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REACH

Notifications of Substances in articles

Derogations

How do I find out if the substance is already registered for a particular use? Can I use information that is disseminated on the ECHA website?

Note that it might require more resources and be more difficult to find out if the substance is already registered for the use, than to prepare and submit a substance in articles notification.

A substance can be considered as having already been registered for a particular use, if two conditions are fulfilled:

  • the substance in question is the same as the substance already registered; and
  • the use in question is the same as the use described in a registration of this substance, i.e. the registration refers to the use in the article.

In this context, “use” includes the use of the substance in the production of an article and, after being incorporated into the article, the use of the substance in the article during the article’s service life stages, including the waste stage.

For more information, see chapter 3.3.1 of the Guidance on requirements for substances in articles.

ECHA’s dissemination portal for substance information, which can be accessed via the ECHA website: https://echa.europa.eu/information-on-chemicals, contains information on registered substances provided by companies in their registration dossiers. It includes a variety of information on the substances which companies manufacture or import and may include information on the uses of the substance, unless the companies have claimed this information as confidential, including use of the substance in articles. The description of the use available here for all life cycle steps consists mainly of elements of the use descriptor system, as well as use name and in some cases contributing activity names. The information will normally not be sufficient on its own to conclude on the sameness of two uses for the purpose of establishing whether an exemption on the basis of Article 7(6) applies. Therefore, the use in question has to be described more in detail than just by using elements of the use descriptor system. For example, the published information that a substance has been registered for use in the Article Category 'Plastic articles' does not necessarily mean the registration is made to cover all plastic articles and all plastic materials. It could mean that use of the substance in production of some specific plastic articles is covered and described in the registration, while other plastic articles are not covered and assessed. The uses of two very different plastic articles may lead to very different exposures to humans and the environment. If the exposure related to the use of your article is not adequately assessed in a registration dossier, it cannot be considered a registered use.

Please note that there are limited possibilities to include information in section 3.5 of an IUCLID registration dossier, apart from the use descriptors. Section 3.5 of the IUCLID registration dossier may however contain 'free text' information, which is not based on the use descriptor system. Whether such information is sufficient to conclude on the sameness of use has to be examined on a case-by-case basis.

Most producers of articles are also downstream users under the REACH Regulation and as such have certain obligations outlined in Title V of the REACH Regulation. Since most substances on the Candidate List are already registered, producers of articles should already have communicated their use to the registrant for the purpose of registrations. Producers of articles may therefore not have to notify if their communicated uses are covered in the registration dossier.

Importers of articles may not have access to detailed information on registered uses. If you are not certain that your specific use is already registered, you should notify.

The Guidance on requirements for substances in articles is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach

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