝖䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ⟶ᙜᒁ䠋ᐁ ᗇ䠅 - 61 - - 62 - 3.5.3 Singapore Nutrition Labelling and Nutrition/Health Claims ᰤ㣴⾲♧ཬ䜃ᰤ㣴/ᗣᙉㄪ⾲♧ 3.5.3 Republic of Singapore 䝅䞁䜺䝫䞊䝹ඹᅜ Singapore Nutrition Labelling Regulations-1.1 䝅䞁䜺䝫䞊䝹 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ 䝅䞁䜺䝫䞊䝹 In Singapore, requirements on nutrition labelling of prepacked food products are covered under the Singapore Food Regulations. Regulation 8A and Twelfth Schedule of the Food Regulations stipulate the requirement for a nutrition information panel (NIP) when product carries a nutrition or health claim. In addition, the respective regulations specifying the provisions on conditions for energy, Relevant Laws/Regulat protein and vitamin and mineral fortification of foods for general consumption are under ions regulations 9(7), 9(8) and 11. 㛵㐃ἲつ䠋 つ๎ 䝅䞁䜺䝫䞊䝹䛷䛿䚸ໟ῭䜏㣗ရ䛾ᰤ㣴⾲♧䛿䚸䝅䞁䜺䝫䞊䝹㣗ရつ๎䛻グ㍕䛥䜜䛶䛔䜛䚹 㣗ရつ๎䛾つ๎8Aཬ䜃⾲12䛿䚸㣗ရ䛜ᰤ㣴䛚䜘䜃ᗣᙉㄪ⾲♧䜢グ㏙䛩䜛ሙྜ䛾䚸ᰤ㣴 ሗ⾲♧ᯟ䠄NIP䠅䛻㛵䛩䜛せ௳䜢つᐃ䛩䜛䚹 䛥䜙䛻䚸୍⯡ᾘ㈝⏝㏵䛾㣗ရ䛾䜶䝛䝹䜼䞊ᙉ䚸䛯䜣䜁䛟㉁ᙉ䚸୪䜃䛻䚸䝡䝍䝭䞁ཬ䜃䝭䝛䝷 䝹ᙉ䛾䛯䜑䛾᮲௳䛻㛵䛩䜛つᐃ䜢ᐃ䜑䜛䛭䛾ྛつ๎䛿䚸つ๎9(7)䚸9(8)ཬ䜃11䛾㐺⏝⠊ᅖ 䛻ྵ䜎䜜䜛䚹 - 63 - 3.5.3 Singapore Singapore Nutrition Labelling Regulations-1.1 䝅䞁䜺䝫䞊䝹 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 䝅䞁䜺䝫䞊䝹 ᰤ㣴⾲♧ Nutrient Reference Values (Definitions, NRVs-R/-NCD) RDA (Recommended Daily Intake) ᥎ዡᰤ㣴ᡤせ㔞 ᰤ㣴ཧ↷㔞䠄ᐃ⩏, NRVsR/-NCD䠅 Nutrition labelling is mandatory when a nutrition claim is made, and for all prepacked edible fats and oils (which is in the group of “Edible Fats and Oils” under Regulation 78 to 92 of Food ᰤ㣴⾲♧䛿䚸ᰤ㣴⾲♧䜢⏝䛩䜛㝿䛾⩏ົ䛷䛒䜚䚸ཪ Regulations) for sale or for use as an 䚸㈍⏝㏵ཪ䛿㣗ရ䛾ㄪ⌮䛻㝿䛧䛶⏝䛩䜛⏝㏵䛾 ingredient in the preparation of foods. 䛩䜉䛶䛾ໟ䛥䜜䛯㣗⏝⬡ཬ䜃㣗⏝Ἔ 䠄㣗ရつ๎78 These products shall be labelled with 䛛䜙つ๎92䛾ୗ䛷䛂㣗⏝⬡ཬ䜃㣗⏝Ἔ䛃䛾䜾䝹䞊䝥䛻 the nutrition information panel (NIP) ᒓ䛩䜛䜒䛾䠅䛻ᑐ䛩䜛⩏ົ䛷䛒䜛䚹䛣䜜䜙䛾〇ရ䛿䚸㣗 in the form specified under the ရつ᱁⾲12䛾ୗ䛷つᐃ䛥䜜䛶䛔䜛ᵝᘧ䛷䚸䝖䝷䞁䝇ᆺ Twelfth Schedule of the Food ⬡⫫㓟䛾ྵ᭷㔞䛻㛵䛩䜛グ㏙䛸ඹ䛻䚸ᰤ㣴⣲ሗ⾲ Regulations, with the amount of ♧ᯟ䠄NIP䠅䛜⾲♧䛥䜜䛶䛔䛺䛡䜜䜀䛺䜙䛺䛔䚹 trans fatty acid content declared. Nutrient Declaration (Application: Mandatory or Voluntary) ᰤ㣴⾲♧䠄㐺⏝䠖 ⩏ົ 䜒 䛧䛟䛿 ௵ព䠅 Food Categories Applied 㐺⏝䛥䜜䜛㣗ရ䜹䝔䝂䝸䞊 All prepackaged foods 䛩䜉䛶䛾ໟ῭䜏㣗ရ 㐺⏝㝖እ䠄㣗ရ䜹䝔䝂 䝸䞊䠅 Not applicable to any prepacked food with small packaging, i.e. a total surface area of less than 100square 100ᖹ᪉䝉䞁䝏䝯䞊䝖䝹ᮍ‶䛾ྜィ⾲㠃✚䛾 centimeters, and do not bear any ᑠ䛥䛺ᐜჾໟ䛻䜘䜚ໟ῭䜏㣗ရ䛻䛿㐺 nutrient claim or other nutrition ⏝䛫䛪䚸ཪ䚸ᰤ㣴䛻㛵䛩䜛グ㏙ཪ䛿䛭䛾 information. (Size of Food Business Operators) Not applicable Exemptions (Food Categories) 䛾ᰤ㣴⣲䛻㛵䛩䜛ሗ䜢グ㍕䛧䛺䛔䚹 つᐃ↓䛧 䠄㣗ရᴗ⪅䛾つᶍ䠅 Singapore Nutrition Labelling Regulations-1.1 䝅䞁䜺䝫䞊䝹 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ 䝅䞁䜺䝫䞊䝹 - 4 core nutrients (energy, carbohydrate, protein and fat) & nutrients as claimed Listing of Nutrients (Nutrients, Order) ᰤ㣴ᡂศ䝸䝇䝖 䠄ᰤ 㣴ᡂศ䚸 グ㍕㡰䠅 - For products carrying the Healthier Choice Symbol, administered by Health Promotion Board, it is compulsory to declare 9 nutrients (energy, protein , fat, saturated fat, trans fat, cholesterol, carbohydrate, dietary fibre, sodium) - 4✀䛾せᰤ㣴⣲䠄䜶䝛䝹䜼䞊䚸ⅣỈ⣲䚸䛯䜣䜁䛟㉁ཬ䜃⬡㉁䠅䛸⾲♧ᰤ㣴⣲ - ᗣಁ㐍ᒁ䛻䜘䜚⟶⌮䛥䜜䛶䛔䜛䛂䜘䜚ᗣ䛺㑅ᢥ䝅䞁䝪䝹䛃䜢᭷䛩䜛〇ရ䛻㛵䛧 䛶䛿䚸9✀䛾ᰤ㣴⣲䠄䜶䝛䝹䜼䞊䚸ⅣỈ⣲䚸䛯䜣䜁䛟㉁䚸㣬⬡⫫䚸䝖䝷䞁䝇⬡⫫䚸 䝁䝺䝇䝔䝻䞊䝹䚸ⅣỈ≀䚸㣗≀⧄⥔䚸ሷศ䠅䜢⾲♧䛩䜛䛣䛸䛜⩏ົ䛸䛺䛳䛶䛔䜛䚹 Optional Ingredients Not specified つᐃ↓䛧 䛭䛾䛾ᰤ㣴ᡂศ - 64 - 3.5.3 Singapore Singapore Nutrition Labelling Regulations-1.2 䝅䞁䜺䝫䞊䝹 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ 䝅䞁䜺䝫䞊䝹 Presentation of Nutrient Content (Expression per 100g/ml or serving or package) ᰤ㣴ᡂศ㔞䛾⾲♧᪉ἲ 䠄⾲♧᪉ἲ 100g/ml 䚸1䝃䞊䝡 䞁䜾䚸ཪ䛿1ໟศ䛒䛯䜚䠅 per 100 g / per 100 ml or per serving* *Serving size and number of servings per package needs to be declared 100 gᙜ䜚 / 100 mlᙜ䜚ཪ䛿1ே๓ᙜ䜚* *୍ே๓䛾䛝䛥ཬ䜃ᐜჾໟᙜ䜚䛻ఱே๓ศ䛜ྵ䜎䜜䛶䛔䜛䛛䛻䛴䛔䛶 ⾲♧䛥䜜䛶䛔䜛ᚲせ䛜䛒䜛䚹 (Expression in Exact values or Ranges) 䠄⾲♧䛩䜛್䠖୍ᐃ್䜒䛧䛟䛿 ᖜ⾲♧䠅 (Analysis or Calculation Basis) 䠄ศᯒ್䜒䛧䛟䛿ィ⟬್䠅 Use of Food Composition Table/ Database for Presentation of Nutrients ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ ⾲䠋䝕䞊䝍䝧䞊䝇 䛾⏝ Food Composition Table/Database for Presentation of Nutrients ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ ⾲䠋䝕䞊䝍䝧䞊䝇 Exact values ୍ᐃ್ Both ඹ䛻ྍ Yes 䝕䞊䝍䝧䞊䝇䛾⏝ྍ Food Composition Database Singapore 䝅䞁䜺䝫䞊䝹㣗ရ⤌ᡂ䝕䞊䝍䝧䞊䝇 Singapore Nutrition Labelling Regulations-1.2 䝅䞁䜺䝫䞊䝹 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ Calculation of Nutrients (Energy/Protein/ Carbohydrate/Fat) ᰤ㣴ᡂศ䛾ィ⟬ 䠄䜶䝛 䝹䜼䞊䠋䛯䜣䜁䛟㉁䠋Ⅳ Ỉ≀䠋⬡㉁) Tolerances and Compliances (Tolerance Limits) බᕪ䛸㐺ྜᛶ䠄ㄗᕪ⠊ ᅖ䠅 䝅䞁䜺䝫䞊䝹 The amount of energy declared in the nutrition information panel must be accurate, when verified by laboratory analysis. ᰤ㣴౯ሗ⾲♧ᯟෆ䛻⾲♧䛥䜜䛶䛔䜛䜶䝛䝹䜼䞊㔞䛿䚸ヨ㦂ᶵ㛵䛷᳨ド 䛥䜜䛯ṇ☜䛺䜒䛾䛷䛺䛡䜜䜀䛺䜙䛺䛔 It is published in Health Promotion Board’s Handbook on Nutrition Labelling. ᰤ㣴⾲♧䛻㛵䛩䜛ᗣಁ㐍ᒁ䛾䝝䞁䝗䝤䝑䜽ෆ䛷බ㛤䛥䜜䜛䚹 - 65 - 3.5.3 Singapore Singapore Nutrition Labelling Regulations-1.2 䝅䞁䜺䝫䞊䝹 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ Specific Features of Presentation (Format, %NRV Labelling) ⾲♧᪉ἲ䛾≉Ⰽ 䠄䝣䜷䞊䝬䝑䝖䚸%NRV䚸 ⾲♧䠅 䝅䞁䜺䝫䞊䝹 In tabular format Optional to declare the % against RDA . ⾲䛾ᵝᘧ䜢⏝ RDA䛻ᑐ䛩䜛%䛾௵ព䛻䜘䜛⾲♧ (Front of Package Labelling, FOP) 䠄䝟䝑䜿䞊䝆ṇ㠃䛾⾲ ♧䚸FOP䠅 A Healthier Choice Symbol programme administered by the Health Promotion Board (HPB) has been implemented since 1998. ᗣಁ㐍ᒁ䠄HPB䠅䛜⟶⌮䛧䛶䛔䜛䛂䜘䜚ᗣ䛺㑅ᢥ䝅䞁䝪䝹䛃 䝥䝻䜾䝷䝮䛿䚸1998ᖺ䛛䜙ᑟධ䛥䜜䛶䛔䜛䚹 Singapore Nutrition Labelling Regulations-1.3 䝅䞁䜺䝫䞊䝹 䠖 ᰤ㣴⾲♧ᇶ‽-1.3 ᰤ㣴⾲♧ 䝅䞁䜺䝫䞊䝹 Administrations/Comp liances for Nutrition Labelling (Governing Authorities/Agencies) Agri-Food and Veterinary Authority of Singapore (AVA) ᰤ㣴⾲♧䛾⾜ᨻ䠋㡰 Ᏺ䠄ᨻᗓᡤ⟶ᙜᒁ䠋ᐁ ᗇ䠅 Inspections and Penalties ᰝᐹ䛸⨩๎ ㎰⏘≀䡡㣗ᩱ䡡⋇་Ꮫⓗ⟶⌮┘╩ᗇ䠄AVA䠅 AVA has in place a systematic surveillance programme, where AVA officers conduct checks on food products for compliance with the labelling requirements including claims, in addition to sampling of food products for food safety testing. AVA officers also regularly screen mediums such as website, Facebook account, print advertisements in newspapers or brochures etc for compliance to the labelling and claims requirements. If there is a breach to food law like a product is found falsely labelled, appropriate enforcement action will be taken against the party concerned. In accordance to the Sale of Food Act, the penalty will be a fine not exceeding $5,000 for first conviction, and in the case of a second or subsequent conviction, it will be a fine not exceeding $10,000 or imprisonment for a term not exceeding three months, or both. AVA䛿య⣔ⓗ┘ど䝥䝻䜾䝷䝮䜢ᑟධ䛧䛶䛚䜚䚸䛣䛾䝥䝻䜾䝷䝮䛾ୗ䛷䚸AVA䛿䚸㣗ရ Ᏻᛶヨ㦂䛾䛯䜑䛾㣗ရ〇ရ䛾䝃䞁䝥䝸䞁䜾䛻ຍ䛘䚸グ㏙ෆᐜ䜢ྵ䜑䛯⾲♧せ௳ 䜈䛾㑂Ᏺ䛻㛵䛩䜛㣗ရ〇ရ䛾᳨ᰝ䜢ᐇ䛧䛶䛔䜛䚹AVA䛿䚸⾲♧せ௳ཬ䜃グ㏙ෆᐜ せ௳䜈䛾㑂Ᏺ䛻㛵䛧䛶䚸䜴䜵䝤䝃䜲䝖䚸 Facebook䜰䜹䜴䞁䝖䚸᪂⪺ཪ䛿䝟䞁䝣䝺䝑䝖䛺 䛹䛾⣬፹య䛾ᗈ࿌䛺䛹䛾䝯䝕䜱䜰䜒ᐃᮇⓗ䛻ᰝ㜀䛩䜛䚹䛘䜀㣗ရ䛜ṇ䛻⾲♧䛥 䜜䛶䛔䜛䛣䛸䛜ุ᫂䛧䛯ሙྜ䛺䛹䚸㣗ရἲ䜈䛾㐪䛜䛒䜛㝿䛻䛿䚸䛭䛾㛵ಀ⪅䛻ᑐ 䛧䛶㐺ᙜ䛺ṇᙉไᥐ⨨䜢ྲྀ䜛䛣䛸䛸䛺䜛䚹㣗ရ㈍ἲ䛻ᚑ䛔䚸ึᅇ䛾㐪䛻ᑐ䛩䜛 ฎ⨩䛿$5,000䜢㉸䛘䛺䛔⨩㔠䚸ཪ䚸2ᅇ┠௨㝆䛾㐪䛻ᑐ䛧䛶䛿$10,000䜢㉸䛘䛺䛔 ⨩㔠ཪ䛿3䞄᭶䜢㉸䛘䛺䛔ᮇ㛫䛾⚗ᅛ䚸ᡈ䛔䛿䛣䜜䜙୧᪉䜢ㄢ䛩䛣䛸䛸䛺䜛䚹 - 66 - 3.5.3 Singapore Singapore Nutrition Claim Regulations-2 䝅䞁䜺䝫䞊䝹 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ 䝅䞁䜺䝫䞊䝹 Regulation 8A and Twelfth Schedule of the Food Regulations stipulate the requirement for a nutrition information panel (NIP) when product carries a nutrition or health claim. In addition, the respective regulations specifying the provisions on conditions for energy, protein and vitamin and mineral fortification of foods for general consumption are under regulations 9(7), 9(8) and 11. 㣗ရつ๎䛾つ๎8Aཬ䜃⾲12䛿䚸㣗ရ䛜ᰤ㣴䛚䜘䜃ᗣᙉㄪ⾲♧䜢グ㍕ 䛩䜛ሙྜ䛾䚸ᰤ㣴ሗ⾲♧ᯟ䠄NIP䠅䛻㛵䛩䜛せ௳䜢つᐃ䛩䜛䚹 䛥䜙䛻䚸୍⯡ᾘ㈝⏝㏵䛾㣗ရ䛾䜶䝛䝹䜼䞊ᙉ䚸䛯䜣䜁䛟㉁ᙉ䚸୪䜃䛻䚸 䝡䝍䝭䞁ཬ䜃䝭䝛䝷䝹ᙉ䛾䛯䜑䛾᮲௳䛻㛵䛩䜛つᐃ䜢ᐃ䜑䜛䛭䛾ྛつ๎ 䛿䚸つ๎9(7)䚸9(8)ཬ䜃11䛾㐺⏝⠊ᅖ䛻ྵ䜎䜜䜛䚹 Definitions (Nutrient Content/Compara Same as Codex -Nutrient Content Claim tive Claims) -Nutrient Comparative Claim ᐃ⩏䠄ᰤ㣴⣲ྵ᭷ 㔞䠋ẚ㍑ᙉㄪ⾲ ♧䠅 䝁䞊䝕䝑䜽䝇つ᱁䛸ྠᵝ 㻙 ᰤ㣴⣲ྵ᭷㔞ᙉㄪ⾲♧ 㻙 ᰤ㣴⣲ẚ㍑ᙉㄪ⾲♧ Singapore Nutrition Claim Regulations-2 䝅䞁䜺䝫䞊䝹 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ Nutrient Content Claims ᰤ㣴⣲ྵ᭷㔞ᙉㄪ ⾲♧ 䝅䞁䜺䝫䞊䝹 For nutrient content claims, as given in Codex, use RDA in place of NRV. Requirements for protein and energy, and RDAs for vitamins & minerals are given in Regulations. To follow guidelines established by Health Promotion Board for other nutrients ᰤ㣴⣲ྵ᭷ᙉㄪ⾲♧䛻㛵䛧䛶䛿䚸䝁䞊䝕䝑䜽䝇つ᱁䛻♧䛥䜜䛶䛔䜛㏻䜚䚸NRV䛾 ௦䜟䜚䛻RDA䜢⏝䛩䜛䚹 䛯䜣䜁䛟㉁ཬ䜃䜶䝛䝹䜼䞊䛻ᑐ䛩䜛せ௳䚸୪䜃䛻䚸䝡䝍䝭䞁&䝭䝛䝷䝹䛻ᑐ䛩䜛 RDAせ௳䛿つ๎ෆ䛻♧䛥䜜䛶䛔䜛䚹䛾ᰤ㣴⣲䛻㛵䛧䛶䛿䚸ᗣಁ㐍ᒁ䛜ᐃ 䜑䜛䜺䜲䝗䝷䜲䞁䛻ᚑ䛖䛣䛸䚹 - 67 - 3.5.3 Singapore Singapore Nutrition Claim Regulations-2 䝅䞁䜺䝫䞊䝹 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ 䝅䞁䜺䝫䞊䝹 Nutrient Comparative Claims For nutrient comparative claim, to follow guidelines established by Health Promotion Board ᰤ㣴⣲ẚ㍑ᙉㄪ⾲♧ ᰤ㣴⣲ẚ㍑ᙉㄪ⾲♧䛻㛵䛧䛶䛿䚸ᗣಁ㐍ᒁ䛜ᐃ䜑䜛䜺䜲䝗䝷䜲䞁䛻ᚑ䛖䛣䛸 For use of claims “No sugar added” and “no sodium added”, food products have to follow the guidelines as established by Health Promotion Board: “No sugar added” - No sugars or ingredients with added sugar, honey, malt and malt extract, with the exception of sugar alcohols, are added during processing of product Non-addition Claims 䠄Non-addition of Sugars/Sodium Salts䠅 ↓ῧຍ⾲♧䠄⢾㢮䠋䝘䝖䝸 䜴䝮ሷ䛾↓ῧຍ䠅 “No sodium/salt added” - No sodium chloride, sodium compounds or any ingredient containing added sodium chloride or other sodium compounds, are added during processing of product 䛂⢾ศ↓ῧຍ䛃ཬ䜃䛂ሷศ↓ῧຍ䛃䛾グ㏙䛾⏝䛻㛵䛧䛶䛿䚸ᗣಁ㐍ᒁ䛜ᐃ䜑 䜛䜺䜲䝗䝷䜲䞁䛻ᚑ䛖䛣䛸䚹 䛂⢾ศ↓ῧຍ䛃 㻙 ↓⢾䛷䛒䜛䛣䛸䚸ᡈ䛔䛿䚸⢾䜰䝹䝁䞊䝹䜢㝖䛟䚸⢾ศ䚸⻏⻤䚸㯏ⱆ ཬ䜃㯏ⱆᢳฟ≀䛜ῧຍ䛥䜜䛯ᡂศ䜢ྵ䜎䛺䛔䛣䛸䜢ᣦ䛩䚹 䛂䝘䝖䝸䜴䝮㻛ሷศ↓ῧຍ䛃 㻙 ሷ䝘䝖䝸䜴䝮䚸䝘䝖䝸䜴䝮ྜ≀䚸ᡈ䛔䛿䚸ሷ䝘 䝖䝸䜴䝮ཪ䛿䛭䛾䛾䝘䝖䝸䜴䝮ྜ≀䜢ྵ䜐ᡂศ䛜〇ရ䛾ຍᕤ䛻㝿䛧䛶ῧຍ䛥 䜜䛶䛔䜛䛣䛸䜢ᣦ䛩䚹 Administrations/Complian ces for Nutrition Claims 䠄Governing Agri-Food and Veterinary Authority of Singapore (AVA) Authorities/Agencies䠅 ᰤ㣴ᙉㄪ⾲♧䛾⾜ᨻ䠋㡰 Ᏺ䠄ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ) ㎰⏘≀䡡㣗ᩱ䡡⋇་Ꮫⓗ⟶⌮┘╩ᗇ䠄AVA䠅 Singapore Nutrition Claim Regulations-2 䝅䞁䜺䝫䞊䝹 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ Inspections and Penalties ᰝᐹ䛸⨩๎ 䝅䞁䜺䝫䞊䝹 AVA has in place a systematic surveillance programme, where AVA officers conduct checks on food products for compliance with the labelling requirements including claims, in addition to sampling of food products for food safety testing. AVA officers also regularly screen mediums such as website, Facebook account, print advertisements in newspapers or brochures etc for compliance to the labelling and claims requirements. If there is a breach to food law like a product is found falsely labelled, appropriate enforcement action will be taken against the party concerned. In accordance to the Sale of Food Act, the penalty will be a fine not exceeding $5,000 for first conviction, and in the case of a second or subsequent conviction, it will be a fine not exceeding $10,000 or imprisonment for a term not exceeding three months, or both. AVA䛿య⣔ⓗ┘ど䝥䝻䜾䝷䝮䜢ᑟධ䛧䛶䛚䜚䚸䛣䛾䝥䝻䜾䝷䝮䛾ୗ䛷AVA䛿䚸㣗 ရᏳᛶヨ㦂䛻䛯䜑䛾㣗ရ〇ရ䛾䝃䞁䝥䝸䞁䜾䛻ຍ䛘䚸グ㏙ෆᐜ䜢ྵ䜑䛯⾲ ♧せ௳䜈䛾㑂Ᏺ䛻㛵䛩䜛㣗ရ〇ရ䛾᳨ᰝ䛾ᐇ䛧䛶䛔䜛䚹AVA䛿䚸⾲♧せ௳ ཬ䜃グ㏙ෆᐜせ௳䜈䛾㑂Ᏺ䛻㛵䛧䛶䚸䜴䜵䝤䝃䜲䝖䚸Facebook䜰䜹䜴䞁䝖䚸᪂⪺ ཪ䛿䝟䞁䝣䝺䝑䝖䛺䛹䛾⣬፹య䛾ᗈ࿌䛺䛹䛾䝯䝕䜱䜰䜒ᐃᮇⓗ䛻ᰝ㜀䛩䜛䚹䛘 䜀㣗ရ䛜ṇ䛻⾲♧䛥䜜䛶䛔䜛䛣䛸䛜ุ᫂䛧䛯ሙྜ䛺䛹䚸㣗ရἲ䜈䛾㐪䛜䛒 䜛㝿䛻䛿䚸䛭䛾㛵ಀ⪅䛻ᑐ䛧䛶㐺ᙜ䛺ṇᙉไᥐ⨨䜢ྲྀ䜛䛣䛸䛸䛺䜛䚹㣗ရ㈍ ἲ䛻ᚑ䛔䚸ึᅇ䛾㐪䛻ᑐ䛩䜛ฎ⨩䛿$5,000䜢㉸䛘䛺䛔⨩㔠䚸ཪ䚸2ᅇ┠௨㝆 䛾㐪䛻ᑐ䛧䛶䛿$10,000䜢㉸䛘䛺䛔⨩㔠ཪ䛿3䞄᭶䜢㉸䛘䛺䛔ᮇ㛫䛾⚗ᅛ䚸ᡈ 䛔䛿䛣䜜䜙୧᪉䜢ㄢ䛩䛣䛸䛸䛺䜛䚹 - 68 - 3.5.3 Singapore Singapore Health Claim Regulations-3.1 䝅䞁䜺䝫䞊䝹 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 ᗣᙉㄪ⾲♧ 䝅䞁䜺䝫䞊䝹 Regulation 8A and Twelfth Schedule of the Food Regulations stipulate the requirement for a nutrition information panel (NIP) when product carries a nutrition or health claim. Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ In addition, the respective regulations specifying the provisions on conditions for energy, protein and vitamin and mineral fortification of foods for general consumption are under regulations 9(7), 9(8) and 11. 㣗ရつ๎䛾つ๎8Aཬ䜃⾲12䛿䚸㣗ရ䛜ᰤ㣴䛚䜘䜃ᗣᙉㄪ⾲♧䜢グ㍕䛩䜛ሙ ྜ䛾䚸ᰤ㣴ሗ⾲♧ᯟ䠄NIP䠅䛻㛵䛩䜛せ௳䜢つᐃ䛩䜛䚹 䛥䜙䛻䚸୍⯡ᾘ㈝⏝㏵䛾㣗ရ䛾䜶䝛䝹䜼䞊ᙉ䚸䝍䞁䝟䜽㉁ᙉ䚸୪䜃䛻䚸䝡䝍 䝭䞁ཬ䜃䝭䝛䝷䝹ᙉ䛾䛯䜑䛾᮲௳䛻㛵䛩䜛つᐃ䜢ᐃ䜑䜛䛭䛾ྛつ๎䛿䚸つ๎ 9(7)䚸9(8)ཬ䜃11䛾㐺⏝⠊ᅖ䛻ྵ䜎䜜䜛䚹 Definitions 䠄Collective Name of Foods with Health Claims, if applicable䠅 ᐃ⩏䠄ᗣᙉㄪ䜢䛧 䛯㣗ရ䜢ᣦ䛩ྡ⛠ 䛜᭷䜛ሙྜ䛿䛭䛾 ྡ⛠䠅 Nutrient function claims Nutrient specific diet-related health claims Other function claims ᰤ㣴ᶵ⬟ᙉㄪ⾲♧ Nutrient specific diet-related health claims 䛭䛾䛾ᶵ⬟ᙉㄪ⾲♧ Singapore Health Claim Regulations-3.1 䝅䞁䜺䝫䞊䝹 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 䝅䞁䜺䝫䞊䝹 ᗣᙉㄪ⾲♧ Nutrient Function Claims 䠄Collective Name of the Foods, if applicable䠅 ᰤ㣴ᶵ⬟ᙉㄪ⾲♧䠄ᰤ㣴ᶵ⬟⾲♧ 䜢䛧䛯㣗ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ 䛿䛭䛾ྡ⛠䠅 Other Function Claims䠄Collective Name of the Foods, if applicable䠅 䛭䛾䛾ᶵ⬟ᙉㄪ⾲♧䠄䛾ᶵ⬟ ⾲♧䜢䛧䛯㣗ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛 ሙྜ䛿䛭䛾ྡ⛠) Reduction of Disease Risk Claims 䠄Collective Name of Foods Applied䠅 䝸䝇䜽పῶᙉㄪ⾲♧䠄㐺⏝䛥䜜 䜛㣗ရ䜢ᣦ䛩ྡ⛠䠅 Types of Approval/Certification 䠄Standardized/ Pre-authorized Claims䠅 Nutrient Function Claims ᰤ㣴ᶵ⬟ᙉㄪ⾲♧ Other Function Claims 䛭䛾ᶵ⬟ᙉㄪ⾲♧ Nutrient specific diet-related health claims 㣗䛻㛵ಀ䛩䜛≉ᐃ䛾ᰤ㣴ᡂศ䛾ᗣᙉㄪ⾲♧ Pre-authorized Claims ᢎㄆ䠋ㄆド䛾✀㢮䠄つ᱁ᇶ‽ᆺ䠋 つ᱁ᇶ‽ᆺ䛾⾲♧ ๓ᢎㄆᆺ䠅 䠄Food Product/Constituent Specific No product specific claims Approval䠅 䠄㣗ရ䠋≉ᐃ䛾⤌ᡂᡂศ䛻ᑐ䛩䜛 ᢎㄆ䠅 〇ရẖ䛾≉ᐃ䛾⾲♧チྍ䛿↓䛔 - 69 - 3.5.3 Singapore Singapore Health Claim Regulations-3.2 䝅䞁䜺䝫䞊䝹 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 䝅䞁䜺䝫䞊䝹 ᗣᙉㄪ⾲♧ Scientific Substantiation of Health Claims Documentation required ドᣐ᭩㢮䛜ᚲせ ᗣᙉㄪ⾲♧䛻 㛵䛩䜛⛉Ꮫⓗᐇ ド Process for the Substantiation (Organizational Systems, Governing Authority/Agency /Commission) Applications for use of nutrient specific diet-related health claims above should be submitted to AVA or HPB. Details on the requirements and application process can be found at the following URL: http://www.ava.gov.sg/FoodSector/FoodlabellingAdvertisement/ Applications for use of new nutrient function and other function claims as defined by Codex should be submitted to AVA. Guidance information, application form and checklist for application are also posted at the following URL: http://www.ava.gov.sg/FoodSector/FoodlabellingAdvertisement/ ᐇド䛾䝥䝻䝉䝇 䠄ᑂᰝ⤌⧊䛾ᵓ㐀䚸 ᨻᗓᡤ⟶ᙜᒁ䠋 ᐁᗇ䠋ጤဨ䠅 Nutrient specific diet-related health claims⏝䛾䛯䜑䛾⏦ㄳ䛿䚸AVAཪ䛿HPB䛻ᑐ 䛧䛶ᥦฟ䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹せ௳ཬ䜃⏦ㄳᡭ⥆䛝䛻㛵䛩䜛ヲ⣽䛿䚸௨ୗ䛾URL䛷 ☜ㄆ䛷䛝䜛䚹 http://www.ava.gov.sg/FoodSector/FoodlabellingAdvertisement/ CODEXつ᱁䛾ᐃ䜑䜛᪂ᰤ㣴ᶵ⬟ཬ䜃䛭䛾ᶵ⬟䛾グ㏙䛾⏝䛻㛵䛩䜛⏦ㄳ䛿䚸 AVA䛻ᑐ䛧䛶ᥦฟ䛧䛺䛡䜜䜀䛺䜙䛺䛔䚹ᡭᘬ䛝ሗ䚸⏦ㄳ᭩ཬ䜃⏦ㄳ䝏䜵䝑䜽䝸䝇䝖 䛿䚸௨ୗ䛾URL䛻䜒ᥖ㍕䛥䜜䛶䛔䜛䚹 http://www.ava.gov.sg/FoodSector/FoodlabellingAdvertisement/ Singapore Health Claim Regulations-3.2 䝅䞁䜺䝫䞊䝹 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ 䝅䞁䜺䝫䞊䝹 AVA made reference to Codex document, “Recommendations on the Scientific Substantiation of Health Claims” for evidence required to justify for use of new nutrient function and other function health claims, Types of evidence include the followings: 1. Human studies: a) Experimental intervention studies eg. RCT, RT b) Observational studies eg. cohort studies, case-control studies, cross-sectional studies 2. Non-human studies eg. animal, ex vivo, in vitro studies 3. Systematic reviews such as pooled analysis, meta-analysis Criteria for the 4. Contradictory information Substantiation and/or 5. Recommendations by food safety authorities of major developed countries on Consideration of the the use of the proposed claims. Evidence ᐇド䛾ᇶ‽䛚䜘䜃䠋 䜎䛯䛿ຠᯝ䛾ホ౯ ᪂ᰤ㣴ᶵ⬟ཬ䜃䛭䛾ᶵ⬟䛻㛵䛩䜛グ㏙䛾⏝䛻䛴䛔䛶䛾ṇᙜᛶ䜢❧ド䛩䜛䛯䜑 䛻せồ䛥䜜䜛ドᣐ䛻㛵䛧䛶䚸AVA䛿ᅜ㝿㣗ရつ᱁䛾ᩥ᭩䛂ಖ⾲♧䛾⛉Ꮫⓗᐇド䛻 㛵䛩䜛່࿌㡯䛃䛻ゝཬ䛧䛶䛚䜚䚸䛭䛾ドᣐ䛾✀㢮䛻䛿௨ୗ䛾䜒䛾䜢ྵ䜐䚹 1.⮫ᗋヨ㦂 a) 䛘䜀RCT䜔RT䛺䛹䛾ᐇ㦂ⓗ⮫ᗋ◊✲ b) 䛘䜀䝁䝩䞊䝖◊✲䚸䜿䞊䝇䝁䞁䝖䝻䞊䝹◊✲䚸ᶓ᩿◊✲䛺䛹䛾ほᐹ䛻䜘䜛◊✲ 2.䛘䜀ື≀䚸Ṛయ䚸ヨ㦂⟶ෆ◊✲䛺䛹䛾㠀⮫ᗋ◊✲ 3.⤫ྜศᯒ䚸䝯䝍ศᯒ䛺䛹䛾య⣔ⓗ᳨ᰝ 4.▩┪䛩䜛ሗ 5.