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Titanium dioxide in masterbatches:
What matters now?
The white pigment titanium dioxide (TiO₂) has recently been making headlines again: In January 2022, the EU Commission issued a ban on the additive in food due to possible risks in relation to cancer. A new regulation has already been in place for titanium dioxide in masterbatches, coatings and liquid colourants since 2020.
The white pigment titanium dioxide (TiO₂) has recently been making headlines again: In January 2022, the EU Commission issued a ban on the additive in food due to possible risks in relation to cancer. A new regulation has already been in place for titanium dioxide in masterbatches, coatings and liquid colourants since 2020. According to this, TiO₂ powder and powder mixes containing at least 1% TiO₂ are classified by the EU according to the Classification, Labelling and Packaging (CLP) Regulation. The new classification has been mandatory in all European Member States since October 2021. We talked to Dr Bettina Hoffmann, Head of Quality Management & Product Safety at Lifocolor Farben GmbH & Co.KG, about the latest developments and their impact on masterbatch production.
Dr Hoffmann, could you please briefly summarise for us what the CLP classification exactly means?
For substances that are classified as particularly critical under the CLP regulation, there is a classification and labelling process that has been harmonised across the EU. Manufacturers are obliged to apply this official classification to their substances and mixtures. This hazard classification is communicated in safety data sheets in the supply chain. The aerodynamic radius of the particles is decisive for the classification of TiO₂. The CLP Regulation also stipulates that additional warnings must be provided for mixtures containing titanium dioxide in concentrations of more than one percent TiO₂, whereby it is no longer decisive whether the TiO₂ used meets these criteria at all.
Should our business partners currently be concerned about colouring their products with formulations containing TiO₂?
No, TiO₂ is a common pigment that has been used in many applications for a very long time. All the types of TiO₂ that we use do not fall under the CLP classification of carcinogen 2. In addition, TiO₂ is always embedded in the polymer matrix when our products are used. This means that it is firmly bound and cannot be inhaled. This is an important point, as the classification according to the CLP Regulation is not based on a substance-specific property. Rather, the deciding factor is its dustiness, i.e. the particle property of TiO₂. Since compliance with the dust limit value has already been implemented in occupational health and safety, the processing of our masterbatches does not pose a problem provided that the existing limit values are observed.
The debate about carcinogenic substances is, of course, a very emotionally charged topic, as we have seen throughout the classification process. With this in mind, it is understandable that some of our customers have requested alternatives or have reduced the maximum content of titanium dioxide in their products in order to be on the safe side.
Will customers have to label their end products in the future, or does the labelling requirement only apply to intermediate products such as our masterbatches?
The CLP Regulation provides for the labelling of substances and mixtures, which means that our masterbatches are affected by this. According to the CLP regulation, safety data sheets do not need to be prepared for final products. However, other legal regulations naturally require manufacturers to affix warnings if there are corresponding hazards for consumers.
What impact does the CLP Regulation have on our masterbatch production?
Regarding the safety of our employees, we have already implemented a high degree of occupational health and safety measures in our operations – such as highly functional ventilation systems or suitable protective clothing – even before the EU Classification was introduced. With the existing dust limits, our masterbatches can be produced without posing any risks to health and safety. The greatest change for us has been the process of adapting the safety data sheets and labelling. Since the majority of products in our portfolio are affected by this, updating the safety data sheets was very time-consuming. In addition, our sales team was increasingly called upon to talk to our customers about their concerns and requirements.
In your opinion, are there any alternatives to TiO₂, should customers still request alternative formulations that do not use this pigment?
Resistance to light and covering capacity of the pigment are very important properties for colourists. For this reason, there will not be a real alternative to titanium dioxide for colouring polymers, as the properties of the pigment are simply too unique. Although there are indeed alternative solutions, they all come with corresponding disadvantages.
Finally, could you give us a brief outline of the latest developments in the discussion on titanium dioxide?
Since the European Commission banned TiO₂ as the food additive E171 on 14 January 2022, this topic has once again been moved into the media spotlight. The European Food Safety Authority (EFSA) had conducted a re-evaluation on titanium dioxide. Since a genotoxic effect cannot be ruled out, the use of titanium dioxide as a so-called dual use additive has now been withdrawn. These are substances that are approved both as food additives and as additives in polymer packaging. While the ban in food is irrespective of the titanium dioxide classification according to the CLP Regulation, this could nevertheless be interpreted as an indication that the discussion on titanium dioxide is not over yet. It remains to be seen how legislation in other areas such as the use in pharmaceuticals or cosmetics will develop.
Thank you very much for the interview!
Info: Titanium dioxide
Titanium dioxide is the most commonly produced and used white pigment in the world. It is an inorganic, crystalline, white solid that is chemically very stable. Titanium dioxide does not decompose when heated, is non-flammable and virtually insoluble in water, acids and organic solvents. These properties ensure that titanium dioxide used in products does not dissolve out of the product or degrade in any way.
The discussion about the pigment titanium dioxide began in 2016 with a proposal by the French Food Safety, Environment and Occupational Health Authority (ANSES) to classify titanium dioxide as carcinogenic (category 1) when inhaled. On 18 February 2020, the European Union published the classification of titanium dioxide powder as “possibly carcinogenic when inhaled” (carcinogen, category 2) in the CLP Regulation. After an 18 month transition period, companies were required to implement the resulting specifications from 1 October 2021.