REACH Industry Preparation Letter No 7
November 2007
Table of content
1. Communication in the Supply Chain
p. 2
2. Implications of late Pre-registration and late Registration
for Phase-In Substances
p. 8
3. Consortia
p. 11
4. Polymers post-reactants
p. 20
5. Registration for Importers
p. 21
6. How to submit your pre-registration
p. 33
7. REACH-IT Milestone dates
p. 35
8. REACH Implementation Workshop I
p. 36
9. Short News
p. 36
10. Workshops
p. 37
Disclaimer
The information contained in REACH Industry Preparation Letter is intended for guidance only and
whilst the information is provided in utmost good faith and has been based on the best information
currently available, is to be relied upon at the user’s own risk.
No representations or warranties are made with regards to its completeness or accuracy and no
liability will be accepted for damages of any nature whatsoever resulting from the use of or reliance
on the information.
Copyright
Copyright © 2007 of Cefic (AISBL), all rights reserved except for the Cefic members. No part of this
publication may be reproduced, stored in a retrieval system or transmitted in any form or by any
means, mechanical, photocopying, recording or otherwise, without prior written permission of the
owner. Please apply to Leo Heezen (LHE@cefic.be, tel. +32-2-676 7333).
1. Communication in the Supply Chain
In newsletter no 5 Cefic introduced the questionnaires part I, II and III. Part I dealing with the DU
request to M/I whether he will (pre-)register his substance under REACH. The parts II and III are
dealing with the communication of the use and exposure up and down the supply chain, emphasizing
that these two questionnaires should only be used for internal preparations as the RIP 3.2 guidance
might change it once it is there.
As was mentioned in the earlier newsletters, part I can be used by DU to investigate the M/I
intentions with regards to (pre-)registration under REACH. As to parts II and III, RIP 3.2 is now close
to its final stage and Cefic is already developing a communication tool for use and exposure
information up and down the supply chain, based on the draft final version of RIP 3.2 guidance. This
should replace the parts II and III of the questionnaire. This paper deals with the structure of the
communication, the different stages and the tools required to run it. The actual questionnaires are
not included yet, but are now under development, waiting for the final RIP 3.2 guidance before we
can circulate them via a newsletter.
AN INDUSTRY PROPOSAL FOR USE AND EXPOSURE COMMUNICATION UNDER REACH,
THROUGHOUT THE SUPPLY CHAIN
November 2007
Introduction
The Cefic Harmonisation working group, in close cooperation with the Distributor’s trade association
FECC has developed a process for communication of use and exposure information up and down
the supply chain for a substance for which a Chemical Safety Assessment (CSA) is required under
REACH1.
The proposed approach is based on industry’s current understanding of RIP 3.2-2 (Guidance on
Preparing a CSR) which is expected to be published before the end of 2007 and the conclusions of
the “Arona workshops” which suggested that a ‘top down’ approach based on the
manufacturer’s/importer’s (M/I) knowledge of its supply chain is the most efficient way of ensuring
effective communication and keeping the administrative burden on all actors to a minimum.
The proposed process with the recommended top down approach envisages at least three phases of
information gathering involving interactive communication between the actors in the supply chain.
These phases are:
- It is assumed that the manufacturers/importers know most of the uses of their substances.
Therefore, the first step is an in house review of existing information to produce a tentative
exposure scenario (ES) for all known uses. If there is insufficient information in-house, key
customers can be approached for additional information required to prepare the tentative
ES.
-
In order to avoid a flood of questionnaires up and down the supply chain, it is proposed that
the main communication will take place following a top-down philosophy. M/I will
communicate their tentative Exposure Scenarios 2 (ES) to key customers or trade
associations and get into a dialogue with them in order to refine the content and to ensure
maximum coverage in terms of number of uses and appropriateness recommended. The
1
Art. 14 of the REACH legislation: Chemical Safety Report and duty to apply and recommend risk
reduction measures.
2 The draft ES in the format as required for the eSDS
2
result of this dialogue will be a draft ES that can be communicated further in the supply
chain.
-
Communication of the draft ES to rest of supply chain to alert downstream users to those
identified uses that will be supported at registration. Downstream users are requested to
check whether their uses are covered and appropriateness of the use description and Risk
Management Measures (RMM) recommended. Silence means confirmation.
These three steps are reflected in the flow diagram (see attachment at the end of this paper).
A fourth information loop is included in the workflow process, to describe the input from Association
and Sector Groups of ES already developed by them, to be included in the M/I in his final Exposure
Scenarios if he can support it.
It is proposed that templates for information gathering during different phases will be developed by
the Supply Chain Communication Task Force, taking into account the examples contained in the
Guidance on Preparation a CSR and other standards further developed by industry. The Cefic
REACH IT group also plan to develop a specification for an IT tool to facilitate the communication
process and both groups are working closely together to determine whether this is achievable or not.
If it is achievable, the goal is for the communication templates and specification for IT tool to be
ready for use by industry during Q1 2008.
General considerations for the communications throughout the supply chain
Complexity of supply chain
It is recognized that supply chains can be very complex and therefore it will be a challenge to obtain
accurate information in a timely manner from all stakeholders. National and European Trade
Associations therefore have an important role in ensuring the communication process is simple and
effective by acting in partnership with M/I.
These Associations are encouraged to translate the Exposure Scenarios developed and
communicated to them by the M/I into understandable and practical use guidance (including RMM)
for their members, applying the calculation algorithms supplied with the Exposure Scenarios.
To facilitate this communication process, a Use Descriptor system is under development as part of
RIP 3.2-2. To ensure harmonized communication the process envisages that these Use Descriptors
should be used by all stakeholders in the supply chain for communication of identified uses.
A similar effort is under consideration for developing standard Risk Management Measures (RMM),
ESs and Standard Phrases. These standards will be compiled in libraries. Where possible, it is
expected that these libraries would form the basis of the information-gathering templates and the IT
tool being considered by the REACH IT group.
IT tool for and timing of the supply chain communication process
The Cefic REACH IT working group in close cooperation with the Cefic Harmonisation group will
develop the software requirements for an IT tool to support the supply chain communication process.
The IT tool itself will than come from professional providers that have systems like that in their
package.
The questionnaires to support the supply chain communication in a standardized way will be
developed by the Cefic Harmonisation group.
As the development of the questionnaire and the development of the tool depend on the availability
of the final RIP 3.2-2 guidance documents, it can only be made available after these documents are
published, which is expected to be early 2008.
3
Players in the supply chain are strongly advised to wait for the standard questionnaires and IT tools
before starting any communication on use and exposure in the supply chain.
Complex and extensive supply chains may result in a very time consuming communication exercise,
which could impair the M/I’s ability to meet either their self-imposed deadline for early registration or
the deadlines for Phase-in substances in the REACH legislation for the applicable tonnage level.
These deadlines need to be realistic and take into account consideration the length and complexity
of the supply chains. It is therefore crucial that the actors in the supply chain start compiling use and
exposure information. The M/I can start to prepare by gathering the available information from its
own trade organization(s) and by contacting their key customers and/or Associations.
Actors in the supply chain are encouraged to review the draft ES in a timely manner to ensure that all
identified uses are considered when the registration, including the CSA, is prepared. The latest
downstream actor can make his supplier aware of his/her use of a supplied substance if they want to
have it included in the registration is 12 months before the registration deadline. In reality, because
downstream users will not always know when the M/I intend to submit the registration (especially in
the case of preparations) it can be anticipated that most downstream users will want to communicate
use information to their supplier well before December 2009.
What should be done in each of the information gathering phases?
In house review
The potential registrant should start gathering all information on use and exposure from the internal
organisation like Sales, Marketing, Technical Support, Production etc to build the tentative ES.
Based on the information obtained there needs to be a judgment whether sufficient information is
available to develop a tentative ES covering the majority of identified uses and exposures, using the
use descriptor system as described in RIP 3.2-2 guidance and the RMM, ES and standards phrases
libraries. If it is decided that there is insufficient in-house information available to build the tentative
ES, then key customers will need to be contacted by M/I and asked to provide the missing use and
exposure information.
Once the potential registrant is reasonably assured that most uses and exposures are covered the
tentative ES can be developed and go to the next step.
Active review of in-house developed ES with key customers
Once a tentative ES has been developed, this can be used to generate a preliminary Chemical
Safety Assessment (CSA). The resulting ES, RMMs and conditions of use can then be shared with
the key customers and/or trade associations. This information gathering phase is expected to be a
highly interactive and iterative process between M/I and key customers/trade associations, where
feedback from the latter should be sought. The output of this phase is a draft ES incorporating the
identified uses and different ESs of key customers consulted, who should have confirmed that
proposed RMMs and calculation algorithms included in the CSA are acceptable.
Check of info completeness and correctness with supply chain
Once confirmed by key customers/trade associations the draft ES will now be circulated with other
DUs including those further down the supply chain who will be asked to check whether their use is
covered and that they can agree to the conditions of use described in the CSA. If that is the case no
further action is required from DU. In case a certain use is not covered by the draft ES, the DU
should inform his supplier before a set deadline, ensuring that he/she uses standard terminology
contained in the industry guidance (RIP 3.2-2) and standard libraries to ensure that all actors
understand each other. This information should be communicated up the supply chain until it
reaches the M/I responsible for developing the ES.
4
The M/I should consider including the new information in the ES and is expected to inform the DU of
his/her decision, especially if the M/I does not agree with the use for health and/or environmental
reasons.
At the end of the process the M/I should have sufficient information to finalise an accurate ES for all
intended uses and can extract specific information for communication down the supply chain via the
extended safety data sheet (eSDS).
Downstream-up tentative ES generation
Although the CSA and resulting ES is the responsibility of the M/I, there are Association who have
already developed or are actively developing generic ESs based on known use and exposure
information for their specific supply chain and/or sector. It is expected that some M/I’s will choose to
use such generic ESs for completing their CSA and ES during compilation of the registration dossier
and for supply chain communication. It is essential though that DU Associations inform their
suppliers as early as possible about their initiatives on developing sector specific ES.
There is also the possibility that a DU does not want to share their particular use with the M/I
because this is considered to be confidential. In that case the DU should develop their own CSA for
the confidential use and notify the Agency. The resulting ES and derived RMM’s can then be used by
the DU for subsequent communication further down the supply chain.
Companies are kindly encouraged to follow this approach and to proactively communicate it with
their customers and suppliers.
Attachment: Workflow supply chain communication.
5
COMMUNICATION REQUIREMENTS FOR SUBSTANCES ON THEIR OWN OR IN PREPARATIONS
THAT DO NOT REQUIRE A SAFETY D ATA SHEET
A. Up the Supply Chain: Duty to communicate information on substances and preparations
up the supply chain (Art. 34).
Q1: What information should be communicated?
A1: New hazardous properties regardless of uses and/or information that may contradict the risk
management measures recommended by the supplier in the product SDS but only for identified
uses. Distributors are also responsible to pass information to the next actor up the supply chain. Art.
34 requirements are not restricted to registered substances and so apply to all substances (including
polymers).
Examples include newly observed and toxicologically significant adverse effects in humans and/or
the environment which in practice are likely to be limited to confirmed cases of respiratory or skin
sensitisation, adverse skin effects associated with acute or chronic exposure (e.g. contact urticaria)
and possibly neurotoxic effects. The need for different mechanical controls to prevent exposure to
man and/or release to the environment for identified uses, or the need for significantly different
personal protective equipment to that advised in the SDS should also be communicated to the next
actor up the supply chain.
As a result, risk management measures will need to be reassessed and information required to carry
out duties assembled and kept for at least 10 years according Article 36 (Obligations to keep
information).
B. Down the Supply Chain: Duty to communicate information down the supply chain for
substances on their own or in preparations for which a safety data sheet is not required (Art.
32).
The criteria concerning the need for an SDS for non-hazardous preparations is given in REACH Art
31.3. An SDS is required “at the recipient’s request” for non-gaseous products containing ≥ 1% of a
hazardous substance (≥ 0.2% by volume for gaseous products) or ≥ 0.1% of a PBT or vPvB
substance or (any amount of) a substance with a Community workplace exposure limit. There are no
de minimis levels given for substances subject to authorisation or restriction in REACH Art 31 but it
would be expected that formulations containing ≥ 0.1% of these materials would have an SDS. Thus
formulations which do not require a SDS must contain very low levels of hazardous substances
(typically < 1%) or solely non hazardous substances.
The requirement to communicate information down the supply chain when a SDS is not required is
therefore only applicable to hazardous substances in preparations (as intentional ingredients or as
impurities) that are below the concentration limits of reporting on the SDS. It is however also
applicable to any amount of substances that are not hazardous and do not have a Community
exposure limit. Additionally, Art. 32 requirements are not restricted to registered substances and so