ᥦ䛥䜜䛶䛔䜛グ㏙䛾⏝䛻㛵䛩䜛せඛ㐍ᅜ䛾㣗ရᏳᙜᒁ䛻䜘䜛່࿌ - 70 - 3.5.3 Singapore Singapore Health Claim Regulations-3.2 䝅䞁䜺䝫䞊䝹 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ 䝅䞁䜺䝫䞊䝹 Specific Safety Concerns ≉ᐃ䛾Ᏻᛶ䛻㛵䛩䜛㡯 Not specified つᐃ↓䛧 Not Specified つᐃ↓䛧 Re-evaluation ホ౯ Product Quality Concerns 䠄GMP, ISO, HACCP or Other Measures䠅 〇ရရ㉁䛻㛵䛩䜛㡯䠄GMP, ISO, HACCP 䜎䛯䛿䛾ホ౯ ᑻᗘ䠅 Adverse Event Reporting System䠄Mandatory/ Voluntary䠅 Not specified つᐃ↓䛧 Not Specified つᐃ↓䛧 ᭷ᐖ㇟䛻㛵䛩䜛ሗ࿌䝅䝇䝔 䝮䠄⩏ົ䠋௵ព䠅 Administrations/Compliances for Health Claims䠄Governing Authorities/Agencies䠅 䝦䝹䝇䜽䝺䞊䝮䛾⾜ᨻ䠋㡰Ᏺ 䠄ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠅 Agri-Food and Veterinary Authority of Singapore (AVA) ㎰⏘≀䡡㣗ᩱ䡡⋇་Ꮫⓗ⟶⌮┘╩ᗇ䠄AVA䠅 Singapore Health Claim Regulations-3.2 䝅䞁䜺䝫䞊䝹 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ Inspections and Penalties ᰝᐹ䛸⨩๎ 䝅䞁䜺䝫䞊䝹 AVA has in place a systematic surveillance programme, where AVA officers conduct checks on food products for compliance with the labelling requirements including claims, in addition to sampling of food products for food safety testing. AVA officers also regularly screen mediums such as website, Facebook account, print advertisements in newspapers or brochures etc for compliance to the labelling and claims requirements. If there is a breach to food law like a product is found falsely labelled, appropriate enforcement action will be taken against the party concerned. In accordance to the Sale of Food Act, the penalty will be a fine not exceeding $5,000 for first conviction, and in the case of a second or subsequent conviction, it will be a fine not exceeding $10,000 or imprisonment for a term not exceeding three months, or both. AVA䛿య⣔ⓗ┘ど䝥䝻䜾䝷䝮䜢ᑟධ䛧䛶䛚䜚䚸䛣䛾䝥䝻䜾䝷䝮䛾ୗ䛷AVA䛿䚸㣗ရ Ᏻᛶヨ㦂䛻䛯䜑䛾㣗ရ〇ရ䛾䝃䞁䝥䝸䞁䜾䛻ຍ䛘䚸グ㏙ෆᐜ䜢ྵ䜑䛯⾲♧せ௳ 䜈䛾㑂Ᏺ䛻㛵䛩䜛㣗ရ〇ရ䛾᳨ᰝ䛾ᐇ䛧䛶䛔䜛䚹AVA䛿䚸⾲♧せ௳ཬ䜃グ㏙ෆ ᐜせ௳䜈䛾㑂Ᏺ䛻㛵䛧䛶䚸䜴䜵䝤䝃䜲䝖䚸Facebook䜰䜹䜴䞁䝖䚸᪂⪺ཪ䛿䝟䞁䝣䝺䝑䝖 䛺䛹䛾⣬፹య䛾ᗈ࿌䛺䛹䛾䝯䝕䜱䜰䜒ᐃᮇⓗ䛻ᰝ㜀䛩䜛䚹䛘䜀㣗ရ䛜ṇ䛻⾲♧ 䛥䜜䛶䛔䜛䛣䛸䛜ุ᫂䛧䛯ሙྜ䛺䛹䚸㣗ရἲ䜈䛾㐪䛜䛒䜛㝿䛻䛿䚸䛭䛾㛵ಀ⪅䛻 ᑐ䛧䛶㐺ᙜ䛺ṇᙉไᥐ⨨䜢ྲྀ䜛䛣䛸䛸䛺䜛䚹㣗ရ㈍ἲ䛻ᚑ䛔䚸ึᅇ䛾㐪䛻ᑐ 䛩䜛ฎ⨩䛿$5,000䜢㉸䛘䛺䛔⨩㔠䚸ཪ䚸2ᅇ┠௨㝆䛾㐪䛻ᑐ䛧䛶䛿$10,000䜢㉸䛘 䛺䛔⨩㔠ཪ䛿3䞄᭶䜢㉸䛘䛺䛔ᮇ㛫䛾⚗ᅛ䚸ᡈ䛔䛿䛣䜜䜙୧᪉䜢ㄢ䛩䛣䛸䛸䛺䜛䚹 - 71 - 3.5.3 Singapore Singapore Health Claim Regulations-3.3 䝅䞁䜺䝫䞊䝹 䠖 ᗣᙉㄪ⾲♧つ๎-3.3 䝦䝹䝇䜽䝺䞊䝮 Relevant Laws/Regulations for Dietary/Food/Health Supplements 䝅䞁䜺䝫䞊䝹 Products labeled as “dietary supplement” may be classified as a health supplement, food, traditional medicine or other categories of products depending on its formulation, dosage, indications and instructions of use. The Food-Health Product classification tree developed by both the Agri-Food and Veterinary Authority of Singapore and the Health Sciences Authority (HSA) of Singapore would provide more information about the classification of health products and foods. This information may be viewed at the following website: http://www.ava.gov.sg/FoodSector/ImportExportTransOfFood/ProcessedFood/ 䝎䜲䜶䝍䝸䞊䠋䝣䞊䝗䠋䝦䝹 䝇 䝃䝥䝸䝯䞁䝖䛻㛵䛩䜛㛵㐃 ἲつ䠋つ๎ 䛂䝎䜲䜶䝍䝸䞊䝃䝥䝸䝯䞁䝖䛃䛸⾲♧䛥䜜䛶䛔䜛〇ရ䛿䚸䛭䛾ㄪྜタィ䚸⏝㔞䚸⏝䛻㛵䛩䜛 ᣦ♧ཬ䜃ฎ᪉䛻ᛂ䛨䛶䚸ᗣ⿵ຓရ䚸㣗ရ䚸ఏ⤫ⓗ䛺་⸆ရཪ䛿䛭䛾䛾༊ศ䛾㣗ရ䛻 ศ㢮䛩䜛䛣䛸䛜䛷䛝䜛䚹䝅䞁䜺䝫䞊䝹㎰⏘≀䡡㣗ᩱ䡡⋇་Ꮫⓗ⟶⌮┘╩ᗇཬ䜃ಖ⛉Ꮫᗇ 䠄HSA䠅䛾୧⪅䛻䜘䜚㛤Ⓨ䛥䜜䛯㣗ရಖ〇ရศ㢮⣔⤫䛿䚸ಖ〇ရཬ䜃㣗ရ䛾ศ㢮䛻 䛴䛔䛶䛾䜘䜚ヲ䛧䛔ሗ䜢ᥦ౪䛧䛶䛔䜛䚹䛣䛾ሗ䛿䚸௨ୗ䛾䜴䜵䝤䝃䜲䝖䛷㜀ぴ䛩䜛䛣䛸 䛜䛷䛝䜛䚹 http://www.ava.gov.sg/FoodSector/ImportExportTransOfFood/ProcessedFood/ Definitions䠄Dietary Supplements, and/or Food Supplements, and/or Health Supplements䠅 There is currently no legal definition for the terms “dietary/food/health supplement” in Singapore. However, the Health Sciences Authority has a working definition for health supplements at the ‘Guidelines for Health Supplements’ under http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/complementary_medicine s/supplements.html ᐃ⩏䠄䝎䜲䜶䝍䝸䞊䝃䝥䝸䝯䞁 ⌧Ⅼ䛻䛚䛔䛶䚸⏝ㄒ䛸䛧䛶䛾䛂㣗㻛㣗ရ㻛ᗣ⿵ຓ䛃䛻ᑐ䛩䜛ἲⓗ䛺ᐃ⩏䛿䝅䞁䜺䝫䞊 䝖䛚䜘䜃䠋䜎䛯䛿䝣䞊䝗䝃䝥䝸 䝹ᅜෆ䛻䛿Ꮡᅾ䛧䛺䛔䚹䛧䛛䛧䚸ಖ⛉Ꮫᗇ䛿䚸௨ୗ䛾䛂ᗣ⿵ຓ䛻㛵䛩䜛䜺䜲䝗䝷䜲䞁䛃 䝯䞁䝖䛚䜘䜃䠋䜎䛯䛿䝦䝹䝇 䛷䚸ᗣ⿵ຓ䛻㛵䛩䜛ᐃ⩏䛾⟇ᐃసᴗ䜢䛚䛣䛺䛳䛶䛔䜛䚹 䝃䝥䝸䝯䞁䝖䠅 Administrations/Compliance s for the Supplements 䠄Governing Authorities/Agencies䠅 つᐃ↓䛧 NA 䝃䝥䝸䝯䞁䝖䛾⾜ᨻ䠋㡰Ᏺ 䠄ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠅 - 72 - 3.5.4 Thailand Nutrition Labelling and Nutrition/Health Claims ᰤ㣴⾲♧ཬ䜃ᰤ㣴/ᗣᙉㄪ⾲♧ 3.5.4 Kingdom of Thailand 䝍䜲⋤ᅜ Thailand Nutrition Labelling Regulations-1.1 䝍䜲 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ 䝍䜲 1. Ministerial Notification No. 182 Re: Nutrition labelling http://iodinethailand.fda.moph.go.th/fda/new/images/cms/top_upload/1147229682_ 182-41(update).pdf 2. Ministerial Notification No. 305 Re: labelling of some kinds of ready-to-eat food http://iodinethailand.fda.moph.go.th/fda/new/images/cms/top_upload/1224646040_ Notification305.pdf Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ 3. Thai FDA Announcement Re: Nutrient Functional Claims (Thai version only) http://iodinethailand.fda.moph.go.th/food_54/law/data/announ_fda/056Nutrition_Cl aim(11-08-51).pdf 1. ┬࿌♧➨182ྕ䠖ᰤ㣴⾲♧ http://iodinethailand.fda.moph.go.th/fda/new/images/cms/top_upload/1147229682_18 2-41(update).pdf 2. ┬࿌♧➨305ྕ䠖ᩘ✀㢮䛾༶ᖍ㣗ရ䛾⾲♧ http://iodinethailand.fda.moph.go.th/fda/new/images/cms/top_upload/1224646040_No tification305.pdf 3. 䝍䜲FDA䠄㣗ရ་⸆ရᒁ䠅࿌▱䠖ᰤ㣴ᶵ⬟ᙉㄪ⾲♧䠄䝍䜲ㄒ䛾䜏䠅 http://iodinethailand.fda.moph.go.th/food_54/law/data/announ_fda/056Nutrition_Clai m(11-08-51).pdf - 73 - 3.5.4 Thailand Thailand Nutrition Labelling Regulations-1.1 䝍䜲 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ 䝍䜲 Nutrient Reference Values (Definitions, NRVs-R/Thai RDI (Recommended Daily Intake) NCD) 䝍䜲RDI 䠄(1᪥ᙜ䛯䜚䠅᥎ዡᰤ㣴ᡤせ㔞䠅 ᰤ㣴ཧ↷㔞䠄ᐃ⩏, NRVsR/-NCD䠅 Nutrient Declaration (Application: Mandatory or Voluntary) - Voluntary - Nutrition labelling is mandatory for 1) foods include - foods with nutrition claim - for enriched/fortified foods - foods for special dietary use 2) some kind of snack foods (potato chip, popcorn, extruded snack, biscuit/cracker, and filled wafer) 䇵 ௵ព 䇵 ᰤ㣴⾲♧䛿௨ୗ䛾ሙྜ䛻䛿⩏ົ 1) ௨ୗ䛾⾲♧䜢ྵ䜐㣗ရ 䇵 ᰤ㣴ᙉㄪ⾲♧䜢᭷䛩䜛㣗ရ 䇵 ᙉ䠋⿵ᙉ㣗ရ 䇵 ≉ู⏝㏵㣗ရ 2) ᩘ✀㢮䛾䝇䝘䝑䜽㣗ရ䠄䝫䝔䝖䝏䝑䝥䚸䝫䝑䝥䝁䞊䞁䚸ᡂᆺ䝇䝘䝑䜽䚸䝡䝇䜿䝑䝖 䠋䜽䝷䝑䜹䞊䚸୰㌟䛾ワ䜎䛳䛯䜴䜶䝝䞊䝇䠅 ᰤ㣴⾲♧䠄㐺⏝䠖 ⩏ົ 䜒 䛧䛟䛿 ௵ព䠅 Food Categories Applied 㐺⏝䜜䜛㣗ရ䜹䝔䝂䝸䞊 All prepackaged foods 䛩䜉䛶䛾ໟ῭䜏㣗ရ Thailand Nutrition Labelling Regulations-1.1 䝍䜲 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ Exemptions (Food Categories) 䝍䜲 - Infant formula, Follow-up formula and Complementary Food for IYC - Foods which are not for sale directly to consumers or foods which are not produced or imported for sale in the country. - Foods which are partially packed from bulk batch intended to sale in whole. 㐺⏝㝖እ䠄㣗ရ䜹䝔䝂 䝸䞊䠅 䇵 䇵 䇵 (Size of Food Business Operators) NA ᗂඣ䜔ᑠඣ䛾䛯䜑䛾ㄪ〇⢊ங䚸䝣䜷䝻䞊䜰䝑䝥䝣䜷䞊䝭䝳䝷䞊䛚䜘䜃 ⿵㣗ရ ᾘ㈝⪅䛻䛿┤᥋㈍䛥䜜䛶䛔䛺䛔㣗ရ䚸䛒䜛䛔䛿䚸ᅜෆ䛷䛾㈍┠ ⓗ䛷〇㐀䛒䜛䛔䛿㍺ධ䛥䜜䛶䛔䛺䛔㣗ရ 䝞䝹䜽㈍┠ⓗ䛾䛯䜑䛻୍㒊䛾䜏ໟ䛥䜜䛶䛔䜛㣗ရ つᐃ↓䛧 䠄㣗ရᴗ⪅䛾つᶍ䠅 - 74 - 3.5.4 Thailand Thailand Nutrition Labelling Regulations-1.1 䝍䜲 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ 䝍䜲 Nutrients can be included in the Nutrition Information Panel into 2 formats no matter voluntary or mandatory. 1) Fully format shall declare: -4 core nutrients (energy, carbohydrate, protein and fat) and -Saturated fat -Cholesterol ᰤ㣴⣲䛿䚸௵ព䛒䜛䛔䛿⩏ົ䜢ၥ䜟䛪2✀㢮䛾Nutrition -Dietary fibre Information Panel䛻ศ䛡䜙䜜䜛䚹 Listing of -Sugar 1) 䛩䜉䛶⾲グ䛩䜛ሙྜ䛿௨ୗ䛾ᰤ㣴⣲䜢グ㍕䠖 Nutrients -Sodium 䇵 4ᰤ㣴⣲䠄䜶䝛䝹䜼䞊䚸ⅣỈ≀䚸䛯䜣䜁䛟㉁䚸⬡㉁䠅䚸 (Nutrients, 䛚䜘䜃 -Vitamin A Order) 䇵 㣬⬡⫫ -Vitamin B1 ᰤ㣴ᡂศ䝸䝇䝖 䇵 䝁䝺䝇䝔䝻䞊䝹 䠄ᰤ㣴ᡂศ䚸 グ㍕ -Vitamin B2 䇵 㣗≀⧄⥔ 㡰䠅 -Calcium 䇵 ⢾㢮 -Iron 䇵 䝘䝖䝸䜴䝮 -Nutrient as claimed 䇵 䝡䝍䝭䞁A 䇵 䇵 䇵 䇵 䇵 䝡䝍䝭䞁B1 䝡䝍䝭䞁B2 䜹䝹䝅䜴䝮 㕲 ᙉㄪ⾲♧䛩䜉䛝ᰤ㣴⣲ Thailand Nutrition Labelling Regulations-1.1 䝍䜲 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ Listing of Nutrients (Nutrients, Order) ᰤ㣴ᡂศ䝸䝇䝖䠄ᰤ 㣴ᡂศ䚸 グ㍕㡰䠅 Optional Ingredients 䛭䛾䛾ᰤ㣴ᡂศ 䝍䜲 2) Simplified format shall declare -4 core nutrients -Sugar -Sodium - Nutrient as claimed Simplified format can be displayed when nutrients up to 8 items from 15 items have no significant amount 2) ⡆␎䛧䛶⾲グ䛩䜛ሙྜ䛿௨ୗ䛾ᰤ㣴⣲䜢グ㍕䠖 䇵 4ᰤ㣴⣲ 䇵 ⢾㢮 䇵 䝘䝖䝸䜴䝮 䇵 ᙉㄪ⾲♧䛩䜉䛝ᰤ㣴⣲ ⡆␎⾲グ䛷䛿䚸15ᰤ㣴⣲୰8ᰤ㣴⣲䜎䛷䛜༑ศ㔞ྵ᭷䛥䜜䛶䛔䛺䛔ሙྜ䛻⾲♧ྍ ⬟䛸䛺䜛 NA Other Nutrients which are not specified in the list can be displayed below the nutrition panel. つᐃ↓䛧 ୖグ䝸䝇䝖䛷≉ᐃ䛥䜜䛶䛔䛺䛔ᰤ㣴⣲䛻㛵䛧䛶䛿䚸Nutrition Panel䠄ᰤ㣴ḍ䠅䛾ୗ䛻グ㍕ 䛩䜛䛣䛸䛜䛷䛝䜛 - 75 - 3.5.4 Thailand Thailand Nutrition Labelling Regulations-1.2 䝍䜲 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ 䝍䜲 • Per serving size- reference serving size for each of the 7 food categories, 68 food items. • Per 100 g/ 100 ml – for others Presentation of Nutrient Content (Expression per 100g/ml or serving or package) ᰤ㣴ᡂศ㔞䛾⾲♧᪉ἲ 䠄⾲♧᪉ἲ 100g/ml 䚸1䝃䞊䝡䞁䜾䚸ཪ 䛿1ໟศ䛒䛯䜚䠅 (Expression in Exact values or Ranges) • • 䝃䞊䝡䞁䜾䝃䜲䝈䛒䛯䜚 – 7䛴䛾㣗ရศ㢮䚸68㣗ရ䛤䛸䛾䝃 䞊䝡䞁䜾䝃䜲䝈䜢ཧ↷ 100 g 䛒䜛䛔䛿100 ml 䛒䛯䜚 –ୖグ㣗ရ௨እ Exact values ୍ᐃ್ Analysis ศᯒ್ NA つᐃ↓䛧 NA つᐃ↓䛧 䠄⾲♧䛩䜛್䠖୍ᐃ್䜒䛧䛟䛿ᖜ⾲♧䠅 (Analysis or Calculation Basis) 䠄ศᯒ್䜒䛧䛟䛿ィ⟬್䠅 Use of Food Composition Table/ Database for Presentation of Nutrients ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲䠋䝕䞊 䝍䝧䞊䝇 䛾⏝ Food Composition Table/Database for Presentation of Nutrients ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲䠋䝕䞊 䝍䝧䞊䝇 Thailand Nutrition Labelling Regulations-1.2 䝍䜲 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ Calculation of Nutrients (Energy/Protein/ Carbohydrate/Fat) ᰤ㣴ᡂศ䛾ィ⟬ 䠄䜶䝛䝹䜼䞊䠋 䛯䜣䜁䛟㉁䠋ⅣỈ≀䠋⬡㉁) Tolerances and Compliances (Tolerance Limits) බᕪ䛸㐺ྜᛶ䠄ㄗᕪ⠊ᅖ䠅 䝍䜲 Energy value is calculated from carbohydrate, protein and fat. 䜶䝛䝹䜼䞊್䛿ⅣỈ≀䚸䛯䜣䜁䛟㉁䛚䜘䜃⬡㉁䜘䜚⟬ฟ Yes, Notification of MOPH No. 182 has criteria for increment of each nutrient. チᐜ㝈⏺䛒䜚䚸 MOPH䠄ಖ┬䠅࿌♧➨182ྕ䛻ྛᰤ㣴⣲䛾ቑศุ᩿ᇶ‽䛒䜚 - 76 - 3.5.4 Thailand Thailand Nutrition Labelling Regulations-1.2 䝍䜲 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ 䝍䜲 Nutrition Panel: In tabular format Nutrition Panel䠄ᰤ㣴ḍ䠅䠖 ⾲ᙧᘧ䛷⾲グ Specific Features of Presentation (Format, %NRV Labelling) GDA (Guideline Daily Intake): In Bullet format ⾲♧᪉ἲ䛾≉Ⰽ 䠄䝣䜷䞊 䝬䝑䝖䚸%NRV䚸⾲♧䠅 Mandatory to declare the % against Thai RDI . GDA䠄ᰤ㣴ᦤྲྀ㔞䜺䜲䝗䝷䜲䞁䠅䠖 䖃༳䛾⾜㢌ᩥᏐ䛷ิグ 䝍䜲䛾RDI䠄㻔㻝᪥ᙜ䛯䜚䠅᥎ዡᰤ㣴ᡤせ㔞䠅䛒䛯䜚䛾ྜ䠄䠂䠅䛷⾲♧䛩䜛䛣䛸䠄⩏ົ䠅 (Front of Package Labelling, FOP) GDA is mandatory on some kind of snack foods followed by Notification of MOPH No. 305. 䠄䝟䝑䜿䞊䝆ṇ㠃䛾⾲♧䚸 FOP䠅 GDA䠄ᰤ㣴ᦤྲྀ㔞䜺䜲䝗䝷䜲䞁㻕䛿䚸MOPH䠄ಖ┬䠅࿌♧➨㻟㻜㻡ྕ䛻䜘䜚ᩘ✀ 㢮䛾༶ᖍ㣗ရ䛻䛚䛔䛶䛿⩏ົ⾲♧䛷䛒䜛 Thailand Nutrition Labelling Regulations-1.3 䝍䜲 䠖 ᰤ㣴⾲♧ᇶ‽-1.3 ᰤ㣴⾲♧ Administrations/Compliances for Nutrition Labelling (Governing Authorities/Agencies) ᰤ㣴⾲♧䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓ ᡤ⟶ᙜᒁ䠋ᐁᗇ䠅 Inspections and Penalties ᰝᐹ䛸⨩๎ 䝍䜲 Thai Food and Drug Administration 䝍䜲Food and Drug Administration䠄㣗ရ་⸆ရᒁ䠅 Have monitoring programs. ┘ど䝥䝻䜾䝷䝮䛒䜚 - 77 - 3.5.4 Thailand Thailand Nutrition Claim Regulations-2 䝍䜲 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ Relevant Laws/Regulations 䝍䜲 1. Ministerial Notification No. 182 Re: Nutrition labelling http://iodinethailand.fda.moph.go.th/fda/new/images/cms/top_upload/1147229 682_182-41(update).pdf 2. Ministerial Notification No. 305 Re: labelling of some kinds of ready-to-eat food http://iodinethailand.fda.moph.go.th/fda/new/images/cms/top_upload/1224646 040_Notification305.pdf 3. Thai FDA Announcement Re: Nutrient Functional Claims (Thai version only) http://iodinethailand.fda.moph.go.th/food_54/law/data/announ_fda/056Nutritio n_Claim(11-08-51).pdf 㛵㐃ἲつ䠋つ๎ ┬࿌♧➨182ྕ䠖ᰤ㣴⾲♧ http://iodinethailand.fda.moph.go.th/fda/new/images/cms/top_upload/1147229682_ 182-41(update).pdf 2. ┬࿌♧➨305ྕ䠖ᩘ✀㢮䛾༶ᖍ㣗ရ䛾⾲♧ http://iodinethailand.fda.moph.go.th/fda/new/images/cms/top_upload/1224646040_ Notification305.pdf 3. 䝍䜲FDA䠄㣗ရ་⸆ရᒁ䠅࿌▱䠖ᰤ㣴ᶵ⬟ᙉㄪ⾲♧䠄䝍䜲ㄒ䛾䜏䠅 http://iodinethailand.fda.moph.go.th/food_54/law/data/announ_fda/056Nutrition_C laim(11-08-51).pdf 1. Definitions (Nutrient Content/Comparative Claims) Same as Codex -Nutrient Content Claim ᐃ⩏䠄ᰤ㣴⣲ྵ᭷㔞䠋 -Nutrient Comparative Claim ẚ㍑ᙉㄪ⾲♧䠅 䝁䞊䝕䝑䜽䝇䛸ྠ䛨 ࡲ ᰤ㣴⣲ྵ᭷㔞ᙉㄪ⾲♧ ࡲ ᰤ㣴⣲ẚ㍑ᙉㄪ⾲♧ Thailand Nutrition Claim Regulations-2 䝍䜲 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ 䝍䜲 For nutrient content claims, format and criteria similar to Codex, but use Thai RDI in place of NRV. For nutrient comparative claim, format and criteria similar to Codex. Nutrient Content Claims ᰤ㣴⣲ྵ᭷㔞ᙉㄪ⾲♧ http://iodinethailand.fda.moph.go.th/food_54/law/data/announ_moph/P182.p df ᰤ㣴⣲ྵ᭷㔞ᙉㄪ㔞⾲♧䛻䛿䚸䝁䞊䝕䝑䜽䝇䛸ྠᵝ䛾⾲♧ᙧᘧ䛚䜘䜃ุ᩿ᇶ‽䛜 䛒䜛䛜䚸ᰤ㣴ཧ↷㔞䛾ḍ䛻䛿䝍䜲RDI䠄㻔㻝᪥ᙜ䛯䜚䠅᥎ዡᰤ㣴ᡤせ㔞䠅䜢⏝䛔䜛䛣䛸 ᰤ㣴⣲ẚ㍑ᙉㄪ⾲♧䛻䛿䚸䝁䞊䝕䝑䜽䝇䛸ྠᵝ䛾⾲♧ᙧᘧ䛚䜘䜃ุ᩿ᇶ‽䛒䜚 http://iodinethailand.fda.moph.go.th/food_54/law/data/announ_moph/P182.pdf - 78 - 3.5.4 Thailand Thailand Nutrition Claim Regulations-2 䝍䜲 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ 䝍䜲 For nutrient comparative claim, format and criteria similar to Codex. Nutrient Comparative http://iodinethailand.fda.moph.go.th/food_54/law/data/announ_moph/P182.pdf Claims ᰤ㣴⣲ẚ㍑ᙉㄪ⾲♧ ᰤ㣴⣲ẚ㍑ᙉㄪ⾲♧䛻䛿䚸䝁䞊䝕䝑䜽䝇䛸ྠᵝ䛾⾲♧ᙧᘧ䛚䜘䜃ุ᩿ᇶ‽䛒䜚 http://iodinethailand.fda.moph.go.th/food_54/law/data/announ_moph/P182.pdf Non-addition Claims “Non-addition” claims are allowed. 䠄Non-addition of Sugars/Sodium Salts䠅 ↓ῧຍ⾲♧䠄⢾㢮䠋䝘 䝖䝸䜴䝮ሷ䛾↓ῧຍ䠅 䇾↓ῧຍ䇿⾲♧䛿チྍ䛥䜜䛶䛔䜛 Administrations/Com pliances for Nutrition Thai Food and Drug Administration Claims䠄Governing Authorities/Agencies䠅 ᰤ㣴ᙉㄪ⾲♧䛾⾜ᨻ 䠋㡰Ᏺ䠄ᨻᗓᡤ⟶ᙜᒁ 䠋ᐁᗇ) Inspections and Penalties ᰝᐹ䛸⨩๎ 䝍䜲Food and Drug Administration䠄㣗ရ་⸆ရᒁ䠅 Have monitoring programs. ┘ど䝥䝻䜾䝷䝮䛒䜚 Thailand Health Claim Regulations-3.1 䝍䜲 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 䝍䜲 ᗣᙉㄪ⾲♧ Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ 1. Ministerial Notification No. 182 Re: Nutrition labelling http://iodinethailand.fda.moph.go.th/fda/new/images/cms/top_upload/1147229 682_182-41(update).pdf 2. Ministerial Notification No. 305 Re: labelling of some kinds of ready-to-eat food http://iodinethailand.fda.moph.go.th/fda/new/images/cms/top_upload/1224646 040_Notification305.pdf 3. Thai FDA Announcement Re: Nutrient Functional Claims (Thai version only) http://iodinethailand.fda.moph.go.th/food_54/law/data/announ_fda/056Nutriti on_Claim(11-08-51).pdf ┬࿌♧➨182ྕ䠖ᰤ㣴⾲♧ http://iodinethailand.fda.moph.go.th/fda/new/images/cms/top_upload/1147229682_1 82-41(update).pdf 2. ┬࿌♧➨305ྕ䠖ᩘ✀㢮䛾༶ᖍ㣗ရ䛾⾲♧ http://iodinethailand.fda.moph.go.th/fda/new/images/cms/top_upload/1224646040_ Notification305.pdf 3. 䝍䜲FDA䠄㣗ရ་⸆ရᒁ䠅࿌▱䠖ᰤ㣴ᶵ⬟ᙉㄪ⾲♧䠄䝍䜲ㄒ䛾䜏䠅 http://iodinethailand.fda.moph.go.th/food_54/law/data/announ_fda/056Nutrition_Cl aim(11-08-51).pdf 1. Definitions 䠄Collective Nutrient function claims and probiotics claims. Name of Foods with Other function claims and disease risk reduction claims are not allowed. Health Claims, if applicable䠅 ᰤ㣴ᶵ⬟ᙉㄪ⾲♧䛚䜘䜃䝥䝻䝞䜲䜸䝔䜱䜽䝇ᙉㄪ⾲♧ ᐃ⩏䠄ᗣᙉㄪ⾲♧䜢 䛭䛾䛾ᶵ⬟ᙉㄪ⾲♧䛚䜘䜃ᝈ䝸䝇䜽పῶᙉㄪ⾲♧䛿ㄆ䜑䜙䜜䛶䛔䛺䛔 䛧䛯㣗ရ䜢ᣦ䛩ྡ⛠䛜 ᭷䜛ሙྜ䛿䛭䛾ྡ⛠䠅 - 79 - 3.5.4 Thailand Thailand Health Claim Regulations-3.1 䝍䜲 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 ᗣᙉㄪ⾲♧ 䝍䜲 Nutrient Function Claims䠄Collective Name of the Foods, if applicable䠅 ᰤ㣴ᶵ⬟ᙉㄪ⾲♧䠄ᰤ㣴ᶵ⬟⾲♧䜢䛧䛯㣗 ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾ྡ⛠䠅 Nutrient Function Claims ᰤ㣴ᶵ⬟ᙉㄪ⾲♧ NA つᐃ↓䛧 NA つᐃ↓䛧 Other Function Claims䠄Collective Name of the Foods, if applicable䠅 䛭䛾䛾ᶵ⬟ᙉㄪ⾲♧䠄䛾ᶵ⬟⾲♧䜢䛧 䛯㣗ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾ྡ⛠) Reduction of Disease Risk Claims 䠄Collective Name of Foods Applied䠅 䝸䝇䜽పῶᙉㄪ⾲♧䠄㐺⏝䛥䜜䜛㣗ရ 䜢ᣦ䛩ྡ⛠䠅 Types of Approval/Certification 䠄Standardized/ Pre-authorized Claims䠅 Pre-authorized Claims ᢎㄆ䠋ㄆド䛾✀㢮䠄つ᱁ᇶ‽ᆺ䠋 ๓ᢎ ㄆᆺ䠅 䠄Food Product/Constituent Specific Approval䠅 䛒䜙䛛䛨䜑チྍ䛥䜜䛯ᙉㄪ⾲♧䛾䜏ྍ⬟ No product specific claims 䠄㣗ရ䠋≉ᐃ䛾⤌ᡂᡂศ䛻ᑐ䛩䜛ᢎㄆ䠅 product specific claims䠄≉ᐃ䛾〇ရ䜔ᵓᡂᡂศ䛻ᑐ䛩 䜛チྍ⾲♧䠅䛿䛺䛔 Thailand Health Claim Regulations-3.2 䝍䜲 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ Scientific Substantiation of Health Claims ᗣᙉㄪ⾲♧䛻㛵䛩䜛⛉ Ꮫⓗᐇド 䝍䜲 Documentation required ⏦ㄳ᭩㢮䛜ᚲせ An approval framework based on scientific evidences is used -Must submit scientific substantiations of claim. -All substantiations are reviewed by an expert group. Process for the Substantiation (Organizational Systems, Expert’s viewpoints are considered by Thai FDA for permission. Governing Authority/Agency/Commi ssion) ᐇド䛾䝥䝻䝉䝇䠄ᑂᰝ⤌⧊ 䛾ᵓ㐀䚸ᨻᗓᡤ⟶ᙜᒁ䠋 ᐁᗇ䠋ጤဨ䠅 ⛉Ꮫⓗ᰿ᣐ䛻ᇶ䛵䛔䛯ᢎㄆᡭ⥆䛝䠄ᯟ⤌䜏䠅䛜䛒䜛 ࡲ ᙉㄪ⾲♧䛾⛉Ꮫⓗᐇド䜢ᥦฟ䛧䛺䛡䜜䜀䛺䜙䛺䛔 ࡲ ⛉Ꮫⓗᐇド䛿ᑓ㛛ᐙ㞟ᅋ䛻䜘䜚ホ౯䛥䜜䜛 䝍䜲FDA䠄㣗ရ་⸆ရᒁ䠅䛻䜘䜛チㅙ䛻䛿ᑓ㛛ᐙ䛾ぢゎ䛜⪃៖䛥䜜䜛 Criteria for the Substantiation and/or Consideration of the Evidence ᐇド䛾ᇶ‽䛚䜘䜃䠋䜎䛯 䛿ຠᯝ䛾ホ౯ Depending on types of claims and totality of evidence. ᙉㄪ⾲♧䛾✀㢮䛸⛉Ꮫⓗ᰿ᣐ䛾యᛶ䛻䜘䜛 - 80 - 3.5.4 Thailand Thailand Health Claim Regulations-3.2 䝍䜲 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ 䝍䜲 Specific Safety Concerns ≉ᐃ䛾Ᏻᛶ䛻㛵䛩䜛㡯 Not specified つᐃ↓䛧 Not Specified つᐃ↓䛧 Re-evaluation ホ౯ Product Quality Concerns 䠄GMP, ISO, HACCP or Other Measures䠅 〇ရရ㉁䛻㛵䛩䜛㡯䠄GMP, ISO, HACCP 䜎䛯䛿䛾ホ౯ ᑻᗘ䠅 Adverse Event Reporting System䠄Mandatory/ Voluntary䠅 All prepackaged foods must be required food quality system certification. 䛩䜉䛶䛾ໟ῭䜏㣗ရ䛿㣗ရရ㉁䝅䝇䝔䝮ㄆド䜢ྲྀᚓ䛧䛺䛡䜜䜀䛺䜙䛺䛔 つᐃ↓䛧 Not Specified ᭷ᐖ㇟䛻㛵䛩䜛ሗ࿌䝅䝇䝔 䝮䠄⩏ົ䠋௵ព䠅 Thailand Health Claim Regulations-3.2 䝍䜲 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ 䝍䜲 Administrations/Comp liances for Health Claims䠄Governing Thai Food and Drug Administration Authorities/Agencies䠅 ᗣᙉㄪ⾲♧䛾⾜ᨻ 䠋㡰Ᏺ䠄ᨻᗓᡤ⟶ᙜᒁ 䠋ᐁᗇ䠅 Inspections and Penalties 䝍䜲Food and Drug Administration䠄㣗ရ་⸆ရᒁ䠅 Have monitoring programs. ᰝᐹ䛸⨩๎ ┘ど䝥䝻䜾䝷䝮䛒䜚 - 81 - 3.5.4 Thailand Thailand Health Claim Regulations-3.3 䝍䜲 䠖 ᗣᙉㄪ⾲♧つ๎-3.3 ᗣᙉㄪ⾲♧ Relevant Laws/Regulations for Dietary/Food/Health Supplements 䝎䜲䜶䝍䝸䞊䠋䝣䞊䝗䠋䝦 䝹䝇 䝃䝥䝸䝯䞁䝖䛻㛵䛩䜛 㛵㐃ἲつ䠋つ๎ Definitions㸦Dietary Supplements, and/or Food Supplements, and/or Health Supplements㸧 ᐃ⩏㸦ࢲ࢚ࢱ࣮ࣜࢧ ࣉ࣓ࣜࣥࢺ࠾ࡼࡧ㸭ࡲ ࡓࡣࣇ࣮ࢻࢧࣉ࣓ࣜࣥ ࢺ࠾ࡼࡧ㸭ࡲࡓࡣ࣊ࣝ ࢫࢧࣉ࣓ࣜࣥࢺ㸧 䝍䜲 -Ministerial Notification No. 293 Re: Food Supplement http://iodinethailand.fda.moph.go.th/fda/new/images/cms/top_upload/11697 06519_no.293.pdf ࡲ ┬࿌♧➨293ྕ䠖䝣䞊䝗䝃䝥䝸䝯䞁䝖 http://iodinethailand.fda.moph.go.th/fda/new/images/cms/top_upload/11697065 19_no.293.pdf Food supplement means products taken for consume other than conventional foods which contain nutrients or other substances as ingredients, are in forms of tablets, capsules, powders, flakes, liquids or others ; which are not conventional foods for consumers who expect for benefit of health promotion. 