Guidance on registration - ECHA - Europa

<strong>Guidance</strong> on registration
Version 2.0 May 2012 115
Appendix 2. Roles and duties of the main actors of REACH
This appendix provides an overview of the main responsibilities defined by REACH or derived
from REACH in the context of the registration, evaluation, authorisation and restriction
processes. It should be noted that it is not an exhaustive list and should only be used for
reference purposes. The reader is advised to consult the related guidance document if in need
of detailed information on a specific process.
I. Industry
(1) Manufacturers and importers of substances in quantities of less than 1 tonne per
year need to:
Prepare and supply safety data sheets (SDS) for substances and mixtures as required
by Article 31 and Annex II to downstream users and distributors.
Prepare and supply information on substances that do not require an SDS as defined by
Article 32 to direct customers.
Comply with any restrictions on manufacture, placing on the market and use of
substances and mixtures as set out in Annex XVII.
Apply for authorisation for use(s) of substances listed in Annex XIV.
In the case of having relevant data, decide whether to act as data holder in Substance
Information Exchange Fora (SIEF).
(2) Manufacturers of substances in quantities of 1 tonne or more per year need to:
Pre-register their substances with ECHA if they wish to secure their substances’ phasein
status
In case their substance is a non phase-in substance, send an inquiry to ECHA as to
whether a registration has already been submitted for the same substance.
Collect and share existing, and generate and propose to generate new, information on
properties and use conditions of substances.
Prepare a technical dossier (note that special provisions apply for intermediates).
Prepare CSA and CSR (for each substance ≥ 10 tonnes per year per manufacturer).
Prepare CSA and CSR including exposure scenarios and risk characterisation (for each
substance ≥ 10 tonnes per year per manufacturer, which fulfils the criteria for any of
the hazard classes or categories set out in Article 14(4) or is assessed to be a PBT or
vPvB).
Implement appropriate Risk Management Measures (RMM) for own manufacture and
use.
Submit registration for substances (≥ 1 tonne per year per manufacturer) unless an
exemption applies.
Keep the information submitted in the registration up to date and submit updates to
ECHA.
Prepare and supply safety data sheets (SDSs) for substances and mixtures as required
by Article 31 and Annex II to downstream users and distributors.
Recommend appropriate RMMs in the SDS.
Communicate ESs developed in CSA as annex(es) to the SDS (≥ 10 tonnes per year per
manufacturer).
Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu