2-Reach 2018 Overview en

REACH
Registration, Evaluation and

Authorisation of Chemicals
The purpose of this Regulation is to ensure a high

level of protection of human health and the
environment as well as the free circulation of
substances on the internal market while
enhancing competitiveness and innovation
(article 1)
REACH Definitions
Substance: chemical element and its compounds in the
natural state or obtained by any manufacturing process,
including any additive necessary to preserve its stability
and any impurity deriving from the process used, but
excluding any solvent which may be separated without
affecting the stability of the substance or changing its
composition
Preparation: a mixture or solution composed of two or
more substances
Article: an object which during production is given a
special shape, surface or design which determines its
function to a greater degree than does its chemical
composition
Time Frames
6/2008-12/2008
All Substances manufactured or imported into EU
Pre-registration at >1tpa
CMR / >1000t/y
R50/53 >100t >100t/y >1t/y
12/2010 6/2013 6/2018
Registration
Testing CMR / >1000t > 100 t

R50/53 >100t >1 t
Authorisation
REACH requirements for new substances
Pre REACH REACH - 11 years Phase-in
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
Purpose of this presentation
This presentation, with notes, was prepared by ECHA, the European Chemicals
Agency, to assist you in preparing a presentation about the REACH 2018, i.e.
last registration deadline of phase-in substances. The intention is that you can
select relevant slides and modify them as necessary to suit your audience,
whether it is management, workers, environmental health and safety
professionals, authorities etc. You may use it without additional permission.
This presentation gives a brief overview of the registration in the context of

REACH and gives an overview of ECHAs REACH 2018 Roadmap. It is the
opening of a series of presentations relating to REACH 2018, which are on the
ECHA website. We welcome your comments and suggestions at reach-
2018@echa.europa.eu.
Legal notice: The information contained in this presentation does not

constitute legal advice and does not necessarily represent in legal terms the
official position of the European Chemicals Agency. The European Chemicals
Agency does not accept any liability with regard to the contents of this
document.
Release: May 2016
echa.europa.eu/reach-2018 5
Outline
Background
REACH registration by 2018
ECHAs REACH 2018
Roadmap
Six phases to successful
registration
REACH 2018 Communication
Background
REACH registration
Knowledge on hazards and uses of substances is a
pre-requisite for responsible action
REACH puts the burden of proof to individual
companies they have to demonstrate that their
substances can be used safely
Companies collect information, analyse it and
document their conclusions in a registration dossier
Information from registrations is used by authorities
and published by ECHA on its website
Registration of chemicals already in the European
market in a stepwise manner: 2010, 2013 and 2018
Information flow from registration
Public information on chemicals
comes from registrations
Infocard
Brief Profile
Source Data
Registration CoRAP List Authorisation Restriction List Harmonised Approved Active PIC Annex I
dossiers List C&Ls Substances
REACH registration by 2018
REACH 2018
Third and last registration deadline for phase-in
substances
Concerns: Companies that manufacture/import
substances between 1 to 100 tonnes/year and have
pre-registered them
What is new?
Higher % of SMEs
Many SMEs might consider becoming lead registrants for the first
time
Many small SIEFs/registrants alone in their SIEF
Less information need to generate new data
Different levels of sector organisations
New economical and political contexts
REACH 2018 - 2
Experience proves: REACH registration is
manageable!
Thousands of companies have already done it since
2008
More than 5 600 registrations for the last deadline

received, 16% from SME companies
ECHA, European Commission, national authorities

and industry organisations are joining their forces
to support companies!
ECHAs REACH 2018 Roadmap
Roadmap document
Published on 14 January 2015

Consultation with stakeholders JuneSeptember 2014
Comments received from 26 organisations
Documents ECHAs activities planned for 2014-2018

Actions to support inexperienced and SME registrants
Main focus in improving the readability and accessibility of support

material
Milestones revised on an annual basis; annual progress report

published
Must be complemented by Member State and industry

actions for successful management of the 2018
registration deadline
Roadmap structure: Seven phases
Know your portfolio
Find co-registrants
Share data
Assess hazards and risks
Prepare your dossier
Submit your registration
Keep your dossier up-to-date