䝣䞊䝗䝃䝥䝸䝯䞁䝖䛸䛿䚸ཎᮦᩱ䛸䛧䛶㏻ᖖ䛾㣗ရ䛻ྵ䜎䜜䜛ᰤ㣴⣲䜔䛭䛾 ᡂศ䛾䛻䚸ᾘ㈝⪅䛜ᦤྲྀ䛩䜛〇ရ䛷䛒䛳䛶䚸㘄䚸䜹䝥䝉䝹䚸⢊ᮎ䚸䝣䝺䞊 䜽䚸ᾮయ䚸䛚䜘䜃䛭䛾䛾ᙧ≧䛛䜙䛺䜛䚹ᗣቑ㐍ຠᯝ䜢ᮇᚅ䛩䜛ᾘ㈝⪅䛜 ᪥ᖖⓗ䛻ᦤྲྀ䛩䜛㣗ရ䛷䛿䛺䛔 Administrations/Complia nces for the Supplements Thai Food and Drug Administration 䠄Governing Authorities/Agencies䠅 䝃䝥䝸䝯䞁䝖䛾⾜ᨻ䠋㡰Ᏺ 䠄ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠅 䝍䜲Food and Drug Administration䠄㣗ရ་⸆ရᒁ䠅 - 82 - 3.5.5 Philippines Nutrition Labelling and Nutrition/Health Claims ᰤ㣴⾲♧ཬ䜃ᰤ㣴/ᗣᙉㄪ⾲♧ 3.5.5 Republic of the Philippines 䝣䜱䝸䝢䞁ඹᅜ Philippines Nutrition Labelling Regulations-1.1 䝣䜱䝸䝢䞁 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ Relevant Laws/Regulations 䝣䜱䝸䝢䞁 -Administrative Oder 88-B s. 1984 (Rules and Regulations Governing the labelling of Prepackaged Food Products Distributed in the Philippines. --B.C. 2007-002 (Guidelines for the Use of Health and Nutrition Claims) - FDA Circular No. 2012-015 Guidelines on Voluntary Declaration of the Front of Pack labelling (Energy or Calorie Content) on Processed Food Products. (www.fda.gov.ph) - FDA Advisory No. 2013-038 Consumer Tips on the Use of Front of Pack (FOP) Labels for Making Healthy Dietary Choices. (www.fda.gov.ph) aims. 㛵㐃ἲつ䠋つ๎ - ⾜ᨻ௧➨88-B s. 1984 ྕ䠄䝣䜱䝸䝢䞁ᅜෆ䛷ὶ㏻䛧䛶䛔䜛ໟ῭䜏㣗ရ䛾⾲♧䛻㛵䛧 䛶ᐃ䜑䜛つᐃཬ䜃つ๎䠅-- B.C. 2007-002䠄ᗣ䛚䜘䜃ᰤ㣴ᙉㄪ⾲♧䛾⏝䛻㛵䛩䜛䜺 䜲䝗䝷䜲䞁䠅 - 㣗ရ་⸆ရᒁ䛾ᅇሗ, ➨2012-015ྕ䛂ຍᕤ㣗ရ〇ရୖ䛾ᐜჾໟ๓㠃㒊⾲♧䠄䜶䝛 䝹䜼䞊䜎䛯䛿䜹䝻䝸䞊㔞䠅䛾௵ព⾲♧䛻㛵䛩䜛䜺䜲䝗䝷䜲䞁䛃䠄www.fda.gov.ph䠅 - 㣗ရ་⸆ရᒁ䛾່࿌,➨2013-038ྕ䛂ᗣⓗ䛺㣗≀䛾㑅ᢥ䛾䛯䜑䛾ᐜჾໟ๓㠃㒊䠄 FOP䠅⾲♧䛾⏝䛻㛵䛩䜛ᾘ㈝⪅䛾䛯䜑䛾ሗ䛃䠄www.fda.gov.ph䠅 - 83 - 3.5.5 Philippines Philippines Nutrition Labelling Regulations-1.1 䝣䜱䝸䝢䞁 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ 䝣䜱䝸䝢䞁 Nutrient Reference Values (Definitions, NRVs-R/-NCD) Recommended Energy and Nutrient Intake or RENI 䜶䝛䝹䜼䞊ཬ䜃ᰤ㣴⣲䛾᥎ዡᦤྲྀ㔞ཪ䛿RENI ᰤ㣴ཧ↷㔞䠄ᐃ⩏, NRVsR/-NCD䠅 - Voluntary - ௵ព - Mandatory for - ௨ୗ䛻㛵䛧䛶䛿⩏ົ - enriched and fortified foods - ᰤ㣴⣲⿵ᙉཬ䜃ᙉ㣗ရ - bottled water as “mineral water” - 䛂䝭䝛䝷䝹䜴䜷䞊䝍䞊䛃䛸䛧䛶䝪䝖䝹ワ 䜑䛥䜜䛯Ỉ - with nutrition and health claims Nutrient Declaration (Application: Mandatory or Voluntary) ᰤ㣴⾲♧䠄㐺⏝䠖 ⩏ົ 䜒 䛧䛟䛿 ௵ព䠅 - ᰤ㣴ཬ䜃ᗣᙉㄪ⾲♧䜢᭷䛩䜛䜒䛾 Food Categories Applied 㐺⏝䛥䜜䜛㣗ရ䜹䝔䝂䝸䞊 Exemptions (Food Categories) 㐺⏝㝖እ䠄㣗ရ䜹䝔䝂 䝸䞊䠅 (Size of Food Business Operators) All prepackaged foods 䛩䜉䛶䛾ໟ῭䜏㣗ရ NA at this moment ⌧Ⅼ䛷䛿つᐃ↓䛧 NA at this moment ⌧Ⅼ䛷䛿つᐃ↓䛧 䠄㣗ရᴗ⪅䛾つᶍ䠅 Philippines Nutrition Labelling Regulations-1.1 䝣䜱䝸䝢䞁 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ Listing of Nutrients (Nutrients, Order) ᰤ㣴ᡂศ䝸䝇䝖 䠄ᰤ㣴ᡂศ䚸 グ㍕㡰䠅 Optional Ingredients 䝣䜱䝸䝢䞁 A total of 4 core nutrients are to be included in the NIP: Energy, Protein, Fat, Carbohydrate (excluding dietary fibre) ྜィ4✀㢮䛾せᰤ㣴⣲䛜NIP䛻ྵ䜎䜜䜛䛣䛸䛸䛺䜛 䜶䝛䝹䜼䞊䚸䛯䜣䜁䛟㉁䚸⬡㉁䚸ⅣỈ≀䠄㣗≀⧄⥔䜢㝖䛟䠅 NIP: Nutition information panel - Mandatory nutrients to be declared for fortificants of fortified foods - Mandatory for claimed nutrients - Vitamins and minerals (except if amount is less than 2% RENI or RDA) 䛭䛾䛾ᰤ㣴ᡂศ - ᙉ㣗ရ䛾ᰤ㣴ᙉ≀㉁䜢⾲♧䛩䜛ሙྜ䛾ᰤ㣴⣲ - 䜽䝺䞊䝮⾲♧䛩䜛ᰤ㣴⣲ - 䝡䝍䝭䞁ཬ䜃䝭䝛䝷䝹䠄ྵ᭷㔞䛜RENIཪ䛿RDA䛾2%ᮍ‶䛷 䛒䜛ሙྜ䜢㝖䛟 䠅 - 84 - 3.5.5 Philippines Philippines Nutrition Labelling Regulations-1.2 䝣䜱䝸䝢䞁 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ 䝣䜱䝸䝢䞁 Presentation of Nutrient Content (Expression per 100g/ml or serving or package) ᰤ㣴ᡂศ㔞䛾⾲♧᪉ἲ 䠄⾲♧᪉ἲ 100g/ml 䚸1䝃䞊䝡䞁 䜾䚸ཪ䛿1ໟศ䛒䛯䜚䠅 All nutrient quantity shall be declared in relation to average or usual serving in terms of slices, pieces or specified weight or volume 䛩䜉䛶䛾ᰤ㣴⣲䛾ྵ᭷㔞䛿䚸㣗ရ䛾୍ษ䜜䚸୍∦䚸ᡈ䛔䛿䚸ᣦᐃ㔜㔞ཪ 䛿య✚䛷⾲䛧䛯䚸ᖹᆒ䜎䛯䛿㏻ᖖ䝃䞊䝡䞁䜾䛸䛧䛶⾲♧䛧䛺䛡䜜䜀䛺䜙䛺䛔 (Expression in Exact values or Ranges) 䠄⾲♧䛩䜛್䠖୍ᐃ್䜒䛧䛟䛿ᖜ ⾲♧䠅 (Analysis or Calculation Basis) ୍ᐃ್ Exact values Should be based on actual analysis of the product 〇ရ䛾ᐇ㝿䛾ศᯒ್䛻ᇶ䛵䛛䛺䛡䜜䜀䛺䜙䛺䛔 䠄ศᯒ್䜒䛧䛟䛿ィ⟬್䠅 Use of Food Composition Table/ Database for Presentation of Nutrients Not allowed ㄆ䜑䜙䜜䛶䛔䛺䛔 Not applicable 㐺⏝↓䛧 ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲ 䠋䝕䞊䝍䝧䞊䝇 䛾⏝ Food Composition Table/Database for Presentation of Nutrients ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲ 䠋䝕䞊䝍䝧䞊䝇 Philippines Nutrition Labelling Regulations-1.2 䝣䜱䝸䝢䞁 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ 䝣䜱䝸䝢䞁 Calculation of Nutrients (Energy/Protein/ Carbohydrate/Fat) -Carbohydrates (g) x 4 -Protein (g) x4 ᰤ㣴ᡂศ䛾ィ⟬ 䠄䜶䝛䝹䜼䞊䠋 -Fat (g) x 9 䛯䜣䜁䛟㉁䠋ⅣỈ≀䠋⬡㉁) Tolerances and Compliances (Tolerance Limits) බᕪ䛸㐺ྜᛶ䠄ㄗᕪ⠊ᅖ䠅 - ⅣỈ≀䠄g䠅 x 4 - 䛯䜣䜁䛟㉁䠄g䠅 x 4 - ⬡㉁䠄g䠅 x 9 For claimed nutrients, at least 80% of the declared value for that nutrient should be present within the claimed shelf life ⾲♧ᰤ㣴⣲䛻㛵䛧䛶䚸㈹ᮇ㝈ෆ䛿䚸⾲♧್䛾ᑡ䛺䛟䛸䜒80䠂䜢 ྵ᭷䛩䜛䛣䛸 - 85 - 3.5.5 Philippines Philippines Nutrition Labelling Regulations-1.2 䝣䜱䝸䝢䞁 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ Specific Features of Presentation (Format, %NRV Labelling) 䝣䜱䝸䝢䞁 In tabular format - Optional for vitamins and minerals. RENI is used as reference. - In the absence of RENI for other nutrients, FAO/WHO or USRDA values may be used. - Imported products are allowed to declare their own RDA values. ⾲ᙧᘧ䜢⏝ - 䝡䝍䝭䞁ཬ䜃䝭䝛䝷䝹䛻ᑐ䛧䛶䛿௵ព䚹ᇶ‽䛸䛧䛶RENI䜢⏝ - 䛭䛾䛾ᰤ㣴⣲䛻ᑐ䛧䛶RENI䛜Ꮡᅾ䛧䛺䛔ሙྜ䚸FAO/WHOཪ䛿⡿ ᅜ䛾RDA䛾್䜢⏝䛩䜛䛣䛸䛜䛷䛝䜛 - ㍺ධ〇ရ䛿䛭䜜䜙⊂⮬䛾RDA್䜢⾲♧䛩䜛䛣䛸䛜ㄆ䜑䜙䜜䛶䛔䜛 ⾲♧᪉ἲ䛾≉Ⰽ 䠄䝣䜷䞊䝬䝑䝖䚸%NRV䚸 ⾲♧䠅 USRDA(United States recommended daily allowance) : ⡿ᅜ䠄1᪥ᙜ䛯䜚䠅᥎ዡᰤ㣴ᡤせ㔞 (Front of Package Labelling, FOP) Front of Pack or Sign Posting for Energy Value is being implemented on a voluntary basis. 䠄䝟䝑䜿䞊䝆ṇ㠃䛾⾲ ♧䚸FOP䠅 䜶䝛䝹䜼䞊౯䛻㛵䛩䜛ໟ๓㠃⾲♧ཪ䛿グྕ⾲♧䛿௵ព䛷ᑟධ䛩䜛 Philippines Nutrition Labelling Regulations-1.3 䝣䜱䝸䝢䞁 䠖 ᰤ㣴⾲♧ᇶ‽-1.3 ᰤ㣴⾲♧ Administrations/Compliances for Nutrition Labelling (Governing Authorities/Agencies) ᰤ㣴⾲♧䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ ⟶ᙜᒁ䠋ᐁᗇ䠅 Inspections and Penalties ᰝᐹ䛸⨩๎ 䝣䜱䝸䝢䞁 Food and Drug Administration 㣗ရ་⸆ရᒁ -Compliance to labelling regulations is part of the regular monitoring scheme being implemented by FDA. Fines/Penalties are stipulated in FDA Act of 2011 (Republic Act 9711) with non-compliance with labelling regulations including health and nutrition claims. - One of the grounds for cancellation of permits (License to Operate or Certificate of Product Registration) is non-compliance of the labels with labelling regulations. - ⾲♧つ๎䛾㡰Ᏺ䛿䚸FDA䛜ᑟධ䛧䛶䛔䜛ᐃᮇ┘ど䛾ᑐ㇟䛸䛺䛳 䛶䛔䜛䚹⨩㔠/⨩๎䛻㛵䛧䛶䛿䚸ᗣཬ䜃ᰤ㣴ᙉㄪ⾲♧䜢ྵ䜑䛯 ⾲♧つ๎䜈䛾㡰Ᏺ䛻㛵䛩䜛2011ᖺFDAἲ䠄ඹᅜἲ➨9711 ྕ䠅䛻つᐃ䛥䜜䛶䛔䜛䚹 - ㄆྍ䠄ྲྀᢅ⪅ㄆドཪ䛿〇ရⓏ㘓ド䠅䛾ྲྀᾘ䛧⏤䛾1䛴䛿⾲♧ つ๎䛾㡰Ᏺ䛷䛒䜛 - 86 - 3.5.5 Philippines Philippines Nutrition Claim Regulations-2 䝣䜱䝸䝢䞁 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ Definitions (Nutrient Content/Comparative Claims) ᐃ⩏䠄ᰤ㣴⣲ྵ᭷㔞䠋 ẚ㍑ᙉㄪ⾲♧䠅 Nutrient Content Claims ᰤ㣴⣲ྵ᭷㔞ᙉㄪ⾲♧ 䝣䜱䝸䝢䞁 Administrative Oder 88-B s. 1984 (Rules and Regulations Governing the labelling of Prepackaged Food Products Distributed in the Philippines. B.C. 2007-002 (Guidelines for the Use of Health and Nutrition Claims. ⾜ᨻ௧➨88-B s. 1984 ྕ䠄䝣䜱䝸䝢䞁ᅜෆ䛷ὶ㏻䛧䛶䛔䜛ໟ῭ 䜏㣗ရ䛾⾲♧䛻㛵䛧䛶ᐃ䜑䜛つᐃཬ䜃つ๎䠅-- B.C. 2007-002䠄 ᗣཬ䜃ᰤ㣴ᙉㄪ⾲♧䛾⏝䛻㛵䛩䜛䜺䜲䝗䝷䜲䞁䠅 Same as Codex -Nutrient Content Claim -Nutrient Comparative Claim 䝁䞊䝕䝑䜽䝇䛸ྠᵝ - ᰤ㣴⣲ྵ᭷㔞ᙉㄪ⾲♧ - ᰤ㣴⣲ẚ㍑ᙉㄪ⾲♧ Conditions defined - The dietary standard used is not the Codex NRV but the Philippine RENI つᐃ᮲௳ - ⏝䛩䜛ᰤ㣴ᇶ‽㔞䛿䚸䝁䞊䝕䝑䜽䝇䛾NRV䛷䛿䛺䛟䝣䜱䝸䝢䞁䛾 RENI䛷䛒䜛 Philippines Nutrition Claim Regulations-2 䝣䜱䝸䝢䞁 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ Nutrient Comparative Claims ᰤ㣴⣲ẚ㍑ᙉㄪ⾲♧ Non-addition Claims 䠄Non-addition of Sugars/Sodium Salts䠅 ↓ῧຍ⾲♧䠄⢾㢮䠋䝘䝖 䝸䜴䝮ሷ䛾↓ῧຍ䠅 䝣䜱䝸䝢䞁 Conditions defined - The dietary standard used is not the Codex NRV but the Philippine RENI つᐃ᮲௳ - ⏝䛧䛶䛔䜛ᰤ㣴ᇶ‽㔞䛿䚸䝁䞊䝕䝑䜽䝇䛾NRV䛷䛿䛺䛟䝣䜱䝸䝢䞁䛾 RENI䛷䛒䜛 Non-addition claims such No (Free) fat , no (Free) cholesterol, No (Free) Sodium, no (Free) sugar, No sugar added are allowed provided these claims conform with the Codex Guidelines for Use of Nutrition and Health Claims. 䛂⬡㉁↓ῧຍ䠄䝣䝸䞊䠅䛃䚸䛂䝁䝺䝇䝔䝻䞊䝹↓ῧຍ䠄䝣䝸䞊䠅䛃䚸䛂ሷศ↓ῧ ຍ䠄䝣䝸䞊䠅䛃䚸䛂⢾ศ↓ῧຍ䠄䝣䝸䞊䠅䛃䚸䛂⢾ศ↓ῧຍ䛃䛺䛹䛾↓ῧຍ⾲ ♧䛿䚸䛣䜜䜙䛾⾲♧䛜ᰤ㣴ཬ䜃ᗣᙉㄪ⾲♧䛾⏝䛻㛵䛩䜛䝁䞊䝕 䝑䜽䝇䞉䜺䜲䝗䝷䜲䞁䛻‽ᣐ䛩䜛䛣䛸䜢᮲௳䛸䛧䛶ㄆ䜑䜙䜜䛶䛔䜛 - 87 - 3.5.5 Philippines Philippines Nutrition Claim Regulations-2 䝣䜱䝸䝢䞁 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ 䝣䜱䝸䝢䞁 Administrations/Compl iances for Nutrition Claims䠄Governing Food and Drug Administration Authorities/Agencies䠅 ᰤ㣴ᙉㄪ⾲♧䛾⾜ᨻ䠋 㡰Ᏺ䠄ᨻᗓᡤ⟶ᙜᒁ䠋 ᐁᗇ) Inspections and Penalties ᰝᐹ䛸⨩๎ ᗣᙉㄪ⾲♧ Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ 㣗ရ་⸆ရᒁ - Compliance to labelling regulations is part of the regular monitoring scheme being implemented by FDA. Fines/Penalties are stipulated in FDA Act of 2011 (Republic Act 9711) with non-compliance with labelling regulations including health and nutrition claims. - One of the grounds for cancellation of permits (License to Operate or Certificate of Product Registration) is non-compliance of the labels with labelling regulations. - ⾲♧つ๎䜈䛾㡰Ᏺ䛿䚸FDA䛜ᑟධ䛧䛶䛔䜛ᐃᮇ┘ど䛾ᑐ㇟䛸䛺䛳䛶䛔䜛 ⨩㔠/⨩๎䛻㛵䛧䛶䛿䚸ᰤ㣴ཬ䜃ᗣᙉㄪ⾲♧䜢ྵ䜑䛯⾲♧つ๎䜈䛾 㡰Ᏺ䛻㛵䛩䜛2011ᖺFDAἲ䠄ඹᅜἲ➨9711ྕ䠅䛻つᐃ䛥䜜䛶䛔䜛䚹 - ㄆྍ䠄ྲྀᢅ⪅ㄆドཪ䛿〇ရⓏ㘓ド䠅䛾ྲྀᾘ䛧⏤䛾1䛴䛿⾲♧䛾⾲♧つ ๎䜈䛾㡰Ᏺ䛷䛒䜛 Philippines Health Claim Regulations-3.1 䝣䜱䝸䝢䞁 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 䝣䜱䝸䝢䞁 Administrative Oder 88-B s. 1984 (Rules and Regulations Governing the labelling of Prepackaged Food Products Distributed in the Philippines. B.C. 2007-002 (Guidelines for the Use of Health and Nutrition Claims. ⾜ᨻ௧➨88-B s. 1984 ྕ䠄䝣䜱䝸䝢䞁ᅜෆ䛷ὶ㏻䛥䜜䜛ໟ῭䜏㣗ရ䛾 ⾲♧䛻㛵䛧䛶ᐃ䜑䜛つᐃཬ䜃つ๎䠅-- B.C. 2007-002䠄ᗣཬ䜃ᰤ㣴ᙉㄪ ⾲♧䛾⏝䛻㛵䛩䜛䜺䜲䝗䝷䜲䞁䠅 Same as Codex: Health claims - Nutrient Function Claims Definitions 䠄Collective - Other function claims Name of Foods with - Reduction of Disease Risk claims Health Claims, if applicable䠅 ᐃ⩏䠄ᗣᙉㄪ⾲♧䜢 䝁䞊䝕䝑䜽䝇䛸ྠᵝ䠖ᗣᙉㄪ⾲♧ 䛧䛯㣗ရ䜢ᣦ䛩ྡ⛠䛜 - ᰤ㣴ᶵ⬟ᙉㄪ⾲♧ ᭷䜛ሙྜ䛿䛭䛾ྡ⛠䠅 - 䛭䛾ᶵ⬟ᙉㄪ⾲♧ - 䝸䝇䜽పῶᙉㄪ⾲♧ - 88 - 3.5.5 Philippines Philippines Health Claim Regulations-3.1 䝣䜱䝸䝢䞁 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 ᗣᙉㄪ⾲♧ Nutrient Function Claims䠄Collective Name of the Foods, if applicable䠅 䝣䜱䝸䝢䞁 Nutrient Function Claims ᰤ㣴ᶵ⬟ᙉㄪ⾲♧䠄ᰤ㣴ᶵ⬟⾲♧䜢䛧䛯㣗 ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾ྡ⛠䠅 ᰤ㣴ᶵ⬟ᙉㄪ⾲♧ Other Function Claims䠄Collective Name of Other Function Claims the Foods, if applicable䠅 䛭䛾䛾ᶵ⬟ᙉㄪ⾲♧䠄䛾ᶵ⬟⾲♧䜢䛧 䛯㣗ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾ྡ⛠) Reduction of Disease Risk Claims 䠄Collective Name of Foods Applied䠅 䛭䛾䛾ᶵ⬟ᙉㄪ⾲♧ Reduction of Disease Risk Claims 䝸䝇䜽పῶᙉㄪ⾲♧䠄㐺⏝䛥䜜䜛㣗ရ 䜢ᣦ䛩ྡ⛠䠅 Types of Approval/Certification 䠄Standardized/ Pre-authorized Claims䠅 䝸䝇䜽పῶᙉㄪ⾲♧ Pre-authorized Claims ๓䛻⾲♧䛜ᐃ䜑䜙䜜䛶䛔䜛 ᢎㄆ䠋ㄆド䛾✀㢮䠄つ᱁ᇶ‽ᆺ䠋 ๓ᢎ ㄆᆺ䠅 䠄Food Product/Constituent Specific Approval䠅 No product specific claims 䠄㣗ရ䠋≉ᐃ䛾⤌ᡂᡂศ䛻ᑐ䛩䜛ᢎㄆ䠅 〇ရ䛻≉᭷䛺⾲♧䛿↓䛔 Philippines Health Claim Regulations-3.2 䝣䜱䝸䝢䞁 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᒃᖒ⚊ Scientific Substantiation of Health Claims ᗣᙉㄪ⾲♧䛻㛵 䛩䜛⛉Ꮫⓗᐇド Process for the Substantiation (Organizational Systems, Governing Authority/Agency/C ommission) ᐇド䛾䝥䝻䝉䝇䠄ᑂ ᰝ⤌⧊䛾ᵓ㐀䚸ᨻᗓ ᡤ⟶ᙜᒁ䠋ᐁᗇ䠋 ጤဨ䠅 䝣䜱䝸䝢䞁 Documentation required ⏦ㄳ᭩㢮䛜ᚲせ - Applications are reviewed by evaluators (field of nutrition, food science and other science related field) - With regards to nutrient function claim, approval of the claim is based on established function of a nutrient, the source of supporting documents (e.g. recognized references like nutrition books, scientific data, etc.) and conformity of the nutrient level to the required amount (pass the criteria for source=15% RENI). - Evaluation of the claims are also discussed among the evaluators. - For other function claims and disease risk reduction claims, evaluation are elevated/referred to the consultants (medical fields, pharmacologists, nutrition experts). - ⏦ㄳ䛿ホ౯⪅䛻䜘䜛ᰝ㜀䜢ཷ䛡䜛䠄ᰤ㣴Ꮫศ㔝䚸㣗ရ⛉Ꮫศ㔝䚸䛭䛾䛾⛉Ꮫ㛵 㐃ศ㔝䠅 - ᰤ㣴ᶵ⬟ᙉㄪ⾲♧䛻㛵䛧䛶䚸䛭䛾⾲♧䛾ㄆྍ䛿䚸ド᫂䛥䜜䛶䛔䜛ᰤ㣴⣲䛾ᶵ⬟䚸 䛡㈨ᩱ䛾ཎ䠄䛘䜀ᗈ䛟ㄆ䜑䜙䜜䛶䛔䜛ᰤ㣴Ꮫ᭩䚸⛉Ꮫ䝕䞊䝍䛺䛹䠅䚸୪䜃 䛻䚸ᰤ㣴⣲䛾せồỈ‽䠄15% RENI䛾ᇶ‽䜢‶䛯䛩䠅䛾㐺ྜ䛻ᇶ䛵䛟䚹 - ⾲♧䛾ホ౯䛿ホ౯ᢸᙜ⪅㛫䛷䜒㆟ㄽ䜢䛚䛣䛺䛖 - 䛭䛾ᶵ⬟ᙉㄪ⾲♧ཬ䜃䝸䝇䜽పῶ⾲♧䛻㛵䛧䛶䛿䚸ホ౯䜢ᑓ㛛ᐙ䠄་⒪ศ 㔝䚸⸆⌮Ꮫ⪅䚸ᰤ㣴Ꮫᑓ㛛ᐙ䠅䛻౫㢗/ㅎၥ䛩䜛 - 89 - 3.5.5 Philippines Philippines Health Claim Regulations-3.2 䝣䜱䝸䝢䞁 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ Criteria for the Substantiation and/or Consideration of the Evidence 䝣䜱䝸䝢䞁 -The consultants would require substantiation other than scientific data depending on the claim. -Evidence from well designed human intervention studies. -These should be peer reviewed, published and reproduced. - ᙉㄪ⾲♧䛻䜘䛳䛶䛿䚸ᑓ㛛ᐙ䛜⛉Ꮫⓗ䝕䞊䝍௨እ䛾ᐇド䜢せồ䛩䜛 ሙྜ䛜䛒䜛 - 㐺ษ䛻䜘䛟タィ䛥䜜䛯䝠䝖ධヨ㦂䛛䜙ᚓ䜙䜜䜛ᐇド - 䛣䜜䜙䛾ᐇド䛿䚸๓ᰝ㜀䚸බ㛤䚸ཬ䜃䚸⌧☜ㄆ䛜䛺䛥䜜䛺䛡䜜䜀 䛺䜙䛺䛔 ᐇド䛾ᇶ‽䛚䜘䜃䠋䜎䛯 䛿ຠᯝ䛾ホ౯ Specific Safety Concerns Take into consideration in the substantiation of claims ≉ᐃ䛾Ᏻᛶ䛻㛵䛩䜛 ᙉㄪ⾲♧䛾ᐇド䛻㝿䛧䛶⪃៖䛩䜛 㡯 Re-evaluation Done when company representatives submit updated scientific studies to support claims ホ౯ ᴗ௦⾲⪅䛜ᙉㄪ⾲♧䜢䝃䝫䞊䝖䛩䜛ヨ㦂⤖ᯝ䜢䜰䝑䝥䝕䞊䝖䛧䛯ሙ ྜ䛿䚸ホ౯䛧䛺䛡䜜䜀䛺䜙䛺䛔 Philippines Health Claim Regulations-3.2 䝣䜱䝸䝢䞁 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ 䝣䜱䝸䝢䞁 Product Quality Concerns Certificate of GMP/ ISO are part of requirements in securing permit or 䠄GMP, ISO, HACCP or Other “ License to operate” Measures䠅 〇ရရ㉁䛻㛵䛩䜛㡯䠄GMP, ISO, HACCP 䜎䛯䛿䛾ホ౯ ᑻᗘ䠅 Adverse Event Reporting System䠄Mandatory/ Voluntary䠅 ᭷ᐖ㇟䛻㛵䛩䜛ሗ࿌䝅䝇䝔 䝮䠄⩏ົ䠋௵ព䠅 GMP/ISOㄆド䛿䚸ㄆྍཪ䛿䛂Ⴀᴗ䝷䜲䝉䞁䝇䛃䛾ಖ᭷䜢☜⣙ 䛩䜛䛯䜑䛾せ௳䛾୍㒊䛷䛒䜛 Not Specified つᐃ↓䛧 Administrations/Compliances for Health Claims䠄Governing Food and Drug Administration Authorities/Agencies䠅 ᗣᙉㄪ⾲♧䛾⾜ᨻ䠋㡰Ᏺ 䠄ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠅 㣗ရ་⸆ရᒁ - 90 - 3.5.5 Philippines Philippines Health Claim Regulations-3.2 䝣䜱䝸䝢䞁 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ Inspections and Penalties 䝣䜱䝸䝢䞁 -Compliance to labelling regulations is part of the regular monitoring scheme being implemented by FDA. Fines/Penalties are stipulated in FDA Act of 2011 (Republic Act 9711) with non-compliance with labelling regulations including health and nutrition claims. - One of the grounds for cancellation of permits (License to Operate or Certificate of Product Registration) is non-compliance of the labels with labelling regulations. ᰝᐹ䛸⨩๎ - ⾲♧つ๎䛾㡰Ᏺ䛿䚸FDA䛜ᑟධ䛧䛶䛔䜛ᐃᮇ┘ど䛾ᑐ㇟䛻䛺䛳䛶䛔䜛䚹⨩㔠/ ⨩๎䛻㛵䛧䛶䛿䚸ಖ⾲♧ཬ䜃ᰤ㣴⣲⾲♧䜢ྵ䜑䛯⾲♧つ๎䜈䛾㡰Ᏺ䛻 㛵䛩䜛2011ᖺFDAἲ䠄ඹᅜἲ➨9711ྕ䠅䛻つᐃ䛥䜜䛶䛔䜛 - ㄆྍ䠄ྲྀᢅ⪅ㄆドཪ䛿〇ရⓏ㘓ド䠅䛾ྲྀᾘ䛧⏤䛾1䛴䛿䚸⾲♧䛾⾲♧つ๎ 䜈䛾㡰Ᏺ䛷䛒䜛 Philippines Health Claim Regulations-3.3 䝣䜱䝸䝢䞁 䠖 ᗣᙉㄪ⾲♧つ๎-3.3 ᗣᙉㄪ⾲♧ Relevant Laws/Regulations for Dietary/Food/Health Supplements 䝎䜲䜶䝍䝸䞊䠋䝣䞊䝗䠋 䝦䝹䝇 䝃䝥䝸䝯䞁䝖䛻㛵 䛩䜛㛵㐃ἲつ䠋つ๎ Definitions㸦Dietary Supplements, and/or Food Supplements, and/or Health Supplements㸧 ᐃ⩏㸦ࢲ࢚ࢱ࣮ࣜࢧ ࣉ࣓ࣜࣥࢺ࠾ࡼࡧ㸭ࡲ ࡓࡣࣇ࣮ࢻࢧࣉ࣓ࣜࣥ ࢺ࠾ࡼࡧ㸭ࡲࡓࡣ࣊ࣝ ࢫࢧࣉ࣓ࣜࣥࢺ㸧 䝣䜱䝸䝢䞁 Health and nutrition claims for dietary supplements are regulated the same way as conventional foods. 䝎䜲䜶䝍䝸䞊䝃䝥䝸䝯䞁䝖䛻㛵䛩䜛ᗣ䛚䜘䜃ᰤ㣴ᙉㄪ⾲♧䛿䚸㏻ᖖ䛾㣗ရ 䛸ྠ➼䛾つไ䜢ཷ䛡䜛 A processed food product intended to supplement the diet that bears or contains one or more of the following dietary ingredients: vitamin, mineral, amino acid, herb, or other dietary substance of botanical, animal, artificial or natural origin to increase the total daily intake in amounts conforming to the latest Philippine Recommended Energy and Nutrient Intakes or internationally agreed minimum daily requirements. It is usually in the form of capsules, tablets, liquid, gels, powders or pills and is not represented for use as a conventional food or as the sole item of a meal or diet or a replacement for drugs and medicines. 