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<AUTHOR>법제처 법령정보센터</AUTHOR>
<DATE>2018.03.09</DATE>
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<TEXT CharShape="12"><CHAR>[시행 2017.12.29] [식품의약품안전처고시 제2017-114호, 2017.12.29, 일부개정]</CHAR>
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<P ParaShape="17"><TEXT CharShape="25"><CHAR>식품의약품안전처(화장품정책과) 043-719-3410</CHAR></TEXT></P>
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{전문}
<P ParaShape="2"><TEXT CharShape="6"><CHAR>        제1장 총칙</CHAR></TEXT></P><P ParaShape="23"><TEXT CharShape="6"><CHAR>제1조(목적)</CHAR></TEXT><TEXT CharShape="5"><CHAR> 이 고시는 「화장품법」 제8조의 규정에 따라 화장품에 사용할 수 없는 원료 및 사용상의 제한이 필요한 원료에 대하여 그 사용기준을 지정하고, 유통화장품 안전관리 기준에 관한 사항을 정함으로써 화장품의 제조 또는 수입 및 안전관리에 적정을 기함을 목적으로 한다. </CHAR></TEXT><TEXT CharShape="7"/></P><P ParaShape="23"><TEXT CharShape="6"><CHAR>제2조(적용범위)</CHAR></TEXT><TEXT CharShape="5"><CHAR> 이 규정은 국내에서 제조, 수입 또는 유통되는 모든 화장품에 대하여 적용한다.</CHAR></TEXT><TEXT CharShape="7"/></P><P ParaShape="2"><TEXT CharShape="6"><CHAR>        제2장 화장품에 사용할 수 없는 원료 및 사용상의 제한이 필요한 원료에 대한 사용기준</CHAR></TEXT></P><P ParaShape="23"><TEXT CharShape="6"><CHAR>제3조(사용할 수 없는 원료)</CHAR></TEXT><TEXT CharShape="5"><CHAR> 화장품에 사용할 수 없는 원료는 별표 1과 같다.</CHAR></TEXT><TEXT CharShape="7"/></P><P ParaShape="23"><TEXT CharShape="6"><CHAR>제4조(사용상의 제한이 필요한 원료에 대한 사용기준)</CHAR></TEXT><TEXT CharShape="5"><CHAR> 화장품에 사용상의 제한이 필요한 원료 및 그 사용기준은 별표 2와 같으며, 별표 2의 원료 외의 살균·보존제, 자외선 차단제 등은 사용할 수 없다.</CHAR></TEXT><TEXT CharShape="7"/></P><P ParaShape="2"><TEXT CharShape="6"><CHAR>                            제3장 유통화장품 안전관리 기준</CHAR></TEXT></P><P ParaShape="23"><TEXT CharShape="6"><CHAR>제5조(유통화장품의 안전관리 기준)</CHAR></TEXT><TEXT CharShape="5"><CHAR> 유통화장품은 제1항부터 제4항까지의 안전관리 기준에 적합하여야 하며, 유통화장품 유형별로 제5항부터 제7항까지의 안전관리 기준에 추가적으로 적합하여야 한다. 또한 시험방법은 별표 4에 따라 시험하되, 기타 과학적·합리적으로 타당성이 인정되는 경우 자사 기준으로 시험할 수 있다.   ① 화장품을 제조하면서 다음 각 호의 물질을 인위적으로 첨가하지 않았으나, 제조 또는 보관 과정 중 포장재로부터 이행되는 등 비의도적으로 유래된 사실이 객관적인 자료로 확인되고 기술적으로 완전한 제거가 불가능한 경우 해당 물질의 검출 허용 한도는 다음 각 호와 같다. </CHAR></TEXT><TEXT CharShape="7"/></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  1. 납 : 점토를 원료로 사용한 분말제품은 50㎍/g이하, 그 밖의 제품은 20㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  2. 니켈: 눈 화장용 제품은 35㎍/g 이하, 색조 화장용 제품은 30㎍/g이하, 그 밖의 제품은 10㎍/g 이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  3. 비소 : 10㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  4. 수은 : 1㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  5. 안티몬 : 10㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  6. 카드뮴 : 5㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  7. 디옥산 : 100㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  8. 메탄올 : 0.2(v/v)%이하, 물휴지는 0.002%(v/v)이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  9. 포름알데하이드 : 2000㎍/g이하, 물휴지는 20㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  10. 프탈레이트류(디부틸프탈레이트, 부틸벤질프탈레이트 및 디에칠헥실프탈레이트에 한함) : 총 합으로서 100㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="36" Style="0"><TEXT CharShape="5"><CHAR>  ② 별표 1의 사용할 수 없는 원료가 제1항의 사유로 검출되었으나 검출허용한도가 설정되지 아니한 경우에는 「화장품법 시행규칙」 제17조에 따라 위해평가 후 위해 여부를 결정하여야 한다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="36" Style="0"><TEXT CharShape="5"><CHAR>  ③ 미생물한도는 다음 각 호와 같다. </CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  1. 총호기성생균수는 영·유아용 제품류 및 눈화장용 제품류의 경우 500개/g(mL)이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  2. 물휴지의 경우 세균 및 진균수는 각각 100개/g(mL)이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  3. 기타 화장품의 경우 1,000개/g(mL)이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  4. 대장균(Escherichia Coli), 녹농균(Pseudomonas aeruginosa), 황색포도상구균(Staphylococcus aureus)은 불검출</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="36" Style="0"><TEXT CharShape="5"><CHAR>  ④ 내용량의 기준은 다음 각 호와 같다. </CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  1. 