中欧美食品接触材料及制品新品种申报差异分析
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摘要
主要介绍了欧盟、美国、中国食品接触材料及制品新品种申报的管理规定,包括监管法规、管理机构、申报流程、数据要求等,通过对比分析,提出了欧美法规于我国的借鉴和参考,建议建立快速评审程序,建立符合中国国情的暴露评估模型,进一步完善我国食品接触材料及制品新品种申报管理,保障我国食品接触材料及制品安全。
This paper mainly discusses the regulations of the European Union, the United States and China on the new substance application for food contact materials and articles, including regulatory regulations, regulatory agencies, declaration procedures and data requirements. The paper also proposed some suggestions for the establishment of rapid evaluation procedure and new exposure assessment model, which could strengthen the new substance management to ensure the safety of food contact materials and articles in China.
This paper mainly discusses the regulations of the European Union, the United States and China on the new substance application for food contact materials and articles, including regulatory regulations, regulatory agencies, declaration procedures and data requirements. The paper also proposed some suggestions for the establishment of rapid evaluation procedure and new exposure assessment model, which could strengthen the new substance management to ensure the safety of food contact materials and articles in China.
引文
[1] 国家卫生和计划生育委员会. GB 4806.1—2016 食品安全国家标准食品接触材料及制品通用安全要求[S].2016.
[2] GROB K, BIEDERMANN M, SCHERBAUM E, et al. Food Contamination with Organic Materials in Perspective: Packaging Materials as the Largest and Least Controlled Source: A View Focusing on the European Situation[J]. Critical Reviews in Food Science & Nutrition, 2006, 46 (7):529-535.
[3] 朱蕾,徐海滨, 张俭波, 等. 各国食品接触材料法规体系研究与比较分析[J]. 中国食品添加剂, 2013(2):149-157. ZHU L, XU H B, ZHANG J B, et al. Study and Comparison of Food Contact Regulation Framework of Various Coutries[J]. China Food Additives, 2013(2):149-157.
[4] 商贵芹, 陈少鸿, 刘君峰. 国内外食品接触材料法规比较及于我国的借鉴[J].食品安全质量检测学报, 2016, 7(3):1 197-1 202. SHANG G Q, CHEN S H, LIU J F. Comparison of Food Contact Materials Regulations at Home and Abroad and the Reference to Our Country[J]. Journal of Food Safety and Quality, 2016, 7(3):1 197-1 202.
[5] European Commission. Commission Regulation (EU) No 10/2011 of 14 January 2011 on Plastic Materials and Articles Intended to Come into Contact with Food[S]. Official Journal of the European Union, 2011.
[6] 国家卫生和计划生育委员会. GB 4806.6—2016食品安全国家标准食品接触用塑料树脂[S]. 2016.
[7] 国家卫生和计划生育委员会.GB 9685—2016食品安全国家标准食品接触材料及制品用添加剂使用标准[S]. 2016.
[8] 中华人民共和国国家卫生和计划生育委员会. 卫监督发[2011]25号:食品相关产品新品种行政许可管理规定[Z]. 2011.
[9] 全国人民代表大会常务委员会. 中华人民共和国主席令第二十一号中华人民共和国食品安全法[Z]. 2015.
[10] 商贵芹,姜欢,刘桂华,等. 中国食品接触材料新食品安全国家标准[J]. 包装工程,2017,38(15):106-110. SHANG G Q, JIANG H, LIU G H, et al. New China National Food Safety Standards on Food Contact Materials[J]. Packaging Engineering,2017,38(15):106-110.
[11] European Commission. Regulation E C. No. 1935/2004 of the European Parliament and of the Council of 27 October 2004 on Materials and Articles Intended to Come into Contact with Food and Repealing Directives 80/590/EEC and 89/109/EEC[S]. Official Journal of the European Union. 2004.
[12] Food and Drug Administration. Code of federal regulations Title 21 food and Drugs Parts 170 to 199[EB/OL].[2018-11-8] https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/ucm135680.htm.
[13] 国家卫生和计划生育委员会. GB 4806.10—2016食品安全国家标准食品接触用涂料及涂层[S]. 2016.
[14] 国家卫生和计划生育委员会. GB 4806.11—2016食品安全国家标准食品接触用橡胶材料及制品[S]. 2016.
[15] 商贵芹, 陈少鸿, 刘君峰,等.食品接触材料质量控制与检验监管使用指南[M]. 北京:化学工业出版社, 2013:122-124.
[16] European Food Safety Authority. Guidelines for Petitioners Presenting an Application for the Safety Assessment of a Substance to Be Used in Food Contact Materials Prior to Its Authorisation[S]. 2008.
[17] Food and Drug Administration. Guidance for Industry: Preparation of Food Contact Notifications (Administrative)[EB/OL].[2018-11-8] https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm081807.htm.
