Guidance for IUCLID 5.2 File for Titanium Dioxide Disclaimer The TDIC consortium has made this guidance document available to members of the TiO2 SIEF as it may assist you in completing the individual sections of IUCLID 5.2 and to help ensure that a consistent approach is adopted by all SIEF members, and is not liable for its use for any purpose by you or others. No representation or warranty is given as to the accuracy, reliability or completeness of the provided information or its acceptability to ECHA. Each SIEF member assumes full responsibility for use of this document and for the accuracy and completeness of its own IUCLID file and its thorough review prior to submission to ECHA. Nothing in this document is intended to provide legal, technical or other professional advice. You should not rely on any information contained in this document as if it were legal, technical or other professional advice. If you require such advice for specific issues, please contact your own providers. There is no helpdesk for individual registration within the TDIC consortium and you should refer to the ECHA Data Submission Manuals especially numbers 4 and 5. Purpose The purpose of this guidance document is to aid members of the TiO2 SIEF in achieving a consistent submission of dossiers to ECHA as part of the Joint Submission : Titanium Dioxide - JS TDIC The Joint Submission dossier will contain sections with :

1. Common information - sections 2 (C&L), 4-7 (End Points), 11 (SDS), 13 (CSA). 2. Sections with data purely relating to individual LEs will not be completed. 3. Sections for individual completion but which have been drafted by the LR for consistency

The coloured highlighting is used throughout this document to indicate the type of information in each section. The IUCLID 5 sections 2, 4, 5, 6 and 7 (the C&L and the endpoints sections) of the Lead Registrant dossier should be complete but these sections of the Joint Registrant member dossier should be empty. Note that if any information is submitted in a Joint Registrant member dossier in sections 2, 4, 5, 6 or 7 (the C&L and the endpoints sections) then this information will be considered as an opt-out by ECHA so this should be avoided.

Initiation of IUCLID 5.2 File The Lead Registrant will make available a IUCLID 5.2 template file which contains as much as possible of the data shown in this guidance document. Please follow the steps described below in order to use the data from the template directly in your own dossier. 1. Import the template into your IUCLID environment.

The Huntsman file will appear in IUCLID under the following name: HP_Titanium Dioxide_Tony 2. You then have two options:

� either you can work directly from this file to create your own dossier. - You would then need to change the dummy legal entity called 'Huntsman' into your own

manufacturing/importing legal entity. - Please be aware that in the modification history, Huntsman legal entities and the name of

Huntsman associates will appear. � or, you copy/paste, using the clipboard functionality, the chapters that you need into your own

dossier General Comments LR will not tick box for “Review by Assessor” (no benefit seen in doing so as ECHA have said that it will have no impact on whether a dossier is selected for evaluation or not) but will tick boxes for common Guidance on Safe Use and CSR. Extract from Data Submission Manual No. 05 - How to complete a technical dossier for registrations and PPORD notifications : “The checkbox “Reviewed by an assessor” is not compulsory, but if the dossier, or parts of it, have been reviewed by an assessor (in accordance to Art. 10 (a) (viii)), it must be indicated here. If your dossier has not been reviewed by an assessor you can leave empty the checkbox “Reviewed by an assessor” and this will not be considered a TCC failure.” Note that some explanatory documents have been added to the IUCLID file as attachments (Sameness document and List of Typical Surface Treating Agents) but the software does not appear to allow them to be associated with a specific section Selecting “REACH Registration member of a joint submission” under Section tree highlights in red the mandatory sections (green sections are optional)

1.1 Identification � Click on the Link symbol to open a search box. Enter Titanium Dioxide and it will automatically

fill in CAS and EINECS numbers. Type of Substance can be completed and both Sameness document and List of Typical Surface Treating Agents (see Appendix 2) have been attached but rest is specific to LE e.g. Legal Entity name, Role in Supply Chain, Trade Names, Contact person details

1.2 Composition � Following the latest guidance from ECHA on how to register hydrates within a dossier for the

anhydrous form contained in “Data Submission Manual Part 18 – How to report the substance identity in IUCLID 5 for registration under REACH” (p23), all the substances covered by the dossier have been included as separate blocks within section 1.2 as shown below.

� For each of the “subsidiary substances” the phrase “This composition is covered by the

registration of titanium dioxide” has been added � All of the data on Typical concentration, Concentration range, Additives and Impurities can be

either the same for all these blocks or can be used to show registrants actual composition

� Description (limited number of characters allowed) has been used to describe SIEF merging but

with reference to attached detailed Sameness document. � Purity is specific to each LE but has been included as per SIP (>87% TiO2) but typical TiO2

concentration 98% – note this is for base crystal only (see Appendix 1) – DO NOT INCLUDE ANY OF THE SURFACE TREATMENT IN THE COMPOSITION OR ANALYSIS

� CAS and EINECS numbers are filled in using Link symbol � Include as a Reference Substance each type of TiO2 that you wish to cover in a separate block i.e.

