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Structure
Scope of REACH
Does REACH apply to substances and
preparations imported or manufactured in volumes below 1 tonne per
annum?
What falls under the definition of PPORD
(Product and Process Orientated Research and Development)?
What are our duties when we import a preparation
into the EU?
What are the duties of a Company importing
substances from Norway and/or Switzerland?
Does REACH apply to imported articles from
outside the EU?
How to register fragrances imported into
the EU?
I think my substance should be exempted from
registration and added to Annex IV. Will the annex be reviewed?
When are the main provisions of REACH applicable:
1st June 2007 or 1st June 2008?
When a substance is sold to a third party
exclusively to be transformed in another substance, can this be
considered a transported isolated intermediate?
A company A delegates the production of
a substance to a third party manufacturer B. Who is responsible
for registration?
Is a household care product contained in
an aerosol packaging considered as being an article?
Which legal entity (e.g. within a multinational
company) must register a substance upon import/manufacture into/in
the European Union?
Does REACH apply to nanoparticles?
Does REACH apply to substances used in biocides?
Pre-registration and registration
Do polymers need to be registered?
Is it possible to benefit from the specific
provisions for phase-in substances if the substance is not pre-registered
by 1st December 2008?
How can I pre-register my substances and
is there a format to fill in?
Can I register a monomer as an intermediate?
When a substance has been registered for
a specific use in articles, is the registration supply chain specific?
Data sharing/SIEF
Can a Downstream User join a SIEF?
As a DU, can I sell my data to SIEF
members?
Art.29 says that “All potential registrants,
downstream users and third parties who have submitted information
to the Agency in accordance with Article 28, or whose information
is held by
the Agency in accordance with Article 15” are entitled to
participate to SIEF.
According to Art.30, point 2 “All participants of the SIEF
who require a study shall contribute to the costs” in case
of sharing data. Does this exclude DU?
How to make known the use of a substance
in a preparation known to your supplier?
If a substance that I use today does not
appear on the list of pre-registered substances published on 1st
January 2009 by the ECHA, is there a process for the substance to
be registered?
Authorisation
Do I need to apply for authorisation for
each use?
Does the candidate list containing the substances
of very high concern (SVHC) already exist?
Scope of Reach
Does REACH apply to substances and preparations
imported or manufactured in volumes below 1 tonne per annum?
Yes, for certain parts.
Any obligations regarding Classification and Labelling need to be
met regardless of the tonnage. If the substance is classified as
dangerous, is a PBT or vPvB or is included in the candidate list
of substances for authorisation a safety data sheet has to be produced
and provided to the recipients of the substances.
If the substance is placed on Annex XIV (list of substances subject
to authorisation) you need to request an authorisation for its use,
irrespective of the volume.
Similarly, restrictions contained in Annex XVII apply, irrespective
of the volume.
Reference: Art. 6 & 31; RIP
3.1; ECHA website
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What falls under the definition of PPORD (Product
and Process Orientated Research and Development)?
Any scientific development of a substance on
its own, in a preparation or an article in the course of which pilot
plant or production trials are used to develop the production process
and /or to test the field of application of the substance, falls
under the definition of PPORD irrespective of the tonnage involved.
Substances are exempted from registration for a period of 5 years
after notification to the Agency.
Reference: Art. 3.22; Guidance on
ECHA website
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What are our duties when we import a preparation
into the EU?
When you import a preparation from a country
outside of the EU, you are an importer of all substances it contains,
and therefore you have to register any substance reaching the threshold
of 1 tonne per year. This implies that you must know the detailed
composition of the preparation.
Note 1: substances which have been registered, exported and then
re-imported are exempted from registration
Note 2: non-EU manufacturers exporting to the EU have the option
to nominate an Only Representative to cover their registration.
Reference: Art 5 & 6; Art. 2.7.c
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What are the duties of a Company importing substances
from Norway and/or Switzerland?
As soon as REACH is implemented by the EEA States
(Iceland, Lichtenstein and Norway), imports will be considered as
intra-Community trade for the purposes of REACH. Imports from Switzerland
will be considered as imports from a third country.