㣗䜢⿵ຓ䛩䜛䛣䛸䜢┠ⓗ䛸䛧䛯䚸௨ୗ䛾1✀㢮௨ୖ䛾㣗ရᡂศ䜢ྵ᭷䛩䜛 ຍᕤ㣗ရ〇ရ䠖 ᭱᪂∧䛾䝣䜱䝸䝢䞁䡡䜶䝛䝹䜼䞊䡡ᰤ㣴⣲᥎ዡᦤྲྀ㔞䚸ᡈ䛔䛿䚸ᅜ㝿ⓗ䛻ྜព 䛻⮳䛳䛶䛔䜛1᪥ᙜ䜚᭱ᑠᦤྲྀ㔞䛻ྜ⮴䛧䚸1᪥ᙜ䜚䛾ྜィᦤྲྀ㔞䜢ቑຍ䛥䛫 䜛䛯䜑䛾䝡䝍䝭䞁䚸䝭䝛䝷䝹䚸䜰䝭䝜㓟䚸䝝䞊䝤䚸ᡈ䛔䛿䚸䛭䛾䛾᳜≀ᛶ䚸ື≀ ᛶ䚸ேᕤཪ䛿ኳ↛䛾㣗ရ⣲ᮦ䚹㏻ᖖ䚸䜹䝥䝉䝹䚸㘄䚸ᾮయ䚸䝆䜵䝹䚸⢊ᮎཪ 䛿⸆䛾ᙧែ䛷䛒䜚䚸㏻ᖖ䛾㣗ရ䚸㣗䜎䛯䛿㣗≀䛾୍㒊䛸䛧䛶䚸ᡈ䛔䛿䚸 ⸆ཬ䜃⸆ရ䛾௦᭰䛸䛧䛶⏝䛩䜛䛣䛸䛿ពᅗ䛥䜜䛶䛔䛺䛔 - 91 - 3.5.5 Philippines Philippines Health Claim Regulations-3.3 䝣䜱䝸䝢䞁 䠖 ᗣᙉㄪ⾲♧つ๎-3.3 ᗣᙉㄪ⾲♧ 䝣䜱䝸䝢䞁 Administrations/Compliance s for the Supplements Food and Drug Administration 䠄Governing Authorities/Agencies䠅 䝃䝥䝸䝯䞁䝖䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻ ᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠅 㣗ရ་⸆ရᒁ - 92 - 3.5.6 Brunei Nutrition Labelling and Nutrition/Health Claims ᰤ㣴⾲♧ཬ䜃ᰤ㣴/ᗣᙉㄪ⾲♧ 3.5.6 Brunei Darussalam 䝤䝹䝛䜲䞉䝎䝹䝃䝷䞊䝮ᅜ Brunei Nutrition Labelling Regulations-1.1 䝤䝹䝛䜲 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ 䝤䝹䝛䜲 The Public Health (Food) Regulations(R1 Chapter 182) was enforced on 1st January 2001 Relevant Laws/Regulations Reference at Ministry of Health website Http:///www.moh.gov.bn 㛵㐃ἲつ䠋つ๎ The Public Health (Food) Regulations䠄බ⾗⾨⏕(㣗ရ)つ๎䠅 (R1 Chapter 182) 2001ᖺ1᭶1᪥⾜ Ministry of Health䠄ಖ┬䠅䜴䜵䝤䝃䜲䝖ཧ↷ Http:///www.moh.gov.bn - 93 - 3.5.6 Brunei Brunei Nutrition Labelling Regulations-1.1 䝤䝹䝛䜲 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ 䝤䝹䝛䜲 Nutrient Reference Values (Definitions, NRVs-R/-NCD) RDA (Recommended Daily Intake) ᰤ㣴ཧ↷㔞䠄ᐃ⩏, NRVs-R/䠄1᪥ᙜ䛯䜚䠅᥎ዡᰤ㣴ᡤせ㔞(RDA) NCD䠅 Nutrient Declaration (Application: Mandatory or Voluntary) Voluntary except 䠄௨ୗ䜢䠅㝖䛝௵ព - Certain flour, bakery and cereal products; -≉ᐃ䛾ᑠ㯏⢊䚸䝧䞊䜹䝸䞊䚸 - Infant formulae; 䝅䝸䜰䝹〇ရ ᰤ㣴⾲♧䠄㐺⏝䠖 ⩏ົ 䜒䛧䛟 -Special purpose foods 䛿 ௵ព䠅 -ᗂඣ⏝ㄪ〇⢊ங -≉ᐃ⏝㏵㣗ရ Food Categories Applied 㐺⏝䛥䜜䜛㣗ရ䜹䝔䝂䝸䞊 Exemptions (Food Categories) NA つᐃ↓䛧 NA つᐃ↓䛧 NA つᐃ↓䛧 㐺⏝㝖እ䠄㣗ရ䜹䝔䝂䝸䞊䠅 (Size of Food Business Operators) 䠄㣗ရᴗ⪅䛾つᶍ䠅 Brunei Nutrition Labelling Regulations-1.1 䝤䝹䝛䜲 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ Listing of Nutrients (Nutrients, Order) ᰤ㣴ᡂศ䝸䝇䝖 䠄ᰤ㣴 ᡂศ䚸 グ㍕㡰䠅 Optional Ingredients 䛭䛾䛾ᰤ㣴ᡂศ 䝤䝹䝛䜲 - Energy in kcal, KJ or both - Protein (g) - Fat (g) - Carbohydrate (g) -Other nutrients for which nutrition claims are made or any other nutrients to be declared -䜶䝛䝹䜼䞊䛿䚸kcal䚸KJ䚸䛒䜛䛔䛿୧᪉ -䛯䜣䜁䛟㉁(g) -⬡㉁(g) -ⅣỈ≀(g) -ᰤ㣴ᙉㄪ⾲♧䛩䜛䛾ᰤ㣴⣲䚸䜎䛯䛿⾲♧䛧䜘䛖䛸䛩䜛䛾ᰤ㣴⣲ Other nutrients for which nutrition claims are made or any other nutrients to be declared ᰤ㣴ᙉㄪ⾲♧䛩䜛䛾ᰤ㣴⣲䚸䜎䛯䛿⾲♧䛥䜜䜛䛾ᰤ㣴⣲ - 94 - 3.5.6 Brunei Brunei Nutrition Labelling Regulations-1.2 䝤䝹䝛䜲 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ 䝤䝹䝛䜲 Presentation of Nutrient Content (Expression per 100g/ml or serving or package) Per serving OR Per 100g or 100 mls ᰤ㣴ᡂศ㔞䛾⾲♧᪉ἲ 䠄⾲♧᪉ἲ 100g/ml 䚸1䝃䞊䝡䞁䜾䚸ཪ䛿1ໟ 䝃䞊䝡䞁䜾ᙜ䛯䜚䚸䜎䛯䛿100gᙜ䛯䜚 䜎䛯䛿100mlᙜ䛯䜚 ศ䛒䛯䜚䠅 (Expression in Exact values or Ranges) 䠄⾲♧䛩䜛್䠖୍ᐃ್䜒䛧䛟䛿ᖜ⾲♧䠅 NA つᐃ↓䛧 (Analysis or Calculation Basis) Only based on analysis 䠄ศᯒ್䜒䛧䛟䛿ィ⟬್䠅 Use of Food Composition Table/Database for Presentation of Nutrients ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲䠋䝕䞊䝍䝧䞊䝇 䛾⏝ Food Composition Table/ Database for Presentation of Nutrients NA つᐃ↓䛧 NA つᐃ↓䛧 ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲䠋䝕䞊䝍䝧䞊䝇 Brunei Nutrition Labelling Regulations-1.2 䝤䝹䝛䜲 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ 䝤䝹䝛䜲 Calculation of Nutrients (Energy/Protein/Carbohydrat e/Fat) ᰤ㣴ᡂศ䛾ィ⟬ 䠄䜶䝛䝹 䜼䞊䠋䛯䜣䜁䛟㉁䠋ⅣỈ≀ 䠋⬡㉁) Tolerances and Compliances (Tolerance Limits) ศᯒ䛻䛾䜏ᇶ䛵䛟 NA つᐃ↓䛧 NA つᐃ↓䛧 බᕪ䛸㐺ྜᛶ䠄ㄗᕪ⠊ᅖ䠅 - 95 - 3.5.6 Brunei Brunei Nutrition Labelling Regulations-1.2 䝤䝹䝛䜲 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ 䝤䝹䝛䜲 Specific Features of Presentation (Format, %NRV Labelling) Tabular format ⾲♧᪉ἲ䛾≉Ⰽ 䠄䝣䜷䞊䝬䝑 䝖䚸%NRV䚸⾲♧䠅 ⾲ᙧᘧ FOP program: Brunei’s Healthy Choice Logo started on pre-packaged cooking oils (Front of Package Labelling, FOP) 䝟䝑䜿䞊䝆⾲㠃䛾⾲♧䠄FOP䠅䝥䝻䜾䝷䝮 䠄䝟䝑䜿䞊䝆ṇ㠃䛾⾲♧䚸FOP䠅 䝤䝹䝛䜲䛾Healthy Choice Logo䛿䚸ண䜑ໟ䛥䜜䛯ㄪ⌮Ἔ䛻ጞ䜎䛳䛯 Brunei Nutrition Labelling Regulations-1.3 䝤䝹䝛䜲 䠖 ᰤ㣴⾲♧ᇶ‽-1.3 ᰤ㣴⾲♧ 䝤䝹䝛䜲 Brunei Ministry of Health Administrations/Complianc -Department of Health Services es for Nutrition Labelling (Food Quality & Control Division) (Governing Authorities/Agencies) Brunei Ministry of Health䠄䝤䝹䝛䜲ಖ┬䠅 ᰤ㣴⾲♧䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻ ᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠅 Inspections and Penalties ᰝᐹ䛸⨩๎ - Department of Health Services䠄බඹ་⒪㒊䠅 Food Quality & Control Division(㣗ရရ㉁⟶⌮ㄢ) NA つᐃ↓䛧 - 96 - 3.5.6 Brunei Brunei Nutrition Claim Regulations-2 䝤䝹䝛䜲 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ 䝤䝹䝛䜲 The Public Health (Food) Regulations(R1 Chapter 182) was enforced on 1st January 2001 Relevant Laws/Regulations Reference at Ministry of Health website Http:///www.moh.gov.bn 㛵㐃ἲつ䠋つ๎ The Public Health (Food) Regulations䠄බ⾗⾨⏕(㣗ရ)つ๎䠅 䠄R1 chapter 182䠅 2001ᖺ1᭶1᪥⾜ Ministry of Health䠄ಖ┬䠅䜴䜵䝤䝃䜲䝖ཧ↷ Http:///www.moh.gov.bn Brunei Nutrition Claim Regulations-2 䝤䝹䝛䜲 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 䝤䝹䝛䜲 ᰤ㣴ᙉㄪ⾲♧ Definitions (Nutrient Content/Compa rative Claims) ᐃ⩏䠄ᰤ㣴⣲ྵ ᭷㔞䠋ẚ㍑ᙉㄪ ⾲♧䠅 “Nutrition claim” means a representation that suggests or implies that a food has a nutritive property, whether general or specific and whether expressed affirmatively or negatively, and includes reference to — (a) energy; (b) salt, sodium or potassium; (c) amino acids, carbohydrate, cholesterol, fats, fatty acids, fibre, protein, starch or sugars; or (d) any other nutrients, but does not include a statement of ingredients or a declaration or claim relating to a vitamin or mineral. 䇾ᰤ㣴ᙉㄪ⾲♧䇿䛸䛿䚸୍⯡ⓗ䛛≉ู䛛䚸⫯ᐃⓗ⾲⌧䛛ྰᐃⓗ⾲⌧䛛䛻ಀ䜟䜙䛪䚸 㣗ရ䛜ᰤ㣴ⓗ≉ᛶ䜢᭷䛧䛶䛔䜛䛣䛸䜢ᥦ♧䜎䛯䛿ᬯ♧䛩䜛⾲⌧䜢♧䛧䚸௨ୗ䜈䛾ゝཬ䜢ྵ䜐 (a)䜶䝛䝹䜼䞊䠗 (b)ሷ䚸䝘䝖䝸䜴䝮䜎䛯䛿䜹䝸䜴䝮䠗 (c)䜰䝭䝜㓟䚸ⅣỈ≀䚸䝁䝺䝇䝔䝻䞊䝹䚸⬡㉁䚸⬡⫫㓟䚸㣗≀⧄⥔䚸䛯䜣䜁䛟㉁䚸䝕䞁䝥䞁䜎䛯 䛿⢾䠗䛒䜛䛔䛿 (d)䛾ᰤ㣴⣲ ణ䛧䚸ཎᮦᩱ䛾グ㏙䜔䝡䝍䝭䞁䜔䝭䝛䝷䝹䛻㛵䛩䜛⾲♧䜔ᙉㄪ⾲♧䛿ྵ䜎 䛺䛔 - 97 - 3.5.6 Brunei Brunei Nutrition Claim Regulations-2 䝤䝹䝛䜲 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ 䝤䝹䝛䜲 Nutrient Content Claims ᰤ㣴⣲ྵ᭷㔞ᙉㄪ⾲♧ Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Nutrient Comparative Claims ᰤ㣴⣲ẚ㍑ᙉㄪ⾲♧ Non-addition Claims (Nonaddition of Sugars/Sodium Salts) ↓ῧຍ⾲♧䠄⢾㢮䠋䝘䝖䝸䜴䝮 ሷ䛾↓ῧຍ䠅 Brunei Nutrition Claim Regulations-2 䝤䝹䝛䜲 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ Administrations/Co mpliances for Nutrition Claims (Governing Authorities/ Agencies) 䝤䝹䝛䜲 Brunei Ministry of Health -Department of Health Services (Food Quality & Control Division) Brunei Ministry of Health䠄䝤䝹䝛䜲ಖ┬䠅 ᰤ㣴ᙉㄪ⾲♧䛾⾜ᨻ 䠋㡰Ᏺ䠄ᨻᗓᡤ⟶ᙜ ᒁ䠋ᐁᗇ) Inspections and Penalties - Department of Health Services䠄බඹ་⒪㒊䠅 Food Quality & Control Division(㣗ရရ㉁⟶⌮ㄢ) NA つᐃ↓䛧 ᰝᐹ䛸⨩๎ - 98 - 3.5.6 Brunei Brunei Health Claim Regulations-3.1 䝤䝹䝛䜲 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 ᗣᙉㄪ⾲♧ 䝤䝹䝛䜲 The Public Health (Food) Regulations(R1 Chapter 182) was enforced on 1st January 2001 Reference at Ministry of Health website Http:///www.moh.gov.bn Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ The Public Health (Food) Regulations䠄බ⾗⾨⏕(㣗ရ)つ๎䠅 䠄R1 chapter 182䠅 2001ᖺ1᭶1᪥⾜ Ministry of Health䠄ಖ┬䠅䜴䜵䝤䝃䜲䝖ཧ↷ Http:///www.moh.gov.bn Definitions (Collective Name of Foods with Health Claims, if applicable) Not specified つᐃ↓䛧 ᐃ⩏䠄ᗣᙉㄪ⾲ ♧䜢䛧䛯㣗ရ䜢ᣦ䛩 ྡ⛠䛜᭷䜛ሙྜ䛿 䛭䛾ྡ⛠䠅 Brunei Health Claim Regulations-3.1 䝤䝹䝛䜲 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 ᗣᙉㄪ⾲♧ 䝤䝹䝛䜲 Nutrient Function Claims (Collective Name of the Foods, if applicable) Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Reduction of Disease Risk Claims (Collective Name of Foods Applied) Not specified 䝸䝇䜽పῶᙉㄪ⾲♧䠄㐺⏝䛥䜜䜛㣗ရ䜢ᣦ䛩ྡ⛠䠅 つᐃ↓䛧 ᰤ㣴ᶵ⬟ᙉㄪ⾲♧䠄ᰤ㣴ᶵ⬟⾲♧䜢䛧䛯㣗ရ䜢ᣦ䛩ྡ ⛠䛜᭷䜛ሙྜ䛿䛭䛾ྡ⛠䠅 Other Function Claims (Collective Name of the Foods, if applicable) 䛭䛾䛾ᶵ⬟ᙉㄪ⾲♧䠄䛾ᶵ⬟⾲♧䜢䛧䛯㣗ရ䜢ᣦ 䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾ྡ⛠) Types of Approval/Certification (Standardized/ Preauthorized Claims) Not applicable 㐺⏝↓䛧 Not applicable 㐺⏝↓䛧 ᢎㄆ䠋ㄆド䛾✀㢮䠄つ᱁ᇶ‽ᆺ䠋 ๓ᢎㄆᆺ䠅 (Food Product/Constituent Specific Approval) 䠄㣗ရ䠋≉ᐃ䛾⤌ᡂᡂศ䛻ᑐ䛩䜛ᢎㄆ䠅 - 99 - 3.5.6 Brunei Brunei Health Claim Regulations-3.2 䝤䝹䝛䜲 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ 䝤䝹䝛䜲 Scientific Substantiation of Health Claims Not specified ᗣᙉㄪ⾲♧䛻㛵䛩䜛⛉Ꮫⓗᐇド Process for the Substantiation (Organizational Systems, Governing Authority/Agency/ Commission) ᐇド䛾䝥䝻䝉䝇䠄ᑂᰝ⤌⧊䛾ᵓ㐀䚸ᨻ ᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠋ጤဨ䠅 つᐃ↓䛧 Yes, done case by case through formal applications to Director General Health Services Director General Health Services䠄බඹ་⒪ᗇᐁ䠅䜈䛾 බᘧ䛺⏦ㄳ䜢⤒䛶䚸ಶู䛻⾜䜟䜜䜛 Brunei Health Claim Regulations-3.2 䝤䝹䝛䜲 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ 䝤䝹䝛䜲 Criteria for the Substantiation and/or Consideration of the Evidence All applications for health claims must be accompanied by scientific data to substantiate the proposed claim •Data from human intervention trails (RCTs) are preferred; data from at least 5 human trials are required •In addition, experimental and epidemiological studies may be included to support the application •Reviews and meta-analysis publications may also be included •Studies should preferably be from a variety of organizations •Published in refereed journals ᐇド䛾ᇶ‽䛚䜘 䜃䠋䜎䛯䛿ຠᯝ 䛾ホ౯ ᗣᙉㄪ⾲♧䛾⏦ㄳ䛿䛶䚸⏦ㄳ䛥䜜䛯ᙉㄪ⾲♧䜢ᐇド䛩䜛⛉Ꮫⓗ䝕䞊䝍䜢ῧ䛧䛺䛡 䜜䜀䛺䜙䛺䛔䚹 䞉䝠䝖ධヨ㦂䠄↓సⅭᑐ↷ヨ㦂䠖RCTs䠅䛿䚸ᑡ䛺䛟䛸䜒5䛴䛾䝠䝖ヨ㦂䝕䞊䝍䛜せồ䛥䜜䜛䚹 䞉ຍ䛘䛶䚸䛭䛾⏦ㄳ䜢ᨭᣢ䛩䜛䛯䜑䚸ヨ㦂◊✲䜔Ꮫ◊✲䜢ྵ䜑䜛䛣䛸䛜䛷䛝䜛䚹 䞉䝺䝡䝳䞊䜔䝯䝍䜰䝘䝸䝅䝇ฟ∧≀䜒ྵ䜑䜛䛣䛸䛜䛷䛝䜛䚹 䞉◊✲䛿䚸䛺䜛䜉䛟䛺䜙ከ䛟䛾ᶵ㛵䛷䛺䛥䜜䜛䜉䛝䛷䛒䜛䚹 䞉ᰝㄞ䛾䛒䜛㞧ㄅ䛻Ⓨ⾲䛥䜜䛶䛔䜛䚹 - 100 - 3.5.6 Brunei Brunei Health Claim Regulations-3.2 䝤䝹䝛䜲 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ 䝤䝹䝛䜲 Specific Safety Concerns ≉ᐃ䛾Ᏻᛶ䛻㛵䛩䜛㡯 Not specified つᐃ↓䛧 Not Specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not Specified つᐃ↓䛧 Re-evaluation ホ౯ Product Quality Concerns (GMP, ISO, HACCP or Other Measures) 〇ရရ㉁䛻㛵䛩䜛㡯䠄GMP, ISO, HACCP 䜎䛯䛿䛾ホ౯ ᑻᗘ䠅 Adverse Event Reporting System (Mandatory/Voluntary) ᭷ᐖ㇟䛻㛵䛩䜛ሗ࿌䝅䝇䝔䝮 䠄⩏ົ䠋௵ព䠅 Brunei Health Claim Regulations-3.2 䝤䝹䝛䜲 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ Administrations/Co mpliances for Health Claims (Governing Authorities/ Agencies) ᗣᙉㄪ⾲♧䛾⾜ ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ⟶ ᙜᒁ䠋ᐁᗇ䠅 Inspections and Penalties ᰝᐹ䛸⨩๎ 䝤䝹䝛䜲 Brunei Ministry of Health -Department of Health Services (Food Quality & Control Division) Brunei Ministry of Health䠄䝤䝹䝛䜲ಖ┬䠅 - Department of Health Services䠄බඹ་⒪㒊䠅 Food Quality & Control Division(㣗ရရ㉁⟶⌮ㄢ) Not specified つᐃ↓䛧 - 101 - 3.5.6 Brunei Brunei Health Claim Regulations-3.3 䝤䝹䝛䜲 䠖 ᗣᙉㄪ⾲♧つ๎-3.3 ᗣᙉㄪ⾲♧ 䝤䝹䝛䜲 Relevant Laws/Regulations for Dietary/Food/Health Supplements 䝎䜲䜶䝍䝸䞊䠋䝣䞊䝗䠋䝦䝹䝇 䝃䝥䝸䝯䞁 䝖䛻㛵䛩䜛㛵㐃ἲつ䠋つ๎ Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Definitions (Dietary Supplements, and/or Food Supplements, and/or Health Supplements) ᐃ⩏䠄䝎䜲䜶䝍䝸䞊䝃䝥䝸䝯䞁䝖䛚䜘䜃䠋䜎 䛯䛿䝣䞊䝗䝃䝥䝸䝯䞁䝖䛚䜘䜃䠋䜎䛯䛿䝦 䝹䝇䝃䝥䝸䝯䞁䝖䠅 Administrations/Compliances for the Supplements (Governing Authorities/Agencies) 䝃䝥䝸䝯䞁䝖䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ⟶ᙜ ᒁ䠋ᐁᗇ䠅 - 102 - 3.5.7 Vietnam Nutrition Labelling and Nutrition/Health Claims ᰤ㣴⾲♧ཬ䜃ᰤ㣴/ᗣᙉㄪ⾲♧ 3.5.7 Socialist Republic of Viet Nam 䝧䝖䝘䝮♫⩏ඹᅜ Viet Nam Nutrition Labelling Regulations-1.1 䝧䝖䝘䝮 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ 䝧䝖䝘䝮 - Relevant Laws/Regulations Decree No. 89/2006/ND-CP of the Government dated 30 Aug 2006 stipulating content, labelling and state management for the labelling of goods circulated in Vietnam and imports/exports goods. Specific provision for food provided under Section II: Article 11, Article 12.2, Article 18.3.a. Content in general concur with CODEX STAN 1-1985. Decree No. 38/2012/ND-CP of the Government dated 25 Apr 2012 stipulating detailed regulations for implementing the Food Safety Law No. 55/2010/QH12 dated 17 Jun 2010. Specific provision provided under Section VI: Article 17, Article 18. Content in general concur with CAC/GL 2-1985. 㛵㐃ἲつ䠋つ๎ - ᨻ௧89ྕNo.89/2006/ND-CP(2006ᖺ8᭶30᪥)䛷䛒䛳䛶䚸䝧䝖䝘䝮䛷ὶ㏻䛩䜛 ၟရཬ䜃㍺ධ/㍺ฟရ䛾⾲♧䛾䛯䜑䛾ෆᐜ≀䚸⾲♧䚸ཬ䜃ᅜᐙ⟶⌮䛻䛴䛔䛶 䛾つᐃ䚹Section II: Article 11, Article 12.2, Article 18.3.a. 䛻つᐃ䛥䜜䜛㣗ရ䛾 ≉Ṧつᐃ䚹䝁䞊䝕䝑䜽䝇つ᱁1-1985䛻ᴫ䛽୍⮴䛩䜛ෆᐜ䚹 - ᨻ௧38ྕNo.38/2012/ND-CP(2012ᖺ4᭶25᪥)䛷䛒䛳䛶䚸㣗ရᏳἲ➨ 55/2010/QH12(2010ᖺ6᭶17᪥)䜢ᐇ䛩䜛䛯䜑䛾ヲ⣽つᐃ䚹 Section VI:Article 17, 18䛷ᥦ౪䛥䜜䜛≉Ṧつᐃ䚹CAC/GL2-1985䛻ᴫ䛽୍⮴ 䛩䜛ෆᐜ䚹 - 103 - 3.5.7 Vietnam Viet Nam Nutrition Labelling Regulations-1.1 䝧䝖䝘䝮 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ 䝧䝖䝘䝮 Nutrient Reference Values (Definitions, NRVs-R/NCD) Using RNI 2002 established by the Viet Nam Ministry of Health in conjunction of Circular No. 08 dated 23 Aug 2004 by the Minister of Health. ᰤ㣴ཧ↷㔞䠄ᐃ⩏, NRVsR/-NCD䠅 - 䝧䝖䝘䝮ಖ┬ไᐃ䛾RNI2002䜢䝧䝖䝘䝮ಖ┬䛻䜘䜛㏻㐩 (circular)No.08(2004ᖺ8᭶8᪥)䛸ే⏝䛩䜛䚹 Mandatory for functional foods, food supplements, fortified foods and food for children aged 0-36 months (Food Safety Law, Decree No. 38/2012/NDCP of the Government dated 25 Apr 2012, Section VI: Article 18.2) Nutrient Declaration (Application: Mandatory or Voluntary) 䠉ᶵ⬟ᛶ㣗ရ䚸㣗ရ⿵ຓ䚸ᙉ㣗ရ䚸0䡚36䞄᭶䛾ஙᗂඣྥ䛡㣗ရ䛻 㝈ᐃ䛩䜛(㣗ရᏳἲ䚸ᨻ௧➨38/2012/ND-CP(2012ᖺ4᭶25᪥)䚸 Section VI: Article 18.2)䚹 ᰤ㣴⾲♧䠄㐺⏝䠖 ⩏ົ 䜒 䛧䛟䛿 ௵ព䠅 All Prepackaged Foods (Decree No. 89/2006/ND-CP of the Government dated 30 Aug 2006) Food Categories Applied 㐺⏝䛥䜜䜛㣗ရ䜹䝔䝂䝸䞊 䠉䛩䜉䛶䛾ໟ῭䜏㣗ရ(ᨻ௧➨89/2006/ND-CP,2006ᖺ8᭶30᪥) National Authority (Section I: Article 5.2 Decree No. 89/2006/ND-CP of the Government dated 30 Aug 2006 Exemptions (Food Categories) 㐺⏝㝖እ䠄㣗ရ䜹䝔䝂䝸䞊䠅 ᅜෆᙜᒁ(Section I Article 5.2 ᨻ௧➨89/2006/ND-CP,2006ᖺ8᭶30᪥) Viet Nam Nutrition Labelling Regulations-1.1 䝧䝖䝘䝮 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ 䝧䝖䝘䝮 (Size of Food Business Operators) 䠄㣗ရᴗ⪅䛾つᶍ䠅 Not specified Listing of Nutrients (Nutrients, Order) 4 core nutrients (energy, carbohydrate, protein and fat) ᰤ㣴ᡂศ䝸䝇䝖 䠄ᰤ㣴ᡂศ䚸 グ㍕㡰䠅 つᐃ↓䛧 4ᰤ㣴⣲(䜶䝛䝹䜼䞊䚸ⅣỈ≀䚸䛯䜣䜁䛟㉁ཬ䜃⬡⫫) Optional Ingredients 䛭䛾䛾ᰤ㣴ᡂศ Not specified - 104 - つᐃ↓䛧 3.5.7 Vietnam Viet Nam Nutrition Labelling Regulations-1.2 䝧䝖䝘䝮 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ 䝧䝖䝘䝮 Presentation of Nutrient Content (Expression per 100g/ml or serving or package) Per 100 g, per 100 ml , per 1 package ᰤ㣴ᡂศ㔞䛾⾲♧᪉ἲ 䠄⾲♧᪉ἲ 100g/ml 䚸1䝃䞊䝡䞁䜾䚸ཪ䛿1ໟ ศ䛒䛯䜚䠅 100gᙜ䜚䚸100mlᙜ䜚䚸1ໟᙜ䜚 (Expression in Exact values or Ranges) 䠄⾲♧䛩䜛್䠖୍ᐃ್䜒䛧䛟䛿ᖜ⾲♧䠅 Ranges ᖜ⾲♧䛜ㄆ䜑䜙䜜䜛 In some cases, calculations are allowed. ィ⟬್䛷䜘䛔ሙྜ䛜䛒䜛䚹 (Analysis or Calculation Basis) In other cases, Certificate of Analysis should be used. 䠄ศᯒ್䜒䛧䛟䛿ィ⟬್䠅 䛭䛾䛾ሙྜ䛿ศᯒド᫂᭩䜢⏝䛩䜛䚹 Use of Food Composition Table/ Database for Presentation of Nutrients ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲䠋䝕䞊䝍䝧䞊䝇 䛾⏝ Food Composition Table/Database for Presentation of Nutrients Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲䠋䝕䞊䝍䝧䞊䝇 Viet Nam Nutrition Labelling Regulations-1.2 䝧䝖䝘䝮 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ Calculation of Nutrients (Energy/Protein/ Carbohydrate/Fat) ᰤ㣴ᡂศ䛾ィ⟬ 䠄䜶 䝛䝹䜼䞊䠋䛯䜣䜁䛟㉁ 䠋ⅣỈ≀䠋⬡㉁) Tolerances and Compliances (Tolerance Limits) බᕪ䛸㐺ྜᛶ䠄ㄗᕪ⠊ ᅖ䠅 䝧䝖䝘䝮 The total energy (Kcal) = (energy of protein + energy of lipid + energy of carbohydrate + energy of alcoho). (1g Protein ~ 4Kcal, 1g Lipid ~ 9Kcal, 1g carbohydrate ~ 4Kcal, 1g alcohol~ 7Kcal) ⥲䜶䝛䝹䜼䞊㔞(kcal) = (䛯䜣䜁䛟㉁䜶䝛䝹䜼䞊㔞䠇⬡⫫䜶䝛䝹䜼䞊㔞䠇 ⅣỈ≀䜶䝛䝹䜼䞊㔞䠇䜰䝹䝁䞊䝹䜶䝛䝹䜼䞊㔞) (䛯䜣䜁䛟㉁1g䡚 4kcal, ⬡⫫1g䡚9kcal, ⅣỈ≀1g䡚4kcal, 䜰䝹䝁䞊䝹1g䡚7kcal) Yes, they are included in the national technical regulations ᅜᐙᢏ⾡つไ䛻ྵ䜎䜜䛶䛔䜛 - 105 - 3.5.7 Vietnam Viet Nam Nutrition Labelling Regulations-1.2 䝧䝖䝘䝮 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ 䝧䝖䝘䝮 Specific Features of Presentation (Format, %NRV Labelling) ⾲♧᪉ἲ䛾≉Ⰽ 䠄䝣䜷䞊䝬䝑 䝖䚸%NRV䚸⾲♧䠅 Not mandatory ᚲ㡲䛷䛿䛺䛔 Not specified つᐃ↓䛧 (Front of Package Labelling, FOP) 䠄䝟䝑䜿䞊䝆ṇ㠃䛾⾲♧䚸FOP䠅 Viet Nam Nutrition Labelling Regulations-1.3 䝧䝖䝘䝮 䠖 ᰤ㣴⾲♧ᇶ‽-1.3 ᰤ㣴⾲♧ Administrations/Compliances for Nutrition Labelling (Governing Authorities/Agencies) ᰤ㣴⾲♧䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓ ᡤ⟶ᙜᒁ䠋ᐁᗇ䠅 Inspections and Penalties 䝧䝖䝘䝮 Vietnam Food Administration (Ministry of Health) 䝧䝖䝘䝮㣗ရᒁ䠄ಖ┬䠅 Competent Authority as stipulated by Food Safety Law No. 55/2010/QH12 dated 17 Jun 2010 ᰝᐹ䛸⨩๎ 㣗ရᏳἲ ➨55/2010/QH12(2010ᖺ6᭶17᪥)䛻᫂グ䛥䜜䛶 䛔䜛ᶒ㝈䛒䜛ᙜᒁ - 106 - 3.5.7 Vietnam Viet Nam Nutrition Claim Regulations-2 䝧䝖䝘䝮 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ 䝧䝖䝘䝮 - Relevant Laws/Regulations Decree No. 89/2006/ND-CP of the Government dated 30 Aug 2006 stipulating content, labelling and state management for the labelling of goods circulated in Vietnam and imports/exports goods. Decree No. 38/2012/ND-CP of the Government dated 25 Apr 2012 stipulating detailed regulations for implementing the Food Safety Law No. 55/2010/QH12 dated 17 Jun 2010. 㛵㐃ἲつ䠋つ๎ Definitions (Nutrient Content/Comparati ve Claims) ᐃ⩏䠄ᰤ㣴⣲ྵ᭷㔞 䠋ẚ㍑ᙉㄪ⾲♧䠅 - 䝧䝖䝘䝮䛷ὶ㏻䛩䜛ၟရཬ䜃㍺ධ/㍺ฟရ䛾⾲♧䛾䛯䜑䛾ෆᐜ≀䚸⾲♧䚸 ཬ䜃ᅜᐙ⟶⌮䛻䛴䛔䛶つᐃ䛩䜛䚸ᨻ௧➨89/2006/ND-CP(2006ᖺ8᭶30 ᪥) - 㣗ရᏳἲ ➨55/2010/QH12(2010ᖺ6᭶17᪥)䜢⾜䛩䜛䛯䜑䛾つ ไ䛜ྵ䜎䜜䜛䚸ᨻ௧➨38/2012/ND-CP(2012ᖺ4᭶25᪥) 1.Nutrient content claim 2.Nutrient comparative claim 1. ᰤ㣴⣲ྵ᭷㔞ᙉㄪ⾲♧ 2. ᰤ㣴⣲ẚ㍑ᙉㄪ⾲♧ Viet Nam Nutrition Claim Regulations-2 䝧䝖䝘䝮 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ 䝧䝖䝘䝮 Nutrient Content Claims ᰤ㣴⣲ྵ᭷㔞ᙉㄪ⾲♧ つᐃ↓䛧 Not specified Nutrient Comparative Claims ᰤ㣴⣲ẚ㍑ᙉㄪ⾲♧ Non-addition Claims 䠄Non-addition of Sugars/Sodium Salts䠅 Not specified つᐃ↓䛧 Yes, allowed チྍ䛥䜜䜛 ↓ῧຍ⾲♧䠄⢾㢮䠋䝘䝖䝸䜴䝮 ሷ䛾↓ῧຍ䠅 - 107 - 3.5.7 Vietnam Viet Nam Nutrition Claim Regulations-2 䝧䝖䝘䝮 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ 䝧䝖䝘䝮 Administrations/Compl iances for Nutrition Claims䠄Governing Vietnam Food Administration (Ministry of Health) Authorities/Agencies䠅 ᰤ㣴ᙉㄪ⾲♧䛾⾜ᨻ䠋 㡰Ᏺ䠄ᨻᗓᡤ⟶ᙜᒁ䠋 ᐁᗇ) Inspections and Penalties 䝧䝖䝘䝮㣗ရᒁ䠄ಖ┬䠅 Competent Authority as stipulated by Food Safety Law No. 55/2010/QH12 dated 17 Jun 2010 ᰝᐹ䛸⨩๎ 㣗ရᏳἲ ➨55/2010/QH12(2010ᖺ6᭶17᪥)䛻᫂グ䛥䜜䛶䛔䜛ᶒ 㝈䛒䜛ᙜᒁ Viet Nam Health Claim Regulations-3.1 䝧䝖䝘䝮 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-3.1 ᗣᙉㄪ⾲♧ 䝧䝖䝘䝮 - Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ Definitions 䠄Collective Name of Foods with Health Claims, if applicable䠅 ᐃ⩏䠄ᗣᙉㄪ⾲♧䜢䛧 䛯㣗ရ䜢ᣦ䛩ྡ⛠䛜᭷ 䜛ሙྜ䛿䛭䛾ྡ⛠䠅 Decree No. 89/2006/ND-CP of the Government dated 30 Aug 2006 stipulating content, labelling and state management for the labelling of goods circulated in Vietnam and imports/exports goods. Decree No. 38/2012/ND-CP of the Government dated 25 Apr 2012 stipulating detailed regulations for implementing the Food Safety Law No. 55/2010/QH12 dated 17 Jun 2010. - 䝧䝖䝘䝮䛷ὶ㏻䛩䜛ၟရཬ䜃㍺ධ/㍺ฟရ䛾⾲♧䛾䛯䜑䛾ෆᐜ≀䚸 ⾲♧䚸ཬ䜃ᅜᐙ⟶⌮䛻䛴䛔䛶䛾つᐃ)䛻㛵䛩䜛ᨻ௧➨89/2006/NDCP(2006ᖺ8᭶30᪥) - 㣗ရᏳἲ ➨55/2010/QH12(2010ᖺ6᭶17᪥)䜢ᐇ䛩䜛䛯䜑䛾ヲ ⣽つᐃ䛻㛵䛩䜛ᨻ௧➨38/2012/ND-CP(2012ᖺ4᭶25᪥) Food Safety Law No. 55/2010/QH12 dated 17 Jun 2010. 㣗ရᏳἲ ➨55/2010/QH12(2010ᖺ6᭶17᪥) - 108 - 3.5.7 Vietnam Viet Nam Health Claim Regulations-3.1 䝧䝖䝘䝮 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-3.1 ᗣᙉㄪ⾲♧ 䝧䝖䝘䝮 Nutrient Function Claims䠄Collective Name of the Foods, if applicable䠅 ᰤ㣴ᶵ⬟ᙉㄪ⾲♧䠄ᰤ㣴ᶵ⬟⾲♧䜢䛧䛯㣗ရ䜢ᣦ 䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾ྡ⛠䠅 Functional Food ᶵ⬟ᛶ㣗ရ Functional Food ᶵ⬟ᛶ㣗ရ Functional Food ᶵ⬟ᛶ㣗ရ Not specified つᐃ↓䛧 Other Function Claims䠄Collective Name of the Foods, if applicable䠅 䛭䛾䛾ᶵ⬟ᙉㄪ⾲♧䠄䛾ᶵ⬟⾲♧䜢䛧䛯㣗ရ 䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾ྡ⛠) Reduction of Disease Risk Claims䠄Collective Name of Foods Applied䠅 䝸䝇䜽పῶᙉㄪ⾲♧䠄㐺⏝䛥䜜䜛㣗ရ䜢ᣦ䛩 ྡ⛠䠅 Types of Approval/Certification䠄Standardized/ Pre-authorized Claims䠅 ᢎㄆ䠋ㄆド䛾✀㢮䠄つ᱁ᇶ‽ᆺ䠋 ๓ᢎㄆᆺ䠅 䠄Food Product/Constituent Specific Approval䠅 Pre-authorized Claims approval process based on Food product dossier/notification. 