Titanium Dioxide, Rutile, Anatase, Tetrahydroxy Titanium and Titanium Dihydroxide Oxide.

� Reference to Surface treatment has been added in Remarks as well as attached detailed Sameness document

� Note that the SIP agreed by the SIEF when agreeing sameness is not actually required anywhere in the dossier but has been added via attachment of the Sameness document – all compositional data is specific to a LE

� Actual impurities or additives should be added by each LE and “Typical Concentration” figures should add up to between 99 and 100% (but can have ranges) - Guidance in RIP 3.10 and from previous EINECS Manual of Decisions is that impurities present

at <1% do not have to be included unless they affect the classification. The only elements >1% in the SIP are Si, Al and S – therefore assume the reference substances are SiO2, Al2O3 and H2SO4 or metal sulphates e.g. K2SO4. Since H2SO4 would affect the classification if present at >5% this is the limit level that will be included in the LR submission – any materials with more H2SO4 should be classified as mixtures not as TiO2.

- It is recommended that SiO2 and Al2O3 are described as stabilising additives rather than impurities (alumina is shown as an example here)

- Do not add anything for impurities <0.1% - it is only likely to confuse ECHA - If the impurities or additives of an LE are within SIP then can use C&L without modification. If

outside SIP then need to assess whether differences affect C&L and if so then request LR to add additional C&L (this is based on ECHA guidance)

1.3 Identifiers Not mandatory but it is recommended that the individual LE REACH pre-registration number is entered here after selecting REACH pre-registration number from Regulatory programme picklist. You may also add information about the SIEF merger here under Remarks if your pre-registration was for Anatase, Rutile, Tetrahydroxy Titanium or Titanium Dihydroxide Oxide rather than Titanium Dioxide

1.4 Analytical information Method used for identification is XRD referencing the standard method EN 13925 “Non-destructive testing - X-ray diffraction from polycrystalline and amorphous materials”. A note has been added to Remarks section that XRD traces identifying the substance as titanium dioxide can be of rutile, anatase or mixtures of the two (or brookite or TiO2-B). Each LE needs to add their own trace (or traces) here. The results of the analysis must be consistent with the data provided in Section 1.2. Use a new repeatable block for each analytical method and attach the results of the analysis. The phrase "Composition varies by grade see concentration range in section 1.2" has been added for each result to highlight that typical analysis may vary between grades The degree of detail needed for the analytical method is described for some types of spectroscopy in the EINECS Manual of Decisions (updated July 2006, p128)

1.5 Joint Submission Lead Registrant and the members of the joint submission must all include the name of the joint submission (Titanium Dioxide – JS TDIC). Description of SIEF merging has been included here under Remarks as advised by ECHA and reference also made to the attached sameness paper.

1.6 Sponsors optional – do not create a repeatable block 1.7 Suppliers Mandatory if you are an Only Representative (OR) and ticked the “Only Representative” box in Section 1.1. If so you need to attach the agreement or appointment letter between the OR and the non-EU manufacturer. 1.8 Recipients - only needed for PPORD notification – do not create a repeatable block 2 Classification and Labelling - included in Lead Registrant dossier only

2.1 - against GHS – Not Classified 2.2 - against DSD – Not Classified

3.1 Technological Process Annex VI “Precise details of the process, particularly those of a commercially sensitive nature, are not required.” Guidance says detail of temperature etc may be included. Propose to keep very generic and refer to BREF document as shown

3.2 Estimated Quantities Individual LE’s provide their own information 3.3 Sites Individual LE’s provide their own information

3.4 Form in the Supply Chain Tick box “Available as a Substance”. Individual LE’s may also indicate as “Substance in Mixture” or “Substance in Article” and add further information including quantities if appropriate for them.

If “Downstream user” is selected in Section 1.1 “Role in the supply chain”, then the “Substance in article” box must be marked.

3.5 Identified Uses ECHA confirmed that this section needs to be completed for all substances regardless of C&L (even if classified as non-hazardous) in order to pass the Technical Completeness Check. At least 1 use has to be entered under uses by workers in industrial settings, uses by professional workers or uses by consumers (or a valid justification if no use is reported). In addition the technical function of the substance must be entered (or a remark). All uses have been selected for each of the three types except those labelled “other” which require further explanation in a remarks box (PROC 0, ERC 0, PC 0, SU 0, AC 0, AC 01, AC 02).

