1. data.fda.gov.tw
  2. 食品法規條文資料集
  3. 1416682
column value
類別 食品製造及衛生安全管理
法規性質 法規命令
法規名稱 食品安全管制系統準則
條文內容 <p class="1" style="text-align: center; margin: 6pt 0cm; line-height: 23pt; mso-line-height-rule: exactly;"><b style="mso-bidi-font-weight: normal;"><span style="font-size: 24pt; font-family: 標楷體;">食品安全管制系統準則<span lang="EN-US"><o:p></o:p></span></span></b></p><p class="1" style="text-align: right; margin: 6pt 0cm 0pt 162.95pt; line-height: 23pt; mso-line-height-rule: exactly; mso-para-margin-top: 6.0pt; mso-para-margin-right: 0cm; mso-para-margin-bottom: .0001pt; mso-para-margin-left: 11.64gd;"><span style="font-size: 10pt; font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';"><br />中華民國</span><span lang="EN-US" style="font-size: 10pt;">103</span><span style="font-size: 10pt; font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">年</span><span lang="EN-US" style="font-size: 10pt;">3</span><span style="font-size: 10pt; font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">月</span><span lang="EN-US" style="font-size: 10pt;">11</span><span style="font-size: 10pt; font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">日部授食字第</span><span lang="EN-US" style="font-size: 10pt;">1031300488</span><span style="font-size: 10pt; font-family: 標楷體;">號令訂定<br /></span><span lang="EN-US" style="font-size: 10pt;"><o:p></o:p></span></p><p class="1" style="text-align: right; margin: 0cm 0cm 0pt; line-height: normal;"><span lang="EN-US" style="font-size: 10pt; color: #333333; mso-bidi-font-family: arial;"><o:p>&nbsp;</o:p></span></p><p class="a" style="margin: 0cm 0cm 0pt 70pt; line-height: 21.45pt; text-indent: -70pt; mso-line-height-rule: exactly;"><span style="font-size: 18px; color: #000000;"><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">第　一　條</span><span style="font-size: 13.5pt; font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">　　</span><span style="font-family: 標楷體;">本準則依食品安全衛生管理法（以下簡稱本法）第八條第四項規定訂定之。</span><span lang="EN-US"><o:p></o:p></span></span></p><p class="a" style="margin: 0cm 0cm 0pt 70pt; line-height: 21.45pt; text-indent: -70pt; mso-line-height-rule: exactly;"><span style="font-size: 18px; color: #000000;"><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">第　二　條</span><span style="font-size: 13.5pt; font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">　　</span><span style="font-family: 標楷體;">本準則所稱食品安全管制系統（以下簡稱本系統），指為鑑別、評估及管制食品安全危害，使用危害分析重要管制點原理，管理原料</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">、</span><span style="font-family: 標楷體;">材料之驗收、加工、製造</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">、</span><span style="font-family: 標楷體;">貯存及運送全程之系統。<span lang="EN-US"><o:p></o:p></span></span></span></p><p class="a" style="margin: 0cm 0cm 0pt 99.1pt; line-height: 22.25pt; text-indent: 0cm; mso-line-height-rule: exactly; mso-para-margin-left: 7.08gd; mso-char-indent-count: 0;"><span style="font-size: 18px; color: #000000;"><span style="font-family: 標楷體;">前項系統，包括下列事項</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">：</span><span lang="EN-US"><o:p></o:p></span></span></p><p style="layout-grid-mode: char; text-align: justify; margin: 0cm 0cm 0pt 99.1pt; text-justify: inter-ideograph; line-height: 22.25pt; mso-line-height-rule: exactly; mso-para-margin-top: 0cm; mso-para-margin-right: 0cm; mso-para-margin-bottom: .0001pt; mso-para-margin-left: 7.08gd;"><span style="font-size: 18px; color: #000000;"><span style="font-size: 14pt; font-family: 標楷體;">一</span><span style="font-size: 14pt; font-family: 新細明體;">、</span><span style="font-size: 14pt; font-family: 標楷體;">成立食品安全管制小組<span lang="EN-US">(</span>以下簡稱管制小組<span lang="EN-US">)</span></span><span style="font-size: 14pt; font-family: 新細明體;">。