apply to all substances (including polymers). However, the information to be communicated for
substances not subject to authorisation or restriction (Art 32.1(d)) is somewhat limited (i.e. all
available and relevant information to enable proper risk management).
Q1: What information should be communicated?
A1: The registration number(s), if available, for substances subject to authorisation or restriction.
Additionally, details of authorisations granted (or denied) and details of restrictions must be
communicated as should any other information considered necessary to ensure appropriate risk
management of the substance; this would include for example any exposure information arising from
the omission of repeated-dose and/or reproductive toxicity testing.
6
Q2: Is there a requirement to communicate information about substances present in preparations at
levels lower than 0.1%?
A2: There is no de minimis threshold concentration. Therefore, actors in the supply chain must
communicate the required information for substances subject to authorisation or restriction even
when they are present at very low concentrations.
Q3: What is the role of a distributor?
A3: Distributors are not considered as downstream users under REACH, but should pass on
information received from their suppliers to their customers.
Q4: When does the information have to be updated?
A4: The requirements for the delivery and revision of this information (Art 32.2) are identical to those
for SDS themselves (see Art 31.9). Thus a formal document with all the appropriate issue/variant
controls and distribution procedure is needed. One potential practical solution is the issuing of a
simple document using the supplier’s existing SDS authoring and distribution system. However it
must be emphasised that this is only one of many potential approaches and each company is able to
choose a communication and updating format which best suits their operations.
7
2. Implications of late Pre-registration and late Registration
for Phase-In (P-I) Substances
The comments below summarise the deadlines, implications of failure to act (possible by human
error). They pertain to each of 6 scenarios. There is some replication in the comments but they have
been set out in this way to highlight the differences between direct registration (registration of the
complete dossier withour prior pre-registration) and registration following pre-registration and those
between existing and new manufacture / import (M/I).
The principles described in the 6 (pre-)registration scenarios below can be applied to the three
tonnage bands shown in Table 1. However the deadlines will be different in scenarios 2, 4, 5 and 6
and these are summarised for each tonnage band in the same Table.
Table 1:
1
Annual Tonnage (MT) /
Chemical Type
2
Deadline date for
Registration following Preregistration of substances in
existing M/I before 1st
December 2008
3
Deadline date for preregistration of substances M/I
for first time after 1st December
2008
(See Article 28.6)
>1000
& R50/53 >100 te
& CMRs >1 te
1st December 2010
30th November 2009
>100 <1000
1st June 2013
31st May 2012
>1 <100
1st June 2018
31st May 2017
Pre-registration and registration deadlines for Phase-In substances, according to Annual Tonnage/ Chemical
Type
Pre-registration of all phase-in substances in existing M/I shall take place from:
1st June 2008 to 1st December 2008
The six (pre-)registration scenarios
1. Failure to meet specific pre-registration deadline for P-I substance in existing manufacture /
import in Europe whose M/I started before Dec 1st 2008
2. Late registration following pre-registration of P-I substance in existing manufacture / import
in Europe whose M/I started before Dec 1st 2008
3. Late direct registration (=registration without prior pre-registration) of P-I substance in
existing manufacture / import in Europe whose M/I started before Dec 1st 2008
4. Late pre-registration of P-I substance that is manufactured / imported in Europe for the first
time after Dec 1st 2008
5. Late registration following pre-registration of P-I substance that is manufactured / imported in
Europe for the first time after Dec 1st 2008
6. Late direct registration of substance that is manufactured / imported in Europe for the first
time after Dec 1st 2008
8
1. Failure to meet specific pre-registration deadline for P-I substance in existing manufacture /
import in Europe whose M/I started before Dec 1st 2008.
a) Pre-registration of phase in substances in existing M/I shall take place from 1 st June
2008 to 1 December 2008.
b) Article 28 indicates that in order to benefit from the transitional regime (tonnage
deadlines) of Article 23, phase in substances must be pre-registered. Article 28(3) says
that if you do not pre-register you do not benefit from the tonnage deadlines of Article 23.
c) The implication of failure to pre-register before 1st December 2008 is that M/I and use
must cease and may only be started again 3 weeks following submission of a
registration to the ECHA if there is no indication from the ECHA to the contrary (Article
21(1)).
d) M/I and use after 1st June 2008 without pre-registration on or before 1 December 2008 is
in breach of the Regulation and liable to fines from the local competent authority backdated to June 1 2008, irrespective of when M/I actually commenced.
2. Late registration following pre-registration of P-I substance in existing manufacture / import
in Europe whose M/I started before Dec 1st 2008
a. Registration of phase in substances in existing M/I that have been pre-registered
shall be completed according to the relevant deadline in Table 1 (column 2). For
example, registration of phase-in substances in existing M/I (>1000 tonnes per year)
that have been pre-registered shall take place from 1st June 2008 to 30th November
2010.
b. The implication of failure to register before these deadlines, following pre-registration
is that M/I and use must cease and may only be started again 3 weeks following
submission of a registration to the ECHA if there is no indication from the ECHA to
the contrary (Article 21(1).
c. M/I after these deadlines with pre-registration but without registration before these
deadlines is in breach of the Regulation and liable to fines from the local competent
authority back-dated to June 1 2008.
3. Late direct registration of P-I substance in existing manufacture / import in Europe whose M/I
started before Dec 1st 2008
a. Direct registration of phase in substances in existing M/I shall take place from 1 st
June 2008 only following the ”inquiry process” (Article 26).
b. Existing M/I on 31st May 2008 should be stopped and only started again 3 weeks
following submission of a registration to the ECHA if there is no indication from the
ECHA to the contrary (Article 21(1).
c. In the absence of pre-registration, the implication of failure to directly register is that
M/I and use must cease and may only be started again 3 weeks following
submission of a registration to the ECHA if there is no indication from the ECHA to
the contrary (Article 21(1).
d. M/I after 1st June 2008 without direct registration or pre-registration is in breach of
the Regulation and liable to fines from the local competent authority back-dated to
1st June 2008.
9
4. Late pre-registration of P-I substance that is manufactured / imported in Europe for the first
time after Dec 1st 2008
a. Pre-registration of a substance that is manufactured /imported for the first time at > 1
tonne per year after Dec 1st 2008 shall take place within 6 months of first M/I
provided the date of pre-registration is at least 12 months before the registration
deadline. Article 28(6), applicable to Phase-in substances only.
b. The deadlines for late pre-registration of P/I substances M/I for the first time after
December 1st 2008 are provided in Table 1 (column 3).
c. Within 6 months of first M/I means that pre-registrations can be made within the
timeframe from the date of first M/I to a maximum of 6 months after date of first M/I.
d. Example, if first M/I started 15th April 2009, pre-registration would have to be
completed on or before 15th October 2009.
e. Therefore only M/I commencing in the period from Dec 1st 2008 up to the relevant
deadline in Table 1 (column 3), may take advantage of the Article 28(6) late preregistration facility.
f. The implication of failure to pre-register before the relevant deadline in Table 1
(column 3), is that M/I and use must cease and may only be started again 3 weeks
following submission of a registration to the ECHA if there is no indication from the
ECHA to the contrary (Article 21(1)).
g. First M/I after 1st Dec 2008 without pre-registration or registration is in breach of the
Regulation and liable to fines from the local competent authority backdated to day of
first M/I.
h. For substances M/I for the first time after the relevant deadline in Table 1 (column
3), no pre-registration is possible. In this case a direct registration shall be placed via
the Inquiry Process. See 6 below.
5. Late registration following pre-registration of P-I substance that is manufactured / imported in
Europe for the first time after Dec 1st 2008
a. Registration of phase in substances M/I for the first time at > 1 tonne per year after 1
Dec 2008, that have been pre-registered shall take place from the date of preregistration (see 4 above) to the relevant deadline in Table 1 (column 2).
b. The implication of failure to register by this deadline, following pre-registration is that
M/I and use must cease and may only be started again 3 weeks following
submission of a registration to the ECHA if there is no indication from the ECHA to
the contrary (Article 21(1)).
c. M/I after 1st Dec 2008 without registration following pre-registration is in breach of
the Regulation and liable to fines from the local competent authority backdated to
the date of first M/I.
6. Late direct registration of substance that is manufactured / imported in Europe for the first
time after Dec 1st 2008
a. This scenario may apply to both Phase-in and non Phase-in substances
b. Late direct registration is the only possible remaining route for registration of
substances with first M/I at > 1 tonne per year after the registration deadline in Table
1 (column 2).
c. Direct registration is always possible and may be chosen over pre-registration for
substances with first M/I before 30 November 2008.
d. Direct registrations in this case shall take place at the latest 3 weeks before the date
of first M/I and only following the “inquiry process” (Article 26).
10
e. The implication of failure to directly register is that M/I and use must cease and may
only be started again 3 weeks following submission of a registration to the ECHA if
there is no indication from the ECHA to the contrary (Article 21(1)).
f. However, pre-registration of P-I substances with first M/I commencing in the period 1
December 2008 to the relevant registration deadline in Table 1 (column 2) is
possible before the relevant pre-registration deadline in Table 1 (column 3), see 4.
Pre-registration would require registration by the relevant deadline in Table 1
(column 2).
g. M/I after 1st Dec 2008 without direct registration and without pre-registration is in
breach of the Regulation and liable to fines from the local competent authority
backdated to the date of first M/I.
3. Consortia
FORMS OF COOPERATION OF THE INDUSTRY INCLUDING CONSORTIA
The REACH Regulation (REACH) does not oblige companies to form consortia 3. It does, however,
oblige them to share existing data, generate new data jointly and in principle submit certain data
jointly to the European Chemical Agency (ECHA). The companies may choose to meet those
obligations thought bilateral agreements on a case by case basis or establish their cooperation in a
more formal way through adoption of a consortium agreement. In other words, the cooperation under
REACH is required, but its form, in the absence of regulatory provisions, is left to the discretion of
industry.
Before presenting further the possible forms of industry cooperation it seems very useful to recall
some of the REACH obligations for which implementation that cooperation will be necessary. The
aim of this description is to give only a high-level overview since an extensive and very
comprehensive presentation of those issues has been compiled in the framework of RIP 3.4 4
I. Regulatory framework
The cooperation of potential registrants is required in particular: 1. in the framework of SIEF
(Substance Information Exchange Forum), and 2. in the joint submission of data.
1. SIEF
As a consequence of pre-registration, all pre-registrants of the same substance will participate in a
SIEF5.
SIEFs are virtual tools designed to facilitate mandatory cooperation between potential registrants.
Moreover, not only potential registrants but also manufacturers or importers of phase-in substances
published on the Agency’s list of pre-registered substances in quantities of less than 1 t/year,
downstream users of those substances and third parties holding any relevant information on those
substances (NGOs, laboratories etc.) who have submitted information to the Agency in accordance
with Article 28 or those whose information is held by the Agency in accordance with Article 15
(substances in plant protection and biocidal products), for the same phase-in substance, or
registrants who have submitted a registration for that phase-in substance before the 11 years after
entry into force may become participants of SIEF.
The word “consortium” was used in the original Commission Proposal from 2003 in the context of
joint submission of data, 2003/0256 (COD). It was deleted by the Council and substituted by the
“lead registrant”.
4 http://reach.jrc.it/docs/guidance_document/data_sharing_en.htm
5 For more guidance on the substance sameness and formation of SIEF please refer to RIP 3.4
3
11
These modifications adopted in the final text are of high importance in term of data-sharing
significantly extending the range of SIEF participants and the obligation to share data itself.
With a view to preserving their identity undisclosed, manufacturers, importers and in some cases
downstream users, while remaining fully responsible for complying with REACH requirements, are
given the possibility to appoint according to Article 4 of REACH a “third party representative” for
proceedings involving discussions with other manufacturers, importers and downstream users. The
name and details of this third party representative should be communicated in the pre-registration
information.
There are two basic aims of each SIEF:
 Facilitate, for the purpose of registration, the exchange of data, thereby avoiding the
duplication of studies;
 Agree on classification and labeling where there is a difference in the classification and
labeling of the substance between potential registrants.
SIEF participants should provide each other with existing studies upon requests from other SIEFmembers, identify needs for further studies and arrange to carry them out. Each SIEF will be
operational until 11 years after entry into force of REACH.
Although REACH provides for basic rules on data sharing it is shifting the burden of organizing the
communication and cooperation between SIEF participants on the industry6:
2. Joint submission of data
When a substance is intended to be manufactured or imported in the Community by one or more
manufacturers or importers a significant part of registration file should first be submitted by one of
them acting with the agreement of the other manufacturers and importers 7 (the “lead registrant”).8
Only in exceptional circumstances registrants may opt out from that joint submission of data9.
Moreover, joint submission will be supported through lower registration fees 10.
Furthermore, some parts of registration file should be submitted separately and certain information,
depending on the agreement, may be submitted separately or by one M/I on behalf of the others.
The table below illustrates this situation more in detail:
6
Detailed guidance on data sharing is provided in RIP 3.4.
Article 11(1) of REACH
8 Articles 11 and 19 of REACH.
9 Registrant may opt out, if:
 Joint submission is disproportionately costly
 Disclosure of commercially sensitive information is likely to cause substantial commercial
detriment
 There is disagreement with the lead registrant on the selection of information.
10 Article 73 (3)
7
12



