化妆品防腐剂甲基异噻唑啉酮的安全风险评估及技术法规要求最新进展
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摘要
甲基异噻唑啉酮是一种广泛应用的化妆品防腐剂。近年来,甲基异噻唑啉酮导致皮肤接触性过敏的案例多有报道,引起社会关注。欧盟消费者安全科学委员会(SCCS)多次开展安全风险评估,欧盟委员会两次发布化妆品相关法规修订案,对甲基异噻唑啉酮允许使用的浓度和范围进行了调整。本文对欧盟相关安全风险评估报告进行分析,并对欧盟法规修订过程及日本、韩国、加拿大等国家的法规要求进行解读,为我国化妆品安全技术法规的修订和行业技术要求的调整提供参考和依据。
Methylisothiazolinone is a widely used cosmetic preservative. In recent years, contact dermatitis induced by methylisothiazolinone had be reported and drawn public attention. In this situation, the EU SCCS conducted several safety risk assessments, and EU commission issued amendments twice to the related cosmetic regulations with adjusting the maximum concentration and applied ranges of methylisothiazolinone allowed. In this article, the relative SCCS opinions were analyzed,and the revision of EU regulation and current requirements about methylisothiazolinone in different countries including Japan,Korea, Canada, etc. were interpreted. It will help to provide reference and guidance for both amendment of regulation in China and technical upgrade of cosmetic industry.
Methylisothiazolinone is a widely used cosmetic preservative. In recent years, contact dermatitis induced by methylisothiazolinone had be reported and drawn public attention. In this situation, the EU SCCS conducted several safety risk assessments, and EU commission issued amendments twice to the related cosmetic regulations with adjusting the maximum concentration and applied ranges of methylisothiazolinone allowed. In this article, the relative SCCS opinions were analyzed,and the revision of EU regulation and current requirements about methylisothiazolinone in different countries including Japan,Korea, Canada, etc. were interpreted. It will help to provide reference and guidance for both amendment of regulation in China and technical upgrade of cosmetic industry.
引文
[1]邓志方,杜达安.化妆品防腐剂的使用概况及进展[J].华南预防医学,2000(2):909-92.
[2]冯士清,赵华.从使用频率看化妆品防腐剂走势(待续)[J].日用化学品科学,2006,29(11):30-33.
[3]冯士清,赵华.从使用频率看化妆品防腐剂走势(续前)[J].日用化学品科学,2006,29(12):32-35.
[4]The Scientific Committee on Cosmetic Products Non-Food Products Intended For Consumers.SCCNFP/0625/02:Opinion Concerning Methylisothiazolinone[EB/OL].(2003-03-18)[2018-05-11].http://ec.europa.en/health/ph_risk/commottees/sccp/document/out_201.pdf.
[5]The Scientific Committee on Cosmetic Products Non-Food Products Intended For Consumers.SCCNFP/0805/04:Opinion Concerning Methylisothiazolinone[EB/OL].(2004-04-23)[2018-05-11].http://ec.europa.en/health/ph_risk/commottees/sccp/documents/out270_en.pdf.
[6]European Union.Regulation(EC)No 1223/2009 of the European parliament and of the council of 30 November 2009on cosmetic products[J].Official Journal of the European Union,2009:88-342.
[7]SVEDMAN C,ANDERSEN K E,BRAND?O F M,et al.Follow-up of the monitored levels of preservative sensitivity in Europe:overview of the years 2001-2008[J].Contact Dermatitis,2012,67(5):312-314.
[8]BRUZE M,FREGERT S,GRUVBERGER B,et al.Contact allergy to the active ingredients of Kathon CG in the guinea pig.[J].Contact Dermatitis,1987,16(4):183-188.
[9]ISAKSSON M,GRUVBERGER B,BRUZE M.Occupational contact allergy and dermatitis from methylisothiazolinone after contact with wallcovering glue and after a chemical burn from a biocide[J].Dermatitis Contact Atopic Occupational Drug,2004,15(4):201.
[10]THYSSEN J P,SEDERBERGOLSEMN N,THOMSEN J F,et al.Contact dermatitis from methylisothiazolinone in a paint factory[J].Digest of World Core Medical Journals,2006,54(6):322-324.
[11]ANJA P M,MICHAEL D L,CLAUS Z,et al.Occupational contact dermatitis in painters-an analysis of patch test data from the Danish Contact Dermatitis Group[J].Contact Dermatitis,2012,67(5):293-297.
[12]G A R CíA-G AV I N J,VA N S I N A S,K E R R E S,e t a l.Methylisothiazolinone,an emerging allergen in cosmetics?[J].Contact Dermatitis,2010,63(2):96-101.
[13]LUNDOV M D,THYSSEN J P,ZACHARIAE C,et al.Prevalence and cause of methylisothiazolinone contact allergy[J].Contact Dermatitis,2010,63(3):164-167.
