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REACH registration guide
Who has to register substances?
Only a natural or legal person established within the Community can be a
registrant. Registration must take place when this person:
(1) manufactures a substance within the Community,
(2) is responsible for import into the Community or
(3) has been appointed as an only representative according to Article 8 of the
REACH Regulation.
The national law of each EU Member State provides the specific provisions
concerning natural or legal personality and when such a natural or legal
person is established in its territory.
It is very important that companies correctly identify their role (or roles) in the
supply chain for each substance they handle, because this will be a decisive
factor in determining their registration obligations.
Please note that non-Community companies that are not established within
the Community do not have direct obligations under REACH. It is the
importer established within the Community that needs to comply with the
obligations of REACH. However, to relieve the importers of their obligations, the company not established within the Community may decide to appoint an “only representative”
Which substances have to be registered?
Registration is required for all substances:
- as defined in Article 3 (1) of the REACH Regulation;
- manufactured in or imported into the Community in quantities of
1 tonne or more per registrant per year;
- unless they are explicitly exempted from the scope of
registration according to Article 2 (1) to (3) and Annexes IV and
V or partially exempted according to Article 2 (5-9) of the
REACH Regulation;
- irrespective of whether they are classified as dangerous or not.
When do I have to register my substances?
Various aspects need to be taken into account when thinking of the
registration deadlines. These include tonnage, dangerous properties, or
whether it is a phase in or a non-phase in substance. Chapter 1.7 of the
Guidance on Registration (Section 1.7.1.1 – phase-in substances) provides
information on this matter.
- The REACH Regulation creates a special transition regime for
phase-in substances (Section 1.7.1.1 – phase-in substances). In
order to benefit from the extended registration deadlines for
phase-in substances (Section 1.7.2 – deadlines for registration),
these substances must be pre-registered between 1 June 2008 and 1 December 2008. Depending on the
intrinsic properties of the substance, along with its tonnage, it
will then need to be registered by 1st December 2010, 1st June
2013 or 1st June 2018.
- Phase in substances which have not been pre-registered must
be registered before manufacture or import can continue.
Therefore, if a phase-in substance is not pre-registered it should
be registered if a company wishes to continue to manufacture or
import. In this case the registrant may have to wait for 3 weeks
before continuing manufacture or import (Article 21 of the
REACH Regulation). Prior to registration of such substances,
the manufacturer or importer has a duty to make an inquiry to
the Agency regarding any previous registration for that
substance.
- Non-phase in substances must be registered before they can be
manufactured or imported. This obligation will start on 1st June
2008. Prior to registration of such substances, the manufacturer
or importer has a duty to make an inquiry to the Agency
regarding any previous registration for that substance.
- Within six months after first manufacture or import above the
one-tonne threshold, and no later than 12 months before the relevant deadline for registration in the case of a first-time
manufacture or import after the pre-registration deadline (1
December 2008) has passed.
How much is the registration fee?
Article 74 of the REACH Regulation lays down the basic provisions on the
requirements for fees. The fees are specified in a Commission Regulation No.
340/2008 on fees and charges payable to the ECHA. However, a fee is not
required for the registration of substances in a quantity of between 1 and 10
tonnes per year for which a registration dossier containing the full information
in Annex VII to the REACH Regulation is submitted. A reduced fee is set for
SMEs. For more information please visit:
http://www.reachor.com/SME.html
How do I calculate the tonnage?
Each registrant has to calculate the yearly tonnage for the registration dossier.
The yearly tonnage is calculated as the volume per manufacturer/importer per
calendar year, unless stated otherwise. For phase-in substances that have
been imported or manufactured for at the least three consecutive years,
quantities are calculated on the basis of the average production or import
volumes for the three preceding calendar years (Article 3 (30) of the REACH
Regulation). Detailed guidance and practical examples are provided in the
Guidance on Registration (Section 1.6.2 – Calculation of volume to be
registered).
Do I have to register alloys?
Alloys are regarded as preparations according to Article 3 (2) of the REACH
Regulation. This implies that only the single chemical elements in the alloys
have to be registered but not the alloys itself.
The Guidance on Registration (Section 1.4 – on definitions) provides further
information on the definition of a preparation and the distinction between a
preparation and a multi-constituent substance. Guidance shall be developed
for preparations, including assessment of substances incorporated into
special preparations, such as metals incorporated in alloys (see also Recital
31 of the REACH Regulation).
Do I have to register intermediates?
According to Article 3 (15) of the REACH Regulation, an intermediate is
defined as a substance that is manufactured for and consumed in or used for
chemical processing in order to be transformed into another substance(s).
Therefore an intermediate should not be present in the final manufactured
substance (except as an impurity). It then depends under which type of
intermediate as described in REACH your intermediate falls whether you have
registration obligations. Different types of intermediates are defined under
REACH:
- Non-isolated intermediates
For the use of a substance as a non-isolated intermediate, there are no
obligations under REACH Regulation.
- Isolated intermediates:
- On-site isolated intermediates
A manufacturer of on-site isolated intermediates in quantities of
1 tonne or more per year needs to register their substances (if
they are not otherwise exempted from registration (see FAQ
6.3). However registrants of on-site isolated intermediates can
provide reduced registration information according to Article
17(2) of the REACH Regulation if they confirm that the
substance is manufactured and used under strictly controlled
conditions as described under Article 17(3).
- Transported isolated intermediates
A manufacturer or importer of transported isolated intermediates
in quantities of 1 tonne or more per year needs to register his
substances if they are not otherwise exempted from registration
(see FAQ 6.3). However, a registrant of transported isolated
intermediates can provide reduced registration information
according to Article 18(2) of the REACH Regulation if he
confirms that he is manufacturing and/or using the substance
under strictly controlled conditions and if he confirms or states
that he has received confirmation from the user that the
substance is used under strictly controlled conditions as
described under Article 18(4). In this case, both the registrant
and the users are each liable for their own statement regarding
the strictly controlled conditions.
The specific Guidance on Intermediates describes when and how the specific
provisions for the registration of intermediates under REACH can be used.
Do I have to register a substance occurring in nature if I have to apply a process to extract this substance, e.g.
extracting wool wax from wool fibres?
Substances occurring in nature are exempted from the duty to register in
accordance with Article 2(7)(b) and Annex V, point 8 of REACH, as long as
they are not chemically modified or classified as dangerous in accordance
with Directive 67/548/EEC. For answering the question, if a process can be
applied to extract such a substance without the need for registration, it has to
be verified if the process applied is one of those listed in Article 3 (39) of the
REACH Regulation. If this is the case, the substance still qualifies as
substance that occurs in nature.
Applied to the example above, there is at first sight no obligation to register
wool wax as such, as it is a substance occurring in nature. To remove the
wool wax from the wool fibre, a process may be applied that may include a
treatment with detergents as wool wax is insoluble in water. When detergents
are used during the process, the question is if the extracted wool wax can still
be considered as a substance which occurs in nature. As mentioned, it has to
be verified, if the process applied is one of those listed in Article 3 (39) of the
REACH Regulation. If this is the case, the substance still qualifies as
substance that occurs in nature. If, for example, the wool wax is processed by
using “flotation” which is a well defined process mentioned in Article 3(39) and
may include treatment with detergents, the wool wax still can be regarded as
a substance which occurs in nature. However, it is important to remember that
it is up to the manufacturer to assess the process applied and to determine if
the definition of Article 3 (39) is applicable or not.
Need more information or assistance?
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