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SUMMARY

1. Edito

2. Substance Description

3. How to access the data needed for registration?

4. How are these fees calculated?

5. Updates of the dossier

5.1. What were the 2014 updates?

5.2. What are the 2015 updates?

5.3. What will be the 2016 updates?

6.Procedure to report new uses and updates

Nickel Oxide SIEF Flash # 11

April 2015

EDITO

Dear SIEF member

Next registration deadline is May 31, 2018, to register nickel metal manufactured or im-

ported in the EU <100t/y and >1t/y. Even if this registration deadline seems far away

companies who need to register can already get legitimate access to the data by

joining the Joint Submission and achieve their own registration.

Dead-line to register nickel oxide was November 30, 2010. If you have not yet regis-

tered nickel oxide or if you are a new comer on the market, please contact us immedi-

ately.

In Fall 2014, the Ni REACH Cs members have decided to review the schedule for the

annual updates of the registration dossier. More information can be found in this SIEF

Flash, as well as the updated fees to get legitimate access to the data needed for the

registration.

The Nickel REACH Consortia

www.nickelconsortia.eu

SUBSTANCE DESCRIPTION

CAS-No.: 131399-1; 11099-02-8

EINECS-No.: 215-215-7; 234-323-5

EINECS Name: Nickel Monoxide; Nickel Oxide

Synonyms: black nickel oxide ; green nickel oxide ; mononickel oxide ; nickel mo-

nooxide ; nickelous oxide ; nickel oxide (NiO) ; nickel (II) oxide ; nickel (2+) oxide.

Molecular Formula: NiO

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April 2015

HOW TO ACCESS THE DATA NEEDED FOR REGISTRATION?

3 ways to access the data required for REACH compliance:

1. You become a member of the Nickel REACH Consortium

Cost estimation on request.

2. You buy a Letter of Access (LoA):

The LoA is a short document that essentially grants recipients the limited and narrow

right to refer to the registration dossier solely to register for REACH with respect to a spe-

cific substance. The recipients' rights to review/inspect the information submitted is lim-

ited to what is strictly necessary.

The Letter of Access fees consist of 4 elements:

1. A fee for the EU Nickel Risk Assessment: 7,4€/ton of nickel content

2. A fee for the 2007-2010 workplan: depends of tonnage, substance and status

3. A fee for the 2011-2014 workplan (updates of the Dossiers): 4,11€/ton of nickel content

4. A fee for the 2015 workplan (updates of the Dossiers): 1,03€/ton of nickel content

With a Letter of Access:

You can refer to the registration dossier for REACH compliance within the EU

You receive a locked pdf copy of the CSR, as well as some parts of the IUCLID file and some

guidance documents.

3. You buy a License to Use (LtU):

A LtU is a License to Use the underlying studies, it grant recipients a broader right which

enables to review the dossier and underlying studies and to use those studies for ex-

pressly agreed purposes (including for example read across, as support for confidential

uses, to be included in a CSR, to support further testing, etc).

The License to Use fees consist of 4 elements:

1. A fee for the EU Nickel Risk Assessment: 7,4€/ton of nickel content

2. A fee for the 2007-2010 workplan: depends of tonnage, substance and status

3. A fee for the 2011-2014 workplan (updates of the Dossiers): 4,62€/ton of nickel content

4. A fee for the 2015 workplan (updates of the Dossiers): 1,16€/ton of nickel content

With a License to Use:

You can refer to the registration dossier for REACH compliance within the EU

You receive a pdf copy of the CSR, a copy of the complete IUCLID file as well as some guid-

ance documents.

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April 2015

HOW ARE THESE FEES CALCULATED?

The amended Implementing Act on Data-Sharing in REACH, which will be released in

the coming months, invites all SIEF Facilitators to disclose more transparency on the cost

sharing.

Historical cost allocation: EU Nickel Risk Assessment

The Risk Assessment costs were made in preparation of the REACH registration dossier,

and this formed the basis for the dossier.

