Was Sie über die EU-Gesetzgebung zu Titandioxid (TiO2) wissen sollten

The use and manufacture of chemicals, including TiO 2 , must follow rigorous registration, testing and approval procedures based on European Union (EU) regulations and standards before the substances can be manufactured or used within the EU. These legal requirements ensure that chemicals are harmless to health and the environment in their intended use.

As a representative of the titanium dioxide industry, the Titanium Dioxide Manufacturers Association (TDMA) works closely with EU authorities to ensure the safe use of TiO in all applications.

The last change is the classification of TiO 2 as a possible carcinogen (Cat. 2) for inhalation by the European Commission. The classification is limited to certain powder forms and comes into force on October 1, 2021.

In this article we inform you about the classification of TiO 2 and introduce other EU regulations relevant for titanium dioxide.

 

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To what extent does the EU regulation on the classification, labeling and packaging of substances and mixtures (CLP) relate to titanium dioxide (TiO 2 )?

The EU regulation on the classification, labeling and packaging of substances and mixtures (CLP) provides for standardized labeling to provide information about the inherent hazard potential of various chemicals. The classification of substances according to the CLP regulation is purely risk-related and does not reflect the actual risks associated with the use of a substance. 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 suspicious carcinogen (Category 2) by inhalation in certain powder forms under the CLP regulation. The classification will apply on October 1, 2021 after an 18-month transition period.

The classification does not correlate with a large number of scientific findings that already show that TiO 2 does not cause cancer in humans .

 

What does the classification of titanium dioxide (TiO2) mean?

During the classification, the EU underlined that the suspected hazard could arise if dust – such as TiO 2 powder – is inhaled in extremely high concentrations over a long period of time, thereby causing lung damage. In fact, the EU authorities point out that the classification does not address or signal that people are or may ever be exposed to the suspected hazardous dust content.

The EU tried to limit the classification of TiO2 to powder and the text of the law refers to “powdered TiO 2 and mixtures placed on the market in powder form containing at least 1% TiO 2 , whether in the form of particles or in particulate form is included “. This means that the classification does not apply if TiO 2 or TiO 2 mixtures are not available in this specific form.

Liquid and some solid mixtures are not classified, but due to the classification , special warnings and labels must be attached to mixtures containing more than 1% TiO 2 .

The text of the entry introduces several new concepts and terms without providing meaningful definitions or guidelines, which allows for various interpretations.

The TDMA will make their interpretation of the classification available to those involved in due course.

 

What is the position of the Titanium Dioxide Association (TDMA) and other titanium dioxide (TiO 2 ) stakeholders?

The Titanium Dioxide Manufacturers Association (TDMA) does not agree with the classification and has repeatedly expressed its views in the entire regulatory discussion since 2017 (see declaration).

The European Commission’s proposal for a classification of TiO 2 was the subject of a four-week public consultation. More than 430 of the consultation submissions rejected the proposal to classify TiO 2  for a variety of scientific, legal and political reasons.

Most of the submissions, including those from TDMA, advocated a binding EU-wide harmonized occupational exposure limit (OEL) as an alternative risk management measure to ensure uniform protection in the workplace across the EU. This would have been a more effective and proportionate measure to address the risk in the workplace than applying the CLP Regulation.

 

What additional steps has the titanium dioxide (TiO 2 ) industry taken to address the hazard and risk potential of TiO ?

The classification of TiO by the EU is not based on new knowledge regarding the dangers or risks of TiO 2,  but on a careful interpretation of old studies. Therefore, the TiO leads two industry and geography through an extensive research program to close the identified data gaps and the safe use of TiO -2  to guarantee.

In addition, the industry has conducted a  Risk Management Options Analysis (RMOA)  to assess whether additional protective measures are required.

The RMOA came to the conclusion that existing risk reduction measures are already being used effectively against possible risks of inhalation exposure. To improve this situation, the analysis recommended EU-wide OSH measures as the most effective and proportionate.

The TiO 2 industry has also worked closely with downstream users in discussions with the Commission and Member States and has advocated alternative regulatory options that would have provided better protection against the workplace dust concerns identified in the RAC’s opinion in a more effective, proportionate and practical way than classifying TiO 2 .

 

 

How is the use of titanium dioxide (TiO 2 ) regulated by the REACH regulation of the EU?

The REACH regulation is the most important EU regulation for chemicals. It aims to protect health and the environment from the risks that chemicals may pose while promoting innovation in the EU chemical industry. This is achieved through four processes: Registration, Evaluation, Authorization and Restriction of Chemicals (REACH).

 

Registration

TiO is registered in all forms according to REACH, which is mandatory for most chemicals before they are allowed on the EU market. The registration dossier provides information on the properties and applications of TiO 2 .

 

Evaluation

Assessors, EU authorities and EU Member States carry out regular reviews of substances in order to update and review the quality of their registration dossiers and to determine whether or not they pose a risk to health and the environment.

