Information Letter 065 (Update of IL-057) – October 2019

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

Dear All,

Following a long-standing political discussion, the European Commission finally decided to include the CMR classification of Titanium Dioxide (Carc. 2) in its 14th Adaptation to the Technical Progress of the CLP Regulation (Annex of the amendment EU No 2019/521). This amendment has been adopted despite serious concerns raised by the industry and the European Parliament and European Council have until December 4th to object. However, this is unexpected to happen, and the amendment must be published as it stands today.

Article 15 of the European Cosmetics Regulation (EC No 1223/2009) establishes a legal bridge with the CLP Regulation and automatically prohibits the use of ingredients classified as carcinogenic. 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 of 10 micrometers or less.

In terms of transition period, the European Commission has recently clarified the Article 15 prohibition procedure, which provided business certainty to the industry. Indeed, every year, the European Commission will publish an “Omnibus Regulation” prohibiting at the same time all substances with a newly enforced CMR classification. This use restriction of Titanium Dioxide will be part of the Omnibus 2020, to be published probably in Q2 of 2021.

Please, consider that an Omnibus Regulation comes with no transition period, meaning that the related bans and restrictions start to apply 20 days after its publication.

As explained in IL-057, BIORIUS recommends that cosmetic brands proactively:

  • 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 micrometers.
  • If impacted, check the properties of the finished product:
    – Sprays and aerosols: proof that the diameter of the emitted droplets is not below 10 micrometers.
    – Loose powders: proof that the diameter of particles in the finished product is not below 10 micrometers.
    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