Intermediate registration is much cheaper than full registration. It is
strongly recommended that companies check with their downstream users whether a
substance is used as an intermediate or not before beginning registration.
Definitions of Intermediates under REACH
Non-isolated intermediates are exempt
from REACH registration: A substance that is manufactured
solely for the purpose of being transformed into another substance (or
synthesis) and is used up within this reaction. Non-isolated intermediate is
not intentionally removed from the synthesizing equipment. Other intermediate
other than non-isolated intermediate are called isolated intermediates, which
can be divided into two sub groups: On-site isolated intermediate and
On-site isolated intermediate: A substance manufactured for or used for chemical processing in order to
be transformed into another substance, the synthesis of which takes places on
the same site and which is operated by one or more legal entities.
Transported isolated intermediate: A substance(for example, pharmaceutical intermediate) manufactured for
or used for chemical processing in order to be transformed into another
substance, the synthesis of which is transported between or supplied to other
On-site isolated intermediate and
transported isolated intermediate can be registered with reduced requirement.
REACH Registration of Intermediate: Data
Registration of intermediates (transported or isolated) requires "all
available data". The Art 17 (d) and 18(d) of the REACH regulation specify
that “if the manufacturer or importer confirms that he is manufacturing and/or
using the substance under strictly controlled conditions and he confirms
himself or states that he has received confirmation from the users that the
substance is used under strictly controlled conditions (section 2.1) and the
annual quantity of substance is less than 1,000 tonnes, the information
requirements on the substance's intrinsic properties (physicochemical, human
health and environment properties) are reduced to available data (e.g.
information he holds himself or that he can obtain from other sources) and only
study summaries have to be submitted if a full study report is available”.
Besides the available data on substance's intrinsic properties, the registrant
still has to provide the following information:
A brief general description of the use;
Details of the risk management measures
applied and recommended to the use;
The identity of the manufacturer or
The identity of the intermediate;
The classification of the intermediate;
Do You Qualify for Intermediate
Registration under REACH?
ECHA encourages registrants of intermediates to proactively reassess and,
where necessary, update their registration dossiers.
According to REACH, two critical conditions need to be met for an on-site or
transported isolated intermediate to benefit from the reduced data set
provisions of articles 17 and 18 of REACH:
1. the use of the substance must meet the
definition of intermediates as described in article 3 (15) of REACH; and
2. the substance must be manufactured
and/or used under strictly controlled conditions (SCC).
In view of these conditions, ECHA is asking registrants to collect and
send an extensive amount of information including a description of the chemical
reactions that take place, and a description of all the measures taken to
ensure strictly controlled conditions at all steps, as well as copy of letters
sent to, or received from all downstream users confirming that they use the
substance as an intermediate under SCCs.
To assess if the intermediate is
manufactured and used under strictly controlled conditions during its whole
lifecycle, the registrant should evaluate if all the following conditions
(a) the substance is rigorously
contained by technical means during its whole lifecycle including manufacture,
purification, cleaning and maintenance of equipment, sampling, analysis,
loading and unloading of equipment or vessels, waste disposal or purification
(b) procedural and control technologies
shall be used that minimise emission and any resulting exposure;
(c) only properly trained and
authorised personnel handle the substance;
(d) in the case of cleaning and maintenance
works, special procedures such as purging and washing are applied before the
system is opened and entered;
(e) in cases of accident and where waste is
generated, procedural and/or control technologies are used to minimise
emissions and the resulting exposure during purification or cleaning and
(f) substance-handling procedures are well
documented and strictly supervised by the site operator.
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