Información importante sobre los reglamentos de la UE relativos al dióxido de titanio (TiO2)

Chemicals, including TiO 2 , must pass a strict registration, testing and approval process based on European Union (EU) regulations and standards in order to be manufactured and used in this territory. These legal requirements serve to ensure that chemicals are not hazardous to human health or the environment in their intended applications.

As the spokesperson for the titanium dioxide industry, the Titanium Dioxide Manufacturers Association (TDMA) works closely with European authorities to ensure the safe use of TiO 2  in all sectors.

The latest development is the classification of TiO 2 by the European Commission as a presumed carcinogen by inhalation (category 2). This classification is limited to certain powdered forms of the substance and will take effect on October 1, 2021.

This article explains what this classification of TiO 2 implies and analyzes other EU regulations related to titanium dioxide.

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Relationship of titanium dioxide (TiO 2 ) with the EU Regulation on classification, labeling and packaging of substances and mixtures (CLP)

The EU Regulation on Classification, Labeling and Packaging of Substances and Mixtures (CLP) uses a standardized labeling method to provide information on the potential hazards intrinsic to different chemicals. The classification proposed by the CLP Regulation is based solely on the hazards associated with a substance and does not reflect the real risks arising from its use. For example, it does not take into account whether there is actual or potential exposure to the substance.

On February 18, 2020, the EU published the classification of titanium dioxide as a presumed inhalation carcinogen (category 2) in certain powdered forms under the CLP Regulation. This classification will enter into force on October 1, 2021 after a transition period of eighteen months.

The classification does not correlate with a vast body of scientific evidence showing that TiO 2 does not cause cancer in humans.

 

Implications of the classification of titanium dioxide (TiO 2 )

In its classification, the EU has emphasized that the presumed hazard would occur when inhaling dust – such as pulverized TiO 2 – at extremely high concentrations over a long period of time, which could lead to lung failure. Indeed, the European authorities note that the classification does not address or consider the question of whether human beings are exposed to a supposedly dangerous level or could ever be.

The EU tried to limit the classification of TiO 2 to dust; in fact, the regulation refers to ” pulverized TiO 2 and mixtures released on the market in powder form that contain 1% or more of TiO 2 in the form of particles or incorporated into them”. This means that the classification is not applicable if the TiO 2 or mixtures containing this substance are not in this specific form.

Liquid mixtures and some solid mixtures are not included in the classification, but due to it it is mandatory to apply specific labels and warnings to those that contain more than 1% TiO 2 .

The text in question introduces several new concepts and terms without offering clarifying definitions or guidelines, which gives rise to multiple interpretations.

TDMA will communicate its interpretation of the rating to industry players when the time comes.

 

Position of the Titanium Dioxide Manufacturers Association (TDMA) and other players in the titanium dioxide (TiO 2 ) industry

TDMA disagrees with this classification and has expressed its point of view repeatedly since the regulatory debate began in 2017 (see statement ).

The  TiO 2 classification proposal  carried out by the European Commission was subject to public consultation for four weeks. More than 430 responses to the query opposed the proposal to classify TiO 2 in this way,  citing countless scientific, legal and political reasons.

Most of the responses sent – including that of the TDMA – were in favor of setting a binding and harmonized occupational exposure limit in the EU as an alternative risk management measure to ensure the same degree of protection in the workplace. This would have been a more efficient and proportionate mechanism to deal with occupational risk than the application of the CLP Regulation.

 

Additional steps taken by the titanium dioxide (TiO 2 ) industry to address concerns about the potential hazards and risks of this substance

The TiO classification published by the EU is not based on new scientific discoveries about the supposed dangers or risks of the substance, but on a preventive interpretation of old studies. For this reason, the TiO 2 industry  has implemented a comprehensive scientific program to obtain the data that appears to be lacking and to help reinforce the safety of the component .

The industry also carried out a  risk management options analysis (RMOA)  to assess whether additional protection measures were needed.

