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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).

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