<span lang="EN-US"><o:p></o:p></span></span></span></p><p style="layout-grid-mode: char; margin: 0cm 0cm 0pt 99.1pt; line-height: 22.25pt; mso-line-height-rule: exactly; mso-para-margin-top: 0cm; mso-para-margin-right: 0cm; mso-para-margin-bottom: .0001pt; mso-para-margin-left: 7.08gd;"><span style="font-size: 18px; color: #000000;"><span style="font-size: 14pt; font-family: 標楷體;">二</span><span style="font-size: 14pt; font-family: 新細明體;">、</span><span style="font-size: 14pt; font-family: 標楷體;">執行危害分析</span><span style="font-family: 新細明體;"><span style="font-size: 14pt;">。</span><span lang="EN-US" style="font-size: 14pt; font-family: 標楷體;"><o:p></o:p></span></span></span></p><p style="layout-grid-mode: char; margin: 0cm 0cm 0pt 99.1pt; line-height: 22.25pt; mso-line-height-rule: exactly; mso-para-margin-top: 0cm; mso-para-margin-right: 0cm; mso-para-margin-bottom: .0001pt; mso-para-margin-left: 7.08gd;"><span style="font-size: 18px; color: #000000;"><span style="font-size: 14pt; font-family: 標楷體;">三</span><span style="font-size: 14pt; font-family: 新細明體;">、</span><span style="font-size: 14pt; font-family: 標楷體;">決定重要管制點</span><span style="font-family: 新細明體;"><span style="font-size: 14pt;">。</span><span lang="EN-US" style="font-size: 14pt; font-family: 標楷體;"><o:p></o:p></span></span></span></p><p style="layout-grid-mode: char; margin: 0cm 0cm 0pt 99.1pt; line-height: 22.25pt; mso-line-height-rule: exactly; mso-para-margin-top: 0cm; mso-para-margin-right: 0cm; mso-para-margin-bottom: .0001pt; mso-para-margin-left: 7.08gd;"><span style="font-size: 18px; color: #000000;"><span style="font-size: 14pt; font-family: 標楷體;">四</span><span style="font-size: 14pt; font-family: 新細明體;">、</span><span style="font-size: 14pt; font-family: 標楷體;">建立管制界限</span><span style="font-family: 新細明體;"><span style="font-size: 14pt;">。</span><span lang="EN-US" style="font-size: 14pt; font-family: 標楷體;"><o:p></o:p></span></span></span></p><p style="layout-grid-mode: char; margin: 0cm 0cm 0pt 99.1pt; line-height: 22.25pt; mso-line-height-rule: exactly; mso-para-margin-top: 0cm; mso-para-margin-right: 0cm; mso-para-margin-bottom: .0001pt; mso-para-margin-left: 7.08gd;"><span style="font-size: 18px; color: #000000;"><span style="font-size: 14pt; font-family: 標楷體;">五、研訂及執行監測計畫</span><span style="font-family: 新細明體;"><span style="font-size: 14pt;">。</span><span lang="EN-US" style="font-size: 14pt; font-family: 標楷體;"><o:p></o:p></span></span></span></p><p style="layout-grid-mode: char; margin: 0cm 0cm 0pt 99.1pt; line-height: 22.25pt; mso-line-height-rule: exactly; mso-para-margin-top: 0cm; mso-para-margin-right: 0cm; mso-para-margin-bottom: .0001pt; mso-para-margin-left: 7.08gd;"><span style="font-size: 18px; color: #000000;"><span style="font-size: 14pt; font-family: 標楷體;">六、研訂及執行矯正措施</span><span style="font-family: 新細明體;"><span style="font-size: 14pt;">。</span><span lang="EN-US" style="font-size: 14pt; font-family: 標楷體;"><o:p></o:p></span></span></span></p><p style="layout-grid-mode: char; margin: 0cm 0cm 0pt 99.1pt; line-height: 22.25pt; mso-line-height-rule: exactly; mso-para-margin-top: 0cm; mso-para-margin-right: 0cm; mso-para-margin-bottom: .0001pt; mso-para-margin-left: 7.08gd;"><span style="font-size: 18px; color: #000000;"><span style="font-size: 14pt; font-family: 標楷體;">七、確認本系統執行之有效性</span><span style="font-family: 新細明體;"><span style="font-size: 14pt;">。