欧盟防晒法规 EU Sun Care Regulation


Measurement system of UVA protection

在亚洲, PA system 基于PPD(黑色素持续沉着指数)方法

PA++++              PPD= 16 or above

PA+++ PPD = 8 or above

PA++ PPD = 4 to less than 8

PA+ PPD = 2 to less than 4

在欧盟 2006, 欧盟委员会UVA: 1/3 of SPF, 临界波长> 370 nmUVA 防护测试: PPD(黑色素持续沉着指数)方法

In EU 2006, EU Commission,UVA: 1/3 of SPF, Critical Wavelength > 370 nm,UVA protection testing: PPD method

欧盟防晒霜的标签标识EU SUNSCREEN Labeling


二氧化钛TiO2吸入风险(TiO2 Risk about Inhaled)

将二氧化钛统一分类并将其标记为“吸入时致癌类别2”(健康危害H351:“吸入可能会致癌”)  “吸入分类为致癌物,适用于粉末形式的混合物,其中含有1%或更多的二氧化钛,且其空气动力学直径≤10 µm的颗粒。”

The classification of Titanium Dioxide will be harmonized and it is going to be labeled as “cancerogenic category 2 when inhaled” (Health hazard H351: “May cause cancer by inhalation” presumably will be added.  “The classification as a carcinogen by inhalation applies to mixtures in powder form containing 1% or more of titanium dioxide and with particles about an aerodynamic diameter ≤ 10 µm.”


氧化锌通过认可(Zinc oxide approved)

      欧盟委员会在《欧盟化妆品法规》附件VI中添加了纳米和非纳米形式的氧化锌,因此可以在化妆品中用作防晒剂。 在去年10月欧盟委员会化妆品工作组中成员国投票后,纳米和非纳米形式的氧化锌现已正式添加到允许用于化妆品的防晒剂列表中。 数十年来,氧化锌以其作为皮肤保护剂的有益特性及其抗菌活性而闻名,是美国仅有的两种获批可用于UVA1保护的UV过滤剂之一。 根据2016年4月21日的(EU)2016/621法规,对《化妆品法规》 [1]附件VI进行了修订,纳米和非纳米形式均允许以最高25%的浓度使用,除了用在 可能暴露在空气中的喷雾,粉体会通过吸入导致消费者的肺部。因此,不允许在喷雾剂中使用,因为可能会无意中激发配方中的部分成分进入消费者肺部。 此化妆品法规的修改于2016年5月11日生效

      The European Commission has added zinc oxide - in both its nano and non-nano forms - to Annex VI of the EU Cosmetics Regulation, thus allowing its use as a UV filter in cosmetic products. Following a vote by member states in the EU Commission Working Group on Cosmetics in October last year, zinc oxide in both its nano and non-nano forms has now been added officially to the list of UV filters allowed for use in cosmetic products. Being known for decades for its beneficial properties as skin protectant and its antimicrobial activity, zinc oxide is one of only two UV filters approved for UVA1 protection in sun care applications in the US According to Regulation (EU) 2016/621 of 21 April 2016, amending Annex VI to the Cosmetics Regulation [1], both the nano and non-nano forms will be authorized for use at a maximum concentration of 25%, except in applications that may lead to exposure of the consumer’s lungs by inhalation. Therefore, the use in an aerosol sunspray would not be allowed as part of the formulation could be unwittingly inspired Furthermore, only the nano forms meeting the criteria mentioned in the annex of the regulation - including particle size, morphology, purity and solubility - are allowed. This modification to the Cosmetics Regulation is effective on May 11, 2016



SCCS 对欧盟市场的TiO2 &ZnO 的观点(SCCS opinion on TiO2 & ZnO for EU Market)


纳米级的ZnO和TiO2在喷雾类产品的应用(Sprayable applications for the nano forms of ZnO and TiO2)


 "Therefore the SCCS does not recommend the use of nano TiO2 in sprayable applications“(SCCS/1516/13) "…the use of ZnO nanoparticles with the characteristics as indicated below, at a concentration up to 25% as a UV-filter in sunscreens, can be considered not to pose a risk of adverse effects in humans after dermal application. This does not apply to other applications that might lead to inhalation exposure to ZnO nanoparticles (such as sprayable products)“(SCCS/1489/12) “For these reasons, the SCCS opinions on nanomaterials (TiO2, ZnO) have not recommended the use of the nanoparticles in sprayable formulations.”