All common uses of TiO2 have been chosen from the picklist “Technical function of substance” (see picklist below) All boxes for “Significant routes of exposure” should be checked though this is optional.

“Technical function of substance” picklist

3.6 Uses advised against

Since all uses have been selected in section 3.5 this section is left blank – do not create any repeatable blocks

3.7 Waste from Production and Use - Individual LE’s can provide their own information on quantities if they wish. However it should be noted that Waste only refers to isolated wastes and not to emissions to air or water. Generic Waste Codes have been included for both Production and Use.

Production

Waste from Use

3.8 Exposure estimates Optional and not applicable 3.9 Biocidal information Optional and not applicable 4, 5, 6 and 7 will be part of the Lead Registrant dossier only and each LE will include via the Joint Submission process. Since the Letters of Access to the studies have been restricted to use for REACH the flag EU REACH has been selected for the studies – this does not incur any confidentiality fee.

8 Analytical Methods Optional and not applicable

11 Guidance on Safe Use LR will tick box for Joint Submission of this section. As currently used in SDS but should be common information. Annex VI “This information shall be consistent with that in the Safety data Sheet”. See Appendix 3 for full data extracted by comparison of TDIC members’ SDS for TiO2.

12 Literature Search Optional and not applicable for Joint Registrant – it is how the literature search was done by the Lead Registrant rather than the outcome. 13 Assessment Reports There will be a Joint Submission of CSR so this will be in the Lead Registrant submission only.

Once complete the dossier should be run through the Technical Completeness Check (TCC) tool to check that all required sections have been completed for the Substance. The final step performed in IUCLID is to create your dossier – for further information see Data Submission Manual 4. The TCC should then be run again to check the dossier. Before submission it is essential to check that the Legal Entity is the same for the Substance, for the dossier, and for REACH-IT

References General - See ECHA website http://echa.europa.eu/help/help_docs_en.asp 1. Data Submission Manual 4: How to Pass Business Rule Verification ("Enforce Rules") :

http://echa.europa.eu/doc/reachit/how_pass_business_verification.pdf 2. Data Submission Manual 5: How to complete a technical dossier for registrations and PPORD

notifications : http://echa.europa.eu/doc/reachit/compl_tech_dossier_manual.pdf 3. Manual of Decisions for Implementation of the Sixth and Seventh Amendments to Directive

67/548/EEC on Dangerous Substances (updated July 2006) : http://ecb.jrc.ec.europa.eu/documents/New-Chemicals/Manual_of_decisions.pdf

4. ECHA Publication : Frequently Asked Questions about REACH, Version 3.1, June 2010 :

http://echa.europa.eu/doc/reach/reach_faq.pdf 5. ECHA Practical guide 9: How to do a registration as a member of joint submission :

http://echa.europa.eu/doc/publications/practical_guides/PG_9_reg_member_subm_en.pdf 6. IUCLID 5 FAQ : http://iuclid.eu/index.php?fuseaction=home.faq 7. REACH-IT FAQ : http://echa.europa.eu/reachit/reachit_faq_en.asp 8. Data Submission Manual Part 18 – How to report the substance identity in IUCLID 5 for registration

under REACH : http://echa.europa.eu/doc/reachit/dsm18/substance_id_report_iuclid_en.pdf

Appendix 1

Substance Identity Profile for Titanium Dioxide EINECS no. 236-675-5, CAS no. 13463-67-7

The registration of Titanium Dioxide also includes the following substances that have been merged together for the purposes of REACH registration by application of the REACH Substance Identification guidelines

- Rutile, EINECS no. 215-282-2, CAS no.1317-80-2 - Anatase, EINECS no. 215-280-1, CAS no.1317-70-0 - Titanium dihydroxide oxide, TiO(OH)2, EINECS no. 234-711-4, CAS no.12026-28-7 - Tetrahydroxytitanium, Ti(OH)4, EINECS no. 243-744-3, CAS no. 20338-08-3

TiO2 Composition Data - covering all grades but base crystal only Notes :

1. % is maximum level present in a grade (except TiO2 which is minimum) 2. Express species as oxide (including Ti) including Sulphate anion as SO3 except N and C 3. Include all impurities present at level >0.1%