The RMOA results indicate that current risk mitigation measures already help to effectively prevent potential hazards from inhaling titanium dioxide. If the situation requires improvement, the analysis recommends applying occupational health and safety measures at European level because it considers it the most efficient and proportionate mechanism to achieve this.

The TiO 2 industry , which also worked closely with downstream users in their discussions with the European Commission and EU Member States, advocated for alternative regulatory measures that would have improved protection against the risk of inhalation of dust in the workplace that the Risk Assessment Committee (RAC) identified in its opinion, but in a more effective, proportionate and practical way than the TiO 2 classification .

 

Monitoring the use of titanium dioxide (TiO 2 ) through the REACH regulation

The REACH regulation is the main EU legislation on chemicals. Its objective is to protect the health of people and the environment against the risks associated with chemical products, while promoting innovation in the European chemical industry. To achieve this, four processes have been established: registration, evaluation, authorization and restriction of chemical substances (in English, “Registration, Evaluation, Authorization and restriction of Chemicals”, words from which the acronym REACH is derived).

 

Registry

TiO 2  is registered in all its forms under REACH. Most chemicals must meet this requirement in order to be marketed in the EU. The registration dossier contains information about the properties and uses of TiO 2 .

 

Evaluation

Producers, European authorities and EU Member States regularly evaluate substances to update and verify the quality of their registration dossiers and determine whether or not they pose any risk to human health or the environment.

In 2018, the French authorities  started an evaluation of TiO 2 . Since then, the TDMA has provided information and shares its knowledge with the French National Agency for Health Safety of Food, Environment and Work (ANSES) and with the European Chemical Substances and Mixtures Agency (ECHA) to dispel doubts and concerns raised during the process.

The evaluation process is expected to end in 2020, after which the ANSES may request more data and / or recommend additional risk management measures if it deems it necessary.

 

Authorization and restriction

Under REACH, TiO 2  is not subject to authorization requirements or restrictions of any kind.

 

Relationship of titanium dioxide to the EU Regulation on Classification, Labeling and Packaging of Substances and Mixtures

The EU Regulation on the Classification, Labeling and Packaging of Substances and Mixtures (CLP) uses a standardized labeling method to provide information on potential hazards intrinsic to different chemicals. The classification proposed by CLP is based solely on the hazards associated with a substance and does not reflect the actual risks arising from its use. For example, it does not take into account whether there is actual or potential exposure to the substance.

The European Commission has adopted the 14th adaptation to technical progress of the EU Regulation on Classification, Labeling and Packaging of Substances and Mixtures (CLP), which includes the proposal to classify TiO 2 as a suspected inhalation carcinogen. This means that products containing pulverized TiO 2 must carry a label warning of the risk of contracting cancer by inhalation at the end of the 18-month transition period.

 

The suspected hazards of titanium dioxide are limited to the workplace and are not intrinsic to the substance

Discussions between Member States, the European Commission and stakeholders have led to the conclusion that the potential hazard of TiO 2  described in the RAC assessment is limited to the workplace.

This is due to the fact that TiO 2  could only be dangerous by inhalation. The risk is based on the “toxicity of the particles”, a side effect of dust that is not specifically associated with TiO 2  and that appears after prolonged inhalation of respirable particles with a very high concentration of the substance. In the absence of these extreme conditions, the TiO 2 particles  are not dangerous.

Therefore, after discussions about the regulation of the substance, it has been determined that it does not pose any risk to consumers, since the extremely high exposure levels that would have to be given for TiO 2 to  be dangerous are not realistic under conditions of use. normal and predictable. Thus, the hazard described by the RAC should not arise in any real situation and constitutes a purely theoretical hazard in the workplace.

 

Position of the TDMA and the players of the titanium dioxide industry

Recently, the European Commission has proposed to  classify TiO 2  as a presumed carcinogen  in CLP Annex VI with derogations that limit this classification to inhalation of dust or spray mixtures.

The  evaluation to classify TiO 2  carried out by the EC was subject to public consultation for four weeks as part of the 14th adaptation to technical progress of CLP. More than 430 responses to the query opposed the proposal to classify TiO 2 in this way,  citing countless scientific, legal and political reasons.