Jointly
Classification & labeling
Study summaries and
robust
study
summaries
of
information
derived
from
application of
Annexes VII to XI (per
tonnage band)
Proposals for testing
where listed in Annexes
IX and X
Choice / per item
Guidance on safe use
(section 5 of Annex IV)
 Chemical
Safety
Report
 Indication
whether
information has been
reviewed
by
an
assessor





Separately
Identification of M/I
Identification
of
substance
Information
on
manufacture & uses
Exposure information
for substances 1 to 10 t
(section 6 of Annex IV)
II. Forms of cooperation of the industry
1. Possible forms of cooperation
There are several forms of cooperation that companies can choose to organize their cooperation
under REACH, from loose ways of cooperating (e.g. IT tools in preparation for SIEF communication
and management) to more structured and binding models (e.g. consortia created by the means of
contracts)11.
There is no requirement to organize the SIEF and joint submission cooperation by concluding a
special consortium agreement or accepting operating rules. However, in practice, given very limited
regulation as regards mechanism of data sharing, an agreed set of rules would facilitate those
discussions.
It should be also noted that the forms of cooperation will depend on the particularities within each
SIEF, e.g. one manufacturer provides a full data set to the other potential registrants who “join” this
data via a letter of access.
According to the RIP 3.4 guidance it is advisable, whatever the form of cooperation chosen, to agree
in writing (e.g. contract, email) on the main rules of data sharing and at least on the ownership of the
studies jointly developed, and the sharing of costs.
2. Consortium12
It is the responsibility of every company to assess pros and cons of different forms of cooperation,
including joining a consortium, and companies should already start elaborating on their “consortium
strategy” now.
The less formal cooperation leaves companies more flexibility in the SIEF discussions, however may
sometimes occur not efficient, e.g. if the companies are unable to reach agreement on the person of
the lead registrant or on cost sharing rules.
11
RIP 3.4, p. 95.
A comprehensive study
http://www.cesio2004.de
12
and
a
model
consortium
agreement
may
be
found
at
13
Therefore, in some cases working on the basis of a contractual framework is recommended, in
particular as regards the substances regarded as “strategic” in the company’s portfolio or for which
elaboration of the information needed could occur costly and time-consuming.
Moreover, consortia are expected to lead to lower individual company costs and time required for the
constitution of a registration file. They will also help to avoid scientific inconsistencies and at the
same time enhancing consortium members’ position vis-à-vis the Agency.
However, managing consortia can become difficult because of legal restrictions such as potential
violation of competition law, danger of unauthorized disclosure of confidential information, complexity
of administration, or just traveling and meeting expenses. Technical issues linked to the fact that the
solution “one study fits all” is not always possible may often emerge. And evidently there are some
pitfalls when it comes to defining data sharing costs.
a) Formation of consortium is a step by step approach
The rules on formation of a consortium are not covered by REACH but by the private law provisions.
Therefore, the contractual freedom of parties as regards details of their cooperation is limited only to
the extent necessary to comply with the applicable regulatory framework (i.e. REACH Regulation
itself, competition law, national laws, etc.). As a consequence, different scenarios of consortium
formation may be envisaged, e.g. within one SIEF it is possible to create several consortia or one
consortium may comprise members of different SIEFs (e.g. for read across reasons) 13.
In this context it should be emphasized that consortia and SIEF are two different concepts and
should not be confused- a SIEF regroups all pre-registrants of the same substance and data holders,
where relevant, and participation in the relevant SIEF is mandatory for pre-registrants, whereas a
consortium is voluntary and may not necessarily regroup all participants to a particular SIEF, but can
regroup only some of them or participants of more than one SIEF. Moreover, the consortium
formation does not bring the SIEF to an end, the SIEF continues to exist through the 11 years, vice
versa, a consortium may continue after SIEF ends.
Companies may decide to form a consortium at any stage of REACH process, e.g. before the preregistration, to ease the process of checking the sameness of the substance in view of the SIEF
formation, and afterwards. This process may be facilitated by the assistance of third parties, such as
trade associations, sectoral associations, consultants, law firms or any other service providers.