[14]LUNDOV M D,KRONGAARD T,MENNéT L,et al.Methylisothiazolinone contact allergy:a review[J].British Journal of Dermatology,2011,165(6):1178.
[15]AMARO C,SANTOS R,CARDOSO J.Contact allergy to methylisothiazolinone in a deodorant[J].Contact Dermatitis,2011,64(5):298-299.
[16]C A S T A N E D O T A R D A N A M P,Z U G K A.M e t h y l i s o t h i a z o l i n o n e[J].D e r m a t i t i s C o n t a c t A t o p i c Occupational Drug,2013,24(1):2.
[17]ACKERMANN L,AALTO‐KORTE K,ALANKO K,et al.Contact sensitization to methylisothiazolinone in Finland-a multicentre study[J].Contact Dermatitis,2011,64(1):49.
[18]URWIN R,WILKNSON M.Methylchloroisothiazolinone and methylisothiazolinone contact allergy:a new'epidemic'[J].Contact Dermatitis,2013,68(4):253.
[19]GONCALO M,AN G.Whilst Rome Burns:The epidemic of contact allergy to methylisothiazolinone[J].Contact Dermatitis,2013,68(5):257-258.
[20]JOHNSTON G A.The rise in prevalence of contact allergy to methylisothiazolinone in the British Isles[J].Contact Dermatitis,2014,70(4):238.
[21]UTER W,GEIER J,BAUER A,et al.Risk factors associated with methylisothiazolinone contact sensitization[J].Contact Dermatitis,2013,69(4):231-238.
[22]GEIER J,LESSMANN H,SCHNUCH A,et al.Recent increase in allergic reactions to methylchloroisothiazolinone/methylisothiazolinone:is methylisothiazolinone the culprit?[J].Contact Dermatitis,2012,67(6):334-341.
[23]McFADDEN J P,MANN J,WHITE J M,et al.Outbreak of methylisothiazolinone allergy targeting those aged≥40 years.[J].Contact Dermatitis,2013,69(1):53-5.
[24]BASKETTER D A,WHITE I R.Diagnostic patch testing-does it have a wider relevance?[J].Contact Dermatitis,2012,67(1):1.
[25]YA Z A R K,L U N D O V M D,FA U R S C H O U A,e t a l.Methylisothiazolinone in rinse‐off products causes allergic contact dermatitis:a repeated open‐application study[J].British Journal of Dermatology,2015,173(1):115-122.
[26]HOSTEING S,MEYER N,WATON J,et al.Outbreak of contact sensitization to methylisothiazolinone:an analysis of French data from the REVIDAL-GERDA network.[J].Contact Dermatitis,2014,70(5):262-269.
[27]AERTS O,BAECK M,CONSTANDT L,et al.The dramatic increase in the rate of methylisothiazolinone contact allergy in Belgium:a multicentre study[J].Contact Dermatitis,2014,71(1):41.
[28]高立雪,胡俊明,白雪涛.进口和国产化妆品中常用防腐剂的使用情况[J].环境与健康杂志,2012,29(3):247-248.
[29]蔡伦华,康晓熙,万莉,等.1134份化妆品中防腐剂使用现状[J].预防医学情报杂志,2016,32(11):1198-1200.
[30]蒋亚奇,王小兵,于海英,等.面膜类化妆品中12种防腐剂使用情况分析[J].香料香精化妆品,2017(4):43-45.
[31]齐佩瑾,王宇,龚怡,等.18款市售儿童化妆品防腐体系调查研究[J].日用化学品科学,2017,40(10):39-43.
[2]冯士清,赵华.从使用频率看化妆品防腐剂走势(待续)[J].日用化学品科学,2006,29(11):30-33.
[3]冯士清,赵华.从使用频率看化妆品防腐剂走势(续前)[J].日用化学品科学,2006,29(12):32-35.
[4]The Scientific Committee on Cosmetic Products Non-Food Products Intended For Consumers.SCCNFP/0625/02:Opinion Concerning Methylisothiazolinone[EB/OL].(2003-03-18)[2018-05-11].http://ec.europa.en/health/ph_risk/commottees/sccp/document/out_201.pdf.
[5]The Scientific Committee on Cosmetic Products Non-Food Products Intended For Consumers.SCCNFP/0805/04:Opinion Concerning Methylisothiazolinone[EB/OL].(2004-04-23)[2018-05-11].http://ec.europa.en/health/ph_risk/commottees/sccp/documents/out270_en.pdf.
[6]European Union.Regulation(EC)No 1223/2009 of the European parliament and of the council of 30 November 2009on cosmetic products[J].Official Journal of the European Union,2009:88-342.
[7]SVEDMAN C,ANDERSEN K E,BRAND?O F M,et al.Follow-up of the monitored levels of preservative sensitivity in Europe:overview of the years 2001-2008[J].Contact Dermatitis,2012,67(5):312-314.
