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What are the obligations of importers of substances in articles?
Under some circumstances substances in articles have to be pre-registered,
registered or notified to ECHA by producers or importers (see Article 7 of the
REACH Regulation). The terms “import” and “article” are defined under Article
3 (3) and (10) of the REACH Regulation). In order to establish whether a
registration or notification is required, any importer of articles needs to carry
out the following actions:
- Determine:
- whether any of the substances in the article is intended to be
released under normal or reasonably foreseeable conditions of use
and, if this is the case,
- whether the total amount of this specific substance imported within
all those articles is one tonne or above per year. If both conditions are
fulfilled, the importer has registration obligations in accordance with
Article 7(1) of the REACH Regulation.
- Determine whether any of the substances listed according to Article 59
of the REACH Regulation (the candidate list of substances meeting
the criteria for being of very high concern) could be contained in the
imported article above a concentration of 0.1 % w/w1. If this is the
case and the substance is present in the imported articles in
quantities totalling one tonne or above/ year, the importer will have
notification duties in accordance with Article 7(2) of the REACH
Regulation.
- A registration or notification of a substance in an article is not required
if the substance has already been registered for that use (Article
7(6) of the REACH Regulation). Consequently, a potential registrant
or notifier of a substance in articles should check whether a
substance has been registered ‘for that use’. This refers to any
registration of that use of the substance up the same supply chain
or any other supply chain. It needs to be ensured that it is the same
substance that has been registered according to the rules set out in
the Guidance for identification and naming of substances under
REACH.
Independent of the duties such as listed above, a number of additional duties
apply to importers of articles:
- Respond to any decision requiring further information as a result of the
dossier or substance evaluation process by ECHA and the Member
States in case registration duties apply.
- Respond to any Agency requirement to submit a registration for a
substance contained in an article in quantities of over 1 tonne/ year,
that is released and that ECHA suspects presents a risk to human
health or the environment.
- Comply with any restrictions on placing on the market and use of
substances in articles as set out in Annex XVII of the REACH
Regulation.
- In the case of SVHC (Substances of Very High Concern) substances
listed in the candidate list in accordance with Article 59(1) of the
REACH Regulation and present in articles at a concentration above
0.1% (w/w), provide the recipient of the article - or on request the
consumer that uses the article - with sufficient information to allow
safe use of the article, including, as a minimum the name of the
substance (see Article 33 of the REACH Regulation).
Need more information or assistance?
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