䠄㣗ရ䠋≉ᐃ䛾⤌ᡂᡂศ䛻ᑐ䛩䜛ᢎㄆ䠅 㣗ရ䛻㛵䜟䜛ᩥ᭩/㏻▱᭩䛻ᇶ䛵䛟ᢎㄆ䝥䝻䝉 䝇䛷๓ᢎㄆ䛥䜜䛯⾲♧ Viet Nam Health Claim Regulations-3.2 䝧䝖䝘䝮 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ Scientific Substantiation of Health Claims ᗣᙉㄪ⾲♧䛻㛵 䛩䜛⛉Ꮫⓗᐇド Process for the Substantiation (Organizational Systems, Governing Authority/Agency/ Commission) ᐇド䛾䝥䝻䝉䝇䠄ᑂ ᰝ⤌⧊䛾ᵓ㐀䚸ᨻ ᗓᡤ⟶ᙜᒁ䠋ᐁᗇ 䠋ጤဨ䠅 䝧䝖䝘䝮 Based on approval process based on Food product dossier/notification. ᙜヱ㣗ရ䛻㛵䛩䜛ᩥ᭩/㏻▱䛾ᢎㄆ䝥䝻䝉䝇䛻ᇶ䛵䛟 Food Administration under the Ministry of Health -Applications are reviewed by expert -Laboratory analysis of nutrient content to be submitted if necessary -Review after Lab results -Approved by certificate given to companies or industry 䝧䝖䝘䝮ಖ┬㣗ရᒁ - ᥦฟ᭩㢮䛿ᑓ㛛ᐙ䛻䝺䝡䝳䞊䛥䜜䜛䚹 - ᚲせ䛺ሙྜ䚸◊✲ᡤ䛾ᰤ㣴ศᯒ್䜢ᥦฟ䛩䜛䚹 - ◊✲ᡤ䛾ศᯒ⤖ᯝ䜢䝺䝡䝳䞊䛩䜛䚹 - ♫䜎䛯䛿ᴗ⏺䛻ᢎㄆチྍ䜢䛘䜛䚹 - 109 - 3.5.7 Vietnam Viet Nam Health Claim Regulations-3.2 䝧䝖䝘䝮 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ Criteria for the Substantiation and/or Consideration of the Evidence 䝧䝖䝘䝮 -Data on value of nutritive content -Clinical intervention results -If necessary, the local clinical trial should be needed -Review of meta analysis results -Publication in the journals ᐇド䛾ᇶ‽䛚䜘䜃䠋䜎䛯䛿 ຠᯝ䛾ホ౯ - ᰤ㣴⣲䛾್䛻㛵䛩䜛䝕䞊䝍 ⮫ᗋⓗධ䛾⤖ᯝ ᚲせ䛺ሙྜ䚸ᅜෆ䛾⮫ᗋヨ㦂⤖ᯝ䚹 䝯䝍ศᯒ⤖ᯝ䛾䝺䝡䝳䞊 䝆䝱䞊䝘䝹䛾ฟ∧ Viet Nam Health Claim Regulations-3.2 䝧䝖䝘䝮 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ 䝧䝖䝘䝮 Specific Safety Concerns ≉ᐃ䛾Ᏻᛶ䛻㛵䛩䜛㡯 Not specified つᐃ↓䛧 3 year period 3ᖺẖ Re-evaluation ホ౯ Product Quality Concerns䠄GMP, ISO, HACCP or Other Measures䠅 Encouraged however not required 〇ရရ㉁䛻㛵䛩䜛㡯䠄GMP, ISO, HACCP 䜎䛯䛿䛾ホ౯ᑻᗘ䠅 ᥎ዡ䛩䜛䛜䚸せồ䛧䛺䛔 Adverse Event Reporting System 䠄Mandatory/ Voluntary䠅 ᭷ᐖ㇟䛻㛵䛩䜛ሗ࿌䝅䝇䝔䝮䠄⩏ົ 䠋௵ព䠅 Not specified - 110 - つᐃ↓䛧 3.5.7 Vietnam Viet Nam Health Claim Regulations-3.2 䝧䝖䝘䝮 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ 䝧䝖䝘䝮 Administrations/Com pliances for Health Claims䠄Governing Vietnam Food Administration (Ministry of Health) Authorities/Agencies䠅 ᗣᙉㄪ⾲♧䛾⾜ᨻ 䠋㡰Ᏺ䠄ᨻᗓᡤ⟶ᙜᒁ 䠋ᐁᗇ䠅 Inspections and Penalties 䝧䝖䝘䝮㣗ရᒁ䠄ಖ┬䠅 Competent Authority as stipulated by Food Safety Law No. 55/2010/QH12 dated 17 Jun 2010 ᰝᐹ䛸⨩๎ 㣗ရᏳἲ ➨55/2010/QH12(2010ᖺ6᭶17᪥)䛻᫂グ䛥䜜䛶䛔䜛ᶒ 㝈䛒䜛ᙜᒁ Viet Nam Health Claim Regulations-3.3 䝧䝖䝘䝮 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-3.3 ᗣᙉㄪ⾲♧ Relevant Laws/Regulations for Dietary/Food/Health Supplements 䝎䜲䜶䝍䝸䞊䠋䝣䞊䝗䠋䝦䝹䝇 䝃䝥䝸䝯䞁䝖 䛻㛵䛩䜛㛵㐃ἲつ䠋つ๎ Definitions䠄Dietary Supplements, and/or Food Supplements, and/or Health Supplements䠅 ᐃ⩏䠄䝎䜲䜶䝍䝸䞊䝃䝥䝸䝯䞁䝖䛚䜘䜃䠋䜎 䛯䛿䝣䞊䝗䝃䝥䝸䝯䞁䝖䛚䜘䜃䠋䜎䛯䛿䝦 䝹䝇䝃䝥䝸䝯䞁䝖䠅 Administrations/Compliances for the Supplements 䠄Governing Authorities/Agencies䠅 䝃䝥䝸䝯䞁䝖䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ⟶ᙜᒁ 䠋ᐁᗇ䠅 䝧䝖䝘䝮 Food Safety Law No. 55/2010/QH12 dated 17 Jun 2010. 㣗ရᏳἲ ➨55/2010/QH12(2010ᖺ6᭶17᪥) Food Safety Law No. 55/2010/QH12 dated 17 Jun 2010. 㣗ရᏳἲ ➨55/2010/QH12(2010ᖺ6᭶17᪥) Vietnam Food Administration (Ministry of Health) 䝧䝖䝘䝮㣗ရᒁ䠄ಖ┬䠅 - 111 - - 112 - 3.5.8 Malaysia Nutrition Labelling and Nutrition/Health Claims ᰤ㣴⾲♧ཬ䜃ᰤ㣴/ᗣᙉㄪ⾲♧ 3.5.8 Malaysia 䝬䝺䞊䝅䜰 ᰤ㣴⾲♧ Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ Malaysia Nutrition Labelling Regulations-1.1 䝬䝺䞊䝅䜰 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 䝬䝺䞊䝅䜰 Food Regulations 1985 are the relevant regulations that relate to the nutrition labelling and claims. The regulations could also be obtained from the website. http://fsq.moh.gov.my/v4/index.php/perundangan2/food-regulations-1985 ᰤ㣴ᡂศ⾲♧䛸ᰤ㣴ᙉㄪ⾲♧䛻㛵㐃䛩䜛䛾䛿㣗ရつ๎1985䛷䛒䜛䚹 䛣䜜䜙䛿௨ୗ䛾䜴䜵䝤䝃䜲䝖䛛䜙ධᡭ䛷䛝䜛䚹 http://fsq.moh.gov.my/v4/index.php/perundangan2/food-regulations-1985 Nutrient Reference Values (Definitions, NRVs-R/-NCD) NRV ᰤ㣴ཧ↷㔞䛜ᐃ䜑䜙䜜䛶䛔䜛 ᰤ㣴ཧ↷㔞䠄ᐃ⩏, NRVsR/-NCD䠅 Nutrient Declaration Nutrition labelling is mandatory for a wide variety of processed and (Application: Mandatory packaged foods. The regulations were enforced in 2005. or Voluntary) ᰤ㣴⾲♧䠄㐺⏝䠖 ⩏ົ 䜒 䛧䛟䛿 ௵ព䠅 Food Categories Applied ᰤ㣴ᡂศ⾲♧䛿ᖜᗈ䛔ຍᕤ㣗ရཬ䜃ໟ㣗ရ䛷⩏ົ䛷䛒䜛䚹䛣䛾 つ๎䛿2005ᖺ䛻⾜䛥䜜䛯䚹 All prepackaged foods 㐺⏝䛥䜜䜛㣗ရ䜹䝔䝂䝸䞊 Exemptions (Food Categories) Not applicable 㐺⏝㝖እ䠄㣗ရ䜹䝔䝂 䝸䞊䠅 (Size of Food Business Operators) Not applicable 䠄㣗ရᴗ⪅䛾つᶍ䠅 䛶䛾ໟ῭䜏㣗ရ 㐺⏝↓䛧 㐺⏝↓䛧 - 113 - 3.5.8 Malaysia Malaysia Nutrition Labelling Regulations-1.1 䝬䝺䞊䝅䜰 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ 䝬䝺䞊䝅䜰 Labelling of mandatory nutrients in the NIP: -Energy value -The amounts of protein, carbohydrate (excluding dietary fibre) and fat Listing of Nutrients -Total sugars (for ready-to-drink beverages only) (Nutrients, Order) -Nutrients as claimed ᰤ㣴ᡂศ䝸䝇䝖 䠄ᰤ 㣴ᡂศ䚸 グ㍕㡰䠅 ᰤ㣴ሗ䝟䝛䝹䛻⾲♧⩏ົ䛾䛒䜛ᰤ㣴⣲䠖 ʊ䜶䝛䝹䜼䞊 ʊ䛯䜣䜁䛟㉁䚸ⅣỈ≀䠄㣗≀⧄⥔䜢㝖䛟䠅䚸⬡⫫ ʊ⢾㢮䠄䠮䠰䠠㣧ᩱ䛾ሙྜ䠅 ʊᙉㄪ⾲♧䛥䜜䛯ᰤ㣴⣲䠅 Optional Ingredients 䛭䛾䛾ᰤ㣴ᡂศ -Labelling of voluntary/optional nutrients in the NIP: -Vitamins and mineral (only those listed in the NRV and must be present in significant amount, ie at least 5% of the NRV per serving) -Dietary fibre ᰤ㣴ሗ䝟䝛䝹䛻௵ព䛷⾲♧䛥䜜䜛ᰤ㣴⣲䠖 -Cholesterol ʊ䝡䝍䝭䞁ཬ䜃䝭䝛䝷䝹䠄ᰤ㣴ཧ↷㔞䛻ᥖ㍕䛥䜜 -Sodium 䛶䛔䜛䜒䛾䛻㝈䜛䚹䜎䛯䚸䠍䝃䞊䝡䞁䜾䛒䛯䜚 䠪䠮䠲䛾䠑䠂௨ୖྵ䜎䜜䛶䛔䛺䛡䜜䜀䛺䜙䛺䛔䠅 ʊ㣗≀⧄⥔ ʊ䝁䝺䝇䝔䝻䞊䝹 ʊ䝘䝖䝸䜴䝮 Malaysia Nutrition Labelling Regulations-1.2 䝬䝺䞊䝅䜰 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ 䝬䝺䞊䝅䜰 Presentation of Nutrient Content (Expression per 100g/ml or serving or package) - Per 100 g, or per 100 ml, or per package (if package contains single portion), AND -per serving ᰤ㣴ᡂศ㔞䛾⾲♧᪉ἲ 䠄⾲♧᪉ἲ 100g/ml 䚸1䝃䞊䝡䞁䜾䚸 ཪ䛿1ໟศ䛒䛯䜚䠅 100 g 䛒䛯䜚ཪ䛿100 ml 䛒䛯䜚䚸1 ໟ䛒䛯䜚䠄1 ໟ䛻1 ໟ 䛾ሙྜ䠅୪䜃䛻䚸䝃䞊䝡䞁䜾䝃䜲䝈䛒䛯䜚䚹 (Expression in Exact values or Ranges) Exact values ୍ᐃ್ Both ඹ䛻ྍ Yes 䝕䞊䝍䝧䞊䝇䛾⏝ྍ 䠄⾲♧䛩䜛್䠖୍ᐃ್䜒䛧䛟䛿ᖜ⾲♧䠅 (Analysis or Calculation Basis) 䠄ศᯒ್䜒䛧䛟䛿ィ⟬್䠅 Use of Food Composition Table/ Database for Presentation of Nutrients ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲䠋 䝕䞊䝍䝧䞊䝇 䛾⏝ Food Composition Table/Database for Presentation of Nutrients ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲䠋 䝕䞊䝍䝧䞊䝇 The Malaysian Food Composition Database should be the main database used but may be supplemented by other database if necessary. 䝬䝺䞊䝅䜰㣗ရ⤌ᡂ䝕䞊䝍䝧䞊䝇䛜せ䝕䞊䝍䝧䞊䝇䛰䛜䚸 ᚲせ䛷䛒䜜䜀䛾䝕䞊䝍䝧䞊䝇䛷⿵㊊䛷䛝䜛䚹 - 114 - 3.5.8 Malaysia Malaysia Nutrition Labelling Regulations-1.2 䝬䝺䞊䝅䜰 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ 䝬䝺䞊䝅䜰 Fat (g) x 9 Kcals Protein (g) x 4Kcals Calculation of Nutrients (Energy/Protein/ Carbohydrates(g) x 4Kcals Carbohydrate/Fat) Alcohol ( ethanol, g) x 7Kcals ᰤ㣴ᡂศ䛾ィ⟬ 䠄䜶䝛䝹䜼䞊 Organic acids (g) x 3 Kcals 䠋䛯䜣䜁䛟㉁䠋ⅣỈ≀䠋⬡㉁) Dietary fibre (g) x 2 Kcals Tolerances and Compliances (Tolerance Limits) ⬡㉁ 䛯䜣䜁䛟㉁ 䜰䝹䝁䞊䝹 ᭷ᶵ㓟 㣗≀⧄⥔ 9 kcal䠋g 4 kcal䠋g 7 kcal䠋g 䜶䝍䝜䞊䝹 3 kcal䠋g 3 kcal䠋g A set of criteria for compliance of nutrient declaration according to various regulations have been established. බᕪ䛸㐺ྜᛶ䠄ㄗᕪ⠊ᅖ䠅 ᰤ㣴⣲䛾࿌▱䛻䛚䛔䛶㑂Ᏺ䛩䜉䛝䛔䛟䛴䛛䛾つ๎䛜⾜䛥䜜䛶䛔䜛 Malaysia Nutrition Labelling Regulations-1.2 䝬䝺䞊䝅䜰 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ Specific Features of Presentation (Format, %NRV Labelling) ⾲♧᪉ἲ䛾≉Ⰽ 䠄䝣䜷䞊䝬䝑䝖䚸%NRV䚸 ⾲♧䠅 (Front of Package Labelling, FOP) 䠄䝟䝑䜿䞊䝆ṇ㠃䛾⾲♧䚸 FOP䠅 䝬䝺䞊䝅䜰 In tabular format Currently, it is optional to label against NRV. However, there is a proposal to require nutrients be expressed against NRV. The reference value used is the Codex NRV with addition of vitamin E to the list of NRV. ⾲ᙧᘧ䚹 NRV%䛾⾲♧䛿⌧ᅾ䛿௵ព䛰䛜䚸ᰤ㣴⣲䛿NRV%䛷 ⾲⌧䛥䜜䜛䜉䛝䛸䛾ᥦ䛜䛒䜛䚹 䝁䞊䝕䝑䜽䝇NRV䝸䝇䝖䛻䝡䝍䝭䞁E䜢㏣ຍ䛧䛯䜒䛾䛜⏝䛥䜜䛶䛔䜛䚹 FOP Sign Posting scheme is being implemented on a voluntary basis. Voluntary fact-based FOP scheme with icon on ENERGY only. 䝃䜲䞁ᘧ䛾FOP⾲♧䛜௵ព䛷ᑟධ䛥䜜䛶䛔䜛䚹௵ព䛾䝕䞊䝍 ᫂♧ᆺFOP⾲♧䛿䜶䝛䝹䜼䞊䛾䜰䜲䝁䞁䜢♧䛩䜒䛾䛾䜏䚹 - 115 - 3.5.8 Malaysia Malaysia Nutrition Labelling Regulations-1.3 䝬䝺䞊䝅䜰 䠖 ᰤ㣴⾲♧ᇶ‽-1.3 ᰤ㣴⾲♧ 䝬䝺䞊䝅䜰 Administrations/Compl iances for Nutrition Food Safety and Quality Division (FSQD), Ministry of Health Labelling (Governing Authorities/Agencies) ᰤ㣴⾲♧䛾⾜ᨻ䠋㡰Ᏺ 䠄ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠅 ಖ┬ 㣗ရᏳရ㉁⟶⌮㒊 There are programs to monitor compliance such as inspections, field monitoring, and other investigations. Inspections and Penalties ᰝᐹ䛸⨩๎ Penalty for non-compliance for false labelling is imprisonment for a term not exceeding 3 years or to fine or both. 㑂ἲᛶ䜢┘ど䛩䜛䚸ᰝᐹ䜔ᕷሙㄪᰝ䚸䛭䛾䛾䝥䝻䜾䝷䝮䛜䛒䜛䚹 ഇ⾲♧䛾⨩๎䛿䚸䠏ᖺ௨ෆ䛾┘ཪ䛿⨩㔠ⱝ䛧䛟䛿୧᪉䚹 Malaysia Nutrition Claim Regulations-2 䝬䝺䞊䝅䜰 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ 䝬䝺䞊䝅䜰 Food Regulations 1985 are the relevant regulations that relate to the nutrition labelling and claims. The regulations could also be obtained from the website http://fsq.moh.gov.my/v4/index.php/perundangan2/food-regulations-1985 ᰤ㣴ᡂศ⾲♧䛸ᰤ㣴ᙉㄪ⾲♧䛻㛵㐃䛩䜛䛾䛿㣗ရつ๎1985䛷䛒䜛䚹 䛣䜜䜙䛿௨ୗ䛾䜴䜵䝤䝃䜲䝖䛛䜙ධᡭ䛷䛝䜛䚹 http://fsq.moh.gov.my/v4/index.php/perundangan2/food-regulations-1985 Definitions (Nutrient Content/Comparati ve Claims) Same as Codex -Nutrient Content Claim -Nutrient Comparative Claim ᐃ⩏䠄ᰤ㣴⣲ྵ᭷㔞 䠋ẚ㍑ᙉㄪ⾲♧䠅 䝁䞊䝕䝑䜽䝇䛸ྠ䛨 䠉ᰤ㣴⣲ྵ᭷㔞ᙉㄪ⾲♧ 䠉ᰤ㣴⣲ẚ㍑ᙉㄪ⾲♧ - 116 - 3.5.8 Malaysia Malaysia Nutrition Claim Regulations-2 䝬䝺䞊䝅䜰 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ 䝬䝺䞊䝅䜰 For nutrient content claims, the format and criteria are similar to Codex except: i) Claims on cholesterol: do not link to Saturated FA and Trans FA ii) Low sugar claim iii) Content claim for sodium in liquid form Nutrient Content Claims ᰤ㣴⣲ྵ᭷㔞ᙉㄪ⾲♧ The list of criteria or condition for claims is provided in the revised guide book, Guide to Nutrition Labelling and Claims (as at December 2010) which could also be obtained from the website: http://fsq.moh.gov.my/v4/index.php/garis-panduan ᰤ㣴ᡂศ㔞ᙉㄪ⾲♧䛾ᵝᘧ䛸ᇶ‽䛿௨ୗ䜢㝖䛝䝁䞊䝕䝑䜽䝇䛸ྠ䛨 i) 䝁䝺䝇䝔䝻䞊䝹䠖㣬⬡⫫㓟䚸䝖䝷䞁䝇ᆺ⬡⫫㓟䛸䝸䞁䜽䛥䛫䛺䛔 ii) ప⢾䛾ᙉㄪ⾲♧ iii)ᾮ≧㣗ရ䛻䛚䛡䜛䝘䝖䝸䜴䝮ྵ㔞䛾ᙉㄪ⾲♧ ᙉㄪ⾲♧䛾ᇶ‽䛸᮲௳䛿䛂ᰤ㣴ᡂศ⾲♧䛸ᙉㄪ⾲♧䛾䜺䜲䝗䛃䠄2010ᖺ12᭶ᨵゞ䠅 䛻♧䛥䜜䛶䛔䜛䚹䛣䜜䛿௨ୗ䛾䜴䜵䝤䝃䜲䝖䛛䜙ධᡭ䛷䛝䜛䚹 http://fsq.moh.gov.my/v4/index.php/garis-panduan Nutrient Comparative Claims ᰤ㣴⣲ẚ㍑ᙉㄪ⾲♧ For nutrient comparative claims, the format and criteria are similar to Codex ᰤ㣴⣲ẚ㍑ᙉㄪ⾲♧䛾ᵝᘧ䛸ᇶ‽䛿䝁䞊䝕䝑䜽䝇䛸ྠ䛨 Malaysia Nutrition Claim Regulations-2 䝬䝺䞊䝅䜰 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ Non-addition Claims 䠄Non-addition of Sugars/Sodium Salts䠅 ↓ῧຍ⾲♧䠄⢾㢮䠋䝘 䝖䝸䜴䝮ሷ䛾↓ῧຍ䠅 䝬䝺䞊䝅䜰 Regulation 18A(1) of the Food Regulations 1985, stipulated that claims which highlight the absence or non-addition of a particular substance in or to food may be included in the label provided that the claims are not misleading and the substance(a)is not subject to specific requirements in the regulation; (b) is one which consumers would normally expect to find in the food; (c) has not been substituted by another substance giving the food equivalent characteristics unless the nature of the substitutions is clearly stated with equal prominence; and (d) the presence or addition is permitted in the food 㣗ရつ๎1985䛾つ๎18䠝䠄䠍䠅䛾つᐃ䛻䜘䜚䚸≉ᐃ䛾≀㉁䛜䛺䛔ཪ䛿ῧຍ䛥䜜䛶䛔䛺 䛔⾲♧䜢䛩䜛ሙྜ䚸ㄗゎ䜢ᣍ䛔䛶䛿䛔䛡䛺䛔䛧䚸䛭䛾≀㉁䛿௨ୗ䛷䛺䛡䜜䜀䛺䜙䛺䛔 (a) つ๎୰䛾≉ู䛺せồ㡯䛾ᑐ㇟䛷䛿䛺䛔 (b) ㏻ᖖ䛭䛾㣗ရ䛻ධ䛳䛶䛔䜛䛸ᾘ㈝⪅䛜ᮇᚅ䛩䜛䜒䛾 (c) ྠ䛨ᶵ⬟䜢ᣢ䛴䛾≀㉁䛻䜘䛳䛶௦᭰䛥䜜䛶䛔䛺䛔䛛䚸௦᭰䛥䜜䛶 䛔䜛ሙྜ䛿䛭䛾᪨䛜ྠ➼䛾᫂░䛥䛷⾲♧䛥䜜䛶䛔䜛 (d)㣗ရ䛻Ꮡᅾ䛩䜛䛣䛸ཪ䛿㣗ရ䜈䛾ῧຍ䛜ㄆ䜑䜙䜜䛶䛔䜛 - 117 - 3.5.8 Malaysia Malaysia Nutrition Claim Regulations-2 䝬䝺䞊䝅䜰 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ 䝬䝺䞊䝅䜰 Administrations/Complia nces for Nutrition Claims 䠄Governing Food Safety and Quality Division (FSQD), Ministry of Health Authorities/Agencies䠅 ᰤ㣴ᙉㄪ⾲♧䛾⾜ᨻ䠋 㡰Ᏺ䠄ᨻᗓᡤ⟶ᙜᒁ䠋ᐁ ᗇ) ಖ┬ 㣗ရᏳရ㉁⟶⌮㒊 There are programs to monitor compliance such as inspections, field monitoring, and other investigations. Penalty for non-compliance for false labelling is imprisonment for a term not Inspections and Penalties exceeding 3 years or to fine or both ᰝᐹ䛸⨩๎ 㑂ἲᛶ䜢┘ど䛩䜛䚸ᰝᐹ䜔ᕷሙㄪᰝ䚸䛭䛾䛾䝥䝻䜾䝷䝮䛜䛒䜛 ഇ⾲♧䛾⨩๎䛿䚸䠏ᖺ௨ෆ䛾┘ཪ䛿⨩㔠ⱝ䛧䛟䛿୧᪉ Malaysia Health Claim Regulations-3.1 䝬䝺䞊䝅䜰 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 ᗣᙉㄪ⾲♧ Relevant Laws/Regulations 䝬䝺䞊䝅䜰 Food Regulations 1985 are the relevant regulations that relate to the nutrition labelling and claims. The regulations could also be obtained from the website http://fsq.moh.gov.my/v4/index.php/perundangan2/food-regulations-1985 㛵㐃ἲつ䠋つ๎ ᰤ㣴ᡂศ⾲♧䛸ᰤ㣴ᙉㄪ⾲♧䛻㛵㐃䛩䜛䛾䛿㣗ရつ๎1985䛷䛒䜛䚹 䛣䜜䜙䛿௨ୗ䛾䜴䜵䝤䝃䜲䝖䛛䜙ධᡭ䛷䛝䜛䚹 http://fsq.moh.gov.my/v4/index.php/perundangan2/food-regulations-1985 Definitions 䠄Collective Name of Foods with Health Claims, if applicable䠅 ᐃ⩏䠄ᗣᙉㄪ⾲♧ 䜢䛧䛯㣗ရ䜢ᣦ䛩ྡ ⛠䛜᭷䜛ሙྜ䛿䛭䛾 ྡ⛠䠅 Same as Codex: Health claims - Nutrient Function Claims - Other function claims -Reduction of Disease Risk claims (Not permitted in Malaysia) 䝁䞊䝕䝑䜽䝇䛸ྠ䛨 䠉ᰤ㣴ᶵ⬟ᙉㄪ⾲♧ 䠉䛭䛾䛾ᶵ⬟ᙉㄪ⾲♧ 䠉䝸䝇䜽పῶᙉㄪ⾲♧䠄䝬䝺䞊䝅䜰䛷䛿チྍ䛥䜜䛶䛔䛺䛔䠅 - 118 - 3.5.8 Malaysia Malaysia Health Claim Regulations-3.1 䝬䝺䞊䝅䜰 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 ᗣᙉㄪ⾲♧ 䝬䝺䞊䝅䜰 Nutrient Function Claims䠄Collective Name of the Foods, if applicable䠅 Nutrient Function Claims ᰤ㣴ᶵ⬟ᙉㄪ⾲♧䠄ᰤ㣴ᶵ⬟⾲♧䜢䛧䛯 㣗ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾ྡ⛠䠅 䠉ᰤ㣴ᶵ⬟ᙉㄪ⾲♧ Other Function Claims䠄Collective Name of the Foods, if applicable䠅 Other Function Claims 䛭䛾䛾ᶵ⬟ᙉㄪ⾲♧䠄䛾ᶵ⬟⾲♧䜢 䠉䛭䛾䛾ᶵ⬟ᙉㄪ⾲♧ 䛧䛯㣗ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾 ྡ⛠) Reduction of Disease Risk Claims 䠄Collective Name of Foods Applied䠅 Reduction of Disease Risk Claims ( Not permitted in Malaysia) 䝸䝇䜽పῶᙉㄪ⾲♧䠄㐺⏝䛥䜜䜛㣗 ရ䜢ᣦ䛩ྡ⛠䠅 Types of Approval/Certification 䠄Standardized/ Pre-authorized Claims䠅 䠉䝸䝇䜽పῶᙉㄪ⾲♧ 䠄䝬䝺䞊䝅䜰䛷䛿チྍ䛥䜜䛶䛔䛺䛔䠅 Pre-authorized Claims ᢎㄆ䠋ㄆド䛾✀㢮䠄つ᱁ᇶ‽ᆺ䠋 ๓ ᢎㄆᆺ䠅 䠄Food Product/Constituent Specific Approval䠅 ๓ㄆド䛥䜜䛯ᙉㄪ⾲♧ No product specific claims 䠄㣗ရ䠋≉ᐃ䛾⤌ᡂᡂศ䛻ᑐ䛩䜛ᢎㄆ䠅 ᗣᙉㄪ⾲♧ ≉ᐃ䛾〇ရ䜔ᵓᡂᡂศ䛻ᑐ䛩䜛チྍ⾲♧䛿䛺䛔 Malaysia Health Claim Regulations-3.2 䝬䝺䞊䝅䜰 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 䝬䝺䞊䝅䜰 Scientific Substantiation of Health Claims Documentation required ᗣᙉㄪ⾲♧䛻㛵 䛩䜛⛉Ꮫⓗᐇド ドᣐ᭩㢮䛜ᚲせ An approval system has been established by Food Safety & Quality Control Division, MOH to review applications for new claims submitted by industry. •All applications made to the MOH for the amendment of any part of the nutrition labelling and claims regulations are reviewed by an Expert Working Committee on Nutrition, Health Claims & Advertisement (established in 1996). The members of the Committee comprise experts from multi government agencies and academia. •All applications must be made in the forms prescribed by MOH with complete documents. There are three (3) types of forms: Process for the 1. Application for addition to the permitted added nutrient list Substantiation 2. Application for the nutrition claims (Organizational 3. Application for addition to the NRV list Systems, •Information required in the forms include physiological role, chemical and physical properties, Governing method, safety evaluation, scientific substantiation. The Committee also looks into Authority/Agency/ processing harmonization of other function claim that are already approved by other countries especially Commission) ASEAN ᐇド䛾䝥䝻䝉䝇䠄ᑂ - ⏘ᴗ⏺䛛䜙ᥦฟ䛥䜜䛯᪂つᶵ⬟⾲♧䜢ᗣ┬㣗ရᏳရ㉁⟶⌮㒊䛜ᑂᰝ䛧ㄆྍ䛩䜛䝅䝇 䝔䝮䛜䛒䜛䚹 ᰝ⤌⧊䛾ᵓ㐀䚸ᨻ ᗓᡤ⟶ᙜᒁ䠋ᐁᗇ Food Safety & Quality Control Division, MOH䛻⏦ㄳ䛥䜜䛯ᰤ㣴ᡂศ⾲♧ཬ䜃ᰤ㣴ᶵ⬟⾲ ♧つไ䛾ಟṇ䛿䛶䛂ᰤ㣴䚸ᗣ⾲♧ཬ䜃ᐉఏ䛻㛵䛩䜛ᑓ㛛సᴗጤဨ䠄1966ᖺタ❧䠅 䠋ጤဨ䠅 䛷ᑂᰝ䛥䜜䜛䚹ጤဨ䛿」ᩘ䛾ᨻᗓᶵ㛵䛸Ꮫ⏺䛾ᑓ㛛ᐙ䛛䜙ᡂ䜛䚹 䞉⏦ㄳ᭩䛿䠏✀㢮䛒䜛䠖 䠍䠊ῧຍ䛜チྍ䛥䜜䛯ᰤ㣴⣲䛾䝸䝇䝖䜈䛾ᰤ㣴⣲䛾㏣ຍ 䠎䠊ᰤ㣴ᙉㄪ⾲♧ 䠏䠊ᰤ㣴ཧ↷㔞䝸䝇䝖䜈䛾㏣ຍ 䞉ᚲせ䛺ሗ䛿䚸⏕⌮Ꮫୖ䛾ᙺ䚸≀⌮Ꮫⓗᛶ㉁䚸ຍᕤ᪉ἲ䚸Ᏻᛶホ౯䚸⛉Ꮫⓗᐇド䚹 ጤဨ䛿᭦䛻ㅖእᅜ≉䛻䜰䝉䜰䞁䛷᪤䛻ㄆྍ䛥䜜䛶䛔䜛䛾ᶵ⬟⾲♧䛸䛾ᩚྜ䜒᳨ウ䛩䜛䚹 - 119 - 3.5.8 Malaysia Malaysia Health Claim Regulations-3.2 䝬䝺䞊䝅䜰 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ 䝬䝺䞊䝅䜰 -All applications for claims must be accompanied by scientific data to substantiate the proposed claim. •Data from human intervention trials are preferred; the data should include both positive and negative findings •In addition, epidemiological and experimental studies and review papers may be included as supportive evidences Criteria for the •The studies cited must be appropriate for the intended target group Substantiation and/or Consideration •Studies should include those conducted by other organizations or institutions of the Evidence •Publications cited should be published in refereed journals ᐇド䛾ᇶ‽䛚䜘䜃䠋 䜎䛯䛿ຠᯝ䛾ホ౯ - ᪂つᶵ⬟⾲♧䛾⏦ㄳ᭩䛻䛿ᥦ䛥䜜䛯ᙉㄪ⾲♧䜢ᐇド䛷䛝䜛⛉Ꮫⓗ䛺䝕䞊䝍䛜 ῧ䛥䜜䛺䛡䜜䜀䛺䜙䛺䛔䚹 䞉䝠䝖ධヨ㦂䛾䝕䞊䝍䛜ዲ䜎䛧䛟䚸Ⰻ䛔⤖ᯝ䜒ᝏ䛔⤖ᯝ䜒ྵ䜎䛺䛡䜜䜀䛺䜙䛺䛔䚹 䞉⿵ຓⓗ䛺ドᣐ䛸䛧䛶䚸Ꮫⓗ◊✲ཬ䜃ヨ㦂ⓗ◊✲䜔⥲ㄝ䛜ྵ䜎䜜䛶䛔䛶䜒Ⰻ䛔䚹 䞉ᘬ⏝䛥䜜䛯◊✲䛿䚸ពᅗ䛥䜜䛶䛔䜛┠ᶆ㞟ᅋ䛻ᑐ䛧䛶㐺ษ䛷䛺䛡䜜䜀䛺䜙䛺䛔䚹 䞉␗䛺䜛⤌⧊ཪ䛿◊✲ᡤ䛜ᐇ䛧䛯◊✲䛜ྵ䜎䜜䛶䛔䛺䛡䜜䜀䛺䜙䛺䛔䚹 䞉ฟ∧≀䛿ᰝㄞ䛥䜜䛯䝆䝱䞊䝘䝹䛛䜙ᘬ⏝䛥䜜䛺䛡䜜䜀䛺䜙䛺䛔䚹 Malaysia Health Claim Regulations-3.2 䝬䝺䞊䝅䜰 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ 䝬䝺䞊䝅䜰 Specific Safety Concerns ≉ᐃ䛾Ᏻᛶ䛻㛵䛩䜛㡯 Not specified つᐃ↓䛧 Not Specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not Specified つᐃ↓䛧 Re-evaluation ホ౯ Product Quality Concerns䠄GMP, ISO, HACCP or Other Measures䠅 〇ရရ㉁䛻㛵䛩䜛㡯䠄GMP, ISO, HACCP 䜎䛯䛿䛾ホ౯ᑻᗘ䠅 Adverse Event Reporting System 䠄Mandatory/ Voluntary䠅 ᭷ᐖ㇟䛻㛵䛩䜛ሗ࿌䝅䝇䝔䝮䠄⩏ົ䠋 ௵ព䠅 - 120 - 3.5.8 Malaysia Malaysia Health Claim Regulations-3.2 䝬䝺䞊䝅䜰 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ 䝬䝺䞊䝅䜰 Administrations/Com pliances for Health Food Safety and Quality Division (FSQD), Ministry of Health Claims䠄Governing Authorities/Agencies䠅 ᗣᙉㄪ⾲♧䛾⾜ᨻ 䠋㡰Ᏺ䠄ᨻᗓᡤ⟶ᙜᒁ 䠋ᐁᗇ䠅 ಖ┬ 㣗ရᏳရ㉁⟶⌮㒊 There are programs to monitor compliance such as inspections, field monitoring, and other investigations. Inspections and Penalties Penalty for non-compliance for false labelling is imprisonment for a term not exceeding 3 years or to