티타늄디옥사이드

* 用途(용도) : 防曬劑 (자외선차단제) * 배합한도 : 25%

<자외선차단제 : Titanium Dioxide> * 【Restrictions】 Maximum Concentration (제한) : 25% * Specific Limitations and Comments : Use of the term ""sunscreen"" or similar sun protection wording in a product's labeling generally causes the product to be subject to regulation as a drug or a drug/cosmetic, depending on the claims. However, sunscreen ingredients may also be used in some cosmetic products to protect the products’ color. The labelling must also state why the sunscreen ingredient is used, for example, ""Contains a sunscreen to protect product color."" If this explanation isn’t present, the product may be subject to regulation as a drug (21 CFR 700.35). For more information on sunscreens, refer to Tanning Products * 특별 제한조건 : ""선스크린""의 단어를 사용하거나 자외선 차단과 비슷한 단어를 사용할 경우, 해당 제품은 클레임(표시광고)에 따라 제약 또는 제약/화장품의 규정을 따라야 한다. 그러나, 자외선 차단의 성분들은 제품의 색을 보호하는 역할로 사용되기도 한다. 자외선을 차단하는 성분이 사용된 목적에 대해 라벨링에 반드시 명시해야한다. 예를 들어, ""제품의 색을 보호하기 위해 자외차단제 성분을 함유하고 있다."" 만약 이러한 설명을 라벨링에 하지 않는다면, 그 상품은 제약으로서의 규정에 따라야한다. (21 CFR 700.35) 자외선 차단에 대한 정보가 궁금하면 태닝 제품을 참고하라. <착색제 : Titanium Dioxide> * Eye Area : Yes * 눈 주위 : 사용가능 * Generally (Includes Lipsticks) : Yes * 일반적인 사용 (립스틱 포함) : 사용가능 * External Use : Yes * 외용 : 사용가능

* Restrictions 【Maximum concentration permitted at final product】 : 25% * 제한 【완제품에서 허용된 최대 농도】 : 25%

<고시명 : Titanium dioxide (VII/27)> * 【Restrictions】 Maximum authorised concentration in the finished cosmetic product : 25% * 제한 【완제품에서 허용된 최대 농도】 : 25% * 【Restrictions】 Other limitations and requirements : Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 µm, to be used in compliance with Annex III, No [338]. For the product types under letter (c) of column (c) in Annex III, No [338], the maximum concentration in ready for use preparation provided in column (d) of this entry applies. * 제한 【기타 제한 및 요구조건】 : 공기역학적 직경이 10µm 이하인 입자를 1% 이상 함유한 분말 형태의 티타늄디옥사이드는 Annex III, No [338]를 참조하십시오. Annex III, No [338]의 (c)열 문자 (c)에 따른 제품 유형의 경우, 이 항목의 (d)열에 제공된 사용 준비 상태의 최대 허용 농도가 적용된다. <고시명 : Titanium dioxide (nano) (VII/27a)> * 【Restrictions】 Maximum authorised concentration in the finished cosmetic product : 25% * 제한 【완제품에서 허용된 최대 농도】 : 25% * 【Restrictions】 Other limitations and requirements : Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation. Only nanomaterials having the following characteristics are allowed: - Purity ≥ 99% - Rutile form, or rutile with up to 5% anatase, with crystalline structure and physical appearance as clusters of spherical, needle, or lanceolate shapes, - Median particle size based on number size distribution ≥ 30 nm, - Aspect ratio from 1 to 4.5 and volume specific surface area ≤ 460 m2/cm3, - Coating materials can be used that have been demonstrated to be safe and not to affect the nanoparticle properties related to the behaviour and/or effects, - Photocatalytic activity ≤ 10% compared with corresponding non-coated or non-doped reference, - Nanoparticles are photostable in the final formulation. * 제한 【기타 제한 및 요구조건】 : 흡입으로 인해 최종 사용자의 폐에 노출될 우려가 있는 제품에서는 사용금지 아래의 특성을 가진 나노물질만 허용된다. : -순도≥99%-구형, 니들 또는 란세이트 형상의 클러스터로서 결정 구조 및 물리적 외관을 가진 최대 5%아나타아제를 사용하는 루틸, -숫자 크기 분포≥30nm를 기반으로 하는 중간 입자 크기, -1에서 4.5까지의 가로 세로 비율과 부피 별 표면적≤460m2/cm3, -안전하며 동작 및/또는 효과와 관련된 나노 입자 특성에 영향을 미치지 않는 것으로 입증된 코팅 소재 사용 -광촉매 활성도는 코팅되지 않았거나 도핑 되지 않은 해당 기준과 비교하여 10%이하, -나노 입자는 최종 제제에서 빛에 노출 <고시명 : CI 77891 (Annex IV)> * Field of application : Colouring agents allowed in all cosmetic products * 적용 범위 : 모든 화장품에서 허용된 착색제 * 【Restrictions】 Other limitations and requirements : Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 µm, to be used in compliance with Annex III, No [338] * 제한 【기타 제한 및 요구조건】 : 공기역학적 직경이 10µm 이하인 입자를 1% 이상 함유한 분말 형태의 티타늄디옥사이드는 Annex III, No [338]를 참조하십시오.

