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intermediates
PREAMBLE: REACH - Registration, Evaluation, Authorisation and Restriction of Chemicals [go to this PREAMBLE]
... (41) For reasons of workability and because of their special nature, specific registration requirements should be laid down for intermediates. Polymers should be exempted from registration and evaluation until those that need to be registered due to the risks posed to human health or the environment can be selected in a practicable and cost-efficient way on the
basis of sound technical and valid scientific criteria. ...
... (66) The Agency should also be empowered to require further information from manufacturers, importers or downstream users on substances suspected of posing a risk to human health or the environment, including by reason of their presence on the internal market
in high volumes, on the basis of evaluations performed. Based on the criteria for prioritising substances developed by the Agency in cooperation with the Member States a Community rolling action plan for substance evaluation should be established, relying on Member State competent authorities to evaluate substances included therein. If a risk equivalent to the level of concern arising from the use of substances subject to authorisation arises from the use of isolated intermediates on site, the competent authorities of the Member States should also be allowed to require further information, when justified. ...
ARTICLE-2: Application [go to this ARTICLE]
... (c) non-isolated intermediates; ...
... 8. On-site isolated intermediates and transported isolated intermediates shall be exempted from: ...
... 8. On-site isolated intermediates and transported isolated intermediates shall be exempted from: ...
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. ...
... 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 ...
... 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. ...
ARTICLE-18: Registration of transported isolated intermediates [go to this ARTICLE]
... Registration of transported isolated intermediates ...
... 4. Paragraphs 2 and 3 shall apply only to transported isolated intermediates if the manufacturer or importer confirms himself or states that he has received confirmation from the user that the synthesis of (an)other substance(s) from
that intermediate takes place on other sites under the following strictly controlled conditions: ...
ARTICLE-19: Joint submission of data on isolated intermediates by multiple registrants [go to this ARTICLE]
... Joint submission of data on isolated intermediates by multiple registrants ...
ARTICLE-28: Duty to pre-register for phase-in substances [go to this ARTICLE]
... 1. In order to benefit from the transitional regime provided for in Article 23 each potential registrant of a phase-in substance in quantities of one tonne or more per year, including without limitation
intermediates, shall submit all the following information to the Agency: ...
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: ...