FINAL DRAFT GUIDANCE DOCUMENT

RIP 3.4. (Data-sharing and Pre-Registration)

REVIEW 02 May, 2007

**CONTENTS**

[ABBREVIATIONS 7](#__RefHeading___Toc165900899)

[1 INTRODUCTION 8](#__RefHeading___Toc165900900)

[1.1 Overview 8](#overview)

[1.2 Objectives of the Guidance Document on Data Sharing
10](#objectives-of-the-guidance-document-on-data-sharing)

[1.3 Link to the other REACH guidance and processes
13](#link-to-the-other-reach-guidance-and-processes)

[2 LEGAL FRAMEWORK: Relevant LEGAL Provisions 14](#OLE_LINK6)

[2.1 Pre-Registration and Data sharing
14](#pre-registration-and-data-sharing)

[2.2 Competition law 16](#competition-law)

[3 PRE-REGISTRATION 16](#__RefHeading___Toc165900907)

[3.1 What are the benefits of pre-Registration?
16](#what-are-the-benefits-of-pre-registration)

[3.2 Who can pre-register? 16](#who-can-pre-register)

[3.3 Is there a deadline for pre-registration?
18](#is-there-a-deadline-for-pre-registration)

[3.4 First-time manufacturers or importers
18](#first-time-manufacturers-or-importers)

[3.5 What if the deadline for pre-registration is not met?
18](#what-if-the-deadline-for-pre-registration-is-not-met)

[3.6 How to pre-register a substance?
18](#how-to-pre-register-a-substance)

[3.7 How to account of substances identification for Pre-registration
purposes? 19](#__RefHeading___Toc165900914)

[3.8 SIEF Facilitator 20](#sief-facilitator)

[3.9 How to establish the first envisaged registration deadline and the
tonnage band for pre-registration?
20](#how-to-establish-the-first-envisaged-registration-deadline-and-the-tonnage-band-for-pre-registration)

[4 FORMATION OF SUBSTANCE INFORMATION EXCHANGE FORUM (SIEF)
20](#__RefHeading___Toc165900917)

[4.1 What is a SIEF? 21](#what-is-a-sief)

[4.2 Who are the SIEF Participants? 21](#who-are-the-sief-participants)

[4.2.1 \"Potential Registrants\" 22](#potential-registrants)

[4.2.2 \"Data Holders\" 22](#data-holders)

[4.3 What are the obligations of SIEF Participants?
23](#what-are-the-obligations-of-sief-participants)

[4.4 What happens after the beginning of Pre-Registration?
23](#what-happens-after-the-beginning-of-pre-registration)

[4.4.1 Before the publication of the list of pre-registered substances
24](#before-the-publication-of-the-list-of-pre-registered-substances)

[4.4.2 Publication of the list of pre-registered substances
24](#publication-of-the-list-of-pre-registered-substances)

[4.4.3 After the publication of the list of pre-registered substances
25](#after-the-publication-of-the-list-of-pre-registered-substances)

[4.5 How and when will a SIEF be formed?
26](#how-and-when-will-a-sief-be-formed)

[4.5.1 Pre-SIEF discussions 26](#__RefHeading___Toc165900930)

[4.5.2 How to determine the sameness of substances?
27](#how-to-determine-the-sameness-of-substances)

[4.5.3 How can communications in SIEF be facilitated? SIEF Facilitator
29](#how-can-communications-in-sief-be-facilitated-sief-facilitator)

[4.5.4. When will data holders join the SIEF?
30](#__RefHeading___Toc165900933)

[5 Data Sharing RULES FOR PHASE-IN SUBSTANCES WITHIN A SIEF
31](#__RefHeading___Toc165900934)

[5.1 Overall approach to data sharing
31](#overall-approach-to-data-sharing)

[5.2 Four step process to fulfil the information requirements for
Registration
32](#four-step-process-to-fulfil-the-information-requirements-for-registration)

[5.3 The collective route 33](#the-collective-route)

[5.3.1 Step 1: Individual gathering of available information
35](#step-1-individual-gathering-of-available-information)

[5.3.2 Step 2: Agreement on the form of co-operation/cost sharing
mechanism
36](#step-2-agreement-on-the-form-of-co-operationcost-sharing-mechanism)

[5.3.3 Step 3: Collection and inventory of all available information
36](#step-3-collection-and-inventory-of-all-available-information)

[5.3.4 Step 4: Evaluation of available information
37](#step-4-evaluation-of-available-information)

[5.3.5 Step 5: Consideration of information needs
38](#step-5-consideration-of-information-needs)

[5.3.6 Step 6: Identification of data gaps and collection of other
available information
39](#step-6-identification-of-data-gaps-and-collection-of-other-available-information)

[5.3.7 Step 7: Generation of new information/testing proposal
40](#step-7-generation-of-new-informationtesting-proposal)

[5.3.8 Step 8: Sharing of data and cost
41](#step-8-sharing-of-data-and-cost)

[5.3.9 Step 9: Joint Submission of Data
42](#step-9-joint-submission-of-data)

[5.4 Classification and labelling 42](#classification-and-labelling)

[5.5 Data Sharing: Individual route 44](#__RefHeading___Toc165900950)

[5.5.1 Step 1 Individual gathering of available information
45](#step-1-individual-gathering-of-available-information-1)

[5.5.2 Step 2 Individual consideration of information needs
45](#step-2-individual-consideration-of-information-needs)

[5.5.3 Step 3 Identification of individual data gaps
45](#step-3-identification-of-individual-data-gaps)

[5.5.4 Step 4 Request for missing data to other SIEF participants
45](#step-4-request-for-missing-data-to-other-sief-participants)

[5.5.5 Step 5 Sharing of available data
45](#step-5-sharing-of-available-data)

[5.5.6 Step 6 Generation of new information/testing proposal
46](#step-6-generation-of-new-informationtesting-proposal)

[5.5.7 Step 7 Joint submission of data -- Opt Out
46](#step-7-joint-submission-of-data-opt-out)

[5.5.8 Data Sharing with Data Holders
46](#data-sharing-with-data-holders)

[5.6 Dispute Resolution in data sharing
47](#__RefHeading___Toc165900963)

[5.6.1 Data on vertebrate animals 47](#data-on-vertebrate-animals)

[5.6.2 Data on non-vertebrate animals
48](#data-on-non-vertebrate-animals)

[6 Exchanges of CONFIDENTIAL BUSINESS INFORMATION (CBI) and Competition
law 48](#__RefHeading___Toc165900966)

[6.1 CBI 48](#cbi)

[6.2 EC Competition law 48](#ec-competition-law)

[7 THE \"INQUIRY PROCESS\": DATA-SHARING rules FOR NON-PHASE-IN
SUBSTANCES AND REGISTRANTS OF PHASE-IN SUBSTANCES WHO HAVE NOT
PRE-REGISTERED 49](#__RefHeading___Toc165900969)

[7.1 What substances are subject to the Inquiry Process?
49](#what-substances-are-subject-to-the-inquiry-process)

[7.2 Inquiry prior to registration 50](#inquiry-prior-to-registration)

[7.3 Sharing of existing data between registrants
52](#__RefHeading___Toc165900973)

[7.4 Relationship with SIEF for Phase-In Substances
53](#relationship-with-sief-for-phase-in-substances)

[8 SIEF: other issues (Miscellaneous) 54](#__RefHeading___Toc165900975)

[8.1 Inter-SIEF rules (grouping, read-across)
54](#inter-sief-rules-grouping-read-across)

[8.2 End of SIEF 54](#end-of-sief)

[8.3 Liability related to data sharing
55](#liability-related-to-data-sharing)

[9 REGISTRATION: JOINT SUBMISSION 56](#__RefHeading___Toc165900981)

[9.1 Overview of what shall and what may be jointly submitted for
Registration
56](#overview-of-what-shall-and-what-may-be-jointly-submitted-for-registration)

[9.2 Mandatory Joint Submission 57](#mandatory-joint-submission)

[9.3 Lead Registrant 58](#__RefHeading___Toc165900984)

[9.3.1 Who is the "Lead Registrant"? 58](#who-is-the-lead-registrant)

[9.3.2 What are the tasks of the Lead Registrant?
59](#what-are-the-tasks-of-the-lead-registrant)

[9.3.3 What is the liability of the Lead Registrant?
60](#what-is-the-liability-of-the-lead-registrant)

[9.4 Opt-Out 60](#__RefHeading___Toc165900994)

[9.4.1 What are the opt-out conditions from joint submission?
60](#what-are-the-opt-out-conditions-from-joint-submission)

[9.4.2 What are the criteria to opt-out of joint submission?
60](#__RefHeading___Toc165901005)

[9.4.3 What are the consequences of opting out?
62](#what-are-the-consequences-of-opting-out)

[9.4.4 What are the remaining obligations of the potential registrant?
62](#what-are-the-remaining-obligations-of-the-potential-registrant)

[9.5 Voluntary Joint Submission 63](#voluntary-joint-submission)

[9.5.1 What are the rules to submit jointly "sensitive data" of the CSR?
64](#what-are-the-rules-to-submit-jointly-sensitive-data-of-the-csr)

[10 Forms of Co-operation 65](#__RefHeading___Toc165901016)

[10.1 What is a Consortium? 67](#what-is-a-consortium)

[10.2 Is a Consortium mandatory under REACH?
68](#is-a-consortium-mandatory-under-reach)

[10.3 How is a Consortium to be created?
68](#how-is-a-consortium-to-be-created)

[10.4 Forms of co-operation in SIEF when using Consortia
69](#forms-of-co-operation-in-sief-when-using-consortia)

[10.5 Elements of co-operation that may be included in a Consortium
71](#elements-of-co-operation-that-may-be-included-in-a-consortium)

[10.6 Categories of participants in a Consortium
72](#categories-of-participants-in-a-consortium)

[10.7 Typical clauses that may be included in a Consortium agreement
72](#typical-clauses-that-may-be-included-in-a-consortium-agreement)

[Annex 1 -- Process description charts 74](#__RefHeading___Toc165901024)

[Annex 2 -- CBI 79](#__RefHeading___Toc165901025)

[1 GENERAL 79](#__RefHeading___Toc165901026)

[1.1 What is Confidential Business Information?
79](#what-is-confidential-business-information)

[1.2 What is considered "secret"? 80](#what-is-considered-secret)

[1.3 When does information loose its CBI status?
80](#when-does-information-loose-its-cbi-status)

[1.4 CBI and Competition law 80](#cbi-and-competition-law)

[1.5 Are there specific provisions on CBI in REACH?
80](#are-there-specific-provisions-on-cbi-in-reach)

[2 WHAT INFORMATION SUBMITTED AT PRE-REGISTRATION MAY BE CBI?
81](#__RefHeading___Toc165901032)

[3 SIEF FORMATION 82](#__RefHeading___Toc165901033)

[4 EXCHANGE OF INFORMATION AMONG POTENTIAL REGISTRANTS
82](#__RefHeading___Toc165901034)

[4.1 Exchanging studies within SIEF 83](#exchanging-studies-within-sief)

[4.2 Separate Submission of Data 84](#separate-submission-of-data)

[4.2.1 General information on registrants (Annex VI.1)
84](#general-information-on-registrants-annex-vi.1)

[4.2.2 Identification of the substance (Annex VI.2)
84](#identification-of-the-substance-annex-vi.2)

[4.2.3 Information on manufacture and use (Annex VI.3).
84](#information-on-manufacture-and-use-annex-vi.3.)

[4.2.4 Exposure information (Annex VI.6)
85](#exposure-information-annex-vi.6)

[4.3 Joint Submission of Data 85](#joint-submission-of-data)

[4.3.1 Annex VII to X information 85](#annex-vii-to-x-information)

[4.3.2 Classification and Labelling (Annex VI.4)
86](#classification-and-labelling-annex-vi.4)

[4.3.3 Guidance on safe use (Annex VI.5)
86](#guidance-on-safe-use-annex-vi.5)

[5 POSSIBLE CBI ISSUES RELATED TO EXCHANGE OF INFORMATION WITH PARTIES
OTHER THAN POTENTIAL REGISTRANTS
86](#possible-cbi-issues-related-to-exchange-of-information-with-parties-other-than-potential-registrants)

[5.1 Visibility of parties involved 87](#visibility-of-parties-involved)

[5.2 Information on Safety Data Sheets (Art. 31) and other information
(Art. 32-33) to Downstream Users 87](#__RefHeading___Toc165901051)

[5.3 Communication of Information on uses
87](#__RefHeading___Toc165901052)

[6 POSSIBLE MEANS OF EXCHANGE WHILE PROTECTING CBI: CONFIDENTIALITY AND
NON-USE AGREEMENTS 88](#__RefHeading___Toc165901053)

[Annex 3 --EC COMPETITION LAW 96](#__RefHeading___Toc165901054)

[1 INTRODUCTION 96](#__RefHeading___Toc165901055)

[1.1 Could Competition law apply to REACH activities?
96](#could-competition-law-apply-to-reach-activities)

[1.2 EC Competition law in brief 96](#__RefHeading___Toc165901060)

[2 EXCHANGE OF INFORMATION UNDER REACH AND EC COMPETITION LAW
97](#__RefHeading___Toc165901061)

[2.1 Avoiding misuse of REACH exchange of information to conduct cartels
97](#__RefHeading___Toc165901062)

[2.3 Type of information to be exchanged with caution
98](#type-of-information-to-be-exchanged-with-caution)

[3 RECOMMENDED TIPS FOR REACH ACTORS WHEN WORKING TOGETHER
100](#__RefHeading___Toc165901064)

[4 Appendix -- Article 81 of the EC Treaty
102](#__RefHeading___Toc165901065)

[Annex 4 -- Cost Sharing 103](#__RefHeading___Toc165901066)

[1 BASIC PRINCIPLES FOR DATA AND COST SHARING
103](#__RefHeading___Toc165901067)

[2 DATA QUALITY 104](#__RefHeading___Toc165901068)

[2.1 Reliability -- Relevance -- Adequacy
104](#__RefHeading___Toc165901069)

[2.2 Data Valuation Approaches 104](#__RefHeading___Toc165901070)

[3 STUDY VALUATION 106](#__RefHeading___Toc165901071)

[3.1 What studies should be valued ? 106](#__RefHeading___Toc165901072)

[3.2 Historic versus Replacement costs
107](#__RefHeading___Toc165901073)

[3.3 What studies should be valued ? 107](#__RefHeading___Toc165901074)

[3.4 Examples of Quality and Financial Valuations
109](#examples-of-quality-and-financial-valuations)

[4 COST ALLOCATION AND COMPENSATION 109](#__RefHeading___Toc165901076)

[4.1 \"Individual route\" 110](#__RefHeading___Toc165901077)

[4.2 \"Collective route\" 110](#__RefHeading___Toc165901078)

[4.2.1 Data compensation based on study quality-weighted models+
110](#__RefHeading___Toc165901079)

[Compensation 111](#compensation)

[4.2.2 Direct data compensation 111](#__RefHeading___Toc165901083)

[5 FURTHER FACTORS 112](#__RefHeading___Toc165901084)

[5.1 Klimisch 3 studies 112](#klimisch-3-studies)

[5.2 Usage Restrictions 112](#usage-restrictions)

[5.3 Volume Factors 112](#volume-factors)

[5.4 New Studies 113](#new-studies)

[5.5 Examples of Further Factor Considerations
113](#examples-of-further-factor-considerations)

[6 NEW PARTIES 113](#__RefHeading___Toc165901090)

[6.1 Example 113](#example)

[EXAMPLES 116](#__RefHeading___Toc165901092)

[Example 1 (Study Valuation) 116](#example-1-study-valuation)

[Example 2 (Study Valuation) 119](#example-2-study-valuation)

[Example 3 (Cost Allocation) 122](#example-3-cost-allocation)

[Example 4 : (Cost Allocation) 123](#example-4-cost-allocation)

[Example 5 : (Cost Allocation) 125](#example-5-cost-allocation)

[Example 6: (Cost Allocation - compensation for best studies)
126](#example-6-cost-allocation---compensation-for-best-studies)

[Example 7 : (Cost Allocation - compensation for key study only)
127](#example-7-cost-allocation---compensation-for-key-study-only)

[Example 8 : (Valuation with usage restrictions)
128](#example-8-valuation-with-usage-restrictions)

[Example 9: (Volume Factors) 130](#example-9-volume-factors)

[Example 10 : (New parties) 132](#example-10-new-parties)

[ANNEX 5: PRE-REGISTRATION AND DATA SHARING EXAMPLES
133](#__RefHeading___Toc165901103)

[1 EXAMPLE 1: \"BASE CASE\" 133](#__RefHeading___Toc165901104)

[2 EXAMPLE 2: DIFFERENT TONNAGE BANS 133](#__RefHeading___Toc165901105)

[3 EXAMPLE 3: SUBSTANCE IDENTITY ISSUES
134](#__RefHeading___Toc165901106)

[4 EXAMPLE 4: EARLY REGISTRANT 135](#__RefHeading___Toc165901107)

[5 EXAMPLE 5: LATE REGISTRANT 135](#__RefHeading___Toc165901108)

[6 EXAMPLE 6: OPT OUT 136](#__RefHeading___Toc165901109)

[7 EXAMPLE 7: NON-PHASE-IN SUBSTANCES / INQUIRY PROCESS
137](#__RefHeading___Toc165901110)

[ANNEX 6: LETTER OF THE LEAD REGISTRANT
138](#__RefHeading___Toc165901111)

[REFERENCES 138](#__RefHeading___Toc165901112)

[]{#__RefHeading___Toc165900899 .anchor}ABBREVIATIONS

1.  []{#__RefHeading___Toc165900900 .anchor}INTRODUCTION

# Overview {#overview .Heading_L2}

The REACH Regulation No 1907/2006 of 18 December 2006 organizes the
Registration, Evaluation, Authorization and Restriction of Chemicals
(REACH) and establishes a European Chemicals Agency (ECHA).

[Registration Obligation]{.underline}

After 1 June 2008, companies manufacturing or importing chemical
substances in the EU in quantities of 1 tonne or more per year will be
required to register them under REACH. Registration also applies to
companies producing or importing articles containing substances intended
to be released in quantities of 1 tonne or more per year.

Registration requires the submission of relevant and available data on
intrinsic properties of substances and exposure scenarios and, when not
available, the generation of data, including testing. Specific
mechanisms and procedures have been introduced in REACH to enable
companies to share existing data before submitting a registration in
order to increase the efficiency of the registration system, to reduce
costs and to reduce testing on vertebrate animals.

[Phase-In and Non Phase-In Substances]{.underline}

The Regulation sets out different procedures for registration and data
sharing of "existing" ("[phase-in]{.underline}") substances and "new"
("[non-phase in]{.underline}") substances. Phase-in substances are
substances which are listed on the European Inventory of Existing
Commercial Chemical Substances (EINECS) or are already manufactured but
not (yet) placed on the market or are so-called \"no-longer
polymers\"[^1] (and are commonly referred to as \"existing\"
substances). Non phase-in substances can be broadly defined as the "new"
substances. They include any substances that do not meet the definition
of phase-in as given in the Regulation.

[Transitional Regime for Registration]{.underline}

Phase-in substances may benefit from a temporary exemption from the
registration requirements. This transitional regime allows companies to
temporarily continue their activities involving phase-in substances
without the need to register. Registration will nevertheless be required
before the expiry of the transitional period, as per the following
deadlines:

+--------------------------------+-------------------------------------+
| *Substance properties/Yearly   | *Deadline for Registration of Phase |
| Volume*                        | In Substances*                      |
+--------------------------------+-------------------------------------+
| CMR[^2] ≥ 1 t/y                | 30 November 2010                    |
|                                |                                     |
| R 50-53[^3] ≥ 100 t/y          |                                     |
|                                |                                     |
| Other substances ≥ 1000 t/y    |                                     |
+--------------------------------+-------------------------------------+
| Other substances *≥ 100 t/y*   | 31 May 2013                         |
+--------------------------------+-------------------------------------+
| Other substances *≥ 1 t/y*     | 31 May 2018                         |
+--------------------------------+-------------------------------------+

Non phase-in substances will not benefit from this transitional regime
and will have to be registered by the company before the start of its
activities involving these substances.

[Pre-Registration]{.underline}

In order to benefit from the temporary exemption, each potential
registrant of a phase-in substance in quantities of 1 tonne or more per
year is required to \"pre-register\" the phase-in substances concerned.
The period for pre-registration is from 1 June until 1 December 2008.
Pre-registration is not obligatory. Companies are free to opt for
immediate registration after 1 June 2008.

[Substance Information Exchange Forum (SIEF)]{.underline}

REACH provides for the formation of a SIEF to share information among
manufacturers and importers of \"phase-in\" substances, as well as
downstream users and other stakeholders in order to avoid multiple
testing on animals and more generally prevent duplicate testing.

As a general rule, there shall be one SIEF for each phase-in substance.
SIEFs will be set up following the pre-registration of phase-in
substances after agreement by the pre-registrants on the sameness of
their substances. Pre-registration shall be made through the REACH IT
system managed by the ECHA.

By 1 January 2009, a list of all pre-registered substances and
substances for which the available information is relevant for QSAR,
grouping of substances and the read-across approach (identified by their
EINECS and CAS and other identity codes) will be published on the
ECHA\'s website, together with the first envisaged registration
deadline. Other stakeholders, such as manufacturers and importers of
substances in quantities of less than one tonne, downstream users and
third parties who hold information on the substances appearing on the
list (hereinafter \"data holders\") will then be able to submit relevant
information on a voluntary basis with the view to participate in the
SIEF for that substance.

The principal aims of the SIEF are to:

-   Facilitate data sharing for the purposes of Registration, and

-   Agree on the classification and labelling of the substances
    concerned.

[SIEF and Forms of Cooperation / Consortia]{.underline}

Participants in a SIEF are free to organize themselves as they see fit
to carry out their obligations under REACH. They can use different forms
of cooperation to do so, including the creation of a \"consortium\".
REACH however does not require SIEF participants to form a consortium
and a consortium can be formed between SIEF participants (or
participants of different SIEFs and other parties) for data sharing
purposes and/or to meet other objectives.

[Joint Submission of Data]{.underline}

In addition to required aspects (data sharing and classification and
labeling), the SIEF also provides a suitable platform for participants
to organize among themselves the mandatory joint submission of data, as
provided for in Article 11 of REACH, including as an option the exchange
of the data needed to perform the Chemical Safety Assessment (CSA),
drafting the Chemical Safety Report (CSR) and agreeing on guidance on
safe use that may be part of this joint submission.

[Inquiry prior to registration]{.underline}

For non phase-in substances (but also for potential registrants of
phase-in substances that have not pre-registered them), a duty to
inquire applies. This Inquiry process requires potential registrants to
inquire from the Agency whether a submission has already been made for
the same substance. This is to ensure that data are shared by the
relevant parties.

# Objectives of the Guidance Document on Data Sharing {#objectives-of-the-guidance-document-on-data-sharing .Heading_L2}

The present Guidance Document aims to provide practical guidance to
Industry on data sharing for Phase-In and Non Phase-In Substances under
REACH.

It includes a detailed description of the following processes:

-   The Pre-Registration Process;

-   The Formation of SIEFs;

-   Data Sharing within SIEF;

-   Data Sharing for Non Phase In Substances;

-   Joint Submission of Data and Opt Out, and

-   

It also contains practical recommendations to help companies meet their
obligations and achieve their objectives.

Specific guidance is also provided on:

-   Cost sharing mechanisms;

-   The protection of Confidential Business Information (CBI);

-   Competition Law, and

-   Forms of Co-operation, including Consortia.

Flow Charts are provided in Annex 1 to describe each specific process.

Examples of the relevant data sharing processes are provided in Annex 5.

A schematic overview of the above processes for phase-in and
non-phase-in substances is provided below:

![](media/image1.wmf){width="7.7131944444444445in" height="10.125in"}

![](media/image2.wmf){width="7.3590277777777775in" height="8.875in"}

# Link to the other REACH guidance and processes {#link-to-the-other-reach-guidance-and-processes .Heading_L2}

[]{#OLE_LINK6 .anchor}This guidance is not intended to be used as stand
alone guidance. Potential registrants and data holders should also
review other relevant Guidance Documents.

In particular, they are encouraged to review RIP 3.1 guidance on
Registration. The present guidance indicates when to refer to the RIP
3.1 guidance, and identifies areas where the approaches in that guidance
need to be adapted for the purpose of data sharing.

Guidance needed for fulfilling the information requirements on intrinsic
properties of substances, including evaluation of available information
and special factors affecting information requirements and testing
strategies is covered in the RIP 3.3 guidance.

For detailed methodological guidance on how to complete a chemical
safety report (CSA), including guidance on how to read across, identify
and measure environmental fate and physico-chemical properties, and make
human health and environmental assessments, the RIP 3.2 guidance should
be consulted.

The duties of downstream users are covered by RIP 3.5 guidance.

RIP 3.6 will develop guidance on classification and labelling under the
Global Harmonized System (GHS).

Finally and most importantly, when assessing the identity of the
substances, pre-registrants should read the RIP 3.10 guidance carefully.

1.  LEGAL FRAMEWORK: Relevant LEGAL Provisions

# Pre-Registration and Data sharing {#pre-registration-and-data-sharing .Heading_L2}

The rules on data sharing and avoidance of unnecessary testing are
provided in Title III of REACH.

As spelled out in Article 25, the [objective]{.underline} of these rules
is to avoid vertebrate animal testing so that it is carried out as the
last resort. As a [general rule]{.underline} REACH provides that sharing
of information should be limited to technical data. It also provides
that the (robust) study summaries provided in support of a registration
dossier shall be freely available for public use after 12 years from the
date of Registration.

The rules for [Non-phase-in substances and non-pre-registered
substances]{.underline} are laid down in Articles 26 and 27.

Article 26 regulates the inquiry phase as follows:

26(1) -- inquiry to the ECHA and information to be submitted;

26(2) -- communication in case of substances non-previously registered;

26(3) -- communication in case of name and contact details of previous
registrant and potential registrant; communication in case of previously
registered substance;

26(4) -- communication in case of several potential registrants making
the inquiry.

Article 27 organizes the data-sharing process, as follows:

Article 27(1) -- request of information from previous registrant;

> Article 27(2) -- obligation to make every effort to reach agreement,
> including submission, to arbitration board;
>
> Article 27(3) -- obligation to make every effort to share costs in
> fair, transparent and non discriminatory way;

Article 27(4) -- communication of information in case of agreement;

Article 27(5) --communication to the ECHA in case of disagreement;

Article 27(6) -- data-and cost sharing rules in case of disagreement.

The rules for [Phase-in substances]{.underline} are spelled out in Title
III, Chapter 3 of REACH.

The definition of phase-in substance is given in Article 3(30).

Article 28 describes the *[Pre-registration]{.underline}* of phase-in
substances. The relevant provisions are as follows:

28(1) - submission of a pre-registration dossier to the ECHA;

28(2) - pre-registration period for current potential registrants;

> 28(4) - publication of the list of pre-registered substances and
> substances for which the available information is relevant for QSAR,
> grouping of substances and the read-across approach;

28(6) -- pre-registration period for newcomers;

28(7) -- submission of information on pre-registered substances by other
data holders.

Articles 29 and 30 organize the formation and functioning of
*[SIEF]{.underline}*, as follows:

Article 29 -- Substance Information Exchange For a:

> 29 (1) -- participants in the SIEF;
>
> 29 (2) -- aim of each SIEF;
>
> 29 (3) -- overall approach - duties of the participants;

Article 30 -- Sharing of data involving tests:

> 30 (1) -- inquiries by SIEF participants before testing is carried
> out;
>
> 30 (2) -- performance of new studies;
>
> 30 (3 to 6) -- procedure in case of refusal to share animal and
> non-animal studies.

Article 11 provides the obligation for potential registrants of the same
substance to [jointly submit data]{.underline} and the list of cases in
which [opt out]{.underline} from joint submission of data is possible.

Article 19 sets out similar provisions exist for isolated intermediates.

[Add reference to Article 53]{.mark}

# Competition law  {#competition-law .Heading_L2}

In addition to compliance with the provisions of the REACH Regulation,
operators shall ensure that they comply with other applicable rules and
regulations. This applies in particular to Community competition rules,
as specified in recital 48 of the REACH Regulation[^4].

Community competition law rules are essentially set forth in the Treaty
establishing the European Union (EC Treaty). These rules principally
seek to eliminate agreements which restrict competition (Article 81).

Annex 3 to the present Guidance Document provide guidance to REACH
operators on compliance with EC Competition law rules.

2.  []{#__RefHeading___Toc165900907 .anchor}PRE-REGISTRATION

Pre-registration is the process whereby manufacturers and importers of
'phase-in substances' have to submit a brief set of information to the
ECHA in order to benefit from the transitional period organised by the
Regulation for the Registration of these substances.

This section of the Guidelines provides additional information on the
pre-registration process for phase-in substances.

# What are the benefits of pre-Registration?  {#what-are-the-benefits-of-pre-registration .Heading_L2}

Pre-registration grants potential registrants additional time before the
registration of phase-in substances, while continuing their manufacture,
importation and use. More specifically:

1\) Pre-registration allows companies to continue manufacturing/
importing/ using activities involving phase in-substances until:

  -------------------------------- --------------------------------------
  *Phase-in substances* *Yearly    *Deadline for Registration of Phase In
  Volume*                          Substances*

  Substances of high tonnage       1 December 2010
  and/or various hazard classes    

  Substances of medium tonnage;    1 June 2013
  and                              

  Substances of lower tonnage      1 June 2018
  -------------------------------- --------------------------------------

-   
-   
-   

2\) Pre-registration also gives companies time to organize the
collection and selection of available data, the sharing of existing
data, and the collective generation of missing information, as described
in Section 4 and 5 of these Guidelines.

# Who can pre-register?  {#who-can-pre-register .Heading_L2}

Each natural and legal person who would be required to register a
phase-in substance after 1 June 2008 may pre-register that substance.
These persons include:

-   Manufacturers and Importers of phase-in substances on their own or
    in preparation in quantities of 1 tonne or more per year, including
    intermediates;

-   Producers and Importers of articles containing substances intended
    to be released and present in those articles in quantities of 1
    tonne or more per year;

-   "Only-representatives" of non-Community manufacturers. As described
    in Section 4.2.1 below, non-EU manufacturers include natural or
    legal persons who:

    -   manufacture a substance on its own, in preparations or in
        articles that is imported into the Community; or

    -   formulate a preparation that is imported into the Community; or

    -   produce an article containing substances intended to be released
        that is imported into the Community.

Non-EU manufacturers cannot pre-register/register the above substances
exported in the EU directly with REACH; they must be represented by a
natural or legal person located in the EU territory, the only
representative".

Only Representatives are natural or legal persons appointed by non-EU
manufacturers to fulfil the obligations on importers. Only natural or
legal persons: (i) established in the established in the and, (ii)
having sufficient background in the practical handling of substances and
the information related to them, may be appointed as Only
Representatives.

When an Only Representative is appointed, the non-EU manufacturer has
the obligation to inform the importer(s) within the same supply chain
(the customers of the non-EU manufacturers) of the appointment.
Following such communication the Only Representative takes up the role
of the EU importers, fulfils their registration obligations. He also has
to keep available and up-to-date information on quantities imported and
customers sold to, as well as information on the supply of the last
update of the safety data sheet. The importer(s) will have the status of
downstream user and will have to comply with the applicable obligations
under REACH

When a phase-in substance is manufactured, imported or used in the
production of an article by [several legal entities belonging to the
same company group]{.underline}, each legal entity has to pre-register
separately. However, REACH-IT will facilitate this task by allowing a
\"Super User\", normally from the parent company or head office, to
pre-register on behalf of all the legal entities (i.e. including
subsidiaries). RIP 3.1, part 1.5.3, provides additional guidance on who
is responsible for registration.

**Important:** Pre-registration is legal-entity specific. This means
that if a holding company is composed of different legal entities in
Europe, each legal entity must pre-register the phase-in substances that
they produce or import.

Manufacturers and importers of phase-in substances or article producers
and importers containing phase-in substances in quantities of less than
1 tonne per year do not need to pre-register (as registration is not
required). However, they can do so based on their prospective intention
to manufacture the substance in the future.

# Is there a deadline for pre-registration? {#is-there-a-deadline-for-pre-registration .Heading_L2}

Pre-registration information has to be submitted to the Agency between 1
June 2008 and 1 December 2008 (inclusive). There is therefore a single
pre-registration period for all phase-in substances for all parties
identified in Section 3.2 above. However, in certain cases
pre-registration may be submitted later by first time manufacturers as
described in Section 3.4 below.

# First-time manufacturers or importers {#first-time-manufacturers-or-importers .Heading_L2}

To benefit from the transitional period as described in section 3.1, the
first-time manufacturer/importer (see Article 28.6) must pre-register
(1) within six month after its manufacturing or import exceeds the
one-tonne threshold, and (2) 12 months before the relevant deadline for
registration. First-time manufacturers or importers will therefore have
to submit their pre-registration by 30 November 2009, 31 May 2012 or 31
May 2017, whichever is relevant in view of their tonnage thresholds.

# What if the deadline for pre-registration is not met? {#what-if-the-deadline-for-pre-registration-is-not-met .Heading_L2}

If a company fails (or does not wish) to pre-register within the
applicable deadline, it will have to suspend its activities involving
the substances concerned and register them without delay prior to
starting to manufacture or import these particular substances after 1
December 2008.

If a company continued manufacturing or importing a substance after 1
June 2008 and if it did not pre-register or register by 1 December 2008,
it would be in breach of the REACH Regulation. This also means that the
downstream uses of these substances may be at risk.

# How to pre-register a substance? {#how-to-pre-register-a-substance .Heading_L2}

Pre-registration takes place when the company has submitted
electronically to the ECHA the required information on a substance. This
information includes:

-   The name(s) of the substance specified in section 2 of Annex VI,
    i.e.

    -   the names in the International Union of Pure and Applied
        Chemistry (IUPAC) nomenclature or other international chemical
        name(s);

    -   other names (usual name, abbreviation and optionally trade name,
        unless this is regarded as CBI)

    -   European Inventory of Existing Commercial Chemical Substances
        (EINECS) number (if available and appropriate);

    -   Chemical Abstract Service (CAS) name and CAS number (if
        available);

    -   other identity code (if available);

-   The name and address of the pre-registrant and the name of the
    contact person and, where appropriate, the name and address of a
    third party representative[^5] whom the pre-registrant has selected
    to represent him for all the proceedings involving discussions with
    other manufacturers, importers and downstream users (Article 4);

-   The envisaged deadline for registration and tonnage band;

-   The name(s) of other substance(s) for which the available
    information is relevant for performing adaptations to the testing
    requirements, i.e. use of results from (Q)SAR models (section 1.3 of
    Annex XI) and read-across approach.[^6]

-   Optionally, the pre-registrant can indicate whether he is willing to
    act as \"facilitator\" in the pre-SIEF discussions -- See Section
    3.7 below and 4.5.3.

Pre-registration does not include information on the composition of the
substance.

The pre-registration can be done in two ways:

1\. by direct encoding the information on the REACH-IT website (On-line
pre-registration)

2\. by submission of a \'bulk\' pre-registration (Off-line
pre-registration).

A bulk pre-registration allows pre-registrants to submit one (or more)
file(s) with the pre-registration information for multiple substances.
The file has to be in accordance with a certain structure which will be
specified and published by the Commission.

# How to account of substances identification for Pre-registration purposes? {#how-to-account-of-substances-identification-for-pre-registration-purposes .Heading_L2}

The joint submission is the end result of the process of
pre/registration, SIEF formation and registration. The joint submission
can only be done for the same substance. In order to establish whether
substances can be regarded the same, their identity should be
established and compared.

This substance identity often corresponds to an existing EINECS or CAS
entry or similar identification code but there are also many cases where
one EINECS entry covers several substances or where several EINECS
entries correspond to one substance. There are also phase-in substances
where no EINECS/CAS entries or other identification codes exist (in
particular cases related to Art. 3(20) (b) and (c)).

The Technical Guidance Document RIP 3.10 gives guidance on how a
substance can be named based on the composition and/or the chemistry.
When relevant in dossier and substance evaluation, the Agency will apply
the guidance of RIP 3.10 to check the identity of a substance and the
\'sameness\' of several substances.

For substances which are not the same by identity, data on substances
with a different identity can and should be utilised whenever
scientifically sound (e.g. read-across). REACH does not give the
possibility to register different substances in one (joint)
registration.

The information required by REACH at pre-registration does not include
information on the composition of the substance.

The identification, and with that the assignment, of an EINECS number or
CAS numbers to a substance has been done according to different working
practices during the years. The harmonisation of these practices is
reflected in RIP 3.10.

Pre-registrants and data holders are therefore strongly encouraged to
establish the EINECS-entry related to their substance using the RIP 3.10
Guidance document.

For mono-constituent substances and UVCB substances, the impact is very
little at this stage. For multi-constituent substances (\"reaction mass
of A and B\") the result of following the approaches as defined in RIP
3.10 is the use of more than one EINECS or CAS number to identify one
single substance. This will be accepted and is even encouraged.

