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Comments and Response to Comments on Clh Proposal on Titanium Dioxide

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Comments and Response to Comments on Clh Proposal on Titanium Dioxide ANNEX 2 - COMMENTS AND RESPONSE TO COMMENTS ON CLH PROPOSAL ON TITANIUM DIOXIDE COMMENTS AND RESPONSE TO COMMENTS ON CLH: PROPOSAL AND JUSTIFICATION Comments provided during public consultation are made available in the table below as submitted through the web form. Any attachments received are referred to in this table and listed underneath, or have been copied directly into the table. ECHA accepts no responsibility or liability for the content of this table. Substance name: Titanium dioxide CAS number: 13463-67-7 EC number: 236-675-5 Dossier submitter: France GENERAL COMMENTS Date Country Organisation Type of Organisation Comment number 02.06.2016 United Individual 1 Kingdom Comment received As he CLH report and decades of human health experience (CLH report p8 Carcinogenicity) Human data do not suggest an association between occupational exposure to TiO2 and risk for cancer. This type of scaremongering brings the work of the ECHA into disrepute and actually leads to detrimental effects on support for EHS awareness in the general public when products of extremely safe wide exposure (in almost every home there is a painted of plastic article containing titanium dioxide). Consequently, when the general public and workers see this sort of classification it is generally ignored with the risk that really dangerous substances are then also ignored. Dossier Submitter’s Response RAC’s response Date Country Organisation Type of Organisation Comment number 02.06.2016 United Individual 2 Kingdom Comment received As he CLH report and decades of human health experience (CLH report p8 Carcinogenicity) Human data do not suggest an association between occupational exposure to TiO2 and risk for cancer. This type of scaremongering brings the work of the ECHA into disrepute and actually leads to detrimental effects on support for EHS awareness in the general public when products of extremely safe wide exposure (in almost every home there is a painted of plastic article containing titanium dioxide). Consequently, when the general public and workers see this sort of classification it is generally ignored with the risk that really dangerous substances are then also ignored. Dossier Submitter’s Response RAC’s response Date Country Organisation Type of Organisation Comment 1(406) ANNEX 2 - COMMENTS AND RESPONSE TO COMMENTS ON CLH PROPOSAL ON TITANIUM DIOXIDE number 02.06.2016 Germany Eternit GmbH BehalfOfAnOrganisation 3 Comment received Eternit GmbH is following the German rules with exposure limits for Titanium dioxide: <1,25mg/m3 of respirable dust and <10mg/m3 of inhalable dust. Eternit GmbH uses up to 300tons Titanium dioxide per year. Eternit GmbH didn't observe any case of cancer caused by Titanium dioxide. Dossier Submitter’s Response RAC’s response Date Country Organisation Type of Organisation Comment number 01.06.2016 Austria BehalfOfAnOrganisation 4 Comment received TiO2 use is ubiquitous in our society. Most of the surfaces and items that are white in color contain TiO2. Thus,we are surrounded by TiO2 containing materials in our homes, workplaces and public areas. Since the introduction of TiO2 as a commercial product in 1923, there have been no identified health concerns associated with its exposure among consumers or the general population. Downstream users can also be exposed to TiO2 dust. Appropriate safe handling and use information are included in product documentation such as Safety Data Sheets (SDS). Consumer exposure to TiO2 dust is presumed to be very low because TiO2 is typically incorporated into a product matrix where it is tightly bound such as in paints or plastics. Thus, inhalation exposure is not considered as relevant for the general public! Based on existing safety information, it can be concluded that the use of titanium dioxide and it´s nanomaterial (ultrafine) as an ingredient in paints poses no risks to human health! Dossier Submitter’s Response RAC’s response Date Country Organisation Type of Organisation Comment number 15.07.2016 Belgium EuPC (European BehalfOfAnOrganisation 5 Plastics Converters Comment received The French agency ANSES is proposing a new harmonised classification for Titanium dioxide : “TiO2 should be considered as being potentially carcinogenic to humans when inhaled and thus be classified Carc. Cat 1B – H350i. This classification applied for both fine particles and nanomaterials of TiO2 without being able of any distinction in terms of morphology, crystal 2(406) ANNEX 2 - COMMENTS AND RESPONSE TO COMMENTS ON CLH PROPOSAL ON TITANIUM DIOXIDE phase, and surface treatment. ”. This substance is used mainly as a white pigment, brightener or opacifier in most plastics applications. It