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Titanium Dioxide Manufacturers Association I n d u s t r y e x p e r i e n c e a n d p o s i t i o n t o T i O 2 c l a s s i f i c a t i o n e f f o r t s TDMA is a sector group of C o n t e n t s Introductions - TDMA members and European

  1. Titanium Dioxide Manufacturers Association I n d u s t r y e x p e r i e n c e a n d p o s i t i o n t o T i O 2 c l a s s i f i c a t i o n e f f o r t s TDMA is a sector group of

  2. C o n t e n t s • Introductions - TDMA members and European operations • TiO 2 CLH process • Situation after the: - 25 th CARACAL 15-16 November 2017 • The way forward 2

  3. T D M A a n d Ti O 2 3

  4. T D M A m e m b e r s & E u r o p e a n o p e r a t i o n s 4

  5. T i O 2 i n t h e E U Production value Market value Growth Jobs 1100 Ktonnes € 3 billion € 473 million 8,150 workers & (ca. annually) (ca. estimated) (gross added value to EEA economy) 22,800 support jobs Paints & Coatings Plastics Paper Specialty applications Architectural: 36% 25% 12% 6% Industrial: 17% Inks: 4% 5

  6. 2 0 % o f a l l T i O 2 p r o d u c e d i n E E A Belgium Czech Republic Poland UK 7% 3% 2% 21% Slovenia 5% Finland Spain 9% 5% France Norway 2% 2% The Netherlands 6% Italy 6% Germany 32% 6

  7. T h e Ti O 2 C L H p r o c e s s 7

  8. U p c o m i n g k e y m i l e s t o n e s We are here June 2018* July/ August November 2017 – March 2018 May 2020* Oct 2017 16 November 2018* Expected March 2018 PSLT/TiO 2 Potential 2017 Publication of RAC discussion of Deadline for TiO 2 Comments to be Discussions at implementation of Caracal discussions opinion PSLT/TiO 2 at to enter onto 2018 submitted to EC Caracal classification Caracal draft ATP 8 *= indicative timing

  9. T h e R A C o p i n i o n • The RAC opinion suggests classifying TiO 2 as ‘Category 2 - Suspected Carcinogen, by inhalation’ • The effect seen with TiO 2 is not unique but because TiO 2 is a poorly soluble low toxicity particle (PSLT) • “RAC acknowledges that the carcinogenicity profile described for TiO 2 is not exclusively characteristic for TiO 2 but applies to a group of chemicals with similar toxicity profile addressed as “poorly soluble low toxicity particle”. The CLH report and this RAC opinion concentrates on TiO 2 data and do not fully consider the data for other PSLT substances (see page 41, para 5). • The Commission now has to make a proposal through an ATP to the legislation • In our view, there is no benefit for environment, consumer or worker safety of classifying and labelling: • Epidemiology studies of more than 24,000 workers demonstrate no correlation between long-term exposure to TiO 2 and lung tumours • Workplace exposure controlled through MS regulation and industry practices • Exposure to consumers in unbound, respirable form limited or nonexistent • To the industry’s knowledge, none of the present uses has ever resulted in significant adverse health effects, particularly related lung carcinogenicity 9

  10. T h e b r o a d e r c h a l l e n g e s The classification of TiO 2 as cat. 2 suspected carcinogen by inhalation has broad public policy and regulatory impacts beyond the specific substance • Setting a precedent for other PSLT substances which could amount to 300+ substances • Concerns among industry (paint producers, automotive, aerospace, food, pharma, cosmetics, plastics & paper) and consumers about the stigmatization of products. For example, undermining the effectiveness of the EU hazard labelling for consumers if all paints are labelled • Impact on wider policy objectives that the EU is promoting, notably a Circular Economy as some waste streams containing more than 1% TiO 2 would be deemed hazardous • Reputational impact on TiO 2 and potential loss of market (10 to 15%); increased costs for downstream users handling TiO 2 and consumers 10

  11. W h a t e f f o r t s a r e u n d e r w a y ? Communication • TDMA is promoting positive messages on TiO 2 with a focus on its excellent qualities and the many innovative and sustainable applications through online channels • TDMA is analysing media coverage and selecting response opportunities to counter misinformation • TDMA is seeking joint media opportunities with downstream users to broaden end-use understanding and support base Advocacy • TDMA is working with European authorities during this process to arrive at solutions to both the science and policy issues identified during TiO 2 CLH deliberations • TDMA is following up with and engaging with additional Member States to understand their views and to build support for the reasonable regulation of TiO 2 and other PSLT substances • TDMA is seeking to collaborate with downstream users in the various Member States 11