符合SCCS*标准的 TiO2总结(SCCS* conformity summary for TiO2)

纯度 >99%, 锐钛矿形 <5%(Purity >99%, Anatase <5%)

基于数量的粒径分布,初级粒径中值为30~100nm(Median primary particle size 30~100nm by number based size distribution)

纵横比<4.5(Aspect ratio <4.5)

体积比表面积<460m2/cm3(Volume specific surface area <460m2/cm3)


通过认证的表面处理剂**(Approved coating ingredients**)

SCCS* conformity summary for ZnO

纯度 >96% 杂质仅限于含有CO2 和 H2O, 同时,其他杂质总含量低于1%(Purity >96% with impurities only of CO2 and H2O, whilst any other impurities are less than 1% total)

初级粒径中值>30nm 以数量为基础的粒径分布(Median primary particle size >30nm by number based size distribution)

批准使用的表面处理剂**(Approved coating ingredients**)



二甲氧基二苯基硅烷基苯氧辛基硅烷交联聚合物(Dimethoxydiphenylsilanetritehoxycaprylyl silane cross-polymer)

辛基三乙氧基硅烷(Octyltriethoxy silane)

氧化锌(Zinc Oxide)

氧化锌概览(Zinc Oxide Overview)








全球首家用鲸蜡醇处理的棒状氧化锌非纳米(World-First Rod Shape Zinc Oxide with Cetyl Alcohol Coating Non-Nano)







包裹型防晒产品和化学防晒剂(UV Capsules and chemical UV filters)


包裹型防晒概述(UV Capsules overview)


包裹型防晒概述 显微镜下(UV Capsules Overview by Microscope)

包裹型防晒概述 体外测试(UV Capsules Overview by In-vitro)

SUNBEMT-S 与增稠剂的相容性测试(SUNSIL-S Thickener compatibility test)

O/W SPF 50.00 PA 16.00 无酒精, 无塑料微粒防晒凝露(O/W SPF 50.00 PA 16.00 EtOH, Micro Plastic Free Sun Ge)

In-vivo test人体测试报告(In-vivo test)

在水相分散的包裹型防晒剂(UV Capsules in water phase)


什么时候以及如何使用包裹型防晒剂(When & How to incorporate UV Capsules)

问: 什么时候? 答:  在乳化,乳化体降温后,低温加入包裹型防晒剂(例如<30℃)

Q: When? A:  After emulsion, after cooling down emulsion, incorporate UV capsules at low temperature(i.e. <30℃)

问: 什么时候? 答:由于BMDBM的熔点是81~86℃,如果Hybrid AB在乳化前加入到乳液中,那么在乳化过程中,乳液的温度会升高超过81℃,那么BMDBM会熔化成为液体,那么就会从PMMA的外壳中流出来

Q: Why? A:  As the Melting point of BMDBM is 81~86℃, if Hybrid AB adds before emulsion, during the emulsion process, the emulsion temperature could go up more than 81℃, BMDBM becomes liquid and it would be leaked out from PMMA shell. 

问: 如何添加? 答:聚合微球体有轻微的疏水性,因此在没有多元醇的情况下直接添加到水中是很困难的。 因此,将微球体预分散在多元醇,例如用1,3丁二醇,丙二醇或甘油做成预分散液,然后再添加到乳液中。

Q: How to add? A:  Polymer Micro Beads are slightly hydrophobic, it would be difficult to incorporate polymer beads directly into water especially  without poly alcohols Thus, premix polymer beads in poly alcohol solutions such as 1,3 Butylene Glycol or Propylene Glycol or Glycerin and add the premixed phase after emulsion