fine or both ᰝᐹ䛸⨩๎ 㑂ἲᛶ䜢┘ど䛩䜛䚸ᰝᐹ䜔ᕷሙㄪᰝ䚸䛭䛾䛾䝥䝻䜾䝷䝮䛜䛒䜛䚹 ഇ⾲♧䛾⨩๎䛿䚸䠏ᖺ௨ෆ䛾┘ཪ䛿⨩㔠ⱝ䛧䛟䛿୧᪉䚹 Malaysia Health Claim Regulations-3.3 䝬䝺䞊䝅䜰 䠖 ᗣᙉㄪ⾲♧つ๎-3.3 ᗣᙉㄪ⾲♧ Relevant Laws/Regulations for Dietary/Food/Health Supplements 䝬䝺䞊䝅䜰 Not Applicable 㐺⏝↓䛧 Not Applicable 㐺⏝↓䛧 䝎䜲䜶䝍䝸䞊䠋䝣䞊䝗䠋䝦䝹䝇 䝃䝥䝸 䝯䞁䝖䛻㛵䛩䜛㛵㐃ἲつ䠋つ๎ Definitions㸦Dietary Supplements, and/or Food Supplements, and/or Health Supplements㸧 ᐃ⩏㸦ࢲ࢚ࢱ࣮ࣜࢧࣉ࣓ࣜࣥࢺ ࠾ࡼࡧ㸭ࡲࡓࡣࣇ࣮ࢻࢧࣉ࣓ࣜࣥ ࢺ࠾ࡼࡧ㸭ࡲࡓࡣ࣊ࣝࢫࢧࣉ࣓ࣜ ࣥࢺ㸧 Administrations/Compliances for the Supplements 䠄Governing Authorities/Agencies䠅 䝃䝥䝸䝯䞁䝖䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ⟶ ᙜᒁ䠋ᐁᗇ䠅 Claim for dietary/health supplements is regulated by the National Pharmaceutical Control Bureau, Ministry of Health Malaysia ᗣ⿵ຓ㣗ရ䛿the National Pharmaceutical Control Bureau, Ministry of Health Malaysia 䛜つไ䛧䛶䛔䜛䚹 - 121 - - 122 - 3.5.9 Myanmar Nutrition Labelling and Nutrition/Health Claims ᰤ㣴⾲♧ཬ䜃ᰤ㣴/ᗣᙉㄪ⾲♧ 3.5.9 Republic of the Union of Myanmar 䝭䝱䞁䝬䞊㐃㑥ඹᅜ Myanmar Nutrition Labelling Regulations-1.1 䝭䝱䞁䝬䞊 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ 䝭䝱䞁䝬䞊 The National Food Law (1997) has some provisions on food labelling but not specific to nutrition labeling. The regulation on Food labeling, covering nutritional food labeling is on going and will be promulgated in the near future. The National Food Law (1997)䠄ᅜᐙ㣗ရἲ䠄1997䠅䠅䛻䛿䚸ᰤ㣴⾲♧䛻 㝈ᐃ䛧䛯䜒䛾䛰䛡䛷䛺䛟䚸㣗ရ⾲♧䛻㛵䛩䜛䛔䛟䛴䛛䛾᮲ᩥ䜒䛒䜛䚹 ᰤ㣴㣗ရ⾲♧䜢ໟྵ䛩䜛㣗ရ⾲♧ᇶ‽䛿䚸⌧ᅾ⟇ᐃ୰䛷㏆䛔ᑗ᮶බ ᕸ䛥䜜䜛 Nutrient Reference Values (Definitions, NRVs-R/-NCD) ᰤ㣴ཧ↷㔞䠄ᐃ⩏, NRVs-R/NCD䠅 Nutrient Declaration (Application: Mandatory or Voluntary) Not available 㐺⏝↓䛧 Not specified (Voluntary) つᐃ↓䛧䠄௵ព䠅 ᰤ㣴⾲♧䠄㐺⏝䠖 ⩏ົ 䜒䛧䛟䛿 ௵ព䠅 - 123 - 3.5.9 Myanmar Myanmar Nutrition Labelling Regulations-1.1 䝭䝱䞁䝬䞊 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ 䝭䝱䞁䝬䞊 Food Categories Applied 㐺⏝䛥䜜䜛㣗ရ䜹䝔䝂䝸䞊 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Exemptions (Food Categories) 㐺⏝㝖እ䠄㣗ရ䜹䝔䝂䝸䞊䠅 (Size of Food Business Operators) 䠄㣗ရᴗ⪅䛾つᶍ䠅 Listing of Nutrients (Nutrients, Order) ᰤ㣴ᡂศ䝸䝇䝖 䠄ᰤ㣴ᡂศ䚸 グ㍕㡰䠅 Optional Ingredients 䛭䛾䛾ᰤ㣴ᡂศ Myanmar Nutrition Labelling Regulations-1.2 䝭䝱䞁䝬䞊 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ Presentation of Nutrient Content (Expression per 100g/ml or serving or package) 䝭䝱䞁䝬䞊 Will use per serving format ᰤ㣴ᡂศ㔞䛾⾲♧᪉ἲ 䠄⾲♧᪉ἲ 100g/ml 䚸1䝃䞊䝡䞁 䜾䚸ཪ䛿1ໟศ䛒䛯䜚䠅 (Expression in Exact values or Ranges) 䠄⾲♧䛩䜛್䠖୍ᐃ್䜒䛧䛟䛿ᖜ ⾲♧䠅 (Analysis or Calculation Basis) 䠄ศᯒ್䜒䛧䛟䛿ィ⟬್䠅 Use of Food Composition Table/Database for Presentation of Nutrients 䝃䞊䝡䞁䜾ᙜ䛯䜚䛾ᙧᘧ䜢⏝䛩䜛 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲ 䠋䝕䞊䝍䝧䞊䝇 䛾⏝ Food Composition Table/ Database for Presentation of Nutrients ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲ 䠋䝕䞊䝍䝧䞊䝇 - 124 - 3.5.9 Myanmar Myanmar Nutrition Labelling Regulations-1.2 䝭䝱䞁䝬䞊 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ 䝭䝱䞁䝬䞊 Calculation of Nutrients (Energy/Protein/Carbohydr ate/Fat) ᰤ㣴ᡂศ䛾ィ⟬ 䠄䜶䝛䝹 䜼䞊䠋䛯䜣䜁䛟㉁䠋ⅣỈ ≀䠋⬡㉁) Tolerances and Compliances (Tolerance Limits) Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 No FOP program FOP⾲♧䝥䝻䜾䝷䝮䛿䛺䛔 බᕪ䛸㐺ྜᛶ䠄ㄗᕪ⠊ᅖ䠅 Specific Features of Presentation (Format, %NRV Labelling) ⾲♧᪉ἲ䛾≉Ⰽ䠄䝣䜷䞊䝬䝑 䝖䚸%NRV䚸⾲♧ (Front of Package Labelling, FOP) 䠄䝟䝑䜿䞊䝆ṇ㠃䛾⾲♧䚸 FOP䠅 Myanmar Nutrition Labelling Regulations-1.3 䝭䝱䞁䝬䞊 䠖 ᰤ㣴⾲♧ᇶ‽-1.3 ᰤ㣴⾲♧ Administrations/Complia nces for Nutrition Labelling (Governing Authorities/Agencies) ᰤ㣴⾲♧䛾⾜ᨻ䠋㡰Ᏺ 䠄ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠅 䝭䝱䞁䝬䞊 Myanmar Food and Drug Administration Myanmar Food and Drug Administration 䠄䝭䝱䞁䝬䞊㣗ရ་⸆ရᒁ䠅 This will come into force after food labeling regulation has come out. Consumer Protection Law was drafted by Ministry of Commerce and submitted to Parliament for approval, and this may be of help. Inspections and Penalties ᰝᐹ䛸⨩๎ 㣗ရ⾲♧ᇶ‽䛜බ⾲䛥䜜䛯ᚋ䛻⾜䛥䜜䜛 Consumer Protection Law䠄ᾘ㈝⪅ಖㆤἲ䠅䛜䚸Ministry of Commerce 䠄ၟᴗ┬䠅䛻䜘䜚㉳ⲡ䛥䜜䚸ᢎㄆ䛾䛯䜑ᅜ䛻ᥦฟ䛥䜜䛯 䛣䜜(Consumer Protection Law)䛜ᙺ❧䛴䛛䜒䛧䜜䛺䛔 - 125 - 3.5.9 Myanmar Myanmar Nutrition Claim Regulations-2 䝭䝱䞁䝬䞊 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 䝭䝱䞁䝬䞊 ᰤ㣴ᙉㄪ⾲♧ The National Food Law (1997) has some provisions on food labelling but not specific to nutrition labeling. The regulation on Food labeling, covering nutritional food labeling is ongoing and will be promulgated in the near future. Relevant Laws/Regulations The National Food Law (1997)䠄ᅜᐙ㣗ရἲ䠄1997䠅䠅䛻䛿䚸ᰤ㣴⾲♧䛻㝈ᐃ䛧䛯 䜒䛾䛰䛡䛷䛺䛟䚸㣗ရ⾲♧䛻㛵䛩䜛䛔䛟䛴䛛䛾᮲ᩥ䜒䛒䜛 㛵㐃ἲつ䠋つ๎ ᰤ㣴㣗ရ⾲♧䜢ໟྵ䛩䜛㣗ရ⾲♧ᇶ‽䛿䚸⌧ᅾ⟇ᐃ୰䛷㏆䛔ᑗ᮶බᕸ䛥䜜䜛 Definitions (Nutrient Content/Comparative Claims) Not specified ᐃ⩏䠄ᰤ㣴⣲ྵ᭷㔞䠋 ẚ㍑ᙉㄪ⾲♧䠅 つᐃ↓䛧 Myanmar Nutrition Claim Regulations-2 䝭䝱䞁䝬䞊 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ Nutrient Content Claims 䝭䝱䞁䝬䞊 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 ᰤ㣴⣲ྵ᭷㔞ᙉㄪ⾲♧ Nutrient Comparative Claims ᰤ㣴⣲ẚ㍑ᙉㄪ⾲♧ Non-addition Claims (Non-addition of Sugars/Sodium Salts) ↓ῧຍ⾲♧䠄⢾㢮䠋䝘 䝖䝸䜴䝮ሷ䛾↓ῧຍ䠅 - 126 - 3.5.9 Myanmar Myanmar Nutrition Claim Regulations-2 䝭䝱䞁䝬䞊 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ 䝭䝱䞁䝬䞊 Administrations/Co mpliances for Nutrition Claims Myanmar Food and Drug Administration (Governing Authorities/Agencies) ᰤ㣴ᙉㄪ⾲♧䛾⾜ᨻ 䠋㡰Ᏺ䠄ᨻᗓᡤ⟶ᙜ ᒁ䠋ᐁᗇ) Myanmar Food and Drug Administration 䠄䝭䝱䞁䝬䞊㣗ရ་⸆ရᒁ䠅 This will come into force after food labeling regulation has come out. Consumer Protection Law was drafted by Ministry of Commerce and submitted to Parliament for approval, and this may be of help. Inspections and Penalties ᰝᐹ䛸⨩๎ 㣗ရ⾲♧ᇶ‽䛜බ⾲䛥䜜䛯ᚋ䛻⾜䛥䜜䜛 Consumer Protection Law䠄ᾘ㈝⪅ಖㆤἲ䠅䛿䚸Ministry of Commerce 䠄ၟᴗ┬䠅䛻䜘䜚㉳ⲡ䛥䜜䚸ᢎㄆ䛾䛯䜑ᅜ䛻ᥦฟ䛥䜜䛯 䛣䜜(Consumer Protection Law)䛜ᙺ❧䛴䛛䜒䛧䜜䛺䛔 Myanmar Health Claim Regulations-3.1 䝭䝱䞁䝬䞊 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 䝭䝱䞁䝬䞊 ᗣᙉㄪ⾲♧ Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ Definitions (Collective Name of Foods with Health Claims, if applicable) The National Food Law (1997) has some provisions on food labelling but not specific to nutrition labeling. The regulation on Food labeling, covering nutritional food labeling is ongoing and will be promulgated in the near future. The National Food Law (1997)䠄ᅜᐙ㣗ရἲ䠄1997䠅䠅䛻䛿䚸ᰤ㣴⾲♧䛻㝈ᐃ䛧䛯䜒 䛾䛰䛡䛷䛺䛟䚸㣗ရ⾲♧䛻㛵䛩䜛䛔䛟䛴䛛䛾᮲ᩥ䜒䛒䜛 ᰤ㣴㣗ရ⾲♧䜢ໟྵ䛩䜛㣗ရ⾲♧ᇶ‽䛿䚸⌧ᅾ⟇ᐃ୰䛷㏆䛔ᑗ᮶බᕸ䛥䜜䜛 Not specified つᐃ↓䛧 ᐃ⩏䠄ᗣᙉㄪ⾲ ♧䜢䛧䛯㣗ရ䜢ᣦ 䛩ྡ⛠䛜᭷䜛ሙྜ 䛿䛭䛾ྡ⛠䠅 - 127 - 3.5.9 Myanmar Myanmar Health Claim Regulations-3.1 䝭䝱䞁䝬䞊 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 ᗣᙉㄪ⾲♧ 䝭䝱䞁䝬䞊 Nutrient Function Claims (Collective Name of the Foods, if applicable) つᐃ↓䛧 ᰤ㣴ᶵ⬟ᙉㄪ⾲♧䠄ᰤ㣴ᶵ⬟⾲♧䜢䛧䛯㣗 Not specified ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾ྡ⛠䠅 Other Function Claims (Collective Name of the Foods, if applicable) Not specified 䛭䛾䛾ᶵ⬟ᙉㄪ⾲♧䠄䛾ᶵ⬟⾲♧䜢䛧 䛯㣗ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾ྡ⛠) Reduction of Disease Risk Claims (Collective Name of Foods Applied) 䝸䝇䜽పῶᙉㄪ⾲♧䠄㐺⏝䛥䜜䜛㣗ရ䜢 ᣦ䛩ྡ⛠䠅 つᐃ↓䛧 Not specified つᐃ↓䛧 Not applicable 㐺⏝↓䛧 Not applicable 㐺⏝↓䛧 Types of Approval/Certification (Standardized/Pre-authorized Claims) ᢎㄆ䠋ㄆド䛾✀㢮䠄つ᱁ᇶ‽ᆺ䠋 ๓ᢎ ㄆᆺ䠅 (Food Product/Constituent Specific Approval ) 䠄㣗ရ䠋≉ᐃ䛾⤌ᡂᡂศ䛻ᑐ䛩䜛ᢎㄆ䠅 Myanmar Health Claim Regulations-3.2 䝭䝱䞁䝬䞊 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ Scientific Substantiation of Health Claims 䝦䝹䝇䜽䝺䞊䝮䛻㛵䛩䜛⛉Ꮫⓗᐇド Process for the Substantiation (Organizational Systems, Governing Authority/Agency/Commission) 䝭䝱䞁䝬䞊 Not specified つᐃ↓䛧 Not yet established 䜎䛰䚸⟇ᐃ䛥䜜䛶䛔䛺䛔 Not yet established 䜎䛰䚸⟇ᐃ䛥䜜䛶䛔䛺䛔 ᐇド䛾䝥䝻䝉䝇䠄ᑂᰝ⤌⧊䛾ᵓ㐀䚸ᨻ ᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠋ጤဨ䠅 Criteria for the Substantiation and/or Consideration of the Evidence ᐇド䛾ᇶ‽䛚䜘䜃䠋䜎䛯䛿ຠᯝ䛾ホ ౯ - 128 - 3.5.9 Myanmar Myanmar Health Claim Regulations-3.2 䝭䝱䞁䝬䞊 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ 䝭䝱䞁䝬䞊 Specific Safety Concerns ≉ᐃ䛾Ᏻᛶ䛻㛵䛩䜛㡯 Not specified つᐃ↓䛧 Not Specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not Specified つᐃ↓䛧 Re-evaluation ホ౯ Product Quality Concerns (GMP, ISO, HACCP or Other Measures) 〇ရရ㉁䛻㛵䛩䜛㡯䠄GMP, ISO, HACCP 䜎䛯䛿䛾ホ౯ᑻ ᗘ䠅 Adverse Event Reporting System (Mandatory/Voluntary) ᭷ᐖ㇟䛻㛵䛩䜛ሗ࿌䝅䝇䝔䝮 䠄⩏ົ䠋௵ព䠅 Myanmar Health Claim Regulations-3.2 䝭䝱䞁䝬䞊 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ 䝭䝱䞁䝬䞊 Administrations/C ompliances for Health Claims Myanmar Food and Drug Administration (Governing Authorities/Agenci es) ᗣᙉㄪ⾲♧䛾⾜ ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ ⟶ᙜᒁ䠋ᐁᗇ䠅 Myanmar Food and Drug Administration䠄䝭䝱䞁䝬䞊㣗ရ་⸆ရᒁ䠅 This will come into force after food labeling regulation has come out. Consumer Protection Law was drafted by Ministry of Commerce and submitted to Parliament for approval, and this may be of help. Inspections and Penalties ᰝᐹ䛸⨩๎ 㣗ရ⾲♧ᇶ‽䛜බ⾲䛥䜜䛯ᚋ䛻⾜䛥䜜䜛 Consumer Protection Law䠄ᾘ㈝⪅ಖㆤἲ䠅䛿䚸Ministry of Commerce䠄ၟ ᴗ┬䠅䛻䜘䜚㉳ⲡ䛥䜜䚸ᢎㄆ䛾䛯䜑ᅜ䛻ᥦฟ䛥䜜䛯 䛣䜜(Consumer Protection Law)䛜ᙺ❧䛴䛛䜒䛧䜜䛺䛔 - 129 - 3.5.9 Myanmar Myanmar Health Claim Regulations-3.3 䝭䝱䞁䝬䞊 䠖 ᗣᙉㄪ⾲♧つ๎-3.3 ᗣᙉㄪ⾲♧ 䝭䝱䞁䝬䞊 Relevant Laws/Regulations for Dietary/Food/Health Supplements 䝎䜲䜶䝍䝸䞊䠋䝣䞊䝗䠋䝦䝹䝇 䝃䝥䝸 䝯䞁䝖䛻㛵䛩䜛㛵㐃ἲつ䠋つ๎ None つᐃ↓䛧 Definitions (Dietary Supplements, and/or Food Supplements, and/or Health Supplements) ᐃ⩏䠄䝎䜲䜶䝍䝸䞊䝃䝥䝸䝯䞁䝖䛚䜘䜃 䠋䜎䛯䛿䝣䞊䝗䝃䝥䝸䝯䞁䝖䛚䜘䜃䠋 䜎䛯䛿䝦䝹䝇䝃䝥䝸䝯䞁䝖䠅 Administrations/Compliances for the Supplements (Governing Authorities/Agencies) Not applicable Not applicable 䝃䝥䝸䝯䞁䝖䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ⟶ ᙜᒁ䠋ᐁᗇ䠅 - 130 - 㐺⏝↓䛧 㐺⏝↓䛧 3.5.10 Lao Nutrition Labelling and Nutrition/Health Claims ᰤ㣴⾲♧ཬ䜃ᰤ㣴/ᗣᙉㄪ⾲♧ 3.5.10 Lao People’s Democratic Republic 䝷䜸䝇ேẸẸඹᅜ Lao Nutrition Labelling Regulations-1.1 䝷䜸䝇 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ 䝷䜸䝇 Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ Regulation 519 MOH, 2009, Article 6, 6.2 MOH䠄ಖ┬䠅つ๎519䚸 2009䚸➨6᮲,6.2㡯 - 131 - 3.5.10 Lao Lao Nutrition Labelling Regulations-1.1 䝷䜸䝇 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ 䝷䜸䝇 Nutrient Reference Values (Definitions, NRVs-R/-NCD) ᰤ㣴ཧ↷㔞䠄ᐃ⩏, NRVs-R/NCD䠅 NA Nutrient Declaration (Application: Mandatory or Voluntary) Article 6. para 6.2.7 states that nutrient declaration should be mandatory for foods which nutrition claim are made. ᰤ㣴⾲♧䠄㐺⏝䠖 ⩏ົ 䜒䛧䛟䛿 ௵ព䠅 つᐃ↓䛧 ᰤ㣴ᙉㄪ⾲♧䜢䛩䜛㣗ရ䛻䛿䚸ᰤ㣴⾲♧䜢⩏ົ䛸䛩䜉䛝 䛣䛸䛜➨6᮲䛾6.2.7㡯䛻グ㍕䛥䜜䛶䛔䜛 Food Categories Applied 㐺⏝䛥䜜䜛㣗ရ䜹䝔䝂䝸䞊 NA つᐃ↓䛧 NA つᐃ↓䛧 NA つᐃ↓䛧 Exemptions (Food Categories) 㐺⏝㝖እ䠄㣗ရ䜹䝔䝂䝸䞊䠅 (Size of Food Business Operators) 䠄㣗ရᴗ⪅䛾つᶍ䠅 Lao Nutrition Labelling Regulations-1.1 䝷䜸䝇 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ Listing of Nutrients (Nutrients, Order) ᰤ㣴ᡂศ䝸䝇䝖 䠄ᰤ㣴ᡂศ䚸 グ㍕㡰䠅 䝷䜸䝇 Energy, protein, fat , carbohydrate, vitamins and minerals when claims are made ᙉㄪ⾲♧䛩䜛ሙྜ䛿䚸 䜶䝛䝹䜼䞊䚸䛯䜣䜁䛟㉁䚸⬡㉁䚸ⅣỈ≀䚸䝡䝍䝭䞁䚸䝭䝛䝷䝹 Optional Ingredients 䛭䛾䛾ᰤ㣴ᡂศ NA つᐃ↓䛧 - 132 - 3.5.10 Lao Lao Nutrition Labelling Regulations-1.2 䝷䜸䝇 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ 䝷䜸䝇 • Declaration of Energy, Protein, fat , carbohydrate should be declared in metric units(numerical) and/or as a percentage of NRV per 100g or 100 ml, or per serving Presentation of Nutrient Content (Expression per 100g/ml or serving or package) ᰤ㣴ᡂศ㔞䛾⾲♧᪉ἲ 䠄⾲♧᪉ἲ 100g/ml 䚸1䝃䞊䝡䞁䜾䚸 ཪ䛿1ໟศ䛒䛯䜚䠅 䜶䝛䝹䜼䞊䚸䛯䜣䜁䛟㉁䚸⬡㉁䚸ⅣỈ≀䛿䚸䝯䞊䝖䝹ἲ䛷䚸䛛䛴/ཪ䛿䚸 100gཪ䛿100mlᙜ䛯䜚䛾䚸ཪ䛿䝃䞊䝡䞁䜾ᙜ䛯䜚䛾ᰤ㣴ཧ↷㔞䛾%䠄 ྜ䠅䛸䛧䛶⾲♧䛧䛺䛡䜜䜀䛺䜙䛺䛔 Where a claim is made, the amount of that nutrient per 100g or per 100ml expressed in metric unit, and/or per serving should be declared. ᙉㄪ⾲♧䛩䜛ሙྜ䛿䚸䝯䞊䝖䝹ἲ䛷♧䛥䜜䛯100gཪ䛿100mlᙜ䛯䜚䚸 䛛䛴/ཪ䛿䝃䞊䝡䞁䜾ᙜ䛯䜚䛾䛭䛾ᰤ㣴⣲㔞䜢⾲♧䛧䛺䛡䜜䜀䛺䜙䛺䛔 (Expression in Exact values or Ranges) Not specified つᐃ↓䛧 Both calculation and lab testing ィ⟬್䛸ᐇ ್䛾୧᪉ྍ Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 䠄⾲♧䛩䜛್䠖୍ᐃ್䜒䛧䛟䛿ᖜ⾲♧䠅 (Analysis or Calculation Basis) 䠄ศᯒ್䜒䛧䛟䛿ィ⟬್䠅 Use of Food Composition Table/ Database for Presentation of Nutrients ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲䠋 䝕䞊䝍䝧䞊䝇 䛾⏝ Food Composition Table/Database for Presentation of Nutrients ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲䠋 䝕䞊䝍䝧䞊䝇 Lao Nutrition Labelling Regulations-1.2 䝷䜸䝇 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ 䝷䜸䝇 Calculation of Nutrients (Energy/Protein/ Carbohydrate/Fat) ᰤ㣴ᡂศ䛾ィ⟬ 䠄䜶䝛䝹䜼䞊䠋䛯䜣䜁䛟㉁ 䠋ⅣỈ≀䠋⬡㉁) Tolerances and Compliances (Tolerance Limits) Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 බᕪ䛸㐺ྜᛶ䠄ㄗᕪ⠊ᅖ䠅 - 133 - 3.5.10 Lao Lao Nutrition Labelling Regulations-1.2 䝷䜸䝇 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ Specific Features of Presentation (Format, %NRV Labelling) ⾲♧᪉ἲ䛾≉Ⰽ 䠄䝣䜷䞊䝬䝑 䝖䚸%NRV䚸⾲♧䠅 䝷䜸䝇 Can be declared against % of NRV ᰤ㣴ཧ↷㔞䛻ᑐ䛩䜛%䛷⾲♧䛩䜛䛣䛸䛜䛷䛝䜛 (Front of Package Labelling, FOP) No つᐃ↓䛧 䠄䝟䝑䜿䞊䝆ṇ㠃䛾⾲♧䚸FOP䠅 Lao Nutrition Labelling Regulations-1.3 䝷䜸䝇 䠖 ᰤ㣴⾲♧ᇶ‽-1.3 ᰤ㣴⾲♧ Administrations/Compliances for Nutrition Labelling (Governing Authorities/Agencies) 䝷䜸䝇 Food and Drug Department ᰤ㣴⾲♧䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ⟶ᙜ ᒁ䠋ᐁᗇ䠅 Food and Drug Department䠄㣗ရ་⸆ရᒁ䠅 Inspections and Penalties ᰝᐹ䛸⨩๎ NA つᐃ↓䛧 - 134 - 3.5.10 Lao Lao Nutrition Claim Regulations-2 䝷䜸䝇 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ Relevant Laws/Regulations 䝷䜸䝇 Regulation 519 MOH, 2009, Article 6, 6.2 㛵㐃ἲつ䠋つ๎ MOH䠄ಖ┬䠅つ๎519䚸 2009䚸➨6᮲,6.2㡯 Definitions (Nutrient Content/Comparati ve Claims) Not specified but Article 6.2.8 states that “Nutrient content claim, nutrient comparative claim and nutrient function claim may be allowed provided they meet with the minimum criteria set by Codex Guidelines for the Use of Nutrition and Health Claims where applicable.” ᐃ⩏䠄ᰤ㣴⣲ྵ᭷㔞 䠋ẚ㍑ᙉㄪ⾲♧䠅 つᐃ䛿䛺䛔䛜䚸᮲㡯6.2.8䛻䛿䚸䇾ᰤ㣴⣲ྵ᭷ᙉㄪ⾲♧䚸ᰤ㣴⣲ẚ㍑ᙉㄪ⾲♧䚸ᰤ㣴 ᶵ⬟⾲♧䛿䚸䛣䜜䜙䛜䚸䛂ᰤ㣴䛸ᗣᙉㄪ⾲♧䛾⏝䛻㛵䛩䜛䝁䞊䝕䝑䜽䝇䜺䜲䝗䝷䜲 䞁䛃䛻つᐃ䛥䜜䛶䛔䜛᭱పᇶ‽䛻ྜ⮴䛩䜛ሙྜ䛻㝈䜚チྍ䛥䜜䜛䇾䛸グ㍕䛥䜜䛶䛔䜛䚹 Lao Nutrition Claim Regulations-2 䝷䜸䝇 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ 䝷䜸䝇 Nutrient Content Claims ᰤ㣴⣲ྵ᭷㔞ᙉㄪ⾲♧ Nutrient Comparative Claims ᰤ㣴⣲ẚ㍑ᙉㄪ⾲♧ Non-addition Claims 䠄Non-addition of Sugars/Sodium Salts䠅 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 ↓ῧຍ⾲♧䠄⢾㢮䠋䝘䝖䝸䜴䝮 ሷ䛾↓ῧຍ䠅 - 135 - 3.5.10 Lao Lao Nutrition Claim Regulations-2 䝷䜸䝇 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ Administrations/Compliances for Nutrition Claims䠄Governing Authorities/Agencies䠅 䝷䜸䝇 Food and Drug Department ᰤ㣴ᙉㄪ⾲♧䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ⟶ ᙜᒁ䠋ᐁᗇ) Food and Drug Department䠄㣗ရ་⸆ရᒁ䠅 Inspections and Penalties ᰝᐹ䛸⨩๎ NA つᐃ↓䛧 Lao Health Claim Regulations-3.1 䝷䜸䝇 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 ᗣᙉㄪ⾲♧ 䝷䜸䝇 Relevant Laws/Regulations Regulation 519 MOH, 2009, Article 6, 6.2 㛵㐃ἲつ䠋つ๎ MOH䠄ಖ┬䠅つ๎519䚸2009䚸➨6᮲,6.2㡯 Definitions 䠄Collective Name of Foods with Health Claims, if applicable䠅 Not specified ᐃ⩏䠄ᗣᙉㄪ⾲♧䜢䛧䛯 㣗ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙ ྜ䛿䛭䛾ྡ⛠䠅 つᐃ↓䛧 - 136 - 3.5.10 Lao Lao Health Claim Regulations-3.1 䝷䜸䝇 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 䝷䜸䝇 ᗣᙉㄪ⾲♧ Nutrient Function Claims䠄Collective Name of the Foods, if applicable䠅 ᰤ㣴ᶵ⬟ᙉㄪ⾲♧䠄ᰤ㣴ᶵ⬟⾲♧䜢䛧䛯㣗 ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾ྡ⛠䠅 Other Function Claims䠄Collective Name of the Foods, if applicable䠅 䛭䛾䛾ᶵ⬟ᙉㄪ⾲♧䠄䛾ᶵ⬟⾲♧䜢䛧䛯 㣗ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾ྡ⛠) Reduction of Disease Risk Claims䠄Collective Name of Foods Applied䠅 䝸䝇䜽పῶᙉㄪ⾲♧䠄㐺⏝䛥䜜䜛㣗ရ䜢 ᣦ䛩ྡ⛠䠅 Types of Approval/Certification 䠄Standardized/ Pre-authorized Claims䠅 ᢎㄆ䠋ㄆド䛾✀㢮䠄つ᱁ᇶ‽ᆺ䠋 ๓ᢎㄆ ᆺ䠅 䠄Food Product/Constituent Specific Approval䠅 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 NA つᐃ↓䛧 NA つᐃ↓䛧 䠄㣗ရ䠋≉ᐃ䛾⤌ᡂᡂศ䛻ᑐ䛩䜛ᢎㄆ䠅 Lao Health Claim Regulations-3.2 䝷䜸䝇 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ Scientific Substantiation of Health Claims ᗣᙉㄪ⾲♧䛻㛵䛩䜛⛉Ꮫⓗᐇ ド Process for the Substantiation (Organizational Systems, Governing Authority/Agency/Commission) 䝷䜸䝇 Not specified つᐃ↓䛧 Not yet established 䜎䛰䚸⟇ᐃ䛥䜜䛶䛔䛺䛔 Not yet established 䜎䛰䚸⟇ᐃ䛥䜜䛶䛔䛺䛔 ᐇド䛾䝥䝻䝉䝇䠄ᑂᰝ⤌⧊䛾ᵓ㐀䚸 ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠋ጤဨ䠅 Criteria for the Substantiation and/or Consideration of the Evidence ᐇド䛾ᇶ‽䛚䜘䜃䠋䜎䛯䛿ຠᯝ 䛾ホ౯ - 137 - 3.5.10 Lao Lao Health Claim Regulations-3.2 䝷䜸䝇 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ 䝷䜸䝇 Specific Safety Concerns ≉ᐃ䛾Ᏻᛶ䛻㛵䛩䜛㡯 Not specified つᐃ↓䛧 Not Specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not Specified つᐃ↓䛧 Re-evaluation ホ౯ Product Quality Concerns 䠄GMP, ISO, HACCP or Other Measures䠅 〇ရရ㉁䛻㛵䛩䜛㡯䠄GMP, ISO, HACCP 䜎䛯䛿䛾ホ౯ ᑻᗘ䠅 Adverse Event Reporting System䠄Mandatory/ Voluntary䠅 ᭷ᐖ㇟䛻㛵䛩䜛ሗ࿌䝅䝇䝔䝮 䠄⩏ົ䠋௵ព䠅 Lao Health Claim Regulations-3.2 䝷䜸䝇 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ Administrations/Compliances for Health Claims䠄Governing Authorities/Agencies䠅 䝷䜸䝇 Food and Drug Department ᗣᙉㄪ⾲♧䛾⾜ᨻ䠋㡰Ᏺ 䠄ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠅 Food and Drug Department䠄㣗ရ་⸆ရᒁ䠅 Inspections and Penalties ᰝᐹ䛸⨩๎ NA つᐃ↓䛧 - 138 - 3.5.10 Lao Lao Health Claim Regulations-3.3 䝷䜸䝇 䠖 ᗣᙉㄪ⾲♧つ๎-3.3 ᗣᙉㄪ⾲♧ 䝷䜸䝇 Relevant Laws/Regulations for Dietary/Food/Health Supplements 䝎䜲䜶䝍䝸䞊䠋䝣䞊䝗䠋䝦䝹䝇 䝃䝥䝸 䝯䞁䝖䛻㛵䛩䜛㛵㐃ἲつ䠋つ๎ NA つᐃ↓䛧 NA つᐃ↓䛧 NA つᐃ↓䛧 Definitions䠄Dietary Supplements, and/or Food Supplements, and/or Health Supplements䠅 ᐃ⩏䠄䝎䜲䜶䝍䝸䞊䝃䝥䝸䝯䞁䝖䛚䜘䜃 䠋䜎䛯䛿䝣䞊䝗䝃䝥䝸䝯䞁䝖䛚䜘䜃䠋 䜎䛯䛿䝦䝹䝇䝃䝥䝸䝯䞁䝖䠅 Administrations/Compliances for the Supplements 䠄Governing Authorities/Agencies䠅 䝃䝥䝸䝯䞁䝖䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ⟶ ᙜᒁ䠋ᐁᗇ䠅 - 139 - - 140 - 3.6.1 India Nutrition Labelling and Nutrition/Health Claims ᰤ㣴⾲♧ཬ䜃ᰤ㣴/ᗣᙉㄪ⾲♧ 3.6.1 Republic of India 䜲䞁䝗ඹᅜ India Nutrition Labelling Regulations-1.1 䜲䞁䝗 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ 䜲䞁䝗 Prevention of Food Adulteration Act (1955). Old Law Replaced By: Food Safety and Standards Regulation (2011) Food Safety and Standards ( Packaging and Labeling Regulations(2011) Bureau of Indian Standards ( BIS) Specifications ᚑ᮶䛾ἲ௧䚸㣗ရഇ㜵Ṇἲ (1955) 䛿௨ୗ䛻⨨䛝䛘䜙䜜䛯䚹 㣗ရᏳᇶ‽つ๎ (2011) 㣗ရᏳᇶ‽ (ໟ䛚䜘䜃⾲♧) (2011) 䜲䞁䝗ᇶ‽ᗇ(BIS)䛾ᵝ᭩ Nutrient Reference Values (Definitions, Definitions for NRVs NRVs-R/-NCD) ᰤ㣴ཧ↷㔞䠄ᐃ⩏, NRVs- List of NRVs R/-NCD䠅 NRVs䛾ᐃ⩏ཬ䜃NRVs䛾䝸䝇䝖䛿ୖグᇶ‽ 䛻♧䛥䜜䛶䛔䜛 Mandatory as per new FSSA regulations. When nutrition/health claims Nutrient Declaration (Application: Mandatory made justification and content to be declared. BIS voluntary or Voluntary) ᰤ㣴⾲♧䠄㐺⏝䠖 ⩏ົ 䜒 䛧䛟䛿 ௵ព䠅 ᪂䛧䛔FSSAつ๎䛻䜘䛳䛶⩏ົ䚹 ᰤ㣴䜽䝺䞊䝮䠋䝦䝹䝇䜽䝺䞊䝮䜢⾜䛖ሙྜ 䛿䚸䛭䛾⌮⏤䠄ṇᙜᛶ䠅䛸ྵ᭷㔞䜢᫂♧䚹 䜲䞁䝗ᇶ‽ᗇ (BIS) つᐃ䛷䛿௵ព䚹 Food Categories Applied 㐺⏝䛥䜜䜛㣗ရ䜹䝔䝂䝸䞊 All prepackaged foods - 141 - 䛶䛾ໟ῭䜏㣗ရ 3.6.1 India India Nutrition Labelling Regulations-1.1 䜲䞁䝗 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ Exemptions (Food Categories) 㐺⏝㝖እ䠄㣗ရ䜹䝔䝂 䝸䞊䠅 䜲䞁䝗 Not applicable 㐺⏝↓䛧 (Size of Food Business Operators) Not applicable 䠄㣗ရᴗ⪅䛾つᶍ䠅 㐺⏝↓䛧 Listing of Nutrients (Nutrients, Order) Energy, Protein, Fat, Carbohydrate (Available Carbohydrate and D.F.) and Sodium ᰤ㣴ᡂศ䝸䝇䝖 䠄ᰤ㣴 ᡂศ䚸 グ㍕㡰䠅 Optional Ingredients ⇕㔞䚸䛯䜣䜁䛟㉁䚸⬡㉁䚸ⅣỈ≀䠄⢾㉁䛸㣗≀⧄⥔䠅䚸䝘䝖䝸䜴䝮 Any other nutritional constituent 䛭䛾䛾ᰤ㣴ᡂศ ᰤ㣴⾲♧ 䛭䛾䛾ᰤ㣴ᡂศ India Nutrition Labelling Regulations-1.2 䜲䞁䝗 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 䜲䞁䝗 Presentation of Nutrient Content (Expression per 100g/ml or serving or package) ᰤ㣴ᡂศ㔞䛾⾲♧᪉ἲ 䠄⾲♧᪉ἲ 100g/ml 䚸1䝃䞊䝡䞁䜾䚸 ཪ䛿1ໟศ䛒䛯䜚䠅 (Expression in Exact values or Ranges) Per 100g/ml (package) or per serving. The serving details to be mentioned. 