Agreed Joint Composition

Analyte (as oxide) %

Ti (as TiO2) >87

Al (as Al2O3) <2

Si (as SiO2) <10

Fe (as Fe2O3) <1

Mn (as MnO2) <0.1

Zr (as ZrO2) <0.3

Ce (as CeO2) <0.1

P (as P2O5) <1

Sb (as Sb2O5) <0.5

Sn (as SnO2) <0.1

K (as K2O) <1

Na ( as Na2O) <0.8

Mg (as MgO) <0.1

Nb (as Nb2O5) <0.4

Ca (as CaO) <0.5

Zn (as ZnO) <0.25

N <0.1

C <0.5

SO3 <5

X-Ray Diffraction : Rutile, anatase, brookite or TiO2-B

Appendix 2

Typical Agents used for Surface Treatment of TiO2

As required by ECHA's Frequently Asked Questions about REACH June 2010 Version 3.1, Question 6.3.8

• Aluminium compounds • Silicon compounds • Zirconium compounds • Tungsten compounds • Cerium compounds • Manganese compounds • Iron compounds • Calcium compounds • Ammonium compounds • Polyols • Silanes • Organic acids • Titanium compounds • Amines • Phosphorous compounds • Organic polymers • Metal nitrates

Appendix 3

IUCLID 5 Section 11 Guidance on Safe Use Based on data extracted by comparison of TDIC members’ SDS for TiO2

FIRST AID MEASURES

Inhalation : Move to a fresh air atmosphere. In case of persistent symptoms, consult a doctor. Skin contact : Wash with soap and water. Eye contact : Rinse immediately with plenty of water. If irritation persists, seek medical attention. Ingestion : No adverse health effects anticipated by this route, however, in the event

of ingestion, increase intake of liquid in order to flush from the body. In case of persistent symptoms, consult a doctor.

FIRE-FIGHTING MEASURES

Extinguishing Methods : Use any media appropriate for combustible material in the area. Specific risks : Product is inert, non flammable and non combustible. Special intervention methods : Product is inert, non flammable and non combustible. Protection of fire-fighters : Usual protective equipment for fire fighters.

ACCIDENTAL RELEASE MEASURES

Personal precautions : Avoid generation of dust. Ensure adequate ventilation. Wear personal protective equipment.

Environmental precautions : Prevent run-off from entering ground, storm sewers and ditches which lead to natural waterways.

Cleaning Methods : Use any feasible mechanical means (e.g. vacuum, sweeping) but avoid dusting during clean-up. The product can cause slippery conditions if wet. Even at low concentration, the product renders the discharge in liquid effluent highly visible.

HANDLING AND STORAGE

Handling : Avoid raising and breathing dust. Observe good industrial hygiene practice for chemical handling. Technical Measures : Avoid raising dust. Handling systems and areas should be operated in such a way as to

minimise exposure to dust. Precautions : Local exhaust ventilation may be necessary. Handle minimising dust. Take precautionary

measures against static discharges.

Advice on usage : Manual handling guidelines should be adhered to when handling sacks. Storage conditions : Pigments should not be stored in outside areas exposed to the weather. Care should be taken to

avoid exposure to moisture. Incompatible materials : None.

Packing material : Paper, Plastic.

TRANSPORT INFORMATION

Titanium dioxide is not regulated under UN, IMDG, ADR, RID, ICAO/IATA.

EXPOSURE CONTROLS / PERSONAL PROTECTION

Technical measures Control parameters : Ensure sufficient ventilation. Reduce inhalation hazards in minimising the occupational exposure.

Comply with the Occupational Exposure Limits found in National Guidance documents. Protective equipment

Respiratory protection : A respirator must be used if the dust concentration is likely to exceed the occupational exposure limit. An approved dust respirator is recommended as appropriate depending on dust levels and other workplace factors.

Skin protection : Respect main rules concerning the protection clothes for chemicals handling. Hand protection : Prolonged exposure should be avoided by wearing suitable impervious protective gloves. Environmental exposure controls : Do not allow material to contaminate ground water system.

Eye protection : The use of dustproof goggles or glasses with side protections is recommended if dust concentrations are likely to exceed the occupational exposure limit.

Hygiene Measures : Individuals having sensitive skin may find it beneficial to use a barrier cream or

moisturizer when excessive or prolonged contact with the skin is likely.

Engineering controls and safe systems of work should be used in preference to Personal Protective Equipment (PPE) to

minimise the risk of exposure.

STABILITY AND REACTIVITY

Stability : Stable under normal conditions. Conditions to avoid : None known. Materials to avoid : None reasonably foreseeable. Hazardous decomposition products : None known

DISPOSAL CONSIDERATIONS

Waste disposal : Dispose of in compliance with local and national regulations. Residue : EWC Code : 06 11 99 for TiO2 manufacture or other according to origin of waste. Not

classified as hazardous waste. Contaminated packaging : Contaminated packages are not considered hazardous. If recycling is not practicable,

dispose of in compliance with local regulations.