[8]BRUZE M,FREGERT S,GRUVBERGER B,et al.Contact allergy to the active ingredients of Kathon CG in the guinea pig.[J].Contact Dermatitis,1987,16(4):183-188.
[9]ISAKSSON M,GRUVBERGER B,BRUZE M.Occupational contact allergy and dermatitis from methylisothiazolinone after contact with wallcovering glue and after a chemical burn from a biocide[J].Dermatitis Contact Atopic Occupational Drug,2004,15(4):201.
[10]THYSSEN J P,SEDERBERGOLSEMN N,THOMSEN J F,et al.Contact dermatitis from methylisothiazolinone in a paint factory[J].Digest of World Core Medical Journals,2006,54(6):322-324.
[11]ANJA P M,MICHAEL D L,CLAUS Z,et al.Occupational contact dermatitis in painters-an analysis of patch test data from the Danish Contact Dermatitis Group[J].Contact Dermatitis,2012,67(5):293-297.
[12]G A R CíA-G AV I N J,VA N S I N A S,K E R R E S,e t a l.Methylisothiazolinone,an emerging allergen in cosmetics?[J].Contact Dermatitis,2010,63(2):96-101.
[13]LUNDOV M D,THYSSEN J P,ZACHARIAE C,et al.Prevalence and cause of methylisothiazolinone contact allergy[J].Contact Dermatitis,2010,63(3):164-167.
[14]LUNDOV M D,KRONGAARD T,MENNéT L,et al.Methylisothiazolinone contact allergy:a review[J].British Journal of Dermatology,2011,165(6):1178.
[15]AMARO C,SANTOS R,CARDOSO J.Contact allergy to methylisothiazolinone in a deodorant[J].Contact Dermatitis,2011,64(5):298-299.
[16]C A S T A N E D O T A R D A N A M P,Z U G K A.M e t h y l i s o t h i a z o l i n o n e[J].D e r m a t i t i s C o n t a c t A t o p i c Occupational Drug,2013,24(1):2.
[17]ACKERMANN L,AALTO‐KORTE K,ALANKO K,et al.Contact sensitization to methylisothiazolinone in Finland-a multicentre study[J].Contact Dermatitis,2011,64(1):49.
[18]URWIN R,WILKNSON M.Methylchloroisothiazolinone and methylisothiazolinone contact allergy:a new'epidemic'[J].Contact Dermatitis,2013,68(4):253.
[19]GONCALO M,AN G.Whilst Rome Burns:The epidemic of contact allergy to methylisothiazolinone[J].Contact Dermatitis,2013,68(5):257-258.
[20]JOHNSTON G A.The rise in prevalence of contact allergy to methylisothiazolinone in the British Isles[J].Contact Dermatitis,2014,70(4):238.
[21]UTER W,GEIER J,BAUER A,et al.Risk factors associated with methylisothiazolinone contact sensitization[J].Contact Dermatitis,2013,69(4):231-238.
[22]GEIER J,LESSMANN H,SCHNUCH A,et al.Recent increase in allergic reactions to methylchloroisothiazolinone/methylisothiazolinone:is methylisothiazolinone the culprit?[J].Contact Dermatitis,2012,67(6):334-341.
[23]McFADDEN J P,MANN J,WHITE J M,et al.Outbreak of methylisothiazolinone allergy targeting those aged≥40 years.[J].Contact Dermatitis,2013,69(1):53-5.
[24]BASKETTER D A,WHITE I R.Diagnostic patch testing-does it have a wider relevance?[J].Contact Dermatitis,2012,67(1):1.
[25]YA Z A R K,L U N D O V M D,FA U R S C H O U A,e t a l.Methylisothiazolinone in rinse‐off products causes allergic contact dermatitis:a repeated open‐application study[J].British Journal of Dermatology,2015,173(1):115-122.
[26]HOSTEING S,MEYER N,WATON J,et al.Outbreak of contact sensitization to methylisothiazolinone:an analysis of French data from the REVIDAL-GERDA network.[J].Contact Dermatitis,2014,70(5):262-269.
[27]AERTS O,BAECK M,CONSTANDT L,et al.The dramatic increase in the rate of methylisothiazolinone contact allergy in Belgium:a multicentre study[J].Contact Dermatitis,2014,71(1):41.
[28]高立雪,胡俊明,白雪涛.进口和国产化妆品中常用防腐剂的使用情况[J].环境与健康杂志,2012,29(3):247-248.
[29]蔡伦华,康晓熙,万莉,等.1134份化妆品中防腐剂使用现状[J].预防医学情报杂志,2016,32(11):1198-1200.
[30]蒋亚奇,王小兵,于海英,等.面膜类化妆品中12种防腐剂使用情况分析[J].香料香精化妆品,2017(4):43-45.
[31]齐佩瑾,王宇,龚怡,等.18款市售儿童化妆品防腐体系调查研究[J].日用化学品科学,2017,40(10):39-43.