countdown to registration member joint submissionmagic wand: allows you change information in...

Countdown to Registration Member Joint Submission

23rd September 2010

Overview

Introduction

Part I: Step-by-step approach to completing the member dossier and running plug-ins

Part II:Submission activities including joint submission, ECHA dossier checking and post-submission

Part III: Q & A and IUCLID demo

Recap on Registration

Responsibility for management of risks

with Manufacturer/Importer (M/I)

Registration requires M/I to:

Generate data on substances

Use data to assess risks

Develop risk management measures

Submit the Registration Dossier to the European Chemicals Agency (ECHA)

Information Exchange - SIEFs

Substance Information Exchange Forum

Formed by companies wishing to register the same substance

Facilitate data sharing and avoid duplication of studies

Agree Classification and Labelling

Share and collate information for registration

Leads to a single joint submission for each substance

No option to opt out but can decide how active to be

Roles in the SIEF – Lead Registrant

Appointed by consent of all members

ECHA must be informed of appointment

Acts with agreement of other registrants and submits the joint dossier

Most likely to submit their registration before the 30 Nov 2010 deadline

Roles in the SIEF – Member Registrant

Will register by deadline, but not the LR

Will submit own member dossier, after the joint submission

Request missing information from other SIEF members

Identify needs for further studies

Arrange to perform identified studies (where TP not required)

Agree on classification and labelling

SIEF Participation and Data Sharing

Joint submission dossier must contain:

Robust study summaries

Testing proposal (if required)

Classification and labelling

If information has been reviewed by assessor

Joint submission dossier may contain:

Guidance on safe use

Chemical safety report

SIEF Participation and Data Sharing

Member registrant must submit separately:

His identity

Identity of the substance

Information on manufacture and use(s)

Request as to which information should not be made publicly available

The lead registrant must submit the joint submission dossier first, followed by the dossiers of the other members

Opt-Out

Opt-out of JS under certain circumstances:

If disproportionately costly

If would lead to disclosure of confidential business information

If disagreement with LR on selection of information

Must be justified and documented

Higher fee (individual rather than joint)

Priority for compliance check by ECHA

Data Sharing and Joint Submission

One Substance

One SIEF

One Lead Registrant

One Joint Submission

IT Tools

IUCLID 5 IUCLID 5 is an IT application built to enter, store and report information on hazardous properties of chemicals

REACH ITOnline system used by industry for the secure submission of data and dossiers on chemicals to ECHA

Step-by-Step

Steps to complete the member dossier:1. Gather required information

2. Create the substance dataset

3. Create the dossier

4. Join the Joint submission

5. Submit the Dossier to ECHA

Gathering Data I

1. Identity of the registrant• Name, address, email, phone & fax

• Role in the supply chain (may be multiple)

• Pre-registration number

• LEO from REACH-IT must be synchronised with IUCLID

• SME status

Gathering Data II

2. Identity of the substance/composition • IUPAC name

• EC and/or CAS number

• Source and process (UVCB)

• Impurity and/or additive information

3. Manufacture and Uses• ‘Technological process’ for manufacturers only

• ‘Estimated quantities’ for all actors

• ‘Sites’ for manufacturer’s production sites only

Gathering Data III

• ‘Form in the supply chain’ must be completed (available as substance, substance in mixture, substance in article)

• At least one use must be filled in - your own use(s) and those intended by an actor in the supply chain or communicated to you

• Use Descriptors

4. Exposure information• Required for substances in the 1-10 T/Y band

• Substances ≥ 10 T/Y: exposure information is submitted in the CSR (own or joint)

Part I

Create the Substance Dataset

Introduction

General Information

Manufacture, use and exposure

Chemical Safety Report

Dataset Checks (TCC tool)

Create the Dossier

Export the Dossier

Introduction

General Information

Manufacture, use and exposure

Create the Dossier

Export the Dossier

IUCLID 5

IUCLID 5 is the tool for industry to fulfill their REACH requirements

Available free of charge

The only tool for preparing the dossier

Download IUCLID 5.2

Due to compatibility issues with other programmes, you must download IUCLID 5.2 available at http://iuclid.echa.europa.eu/

Not an online tool

IUCLID Account Set-up

Create an account (internal administrator)

Import your legal entity object (LEO) from REACH-IT into IUCLID

Import the EC inventory and reference substance inventory (will download at step 7)

Create user accounts (administrator login does not support working in IUCLID)

Execute downloads and finish

Icons Explained

Legal Entity: Imported from REACH-IT LEO Legal Entity Site

Substance Dataset Reference Substance

Repeatable Block (hide; move block down; up; create; delete)

Golden Link: links information from local and downloaded inventories

Magic wand: allows you change information in automatically filled boxes

Mixture Dataset

Paper clip: allows you to attach files (word processing or pdf)

Confidentiality flag: fields that you can hide from public dissemination (cost)

Terminology Explained

Substance dataset: central core of information stored in IUCLID linking all entered data related to the substance

Reference substance: obtained from the inventory, links all known identifiers with the substance

Dossier: final information file, contains the substance dataset, legal entity, reference substance and dossier header

Dossier Header: the information entered by you while creating the dossier

IUCLID Main Page

Create the legal entity site (manufacturers only)

Select ‘New’

Create the legal entity site (manufacturers only)

At a minimum

provide name,

city and

country.

