New Approved Coatings for Titanium Dioxide (nano)

November 17^th, 2019

The nano form of Titanium Dioxide is used in cosmetic products as a UV filter and this use is regulated via the European Cosmetics Regulation (Annex VI, Entry 27a).

One of the use conditions is the coating of Titanium Dioxide with one of these materials: Silica, Hydrated Silica, Alumina, Aluminium Hydroxide, Aluminium Stearate, Stearic Acid, Trimethoxycaprylylsilane, Glycerin, Dimethicone, Hydrogen Dimethicone, Simethicone.

With Regulation EU No 2019/1857, the European Commission approved three new coatings for Titanium Dioxide (nano), namely:

• 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 %

The combination “Alumina at a maximum concentration of 7 % and Manganese Dioxide at a maximum concentration of 0.7 %” is toxic by ingestion. Therefore, the legal warning “Not to be used on the lips” shall be displayed on the product labels each time this specific coating is used and regardless of the product category.

Follow-up: Upcoming Ban of Titanium Dioxide in Some Specific Cosmetic Applications

October 17^th, 2019

Following a long-standing political discussion, the European Commission finally decided to include the CMR classification of Titanium Dioxide (Carc. 2) in its 14^th 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 4^th 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 below, 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 CRM (Customer Relationship 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.

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

February 17^th, 2019

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 ≤ 10µm 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 10µm.

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 10µm.
• If impacted, check the properties of the finished product:
  – Sprays and aerosols: proof that the diameter of the emitted droplets is not below 10µm
  – Loose powders: proof that the diameter of particles in the finished product is not below 10µm
  Specific tests exist to measure those parameters and you should contact your CRM (Customer Relationship 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.

A New Regulation on [Nano] Titanium Dioxide

July 18th, 2016

On July 13 th , 2016, the EU Commission published a new piece of legislation (Regulation EU No 2016/1143), which aims to regulate further the UV filter use of Titanium Dioxide (in its nanometer form) in cosmetic products. This new amendment to the EU Cosmetics Regulation (EC No 1223/2009) will enter into force on August 3rd, 2016 and foresees no transitional period meaning that the implementation of the new legal requirements will therefore be immediate.

You may know that Titanium Dioxide can be used as a colorant (see Entry 143 of Annex IV) and as a UV filter (see Entry 27 of Annex VI). This new piece of legislation only affects the UV filter use of Titanium Dioxide, meaning that the use of nano Titanium Dioxide as a colorant remains unchanged and is still conditioned by an Article 16 notification to the EU Commission.

The use of Titanium Dioxide in its normal form and as a UV filter did not change. However, a new entry (27a) has been created for nano Titanium Dioxide. The nanometer form can be used as a UV filter at up to 25% provided that some criteria are fulfilled:

• Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation (which notably includes loose powders, sprays and atomizers).
•  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

In case both forms of Titanium Dioxide are used as UV filter, the maximum use level of 25 % applies to their mixture.