제품 3개를 가지고 시험할 때 그 평균 내용량이 표기량에 대하여 97%이상</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  2. 제1호의 기준치를 벗어날 경우 : 6개를 더 취하여 시험할 때 9개의 평균 내용량이 제1호의 기준치 이상 </CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  3. 그 밖의 특수한 제품 :「대한민국약전」(식품의약품안전처 고시)을 따를 것</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="36" Style="0"><TEXT CharShape="5"><CHAR>  ⑤ 영·유아용 제품류(영·유아용 샴푸, 영·유아용 린스, 영·유아 인체 세정용 제품, 영·유아 목욕용 제품 제외), 눈 화장용 제품류, 색조 화장용 제품류, 두발용 제품류(샴푸, 린스 제외), 면도용 제품류(셰이빙 크림, 셰이빙 폼 제외), 기초화장용 제품류(클렌징 워터, 클렌징 오일, 클렌징 로션, 클렌징 크림 등 메이크업 리무버 제품 제외) 중 액, 로션, 크림 및 이와 유사한 제형의 액상제품은 pH 기준이 3.0∼9.0 이어야 한다. 다만, 물을 포함하지 않는 제품과 사용한 후 곧바로 물로 씻어 내는 제품은 제외한다. </CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="36" Style="0"><TEXT CharShape="5"><CHAR>  ⑥ 기능성화장품은 기능성을 나타나게 하는 주원료의 함량이 「화장품법」제4조 및 같은 법 시행규칙 제9조 또는 제10조에 따라 심사 또는 보고한 기준에 적합하여야 한다. </CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="36" Style="0"><TEXT CharShape="5"><CHAR>  ⑦ 퍼머넌트웨이브용 및 헤어스트레이트너 제품은 다음 각 호의 기준에 적합하여야 한다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  1. 치오글라이콜릭애씨드 또는 그 염류를 주성분으로 하는 냉2욕식 퍼머넌트웨이브용 제품 : 이 제품은 실온에서 사용하는 것으로서 치오글라이콜릭애씨드 또는 그 염류를 주성분으로 하는 제1제 및 산화제를 함유하는 제2제로 구성된다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="38" Style="0"><TEXT CharShape="5"><CHAR>    가. 제1제 : 이 제품은 치오글라이콜릭애씨드 또는 그 염류를 주성분으로 하고, 불휘발성 무기알칼리의 총량이 치오글라이콜릭애씨드의 대응량 이하인 액제이다. 단, 산성에서 끓인 후의 환원성물질의 함량이 7.0%를 초과하는 경우에는 초과분에 대하여 디치오디글라이콜릭애씨드 또는 그 염류를 디치오디글라이콜릭애씨드로서 같은량 이상 배합하여야 한다. 이 제품에는 품질을 유지하거나 유용성을 높이기 위하여 적당한 알칼리제, 침투제, 습윤제, 착색제, 유화제, 향료 등을 첨가할 수 있다. </CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   1) pH : 4.5 ∼ 9.6</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   2) 알칼리 : 0.1N염산의 소비량은 검체 1mL 에 대하여 7.0mL이하  </CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   3) 산성에서 끓인 후의 환원성 물질(치오글라이콜릭애씨드) : 산성에서 끓인 후의 환원성 물질의 함량(치오글라이콜릭애씨드로서)이 2.0 ∼ 11.0％</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   4) 산성에서 끓인 후의 환원성 물질이외의 환원성 물질(아황산염, 황화물 등) : 검체 1mL 중의 산성에서 끓인 후의 환원성 물질이외의 환원성 물질에 대한 0.1N 요오드액의 소비량이 0.6mL이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   5) 환원후의 환원성 물질(디치오디글라이콜릭애씨드) : 환원후의 환원성 물질의 함량은 4.0％이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   6) 중금속 : 20㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   7) 비소 : 5㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   8) 철 : 2㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="38" Style="0"><TEXT CharShape="5"><CHAR>    나. 제2제 </CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   1) 브롬산나트륨 함유제제 : 브롬산나트륨에 그 품질을 유지하거나 유용성을 높이기 위하여 적당한 용해제, 침투제, 습윤제, 착색제, 유화제, 향료 등을 첨가한 것이다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="36" Style="0"><TEXT CharShape="5"><CHAR>   가) 용해상태 : 명확한 불용성이물이 없을 것</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="36" Style="0"><TEXT CharShape="5"><CHAR>   나) pH : 4.0 ∼ 10.5</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="36" Style="0"><TEXT CharShape="5"><CHAR>   다) 중금속 : 20㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="36" Style="0"><TEXT CharShape="5"><CHAR>   라) 산화력 : 1인 1회 분량의 산화력이 3.5이상</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   2) 과산화수소수 함유제제 : 과산화수소수 또는 과산화수소수에 그 품질을 유지하거나 유용성을 높이기 위하여 적당한 침투제, 안정제, 습윤제, 착색제, 유화제, 향료 등을 첨가한 것이다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="36" Style="0"><TEXT CharShape="5"><CHAR>   가) pH : 2.5 ∼ 4.5</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="36" Style="0"><TEXT CharShape="5"><CHAR>   나) 중금속 : 20㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="36" Style="0"><TEXT CharShape="5"><CHAR>   다) 산화력 : 1인 1회 분량의 산화력이 0.8 ∼ 3.0</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  2. 시스테인, 시스테인염류 또는 아세틸시스테인을 주성분으로 하는 냉2욕식 퍼머넌트웨이브용 제품 : 이 제품은 실온에서 사용하는 것으로서 시스테인, 시스테인염류 또는 아세틸시스테인을 주성분으로 하는 제1제 및 산화제를 함유하는 제2제로 구성된다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="38" Style="0"><TEXT CharShape="5"><CHAR>    가. 제1제 : 이 제품은 시스테인, 시스테인염류 또는 아세틸시스테인을 주성분으로 하고 불휘발성 무기알칼리를 함유하지 않은 액제이다. 