Preliminary discussions
Preliminary discussions between potential participants are crucial to set up a structure and define
main principles. They should include negotiations on sensitive items like substance definition,
membership criteria, study evaluation and data sharing. In general, such discussions involving
multiple interested parties are complex and time consuming, therefore it is highly recommended to
start as soon as possible14.
During this preliminary phase all parties should gain clarity whether or not to participate in a future
consortium. They should be able to estimate the financial expense in case of opting out from this
form of cooperation and possible savings if joining a consortium.
Furthermore, this early stage discussion may in some cases provide already arguments for future
opting out from the joint submission of data, e.g. in case of high profile substance where risk
stemming from disclosure of commercially sensitive information is likely to cause substantial
commercial detriment to the potential registrant.
13
RIP 3.4,p. 97.
For more details regarding the preliminary agreement for consortium formation and model
consortium agreement contact directly Joanna Warnel, Legal Counsellor, (jkw@cefic.be, tel. 02 676
73 14).
14
14

How to recognize other potential registrants?
As it was already mentioned, the manufacturers, importers and only representatives who pre-register
the same substance will find each other in the respective SIEF. In the meantime, in order to maintain
a satisfactory degree of transparency companies organizing consortium may make it publicly known,
for instance by listing free of charge the substances for which consortium agreement have been
signed on a dedicated website managed by Cefic or ReachCentrum. A contact person should be
also appointed in order to ensure access to these structures to other companies interested in the
same substance.

Adoption of the agreement
If the outcome of the cooperation undertaken in the framework of the preliminary discussions is
positive, by either signing the consortium agreement or accepting the operating rules by a decision in
a meeting or deciding to refer to a commonly agreed set of rules, participants in the agreement de
facto create a consortium. There is no need for 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, though the parties may decide otherwise (e.g. as EEIG or a company).
b) Content of the consortium agreement
Within the limits of contractual freedom and subject to compliance with EU competition law the
parties may include in the consortium agreement several provisions listed below. Ultimately, it is for a
group to decide what elements they wish to adopt and at what level but when making any decisions
it is recommended that these fundamental points should be taken into consideration.
Clauses that may be included in consortium agreement15:
1. General information (identification of the parties)
2. Preamble (the context of the agreement)
3. Definitions, name of the consortium and acronym, if any;
4. Scope:
 identification of the substance according to requirement in section 2 of Annex VI of
REACH or according to other criteria decided by the Parties, e.g. substance purity/ degree
and nature of impurities included/ group of substances
 decisive who can become a member
5. Purpose : Purpose and description of tasks or elements of cooperation:

Preparation of data package for the joint submission- sharing of existing data and
conduct of new studies/ testing proposals if required for Annexes VI-XI/ depending
on tonnage band, (orientation towards the highest tonnage band- shortest
registration deadline), including:
- C&L,
- study summaries of the information derived from the application of Annexes
VII to XI,
15
This list is by no means intended to be mandatory or prescriptive. It is intended for guidance and
does not constitute an exhaustive and accurate list. It should rather serve as a checklist for
discussion in order to ensure that parties address a range of aspects when considering consortia
formation. Ultimately, it is for parties to decide what elements they wish to adopt and at what level
but when making any decisions it is recommended that these fundamental points should be taken
into consideration.
15
robust study summaries of the information derived from the application of
Annexes VII to XI, if required in Annex I,
- testing proposals where listed in Annexes IX and X,
Optional:
- preparation of CSR and guidance on safe use,
- identification of use and exposure categories
Submission of the dossier by the Lead Company
Any other tasks as follow up of the submission
Evaluation of the substance and performance of testing proposals
Other tasks, e.g. preparation of the application for the authorisation
-




Regarding the Purpose of the consortium the members are free to limit their cooperation to meeting
REACH compulsory cooperation requirements, i.e. data sharing and agreement on classification and
labeling, but they may also decide to cooperate in order to prepare the joint submission of the core
data relating to the substance or even of the CSR, they may also extend the cooperation to the
evaluation when the testing proposals will have to be conducted. If the members find it appropriate,
the cooperation may also include preparation of the joint application for the authorization.
6. Individual obligations of Members
7. Membership

Categories of members and conditions of admittance
 Regular members: Manufacturers, Importers, Only representatives- subject
to REACH registration requirement
 Optional: Associate members, e.g. Downstream users, Distributors,
Manufacturers/ Formulators not established within the EU – not subject to
the registration requirements, but may contribute to the Purpose of the
consortium;
 Late members- admission and compensation rules
The membership criteria should be objective, non discriminatory and complaint with competition law.
Different categories of membership with different rights and obligations associated with these
categories may be decided and included in the consortium agreement (Regular members, Associate
Members) if relevant for the Purpose. For more details please refer to Cefic REACH Competition
Law Compliance Guidance16.