  12. S i t u a t i o n a f t e r t h e 2 5 t h C A R A C A L 1 5 - 1 6 N o v e m b e r 2 0 1 7 12

  13. T h e i s s u e s r a i s e d b y t h e C o m m i s s i o n • There were issued raised in the RAC opinion already, and prior to the November CARACAL, the Commission articulated these in the following way: 1) Do CARACAL members and observers consider that the proposed classification of TiO 2 can be translated directly into Annex VI, or, taking into account the scientific evidence, is there a possibility for adaptations (e.g. through further footnotes to differentiate between particles that can be inhaled and larger particles/massive forms of TiO2)? 2) What are the views of CARACAL members and observers on the application of derogations such as Article 12(b) or Annex I, section 1.3.4? 3) Is it appropriate to limit harmonised classification to TiO 2 ? or would it not be preferable to also classify poorly soluble low toxicity particles (PSLT), or a well-defined group of PSLT, in the same way in a grouping approach? 13

  14. M e m b e r S t a t e f e e d b a c k • The direct translation of TiO 2 into Annex VI finds little support amongst the Member States. There is overall support for further discussion before decisions are taken due to numerous issues • There is little support from MS for the application of derogations such as Article 12(b) or Annex I, section 1.3.4 • A grouping approach for classification of PSLTs seems to find little support amongst the MSCA. Meanwhile, multiple MSCA express interest in the idea of PSLT Working Group (WG) to determine the appropriate risk management option (RMO). While the MSCA are unsure about the scope and the purpose of a PSLT WG, the idea is not rejected and the establishment could be supported with an appropriate mandate. 14

  15. I n s u m m a r y : m o r e t i m e i s n e e d e d • The Commission understands that there are still many open issues regarding the RAC opinion • Doubtful whether the issues regarding the RAC opinion can be resolved in the course of the next CARACAL meeting • In this context, the Member States supports more time to resolve the outstanding issues as the solutions outlined by the Commission find limited support TDMA’s proposal sets out a clear path for the further discussions to find constructive solutions to the issues raised by the Commission and others 15

  16. T h e w a y f o r w a r d 16

  17. O u r p r o p o s a l : a c l e a r w a y f o r w a r d TDMA is proposing the following, giving a clear way forward for the process: 1. A Working Group of Member States, ECHA, the Commission, NGO and industry experts to consider the appropriate mechanism for any regulation of PSLTs. 2. Regardless on any progress on a PSLT WG, substance evaluation, e.g., the 2018 CoRAP for TiO 2 should be allowed to proceed before any further actions under the CLP. 3. An interim derogation on the labelling requirement, should the RAC opinion be incorporated to the ATP before any outcomes of the PSLT working group or CoRAP review (on 2018 work programme) are available. 4. Undertake a Better Regulation Public Consultation for the European Commission and other interested stakeholders to better understand the real world implications of any decision before they are taken. There is ample precedent with the European Commission routinely undertaking such public consultations on Annex XIV listing of substances after the formal ECHA stage. For example, see Public Consultation of 16 September 2016 here. 5. Pause the entry of TiO 2 into ATP while considering steps 1, 2, 3 and 4. 17

  18. W h y a P S LT W o r k i n g G r o u p ? • TDMA would support the efforts of PSLT WG as a forum to answer the numerous issues arising out of this CLP matter, e.g.: • Whether or not the form, or the particle shape alone without specification of the physico- chemical properties can be considered an “intrinsic hazard” under the CLP; • and the weight to be given to particle overload animal studies and their application to humans. • Importantly, regardless on any progress on a PSLT WG, substance evaluation, e.g., the 2018 CoRAP for TiO 2 should be allowed to proceed before any further actions under the CLP. 18

  19. T D M A a d d i t i o n a l o n g o i n g a c t i v i t i e s • Shadow RMOa • TDMA is currently developing a shadow RMOa foreseen to be finalized in February 2018 • Science programme • The members of TDMA have embarked on a 14m Euro science programme with the objective to answer remaining questions on our substance, including discussions on questions related to all forms of TiO 2 , including surface treated nanoforms • We aim to further discuss the scope of the studies with EU regulators • Industry-wide initiative which TDMA is part of • TDMA is currently putting together an overview on what a PSLT working group could look like. Once progress is made, we would be happy to share our views with stakeholders. • Initiate and promote a thorough discussion of regulation of PSLTs through OELs. 19

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