이 제품에는 품질을 유지하거나 유용성을 높이기 위하여 적당한 알칼리제, 침투제, 습윤제, 착색제, 유화제, 향료 등을 첨가할 수 있다. </CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   1) pH : 8.0 ∼ 9.5</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   2) 알칼리 : 0.1N 염산의 소비량은 검체 1mL에 대하여 12mL이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   3) 시스테인 : 3.0 ∼ 7.5％ </CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   4) 환원후의 환원성물질(시스틴) : 0.65％이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   5) 중금속 : 20㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   6) 비소 : 5㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   7) 철 : 2㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="38" Style="0"><TEXT CharShape="5"><CHAR>    나. 제2제 기준 : 1. 치오글라이콜릭애씨드 또는 그 염류를 주성분으로 하는 냉2욕식 퍼머넌트웨이브용 제품 나. 제2제의 기준에 따른다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  3. 치오글라이콜릭애씨드 또는 그 염류를 주성분으로 하는 냉2욕식 헤어스트레이트너용 제품 : 이 제품은 실온에서 사용하는 것으로서 치오글라이콜릭애씨드 또는 그 염류를 주성분으로 하는 제1제 및 산화제를 함유하는 제2제로 구성된다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="38" Style="0"><TEXT CharShape="5"><CHAR>    가. 제1제 : 이 제품은 치오글라이콜릭애씨드 또는 그 염류를 주성분으로 하고 불휘발성 무기알칼리의 총량이 치오글라이콜릭애씨드의 대응량 이하인 제제이다. 단, 산성에서 끓인 후의 환원성물질의 함량이 7.0%를 초과하는 경우, 초과분에 대해 디치오디글라이콜릭애씨드 또는 그 염류를 디치오디글라이콜릭애씨드로 같은 양 이상 배합하여야 한다. 이 제품에는 품질을 유지하거나 유용성을 높이기 위하여 적당한 알칼리제, 침투제, 착색제, 습윤제, 유화제, 증점제, 향료 등을 첨가할 수 있다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   1) pH : 4.5 ∼ 9.6</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   2) 알칼리 : 0.1N 염산의 소비량은 검체 1mL에 대하여 7.0mL이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   3) 산성에서 끊인 후의 환원성물질(치오글라이콜릭애씨드) : 2.0 ∼ 11.0％</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   4) 산성에서 끓인 후의 환원성물질 이외의 환원성물질(아황산, 황화물 등) : 검체 1mL중의 산성에서 끓인 후의 환원성물질 이외의 환원성물질에 대한 0.1N 요오드액의 소비량은 0.6mL이하 </CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   5) 환원후의 환원성물질(디치오디글리콜릭애씨드) : 4.0％이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   6) 중금속 : 20㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   7) 비소 : 5㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   8) 철 : 2㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="38" Style="0"><TEXT CharShape="5"><CHAR>    나. 제2제 기준 : 1. 치오글라이콜릭애씨드 또는 그 염류를 주성분으로 하는 냉2욕식 퍼머넌트웨이브용 제품 나. 제2제의 기준에 따른다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  4. 치오글라이콜릭애씨드 또는 그 염류를 주성분으로 하는 가온2욕식 퍼머넌트웨이브용 제품 : 이 제품은 사용할 때 약 60℃이하로 가온조작하여 사용하는 것으로서 치오글라이콜릭애씨드 또는 그 염류를 주성분으로 하는 제1제 및 산화제를 함유하는 제2제로 구성된다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="38" Style="0"><TEXT CharShape="5"><CHAR>    가. 제1제 : 이 제품은 치오글라이콜릭애씨드 또는 그 염류를 주성분으로 하고 불휘발성 무기알칼리의 총량이 치오글라이콜릭애씨드의 대응량 이하인 액제이다. 이 제품에는 품질을 유지하거나 유용성을 높이기 위하여 적당한 알칼리제, 침투제, 습윤제, 착색제, 유화제, 향료 등을 첨가할 수 있다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   1) pH : 4.5 ∼ 9.3</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   2) 알칼리 : 0.1N 염산의 소비량은 검체 1mL에 대하여 5mL이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   3) 산성에서 끓인 후의 환원성물질(치오글라이콜릭애씨드) : 1.0 ∼ 5.0％</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   4) 산성에서 끓인 후의 환원성물질 이외의 환원성물질(아황산, 황화물 등) : 검체 1mL중의 산성에서 끓인 후의 환원성물질 이외의 환원성물질에 대한 0.1N 요오드액의 소비량은 0.6mL이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   5) 환원후의 환원성물질(디치오디글라이콜릭애씨드) : 4.0％이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   6) 중금속 : 20㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   7) 비소 : 5㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   8) 철 : 2㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="38" Style="0"><TEXT CharShape="5"><CHAR>    나. 제2제 기준 : 1. 치오글라이콜릭애씨드 또는 그 염류를 주성분으로 하는 냉2욕식 퍼머넌트웨이브용 제품 나. 제2제의 기준에 따른다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  5. 시스테인, 시스테인염류 또는 아세틸시스테인을 주성분으로 하는 가온 2욕식 퍼머넌트웨이브용 제품 : 이 제품은 사용 시 약 60℃ 이하로 가온조작하여 사용하는 것으로서 시스테인, 시스테인염류, 또는 아세틸시스테인을 주성분으로 하는 제1제 및 산화제를 함유하는 제2제로 구성된다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="38" Style="0"><TEXT CharShape="5"><CHAR>    가. 