Changes in membership: Transfer/ Withdrawal/ Exclusion
 Data ownership and right to use data of the exiting member
Procedure in case of decision refusing admission as a member, e.g. offer to provide
a letter of access to the Studies available to the Members.
8. Consortium organisation
 Group of interest- no legal personality
 Structure, composition, procedure of appointing and tasks:

Steering Committee/ General Assembly => decision-making body,
sets working plan, general policy, decisions on new members, cost
allocation, etc.

Technical Committee

Optional: Lead Company => submission of registration file

Secretariat / Independent third party=> day to day management,
archiving and management of data
16
Guidance for Cefic and its members, for further clarification and questions contact directly Nicole
L. Maréchal, Senior Legal Counsellor & Governance Officer (nma@cefic.be, tel. 02 676 72 18).
16

Other bodies, e.g. ad hoc groups
The consortium may be composed of several bodies, e.g. Steering Committee as a decision making
body, a Technical Committee in charge of technical decisions, e.g. scientific evaluation of studies,
selection of key studies, Task Forces for different substances if the consortium is covering in its
scope more than one of substance (e.g. a family of substances). If the consortium recoups several
members an Executive Committee limited to only a few members of the Steering Committee might
be set-up to ensure the overall direction and control. With a view to ensuring efficient and timely
execution of the consortium related tasks the members should take into consideration appointing of a
Secretary for the consortium management.
Consortium members are free to appoint a Lead Company to submit the data on their behalf to
ECHA. The Lead Company may be the company with the shortest registration deadline or a
company having technical expertise valuable to the consortium members. If the members decide to
appoint a Lead Company the agreement may contain rules related to financial compensation for the
lead registrant for his efforts and provisions on his liability.


Decision-making process
 Number of votes per each member
 One vote per equal share, or
 In accordance with volumes (share of the costs)
 Voting rules- single/ qualified majority and unanimity depending on matters
concerned
 Quorum
Representation, e.g. by the Secretary or Lead Company.
9. Rights to data




Sharing of existing studies => remain the sole property of the contributing member,
others obtain a right to refer for the purpose of REACH/ any regulatory purpose,
depending on the decision of the members- the differentiation may be reflected in
the reduction of the cost of the study
Sharing of new studies => joint ownership, possible limitations of use, e.g. right to
use only for the purpose of REACH/ any regulatory purpose
Ownership and citation rights => rules on granting right to use or refer to data to
third parties, Letter of Access
Rights of the Affiliates => the agreement may provide the same rights for the
Affiliates as for the members to which they are affiliated. If a company has numerous
Affiliates the access may be subject to additional obligations/ reflected in the cost
sharing key.
10. Costs




Budget
Financial year
Invoicing and payment
Apportionment:
 Administrative costs
 Late entry fees for new members
 Data compensation rules:
 Existing studies:
o Evaluation- scientific value- e.g. Klimisch method
o Financial value- verifiable documentation needed or rules
on estimate costs assessment:
• Determined on the basis of its replacement value at
the time of assessment / historical value
17
•

Only studies reliable without restrictions and reliable
with restrictions may qualify for financial
compensation
• Possible surcharge may be
provided for
administrative
expenses
incurred
by
the
commissioning party
New studies => joint commissioning, sharing among the parties who
need the Study according to their tonnage band.
It is important to agree upfront how any costs incurred will be shared. REACH stipulates “fair,
transparent and non-discriminatory” sharing of costs for the studies. Cost sharing can be freely
determined by the parties provided that it complies with these criteria- in case where no agreement is
reached the Regulation provides for equal sharing.
It is usual for member companies to absorb their own costs such as travel or the cost of hosting a
meeting but third party costs such as paying for a Secretariat would need to be shared out. Apart
from the administrative costs parties should also decide on cost key for sharing the existing and new
studies and any other costs associated to the Purpose of the consortium, e.g. preparation of the joint
submission, transfer of data into IUCLID 5 format. Possible mechanisms include - membership fee
proportional to turnover, equal sharing, sharing of costs related to number of substances or interest
to a company or sharing of costs in proportion to volume manufactured17. If the last mechanism is
used then costs would need to be allocated by an independent third party to ensure that competition
law is not breached.
11. Miscellaneous, e.g.:

Confidentiality
Apart from internal organization in order to ensure confidential treatment of information all
consortium members should insert in the agreement provisions (or sign a separate confidentiality
agreement) laying down obligations to maintain confidentiality vis-à-vis third parties concerning all
information made available to them in the framework of the cooperation. It should be ensured that
this obligation remains unaffected for clearly defined period even in case of dissolution of the
consortium, withdrawal or exclusion of a consortium member.
This confidentiality obligation should apply also to any external experts included through the staff
assigned for the cooperation and to any trustees appointed with view of ensuring confidential
processing of information.

Allocation of liabilities
 Among the members, including the liability of the Lead Company
 Vis-à-vis third parties

Applicable law
To be chosen by the parties, e.g. the law of place of establishment of the Secretary, of the Lead
Company, or of any other Party entitled to represent the Members of the Consortium in law suits.
There should be consistency with the jurisdictional venue.
17

Jurisdictional venue

Dispute resolution
For more details RIP 3.4.
18
 Duration- indefinite/ definite, may depend on objective agreed, e.g. data needed
gathered, registration has been submitted, studies in the test plan have been completed