In practice this means that a multi-constituent substance is
pre-registered using more then one identifier (usually multiple EINECS
numbers) for the different constituents.

**Importantly**, the REACH provisions on data sharing and joint
submission of data will apply between those companies pre-registering
the \"same\" phase-in substances. It is therefore highly recommended
that companies verify the EINECS-entry related to their substance for
pre-registration purposes using the RIP 3.10 Guidance document.

# SIEF Facilitator {#sief-facilitator .Heading_L2}

In order to initiate and conduct discussions after pre-registration, and
facilitate the exchange of information and data to form a SIEF and once
a SIEF is formed, REACH IT will allow pre-registrants to volunteer to be
\"SIEF facilitators\" by identifying this on the pre-registration
template. Additional guidance on the possible role of the facilitator is
provided in Section 4.5.3 below.

# How to establish the first envisaged registration deadline and the tonnage band for pre-registration? {#how-to-establish-the-first-envisaged-registration-deadline-and-the-tonnage-band-for-pre-registration .Heading_L2}

The envisaged yearly quantity shall be calculated per calendar year. RIP
3.1, section 1.6.2 describes how this is to be done for phase-in and non
phase-in substances, as such, in preparations or in articles. For
substances that have been imported or manufactured for at least three
consecutive years, quantities per year have to be calculated on the
basis of the average production or import volumes for the three
preceding calendar years (Article 3.30). This rule also applies to
substances intended to be released from articles.

3.  []{#__RefHeading___Toc165900917 .anchor}FORMATION OF SUBSTANCE
    INFORMATION EXCHANGE FORUM (SIEF)

REACH provides for the formation of a \"Substance Information Exchange
Forum\" (SIEF) to share relevant and available data among all potential
registrants of the same phase-in substance, as well as with downstream
users and other stakeholders who have relevant data and are willing to
share them.

This Section specifies who are the participants in a SIEF, their rights
and duties, and how and when a SIEF is formed. It also provides guidance
to industry in ascertaining the sameness of the substances
pre-registered for purposes of data sharing and the joint submission of
data.

# What is a SIEF? {#what-is-a-sief .Heading_L2}

REACH provides for the formation of SIEFs to share data among
manufacturers and importers of phase-in substances, downstream users and
other stakeholders.

A SIEF will be formed for each pre-registered substance with the same
chemical identity. The participants in the SIEF will essentially be the
pre-registrants, the early registrants and the data holders of that
substance, as further described below. REACH sets forth the rights and
obligations of each category of SIEF participants.

The principal aims of the SIEF are to:

-   Facilitate data sharing for the purposes of Registration, and

-   Agree on the classification and labelling of the substances
    concerned where there is a difference in the classification and
    labelling of the substance between the potential registrants.

Article 29.3 describes the fundamental functions of the SIEF as follows:

> *\"SIEF participants shall provide other participants with existing
> studies, react to requests by other participants for information,
> collectively identify needs for further studies (...) and arrange for
> such studies to be carried out\".*

The more specific rules of Article 30 are designed to address specific
situations within a SIEF and provide solutions in case the participants
do not agree.

A SIEF is not a legal entity or a consortium, but a forum to share data
and other information on a given substance.

Participants in a SIEF are free to organize themselves as they see fit
to carry out their obligations under REACH, i.e. (i) to share data,
especially those involving vertebrate animal testing, and (ii) to submit
jointly the hazard data on the substance. They can use different forms
of co-operation to do so as described in Chapter X below.

Technically speaking, a SIEF once formed only entails obligations on
potential registrants in terms of data sharing and classification and
labelling. However, because the same potential registrants also have
obligations for joint submission under REACH, the SIEF, once formed,
also provides a suitable platform for them to organize the mandatory
joint submission of data, as provided for in Articles 11 and 19 of
REACH.

# Who are the SIEF Participants? {#who-are-the-sief-participants .Heading_L2}

Several categories of parties will be \"participants\" in SIEFs, as
specified in Articles 29 and 30. These are (1) \"Potential Registrants\"
and (2) \"Data Holders\". The obligations of each category of
participant are described in Section 4.3 below.

## \"Potential Registrants\" {#potential-registrants .Heading_L3}

Potential Registrants are those parties who have pre-registered Article
28(1) information to the ECHA on a given phase-in substance (see Section
3.2 and 3.5 above). These include:

-   [Manufacturers and importers]{.underline} of phase-in substances
    having pre-registered that substance.

-   [Producers and importers of articles]{.underline} having
    pre-registered that substance if intended to be released from
    articles.

-   [Only representatives]{.underline} of non-EU manufacturers having
    pre-registered that phase-in substance.

In respect of the first two categories, any manufacturer or importer may
appoint a [Third Party representative]{.underline} for certain tasks
relating to data and cost sharing. This is typically the case when a
company wishes not to disclose their interest in a particular substance
as this may give indications to competitors about production or
commercial secrets. The legal entity nominating a Third Party
representative retains the full legal responsibility for complying with
his obligations under REACH. In this way the Third Party representative
acts as an "agent" for the manufacturer or importer who remains
anonymous vis-à-vis the other stakeholders involved in the SIEF. The
identity of a manufacturer or importer who has appointed a Third Party
representative indeed will not be disclosed by the ECHA to other
manufacturers or importers. However that does not make the Third Party
representative the \"potential registrant\". The manufacturer or
importer legally remains the pre-registrant and will be the party that
is required to register. The third party representative only has a role
in the context of data sharing proceedings. A Third Party representative
can represent several legal entities but will appear as a separate SIEF
participant for each different legal entity he represents.

The \"third party representative\" discussed above must not be confused
with the \"third party holding information\" as described in Section
4.2.2 below, nor with the \"independent third party\" which may act as a
trustee for a consortium or group of companies, as described in other
parts of this Guidance Document.

## \"Data Holders\" {#data-holders .Heading_L3}

Any person holding information/data relevant to a phase-in substance can
identify itself and lodge a request to the ECHA in view of being a
participant in the SIEF for that substance. They can do so by submitting
to the ECHA any or all of the information listed in Article 28.1. Data
holders may include:

-   [Manufacturers and importers]{.underline} of phase-in substances in
    quantities of [less than 1 tonne]{.underline} per year who have not
    pre-registered.

-   [Downstream users]{.underline} of phase-in substances.

-   [Third parties holding information]{.underline} on phase-in
    substances, such as:

    -   Trade or industry associations, sector specific groups and
        consortia already formed.

    -   Non Governmental Organisations (NGOs), laboratories,
        universities, international or national agencies.

    -   Manufacturers of a substance who have no interest in registering
        a substance under REACH because they do not produce or place it
        on the market in Europe (e.g. a non-EU manufacturer who does not
        export into the EU).

In addition, two categories of data holders will automatically be
participants in SIEF, as they have already submitted information on
phase-in substances either (1) as registrants or (2) in the framework of
Community legislation on plant protection products and/or biocidal
products:

-   [Any manufacturer or importer]{.underline} and any
    substance-releasing article producer or importer [who has registered
    a phase-in substance before 1 June 2018]{.underline} automatically
    becomes a data holder. This includes operators that do not
    pre-register as well as operators that, having pre-registered,
    decide to register before the relevant deadline of Article 23.

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-   [Any party for which the ECHA has information submitted in the
    framework of the Plant Protection Product Directive (91/414/EC) or
    the Biocidal Product Directive (98/8/EC) that meet the conditions
    established in Article 15]{.underline}. They will have the same
    obligation to share data as any other participant in the SIEF.

# What are the obligations of SIEF Participants? {#what-are-the-obligations-of-sief-participants .Heading_L2}

[All SIEF participants]{.underline} shall:

-   React to requests for information from other participants;

-   Provide other participants with existing studies upon request.

[Potential registrants]{.underline} shall:

-   Collectively identify needs for further studies to comply with
    Registration requirements;

-   Make arrangements to perform the identified studies;

-   Agree on classification and labelling where there is a difference in
    the classification and labelling of the substance between potential
    registrants.

[Data holders]{.underline}: data holders can provide information to the
ECHA in order to participate in a SIEF. Once they do so, data holders
have certain obligations: in particular, they must respond to any query
from potential registrants if they hold the data relating to this query.
Data holders, however, are not entitled to request data.

# What happens after the beginning of Pre-Registration? {#what-happens-after-the-beginning-of-pre-registration .Heading_L2}

The REACH Regulation requires the ECHA to publish on its website, by 1
January 2009, a list of pre-registered substances. This publication will
have specific effects. It therefore is necessary to distinguish what
happens (1) after Pre-registration but before the publication on the
ECHA\'s website of the list of pre-registered substances and (2) after
that publication.

## Before the publication of the list of pre-registered substances {#before-the-publication-of-the-list-of-pre-registered-substances .Heading_L3}

[When a potential registrant pre-registers a substance corresponding to
an entry in EINECS and is the first one to do so]{.underline}, REACH IT
triggers the creation of a dedicated web-based page. At this point in
time, this page can only be seen by the potential registrants of that
substance and the potential registrants of the substance(s) listed in
the pre-registration dossier as candidate for the purpose of read across
and the ECHA.

The page displays the following information:

-   The corresponding entry in EINECS, i.e. IUPAC name or substance
    description;

-   EINECS and CAS numbers;

-   The individual details of the potential registrant, i.e.

    -   Identity and contact details (or those of the third party
        representative if he elected not to disclose his company name
        for this substance);

    -   The tonnage band for which he is planning to register the
        substance, and the envisaged registration deadline;

    -   Whether he indicated in the pre-registration his willingness to
        act as a facilitator in the SIEF.

-   The other substances in relation to which data can be shared
    (read-across).

When another legal entity subsequently pre-registers the same substance,
he/she will be automatically granted access to the same dedicated
web-page. He/she will be able to see the identity of all pre-registrants
who have pre-registered the same substance before him/her.

This subsequent pre-registration will prompt REACH IT to automatically
notify by e-mail to all previous pre-registrants of the same substance
that a modification has occurred in the substance web-page.

[If a potential registrant pre-registers a substance for which another
legal entity has already submitted a pre-registration]{.underline}, as
mentioned above, that potential registrant will be prompted to the
corresponding existing page where he will be able to see the
identification of all previous pre-registrants of the same substance.

During this phase, it is possible for potential registrants having
pre-registered the same substance and appearing on the same web-based
page to contact each others.

## Publication of the list of pre-registered substances {#publication-of-the-list-of-pre-registered-substances .Heading_L3}

Based on the information submitted by pre-registrants, the ECHA will
publish on its website, by 1 January 2009, a list of pre-registered
substances.

The list published on the ECHA\'s website will specify for each
substance, the name of the substance including their EINECS and CAS
number if available and other identity codes, and the first envisaged
registration deadline.

The list will also include the names and other identifiers of related
substances, i.e. those for which the available information is believed
to be relevant for read across or the use of results from (Q)SARs.

The list as published by the ECHA will not show the identity of the
pre-registrants. This information will only be visible by those who have
pre-registered the same substance and those who have pre-registered
related substances for read-across.

## After the publication of the list of pre-registered substances {#after-the-publication-of-the-list-of-pre-registered-substances .Heading_L3}

### Submission of information on pre-registered substances by \"data holders\"  {#submission-of-information-on-pre-registered-substances-by-data-holders .Heading_L4}

Following the publication of the list, \"data holders\", as defined in
Section 4.2 above, may wish to share with pre-registrants the
information they have at their disposal on phase-in substances. They can
do so by making a submission to the ECHA of any or all of the
information listed in Article 28.1 of REACH for a given phase-in
substance with the purpose of joining a SIEF for that substance.

**Recommendation: Data holders should submit information on
pre-registered substances as early as possible after 1^st^ January
2009.** There is no requirement/deadline in REACH for a data holder to
notify to the ECHA their willingness to join a SIEF in view of sharing
information. It is however highly recommended for data holders to
identify themselves as early as possible after the publication of the
list of pre-registered substance to facilitate the data sharing process.
The earlier data holders indicate their interest, the more likely will
the potential registrants be able to share relevant data from data
holders in time before the compilation of the Registration dossier.

-   **Request by downstream users of phase-in substance not appearing on
    the list of pre-registered substances**

The publication of the list of pre-registered substances will also give
the opportunity for Downstream Users to ascertain that all substances
they need in their own processes are on the list and there will be no
discontinuity in their supply. Should one or several of them be missing
in the list, a mechanism is foreseen, through an intervention of the
ECHA in order to facilitate contact of downstream users with a potential
registrants for their substance.

After the publication of the list, a downstream user of a substance not
appearing on the list may notify the ECHA of his interest in the
substance, his contact details and the details of his current supplier.
The ECHA will publish on its website the name of the substance. In case
a manufacturer or importer contacts the ECHA, the ECHA can provide
contact details of the downstream user to a potential registrant.

This mechanism aims at allowing Downstream User to find another supplier
and/or get this other supplier to pre-register under the *late
pre-registration* procedure described in Article 28(5).

-   **Formation of the SIEF**

The publication of the list of pre-registered substances also allows
potential registrants (and subsequently data holders) to form a SIEF for
each pre-registered substance, as described in Section 4.5 below.

# How and when will a SIEF be formed? {#how-and-when-will-a-sief-be-formed .Heading_L2}

Article 29 of the REACH Regulation provides that all potential
registrants and data holders for the \"same\" phase-in substance shall
be participants in a SIEF. However, the REACH Regulation does not define
\"sameness\".

In many cases the substances that have been pre-registered under an
entry in EINECS (either defined by its EINECS or CAS number, or its
description of the entry) are well defined and after a quick check by
potential registrants for gross errors, there will be a general
agreement that a joint submission of data is possible and cooperation
between potential registrants can start immediately.

In certain cases, however, the exact nature of the substance covered by
an EINECS entry will have to be scrutinised in order to ascertain that
it can be covered by a joint submission of data and that the relevant
hazard data can be purposefully exchanged. Typically, this may happen in
the following situations:

-   The description in EINECS given for a substance (this may
    particularly be the case for UVCB) can be very broad to an extend
    that the behaviour of the different substances covered by this one
    entry is not sufficiently similar to use the same data to describe
    it

-   Substances for which there is more than one entry in EINECS and that
    are considered the same under REACH and RIP 3-10.

The assessment of the exact nature of an EINECS entry and the different
species it may cover can only be carried out by the manufacturers or
importers who should be aware of the composition of the substance. It
is, therefore, up to them to take the responsibility of defining
precisely the substance for which a SIEF will be formed. Neither the
Agency nor the Commission have the mandate under REACH to intervene in
this process.

As a consequence of this, [a SIEF is formed when the potential
registrants of a substance in the pre-registration list, actually agree
that they effectively manufacture, intend to manufacture or import a
substance that is sufficiently equivalent to allow a valid joint
submission of data]{.underline}.  

ECHA will not participate in the discussions between potential
registrants. [To be discussed: recommendation that once a SIEF is
formed, its members inform ECHA of their decision, so that the list of
pre-registered substances can be updated.]{.mark}

[]{#__RefHeading___Toc165900930 .anchor}Pre-SIEF discussions

Sameness verification will require potential registrants to enter into
\"pre-SIEF\" discussions. Data holders will not be involved in pre-SIEF
discussions. They will be considered as members of all SIEFs once formed
as a consequence of the pre-SIEF discussions between pre-registrants of
the same EINECS entry.

REACH IT will initially support this process by allowing potential
registrants of the same EINECS entry to establish contacts with each
other.

As a first step in the exchange of information, potential registrants
must ensure the sameness of the substances that have been
pre-registered.

For substances with a well-defined composition (i.e. mono-constituent
and multi-constituents substances) the sameness of the naming is in
principle sufficient to be able to share data even though certain
impurities might lead to a different classification/hazard profile. Only
in cases where all data is clearly not suitable for the other substance
these substances can be regarded as different (e.g. in case of very
different physical properties which have essential impact on the hazard
properties, like water solubility).

For UVCB substances also -- in general - the name is leading to
determine the \'sameness\'. If the name is the same, the substance is
regarded the same, unless available data shows the contrary.

-   
-   
-   

## How to determine the sameness of substances? {#how-to-determine-the-sameness-of-substances .Heading_L3}

In assessing the identity of the substances, potential registrants are
invited to read and use the RIP 3.10 guidance carefully.

REACH requires pre-registrants to submit identifiers for the substances
(e.g. EINECS number, CAS number). The alignment of an EINECS number or
CAS numbers to a substance has been done according to different working
practices during the years. The harmonisation of these practices is
reflected in the Technical Guidance Document RIP 3.10, which gives
guidance on how a substance can be identified. It is strongly
recommended that companies read carefully the 3.10 guidance prior to
submit the pre-registration information.

In order to avoid typing errors and wrong entries, the computer-based
pre-registration system put in place by REACH IT. Upon entering the
EINECS (or CAS) number in your pre-registration, the corresponding
EINECS entry description will automatically appear in the corresponding
field. However, the submission of the identifiers does not include
information on the composition of the substance and therefore the fact
that several potential registrants have pre-registered the same
identifiers does not mean that they intend to register the \"same\"
substance.

**Examples of identity issues** **and related solutions:**

Once the list of pre-registered substances is published, the following
situations may occur:

*A. Substance pre-registered in a wrong SIEF and there is another entry
in EINECS better describing it*

Before 1^st^ December 2008, the substance can be pre-registered a second
time in the appropriate EINECS entry. By doing this, the pre-registrant
will become an active participant in the new SIEF and a dormant
participant in the former SIEF. Since he is no longer expected to
register his substance under the former SIEF, the data sharing
provisions of Article 29 and 30 will no longer apply to him in the
former SIEF.

*B. There are several EINECS entries for the same substance*

In case there are several EINECS entries for the same substance, a
similar solution can apply: an additional pre-registration is made by
the manufacturers or importers in one of the other EINECS entries in
order regroup all participants in one single SIEF.

It should be noted that the fact that there are several pre-SIEF
operating in parallel on the same substance might not come immediately
to the attention of participants. Therefore, potential registrants are
invited to review the possible entries in the pre-registration list and
assess with the participants in those entries the relevance of forming a
single SIEF.

*C. The EINECS entry for a substance also covers other different
substances*

If the substance of one potential registrant appears to be sufficiently
different to prevent data sharing with some or all other potential
registrants, a split of the entry can be considered. To this end,
participants can exchange the specifications of their substance in view
of assessing the equivalence and the possibility to submit jointly the
hazard data set. Once equivalence is agreed among participants, data
sharing and the compilation of the data set can commence

Alternatively, the opt-out provisions can apply in order to allow
participant to submit separate registrations, with the consequences
described above in terms of SIEF formation.

*D.* *Phase-in substances where no EINECS/CAS entries or other
identification codes exist (in particular cases related to Art. 3(20)
(b) and (c)).*

In principle, the identity of substances as pre-registered (using
EINECS/CAS or other identifiers if no EINECS/CAS is available) should be
the point of departure to clarify substance identity and the composition
of the SIEF. However, in certain cases, the actual composition of the
substance in the context of an eventual joint submission of data may
deviate the sameness from their identification codes. RIP 3.10 on
substance identification will provide a methodology to help deciding
whether two substances are sufficiently similar for joint registration
purpose.

**Outcome of the sameness analysis**

Following the sameness review, either:

\(i\) all potential registrants agree that their substance is
sufficiently similar to the other participants' substance and that they
may proceed with data sharing within a SIEF for that substance; or

\(ii\) one or potential registrants consider that their substance is not
similar enough to the substance(s) pre-registered by the other
participant(s), in which case the other parti+cipant(s)'data may not be
relevant to describe their substance's profile.

In that later case, it is for potential registrants to decide among
themselves what SIEF(s) shall be formed to represent each of the
substances so identified.

Once the substance identity is agreed among potential registrants, up to
the companies to decide to form either:

-   one SIEF is if all substances pre-registered under the EINECS entry
    are sufficiently similar to make a joint submission;

-   several SIEFs to cover the different substance species of the EINECS
    entry; or

-   merge in one SIEF with other pre-registered substances if they
    relate to different EINECS entries, [but]{.underline} can be
    regarded as similar under RIP 3.10.

Once a SIEF is formed data sharing obligations become obligatory within
the SIEF.

**Confidentiality issues**

In most cases, verifying sameness under the criteria of RIP 3.10 will
not involved exchange oof sensitive information. However, in some cases
there may be a risk of disclosing company secrets, know-how and
confidential data or information (hereinafter CBI).

This risk can be mitigated by entering into prior arrangements between
companies to preserve the confidentiality of the information to be
exchanged. If at least one of the participants indicates that substance
identification may involve the disclosure of CBI, participants must
consider several possible options, including limiting the information
that is shared, or granting restricted access to selected company staff,
preferably with the signature of a confidentiality agreement, or the
appointment of an independent third party or trustee. These options are
further described in Annex 3 hereto on CBI.

The case may be that the nature of the confidential information is such
that a confidentiality agreement cannot sufficiently protect the
company's secrets. In this case, the concerned company will have to
decide to appoint a third party representative or to apply the "opt out"
clause of Article 11.3 with a view to submitting of a separate
registration (see Section 8.1.2 of this guidance for further details
about "opt out").

## How can communications in SIEF be facilitated? SIEF Facilitator {#how-can-communications-in-sief-be-facilitated-sief-facilitator .Heading_L3}

Exchange of information within a SIEF will be greatly facilitated if one
participant agrees to play the role of a coordinator and initiate the
acting together.

REACH includes provisions related to a Lead Registrant for testing and
Registration purposes (see REACH art. 11.1.) and it would be helpful if
the \"lead registrant to be\" or another participant would take the
initiative already at the SIEF formation stage.

While there are no specific provisions in REACH to that effect, REACH IT
will offer the possibility for potential Registrants when
pre-registering to indicate their willingness to act as a \"SIEF
facilitator\" so as to facilitate the identification of a potential
leader.

It is important to specify that:

-   Acting as a SIEF facilitator is totally voluntary and does not
    entail any specific obligation. It simply means that the
    company/companies volunteering are those expected to take the
    initiative to contact the others within the SIEF;

-   Ticking the box in REACH-IT to indicate willingness to act as "SIEF
    facilitator" is not legally binding. It means that the "potential
    SIEF facilitator" could freely review his position at any moment and
    decide to not play the role of facilitator without any penalty.

The role of a facilitator can start in the \"pre-SIEF\" phase, during
which pre-registrants exchange information to ensure they all belong to
the same SIEF (see Section 4.5.1). For example, the facilitator can
contact all potential registrants and organize the exchange of
information on the identity of the substance. As a second step, when the
SIEF is formed, he can propose means of organizing exchange of
substantial information on the substance. In case the information to be
exchanged is considered commercially sensitive by one or more potential
registrants (e.g. because of an impurity content that can give
indication on a production process), the facilitator can propose a
confidentiality agreement or the use of an independent third party or
trustee who can handle the confidential information on behalf of
potential registrants.

The next step may be for the facilitator to make proposals related to
any or all of the possible following steps:

-   The form of co-operation between the parties and possible internal
    rules (see Chapter 10).

-   Who could perform the necessary technical work (either the potential
    registrants themselves or a contracting third party or a combination
    of both).

-   Scope of the co-operation: whether the co-operation should be
    limited to the SIEF obligations (data sharing and classification and
    labelling) or whether it should be extended to cover other
    objectives.

-   Organization of the exchange of data.

-   Designation of a lead registrant.

The facilitator may also potentially carry out several other
organisational tasks on behalf of the potential registrants, such as:

-   Channel the communication with other SIEFs, with which read across
    applies

-   Ensure a smooth entry of late registrants in the SIEF

-   Launches the queries for data in SIEF

-   Prepare an inventory of available data within SIEF

In some cases, the tasks that the facilitator may propose to undertake
will be substantial and it might be appropriate for the parties to
consider a financial compensation for the resources spent by the
facilitator, beyond the initial contact and proposal, in particular when
the facilitator would provide services that otherwise would have to be
compensated.

[]{#__RefHeading___Toc165900933 .anchor}4.5.4. When will data holders
join the SIEF?

Data holders can submit information on phase-in substances after the
publication of the list of pre-registered substances by the ECHA. At
that stage, however, the SIEF or SIEFs for the substance, as
pre-registered, may not yet be formed.

Data holders will not be involved in pre-SIEF discussions. They will be
considered as members of all SIEFs once formed as a consequence of the
pre-SIEF discussions between pre-registrants of the same EINECS entry.
In other words, data queries from a SIEF member must be directed not
only to all potential registrants who have agreed to submit a joint set
of data but also all data holders who have made a submission to ECHA for
the corresponding EINECS entry. In the latter case, the relevance of the
data will have to be assessed on a case by case basis.

Potential registrants will only start investigating about data
availability once the SIEF is finally formed and when nthey have
identified data gaps (See Section 5 below). At that stage, they can
launch queries for missing data (this is mandatory if the missing piece
of data involves vertebrate animal testing). In doing so, potential
registrants must bear in mind the fact that there may be several SIEFs
corresponding to the entry in the list of pre-registered substances.
Queries must consequently be sent to all data holders corresponding to
the entry in the list of pre-registered substances, and possibly those
in another entry if the final SIEF is the result of a merger of several
pre-registered substances.

Potential registrants will then assess the relevance of data held by
data holders taking into account the identity of the substance covered
by the SIEF. This will require data holders to communicate information
on the identity of the substance. Data holders are therefore also
recommended to review identity information on the basis of the RIP 3.10
criteria for the data they have available and when deciding to
contribute for REACH data sharing purposes.

**Recommendation**: Data holders should be aware of the identity of the
substance relating to the data they are holding in order to allow
potential registrants to ascertain the relevance to their substance.
They have to approach the establishment of the identity of the tested
substance and the relevance of that in relation to the substances
pre-registered in a similar way as the pre-registrants (i.e. based on
the RIP 3.10 guidance)

4.  []{#__RefHeading___Toc165900934 .anchor}Data Sharing RULES FOR
    PHASE-IN SUBSTANCES WITHIN A SIEF

This section of the Guidelines describes and discusses the rules
applicable to data sharing for Phase-in substances within a SIEF among
potential registrants and data holders. It also addresses classification
and labeling issues within a SIEF.

# Overall approach to data sharing {#overall-approach-to-data-sharing .Heading_L2}

Article 29.3 describes the fundamental rule for the functioning of a
SIEF as follows:

> *\"SIEF participants shall provide other participants with existing
> studies, react to requests by other participants for information,
> collectively identify needs for further studies (...) and arrange for
> such studies to be carried out\".*

The more specific rules of Article 30 are designed to address specific
situations within a SIEF and to provide solutions in case the
participants do not agree.

Article 30.1 provides that \"before testing is carried out\",
participants in a SIEF inquire whether a relevant study is available
within the SIEF. If it is available, the participants shall request that
study (in the case of tests on vertebrate animals) and may request it
(in the case of information not involving tests on vertebrate animals).
This request for missing information then triggers the obligation for
the data owner to provide proof of its cost and further data sharing
obligations.

In practice, however, it will not be sufficient for each participant to
individually request the data they are missing. This will not allow
participants to agree on classification and labelling, nor will this
exchange of missing information be sufficient for the participants to
prepare for the joint submission of data. This guidance considers both
the need to meet the legal obligations under the data sharing process
and the process leading to a joint submission.

From that experience with industry consortia shows that, it is
recommended for participants to share information on and review all data
available to them (including publicly available data). Only this more
complete exchange will allow participants to determine and agree on
classification and labelling (a mandatory requirement for SIEFs), draft
study summaries, agree on testing proposals, jointly draft a chemical
safety report, agree on guidance for safe use, etc.

In line with the \"collective approach\" described in Article 29.3, once
a SIEF is formed, SIEF participants should therefore first organize
between themselves to collect and review all existing studies, whether
available to them or in the public literature. This is the best way for
them to:

> \(1\) collectively agree on classification and labelling (and so meet
> their obligation under Article 29.2);
>
> \(2\) collectively identify needs for further studies and arrange for
> them to be carried out (and so meet their obligations under Articles
> 29.3 and 30.1);
>
> \(3\) collectively decide on the study summaries and robust study
> summaries and other information that they will have to submit jointly
> at Registration (and so meet their obligations under Article 11);
>
> \(4\) establish data and cost sharing rules between them that are
> \"fair, transparent and non discriminatory\" (in line with Article
> 30.2 second paragraph), taking into account the specificity of each
> SIEF and;
>
> \(5\) allow each registrant to be in \"legitimate possession\" or
> \"have permission to refer to\" the full study reports summarized in
> the Registration dossier (in line with Article 10.a final paragraph).

If all studies are available within a SIEF, then there is no testing to
be carried out and the provisions of Article 30.1 first paragraph do not
need to be applied literally, i.e. it will not be necessary for each
SIEF participant to \"individually\" and \"formally\" request the
studies that he is missing within the SIEF and for each data owner to
respond with proof of cost within one month of that request.

The necessary data sharing exercise can be organized in many other ways,
as described later in these guidelines.

The specific provisions of Article 30.1 and 30.2, however, become fully
relevant and should be followed strictly in all circumstances where the
collective approach described above fails and/or if the participants do
not agree among themselves.

# Four step process to fulfil the information requirements for Registration {#four-step-process-to-fulfil-the-information-requirements-for-registration .Heading_L2}

Data sharing must first be reviewed with reference to the information
requirements for Registration. Essentially, REACH requires manufacturers
and importers to collect data on the substances they manufacture or
import, to use these data to assess the risks related to these
substances and to develop and recommend appropriate risk management
measures for using the substance throughout its life cycle. Documenting
these obligations requires them to submit a registration dossier to the
ECHA.

In order to provide the registration dossier, manufacturers and
importers are, as a starting point, obliged to collect all available
relevant information on the intrinsic properties of a substance
regardless of tonnage manufactured or imported. This information has in
turn to be compared with the standard information requirements, which
largely depends on the quantity of the given substance for each
manufacturer or importer. If data gaps are identified, then new testing
may have to be conducted or test proposals made.

From the above, fulfilling the information requirements for Registration
is essentially a four step process, which consists in:

-   Step 1: Gathering existing information

-   Step 2: Considering information needs

-   Step 3: Identifying information gaps

-   Step 4: Generating new information or propose a testing strategy

The above is valid when only one company registers a given chemical and
if all existing information would be available to that company. In the
real world, however, and for most phase-in substances, several companies
are producing or importing the same substance and data on the intrinsic
properties, use and exposure may be available between them as well as
with third parties.

This is where the provisions on REACH on data sharing become fully
relevant and the question is how data sharing can best be organized
considering the above four step process, which remains generally
relevant.

Annex VI of REACH which refers to the four steps mentioned above refers
to step 1 as \"Gather and share existing information\". However, the
actual sharing of data does not necessarily fit within this first step,
if considered sequentially.

# The collective route  {#the-collective-route .Heading_L2}

This Section of the Guidelines describes how data sharing can be
organized collectively within a SIEF with the view to meet the
objectives listed in Section 5.1 above, including both the obligations
related to data sharing and the preparation for the joint submission of
data at Registration.

Essentially, the collective route is a multiple step process as follows:

-   Step 1 Individual gathering of information available to potential
    registrants

-   Step 2 Agreement on the form of cooperation/cost sharing mechanism

-   Step 3 Collection and inventory of information available to
    potential registrants

-   Step 4 Evaluation of available information

-   Step 5 Consideration of information needs

-   Step 6 Identification of data gaps and collection of other available
    information

-   Step 7 Generation of new information/testing proposal

-   Step 8 Data and cost sharing

-   Step 9 Joint submission of data

> ![](media/image3.wmf){width="6.717361111111111in" height="10.0in"}

### 

### 

### 

### 

### Step 1: Individual gathering of available information

Potential registrants should first gather all existing available
information on the substance they intend to register. This must include
both data available \"in-house\", as well as from other sources, such as
data in the public domain that can be identified through a literature
search.

In the context of a SIEF, where there are several participants, data may
also be available to other participants, including \"data holders\".
Also, it is likely to be cost effective for participants to conduct a
literature search collectively, i.e. to agree on conducting a single
literature search for all SIEF participants.

On the other hand, the research, identification and documentation
relating to [\"in house\" information]{.underline} must remain an
individual exercise and companies are encouraged to conduct this data
gathering exercise well ahead of the SIEF/data sharing phase, and even
before the pre-registration phase as the availability of the data (or
lack thereof and therefore the cost of generating the required data) may
be one of the elements they would want to consider before making a
decision to become a potential registrant for that substance.

Data gathering must be thorough, reliable and well documented as failure
to collate all of the available information on a substance may lead to
unnecessary animal use with related resource implications.

The information to be gathered by each potential registrant must include
all information relevant for purposes of Registration, i.e.:

-   Information on the intrinsic properties of the substance
    (Physicochemical properties, mammalian toxicity, environmental
    toxicity, environmental fate, including chemical and biotic
    degradation). This information may come from in vivo or in vitro
    test results, non-testing data such as QSAR estimates, existing data
    on human effects, read across from other substances, epidemiological
    data;

-   Information on uses: current and foreseen;

-   Information on exposure: current and anticipated;

-   Information on Risk Management Measures (RMM): already implemented
    or proposed.

This data gathering exercise should be done irrespective of volume.
Indeed, if the data requirements at Registration depend upon the volume
manufactured or imported by each registrant, registrants must register
all available data, including data they have available that correspond
to a higher tonnage threshold. Also, this is needed to avoid duplicate
testing by those potential registrants that do need the additional data
in question and may offer the data owner a source of revenue or a way to
mitigate its costs in the data sharing phase.

Potential registrants may also consider identifying as part of Step 1
the information requirements for the substance at stake, considering in
particular the tonnage band that is relevant to them, as well as
uses/exposure patterns, and comparing them with the information
available so that they understand their individual data gaps (Steps 2
and 3 as described in Annex VI of REACH). However, under the collective
route, these steps will be principally achieved collectively.

In summary, Step 1 requires each potential registrant to assemble and
document all the information on the substance, that he has available in
house (and that he knows is in the public domain), and any other
information that may be useful to be informed on the properties of that
substance, including information on the substance\'s (1) intrinsic
properties (irrespective of tonnage), (2) uses, exposure and risk
management measures. Potential registrants are encouraged to perform
Step 1 as soon as possible, before the formation of the SIEF for that
substance and if possible before Pre-registration.

### Step 2: Agreement on the form of co-operation/cost sharing mechanism

Before potential registrants (and potentially other SIEF participants)
start exchanging information on the data they have available, it is
recommended that they first agree on the form of cooperation that best
suit them and the main rules applicable to that cooperation, in terms of
data and cost sharing, and whether it should include other participants
in SIEF.

As described in Chapter 10 below, REACH does not prescribe the way in
which participants in a SIEF should cooperate, such as by entering into
a formal consortium agreement or otherwise. Parties are therefore free
to select the form of cooperation that suits them best and allows them
to meet their obligations under REACH while safeguarding their CBI
interests and ensure compliance with EU competition law.

Also, possible options and recommendations for cost sharing are
discussed in Annex 4 that would need to be considered and agreed upon at
this stage.

As a minimum, pursuing the \"collective route\" would seem to require
agreement between potential registrants on the main elements of the
collective data sharing that are discussed in the following sections as
Steps 3 to 9.

In summary, Step 2 requires potential registrants (and potentially data
holders) to meet, discuss and agree on the form of cooperation that best
suit them and the main rules applicable to that cooperation, in terms of
data and cost sharing.

### Step 3: Collection and inventory of all available information

Having agreed on their mode of cooperation, potential registrants (and
potentially other SIEF participants) are now in a position to share
information on and review all available information/data.

In step 3, potential registrants should first organize to complete the
data collection phase, by collecting all information they have available
individually (and from previously conducted literature searches), as
collected individually in Step 1 above.

It is only to the extent that available data is not sufficient for
Registration purposes (See Step 6 below), that it will be necessary for
potential registrants to collect data available to (1) data holders, (2)
other SIEFs and (3) outside of the SIEFs. However, if the potential
registrants know in advance, for example from previous contacts, that
they do not have a complete data set with their own data, they may
decide to conduct a literature search and/or contact data holders or
other SIEFs rapidly.

Collecting data available to potential registrants can be done in the
form of a questionnaire structured pursuant to Annexes VI to X of REACH
that is being sent to all potential registrants by the SIEF facilitator
or otherwise and that is returned to the facilitator, trustee or
designated expert. This could also include a request to communicate the
classification and labelling of the substance.

In order to help participants review available data a form can be used.
A format is proposed in Annex 7.

As the above data is being collected, it should be entered into a common
inventory. This would best be a matrix which compares the data available
for each end point (up to the highest tonnage threshold among potential
registrants) with the data needs and identifies key elements for each
study, including the identity of the data holder.

To the extent that the literature search may require considerable time
to be completed, it is recommended that potential registrants continue
their work and initiate steps 4 and possibly 5 below without waiting for
step 3 to be completed.

In summary, Step 3 requires potential registrants to collect and put
together in an inventory all information on the substance they have
available between them. As an option, they may also consider at this
early stage data available to data holders, in other SIEFs and outside
of the SIEFs, in particular in situations where potential registrants
know they do not have a full data set for Registration purposes.

### Step 4: Evaluation of available information

The next step is for potential registrants (and potentially other SIEF
participants) to evaluate the data available on the substance to be
registered.

