In November 2015, the French Agency for Food, Environmental and Occupational Health Safety (ANSES) had assessed titanium dioxide as hazardous. It has thus submitted a harmonized classification and labelling proposal (CLH) (to ECHA for titanium dioxide as a carcinogen 1B.
This classification has significant consequences with respect to the REACH Regulation:
- According to Article 57(a), titanium dioxide would be considered as an SVHC
- The number of authorized uses for titanium dioxide would be reduced
The economic weight of titanium dioxide in Europe
According to ECHA, 1 to 10 million tons of titanium dioxide are manufactured and/or imported in the European Economic Area every year. This chemical is used in a wide range of industries and products such as:
- Plastics
- Paints, plasters, coatings and printing inks
- Ceramics, clays and glasses
- Food additives and supplements
- Cosmetics
- Electrical products
- Household detergents and cleansers
- Adhesives and sealants
- Toys and textiles
- etc.
Following this proposal, ECHA organized a public consultation to receive the opinion of the parties concerned with this decision. More than 500 comments have been submitted from industry, trade bodies and individuals.
Many comments go against this classification
Industry�s comments
TMDA (Titanium Dioxide Manufacturers Association) estimates the harmonized classification and labelling report (CLH) proposed by ANSES reflects an �inaccurate and misleading picture� of the carcinogen hazard presented by the substance�s inhalation.
European Plastics Converters (EuPC) reminds that studies have been led on over 20.000 workers in 15 plants manufacturing titanium dioxide. The reports on the occupational exposure over several decades, showed no adverse effects on the site workers.
PlasticsEurope adds that the �most thorough possible processes� are applied to the substance's assessment.
Cosmetics Europe recalled that more than 20.000 cosmetic products launched on the European market the past five years contained titanium dioxide. �A classification as a 1B carcinogen would mean that titanium dioxide is banned for use in cosmetics products,�
The association also notes that the CHL proposal submission by France had never been induced by new data or concerns regarding titanium dioxide.
The European Federation for Cosmetic Ingredients concluded that �no human evidence for increased lung cancer risk exists�.
CEPEwhich represents the paint and printing ink industry in Europe, said the substance is a constituent of over 85% of its members� products. �In paint, titanium dioxide is embedded in a liquid matrix and is not able to cause inhalation toxicity (should the alleged toxicological effects be confirmed). It has been used successfully for nearly a century and there is no alternative available that matches the performance in our products.�
Comments of the member States
The member States have also worried about the consequences of this new classification and the physico-chemical properties of titanium dioxide.
Germany's Federal Institute for Occupational Safety and Health (Baua) estimates that titanium dioxide should be classified as a category 2 carcinogen.
For Netherlands, titanium dioxide �is considered a borderline case between category 1B and 2�, though they agree with ANSES�s view.
Finland is in favor of ANSES�s proposal, but calls to deeper thinking on the possible role of the substance�s physico-chemical properties with regards to its carcinogenity.
According to Belgium, titanium dioxide should be classified depending on its different forms and uses, because it could meet different risk categories.
Comments of non-European federations
Because titanium dioxide�s classification in SVHC also impacts imports, other federations representing the other markets concerned (Northern America, Canada, Japan, Australia, New-Zealand) have shown their clear disapproval.
The Mexican professional association considers this classification "clearly disproportionate" compared to any speculative risks posed to human health.
ANSES�s answer to the comments
ANSES is currently preparing an answer to these comments. The initial proposal, the comments and their answers will be sent to Echa's Committee for Risk Assessment (Rac). The discussions will start around June 2017 and an opinion will be submitted to the Commission within 18 months.
In November 2015, the French Agency for Food, Environmental and Occupational Health Safety (ANSES) had assessed titanium dioxide as hazardous. It has thus submitted a harmonized classification and labelling proposal (CLH) (to ECHA for titanium dioxide as a carcinogen 1B.
This classification has significant consequences with respect to the REACH Regulation:
- According to Article 57(a), titanium dioxide would be considered as an SVHC
- The number of authorized uses for titanium dioxide would be reduced
The economic weight of titanium dioxide in Europe
According to ECHA, 1 to 10 million tons of titanium dioxide are manufactured and/or imported in the European Economic Area every year. This chemical is used in a wide range of industries and products such as:
- Plastics
- Paints, plasters, coatings and printing inks
- Ceramics, clays and glasses
- Food additives and supplements
- Cosmetics
- Electrical products
- Household detergents and cleansers
- Adhesives and sealants
- Toys and textiles
- etc.
Following this proposal, ECHA organized a public consultation to receive the opinion of the parties concerned with this decision. More than 500 comments have been submitted from industry, trade bodies and individuals.
Many comments go against this classification
Industry�s comments
TMDA (Titanium Dioxide Manufacturers Association) estimates the harmonized classification and labelling report (CLH) proposed by ANSES reflects an �inaccurate and misleading picture� of the carcinogen hazard presented by the substance�s inhalation.
European Plastics Converters (EuPC) reminds that studies have been led on over 20.000 workers in 15 plants manufacturing titanium dioxide. The reports on the occupational exposure over several decades, showed no adverse effects on the site workers.
PlasticsEurope adds that the �most thorough possible processes� are applied to the substance's assessment.
Cosmetics Europe recalled that more than 20.000 cosmetic products launched on the European market the past five years contained titanium dioxide. �A classification as a 1B carcinogen would mean that titanium dioxide is banned for use in cosmetics products,�
The association also notes that the CHL proposal submission by France had never been induced by new data or concerns regarding titanium dioxide.
The European Federation for Cosmetic Ingredients concluded that �no human evidence for increased lung cancer risk exists�.
CEPEwhich represents the paint and printing ink industry in Europe, said the substance is a constituent of over 85% of its members� products. �In paint, titanium dioxide is embedded in a liquid matrix and is not able to cause inhalation toxicity (should the alleged toxicological effects be confirmed). It has been used successfully for nearly a century and there is no alternative available that matches the performance in our products.�
Comments of the member States
The member States have also worried about the consequences of this new classification and the physico-chemical properties of titanium dioxide.
Germany's Federal Institute for Occupational Safety and Health (Baua) estimates that titanium dioxide should be classified as a category 2 carcinogen.
For Netherlands, titanium dioxide �is considered a borderline case between category 1B and 2�, though they agree with ANSES�s view.
Finland is in favor of ANSES�s proposal, but calls to deeper thinking on the possible role of the substance�s physico-chemical properties with regards to its carcinogenity.
According to Belgium, titanium dioxide should be classified depending on its different forms and uses, because it could meet different risk categories.
Comments of non-European federations
Because titanium dioxide�s classification in SVHC also impacts imports, other federations representing the other markets concerned (Northern America, Canada, Japan, Australia, New-Zealand) have shown their clear disapproval.
The Mexican professional association considers this classification "clearly disproportionate" compared to any speculative risks posed to human health.
ANSES�s answer to the comments
ANSES is currently preparing an answer to these comments. The initial proposal, the comments and their answers will be sent to Echa's Committee for Risk Assessment (Rac). The discussions will start around June 2017 and an opinion will be submitted to the Commission within 18 months.