Substance Dataset Creation

Select ‘New’

If you select the

template before

you enter data, it

will colour code

required endpoints

Expand and Collapse the Tree

Introduction

General Information1.1 Identification

1.2 Composition

1.3 Identifiers

1.4 Analytical Information

(1.5 Joint Submission)

(1.7 Suppliers)

1.1 Substance Identification

The legal entity’s role in the supply chain

The reference substance

The substance composition

The contact details of the IUCLID owner

Identification

A Note on Confidentiality

Confidentiality may be selected for certain information fields based on:

Confidential Business Information (CBI), Intellectual Property (IP), Not Publically Available (no PA)

Certain information such as substance identification (see Art 119(1))cannot be made confidential

Each claim for confidentiality will cost the dossier submitter and a justification must be provided

Identification

IdentificationIdentification

If no substance

appears you must create

your own reference

substance by clicking on

‘New’.

IdentificationIdentification

1.2 Composition

Substance identity crucial

Substance, including any impurities or additives

Composition must be fully described

If a mono-constituent the constituent must correlate with the (reference) substance in section 1.1

Multiple constituents added using repeatable blocks (e.g. multi-constituent)

Impurities ≥ 1% must have at least one chemical identifier

If identifiers unknown, type ‘unknown’ under IUPAC name

Composition

Create a repeatable block

Composition

At least 1 constituent must

be provided

Composition

1.3 Identifiers

Links registration with the pre-registration or inquiry number

A regulatory programme must be selected and pre-registration or inquiry number entered

Identifiers

Fill in pre-registration

(or inquiry) number

1.4 Analytical Information

What’s needed? Spectral data (UV, IR, NMR, MS)

HPLC and GC

Description of the analytical methods sufficient to allow the methods to be reproduced

Analytical Information

Analytical methods (type or attach)

Create a new block for each

result e.g. ir, uv etc.

1.5 Joint Submission

Information on JS is obtained solely from REACH-IT, any information (name of JS) provided here will not be taken into account but can be used for your administrative purposes

If you are not submitting jointly, do not complete any information in this section

Joint Submission

JS name communicated in SIEF by LR

1.7 Suppliers (ORs ONLY)

Only representatives (ORs) are advised to complete this section with information on the importers whose tonnages represented

Letter of appointment from the non-EU manufacturer

Suppliers

Introduction

General Information

Manufacture, use and Exposure3.1 Technological process

3.2 Estimated quantities

3.3 Sites

3.4 Form in the supply chain

3.5 Identified uses

3.6 Uses advised against

3.7 Waste from production and use

3.1 Technological Process

Description(s) of the technological process used in the manufacture of the substance or production of articles, as appropriate

Repeatable blocks, in case used in more than one process

ORs / importers must provide justification e.g. “as an importer I am not involved in the manufacture of substances or the production of articles”

Technological process

3.2 Estimated Quantities

Tonnage per year that is subject to REACH registration

Indication of M/I own use(s)

Tonnage calculated per calendar year, since REACH came into effect

Estimated quantities

3.3 Sites (Manufacturers ONLY)

Only complete if ticked checkbox for manufacturer in section 1.1

Manufacturing

ORs / importers must skip this section (no justification required)

It will link to the LE site created

earlier

3.4 Form in the Supply Chain

Must indicate if registering: A substance

A substance in a mixture

A substance in an article

Physical state in which it is made available to downstream user

Form in the supply chain

Repeatable blocks for the % of

Substance in each mixture manu

or imported and each article

produced

3.5 Identified Uses

General description on the identified use(s)

One use per line created

At least one use must be provided

If several lines are created in the table, then all lines must be completed

If multiple uses, multiple lines must be created

Use Descriptors

Abbreviation Full Name Description

SU Sector of use category Main user groups for all usesof the substance known / communicated to you.

PC Chemical product category Chemical product type in which the substance is supplied to end user.

PROC Process category Application / process types relevant to occupational exposure

ERC Environmental release category

Conditions of use defined from environmental exposure

AC Article category Article types in subsequentservice and waste life.

Identified uses

Provide at least one use per line in any of the three use types

Identified uses

Where no use is recorded, a justification

with a reason must be provided

Identified uses

3.6 Uses advised against

Information on use(s) registrant advises against as specified in Annex VI section 3.7 of REACH and why

Uses advised against

3.7 Waste from Production and Use

Information on waste quantities and composition of the waste resulting from the production and identified use(s) as specified in section 3.6 of Annex VI of REACH

Non-manufacturers or no waste must provide a justification

Waste from production and use

Introduction

General Information

Manufacture, use and Exposure

Create the Dossier

Export the Dossier

Chemical Safety Report (CSR)

Whether you are providing your own CSR & Guidance on safe use (Opt-out) or not, you must create an endpoint in this section.