Consortium dissolution and wind up, survival clauses

Revision of the consortium agreement
III. Remarks on compliance with competition law
Parties to consortium agreement should ensure compliance with the competition law when
addressing issues which may be sensitive with regard to the requirements of Article 81 and 82 of the
EC Treaty18. In general, the European Commission takes a positive attitude vis-à-vis pure
cooperation in R&D as a way of reducing duplicative unnecessary costs, however, the situation gets
more complicated whenever the combined market shares of the companies involved are significant
and thus the cooperation needs to ensure that no foreclosure problems vis-à-vis third parties occur.
Therefore, several issues should be addressed with particular attention to the competition law:
- Membership and conditions for access, including the degree of openness to
potential competitors,
- Substance definition,
- Cost sharing (including late entry fee and risk premium for companies joining the
consortium at a later stage)
- Exchanges of information, in particular related to confidential uses or niche
applications (appointment of an independent third party should be considered).
It should be ensured that the regulation of those issues:
- be objective, sufficiently determinate and not go beyond what is necessary for the purposes
of the association;
- be transparent, i.e. available to potential members;
- be applied in a uniform and non-discriminatory manner;
- as regards membership- it should be quasi "automatic", and thus not conditional upon the
satisfaction of unnecessary requirements or subject to "discretionary" decisions of the
existing members over and above fulfillment of the membership criteria.:
- as regards cost sharing- as long as the rule can be justified objectively as non-discriminatory
and is accepted by all parties it would be difficult to regard it as restrictive of competition.
Furthermore, it should be forbidden to share information on price and customer policy, distribution
plans, production costs, capacity, sales or any other piece of information that may be considered
commercially sensitive in the relevant industry.
Parties may refer or even attach to their agreement specific guides, ”do & don’ts” or other
competition compliance programmes (e.g. Cefic REACH Competition Law Compliance Guidance).
They may also decide to appoint an independent third party or a Secretariat responsible for
collecting, storing and structuring sensitive data- this data must never be computed by the
consortium members themselves, but by a body ensuring confidential processing of information
which will produce aggregates and summaries from the confidential information.
18
For more detailed guidance on competition compliance contact directly Nicole L. Maréchal, Senior
Legal Counsellor & Governance Officer (nma@cefic.be, tel. 02 676 72 18).
19
4. Polymers and post-reactants
POLYMER GUIDANCE DOCUMENT (PGD) AND POST REACTANTS
SUMMARY & CONCLUSIONS
The CEFIC Polymer Working Group has invested significant effort in considering where and how
Post Reactants fit into the definition and text of the Regulation and the Polymer Guidance Document
(PGD). This article reports the conclusions and decisions of the group.
The definitions and pertinent text are as follows:
Monomer means a substance which is capable of forming covalent bonds with a sequence of
additional like or unlike molecules under the conditions of the relevant polymer-forming reaction used
for the particular process (Article 3(6)). The definition of monomer has been clarified in the PGD,
section 2.1 to include:
In other words, it is a substance which, under the polymerisation reaction, is converted into a
repeating unit of the polymer sequence. Substances exclusively involved in the catalysis,
initiation or termination of the polymer reaction are not monomers.
Other Reactant refers to a molecule that can be linked to one or more sequences of monomer
units but which cannot be regarded as a monomer under the relevant reaction conditions
used for the polymer formation process.
Manufacture of Polymer: It should be highlighted that polymers may be synthesised not only
from the polymerisation of monomers, but also from other processes such as the chemicals
post-modification of polymer substances. Examples of such post-modification reactions
include polymer curing, polymer functionalisation via grafting, and controlled polymer
degradation such as visbreaking.
An important aspect is that certain kinds of substances are excluded from the monomer definition.
i.e. catalysts, initiation, terminators. However, the Polymer Working Group firmly believes that this is
not intended to be a definitive list and that post reactants and other types of substances that fall
outside the definition of monomers, can also be included under the ‘Other Reactant’ descriptor.
Indeed in Section 2.3 of the PGD, it specifically acknowledges that post modification is outside the
scope of synthesis from the polymerisation of monomers.
Therefore, the PWG firmly believes that post reactants are included in the definition of Other
Reactants, a decision that has now been adopted as a formal CEFIC position. This interpretation is
also in keeping with the EINECS reporting rules which stated: Polymers which have been postreacted (undergone reactions after polymerisation) should not be reported as such. Instead, the
monomeric substances from which the polymer is manufactured and the post reacting reagent(s) can
be reported separately.
Section 3.1 of the PGD clearly states that the provisions of Articles 17 and 18 apply for other
substances ie Other Reactants used in the manufacture of the polymer. Therefore, Post Reactants
can be treated as intermediates in the entire REACH process and may thus be associated with
reduced testing and cannot be subject to Authorisation.
CEFIC therefore, urges industry to carefully determine the role of the chemicals used during
polymerisation in order to take advantage of the reduced requirements that are available.
20
5. Registration for Importers
The aim of this paper is to assist industry in determining the role and obligations of importers under
REACH Regulation (“REACH”).
This paper intends to serve as guidance for CONCAWE and Cefic members. Although it is based on
opinions from CONCAWE’s and Cefic’s legal advisers the arrangements between individual sellers
and individual buyers may be more complex than the cases considered in this guidance. Member
companies are therefore advised to check individual cases with their company lawyers.
1. Definition of importer
REACH requires manufacturers and importers of a substance, either on its own or in one or more
preparation(s), in quantities of 1 tonne or more per year to register with the European Chemical
Agency (ECHA).
It should be noted that one legal entity could have various roles (e.g. importer and manufacturer or
downstream user) depending on its activities, even for the same substance. Therefore, it is very
important that companies correctly identify their roles in the supply chain for each substance they
handle and this will be decisive in determining their registration obligations.
In this respect, Article 3 of REACH provides more detailed definitions of the actors under REACH,
including the definition of the importer:
“Importer: means any natural or legal person established within the Community 19 who is
responsible for import” (Article 3.11));
“Import: means the physical
Community”20(Article 3.10));
introduction
into
the
customs
territory
of
the
This legal definition of importer consists of two elements: a) he is a natural or legal person
established within the Community (legal entity) AND b) he is responsible for the physical introduction
into the customs territory of the Community.
The first element relating to the status of legal entity should be determined in accordance with the
national law of the country where the legal entity is established (the European law does not provide
for a complete harmonisation of civil and company law).21
The second element relating to the responsibility for the physical introduction into the customs
territory of the Community depends on many factors such as who orders, who pays, who is dealing
with the customs clearance, but this might not be conclusive on its own 22. Companies themselves
will need to assess their obligations under REACH on a case-by-case basis. In this respect, the
commercial obligations as allocated according to INCOTERMS may be helpful since they define the
19
REACH is with EEA relevance therefore as soon as REACH is implemented by EEA EFTA-States
(Norway, Iceland and Liechtenstein) imports from those states will be considered as intra-Community
trade for the purpose of REACH. EFTA envisages having the Regulation implemented by 1 June
2008. For a list of affected and non-affected countries and territories see Appendix 2.
20 Import shall be deemed to be placing on the market (Article 3.12)
21 The Technical Guidance Document on Registration on the ECHA website provides more detailed
guidance on legal entity: http://reach.jrc.it/docs/guidance_document/registration_en.pdf.
22
Technical
Guidance
Document
on
Registration,
section
1.5.3.3
(http://reach.jrc.it/docs/guidance_document/registration_en.pdf ): To illustrate the process of
determining the obligations of the actors in the supply chain the Technical Guidance Document gives
an example of “sales agency”. In case of this kind of agency established in the EU but only acting as
a kind of facilitator, a letter box transmitting an order from a buyer to a supplier (and being paid for
that service) but taking no responsibility whatsoever on the goods or the payment for the goods and
not having their ownership at any stage, then, the sales agency is not to be considered as the
“importer” for purposes of REACH. The sales agency is not responsible for the physical introduction
of the goods.
21
seller, the buyer and their respective obligations, in particular regarding customs clearance and
payment for goods.
It should be noted however, that there is no direct link or interdependence between the INCOTERMS
and REACH roles. INCOTERMs deal with the transfer of ownership, cost, freight/transport, insurance
and customs duty, not with other legal obligations that may exist, such as obligations under REACH.
2. Importer vs. Only Representative
The role and obligations of the EU-legal entities, which are responsible for the physical introduction
of the substance into the Community customs territory, depend on the decision of the exporter
established outside the Community whether or not to appoint an Only Representative pursuant to
Article 8 of REACH. The non-EU supplier has no responsibilities under REACH. However, instead of
letting his importers register, the natural or legal person established outside the Community who
manufactures a substance on its own, in preparations or in articles, formulates a preparation or
produces an article that is imported into the Community may appoint an Only Representative
established within the Community to carry out the registration and comply with obligations of
importers under REACH. As a consequence, his importers within the same supply chain are
relieved from their obligation to register and regarded as downstream users for the purpose of the
Regulation.
In principle, the designation of the Only Representative has no impact on the commercial relations
within the supply chain, i.e. an Only Representative will be regarded as an importer only for the
purpose of REACH and should comply with all obligations of importers under REACH (article 8). The
Only Representative will therefore be responsible for registering the substance and updating the
registration file, but will not be liable for complying with other, non-REACH related, obligations of
importers (e.g. customs clearance, invoicing etc.) unless decided otherwise in the mutual agreement.
3. Who should register based on the INCOTERMS agreed between buyer and seller?
INCOTERMs define three actors in a chain: the seller  the carrier  the buyer.
The table in appendix 1 indicates for the various INCOTERMS the respective roles of the buyer,
seller or carrier under REACH.
The carrier, being a "mere" transporter, generally has no knowledge of the substance he is charged
with transporting and should not be considered as the importer under REACH. (Article 2(1)(d)).
As regards the seller, if he has appointed an Only Representative, this Only Representative will be
regarded as the importer (i.e. responsible for registering the substances) regardless of which
INCOTERMS are used or the identity of the buyer. In such cases, the buyer will be considered as a
downstream user.
If the seller has not appointed an Only Representative, then, in order to identify the importer under
REACH, one may refer to the allocation of responsibilities according to INCOTERMS, for example in
respect of customs clearance (though in some cases, like DDP, this criterion may be insufficient). In
most of the cases where any of the INCOTERMS listed in Appendix 1 apply, the EU- based buyer
will be the importer for the purposes of fulfilling the obligation to register the substance under
REACH. This will be the case even under "DDP" (Delivered Duty Paid) INCOTERM where despite
the fact that the customs duties remain with the seller the EU-based buyer should in principle register
the substance under REACH. This is because the buyer is established in the EU, is the entity
requesting introduction of the substance and receives and handles it once it arrives at its destination.
The buyer can therefore be seen as being responsible for the physical introduction of the substance
into the customs territory of the Community.
Pursuant to the REACH Regulation, substances on their own, in preparations or in articles shall not
be placed on the market unless they have been registered. Companies are therefore strongly
advised to assess their obligations in the supply chain, to make necessary judgments on who should
register and to document the reasons for their decisions in order to ensure that the substances
placed on the Community market are compliant with the regulatory requirements.
22
4. How may the obligation to register be affected by treatment or processing in free zones
etc.?
Article 2(b) of REACH exempts under certain circumstances substances from registration:
Article 2(b)
substances, on their own, in a preparation or in an article, which are subject
to customs supervision, provided that they do not undergo any treatment or processing, and
which are in temporary storage, or in a free zone or free warehouse with a view to reexportation, or in transit;
The following cases serve as an illustration. In reality, situations can, or rather will be more complex.
Consultation with company lawyers is therefore strongly recommended.
The cases involve four hypothetical companies (legal entities):

Company A is established outside the “REACH Area”, i.e. the territory of the member states of
the European Economic Area (EEA)23. Company A is in most cases what under INCOTERMs
would be a “seller”.

Company B is established outside the “REACH Area”. It is what under INCOTERMs would be a
“buyer”.

Company C is established within the “REACH area”. It is what under INCOTERMs would be a
“buyer”.

The “carrier” under INCOTERMs has not been included as the he will not have obligations under
REACH (see section 3 above).

