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SAFEGUARDS | Cosmetics, Personal Care & Household NO. 152/16

Sunscreen

The European Commission published Commission Regulation (EU) 2016/1143 on July 13, 2016 amending Annex VI of Regulation (EC) No. 1223/2009. The entry for Titanium Dioxide as a UV filter has been updated. 

Following opinions SCCS/1516/13 and SCCS/1539/14, from the Scientific Committee on Consumer Safety (SCCS), Titanium Dioxide (nano) is authorized at a maximum concentration of 25% by weight. However, its use in applications that may lead to exposure of the end-user's lungs by inhalation is not allowed.

The new entry becomes effective August 2, 2016.

Table 1: Annex VI of Regulation (EC) No. 1223/2009 is amended as follows:

Reference number Substance identification
Chemical name/INN Name of Common Ingredients Glossary CAS number EC number
a b c d e
‘27 Titanium dioxide (*) Titanium Dioxide 13463-67-7/ 1317-70-0/ 1317-80-2 236-675-5/ 215-280-1/ 215-282-2
‘27a Titanium dioxide (***) Titanium Dioxide (nano) 13463-67-7/ 1317-70-0/ 1317-80-2 236-675-5/ 215-280-1/ 215-282-2

Continued:

Reference number Conditions Wording of conditions of use and warnings
Product type, body parts Maximum concentration in ready for use preparation Other
a f g h i
‘27 25 % (**)
‘27a 25 % (****) 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 shapesMedian particle size based on number size distribution ≥ 30 nmAspect ratio from 1 to 4.5,and volume specific surface area ≤ 460 m2/cm3Coated with Silica, Hydrated Silica, Alumina, Aluminium Hydroxide,
Aluminium Stearate, Stearic Acid, Trimethoxycaprylylsilane, Glycerin,
Dimethicone, Hydrogen Dimethicone, SimethiconePhotocatalytic activity ≤ 10% compared to corresponding non-coated or
non-doped referenceNanoparticles 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.’

(***)  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.’

It is crucial that all cosmetic, personal care and household products are safe, effective and stable. SGS provides testing, inspection, auditing and consulting services to manufacturers, distributors and importers to ensure a high level of product quality in every area. Our state of the art laboratories offer custom-made solutions for chemical, biophysical, microbiological, stability and biological aspects. We also have extensive capabilities in performance testing, claim support studies and consumer panels. Our testing is conducted according to customer specific or recognized standard methods, some of which were developed by SGS. Our cosmetic safety assessors and other technical experts can support customers by making sure new products comply with regulatory requirements.

Reference Sources:

[1] Commission Regulation (EU) 2016/1143 on 13 July 2016

[2] Scientific Opinion SCCS/1516/13 on Titanium Dioxide (nano form)

[3] Scientific Opinion SCCS/1539/14 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

For enquiries, please contact:

Queenie Tse
Technical Service Executive, Cosmetics, Personal Care & Household

t: +852 2765 3672

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