<자외선차단제> * 【화장품 중 최대사용농도】 배합한도 (일반) : 25% <착색제> * 착색제 【사용허가 범위】 : 각종 화장품

* 【Restrictions】 Maximum Concentration Permitted : ≤ 25% * 【제한】 허용된 최대 농도 : ≤ 25%

<자외선차단제> ∙ 25% <비타르색소> * CI Number(색소) : CI 77891

<자외선차단제> 25%

<고시명 : Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm ( III/321)> * 【Restrictions】 Other : (a) (b) Only in the pigmentary form (c) Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation <고시명 : Titanium dioxide (IV/143)> * 【Restrictions】 Other : — Purity criteria as set out in Commission Directive 95/45/E (E 171) — Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm, to be used in compliance with Annex III, No 321 (For use as a UV filter, see Annex VI, No 27) <고시명 : Titanium dioxide (nano) (VI/27a)> * 【Restrictions】 Maximum concentration in ready for use preparation : 25% - In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit of 25% * Wording of conditions of use and warnings : Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation Only nanomaterials having the following characteristics are allowed: — purity ≥ 99 %, — rutile form, or rutile with up to 5 % anatase, with crystalline structure and physical appearance as clusters of spherical, needle, or lanceolate shapes, — median particle size based on number size distribution ≥ 30 nm, — aspect ratio from 1 to 4,5, and volume specific surface area ≤ 460 m2/cm3, — coated with Silica, Hydrated Silica, Alumina, Aluminium Hydroxide, Aluminium Stearate, Stearic Acid, Trimethoxycaprylylsilane, Glycerin, Dimethicone, Hydrogen Dimethicone, Simethicone; or coated with one of the follow­ing combinations: —Silica at a maximum concen­tration of 16 % and Cetyl Phosphate at a maximum concentration of 6 %, —Alumina at a maximum con­centration of 7 % and Manga­nese Dioxide at a maximum concentration of 0,7 % (not to be used in lip products), —Alumina at a maximum con­centration of 3 % and Triethoxycaprylylsilane at a maximum concentration of 9 %, — photocatalytic activity ≤ 10 % compared to corresponding non-coated or non-doped re­ference, — nanoparticles are photostable in the final formulation. * Wording of conditions of use and warnings: For face products containing Tita­nium Dioxide (nano) coated with the combination Alumina and Manganese Dioxide: Not to be used on the lips. <고시명 : Titanium dioxide (VI/27)> * 【Restrictions】 Maximum concentration in ready for use preparation : 25% In case of combined use of Titanium Dioxide and Titanium Dioxide (nano) , the sum shall not exceed the limit of 25% * 【Restrictions】 Other : Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm, to be used in compliance with Annex III, No 321. For the product types under letter (c) of column (f) in Annex III, No 321, the maximum concentration in ready for use preparation provided in column (g) of this entry applies. (For use as a colourant, see Annex IV, No 143) powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm