<P style="TEXT-ALIGN: center; MARGIN: 0cm 0cm 0pt; mso-pagination: widow-orphan" class=MsoNormal align=center><SPAN style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 仿宋; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"> 卫监督发〔<SPAN lang=EN-US>2011</SPAN>〕<SPAN lang=EN-US>49</SPAN>号<SPAN lang=EN-US><?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /><o:p></o:p></SPAN></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; MARGIN: 0cm 0cm 0pt; mso-pagination: widow-orphan" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 22pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体" lang=EN-US><o:p> </o:p></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; MARGIN: 0cm 0cm 0pt; mso-pagination: widow-orphan" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; COLOR: black; FONT-SIZE: 16pt; mso-hansi-font-family: 仿宋; mso-bidi-font-size: 12.0pt; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">各省、自治区、直辖市卫生厅局，新疆生产建设兵团卫生局，中国疾病预防控制中心、卫生部卫生监督中心：</SPAN><B style="mso-bidi-font-weight: normal"><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体" lang=EN-US><o:p></o:p></SPAN></B></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32.3pt; MARGIN: 0cm 0cm 0pt; mso-char-indent-count: 2.02; mso-pagination: widow-orphan" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">为贯彻《食品安全法》及其实施条例，规范食品相关产品新品种行政许可工作，根据《食品相关产品新品种行政许可管理规定》，我部组织制定了《食品相关产品新品种申报与受理规定》。现印发给你们，请遵照执行<SPAN lang=EN-US>,</SPAN>并将执行中的有关问题及时反馈我部。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; MARGIN: 0cm 32pt 0pt 0cm; mso-pagination: widow-orphan" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体" lang=EN-US><o:p> </o:p></SPAN></P>
<P><SPAN style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-bidi-font-family: 宋体; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA"> 二○一一年五月二十三日</SPAN></P>
<P><SPAN style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-bidi-font-family: 宋体; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA"></SPAN> </P><SPAN style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-bidi-font-family: 宋体; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA">
<P style="TEXT-ALIGN: center; LINE-HEIGHT: 30pt; MARGIN: 0cm 0cm 0pt; mso-pagination: widow-orphan" class=MsoNormal align=center><B style="mso-bidi-font-weight: normal"><SPAN style="FONT-FAMILY: 宋体; FONT-SIZE: 22pt; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">食品相关产品新品种申报与受理规定<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></B></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 30pt; TEXT-INDENT: 54.1pt; MARGIN: 0cm 0cm 0pt; mso-char-indent-count: 2.45; mso-pagination: widow-orphan" class=MsoNormal align=left><B style="mso-bidi-font-weight: normal"><SPAN style="FONT-FAMILY: 宋体; FONT-SIZE: 22pt; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体" lang=EN-US><o:p> </o:p></SPAN></B></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 黑体; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">第一条</SPAN><FONT face="Times New Roman"><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体" lang=EN-US><SPAN style="mso-spacerun: yes"> </SPAN></SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">为规范食品相关产品新品种的申报与受理工作，根据《食品相关产品新品种行政许可管理规定》，制定本规定。<SPAN lang=EN-US> <o:p></o:p></SPAN></SPAN></FONT></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 黑体; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">第二条</SPAN><FONT face="Times New Roman"><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体" lang=EN-US><SPAN style="mso-spacerun: yes"> </SPAN></SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">申请食品相关产品新品种的单位或个人（以下简称申请人）应当向卫生部卫生监督中心提交申报资料原件<SPAN lang=EN-US>1</SPAN>份、复印件<SPAN lang=EN-US>4</SPAN>份、电子文件光盘<SPAN lang=EN-US>1</SPAN>件以及必要的样品。同时，填写供公开征求意见的内容。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></FONT></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 黑体; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">第三条</SPAN><FONT face="Times New Roman"><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体" lang=EN-US><SPAN style="mso-spacerun: yes"> </SPAN></SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">申报资料应当按照下列顺序排列，逐页标明页码，使用明显的区分标志，并装订成册。<SPAN lang=EN-US> <o:p></o:p></SPAN></SPAN></FONT></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（一）申请表；<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（二）理化特性；<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（三）技术必要性、用途及使用条件；<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（四）生产工艺；<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（五）质量规格要求、检验方法及检验报告；<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（六）毒理学安全性评估资料<SPAN lang=EN-US>;<o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（七） 迁移量和<SPAN lang=EN-US>/</SPAN>或残留量、估计膳食暴露量及其评估方法；<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（八）国内外允许使用情况的资料或证明文件；<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（九）其他有助于评估的资料。