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On November 6, 2019, the European Commission published Regulation (EU) 2019/1857 amending Annex VI to Regulation (EC) No. 1223/2009. An entry on requirements for Titanium dioxide and its nano form are amended.

SAFEGUARDS | Cosmetics, Personal Care & HouseholdNO. 179/19

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Titanium dioxide and its nano form are allowed as a UV-filter in cosmetic products. They may be used as a UV-filter with a maximum concentration of 25%. However, the nano form shall not be used in applications that may lead to exposure of the end user’s lungs by inhalation and subject to the characteristics listed in the entry.

Following the release of opinion SCCS/1580/16 from the EU’s Scientific Committee on Consumer Safety (SCCS), due to the potential harmful effect of manganese dioxide through oral ingestion (with the use of titanium dioxide in nano form with combinations of coatings Alumina and Manganese Dioxide) face products shall display a warning against the use of these products on lips. 

This Regulation came into force on November 27, 2019.
Entry 27a of Annex VI to Regulation (EC) No 1223/2009 is replaced by the following entry:

Reference Number '27a
Substance Identification Chemical name / INN / INCI Name  Titanium dioxide (*1)
Name of Common Ingredients Glossary  Titanium dioxide (nano)
CAS number  13463-67-7/ 1317-70-0/ 1317-80-2
EC number  236-675-2/ 215-280-1/ 215-282-2
Conditions Product type, body parts  -
Maximum concentration in ready for use preparation  25% (*2)
Other 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, Aluminum Hydroxide, Aluminum 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 for
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.
Table 1

Remark:

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

References

  1. Commission Regulation (EU) 2019/1857 of 6 November 2019 amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on Cosmetic Products
  2. Opinion SCCS/1580/16, Scientific Committee on Consumer Safety (SCCS)

It is crucial for all cosmetic, personal care and household products to be 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.

Next Step

Especially for face products with nano Titanium Dioide as an UV filter, the product label is required to update with a warning statement ‘Not to be used on lips’. 

For enquiries, please contact:

Queenie Ho-yan, TSE
Assistant Technical Service Manager
Tel: +852 2765 3672

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