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研究生:趙唯舜
研究生(外文):Wei-Shun Chao
論文名稱:食品塑膠容器包裝管制政策對塑化劑 溶出量改變之影響研究
論文名稱(外文):Regulatory Impact Assessment on Plasticizers Migration Levels from Food Contacting Materials
指導教授:陳美蓮陳美蓮引用關係
指導教授(外文):Mei-Lien Chen
學位類別:碩士
校院名稱:國立陽明大學
系所名稱:環境與職業衛生研究所
學門:醫藥衛生學門
學類:公共衛生學類
論文種類:學術論文
論文出版年:2013
畢業學年度:101
語文別:英文
論文頁數:129
中文關鍵詞:塑化劑食品包裝材料與容器溶出試驗管制政策
外文關鍵詞:PlasticizerPlastic food packing and containerMigration testRegulation
相關次數:
  • 被引用被引用:1
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鄰苯二甲酸酯類(Phthalic acid esters, PAEs)為常見之塑化劑,廣泛添加於塑膠材質以增加其彈性,特別像是聚氯乙烯(PVC)塑膠產品。在動物實驗中已證實會造成生殖發育毒性,亦被認為是內分泌干擾物質。己二酸二(2-乙基己基)酯(Bis(2-ethylhexyl)adipate,DEHA)亦為常添加於食品包裝容器的塑化劑,而台灣民眾經常使用塑膠之食品包裝材料於日常生活飲食中。
本研究根據台灣衛生福利部食品藥物管理署於2011年公布的「食品器具容器包裝衛生標準」中塑化劑的溶出標準,探討製造於管制政策前後的塑膠容器及包裝材質其塑化劑溶出量的差異,將市售六種塑膠材質-PET、PE、PVC、PP、PS、PVDC,以正庚烷 25 ℃,1 小時之溶出條件進行溶出試驗,並以GC-MS分析十種塑化劑-Dimethyl Phthalate (DMP)、Diethyl Phthalate (DEP)、Dibutyl Phthalate (DBP)、Butylbenzyl Phthalate (BBzP)、DEHA、Diethylhexyl Phthalate (DEHP)、Di-isonoyl Adipate (DINA)、Di-n-octyl Phthalate (DnOP)、Di-isonoyl Phthalate (DINP) 以及Di-isodecyl Phthalate (DIDP)。
結果顯示,在六種塑膠材質中DBP、DEHP 和DINA有較高的檢出率,特別是在PE、PVC、PVDC三種塑膠包裝材料中,DBP和DEHP檢出率到高達100%,而DEHA和DINA在PVC材質中的檢出率亦為100 %。十種塑化劑中以DINA的溶出濃度及DBP最高,其次是DEHP。六種塑膠材料則以PVC保鮮膜最高,其次是PVDC保鮮膜及PE塑膠袋。在DINA的檢測結果中,以PVC保鮮膜的溶出濃度為最高,在管制政策前的樣本平均濃度為 36.1 (8.6 - 77.5, N = 33) mg/kg food,在管制政策後的樣本平均濃度為 43.9 (7.5 - 94.6, N = 30) mg/ kg food。
與塑化劑的溶出標準相比較,本研究的食品塑膠樣本,在管制政策前後均未超過限值。在未超過限值之下,本研究並未發現在管制政策後的濃度有明顯下降趨勢。至於替代塑化劑DINA並未在管制項目之列,但溶出濃度特別高,有必要進一步加以注意。