Instead Company D has been introduced which owns temporary storage under customs
supervision and, in certain circumstances, might become an operator under REACH.
Case 1a: direct import without transit through an area
under customs supervision
“REACH Area”, i.e. the territory
of the EEA
 Registrant:
Company C
Company C
Company A
Case 1a is straight forward
Note
Company A :
Established outside the
“REACH Area”, i.e. the
EEA
Company C:
Established inside the
“REACH Area”, i.e. the
EEA
23
Temporary
storage
Area under
customs
supervision
See also appendix 2.
23
Case 1b: indirect import; no transit through an area under
customs supervision
“REACH Area”, i.e. the territory
of the EEA
Company C
Company A
Note
Company A:
Established outside the
“REACH Area”, i.e. the
EEA
Company C:
Established inside the
“REACH Area”, i.e. the
EEA
Affiliate of Company A:
Established inside the
“REACH Area”, i.e. the
EEA
 Registrant:
Affiliate of
Company A
Case 1b is straight forward.
However, Company C is
advised to ascertain that the
Affiliate of Company A is in the
possession of a registration if
the Affiliate of Company A is
merely an importer without
own manufacturing.
Ownership of the
product and the
storage facility
Affiliate of
Company A
Case 2a: import with transit through an area under
customs supervision
“REACH Area”, i.e. the territory
of the EEA
Company A
 Registrant:
Company C
Company C
Case 2a is straight forward
Note
Company A :
Established outside the
“REACH Area”, i.e. the
EEA
Company C:
Established inside the
“REACH Area”, i.e. the
EEA
Temporary
storage, no
processing/
treatment
Area under
customs
supervision
24
Case 2b: import with processing/ treatment in an area
under customs supervision
“REACH Area”, i.e. the territory
of the EEA
Company A
 Registrant:
Company D
Company C
Note
Company A :
Established outside the
“REACH Area”, i.e. the
EEA
Company C and D:
Established inside the
“REACH Area”, i.e. the
EEA
Temporary storage,
but processing/
treatment
Company D
Case 2b: The common
interpretation of REACH is that the
operator, not the owner of a
substance, has to register, in this
case Company D. Terminal
operators will therefore have to
register and become participants of
Substance Information Exchange
Fora (SIEFs) if they process or
treat the substance
Area under
customs
supervision
Case 3a: re-exportation/transit
“REACH Area”, i.e. the territory
of the EEA
Company A
 Registrant:
none
Case 3a is straight forward
Temporary
storage, no
processing/
treatment
Note
Company A:
Established outside the
“REACH Area”, i.e. the
EEA
Area under
customs
supervision
25
Case 3b: re-exportation/transit
“REACH Area”, i.e. the territory
of the EEA
Company A
 Registrant:
none
Case 3b is straight forward
Company B
Note
Company A and
Company B:
Established outside
the “REACH Area”, i.e.
the EEA
Temporary
storage, no
processing/
treatment
Area under
customs
supervision
Case 3c: re-exportation/transit with processing
“REACH Area”, i.e. the territory
of the EEA
Company A
 Registrant:
Company D
Temporary storage,
but processing/
treatment
Note
Company A :
Established outside the
“REACH Area”, i.e. the
EEA
Company D:
Established inside the
“REACH Area”, i.e. the
EEA
Company D
Area under
customs
supervision
26
Case 3d: re-exportation/transit with processing
“REACH Area”, i.e. the territory
of the EEA
Company A
 Registrant:
Company D
Company B
Note
Company A and
Company B:
Established outside the
“REACH Area”, i.e. the
EEA
Company D:
Established inside the
“REACH Area”, i.e. the
EEA
Temporary storage,
but processing/
treatment
Company D
Area under
customs
supervision
Company A and company B are not established in the EEA. Company D, the terminal operator, is
regarded under REACH as a manufacturer and will have to register and become participant of the
relevant SIEF.
27
Appendix 1
Actors under INCOTERMs and under REACH and their obligations with respect to registration under REACH
The following table provides an overview of the INCOTERMs and the obligation to register under REACH. Where the seller has appointed an Only
Representative, the Only Representative will always be responsible for registration.
Actors according to INCOTERMs
http://www.iccwbo.org/incoterms/id3040/ind
ex.html
Actors according to REACH
Seller
Carrier
Buyer
- non-EU
manufacturer
- non-EU trader
Actors neither defined by INCOTERMs nor
by REACH
- importer
1
EXW
EX WORKS (named place)
not the registrant
seller's
customs
representative
clearing
customs
n.a.
2
FCA
not the registrant
n.a.
3
FAS
not the registrant
n.a.
4
FOB
not the registrant
n.a.
5
CFR
not the registrant
n.a.
6
CIF
not the registrant
n.a.
7
CPT
not the registrant
n.a.
8
CIP
FREE CARRIER (named
place)
FREE ALONGSIDE SHIP
(named port of shipment)
FREE ON BOARD (named
port of shipment)
COST AND FREIGHT
(named port of destination)
COST, INSURANCE AND
FREIGHT (named port of
destination)
CARRIAGE PAID TO
(named place of destination)
CARRIAGE AND
INSURANCE PAID TO
not the registrant
n.a.
not the
registrant
not the
registrant
not the
registrant
not the
registrant
not the
registrant
not the
registrant
buyer's
customs
representative
clearing
customs
not the
registrant
not the
registrant
not the
registrant
not the
registrant
not the
registrant
not the
registrant
not the
registrant
not the
registrant
not the
registrant
not the
registrant
registrant
registrant
registrant
registrant
registrant
registrant
registrant
registrant
28
Actors according to INCOTERMs
http://www.iccwbo.org/incoterms/id3040/ind
ex.html
Actors according to REACH
Seller
DAF
10
DES
11
DEQ
12
DDU
13
DDP
(named place of destination)
DELIVERED AT FRONTIER
(named place)
DELIVERED EX SHIP
(named port of destination)
DELIVERED EX QUAY
(named port of destination)
DELIVERED DUTY UNPAID
(named place of destination)
DELIVERED DUTY PAID
(named place of destination)
Buyer
- non-EU
manufacturer
- non-EU trader
Actors neither defined by INCOTERMs nor
by REACH
9
Carrier
- importer
seller's
customs
representative
clearing
customs
not the registrant
n.a.
not the registrant
n.a.
not the registrant
n.a.
not the registrant
n.a.
in theory
responsible for
registration but see
text above
not the
registrant
buyer's
customs
representative
clearing
customs
not the
registrant
not the
registrant
not the
registrant
not the
registrant
not the
registrant
not the
registrant
not the
registrant
not the
registrant
not the
registrant
n.a.
registrant
registrant
registrant
registrant
registrant
29
Appendix 2
Territories where REACH applies
The following information was provided by the Commission’s REACH Helpdesk (Reply to
question A18704)
Any introduction of substances in the EU customs territory from outside the EU customs
territory is considered an “import”. Trade inside the EU customs territory is not considered as
“import”. In addition, we note that trade to and from the EEA countries will be assimilated to
intra-community trade, once REACH is implemented in these countries.
REACH will only be applicable in the EEA when it is implemented by Norway, Iceland and
Liechtenstein. The EEA Joint Committee is currently working on the implementation of the
REACH Regulation by the EFTA EEA Member States, including the conditions for the EEA
EFTA participation in the European Chemicals Agency.
Article 299 of the EC Treaty specifies the territories in which the Treaty applies.
According to paragraph 4, only Part 4 of the Treaty, foreseeing an association relation,
applies to the French overseas territories, Saint Pierre and Miquelon and Mayotte. This
implies that REACH does not apply there.
According to paragraph 2, the provisions of the Treaty apply to the Départements d’Outre
Mers (DOMs) which implies that REACH applies in the DOMs.
REACH applies to the Channel Islands and the Isle of Man.
REACH does not apply to Gibraltar, to Ceuta and Melilla, as they are not part of the
Community custom territory. Consequently, provisions on the free movement of goods do not
apply.
Country
Austria
Belgium
Bulgaria
Cyprus
Czech
Republic
Denmark
Estonia
Finland
France
Germany
24
the Republic of
Austria
the Kingdom of
Belgium
the REPUBLIC
of Cyprus
the Czech
Republic
the Kingdom of
DENMARK
the Republic of
ESTONIA
the Republic of
FINLAND
the French
REPUBLIC
the Federal
Republic of
EU
Member
State
x
Territory
of
EFTA
States
European
Economic
Area (EEA)
x
Subject
to
REACH24
Yes
x
x
Yes
x
x
x
x
Yes
Yes
x
x
Yes
x
x
Yes
x
x
Yes
x
x
Yes
x
x
Yes
x
x
Yes
Yes means: Imports from these countries or territories are not imports under REACH, i.e.
the importer does not have to register.
Country
EU
Member
State
Territory
of
EFTA
States
European
Economic
Area (EEA)
Subject
to
REACH24
x
x
Yes
x
x
Yes
x
x
x
x
Yes
Yes
x
x
Yes
x
x
Yes
x
x
Yes
x
x
Yes
x
x
Yes
x
x
Yes
x
x
Yes
x
x
x
x
Yes
Yes
x
x
Yes
x
x
Yes
x
x
Yes
x
x
Yes
x
x
Yes
x
x
Yes
x
x
Yes
Germany
Greece
Hungary
Ireland
Italy
Latvia
Lithuania
Luxembourg
Malta
Netherlands
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
UK
Iceland
Liechtenstein
Norway
Switzerland
French
Guiana
French
Polynesia
French
Southern and
Antarctic
Lands
the Hellenic
REPUBLIC
the Republic of
Hungary
Ireland
the ITALIAN
Republic
the REPUBLIC
of Latvia
the REPUBLIC
of Lithuania
the Grand
DUCHY of
Luxembourg
the Republic of
Malta
the KINGDOM
of the
Netherlands
the Republic of
Poland
the
PORTUGUESE
Republic
the Slovak
REPUBLIC
the Republic of
Slovenia
the Kingdom of
SPAIN
the Kingdom of
Sweden
the United
Kingdom of
Great Britain
and Northern
Ireland
the Republic of
Iceland
the Principality
of Liechtenstein
the Kingdom of
Norway
France
x
No
Yes
France
No
France
No
31
Country
Guadeloupe
Martinique
Mayotte
Miquelon
Reunion
Saint Pierre
Ceuta
Melilla
Anguilla
Bermuda
British Virgin
Islands
Cayman
Islands
Channel
Islands
Falkland
Islands
Gibraltar
Isle of Man
Montserrat
St. Helena
Turks and
Caicos Islands
EU
Member
State
Territory
of
EFTA
States
European
Economic
Area (EEA)
France
France
France
France
France
France
Spain
Spain
UK
UK
UK
Subject
to
REACH24
Yes
Yes
No
No
Yes
No
No
No
No
No
No
UK
No
UK
Yes
UK
No
UK
UK
UK
UK
UK
No
Yes
No
No
No
32
6. How to submit your pre-registration?
How Pre-Registration will be done:
Below paragraph is an extract from RIP 3.4 guidance:
The pre-registration can be done in two ways:
1. by direct encoding of the information on the REACH-IT website (On-line preregistration)
2. by submission of a 'bulk' pre-registration prepared separately on an specified
computer file format required by ECHA and uploaded at the moment of the On-line
pre-registration.
A bulk pre-registration allows Pre-Registrants to submit one (or more) file(s) with the preregistration information for multiple substances. The file has to be in accordance with a
certain structure which will be specified and published by ECHA.
The REACH-IT system will also provide a function to allow parent companies or head offices
to submit pre-registration for several legal entities belonging to the same company group
(“Super User”) provided that all legal entities are informed by the parent company or head
office and have access to the information submitted in the pre-registration. Nevertheless,
even if this function is used, the pre-registration remains specific for each legal entity.
There will be 3 IT options to submit Pre-registration data to ECHA:
1. On-line data entry in REACH-IT (Pre-Registration sub-system). In this case, PreRegistration data will be entered Substance by Substance. As such, it will be used if a
Legal
Entity
has
a
limited
number
of
Substances
2. Using the IUCLID5 Plug-in module for Pre-Registration: Most of the data will be
extracted from the IUCLID5 database, however, there are a couple of data fields
(which are not stored in IUCLID5) that will need to be entered separately.
The plug-in module will create a submission file that is compliant with the standard
data format (XML based) that will be required by ECHA.
This option is useful in case a significant number of Substances will be pre-registered.
3. Preparing the Pre-Registration data in another file, e.g. Excel or Access, from
which a submission file will be created that is compliant with the required XML
standard data format. The Pre-Registration XML file will then be submitted to the
REACH-IT system.
Similar to previous option, this one is also useful in case a significant number of
Substances will be pre-registered. (although it is possible also to submit just one
substance).
Although the above options describe the technical possibilities, there are a couple of
constraints that need to be taken into account to select the appropriate option to be used, i.e.
- In case of bulk submission, an EC number is mandatory for the substances
entered. Below table shows an overview of this prerequisite for the various cases.
- After the Pre-Registration period, ending 1 December 2008, only Pre-Registration
can be done for a single Substance (not bulk).
33
On-line,
created in
REACH-IT
A substance listed in the EC
inventory or a multi-constituent
substance of which all constituents
are listed in the EC inventory
A substance not listed in the
EC inventory or a multi-constituent
substance of which one or more
constituents are not listed the
in EC inventory
As a newcomer, after 1 December
2008
Single upload,
created in
IUCLID or
other
system (e.g.
Excel)
Bulk upload,
created in
IUCLID or
other
system (e.g.
Excel)
x
x
x
x
x
n.a.
x
x
n.a.
Timing:
- The (XML) data standard for Pre-Registration will be published in December 2007.
- The IUCLID5 plug-in and REACH-IT Pre-Registration modules will be available for
testing by stakeholders in January 2008
34
7. REACH IT — Milestone dates
Topic
IUCLID5
(developed by ECHA)
Pre-Registration IT tool
(developed by ECHA)
SIEF IT tool
(developed by Cefic)
REACH-IT Workflow system
Subject
Milestone date
Release 1.0
- Available now
Development of:
- Advanced Query tool
- Pre-Registration Plug-in module.
- SNIF Migration Tool
- Translations for most important parts of user
manuals.
- Data standard for Pre-Registration submission
- Test version Pre-Registration tools
- 1 June 2008
-
Dec 2007
Jan 2008
Available for users:
- Pre-Registration module in REACH-IT
- IUCLID5 Pre-Registration plug-in
- Pre-SIEF Web page (at REACH-IT system)
- Testing
- SIEF IT system available for users
- Data Holders sign-in to SIEF
-
1 June 2008
1 June 2008
1 June 2008
1 Apr 2008
June 2008
Jan 2009
-
Testing
Available for industry users
-
Jan - May 2008
1 June 2008
-
Data Model
-
Dec 2007
-
Analysis / Design phase (RIP 3.2.2 – Task III)
Build Phase
Tentative CSR tool
-
Mar 2008
2008 – 2009
June 2008
-
SC Questionnaire (data standard)
Standard Library (RMM, Std Phrases)
-
Jan 2008
Mar 2008
(developed by ECHA)
Substance Inventory Mgt.
System – SIMS
(developed by Cefic)
ES/CSA/CSR IT tools
(developed by ECHA)
Supply Chain
communication
(developed by Cefic)
35
8. REACH Implementation Workshop I
The Cefic REACH Implementation Group has organized its REACH Awareness Workshop at
the end of September in the Sheraton Brussels Airport hotel. As the pre-registration date is
coming closer now, the number of practical issues to be addressed is increasing and
therefore it was decided to organize a two day workshop. Some 185 participants had
registered and many of them came for the first time to this event.
There were 16 different presentations dealing with the status of the different RIPs, IT
developments and industry practices. Also Geert Dancet, the new Agency Director gave a
presentation about the Agency organization. In between the different presentations there was
sufficient time for Q&A sessions with lively discussions.
The next REACH Implementation workshop II is scheduled for 16 and 17 January 2008.
9. Short news