<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">申请食品用消毒剂、洗涤剂新原料的，可以免于提交第七项资料。<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">申请食品包装材料、容器、工具、设备用新添加剂的，还应当提交使用范围、使用量等资料。<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">受委托申请人还应当提交委托书。<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 黑体; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">第四条</SPAN><FONT face="Times New Roman"><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体" lang=EN-US><SPAN style="mso-spacerun: yes"> </SPAN></SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">申请食品包装材料、容器、工具、设备用添加剂扩大使用范围或使用量的，应当提交本规定第三条的第一项、第三项、第六项、第七项及使用范围、使用量等资料。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></FONT></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 黑体; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">第五条</SPAN><FONT face="Times New Roman"><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体" lang=EN-US><SPAN style="mso-spacerun: yes"> </SPAN></SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">申请首次进口食品相关产品新品种的，除提交第三条规定的材料外，还应当提交以下材料：<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></FONT></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（一）出口国（地区）相关部门或者机构出具的允许该产品在本国（地区）生产或者销售的证明材料；<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（二）生产企业所在国（地区）有关机构或者组织出具的对生产企业审查或者认证的证明材料；<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（三）中文译文应当有中国公证机关的公证。<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 黑体; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">第六条</SPAN><FONT face="Times New Roman"><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体" lang=EN-US><SPAN style="mso-spacerun: yes"> </SPAN></SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">除官方证明文件外，申报资料原件应当逐页加盖申请人印章或骑缝章，电子文件光盘的封面应当加盖申请人印章；如为个人申请，还应当提供身份证件复印件。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></FONT></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 黑体; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">第七条</SPAN><FONT face="Times New Roman"><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体" lang=EN-US><SPAN style="mso-spacerun: yes"> </SPAN></SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">申请资料应当完整、清晰，同一项目的填写应当前后一致。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></FONT></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 黑体; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">第八条</SPAN><FONT face="Times New Roman"><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体" lang=EN-US><SPAN style="mso-spacerun: yes"> </SPAN></SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">申报资料中的外文应当译为规范的中文，文献资料可提供中文摘要，并将译文附在相应的外文资料前。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></FONT></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 黑体; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">第九条</SPAN><FONT face="Times New Roman"><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体" lang=EN-US><SPAN style="mso-spacerun: yes"> </SPAN></SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">理化特性资料应当包括：<SPAN lang=EN-US> <o:p></o:p></SPAN></SPAN></FONT></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（一）基本信息：化学名、通用名、化学结构、分子式、分子量、<SPAN lang=EN-US>CAS</SPAN>号等。<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（二）理化性质：熔点、沸点、分解温度、溶解性、生产或使用中可能分解或转化产生的产物、与食物成分可能发生相互作用情况等。<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（三）如申报物质属于不可分离的混合物，则提供主要成分的上述资料。<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 黑体; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">第十条</SPAN><FONT face="Times New Roman"><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体" lang=EN-US><SPAN style="mso-spacerun: yes"> </SPAN></SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">技术必要性、用途及使用条件资料应当包括：<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></FONT></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（一）技术必要性及用途资料：预期用途、使用范围、最大使用限量和达到功能所需要的最小量、使用技术效果。<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（二）使用条件资料：使用时可能接触的食品种类（水性食品、油脂类食品、酸性食品、含乙醇食品等），与食品接触的时间和温度；可否重复使用；食品容器和包装材料接触食品的面积<SPAN lang=EN-US>/</SPAN>容积比等。 <SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 黑体; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">第十一条</SPAN><FONT face="Times New Roman"><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体" lang=EN-US><SPAN style="mso-spacerun: yes"> </SPAN></SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">生产工艺资料应当包括：原辅料、工艺流程图以及文字说明，各环节的技术参数等。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></FONT></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 黑体; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">第十二条</SPAN><FONT face="Times New Roman"><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体" lang=EN-US><SPAN style="mso-spacerun: yes"> </SPAN></SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">质量规格要求包括纯度、杂质成分、含量等，以及相应的检验方法、检验报告。