Essentially, for each endpoint potential registrants must:

-   Assess the [relevance, reliability, adequacy and fitness for
    purpose]{.underline} of all gathered data (See RIP 3.3) for arriving
    at conclusions on the hazard assessment and for risk
    characterization. Annex 4 to these Guidelines include a description
    of possible means and options for assessing the relevance,
    reliability and adequacy of data.

```{=html}
<!-- -->
```
-   Determine the [key study for each endpoint]{.underline}. Normally
    this is the study giving rise to the highest concern taking into
    account the quality, completeness and representativeness of the
    study (see text box below). In other words they have to determine
    which study shall be used in the assessment later on, as these key
    studies are generally the basis for the assessment of the substance.

-   Determine which information/study (or studies) needs a [robust study
    summary]{.underline} (normally the key study) or a study summary
    (other studies). A robust study summary should reflect the
    objectives, methods, results and conclusions of a full study report.
    The information must be provided in sufficient detail to allow a
    technically qualified person to make an independent assessment of
    its reliability and completeness -- without having to go back to the
    full study report (for more details see RIP 3.3).

Depending on the situation, potential registrants may be in possession
of only one study on an endpoint or may have several studies.

[If only one valid]{.underline} [study is reported on an
endpoint:]{.underline}

Potential registrants have to use the information available in the
robust study summary for that study and to conclude on the endpoint in
the endpoint study summary. If the endpoint study record has been
documented sufficiently, potential registrants would only need to use
information already summarized in the endpoint study record.

[If more than one valid]{.underline} [study is available on an
endpoint:]{.underline}

Potential registrants have to use all available information reported in
the different endpoint study records in order to conclude on the
endpoint. Usually the first information to be used should be the robust
study summary of the key study documented in the endpoint study record.
The other information should be used only as supporting evidence.[^7]

However, there might be cases where there will be more than one key
study on a specific endpoint or no key study. In these situations the
assessment should be done by using all available information in a weight
of evidence approach. In such situations the endpoint study summary
should be well documented and all studies discussed to justify the final
conclusion.

The same applies when alternative methods (e.g. QSARs, read across,
*in-vitro* methods) are used as relevant information for the final
assessment and conclusion.

Guidance on how to use alternative methods or a weight of evidence
approach is available in RIP3.3 and guidance on how to identify and
measure environmental fate and physico-chemical properties, and make
human health and environmental assessments is available under
RIP3.2-2.This approach should be used by the registrant to fill the
endpoint study summary with the three following types of information:

-   A summary of the data available on a specific endpoint as well as a
    conclusion regarding the assessment of a specific endpoint of the
    substance (e.g. reprotoxicity, acute toxicity to fish,
    biodegradation)

-   The classification and labelling of the substance (for human health,
    environment and physico-chemical properties) as well as the
    justification for this classification

-   PNECs and DNELs values as well as the justification of the reported
    values.

Technical guidance on how to complete the endpoint study summaries is
given in IUCLID5 guidance. It should be noted that information included
in the endpoint study summaries in IUCLID5 can be automated extracted to
generate the Chemical Safety Report

In summary, Step 4 requires potential registrants to evaluate all
available data, which includes an evaluation of the quality of the data,
the selection of key studies for each end point and the drafting of
relevant (robust) study summaries.

### Step 5: Consideration of information needs

The next step is for potential registrants to identify precisely what
are the information requirements for the substance that they intend to
register, considering in particular the tonnage band that is relevant to
them, but also uses/exposure patterns.

As described more fully in RIP 3.1, Article 11 requires registrants to:

-   provide all relevant physicochemical, toxicological and
    ecotoxicological information that is available to him, irrespective
    of tonnage;

-   fulfill the standard information requirements as laid down in Column
    1 of REACH Annexes VII to X for substances produced or imported in a
    certain tonnage band, subject to waiving possibilities, as described
    below.

For each of the REACH Annexes VII to X, Column 2 lists specific criteria
(e.g. exposure or hazard characteristics), according to which the
standard information requirements for individual endpoints may be
adapted (i.e. modified both specifying possibilities for waiving, or
specifying when additional information is needed).

In addition, registrants may adapt the required standard information set
according to the general rules contained in Annex XI of the REACH
Regulation which refer to situations where:

-   testing does not appear scientifically necessary;

-   testing is technically not possible;

-   testing may be omitted based on exposure scenarios developed in the
    chemical safety report (CSR)

Additionally, in some cases of phase-in substances, information
requirements can also be waived if the criteria laid down in Annex III
(for substances between 1 and 10 tons) are not met. In all such cases,
again the registrant should indicate clearly and justify each adaptation
in the registration.

In summary, Step 5 requires potential registrants to identify precisely
what are the information requirements for the substance they intend to
register, considering in particular the tonnage band that are relevant
to all potential registrants, but also uses/exposure patterns for
exposure waiving purposes.

### Step 6: Identification of data gaps and collection of other available information

At this stage, potential registrants are in a position to compare the
information requirements and information gathered and to identify
whether there are information gaps and consider how missing information
can be generated.

-   If the [available information is sufficient]{.underline} and the
    standard information requirements are met, no further gathering of
    information is necessary. In case the available information is
    judged to be sufficient to meet the regulatory needs while the
    standard information requirements are not met, under certain
    circumstances, in particular for Annexes IX and X, this might be
    part of a justification for waiving a certain test that is requested
    in the standard information requirements.

-   In case the [available information is considered
    insufficient]{.underline}, then potential registrants should verify
    whether data is available with (1) data holders, (2) in other SIEFs
    and/or (3) outside of SIEFs, before generating new information or a
    testing proposal:

> \(1\) First, potential registrants must verify whether data holders
> have identified themselves that may have the missing data. They can do
> so by requesting data holders within the SIEF to identify the
> information/data they have available. This may also be done by
> requesting data holders whether they have a relevant study for one or
> more given end-point, or by means of a questionnaire linked to Annexes
> VI to X of REACH, if more data is missing. It is recommended that a
> short but reasonable delay is given to data holders to communicate the
> requested data, e.g. 1-3 months. The request should also specify
> whether data holders are requested to provide \"proof of cost\" for
> the studies they have or whether compensation is envisaged on another
> basis (e.g. replacement costs).
>
> \(2\) If the data gaps still exist, potential registrants can proceed
> similarly with data holders in other SIEFs where a potential for QSARs
> or read across has been identified at pre-registration. See Section
> 8.1.
>
> \(3\) Alternatively, of if data is still missing despite (2) above,
> potential registrants can decide to conduct a (new or updated)
> literature search to complete their data set. They could decide that
> one potential registrant would perform the search on behalf of the
> others, or that it be done by a trustee or other outside expert. In
> all cases, a decision will need to be made on the financial aspects of
> the literature search before the literature search is actually
> conducted.

-   Finally, in all cases, instead of commissioning further testing, the
    registrant may propose the limitation of exposure through the
    application of risk management measures, e.g. providing closed
    systems (see RIP 3.3).

Data gaps may be different for each of the relevant tonnage bands. For
example, all necessary data may be available for the registration of the
substance up to 100 tons, but the data is not sufficient for those
companies manufacturing or importing the substance above that threshold.
In that case, and unless they would have an interest in acquiring
additional studies for other or future use, only these companies
requiring these studies will need to share the cost of the studies to be
generated.

In summary, Step 6 requires potential registrants to identify precisely
the data gaps that will need to be filled in before registration
dossiers can be filed. Before testing is conducted or a testing proposal
made, potential registrants MUST verify whether the missing data is not
available to data holders within the SIEF and, if not, MUST conduct a
literature search. They can also request data from data holders in other
SIEFs.

### Step 7: Generation of new information/testing proposal

Information on intrinsic properties of substances may be generated by
using alternative sources for information other than *in vivo* testing,
provided that the conditions set out in Annex XI are met. The registrant
may use a variety of methods such as (Q)SARs ((Quantitative) Structure
Activity Relationships), in vitro tests, weight of evidence approaches,
grouping approaches (including read-across).

When there is an information gap which cannot be filled by any of the
non-testing methods mentioned in step 3, potential registrants have to
take action depending on the missing test/information:

-   when Annexes VII and VIII apply, the registrant has to **generate**
    new information according to the guidance given in RIP 3.3;

-   when Annexes IX and X apply, the registrant has to prepare
    (following the guidance in RIP 3.3) a **testing proposal** and
    submit this as part of the registration dossier to the ECHA for its
    consideration. In this case, registrants have to implement and/or
    recommend to downstream users interim risk management measures while
    awaiting the outcome of the ECHA\'s decision regarding the test
    proposal[^8].

It is important to stress that **testing on animals should be seen as
the last resort**. Testing on animals should only be proposed when the
registrant considers it necessary to obtain additional information for
assessing and documenting that risks are adequately controlled.

The procedure to be followed when a relevant study involving tests is
not available is described in Article 30.2. Essentially, the potential
registrants cannot proceed alone with the generation of missing data.
They have the obligation to agree on one of them performing the study on
behalf of the others. The agreement has to be reached within a deadline
set by the ECHA; otherwise the decision will be taken by the ECHA
itself. All participants who require the study are obliged to contribute
to the costs for the elaboration of the study by a share corresponding
to the number of participating potential registrants. Within three weeks
of payment, each SIEF participant has the right to receive a copy of the
full study report.

In summary, when there is no other alternatives, Step 7 requires
potential registrants to generate new information (when Annexes VII or
VIII apply) or to prepare a testing proposal (when Annexes IX and X
apply). Testing on animals should always be the last resort.

### Step 8: Sharing of data and cost 

Once the potential registrants have accomplished the steps above, they
can organize the actual sharing of the available data and of the costs
involved. This can be done in stages, for example, starting with the
data available data within the SIEF and then with the newly developed
data, or as a single exercise, when all data is available.

It is for the potential registrants and data holders involved to agree
on the terms and conditions of this data and cost sharing and many
options exist to structure and organize this. As described in Section
5.3.2 above, it is recommended that potential registrants and data
holders agree on this early in the data sharing process.

A few important points must be considered by the parties when doing so:

**What is being shared?**

Article 10.(a) last indent requires every registrant to be \"in
legitimate possession of or have permission to refer to the full study
report\" for the studies for which a summary or robust study summary is
provided.

From this article different concepts must be distinguished:

-   Ownership, legitimate possession and right to refer to a study

-   Full study report, study summary and study results

[To be developed]{.mark}

**When must the data and costs be shared?**

Potential registrants must be in legitimate possession or have
permission to refer to the studies before they register, i.e. before the
relevant phase in deadlines.

When potential registrants include manufacturers and importers in
different tonnage bands, then \[...\] [To be developed]{.mark}

1)  
2)  
3)  
4)  
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**How can the data and costs be shared?**

Several compensation formulae exist for cost sharing, as described in
Annex 4 to these Guidelines. Also, the parties must organize the
physical transfer of the data (studies, or letter of access) between
each others.

In summary, under Step 8, potential registrants organize between
themselves the actual exchange of data and compensation thereof, so that
each potential registrant is entitled to register and is/has properly
compensated for the data it has/is provided.

### Step 9: Joint Submission of Data

Once all the steps described above have been completed, then potential
registrants within a SIEF have all necessary elements to proceed with
Registration and the joint submission of data, as described in Section 9
below and in RIP 3.1.

All existing available information gathered when preparing the
registration dossier has to be documented by the registrant in both the
technical dossier and for substances manufactured or imported in
quantities of 10 tonnes or more per year per registrant in the chemical
safety report (CSR). At least all the information required under Article
10(a) for the technical dossier and under Article 10(b) for the chemical
safety report (CSR) needs to be documented in the recommended reporting
formats.

In case of a joint submission, the [lead registrant]{.underline} has to
identify himself but also all the other registrants who are part of the
joint submission. The same applies to the other registrants who have to
identify themselves in their dossier but also the registrant who submits
the dossier on their behalf.

The lead registrant will also have to request confidential treatment of
data (Art 10(a)(xi), if appropriate. The argumentation for the
confidential treatment generally will be provided by the proprietor of
said data, but other arrangements can be made between the registrants
(see also Annex 2 paragraph 4.5).

# Classification and labelling  {#classification-and-labelling .Heading_L2}

Harmonization of classification and labelling is the second objective of
SIEF\'s. Registrants are required to provide the classification and
labelling of the substance in the registration dossier as described in
Annex VI, section 4.

Classification is directly dependent on the hazard data of the substance
and consequently can only be finally decided once all relevant data have
been validated and interpreted by the SIEF participants.

In accordance with Article 113, all manufacturers and importers must
notify the ECHA of the classification and labeling of the substances
they place on the market as from 1^st^ December 2010, irrespective of
when the substance is to be registered for the first time.

It is recommended that early in the process, potential registrants
exchange information on the classification and labelling that they
individually apply to the substance at stake, so that the potential
registrants know whether they all came to the same evaluation or whether
there are differences.

It can be reasonably anticipated that if there is no difference in
classification and labelling between participants, this is a good
indication that data sharing can be contemplated in view of a joint
submission for the substance.

If there are differences, participants can then investigate if
differences in classification and labelling stem from missing
information or from different characteristics of the substances.

**Examples**

**Case 1**: Producer A classifies his substance for a given end point on
the basis of a study which is not available to producer B; producer B
does not classify for the same end point due to lack of data.

**Case 2**: Both producers A and B have studies on a given end point.
The study on the substance from producer A suggests classification.
Another study on the substance manufactured by producer B suggests no
classification. The substance produced by A may have a different hazard
profile because of intrinsic differences linked to the production
process (e.g. impurities, isomers)

**Discussion:** In both examples, producer A classifies and producer B
does not classify. In the first example, producer B should require in
accordance with the provisions of Art 30.1 the missing data to producer
A and both A and B should also consider applying the same
classification. In example 2, classification does differ and the
possibility to share data for some end-points among producers A and B
may be put into question.[^9]

Participants of the same SIEF are required to agree with each other on
classification and labelling. This does not necessarily mean that the
classification and labelling is the same for all manufacturers and
importers of the same substance. The same substance may be produced
under different grades, leading to different impurity profiles, which
can entail a more stringent classification than the pure substance. The
same situation may also occur when different processes or raw materials
are used. In these cases, however, data sharing may still be possible.

**Can data be shared when classification and labelling differ?**

Participants should always carefully look into whether studies are
relevant to their substance. Good quality studies always give a precise
description of the tested material, including its impurity profile. In
the case of a positive result of a study it is essential to assess
whether the observed effect is caused by an impurity or not. Extended
guidance on this can be obtained from RIP 3.2.

Registrations may be submitted jointly on substances with a different
classification provided it can be clearly established that the
difference is attributed to a well identified impurity, for which the
relevant hazardous properties are known.

It must be noted that these impurities are likely to have an impact on
the risk assessment and the possibility to share the Chemical Safety
Assessment may become questionable.

1.  []{#__RefHeading___Toc165900950 .anchor}Data Sharing: Individual
    route

There may be some cases where the collective route described above
cannot be followed, for example because potential registrants fail to
agree on means of cooperation for justified or unjustified reasons. In
these cases, potential registrants are legally required to proceed as
described in Article 30.1 (and if need be 30.3) of the REACH Regulation.

Examples were companies may resort to the individual route are when
potential registrants cannot agree on means of cooperation in time for
meeting the Registration deadline or when they have justified reasons to
\"opt out\" from the joint submission of data and therefore do not need
to agree on a single data package.

The individual route also may be an appropriate way of requesting and
sharing data with data holders.

The data sharing process under the individual route is essentially made
of the following steps:

-   Step 1 Individual gathering of available information

-   Step 2 Individual consideration of information needs

-   Step 3 Identification of individual data gaps

-   Step 4 Request for missing data to other SIEF participants

-   Step 5 Sharing of available data, if needed

-   Step 6 Generation of new information/testing proposal

-   Step 7 Joint submission of data -- Opt Out

Steps 1 to 3 and 5 are the same as those described above in the
\"collective route\" except that they will be conducted individually.
They are only summarized below.

Step 4, 5 and 6 are specific steps that follow the procedure described
in Articles 30.1, 30.2 30.3 of REACH.

The difficulty with the individual approach is that it does not
naturally lead to the joint submission of data (Step 7), a legal
requirement unless the companies involved can \"opt out\".

A flow chart describing the data sharing process as described in
Articles 30.1, 30.2 30.3 of REACH is provided in Annex I to this
Guidance Document (See Flow chart II B).

### Step 1 Individual gathering of available information

Step 1 requires each potential registrant to assemble and document all
the information on the substance, that he has available in house (and to
perform a literature search as the case may be) for information on the
substance\'s (1) intrinsic properties (irrespective of tonnage), (2)
uses, exposure and risk management measures.

### Step 2 Individual consideration of information needs

Step 2 requires each potential registrant to identify precisely what are
the information requirements for the substance he intends to register,
considering in particular the tonnage band that is relevant to him, but
also his own uses/exposure pattern. This includes consideration of
possible data waivers.

### Step 3 Identification of individual data gaps 

Step 3 requires each potential registrant to compare the information
available from Step 1 and the data needs from Step 2 and identify
precisely the data gaps that will need to be filled in before
registration dossiers can be filed.

### Step 4 Request for missing data to other SIEF participants

If the potential registrant lacks data that requires testing for
purposes of his registration, he has to communicate with the other SIEF
participants to determine if relevant studies are available.

IMPORTANT: Data sharing is obligatory for studies involving tests on
vertebrate animals and voluntary for studies not involving vertebrate
animal studies. In other words, the potential registrant is obliged to
request studies involving vertebrate animals, while he may request the
study if it does not involve vertebrate animals. Data sharing for
non-vertebrate animal studies is also recommended and failure to do so
may entail penalties.

Two situations may arise:

-   the missing study is available within the SIEF (Step 5)

-   the missing information is not available within the SIEF (Step 6)

### Step 5 Sharing of available data

The potential registrant requests the missing studies from the SIEF
participant(s) who own(s) them.

Before the study is made available to the requesting participant, an
agreement has to be reached on the cost of sharing the requested
information according to the following procedure:

-   The owner of the study is obliged to provide proof of its cost to
    the participant(s) requesting it within one month of the request.

-   The cost of sharing the information has to be determined in a fair,
    transparent and non-discriminatory way (see cost sharing guidance in
    section 5.5).

-   In the case where no agreement can be reached, the cost will be
    shared equally.

Following settlement on cost sharing, the owner must give permission to
refer to the full study report within 2 weeks of receipt of payment.

### Step 6 Generation of new information/testing proposal

The potential registrant cannot proceed alone with the generation of
missing data. He is obliged to obtain agreement that one member of the
SIEF will perform, or arrange for a third party to make the study on
behalf of the others. The agreement has to be reached within a deadline
set by the ECHA; otherwise the decision will be taken by the ECHA
itself.

In case the participants do not agree otherwise, all participants who
require the study are obliged to contribute to the costs for the
elaboration of the study by a share corresponding to the number of
participating potential registrants.

Within three weeks of payment, each SIEF participant has the right to
receive a copy of the full study report.

### Step 7 Joint submission of data -- Opt Out

Joint submission of data is described in Section 9 below. As mentioned
above, the difficulty with the \"individual route\" is that it does not
pave the way for the joint submission of data. It is therefore suggested
to be used only in case where joint submission does not apply, for
example to share data with data holders or when companies have justified
reasons to opt-out from the joint submission of data. The REACH legal
text provides for the right to opt out from a joint submission in very
clearly defined circumstances. Details of the prescribed circumstances
in which opting out is allowed are in section 9.1.2.

### Data Sharing with Data Holders 

The individual route is probably the most appropriate route to share
data with data holders.

Data holders will receive a financial compensation for the data they
share with potential registrants. Since data holders are not expected to
register the substance, they do not have stricto sensu "a share" in the
registration of the substance; the level of the compensation is
consequently to be negotiated accordingly between the concerned SIEF
participants. To this effect, the data holder must provide a proof of
its cost. The agreed financial compensation should take into
consideration the value of the data and its relevance to the substance
undergoing registration. It should also reflect possible limitations
that the data owner can put on the use of the data, e.g. if the access
to the data is only granted for REACH. More information on these aspects
of data compensation can be found in the Annex 4 to this guidance.

[]{#__RefHeading___Toc165900963 .anchor}Dispute Resolution in data
sharing

The REACH Regulation sets out a specific procedure in case the owner of
a study refuses to provide proof of costs of the study or the study
itself. The procedure differs for data on vertebrate or non-vertebrate
animals.

This process is described in Article 30 (3 to 6) of REACH and
schematically in Annex I to the present Guidelines (Flow chart II B).

### Data on vertebrate animals 

The owner of the study will not be able to proceed with his registration
until he provides the requested information. The potential registrant
will proceed with his registration without fulfilling the relevant
information requirements, which he has to justify in the dossier.

At this stage, three possibilities for data sharing and submission of
registration exist:

(1) **The owner of the study finally provides proof of the costs or the
    study itself**

Data sharing proceed according to the normal rules and the owner of the
study can proceed with registration.

(2) **The owner has not provided the study to the potential registrant
    within 12 months and no registration has already been submitted**

The ECHA decides that the test should be repeated, and the registration
dossier will be completed with the information resulting from the new
study. The owner of the study who refused to provide proof of cost or
the study will be penalized (penalties to be laid down by Member States)

(3) **The owner has not provided the study to the potential registrant
    within 12 months and a registration containing the information has
    already been submitted by another registrant**

The ECHA gives the potential registrant permission to refer to this
information in the existing registration dossier and no financial
compensation is due. However, the other registrant can decide to make
the full study report available to the other potential registrant; he
will then have a claim on the other participant for an equal share of
the costs.

The owner of the study who refused to provide proof of cost or the study
will be penalized (penalties to be laid down by Member States).

### Data on non-vertebrate animals 

The other SIEF participants must proceed with registration as if no
relevant study is available in the SIEF. They will therefore have to
carry out the test in order to obtain the information needed to meet the
requirements of the registration dossier.

However, the owner of the study who refused to provide proof of cost or
the study including non-vertebrate animals will be penalized (penalties
to be laid down by Member States).

5.  []{#__RefHeading___Toc165900966 .anchor}Exchanges of CONFIDENTIAL
    BUSINESS INFORMATION (CBI) and Competition law

Participants to exchange of information under REACH are recommended to
be careful when exchanging data to ensure the preservation of CBI while
complying with EC competition law rules. However, most of the
information to be exchanged are more likely to raise concerns under
confidentiality rather that EC Competition law rules (as for most part,
this information is purely technical and cannot really provide
competitors the ability to distort markets).

# CBI {#cbi .Heading_L2}

[As described here fully in Annex 2, several]{.underline}
[recommendations]{.underline} can be made to participants to ensure
appropriate management of CBI (for more details, see Annex 2):

-   Potential registrants wishing to keep their identity secret from
    other potential registrants within the SIEF should nominate a
    independent third party at pre-registration.

-   

-   To limit the use of the information being exchanged, they can
    specify that the information shared within a SIEF (such as substance
    identity) is to be used solely within the SIEF for registration
    purposes and does not lose its CBI status because it is exchanged.

-   

-   Downstream user willing to keep its information confidential, can
    either decide not to participate in a SIEF or use a third party
    representative to preclude disclosure of its identity.

In most cases, the signature of a confidential agreement may offer a
solution to protect CBI, but participants may also decide to use the
services of an independent third party (trustee). IN some cases,
however, they may require to opt out, as described in Section 2 below .

# EC Competition law {#ec-competition-law .Heading_L2}

As described in Annex 3 hereto, exchanges of information under REACH are
not likely to pose problems under competition law. However, in certain
circumstances participants need to be particularly carefully and are
[recommended]{.underline} the following:

-   Avoid misusing REACH exchange of information to conduct cartels (for
    example to fix prices between competitors).

-   Restrict the scope of activities to what is necessary under REACH.

-   For certain information to be exchanged under REACH and which is
    sensitive under EC Competition law, participants are advised to use
    "precautionary measures" such as :

    -   Reduce frequency of exchange.

    -   Reference to tonnage bands rather than individual figures.

    -   However, if there is still a need to exchange sensitive
        information, it is highly recommended to use an independent
        third party (trustee).

More explanations are included in Annex 3 as well as some recommended
tips for REACH actors when working together.

6.  []{#__RefHeading___Toc165900969 .anchor}THE \"INQUIRY PROCESS\":
    DATA-SHARING rules FOR NON-PHASE-IN SUBSTANCES AND REGISTRANTS OF
    PHASE-IN SUBSTANCES WHO HAVE NOT PRE-REGISTERED

REACH provides for separate data sharing provisions for (1) phase-in
substances (as described in Sections 3 to 5 of these Guidelines) and (2)
non-phase-in substances, as well as phase-in substances that the
manufacturer or the importer (or article producer or importer) does not
pre-register in time (as described in the present Section 7).

The process in place for this second category of substances is generally
referred to as the \"inquiry process\". It is regulated in Articles 26
and 27 of REACH.

The inquiry process is essentially a three-step process whereby:

-   The potential registrant must inquire with the ECHA prior to
    registration if the same substance has already been registered;

-   The ECHA facilitates contact between the previous registrant(s) and
    the potential registrant(s) and/or other potential registrants, if
    any;

-   Data sharing is organized between previous registrant(s) and/or
    potential registrants for new tests to be conducted.

One of the main differences with the rules for phase-in substances is
the early involvement of the ECHA, its exclusive responsibility in
determining substance equivalence and its close supervision of the data
sharing process.

The inquiry process is described visually in Annex 1 (Chart V)

# What substances are subject to the Inquiry Process? {#what-substances-are-subject-to-the-inquiry-process .Heading_L2}

The inquiry process applies to (1) non-phase-in substances and (2)
phase-in substances that the manufacturer or the importer (or article
producer or importer) does not pre-register in due time.

\(1\) [Non-phase-in substances]{.underline}

Non-phase-in substances are substances that do not meet the definition
of phase-in substances as provided in Article 3.20 of the REACH
Regulation.

This includes substances not listed on EINECS (and that do not qualify
as no longer polymer or substances manufactured but not placed on the
market in the relevant period -- See Chapter 1 above).

[Quid of substances listed on ELINCS when they reach the additional
tonnage threshold?]{.mark}

\(2\) [Phase-in substances]{.underline}

Phase-in substances subject to the inquiry process are essentially:

-   those for which potential registrants opt for immediate
    registration, i.e. opt to not benefit from the transitional period
    that follows pre-registration; or

-   those for which potential registrants cannot or fail to pre-register
    in time (i.e. between 1 June and 1 December 2008 or within 6 months
    from reaching the 1 ton tonnage threshold).

Importantly, the phase-in substances that shall be subject to the
inquiry process may also be subject to the rules applicable to phase-in
substances because other manufacturers or importers (or article
producers or importers) have pre-registered the same substances. See
Section 7.4 below.

# Inquiry prior to registration {#inquiry-prior-to-registration .Heading_L2}

Prior to Registration, a potential registrant of a non-phase-in
substance or a potential registrant of a phase-in substance who has not
pre-registered that substance must inquire with the ECHA whether a
registration has already been submitted for that substance.

With its inquiry, the potential registrant must submit the following
information (Article 26.1):

-   his identity, as specified in section 1 of Annex VI, with the
    exception of the use sites;

-   the \"full\" identity of the substance, as specified in section 2 of
    Annex VI;

-   which information requirements would require new studies involving
    vertebrate animals to be carried out by him; and

-   which information requirements would require other studies involving
    vertebrate animals to be carried out by him.

The inquiring potential registrant will then be confronted with one of
the following three situations:

1.  **The substance has already been registered and the relevant
    information has been submitted [less]{.underline} than 12 years
    earlier**

The ECHA will inform the potential registrant without delay of:

-   the name(s) and address(es) of the previous registrant(s);

-   relevant summaries or robust study summaries already submitted by
    them.

At the same time, the ECHA will inform the previous registrant of the
name and address of the potential registrant. The procedure under
section 7.3 below will then apply.

1.  **The substance has already been registered and the relevant
    information has been submitted [more]{.underline} than 12 years
    earlier**

The applicant can make \"free\" use of study summaries or robust study
summaries of studies submitted by the previous registrants for the
purpose of his registration (Article 25.3).

This information is normally made available on the ECHA\'s website but
cannot be used by registrants who are not in legitimate possession of,
or who do not have permission to refer to the full study report[^10]. It
is therefore necessary, for legal certainty reason, that the ECHA will
informs the potential registrant of the relevant summaries or robust
study summaries of which he can make free use.

In certain cases, the information is not available on the ECHA website.
This is the case of study summaries or robust study summaries for which
the Agency has accepted as valid the justification for confidential
treatment submitted by the registrant concerned. The Agency should
therefore treat the inquiry as a request for access to documents held by
the Agency (Article 118), which normally involves consultation of the
original registrant and a decision.

[The above 2 paragraphs should be discussed with/reviewed by the
Commission]{.mark}

2.  **Information on that substance has not previously been registered**

The applicant has to carry out all tests required to satisfy his
registration requirements, alone or with other possible applicant(s).
However, testing on vertebrate animals must be avoided by making use of
available data, read across or the results of validated (Q)SAR Models,
if this is sufficient for the purpose of registration.

**The \"12 Years rule\":**

The period of data protection is 12 years. This applies to summaries and
robust study summaries submitted in the framework of a registration,
which can only be used for 12 years by registrants who are in legitimate
possession of, or have obtained permission to, refer to the full study
report summarized in the technical dossier.

Article 25.3 provides that this period starts running from the
\"submission\" date. The reference to \"submission\" rather than
\"registration\" is important in cases where the information has been
submitted after the original registration, for example when an update
was needed due to an increased production. In such cases, the
registration and the submission dates do not coincide and the protection
of data submitted in the framework of an update will therefore be more
than 12 years after the registration date.

The 12-year rule is also applicable to data on substances submitted in
the framework of a notification made in accordance with the Directive
67/548/EEC. Article 24.1 provides that a notification in accordance with
that Directive shall be regarded as a registration and that the the ECHA
shall assign a registration number by 1 December 2008.

Under Directive 67/548/EEC, the data protection period is 10 years from
submission. As a result of Article 24.1, the data already submitted will
benefit from a 2-year extension. However, the original submission date
will continue to be the starting date for the application of the 12-year
rule. This means, e.g. that the data submitted in the framework of a
notification on 1 June 2001 will continue to be protected under REACH
until 2013.

#  {#section-4 .Heading_L2 .unnumbered}

1.  []{#__RefHeading___Toc165900973 .anchor}Sharing of existing data
    between registrants

In cases as described in Section 7.2 (1) above where information on the
substance to be pre-registered has been submitted less than 12 years ago
and there one or more previous registrant(s) and/or several potential
registrants inquiring with the ECHA, the following process applies:

**Step 1 -- Request for studies**

The potential registrant cannot repeat testing on vertebrate animals and
is encouraged not to duplicate other tests. He is required to request
information involving tests on vertebrate animals from previous
registrant(s). He may also request information involving other types of
tests.

**Step 2 -- Negotiation on data and cost sharing, and possible
outcomes**

The potential and the previous registrant shall seek to reach an
agreement on data and cost sharing within one month upon receipt by the
potential registrant of the contact details of the previous registrant.
This can be achieved either by direct agreement or by submission of the
matter to an arbitration board whose decision the parties agree to
accept.

The costs of sharing the information have to be determined in a fair,
transparent and non-discriminatory way, on which guidance is provided in
Annex IV hereto, with the adaptations that the Agency will introduce
before adopting it.

(1) **An agreement is reached within one month**

The previous registrant makes available to the new registrant the agreed
information. He also gives the new registrant the permission to refer to
the full study report.

(2) **Failure to reach an agreement within one month**

The potential registrant informs the ECHA and the previous registrant of
the failure to reach an agreement. Within the following month the ECHA
gives the potential registrant permission to refer to the information he
requested.

The previous registrant has the right to be compensated for the use of
his information by the potential registrant. Specifically, the previous
registrant has the right to receive a \"proportional share\" of the
costs incurred in the development of the studies used by the potential
registrant, or an \"equal\" share if it has made the full study report
available to the potential registrant. Although the Agency may ask the
potential registrant to provide evidence that he has made a payment to
the previous registrant, it is not for the Agency to decide whether such
a payment is adequate. In this regard, if the previous registrant
considers that the amount paid by the potential registrant is
insufficient, he must present his claim before a national court.

The previous registrant may also decide to make the full study available
to the potential registrant. In this case, he has a claim for an
\"equal\" share of the cost incurred by him.

The concepts of \"share\", \"proportional\" share or \"equal\" share of
the cost and the cost itself are discussed in Annex 4 on cost sharing in
this guidance.

# Relationship with SIEF for Phase-In Substances {#relationship-with-sief-for-phase-in-substances .Heading_L2}

The same phase-in substance for which a potential registrant has
submitted an inquiry can be the subject of pre-registration by other
potential registrants. A SIEF may or may not exist when an inquiry is
submitted, depending on the time of the submission. A registration may
also have been submitted by a SIEF participant.

Different situations can be identified, as follows:

(1) 

(2) 

(3) An inquiry is made in the pre-registration period or thereafter but
    before a SIEF is formed by other potential registrants for the same
    substance. The inquiry process will proceed, leading to registration
    by the inquiring potential registrant (\"early registrant\"). If the
    same substance is then pre-registered and a SIEF is formed, then the
    early registrant will automatically be a participant in that SIEF
    (Article 29.1). The early registrant will be a \"data holder\" in
    that SIEF with regard to the information he has registered[^11].

(4) An inquiry is made at a time when a SIEF has been formed for the
    same substance. The ECHA then informs the inquirer that a SIEF
    exists, allowing data sharing between the inquiring potential
    registrants and the potential registrants within the SIEF. ([To be
    discussed)]{.mark}. However, the inquiring potential registrant will
    become a SIEF member only after he has registered the substance and
    the other potential registrants have not yet registered and
    therefore there are no mandatory data sharing provisions applicable
    between these two categories of potential registrants. This does not
    mean, however, that all potential registrants cannot share existing
    data. To the contrary, they are certainly recommended to do so to
    avoid duplication testing and share costs.

(5) An inquiry is submitted after one or more SIEF participants have
    already registered the substance. The inquiry process will follow
    the normal procedure described in Section 7.2 and 7.3 above and the
    registrant(s) in a SIEF will have to share data according to the
    rules for non-phase-in substances. The new registrant will become a
    participant to that SIEF once he has registered.

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7.  []{#__RefHeading___Toc165900975 .anchor}SIEF: other issues
    (Miscellaneous)

[Final place of each of the sections below to be discussed at SEG
3]{.mark}

# Inter-SIEF rules (grouping, read-across)  {#inter-sief-rules-grouping-read-across .Heading_L2}

The avoidance of animal testing is one of the overriding principles of
REACH. One way of achieving this is to use data relating to another
substance for your own substance, if it can be considered that the
substances are similar enough to justify it. Reading data across
different substances should always be carried out according to expert
judgment. RIP 3.2 explains in detail how and when reading across can be
made. Beyond the technical aspects of read across, other issues must be
considered:

When pre-registering, Company A has the possibility to indicate those
other substances (e.g. substance B) with which reading across may be
considered. The Agency will make this information available to the
participants in the SIEF corresponding to the other substance, who will
have the possibility to see the identity of the pre-registrants of
substance A and send queries for data sharing. Similarly, company A will
be able to see the identity of the participants in the other SIEF and
send data sharing queries.

It is worth noting that the fact that substance B is flagged as a
potential read cross substance when pre-registering A does not
necessarily mean that a pre-registrant of substance B has flagged the
same opposite reading across with A. Reading across reading from A to B
will consequently be indicated to the B SIEF, irrespective of the fact
that no B participant has flagged this reading across in his own
pre-registration.

There is no cascading of reading across, though. In case SIEF A reads
across with SIEF B and SIEF B reads across with SIEF C, there is no
automatic connection between SIEF A and SIEF C. The validity of reading
across is always based on an expert judgment and cascading across
several substances cannot be assumed to be valid unless scientific
checked for validity. It is impossible to address all possible cases
involving reading across, the validity of which should always be
assessed on a case by case basis.

Although it is encouraged by REACH in order to reduce animal testing and
curb compliance costs, it is not mandatory for participants in different
SIEFs to share data. A direct consequence of this is that the data
sharing provisions of REACH do not apply. Every request for access to
studies across different SIEFs will have to be negotiated on a case by
case basis by the concerned companies. In order to facilitate this
negotiation, you may consider the options proposed in section 5.5 of
this guidance.

REACH IT is designed to allow the exchange of data requests with other
SIEFs and you are invited to explore all read across potential.

#  {#section-5 .Heading_L2}

# End of SIEF {#end-of-sief .Heading_L2}

According to Article 29, last sentence, \"each SIEF shall be operational
until 1 June 2018\". This date coincides with the last registration
deadline for phase-in substances, meaning that by that date all
pre-registrants should have registered their substances, unless they
have decided to cease their activities involving that substance or have
not exceeded the 1 tonne threshold which triggers registration.