The European Chemicals Agency (ECHA) has started its activities in Helsinki.
Their website is: http://echa.europa.eu/

You can find the final guidance
http://echa.europa.eu/home_en.html

IUCLID 5 has been released in June and can be downloaded from:
documents
on
the
ECHA
website
http://echa.europa.eu/reach/software/iuclid_en.html

The draft guidance on information requirements and preparing the CSA will be
discussed in the Competent Authority Meeting of 19 – 20 Dec. If accepted and
approved, they are expected to be published early 2008.

The draft regulation on fees will be on vote at the committee meeting of 10 Dec

As REACH is now in force, Cefic is reorganising its REACH working groups to
focus more on the practical implementation of REACH.

Cefic with other industry partners is developing a software tool to manage the
exchange of information in a SIEF including Consortia activities. This tool is called
the SIEF IT system and will be available 1 June 2008. Further details will follow in
next newsletters.
36
10. Workshops
CEFIC

REACH Implementation Workshop II: 16 and 17 January 2008, Brussels
Sheraton Airport hotel.

REACH IT Workshop: 03 April 2008, Brussels Sheraton Airport Hotel.
REACHCENTRUM

W ORKSHOPS: REACH for business managers; REACH Advanced; REACH in
PRACTICE–Pre-registration and onwards; Using the IT Tools for the PreRegistration Period

TRAININGS: IUCLID 5

W EBINARS
For more details please check the ReachCentrum website:
http://www.reachcentrum.eu/
37