[18] Food and Drug Administration. Guidance for Industry: Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations[EB/OL].[2018-11-8] https://www.fda.gov/Food/GuidanceRegulation/ucm081818.htm.
[19] Food and Drug Administration. Guidance for Industry: Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations[EB/OL].[2018-11-8] https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm081807.htm.
[20] Food and Drug Administration. Guidance for Industry: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition[EB/OL].[2018-11-8]https://www.fda.gov/Food/GuidanceRegulation/Guidance DocumentsRegulatoryInformation/ucm081049.htm.
[21] 中华人民共和国国家卫生和计划生育委员会. 食品相关产品新品种申报与受理规定[Z]. 2011.
[2] GROB K, BIEDERMANN M, SCHERBAUM E, et al. Food Contamination with Organic Materials in Perspective: Packaging Materials as the Largest and Least Controlled Source: A View Focusing on the European Situation[J]. Critical Reviews in Food Science & Nutrition, 2006, 46 (7):529-535.
[3] 朱蕾,徐海滨, 张俭波, 等. 各国食品接触材料法规体系研究与比较分析[J]. 中国食品添加剂, 2013(2):149-157. ZHU L, XU H B, ZHANG J B, et al. Study and Comparison of Food Contact Regulation Framework of Various Coutries[J]. China Food Additives, 2013(2):149-157.
[4] 商贵芹, 陈少鸿, 刘君峰. 国内外食品接触材料法规比较及于我国的借鉴[J].食品安全质量检测学报, 2016, 7(3):1 197-1 202. SHANG G Q, CHEN S H, LIU J F. Comparison of Food Contact Materials Regulations at Home and Abroad and the Reference to Our Country[J]. Journal of Food Safety and Quality, 2016, 7(3):1 197-1 202.
[5] European Commission. Commission Regulation (EU) No 10/2011 of 14 January 2011 on Plastic Materials and Articles Intended to Come into Contact with Food[S]. Official Journal of the European Union, 2011.
[6] 国家卫生和计划生育委员会. GB 4806.6—2016食品安全国家标准食品接触用塑料树脂[S]. 2016.
[7] 国家卫生和计划生育委员会.GB 9685—2016食品安全国家标准食品接触材料及制品用添加剂使用标准[S]. 2016.
[8] 中华人民共和国国家卫生和计划生育委员会. 卫监督发[2011]25号:食品相关产品新品种行政许可管理规定[Z]. 2011.
[9] 全国人民代表大会常务委员会. 中华人民共和国主席令第二十一号中华人民共和国食品安全法[Z]. 2015.
[10] 商贵芹,姜欢,刘桂华,等. 中国食品接触材料新食品安全国家标准[J]. 包装工程,2017,38(15):106-110. SHANG G Q, JIANG H, LIU G H, et al. New China National Food Safety Standards on Food Contact Materials[J]. Packaging Engineering,2017,38(15):106-110.
[11] European Commission. Regulation E C. No. 1935/2004 of the European Parliament and of the Council of 27 October 2004 on Materials and Articles Intended to Come into Contact with Food and Repealing Directives 80/590/EEC and 89/109/EEC[S]. Official Journal of the European Union. 2004.
[12] Food and Drug Administration. Code of federal regulations Title 21 food and Drugs Parts 170 to 199[EB/OL].[2018-11-8] https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/ucm135680.htm.
[13] 国家卫生和计划生育委员会. GB 4806.10—2016食品安全国家标准食品接触用涂料及涂层[S]. 2016.
[14] 国家卫生和计划生育委员会. GB 4806.11—2016食品安全国家标准食品接触用橡胶材料及制品[S]. 2016.
[15] 商贵芹, 陈少鸿, 刘君峰,等.食品接触材料质量控制与检验监管使用指南[M]. 北京:化学工业出版社, 2013:122-124.
[16] European Food Safety Authority. Guidelines for Petitioners Presenting an Application for the Safety Assessment of a Substance to Be Used in Food Contact Materials Prior to Its Authorisation[S]. 2008.
[17] Food and Drug Administration. Guidance for Industry: Preparation of Food Contact Notifications (Administrative)[EB/OL].[2018-11-8] https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm081807.htm.
[18] Food and Drug Administration. Guidance for Industry: Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations[EB/OL].[2018-11-8] https://www.fda.gov/Food/GuidanceRegulation/ucm081818.htm.
[19] Food and Drug Administration. Guidance for Industry: Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations[EB/OL].[2018-11-8] https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm081807.htm.
[20] Food and Drug Administration. Guidance for Industry: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition[EB/OL].[2018-11-8]https://www.fda.gov/Food/GuidanceRegulation/Guidance DocumentsRegulatoryInformation/ucm081049.htm.
[21] 中华人民共和国国家卫生和计划生育委员会. 食品相关产品新品种申报与受理规定[Z]. 2011.