End of SIEF does not mean termination of cooperation
agreements/data-sharing arrangements among registrants (or
pre-registrants who did not register) belonging to that SIEF. The data
submitted in the framework of registrations will continue to be
protected from unauthorized use by other potential registrants, whose
duration depends on the date of submission. There may be also a need to
generate data after the end of SIEF.

It is recommended that the forms of cooperation put in place by
pre-registrants including consortia extend beyond the end-of-SIEF in
order to take into account that :

> Registrants may need to update their registration dossier as a result
> of an increase of the yearly quantities or jointly carry out testing
> following decisions on testing proposals ;
>
> New potential registrants may need the data already submitted for the
> purpose of their registration.

However, the end of SIEF will end the application of the mandatory data
sharing provisions within SIEFs described in Section 5 below. From that
time, the rules for data-sharing for non-phase-in substances will become
of general application and will be the framework for data-sharing (see
section 7).

#  {#section-6 .Heading_L2}

# Liability related to data sharing {#liability-related-to-data-sharing .Heading_L2}

In complement to obligations of SIEF participants laid down in REACH
(specified in detail in Section 4.3) and sanctions contemplated by the
Member States for non compliance with those obligations, the general
rules of national law will apply with respect to the liability of SIEF
participants when sharing information under REACH. It should be noted
that the regime and regulation of responsibility will depend on
provisions of national law which will be held applicable in the given
case.

In assessing the issue of liability different categories of SIEF
participants should be distinguished:

-   [Potential registrants]{.underline} will be liable only for the
    content of their own registration. As regards liability towards
    other potential registrants within a SIEF, it may relate to the
    ownership or the quality of studies or information provided[^12].

> In the category of potential registrants it should be specified that:

-   The [SIEF facilitator]{.underline} described in Section 4.5.3 above
    is a voluntary initiative and as such does not entail any specific
    obligations nor can lead to any liability of the facilitator.

-   With respect to the [third party representative]{.underline} the
    general rules concerning the liability will apply to the extent not
    otherwise contractually agreed. It would seem advisable to specify
    the applicable law and clear allocation of obligations and
    responsibilities in the contract between the SIEF participant and
    his representative.

-   [Lead registrant]{.underline} will be only liable for his own
    registration. The additional guidance on the liability of the lead
    registrant is provided in Section 9.2.1.4 below.

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-   [Data holder]{.underline} may be held liable for the quality of
    studies and any relevant information provided to the potential
    registrant(s). His liability may also occur if he provides studies,
    grants legitimate possession or access to studies to which he does
    not have proprietary rights.

In the event of establishing a consortium the liability of [consortium
members\']{.underline} vis-à-vis third parties is subject to general
rules and cannot be limited in an agreement. Every consortium member is
responsible with respect to his external activities. When consortium
acts jointly in an external relationship (e.g. by providing jointly
generated studies to third parties) there may be joint liability; its
modalities will be governed by the provisions of applicable law. As
regards the liability towards other consortium members it may be
contractually limited to intent and gross negligence, excluding minor
negligence, in order to ensure more efficient cooperation.

8.  []{#__RefHeading___Toc165900981 .anchor}REGISTRATION: JOINT
    SUBMISSION

It is a common misunderstanding that "joint submission of data" means
that a single registration can be used to cover all the obligations of
multiple manufacturers and importers. In fact, each manufacturer,
importer or Only Representative is individually obliged to submit a
registration for each of his substances. However in cases where a
substance is manufactured or imported by more than one company, they are
required to submit certain information together. It is important to
stress that the Only Representative shall also be part of a joint
submission when other manufacturers, importers or Third Party
Representatives exist for the same substance.

To reduce costs for industry, the Agency and Competent Authorities,
registrants are required to jointly submit information on the hazardous
properties of the substance and its classification, and can, if they
agree, also jointly submit the CSR. The intention is that registrants
will save money by co-operating on the preparation of the dossier. The
information is submitted by one lead registrant on behalf of the others;
the other joint registrants have to submit other information
individually (see above).

The present section will explain the mechanisms of joint submission
including the status of Lead Registrant and the opt out conditions
described in REACH.

# Overview of what shall and what may be jointly submitted for Registration {#overview-of-what-shall-and-what-may-be-jointly-submitted-for-registration .Heading_L2}

Table 1: Summary of data to be submitted jointly and/or separately.

  ----------------------- ----------------------- -----------------------
  **Joint submission**    **Separate submission** **Joint or separate
                                                  submission: free
                                                  decision**

  10(aIV)                 10 (aI) **Identify of   10 (aV) Guidance of
  **Classification and    manufacturer or         safe use of the
  Labelling** of the      importer of the         substance as specified
  substance as specified  substance** as          in section 5 of Annex
  in section 4 of Annex   specified in section 1  VI
  VI                      of Annex VI             

  10 (aVI) **Study        10 (aII) **Identity of  10 (b) **Chemical
  summaries** of the      substance** as          Safety Report** when
  information derived     specified in section 2  required under Article
  from the application of of Annex VI             14, in the format
  Annexes VII to XI                               specified in Annex I.
                                                  the relevant sections
                                                  of this report may
                                                  included, if the
                                                  registration considers
                                                  appropriates, the
                                                  relevant use and
                                                  exposure categories

  10 (aVII) **Robust      10 (aIII) **Info on the 
  study summaries** of    manufacture and use(s)  
  the information derived of the substance** as   
  from the application of specified in section 3  
  Annexes VII to XI, if   of Annex VI; this       
  required under Annex I  information shall       
                          represent all the       
                          registrant's identified 
                          use(s). This            
                          information may         
                          include, if the         
                          registrant deems        
                          appropriate, the        
                          relevant use and        
                          exposure categories     

  10 (aIX) **Proposals    10 (aX) **for           
  for testing** where     substances in           
  listed in Annexes IX    quantities of 1 to 10   
  and IX                  tonnes, exposure        
                          information** as        
                          specified in section 6  
                          of Annex VI             

  Optional: 10 (aVIII)                            
  Indication as to which                          
  of the information                              
  submitted under Article                         
  10(a)(iii), (iv), (vi),                         
  (vii) or (b) has been                           
  **reviewed by an                                
  assessor** chosen by                            
  the manufacturer or                             
  importer and having                             
  appropriate experience                          
  ----------------------- ----------------------- -----------------------

# Mandatory Joint Submission  {#mandatory-joint-submission .Heading_L2}

The REACH Regulation imposes the joint submission of a part of the
Technical Dossier including:

-   Classification and labelling of the substance;

-   Study Summaries;

-   Robust study summaries;

-   Proposal of testing;

-   Whether the information has been reviewed by an assessor [(Check if
    not rather optional)]{.mark}

The joint submission will be made by a "Lead Registrant" elected by the
other potential registrants of a same substance. The joint submission is
made on behalf of the other registrants. Liability with regards to the
quality of the dossier submitted jointly will remain with each
registrant. When the "Lead Registrant" will register, he shall identify
the other registrants (or the coordinates of their Third Party
Representative) on behalf of who he acts. He has to specify:

-   Their names, address, phone number, fax number and e-mail address;

-   Parts of the registration which apply to other registrants.

Any other registrant shall identify the "Lead Registrant" submitting on
his behalf specifying:

-   His name, address, phone number, fax number, and e-mail address;

-   

-   Parts of the registration which are submitted by the "Lead
    Registrant".

# Lead Registrant {#lead-registrant .Heading_L2}

##  {#section-7 .Heading_L3}

##  {#section-8 .Heading_L3}

## Who is the "Lead Registrant"? {#who-is-the-lead-registrant .Heading_L3}

No rules are developed in REACH Regulation to elect the "Lead
Registrant". Following the Regulation the "Lead registrant" is the one
registrant acting with the agreement of the other assenting
registrant(s) and who shall submit the "joint dossier".

Logically, the "Lead Registrant" will be one of the Registrants who plan
to submit his registration file before the [first]{.underline}
registration deadline. It means that the "Lead Registrant" will likely
be one of the "biggest" manufacturers or importers of a substance.

However, this is not an obligation: the joint submission registrants
have the possibility to appoint a leader with a lower tonnage (for
instance, because they together pre-register many other substances and
decide to share the workload of managing the joint submissions). If so
that, a lead registrant in a lower tonnage band has to provide a
complete dossier anyway (i.e. including studies for the higher tonnage)
meeting the first deadline applying to any of the registrants. This lead
registrant will still pay the fee corresponding to his own tonnage and
not to the highest tonnage band.

All the potential registrants have to agree on:

-   the identity of the lead registrant;

-   the information to be jointly submitted

Only one Lead Registrant could be appointed by substance (see Sections 3
and 4: one SIEF = one substance = one joint submission = one Lead
Registrant) even if several tonnage bands co-exist and even if the
substance has to be register as a substance or as an intermediate.

It means that all the producers, manufacturers and Only Representatives
concerned by a substance (independently of the tonnage band and of the
use of this substance as intermediate) must participate to the
discussion as soon as possible and agree on a Lead Registrant, on the
information to submit jointly and on the cost sharing.

*How to choose the Lead Registrant?*

-   If only one potential Registrant volunteers to become Lead
    Registrant he has to convince the other potential registrants to
    elect him as Lead Registrant.

-   If two or more potential registrants volunteer to become Lead
    Registrant, they can seek an agreement between them as to who will
    be the lead registrant and propose it to be supported by all
    potential registrants. If the volunteers cannot agree, then it is
    recommended that the other potential Registrants elect the Lead
    Registrant. The rules of elections could be described in the
    agreement signed by the several Registrants (see chapter 10 forms of
    cooperation). In case of disagreement the situation could lead to a
    "double joint submission" of the common part of the Registration
    dossier. This situation has to be avoided by the Registrants since
    the Agency will probably prioritize the dossier/substance for
    evaluation.

-   If no potential Registrant volunteers to become Lead registrant, a
    mechanism by default is proposed and follows the rules established
    in the EU Risk Assessment for Existing substances. The mechanism by
    default foresees that the Lead Registrant will be the EU
    Manufacturer or EU Importer with the highest capacity of production
    or import of the substance.

In all these cases, to ensure that the Lead Registrant will not escape
its obligations and to make clear who is acting on behalf of whom, it is
recommended that all the stakeholders sign a letter clarifying the
situation (See example in Annex 6).

This letter could be a part of the agreement signed between the
potential registrant (see chapter 10 on Forms of cooperation).

N.B.: if the Lead Registrant stops to manufacture or import the
substance, he has to be replaced and the previous rules can be followed.

##  {#section-9 .Heading_L3}

##  {#section-10 .Heading_L3}

##  {#section-11 .Heading_L3}

## What are the tasks of the Lead Registrant? {#what-are-the-tasks-of-the-lead-registrant .Heading_L3}

The main task of the Lead Registrant is to jointly submit the
information described here above.

The Lead Registrant has also to update the registration dossier as long
as this dossier must exist. Therefore, even if the SIEF does not exist
anymore (after 2018), a form a cooperation must be maintained between
the several registrants who have submitted jointly a part of their
Registration dossier.

During all the process, the Lead Registrant has to ensure a good
communication between the different stakeholders (other registrants,
Agency...).

[To be discussed: Cases where the lead registrant ceases
manufacture]{.mark}

##  {#section-12 .Heading_L3}

## What is the liability of the Lead Registrant? {#what-is-the-liability-of-the-lead-registrant .Heading_L3}

The Lead Registrant will only be liable for his own Registration. He
will prepare the part of the dossier which will be submitted jointly on
behalf and with the agreement of the other registrants. Technically,
only the Lead Registrant will have access to the jointly submitted part
of the dossier on the REACH IT system. It would therefore seem advisable
that the other potential registrants seek to ensure by contract that the
Lead Registrant is legally bound to submit the dossier as has been
agreed for submission by all potential registrants and is liable if he
fails to do so.

# Opt-Out {#opt-out .Heading_L2}

## What are the opt-out conditions from joint submission?  {#what-are-the-opt-out-conditions-from-joint-submission .Heading_L3}

Under REACH, data sharing is obligatory in the case of vertebrate animal
test data. Registrants requiring information to complete their dossiers
must enquire whether others in their SIEF already hold such data, and
holders must make the data available on request. In the case of
non-animal data, those requiring data may, but are not obliged, to seek
it from other SIEF members, while data holders are again required to
make data available if asked.

The data sharing process naturally leads to a joint submission of data.
However, the legal text allows for registrants to opt out of joint
submission under very specific conditions as itemised in the following
paragraph. The right to opt out does not extend to evading general data
sharing obligations, or to opting out of membership of the SIEF. Any
exercise of the opt out must be fully justified in each case as
prescribed by the REACH text. Such an opt out can be partial, for
example a registrant may seek to protect confidential business
information, or disagree with the lead registrant\'s selection of
information, for a particular test, but otherwise use the dossier lodged
by the lead registrant for all other shared information.

##  {#section-13 .Heading_L3}

##  {#section-14 .Heading_L3}

##  {#section-15 .Heading_L3}

1.  []{#__RefHeading___Toc165901005 .anchor}What are the criteria to
    opt-out of joint submission?

Paragraph 3 of Article 11 (and repeated in Article 19, which deals with
joint submission of data for isolated intermediates) gives three allowed
reasons for a registrant to opt out of joint submission:

\(1\) it would be disproportionately costly for him to submit this
information jointly; or

\(2\) submitting the information jointly would lead to disclosure of
information which he considers to be commercially sensitive and is
likely to cause him substantial commercial detriment; or

\(3\) he disagrees with the lead registrant on the selection of this
information.\"

Registrants invoking any or all of these conditions are required to
\"submit, along with the dossier, an explanation as to why the costs
would be disproportionate, why disclosure of information was likely to
lead to substantial commercial detriment or the nature of the
disagreement, as the case may be.\" (Article 11, paragraph 3)

**(1) Disproportionate Costs**

The first case -- of disproportionate cost -- might arise when a
potential registrant already has a complete set of the necessary test
data for his product in his possession, and believes the administrative
time and effort involved in becoming a full participant in a joint
registration would not be justified. Another example could be that the
cost sharing formula adopted by a SIEF (or consortium formed by a
subgroup within it) is particularly disadvantageous to certain members,
who consequently find the cost of tests it is proposed to share have
become excessive. This could alternatively be seen as an example of the
third opt-out criterion (disagreement over choice of test data),
although the fundamental issue would be one of cost. Exactly what is
"disproportionate" cost is not defined in the legal text, so some common
sense must be used, and this will have to be argued by the registrant in
each case when he provides evidence for why he is claiming his opt out.
Whatever the circumstances, the registrant -- if only for his own
decision making -- should therefore calculate as methodically and
accurately as he can all the costs involved, how much he could save by
exercising the opt out, and be prepared to set these out in
justification of his opt out.

**(2) Protection of confidential business information (CBI)**

The Protection of CBI is addressed in the second opt out criterion. The
case must be based on the commercial loss which would be sustained if
such CBI were disclosed by joint registration. Circumstances will of
course vary from case to case, but it would seem necessary in most cases
to demonstrate (1) the route by which confidential information would be
disclosed, (2) how it could benefit competitors and (3) that no
mechanisms can be used or is accepted by the other party/parties (e.g.
use of a trustee) to prevent disclosure.

Examples might include information allowing details of manufacturing
methods to be deduced (such as technical characteristics, including
impurity levels, of the product used in testing), or marketing plans
(test data obviously indicating use for a particular, perhaps novel,
application), for example because there are only 2 participants in a
SIEF The fewer participants in a SIEF, the more likely it is that CBI
might be released through indications of sales volumes. Competition law
could also become a factor in these circumstances. Although there is no
further quantification in the legal text of what constitutes
"substantial" detriment, a registrant seeking to use this opt out must
at a minimum establish the value of the CBI at stake. This might be done
by setting out the total value of business for the product, the
proportion potentially affected and the associated gross margin. If a
simple calculation of annual loss is not enough to demonstrate
"substantial" detriment, a further stage might include an estimate of
the forward period over which business might be affected and the
consequent calculated net present value of gross margin lost.

**(3) Disagreement with the Lead Registrant on the selection of
information**

Disagreements over choice of information are likely to fall into one of
three principal categories.

> \(i\) A registrant may consider the nominated test data is not
> appropriate to his product's specific application(s). In such a case
> he would have to provide a qualitative explanation for why he held
> this view. This may be the case for example due to differences in the
> physical form in which the product was supplied, the processes in
> which it was used, the exposure risks for downstream users, the
> likelihood of dispersion during use, the probable final disposal
> routes, and any other relevant arguments.
>
> \(ii\) A registrant may believe the data proposed for the joint
> registration is of an unsatisfactory standard, and does not wish to
> compromise his reputation by being associated with what he sees as
> inferior material, especially if the authorities later reject it. In
> such a case there would also be additional administration costs
> involved with resubmitting a registration dossier with replacement
> data of higher standard. The registrant's view may also be influenced
> by his ownership or otherwise of relevant data and/or the different
> purposes for which his product is used.
>
> \(iii\) In the opposite case to (ii), a registrant might consider the
> data proposed for use in the joint registration to be of an
> unnecessarily high standard (and therefore excessively costly), at
> least for his applications. Justification of his opt out would be
> grounded in demonstrating the adequacy of the alternative test data he
> was using, coupled with the disproportionate cost to himself if he
> otherwise accepted the data proposed by the lead registrant.

## What are the consequences of opting out? {#what-are-the-consequences-of-opting-out .Heading_L3}

An immediate consequence will be the further administrative work
incurred in justifying the opt-out, and, depending on the reasons cited,
the possibility of further correspondence with the ECHA, as well as
possibly a higher individual registration fee. On the other hand,
disproportionate costs may be avoided, and confidential business
information protected.

Cases of disagreement over which test data should be used for the joint
submission appear the most likely to have wider implications. For
example, a SIEF participant may believe that the test data proposed for
adoption in the joint registration are inadequate, or likely to be
rejected by the authorities. In such a case he would have to pay the
costs of any further testing. A variant on this theme could occur if the
dissenter did not believe the test proposed was appropriate to the
conditions in which his product was normally used. There could also be
consequences for the other potential registrants if their proposed test
data was implicitly being queried as possibly unsatisfactory. It would
be sensible to make every effort to reach agreement.

Conversely, a participant may believe that another source of test data,
possibly already in his own possession or otherwise available within the
SIEF, is fully adequate and represents better value than that proposed
by the lead registrant. This is as much an issue of disproportionate
cost as a case of disagreement over selection of appropriate data.

[Note: Add impact of fee regulation]{.mark}

## What are the remaining obligations of the potential registrant? {#what-are-the-remaining-obligations-of-the-potential-registrant .Heading_L3}

As a member of the SIEF, the potential registrant is still required to
respond to requests for the sharing of test data in his possession. The
legal text says that refusal to provide either proof of the cost of a
study, or the study itself, even when animal testing is not involved,
makes the owner liable to a penalty (Art 30.6; Art 126.)

At first sight this appears difficult to reconcile with opt out rights
on grounds of divulging CBI. However, it should be possible in most
cases for the holder of a study involving possible CBI to indicate its
scope and validity and give proof of cost, so that other SIEF members
can make a reasoned judgment as to its suitability for supporting their
own registration(s), while still protecting its confidential elements.
In more difficult cases, it might be necessary to employ a neutral third
party (independent consultant), with confidentiality agreements in
place, to evaluate the study and provide an assessment.

By whatever route, the other SIEF members could then make an evaluation
and if desired obtain permission to cite the study in their (joint)
registration. The owner would undertake to lodge the actual study
documentation with the Agency as part of his own separate registration.
He in turn would have permission to refer to the other required material
submitted by the lead registrant.

This arrangement could in theory be extended to several individual cases
of opt outs within the SIEF. The lead registrant submits a dossier with
full documentation for all shared studies not involving CBI, while each
opting out registrant submits documentation for his own, CBI sensitive
study. All parties arrange permission to refer to studies included in
dossiers submitted by other registrants for any material required to
complete their own (joint or separate) registration dossiers.

# Voluntary Joint Submission {#voluntary-joint-submission .Heading_L2}

Part of the registration dossier may be submitted jointly on a voluntary
basis. This part consists of:

-   The Guidance of safe use of the substance

-   The Chemical Safety Report (CSR)

A **Chemical Safety Assessment** (CSA) will be performed and a
**Chemical Safety Report** (CSR) will be completed for all substances
subject to registration when the registrant manufactures or imports such
substances in quantities of 10 tonnes or more per year. The CSR will
document that risks are adequately controlled through the whole
life-cycle of a substance. For detailed methodological guidance on the
various steps, refers to the Technical Guidance Document on preparing
the CSR under REACH to be developed under RIP 3.2.

Under REACH, the duty of carrying out a CSA for a particular use or for
certain conditions of use may shift from the manufacturer or importer to
a Downstream User in particular situations. For detailed guidance on
this issue, please refer to the Technical Guidance Document on
Downstream Users to be developed under RIP 3.5.

The CSA consists of the following parts:

-   Development of exposure scenario(s);

-   Refinement of the hazard assessment, if necessary;

-   Risk Characterization.

Some confidential data such as the uses, processes used... have to be
exchanged in order to carry out this CSA. This information could be
exchanged in a vertical way (between suppliers and downstream users) and
in a horizontal way (between the suppliers carrying out the CSA
together, for common uses).

A "Trustee" (independent consultant) could be appointed to exchange this
informatrion if considered CBI .

**The Guidance of Safe Use of a substance** is a part of the technical
dossier and it will be included in the Safety Data Sheet (SDS). For
detailed methodological guidance on the Guidance of Safe use, RIP 3.4
refers to the Technical Guidance Document on Information requirements to
be developed under RIP 3.3.

If a CSR is not required, some confidential data needs to be exchanged
to draft the Guidance of Safe Use.

It is important for Industry to consider working together on the CSR and
the development of Exposure Scenario via exposure categories. Working
together will be cost efficient and important for the coherence and the
consistency to perform CSA. However, a separate submission of this part
of the Registration dossier may be justified in cases there are CBI
issues and if regular updates of the CSR are contemplated since this
could be more complicated to do so via a Lead Registrant that directly
by each Registrant.

  -----------------------------------------------------------------------

  -----------------------------------------------------------------------

## What are the rules to submit jointly "sensitive data" of the CSR?  {#what-are-the-rules-to-submit-jointly-sensitive-data-of-the-csr .Heading_L3}

The joint submission has to be made by the "Lead Registrant", but what
about the confidential data?

The guidance of safe use will be published by ECHA (Art 119.1(g),
whereas part of the information in a safety data sheet may be kept
confidential (Art 119.2(d). The submission of this data jointly is on
voluntary basis. Hence, in case confidential data would have to be
submitted to show the agency that the CSR is correct, the submission of
confidential information can be done separately. Otherwise, the owner of
the confidential data can agree with the lead registrant on a (strict,
maybe personal) confidentiality agreement. With respect to the request
to keep information confidential (Art 119.2), see Annex 2, paragraph 6.

9.  []{#__RefHeading___Toc165901016 .anchor}Forms of Co-operation

The REACH Regulation (Article 29) provides that the aim of a SIEF is to:

(a) "facilitate for the purpose of registration, the exchange of
    information", in other words, data sharing, and

(b) agree classification and labelling".

Within each SIEF participants have to organize themselves in order to
achieve the above objectives. A SIEF in itself has no prescribed legal
form. The REACH Regulation neither organizes the way participants to a
SIEF would achieve these objectives, nor describes the form of
co-operation to be used in each case.

Participants will undoubtedly try to find methods, proceedings and rules
to further organize their co-operation while minimizing administrative
burden and use of resources. This may include the use of an IT system
such as an intranet (see above), but also developing some forms of
co-operation including more sophisticated one using 'legal
models'[/Consortium]{.mark}.

The use of "legal models" i. e. formalized agreements is certainly not
necessary. Parties may decide to co-operate in a fairly non formalized
way by just acting and not agreeing on rules or even signing an
agreement. There may be advantages and disadvantages on working with
either way of co-operation.

Other examples of forms of co-operation may be envisaged for example:
one manufacturer provides a full data set to the other manufacturers in
a SIEF which are invited to "join" this data set via a simple letter of
access.

Many participants may be tempted to just co-operate amongst themselves
without even consider this, and an agreement / rules defined. This may
be seen at first glance as a easier and more practical way to work.
However, in view of the complexity of the REACH process, the importance
of certain issues such as the need to preserve confidential business
information, the further organized and legalistic route to co-operate
may be seen as advantageous on the long term and once a deeper analysis
is conducted

"Legal models" are expected to lead to lower individual company costs
and time required for the participation in data-sharing mechanisms and
eventually constitution of a registration file. They may enhance
read-across possibilities and improve preparation of risk assessments
and therefore optimize the data sharing. "Legal models" could also help
to avoid scientific inconsistencies enhancing the technical and
scientific quality of registration dossier.

Furthermore, the manufacturers and importers of the same substance who
jointly submit parts of the registration dossier will not only benefit
from the reduced registration fee but also will avoid being treated by
the ECHA as a 'priority' in the evaluation process.

Not to mention that at the evaluation stage the position *vis-à-vis* the
ECHA and Member States of a registration file supported by a consortium
may be favoured over files from individual registrants.

**It is the responsibility of every company to assess the advantages and
disadvantages of either formally creating or joining a consortium
already created.**

+-----------------------------------+----------------------------------+
| **Items to be considered when     | **Items to be considered when    |
| using a "Legal model"**           | NOT using a "Legal model"**      |
+-----------------------------------+----------------------------------+
| [Organizational                   | [Co-operation with "Legal        |
| efficiencies]{.underline} to      | models" can become over rigid    |
| streamline the process of data    | and hamper the possibility of    |
| sharing (have in place a          | having more                      |
| disciplined organization, a good  | flexibility.]{.underline}        |
| communication system). Work with  |                                  |
| a [third independent              | [Even if participants are        |
| party]{.underline}, if decided.   | working without "Legal models"   |
|                                   | they can always decide to use a  |
| May [constitute a more            | third independent party as       |
| systematic]{.underline} way to    | well.]{.underline}               |
| [preserve CBI]{.underline} and    |                                  |
| organize [compliance]{.underline} | [Time taken to                   |
| with [competition]{.underline}    | establish]{.underline} the       |
| law[.]{.underline}                | "Legal model" , [discuss the     |
|                                   | rules]{.underline} and           |
| [Fix the rules]{.underline} on    | contemplated agreement, in       |
| [data sharing]{.underline} (e.g.  | particular, for example, if not  |
| data ownership, sharing of        | using a model agreement, so that |
| related costs, methods of         | participants cannot agree on the |
| evaluation of data).              | rules and clauses to apply.      |
|                                   |                                  |
| [Reduces costs]{.underline} (save | The preservation of              |
| effort by sharing tasks, sharing  | [CBI]{.underline} and            |
| administrative costs; avoiding    | [compliance]{.underline} with    |
| duplication of work; minimizing   | [competition]{.underline} law    |
| paperwork, benefiting from        | may be [organized in a looser    |
| reduced registration fees).       | way.]{.underline}                |
|                                   |                                  |
| [Technical and                    | [Lack of mutually agreed rules   |
| scientific]{.underline}           | on data sharing.]{.underline}    |
| advantages: maximizing efficient  |                                  |
| use of combined and larger        | [Participation in a "Legal       |
| expertise and experience;         | model" is usually resource and   |
| optimizing the quality of the     | time-consuming.]{.underline}     |
| registration dossier; avoiding    |                                  |
| inconsistencies in data submitted | [Less control over conduct of    |
| to the ECHA; maximizing cross     | studies.]{.underline}            |
| reading potential; allowing       |                                  |
| extension of co-operation to CSR  | [Co-operation between SIEFs (for |
| if feasible and appropriate;      | other purpose than               |
| improved risk assessment with     | cross-reading) may be more       |
| enlarged data base on the         | difficult.]{.underline}          |
| substance.                        |                                  |
|                                   |                                  |
| [Develop experience]{.underline}  |                                  |
| in REACH as a team and have a     |                                  |
| stronger position *vis-à-vis* the |                                  |
| ECHA.                             |                                  |
|                                   |                                  |
| [Allows co-operation regarding    |                                  |
| more than one SIEF with the same  |                                  |
| consortium.]{.underline}          |                                  |
|                                   |                                  |
| [Optimization of pre-registration |                                  |
| actions]{.underline} (early       |                                  |
| preparation, if decided by        |                                  |
| potential participants to a SIEF) |                                  |
| improving definition and          |                                  |
| allocation of substances in the   |                                  |
| correct area, maximizing          |                                  |
| groupings, and read across for    |                                  |
| some substances.                  |                                  |
|                                   |                                  |
| [Optimization of the Registration |                                  |
| Dossier in terms of quality,      |                                  |
| harmonization and                 |                                  |
| consistency.]{.underline}         |                                  |
+-----------------------------------+----------------------------------+

Even though the word consortium is often referred to as one "legal
models" for companies to organize themselves when referring to a SIEF,
the way to co-operate in a SIEF is left quite open in REACH. There may
be various ways to organize co-operation to be decided by each company
involved, but, also collectively by SIEFs participants for example. One
of the reasons for which the word consortium is so often associated with
the REACH Regulation is because it was included in the very first draft
but it no longer appears in the approved Regulation.

In view of the complexity of the REACH process, the experience gathered
by industry at other occasions such as the HPV project and the biocides
registration co-operation, and the advantages that using a "Legal model"
will bring to the participants, it is highly recommended to them to use
one of the most achieved way of legal model and co-operation : by
consortium.

# What is a Consortium?  {#what-is-a-consortium .Heading_L2}

The word 'consortium' no longer appears in the REACH Regulation, nor is
it defined in Community law in general terms (although it is in other
specific areas, such as FP6 projects).

A consortium is a tool to organize co-operation and may take various
forms. At the two extremes of the spectrum, co-operation could be
achieved by:

(i) a legally bound set of operational rules included in a signed
    agreement, or;

(ii) an informal gathering of people working together without any sets
     of rules.

The latter is not recommended as it may always be advisable to have, at
least, the main 'rules of data sharing (e.g. data ownership, sharing of
costs...) put in writing and agreed by the participants.

SIEF and Consortium are therefore to be clearly differentiated. One may
not see a consortium as a sort of 'automatic mutation of a SIEF: on the
contrary.

For the purpose of this guidance the term \"consortium\" will be used to
refer to a more organized and formal type of co-operation between
parties (implying either a signed agreement or the adoption of operating
rules, or reference to an agreed set of general rules).

#  Is a Consortium mandatory under REACH? {#is-a-consortium-mandatory-under-reach .Heading_L2}

No the Consortium is not mandatory.

However, even if the participants in a SIEF are free to organize their
co-operation by way of a either a consortium or other form of
co-operation they must in any case:

-   Be compliant with the requirements of the REACH Regulation (for
    example, under the mandatory sharing of studies or data involving
    vertebrate animals, they could not decide to duplicate a test having
    the same purpose);

-   Respect competition law and any other applicable sets of law;

-   Respect IP Rights and preserve CBI.

# How is a Consortium to be created? {#how-is-a-consortium-to-be-created .Heading_L2}

REACH actors may decide to create a consortium at any stage of the REACH
Process, e.g. before pre-registration, to ease the process of checking
the identity and sameness in view of the formation of a SIEF, and
afterwards.

When a SIEF has been formed, participants in that SIEF who need to
fulfill the obligations of the REACH Regulation would necessarily have
to co-operate to reach this aim. They will look for ways to achieve
this. The facilitator or any other participant in a SIEF and its related
virtual forum may propose to the others a means of working together
through 'formal co-operation' and signing a consortium agreement, or by
adopting common rules. This proposal and chosen form of co-operation
could be made by the SIEF participants on their own, or by asking for
the services and assistance of a third party such as a trade
association, a sectoral association, a consultant, a law firm or any
other service provider.

By either signing the consortium agreement, or accepting operating rules
by a decision in a meeting, or deciding to refer to a common agreed set
of rules (hereinafter only referred to as an agreement), participants in
the agreement will *de facto* 'create the consortium'. There is no need
to have any additional formalities. As a consequence, there is no
specific requirement that consortia be organized by way of the creation
of a separate legal entity having legal personality under the
legislation of a Member State.

It should be noted that when a consortium is created by a trade
association or a law firm it should not be confused with that body, and
must be distinctly identified from it.

It may well also be the case that some companies are already organized
by having for example either a sectoral group or a consortium preparing
the work to be ready for REACH. In this case, they may decide either to
continue their co-operation with the same structure, or to create a new
parallel structure, or to have any other pattern for co-operating.

In the following examples note that the life of a SIEF may involve one
or more pattern of co-operation but these are only to be considered as
facilitation. The consortium formation does not bring the SIEF to an
end. The SIEF continues to exist through the eleven years specified in
the REACH Regulation. Vice versa, a consortium may continue after the
SIEF ends.

[Example]{.underline} [1]{.underline}:

Companies having pre-registered decide to co-operate by way of a
consortium for the discussion on the identity check and the sameness of
the substance. Once the SIEF is formed they may decide to pursue their
activity with the same consortium (but to be modified e.g. regarding its
composition, if needed). Once they sign the consortium agreement, it is
created.

+-----------------------------------+----------------------------------+
|                                   |                                  |
+-----------------------------------+----------------------------------+
| [Example]{.underline}             |                                  |
| [2]{.underline}:                  |                                  |
|                                   |                                  |
| The Companies having              |                                  |
| pre-registered decide to          |                                  |
| cooperate for the discussion on   |                                  |
| the identity check and the        |                                  |
| sameness of the substance But,    |                                  |
| not immediately by creating a     |                                  |
| consortium. They first meet and   |                                  |
| sign a pre-consortium agreement   |                                  |
| including appropriate             |                                  |
| confidentiality clauses. Once the |                                  |
| SIEF is created, they decide to   |                                  |
| create a consortium.              |                                  |
+-----------------------------------+----------------------------------+
|                                   |                                  |
+-----------------------------------+----------------------------------+

# Forms of co-operation in SIEF when using Consortia {#forms-of-co-operation-in-sief-when-using-consortia .Heading_L2}

Co-operation by way of consortia to achieve effectiveness of the SIEF,
once it is formed may take different forms. [You will find a few
examples below]{.underline}.

  ----------------------- ----------------- ----------------- -----------------
  [Example]{.underline}                                       
  [3]{.underline}:                                            
  Participants in a SIEF                                      
  decide to form a unique                                     
  consortium.                                                 

                                                              

  [Example]{.underline}                                       
  [4]{.underline}:                                            
  Participants in a SIEF                                      
  may decide to                                               
  constitute two or more                                      
  consortia and to                                            
  organize the                                                
  co-operation regarding                                      
  data sharing amongst                                        
  these consortia (eg if                                      
  different                                                   
  classification and                                          
  labelling are foreseen                                      
  for a substance with                                        
  the same CAS number).                                       

                                                              

  [Example]{.underline}                                       
  [5]{.underline}: A                                          
  company (participant to                                     
  a SIEF) decides to stay                                     
  outside a consortium,                                       
  but, to fully                                               
  co-operate with the                                         
  consortium regarding                                        
  data sharing (under                                         
  terms and conditions to                                     
  be mutually agreed).                                        

                                                              one company

  [Example]{.underline}                                       
  [6]{.underline}:                                            
  Participants in a SIEF                                      
  (companies, importers                                       
  and data holders)                                           
  decide to form a                                            
  consortium, and                                             
  downstream users decide                                     
  also to form a                                              
  consortium to                                               
  co-operate together,                                        
  and with the other                                          
  consortium.                                                 

                                                              

  [Example]{.underline}                                       
  [7]{.underline}: Two                                        
  SIEFs -- with three                                         
  consortia decide to                                         
  co-operate for specific                                     
  purposes eg                                                 
  read-across.                                                

                                                              

                                                              

                                                              

  [Example]{.underline}                                       
  [8]{.underline}: A                                          
  major consortium may                                        
  also be created (eg for                                     
  a family of substances)                                     
  for companies to                                            
  participate in several,                                     
  but different SIEFs.                                        

                                                              

                                                              

                                                              
  ----------------------- ----------------- ----------------- -----------------

#  Elements of co-operation that may be included in a Consortium {#elements-of-co-operation-that-may-be-included-in-a-consortium .Heading_L2}

***[A. SIEF participants may consider covering within their consortium
various tasks listed below to meet their obligations under
SIEF]{.underline}:***

-   Conducting the necessary substance identity check;

-   Designation in a SIEF of the facilitator;

-   Organization of the co-operation and thus the consortium;

-   Consideration of data (existing data, missing data, new data to be
    developed);

-   Defining data to be shared;

-   Facilitating data-sharing and coordination;

-   Data valuation, data evaluation (including identification, data
    access and collection);

-   Facilitating cross-reading between SIEFs;

-   Organizing the safe exchange of confidential/sensitive information

-   Adopting competition law compliance rules

-   Organization to preserve the confidentiality of business information
    and data;

-   Cost sharing;

-   Data ownership;

-   Preparation of letter of access to data for non-consortium
    participants;

-   Liability;

-   Classification and labelling.

***[B. Participants may also decide to add other elements to a
consortium]{.underline}:***

These may either relate to:

-   [pre-REACH actions:]{.underline} e.g. exchange of views before
    pre-registration,

-   [for the period]{.underline} after pre-registration and before the
    formation of SIEFs: e.g. identity check and discussions on the
    sameness, or SIEFs actions, or

-   [post-SIEFs actions:]{.underline} e.g. joint submission of data,
    joint registration, and maintaining the life of the consortium even
    after the joint registration - jointly to follow-up the file until
    final registration/evaluation, including interacting with the ECHA.