Know your portfolio
Identify if you need to register (role in the supply

chain) and if yes, which substances in your
portfolio need to be registered
Identify and name your substances accurate

identification essential for data sharing and joint
registration
Familiarise yourself with the information

requirements
Plan your work and inform your downstream

users
Find your co-registrants
Check your pre-registration
Identify the lead registrant, or
Find your co-registrants
Discuss the sameness of your substance to share

data and submit jointly
Share data
Organise your SIEF cooperation, or get active in the
existing SIEF of your substance
Share data to meet your information requirements
Avoid unnecessary testing on animals
Reduce costs of registration
Negotiate costs in a fair, transparent and non-

discriminatory manner
Share the costs of common data
Assess hazards and risks
Information required depends on tonnage and
uses
1-10 tonnes: Possible reduced data requirements
for less hazardous substances
> 10 tonnes: chemical safety report needed
Pay attention to data quality: relevance,
adequacy and reliability
Animal testing is the last resort - consider
alternatives first
Some long-term studies require a testing
proposal
Prepare your dossier
Prepare your technical dossier in IUCLID
Identity of the registrant
Identity of the substance
Information on the substances intrinsic properties
Information on use and exposure
Companies preparing a member dossier without any opt-outs

can do it on-line in REACH-IT
Chemical safety report needs to be included if

manufacture/import is at or above 10 tonnes/year
Use of ECHA tool Chesar recommended
ECHA provides IUCLID free-of-charge
Submit your registration
Check and update the information that is relevant
for registration in REACH-IT
Carefully assess your SME status
Set up or join the joint submission in REACH-IT
Submit your registration dossier: first the lead

registrant, then all co-registrants
Follow up on the communication in REACH-IT
Keep you registration up-to-date
Registration dossier is a living document!
Duty to update the registration dossier if
Regulatory decision
New information on substance (properties, uses)
Be proactive
Consult ECHAs Evaluation Progress Reports for most

common anomalies in registration dossiers
Follow regulatory developments for your substance on the

ECHA website
REACH 2018
Communication
REACH 2018 website:
http://echa.europa.eu/reach-2018
Simple language
Available in 23
languages
Structured around the
registration workflow
ECHA support material
for each step
organised in three
layers of complexity
Getting started
Essential reading
Going deeper
Advance notice on
upcoming issues
Support material in three
categories
1. Getting started:
An overview of
what the phase is
about
2. Essential
reading: More
about the content
to help you decide
e.g. if you need to
outsource the work
3. Going deeper:
How to carry out
the tasks
REACH 2018
Communicators Network
Set up to:
- Plan and coordinate awareness raising activities
- Help to produce and distribute material in all EU
languages
- Collect feedback from target audiences
- Measure impact of coordinated activities
ECHA, European Commission, Member States,
industry organisations, Enterprise Europe
Network local organisations
Active since early 2015
Joint activities around phase
launches
Awareness raising through
various audiences

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REACH

Registration, Evaluation and

The purpose of this Regulation is to ensure a high

Testing CMR / >1000t > 100 t

REACH requirements for new substances

Pre REACH REACH - 11 years Phase-in

This presentation gives a brief overview of the registration in the context of

Legal notice: The information contained in this presentation does not

Release: May 2016

More than 5 600 registrations for the last deadline

ECHA, European Commission, national authorities

Published on 14 January 2015

Comments received from 26 organisations

Documents ECHAs activities planned for 2014-2018

Main focus in improving the readability and accessibility of support

Milestones revised on an annual basis; annual progress report

Must be complemented by Member State and industry

Assess hazards and risks

Prepare your dossier

Submit your registration

Keep your dossier up-to-date

Identify if you need to register (role in the supply

Identify and name your substances accurate

Familiarise yourself with the information

Plan your work and inform your downstream

Identify the lead registrant, or

Find your co-registrants

Discuss the sameness of your substance to share

Share data to meet your information requirements

Avoid unnecessary testing on animals

Reduce costs of registration

Negotiate costs in a fair, transparent and non-

Share the costs of common data

Companies preparing a member dossier without any opt-outs

Chemical safety report needs to be included if

Use of ECHA tool Chesar recommended

ECHA provides IUCLID free-of-charge

Carefully assess your SME status

Set up or join the joint submission in REACH-IT

Submit your registration dossier: first the lead

Follow up on the communication in REACH-IT

Duty to update the registration dossier if

New information on substance (properties, uses)

Consult ECHAs Evaluation Progress Reports for most

Follow regulatory developments for your substance on the

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