Widely used as plasticizers, phthalic acid esters (PAEs) increase the flexibility of plastics such as polyvinyl chloride (PVC) based products. Capable of causing reproductive and developmental toxicity, phthalates are also considered as endocrine disruptors, as demonstrated in earlier animal studies. Additionally, Bis(2-ethylhexyl)adipate (DEHA) is commonly used as plasticizers in food packaging containers.
Plastic materials for food packaging are common in Taiwan. The migration limits of plasticizers have been promulgated since 2011. This study evaluates the regulatory impact in terms of migration levels for plastic products made in pre- and post-regulation periods. Six food contacting plastics (i.e. PET, PE, PVC, PP, PS and PVDC) are analyzed. The migration test follows the procedure described in the Sanitation Standard for Food Utensils, Containers and Packages of Food and Drug Administration, Ministry of Health and Welfare of the Republic of China, Taiwan. The simulant of the migration test is n-heptane at 25℃ for 1 hour, followed by analysis of DMP, DEP, DBP, BBzP, DEHA, DEHP, DINA, DnOP, DINP and DIDP by using GC-MS.
Analysis results indicate that the detection rates are relatively high for DBP, DEHP and DINA in all six material types. Especially in PE, PVC and PVDC packing materials, the detection rates of DBP and DEHP are 100 %; the detection rates of DEHA and DINA in PVC materials are also 100%. Among the ten plasticizers, the highest migration levels appear at DINA, followed by DEHP and DBP. Meanwhile, the detected concentration of plasticizers is the highest in PVC film, followed by PVDC film and PE packaging materials. Moreover, the highest levels of DINA are detected in the PVC packaging materials, in which the average concentrations was 36.1 (8.6 - 77.5, N = 33) mg/kg food for pre-regulated products and 43.9 (7.5 - 94.6, N = 30) mg/ kg food for post-regulated ones.
To compare analysis results with the migration limits of plasticizers in Taiwan, all products do not exceed the limits both in pre- and post- regulation. Therefore, the results show no decrease in migration levels. The extremely high concentration of DINA indicated the need for further study because the plasticizer has not yet been regulated.

Content
摘要-----------------------------------------------------I
Abstract------------------------------------------------II
Content------------------------------------------------III
List of Tables----------------------------------------- V
List of Figures----------------------------------------VII
Chapter 1 Introduction-----------------------------------1
1.1 Background-------------------------------------------1
1.2 Study aims-------------------------------------------4
Chapter 2 Literature Review------------------------------5
2.1 Current status of food plastic materials-------------5
2.2 Introductions of plasticizer-------------------------6
2.2.1 Phthalic acid Esters (PAEs or Phthalates)----------6
2.2.2 Adipic acid esters (Adipates)----------------------7
2.3 Health effect of plasticizers------------------------8
2.3.1 Animal study---------------------------------------8
2.3.2 Epidemiological study------------------------------9
2.4 Study of plasticizers in food-----------------------10
2.5 Policy and regulation ------------------------------12
2.5.1 Taiwan--------------------------------------------12
2.5.2 European Union------------------------------------13
2.5.3 United States-------------------------------------13
2.5.4 Japan---------------------------------------------14
2.5.5 Korea---------------------------------------------14
2.5.6 Canada--------------------------------------------14
Chapter 3 Materials and methods-------------------------15
3.1 Instruments and reagents----------------------------15
3.1.1 Equipments----------------------------------------15
3.1.2 Chemicals-----------------------------------------15
3.1.3 Instruments---------------------------------------16
3.2 Method ---------------------------------------------17
3.2.1 Sample collection---------------------------------17
3.2.2 Preparation of reagents---------------------------17
3.2.3 Experimental method-------------------------------19
3.3 Method validation-----------------------------------21
3.3.1 Calibration curve --------------------------------21
3.3.2 Quality assurance and quality control-------------21
3.3.3 Limit of detection (LOD)--------------------------21
3.4 Calculation of migration levels---------------------22
Chapter 4 Results and Discussions-----------------------23
Chapter 5 Conclusions ----------------------------------31
References----------------------------------------------33
Appendix------------------------------------------------94



List of Tables
Table 1. The physical and chemical properties of plasticizers--------------------------------------------40
Table 2. Specific migration limits (SML) of PAEs in Taiwan --------------------------------------------------------41
Table 3. Tolerable daily intake (TDI) of PAEs in Taiwan--------------------------------------------------41
Table 4. Classification of PAEs as regulated toxic chemical substances in Taiwan------------------------------------42
Table 5. Sample number and classification for pre- and post-regulation products--------------------------------43
Table 6. Analytical parameters of ten plasticizers------44
Table 7. Migration concentration for PET pre-regulated products------------------------------------------------45
Table 8. Migration concentration for PET post-regulated products------------------------------------------------46
Table 9. Migration concentration for PE pre-regulated products------------------------------------------------47
Table 10. Migration concentration for PE post-regulated products------------------------------------------------48
Table 11. Migration concentration for PVC pre-regulated products------------------------------------------------50
Table 12. Migration concentration for PVC post-regulated products------------------------------------------------53
Table 13. Migration concentration for PP pre-regulated products------------------------------------------------55
Table 14. Migration concentration for PP post-regulated products------------------------------------------------56
Table 15. Migration concentration for PS pre-regulated products------------------------------------------------58
Table 16. Migration concentration for PS post-regulated products------------------------------------------------59
Table 17. Migration concentration for PVDC pre-regulated products------------------------------------------------60
Table 18. Migration concentration for PVDC post-regulated products------------------------------------------------62
Table 19. Comparison of plasticizers' migration levels between six kinds of packing materials------------------64
Table 20. Comparison of plasticizers' migration levels between pre- and post- regulation products for five kinds of food container material------------------------------68
Table 21. Comparison of plasticizers' migration levels between pre- and post- regulation products for three kinds of packing material-------------------------------------72
Table 22 Comparison of plasticizers' migration levels between three countries for PVC plastic films-----------76



List of Figures
Figure 1. The chemical structure of phthalate esters----77
Figure 2. The chemical structure of adipates------------78
Figure 3. The migration apparatus-----------------------79
Figure 4. Chromatogram of ten plasticizers--------------80
Figure 5. Chromatogram of ten plasticizers in six types of plastic samples-----------------------------------------81
Figure 6. The calibration curves of ten compounds-------83
Figure 7. Comparison of four plasticizers' migration levels between six plastic materials---------------------------88
Figure 8. Comparison of plasticizers' migration levels between six kinds of material---------------------------89
Figure 9. Comparison of plasticizers' migration levels between pre- and post-regulation products for food container-----------------------------------------------90
Figure 10. Comparison of plasticizers' migration levels between pre- and post- regulation products for food packing-------------------------------------------------92
Figure 11. Comparison of migration levels between three countries for PVC plastic films-------------------------93


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1. 黃啟方:〈水滸傳的重要女性〉,《現代文學》第45期,1971年12月,頁31-61
2. 陸基:〈師範生小學教員都應練習白話文字〉,《教育雜誌》11:3,1919年3月
3. 黃啟方:〈水滸傳的重要女性〉,《現代文學》第45期,1971年12月,頁31-61
4. 黃啟方:〈水滸傳的重要女性〉,《現代文學》第45期,1971年12月,頁31-61
5. 陸基:〈師範生小學教員都應練習白話文字〉,《教育雜誌》11:3,1919年3月
6. 陸基:〈師範生小學教員都應練習白話文字〉,《教育雜誌》11:3,1919年3月
7. 陳英德:〈海外看大陸藝術:一種「最厲害、最普遍的民眾教育工具」——連環畫〉,《藝術家》21:3=123,1985年8月,頁193-211
8. 陳英德:〈海外看大陸藝術:一種「最厲害、最普遍的民眾教育工具」——連環畫〉,《藝術家》21:3=123,1985年8月,頁193-211
9. 張慧琴:〈談談水滸傳的板本和它的章回數目〉,《幼獅文藝》44:4=274,1976年10月,頁16-18
10. 陳英德:〈海外看大陸藝術:一種「最厲害、最普遍的民眾教育工具」——連環畫〉,《藝術家》21:3=123,1985年8月,頁193-211
11. 張慧琴:〈談談水滸傳的板本和它的章回數目〉,《幼獅文藝》44:4=274,1976年10月,頁16-18
12. 馬孟晶:〈文人雅趣與商業書坊:十竹齋書畫譜和箋譜的刊印與胡正言的出版事業〉,《新史學》第10卷第3期,1999年9月,頁1-54
13. 高桂惠:〈水滸故事傳播中的江湖與江山:以明.陳忱《水滸後傳》的「地景書寫」與「場域效應」為主的討論〉,《東華人文學報》10,2007年1月,頁157-180
14. 高桂惠:〈水滸故事傳播中的江湖與江山:以明.陳忱《水滸後傳》的「地景書寫」與「場域效應」為主的討論〉,《東華人文學報》10,2007年1月,頁157-180
15. 高桂惠:〈水滸故事傳播中的江湖與江山:以明.陳忱《水滸後傳》的「地景書寫」與「場域效應」為主的討論〉,《東華人文學報》10,2007年1月,頁157-180