제1제 : 이 제품은 시스테인, 시스테인염류, 또는 아세틸시스테인을 주성분으로 하고 불휘발성 무기알칼리를 함유하지 않는 액제로서 이 제품에는 품질을 유지하거나 유용성을 높이기 위해서 적당한 알칼리제, 침투제, 습윤제, 착색제, 유화제, 향료 등을 첨가할 수 있다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   1) pH : 4.0 ∼ 9.5</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   2) 알칼리 : 0.1N염산의 소비량은 검체 1mL에 대하여 9mL이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   3) 시스테인 : 1.5 ∼ 5.5%</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   4) 환원후의 환원성물질(시스틴) : 0.65%이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   5) 중금속 : 20㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   6) 비소 : 5㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   7) 철 : 2㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="38" Style="0"><TEXT CharShape="5"><CHAR>    나. 제2제 기준 : 1. 치오글라이콜릭애씨드 또는 그 염류를 주성분으로 하는 냉2욕식 퍼머넌트웨이브용 제품 나. 제2제의 기준에 따른다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  6. 치오글라이콜릭애씨드 또는 그 염류를 주성분으로 하는 가온2욕식 헤어스트레이트너 제품 : 이 제품은 시험할 때 약 60℃이하로 가온 조작하여 사용하는 것으로서 치오글라이콜릭애씨드 또는 그 염류를 주성분으로 하는 제1제 및 산화제를 함유하는 제2제로 구성된다. </CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="38" Style="0"><TEXT CharShape="5"><CHAR>    가. 제1제 : 이 제품은 치오글라이콜릭애씨드 또는 그 염류를 주성분으로 하고 불휘발성 알칼리의 총량이 치오글라이콜릭애씨드의 대응량 이하인 제제이다. 이 제품에는 품질을 유지하거나 유용성을 높이기 위하여 적당한 알칼리제, 침투제, 습윤제, 유화제, 점증제, 향료 등을 첨가할 수 있다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   1) pH : 4.5 ∼ 9.3</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   2) 알칼리 : 0.1N 염산의 소비량은 검체 1mL에 대하여 5.0mL이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   3) 산성에서 끓인 후의 환원성물질(치오글라이콜릭애씨드) : 1.0 ∼ 5.0％</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   4) 산성에서 끓인 후의 환원성물질 이외의 환원성물질(아황산염, 황화물 등) : 검체 1mL중의 산성에서 끓인 후의 환원성물질 이외의 환원성물질에 대한 0.1N 요오드액의 소비량은 0.6mL이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   5) 환원 후의 환원성물질(디치오디글라이콜릭애씨드) : 4.0％이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   6) 중금속 : 20㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   7) 비소 : 5㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   8) 철 : 2㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="38" Style="0"><TEXT CharShape="5"><CHAR>    나. 제2제 기준 : 1. 치오글라이콜릭애씨드 또는 그 염류를 주성분으로 하는 냉2욕식 퍼머넌트웨이브용 제품 나. 제2제의 기준에 따른다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  7. 치오글라이콜릭애씨드 또는 그 염류를 주성분으로 하는 고온정발용 열기구를 사용하는 가온2욕식 헤어스트레이트너 제품 : 이 제품은 시험할 때 약 60℃이하로 가온하여 제1제를 처리한 후 물로 충분히 세척하여 수분을 제거하고 고온정발용 열기구(180℃이하)를 사용하는 것으로서 치오글라이콜릭애씨드 또는 그 염류를 주성분으로 하는 제1제 및 산화제를 함유하는 제2제로 구성된다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="38" Style="0"><TEXT CharShape="5"><CHAR>    가. 제1제 : 이 제품은 치오글라이콜릭애씨드 또는 그 염류를 주성분으로 하고 불휘발성 알칼리의 총량이 치오글라이콜릭애씨드의 대응량 이하인 제제이다. 이 제품에는 품질을 유지하거나 유용성을 높이기 위하여 적당한 알칼리제, 침투제, 습윤제, 유화제, 점증제, 향료 등을 첨가할 수 있다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   1) pH : 4.5 ∼ 9.3</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   2) 알칼리 : 0.1N 염산의 소비량은 검체 1mL에 대하여 5.0mL이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   3) 산성에서 끓인 후의 환원성물질(치오글라이콜릭애씨드) : 1.0 ∼ 5.0％</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   4) 산성에서 끓인 후의 환원성물질 이외의 환원성물질(아황산염, 황화물 등) : 검체 1mL중의 산성에서 끓인 후의 환원성물질 이외의 환원성물질에 대한 0.1N 요오드액의 소비량은 0.6mL이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   5) 환원 후의 환원성물질(디치오디글라이콜릭애씨드) : 4.0％이하 </CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   6) 중금속 : 20㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   7) 비소 : 5㎍/g이하       </CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   8) 철 : 2㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="38" Style="0"><TEXT CharShape="5"><CHAR>    나. 제2제 기준 : 1. 치오글라이콜릭애씨드 또는 그 염류를 주성분으로 하는 냉2욕식 퍼머넌트웨이브용 제품 나. 제2제의 기준에 따른다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  8. 치오글라이콜릭애씨드 또는 그 염류를 주성분으로 하는 냉1욕식 퍼머넌트웨이브용 제품 : 이 제품은 실온에서 사용하는 것으로서 치오글라이콜릭애씨드 또는 그 염류를 주성분으로 하고 불휘발성 무기알칼리의 총량이 치오글라이콜릭애씨드의 대응량 이하인 액제이다. 이 제품에는 품질을 유지하거나 유용성을 높이기 위하여 적당한 알칼리제, 침투제, 습윤제, 착색제, 유화제, 향료 등을 첨가할 수 있다. </CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   1) pH : 9.4 ∼ 9.6</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   2) 알칼리 : 0.1N 염산의 소비량은 검체 1mL에 대하여 3.5 ∼ 4.6mL</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   3) 산성에서 끓인 후의 환원성 물질(치오글라이콜릭애씨드) : 3.0 ∼ 3.3％</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   4) 산성에서 끓인 후의 환원성물질 이외의 환원성물질(아황산염, 황화물 등) : 검체 1mL 중인 산성에서 끓인 후의 환원성물질 이외의 환원성 물질에 대한 0.1N 요오드액의 소비량은 0.6mL이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   5) 환원후의 환원성물질(디치오디글라이콜릭애씨드) : 0.5％이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   6) 중금속 : 20㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   7) 비소 : 5㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   8) 철 : 2㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  9. 치오글라이콜릭애씨드 또는 그 염류를 주성분으로 하는 제1제 사용시 조제하는 발열2욕식 퍼머넌트웨이브용 제품 : 이 제품은 치오글라이콜릭애씨드 또는 그 염류를 주성분으로 하는 제1제의 1과 제1제의 1중의 치오글라이콜릭애씨드 또는 그 염류의 대응량 이하의 과산화수소를 함유한 제1제의 2, 과산화수소를 산화제로 함유하는 제2제로 구성되며, 사용시 제1제의 1 및 제1제의 2를 혼합하면 약 40℃로 발열되어 사용하는 것이다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="38" Style="0"><TEXT CharShape="5"><CHAR>    가. 제1제의 1 : 이 제품은 치오글라이콜릭애씨드 또는 그 염류를 주성분으로 하는 액제로서 이 제품에는 품질을 유지하거나 유용성을 높이기 위하여 적당한 알칼리제, 침투제, 습윤제, 착색제, 유화제, 향료 등을 첨가할 수 있다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   1) pH : 4.5 ∼ 9.5    </CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   2) 알칼리 : 0.1N 염산의 소비량은 검체 1mL에 대하여 10mL이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   3) 산성에서 끓인 후의 환원성물질(치오글라이콜릭애씨드) : 8.0 ∼ 19.0％</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   4) 산성에서 끓인 후의 환원성물질 이외의 환원성물질(아황산염, 황화물 등) : 검체 1mL중의 산성에서 끓인 후의 환원성물질 이외의 환원성물질에 대한 0.1N 요오드액의 소비량은 0.8mL이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   5) 환원후의 환원성물질(디치오디글라이콜릭애씨드) : 0.5％이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   6) 중금속 : 20㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   7) 비소 : 5㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   8) 철 : 2㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="38" Style="0"><TEXT CharShape="5"><CHAR>    나. 제1제의 2 : 이 제품은 제1제의 1중에 함유된 치오글라이콜릭애씨드 또는 그 염류의 대응량 이하의 과산화수소를 함유한 액제로서 이 제품에는 품질을 유지하거나 유용성을 높이기 위하여 적당한 침투제, pH조정제, 안정제, 습윤제, 착색제, 유화제, 향료 등을 첨가할 수 있다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   1) pH : 2.5 ∼ 4.5</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   2) 중금속 : 20㎍/g이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>   3) 과산화수소 : 2.7 ∼ 3.0％</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="38" Style="0"><TEXT CharShape="5"><CHAR>    다. 제1제의 1 및 제1제의 2의 혼합물 : 이 제품은 제1제의 1 및 제1제의 2를 용량비 3 : 1로 혼합한 액제로서 치오글라이콜릭애씨드 또는 그 염류를 주성분으로 하고 불휘발성 무기알칼리의 총량이 치오글라이콜릭애씨드의 대응량 이하인 것이다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  1) pH : 4.5 ∼ 9.4  </CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  2) 알칼리 : 0.1N 염산의 소비량은 검체 1mL 에 대하여 7mL이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  3) 산성에서 끓인 후의 환원성물질(치오글라이콜릭애씨드) : 2.0 ∼ 11.0％</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  4) 산성에서 끓인 후의 환원성물질 이외의 환원성물질(아황산염, 황화물 등) : 산성에서 끓인 후의 환원성물질 이외의 환원성물질에 대한 0.1N 요오드액의 소비량은 0.6mL이하</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  5) 환원후의 환원성물질(디치오디글라이콜릭애씨드) : 3.2 ∼ 4.0％</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="37" Style="0"><TEXT CharShape="5"><CHAR>  6) 온도상승 : 온도의 차는 14℃ ∼ 20℃</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="38" Style="0"><TEXT CharShape="5"><CHAR>    라. 제2제 : 1. 치오글라이콜릭애씨드 또는 그 염류를 주성분으로 하는 냉2욕식 퍼머넌트웨이브용 제품 나. 제2제의 기준에 따른다.</CHAR></TEXT><TEXT CharShape="7" /></P><P ParaShape="23"><TEXT CharShape="6"><CHAR>제6조(규제의 재검토)</CHAR></TEXT><TEXT CharShape="5"><CHAR> 「행정규제기본법」제8조 및 「훈령·예규 등의 발령 및 관리에 관한 규정」(대통령훈령 제248호)에 따라 2014년 1월 1일을 기준으로 매 3년이 되는 시점(매 3년째의 12월 31일까지를 말한다)마다 그 타당성을 검토하여 개선 등의 조치를 하여야 한다.</CHAR></TEXT><TEXT CharShape="7"/></P>