The Total historical costs for the Nickel Risk Assessment without salaries were calculated

to be close to 7 mio US $. This covered the legal obligations as well as the establishment

or refinements of the Risk Assessment to escape or reduce risk scenario. 5.3 mio US $ of

the total costs was identified as covering direct REACH obligations and are therefore

potentially sharable. Divided by a total average primary Ni production in and import

into the EU of 535.000 t /year, this corresponds with an historical cost fee of 10 US $ /t or

7, 4 €/t Ni.

REACH implementation plan: 2007-2010 workplan

The overall costs for the REACH implementation plan were estimated by Consortium (1,

2 or 3), based on estimations provided by consultants, test labs, experience derived

from the Nickel Risk Assessment and estimated resource needs.

Most of the REACH costs made for nickel oxide during the 2007/2010 WP, with excep-

tion of the administrative costs and the local exposure assessment costs, have been

divided by volume band. The administrative costs have been divided by the number of

Cs2 members, and the local exposure costs are only paid by European producers indi-

vidually.

Type of cost Drivers Generic administrative costs Number of regulars members by Cs

Generic costs for preparation/compilation of re-gistration dossier + GHS + Risk Characterisation

Number of registration dossiers

Costs associated with effects assessment Volume

Costs associated with local exposure assessments Number of sites assessed for manufacturers only (DU’s also for importers)

Costs associated with regional/continental expo-sure assessment

Volume

Salaries Volume

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April 2015

These costs drivers for the REACH implementation result in a different fee depending on

the tonnage, status and volume of the registrant.

The Consortium provides additional services to the members, which are not provided to

LoA/LtU holders. This is why a discount is apply for these companies (20% for LoA, 10%

for LtU). For small tonnage bands (<1000t/y), a fixed fee is applied in order to minimize

administrative costs.

Updates made to the dossier: 2011-2014 and 2015 workplans

As it is a legal obligation to keep the Registration Dossiers up-to-date, the Nickel Reach

Consortium has been updating the Registration Dossier since 2010 on a yearly basis.

The major updates are :

In the Chemical Safety Report with new information on exposure and especially new information

on existing or new uses;

In the environmental compartment with the outcome of the Conclusion i) program of the Risk

Assessment carried out under (EEC) 793/93, on the sediment compartment http://echa.europa.eu/documents/10162/13639/sediment_workshop_nickel_summary_report_en.pdf

Due to changes in the REACH guidance or regulatory updates, the publication of the 2nd ATP

classification and labelling requirements.

A more detailed list of annual updates is generally listed in the SIEF Flash and is availa-

ble upon request to reach@nickelinstitute.org.

The preparation of the updates required additional costs. As companies who buy a

LoA/LtU will benefit of the update of the dossier, it is fair that costs related to this update

will be added to the fee.

Not all costs of the Ni REACH Cs Workplan can be allocated to LoA/LtU since part of

the workplan is focusing on services provided to Consortium Members only. Only costs

related to Data-Sharing and Dossier Maintenance can be allocated to the LoA/LtU

holders. The calculation of these allocation is based on tonnage band, which is the

most objective way, applying the same discounts for LoA (20%) and LtU(10%) as done

for the 2007-2010 Workplan costs.

Letter of Access License to Use Cs1 - nickel metal, nickel sulphate, nickel chloride, nickel nitrate

<1000t/y 3.300 € 4.000 €

>1000t/y Cs membership -20% Cs membership -10%

Cs2 - nickel oxide, nickel hydroxycarbonate, nickel dihydroxide, nickel sulphamate, nickel acetate, nickel sulphide, nickel subsulphide

<1000t/y 22.000 € 25.000 €

>1000t/y Cs membership -20% Cs membership -10%

Cs3 - nickel matte

<1000t/y 38.500 €

>1000t/y Cs membership -20%

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April 2015

UPDATES OF THE NICKEL OXIDE DOSSIER

In Fall 2014, the Ni REACH Cs members have revised the current process for the updates

of the dossier. Two levels of updates (level 1 and level 2) have been defined. Only criti-

cal updates (level 1) will be submitted every year while complete updates will be sub-

mitted every other year.

