What you should know about the 14th amendment to the CLP Regulation (14th ATP)?

The 14th ATP enters into force on 9 September 2021.

This fundamental amendment can be summed up in two words - titanium dioxide.

Let’s look at the details.

The amendment applies to mixtures containing titanium dioxide (CAS No 13463-67-7), which did not need to be disclosed in Safety Data Sheets (SDSs) and labels before this Regulation.

According to the 14th ATP, for mixtures containing titanium dioxide (TiO2), the classification as carcinogenic (H351) would now apply when:

• the mixture is in powder form; and
• contains 1% or more titanium dioxide contained in the form of particles with an aerodynamic diameter ≤ 10 μm.

The reason is that such large particles can be inhaled and thus increase the risk of cancer.

As hazardous dust can also be formed during the use of certain TiO2-containing mixtures, Annex II to CLP introduces a requirement to warn users via the product label with additional information on the label:

• For liquid mixtures containing 1% or more of titanium dioxide particles with an aerodynamic diameter of 10 μm or less: EUH211. The following hazard statement must be added: “Warning! Hazardous respirable droplets may be formed when sprayed. Do not breathe spray or mist”.
• For solid mixtures containing 1% or more titanium dioxide: EUH212 The following hazard statement must be added: “Warning! Hazardous respirable dust may be formed when used. Do not breathe dust”.

Where is titanium dioxide most commonly used?

It is most widely used in a variety of product types, including paints, coatings, printing inks, and plastics. Precisely for this reason, concerns remain about the possible negative impact of the harmonized classification and the required warnings on labels, in particular with regard to misleading the general public and the loss of consumer confidence. Honest disclosure and citation of such statements are crucial to raising user awareness and protecting the health of all of us.

Before concluding, let me reiterate that by 9 September 2021 you must already have SDSs and labels in line with the 14th amendment to the CLP Regulation (14th ATP).

If you need help with this, we are only one e-mail or phone call away.