Law-ref.org REACH - Registration, Evaluation and Authorisation of Chemicals
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on-site isolated intermediate [Global Index]


ARTICLE-2: Application     [go to this ARTICLE]
... 8. On-site isolated intermediates and transported isolated intermediates shall be exempted from: ...


ARTICLE-3: Definitions     [go to this ARTICLE]
... (b) on-site isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site, operated by one or more legal entities; ...


ARTICLE-6: General obligation to register substances on their own or in preparations     [go to this ARTICLE]
... 2. For monomers that are used as on-site isolated intermediates or transported isolated intermediates, Articles 17 and 18 shall not apply. ...


ARTICLE-17: Registration of on-site isolated intermediates     [go to this ARTICLE]
... Registration of on-site isolated intermediates ...
... 1. Any manufacturer of an on-site isolated intermediate in quantities of 1 tonne or more per year shall submit a registration to the Agency for the on-site isolated intermediate. ...
... 1. Any manufacturer of an on-site isolated intermediate in quantities of 1 tonne or more per year shall submit a registration to the Agency for the on-site isolated intermediate. ...
... 2. A registration for an on-site isolated intermediate shall include all the following information, to the extent that the manufacturer is able to submit it without any additional testing: ...
... 3. Paragraph 2 shall apply only to on-site isolated intermediates if the manufacturer confirms that the substance is only manufactured and used under strictly controlled conditions in that it is rigorously contained by technical means during its whole lifecycle. Control and procedural technologies shall be used to minimise emission and any resulting exposure. If these conditions are not fulfilled, the registration shall include the information specified in Article 10. ...


ARTICLE-19: Joint submission of data on isolated intermediates by multiple registrants     [go to this ARTICLE]
... 1. When an on-site isolated intermediate or transported isolated intermediate is intended to be manufactured in the Community by one or more manufacturers and/or imported by one or more importers, the following shall apply. Subject to paragraph 2 of this Article, the information specified in Article 17(2)(c) and (d) and Article 18(2)(c) and (d) shall first be submitted by one manufacturer or importer acting with the agreement of the other assenting manufacturer(s) or importer(s) (hereinafter referred to as "the lead registrant"). Each registrant shall subsequently submit separately the information specified in Article 17(2)(a), (b), (e) and (f) and Article 18(2)(a),(b), (e) and (f). ...


ARTICLE-49: Further information on on-site isolated intermediates     [go to this ARTICLE]
... Further information on on-site isolated intermediates ...
... For on-site isolated intermediates that are used in strictly controlled conditions, neither dossier nor substance evaluation shall apply. However, where the competent authority of the Member State in whose territory the site is located considers that a risk to human health or the environment, equivalent to the level of concern arising from the use of substances meeting the criteria in Article 57, arises from the use of an on-site isolated intermediate and that risk is not properly controlled, it may: ...
... For on-site isolated intermediates that are used in strictly controlled conditions, neither dossier nor substance evaluation shall apply. However, where the competent authority of the Member State in whose territory the site is located considers that a risk to human health or the environment, equivalent to the level of concern arising from the use of substances meeting the criteria in Article 57, arises from the use of an on-site isolated intermediate and that risk is not properly controlled, it may: ...


ARTICLE-68: Introducing new and amending current restrictions     [go to this ARTICLE]
... 1. When there is an unacceptable risk to human health or the environment, arising from the manufacture, use or placing on the market of substances, which needs to be addressed on a Community-wide basis, Annex XVII shall be amended in accordance with the procedure referred to in Article 133(4) by adopting new restrictions, or amending current restrictions in Annex XVII, for the manufacture, use or placing on the market of substances on their own, in preparations or in articles, pursuant to the procedure set out in Articles 69 to 73. Any such decision shall take into account the socio-economic impact of the restriction, including the availability of alternatives. The first subparagraph shall not apply to the use of a substance as an on-site isolated intermediate. ...