Titanium Dioxide Proposed As Category 2 Carcinogen

Earlier this year, ECHA’s Committee for Risk Assessment (RAC) concluded that the available scientific evidence meets the criteria in the CLP Regulation to classify Titanium Dioxide (TiO2) as a carcinogen by inhalation. The RAC’s draft Opinion – which was provided in June 2017 following an application from the French authorities – rejected France’s initial petition for a more severe Category 1B classification, but instead classified TiO2 as a Category 2 Carcinogen. Should the Opinion be approved (the expected date for this classification to take effect is around mid-2019), this would have a major impact on many sectors of the chemicals industry, including paints, plastics, coatings, inks and cosmetics. In addition to this, ECHA has just last week proposed to include TiO2 in its Community Rolling Action Plan(CoRAP) for 2018-2020 to be evaluated by EU Member States for CMR (carcinogenic, mutagenic or toxic to reproduction) and suspected sensitiser properties.

What is Titanium Dioxide?

Titanium Dioxide (TiO2) is a bright white substance used primarily as a vivid colourant in a vast range of common products. The whitest and brightest of known pigments, TiO2 has reflective qualities and can both scatter and absorb UV rays. In addition to this, it also has a number of lesser-known properties, making it a useful ingredient in fighting climate change and preventing skin cancer. Common applications for TiO2 include paints, plastics, paper, packaging, cosmetics, pharmaceuticals, sunscreen and food (where it is listed as the food colourant E171), and it can be added to paints, cements, windows and tiles as a ‘photocatalyst’ to decompose environmental pollutants. With the DIY market for TiO2-containing paints estimated at over £3.5 billion alone, the compound is considered one of the most important raw materials for the paints and coatings industry.

What would be the impact of this potential classification?

If the RAC’s draft Opinion is approved, and TiO2 is classified under CLP as a Category 2 Carcinogen, it would have a major impact on industry, and would bring about a number of additional legal obligations:

Classification and Labelling: Under the CLP Regulation, all mixtures containing ? 1.0% of TiO2 will be legally required to be labelled with:

  • The GHS08 Health Hazard pictogram
  • The signal word ‘Warning’
  • The hazard statement and code H351 ‘Suspected of causing cancer’ (The exposure route (i.e. by inhalation) will only be indicated if there is conclusive proof that no other routes of exposure cause the hazard)

If a mixture contains ? 0.1% of TiO2, an SDS is to be provided free of charge on request. The mixture will also be required to be labelled with:

  • The tactile warning of danger label (raised equilateral triangle
  • The EU H210 phrase ‘Safety Data Sheet available on request’(this is only for non-consumer use mixtures, i.e. those not intended for the general public)
  • In addition to this, the following Precautionary Statements (in order of importance) may need to be used:
  • P280 Wear protective gloves/protective clothing/eye protection/face protection. This is highly recommended to be used for all market sectors.
  • P501 Dispose of contents/container to… This is mandatory for products sold to the general public.
  • P405 Store locked up. This is highly recommended for products sold to the general public, whilst it is optional for others.
  • P201 Obtain special instructions before use.
  • P308+P313 IF exposed or concerned: Get medical advice/attention. Both of these are recommended.
  • P202 Do not handle until all safety precautions have been read and understood. This is optional.

Safety Data Sheets

Under Article 31 of the REACH Regulation:

  • SDSs are to be provided for any substance or mixture that is classified as hazardous under CLP. The SDS is to be provided free of charge if the mixture contains ?1% of TiO2
  • SDSs are not required “If you offer or sell dangerous substances or mixtures to the general public and you provide sufficient information to enable users to take the necessary measures as regards safety and the protection of human health and the environment. However, a downstream user or distributor can ask you to provide one.”

Packaging

Hazardous mixtures must comply with the following packaging requirements:

  • The packaging shall be designed and constructed so that its contents cannot escape, except in cases where other more specific safety devices are prescribed
  • The materials constituting the packaging and fastenings shall not be susceptible to damage by the contents, or liable to form hazardous compounds with the contents
  • Packaging fitted with replaceable fastening devices shall be designed so that it can be refastened repeatedly without the contents escaping
  • Packaging containing a hazardous substance or a mixture supplied to the general public shall not have either a shape or design likely to attract or arouse the active curiosity of children or to mislead consumers, or have a similar presentation or a design used for foodstuff or animal feeding stuff or medicinal or cosmetic products, which would mislead consumers.

Worker Exposure

With regards to the handling of pigments and powders, whilst the Control of Substances Hazardous to Health Regulation(COSHH) applies, there are no additional special requirements for handling a Category 2 Carcinogen compared with an unclassified pigment. However, the Occupational Exposure Limit (OEL) for TiO2 is expected to be reduced substantially should the classification be approved. It is currently 10mg/m3 (which is the standard dust OEL), but it has been suggested that this will likely be brought down on review by the authorities. This would have an impact on the use of dry TiO2 as a pigment in items such as personal protective equipment (PPE), and in terms of monitoring worker exposure. Additionally, there is a strong possibility that if TiO2 is classified as a Category 2 Carcinogen, suppliers may set a relatively low Derived No-Effect Level (DNEL), which could affect the ability to prove that TiO2 is safe for consumer use.

Poison Centres

It should be noted that the forthcoming Poison Centre legislation applies to any hazardous mixture, which means that if TiO2 is classified as a Category 2 Carcinogen additional products would now fall into scope. Any mixture with ? 1.0% TiO2 would now fall under the requirements and would need to be registered with national Poison Centres. This legislation comes into effect on:

  • 1st January 2020 for Consumer Uses
  • 1st January 2021 for Professional Uses
  • 1st January 2024 for Industrial Uses

If the proposals for a Category 2 classification are approved, it is expected that this will come into effect in 2019. Should this be the case, affected products would fall under the new Poison Centre requirements in time for the January 2020 deadline.

Next Steps

If TiO2 is classified as a Category 2 Carcinogen it would have a significant impact on the chemicals industry, and as such it is important to be aware of the RAC’s proposal, and its potential ramifications.

Safeware Quasar, 10 November 2017 ; https://safeware-int.com