Friday, July 15, 2016Ingredients news

Titanium Dioxide [nano] in Annex VI to Cosmetics Regulation

© CosmeticOBS-L'Observatoire des Cosmétiques

The Regulation 2016/1143 of 13 July 2016, published in Official Journal of the European Union on 14 July, amends Annex VI to Cosmetics Regulation 1223/2009, to introduce Titanium Dioxide in its nano-form, and make it an authorised UV-filter, except in spray products.

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The whereas of Regulation 2016/1143

(1) Titanium dioxide is authorised both as a colorant under entry 143 of Annex IV to Regulation (EC) No1223/2009 and as a UV-filter under entry 27 of Annex VI to that Regulation. In accordance with point (3) of the Preamble to Annexes II to VI to Regulation (EC) No1223/2009, the substances listed in Annexes III to VI to that Regulation do not cover nanomaterials, except where specifically mentioned. Titanium dioxide (nano) is currently not regulated.

(2) According to the opinion of the Scientific Committee on Consumer Safety (‘SCCS’) of 22 July 2013, which was revised on 22 April 2014, the use of titanium dioxide (nano) as a UV-filter in sunscreens, with the characteristics as indicated in the opinion, and at a concentration up to 25%  w/w, can be considered to not pose any risk of adverse effects in humans after application on healthy, intact or sunburnt skin. In addition, considering the absence of a systemic exposure, the SCCS considers that the use of titanium dioxide (nano) in dermally applied cosmetic products should not pose any significant risk to the consumer.

(3) The characteristics indicated by the SCCS in its opinion concern the physico-chemical properties of the material (such as purity, structure and physical appearance, particle number size distribution, aspect ratio, volume specific surface area and photocatalytic activity) and whether it is uncoated or coated with specific chemicals. Therefore, these physico-chemical properties and requirements regarding coatings should be reflected in Regulation (EC) No1223/2009.

(4) The SCCS also considered that, on the basis of available information, the use of titanium dioxide (nano) in spray products cannot be considered safe. In addition, the SCCS indicated, in a further opinion of 23 September 2014 for clarification of the meaning of the term ‘sprayable applications/products’ for the nano forms of carbon black CI 77266, titanium dioxide and zinc oxide, that its concern is limited to spray applications that might lead to exposure of the consumer’s lungs to titanium dioxide (nano) by inhalation.

(5) In light of the SCCS opinions mentioned above, titanium dioxide (nano), according to the SCCS’s specifications, should be authorised for use as a UV-filter in cosmetic products at a maximum concentration of 25% w/w, except in applications that may lead to exposure of the end-user’s lungs by inhalation.

(6) Annex VI to Regulation (EC) No 1223/2009 should be amended for the purpose of adapting it to technical and scientific progress.

(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products.

The modifications of Annex VI

Modification of entry 27

• Chemical name: Titanium dioxide*
• Name of Common Ingredients Glossary: Titanium dioxide
• CAS number: 13463-67-7 / 1317-70-0 / 1317-80-2
• EC number: 236-675-5 / 215-280-1 / 215-282-2

Conditions of use
• Maximum concentration in ready for use preparation: 25%
*For use as a colorant, see Annex IV, No 143
**In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit given in column g (25%)

The new entry 27a
• Chemical name: Titanium dioxide***
• Name of Common Ingredients Glossary: Titanium dioxide [nano]
• CAS number: 13463-67-7 / 1317-70-0 / 1317-80-2
• EC number: 236-675-5 / 215-280-1 / 215-282-2

Conditions of use
• Maximum concentration in ready for use preparation: 25%****
• Other conditions
> 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
- Photocatalytic activity ≤ 10 % compared to corresponding non-coated or non-doped reference
- Nanoparticles are photostable in the final formulation

***For use as a colorant, see Annex IV, No 143
****In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit given in column g (25%)

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