化妆品安全技术规范(2015年版)(国食药监总局公告2015年第268号) ... ... ... ... ...

2018-8-28 17:55| 发布者: 国医正宗| 查看: 1049| 评论: 0|来自: 国家药监局

摘要: 本规范规定了化妆品的安全技术要求,包括通用要求、禁限用组分要求、准用组分要求以及检验评价方法等,适用于中华人民共和国境内生产和经营的化妆品(仅供境外销售的产品除外)。自2016年12月1日起实施。 ... ... .. ...


2.25 米诺地尔........................................................................................................................298
2.26 氢醌、苯酚 ....................................................................................................................302
2.27 石棉................................................................................................................................308
2.28 维甲酸和异维甲酸 ........................................................................................................315
2.29 维生素 D2 和维生素 D3 .................................................................................................319
2.30 邻苯二甲酸二甲酯等 10 种组分 ..................................................................................322
2.31 邻苯二甲酸二丁酯等 8 种组分 ....................................................................................327
2.32 二氯甲烷等 15 种组分 ..................................................................................................332
2.33 乙醇等 37 种组分 ..........................................................................................................337
3 限用组分检验方法...................................................................................................................353
3.1 α-羟基酸............................................................................................................................353
3.2 二硫化硒..........................................................................................................................360
3.3 过氧化氢..........................................................................................................................363
3.4 间苯二酚..........................................................................................................................366
3.5 可溶性锌盐......................................................................................................................368
3.6 奎宁..................................................................................................................................370
3.7 硼酸和硼酸盐 ..................................................................................................................372
3.8 羟基喹啉..........................................................................................................................374
3.9 巯基乙酸..........................................................................................................................376
3.10 水杨酸............................................................................................................................383
3.11 酮麝香 ............................................................................................................................385
3.12 游离氢氧化物 ................................................................................................................387
3.13 总硒................................................................................................................................389
4 防腐剂检验方法.......................................................................................................................392
4.1 苯甲醇..............................................................................................................................392
4.2 苯甲酸及其钠盐 ..............................................................................................................399
4.3 苯氧异丙醇......................................................................................................................406
4.4 苯扎氯铵..........................................................................................................................409
4.5 劳拉氯铵、苄索氯铵和西他氯铵 ..................................................................................411
4.6 甲醛..................................................................................................................................413
4.7 甲基氯异噻唑啉酮等 12 种组分 ....................................................................................419
4.8 氯苯甘醚..........................................................................................................................423
4.9 三氯卡班..........................................................................................................................425
4.10 山梨酸和脱氢乙酸 ........................................................................................................427
4.11 水杨酸等 5 种组分 ........................................................................................................429
5 防晒剂检验方法..................................................................................................................432
5.1 苯基苯并咪唑磺酸等 15 种组分 ....................................................................................432
5.2 二苯酮-2...........................................................................................................................438
5.3 二氧化钛..........................................................................................................................441
5.4 二乙氨羟苯甲酰基苯甲酸己酯 ......................................................................................443
5.5 二乙基己基丁酰胺基三嗪酮 ..........................................................................................445
5.6 亚苄基樟脑磺酸 ..............................................................................................................447
5.7 氧化锌..............................................................................................................................450
6 着色剂检验方法.......................................................................................................................452
6.1 碱性橙 31 等 7 种组分 .....................................................................................................452
6.2 着色剂 CI 59040 等 10 种组分 ........................................................................................455
7 染发剂检验方法.......................................................................................................................461
7.1 对苯二胺等 8 种组分 ......................................................................................................461
7.2 对苯二胺等 32 种组分 ....................................................................................................464

第五章 微生物检验方法 .........................................................................................469
1 微生物检验方法总则...............................................................................................................469
2 菌落总数检验方法...................................................................................................................471
3 耐热大肠菌群检验方法...........................................................................................................474
4 铜绿假单胞菌检验方法...........................................................................................................477
5 金黄色葡萄球菌检验方法.......................................................................................................480
6 霉菌和酵母菌检验方法...........................................................................................................483

第六章 毒理学试验方法 .........................................................................................485
1 毒理学试验方法总则...............................................................................................................485
2 急性经口毒性试验...................................................................................................................486
3 急性经皮毒性试验...................................................................................................................488
4 皮肤刺激性/腐蚀性试验..........................................................................................................490
5 急性眼刺激性/腐蚀性试验......................................................................................................493
6 皮肤变态反应试验...................................................................................................................496
7 皮肤光毒性试验.......................................................................................................................500
8 鼠伤寒沙门氏菌/回复突变试验...........................................................................................503
9 体外哺乳动物细胞染色体畸变试验.......................................................................................510
10 体外哺乳动物细胞基因突变试验.........................................................................................513
11 哺乳动物骨髓细胞染色体畸变试验.....................................................................................516
12 体内哺乳动物细胞微核试验.................................................................................................519
13 睾丸生殖细胞染色体畸变试验.............................................................................................522
14 亚慢性经口毒性试验.............................................................................................................525
15 亚慢性经皮毒性试验.............................................................................................................528
16 致畸试验.................................................................................................................................532
17 慢性毒性/致癌性结合试验....................................................................................................535

第七章 人体安全性检验方法 .................................................................................540
1 人体安全性检验方法总则.......................................................................................................540
2 人体皮肤斑贴试验...................................................................................................................541IV
3 人体试用试验安全性评价.......................................................................................................543

第八章 人体功效评价检验方法 .............................................................................545
1 人体功效评价检验方法总则...................................................................................................545
2 防晒化妆品防晒指数(SPF 值)测定方法...........................................................................546
3 防晒化妆品防水性能测定方法...............................................................................................552
4 防晒化妆品长波紫外线防护指数(PFA 值)测定方法............................................................554

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