Level 1 (every year, if applicable):

Updates to compositions affecting classification

Updates to classifications & labelling following new classifications rules (e.g. new CLP Guidance)

Incorporation of new GES to cover new uses

Update to existing DNELs

Update to existing PNECs

Level 2 (every 2 years)

Literature review and inclusion of new study records

Updates to compositions not affecting classification

New compositions not affecting classification

Update of existing GES to include new exposure data

What were the 2014 updates to the nickel oxide Dossier (1/2)?

New study records were added in the following IUCLID sections: Environmental Fate and Path-

ways, Ecotoxicological Information, and Toxicological Information. The K1/K2 studies were trans-

ferred to the CSR and highlighted for your review. Endpoint summaries in IUCLID and the CSR

were updated as needed.

New composition, with associated changes in classification and labelling, were added for nickel

oxide with nickel hydroxycarbonate impurity.

Recently completed acute inhalation toxicity study added.

Dermal DNEL was updated in CSR DNEL Tables and GES as well as in IUCLID Section 7. Appendix

C3 was also updated to reflect the revised dermal DNEL.

Read-Across Dermal Route-Appendix B3- was updated in CSR to reflect new dermal DNELs for

water insoluble Ni substances and results from irritation test with Ni acetate.

Read-Across Inhalation Route-Appendix B2- was updated in CSR to reflect new acute toxicity

data (black nickel oxide) and revised data analysis.

Appendix C2- Background document for Workplace DNEL derivation for repeated exposure was

updated in CSR to reflect a new approach to practical threshold derivation based on epidemio-

logical cancer data and updated justification for dose-metric selection. Once finalized, this ap-

pendix will be included as an attachment in IUCLID.

Appendix D6. Minor changes were made to this appendix.

In section 9 and Appendix D3 of the CSR, the environmental section in all GES has been exten-

sively updated to incorporate the following changes:

The updated freshwater PNEC of 7.1 µg Ni/L.

The inclusion of the exposure assessment for the sediments compartment.

In some GES, certain parameters (tonnages, emission factors or dilution factors) have been

optimized to allow a more conservative exposure assessment.

Non-essential information was removed from the GES and from Appendix D3 (e.g. PEC in

porewater).

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What were the 2014 updates to the nickel oxide Dossier (2/2)?

Section 2 of the CSR (Manufacture and uses) has been updated to reflect the updates to the

exiting GES.

The Man via the Environment section has been updated in all GES according to the proposal

circulated to the Working Group on November 28th 2013.

In the CSR, section 9.1.1, the headings in the table were updated to reflect the life cycle stages

in IUCLID section 3.5. The updated headings are highlighted in red.

All GES were incorporated into section 3.7.1 of IUCLID

Section 3.7.2 of IUCLID was completed

Dermal DNEL was updated in all GES and in Appendix D4.

In IUCLID and the CSR, some use descriptors were modified according to the assigned life cycle

stages of each GES in IUCLID. The changes have been made according to the proposal circu-

lated to the Working Group on December 9th 2013.

In IUCLID and the CSR, GES 1: Production of nickel oxide-containing catalysts and catalyst pre-

cursors” was updated with new occupational exposure information.

All updates to Appendix D4 of the CSR were consolidated in one single Annex to this Appendix.

Section 7.1.2.1 Calculation of PNEC water and Appendix D1 of the CSR and Section 6 Ecotoxico-

logical Information Endpoint Summary in IUCLID was modified to update the values and lan-

guage associated with the new Assessment Factor of 1, as agreed at the March 26, 2013

Working Group meeting.