</span><span lang="EN-US" style="font-size: 14pt; font-family: 標楷體;"><o:p></o:p></span></span></span></p><p class="a" style="margin: 0cm 0cm 0pt 99.1pt; line-height: 22.25pt; text-indent: 0cm; mso-line-height-rule: exactly; mso-para-margin-left: 7.08gd; mso-char-indent-count: 0;"><span style="font-size: 18px; color: #000000;"><span style="font-family: 標楷體; mso-bidi-font-size: 14.0pt;">八、建立本系統執行之文件及紀錄</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman'; mso-bidi-font-size: 14.0pt;">。</span><span lang="EN-US"><o:p></o:p></span></span></p><p class="a" style="margin: 0cm 0cm 0pt 70pt; line-height: 21.45pt; text-indent: -70pt; mso-line-height-rule: exactly;"><span style="font-size: 18px; color: #000000;"><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">第　三　條　　</span> <span style="font-family: 標楷體;">中央主管機關依本法第八條第二項公告之食品業者<span lang="EN-US">(</span>以下簡稱食品業者<span lang="EN-US">)</span>，應成立管制小組，統籌辦理前條第二項第二款至第八款事項</span><span style="font-family: 標楷體; mso-ascii-font-family: 新細明體; mso-hansi-font-family: 新細明體;">。</span><span lang="EN-US" style="font-family: '新細明體','serif'; mso-fareast-font-family: 標楷體;"><o:p></o:p></span></span></p><p class="a" style="margin: 0cm 0cm 0pt 70pt; line-height: 21.45pt; text-indent: 29.1pt; mso-line-height-rule: exactly; mso-para-margin-left: 5.0gd; mso-char-indent-count: 2.08;"><span style="font-size: 18px; color: #000000;"><span style="font-family: 標楷體;">管制小組成員，由食品業者之負責人或其指定人員，及品保、生產、衛生管理人員或其他幹部人員組成，至少三人，其中負責人或其指定人員為必要之成員</span><span style="font-family: 標楷體; mso-ascii-font-family: 新細明體; mso-hansi-font-family: 新細明體;">。</span><span lang="EN-US" style="font-family: '新細明體','serif'; mso-fareast-font-family: 標楷體;"><o:p></o:p></span></span></p><p class="a" style="margin: 0cm 0cm 0pt 70pt; line-height: 21.45pt; text-indent: 29.1pt; mso-line-height-rule: exactly; mso-para-margin-left: 5.0gd; mso-char-indent-count: 2.08;"><span style="font-size: 18px;"><span style="font-family: 標楷體; color: #000000;">前項成員中，至少一人應為食品業者專門職業或技術證照人員設置及管理辦法規定之專門職業人員，並負責規劃及管理本系統執行之文件及紀錄。</span><span lang="EN-US"><o:p></o:p></span></span></p><p class="a" style="margin: 0cm 0cm 0pt 70pt; line-height: 22.25pt; text-indent: -70pt; mso-line-height-rule: exactly;"><span style="font-size: 18px; color: #000000;"><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">第　四　條</span><span style="font-size: 13.5pt; font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">　　</span><span style="font-family: 標楷體;">管制小組成員，應曾接受中央主管機關認可之食品安全管制系統訓練機關<span lang="EN-US">(</span>構<span lang="EN-US">)(</span>以下簡稱訓練機關<span lang="EN-US">(</span>構<span lang="EN-US">))</span>辦理之相關課程至少三十小時，並領有合格證明書</span><span style="font-family: 標楷體; mso-ascii-font-family: 新細明體; mso-hansi-font-family: 新細明體;">；</span><span style="font-family: 標楷體;">從業期間，應持續接受訓練機關<span lang="EN-US">(</span>構<span lang="EN-US">)</span>或其他機關<span lang="EN-US">(</span>構<span lang="EN-US">)</span>辦理與本系統有關之課程，每三年累計至少十二小時。</span><span lang="EN-US"><o:p></o:p></span></span></p><p class="a0" style="margin: 0cm 0cm 0pt 70pt; line-height: 21.85pt; text-indent: 28pt; mso-line-height-rule: exactly;"><span style="font-size: 18px; color: #000000;"><span style="font-family: 標楷體;">前項其他機關<span lang="EN-US">(</span>構<span lang="EN-US">)</span>辦理之課程，應經中央主管機關認可</span><span style="font-family: 標楷體; mso-ascii-font-family: 新細明體; mso-hansi-font-family: 新細明體;">。