***[C. Duration]{.underline}:***

Parties may also decide to have a consortium either just to achieve
together either some activities before the SIEFs, or the two aims of the
SIEF or to maintain it for the full duration of the SIEF as mentioned in
the REACH Regulation, for 11 years, or even to keep it afterwards in
case they have collectively to answer to some queries for example.

#  Categories of participants in a Consortium {#categories-of-participants-in-a-consortium .Heading_L2}

As mentioned above, there is also no need for the membership of a
consortium for SIEF purposes to coincide exactly with the participants
in a SIEF.

The following categories of participants may be considered to be members
of a consortium/co-operation agreement (this list is not exhaustive):

[(A) Categories strictly deriving from a SIEF]{.underline}:

-   Manufacturer(s);

-   Importer(s);

-   Only representative(s);

-   Data owner(s) who are willing to share data (for example
    laboratories, organisations, consultants, trade/industry
    associations);

-   Downstream user(s) if they have relevant information, for example
    study data and exposure data.

[(B) Other categories may be considered, such as]{.underline}:

-   Downstream user(s), in other cases that mentioned in (A);

-   Third parties providing services and assistance to a consortium such
    as trade/industry associations, sectoral associations, service
    providers, and law firms;

-   Non-EU manufacturer(s) who are also willing to participate directly,
    and not only through their EU-only representative, although not
    being entitled to register directly;

-   Potential manufacturers and importers which according to Article
    28.6 are considered under the REACH Regulation as potential
    registrants;

-   Early registrants.

Different categories of membership with different rights and obligations
associated with these categories may be decided and included in the
consortium agreement. For example:

-   Full members;

-   Associate members;

-   Observers (either as third parties or not)

#  Typical clauses that may be included in a Consortium agreement  {#typical-clauses-that-may-be-included-in-a-consortium-agreement .Heading_L2}

The following list of clauses is to be considered as a non-exhaustive
checklist:

+-----------------+----------------------------------------------------+
| **1. General    | [Identity of each party]{.underline}               |
| Information**   |                                                    |
|                 | [Contact details]{.underline}                      |
|                 |                                                    |
|                 | [Preamble]{.underline}: including a reference to   |
|                 | the REACH Regulation and a declaration of intent   |
|                 | to explain the overall purpose of the consortium.  |
|                 |                                                    |
|                 | [Scope cooperation]{.underline}: the substances(s) |
|                 | on which the parties will co-operate. It may also  |
|                 | include the criteria chosen to agree on the        |
|                 | identification of the substance(s);                |
|                 |                                                    |
|                 | [Subject of the agreement]{.underline}: list of    |
|                 | elements of co-operation or tasks on which parties |
|                 | have elected to work;                              |
|                 |                                                    |
|                 | [Definitions]{.underline}: general reference to    |
|                 | the definitions included in the REACH Regulation   |
|                 | (Article 3) and additional definitions, if any;    |
|                 |                                                    |
|                 | [Duration]{.underline}                             |
|                 |                                                    |
|                 | [Identity of a third independent                   |
|                 | party]{.underline}: if the parties elect to have   |
|                 | the assistance from a law firm, service provider,  |
|                 | sectoral or trade association to manage their      |
|                 | consortium.                                        |
+-----------------+----------------------------------------------------+
| **2.            | [Membership categories]{.underline}: definition,   |
| Membership**    | rights and obligations of each category;           |
|                 |                                                    |
|                 | [Membership rules]{.underline}: admission,         |
|                 | revocation, dismissal of members;                  |
|                 |                                                    |
|                 | [Change in membership]{.underline}: late entrant / |
|                 | early departure                                    |
+-----------------+----------------------------------------------------+
| **3. Data       | [Rules on data sharing]{.underline}                |
| sharing**       |                                                    |
|                 | [Data Ownership]{.underline}                       |
|                 |                                                    |
|                 | [Letter of access]{.underline}                     |
+-----------------+----------------------------------------------------+
| **4.            | [Committees]{.underline}: (membership, attendance, |
| Organization**  | rules of functioning, quorum, voting ...)          |
|                 |                                                    |
|                 | [Working language]{.underline}                     |
|                 |                                                    |
|                 | [Role of the facilitator]{.underline}, if any      |
|                 |                                                    |
|                 | [Role of the Lead Registrants]{.underline}, if any |
|                 |                                                    |
|                 | [Role of third independent party]{.underline}, if  |
|                 | any                                                |
+-----------------+----------------------------------------------------+
| **5. Budget and | [Budget]{.underline}                               |
| finances**      |                                                    |
|                 | [Apportionment]{.underline}                        |
|                 |                                                    |
|                 | [Financial year]{.underline}                       |
|                 |                                                    |
|                 | [Invoicing and payment]{.underline}                |
|                 |                                                    |
|                 | [Taxes and other costs]{.underline}                |
+-----------------+----------------------------------------------------+
| **6.            | [Confidentiality clause]{.underline}               |
| Confidentiality |                                                    |
| and right of    | [Who is entitled to access                         |
| information**   | information]{.underline}?                          |
|                 |                                                    |
|                 | [Measures in place regarding the exchange of       |
|                 | confidential and sensitive                         |
|                 | information?]{.underline}                          |
|                 |                                                    |
|                 | [Sanctions in case of breach]{.underline}          |
+-----------------+----------------------------------------------------+
| **7.            |                                                    |
| Liabilities**   |                                                    |
+-----------------+----------------------------------------------------+
| **8.            | [Reference to competition compliance               |
| Miscellaneous** | rules]{.underline}                                 |
|                 |                                                    |
|                 | [Applicable law]{.underline}                       |
|                 |                                                    |
|                 | [Dispute resolution / settlement or choice of      |
|                 | jurisdiction]{.underline}                          |
|                 |                                                    |
|                 | [Changes to the agreement]{.underline}             |
|                 |                                                    |
|                 | [Dissolution]{.underline}                          |
+-----------------+----------------------------------------------------+

[]{#__RefHeading___Toc165901024 .anchor}Annex 1 -- Process description
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[]{#__RefHeading___Toc165901025 .anchor}Annex 2 -- CBI

The REACH Regulation requires companies to share information and data in
order to (a) avoid duplicate testing and/or (b) jointly submit data at
Registration. Some of this information or data may be considered by
companies to be confidential business information (CBI) that they
consider essential to protect. To the extent that companies have a
legitimate interest in protecting CBI, mechanisms should be found to
allow them to meet their REACH requirements while protecting their
legitimate interests.

This Annex provides guidance on what is considered CBI that may have to
be shared at each step of the data sharing processes under REACH,
starting from pre-registration and ending with the joint submission of
data. It also provides information on how companies can share this
information in a way that protects their CBI.

CBI can be defined as information that a company will not disclose to
the public as it can harm its commercial interests. CBI issues must not
be confused with competition law (see Section 6, main text) which refers
to situations where the sharing of data is likely to negatively affect
market behavior.

REACH refers to CBI when it comes to the point where access is required
to information provided by registrants and data holders, and for the
joint submission of information for registration purposes. This Annex
pinpoints the types of information which can be considered CBI at the
different stages of the process, from pre-registration for phase-in
substances, when forming a SIEF or when exchanging data for the joint
submission. A special focus is placed on these last two stages as the
exchange becomes crucial and more sensitive, with the possibility to opt
out on grounds of a threat to the confidentiality of business
information. These data will be exchanged between pre- and potential
registrants, but also with data holders or more specifically downstream
users when it comes to uses.

1.  []{#__RefHeading___Toc165901026 .anchor}GENERAL

# What is Confidential Business Information? {#what-is-confidential-business-information .Heading_L2}

Confidential Business Information (CBI) is defined in the text box below
and is one of the valuable assets of companies. All companies possess
CBI, and need to take sufficient measures to keep the information
secret.

The Reach Regulation does not define CBI. However, reference is made to
information the disclosure of which to the public could be harmful to
the concerned party's commercial interests (See Articles 10(a)(xi), 118
and 119).

Many countries have comparable, although slightly different definitions
of CBI. A commonly accepted definition may be found in Article 39.2 of
the World Trade Organization (WTO) Agreement on Trade Related Aspects of
Intellectual Property Rights (TRIPs), as follows:

**DEFINITION**: Confidential Business Information

\(a\) is secret in the sense that it is not, as a body or in the precise
configuration and assembly of its components, generally known among or
readily accessible to persons within the circles that normally deal with
the kind of information in question;

\(b\) has commercial value because it is secret; and

\(c\) has been subject to reasonable steps under the circumstances, by
the person lawfully in control of the information, to keep it secret.

Two concepts from this definition require further explanation: (i) what
is considered "secret" under (a) above and (ii) how can confidential
information loses its CBI-status under (c) above.

# What is considered "secret"?  {#what-is-considered-secret .Heading_L2}

The phrase "as a body or in the precise configuration" carries the
notion that, even if certain information may be described somewhere
(e.g. in two separate documents), the information together still may be
confidential. Hence, the combination of (two or more) portions of
information is not to be considered as being non-confidential merely
because each portion is available to the public separately. For example,
it may not be known that a certain company is using technology in a
certain way, even though the technology may be described somewhere.
Therefore, the fact that such a company uses that technology is secret
information. Equally, when a company produces a certain compound, a
"name plate capacity" may be known, but the actual amount of production
is not public information.

# When does information loose its CBI status? {#when-does-information-loose-its-cbi-status .Heading_L2}

The company or person in control of CBI needs to take measures to keep
the information secret. Information loses its CBI status, if it is no
longer secret. In the case where information (considered to be CBI) is
sent to an independent third party without any explicit or implicit
limitation on the use or publication of that information, then in
principle the said information loses its CBI status, because the third
party is "free" to do with the information what he deems fit, including
publication.

# CBI and Competition law {#cbi-and-competition-law .Heading_L2}

The need to protect CBI and to ensure compliance with EC Competition law
rules are two different concepts, which should no be confused. In most
cases, disclosure of information that is considered CBI may harm the
commercial interest of the owner but will not constitute a breach of
competition law (see Annex 3 of this Guidance Document).

# Are there specific provisions on CBI in REACH? {#are-there-specific-provisions-on-cbi-in-reach .Heading_L2}

The REACH Regulation does not contain a specific article or section on
the protection of CBI. However, references to the CBI concept are made
in several Articles of REACH, which demonstrate that the protection of
CBI is a legitimate interest, recognized by REACH, that does require
some protection:

-   Article 118 relates to "Access to Information" held by the ECHA.
    Article 118(2) specifically refers to information the disclosure of
    which "shall normally be deemed to undermine the protection of the
    commercial interests of the concerned persons". This includes
    details of the full composition of a preparation; precise use,
    function or application of a substance or preparation; precise
    tonnage of substances and preparations; links between a manufacturer
    or importer and downstream user.

-   Article 10(a)(ix) and Article 119.2 allow a party submitting certain
    information to request confidential treatment of that information.
    The party submitting the information must submit a justification
    that is accepted by the ECHA as to why publication of this
    information is potentially harmful to the commercial interests of
    himself or of any other involved party.

-   Article 11.3(b) and 19.2(b) allow registrants to 'opt-out' from the
    joint submission of data "if submitting the information jointly
    would lead to disclosure of information which he considers to be
    commercially sensitive and is likely to cause him substantial
    commercial detriment".

10. []{#__RefHeading___Toc165901032 .anchor}WHAT INFORMATION SUBMITTED
    AT PRE-REGISTRATION MAY BE CBI?

This section reviews the information that is required to be submitted to
the ECHA at pre-registration and partially made public by 1 January
2009.

The following data must be submitted at pre-registration:

-   The name(s) of the substance specified in section 2 of Annex VI,
    i.e.

-   The name and address of the pre-registrant and the name of the
    contact person and, where appropriate, the name and address of a
    third party representative whom the pre-registrant has selected to
    represent him for all the proceedings involving discussions with
    other manufacturers, importers and downstream users;

-   The envisaged deadline for registration and tonnage band;

-   The name(s) of other substance(s) for which the available
    information is relevant for performing adaptations to the testing
    requirements, i.e. use of results from (Q)SAR models (section 1.3 of
    Annex XI) and read-across approach.

-   Optionally, the pre-registrant can indicate whether he is willing to
    act as \"facilitator\" in the pre-SIEF discussions

Of that information, by 1 January 2009, the ECHA will publish a list of
pre-registered substances containing only the substance identifier
(EINECS No, CAS No or other identity code) and the first envisaged
registration deadline. This raises no concern of disclosure of CBI,
unless the "other identity code" would comprise detailed information
(because no simple code is available). N.B. Use of a Trade Name could
compromise CBI in certain cases.

As soon as one company has pre-registered, the names of the potential
registrants of each pre-registered substance will be visible to them,
but not the downstream users, or third parties or others, so this should
normally raise no CBI issue. In case a potential registrant does not
want to be visible to other potential registrants, he has the option to
appoint a third party representative, according to Art 4 of REACH. In
that case, it is the identity of the third party representative that
shall be visible to other potential registrants.

Companies with a number of subsidiaries in the EU may name one of their
companies as third party representative. This will preclude information
on which substance is produced by which subsidiary becoming known to
other potential registrants.

**Recommendation**: Potential registrants wishing to keep their identity
secret towards other potential registrants should nominate a third party
representative at pre-registration.

11. []{#__RefHeading___Toc165901033 .anchor}SIEF FORMATION

As mentioned in Section 4 of this Guidance Document, before a SIEF is
formed, potential registrants must ensure that they are producing or
importing the same substance in accordance with the criteria set out in
RIP 3.10. This will require the exchange of detailed technical
information on the composition of the substance, its impurities, and
possibly on the manufacturing process. The latter may include the raw
materials used, the purification steps etc.

-   
-   
-   
-   
-   
-   
-   

This technical information is normally considered CBI and therefore
companies willing to protect such information must find ways to do so,
as described in Section X below, such as the signing of a
confidentiality agreement or the intervention of an independent third
party/trustee (independent consultant).

This obviously would add costs and requires time, which may be
burdensome in particular for SMEs. As a minimum, potential registrants
who intend to protect the CBI character of substance identity
information should specify when submitting it that this information is
indeed CBI and, as such, is communicated and can be used only for
purposes of the verification of substance identity under REACH.

Where participants cannot come to an agreement, and do not want to share
CBI of their products, the non-sharing participants will have to
opt-out, and go for individual registration. Data-sharing obligations
will remain. It will however be necessary to ascertain that certain
study reports are useful for other participants. This assessment can be
done by an independent third party (trustee), but this will need
agreement between the parties.

**Recommendation**: It would be appropriate to specify that the
information required to be shared within a SIEF (such as exchange on
substance identity, requests or answers to requests) is to be used
solely within the SIEF**.** Such exchange of information must not be
used outside a SIEF (unless required by REACH).

12. []{#__RefHeading___Toc165901034 .anchor}EXCHANGE OF INFORMATION
    AMONG POTENTIAL REGISTRANTS

This section reviews the information that must be exchanged within SIEF
and that requires to be submitted to the ECHA at Registration, including
information justifying a request to opt out, as specified in Article 10
and Annexes VI to IX of REACH.

A table is provided below (**Table** **1**) that lists:

-   the information to be submitted;

-   whether it is to be submitted at Registration jointly, separately or
    as an option either jointly or separately;

-   if it is or can be considered CBI; and

-   whether or not and under what conditions the information, as
    submitted, will be published by the ECHA.

Table 1 can be used to guide potential registrants in determining which
items of information they will need to submit at Registration and may
have to share for registration purposes may constitute CBI and may
therefore require protection. If the information submitted is to be
published by the ECHA without the possibility for the owner to require
confidential treatment then it either cannot be considered CBI or will
in any event lose its CBI status.

# Exchanging studies within SIEF  {#exchanging-studies-within-sief .Heading_L2}

The 'individual route' described in Section 5.5 of this Guidance
requires parties to request missing data before conducting testing. As
this information (who needs which data) is not publicly known, it is
considered CBI. Knowledge of this information may also be commercially
sensitive, as parties would be able to assess how much money another
company needs to spend to get its products registered. Further, it is
likely to show in which tonnage bands manufacturers or importers intend
to register. Such information could be used for 'comparative
advertising'.

A further issue may arise when a participant 'makes a full study report
available' to another SIEF participant according to Article 30.3. The
full study report -- assuming it was CBI protected -- arguably would
lose its CBI status if nothing was agreed beforehand between the
parties. This would be a strange result, as the receiving person may
then publish the said report, and it would be free to be used by
anybody.

In a case where there is no agreement and either no secrecy applies at
all, or the implicit secrecy under REACH is considered insufficient, a
participant can opt-out, and preserve its CBI. However, the data-sharing
obligations remain applicable.

**Recommendation**: Ensure by means of secrecy agreements that
information received in SIEF will only be used for registration purposes
and does not lose its CBI status because it is exchanged.

By contrast, under the 'collective route' described in Section 56.4 of
this Guidance, generally, the information to be exchanged for filing a
full registration dossier will require an inventory of existing studies,
an evaluation of the reliability of the data, determination of the key
results to be used in registration -- etc. 'Inventory & Evaluation'. In
particular, Annex VI Step 1 seems to require sharing of all existing
data.

The information considered to be CBI will be shared in this case under a
secrecy agreement. Where such an agreement would not sufficiently
protect a party, a registrant can [opt out]{.underline}, and preserve
its confidential information. However, an opt-out will only be partly
effective, as the party is obliged to request missing data and supply
available data on request.

When and whether someone has legitimate possession of the full study
report for the purpose of registration (article 10(a) last sentence) is
described in the Annex .

**Recommendation**: Sharing information for the registration dossier
will preferably be done under secrecy agreement rather than opt-out as
the party is obliged to request missing data and supply available data
on request in any case.

# Separate Submission of Data {#separate-submission-of-data .Heading_L2}

## General information on registrants (Annex VI.1)  {#general-information-on-registrants-annex-vi.1 .Heading_L3}

Information about the registrant identity, as such, is not confidential.
However, identity information in combination with other information
(e.g. substance name, uses, impurities) can be CBI. If so, the potential
registrant should use a third party representative. If a third party
representative is used, only the identity of the representative will be
known to pre-registrants and within the SIEF.

In markets with few manufacturers or importers, and/or few uses, use of
a third party representative may not be sufficient to keep the identity
of the actual registrant confidential, in particular if a substantial
amount of information has to be exchanged to achieve, e.g. agreement on
Classification & Labelling (C&L), or Guidance on safe use.

**Recommendation**: Potential registrants wishing to keep their identity
secret from other potential registrants within the SIEF should nominate
a third party representative at pre-registration.

## Identification of the substance (Annex VI.2) {#identification-of-the-substance-annex-vi.2 .Heading_L3}

A substance is identified at Registration by a number of "identifiers"
that may or may not be CBI:

-   [Trade name]{.underline}: The trade name can be CBI. It is not
    published in the list of pre-registered substances. In principle,
    the trade name will be published by the ECHA after Registration but
    CBI status can be requested.

-   [EINECS, IUPAC or other identity codes]{.underline} will be
    published in the list of pre-registered substances. At registration,
    the EINECS Number is published.

-   [Structural information and spectra]{.underline} of the substance
    are not necessarily shared within SIEF; these can be CBI, and are
    not published by the ECHA

-   [Impurity information]{.underline} generally will be CBI, is not
    published in the list of pre-registered substances, but may be
    published if essential to C&L, although confidential status may be
    requested

-   [Description of analytical methods]{.underline}, sufficient to
    enable the analysis of the substance, and -- if necessary --
    impurities: This generally will be CBI, but is not protected if
    publication allows detection of the substance when discharged into
    the environment or to determine its direct exposure to humans
    (Article 119.1.h).[^13]

## Information on manufacture and use (Annex VI.3).  {#information-on-manufacture-and-use-annex-vi.3. .Heading_L3}

This type of information generally is, or can be CBI. It is to be
submitted to the ECHA separately at Registration.

-   [Volume and tonnage bands]{.underline}: Volume of production and/or
    imports is CBI. Tonnage bands are not but may be kept confidential
    on request. Considering the need to agree on the generation of
    missing data within a SIEF, it is unlikely that it is possible to
    keep the tonnage band confidential within a SIEF. Precise volume
    figures generally are also sensitive from a competition law
    standpoint, and should not be exchanged.

-   [Brief description of process of manufacture]{.underline}: This will
    often not be CBI, but it may be. It will neither be published nor
    shared.

-   [Concentration (ranges) of substances in preparations, or in
    articles]{.underline}: This generally will be CBI; it is not
    necessarily shared, but see 1.5 (preparation/polymer import).

-   [Brief general description of use]{.underline} will generally not be
    CBI, but may raise concern as it may reveal downstream uses. See
    Section 5 below. Equally, 'uses advised against' will not be CBI,
    and are necessarily at least shared within SIEF.

-   [Information on waste]{.underline} generally will be CBI, as it
    allows cost price determination. It is generally neither published,
    nor shared.

## Exposure information (Annex VI.6)  {#exposure-information-annex-vi.6 .Heading_L3}

Exposure information normally is not CBI. However, it may be fairly easy
to touch on CBI issues when special exposure scenarios need to be
discussed, as that may reveal specific uses. The exposure scenarios are
to be submitted separately but relevant information has to be exchanged
in a SIEF.

# Joint Submission of Data {#joint-submission-of-data .Heading_L2}

The SIEF will assemble as one part of its output a joint section of the
registration dossier with items according to Article 10(a)(iv), (vi),
(vii), and (ix), including an agreement on Classification and Labelling
(C&L). Further, guidance on safe use (Article 10(a)(v)), and a Chemical
Safety Report (CSR) (Article 10(b)) can be submitted jointly. The
information submitted is published, and non-CBI. The full studies may be
CBI, and both the data submitted, and the underlying studies can be
otherwise protected (see separate annex).

## Annex VII to X information  {#annex-vii-to-x-information .Heading_L3}

The main aim of the SIEF is for potential registrants to share the data
required in Annexes VII to X. These Annexes refer to the
physico-chemical, toxicological and eco-toxicological data that must be
submitted at Registration. REACH requires registrants to submit (robust)
study summaries of the data and requires registrants to be in legitimate
possession or have a letter of access to the underlying data.

Even if the data themselves may not be CBI, requests made within a SIEF
for a given piece of information will identify the tonnage band, which
could be CBI.

As regards the Annex VII to X data once registered with the ECHA:

-   End point information will be made public.

-   The (robust) study summaries are published unless CBI is claimed.
    The information is mandatory for a joint submission.

-   The full study report will not be disclosed, and can be CBI. The
    full studies will be shared (to some extent) within the SIEF,
    subject to cost sharing.

## Classification and Labelling (Annex VI.4)  {#classification-and-labelling-annex-vi.4 .Heading_L3}

Classification and labelling (C&L) information is public. Of course,
information necessary to determine C&L, and to determine whether
registrants can agree on the same set of C&L categories is likely to be
CBI. The SIEF members should agree on C&L, hence this information needs
to be shared within the SIEF.

## Guidance on safe use (Annex VI.5) {#guidance-on-safe-use-annex-vi.5 .Heading_L3}

Guidance on safe use is to be made public but information necessary to
determine the guidance is likely to be CBI. Further, the guidance may be
submitted jointly.