Section 7.1.2.2 Calculation of PNEC sediment, the discussion section of 7.1.1.4 Sediment Orga-

nisms, and the sediment endpoint in Section 6 Ecotoxicological Information Endpoint Summary in

IUCLID were amended to include the new sediment data and PNEC. The report on the Advan-

ced Sediment Testing Program was added to the CSR in Appendix A3.

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April 2015

What are the 2015 updates to the nickel oxide Dossier?

The acute toxicity systemic DNEL for inhalation was removed from DNEL tables and from GES in

CSR and from Toxicological endpoints in IUCLID.

In IUCLID and the CSR, the Compositions section was updated to include unknown impurities not

affecting classification and impurities present in concentrations of less than 1% that do not affect

classification and labelling in one category called “Other Impurities.”

In IUCLID and the CSR, the Compositions section was updated by modifying the concentrations

of impurities to the closest concentration limit that would not alter the classification and labelling

of the composition, or to the closest percent (or tenth of a percent for small values) value in or-

der to prevent small changes in the compositions from requiring update of the compositions in

the dossier.

Appendix B3 had a slight modification to cite the CLP as precedent for the use of bioelution in

sweat for classification to support the use of bioelution in the derivation of the dermal DNEL.

Appendix C1 (Derivation of human health DNELs for four reference substances) was revised to

delete any reference to the potential derivation of a DMEL. Since no DMEL is included in the CSRs

for any of the health endpoints, it was confusing to have this in the appendix. Other minor

changes were made.

Appendix C2 (Background document in support of the derivation of workplace long-term inhala-

ble DNEL for Ni metal and Ni compounds) has been revised in its entirety to reflect comments

from two external reviewers. The final DNEL numbers were not changed.

In section 9 and Appendix D5 of the CSR (Man via Environment), the background level of Ni in

ambient air has been updated from 6.2 ng Ni/m3 (2007-2009 data) to 4.5 ng Ni/m3 (2012 data).

This change has been incorporated in all the exposure scenarios.

In some GES, the PNEC for marine environment was erroneously indicated as 8.4 µg Ni/L. This was

a typo and it has been corrected to 8.6 µg Ni/L.

What will be the 2016 updates to the nickel oxide Dossier?

In 2016, the nickel Consortia will submit full updates to all the Registration dossiers. This

will include both Level 1 and 2 updates, namely:

Literature review and inclusion of new study records

Updates to compositions

Updates to classification and labeling

Update of new and existing GES

Update to DNELs/PNECs

This list is provisional and is subject to change. Moreover, completely revised exposure

scenarios will be submitted in 2016 for all the uses identified in the dossier.

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April 2015

PROCEDURE TO REPORT NEW USES AND UPDATES

The Nickel REACH Consortia Dossiers are updated annually on a voluntarily basis to in-

clude any new data on nickel and its compounds registered by the Consortia. This in-

cludes new reported uses or effects data or information resulting in updates to existing

GES. For any new uses reported, a generic exposure scenario (GES) must be developed

for inclusion in the updated CSR.

Any new use to be covered in the next update needs to be reported in the previous

calendar year. The following table summarizes the process and timing for the annual

updates:

A comment period is scheduled for company/DU association and members of the Consortia.

Additional information and a questionnaire to report new uses or new data can be found here

The next SIEF Flash of nickel oxide will be issued in 2016.

Meanwhile, the Nickel REACH Consortia is available for all information requests.

WWW.NICKELCONSORTIA .EU REACH@NICKELINSTITUTE .ORG

Date Activity Responsibility May 30 Final dead-line to report new uses or new information

on uses Company/DU association

June - February

Drafting new and updated GES and exposure assessments reports*

Ni REACH Cs secretariat

March Inclusion of new and updated GES in CSR/Iuclid Ni REACH Cs secretariat

April Final approval of the dossiers from Ni REACH Cs members (WG, ST and GA)

Ni REACH Cs members

May Lead Registrant to receive final dossier to submit update to ECHA

Ni REACH Cs secretariat