</span><span lang="EN-US"><o:p></o:p></span></span></p><p class="a" style="margin: 0cm 0cm 0pt 70pt; line-height: 22.25pt; text-indent: -70pt; mso-line-height-rule: exactly;"><span style="font-size: 18px; color: #000000;"><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">第　五　條</span><span style="font-size: 13.5pt; font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">　　</span><span style="font-family: 標楷體;">管制小組應以產品之描述、預定用途及加工流程圖所定步驟為基礎，確認生產現場與流程圖相符，並列出所有可能之生物性、化學性及物理性危害物質，執行危害分析，鑑別足以影響食品安全之因子及發生頻率與嚴重性，研訂危害物質之預防</span><span style="font-family: 標楷體; mso-ascii-font-family: 新細明體; mso-hansi-font-family: 新細明體;">、</span><span style="font-family: 標楷體;">去除及降低措施。<span lang="EN-US"><o:p></o:p></span></span></span></p><p class="a" style="margin: 0cm 0cm 0pt 70pt; line-height: 22.25pt; text-indent: -70pt; mso-line-height-rule: exactly;"><span style="font-size: 18px; color: #000000;"><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">第　六　條</span><span style="font-size: 13.5pt; font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">　　</span><span style="font-family: 標楷體;">管制小組應依前條危害分析獲得之資料，決定重要管制點。<span lang="EN-US"><o:p></o:p></span></span></span></p><p class="a" style="margin: 0cm 0cm 0pt 70pt; line-height: 22.25pt; text-indent: -70pt; mso-line-height-rule: exactly;"><span style="font-size: 18px; color: #000000;"><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">第　七　條</span><span style="font-size: 13.5pt; font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">　　</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-bidi-font-size: 14.0pt;">管制小組應對每一重要管制點建立管制界限，並進行驗效。</span><span lang="EN-US" style="font-family: 標楷體;"><o:p></o:p></span></span></p><p class="a" style="margin: 0cm 0cm 0pt 70pt; line-height: 22.25pt; text-indent: -70pt; mso-line-height-rule: exactly;"><span style="font-size: 18px; color: #000000;"><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">第　八　條</span><span style="font-size: 13.5pt; font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">　　</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-bidi-font-size: 14.0pt;">管制小組應訂定監測計畫，其內容包括每一重要管制點之監測項目、方法、頻率及操作人員。</span><span lang="EN-US" style="font-family: 標楷體;"><o:p></o:p></span></span></p><p class="a" style="margin: 0cm 0cm 0pt 70pt; line-height: 22.25pt; text-indent: -70pt; mso-line-height-rule: exactly;"><span style="font-size: 18px; color: #000000;"><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">第　九　條</span><span style="font-size: 13.5pt; font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">　　</span><span style="font-family: 標楷體;">管制小組應對每一重要管制點，研訂發生系統性變異時之矯正措施；其措施至少包括下列事項：<span lang="EN-US"><o:p></o:p></span></span></span></p><p class="10" style="margin: 0cm 0cm 0pt 127.55pt; line-height: 22.25pt; text-indent: -28.3pt; mso-line-height-rule: exactly; mso-para-margin-left: 7.09gd; mso-char-indent-count: -2.02;"><span style="font-size: 18px; color: #000000;"><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">一、</span><span style="font-family: 標楷體;">引起系統性變異原因之矯正。</span><span lang="EN-US"><o:p></o:p></span></span></p><p class="10" style="margin: 0cm 0cm 0pt 127.55pt; line-height: 22.25pt; text-indent: -28.3pt; mso-line-height-rule: exactly; mso-para-margin-left: 7.09gd; mso-char-indent-count: -2.02;"><span style="font-size: 18px; color: #000000;"><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">二、</span><span style="font-family: 標楷體;">食品因變異致違反本法相關法令規定或有危害健康之虞者，其</span><span style="font-family: 標楷體;">回收、處理及銷毀。