<P ParaShape="2"><TEXT CharShape="5"/></P><P ParaShape="2"><TEXT CharShape="6"><CHAR>&nbsp;&nbsp;&nbsp;&nbsp;부칙&nbsp;</CHAR></TEXT><TEXT CharShape="23"><CHAR>&nbsp;&lt;제2013-2호, 2013.1.16&gt; &nbsp;</CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제1조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(시행일) 이 고시는 고시 후 1개월이 경과한 날부터 시행한다.</CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제2조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(다른 고시의 폐지) 「화장품 기준 및 시험방법」(식품의약품안전청 고시 제2009-158호, 2009.10.7.)은 이를 폐지한다.</CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제3조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(적용례) 이 고시는 고시 시행 후 최초로 화장품 제조업자 및 제조판매업자가 제조 또는 수입(통관일을 기준으로 한다)하는 화장품부터 적용한다.</CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제4조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(경과조치) ① 이 고시 시행 당시 종전의 규정에 따라 제조 또는 수입된 화장품에 대하여는 종전의 규정을 적용한다.</CHAR></TEXT></P><P ParaShape="24" Style="0"><TEXT CharShape="5"><CHAR>  ② 이 고시 시행 당시 종전 규정에 따라 심사받은 기능성화장품의 별첨규격과 기준 및 시험방법에서 “장원기 일반시험법” 및 “「화장품 기준 및 시험방법」(식품의약품안전청 고시)”을 인용하고 있는 경우, 이를 각각 “「기능성화장품 기준 및 시험방법」(식품의약품안전청 고시) 일반시험법 Ⅵ-1. 원료” 및 “「기능성화장품 기준 및 시험방법」(식품의약품안전청 고시) 일반시험법 Ⅵ-2. 제제”를 인용한 것으로 본다.</CHAR></TEXT><TEXT CharShape="7"/></P><P ParaShape="24" Style="0"><TEXT CharShape="5"><CHAR>  ③ 이 고시 시행 당시 종전 규정에 따라 허가 또는 신고 수리 된 의약품 및 의약외품의 별첨규격과 기준 및 시험방법에서 “장원기 일반시험법” 및 “「화장품 기준 및 시험방법」(식품의약품안전청 고시)”을 인용하고 있는 경우, 이를 “「의약외품에 관한 기준 및 시험방법」(식품의약품안전청 고시) 의약외품 각조 제4부 첨가제”를 인용한 것으로 본다.</CHAR></TEXT><TEXT CharShape="7"/></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제5조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(다른 고시의 개정) ① 「의약품의 품목허가·신고·심사 규정」(식품의약품안전청 고시 제2012-137호, 2012.12.28.)을 다음과 같이 개정한다.</CHAR></TEXT></P><P ParaShape="24"><TEXT CharShape="5"><CHAR>  제12조제3항제2호사목 중 “「화장품 원료지정에 관한 기준」(식약청 고시) 별표 1의 화장품원료기준”을 “「의약외품에 관한 기준 및 시험방법」(식품의약품안전청 고시) 의약외품 각조 제4부 첨가제”로 한다.</CHAR></TEXT><TEXT CharShape="7"/></P><P ParaShape="24" Style="0"><TEXT CharShape="5"><CHAR>  ② 「의약외품 품목허가·신고·심사 규정」(식품의약품안전청고시 제2011-5호, 2011.2.1.)을 다음과 같이 개정한다.</CHAR></TEXT><TEXT CharShape="7"/></P><P ParaShape="24"><TEXT CharShape="5"><CHAR>  제9조제3항제2호자목 중 “「화장품 원료지정에 관한 규정」(식품의약품안전청 고시) 별표 1에 따른 화장품원료기준”을 “「의약외품에 관한 기준 및 시험방법」(식품의약품안전청 고시) 의약외품 각조 제4부 첨가제”로 한다.</CHAR></TEXT><TEXT CharShape="7"/></P><P ParaShape="24" Style="0"><TEXT CharShape="5"><CHAR>  ③ 「생물학적제제 등의 품목허가·심사 규정」(식품의약품안전청 고시 제2012-123호, 2012.12.26.)을 다음과 같이 개정한다.</CHAR></TEXT><TEXT CharShape="7"/></P><P ParaShape="24"><TEXT CharShape="5"><CHAR>  제12조제3항제2호아목 중 “「화장품 원료지정에 관한 기준」(식품의약품안전청 고시) 별표 1의 화장품원료기준”을 “「의약외품에 관한 기준 및 시험방법」(식품의약품안전청 고시) 의약외품 각조 제4부 첨가제”로 한다.</CHAR></TEXT><TEXT CharShape="7"/></P><P ParaShape="24" Style="0"><TEXT CharShape="5"><CHAR>  ④ 「한약(생약)제제 등의 품목허가·신고에 관한 규정」(식품의약품안전청 고시 제2012-22호, 2012.5.22.)을 다음과 같이 개정한다.</CHAR></TEXT><TEXT CharShape="7"/></P><P ParaShape="24"><TEXT CharShape="5"><CHAR>  제12조제3항제2호바목 중 “「화장품 원료지정에 관한 규정」(식약청 고시) 별표 1의 화장품원료기준”을 “「의약외품에 관한 기준 및 시험방법」(식품의약품안전청 고시) 의약외품 각조 제4부 첨가제”로 한다.</CHAR></TEXT><TEXT CharShape="7"/></P><P ParaShape="2"><TEXT CharShape="5"/></P><P ParaShape="2"><TEXT CharShape="6"><CHAR>&nbsp;&nbsp;&nbsp;&nbsp;부칙&nbsp;</CHAR></TEXT><TEXT CharShape="23"><CHAR>&nbsp;&lt;제2013-24호, 2013.4.5&gt; &nbsp;</CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제1조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(시행일) 이 고시는 고시한 날로부터 시행한다.</CHAR></TEXT></P><P ParaShape="2"><TEXT CharShape="5"/></P><P ParaShape="2"><TEXT CharShape="6"><CHAR>&nbsp;&nbsp;&nbsp;&nbsp;부칙&nbsp;</CHAR></TEXT><TEXT CharShape="23"><CHAR>&nbsp;&lt;제2014-79호, 2014.2.12&gt; &nbsp;</CHAR></TEXT></P><P ParaShape="24"><TEXT CharShape="5"><CHAR>이 고시는 고시한 날부터 시행한다.