In line with the conclusion that concerns about the substance are limited to the workplace, the majority of the responses sent – including that of the TDMA – were in favor of setting a binding and harmonized occupational exposure limit in the EU as an alternative measure. risk management. This would have been a more effective and proportionate mechanism to deal with occupational risk than the application of CLP.

The industry expressed its willingness to assess other regulatory solutions that would provide a direct benefit for safety without the unjustified and undesirable negative consequences of adopting the CLH classification.

 

Is Titanium Dioxide Safe For Workers?

According to European legislation , companies have a duty to protect workers against any chemical or spray substance. This forces them to identify and assess exposure to these components, control it and communicate the dangers posed to their workforce.

The TiO 2 industry has always ensured the safety of employees and users (in every way) by providing information and guidelines on the safe handling of the substance. Initiatives to control exposure include the implementation of a local ventilation system, the implementation of dust reduction measures and the use of personal protective equipment.

Companies can also use qualitative and quantitative risk assessments to attest to control and, where necessary, compliance with the local exposure limit.

Almost all EU Member States already have general limits on dust or specific limits on TiO 2 in the workplace following international standards that describe how to measure them.

Based on the findings of four major epidemiological studies conducted in North America and Europe with more than 24,000 workers in the TiO 2 production industry , exposure to this substance is not associated with any adverse health effects. No additional cases of lung cancer were detected, nor was there any indication that there is a causal relationship between exposure to TiO 2 and the occurrence of this disease in humans.

In Germany there have also been no recognized cases of occupational disease associated with exposure to TiO 2 or cases of medically diagnosed respiratory diseases that were linked to exposure to TiO 2 in the workplace .

 

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Conducting Rigorous Titanium Dioxide Testing in Food, Cosmetics, and Pharmaceuticals

The use of TiO 2 in consumer applications is subject to the execution of rigorous tests and the use of strict regulations, which helps to guarantee the safety of products for human health and the environment. Regulatory authorities in the European Union (EU) have regularly reviewed and authorized the use of TiO 2 in food, cosmetics and pharmaceuticals.

Titanium dioxide in food

The use of TiO 2 in food as a coloring additive E171 has the mandatory authorization.

The evaluation of the safety of E171 is the responsibility of the European Food Safety Authority (EFSA), a body that established in 2016 that the data related to E171 did not pose any problem for the health of consumers . EFSA endorsed this conclusion in its opinions of 2018 , May 2019 and June 2019 .

The latest EFSA opinion on E171, published in May 2021, does not provide conclusive evidence to show that ingesting E171 has harmful effects. However, EFSA concluded that E171 is no longer considered safe when used as a food additive because problems related to genotoxicity could not be ruled out. The latest opinion issued by EFSA is based on new evaluation criteria that the TDMA considers inappropriate.

Subsequently, the European Commission announced that it intended to remove E171 from the list of authorized food colors in the EU.

TDMA continues to support the safety of the E171 in all intended applications. TDMA will address EFSA’s opinion by updating its scientific program to generate additional data to support the safety of E171 subject to EFSA’s new risk assessment approach to food additives.

Learn more about the use and safety of the  E171 .

Is Titanium Dioxide In Cosmetics And Sunscreens Safe?

TiO 2 is included in the list of authorized colorants established by the EU cosmetic products regulations. In addition, in 2014 the Scientific Committee on Consumer Safety (CCSC), dependent on the EU, subjected it to evaluation and authorized its use as a UV filter in sunscreens in a maximum concentration of 25%, if applied on skin that is healthy or intact or burned by the sun. TiO 2 acts as an effective screen against harmful short-wave UVA and UVB radiation emitted by the sun.

 

Is titanium dioxide in pharmaceuticals safe?

Ultra- high purity TiO 2 is used in many medicines as an excipient. The purity of TiO 2 meets the requirements of the relevant official pharmaceutical regulations, including the standards dictated by the Pharmacopoeias of Europe, Japan and the USA.