Once the EEA countries have adopted the REACH Regulation “as
is”, and have negotiated with the EU their role within the
ECHA, they will label their goods according to the European legislation.
Therefore a company importing substances from Switzerland will have
to register them (as long as the total annual volume is above 1
tonne), but not from the EEA countries after they have adopted the
REACH Regulation.
Reference: See web site http://reach.jrc.it/actors_en.htm;
ECHA website
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Does REACH apply to imported articles from outside
the EU?
Yes
The REACH Regulation applies both to imported and EU-produced articles
in certain cases.
Any producer or importer of articles shall submit a registration
to the Agency for any substance that is intentionally released from
articles and is present in those articles in quantities of 1 tonne
and more per year, unless this particular use is covered in the
registration dossier for the substance.
If the articles contain substances of very high concern which are
listed on the "candidate list" for authorisation, the
EU producer and the importer of the article have the obligation
to notify these substances to the Agency, if the substance is present
in those articles in quantities over 1 tonne per producer/importer
per year and the concentration is above 0.1 % (w/w), and if exposure
cannot be excluded and if substance is not registered for that use.
Producers and importers of those articles have to provide the recipient
of the articles with sufficient information to allow safe use of
the article including, as a minimum, the name of that substance.
Notification applies only as of 1st June 2011, 6 months after the
substance is added on the “candidate list” (see Q 27
for further details on “candidate list”).
Reference: Art 3(3), 7 & 33;
RIP 3.8
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How to register fragrances imported into the EU?
Fragrance is a preparation, and each of its constituents
(substances) should be registered separately (if they are imported
in quantity exceeding 1 tonne per year), not the fragrance itself.
However, its composition is normally not known, as the supplier
is not usually willing to unveil its composition. It is therefore
recommended that you ask the supplier to appoint an Only Representative
in the EU who will take care of the registration. Such an Only Representative
will cover all imports into the EU.
Reference: Art 5 & 6; Guidance on Registration
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I think my substance should be exempted from registration
and added to Annex IV. Will the annex be reviewed?
Yes
The Commission is required to carry out a review of Annex IV by
1 June 2008 with a view to proposing amendments, if appropriate.
Annex IV may be amended following the Committee procedure (comitology),
and third parties may provide their input to the Commission, a Member
State or Industry Associations that are observers of the REACH CA
Sub-Group . To be kept updated with the process please regularly
check the website of DG Environment.
The Commission has asked a consultant to develop criteria to be
fulfilled for substances to be included in Annex IV.
There is no certainty as whether a substance will be on the Annex
IV (even if it is so today).
Reference: Art 2(7)(a)(b), 133(4); Annex
IV & V; ECHA website
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When are the main provisions of REACH applicable:
1st June 2007 or 1st June 2008?
Titles I (General Issues), IV (Information in
the Supply Chain), IX (Fees and charges - except Art. 74), X (Agency),
XIII (Competent Authorities), XIV (Enforcement) and XV (Transitional
and final provisions - except Art. 138(4)) as well as Article 115
apply as of 1st June 2007.
Title II (Registration of substances), Title III (Data sharing and
avoidance of unnecessary testing), Title V (Downstream users), Title
VI (Evaluation), Title VII (Authorisation) Title XI (Classification
and labeling inventory) and Title XII (Information) as well as Art
74 and 138(4) apply as of 1st June 2008.
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When a substance is sold to a
third party exclusively to be transformed in another substance,
can this be considered a transported isolated intermediate?
Yes.
The definition of transported isolated material does apply to this
case:
“transported isolated intermediate means an intermediate not
meeting the criteria of a non-isolated intermediate and transported
between or supplied to other sites”.
Art.18 applies and the intermediate needs be registered following
Art 18(2)(3)(4) if their volume exceeds 1 tonne per year.
Intermediates are subject to reduced registration requirements.
Intermediates are out of the scope of Authorisation.
It should be noted that it will have to be demonstrated that the
substance is handled under strictly controlled conditions in order
to benefit from the intermediates status (guidance available on
ECHA website). This must be confirmed in writing by the user (being
inside or outside of the EU).
Finally monomers that are used as transported isolated intermediates
in the production of polymers have to be registered in accordance
with the normal registration obligation and not according to specific
provisions on the registration for intermediates (Art 6(2)).