100g/ml 䛒䛯䜚(䝟䝑䜿䞊䝆) 䜎䛯䛿䝃䞊䝡䞁䜾䛒䛯䜚䚹䝃䞊䝡䞁䜾 䛾ヲ⣽䜢᫂グ Exact values / Range ୍ᐃ್䠋ᖜ⾲♧ 䠄⾲♧䛩䜛್䠖୍ᐃ್䜒䛧䛟䛿ᖜ⾲♧䠅 (Analysis or Calculation Basis) Analysis or Calculation basis allowed 䠄ศᯒ್䜒䛧䛟䛿ィ⟬್䠅 Use of Food Composition Table/ Database for Presentation of Nutrients ศᯒ್䜎䛯䛿ィ⟬್䛜ㄆ䜑䜙䜜䜛 ㄆ䜑䜙䜜䜛 Allowed ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲䠋 䝕䞊䝍䝧䞊䝇 䛾⏝ Food Composition Table/Database for Presentation of Nutrients ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲䠋 䝕䞊䝍䝧䞊䝇 Indian Council of Medical Research and National Institute of Nutrition data Table 䜲䞁䝗་⒪ホ㆟䛸ᅜ❧ᰤ㣴◊✲ᡤ䛾䝕䞊䝍⾲ - 142 - 3.6.1 India India Nutrition Labelling Regulations-1.2 䜲䞁䝗 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ 䜲䞁䝗 Calculation of Nutrients (Energy/Protein/ Carbohydrate/Fat) Identical to Codex Guidelines ᰤ㣴ᡂศ䛾ィ⟬ 䠄䜶䝛䝹䜼䞊 䠋䛯䜣䜁䛟㉁䠋ⅣỈ≀䠋⬡㉁) Tolerances and Compliances (Tolerance Limits) බᕪ䛸㐺ྜᛶ䠄ㄗᕪ⠊ᅖ䠅 Codex䜺䜲䝗䝷䜲䞁䛻‽䛪䜛 No Specific tolerations defined for nutrients ᰤ㣴⣲䛻ᐃ䜑䜙䜜䛯≉ᐃ䛾チᐜ㔞䛿䛺䛔 Specific Features of Presentation (Format, %NRV Labelling) ⾲♧᪉ἲ䛾≉Ⰽ 䠄䝣䜷䞊䝬䝑 䝖䚸%NRV䚸⾲♧䠅 (Front of Package Labelling, FOP) 䠄䝟䝑䜿䞊䝆ṇ㠃䛾⾲♧䚸FOP䠅 Tabular format No %NRV labelling applied ୍ぴ⾲ᙧᘧ䚹 %NRV ⾲♧䛾㐺⏝䛿䛺䛔 No FOP labelling applied Principle Display Panel to be used. せ⾲♧䝟䝛䝹䛻㐺⏝䛥䜜䜛㻲㻻㻼⾲♧䛿䛺䛔 India Nutrition Labelling Regulations-1.3 䜲䞁䝗 䠖 ᰤ㣴⾲♧ᇶ‽-1.3 ᰤ㣴⾲♧ 䜲䞁䝗 Administrations/Compl Food Safety Agency under FSSAI and Local Governments . iances for Nutrition BIS Certification system Labelling (Governing Authorities/Agencies) FSSAI䛸ᆅ᪉⮬య䛾㣗ရᏳᒁ BIS䛾ㄆド䝅䝇䝔䝮 ᰤ㣴⾲♧䛾⾜ᨻ䠋㡰Ᏺ 䠄ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠅 Inspections and Penalties ᰝᐹ䛸⨩๎ Periodical inspections Penalties defined ᐃᮇⓗ䛺ᰝᐹ䚸 ⨩๎つᐃ䛒䜚 - 143 - 3.6.1 India India Nutrition Claim Regulations-2 䜲䞁䝗 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ Relevant Laws/Regulations 䜲䞁䝗 Prevention of Food Adulteration Act (1955) Food Safety and Standards Regulation (2011) Food Safety and Standards ( Packaging and Labeling Regulations(2011) 㣗ရഇ㜵Ṇἲ (1955) 㣗ရᏳᇶ‽つ๎ (2011) 㣗ရᏳᇶ‽ (ໟ䛚䜘䜃⾲♧) (2011) 㛵㐃ἲつ䠋つ๎ Definitions (Nutrient Content/Comparative Claims) Identical to Codex Guidelines Codex䜺䜲䝗䝷䜲䞁䛻‽䛪䜛 ᐃ⩏䠄ᰤ㣴⣲ྵ᭷㔞䠋ẚ ㍑ᙉㄪ⾲♧䠅 Nutrient Content Claims ᰤ㣴⣲ྵ᭷㔞ᙉㄪ⾲♧ Nutrient Comparative Claims ᰤ㣴⣲ẚ㍑ᙉㄪ⾲♧ Non-addition Claims 䠄Non-addition of Sugars/Sodium Salts䠅 Conditions defined ᮲௳䛾つᐃ䛒䜚 Conditions defined ᮲௳䛾つᐃ䛒䜚 Conditions defined ᮲௳䛾つᐃ䛒䜚 ↓ῧຍ⾲♧䠄⢾㢮䠋䝘䝖 䝸䜴䝮ሷ䛾↓ῧຍ䠅 India Nutrition Claim Regulations-2 䜲䞁䝗 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ 䜲䞁䝗 Administrations/Complian ces for Nutrition Claims Food Safety Agency under FSSAI and 䠄Governing Local Governments Authorities/Agencies䠅 ᰤ㣴ᙉㄪ⾲♧䛾⾜ᨻ䠋㡰 Ᏺ䠄ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ) Inspections and Penalties ᰝᐹ䛸⨩๎ FSSAI 䛸ᆅ᪉⮬య䛾㣗ရᏳᒁ Periodical Inspections Penalties defined - 144 - ᐃᮇⓗ䛺ᰝᐹ䚸 ⨩๎つᐃ䛒䜚 3.6.1 India ᗣᙉㄪ⾲♧ India Health Claim Regulations-3.1 䜲䞁䝗 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 䜲䞁䝗 Prevention of Adulteration Act (1955) Food Safety and Standards Regulation (2011) Food Safety and Standards ( Packaging and Labeling Regulations(2011) Relevant Laws/Regulations 㣗ရഇ㜵Ṇἲ (1955) 㣗ရᏳᇶ‽つ๎(2011) 㣗ရᏳᇶ‽ (ໟ䛚䜘䜃⾲♧つ๎ (2011) ) 㛵㐃ἲつ䠋つ๎ Definitions 䠄Collective Name of Foods with Health Claims, if applicable䠅 ᐃ⩏䠄ᗣᙉㄪ⾲♧䜢䛧䛯㣗ရ䜢 ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾ྡ⛠䠅 Nutrient Function Claims 䠄Collective Name of the Foods, if applicable䠅 ᰤ㣴ᶵ⬟ᙉㄪ⾲♧䠄ᰤ㣴ᶵ⬟⾲♧ 䜢䛧䛯㣗ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ 䛿䛭䛾ྡ⛠䠅 Other Function Claims䠄Collective Name of the Foods, if applicable䠅 䛭䛾䛾ᶵ⬟ᙉㄪ⾲♧䠄䛾ᶵ⬟ ⾲♧䜢䛧䛯㣗ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛 ሙྜ䛿䛭䛾ྡ⛠) Foods with Health Claims (FHC) ᗣᙉㄪ⾲♧㣗ရ (FHC) Foods with Nutrient Function Claims , applicable to all prepackaged foods. ᰤ㣴ᶵ⬟ᙉㄪ⾲♧㣗ရ 䛩䜉䛶䛾ໟ῭䜏㣗ရ䛻㐺⏝䛥䜜䜛 Draft Food Safety & Standards ( Packaging & Labeling) 2nd Amendment Regulation 2013 ( related to labeling requirement for foods containing oligosaccharides, Plant stanol esters, Trehalose.) 2013ᖺ䛾㣗ရᏳᇶ‽( ໟ䛚䜘䜃⾲♧)䛾➨䠎ᅇ┠䛾ᨵṇつ๎ (䜸䝸䝂⢾䚸᳜≀䝇䝍䝜䞊䝹䜶䝇䝔䝹䚸䝖䝺䝝䝻䞊䝇 (Trelalose=Trehalose䛾ㄗグ䛸᥎ᐹ)ྵ᭷㣗ရ䛾⾲♧せồ㡯䛻㛵䛩 䜛䜒䛾) India Health Claim Regulations-3.1 䜲䞁䝗 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 ᗣᙉㄪ⾲♧ Reduction of Disease Risk Claims 䠄Collective Name of Foods Applied䠅 䝸䝇䜽పῶᙉㄪ⾲♧䠄㐺⏝䛥䜜 䜛㣗ရ䜢ᣦ䛩ྡ⛠䠅 Types of Approval/Certification 䠄Standardized/ Pre-authorized Claims䠅 ᢎㄆ䠋ㄆド䛾✀㢮䠄つ᱁ᇶ‽ᆺ䠋 ๓ᢎㄆᆺ䠅 䜲䞁䝗 Notification of Food Safety & Standards ( Packaging & Labeling) 2nd Amendment Regulation 2013 ( related to labeling requirement for trans fatty acids). 2013ᖺ䛾㣗ရᏳᇶ‽ ( ໟ䛚䜘䜃⾲♧)䛾➨䠎ᅇ┠䛾ᨵṇつ๎ 䛾㏻▱ ( 䝖䝷䞁䝇⬡⫫㓟䛾⾲♧せồ㡯䛻㛵䛩䜛䜒䛾) Notification of Food Safety & Standards ( Packaging & Labeling) 1st Amendment Regulation 2013 ( related to license number on label) 2013ᖺ䛾㣗ရᏳᇶ‽ ( ໟ䛚䜘䜃⾲♧)䛾➨1ᅇ┠䛾ᨵṇつ๎䛾 ㏻▱(䝷䝧䝹䛾䝷䜲䝉䞁䝇␒ྕ䛻㛵䛩䜛䜒䛾) 䠄Food Product/Constituent Specific Approval䠅 䠄㣗ရ䠋≉ᐃ䛾⤌ᡂᡂศ䛻ᑐ䛩䜛 ᢎㄆ䠅 Product Specific - 145 - ၟရಶู 3.6.1 India ᗣᙉㄪ⾲♧ India Health Claim Regulations-3.2 䜲䞁䝗 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 䜲䞁䝗 Scientific Substantiation of Health Claims ᗣᙉㄪ⾲♧䛻㛵䛩䜛⛉Ꮫⓗᐇド Documentation required for approval. Formats and application with justification Process for the Substantiation (Organizational Systems, Governing Authority/Agency/Commission) Submission to FSSAI with proposed claims and labels Review by Scientific Panel on Claims and Labels Product registration and approval ᢎㄆ䛻䛿ドᣐ᭩㢮䛾ᥦฟ䛜ᚲせ䚹 ᰿ᣐ䜢క䛖⏦ㄳ᭩䛸䝣䜷䞊䝬䝑䝖 ⏦ㄳᙉㄪ⾲♧䛸䝷䝧䝹䜢FSSAI䛻⏦ㄳ э ⛉Ꮫ䝟䝛䝹䛻䜘䜛⏦ㄳᙉ ㄪ⾲♧䛸䝷䝧䝹䛾ホ౯ э ၟရⓏ㘓䛸ᢎㄆ ᐇド䛾䝥䝻䝉䝇䠄ᑂᰝ⤌⧊䛾ᵓ㐀䚸 ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠋ጤဨ䠅 Criteria for the Substantiation and/or Consideration of the Evidence Documentation required ドᣐ᭩㢮䛜ᚲせ Documentation required ドᣐ᭩㢮䛜ᚲせ Not Specified ヲ⣽䛿ᐃ䜑䜙䜜䛶䛔䛺䛔 ᐇド䛾ᇶ‽䛚䜘䜃䠋䜎䛯䛿ຠᯝ䛾 ホ౯ Specific Safety Concerns ≉ᐃ䛾Ᏻᛶ䛻㛵䛩䜛㡯 Re-evaluation ホ౯ India Health Claim Regulations-3.2 䜲䞁䝗 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ 䜲䞁䝗 Product Quality Concerns䠄GMP, ISO, HACCP or Other Measures䠅 〇ရရ㉁䛻㛵䛩䜛㡯䠄GMP, ISO, HACCP 䜎䛯䛿䛾ホ౯ᑻᗘ䠅 Adverse Event Reporting System 䠄Mandatory/ Voluntary䠅 ᭷ᐖ㇟䛻㛵䛩䜛ሗ࿌䝅䝇䝔䝮䠄⩏ົ䠋 ௵ព䠅 Administrations/Compliances for Health Claims䠄Governing Authorities/Agencies䠅 Documentation required ドᣐ᭩㢮䛜ᚲせ Not Specified ヲ⣽䛿ᐃ䜑䜙䜜䛶䛔䛺䛔 Food Safety Agency under FSSAI & Local Governments FSSAI䛸ᆅ᪉⮬య䛾㣗ရᏳᒁ ᗣᙉㄪ⾲♧䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ⟶ ᙜᒁ䠋ᐁᗇ䠅 Inspections and Penalties ᰝᐹ䛸⨩๎ Periodical Inspections Penalties defined - 146 - ᐃᮇⓗ䛺ᰝᐹ䚸 ⨩๎つᐃ䛒䜚 3.6.1 India India Health Claim Regulations-3.3 䜲䞁䝗 䠖 ᗣᙉㄪ⾲♧つ๎-3.3 ᗣᙉㄪ⾲♧ Relevant Laws/Regulations for Dietary/Food/Health Supplements 䝎䜲䜶䝍䝸䞊䠋䝣䞊䝗䠋䝦䝹䝇 䝃䝥䝸 䝯䞁䝖䛻㛵䛩䜛㛵㐃ἲつ䠋つ๎ Definitions㸦Dietary Supplements, and/or Food Supplements, and/or Health Supplements㸧 ᐃ⩏㸦ࢲ࢚ࢱ࣮ࣜࢧࣉ࣓ࣜࣥࢺ ࠾ࡼࡧ㸭ࡲࡓࡣࣇ࣮ࢻࢧࣉ࣓ࣜࣥ ࢺ࠾ࡼࡧ㸭ࡲࡓࡣ࣊ࣝࢫࢧࣉ࣓ࣜ ࣥࢺ㸧 Administrations/Compliances for the Supplements 䠄Governing Authorities/Agencies䠅 䝃䝥䝸䝯䞁䝖䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ⟶ ᙜᒁ䠋ᐁᗇ䠅 䜲䞁䝗 Not specifically defined, Treated in the same manner as foods. New regulations are under preparation and formalization ヲ⣽䛺ᐃ⩏䛿ᐃ䜑䜙䜜䛶䛔䛺䛔 㣗ရ䛸ྠᵝ䛻ྲྀ䜚ᢅ䜟䜜䜛 ᪂䛧䛔つ๎䛜ṇᘧ䛻ྥ䛡䛶‽ഛ䛥䜜䛶䛔䜛 Not specifically defined Treated in the same manner as foods ヲ⣽䛺ᐃ⩏䛿ᐃ䜑䜙䜜䛶䛔䛺䛔 㣗ရ䛸ྠᵝ䛻ྲྀ䜚ᢅ䜟䜜䜛 Not specifically defined Treated in the same manner as foods ヲ⣽䛺ᐃ⩏䛿ᐃ䜑䜙䜜䛶䛔䛺䛔 㣗ရ䛸ྠᵝ䛻ྲྀ䜚ᢅ䜟䜜䜛 - 147 - - 148 - 3.6.2 Sri Lanka Nutrition Labelling and Nutrition/Health Claims ᰤ㣴⾲♧ཬ䜃ᰤ㣴/ᗣᙉㄪ⾲♧ 3.6.2 Democratic Socialist Republic of Sri Lanka 䝇䝸䝷䞁䜹Ẹ♫⩏ඹᅜ Sri Lanka Nutrition Labelling Regulations-1.1 䝇䝸䝷䞁䜹 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ Nutrient Reference Values (Definitions, NRVs-R/NCD) ᰤ㣴ཧ↷㔞䠄ᐃ⩏, NRVsR/-NCD䠅 䝇䝸䝷䞁䜹 Food Act No.26 of 1980 Food Act (Amendment) No.20 of 1991 Food (Labelling & Advertising) Regulations -2005 㣗ရἲ No.26, 1980 㣗ရ䠄ᨵṇ䠅ἲ No.20, 1991 㣗ရ䠄⾲♧䛚䜘䜃ᗈ࿌䠅つ๎䚸2005 Definitions for NRVs List of NRVs are currently being processed in terms of the latest revision of CAC NRV䛾ᐃ⩏䛸䝸䝇䝖䛿䝁䞊䝕䝑䜽䝇䜺䜲䝗䝷䜲䞁䛾᭱᪂∧䜢ඖ䛻⟇ᐃ୰ Nutrient Declaration (Application: Mandatory or Voluntary, Mandatory when nutrition/health claims made Voluntary) ᰤ㣴⾲♧䠄㐺⏝䠖 ⩏ົ 䜒䛧 䛟䛿 ௵ព䠅 Food Categories Applied 㐺⏝䛥䜜䜛㣗ရ䜹䝔䝂䝸䞊 ௵ព䚸ᰤ㣴䠋ᗣᙉㄪ⾲♧䛾ሙྜ䚸⩏ົ All prepackaged foods 䛶䛾ໟ῭䜏㣗ရ - 149 - 3.6.2 Sri Lanka Sri Lanka Nutrition Labelling Regulations-1.1 䝇䝸䝷䞁䜹 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ 䝇䝸䝷䞁䜹 Exemptions (Food Categories) 㐺⏝㝖እ䠄㣗ရ䜹䝔䝂䝸䞊䠅 Not applicable (Size of Food Business Operators) 䠄㣗ရᴗ⪅䛾つᶍ䠅 Not applicable Listing of Nutrients (Nutrients, Order) Energy, Protein, Fat, Carbohydrate (Available Carbohydrate and D.F.) and Sodium 㐺⏝↓䛧 㐺⏝↓䛧 ᰤ㣴ᡂศ䝸䝇䝖 䠄ᰤ㣴ᡂศ䚸 グ㍕㡰䠅 ⇕㔞䚸䛯䜣䜁䛟㉁䚸ⅣỈ≀䠄⢾㉁䛚䜘䜃㣗≀⧄⥔䠅䚸䝘䝖䝸䜴䝮 Any other nutritional constituent Optional Ingredients 䛭䛾䛾ᰤ㣴ᡂศ 䛭䛾䛾䛶䛾ᰤ㣴ᡂศ Sri Lanka Nutrition Labelling Regulations-1.2 䝇䝸䝷䞁䜹 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ Presentation of Nutrient Content (Expression per 100g/ml or serving or package) ᰤ㣴ᡂศ㔞䛾⾲♧᪉ἲ 䠄⾲♧᪉ἲ 100g/ml 䚸1䝃䞊䝡䞁 䜾䚸ཪ䛿1ໟศ䛒䛯䜚䠅 (Expression in Exact values or Ranges) 䠄⾲♧䛩䜛್䠖୍ᐃ್䜒䛧䛟䛿ᖜ ⾲♧䠅 (Analysis or Calculation Basis) 䠄ศᯒ್䜒䛧䛟䛿ィ⟬್䠅 Use of Food Composition Table/ Database for Presentation of Nutrients 䝇䝸䝷䞁䜹 Per 100g/ml, per package 100 g/mlᙜ䛯䜚䚸1ໟᙜ䛯䜚 Exact values / Range ୍ᐃ್䚸ᖜ⾲♧ྍ Analysis or Calculation basis allowed ศᯒ್䜎䛯䛿ィ⟬್ྍ Allowed ㄆ䜑䜙䜜䜛 ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲ 䠋䝕䞊䝍䝧䞊䝇 䛾⏝ Food Composition Table/Database for Presentation Sri Lanka /International Food Composition Table of Nutrients ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲ 䠋䝕䞊䝍䝧䞊䝇 䝇䝸䝷䞁䜹䠋ᅜ㝿㣗ရᡂศ⾲ - 150 - 3.6.2 Sri Lanka Sri Lanka Nutrition Labelling Regulations-1.2 䝇䝸䝷䞁䜹 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ 䝇䝸䝷䞁䜹 Calculation of Nutrients (Energy/Protein/ Carbohydrate/Fat) Identical to Codex Guidelines ᰤ㣴ᡂศ䛾ィ⟬ 䠄䜶䝛䝹䜼䞊 䠋䛯䜣䜁䛟㉁䠋ⅣỈ≀䠋⬡㉁) Tolerances and Compliances (Tolerance Limits) බᕪ䛸㐺ྜᛶ䠄ㄗᕪ⠊ᅖ䠅 䝁䞊䝕䝑䜽䝇䜺䜲䝗䝷䜲䞁䛻㡰䛪䜛 Values plus or minus 20%, Specific tolerations defined for certain nutrients (CURRENTLY UNDER REVISION) ⾲♧್䠇/䠉20䠂䚸ᰤ㣴ᡂศ䛻䜘䜚≉ᐃ䛾ㄗᕪ⠊ᅖ䛒䜚 䠄⌧ᅾᨵᐃ୰䠅 Specific Features of Presentation (Format, %NRV Labelling) Tabular format No %NRV labeling applied ⾲♧᪉ἲ䛾≉Ⰽ 䠄䝣䜷䞊䝬䝑 䝖䚸%NRV䚸⾲♧䠅 ୍ぴ⾲ᙧᘧ %NRV ⾲♧䛾㐺⏝↓䛧 (Front of Package Labelling, FOP) No FOP labeling applied 䠄䝟䝑䜿䞊䝆ṇ㠃䛾⾲♧䚸FOP䠅 FOP ⾲♧䛾㐺⏝↓䛧 Sri Lanka Nutrition Labelling Regulations-1.3 䝇䝸䝷䞁䜹 䠖 ᰤ㣴⾲♧ᇶ‽-1.3 ᰤ㣴⾲♧ Administrations/Compliances for Nutrition Labelling (Governing Authorities/Agencies) ᰤ㣴⾲♧䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ ⟶ᙜᒁ䠋ᐁᗇ䠅 Inspections and Penalties ᰝᐹ䛸⨩๎ 䝇䝸䝷䞁䜹 Chief Food Authority, Local Bodies. ୰ኸ㣗ရᒁ ᆅ᪉ᨻᗓ Periodical inspections Penalties defined ᐃᮇⓗ䛺ᰝᐹ䛒䜚 ⨩๎つᐃ䛒䜚 - 151 - 3.6.2 Sri Lanka Sri Lanka Nutrition Claim Regulations-2 䝇䝸䝷䞁䜹 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ 䝇䝸䝷䞁䜹 Food Act No.26 of 1980 Food Act (Amendment) No.20 of 1991 Food (Labelling & Advertising) Regulations -2005 Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ 㣗ရἲ No.26, 1980 㣗ရ䠄ಟṇ䠅ἲ No.20, 1991 㣗ရ䠄⾲♧ཬ䜃ᗈ࿌䠅つ๎䚸2005 Definitions (Nutrient Content/Comparative Claims) ᐃ⩏䠄ᰤ㣴⣲ྵ᭷㔞䠋ẚ㍑ᙉㄪ ⾲♧䠅 Nutrient Content Claims Identical to Codex Guidelines 䝁䞊䝕䝑䜽䝇䜺䜲䝗䝷䜲䞁䛻㡰䛪䜛 Conditions defined ᰤ㣴⣲ྵ᭷㔞ᙉㄪ⾲♧ ⾲♧つᐃ䛒䜚 Nutrient Comparative Claims ᰤ㣴⣲ẚ㍑ᙉㄪ⾲♧ Conditions defined ⾲♧つᐃ䛒䜚 Non-addition Claims 䠄Non-addition of Sugars/Sodium Salts䠅 Conditions defined ↓ῧຍ⾲♧䠄⢾㢮䠋䝘䝖䝸䜴䝮 ሷ䛾↓ῧຍ䠅 ⾲♧つᐃ䛒䜚 Sri Lanka Nutrition Claim Regulations-2 䝇䝸䝷䞁䜹 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ 䝇䝸䝷䞁䜹 Chief Food Authority, Administrations/Compliances for Nutrition Claims䠄Governing Local Bodies Authorities/Agencies䠅 ᰤ㣴ᙉㄪ⾲♧䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻ ᗓᡤ⟶ᙜᒁ䠋ᐁᗇ) Inspections and Penalties ᰝᐹ䛸⨩๎ ୰ኸ㣗ရᒁ ᆅ᪉ᨻᗓ Periodical Inspections Penalties defined ᐃᮇⓗ䛺ᰝᐹ䛒䜚 ⨩๎つᐃ䛒䜚 - 152 - 3.6.2 Sri Lanka Sri Lanka Health Claim Regulations-3.1 䝇䝸䝷䞁䜹 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 ᗣᙉㄪ⾲♧ 䝇䝸䝷䞁䜹 Food Act No.26 of 1980 Food Act (Amendment) No.20 of 1991 Food (Labelling & Advertising) Regulations -2005 Relevant Laws/Regulations 㣗ရἲ No.26, 1980 㣗ရ䠄ಟṇ䠅ἲ No.20, 1991 㣗ရ䠄⾲♧ཬ䜃ᗈ࿌䠅つ๎䚸2005 㛵㐃ἲつ䠋つ๎ Definitions 䠄Collective Name of All prepackaged foods and labeled with claims Foods with Health Claims, if applicable䠅 ᐃ⩏䠄ᗣᙉㄪ⾲♧䜢䛧䛯㣗ရ 䛶䛾ໟ῭䜏㣗ရཬ䜃ᙉㄪ⾲♧䛧䛯㣗ရ 䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾ྡ ⛠䠅 Nutrient Function Claims 䠄Collective Name of the Foods, if applicable䠅 Pre-approval required- None granted yet. ᰤ㣴ᶵ⬟ᙉㄪ⾲♧䠄ᰤ㣴ᶵ⬟⾲ ♧䜢䛧䛯㣗ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛 ሙྜ䛿䛭䛾ྡ⛠䠅 ๓ㄆド䛜ᚲせ 䠄ㄆド䛥䜜䛯䜒䛾䛿↓䛔䠅 Sri Lanka Health Claim Regulations-3.1 䝇䝸䝷䞁䜹 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 ᗣᙉㄪ⾲♧ Other Function Claims䠄Collective Name of the Foods, if applicable䠅 䛭䛾䛾ᶵ⬟ᙉㄪ⾲♧䠄䛾ᶵ⬟⾲ ♧䜢䛧䛯㣗ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ 䛿䛭䛾ྡ⛠) 䝇䝸䝷䞁䜹 Not specified つᐃ↓䛧 Reduction of Disease Risk Claims 䠄Collective Name of Foods Applied䠅 Not specified 䝸䝇䜽పῶᙉㄪ⾲♧䠄㐺⏝䛥䜜 䜛㣗ရ䜢ᣦ䛩ྡ⛠䠅 Types of Approval/Certification 䠄Standardized/ Pre-authorized Claims䠅 ᢎㄆ䠋ㄆド䛾✀㢮䠄つ᱁ᇶ‽ᆺ䠋 ๓ᢎㄆᆺ䠅 䠄Food Product/Constituent Specific Approval䠅 䠄㣗ရ䠋≉ᐃ䛾⤌ᡂᡂศ䛻ᑐ䛩䜛ᢎ ㄆ䠅 つᐃ↓䛧 Not available 㐺⏝↓䛧 Food (Standards) Regulations-1989 㣗ရ䠄⾲♧ཬ䜃ᗈ࿌䠅つ๎䚸1989 - 153 - 3.6.2 Sri Lanka Sri Lanka Health Claim Regulations-3.2 䝇䝸䝷䞁䜹 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ 䝇䝸䝷䞁䜹 Scientific Substantiation of Health Claims ᗣᙉㄪ⾲♧䛻㛵䛩䜛⛉Ꮫⓗᐇド Process for the Substantiation (Organizational Systems, Governing Authority/Agency/Commission) ᐇド䛾䝥䝻䝉䝇䠄ᑂᰝ⤌⧊䛾ᵓ㐀䚸ᨻ ᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠋ጤဨ䠅 Required to be furnished by manufacturers /sellers for determination by the Committee ጤဨホ౯䛾䛯䜑㣗ရ〇㐀⪅/㈍⪅䛻䜘䜛ドᣐ᭩㢮䛾ᥦฟ䛜ᚲせ Applications when received by the Chief Food Authority ( CFA) with substantiations, referred to Special Sub Committee on Health/ Nutritional Claims for recommendations. 