#  {#section-16 .Heading_L2}

(1) 

```{=html}
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a)  
b)  

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(2) 

# **Request to keep secret:** According to Art 119(2) on electronic public access, certain information (**see List 3**) will be kept secret by the ECHA if justification of opt out is accepted, as to why publication is potentially harmful for commercial interest, for the registrant, or the other party. Art. 10(a)(xi) allows to request which information of 119(2) should be kept secret, including justification. However REACH does not provide further guidance on what is a publication "potentially harmful for commercial interest, for himself, or other concerned party" and the applicant will have to demonstrate potential harm. {#request-to-keep-secret-according-to-art-1192-on-electronic-public-access-certain-information-see-list-3-will-be-kept-secret-by-the-echa-if-justification-of-opt-out-is-accepted-as-to-why-publication-is-potentially-harmful-for-commercial-interest-for-the-registrant-or-the-other-party.-art.-10axi-allows-to-request-which-information-of-1192-should-be-kept-secret-including-justification.-however-reach-does-not-provide-further-guidance-on-what-is-a-publication-potentially-harmful-for-commercial-interest-for-himself-or-other-concerned-party-and-the-applicant-will-have-to-demonstrate-potential-harm. .Heading_L2}

#  {#section-17 .Heading_L2}

# POSSIBLE CBI ISSUES RELATED TO EXCHANGE OF INFORMATION WITH PARTIES OTHER THAN POTENTIAL REGISTRANTS {#possible-cbi-issues-related-to-exchange-of-information-with-parties-other-than-potential-registrants .Heading_L2}

One of the most commercially sensitive issues relates to the customers,
uses and other issues vertically in the supply chain.

Downstream users (independently of those which must register substances
as importers of preparations, or of components of preparations) may
(Article 37):

-   inform the manufacturer or importer (or supplier) of their uses of a
    substance ("identified use") or specific process;

-   make available their own studies or data; and

-   provide this or other information to a manufacturer or importer, in
    order to allow these suppliers to prepare exposure scenarios for a
    CSA, and subsequently a CSR to be annexed to the SDS (Article 34).

Nevertheless, customers or downstream users themselves could be in a
position where they do not want to disclose some specific uses or
specific processes, because this would highlight confidential
information or facts prejudicial to the best interests of the downstream
user company.

# Visibility of parties involved {#visibility-of-parties-involved .Heading_L2}

REACH-IT envisages that third parties (downstream users), or others that
may have relevant information) will be visible to pre-registrants.
Conversely, the third parties will not know who pre-registrants
(manufacturers and importers) are.

From the manufacturers/importers to the third parties, this is
sufficient 'protection'. For downstream users being visible to the
manufacturers/importers may raise a potential CBI issue, as not all
downstream users will be known by all manufacturers and importers.

**Recommendation**: Where a downstream users wants to keep its
confidentiality, it can either not participate in a SIEF, or use a third
party representative (Art. 4) to preclude disclosure of its identity.

1.  []{#__RefHeading___Toc165901051 .anchor}Information on Safety Data
    Sheets (Art. 31) and other information (Art. 32-33) to Downstream
    Users

As this information is commonly supplied at this moment, no new CBI
issues should arise; also because information is supplied to own
customers.

# Communication of Information on uses {#communication-of-information-on-uses .Heading_L2}

Under the REACH Regulation, downstream users have to disclose
information in order to ensure the registration of their uses of a
substance, on its own or in a preparation.

A downstream users may specify a use to the manufacturer, importer, DU
or distributor who supplies him with the substance on its own or in a
preparation (supplier) with the aim to making this an identified use
(Article 37.2).

Disclosure of a use to his supplier may in itself be sensitive, as it
may be commercially valuable information, for instance in the case where
the substance is used in a unique and innovative process, or the use is
different from that of competitors for the same substance.

The disclosure of a use may become an issue also for the suppliers, not
just for the DUs, as this may disclose a competitive advantage of one
supplier over his competitors. The use of a substance covered in the
registration file of a manufacturer may indirectly let his competitors
know that he trades this substance, while they don't. The issue may
arise at the other end of the supply chain with a distributor not being
willing to let suppliers know the uses or users. The problem becomes all
the more crucial when it comes to SMEs, whose business may rely on niche
uses of substances.

DUs are given the possibility to submit separately to the Agency
information on uses of a substance which has been registered (Article
38.1) and could therefore use this possibility for a substance whose use
they feel would be commercially too sensitive to disclose by liaising
with their suppliers.

For phase-in substances, DUs are given the possibility to react to the
publication of pre-registered substances by notifying the Agency of
their interest in the substance. The DU cannot determine whether his
supplier is pre-registering his substance. The DU will have to request
that information directly from his supplier. In contrast, the Agency
provides on request to potential registrants the contact details of the
DUs, to which the pre-registrant might not otherwise have access.

In making the use known, the DU must supply some information on the use
(Article 37.2). He must as a minimum, give a brief description of the
use, and also provide sufficient information to allow the supplier he is
informing to prepare an exposure scenario, or, if appropriate a use and
exposure category, which will be included in the supplier's chemical
safety assessment.

A Downstream User of a substance on its own or in a preparation has to
prepare a chemical safety report (Article 37 (4)) for any use outside
the conditions described in the exposure scenario/use and exposure
category communicated to him in a Safety Data Sheet or for any use his
supplier advises against. For phase-in substances such information would
be disclosed to the other participants of a SIEF if the supplier decides
to submit jointly a chemical safety report for substances
manufactured/imported over 10 tonnes per year.

The information on uses provided by the DU in the exposure scenarios and
the CSR may disclose to the supplier related CBI information, such as
the protocol by which the exposure scenario was developed. In this case,
it is advised to use a proper secrecy agreement.

The determination of the sameness of substances, as well as the
classification & labelling of substances can also be susceptible to CBI
issues. The impurity profile, which may in certain cases lead to a
different C&L for a substance, can allow the competitors of the
manufacturer/ importer access to valuable information on the profile of
the substance the DU uses as well as the processing route.

Summarizing: the DU is free to choose whether he supplies information to
the Agency, his supplier, as SIEF member or by himself. Although not
participating in a SIEF generally will be more expensive, it is for the
DU to choose its course of action, by virtue of which it can protect its
CBI. It would also be possible to share certain information for exchange
within a SIEF under a proper confidentiality agreement. Furthermore, the
DU can supply information through a third party representative.

13. []{#__RefHeading___Toc165901053 .anchor}POSSIBLE MEANS OF EXCHANGE
    WHILE PROTECTING CBI: CONFIDENTIALITY AND NON-USE AGREEMENTS

[To be developed]{.mark}

The above description is limited to necessary exchange/submission of
information. Often, it can be useful or it may even be necessary to
share more information according to Annex VI, 'Step 1'. In case SIEF
participants need to share further information, CBI can be protected
with proper agreements. Proper agreements to protect CBI may be:

> \(1\) Confidentiality Agreements that bind companies (and an undefined
> group of persons within a company will be able to access information /
> documents exchanged).
>
> \(2\) Confidentiality Agreements that limit access to documents or
> other information to specific named persons, or departments, e.g. only
> the persons working within a regulatory section are allowed to see
> certain information. This can be strengthened with using additional
> personal confidentiality agreements.
>
> \(3\) In addition to (1) or (2), one can agree to allowing access to
> certain documents in a 'reading room' only (copying is not allowed).
>
> \(4\) In addition to the above, one can agree to have certain
> documents reviewed and/or assessed by a third party expert
> (independent consultant), and no-one from the other SIEF participants
> will see such documents.

Generally, Confidentiality Agreements (Non-Disclosure and Non-Use
Agreement) will comprise clauses on receiving, collecting, recording and
aggregating confidential information, and may define specific internal
rules and procedures to effectively protect confidential data. In the
document on competition law \[\], further examples are presented on ways
to cooperate properly.

Table 1 information requirements and CBI

  ---------------- ------------------ ----------- -- ----------------- -------------- --------------- -------------------
  **REACH Annexes  **Information      **Annex        **INFORMATION     **Joint/       **CBI**         **published by
  VI-X**           required**         Reference      POINT             separate                       agency**
                                      Point**        (abbreviated,     submission**                   
                                                     refer to text for                                
                                                     full                                             
                                                     description)**                                   

  ** **            ** **              ** **          ** **             ** **          ** **           **apart from info
                                                                                                      on sds 11.2.d**

  **VI. General    **1.Registrant     **1.1.1**      **Registrant      **S**          **can be cbi,   **no; but known in
  registration     general                           name, address,                   but only in     SIEF**
  information      information**                     telephone number,                combination     
  requirements**                                     fax number and                   with further    
                                                     e-mail address**                 information**   

  ** **            ** **              **1.1.2**      **Registrant      **S**          ** See 1.1.1**  ** See 1.1.1**
                                                     contact person**                                 

  ** **            ** **              **1.1.3**      **Location of the **S**          **can be cbi**  **no**
                                                     registrant\'s                                    
                                                     production and                                   
                                                     own use site(s),                                 
                                                     as appropriate**                                 

  ** **            ** **              **1.2**        **Joint           **S**          **can be cbi**  **no; but known in
                                                     submission of                                    SIEF**
                                                     data: lead                                       
                                                     registrant                                       
                                                     identifies all                                   
                                                     other registrants                                
                                                     and parts of                                     
                                                     registration                                     
                                                     which apply to                                   
                                                     other                                            
                                                     registrants;                                     
                                                     other registrant                                 
                                                     identifies the                                   
                                                     lead registrant                                  
                                                     and relevant                                     
                                                     parts of his                                     
                                                     registration**                                   

  ** **            ** **              **1.3.1**      **Third party     **S**          **no cbi**      **no; but known in
                                                     representative                                   SIEF**
                                                     name, address,                                   
                                                     telephone number,                                
                                                     fax number and                                   
                                                     e-mail address**                                 

  ** **            ** **              **1.3.2**      **Third party     **S**          **See 1.3.1**   ** See 1.3.1**
                                                     representative                                   
                                                     contact person**                                 

  ** **            **2.               **2.1**        **Name /          **S**          **can be cbi**  **119.2.e;
                   Identification of                 identifiers of                                   published after
                   the substance**                   each substance**                                 preregistration**

  ** **            ** **              **2.1.1**      **IUPAC Name**    **S**          **see 2.1**     **119.1.a,f,g (if
                                                                                                      dangerous)**

  ** **            ** **              **2.1.2**      **Other names**   **S**          **see 2.1**     ** See 2.1**

  ** **            ** **              **2.1.3**      **EINECS / ELINCs **S**          **see 2.1**     **119.1.b and see
                                                     number**                                         2.1**

  ** **            ** **              **2.1.4**      **CAS name / CAS  **S**          **see 2.1**     ** See 2.1**
                                                     number**                                         

  ** **            ** **              **2.1.5**      **Other identity  **S**          **see 2.1**     ** See 2.1**
                                                     code**                                           

  ** **            ** **              **2.2.1**      **Molecular and   **S**          **can be cbi**  ** **
                                                     structural                                       
                                                     formula**                                        

  ** **            ** **              **2.2.2**      **Information on  **S**          **see 2.2.1**   ** **
                                                     optical activity                                 
                                                     and typical ratio                                
                                                     of (stereo)                                      
                                                     isomers**                                        

  ** **            ** **              **2.2.3**      **Molecular       **S**          **see 2.2.1**   ** **
                                                     weight /                                         
                                                     molecular weight                                 
                                                     range**                                          

  ** **            ** **              **2.3.1**      **Degree of       **S**          **generally     **if essential to
                                                     purity (%)**                     cbi**           C&L 119.2.a**

  ** **            ** **              **2.3.2**      **Nature of       **S**          **generally     ** **
                                                     impurities /                     cbi**           
                                                     isomers and                                      
                                                     by-products**                                    

  ** **            ** **              **2.3.3**      **Percentage of   **S**          **generally     ** **
                                                     (significant)                    cbi**           
                                                     main impurities**                                

  ** **            ** **              **2.3.4**      **Information on  **S**          **generally     ** **
                                                     additives etc**                  cbi**           

  ** **            ** **              **2.3.5**      **Spectral data** **S**          **can be cbi**  ** **

  ** **            ** **              **2.3.6**      **HPLC / GC**     **S**          **can be cbi**  ** **

  ** **            ** **              **2.3.7**      **Description of  **S**          **can be cbi**  **as far as this
                                                     the analytical                                   overlaps with
                                                     methods etc to                                   119.1.h**
                                                     allow the methods                                
                                                     to be                                            
                                                     reproduced**                                     

  ** **            **3. Information   **3.1**        **Overall annual  **S**          **generally     ** To be kept
                   on manufacture and                manufacture                      cbi**           secret Art 118**
                   use(s) of the                     and/or imports                                   
                   substance(s)**                    volumes                                          
                                                     (estimated                                       
                                                     quantity in year                                 
                                                     of                                               
                                                     registration)**                                  

  ** **            ** **              **3.2**        **Brief           **S**          **can be cbi**  ** **
                                                     description of                                   
                                                     the technological                                
                                                     process used in                                  
                                                     manufacture**                                    

  ** **            ** **              **3.3**        **Tonnage band    **S**          **can be cbi**  **119.2.b**
                                                     (indication) for                                 
                                                     his own use(s)**                                 

  ** **            ** **              **3.4**        **Form            **S**          **can be cbi**  ** **
                                                     (substance,                                      
                                                     preparation or                                   
                                                     article) and/or                                  
                                                     physical state                                   
                                                     under which the                                  
                                                     substance is made                                
                                                     available to                                     
                                                     downstream                                       
                                                     users.**                                         

  ** **            ** **              **3.4**        **Concentration   **S**          **can be cbi**  ** **
                                                     or concentration                                 
                                                     range of the                                     
                                                     substance in                                     
                                                     preparations made                                
                                                     available to                                     
                                                     downstream users                                 
                                                     and quantities of                                
                                                     the substance in                                 
                                                     articles made                                    
                                                     available to                                     
                                                     downstream                                       
                                                     users**                                          

  ** **            ** **              **3.5**        **Brief General   **S**          **can be cbi**  ** **
                                                     description of                                   
                                                     the identified                                   
                                                     use(s)**                                         

  ** **            ** **              **3.6**        **Information on  **S**          **generally     ** **
                                                     waste quantities                 cbi**           
                                                     and compostion of                                
                                                     waste resulting                                  
                                                     from production**                                

  ** **            ** **              **3.6**        **Information on  **S**          **can be cbi**  ** **
                                                     waste quantities                                 
                                                     and compostion of                                
                                                     wasteresulting                                   
                                                     from identified                                  
                                                     uses**                                           

  ** **            ** **              **3.7**        **Uses advised    **S**          **no cbi**      ** **
                                                     against**                                        

  ** **            **4.               **4.1**        **Hazard          **MJ**         **no cbi**      **119.1.c**
                   Classification and                classification                                   
                   labelling**                       resulting from                                   
                                                     the application                                  
                                                     of 67/548/EEC**                                  

  ** **            ** **              **4.2**        **Hazard label**  **MJ**         **no cbi**      ** **

  ** **            ** **              **4.3**        **Specific        **MJ**         **no cbi**      ** **
                                                     concentration                                    
                                                     limits**                                         

  ** **            **5. Guidance on   **5**          **all of 5**      **OJ**         **no cbi**      **119.1.9**
                   safe use**                                                                         

  ** **            **6. Exposure      **6.1**        **Main use        **S**          **no cbi**      ** **
                   information for                   category                                         
                   substances in                     (industrial,                                     
                   quantities 1-10                   professional,                                    
                   tonnes/year per                   consumer)**                                      
                   manufacturer or                                                                    
                   importer**                                                                         

  ** **            ** **              **6.1.2**      **Specification   **S**          **can be cbi**  ** **
                                                     for industrial                                   
                                                     and professional                                 
                                                     use**                                            

  ** **            ** **              **6.2**        **Significant     **S**          **can be cbi**  **end point 119.d
                                                     route(s) of                                      and (robust) study
                                                     exposure**                                       summary 119.2.c**

  ** **            ** **              **6.2.2**      **Environmental   **S**          **can be cbi**  ** **
                                                     exposure**                                       

  ** **            ** **              **6.3**        **Pattern of      **S**          **can be cbi**  ** **
                                                     exposure**                                       

  **VII. Standard  **7. Information   **7.1**        ** **             **MJ**         **end point     ** **
  infromation      on the                                                             generally not   
  requirements for physicochemical                                                    cbi; study      
  substances in    properties of the                                                  report, and in  
  quantities of 1  substance**                                                        particular full 
  tonne or more**                                                                     study report    
                                                                                      may be cbi, if  
                                                                                      info is tied to 
                                                                                      defined         
                                                                                      substance**     

  ** **            **8. Toxicological **8.1**        ** **             **MJ**         **end point     **end point 119.1.e
                   information**                                                      generally not   and (robust study
                                                                                      cbi; study      summary 119.2.c**
                                                                                      report, and in  
                                                                                      particular full 
                                                                                      study report    
                                                                                      may be cbi, if  
                                                                                      info is tied to 
                                                                                      defined         
                                                                                      substance**     

  ** **            **9.               **9.1.1**      ** **             **MJ**         ** **           ** **
                   Ecotoxicological                                                                   
                   information**                                                                      

  **VIII.          **8. Additional    **8.4.2**      ** **             **MJ**         **see 7; the    ** **
  Additional       toxicological                                                      fact that this  
  standard         information**                                                      info has to be  
  information for                                                                     supplied shows  
  substances in                                                                       tonnage band,   
  quantities of 10                                                                    which may be    
  tonnes or more**                                                                    cbi**           

  ** **            **9. Additional    **9.1.3**      ** **             **MJ**         **see 7**       ** **
                   ecotoxicological                                                                   
                   information**                                                                      

  **IX. Additional **7. Additional    **7.15**       ** **             **MJ**         **see 7; the    ** **
  standard         information on the                                                 fact that this  
  information for  physicochemical                                                    info has to be  
  substances in    properties of the                                                  supplied shows  
  quantities of    substance**                                                        tonnage band,   
  100 tonnes or                                                                       which may be    
  more**                                                                              cbi**           

  ** **            **8. Additional    **8.6.2**      ** **             **MJ**         **see 7**       **end point 119.1.e
                   toxicological                                                                      and (robust study
                   information**                                                                      summary 119.2.c**

  ** **            **9. Additional    **9.1.5**      ** **             **MJ**         **see 7**       ** **
                   ecotoxicological                                                                   
                   information**                                                                      

  **X. Additional  **8. Additional    **8.7.2**      ** **             **MJ**         **see 7; the    ** **
  standard         toxicological                                                      fact that this  
  information for  information**                                                      info has to be  
  substances in                                                                       supplied shows  
  quantities of                                                                       tonnage band,   
  1000 tonnes or                                                                      which may be    
  more**                                                                              cbi**           

  **Submission                                                                                        
  requirements: MJ                                                                                    
  = mandatory                                                                                         
  joint                                                                                               
  submission; OJ =                                                                                    
  optional joint                                                                                      
  submission; S =                                                                                     
  to be supplied                                                                                      
  separately**                                                                                        
  ---------------- ------------------ ----------- -- ----------------- -------------- --------------- -------------------

**List 3: CBI on information for which publication is potentially
harmful for the commercial interest of the registrant or any other party
concerned (Article 119(2))**

a)  if essential to classification and labeling, the degree of purity of
    the substance and the identity of impurities and/or additives which
    are known to be dangerous;

b)  the total tonnage band (i.e. 1-10 tonnes, 10-100 tonnes, 100-1000
    tonnes or over 1000 tonnes) within which a particular substance has
    been registered;

c)  the study summaries or robust study summaries of the result of each
    toxicological or ecotoxicological study; as well as physicochemical
    data concerning the substance and on pathways and environmental
    fate;

d)  information other than that listed in[....]{.mark}contained in the
    safety data sheet;

e)  the trade name(s) of the substance;

f)  the name in the IUPAC Nomenclature for non-phase-in substances which
    are dangerous with the meaning of Directive 67/548/EEC for a period
    of 6 years;

g)  the name in the IUPAC Nomenclature for dangerous substance within
    the meaning of Directive 67/548/EEC that are only used as one or
    more of the following:

-   as an intermediate;

-   in scientific research and development;

-   in product and process oriented research and development;

    []{#__RefHeading___Toc165901054 .anchor}Annex 3 --EC COMPETITION LAW

1.  []{#__RefHeading___Toc165901055 .anchor}INTRODUCTION

# Could Competition law apply to REACH activities? {#could-competition-law-apply-to-reach-activities .Heading_L2}

**YES,** as it is expressly stated in the REACH Regulation *"this
Regulation should be without prejudice to the full application of the
Community competition rule."* (Recital 48). Therefore, rules of
Competition law adopted at Community level (hereinafter EC Competition
law), but also at national level may apply to REACH and all related
activities, including data sharing.

This guidance on EC competition law rules is intended to help the REACH
actors to assess the compatibility of their activities for sharing data
and exchange of information.

Although the focus of this guidance is on exchange of information this
does not exclude however that EC Competition law may apply to other
aspects of REACH related activities.

Data sharing and information exchange may occur at the different steps
of the REACH procedure (eg during pre-Registration, and/or pre-SIEF,
and/or SIEF). This guidance is only limited to the "most common types of
questions" related thereto.

Furthermore, this guidance may apply to any form of co-operation that
actors may decide to adopt to fulfil their obligations and co-operate
under REACH; including consortia (see Chapter 10).

REACH actors should always ensure that their activities comply with EC
Competition law whatever the form of co-operating that they choose.

1.  []{#__RefHeading___Toc165901060 .anchor}EC Competition law in brief

EC Competition law is not intended to inhibit legitimate activities of
companies, such as those with commitments under the REACH Regulation.
Its objective is to protect competition on the market as a means of
enhancing consumer welfare. Therefore, agreements between companies or
decisions by associations or concerted practices which may affect trade
between Member States and which have as their object or effect the
prevention, restriction or distortion of competition within the common
market are prohibited (Article 81 of the EC Treaty -- *see attachment*).

Any agreement that infringes Article 81 is void and unenforceable.
Besides this, companies that have implemented conduct in breach of
Article 81 may face fines, in case of an investigation by a competent
national or European competition authority. Such investigation may be
initiated either by the authority itself, following a complaint by a
third party or even, by a party to the agreement applying for leniency.

For more information on EC Competition law, refer to the Commission
Directorate General Competition's web site...

14. []{#__RefHeading___Toc165901061 .anchor}EXCHANGE OF INFORMATION
    UNDER REACH AND EC COMPETITION LAW

The REACH Regulation encourages the sharing of information between
companies *"in order to increase the efficiency of the registration
system, to reduce costs and to reduce testing on vertebrate animals"*
(Recital 33); it also mentions that SIEFs are aimed to *"help exchange
of information on the substances that have been registered"* (Recital
54).

REACH provides for significant flows of information between actors, at
various stages throughout its implementation process, for example: for
phase-in substances in the pre-registration and the pre-SIEF stage;
within SIEF (including for classification and labelling); during the
inquiry for non-phase-in and phase-in substances, which have not been
pre-registered, in order to evaluate if a substance has already been
registered; in the context of information to be shared between
Downstream Users and their suppliers and in the context of joint
registration (see Chapters......).

Actors have to make sure that their exchanges do not go beyond what is
required under REACH in a manner that would be contrary to competition
law, as explained below:

-   Firstly, actors must avoid any illegal activity (eg creating
    cartels) when complying with REACH (2.1).

-   Secondly, actors should restrict the scope of their activity to what
    is strictly required by REACH to avoid creating unnecessary risks of
    infringing Article 81 (2.2).

-   Thirdly, if actors have to exchange information which is sensitive
    under competition law, then it is advisable that they use
    "precautionary measures" to prevent infringement (2.3).

# Avoiding misuse of REACH exchange of information to conduct cartels  {#avoiding-misuse-of-reach-exchange-of-information-to-conduct-cartels .Heading_L2}

A cartel is an illegal agreement (either formal or informal) between
competitors who collaborate to fix prices or restrict supply or their
production capacities or divide up markets or consumers and that, in
general, shield the participants from competition.

[Examples of activities to be avoided between competitors or related
actors in the distribution chain:]{.underline}

-   Fixing the prices of products or conditions of sale;

-   Limiting production, fixing production quotas or limiting the supply
    of products to the markets;

-   Dividing up the market or sources of supply, either geographically
    or by class of customers;

-   Limiting or controlling investments or technical developments.

**Recommendation:** Exchange of information under REACH should not to be
used by participants to organise or cover the operation of a cartel

**2.2 The scope of the activities should be limited to what is necessary
under REACH**

It is important to ensure that the exchange of information under REACH
is limited to what is required under REACH itself.

Article 25.2 of the REACH Regulation gives examples of information which
must not be exchanged: *"Registrants shall refrain from exchanging
information concerning their market behaviour, in particular as regards
production capacities, production or sales volumes, import volumes or
market share."*

[Examples of information which must not be exchanged under
REACH:]{.underline}

-   Individual company prices, price changes, terms of sales, industry
    pricing policies, price levels, price differentials, price
    marks-ups, discounts, allowances, credit terms etc;

-   Costs of production or distribution etc;

-   Individual company figures on sources of supply costs, production,
    inventories, sales etc;

-   Information as to future plans of individual companies concerning
    technology, investments, design, production, distribution or
    marketing of particular products including proposed territories or
    customers;

-   Matters relating to individual suppliers or customers, particularly
    in respect of any action that might have the effect of excluding
    them from the market.

Actors should also refrain from exchanging technical information if this
exchange is not necessary under REACH where this technical data may
provide the competitors the ability to define individual company
information enabling competitors to align their market behavior.

Participants should restrict the scope of their exchange of information
strictly to what is required for REACH activities.

# Type of information to be exchanged with caution  {#type-of-information-to-be-exchanged-with-caution .Heading_L2}

Even if most of the information to be exchanged under REACH is unlikely
to be problematic under EC Competition law rules (because for the most
part, this information is purely scientific or technical, and it cannot
really enable competitors to align their market behavior) there may be
cases where actors need to be especially careful.

In particular, actors may be induced to exchange individual production,
import or sales volumes between them. For example, in the context of a
joint CSA/CSR actors may want to know the total count of volumes by
adding up their individual production volumes in order to estimate the
release into the environment. Actors may also want to share costs based
on their individual production or sales volumes.

In 2.3.1 and 2.3.3 below, guidance is given on how to avoid that the
exchange of such volume information, to the extent that it is at all
necessary and opportune under REACH, constitutes an infringement of
Article 81.

**2.3.1 Reduce frequency of exchange**

Exchanges of individual volume information between actors taking place
only once or sporadically (e.g. once every several years) are unlikely
to give rise to competition problems because they would not seem to
allow exchanging parties to align market behaviour.

Recommendation: Actors to exchange information only once or, as
explained above, on very sporadic occasions. If this is not possible or
unclear, actors are recommended to consider the further guidance below

**2.3.2 Reference to bands rather than individual figures when
feasible**

The REACH Regulation mentions that *"Requirements for generation of
information on substances should be tiered according to the volumes of
manufacture or importation of a substance, because these provide an
indication of the potential for exposure of man and the environment to
the substance, and should be described in detail"* (Recital 34), thus
indicating the use of tonnage bands.

Recommendation: Actors to refer to their respective tonnage band as
defined under REACH and not to exchange individual or more detailed
figures

**2.3.3 Use of precautionary measures if individual sensitive
information would still be exchanged**

If under particular circumstances, actors need to either use individual
figures or aggregates of these individual figures (for example at the
occasion of the carrying out of CAR/CSR) it is recommended do so via a
independent third party or trustee

[Who could be a third independent party?]{.underline} A legal or natural
person not directly or indirectly linked to a manufacturer/importer or
their representatives. This third party (hereinafter the person) may be
for example a consultant, a law firm, a laboratory, a
European/international organization, a company, etc. The person will not
necessarily represent any actor but, is hired by the participants to a
SIEF for example to help them for certain activities. It is advisable
that the person signs a confidentiality agreement as it is important
that the person undertakes not to disclose the sensitive information
received (to the participating companies or anyone else), and also
undertakes to preserve confidentiality (see Chapter 6 and Annex 2).
Actors may also decide to use the services of such person even if
competition law rules are not concerned but, there is a need to preserve
the CBI when data is exchanged.

[Activities to be facilitated by using a trustee]{.underline} [for
competition law purposes:]{.underline}

-   [Produce aggregated anonymous figures:]{.underline} When the actors
    are willing to refer to a figure made of an aggregation of sensitive
    individual figures, the person will send questionnaires to the
    participants who would send back their inputs. All input will be
    collated, checked and aggregated into a composite return that does
    not give the possibility of deducing individual figures (by having a
    minimum of three real inputs for example).

-   [Calculation of cost allocation based on individual figures for cost
    sharing:]{.underline} Where actors decide that for all or part of
    their cost sharing these are based on actual individual figures
    (e.g. production volumes or sales volumes) the person will send a
    questionnaire to each of the individual participants, collect
    related confidential individual information, and send to each
    participant an invoice corresponding to their particular amount. The
    receiving company would be the only one to see their particular
    share of the total amount to be paid.

-   [Sending sensitive information from individual companies to the
    authorities, without circulating it to the other
    participants:]{.underline} The person would produce a non
    confidential version of the same document for the competing
    companies or the public including only the non-sensitive
    information.

15. []{#__RefHeading___Toc165901064 .anchor}RECOMMENDED TIPS FOR REACH
    ACTORS WHEN WORKING TOGETHER

+-------------------+--------------------------------------------------+
| **Competition     | Ensure that before entering into an exchange of  |
| compliance**      | information under REACH you have read the        |
|                   | guidance and that you will apply it.             |
|                   |                                                  |
|                   | In case of doubt, or questions, please seek      |
|                   | advise (eg from legal advisor).                  |
|                   |                                                  |
|                   | Adopt rules on competition compliance (for       |
|                   | example from a company, a trade organization, or |
|                   | a law firm). Keep the rules handy and refer to   |
|                   | them when working with other participants,       |
|                   | either in meetings, conference calls, using      |
|                   | electronic means (eg intranet), and social       |
|                   | gathering.                                       |
+-------------------+--------------------------------------------------+
| **Record          | Prepare agendas and minutes for conference calls |
| keeping**         | or meetings which accurately reflect the matters |
|                   | and discussions which are adopted by the         |
|                   | participants.                                    |
+-------------------+--------------------------------------------------+
| **Vigilance**     | Limit your discussion or meeting activities to   |
|                   | the circulated agenda.                           |
|                   |                                                  |
|                   | Protest against any inappropriate activity or    |
|                   | discussion (whether it occurs during meetings,   |
|                   | conference calls or when working via electronic  |
|                   | means - for example using a dedicated intranet). |
|                   | Ask for these to be stopped; dissociate yourself |
|                   | from these and have your position clearly        |
|                   | expressed in writing, including in the minutes.  |
+-------------------+--------------------------------------------------+

**[Important Note:]{.underline}** Readers of this guidance should not
presume that they know all there is to know about competition law just
by reading this document.

This guidance is designed to allow REACH participants to make a
preliminary assessment of their conduct under competition law rules.

This Guidance has no intent to substitute the applicable competition law
provisions, as these have been interpreted by the European Commission
and the European Courts.

This Guidance is designed in a generic way and thus it does not and it
cannot cover all the different scenarios that may arise from the
data-sharing obligations provided by REACH.

16. []{#__RefHeading___Toc165901065 .anchor}Appendix -- Article 81 of
    the EC Treaty

*1. The following shall be prohibited as incompatible with the common
market: all agreements between undertakings, decisions by associations
of undertakings and concerted practices which may affect trade between
Member States and which have as their object or effect the prevention,
restriction or distortion of competition within the common market, and
in particular those which:*

*(a) directly or indirectly fix purchase or selling prices or any other
trading conditions;*

*(b) limit or control production, markets, technical development, or
investment;*

*(c) share markets or sources of supply;*

*(d) apply dissimilar conditions to equivalent transactions with other
trading parties, thereby placing them at a competitive disadvantage;*

*(e) make the conclusion of contracts subject to acceptance by the other
parties of supplementary obligations which, by their nature or according
to commercial usage, have no connection with the subject of such
contracts*\".

*2. Any agreements or decisions prohibited pursuant this Article shall
be automatically void.*

*3. The provisions of paragraph 1 may, however, be declared inapplicable
in the case of:*

*-any agreement or category of agreements between undertakings;*

*-any decision or category of decisions by associations of
undertakings;*

*-any concerted practice or category of concerted practices;*

*which* *contributes to improving the production or distribution of
goods or to promoting technical or economic progress, while allowing
consumers a fair share of the resulting benefit, and which do not:*

*(a) impose on the undertakings concerned restrictions which are not
indispensable to the attainment of these objectives;*

*(b) afford such undertakings the possibility of eliminating competition
in respect of a substantial part of the products in question*".

[]{#__RefHeading___Toc165901066 .anchor}Annex 4 -- Cost Sharing

1.  []{#__RefHeading___Toc165901067 .anchor}BASIC PRINCIPLES FOR DATA
    AND COST SHARING

A key objective of REACH is to avoid unnecessary testing, especially
vertebrate animal testing. Replicate animal testing must be avoided and
new tests on vertebrate animals should only be undertaken as a last
resort (Article 25). To meet this objective, data sharing mechanisms
have been developed and incorporated into the legislation (Title III:
Data sharing and avoidance of unnecessary testing). With respect to data
sharing under REACH, information must be shared for the same substance
for all tests on vertebrate animals. Information not involving tests on
vertebrate animals must also be shared if requested by a potential
registrant of the same substance. As data gathering induces costs data
sharing implies some form of cost sharing. As required under the REACH
Regulation parties sharing data must make every effort to ensure that
cost sharing is determined in a ***fair, proportionate and
non-discriminatory way. This is*** particularly important in relation to
small and medium sized enterprises.

In general, it is recommended that an agreement on cost sharing is
reached prior to the disclosure of any available information by each
participant (see Chart III, section 5.3). To facilitate this, a number
of steps with respect to addressing data quality, study valuation and
final cost allocation need to be considered. The most important of these
aspects are dealt with in the following sections but it should be
recognized that **these are not intended to be either prescriptive or
mandatory**. They should serve rather primarily as a checklist or prompt
for agreements in order to ensure that all interested parties identify
relevant factors when organizing study valuations and cost sharing
activities.

For cost sharing within the context of a SIEF, two scenarios may be
foreseen as described below:

-   Spot purchase of a single study to fill an endpoint gap (the
    \"individual route\", as described in Section 5.5)

-   Cost sharing for a range of studies reflecting the comprehensive
    dataset for the endpoint (the \"collective route\", as described in
    Section 5.4)

In view of the need ultimately to generate a Lead Registrant data
package and the intention then that this consolidated dataset should
form the basis for subsequent risk assessment for all compliant parties,
it is expected that the latter route will in practice be most commonly
adopted for cost sharing purposes. Nevertheless, in circumstances where
a registrant may opt-out of from the joint submission of data, single
studies may still need to be shared in order to fulfil endpoint data
gaps. In this Annex on Cost Sharing section below, both scenarios are
accordingly addressed.

Prior to undertaking a data valuation exercise, it is assumed that a
number of associated issues would have already been resolved. These
might include agreeing substance equivalence and classification and
labelling position(s) and resolving any accompanying CBI points and
liability issues. Further information on these highly relevant points
can be found in the main body of the Guidance Document.

17. []{#__RefHeading___Toc165901068 .anchor}DATA QUALITY

# Reliability -- Relevance -- Adequacy  {#reliability-relevance-adequacy .Heading_L2}

A prerequisite for the valuation of existing studies is to establish
their scientific quality.

In line with **OECD guidance**, the process of determining the quality
of existing data should take into consideration three aspects -
adequacy, reliability and relevance of the available information to
describe a given element. These terms were defined by **Klimisch** **et
al.** **(1997)** along the following lines:

**Reliability** - evaluating the inherent quality of a test report or
publication relating to preferably standardized methodology and the way
the experimental procedure and results are described to give evidence of
the clarity and plausibility of the findings;

**Relevance** - covering the extent to which data and tests are
appropriate for a particular hazard identification or risk
characterization; and

**Adequacy** - defining the usefulness of data for hazard/risk
assessment purposes.

When there is more than one study for an endpoint, the greatest weight
is normally attached to the study that is the most reliable and
relevant. When determining reliability, this essentially relates to how
the study was carried out. Careful consideration must be made of the
quality of the study, the method, the reporting of the results, the
conclusions drawn and the results in order to be able to generate a
robust study summary.

There are several reasons why existing study data may be of variable
quality. Klimisch et al, 1997, have suggested the following:

-   the use of different test guidelines (compared with today\'s
    standards);

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-   the inability to characterize the test substance properly (in terms
    of purity, physical characteristics, etc.);

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-   the use of crude techniques/procedures which have since become
    refined; and

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-   the fact that certain information may have not been recorded (or
    possibly even measured) for a given endpoint, but that it has since
    been recognized as being important.

At least a minimal amount of information on the reliability of a given
study needs to be known before proceeding to determine its relevance and
adequacy for assessment purposes and before proceeding to develop a
robust study summary. The reliability of data is therefore a key initial
consideration which is needed to filter out unreliable studies, thus
allowing the focus to be on those considered most reliable. Without
knowledge of how the study has been conducted all further considerations
may be irrelevant.

# Data Valuation Approaches  {#data-valuation-approaches .Heading_L2}

Two approaches have been proposed by OECD to assist the initial
screening of study reports to set aside unreliable study data. Both are
compatible and may be used either alone or together when considering
data quality.

\(1\) The first approach is that developed by Klimisch et al. (1997).
This approach was developed as a scoring system for reliability,
particularly for ecotoxicological and health studies; however it may be
extended to physicochemical and environmental fate and pathway studies.

(2)The other approach was developed in 1998 as part of the US EPA HPV
Challenge Program. Other systems might also be identified for
consideration.

\(1\) Under the **first approach,** **Klimisch et al.** (1997),
developed a scoring system which can be used to categorize the
reliability of a study as follows:

> **1 = reliable without restrictions**: "studies or data\...generated
> according to generally valid and/or internationally accepted testing
> guidelines (preferably performed according to GLP) or in which the
> test parameters documented are based on a specific (national) testing
> guideline\...or in which all parameters described are closely
> related/comparable to a guideline method."
>
> **2 = reliable with restrictions**: "studies or data\...(mostly not
> performed according to GLP), in which the test parameters documented
> do not totally comply with the specific testing guideline, but are
> sufficient to accept the data or in which investigations are described
> which cannot be subsumed under a testing guideline, but which are
> nevertheless well documented and scientifically acceptable."
>
> **3 = not reliable**: "studies or data\...in which there were
> interferences between the measuring system and the test substance or
> in which organisms/test systems were used which are not relevant in
> relation to the exposure (e.g., unphysiologic pathways of application)
> or which were carried out or generated according to a method which is
> not acceptable, the documentation of which is not sufficient for
> assessment and which is not convincing for an expert judgment."
>
> **4 = not assignable**: "studies or data\....which do not give
> sufficient experimental details and which are only listed in short
> abstracts or secondary literature (books, reviews, etc.)."

The use of Klimisch codes provides a useful tool for organizing the
studies for further review. Studies, which failed to meet essential
criteria for reliability, would normally be initially set aside if
higher quality information is available.

**(2)** **The second approach** developed by the **US EPA** provides
more information than the Klimisch system by describing the key
reliability criteria for each group of data elements (see Table 1).
These criteria address the overall scientific integrity and validity of
the information in a study, i.e. reliability. This approach is
consistent with the Klimisch approach as any study which does not meet
the criteria in Table 1 would also not be assignable under the Klimisch
system. Such studies may, however, be considered later as supplementary
information to the overall assessment of a particular endpoint
particularly if there is no single key study.

When addressing relevance and adequacy, these aspects will be
facilitated by having a clear picture of the reliability of a study.
This is because at this stage, one or more key studies per endpoint will
have been identified and it will be clear whether full robust study
summaries can be prepared which can be used for judging relevance and
adequacy.

The use of tools for identifying reliable, relevant and adequate data
helps to ensure that high quality data are identified but this does not,
however, remove the need for a weight-of-evidence analysis approach
during the assessment of data.

Because of the nature of existing data, it is reasonable to expect that
there will be some cases in which several studies - some of which may
not have passed the initial screen, may be collectively used to address
an endpoint, thereby avoiding additional testing.

The pooling of several studies, one or more of which alone may be
inadequate to satisfy a specific element is therefore a way that a
weight-of-evidence analysis can be applied. For example, if several
repeated dose studies are available on a particular chemical it may be
that none would be acceptable by itself due to some protocol deficiency
(i.e., low number of test animals/dose group, only one dose group in
addition to control group, change in dose amount or frequency during the
course of the study, etc). Collectively, however, as the different
studies show effects in the same target organ at approximately the same
dose and time, this could be judged to satisfy the repeated dose
toxicity data element required.

All reports for consideration should ideally be documented as IUCLID V
datasets with a Robust Study Summary (if available). If the IUCLID V
file needs to be generated, however, this may be deferred until study
selection(s) for a given endpoint has been made. Generally, robust study
summaries would be prepared only for the highest quality or "key"
studies in a data evaluation exercise.

Criteria for accepting proposed studies / quality ratings should be
agreed in advance. This could recognize a self assessment approach by
study owners but in case any problems should arise, an arbitration
mechanism might need to be utilized. This could involve commissioning an
expert third party to evaluate the initial assessment. If a data
supplier does not meet this requirement, then the study may have to be
treated as "not assignable" information for the purposes of subsequent
valuation and cost sharing (unless proven otherwise).

There may additionally be other ways of evaluating the reliability of
existing data, which have been developed to address the specific
characteristics of substances that might not be (sufficiently) covered
by the generic approaches described above. As an example, for metals,
metal compounds and minerals, the MERAG (MEtals Risk Assessment
Guidance) Project proposes criteria to be considered when scrutinising
ecotoxicity data for hazard classification (MERAG Fact Sheet 08, pp
6-12). Other sectorial approaches may also be available. 

18. []{#__RefHeading___Toc165901071 .anchor}STUDY VALUATION

An accurate and realistic valuation of studies is a critical component
in the cost sharing process. Initially, studies should be assessed in
terms of their scientific quality and then with this basis established,
a financial value can be determined taking account of various mark-up
and / or reduction elements. In undertaking a financial assessment, the
objective should be to ensure that an adequate and appropriate
compensation is made available to the study owner taking full account of
the data sharing principles embodied in the REACH legislation.

# What studies should be valued ? {#what-studies-should-be-valued .Heading_L2}

From a quality perspective and taking Klimisch ratings as a model, only
studies with a reliability rating of 1 or 2 should normally qualify for
financial compensation. Reports in categories (3) "not reliable\" and
(4) "not assignable\" can therefore effectively be deselected from a
valuation procedure whenever higher reliability studies are available.