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></FONT></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 黑体; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">第十三条</SPAN><FONT face="Times New Roman"><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体" lang=EN-US><SPAN style="mso-spacerun: yes"> </SPAN></SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">毒理学安全性评估资料应当符合下列要求：<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></FONT></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（一）申请食品相关产品新品种（食品用消毒剂、洗涤剂新原料除外）应当依据其迁移量提供相应的毒理学资料：<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><FONT face="Times New Roman"><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体" lang=EN-US>1.</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">迁移量小于等于<SPAN lang=EN-US>0.01mg/kg</SPAN>的，应当提供结构活性分析资料以及其他安全性研究文献分析资料；<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></FONT></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><FONT face="Times New Roman"><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体" lang=EN-US>2.</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">迁移量为<SPAN lang=EN-US>0.01mg-0.05mg/kg</SPAN>（含<SPAN lang=EN-US>0.05mg/kg</SPAN>），应当提供三项致突变试验（<SPAN lang=EN-US>Ames</SPAN>试验、骨髓细胞微核试验、体外哺乳动物细胞染色体畸变试验或体外哺乳动物细胞基因突变畸变试验）；<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></FONT></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><FONT face="Times New Roman"><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体" lang=EN-US>3.</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">迁移量为<SPAN lang=EN-US>0.05mg-5.0mg/kg</SPAN>（含<SPAN lang=EN-US>5.0mg/kg</SPAN>），应当提供三项致突变试验（<SPAN lang=EN-US>Ames</SPAN>试验、骨髓细胞微核试验、体外哺乳动物细胞染色体畸变试验或体外哺乳动物细胞基因突变畸变试验）、大鼠<SPAN lang=EN-US>90</SPAN>天经口亚慢性毒性试验资料；<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></FONT></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><FONT face="Times New Roman"><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体" lang=EN-US>4.</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">迁移量为<SPAN lang=EN-US>5.0mg-60mg/kg</SPAN>，应当提供急性经口毒性、三项致突变试验（<SPAN lang=EN-US>Ames</SPAN>试验、骨髓细胞微核试验、体外哺乳动物细胞染色体畸变试验或体外哺乳动物细胞基因突变畸变试验），大鼠<SPAN lang=EN-US>90</SPAN>天经口亚慢性毒性，繁殖发育毒性（两代繁殖和致畸试验），慢性经口毒性和致癌试验资料；<SPAN lang=EN-US> <o:p></o:p></SPAN></SPAN></FONT></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><FONT face="Times New Roman"><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体" lang=EN-US>5.</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">高分子聚合物（平均分子量大于<SPAN lang=EN-US>1000</SPAN>道尔顿）应当提供各单体的毒理学安全性评估资料。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></FONT></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（二）申请食品用洗涤剂和消毒剂新原料的，应当按照《食品毒理学评价程序和方法》（<SPAN lang=EN-US>GB/T15193</SPAN>）提供毒理学资料。<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（三）毒理学试验资料原则上要求由各国（地区）符合良好实验室操作规范<SPAN lang=EN-US>(GLP)</SPAN>实验室或国内有资质的检验机构出具。<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 黑体; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">第十四条</SPAN><FONT face="Times New Roman"><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体" lang=EN-US><SPAN style="mso-spacerun: yes"> </SPAN></SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">迁移量和<SPAN lang=EN-US>/</SPAN>或残留量、估计膳食暴露量及其评估方法等资料应当包括：<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></FONT></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（一）根据预期用途和使用条件，提供向食品或食品模拟物中迁移试验数据资料、迁移试验检测方法资料或试验报告；<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（二）在食品容器和包装材料中转化或未转化的各组分的残留量数据、残留物检测方法资料或试验报告；<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（三）人群估计膳食暴露量及其评估方法资料；<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（四）试验报告应当由各国具有相应试验条件的实验室或国内有资质的检验机构出具。<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 黑体; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">第十五条</SPAN><FONT face="Times New Roman"><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体" lang=EN-US><SPAN style="mso-spacerun: yes"> </SPAN></SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">国内外允许使用情况的资料或证明文件为国家政府机构、行业协会或者国际组织允许使用的证明文件。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></FONT></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 黑体; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">第十六条</SPAN><FONT face="Times New Roman"><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体" lang=EN-US><SPAN style="mso-spacerun: yes"> </SPAN></SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">出口国（地区）相关部门或者机构出具的允许该产品在本国（地区）生产或销售的证明文件应当符合下列要求<SPAN lang=EN-US>:<o:p></o:p></SPAN></SPAN></FONT></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（一）由出口国（地区）政府主管部门、行业协会出具。