Opt-out: must meet the criteria of Article 11(3) and 19(2)

Otherwise you must communicate with the LR to ensure your uses are covered by their CSR

COFFEE BREAK

Part I…contd

Introduction

General Information

Create the Dossier

Export the Dossier

TCC check on the substance dataset

Click on this in the grey

Areas only, and it will

bring you to the error

No constituent entered:

select edit and add the

constituent(s)

Introduction

General Information

Create the Dossier

Export the Dossier

Create the Dossier

READ ONLY

Any changes must be made to the substance dataset and the dossier re-created

Run the TCC tool on the dossier again

When no more failures show up, your dossier is ready for export

Create the dossier

Select both EU REACH and No

Regulatory Purpose

Create the dossier

Negative selection

Create the dossier

Re-run the TCC tool

Introduction

General Information

Create the Dossier

Export the Dossier

Exporting

Select the dossier for export

In the file menu, select export

Choose a file name and location on your drive

Select finish

This file can now be uploaded to REACH-IT

Export the dossier

It will look like this

on your desktop

Part II

Submission Activities

Joining the joint submission

Submitting the Dossier

Business Rules Verification

Technical Completeness Check

Fees and invoicing

Post submission

Joining the joint submission

Fees and invoicing

Post submission

Chronology of Submission

Lead Registrant creates the Joint submission (& communicates tokens)

submits the Lead Dossier

passes BRV and dossier is accepted for processing

Member Registrantreceives a message in RIT

commence submissions

submission complete only when Lead dossier is complete

The Security Token

Automatically generated string of alpha- numeric characters

Made available to the LR on his creation of the Joint Submission Object (JSO)

Ensure a definite association between the Lead and member dossiers

Communicated to member registrant outside of REACH IT

Each token has a validity of 30 days

Member has 5 attempts to enter token

REACH IT

Log on to REACH IT from the ECHA Website

Confirm Membership of the Joint Submission

Joint Submission

Confirm Membership

Use of the Security Token

JS Formaldehyde

835-d34-c518-297849814

Confirming membership of a JS: Step 2

Insert contact of person responsible for the submission if different from original contact

Formaldehyde

Confirm Membership

Joint Submission Status

View Status of the Joint Submission

Joining the Joint submission

Fees and invoicing

Post submission

Registration/Notification

Submit Registration/Notification

Submit the Member Dossier in REACH IT Submit a New Registration

Submit the Member Dossier in REACH IT

Registration

Submit the Member Dossier in REACH IT Provide Registration Info

Verify Company size by ticking the declaration

Related to a Joint submission must be

selected

JS Formaldehyde

Submit the Member Dossier in REACH IT Upload IUCLID 5 file

Submit the Member Dossier in REACH IT Confirm Submission

Confirm Submission

Submit the Member Dossier in REACH IT Issuing preliminary submission Number

Message relating to the Submission will appear in the RIT message Box

Fees and invoicing

Post submission

Screen Shot

Business rule verification

Business rules Verification

Set of prerequisites that must be fulfilled before REACH IT can establish that the dossier can be handled

Checked in REACH IT

For example: Incorrect IUCLID format ( Must be 5.2), no valid identifier eg pre-registration, inquiry number etc

Once passed, Dossier progresses to processing

Majority automatic (Enforce rules) and results found in submission report

Other (Mandatory rules) checked by ECHA and failures communicated via PDF file under ‘Annotations section’

Examples: Top Ten

Run the TCC tool also for BR checking

Fees and invoicing

Post submission

Technical Completeness (ECHA)

Activity performed by ECHA on all dossiers

Same as TCC Tool Check

Check on all required elements of the dossier type and receipt of fees

Consequence: 2 failures = repayment of fee

Completeness Check (ECHA)

Within 3 weeks or 3 months (from 30th Sept 2010)

If dossier is incomplete or invoice not paid ECHA will communicate extended deadline

Failure to meet this deadline: a second deadline is set

Failure to meet second deadline, failure to pay and failure to submit missing information = 2nd Failure of TCC and second fee chargeable

Fees and invoicing

Post submission

Invoicing

An invoice is issued for a registrationIf the dossier is accepted for processing and

If a fee is required according to the Fee Regulation

Invoice is sent via the REACH IT internal messaging system

Main factors affecting the Fee amount ;Tonnage band

Dossier type

Company size

Confidentiality Claims

Joint versus individual submission

Invoice location

Arrangements with accounting department

Pay the invoice in time (currently max 44 days from date of opening the invoice; for 2010 dossiers submitted after 1 Oct, will become max 60 days)

One invoice, one payment

Fees & Invoicing

A new Fee calculator tool to be released in October

IUCLID Plug-in available from the IUCLID website

Fees and invoicing

Post submission

Post Submission

Request for updates

Communications from ECHA

ECHA sends registration number to Lead once dossier is considered complete

ECHA will send registration number to member once member dossier is considered complete

ECHA REACH IT web-pages

Helpdesk reachright@hsa.ie

Countdown to Registration Webpage

Email communications

IUCLID Demo

Guidance documents

Part III

Q & A and IUCLID demo

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