This does not mean that the information contained in such reports should
be considered to be of no importance but rather that pragmatically,
there is little basis for compensation when they are put into comparison
with higher quality studies.

An exception may arise for Klimisch 3 reports if they can satisfy an
endpoint via the weight - of - evidence approach described above. In
this case, there would be no higher ranking studies available but if the
existing information was sufficient to support the endpoint, the studies
could be treated for costing purposes in the same manner as that for
higher ranking data. Payments in this instance would normally be subject
to formal acceptance of the studies and thus avoidance of any repeat
testing charges.

# Historic versus Replacement costs {#historic-versus-replacement-costs .Heading_L2}

Although Article 30.1 requires participants SIEF to provide the \"proof
of costs\" of the study they have upon request, under the \"collective
route\", nothing prevents potential registrants to agree another
valuation means. In particular, potential registrants (and data holders)
can agree to value a study on the basis of its \"replacement value\",
i.e. the price it would pay today to obtain the same study.

The advantage of using the \"replacement cost\" approach is that using
the \"historic cost\" approach brings complications in terms of
inflation allowance, lost interest related to the sums invested earlier
to fund the testing activity, etc.

# What studies should be valued ? {#what-studies-should-be-valued-1 .Heading_L2}

[The elements listed below require qualification]{.mark} [as]{.mark} [to
when they may apply, if at all, in cases the valuation is based on (1)
replacement costs or (2) historic costs]{.mark}

Elements which may be included in the valuation process are expenses for
the following activities or measures:

i.  Preliminary testing for determining test concentrations;

ii. Substance testing according to the standard protocol;

iii. Development of suitable analytical methods;

iv. Supplementary analyses;

    1.  Substance characterization;

    2.  Stability in test medium;

    3.  Concentration in test medium;

    4.  Administrative expenses;

    5.  Processing and professional support by the commissioning party;
        (may include study design and /or preparation of test material)

    6.  Travel expenses;

    7.  Archiving of the test substance and raw data;

    8.  Preparation of IUCLID data set and robust study summary.

        The calculation should only include expenses which are supported
        by verifiable documentation or, if such documentation is not
        available, expenses that can be justified with sufficient
        plausibility.

Expenses for preliminary testing and substance testing according to a
standard protocol (baseline costs) may be calculated as an average of
the prices charged by two or three agreed testing institutes according
to their price lists. Standard pricing should be assumed and special
conditions, such as those granted when commissioning large testing
programmes, are not taken into account.

When testing for inherent substance properties, the limitation (2)
\"reliable with restriction\" arises most commonly from the fact that
the study was conducted at a date prior to the introduction of GLP
standards. A deduction in value for non-GLP data may accordingly be
assigned in relation to current standards and pricings.

Deductions due to any other deficiencies can only be evaluated on a
case-by-case basis. In total, deductions might be expected not to exceed
20% of the price of the standard test since otherwise, the justification
for classifying the information as reliable data might reasonably be
questioned and placed in doubt.

The calculation of expenses for substance analysis, for which no market
prices are available, requires the following information from the party
supplying the report for each analytical procedure:

i\) Brief description of the methodology, including the limit of
detection;

ii) Estimated costs for the development or provision[^14] of the method;

iii\) Costs per analysis;

iv) Number of analyses performed.

    In some cases, the development and provision costs may not be cited
    separately but could be included in the charges made for each
    analysis.

A surcharge to the sum of experimental costs (substance testing and
analysis) may be charged for administrative expenses (processing and
professional support by the commissioning party, travel expenses,
archival of the test substance and raw data). The surcharge should [not
be fixed]{.underline} but rather should be related to the value of the
study concerned. An example of the variable costs which might be applied
is shown in Table 2. If factual information relating to these expenses
is available this could, of course, override the use of guideline
figures. In the case of significant deviation in excess of the guideline
surcharge, however, expenses would need to be fully substantiated and
documented individually.

The provision of robust study summaries for key studies which may be
contributed by the study owner (or developed by experts commissioned for
this task) should be compensated by a value of up to 30% of the
[administrative costs]{.underline} mentioned above.

As the decision to conduct a study involves a risk for the initiator
that the project may not be successful in generating the information
desired (with no possibility then for any future recompense), it can be
appropriate to acknowledge this in the valuation exercise. This can be
particularly true for recognized problematic substances or those
difficult to test. When accessing an existing study with a known
outcome, there is no exposure to this risk for a new party and
accordingly, in certain circumstances, a certainty premium may be
assigned to the study. This would only be applicable for justifiable
toxicity or ecotoxicity studies where testing difficulties might
reasonably be anticipated. In this instance, a surcharge of up to 10% of
the sum of the experimental costs could typically be assigned. Higher
factors (up to 30 %) may sometimes be justified in particular
circumstances especially for studies relating to Annexes IX and X.
Alternatively, in many other scenarios, there may be little
justification for the application of this premium due to the nature of
the testing and the inherent properties of the substance involved.

Overall, the current value of a given study may therefore be comprised
of the assignable experimental and administrative expenses, along with
the certainty / risk premium as specified above where appropriate.

Aside from the valuation aspects for single studies as defined above, in
some cases additional expenditure may also need to be considered for
compensation. This could arise for example where substances have been
processed in the ICCA / OECD HPV chemicals programme. Here, it is normal
for data to have already been overviewed and key studies selected and a
recognition of the value of this activity should be made reflecting the
expenditure incurred. This element would encompass all relevant
endpoints and it is an extra cost on top of the valuation of the studies
concerned. The process undertaken is in effect similar to that required
to deliver a Lead Registrant data package.

# Examples of Quality and Financial Valuations  {#examples-of-quality-and-financial-valuations .Heading_L2}

See numbers 1&2 in the Examples Section for illustrations of the study
valuation process

19. []{#__RefHeading___Toc165901076 .anchor}COST ALLOCATION AND
    COMPENSATION

As mentioned previously, it is the intention within REACH that any
sharing of the costs of studies should be undertaken in a ***fair,
proportionate and non-discriminatory way***. In this section, key
factors for consideration in this context together with associated cost
sharing mechanisms are reviewed. Cost allocations may be calculated for
studies relating to all end points for which information is required
according to REACH.

The current value of all study reports should be determined in
accordance with the guidelines referenced above. This serves as the
measurement base for subsequent cost allocation and compensation. Note
that costing activities are not appropriate for reports which are
recognized to be in the public domain (see Annex X for further guidance
on this point).

In the absence of specific rules, potential registrants are free to
select any cost allocation and compensation mechanism that they perceive
to be fair, proportionate and non-discriminatory. Possible mechanisms
include:

-   Sharing data equally, based on the number of parties involved;

-   Proportionality, based on production or sales volume or otherwise;

-   Alternative mechanisms using part of the above models in different
    mode.

The REACH Regulation refers to equal sharing as a default mechanisms in
some cases and this will be an important element. However, parties are
free to agree on any model.

# \"Individual route\" {#individual-route .Heading_L2}

In this instance, the study value should be determined and then shared
by all parties requiring the information for registration purposes. If
the data owner is included in this group of potential registrants, he
would be incorporated into the allocation calculations. If the data
supplier has no registration intentions, costs would be distributed only
amongst the purchasing parties. If any additions to the number of
interested parties occurs throughout the lifetime of the SIEF,
compensation adjustments would need to be subsequently effected by the
study owner(s).

# \"Collective route\" {#collective-route .Heading_L2}

In view of the requirements under REACH for a Lead Registrant
consolidated dataset package, this approach is likely to be employed for
most data sharing activities.

In this case, solely for the purposes of cost allocation, when
addressing a particular end-point, only one study per registrant should
normally be proposed (even though all studies may be used for technical
support).

Companies participating in the collective route are free to decide on
any data compensation mechanism they see fit for purpose. Both models
explained under 4.2.1 and 4.2.2 have been used in the past and can be
considered for apportioning cost between participants.

## Data compensation based on study quality-weighted models+ {#data-compensation-based-on-study-quality-weighted-models .Heading_L3}

Such possible data compensation mechanisms are illustrated by example 3,
4 and 5 at the end of this Annex. Those models are based on the
principle that compensation for a given end point.is due by non
contributors only for the best study;

If there is then more than one contributing source, the following
guidance may be applied in order to arrive at an appropriate cost
allocation. For the purposes of illustration, Klimisch ratings are
employed and again, the current value of all relevant reports should be
determined first.

**Case (i) : only Klimisch 1 studies available**

By contribution of a category (1) report ("reliable without
restrictions"), the share of that contributor is considered as paid for
the relevant end point. This applies also for any other parties who
contribute reports of equal quality. The cost allocation against this
end-point is then borne only by the remaining (non-contributory)
parties.

If any reports are jointly owned by a number of contributors, each would
be considered to have met his obligation for that endpoint from a cost
share perspective.

**Case (ii) : Klimisch 1 & 2 studies available**

If reports from both category (1) and (2) ("reliable with
restrictions\") are available for the same end point, the report with
the higher rating will be used as the key study for cost allocation
purposes. Contributors supplying a lower rated report contribute
according to the difference in value of their study to the key one
selected. Other (non-contributory) parties support the cost on the basis
of the key study value.

If any category (1) reports are jointly owned by a number of
contributors, each would be considered to have met his obligation for
that endpoint from a cost share perspective. For category (2) study
joint owners, contributions would be required as indicated.

**Case (iii) : Only Klimisch 2 studies available**

If a report of category (1) standard is not in existence and only one or
more reports of category (2) are available, the report with the highest
assigned value will be selected as the key study for cost allocation.
Contributory members will pay by difference (as above) whilst others
will support the cost on the basis of the key study value.

# Compensation {#compensation .Heading_L2 .unnumbered}

The total compensation available for allocation against any endpoint
results from adding together the contributions identified for all
participants in line with the guidelines described.

Compensation is then divided among the parties supplying reports in
relation to the values of the studies provided against each of the range
of end-points covered.

##  {#section-18 .Heading_L3}

##  {#section-19 .Heading_L3}

## Direct data compensation  {#direct-data-compensation .Heading_L3}

This model is illustrated in examples 6 and 7.

As an alternative to the approach defined above, other more direct cost
allocation mechanisms could also be utilized. In all cases, clear rules
for the study valuation step need to be firmly established as a
prerequisite to applying any distribution mechanism. This could follow
the guidance outlined in section 3 or, if there was general agreement /
acceptance, a table of nominal costs for all endpoints could be
developed by the group. With study costs established, the following
allocation options could be considered:

**Compensation for all studies**

All studies for a given endpoint would be used to calculate a total
endpoint value. This total value would then be shared amongst all
participants to define a member contribution. Cost adjustments per
participant would be made depending on the value of the studies provided
relative to the member contribution required. This route has the benefit
of recognizing the full weight of the studies available but in order to
avoid the possible situation where the number of existing reports
exceeds the number of participants to the sharing process contributors
should normally not be compensated for more than one study per end
point.

**Compensation for key study only**

In this approach, compensation would only be based around the key study
selected for an endpoint. Other data holders for the endpoint would be
exempted from the compensation process and only non data holders would
be expected to provide a financial contribution to the key study holder.
Agreement on key study selection is critical for this mechanism and
there could be difficulties to resolve this if a number of comparable
studies are available. If necessary, however, more than one key study
might be assigned.

#  {#section-20 .Heading_L2}

#   {#section-21 .Heading_L2}

20. []{#__RefHeading___Toc165901084 .anchor}FURTHER FACTORS

A range of additional factors may also need to be considered when
addressing cost sharing issues and these are noted below. In each case,
the basic valuation and sharing mechanisms described above may still be
applied but with appropriate adjustments then being made at relevant
points in the process.

# Klimisch 3 studies  {#klimisch-3-studies .Heading_L2}

As mentioned above**,** in certain cases it may be possible that whilst
Klimisch (3) studies represent the best information available, by
adopting a weight-of-evidence approach this can be sufficient to satisfy
the requirements of an endpoint. In this event and assuming that the
studies are formally accepted thereby avoiding any repeat testing
charges, it would be appropriate to recognize the data in valuation
terms in line with the criteria for higher level Klimisch (2) data.

# Usage Restrictions {#usage-restrictions .Heading_L2}

Whilst consideration of the costing elements described above should lead
to a realistic valuation of a study, this describes its full value
assuming there would be no restriction in its use. If usage conditions
are to be applied, it becomes appropriate to reflect this limitation in
the value figure assigned to the study. Examples of restricted
application might include the following situations or a combination of
these points:

Usage is limited to REACH purposes only (as opposed to a study being
available for more general exploitation).

The full study report is not being made available but rather a Letter of
Access giving authority to refer to the work is proposed.

Beyond the EU countries, some geographic boundaries are placed on areas
where the information may be exploited.

In these cases (and perhaps others), deductions in the assigned value of
a study for cost sharing purposes should be agreed as a percentage
reduction of the original valuation . Allocation of the study value
would then follow the normal procedures applicable to any non-reduced
study item.

# Volume Factors {#volume-factors .Heading_L2}

As mentioned earlier, there may be cases where the allocation of study
charges could be considered to be imbalanced when considering parties
handling very disparate manufactured or imported volumes. This would
generally prevail only for the higher tonnage band (above 1000 tonnes)
but in this event, the introduction of a volume factor should be
considered by the parties agreeing the cost sharing mechanism. In this
case, a weighting against further tonnage ranges would be assigned
thereby effectively increasing the number of shares across which a
charge is allocated. For multi-site operators, tonnage may be combined
to assign the appropriate banding factor. To effect this, in view of the
need to have a knowledge of the population of the relevant volume bands,
third party processing of the information is likely to be required.

If appropriate and there is agreement, the use of a volume factor could
also be considered for the other volume bands. Care should be taken,
however, to recognize any confidentiality or competition concerns which
might potentially arise from the application / usage of bands with
relatively narrow volume ranges. Third party processing of such
information in this instance would be required.

# New Studies {#new-studies .Heading_L2}

##### If new studies are generated as a consequence of the registration activity (following the necessary approval processes as required), the general principles on cost sharing as explained above for existing studies should be employed for the valuation and assignment of any resultant charges. This would ensure that there is a consistency of approach for all data utilized in the registration process and the format would also be clear then to any party requiring this information at a later stage. 

# Examples of Further Factor Considerations  {#examples-of-further-factor-considerations .Heading_L2}

##### See numbers 8 & 9 in the Examples Section for illustrations of some of the further factor considerations described above.

21. []{#__RefHeading___Toc165901090 .anchor}NEW PARTIES

For new parties subsequently joining any existing cost sharing
arrangement, the same criteria will be applied in determining the
financial contribution to be provided for all end-point data. This would
apply also for any situations within existing arrangements where
additional registration requirements become necessary due to increases
in volume. Following this approach, any credit generated would be
allocated to all relevant qualifying parties as appropriate.

# Example  {#example .Heading_L2}

See number 10 in the Examples Section for an illustration of the
principles described.

**Table 1: Initial Screening Criteria for data reliability by type of
information**

+----------------------------------------------+-------+-------+-------+
| Criteria                                     | Req   |       |       |
|                                              | uired |       |       |
|                                              | for   |       |       |
|                                              | the   |       |       |
|                                              | foll  |       |       |
|                                              | owing |       |       |
|                                              | I     |       |       |
|                                              | nform |       |       |
|                                              | ation |       |       |
|                                              | Items |       |       |
+----------------------------------------------+-------+-------+-------+
|                                              | P     | Env   | E     |
|                                              | /Chem | Fate  | cotox |
|                                              |       |       |       |
|                                              |       |       | /H    |
|                                              |       |       | ealth |
+----------------------------------------------+-------+-------+-------+
| **Test Substance Identification**            | **X** | **X** | **X** |
|                                              |       |       |       |
| (Adequate description of test substance,     |       |       |       |
| including                                    |       |       |       |
|                                              |       |       |       |
| chemical purity and                          |       |       |       |
| identification/quantification of             |       |       |       |
|                                              |       |       |       |
| impurities to the extent available).         |       |       |       |
+----------------------------------------------+-------+-------+-------+
| **Temperature**                              | **X   | **X** | **X** |
|                                              | ^1^** |       |       |
+----------------------------------------------+-------+-------+-------+
| **Full Reference/Citation**                  | **X** | **X** | **X** |
+----------------------------------------------+-------+-------+-------+
| **Controls^2^**                              |       | **X** | **X** |
+----------------------------------------------+-------+-------+-------+
| **Statistics**                               |       |       | **X** |
|                                              |       |       |       |
| With some exceptions (e.g., the              |       |       |       |
| *Salmonella*/Ames assays**)**                |       |       |       |
+----------------------------------------------+-------+-------+-------+
| **Species, strain, number, gender, & age of  |       |       | **X** |
| organism**                                   |       |       |       |
+----------------------------------------------+-------+-------+-------+
| **Dose/conc. Levels**                        |       | **X** | **X** |
+----------------------------------------------+-------+-------+-------+
| **Route/type of exposure^3^**                |       |       | **X** |
+----------------------------------------------+-------+-------+-------+
| **Duration of exposure**                     |       | **X** | **X** |
+----------------------------------------------+-------+-------+-------+

Footnotes to Table 1

1\. For vapour pressure, octanol/water partition coefficient and water
solubility values

2\. All studies must have negative controls and some studies (e.g.
biodegradation, Salmonella/Ames assay) must also have positive controls.
If a vehicle is used in the administration of the test agent, vehicle
controls should be established and reported. Exceptions may be allowed
for acute mammalian toxicity studies.

3\. The route/type of exposure (e.g., oral inhalation. etc for mammalian
studies) or test system (static, flowthrough, etc for ecotoxicity) must
be reported.

**\
**

**Table 2: Examples of surcharge to the total experimental costs to
allow for administrative expenses**

  -------------------------- ---------------------- ----------------------
  **Study value(€)**         **Admin. (€)**         **%**

  3000                       600                    20

  5000                       900                    18

  20000                      3000                   15

  50000                      5000                   10

  100000                     7000                   7

  200000                     10000                  5

  300000                     12000                  4

  500000                     15000                  3

                                                    
  -------------------------- ---------------------- ----------------------

**Note : column one limits reflect study values "up to" these levels**

**REFERENCES**

OECD Guidance see <http://www.oecd.org/dataoecd/60/46/1947501.pdf>

H.-J. Klimisch, M. Andeae, and U. Tillmann, A systematic approach for
evaluating the quality of experimental toxicological and
ecotoxicological data, Regulatory Toxicology and Pharmacology 25, 1-5
(1997)

US EPA see <http://www.epa.gov/chemrtk/pubs/general/datadfin.htm>

MERAG (MEtals Risk Assessment Guidance) Project see
[www.euras.be/merag](../www.euras.be/merag)

[]{#__RefHeading___Toc165901092 .anchor}EXAMPLES

# Example 1 (Study Valuation)  {#example-1-study-valuation .Heading_L2 .unnumbered}

7 Potential registrants (A, B, C, D, E, F, G) form a SIEF for the same
substance, SIEF member A owns a report Klimisch category 1, SIEF member
B owns a report Klimisch category 2, SIEF members C, D, E, F and G do
not own a relevant study.

The attached example does not reflect

-   a deduction because of limitation of a study for REACH registration
    purposes exclusively

-   a surcharge for RSS established for a given report.

**a) Substance testing**

  ----------------------- ----------------------- -----------------------
                          Report 1                Report 2

  Owner                   Member A                Member B

  Year of testing         2001                    1984

  Method                  OECD Guideline xyz      similar to OECD
                                                  Guideline xyz

  GLP                     yes                     no

  Analysis of test        pharmaceutical grade    unknown, presumably
  substance               99.9 %                  \>99%

  Stability               yes                     unknown, reliably yes

  Concentration           yes                     yes
  monitoring                                      

  Comments                Study conducted in      Several details of test
                          accordance with OECD    conditions are not
                          and EC and EPA test     given, e.g. sex, age or
                          guidelines and in       body weight of the test
                          accordance with GLP     animals, housing
                                                  conditions etc.
                                                  However, the study is
                                                  acceptable since the
                                                  general conduct of the
                                                  study is acceptable,
                                                  and since a detailed
                                                  description of the
                                                  observations is
                                                  provided in the report.
  ----------------------- ----------------------- -----------------------

**b) Analyses**

+---+------------------+-----------------------+-----------------------+
| T |                  | standard              | standard              |
| e |                  |                       |                       |
| s |                  |                       |                       |
| t |                  |                       |                       |
| s |                  |                       |                       |
| u |                  |                       |                       |
| b |                  |                       |                       |
| s |                  |                       |                       |
| t |                  |                       |                       |
| a |                  |                       |                       |
| n |                  |                       |                       |
| c |                  |                       |                       |
| e |                  |                       |                       |
+---+------------------+-----------------------+-----------------------+
| S |                  | standard              | standard              |
| t |                  |                       |                       |
| a |                  |                       |                       |
| b |                  |                       |                       |
| i |                  |                       |                       |
| l |                  |                       |                       |
| i |                  |                       |                       |
| t |                  |                       |                       |
| y |                  |                       |                       |
+---+------------------+-----------------------+-----------------------+
| C |                  |                       |                       |
| o |                  |                       |                       |
| n |                  |                       |                       |
| c |                  |                       |                       |
| e |                  |                       |                       |
| n |                  |                       |                       |
| t |                  |                       |                       |
| r |                  |                       |                       |
| a |                  |                       |                       |
| t |                  |                       |                       |
| i |                  |                       |                       |
| o |                  |                       |                       |
| n |                  |                       |                       |
| m |                  |                       |                       |
| o |                  |                       |                       |
| n |                  |                       |                       |
| i |                  |                       |                       |
| t |                  |                       |                       |
| o |                  |                       |                       |
| r |                  |                       |                       |
| i |                  |                       |                       |
| n |                  |                       |                       |
| g |                  |                       |                       |
|   |                  |                       |                       |
+---+------------------+-----------------------+-----------------------+
|   | Method           | literature            | literature            |
+---+------------------+-----------------------+-----------------------+
|   | Development      | none                  | none                  |
+---+------------------+-----------------------+-----------------------+
|   | Provision        |                       |                       |
+---+------------------+-----------------------+-----------------------+
|   | Working days     | 10                    | 8                     |
|   |                  |                       |                       |
|   |                  |                       |                       |
+---+------------------+-----------------------+-----------------------+
|   | Per diem rate    | € 600                 | € 600                 |
+---+------------------+-----------------------+-----------------------+
|   | Analysis costs   | € 100 per analysis    | € 100 per analysis    |
+---+------------------+-----------------------+-----------------------+
|   | Number of        | 60                    | 50                    |
|   | analyses         |                       |                       |
+---+------------------+-----------------------+-----------------------+

**c) Determination of the current value of the report**

+---+--------------------------------+--------+--------+--------+--------+
| T |                                | Report |        | Report |        |
| y |                                | 1      |        | 2      |        |
| p |                                |        |        |        |        |
| e |                                |        |        |        |        |
| o |                                |        |        |        |        |
| f |                                |        |        |        |        |
| e |                                |        |        |        |        |
| x |                                |        |        |        |        |
| p |                                |        |        |        |        |
| e |                                |        |        |        |        |
| n |                                |        |        |        |        |
| s |                                |        |        |        |        |
| e |                                |        |        |        |        |
| / |                                |        |        |        |        |
| s |                                |        |        |        |        |
| u |                                |        |        |        |        |
| r |                                |        |        |        |        |
| c |                                |        |        |        |        |
| h |                                |        |        |        |        |
| a |                                |        |        |        |        |
| r |                                |        |        |        |        |
| g |                                |        |        |        |        |
| e |                                |        |        |        |        |
| / |                                |        |        |        |        |
| d |                                |        |        |        |        |
| e |                                |        |        |        |        |
| d |                                |        |        |        |        |
| u |                                |        |        |        |        |
| c |                                |        |        |        |        |
| t |                                |        |        |        |        |
| i |                                |        |        |        |        |
| o |                                |        |        |        |        |
| n |                                |        |        |        |        |
+---+--------------------------------+--------+--------+--------+--------+
|   | Preliminary test to determine  | €      |        | €      |        |
|   | concentration                  | 35,000 |        | 35,000 |        |
|   |                                |        |        |        |        |
|   | (range finding)                |        |        |        |        |
+---+--------------------------------+--------+--------+--------+--------+
|   | Test per standard protocol     | €      |        | €      |        |
|   |                                | 1      |        | 1      |        |
|   |                                | 00,000 |        | 00,000 |        |
+---+--------------------------------+--------+--------+--------+--------+
|   | Without GLP                    | 0      |        | €      |        |
|   |                                |        |        | -      |        |
|   |                                |        |        | 15,000 |        |
+---+--------------------------------+--------+--------+--------+--------+
|   | Other deficiencies             | 0      |        | €      |        |
|   |                                |        |        | -5,000 |        |
+---+--------------------------------+--------+--------+--------+--------+
| C |                                |        | €      |        | €      |
| o |                                |        | 1      |        | 1      |
| s |                                |        | 35,000 |        | 15,000 |
| t |                                |        |        |        |        |
| s |                                |        |        |        |        |
| o |                                |        |        |        |        |
| f |                                |        |        |        |        |
| s |                                |        |        |        |        |
| u |                                |        |        |        |        |
| b |                                |        |        |        |        |
| s |                                |        |        |        |        |
| t |                                |        |        |        |        |
| a |                                |        |        |        |        |
| n |                                |        |        |        |        |
| c |                                |        |        |        |        |
| e |                                |        |        |        |        |
| t |                                |        |        |        |        |
| e |                                |        |        |        |        |
| s |                                |        |        |        |        |
| t |                                |        |        |        |        |
| i |                                |        |        |        |        |
| n |                                |        |        |        |        |
| g |                                |        |        |        |        |
+---+--------------------------------+--------+--------+--------+--------+
|   | Development of analytical      | 0      |        | 0      |        |
|   | procedure/method               |        |        |        |        |
+---+--------------------------------+--------+--------+--------+--------+
|   | Provision of analytical        | €      |        | €      |        |
|   | procedure/method\              | 6,000  |        | 4,800  |        |
|   | (10 or 8 working days at €     |        |        |        |        |
|   | 600)                           |        |        |        |        |
+---+--------------------------------+--------+--------+--------+--------+
|   | Analysis of test substance     | €      |        | 0      |        |
|   |                                | 1,000  |        |        |        |
+---+--------------------------------+--------+--------+--------+--------+
|   | Stability                      | € 500  |        | 0      |        |
+---+--------------------------------+--------+--------+--------+--------+
|   | Concentration monitoring\      | €      |        | €      |        |
|   | (60 or 50 analyses at € 100)   | 6,000  |        | 5,000  |        |
+---+--------------------------------+--------+--------+--------+--------+
| A |                                |        | €      |        | €      |
| n |                                |        | 13,500 |        | 9,800  |
| a |                                |        |        |        |        |
| l |                                |        |        |        |        |
| y |                                |        |        |        |        |
| s |                                |        |        |        |        |
| i |                                |        |        |        |        |
| s |                                |        |        |        |        |
| c |                                |        |        |        |        |
| o |                                |        |        |        |        |
| s |                                |        |        |        |        |
| t |                                |        |        |        |        |
| s |                                |        |        |        |        |
+---+--------------------------------+--------+--------+--------+--------+
| E |                                |        | €      |        | €      |
| x |                                |        | 1      |        | 1      |
| p |                                |        | 48,500 |        | 24,800 |
| e |                                |        |        |        |        |
| r |                                |        |        |        |        |
| i |                                |        |        |        |        |
| m |                                |        |        |        |        |
| e |                                |        |        |        |        |
| n |                                |        |        |        |        |
| t |                                |        |        |        |        |
| a |                                |        |        |        |        |
| l |                                |        |        |        |        |
| c |                                |        |        |        |        |
| o |                                |        |        |        |        |
| s |                                |        |        |        |        |
| t |                                |        |        |        |        |
| s |                                |        |        |        |        |
+---+--------------------------------+--------+--------+--------+--------+
|   | Administrative costs\          | €      |        | €      |        |
|   | (ref. table 2)                 | 10,000 |        | 10,000 |        |
+---+--------------------------------+--------+--------+--------+--------+
|   | Risk premium\                  | €      |        | €      |        |
|   | (10 % of experimental costs)   | 14,850 |        | 12,480 |        |
|   |                                |        |        |        |        |
|   |                                | 44,550 |        |        |        |
+---+--------------------------------+--------+--------+--------+--------+
| T |                                |        | €      |        | €      |
| o |                                |        | 24,850 |        | 22,480 |
| t |                                |        |        |        |        |
| a |                                |        |        |        |        |
| l |                                |        |        |        |        |
| s |                                |        |        |        |        |
| u |                                |        |        |        |        |
| r |                                |        |        |        |        |
| c |                                |        |        |        |        |
| h |                                |        |        |        |        |
| a |                                |        |        |        |        |
| r |                                |        |        |        |        |
| g |                                |        |        |        |        |
| e |                                |        |        |        |        |
| s |                                |        |        |        |        |
+---+--------------------------------+--------+--------+--------+--------+
|   |                                |        | €      |        | €      |
| C |                                |        | 1      |        | 1      |
| u |                                |        | 73,350 |        | 47,280 |
| r |                                |        |        |        |        |
| r |                                |        |        |        |        |
| e |                                |        |        |        |        |
| n |                                |        |        |        |        |
| t |                                |        |        |        |        |
| r |                                |        |        |        |        |
| e |                                |        |        |        |        |
| p |                                |        |        |        |        |
| o |                                |        |        |        |        |
| r |                                |        |        |        |        |
| t |                                |        |        |        |        |
| v |                                |        |        |        |        |
| a |                                |        |        |        |        |
| l |                                |        |        |        |        |
| u |                                |        |        |        |        |
| e |                                |        |        |        |        |
+---+--------------------------------+--------+--------+--------+--------+

# Example 2 (Study Valuation)  {#example-2-study-valuation .Heading_L2 .unnumbered}

7 Potential registrants (A, B, C, D, E, F, G) form a SIEF for the same
substance, SIEF member A owns a report (compliant to OECD guideline,
SIEF member B owns a report non-compliant to OECD guidelines, SIEF
members C,D,E, F and G do not own a relevant study.

The attached example (vapor pressure OECD 104) does not reflect

-   a deduction because of limitation of a study for REACH registration
    purposes exclusively

-   a surcharge for RSS established for a given report.

**a) Substance testing**

  ----------------------- ----------------------- -----------------------
                          Report 1                Report 2

  Owner                   Member A                Member B

  Year of testing         2001                    1984

  Method                  OECD Guideline xyz      similar to OECD
                                                  Guideline xyz

  GLP                     yes                     no

  Analysis of test        pharmaceutical grade    unknown, presumably
  substance               99.9 %                  \>99%

  Stability               yes                     unknown, reliably yes

  Concentration           yes                     yes
  monitoring                                      

  Comments                Study conducted in      Some details of test
                          accordance with OECD    conditions are not
                          test guidelines and in  given. However, the
                          accordance with GLP     study is acceptable
                                                  since the general
                                                  conduct of the study is
                                                  acceptable, and since a
                                                  detailed description of
                                                  the observations is
                                                  provided in the report.
  ----------------------- ----------------------- -----------------------

**b) Analyses**

+---+------------------+-----------------------+-----------------------+
| T |                  | standard              | standard              |
| e |                  |                       |                       |
| s |                  |                       |                       |
| t |                  |                       |                       |
| s |                  |                       |                       |
| u |                  |                       |                       |
| b |                  |                       |                       |
| s |                  |                       |                       |
| t |                  |                       |                       |
| a |                  |                       |                       |
| n |                  |                       |                       |
| c |                  |                       |                       |
| e |                  |                       |                       |
+---+------------------+-----------------------+-----------------------+
| S |                  | standard              | standard              |
| t |                  |                       |                       |
| a |                  |                       |                       |
| b |                  |                       |                       |
| i |                  |                       |                       |
| l |                  |                       |                       |
| i |                  |                       |                       |
| t |                  |                       |                       |
| y |                  |                       |                       |
+---+------------------+-----------------------+-----------------------+
| C |                  |                       |                       |
| o |                  |                       |                       |
| n |                  |                       |                       |
| c |                  |                       |                       |
| e |                  |                       |                       |
| n |                  |                       |                       |
| t |                  |                       |                       |
| r |                  |                       |                       |
| a |                  |                       |                       |
| t |                  |                       |                       |
| i |                  |                       |                       |
| o |                  |                       |                       |
| n |                  |                       |                       |
| m |                  |                       |                       |
| o |                  |                       |                       |
| n |                  |                       |                       |
| i |                  |                       |                       |
| t |                  |                       |                       |
| o |                  |                       |                       |
| r |                  |                       |                       |
| i |                  |                       |                       |
| n |                  |                       |                       |
| g |                  |                       |                       |
|   |                  |                       |                       |
+---+------------------+-----------------------+-----------------------+
|   | Method           | literature            | literature            |
+---+------------------+-----------------------+-----------------------+
|   | Development      | none                  | none                  |
+---+------------------+-----------------------+-----------------------+
|   | Provision        |                       |                       |
+---+------------------+-----------------------+-----------------------+
|   | Working days     | 0                     | 0                     |
|   |                  |                       |                       |
|   |                  |                       |                       |
+---+------------------+-----------------------+-----------------------+
|   | Per diem rate    | € 600                 | € 600                 |
+---+------------------+-----------------------+-----------------------+
|   | Analysis costs   | € 100 per analysis    | € 100 per analysis    |
+---+------------------+-----------------------+-----------------------+
|   | Number of        | 0                     | 0                     |
|   | analyses         |                       |                       |
+---+------------------+-----------------------+-----------------------+

**c) Determination of the current value of the report**

+---+--------------------------------+--------+--------+--------+--------+
| T |                                | Report |        | Report |        |
| y |                                | 1      |        | 2      |        |
| p |                                |        |        |        |        |
| e |                                |        |        |        |        |
| o |                                |        |        |        |        |
| f |                                |        |        |        |        |
| e |                                |        |        |        |        |
| x |                                |        |        |        |        |
| p |                                |        |        |        |        |
| e |                                |        |        |        |        |
| n |                                |        |        |        |        |
| s |                                |        |        |        |        |
| e |                                |        |        |        |        |
| / |                                |        |        |        |        |
| s |                                |        |        |        |        |
| u |                                |        |        |        |        |
| r |                                |        |        |        |        |
| c |                                |        |        |        |        |
| h |                                |        |        |        |        |
| a |                                |        |        |        |        |
| r |                                |        |        |        |        |
| g |                                |        |        |        |        |
| e |                                |        |        |        |        |
| / |                                |        |        |        |        |
| d |                                |        |        |        |        |
| e |                                |        |        |        |        |
| d |                                |        |        |        |        |
| u |                                |        |        |        |        |
| c |                                |        |        |        |        |
| t |                                |        |        |        |        |
| i |                                |        |        |        |        |
| o |                                |        |        |        |        |
| n |                                |        |        |        |        |
+---+--------------------------------+--------+--------+--------+--------+
|   | Preliminary test to determine  | 0      |        | 0      |        |
|   | concentration                  |        |        |        |        |
|   |                                |        |        |        |        |
|   | (range finding)                |        |        |        |        |
+---+--------------------------------+--------+--------+--------+--------+
|   | Test per standard protocol     | €      |        | €      |        |
|   |                                | 11,000 |        | 11,000 |        |
+---+--------------------------------+--------+--------+--------+--------+
|   | Without GLP                    | 0      |        | €      |        |
|   |                                |        |        | -1,100 |        |
+---+--------------------------------+--------+--------+--------+--------+
|   | Other deficiencies             | 0      |        | €      |        |
|   |                                |        |        | -1,000 |        |
+---+--------------------------------+--------+--------+--------+--------+
| C |                                |        | €      |        | €      |
| o |                                |        | 11,000 |        | 8,900  |
| s |                                |        |        |        |        |
| t |                                |        |        |        |        |
| s |                                |        |        |        |        |
| o |                                |        |        |        |        |
| f |                                |        |        |        |        |
| s |                                |        |        |        |        |
| u |                                |        |        |        |        |
| b |                                |        |        |        |        |
| s |                                |        |        |        |        |
| t |                                |        |        |        |        |
| a |                                |        |        |        |        |
| n |                                |        |        |        |        |
| c |                                |        |        |        |        |
| e |                                |        |        |        |        |
| t |                                |        |        |        |        |
| e |                                |        |        |        |        |
| s |                                |        |        |        |        |
| t |                                |        |        |        |        |
| i |                                |        |        |        |        |
| n |                                |        |        |        |        |
| g |                                |        |        |        |        |
+---+--------------------------------+--------+--------+--------+--------+
|   | Development of analytical      | 0      |        | 0      |        |
|   | procedure/method               |        |        |        |        |
+---+--------------------------------+--------+--------+--------+--------+
|   | Provision of analytical        | 0      |        | 0      |        |
|   | procedure/method\              |        |        |        |        |
|   | (0 working days at € 600)      |        |        |        |        |
+---+--------------------------------+--------+--------+--------+--------+
|   | Analysis of test substance     | € 500  |        | 0      |        |
+---+--------------------------------+--------+--------+--------+--------+
|   | Stability                      | € 100  |        | 0      |        |
+---+--------------------------------+--------+--------+--------+--------+
|   | Concentration monitoring\      | 0      |        | 0      |        |
|   | (0 analyses at € 100)          |        |        |        |        |
+---+--------------------------------+--------+--------+--------+--------+
| A |                                |        | € 600  |        | 0      |
| n |                                |        |        |        |        |
| a |                                |        |        |        |        |
| l |                                |        |        |        |        |
| y |                                |        |        |        |        |
| s |                                |        |        |        |        |
| i |                                |        |        |        |        |
| s |                                |        |        |        |        |
| c |                                |        |        |        |        |
| o |                                |        |        |        |        |
| s |                                |        |        |        |        |
| t |                                |        |        |        |        |
| s |                                |        |        |        |        |
+---+--------------------------------+--------+--------+--------+--------+
| E |                                |        | €      |        | €      |
| x |                                |        | 11,600 |        | 8,900  |
| p |                                |        |        |        |        |
| e |                                |        |        |        |        |
| r |                                |        |        |        |        |
| i |                                |        |        |        |        |
| m |                                |        |        |        |        |
| e |                                |        |        |        |        |
| n |                                |        |        |        |        |
| t |                                |        |        |        |        |
| a |                                |        |        |        |        |
| l |                                |        |        |        |        |
| c |                                |        |        |        |        |
| o |                                |        |        |        |        |
| s |                                |        |        |        |        |
| t |                                |        |        |        |        |
| s |                                |        |        |        |        |
+---+--------------------------------+--------+--------+--------+--------+
|   | Administrative costs\          | €      |        | €      |        |
|   | (ref. table 2)                 | 1,650  |        | 1,650  |        |
+---+--------------------------------+--------+--------+--------+--------+
|   | Risk premium\                  | 0      |        | 0      |        |
|   | (N/A)                          |        |        |        |        |
|   |                                | 44,550 |        |        |        |
+---+--------------------------------+--------+--------+--------+--------+
| T |                                |        | €      |        | €      |
| o |                                |        | 1,650  |        | 1,650  |
| t |                                |        |        |        |        |
| a |                                |        |        |        |        |
| l |                                |        |        |        |        |
| s |                                |        |        |        |        |
| u |                                |        |        |        |        |
| r |                                |        |        |        |        |
| c |                                |        |        |        |        |
| h |                                |        |        |        |        |
| a |                                |        |        |        |        |
| r |                                |        |        |        |        |
| g |                                |        |        |        |        |
| e |                                |        |        |        |        |
| s |                                |        |        |        |        |
+---+--------------------------------+--------+--------+--------+--------+
|   |                                |        | €      |        | €      |
| C |                                |        | 13,250 |        | 10,550 |
| u |                                |        |        |        |        |
| r |                                |        |        |        |        |
| r |                                |        |        |        |        |
| e |                                |        |        |        |        |
| n |                                |        |        |        |        |
| t |                                |        |        |        |        |
| r |                                |        |        |        |        |
| e |                                |        |        |        |        |
| p |                                |        |        |        |        |
| o |                                |        |        |        |        |
| r |                                |        |        |        |        |
| t |                                |        |        |        |        |
| v |                                |        |        |        |        |
| a |                                |        |        |        |        |
| l |                                |        |        |        |        |
| u |                                |        |        |        |        |
| e |                                |        |        |        |        |
+---+--------------------------------+--------+--------+--------+--------+

# Example 3 (Cost Allocation) {#example-3-cost-allocation .Heading_L2 .unnumbered}

As shown in example 1, the value of report 1 (Klimisch 1) has been
calculated to be € 173,350; the value of report 2 (Klimisch 2) has been
calculated to be € 147,280.

+-----------------------------------------------------+----------------+
| Value of key study                                  | € 173,350      |
+-----------------------------------------------------+----------------+
| Share per member (€ 173,350 / 7)                    | € 24,764       |
+-----------------------------------------------------+----------------+
| Financial contribution of Member A (Owner of Report | € 0            |
| 1)                                                  |                |
+-----------------------------------------------------+----------------+
| Financial contribution of Member B (Owner of Report | € 3,724        |
| 2 having the lower value):                          |                |
|                                                     |                |
| 24,764 x (173,350 -- 147,280) / 173,350             |                |
+-----------------------------------------------------+----------------+
| Financial contribution of other members: 5 x 24,764 | € 123,820      |
+-----------------------------------------------------+----------------+

Cost compensation:

  ----------------------------------------------------- -----------------
  Total amount of assigned contributions (123,820 +     € 127,544
  3,724)                                                

  Share for Member A having the higher value Report 1\  € 68,957
  127,544 x 173,350 / (173,350 + 147,280)               

  Share of Member B having the lower value Report 2\    € 58,587
  127,544 x 147,280 / (173,350 + 147,280)               
  ----------------------------------------------------- -----------------

The balance (cost allocation -- cost compensation) results in the
following:

SIEF member A receives € 68,957

SIEF member B receives € 54,863 (58,587 -- 3,724)

SIEF members C, D, E, F, G pay € 24,764 each

# Example 4 : (Cost Allocation) {#example-4-cost-allocation .Heading_L2 .unnumbered}

Two Klimisch 1 & two Klimisch 2 studies available, one study not