无法提供原件的，可提供复印件，复印件须由文件出具单位或我国驻出口国使（领）馆确认；<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（二）载明产品名称、生产企业名称、出具单位名称及出具日期；<SPAN lang=EN-US><SPAN style="mso-spacerun: yes"> </SPAN><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（三）有出具单位印章或法定代表人（授权人）签名；<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（四）所载明的产品名称和生产企业名称应当与所申请的内容完全一致；<SPAN lang=EN-US> <o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（五）一份证明文件载明多个产品的，在首个产品申报时已提供证明文件原件后，该证明文件中其他产品申报可提供复印件，并提交书面说明，指明证明文件原件所在的申报产品；<SPAN lang=EN-US> <o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（六）证明文件为外文的，应当译为规范的中文，中文译文应当由中国公证机关公证。<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 黑体; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">第十七条</SPAN><FONT face="Times New Roman"><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体" lang=EN-US><SPAN style="mso-spacerun: yes"> </SPAN></SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">申报委托书应当符合下列要求：<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></FONT></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; LAYOUT-GRID-MODE: char; mso-char-indent-count: 2.0; mso-pagination: widow-orphan" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（一）应当载明委托申报的产品名称、受委托单位名称、委托事项和委托日期，并加盖委托单位的公章或由法定代表人签名；<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（二）一份申报委托书载明多个产品的，在首个产品申报时已提供证明文件原件后，该委托书中其他产品申报可提供复印件，并提交书面说明，指明委托书原件所在的申报产品；<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; LAYOUT-GRID-MODE: char; mso-char-indent-count: 2.0; mso-pagination: widow-orphan" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（三）申报委托书应当经真实性公证；<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; LAYOUT-GRID-MODE: char; mso-char-indent-count: 2.0; mso-pagination: widow-orphan" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体"><FONT face="Times New Roman">（四）申报委托书如为外文，应当译成规范的中文，中文译文应当经中国公证机关公证。<SPAN lang=EN-US><o:p></o:p></SPAN></FONT></SPAN></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 黑体; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">第十八条</SPAN><FONT face="Times New Roman"><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体" lang=EN-US><SPAN style="mso-spacerun: yes"> </SPAN></SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">卫生部卫生监督中心接收申报资料后，应当当场或在<SPAN lang=EN-US>5</SPAN>个工作日内作出是否受理的决定。对申报资料符合要求的，予以受理；对申报资料不齐全或不符合法定形式的，应当一次性书面告知申请人需要补正的全部内容。<SPAN lang=EN-US> <o:p></o:p></SPAN></SPAN></FONT></P>
<P style="TEXT-ALIGN: left; LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm -9.85pt 0pt 0cm; mso-char-indent-count: 2.0; mso-pagination: widow-orphan; mso-para-margin-right: -.94gd" class=MsoNormal align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 黑体; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">第十九条</SPAN><FONT face="Times New Roman"><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体" lang=EN-US><SPAN style="mso-spacerun: yes"> </SPAN></SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: 宋体">申请人应当按照技术审查意见，在<SPAN lang=EN-US>1</SPAN>年内一次性提交完整补充资料原件<SPAN lang=EN-US>1</SPAN>份，补充资料应当注明日期，逾期未提交的，视为终止申报。如因特殊原因延误的，应当提交书面申请。<SPAN lang=EN-US> <o:p></o:p></SPAN></SPAN></FONT></P>
<P><SPAN style="FONT-FAMILY: 黑体; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-bidi-font-family: 宋体; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA">第二十条</SPAN><FONT face=宋体><SPAN style="FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-bidi-font-family: 宋体; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA" lang=EN-US><SPAN style="mso-spacerun: yes"> </SPAN></SPAN><SPAN style="FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-bidi-font-family: 宋体; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA">终止申报或者未获批准的，申请人可以申请退回已提交的出口国（地区）相关部门或机构出具的允许生产和销售的证明文件、对生产企业审查或者认证的证明材料、申报委托书（载明多个产品的证明文件原件除外），其他申报资料一律不予退还，由审评机构存档备查。</SPAN></FONT></P>
<P><FONT face=宋体><SPAN style="FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-bidi-font-family: 宋体; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA"></SPAN></FONT> </P><FONT face=宋体><SPAN style="FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-bidi-font-family: 宋体; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA">
<P style="MARGIN: 0cm 0cm 0pt" class=MsoNormal><SPAN style="FONT-FAMILY: 仿宋; FONT-SIZE: 16pt"><FONT face="Times New Roman">附件：<SPAN lang=EN-US><A href="http://www.moh.gov.cn/publicfiles/business/cmsresources/mohwsjdj/cmsrsdocument/doc12035.doc" target=_blank><SPAN lang=EN-US><SPAN lang=EN-US>食品相关产品新品种行政许可申请表.doc</SPAN></SPAN></A><o:p></o:p></SPAN></FONT></SPAN></P></SPAN></FONT></SPAN>
<P><SPAN style="FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-hansi-font-family: 宋体; mso-bidi-font-family: 宋体; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA"></SPAN> </P>
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