also provides excellent UV stability important for outdoor applications. In the plastics converting industry, most of the applications contain TiO2 substance. The plastics converting industry turnover is estimated at 280 billion € (Eurostat 2014). The impact upstream is not taken into account here but as an order of magnitude the whole plastics supply chain consolidated turnover is estimated at 350 billion € including polymer producers. It is estimated that almost all the 50,000 companies in the plastics converting sector, mainly SMEs, may be potentially impacted in case the availability of titanium dioxide would become uncertain. The classification dossier relies on a limited number of studies in animals either of low quality or with extreme doses provided which are not in relation with any foreseeable exposures. In the plastics industry, exposure is effectively controlled today. There is today no alternatives with the same properties and those alternatives may not be better from environment or health point of view. Classification and labelling of TIO2 would have disproportionate socio-economic effects compared to the expected health benefits and is not the most efficient measure to improve safety. In case of concern, the use of binding EU occupational exposure limits should be considered instead. ECHA note – A confidential and a non confidential attachment were submitted with the comment above. 2013-07-15_TiO2 CLH comment EuPC_confidential.pdf 2013-07-15_TiO2 CLH comment EuPC_public.pdf Dossier Submitter’s Response RAC’s response Date Country Organisation Type of Organisation Comment number 15.07.2016 Germany Individual 6 Comment received General appraisal of the classification of Titanium dioxide (TiO2) The classification of TiO2 will heavily impact the entire ceramic industry that is dealing with natural clays, bauxites and further raw materials belonging to the chemical System of SiO2- Al2O3, because TiO2 is a natural occurring impurity in all said materials. A classification of TiO2 in Carc. 1B would - according to the CLP-Regulation- require a classification of these natural materials and ceramic products as Carc. 1B and would also render these raw materials and a lot of ceramic products to dangerous waste. Beside natural occurring TiO2 predominantly mineralized as rutile the ceramic industry uses TiO2 as white pigment in glazes and engobes. There is no proper solution for a substitution available on the market that will be competitive with Products from outside EU. This will have a considerable strong impact on the industry branch that produces sanitary-ware, tableware and tiles, where already a strong competition exists with producers in Asia. Conclusion The classification of TiO2 as Carc. 1B is not the proper answer for better worker protection, as the same level of protection can be achieved by using more targeted directives on occupational safety and health (OSH) and effective and appropriate risk management 3(406) ANNEX 2 - COMMENTS AND RESPONSE TO COMMENTS ON CLH PROPOSAL ON TITANIUM DIOXIDE measures for worker protection with less administrative costs, much less negative socio- economic consequences. Dossier Submitter’s Response RAC’s response Date Country Organisation Type of Organisation Comment number 15.07.2016 Belgium European Expanded BehalfOfAnOrganisation 7 Clay Association Comment received TiO2 is present in the clay produced by expanded clay manufacturers. There are inconsistencies between the CLH report and ongoing scientific studies, in particular the 'one size fits all' approach adopted by the report. The proposed classification as cat 1B. carcinogenic is not supported by sound scientific evidence. ECHA note – A non confidential attachment was submitted with the comment above. 16 07 15 Cerame-Unie comments to the proposed classification of TiO2.docx Dossier Submitter’s Response RAC’s response Date Country Organisation Type of Organisation Comment number 15.07.2016 Belgium Cerame-Unie - The BehalfOfAnOrganisation 8 European Ceramic Industry Association Comment received Cerame-Unie, the European Ceramic Industry association, covers a wide range of products including bricks & roof tiles, clay pipes, wall & floor tiles, refractory products, sanitary ware, table & decorative ware, technical ceramics, expanded clay, abrasives and enamels. It accounts for more than 200 000 direct employments within the EU. In addition to its wide spread use as a white pigment in the ceramics industry, a number of ceramic products (e.g. certain ceramic wall tiles or roof tiles) use TiO2 for surface coating based on its photocatalytic properties. TiO2 is present, in trace amounts, in a number of ceramic and clay processing plants. In enamel industry, titanium dioxide is used approximately around 1000 tons per year. Titanium dioxide is also an essential raw material for the production of different types of
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