㣗ရᒁ㛗䛾ᥦฟ䛥䜜䛯⏦ㄳ᭩㢮䛿䚸ᰤ㣴/ᗣᙉㄪ⾲♧䛻㛵䛩䜛≉ ูጤဨ䛻ㅎၥ䛥䜜䚸Ỵᐃ䛥䜜䜛 Criteria for the Substantiation and/or Consideration of scientific data available with various specialties Consideration of the Evidence ᐇド䛾ᇶ‽䛚䜘䜃䠋䜎䛯䛿ຠᯝ䛾ホ ౯ ᥦฟ䛥䜜䛯⛉Ꮫⓗドᣐ䛿䚸ྛ㡿ᇦ䛾ᑓ㛛ᐙ䛻䜘䜚᳨ウ䛥䜜䜛 Suitability for young children, elderly, and immuno-compromised Specific Safety Concerns ≉ᐃ䛾Ᏻᛶ䛻㛵䛩䜛㡯 ≉䛻䚸ᗂඣ䚸㧗㱋⪅䚸චຊపୗ⪅䛻ᑐ䛩䜛㐺ษᛶ䛜⪃៖䛥䜜䜛 On customer complaint/ feed-backs Re-evaluation ᾘ㈝⪅䜘䜚䛾ⱞ䚸ሗ࿌➼䛻䜘䜚ᚲせ䛸䛥䜜䛯ሙྜ ホ౯ Sri Lanka Health Claim Regulations-3.2 䝇䝸䝷䞁䜹 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ Product Quality Concerns䠄GMP, ISO, HACCP or Other Measures䠅 〇ရရ㉁䛻㛵䛩䜛㡯䠄GMP, ISO, HACCP 䜎䛯䛿䛾ホ౯ᑻᗘ䠅 Adverse Event Reporting System 䠄Mandatory/ Voluntary䠅 ᭷ᐖ㇟䛻㛵䛩䜛ሗ࿌䝅䝇䝔䝮䠄⩏ ົ䠋௵ព䠅 Administrations/Compliances for Health Claims䠄Governing Authorities/Agencies䠅 ᗣᙉㄪ⾲♧䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ ⟶ᙜᒁ䠋ᐁᗇ䠅 Inspections and Penalties 䝇䝸䝷䞁䜹 GMP, ISO, HACCP GMP, ISO, HACCP ➼䛜່䜑䜙䜜䜛 Voluntary ௵ព Chief Food Authority, Local Authorities, Sri lanka Standards Institution (SLSI), Consumer Affairs Authority (CAA). ୰ኸ㣗ရᒁ䚸ᆅ᪉ᨻᗓ䚸䝇䝸䝷䞁䜹ᇶ‽ᶵ㛵䠄SLSI䠅䚸ᾘ㈝⪅ၥ㢟 ᒁ䠄CAA䠅 Authorized Officers under the Food Act Fine Not less than Rs.5000 and not exceeding Rs. 10,000 and for subsequent offenses cancellation of licenses. ᰝᐹ䛸⨩๎ 㣗ရἲ䛻䜘䜚ㄆᐃ䛥䜜䛯ᰝᐹᐁ䚸⨩㔠䠄RS 5,000-10,000䠅ཬ䜃ච チ䛾ྲྀ䜚ᾘ䛧 - 154 - 3.6.2 Sri Lanka Sri Lanka Health Claim Regulations-3.3 䝇䝸䝷䞁䜹 䠖 ᗣᙉㄪ⾲♧つ๎-3.3 ᗣᙉㄪ⾲♧ Relevant Laws/Regulations for Dietary/Food/Health Supplements 䝎䜲䜶䝍䝸䞊䠋䝣䞊䝗䠋䝦䝹䝇 䝃䝥䝸 䝯䞁䝖䛻㛵䛩䜛㛵㐃ἲつ䠋つ๎ Definitions㸦Dietary Supplements, and/or Food Supplements, and/or Health Supplements㸧 ᐃ⩏㸦ࢲ࢚ࢱ࣮ࣜࢧࣉ࣓ࣜࣥࢺ ࠾ࡼࡧ㸭ࡲࡓࡣࣇ࣮ࢻࢧࣉ࣓ࣜࣥ ࢺ࠾ࡼࡧ㸭ࡲࡓࡣ࣊ࣝࢫࢧࣉ࣓ࣜ ࣥࢺ㸧 Administrations/Compliances for the Supplements 䠄Governing Authorities/Agencies䠅 䝃䝥䝸䝯䞁䝖䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ⟶ ᙜᒁ䠋ᐁᗇ䠅 䝇䝸䝷䞁䜹 Food (Labelling & Advertising )Regulations -2005 㣗ရ䠄⾲♧ཬ䜃ᗈ࿌䠅つ๎䚸2005 In formative stage ᮍ䛰ሗ䛾ẁ㝵䠄つᐃ䛥䜜䛶䛔䛺䛔䠅 CFA, Local Authorities, Nutrition Division of the Medical Research Institute (MRI9) ୰ኸ㣗ရᒁ䚸ᆅ᪉ᨻᗓ䚸་Ꮫ⸆◊✲ᡤ䛾ᰤ㣴㒊㛛䠄Nutrition Division of the Medical Research Institute䠖MRI9䠅 - 155 - - 156 - 3.6.3 Napal Nutrition Labelling and Nutrition/Health Claims ᰤ㣴⾲♧ཬ䜃ᰤ㣴/ᗣᙉㄪ⾲♧ 3.6.3 Federal Democratic Republic of Nepal 䝛䝟䞊䝹㐃㑥Ẹඹᅜ Nepal Nutrition Labelling Regulations-1.1 䝛䝟䞊䝹 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ Nutrient Reference Values (Definitions, NRVs-R/-NCD) ᰤ㣴ཧ↷㔞䠄ᐃ⩏, NRVsR/-NCD䠅 䝛䝟䞊䝹 No specific laws in place governing nutrition labelling. However, the general food products are governed by Food Act (1967) and Food Regulation(1970) ᰤ㣴⾲♧䜢つᐃ䛩䜛≉ᐃ䛾ἲᚊ䛿䛺䛔䚹 䛧䛛䛧䚸୍⯡㣗ရ䛿䚸㣗ရἲ䠄1967䠅ཬ䜃㣗ရつ๎䠄1970䠅䛷つᐃ䛥䜜䛶䛔䜛 Not specified つᐃ↓䛧 Voluntary. Mandatory when nutrition / heath claims are made. According to general food laws any nutrients, vitamins or minerals added shall be Nutrient Declaration (Application: Mandatory specified in label or Voluntary) ᰤ㣴⾲♧䠄㐺⏝䠖 ⩏ົ 䜒 䛧䛟䛿 ௵ព䠅 ௵ព䛷䛒䜛 ణ䛧䚸ᰤ㣴䠋ᗣᙉㄪ⾲♧䜢⾜䛖㝿䛿⾲♧䛿⩏ົ䛷䛒䜛䚹 ୍⯡㣗ရἲ䛻ᚑ䛔䚸ῧຍ䛥䜜䛯䚸䛔䛛䛺䜛ᰤ㣴⣲䚸䝡䝍䝭䞁䚸䝭䝛䝷䝹䜒䚸䝷䝧 䝹䛻᫂♧䛥䜜䛺䛡䜜䜀䛔䛡䛺䛔 - 157 - 3.6.3 Napal Nepal Nutrition Labelling Regulations-1.1 䝛䝟䞊䝹 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ Food Categories Applied 䝛䝟䞊䝹 General food labelling requirements applied to all prepackaged foods 㐺⏝䛥䜜䜛㣗ရ䜹䝔䝂䝸䞊 Exemptions (Food Categories) 㐺⏝㝖እ䠄㣗ရ䜹䝔䝂 䝸䞊䠅 (Size of Food Business Operators) 䠄㣗ရᴗ⪅䛾つᶍ䠅 Listing of Nutrients (Nutrients, Order) ୍⯡㣗ရ䛾⾲♧せ௳䛿䚸䛩䜉䛶䛾ໟ㣗ရ䛻㐺⏝䛥䜜䜛 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 The general food law has the provision that the label of food that claims to contain vitamins, minerals or other nutritional substances shall clearly specify each in the prescribed unit(Schedule-9) ᰤ㣴ᡂศ䝸䝇䝖 䠄ᰤ㣴ᡂ ศ䚸 グ㍕㡰䠅 ୍⯡㣗ရἲ䛻䛿䚸䝡䝍䝭䞁䜔䝭䝛䝷䝹䚸䛭䛾ᰤ㣴≀㉁䛾ྵ᭷䜽䝺䞊䝮䜢 ⾜䛖㣗ရ䛾⾲♧䛿䚸ྛ䚻つᐃ䛥䜜䛶䛔䜛༢䠄⾲9ཧ↷䠅䛷䚸䛿䛳䛝䜚䛸᫂ ♧䛥䜜䛺䛡䜜䜀䛺䜙䛺䛔䛸䛔䛖つᐃ䛜䛒䜛 Optional Ingredients 䛭䛾䛾ᰤ㣴ᡂศ Not specified つᐃ↓䛧 Nepal Nutrition Labelling Regulations-1.2 䝛䝟䞊䝹 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ 䝛䝟䞊䝹 Presentation of Nutrient Content (Expression per 100g/ml or serving or package) ᰤ㣴ᡂศ㔞䛾⾲♧᪉ἲ 䠄⾲♧᪉ἲ 100g/ml 䚸1䝃䞊䝡䞁䜾䚸 ཪ䛿1ໟศ䛒䛯䜚䠅 (Expression in Exact values or Ranges) Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 䠄⾲♧䛩䜛್䠖୍ᐃ್䜒䛧䛟䛿ᖜ⾲♧䠅 (Analysis or Calculation Basis) 䠄ศᯒ್䜒䛧䛟䛿ィ⟬್䠅 Use of Food Composition Table/ Database for Presentation of Nutrients ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲䠋 䝕䞊䝍䝧䞊䝇 䛾⏝ Food Composition Table/Database for Presentation of Nutrients ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲䠋 䝕䞊䝍䝧䞊䝇 Not specified - 158 - つᐃ↓䛧 3.6.3 Napal Nepal Nutrition Labelling Regulations-1.2 䝛䝟䞊䝹 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ 䝛䝟䞊䝹 Publication of National Nutrition Program under the Department of Food Technology and Quality Control(DFTQC) is referred for calculation. Calculation of Nutrients (Energy/Protein/ Carbohydrate/Fat) ᰤ㣴ᡂศ䛾ィ⟬ 䠄䜶䝛䝹䜼䞊 䠋䛯䜣䜁䛟㉁䠋ⅣỈ≀䠋⬡㉁) Tolerances and Compliances (Tolerance Limits) 㣗ရᢏ⾡䞉ရ㉁⟶⌮ᒁ䠄DFTQC䠅䛜බ⾲䛧䛶䛔䜛䝛䝟䞊䝹ᰤ㣴䝥 䝻䜾䝷䝮䛿䚸ᰤ㣴ィ⟬䛻㛵㐃䛧䛶䛔䜛 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 බᕪ䛸㐺ྜᛶ䠄ㄗᕪ⠊ᅖ䠅 Specific Features of Presentation (Format, %NRV Labelling) ⾲♧᪉ἲ䛾≉Ⰽ 䠄䝣䜷䞊䝬䝑 䝖䚸%NRV䚸⾲♧䠅 (Front of Package Labelling, FOP) 䠄䝟䝑䜿䞊䝆ṇ㠃䛾⾲♧䚸FOP䠅 Nepal Nutrition Labelling Regulations-1.3 䝛䝟䞊䝹 䠖 ᰤ㣴⾲♧ᇶ‽-1.3 ᰤ㣴⾲♧ 䝛䝟䞊䝹 Governance of Nutrition Labelling is not in practice. Administrations/Complianc However general labelling under food regulation is governed by DFTQC es for Nutrition Labelling (Governing Authorities/Agencies) ᰤ㣴⾲♧䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻ ᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠅 ᰤ㣴⾲♧䛾⟶⌮䛿䚸ᐇ㝿䛻䛿⾜䜟䜜䛶䛔䛺䛔䚹䛧䛛䛧㣗ရつ๎䛻䜒䛸 䛵䛟୍⯡⾲♧䛿䚸㣗ရᢏ⾡䞉ရ㉁⟶⌮ᒁ䛻䜘䛳䛶⟶⌮䛥䜜䛶䛔䜛䚹 Inspection for general labeling is done periodically by DFTQC. Inspections and Penalties ᰝᐹ䛸⨩๎ ୍⯡⾲♧䛾ᰝᐹ䛿䚸ᐃᮇⓗ䛻㣗ရᢏ⾡䞉ရ㉁⟶⌮ᒁ䛻䜘䛳䛶ᐇ䛥 䜜䛶䛔䜛䚹䛧䛛䛧䚸ᰤ㣴⾲♧䛾ᰝᐹ䛻㛵䛧䛶䚸≉ᐃ䛾䝥䝻䜾䝷䝮䛿䛺䛔 - 159 - 3.6.3 Napal Nepal Nutrition Claim Regulations-2 䝛䝟䞊䝹 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ Definitions (Nutrient Content/Comparative Claims) 䝛䝟䞊䝹 No specific Law and Regulation for nutrition claims. The only act enacted in the sector of food quality is Food Act 1967 and Food Regulation 1970 ᰤ㣴䜽䝺䞊䝮䛻㛵䛩䜛≉ᐃ䛾ἲ௧䜔つ๎䛿䛺䛔䚹 㣗ရရ㉁䛾㒊㛛䛻䛚䛔䛶ไᐃ䛥䜜䛶䛔䜛ἲ௧䛿䚸㣗ရἲ䠄1967䠅ཬ䜃㣗ရ つ๎䠄1970䠅䛾䜏䛷䛒䜛 Not defined つᐃ↓䛧 Not defined つᐃ↓䛧 Not defined つᐃ↓䛧 Not defined つᐃ↓䛧 ᐃ⩏䠄ᰤ㣴⣲ྵ᭷㔞䠋ẚ㍑ ᙉㄪ⾲♧䠅 Nutrient Content Claims ᰤ㣴⣲ྵ᭷㔞ᙉㄪ⾲♧ Nutrient Comparative Claims ᰤ㣴⣲ẚ㍑ᙉㄪ⾲♧ Non-addition Claims 䠄Non-addition of Sugars/Sodium Salts䠅 ↓ῧຍ⾲♧䠄⢾㢮䠋䝘䝖䝸䜴 䝮ሷ䛾↓ῧຍ䠅 Nepal Nutrition Claim Regulations-2 䝛䝟䞊䝹 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ 䝛䝟䞊䝹 Department of Food Technology and Quality Control is the authority to Administrations/Compliances govern general food products. But there is no special focus on Nutrition for Nutrition Claims Claims. 䠄Governing Authorities/Agencies䠅 ᰤ㣴ᙉㄪ⾲♧䛾⾜ᨻ䠋㡰Ᏺ 䠄ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ) Inspections and Penalties ᰝᐹ䛸⨩๎ 㣗ရᢏ⾡䞉ရ㉁⟶⌮ᒁ䛜୍⯡㣗ရ䛾┘╩ᐁᗇ䛷䛒䜛䚹䛧䛛䛧ᰤ 㣴䜽䝺䞊䝮䛻ᑐ䛧≉ู䚸㔜Ⅼ䛿⨨䛔䛶䛔䛺䛔 No inspection schedule for Nutrition Claims. No provision of Penalties. ᰤ㣴䜽䝺䞊䝮䛾ᰝᐹ䝇䜿䝆䝳䞊䝹䛿䛺䛔䚹⨩๎つᐃ䜒䛺䛔 - 160 - 3.6.3 Napal Nepal Health Claim Regulations-3.1 䝛䝟䞊䝹 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 ᗣᙉㄪ⾲♧ Relevant Laws/Regulations 䝛䝟䞊䝹 No Laws and Regulations exist to govern Health Claims. The prevailing laws on general foods are: Food Act (1967) Food Regulation(1970) 㛵㐃ἲつ䠋つ๎ 䝦䝹䝇䜽䝺䞊䝮䜢⟶⌮䛩䜛ἲ௧䜔つ๎䛿䛺䛔 ୍⯡㣗ရ䛻㛵䛩䜛୍⯡ⓗ䛺ἲ௧䛿䚸㣗ရἲ䠄1967䠅ཬ䜃㣗ရつ๎䠄1970 Definitions 䠄Collective Name of Foods with Health Claims, if applicable䠅 Not defined ᐃ⩏䠄ᗣᙉㄪ⾲♧䜢䛧 䛯㣗ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛 ሙྜ䛿䛭䛾ྡ⛠䠅 つᐃ↓䛧 Nepal Health Claim Regulations-3.1 䝛䝟䞊䝹 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 ᗣᙉㄪ⾲♧ 䝛䝟䞊䝹 Nutrient Function Claims䠄Collective Name of the Foods, if applicable䠅 ᰤ㣴ᶵ⬟ᙉㄪ⾲♧䠄ᰤ㣴ᶵ⬟⾲♧䜢䛧䛯㣗ရ䜢 ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾ྡ⛠䠅 Not defined つᐃ↓䛧 Not defined つᐃ↓䛧 Not defined つᐃ↓䛧 Not defined つᐃ↓䛧 Not defined つᐃ↓䛧 Other Function Claims䠄Collective Name of the Foods, if applicable䠅 䛭䛾䛾ᶵ⬟ᙉㄪ⾲♧䠄䛾ᶵ⬟⾲♧䜢䛧䛯㣗 ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾ྡ⛠) Reduction of Disease Risk Claims䠄Collective Name of Foods Applied䠅 䝸䝇䜽పῶᙉㄪ⾲♧䠄㐺⏝䛥䜜䜛㣗ရ䜢ᣦ䛩 ྡ⛠䠅 Types of Approval/Certification䠄Standardized/ Pre-authorized Claims䠅 ᢎㄆ䠋ㄆド䛾✀㢮䠄つ᱁ᇶ‽ᆺ䠋 ๓ᢎㄆᆺ䠅 䠄Food Product/Constituent Specific Approval䠅 䠄㣗ရ䠋≉ᐃ䛾⤌ᡂᡂศ䛻ᑐ䛩䜛ᢎㄆ䠅 - 161 - 3.6.3 Napal ᗣᙉㄪ⾲♧ Nepal Health Claim Regulations-3.2 䝛䝟䞊䝹 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 䝛䝟䞊䝹 Scientific Substantiation of Health Claims No provision ᗣᙉㄪ⾲♧䛻㛵䛩䜛⛉Ꮫⓗᐇド Process for the Substantiation (Organizational Systems, Governing Authority/Agency/Commission) つᐃ↓䛧 No provision つᐃ↓䛧 No provision つᐃ↓䛧 No provision つᐃ↓䛧 No provision つᐃ↓䛧 ᐇド䛾䝥䝻䝉䝇䠄ᑂᰝ⤌⧊䛾ᵓ㐀䚸 ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠋ጤဨ䠅 Criteria for the Substantiation and/or Consideration of the Evidence ᐇド䛾ᇶ‽䛚䜘䜃䠋䜎䛯䛿ຠᯝ䛾 ホ౯ Specific Safety Concerns ≉ᐃ䛾Ᏻᛶ䛻㛵䛩䜛㡯 Re-evaluation ホ౯ Nepal Health Claim Regulations-3.2 䝛䝟䞊䝹 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ Product Quality Concerns䠄GMP, ISO, HACCP or Other Measures䠅 〇ရရ㉁䛻㛵䛩䜛㡯䠄GMP, ISO, HACCP 䜎䛯䛿䛾ホ౯ᑻᗘ䠅 䝛䝟䞊䝹 No mandatory provision for certification of such products. Even for general food products, there is no mandatory provision. 〇ရ䛾ㄆド䛻㛵䛩䜛⩏ົⓗ䛺つᐃ䛿䛺䛔䚹୍⯡㣗ရ䛻䛴䛔䛶䜒䚸 ⩏ົⓗ䛺つᐃ䛿䛺䛔 Adverse Event Reporting System 䠄Mandatory/ Voluntary䠅 ᭷ᐖ㇟䛻㛵䛩䜛ሗ࿌䝅䝇䝔䝮䠄⩏ ົ䠋௵ព䠅 Administrations/Compliances for Health Claims䠄Governing Authorities/Agencies䠅 No provision No Governing Authorities for Health Claims 䝦䝹䝇䜽䝺䞊䝮┘╩ᐁᗇ䛺䛧 ᗣᙉㄪ⾲♧䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓ ᡤ⟶ᙜᒁ䠋ᐁᗇ䠅 Inspections and Penalties ᰝᐹ䛸⨩๎ つᐃ↓䛧 No Schedule for Periodical Inspection of Health Claim products 䝦䝹䝇䜽䝺䞊䝮䜢ㅻ䛖〇ရ䛾ᐃᮇⓗ䛺ᰝᐹ䝇䜿䝆䝳䞊䝹䛿䛺䛔 - 162 - 3.6.3 Napal Nepal Health Claim Regulations-3.3 䝛䝟䞊䝹 䠖 ᗣᙉㄪ⾲♧つ๎-3.3 ᗣᙉㄪ⾲♧ Relevant Laws/Regulations for Dietary/Food/Health Supplements 䝎䜲䜶䝍䝸䞊䠋䝣䞊䝗䠋䝦䝹䝇 䝃䝥䝸 䝯䞁䝖䛻㛵䛩䜛㛵㐃ἲつ䠋つ๎ Definitions㸦Dietary Supplements, and/or Food Supplements, and/or Health Supplements㸧 ᐃ⩏㸦ࢲ࢚ࢱ࣮ࣜࢧࣉ࣓ࣜࣥࢺ ࠾ࡼࡧ㸭ࡲࡓࡣࣇ࣮ࢻࢧࣉ࣓ࣜࣥ ࢺ࠾ࡼࡧ㸭ࡲࡓࡣ࣊ࣝࢫࢧࣉ࣓ࣜ ࣥࢺ㸧 Administrations/Compliances for the Supplements 䠄Governing Authorities/Agencies䠅 䝃䝥䝸䝯䞁䝖䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ⟶ ᙜᒁ䠋ᐁᗇ䠅 䝛䝟䞊䝹 No Laws Governing such products 㐺⏝ἲ௧↓䛧 Such products are not included in the definition of prevailing food laws. Even there is no separate laws governing these products. ୍⯡ⓗ䛺㣗ရἲ䛾ᐃ⩏䛻ྵ䜎䜜䛺䛔䚹ู䛾ἲ௧䜒䛺䛔 No Authority in place for the administration of these categories of products ┘╩ᐁᗇ䛺䛧 - 163 - - 164 - 3.6.4 Bangladesh Nutrition Labelling and Nutrition/Health Claims ᰤ㣴⾲♧ཬ䜃ᰤ㣴/ᗣᙉㄪ⾲♧ 3.6.4 People’s Republic of Bangladesh 䝞䞁䜾䝷䝕䝅䝳ேẸඹᅜ Bangladesh Nutrition Labelling Regulations-1.1 䝞䞁䜾䝷䝕䝅䝳 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ Nutrient Reference Values (Definitions, NRVs-R/-NCD) ᰤ㣴ཧ↷㔞䠄ᐃ⩏, NRVsR/-NCD䠅 䝞䞁䜾䝷䝕䝅䝳 The Bangladesh Pure Food Ordinance ( 1959) Bangladesh New Food Safety Laws ( 2010) Bangladesh Food & Nutrition Policy ,(1997) 䝞䞁䜾䝷䝕䝅䝳⣧⢋㣗ရἲ௧ 㻔㻝㻥㻡㻥㻕 䝞䞁䜾䝷䝕䝅䝳᪂㣗ရᏳἲ 㻔㻞㻜㻝㻜㻕 䝞䞁䜾䝷䝕䝅䝳㣗ရ䛚䜘䜃ᰤ㣴᪉㔪 㻔㻝㻥㻥㻣㻕 No information available. Generally Codex guidelines and PFA India rules followed ሗ䛺䛧䚹୍⯡䛻䚸CODEXᇶ‽䛸䜲䞁䝗䛾㣗ရởᰁ㜵Ṇἲ䠄PFA [Prevention of Food Adulteration] India rules䠅䛻‽ᣐ䛧䛶䛔䜛 Nutrient Declaration (Application: Mandatory Voluntary. Not specified or Voluntary) ᰤ㣴⾲♧䠄㐺⏝䠖 ⩏ົ 䜒 䛧䛟䛿 ௵ព䠅 ௵ព䛷䛒䜚䚸つᐃ↓䛧 - 165 - 3.6.4 Bangladesh Bangladesh Nutrition Labelling Regulations-1.1 䝞䞁䜾䝷䝕䝅䝳 䠖 ᰤ㣴⾲♧ᇶ‽-1.1 ᰤ㣴⾲♧ 䝞䞁䜾䝷䝕䝅䝳 Food Categories Applied Not specified. Guidelines under BSTI Amendment Act 2003 つᐃ↓䛧 BSTI䠄Bangladesh Standards & Testing Institution䠅 ಟṇἲ 2003 䛾ୗ䛷䛾䜺 䜲䝗䝷䜲䞁䛜䛒䜛 㐺⏝䛥䜜䜛㣗ရ䜹䝔䝂䝸䞊 Exemptions (Food Categories) 㐺⏝㝖እ䠄㣗ရ䜹䝔䝂 䝸䞊䠅 Not applicable 㐺⏝↓䛧 (Size of Food Business Operators) 䠄㣗ရᴗ⪅䛾つᶍ䠅 Not applicable 㐺⏝↓䛧 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Listing of Nutrients (Nutrients, Order) ᰤ㣴ᡂศ䝸䝇䝖 䠄ᰤ㣴ᡂ ศ䚸 グ㍕㡰䠅 Optional Ingredients 䛭䛾䛾ᰤ㣴ᡂศ Bangladesh Nutrition Labelling Regulations-1.2 䝞䞁䜾䝷䝕䝅䝳 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ 䝞䞁䜾䝷䝕䝅䝳 Presentation of Nutrient Content (Expression per 100g/ml or serving or package) ᰤ㣴ᡂศ㔞䛾⾲♧᪉ἲ 䠄⾲♧᪉ἲ 100g/ml 䚸1䝃䞊䝡䞁䜾䚸 ཪ䛿1ໟศ䛒䛯䜚䠅 (Expression in Exact values or Ranges) Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 No provision つᐃ↓䛧 Not available ヱᙜ↓䛧 䠄⾲♧䛩䜛್䠖୍ᐃ್䜒䛧䛟䛿ᖜ⾲♧䠅 (Analysis or Calculation Basis) 䠄ศᯒ್䜒䛧䛟䛿ィ⟬್䠅 Use of Food Composition Table/ Database for Presentation of Nutrients ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲䠋 䝕䞊䝍䝧䞊䝇 䛾⏝ Food Composition Table/Database for Presentation of Nutrients ᰤ㣴⾲♧䛾䛯䜑䛾㣗ရᡂศ⾲䠋 䝕䞊䝍䝧䞊䝇 - 166 - 3.6.4 Bangladesh Bangladesh Nutrition Labelling Regulations-1.2 䝞䞁䜾䝷䝕䝅䝳 䠖 ᰤ㣴⾲♧ᇶ‽-1.2 ᰤ㣴⾲♧ 䝞䞁䜾䝷䝕䝅䝳 Calculation of Nutrients (Energy/Protein/ Carbohydrate/Fat) No provision つᐃ↓䛧 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 ᰤ㣴ᡂศ䛾ィ⟬ 䠄䜶䝛䝹䜼䞊 䠋䛯䜣䜁䛟㉁䠋ⅣỈ≀䠋⬡㉁) Tolerances and Compliances (Tolerance Limits) බᕪ䛸㐺ྜᛶ䠄ㄗᕪ⠊ᅖ䠅 Specific Features of Presentation (Format, %NRV Labelling) ⾲♧᪉ἲ䛾≉Ⰽ 䠄䝣䜷䞊䝬䝑 䝖䚸%NRV䚸⾲♧䠅 (Front of Package Labelling, FOP) 䠄䝟䝑䜿䞊䝆ṇ㠃䛾⾲♧䚸FOP䠅 Bangladesh Nutrition Labelling Regulations-1.3 䝞䞁䜾䝷䝕䝅䝳 䠖 ᰤ㣴⾲♧ᇶ‽-1.3 ᰤ㣴⾲♧ 䝞䞁䜾䝷䝕䝅䝳 Bangladesh Standards and Testing Institution Administrations/Complianc Local Governments es for Nutrition Labelling (Governing Authorities/Agencies) ᰤ㣴⾲♧䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻ ᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠅 Inspections and Penalties ᰝᐹ䛸⨩๎ 䝞䞁䜾䝷䝕䝅䝳ᶆ‽䞉ヨ㦂ᶵ㛵䠄Bangladesh Standards & Testing Institution: BSTI䠅 ᆅ᪉ᨻᗓ Periodical inspections and Penalties defined for general violations of laws. ᐃᮇᰝᐹ䛸୍⯡ⓗ䛺ἲᚊ㐪䛻క䛖⨩๎ - 167 - 3.6.4 Bangladesh Bangladesh Nutrition Claim Regulations-2 䝞䞁䜾䝷䝕䝅䝳 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ 䝞䞁䜾䝷䝕䝅䝳 Relevant Laws/Regulations The Bangladesh Pure Food Rules (1967) 㛵㐃ἲつ䠋つ๎ 䝞䞁䜾䝷䝕䝅䝳⣧⢋㣗ရつᐃ(1967) Definitions (Nutrient Content/Comparative Claims) Codex Guidelines are referred CODEX 䜺䜲䝗䝷䜲䞁䛻‽ᣐ ᐃ⩏䠄ᰤ㣴⣲ྵ᭷㔞䠋ẚ㍑ ᙉㄪ⾲♧䠅 Nutrient Content Claims ᰤ㣴⣲ྵ᭷㔞ᙉㄪ⾲♧ Nutrient Comparative Claims ᰤ㣴⣲ẚ㍑ᙉㄪ⾲♧ Non-addition Claims 䠄Non-addition of Sugars/Sodium Salts䠅 Not defined つᐃ↓䛧 Not defined つᐃ↓䛧 Not defined つᐃ↓䛧 ↓ῧຍ⾲♧䠄⢾㢮䠋䝘䝖䝸䜴 䝮ሷ䛾↓ῧຍ䠅 Bangladesh Nutrition Claim Regulations-2 䝞䞁䜾䝷䝕䝅䝳 䠖 ᰤ㣴ᙉㄪ⾲♧つ๎-2 ᰤ㣴ᙉㄪ⾲♧ 䝞䞁䜾䝷䝕䝅䝳 Administrations/Compliances Bangladesh Standards & Testing Institution Local Governments for Nutrition Claims 䠄Governing Authorities/Agencies䠅 䝞䞁䜾䝷䝕䝅䝳ᶆ‽䞉ヨ㦂ᶵ㛵䠄Bangladesh Standards & ᰤ㣴ᙉㄪ⾲♧䛾⾜ᨻ䠋㡰Ᏺ 䠄ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ) Inspections and Penalties ᰝᐹ䛸⨩๎ Testing Institution: BSTI䠅 ᆅ᪉ᨻᗓ Not specified つᐃ↓䛧 - 168 - 3.6.4 Bangladesh Bangladesh Health Claim Regulations-3.1 䝞䞁䜾䝷䝕䝅䝳 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 ᗣᙉㄪ⾲♧ Relevant Laws/Regulations 㛵㐃ἲつ䠋つ๎ 䝞䞁䜾䝷䝕䝅䝳 No regulation available ≉ᐃ䛾つ๎↓䛧 Definitions 䠄Collective Name of Foods with Health Claims, if applicable䠅 Not defined ᐃ⩏䠄ᗣᙉㄪ⾲♧䜢䛧 䛯㣗ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛 ሙྜ䛿䛭䛾ྡ⛠䠅 つᐃ↓䛧 Bangladesh Health Claim Regulations-3.1 䝞䞁䜾䝷䝕䝅䝳 䠖 ᗣᙉㄪ⾲♧つ๎-3.1 ᗣᙉㄪ⾲♧ 䝞䞁䜾䝷䝕䝅䝳 Nutrient Function Claims䠄Collective Name of the Foods, if applicable䠅 ᰤ㣴ᶵ⬟ᙉㄪ⾲♧䠄ᰤ㣴ᶵ⬟⾲♧䜢䛧䛯㣗ရ䜢 ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾ྡ⛠䠅 Not defined つᐃ↓䛧 Not defined つᐃ↓䛧 Not defined つᐃ↓䛧 Not defined つᐃ↓䛧 Not defined つᐃ↓䛧 Other Function Claims䠄Collective Name of the Foods, if applicable䠅 䛭䛾䛾ᶵ⬟ᙉㄪ⾲♧䠄䛾ᶵ⬟⾲♧䜢䛧䛯㣗 ရ䜢ᣦ䛩ྡ⛠䛜᭷䜛ሙྜ䛿䛭䛾ྡ⛠) Reduction of Disease Risk Claims䠄Collective Name of Foods Applied䠅 䝸䝇䜽పῶᙉㄪ⾲♧䠄㐺⏝䛥䜜䜛㣗ရ䜢ᣦ䛩 ྡ⛠䠅 Types of Approval/Certification䠄Standardized/ Pre-authorized Claims䠅 ᢎㄆ䠋ㄆド䛾✀㢮䠄つ᱁ᇶ‽ᆺ䠋 ๓ᢎㄆᆺ䠅 䠄Food Product/Constituent Specific Approval䠅 䠄㣗ရ䠋≉ᐃ䛾⤌ᡂᡂศ䛻ᑐ䛩䜛ᢎㄆ䠅 - 169 - 3.6.4 Bangladesh Bangladesh Health Claim Regulations-3.2 䝞䞁䜾䝷䝕䝅䝳 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ 䝞䞁䜾䝷䝕䝅䝳 Scientific Substantiation of Health Claims Not specified ᗣᙉㄪ⾲♧䛻㛵䛩䜛⛉Ꮫⓗᐇド Process for the Substantiation (Organizational Systems, Governing Authority/Agency/Commission) つᐃ↓䛧 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 Not specified つᐃ↓䛧 ᐇド䛾䝥䝻䝉䝇䠄ᑂᰝ⤌⧊䛾ᵓ㐀䚸 ᨻᗓᡤ⟶ᙜᒁ䠋ᐁᗇ䠋ጤဨ䠅 Criteria for the Substantiation and/or Consideration of the Evidence ᐇド䛾ᇶ‽䛚䜘䜃䠋䜎䛯䛿ຠᯝ䛾 ホ౯ Specific Safety Concerns ≉ᐃ䛾Ᏻᛶ䛻㛵䛩䜛㡯 Re-evaluation ホ౯ Bangladesh Health Claim Regulations-3.2 䝞䞁䜾䝷䝕䝅䝳 䠖 ᗣᙉㄪ⾲♧つ๎-3.2 ᗣᙉㄪ⾲♧ Product Quality Concerns䠄GMP, ISO, HACCP or Other Measures䠅 〇ရရ㉁䛻㛵䛩䜛㡯䠄GMP, ISO, HACCP 䜎䛯䛿䛾ホ౯ᑻᗘ䠅 䝞䞁䜾䝷䝕䝅䝳 Bangladesh New Food Safety laws ( 2010) – general guidelines 䝞䞁䜾䝷䝕䝅䝳᪂㣗ရᏳἲ( 2010) 䇵 ୍⯡ⓗ䛺䜺䜲䝗䝷䜲䞁 Adverse Event Reporting System 䠄Mandatory/ Voluntary䠅 ᭷ᐖ㇟䛻㛵䛩䜛ሗ࿌䝅䝇䝔䝮䠄⩏ ົ䠋௵ព䠅 Administrations/Compliances for Health Claims䠄Governing Authorities/Agencies䠅 ᗣᙉㄪ⾲♧䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓ ᡤ⟶ᙜᒁ䠋ᐁᗇ䠅 No provision Bangladesh Standards & Testing Institution and Local Governments 䝞䞁䜾䝷䝕䝅䝳ᶆ‽䞉ヨ㦂ᶵ㛵䠄Bangladesh Standards & Testing Institution: BSTI䠅 ᆅ᪉ᨻᗓ Inspections and Penalties ᰝᐹ䛸⨩๎ つᐃ↓䛧 Not specified - 170 - つᐃ↓䛧 3.6.4 Bangladesh Bangladesh Health Claim Regulations-3.3 䝞䞁䜾䝷䝕䝅䝳 䠖 ᗣᙉㄪ⾲♧つ๎-3.3 ᗣᙉㄪ⾲♧ Relevant Laws/Regulations for Dietary/Food/Health Supplements 䝎䜲䜶䝍䝸䞊䠋䝣䞊䝗䠋䝦䝹䝇 䝃䝥䝸 䝯䞁䝖䛻㛵䛩䜛㛵㐃ἲつ䠋つ๎ Definitions㸦Dietary Supplements, and/or Food Supplements, and/or Health Supplements㸧 ᐃ⩏㸦ࢲ࢚ࢱ࣮ࣜࢧࣉ࣓ࣜࣥࢺ ࠾ࡼࡧ㸭ࡲࡓࡣࣇ࣮ࢻࢧࣉ࣓ࣜࣥ ࢺ࠾ࡼࡧ㸭ࡲࡓࡣ࣊ࣝࢫࢧࣉ࣓ࣜ ࣥࢺ㸧 Administrations/Compliances for the Supplements 䠄Governing Authorities/Agencies䠅 䝃䝥䝸䝯䞁䝖䛾⾜ᨻ䠋㡰Ᏺ䠄ᨻᗓᡤ⟶ ᙜᒁ䠋ᐁᗇ䠅 䝞䞁䜾䝷䝕䝅䝳 Not specifically defined, Treated in the same manner as foods ≉ᐃ䛾㐺⏝ἲ௧䛿↓䛟䚸㣗ရ䛸ྠᵝ䛻ྲྀ䜚ᢅ䜟䜜䜛 Not specifically defined, Treated in the same manner as foods ≉ᐃ䛾㐺⏝ἲ௧䛿↓䛟䚸㣗ရ䛸ྠᵝ䛻ྲྀ䜚ᢅ䜟䜜䜛 Not specifically defined, Treated in the same manner as foods ≉ᐃ䛾㐺⏝ἲ௧䛿↓䛟䚸㣗ရ䛸ྠᵝ䛻ྲྀ䜚ᢅ䜟䜜䜛 - 171 - - 172 -
© Copyright 2026 Paperzz