Information Letter 057 – February 2019

Subject: IMPORTANT – Upcoming Ban of Titanium Dioxide in Some Specific Cosmetic Applications

Dear All,

Titanium Dioxide is a ubiquitous ingredient used in various cosmetic products and fulfilling miscellaneous functions, the most common being Colorant and UV Filter.

A draft regulation (an amendment of the CLP Regulation EC No 1272/2008) classifying Titanium Dioxide as a carcinogenic substance (class 2) by inhalation has been published at the WTO level. This legal text focuses on Titanium Dioxide in a powder form containing 1% or more of particles with diameter ? 10?m that may be inhaled.

This draft regulation is expected to be enforced in the next 4 to 6 months. Article 15 of the European Cosmetics Regulation (EC No 1223/2009) establishes a bridge with the CLP Regulation and automatically prohibits the use of ingredients classified as carcinogenic.

In terms of transition period, the European Commission used to interpret the Article 15 of the Cosmetics Regulation as a ban starting when the classification is implemented, namely after the 18-month transition period of the amendment. This interpretation changed in December 2018 and the European Commission is now expecting that the ban to use a carcinogenic substance in cosmetic products starts to apply when the classification is enforced (and not implemented). This means that the traditional 18-month transition period will not apply any longer.

In practice, it means that Titanium Dioxide will be banned from cosmetic applications leading to an exposure of the lungs (loose powders, sprays and aerosols…) if it contains 1% or more of particles with a diameter lower than 10?m.

In theory, this ban will be effective within 4 to 6 months. Non-compliant cosmetic products should be withdrawn from the market by this date. In practice, an amendment of the Cosmetics Regulation prohibiting formally Titanium Dioxide in these specific uses will be published between February and April 2020 (and come without transition periods). The status of the period separating these two publications is still relatively unclear for the cosmetics industry.

Titanium Dioxide does not necessarily fall within the scope of this ban but sufficient evidences must be provided in case of doubt:

  • Check the product type and focus on loose powders, sprays and aerosols: there is no regulatory impact if the product cannot be inhaled (ex. sunscreen lotion, pressed powders, baked powders, etc.)
  • If impacted, check with your supplier the particle size distribution (in quantity) of Titanium Dioxide (or perform the test by yourself): there is no regulatory impact if less than 1% of the Titanium Dioxide particles has a diameter below 10?m.
  • If impacted, check the properties of the finished product:
    – Sprays and aerosols: proof that the diameter of the emitted droplets is not below 10?m
    – Loose powders: proof that the diameter of particles in the finished product is not below 10?m
    Specific tests exist to measure those parameters and you should contact your account manager if you need assistance.
  • If impacted, then consider reformulating the product with a compliant quality of Titanium Dioxide and ensure that your product is withdrawn from the European market on time.

We hope that this letter will provide you with helpful information and invite you to contact your account manager in case of questions.

Best regards,
Dr. Fred Lebreux