Reference: Art 3(15)(c), 18; Art 6; ECHA
website
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A company A delegates the production of a substance
to a third party manufacturer B. Who is responsible for registration?
According to article 6, it is up to the manufacturer
to register the substance. Definition of the manufacturer is given
in article 3(9):
"any natural or legal person established within the community
who manufactures a substance with the Community".
Therefore, Company B should register the substance.
Of course, it may happen that Company B does not have data for supporting
the registration when Company A has them. It is then foreseeable
that Company B will not produce for Company A without ensuring first
that Company A will provide all necessary information.
Reference: Art 3 & 6;
ECHA website
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Is a household care product contained in an aerosol
packaging considered as being an article?
No.
The function is a decisive element in the definition of article,
and is determined by the manufacturer’s intention. The main
function of a spray can is to release a preparation. A spray can
is therefore considered as being a container (i.e. an article).
Substances contained in the aerosol container are therefore intended
to be released and should be registered under Article 6.
Reference: RIP 3.8 (under development)
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Which legal entity (e.g. within a multinational
company) must register a substance upon import/manufacture into/in
the European Union?
Within a multinational company, those legal entities
(natural or legal persons) manufacturing or importing a substance
in the Community are responsible for the registration of the substance(s)
they each manufacture or import. Only Manufacturers and Importers,
which are legal (or natural) persons established within the European
Community can be responsible for registration.
Note 1: Volumes should be calculated by legal
entity for registration purpose.
Note 2: In case a non-EU manufacturer has appointed an Only Representative,
this Only Representative acts as a single registrant for all imports
into the EU, and therefore individual legal entities do not have
to register the substances.
Reference: ECHA website
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Does REACH apply to nanoparticles?
Yes.
Substances in the nano-scale fall under the scope of REACH and their
health and environment properties must therefore be assessed following
the provisions of the Regulation. The nanoform of a substance can
be registered as part of the registration for the non-nano form
of the substance.
Methodologies for identifying hazards and evaluating risks of substances
at the nano-scale need to be further refined. The European Commission
is funding research projects to assess the health and environment
impacts of nano-particles under the 7th Research Framework Programme.
Reference: ECHA website
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Does REACH apply to substances used in biocides?
Active substances used in biocidal products are
regarded as registered as they are covered by Directive 98/9/EC
(Biocidal products Directive). However, several conditions have
to be fulfilled to benefit from the exemption:
- the substance must be an active substance for
use in a biocidal product
- it must be included in one of the following documents:
Annex I, IA, IB to Directive 98/8/EC or Regulation (EC) No 2032/2003.
Only the quantities used in biocidal products
are exempted from the REACH obligation.
Reference: ECHA website
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Pre-registration and registration
Do polymers need to be registered?
No, but the monomers in the polymers need to be registered.
Monomer substance(s) and other substances of the polymers that have
not already been registered by an actor up the supply chain are
to be registered if:
- the polymer consists of 2 % weight by weight
(w/w) or more of such monomer substance(s) or other substance(s)
in the form of monomeric units and chemically bound substance(s);
- the total quantity of such monomer substance(s)
or other substance(s) in bound or unbound form makes up 1 tonne
or more per year.
N.B.: Polymers are not exempted from Authorisation
or Restriction. They are also subject to Classification & Labeling
provisions.
Reference: Art 2(9), 3(5)(6), 6
& 138(2); RIP 3.1; ECHA website
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Is it possible to benefit from the specific provisions
for phase-in substances if the substance is not pre-registered by
1st December 2008?
Yes, but only in case you are first time manufacturer
or importer.
As a first time manufacturer or importer of a substance in quantities
of 1 tonne or more per year, you must pre-register at the latest
6 months after the first manufacture/import and at least 12 months
before the relevant deadline for registration.
This is very important for a DU who uses a substance which has not
been pre-registered: he can use this possibility offered by the
Regulation for pre-registering the substance.
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How can I pre-register my substances and is there
a format to fill in?
There will be 2 possibilities to submit the pre-registration
information:
- direct encoding of the information on the REACH-IT
website
- submission of a “bulk” pre-registration
dossier prepared separately. The file must be of the format produced
by IUCLID5.