</span><span lang="EN-US" style="font-family: 'arial','sans-serif'; mso-hansi-font-family: 標楷體;"><o:p></o:p></span></span></p><p class="10" style="margin: 0cm 0cm 0pt 70.85pt; line-height: 22.25pt; text-indent: 28.3pt; mso-line-height-rule: exactly; mso-para-margin-left: 5.06gd; mso-char-indent-count: 2.02;"><span style="font-size: 18px; font-family: 標楷體; color: #000000;">管制小組於必要時，應對前項變異，重新執行危害分析。<span lang="EN-US"><o:p></o:p></span></span></p><p class="a" style="margin: 0cm 0cm 0pt 70pt; line-height: 22.25pt; text-indent: -70pt; mso-line-height-rule: exactly;"><span style="font-size: 18px; color: #000000;"><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">第　十　條</span><span style="font-size: 13.5pt; font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">　　</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-bidi-font-size: 14.0pt;">管制小組應確認本系統執行之有效性，每年至少進行一次內部稽核。</span><span lang="EN-US" style="font-family: 'arial','sans-serif'; mso-hansi-font-family: 標楷體; mso-bidi-font-size: 14.0pt;"><o:p></o:p></span></span></p><p class="a" style="margin: 0cm 0cm 0pt 70pt; line-height: 22.25pt; text-indent: -70pt; mso-line-height-rule: exactly;"><span style="font-size: 18px; color: #000000;"><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">第 十一 條</span><span style="font-size: 13.5pt; font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">　　</span><span style="font-family: 標楷體;">食品業者應每年至少一次對執行本系統之人員，辦理內部教育訓練</span><span style="font-family: 標楷體; mso-ascii-font-family: 新細明體; mso-hansi-font-family: 新細明體;">。</span><span lang="EN-US" style="font-family: 標楷體;"><o:p></o:p></span></span></p><p class="a" style="margin: 0cm 0cm 0pt 70pt; line-height: 22.25pt; text-indent: -70pt; mso-line-height-rule: exactly;"><span style="font-size: 18px; color: #000000;"><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">第 十二 條　　</span><span style="font-family: 標楷體;">管制小組應就第五條至前條之執行，作成書面紀錄，連同相關文件，彙整為檔案，妥善保存至產品有效日期後六個月</span><span style="font-family: 標楷體; mso-ascii-font-family: arial; mso-bidi-font-family: arial;">。</span><span lang="EN-US" style="font-family: 'arial','sans-serif'; mso-hansi-font-family: 標楷體;"><o:p></o:p></span></span></p><p class="a" style="margin: 0cm 0cm 0pt 70pt; line-height: 22.25pt; text-indent: 29.1pt; mso-line-height-rule: exactly; mso-para-margin-left: 5.0gd; mso-char-indent-count: 2.08;"><span style="font-size: 18px; color: #000000;"><span style="font-family: 標楷體;">前項書面紀錄，應經負責人或其指定人員簽署，並註記日期</span><span style="font-family: '新細明體','serif';">。</span><span lang="EN-US" style="font-family: 標楷體;"><o:p></o:p></span></span></p><p><span style="font-size: 18px; color: #000000;"><span style="font-size: 14pt; font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman'; mso-bidi-font-family: 'times new roman'; mso-bidi-font-size: 10.0pt; mso-ansi-language: en-us; mso-fareast-language: zh-tw; mso-bidi-language: ar-sa;">第 十三 條</span><span style="font-size: 13.5pt; font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman'; mso-bidi-font-family: 'times new roman'; mso-ansi-language: en-us; mso-fareast-language: zh-tw; mso-bidi-language: ar-sa;">　　</span><span style="font-size: 14pt; font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-bidi-font-family: 'times new roman'; mso-ansi-language: en-us; mso-fareast-language: zh-tw; mso-bidi-language: ar-sa;">本準則<span style="mso-bidi-font-weight: bold;">自發布日施行。<br /></span></span></span></p>
發佈日期 2014-03-11
附件下載