Guidance on registration - ECHA - Europa
Guidance on registration - ECHA - Europa
Guidance on registration - ECHA - Europa
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116<br />
<str<strong>on</strong>g>Guidance</str<strong>on</strong>g> <strong>on</strong> registrati<strong>on</strong><br />
Versi<strong>on</strong> 2.0 May 2012<br />
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Prepare and supply informati<strong>on</strong> <strong>on</strong> substances that do not require an SDS within the<br />
scope of Article 32 to downstream users and distributors.<br />
Resp<strong>on</strong>d to any decisi<strong>on</strong> requiring further informati<strong>on</strong> as a result of the evaluati<strong>on</strong><br />
process.<br />
Comply with any restricti<strong>on</strong>s <strong>on</strong> manufacture, placing <strong>on</strong> the market and use of<br />
substances and mixtures as set out in Annex XVII.<br />
Apply for authorisati<strong>on</strong> for use(s) of substances listed in Annex XIV.<br />
(3) Importers of substances and mixtures in quantities of 1 t<strong>on</strong>ne or more per year:<br />
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Pre-register their substances with <strong>ECHA</strong> if they wish to secure their substances’ phasein<br />
status<br />
In case their substance is a n<strong>on</strong> phase-in substance, send an inquiry to <strong>ECHA</strong> as to<br />
whether a registrati<strong>on</strong> has already been submitted for the same substance.<br />
Collect and share existing, and generate and propose to generate new, informati<strong>on</strong> <strong>on</strong><br />
properties and use c<strong>on</strong>diti<strong>on</strong>s of substances.<br />
Prepare a technical dossier (note that special provisi<strong>on</strong>s apply for intermediates).<br />
Prepare CSA and CSR including exposure scenarios and risk characterisati<strong>on</strong> (for each<br />
substance ≥ 10 t<strong>on</strong>nes per year per manufacturer, which fulfils the criteria for any of<br />
the hazard classes or categories set out in Article 14(4) or is assessed to be a PBT or<br />
vPvB).<br />
Implement appropriate RMMs for own use.<br />
Submit registrati<strong>on</strong> for substances, <strong>on</strong> their own or in mixtures (≥ 1 t<strong>on</strong>ne per year per<br />
importer) unless an exempti<strong>on</strong> applies.<br />
Keep the informati<strong>on</strong> submitted in the registrati<strong>on</strong> up-to-date and submit updates to<br />
<strong>ECHA</strong>.<br />
Prepare and supply safety data sheets (SDS) for substances and mixtures as required<br />
by Article 31 and Annex II to downstream users and distributors.<br />
Recommend appropriate RMMs in the SDS.<br />
Communicate ESs developed in CSA as annex(es) to SDS (≥ 10 t<strong>on</strong>nes per year per<br />
importer).<br />
Prepare and supply informati<strong>on</strong> <strong>on</strong> substances that do not require an SDS within the<br />
scope of Article 32 to downstream users and distributors.<br />
Resp<strong>on</strong>d to any decisi<strong>on</strong> requiring further informati<strong>on</strong> as a result of the evaluati<strong>on</strong><br />
process.<br />
Comply with any restricti<strong>on</strong>s <strong>on</strong> manufacture, placing <strong>on</strong> the market and use of<br />
substances and mixtures as set out in Annex XVII.<br />
Apply for authorisati<strong>on</strong> for use(s) of substances listed in Annex XIV.<br />
(4) Producers of articles:<br />
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Under some circumstances register substances in articles (t<strong>on</strong>nage trigger > 1 t<strong>on</strong>ne<br />
per year per producer). Comply with pre-registrati<strong>on</strong> and inquiry obligati<strong>on</strong>s if relevant.<br />
Keep the informati<strong>on</strong> submitted in the registrati<strong>on</strong> up todate.<br />
Under some circumstances notify substances in articles (t<strong>on</strong>nage trigger > 1 t<strong>on</strong>ne per<br />
year per producer).<br />
Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu