Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
권호 표지

Investigation for the Management Methods of Pure Tar Color Additives for Drugs and Quasi-drugs

의약품과 의약외품에 사용되는 타르순색소의 관리방안을 위한 조사연구

  • Received : 2013.04.19
  • Accepted : 2013.06.03
  • Published : 2013.06.30
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Abstract

Background: This study was aimed to establish the systematic management methods of tar color additives used in Korea for drugs and quasi-drugs. Although tar color additives have been used in various areas, safety problems are continuously being reported by several studies. For that reason, major countries like US, Japan, Europe are trying to update the safety information of tar color additives and the related management methods, and Korea also need to complement them based on the updated information for their safer use. Method: This report includes the compared information of all legally used tar color additives of each country, such as color additive name, compound name and chemical abstracts service registry number. Conclusion: It is expected that these investigated results will be useful as the basic materials for proper management guidelines of tar color additives in Korea.

Keywords

References

  1. Branen AL, Davidson PM, Salminen S, et al., Food Additives. 2nd ed. New York, Marcel Dekker, 2002.
  2. Mitsui T. New Cosmetic Science. New York, Elsevier, 1997.
  3. 장재연. 식품 중 타르계 색소의 사용실태조사, KFDA Study, 2005.
  4. Simon RA. Adverse reactions to food additives. N Engl Reg Allergy 1986; Proc 7: 533-42. https://doi.org/10.2500/108854186779045421
  5. [1984, FAS 19-JECFA 28] Toxicological evaluation of certain food additives and contaminants. WHO Food Additives Series, No. 19. 1984.
  6. Reports from the Scientific Committee for Food (14th series). Opinion expressed 1983. Food science and techniques. 1984.
  7. 영국식품기준청(FSA)의 영국 Southampton대학 Study Report. 2007.9.10. Internet site: http://www.food.gov.uk/ multimedia/pdfs/additivesbehaviourfinrep.pdf Internet site: http://www.foodstandards.gov.uk/news/newsarchive/2008/ nov/colours
  8. KFDA News Letter: "색소 없는 어린이 감기약 확대 된다"(2009. 6. 30) Internet site: http://www.kfda.go.kr/ index.kfda?mid=56&seq=1872&cmd=v(Accessed on Dec 10, 2012)
  9. 식품의약품안전청 해명설명참고자료. "산부 철분제 타르 색소 관련 Q&A" 2010. 10. 19 Internet site: http://www. kfda.go.kr/index.kfda?mid=57&seq=13368&cmd=v (Accessed on Dec 10, 2012)
  10. 일본 후생성 타르색소 자료. 最終改正 : 平成一六年七月九 日厚生省令第一一二묵 2012. 5. 31. Internet site: http:// kousei.active-reader.net/32/3241/046029.html (Accessed on June 10, 2012)
  11. 미국 FDA 타르색소 개정자료. 2012. 6. 7. Internet site: http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid =1070b19eb50e562daa872cfa1755aa09&rgn=div5&view= text&node=21:1.0.1.1.27&idno=21 (Accessed on June 11, 2012)
  12. Ministry of Health of the People's Republic of China. Hygienic Standard for Cosmetics 2007.1. Internet site: http://www.moh.gov.cn/open/web_edit_file/2007012 4145740.pdf
  13. 의약품등의 타르색소 지정과 기준 및 시험방법, 식품의약 품안전청고시 제2011-47호. Internet site: http://www.kfda. go.kr/index.kfda?mid=92&seq=3630&cmd=v
  14. 이원재. 의약품, 의약외품 및 화장품용 타르색소 안전관리 연구, KFDA. 2009.
  15. 김광진, 허수정, 염태경, 김성열, 김미혜, 이효민. 식품첨가 물 중 타르계 색소에 대한 위해 분석 연구, KFDA Study Report, Vol. 9, 2005.
  16. 식품의약품안전청고시 제2007-40호 '약외품에 관한 기준 및 시험방법 전부개정고시안' 2007.6.20. Internet site: http://www.kfda.go.kr/index.kfda?mid=95&pageNo =56&seq=2261&cmd=vKorea
  17. 식품의약품안전청고시 제2011-18호 '화장품의 타르색소 종류와 기준 및 시험방법 제정 고시안'. 2011.4.21. Internet site: http://www.kfda.go.kr/index.kfda?mid=95&pageNo=9 &seq=3497&cmd=v
  18. 일본 후생성 타르색소자료112호( ) 2004.7.9. Internet site: http://kousei.active-reader.net/32/3241/046029.html
  19. U.S. Department of Health & Human Services, U.S. Food & Drug Administration, Center for Food Safety & Applied Nutrition. Summary of Color Additives Listed for Use in the United States in Food, Drugs, Cosmetics, and Medical Devices. 2009.2. Internet site: http://www.cfsan.fda.gov/-dms/ opa-col2.html