assessed in a SIEF consisting of 7 members

##### Participant A owns a study Klimisch 1, report has been valued € 215,325 

Participant B owns a study Klimisch 1, report has been valued € 202,100

Participant C owns a study Klimisch 2, report has been valued € 165,390

Participant D owns a study Klimisch 2, report has been valued € 158,270

Participant E owns a study, which has not been assessed for its quality

Participant F and G do not own a study

+-----------------------------------------------------+----------------+
| Value of key study                                  | € 215,325      |
+-----------------------------------------------------+----------------+
| Share per member (€ 215,325 / 7)                    | € 30,761       |
+-----------------------------------------------------+----------------+
| Financial contribution of Member A (Owner of Report | € 0            |
| 1; key study)                                       |                |
+-----------------------------------------------------+----------------+
| Financial contribution of Member B (Owner of Report | € 0            |
| 2 not being the key study but being rated Klimisch  |                |
| 1):                                                 |                |
+-----------------------------------------------------+----------------+
| Financial contribution of Member C (Owner of Report | € 7,134        |
| 3, Klimisch 2 study)                                |                |
|                                                     |                |
| 30,761 x (215,325 - 165,390) / 215,325              |                |
+-----------------------------------------------------+----------------+
| Financial contribution of Member D (Owner of Report | € 8,151        |
| 4, Klimisch 2 study)                                |                |
|                                                     |                |
| 30,761 x (215,325 - 158,270) / 215,325              |                |
+-----------------------------------------------------+----------------+
| Financial contribution of Member E (Owner of Report | € 30,761       |
| 5, but no quality assessment available)             |                |
+-----------------------------------------------------+----------------+
| Financial contribution of Member F and G (do not    | € 61,522       |
| own a Report) 2 x € 30,761                          |                |
+-----------------------------------------------------+----------------+
| Total financial contributions                       | € 107,566      |
+-----------------------------------------------------+----------------+

Cost compensation:

+-----------------------------------------------------+----------------+
| Share for Member A owning Report 1; the key study   | € 31,254       |
|                                                     |                |
| (7,134 + 8151 + 30,761 \* 3) \* 215,325 /           |                |
|                                                     |                |
| (215,325 + 201,100 + 165,390 + 158, 270)            |                |
+-----------------------------------------------------+----------------+
| Share for Member B owning Report 2; Klimisch 1 but  | € 29,334       |
| not the key study                                   |                |
|                                                     |                |
| (7,134 + 8151 + 30,761 \* 3) \* 201,100 /           |                |
|                                                     |                |
| (215,325 + 201,100 + 165,390 + 158, 270)            |                |
+-----------------------------------------------------+----------------+
| Share for Member C owning Report 3; Klimisch 2      | € 24,006       |
|                                                     |                |
| (7,134 + 8151 + 30,761 \* 3) \* 165,390 /           |                |
|                                                     |                |
| (215,325 + 201,100 + 165,390 + 158, 270)            |                |
+-----------------------------------------------------+----------------+
| Share for Member D owning Report 4; Klimisch 2      | € 22,279       |
|                                                     |                |
| (7,134 + 8151 + 30,761 \* 3) \* 158,270 /           |                |
|                                                     |                |
| (215,325 + 201,100 + 165,390 + 158, 270)            |                |
+-----------------------------------------------------+----------------+
| Total compensations                                 | € 107,566      |
+-----------------------------------------------------+----------------+

Balancing cost allocation and cost compensation leads to the following
results

Participant A receives € 31,254

Participant B receives € 29,334 (Klimisch 1 but not key study / lead
value)

Participant C receives € 16,872

Participant D receives € 14,822

Participants E, F and G pay € 30,761 each.

# Example 5 : (Cost Allocation) {#example-5-cost-allocation .Heading_L2 .unnumbered}

Here we assume SIEF member A owns a Klimisch 2 study, the value of the
report has been calculated to be € 158,300.00; SIEF member B owns a
Klimisch 2 study, the value of the report has been calculated to be €
145,000.00; SIEF member C owns a Klimisch 2 study, the value of the
report has been calculated to be € 144,000.00. The remaining
participants of the SIEF, members D-F, don't contribute a study.

+-----------------------------------------------------+----------------+
| Value of key study                                  | € 158,300      |
+-----------------------------------------------------+----------------+
| Share per member (€ 158,300 / 7)                    | € 22,614       |
+-----------------------------------------------------+----------------+
| Financial contribution of Member A (Owner of Report | € 0            |
| 1; Klimisch 2, key study)                           |                |
+-----------------------------------------------------+----------------+
| Financial contribution of Member B (Owner of Report | € 1,900        |
| 2, Klimisch 2):                                     |                |
|                                                     |                |
| 22,614 x (158,300 - 145,000) / 158,300              |                |
+-----------------------------------------------------+----------------+
| Financial contribution of Member C (Owner of Report | € 2,043        |
| 3, Klimisch 2):                                     |                |
|                                                     |                |
| 22,614 x (158,300 - 144,000) / 158,300              |                |
+-----------------------------------------------------+----------------+
| Financial contribution of Member D, E, F and G (do  | € 90,456       |
| not own a Report) 4 x € 22,614                      |                |
+-----------------------------------------------------+----------------+
| Total financial contributions                       | € 94,400       |
+-----------------------------------------------------+----------------+

Cost compensation:

+-----------------------------------------------------+----------------+
| Share for Member A owning Report 1; the key study   | € 33,408       |
|                                                     |                |
| (1,900 + 2,043 + 22,614 \* 4) \* 158,300 /          |                |
| (158,300 + 145,000 + 144,000)                       |                |
+-----------------------------------------------------+----------------+
| Share for Member B owning Report 2                  | € 30,601       |
|                                                     |                |
| (1,900 + 2,043 + 22,614 \* 4) \* 145,000 /          |                |
| (158,300 + 145,000 + 144,000)                       |                |
+-----------------------------------------------------+----------------+
| Share for Member C owning Report 3                  | € 30,390       |
|                                                     |                |
| (1,900 + 2,043 + 22,614 \* 4) \* 144,000 /          |                |
| (158,300 + 145,000 + 144,000)                       |                |
+-----------------------------------------------------+----------------+
| Total compensations                                 | € 94,400       |
+-----------------------------------------------------+----------------+

Balancing cost allocation and cost compensation leads to the following
results

Participant A receives € 33,408

Participant B receives € 28,701 (Klimisch 2 but not key study / lead
value)

Participant C receives € 28,347 (Klimisch 2 but not key study / lead
value)

Participants D, E, F and G pay € 22,614 each.

#  {#section-22 .Heading_L2 .unnumbered}

#  {#section-23 .Heading_L2}

# Example 6: (Cost Allocation - compensation for best studies) {#example-6-cost-allocation---compensation-for-best-studies .Heading_L2 .unnumbered}

Using the dataset and nominal study values described in example 6;

Total number of studies (for calculation purposes) = 4

Total value of these studies = (2 x 100) + (2 x 70) = 340 K€

Participant contribution is then 340 / 5 = 68 K€

In payment / compensation terms;

Member B pays 68 K€

Members A,C, D and E ( all holders of qualifying data ) each receive 17
K€

**For comparison purposes**, treatment of the above example utilising
the earlier allocation mechanism would yield the following balance:

Member A receives € 11,283

Member B pays € 21,000

Member C receives € 10,208

Member D receives € 2,059

Member E pays € 2,552

# Example 7 : (Cost Allocation - compensation for key study only) {#example-7-cost-allocation---compensation-for-key-study-only .Heading_L2 .unnumbered}

Using again the dataset and nominal study values described in example 6
but now with the key study assigned as that held by participant C;

Members A, D and E are exempted from the compensation process.

Key Study value is 100 K€

In payment / compensation terms;

Member B pays 50 K€ (half of the value of the study)

Member C (holder of the key study) receives 50 K€

**For comparison purposes**, treatment of the above example utilising
the earlier allocation mechanism would yield the following balance:

Member A receives € 9,403

Member B pays € 19,000

Member C receives € 8,507

Member D receives € 2,716

Member E pays € 1,627

If, however, **both of the Klimisch 1 studies** were accepted as key
studies;

Members D and E are exempted from the compensation process.

Key Study value is 100 K€ (for each study), giving a total value of 200
K€

In payment / compensation terms;

Member B pays 66.6 K€ (one third of the value of the two studies)

Members A and C (holders of the key studies) each receive 33.3 K€

# Example 8 : (Valuation with usage restrictions) {#example-8-valuation-with-usage-restrictions .Heading_L2 .unnumbered}

As shown in examples 1 and 3, the value of report 1 (Klimisch 1) has
been calculated to be € 173,350; the value of report 2 (Klimisch 2) has
been calculated to be € 147,280.

Cost Allocation

SIEF members C, D, E, F and G don't own a study.

SIEF member C will use the study exclusively for REACH and requires only
a Letter of Access, he will get a reduced allocation by a factor of 50 %
(therefore he pays at a rate of 50%)

SIEF member D declares, he needs to reference the study for global
regulatory purposes (includes REACH in the EU) but only requires only a
Letter of Access, he will get a reduced allocation by a factor of 30 %
(therefore he pays at a rate of 70%)

Other SIEF members will have full usage rights with the full study
report

+-----------------------------------------------------+----------------+
| Value of key study                                  | € 173,350      |
+-----------------------------------------------------+----------------+
| Share per member (€ 173,350 / 7)                    | € 24,764       |
+-----------------------------------------------------+----------------+
| Financial contribution of Member A (Owner of Report | € 0            |
| 1)                                                  |                |
+-----------------------------------------------------+----------------+
| Financial contribution of Member B (Owner of Report | € 3,724        |
| 2 having the lower value):                          |                |
|                                                     |                |
| 24,764 x (173,350 -- 147,280) / 173,350             |                |
+-----------------------------------------------------+----------------+
| Financial contribution of members E, F and G: 3 x   | € 74,292       |
| 24,764                                              |                |
+-----------------------------------------------------+----------------+
| Financial contribution of member C, who can use the | € 12,382       |
| study (Letter of Access) only for REACH             |                |
|                                                     |                |
| 24,764 \* ((100-50)/100)                            |                |
+-----------------------------------------------------+----------------+
| Financial contribution of member D, who can use the | € 17,335       |
| study for all regulatory purposes, including REACH, |                |
| but needs only Letter of Access.                    |                |
|                                                     |                |
| 24,764 \* ((100-30)/100)                            |                |
+-----------------------------------------------------+----------------+
| Total financial contribution                        | € 107,733      |
+-----------------------------------------------------+----------------+

Cost compensation:

  ------------------------------------------------------ ----------------
  Total amount of assigned contributions (123,820 +      € 107,733
  3,724)                                                 

  Share for Member A having the higher value Report 1\   € 58,246
  107,733 x 173,350 / (173,350 + 147,280)                

  Share of Member B having the lower value Report 2\     € 49,487
  107,733 x 147,280 / (173,350 + 147,280)                
  ------------------------------------------------------ ----------------

The balance (cost allocation -- cost compensation) results in the
following:

SIEF member A receives € 58,246

SIEF member B receives € 45,763 (49,487 -- 3,724)

SIEF member C pays € 12,382

SIEF member D pays € 17,335

SIEF members E, F, G pay € 24,764 each

# Example 9: (Volume Factors) {#example-9-volume-factors .Heading_L2 .unnumbered}

The following calculation describes a case where there is one study
available which is required by four SIEF participants. We assume in this
case the study owner is a third party which does not have any obligation
to register the substance under REACH. The value of the study has been
calculated to be **100.000 €.**

In order to demonstrate the volume impact of the SIEF participants, the
following two sets of illustrative volume band factors are introduced.
Note that other factor ratings could also be selected as agreed by the
participants in the process.

  ----------------------- ----------------------- -----------------------
  Volume Range            Factor Set A            Factor Set B

  1 -- 10 ktonnes         1                       1

  10-100 ktonnes          5                       2

  \> 100 ktonnes          10                      3
  ----------------------- ----------------------- -----------------------

SIEF participant A has a volume of 200 ktonnes, SIEF participant B has a
volume of 60 ktonnes, SIEF participant C has a volume of 30 ktonnes and
participant D has a volume of 8 ktonnes.

With Factor Set A, allocations are as follows:

  ------------- ----------- ----------- -------------- ----------- -----------
  Participant   Volume      Factor      Contribution   Volume      Cost Share
                (ktonnes)               (K€)           share (%)   (%)

  A             200         10          47.6           67          48

  B             60          5           23.8           20          24

  C             30          5           23.8           10          24

  D             8           1           4.8            3           5

  Totals        298         21 (shares) 100.00         100.00      100.00
  ------------- ----------- ----------- -------------- ----------- -----------

With Factor Set B, allocations would be:

  ------------- ----------- ----------- -------------- ----------- -----------
  Participant   Volume      Factor      Contribution   Volume      Cost Share
                (ktonnes)               (K€)           share (%)   (%)

  A             200         3           37.5           67          38

  B             60          2           25.0           20          25

  C             30          2           25.0           10          25

  D             8           1           12.5           3           12

  Totals        298         8 (shares)  100.00         100.00      100.00
  ------------- ----------- ----------- -------------- ----------- -----------

# Example 10 : (New parties)  {#example-10-new-parties .Heading_L2 .unnumbered}

Cost allocation and compensation

As shown in examples 1 and 3 the value of report 1 (Klimisch 1) has been
calculated to be € 173,350; the value of report 2 (Klimisch 2) has been
calculated to be € 147,280.

The initial SIEF consisted of 7 members, A -- G. A new member H joins
the SIEF, SIEF member H

does not contribute with a study.

+-----------------------------------------------------+----------------+
| Value of key study                                  | € 173,350      |
+-----------------------------------------------------+----------------+
| Share per member in initial SIEF (173,350 / 7)      | € 24,764       |
+-----------------------------------------------------+----------------+
| Share per member in SIEF after member H joined (    | € 21,669       |
| 173,350 / 8)                                        |                |
+-----------------------------------------------------+----------------+
| Additional compensation for each initial SIEF       | € 3,096        |
| member A -- G                                       |                |
|                                                     |                |
| 21,669 / 7                                          |                |
+-----------------------------------------------------+----------------+
| Allocation for new SIEF member H                    | € 21,669       |
+-----------------------------------------------------+----------------+

+-----------------+----------------+----------------+-----------------+
| Participant     | Balance 7 SIEF | Balance 8 SIEF | Adjusted        |
|                 | members        | members        | balance         |
|                 |                |                |                 |
|                 | (Example 3)    | (Example 11)   |                 |
+-----------------+----------------+----------------+-----------------+
| A               | 68,958.14      | 72,053.68      | 3,095.54        |
+-----------------+----------------+----------------+-----------------+
| B               | 54,863.29      | 57,958.82      | 3,095.54        |
+-----------------+----------------+----------------+-----------------+
| C               | -24,764.29     | -21,668.75     | 3,095.54        |
+-----------------+----------------+----------------+-----------------+
| D               | -24,764.29     | -21,668.75     | 3,095.54        |
+-----------------+----------------+----------------+-----------------+
| E               | -24,764.29     | -21,668.75     | 3,095.54        |
+-----------------+----------------+----------------+-----------------+
| F               | -24,764.29     | -21,668.75     | 3,095.54        |
+-----------------+----------------+----------------+-----------------+
| G               | -24,764.29     | -21,668.75     | 3,095.54        |
+-----------------+----------------+----------------+-----------------+
| H               | 0.00           | -21,668.75     | -21,668.75      |
+-----------------+----------------+----------------+-----------------+

[]{#__RefHeading___Toc165901103 .anchor}ANNEX 5: PRE-REGISTRATION AND
DATA SHARING EXAMPLES

1.  []{#__RefHeading___Toc165901104 .anchor}EXAMPLE 1: \"BASE CASE\"

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```
1.  *Parties involved*: Companies A, B, C and D manufacture substance X
    in the EU, each above 1000 tons per year. Substance X is a
    mono-component substance listed on EINECS.

2.  *Pre*-*Registration*: Companies A, B, C and D each pre-register
    substance X in July and August 2008. Company B indicates its
    readiness to serve as a facilitator.

3.  *Publication*: On 30 December 2008, the ECHA publishes the list of
    pre-registered substances which includes substance X. Company F
    (Downstream User) then indicates to the ECHA that it holds data on
    substance X.

4.  *Pr*e-*SIEF*: Company B calls a meeting of Companies A, B, C and D
    and proposes to verify whether substance X, as manufactured by each
    company, are equivalent under the criteria of RIP 3.10 by exchanging
    information on substance identification under a proposed
    Confidentiality Agreement. All agree.

5.  *SIEF* *Formation*: The equivalence of the 4 substances X being
    confirmed, the SIEF is formed and the four pre-registrants enter
    into a consortium agreement to agree on the classification and
    labeling of substance X, share data on that substance, using an
    expert as \"trustee\" and to register substance X jointly (but with
    separate CSR and guidance on safe use). Cost sharing shall be on an
    equal sharing basis using average replacement costs, as requested
    from Labs L, M and N.

6.  *Data Sharing*: The expert collects all data available among
    pre-registrants, compares it with the data needs at the 1000 tonnage
    threshold, proposes key studies and identifies data gaps. Consortium
    members request the expert to conduct a literature search, to
    request data from Company F and to prepare the necessary robust
    study summaries and other study summaries. Company F has data on an
    end point that is missing to the pre-registrants and they agree to
    pay Company F 80% of the costs of that data, each company paying
    20%. After the literature search, some data required under Annex IX
    is still missing and the pre-registrants agree that Company B will
    conduct the necessary testing (once approved) and will share the
    study on an equal sharing basis. Pre-registrants also agree that
    Company B shall be the \"lead registrant\".

7.  *Joint Submission of Data*: Company B registers substance X as a
    lead registrant with a testing proposal for the data missing under
    Annex IX on 15 October 2010. Companies A, C and D separately
    register substance X in November 2010 with a reference to the data
    submitted and test proposal made on their behalf by Company B.

8.  *Registration*: Companies A, B, C and D each receive a registration
    number.

9.  

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22. []{#__RefHeading___Toc165901105 .anchor}EXAMPLE 2: DIFFERENT TONNAGE
    BANS

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```
1.  *Parties Involved*: Companies A, B, C and D manufacture and/or
    import or intend to import substance X in the EU. Companies A and B
    manufacture substance X above 1.000 tons per year. Company C is a
    trader who imports substance X between 10 and 100 tons per year and
    Company D intends to import substance X in the EU above 1 ton in the
    years to come.

2.  *Pre-Registration*: Companies A, B, C and D all pre-register
    substance X. Companies A and B indicate they will register before 1
    June 2010, Company C before 1 June 2013 and Company D before 1
    June 2018. Company A indicates its readiness to serve as a
    facilitator.

3.  *Publication*: On 30 December 2007, the ECHA publishes the list of
    pre-registered substances which includes substance X.

4.  *Pre-SIEF*: Company A calls a meeting of experts from companies A,
    B, C and D to receive and review under a confidential agreement the
    information from the other companies necessary to confirm sameness
    of the substance as produced by each company and classification and
    labeling information.

5.  *SIEF Formation*: The company experts confirm the substances all are
    the same under the RIP 3.10 criteria but different impurities may
    justify the differences in classification and labeling. Company A
    and B propose to enter into a consortium agreement on an equal share
    basis using replacement costs; company C proposes proportionality
    per volume on the basis of historic costs. Company D declares it
    will not participate to any consortium at this stage. Companies A, B
    and C decide to appoint a third party to act as trustee and to
    propose a consortium agreement with a \"fair\" data sharing
    mechanism; they communicate production volume information to the
    trustee. They also agree that data collection and review will be
    made by the three company experts and that Company B shall be the
    lead registrant.

6.  *Data Sharing*: The trustee proposes to share costs using a ratio
    that partly takes into account actual tonnage thresholds (See Annex
    4, page X). The experts collect all data available among
    pre-registrants and compare available data with the data needs at
    the different tonnage thresholds; they propose key studies and
    identify data gaps. After the collection exercise and a literature
    search, the experts conclude that all data required up to 1000 tons
    is available but that data is missing in the 1000+ tonnage range.
    Companies A and B agree to make a test proposal for Company B to
    conduct testing for the missing data and share the costs on an equal
    share basis.

7.  *Joint Submission of Data*: Company B registers substance X as the
    lead registrant on 1 May 2010 and Companies A registers on 2 May.
    Company C does not see why it shall wait until 2013 and decides to
    register on 15 May 2010. In 2015, Company D reaches the 1 ton
    threshold and would like to register as soon as possible. Company D
    only need to submit available data and physico-chemical property
    information (as it does not meet Annex III criteria), but still
    needs to agree with the other parties to refer to the lead
    registrant\'s submission for that data and classification and
    labeling. Company D offers a flat fee of 5000 € for receiving the
    necessary letter of access, which is accepted by the other
    participants.

8.  *Registration*: Companies A, B, C and D each receives a registration
    number.

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```
23. []{#__RefHeading___Toc165901106 .anchor}EXAMPLE 3: SUBSTANCE
    IDENTITY ISSUES

> [To be developed]{.mark}

24. []{#__RefHeading___Toc165901107 .anchor}EXAMPLE 4: EARLY REGISTRANT

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```
1.  *Parties involved*: Companies A,B and C manufacture substance X
    above 1 tonne.

2.  *Pre-registration*: Company A could pre-register the substance as
    potential registrant but decides to proceed with registration
    instead after going through the inquiry process for non-phase-in
    substances. Companies B,C and D pre-register substance X.

3.  *Inquiry process*: The ECHA then informs Company Athat the substance
    has not been registered but that a SIEF may exist for that
    substance. (

4.  *Registration*: Company A registers the substance after having
    generated the missing information,.

5.  *Participation in the SIEF*: [To be discussed at SEG 3.]{.mark}

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```
25. []{#__RefHeading___Toc165901108 .anchor}EXAMPLE 5: LATE REGISTRANT

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```
1.  *Parties involved*: in Company A, a manufacturer of an EINECS-listed
    substance, has experienced a rapid grow in the yearly volumes
    manufactured in the period 2007-2010, which brings its three-year
    average quantities to more than 1 tonne in 2011.

2.  *Pre-registration*: Company A pre-registers the substance in June
    2011.

3.  *Participation in the SIEF* : Company A is granted access to the
    contact details of Companies B, C and D, which have also submitted a
    pre-registration for that EINECS-listed substance. A SIEF has
    already been formed by Companies B, C and D. Company B has already
    registered the substance as the lead registrant, while Companies C
    and D are expected to register in the following months. Based on
    preliminary contacts and on other information published on the
    ECHA\'s website, Companies A, B, C and D agree that the substance is
    \"the same\" for data sharing and registration purposes and starts
    cooperating in the SIEF.

4.  *Data-sharing*: Company A decides to accept all data already
    submitted in the framework of the lead registrant\'s registration
    and joins the pre-existing agreement/consortium among Companies B, C
    and D and contribute to the costs in accordance with the
    data-sharing and cost sharing arrangements in force among Companies
    B, C and D. This is restricted to the information required for the
    1-100 tonnage band.

5.  *Joint submission of data*: Company B submits an update of its
    registration by adding the name and contact details of company A to
    the list of other registrants (Companies C and D) on behalf of which
    the information is submitted as well as the information to which
    this applies (1-100 tonnage band)

6.  *Registration*: Company A registers the substance before 1 June 2013
    and receives a registration number.

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26. []{#__RefHeading___Toc165901109 .anchor}EXAMPLE 6: OPT OUT

*1* *Parties Involved*: Companies A, B, and C manufacture and/or import
or intend to import substance X in the EU. Companies A and B manufacture
substance X above 1.000 tons per year. Company C produces substance X in
the 100 - 1000 tons range.

2 *Pre-Registration*: Companies A, B, and C all pre-register substance
X. Companies A and B indicate they will register before 1 June 2010, and
Company B before 1 June 2013. Company C indicates its readiness to serve
as a facilitator.

*3* *Publication*: On 30 December 2007, the ECHA publishes the list of
pre-registered substances which includes substance X.

*4* *Pre-SIEF*: Company B calls a meeting of experts from companies A,
B, and C to receive and review the information from the other companies
necessary to confirm sameness of the substance as produced by each
company and classification and labelling information.

*5* *SIEF Formation*: The three companies agree the equivalence of their
substances X, the SIEF is formed and enter into a consortium agreement
to agree on the classification and labelling of substance X, share data
on that substance, using an expert as \"trustee\", and to register
substance X jointly (but with separate CSR and guidance on safe use). A
cost sharing formula is agreed. B also agrees to serve as lead
registrant.

*6* *Data Sharing*: The experts collect all data available to themselves
and compare availability with needs at the different tonnage thresholds.
The collection exercise shows that A alone holds data on a key study
required for the 1000+ tonnage range (ie, by A and B) but that A is
unwilling to share the full study with its commercial rival, B, on
grounds of the need to protect confidential business information which
would be revealed by the detailed results. Company A claims its right to
opt out of joint submission in respect of this particular test. As B
still wishes to be able to rely upon A's test results for its own
registration, subject to adequate proof of reliability and reasonable
cost, A and B agree that a mutually acceptable independent expert who
has signed a secrecy agreement shall evaluate the suitability of A's
material on B's behalf. A and B subsequently agree a fee for B's right
to refer to A's results; full details will be lodged by A.

*7* *Submission of Data*: Company B registers substance X as the lead
registrant on 1 May 2010, referring to the study results to be provided
by A under its separate registration; Company A registers on 2 May,
including the detailed results which are the subject of its opt out and
referring for other tests to the material submitted on its behalf by the
lead registrant B. Company C decides it too might as well register
immediately, and does so on 15 May 2010.

*8* *Additional material to be lodged by A*: A is required to justify
its opt out, first explaining how the circumstances of its test results
would reveal how it has developed new applications for substance X, and
which B might be expected rapidly to copy. A goes on to demonstrate the
value of the business it has been able to generate, and to show that
loss of a significant part of this business (as might be expected if B
was in a position to compete) could cost it annually a sum in excess of
€1m. A also requests that ECHA maintain the confidentiality of A's
results.

27. []{#__RefHeading___Toc165901110 .anchor}EXAMPLE 7: NON-PHASE-IN
    SUBSTANCES / INQUIRY PROCESS

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1.  *Parties involved*: Company A has planned to start manufacturing a
    non-phase-in substance listed in the ELINCS in 2009, with volumes
    being expected to exceed 1 tonne during the same calendar year. The
    same substance was already notified in accordance with Directive
    67/548/EEC by company B, which also submitted further information as
    part of an update in 2000 as a consequence of an increase in
    production. The information originally submitted is published on the
    ECHA website in the form of summaries/robust study summaries.

2.  

3.  

4.  

5.  *Inquiry process - Step 1:* The company submits an inquiry to the
    ECHA as per Article 26 before carrying out the testing necessary to
    meet the information requirements and submitting a registration. The
    ECHA informs company A of the names and address of company B, which
    has now the status of registrant under REACH, and of the relevant
    study summaries already submitted by him. Company B is also informed
    of the name and address of company A. At the same time, the ECHA
    indicates to company A the study summaries that may be freely used
    by him, i.e. without the need to obtain a permission to refer from
    company B, as they were notified more than 12 years ago

6.  

7.  

8.  

9.  

10. 

11. *Data sharing:* Company A and company B enters into discussion on
    how to share the \"protected\" information submitted by company B.
    After 40 days (following receipt of company B\'s contact details) of
    hard negotiations, agreement is still not reached on the sharing of
    information and on the 41^st^ day, company A informs the Agency and
    company B of \"failure to reach an agreement\". The Agency asks
    company A to give proof that it has paid a share of the costs of the
    study, after which company A pays ¼ of the costs and the Agency
    takes a decision giving company A permission to refer to the full
    study report summarized in the original updated notification report
    submitted by company B. Company B then decides to make the full
    study report available to company A and bring the case before the
    national Court to have its right to an equal share of the costs
    enforced.

    []{#__RefHeading___Toc165901111 .anchor}ANNEX 6: LETTER OF THE LEAD
    REGISTRANT

**REACH Regulation EC/1907/2006**

**SIEF of \[Name of substance\]**

EINECS N°:................. CAS N°.....................

Name of the
Company........................................................................

Contact
Person.................................................................................

Address......................................................................................................................................................................................................................................................................................................\....

Phone
number....................................................................................\...

Fax
number.......................................................................................\...

E-mail.............................................................................................\...

We hereby confirm that \[Name of company\] (contact
person:.....................) will act on behalf of \[List of
registrants\] as Lead Registrant during the procedure of Registration
under Regulation EC/1907/2006.

Date..........................

Name......................

Signature..................

**ANNEX 7 -- DATA EXCHANGE FORM**

  ----------------------------- ------------------- ---------------------------- ------------------- -------------- ---------- ------------ ---------- ---- -----------
  Name of legal entity                                                                                                                                      

  Contact name                                                                                                                                              

  Contact details                                                                                                                                           

  Identity of substance                                                                                                                                     

  Test number                   Annex (REACH)       Information requirement      Rating              Data                                                   
                                                                                                     availability                                           

                                                                                 Estimated Klimisch  Complete study My company Reference to Language        Identity of
                                                                                 rating              report owned   has access data in open of the          substance
                                                                                                     by my company  to         literature   report          (s) for
                                                                                                                    complete                                read across
                                                                                                                    study                                   
                                                                                                                    report                                  

  *[Phys.-chem.]{.underline}*   *[ ]{.underline}*   ** **                        ** **                                                                       

  5.1.                          VII                 State of the substance at                                                                                
                                                    20° C and 101,3 kPa                                                                                     

  5.2.                          VII                 Melting/freezing point                                                                                   

  5.3.                          VII                 Boiling point                                                                                            

  5.4.                          VII                 Relative density                                                                                         

  5.5.                          VII                 Vapour pressure                                                                                          

  5.6.                          VII                 Surface tension                                                                                          

  5.7.                          VII                 Boiling point                                                                                            

  5.8.                          VII                 Partition coefficient                                                                                    
                                                    n-octanol/water, flask shake                                                                            
                                                    method                                                                                                  

  5.9.                          VII                 Flash-point                                                                                              

  5.10.                         VII                 Flammability, liquids                                                                                    

  5.11.                         VII                 Explosive properties                                                                                     

  5.12.                         VII                 Auto-ignition temperature                                                                                
                                                    for liquids and gases                                                                                   

  5.13.                         VII                 Oxidizing properties                                                                                     

  5.14.                         VII                 Granulometry (particle size                                                                              
                                                    distribution)                                                                                           

  5.18.                         XI                  Stability in organic                                                                                     
                                                    solvents and identity of                                                                                
                                                    relevant degradation                                                                                    
                                                    products                                                                                                

  5.19.                         XI                  Dissociation constant                                                                                    

  5.20.                         XI                  Viscosity                                                                                                

                                                                                                                                                             

  *[Mammalian                   *[ ]{.underline}*   ** **                        ** **                                                                       
  tox.]{.underline}*                                                                                                                                        

  8.1.                          VII                 skin irritation (indicate if                                                                             
                                                    [in vitro]{.underline})                                                                                 

  8.2.                          VII                 eye irritation (indicate if                                                                              
                                                    [in vitro]{.underline})                                                                                 

  8.3.1                         VII                 Skin sensitisation                                                                                       

  8.4.1.                        VII                 *In vitro* gene mutation     * *                                                                         
                                                    study in bacteria                                                                                       

  8.4.2.                        VIII                *In vitro* cytogenicity      * *                                                                         
                                                    study in mammalian cells                                                                                

  8.4.3.                        VIII                *In vitro* gene mutation     * *                                                                         
                                                    study in mammalian cells                                                                                

  8.4.4.                        VIII                Other *in vivo* mutagenicity                                                                             
                                                    test: micronucleus test                                                                                 
                                                    (OECD 474) or UDS assay                                                                                 
                                                    (OECD 486)                                                                                              

  8.5.1.                        VIII                Acute toxicity, oral route                                                                               
                                                    (OECD 420, 423 or 425)                                                                                  

  8.5.2.                        VIII                Acute toxicity, inhalation                                                                               

  8.5.3.                        VIII                Acute toxicity, dermal route                                                                             

  8.6.1.a/b/c                   VIII                Short-term repeated dose                                                                                 
                                                    toxicity study in rats (28                                                                              
                                                    days),                                                                                                  
                                                    oral/dermal/inhalation                                                                                  

  8.6.2.ab/c                    IX                  Sub-chronic toxicity study                                                                               
                                                    (90-day) in rats,                                                                                       
                                                    oral/dermal/inhalation                                                                                  

  8.6.3.                        X                   Chronic toxicity (12 months                                                                              
                                                    or longer), rats                                                                                        
                                                    (Exposure/use driven)                                                                                   

  8.7.1.a                       VIII                Screening for                                                                                            
                                                    reproduction/developmental                                                                              
                                                    toxicity, rats                                                                                          

  8.7.2.a                       IX                  Developmental toxicity                                                                                   
                                                    study, rats,                                                                                            

  8.7.2.b                       IX                  Developmental toxicity                                                                                   
                                                    study, rabbits,                                                                                         

  8.7.3/4.a                     IX                  One-generation reproduction                                                                              
                                                    toxicity study (enhanced)                                                                               

  8.7.3/4.b                     IX                  Two-generation reproduction                                                                              
                                                    toxicity study                                                                                          

  8.8.1.                        VIII/IX             Assessment of toxicokinetic                                                                              
                                                    behaviour (based on required                                                                            
                                                    studies)                                                                                                

  8.9.                          X                   Carcinogenicity                                                                                          
                                                    study/combined chronic                                                                                  
                                                    toxicity, rats (Exposure/use                                                                            
                                                    driven)                                                                                                 

                                                    Other studies (to be listed                                                                              
                                                    below):                                                                                                 

                                                                                                                                                             

  *[Ecotox. /env.               *[ ]{.underline}*                                                                                                            
  fate]{.underline}*                                                                                                                                        

  9.1.1.                        VII                 Short-term toxicity testing                                                                              
                                                    on Daphnia                                                                                              

  9.1.2.                        VII                 Growth inhibition study on                                                                               
                                                    algae                                                                                                   

  9.1.3.                        VIII                Short-term toxicity testing                                                                              
                                                    on fish                                                                                                 

  9.1.4.                        VIII                Activated sludge respiration                                                                             
                                                    inhibition testing                                                                                      

  9.1.5.                        IX                  Long-term toxicity testing                                                                               
                                                    on Daphnia, 21-days                                                                                     

  9.1.6.1                       IX                  Fish early-life stage (FELS)                                                                             
                                                    toxicity test                                                                                           

  9.1.6.2 (or)                  IX                  Fish short-term toxicity                                                                                 
                                                    test on embryo and sac-fry                                                                              
                                                    stages                                                                                                  

  9.1.6.3 (or)                  IX                  Fish, juvenile growth test                                                                               

  9.2.1.1.a                     VII                 Ready biodegradability -                                                                                 
                                                    Modified Sturm test                                                                                     

  9.2.1.1.b                     VII                 Ready biodegradability -                                                                                 
                                                    Closed bottle test                                                                                      

  9.2.1.2.                      IX                  Simulation testing on                                                                                    
                                                    ultimate degradation in                                                                                 
                                                    surface water                                                                                           

  9.2.1.3.                      IX                  Soil simulation testing (for                                                                             
                                                    substances adsorbing to                                                                                 
                                                    soil):                                                                                                  

  9.2.1.4.                      IX                  Sediment simulation testing                                                                              
                                                    (for substances adsorbing to                                                                            
                                                    sediment)                                                                                               

  9.2.1.5.                      IX                  Confirmatory testing on                                                                                  
                                                    biodegradation rates                                                                                    
                                                    (aerobic and/or anaerobic)                                                                              

  9.2.2.1.                      VIII                Hydrolysis as a function of                                                                              
                                                    pH and identification of                                                                                
                                                    degradation products                                                                                    

  9.2.3.                        IX                  Identification of                                                                                        
                                                    degradation products                                                                                    

  9.3.1.                        VIII                Adsorption/desorption                                                                                    
                                                    screening study (HPLC                                                                                   
                                                    method)                                                                                                 

  9.3.2.                        IX                  Bioconcentration in (one)                                                                                
                                                    aquatic species, preferably                                                                             
                                                    fish                                                                                                    

  9.3.3.                        IX                  Further studies on                                                                                       
                                                    adsorption/desorption                                                                                   

  9.3.4.                        X                   Further environmental fate                                                                               
                                                    and behaviour studies                                                                                   

  9.4.1.                        IX                  Short-term toxicity to                                                                                   
                                                    earthworms                                                                                              

  9.4.2.                        IX                  Effects on soil                                                                                          
                                                    micro-organisms                                                                                         

  9.4.3.                        IX                  Short-term toxicity to                                                                                   
                                                    plants                                                                                                  

  9.4.4.                        X                   Long-term toxicity testing                                                                               
                                                    on earthworms                                                                                           

  9.4.5.                        VIII                Long-term toxicity testing                                                                               
                                                    on soil invertebrates other                                                                             
                                                    than earthworms                                                                                         

  9.4.6.                        X                   Long-term toxicity testing                                                                               
                                                    on higher plants                                                                                        

  9.5.                          X                   Long-term toxicity to                                                                                    
                                                    sediment organisms                                                                                      

  9.6.                          X                   Long-term or reproductive                                                                                
                                                    toxicity to birds                                                                                       

                                                    Other studies (to be listed                                                                              
                                                    below):                                                                                                 

                                                                                                                                                             

  *[Exposure Data]{.underline}* *[ ]{.underline}*   *[ ]{.underline}*            *[ ]{.underline}*                                                           

                                                    emissions to water                                                                                       

                                                    emissions to land                                                                                        

                                                    emissions to air                                                                                         

                                                    occupational exposure in                                                                                 
                                                    manufacture                                                                                             

                                                    occupational exposure in use                                                                             

                                                    consumer exposure                                                                                        

                                                    end of life                                                                                              
  ----------------------------- ------------------- ---------------------------- ------------------- -------------- ---------- ------------ ---------- ---- -----------

[]{#__RefHeading___Toc165901112 .anchor}REFERENCES

[^1]: \"No longer polymers\" are substances which do not meet the
    definition of a polymer in REACH but were considered as having been
    notified under Directive 67/548/EEC as they met the polymer
    definition of the 5^th^ Amendment to that Directive.

[^2]: Classified as carcinogenic, mutagenic or toxic to reproduction,
    categories 1 and 2, in accordance with Directive 67/548/EEC.

[^3]: Classified as very toxic to aquatic organisms and may cause
    long-term adverse effects in the aquatic environment (R50-53) in
    accordance with Directive 67/548/EEC.

[^4]: Recital 48 specifies that *"This Regulation should be without
    prejudice to the full application of the Community competition
    rules"*

[^5]: Add note to avoid confusion between only representatives and third
    party representatives.

[^6]: Additional information on these issues is provided in RIP 3.3

[^7]: It may still represent value to the owner. See Annex 4.

[^8]: It should be noted that the obligation to prepare a testing
    proposal also applies to situations where the registrant as a result
    of the application of the rules in column 2 of the annexes proposes
    (higher tier) tests of Annexes IX or X as an alternative to the
    standard requirements of Annexes VII and VIII.

[^9]:

[^10]: Article 25.3 and Articles 10(a), last subparagraph, 17.2, second
    sub-paragraph 18.2, second sub-paragraph

[^11]: There is one exception to this principle, and this is when a
    study available in the SIEF is necessary to complete or update their
    registration dossier. In this case, early registrants have the right
    to request that study (and pay accordingly) because they need the
    information for the purposes of one of the objectives of Article
    29.2.

[^12]: It should be noted that this liability may also exist in relation
    to potential registrants from other SIEF(s) for which the substance
    has been identified at the pre-registration stage as potentially
    relevant for read-across or the use of results from (Q)SARS.

[^13]: This may be inconsistent with 119.2.a, which allows impurity
    profile to be CBI, as far as the analytical method is used for
    assessing impurities.

[^14]: Provision of analytical procedure or method includes the measures
    required for testing a method known from the literature for
    compatibility with the intended use.