</CHAR></TEXT><TEXT CharShape="7"/></P><P ParaShape="2"><TEXT CharShape="5"/></P><P ParaShape="2"><TEXT CharShape="6"><CHAR>&nbsp;&nbsp;&nbsp;&nbsp;부칙&nbsp;</CHAR></TEXT><TEXT CharShape="23"><CHAR>&nbsp;&lt;제2014-118호, 2014.5.30&gt; &nbsp;</CHAR></TEXT></P><P ParaShape="24"><TEXT CharShape="5"><CHAR>이 고시는 고시한 날부터 시행한다.</CHAR></TEXT><TEXT CharShape="7"/></P><P ParaShape="2"><TEXT CharShape="5"/></P><P ParaShape="2"><TEXT CharShape="6"><CHAR>&nbsp;&nbsp;&nbsp;&nbsp;부칙&nbsp;</CHAR></TEXT><TEXT CharShape="23"><CHAR>&nbsp;&lt;제2014-199호, 2014.12.23&gt; &nbsp;</CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제1조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(시행일) 이 고시는 고시 후 1개월이 경과한 날부터 시행한다.</CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제2조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(적용례) 이 고시는 고시 시행 후 최초로 제조 또는 수입(통관일을 기준으로 한다)된 화장품부터 적용한다.</CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제3조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(경과조치) 이 고시 시행 당시 종전의 규정에 따라 제조 또는 수입(통관일을 기준으로 한다)된 화장품은 종전의 규정을 적용한다.</CHAR></TEXT></P><P ParaShape="2"><TEXT CharShape="5"/></P><P ParaShape="2"><TEXT CharShape="6"><CHAR>&nbsp;&nbsp;&nbsp;&nbsp;부칙&nbsp;</CHAR></TEXT><TEXT CharShape="23"><CHAR>&nbsp;&lt;제2015-43호, 2015.7.10&gt; &nbsp;</CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제1조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(시행일) 이 고시는 고시한 날부터 시행한다. 다만, 별표 2의 개정규정은 고시 후 1개월이 경과한 날부터 시행한다.</CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제2조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(적용례) 이 고시는 고시 시행 후 화장품 제조업자 및 제조판매업자가 제조 또는 수입(통관일을 기준으로 한다)하는 화장품부터 적용한다.</CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제3조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(경과조치) 이 고시 시행 당시 종전의 규정에 따라 제조 또는 수입된 화장품에 대하여는 종전의 규정을 적용한다.</CHAR></TEXT></P><P ParaShape="2"><TEXT CharShape="5"/></P><P ParaShape="2"><TEXT CharShape="6"><CHAR>&nbsp;&nbsp;&nbsp;&nbsp;부칙&nbsp;</CHAR></TEXT><TEXT CharShape="23"><CHAR>&nbsp;&lt;제2015-110호, 2015.12.29&gt; &nbsp;</CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제1조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(시행일) 이 고시는 고시한 날부터 시행한다. 다만, 별표 2 중 드로메트리졸의 사용한도란 및 별표 3의 개정규정은 고시 후 1개월이 경과한 날부터 시행한다.</CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제2조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(자일렌, 드로메트리졸, 유통화장품 안전관리 기준 시험방법 변경의 적용례) 별표 1, 별표 2, 별표 4의 개정규정은 고시 시행 후 제조 또는 수입(통관일을 기준으로 한다)되는 화장품부터 적용한다. </CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제3조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(인체세포·조직배양액의 안전기준에 관한 적용례) 별표 3의 개정규정은 이 고시 시행 후 제조 또는 수입(통관일 기준으로 한다)되는 ‘인체 세포·조직 배양액’부터 적용한다.</CHAR></TEXT></P><P ParaShape="2"><TEXT CharShape="5"/></P><P ParaShape="2"><TEXT CharShape="6"><CHAR>&nbsp;&nbsp;&nbsp;&nbsp;부칙&nbsp;</CHAR></TEXT><TEXT CharShape="23"><CHAR>&nbsp;&lt;제2016-74호, 2016.7.28&gt; &nbsp;</CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제1조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(시행일) 이 고시는 고시한 날로부터 시행한다.</CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제2조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(적용례) 이 고시는 고시 시행 후 화장품 제조업자 및 제조판매업자가 제조 또는 수입(통관일을 기준으로 한다)하는 화장품부터 적용한다.</CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제3조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(경과조치) 이 고시 시행 당시 종전의 규정에 따라 제조 또는 수입 된 화장품에 대하여는 종전의 규정을 적용한다.</CHAR></TEXT></P><P ParaShape="2"><TEXT CharShape="5"/></P><P ParaShape="2"><TEXT CharShape="6"><CHAR>&nbsp;&nbsp;&nbsp;&nbsp;부칙&nbsp;</CHAR></TEXT><TEXT CharShape="23"><CHAR>&nbsp;&lt;제2017-3호, 2017.1.11&gt; &nbsp;</CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제1조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(시행일) 이 고시는 2017년 7월 1일부터 시행한다.</CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제2조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(적용례) 이 고시는 고시 시행 후 화장품 제조업자 및 제조판매업자가 제조 또는 수입(통관일을 기준으로 한다)하는 화장품부터 적용한다.</CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제3조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(경과조치) 이 고시 시행 당시 종전의 규정에 따라 제조 또는 수입된 화장품에 대해서는 종전의 규정을 적용한다. 다만 해당 제품은 고시 시행 후 1년이 경과한 날까지만 판매하거나 판매의 목적으로 진열 또는 보관할 수 있다.</CHAR></TEXT></P><P ParaShape="2"><TEXT CharShape="5"/></P><P ParaShape="2"><TEXT CharShape="6"><CHAR>&nbsp;&nbsp;&nbsp;&nbsp;부칙&nbsp;</CHAR></TEXT><TEXT CharShape="23"><CHAR>&nbsp;&lt;제2017-12호, 2017.2.23&gt; &nbsp;</CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제1조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(시행일) 이 고시는 고시한 날부터 시행한다. </CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제2조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(적용례) 이 고시는 고시 시행 후 화장품 제조업자 및 제조판매업자가 제조 또는 수입(통관일을 기준으로 한다)하는 화장품부터 적용한다.</CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제3조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(경과조치) 이 고시 시행 당시 종전의 규정에 따라 제조 또는 수입된 화장품에 대해서는 종전의 규정을 적용한다. 다만, 해당 제품은 이 고시 시행 후 1년6개월이 경과한 날까지만 판매하거나 판매의 목적으로 진열 또는 보관할 수 있다.</CHAR></TEXT></P><P ParaShape="2"><TEXT CharShape="5"/></P><P ParaShape="2"><TEXT CharShape="6"><CHAR>&nbsp;&nbsp;&nbsp;&nbsp;부칙&nbsp;</CHAR></TEXT><TEXT CharShape="23"><CHAR>&nbsp;&lt;제2017-41호, 2017.5.23&gt; &nbsp;</CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제1조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(시행일) 이 고시는 2017년 5월 30일부터 시행한다. </CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제2조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(적용례) 이 고시는 고시 시행 후 화장품 제조업자 또는 제조판매업자가 제조 또는 수입(통관일을 기준으로 한다)하는 화장품부터 적용한다.</CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제3조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(안전기준 등의 변경에 따른 화장품의 제조·수입에 대한 경과조치) 부칙 제2조에도 불구하고 이 고시 시행 당시 종전의 「약사법」 제31조제4항에 따른 품목허가를 받았거나 품목신고를 한 의약외품의 제조업자 또는 수입자는 이 고시 시행 이후 1년이 되는 날까지는 종전 규정에 따라 해당 품목을 제조 또는 수입할 수 있다. </CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제4조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(안전기준 등의 변경에 따른 화장품의 판매 등에 대한 경과조치) 이 고시 시행 당시 종전의 「약사법」 제31조제4항에 따른 품목허가를 받았거나 품목신고를 하여 이미 제조 또는 수입된 제품이나 부칙 제3조에 해당하여 제조 또는 수입한 제품의 경우에는 이 고시 시행 이후 2년이 되는 날까지는 판매하거나 판매의 목적으로 진열 또는 보관할 수 있다.</CHAR></TEXT></P><P ParaShape="2"><TEXT CharShape="5"/></P><P ParaShape="2"><TEXT CharShape="6"><CHAR>&nbsp;&nbsp;&nbsp;&nbsp;부칙&nbsp;</CHAR></TEXT><TEXT CharShape="23"><CHAR>&nbsp;&lt;제2017-50호, 2017.6.13&gt; &nbsp;</CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제1조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(시행일) 이 고시는 고시한 날로부터 시행한다.  </CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제2조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(적용례) 이 고시는 고시 시행 후 화장품 제조업자 및 제조판매업자가 제조 또는 수입(통관일을 기준으로 한다)하는 화장품부터 적용한다. </CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제3조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(안전기준 등의 변경에 따른 화장품의 제조·수입에 대한 경과조치) ① 부칙 제2조에도 불구하고 이 고시 시행 당시 종전의 「약사법」 제31조제4항에 따른 품목허가를 받았거나 품목신고를 한 의약외품의 제조업자 또는 수입자는 2018년 5월 30일까지 종전 규정에 따라 해당 품목을 제조 또는 수입할 수 있다. </CHAR></TEXT></P><P ParaShape="24" Style="0"><TEXT CharShape="5"><CHAR>  ② 부칙 제2조에도 불구하고 화장품 제조업자 또는 제조판매업자는 이 고시 시행 당시 이미 제조 또는 수입한 적이 있는 화장품의 경우에는 2018년 5월 30일까지 종전 규정에 따라 제조 또는 수입할 수 있다.</CHAR></TEXT><TEXT CharShape="7"/></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제4조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(안전기준 등의 변경에 따른 화장품의 판매 등에 대한 경과조치) 이 고시 시행 당시 이미 제조 또는 수입된 제품이나 부칙 제3조제1항 또는 제2항에 해당하여 제조 또는 수입한 제품의 경우에는 2019년 5월 30일까지 판매하거나 판매의 목적으로 진열 또는 보관할 수 있다. </CHAR></TEXT></P><P ParaShape="2"><TEXT CharShape="5"/></P><P ParaShape="2"><TEXT CharShape="6"><CHAR>&nbsp;&nbsp;&nbsp;&nbsp;부칙&nbsp;</CHAR></TEXT><TEXT CharShape="23"><CHAR>&nbsp;&lt;제2017-114호, 2017.12.29&gt; &nbsp;</CHAR></TEXT></P><P ParaShape="23" Style="0"><TEXT CharShape="6"><CHAR>제1조</CHAR></TEXT><TEXT CharShape="5"><CHAR>(시행일) 이 고시는 고시한 날로부터 시행한다. </CHAR></TEXT></P>


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