보고서 정보
주관연구기관 |
식품의약품안전평가원 |
연구책임자 |
박창원
|
참여연구자 |
이정표
,
김진호
,
최용규
,
안재형
,
박순영
,
김상섭
|
보고서유형 | 최종보고서 |
발행국가 | 대한민국 |
언어 |
한국어
|
발행년월 | 2014-12 |
과제시작연도 |
2014 |
주관부처 |
식품의약품안전평가원 |
사업 관리 기관 |
식품의약품안전처 Ministry of Food and Drug Safety |
등록번호 |
TRKO201500007488 |
과제고유번호 |
1475007849 |
DB 구축일자 |
2015-06-27
|
키워드 |
배합한도성분,비타민E,톨루엔,폴리아크릴아마이드,클로로아세타마이드Restricted ingredients,Vitamin E,Toluene,Polyacrylamide,Chloroacetamide
|
초록
연구결과
필요성 및 목표
○ 화장품 중 배합한도 성분 분석법의 부재로 품질관리의 어려움이 있음
○ 화장품 중 배합한도 성분 분석법을 정부가 제공하여 화장품 품질 분석의 신뢰성 확보 및 사전·사후관리에 도움을 줌
방 법 및 결 과
○ 화장품 중 배합한도 성분 시험법 확립
○ 유통화장품 대상 모니터링 및 시험법 검증
기대성과
○ 화장품 중 배합한도 성분 분석법 제공으로 화장품 품질 분석의 신뢰성 확보
○ 화장품의 사전·사후관리에 도움
Abstract
▼
This research aims to set up methods of analyzing the restricted ingredients of the cosmetic products, i.e., vitamin E, toluene, polyacrylamide and chloroacetamide. The maximum permissible Vitamin E content of cosmetics is up to 20% and chloroacetamide, used as a preservative, is up to 0.3%. Toluene
This research aims to set up methods of analyzing the restricted ingredients of the cosmetic products, i.e., vitamin E, toluene, polyacrylamide and chloroacetamide. The maximum permissible Vitamin E content of cosmetics is up to 20% and chloroacetamide, used as a preservative, is up to 0.3%. Toluene, used as a solvent in nail products, is limited to a maximum content of 25%. Polyacrylamide, used as a bonding agent, film forming agent, viscosity controlling agent, etc, in cosmetics, is limited to a maximum content of 0.00001% as residual acrylamide in the body care products that do not rinse after use, and also as residual acrylamide in other products it is limited to a maximum content of 0.00005%. Testing methods for the restricted ingredients are provided to the related industries through the guidelines for analysis method for the restricted ingredients in cosmetics, whereas analysis methods for vitamin E, toluene, polyacrylamide and chloroacetamide have not been established yet. In order to establish the analysis methods for vitamin E, toluene, polyacrylamide and chloroacetamide, we used liquid chromatography, gas chromatography mass spectrometer, liquid chromatography mass spectrometer and gas chromatography mass spectrometer respectively. As internal standards of vitamin E, toluene, polyacrylamide and chloroacetamide, tocol, benzyl chloride, 13C3-acrylamideandbenzylchloridewerechosenrespectively. On the basis of the guidelines for validation of the test method for medical substances, etc., analysis methods were established and validation was conducted. As a result, analysis methods for vitamin E, toluene, polyacrylamide and chloroacetamide all showed linearity with correlation coefficient(R²) of more than 0.999 and superior selectivity. The limits of detection of vitamin E, toluene, polyacrylamide and chloroacetamide were 300, 166, 1.36 and 499 ng/mL and the limits of quantitation 1001, 553, 4.52 and 1663 ng/mL respectively. And accuracy(recovery) and precision were estimated using a number of ingredients. The results indicated that recovery rates for vitamin E, toluene, polyacrylamide and chloroacetamide were 94.7~107.4 100.4~101.6, 97.8~103.6 and 100.7~105.5% respectively and the precision was in less than 2% with the relative standard deviation(%RSD) of 0.31~1.65, 1.02, 1.41~1.89 and 1.13~1.63% respectively. In addition, monitoring of 42 nail products and 50 cosmetic products were carried out. The results showed these restricted ingredients were not detected or only small amounts of them within their respective limits were detected. Cross-validation of these analysis methods conducted by outside agencies showed consistent results. These analysis methods for vitamin E, toluene, polyacrylamide and chloroacetamide will be expected to contribute to safety control of the cosmetics available on the markets, being used for quality control and follow-up control in the related industries.
목차 Contents
- 표지 ... 1
- 자체연구개발과제 최종보고서 ... 2
- 국문 요약문 ... 3
- Summary ... 4
- 목 차 ... 5
- 연구개발과제 연구결과 ... 6
- 제1장 연구개발과제의 개요 ... 6
- 제1절 연구개발과제의 목표 ... 6
- 제2절 연구개발과제의 필요성 ... 6
- 제2장 연구개발과제의 국내·외 연구개발 현황 ... 6
- 제3장 연구개발과제의 연구수행 내용 및 결과 ... 15
- 제1절 연구수행 내용 ... 15
- 제2절 연구수행 결과 ... 27
- 제3절 유통화장품 모니터링 ... 57
- 제4장 연구개발과제의 연구결과 고찰 및 결론 ... 58
- 제1절 시험법 유효성 검증 ... 58
- 제2절 유통화장품 중 모니터링 ... 60
- 제5장 연구개발과제의 목표달성도 및 관련분야에의 기여도 ... 61
- 제1절 목표달성도 ... 61
- 제2절 관련분야에의 기여도 ... 62
- 제6장 연구개발과제의 연구개발 결과 활용계획 ... 68
- 제1절 활용성과 ... 68
- 제2절 활용계획 ... 68
- 제7장 참고문헌 ... 70
- 제8장 첨부서류 ... 71
- 끝페이지 ... 72
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