Page 12 - CITDBooklet

Guide on the application of REACH Regulation

02

REACH REGISTRATION

2.1 REGISTRATION PRINCIPLES

2.1.1 One Substance One Registration (OSOR) principle
■ After pre-registration deadline ECHA has published a list of all pre-registered substances
on Internet.
■ For same substances ‘Substance Information Exchange Forums’ (SIEF) to be formed:
■ All SIEF members are informed about identity of participants
Identity can be hidden by nominating ‘third party representative’ (not to be mixed
with ‘only representative’)
■ Technical registration dossiers including exposure scenarios for all ‘identified uses’ to
be prepared for all substances
■ One of a group of multiple registrants (the “lead registrant”) should submit information
on behalf of the others while allowing sharing the burden of the costs
■ Joint submission of registration by all SIEF members via lead registrant preferred by the
European Commission
■ Joint submission and the sharing of information on substances should be provided for
in order to:
- increase the efficiency of the registration system,
- reduce costs, and
- reduce testing on vertebrate animals.
■ Registrants are manufacturers or importers of a substance
■ Each manufacturer or importer need only comply with requirements specified for ‘his’
volume
■ ‘Opting out’ possible if
– Costs of joint submission appear too high
– Confidential business information could be disclosed
– The ‘lead registrant’ is deemed unacceptable
■ Chemical dossier with basic information for all substances
■ Chemical safety report (CSR) obligatory for all substances > 10 t/a:
Target is to demonstrate that risks identified in CSA are controlled
■ CSR comprises chemical safety assessments (CSA) depending on substance properties
and is obligatory for substances > 10 t/a
- human health hazard assessment
- physicochemical hazard assessment
- environmental hazard assessment;
- persistent, bio-accumulative and toxic (PBT) and very persistent and very bio-
accumulative (vPvB) assessment

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