In 2018, the French authorities started the substance assessment of TiO 2 . Since then, the TDMA has been working closely with the French  Food, Environment and Safety at Work (ANSES) and European Chemicals Agency (ECHA) to provide information and expertise to address their concerns and questions that arose during this process.

This assessment is expected to be completed in 2020, whereupon ANSES can request further data and / or recommend further risk management measures if necessary.

 

Restriction and admission

TiO 2  is not subject to any authorization requirements or restrictions under REACH.

 

Is titanium dioxide (TiO 2 ) safe in the workplace?

According to European law, employers are obliged to protect employees from all chemicals and dusts. This includes the obligation to determine and evaluate the exposure to these substances, to control them and to inform the workers about their dangerousness.

The TiO 2 industry has always advocated the safety of its employees and users (pre and post production) by providing information and guidance on safe use. Measures to limit exposure can include the use of local exhaust air ventilation (LEV), measures to reduce dust and personal protective equipment.

Employers can also use qualitative and quantitative risk assessments to demonstrate control and, where appropriate, compliance with local exposure limit values.

Most EU member states have general limit values ??for dust or specific limit values ??for TiO 2 in the workplace with international standards describing how these should be measured.

Four large epidemiological studies in North America and Europe involving more than 24,000 workers in the TiO 2 manufacturing industry have shown no association with health effects from TiO 2 exposure. They showed no increase in lung cancer and no evidence of a causal relationship between exposure to TiO 2 and the development of lung cancer in humans.

There was in Germany also no recognized cases of occupational diseases due to TiO 2 exposure assessment or medically reported cases of respiratory diseases due to TiO 2 exposure assessment for workers .

 

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Strenge tests van titaandioxide in voedsel, cosmetica en geneesmiddelen

Het gebruik van TiO2 in consumententoepassingen is onderworpen aan strenge toetsingen en normen die de veiligheid van producten voor de menselijke gezondheid en het milieu helpen waarborgen. De Europese regelgevende instanties hebben het gebruik van TiO2 in voeding, cosmetica en geneesmiddelen regelmatig beoordeeld en goedgekeurd.

Titaandioxide in voedsel

TiO2 is goedgekeurd voor gebruik in levensmiddelen als kleurstofadditief E171.

De veiligheid van E171 wordt beoordeeld door de Europese Autoriteit voor voedselveiligheid (EFSA), die in 2016 heeft vastgesteld dat de gegevens over het gebruik van E171 geen gezondheidsproblemen voor de consument hebben aangetoond. De EFSA heeft die conclusie opnieuw bevestigd in haar adviezen van 2018, mei 2019 en juni 2019.

In het laatste EFSA-advies over E171, gepubliceerd in mei 2021, is geen overtuigend bewijs gevonden voor schadelijke effecten van de inname van E171. Toch concludeerde de EFSA dat E171 niet langer als veilig voedseladditief kan worden beschouwd aangezien bezorgdheid over genotoxiciteit niet kan worden uitgesloten. Het laatste advies van de EFSA is gebaseerd op nieuwe beoordelingscriteria die de TDMA als ongeschikt beschouwt.

De Europese Commissie heeft vervolgens aangekondigd dat zij van plan is om E171 van de lijst van goedgekeurde kleurstoffen voor levensmiddelen in de EU te schrappen.

De TDMA blijft staan achter de veiligheid van E171 in alle beoogde toepassingen. De TDMA beantwoordt het advies van de EFSA met een herziening van het wetenschappelijke programma dat wordt gebruikt om verdere gegevens te genereren die de veiligheid van E171 bevestigen en te voldoen aan de nieuwe risicobeoordelingsaanpak van de EFSA voor voedseladditieven.

Meer informatie over het gebruik en de veiligheid van E171.

 

Hoe veilig is titaandioxide in cosmetica en zonnebrandproducten?

TiO2 staat op de lijst van goedgekeurde kleurstoffen in het kader van de EU-verordening voor cosmetische producten. Het werd in 2014 eveneens door het Wetenschappelijk Comité voor consumentenveiligheid (WCCV) van de EU beoordeeld en goedgekeurd voor gebruik als uv-filter in zonnebrandproducten bij een maximale concentratie van 25%, wanneer het op een gezonde, intacte of in de zon verbrande huid wordt aangebracht. TiO2 is effectief in het blokkeren van schadelijke kortgolvige uv-A- en uv-B-straling van de zon.

 

Hoe veilig is titaandioxide in geneesmiddelen?

TiO2 van ultrahoge zuiverheid wordt in veel geneesmiddelen gebruikt als excipiëns (hulpstof). De zuiverheid van TiO2 voldoet aan de vereisten van belangrijke officiële farmaceutische normen, zoals de normen die zijn bepaald door de Europese Farmacopee, de Japanse Farmacopee en de Amerikaanse Farmacopee.