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 - - PowerPoint PPT Presentation

Titanium Dioxide Manufacturers Association

TDMA is a sector group of

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

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C o n t e n t s

• Introductions
• TDMA members and European operations
• TiO2 CLH process
• Situation after the:
• 25th CARACAL 15-16 November 2017
• The way forward

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T D M A a n d Ti O 2

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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

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T i O 2 i n t h e E U

1100 Ktonnes

(ca. annually)

Production value

€3 billion

(ca. estimated)

Market value

€473 million

(gross added value to EEA economy)

Growth

Architectural: 36% Industrial: 17% Inks: 4%

Paints & Coatings

25%

Plastics

12%

Paper

6%

Specialty applications Jobs

8,150 workers & 22,800 support jobs

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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 7% Czech Republic 3% Poland 2% Slovenia 5% Finland 9% France 2% Germany 32% Italy 6% The Netherlands 6% Norway 2% Spain 5% UK 21%

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

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U p c o m i n g k e y m i l e s t o n e s

Oct 2017 Publication of RAC

• pinion

16 November 2017 Caracal discussions November 2017 – March 2018 Comments to be submitted to EC March 2018 PSLT/TiO2 Discussions at Caracal June 2018* Expected discussion of PSLT/TiO2 at Caracal July/ August 2018* Deadline for TiO2 to enter onto 2018 draft ATP May 2020* Potential implementation of classification

We are here

*= indicative timing

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T h e R A C o p i n i o n

• The RAC opinion suggests classifying TiO2 as ‘Category 2 - Suspected Carcinogen, by inhalation’
• The effect seen with TiO2 is not unique but because TiO2 is a poorly soluble low toxicity particle (PSLT)
• “RAC acknowledges that the carcinogenicity profile described for TiO2 is not exclusively characteristic for TiO2 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 TiO2 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 TiO2 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

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T h e b r o a d e r c h a l l e n g e s

The classification of TiO2 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% TiO2 would be deemed hazardous

• Reputational impact on TiO2 and potential loss of market (10 to 15%); increased costs for downstream users

handling TiO2 and consumers

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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 TiO2 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 TiO2 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 TiO2 and other PSLT substances

• TDMA is seeking to collaborate with downstream users in the various Member States

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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

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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 TiO2 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 TiO2? 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?

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M e m b e r S t a t e f e e d b a c k

• The direct translation of TiO2 into Annex VI finds little support amongst the Member States. There is
• verall 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.

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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

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

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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 TiO2 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 TiO2 into ATP while considering steps 1, 2, 3 and 4.

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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
• f 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 TiO2 should be allowed to proceed before any further actions under the CLP.

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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 TiO2, 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.

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Q u e s t i o n s ?