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Can I register a monomer as an intermediate?
Although a monomer can be considered as an intermediate,
Article 6.2 specifies that monomers cannot benefit from reduced
registration provisions. This means that a full dossier must be
submitted even if a monomer is used as an intermediate under strictly
controlled conditions.
Reference: Art. 6.2
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When a substance has been registered for a specific
use in articles, is the registration supply chain specific?
Provided that the substance has been registered
by any manufacturer/importer for that use, it is not relevant that
the registration was done within the same supply chain or within
another supply chain.
Reference: Art 7.6
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Data sharing/SIEF
Can a Downstream User join a SIEF?
Yes
If you hold data and have submitted the corresponding information
on a substance to the Agency, you will be participant in the related
SIEF as a Data Holder.
You can also pre-register a substance as a potential registrant
(e.g. in the case you intend to import the substance in the future
from a non-EU country). In which case you will have the same status
as other registrants in the SIEF.
Reference: Art 29(1)
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As a DU, can I sell my data to SIEF members?
As a DU, and if you have submitted the corresponding
information to the Agency, you are considered as being a Data Holder.
As such, you must respond to any query from potential registrants.
However, a Data Holder is not entitled to request data. Therefore
you can sell data only if the SIEF members request them.
Other SIEF members should consider data from data holders.
Guidance on Data Sharing (ECHA website)
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Art.29 says that “All potential
registrants, downstream users and third parties who have submitted
information to the Agency in accordance with Article 28, or whose
information is held by
the Agency in accordance with Article 15” are entitled to
participate to SIEF.
According to Art.30, point 2 “All participants of the SIEF
who require a study shall contribute to the costs” in case
of sharing data.
Does this exclude DU?
Any company can participate to a SIEF under either
of the following status: Potential Registrant or Data Holder (but
with different rights). A today Downstream User can enter a SIEF
as a potential registrant (if he intends to import a substance from
a non-EU country) or as a data holder.
In the first case, he will have the same obligation as any other
registrant, i.e. he will have to share the cost of missing data
(when applicable to his registration file). In the latter case,
not.
Guidance on Data Sharing (ECHA website)
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How to make known the use of a substance in a
preparation known to your supplier?
You should inform in writing (letter or e-mail)
as soon as possible your supplier of your own use and uses of your
customers of his substance in your preparation. You should provide
sufficient information to allow him to prepare an exposure scenario
which covers your use.
Also make sure that he intends to cover your use in his registration
file.
Guidance on how to do so will be provided under RIP 3.2
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If a substance that I use today does not appear
on the list of pre-registered substances published on 1st January
2009 by the ECHA, is there a process for the substance to be registered?
You should first inform the Agency of your interest
in the substance with the name of your current supplier. The ECHA
will then publish on its website the name of the substance and on
request provide your contact details to a potential registrant.
This mechanism aims to allow Downstream User to find another supplier.
An alternative provided by Art. 28(6) allows this other supplier
to pre-register under the late pre-registration procedure described
in Article 28(6). The pre-registration should then be completed
within 6 months of the notification to the Agency.
The late pre-registration should be no later than 12 months before
the registration deadline.
Another possibility is for the DU to manufacture or import the substance
for the first time. The same process as above applies to his case.
Reference: Guidance on Data Sharing (ECHA
website)
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Authorisation
Do I need to apply for authorisation for each
use?
Yes.
Authorisations are given per use. Those using or making available
substances identified as of high concern will need to apply for
an authorisation for each use of the substance within certain deadlines
(the application will have to include an analysis of possible substitutes).
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Does the candidate list
including the substance of very high concern (SVHC) already exist?
So far no candidate list exists. When an Authority
(Commission or Member State) considers that a substance may meet
the criteria for identification as SVHC, the Agency or a Member
State will prepare an Annex XV dossier. Then the substance may be
included in the candidate list for possible inclusion in Annex XIV
after review by relevant Committees.
The candidate list will be made available on the ECHA website. SHVC
will be prioritised. The Agency shall indicate which substances
are on its work programme for authorisation (Annex XIV).
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