Guidance on registration - ECHA - Europa

<strong>Guidance</strong> on registration
Version 2.0 May 2012 57
9.4.6 Long-term terrestrial toxicity to plants
9.5.1 Long-term toxicity to sediment organisms
9.6.1 Long-term or reproductive toxicity to birds
3.1.2 Use of information from other assessments
As stated under REACH, ‘Available information from assessments carried out under other
international and national programmes shall be included. Where available and appropriate, an
assessment carried out under Community legislation (e.g. risk assessments completed under
Regulation (EEC) No 793/93) shall be taken into account in the development of, and reflected
in, the chemical safety report. Deviations from such assessments shall be justified’ (Annex I
Section 0.5). Therefore registrants need to take into account and to use these already
available assessments to prepare their registration dossier. This includes in particular
assessments carried out under other EU programmes such as the Existing Substances Risk
Assessment Programme, assessments of active substances under the Biocidal Products
Directive or the Plant Protection Products Directive when such substances are covered by
REACH.
Another important source of information is the OECD HPV (Organisation for Economic Cooperation
and Development High Production Volume) Chemicals Programme where a lot of
similarities exist with REACH. Those similarities should be taken into account when preparing a
registration dossier where a dossier for the OECD HPV Chemicals Programme is available.
3.2 Registration dossier
3.2.1 Structure of the registration dossier
The registration dossier is the set of information submitted electronically by a registrant for a
particular substance. It consists of two main components:
a technical dossier, always required for all substances subject to the registration
obligations;
a chemical safety report, required if the registrant manufactures or imports a
substance in quantities of 10 tonnes or more per year.
The technical dossier contains a set of information about:
(i)
the identity of the manufacturer/importer;
(ii) the identity of the substance;
(iii) information on the manufacture and use of the substance;
(iv) the classification and labelling of the substance;
(v) guidance on its safe use;
(vi) study summaries of the information on the intrinsic properties of the substance;
(vii) robust study summaries of the information on the intrinsic properties of the substance,
if required;
(viii) an indication as to whether the information on manufacture and use, the classification
and labelling, the (robust) study summaries and/or, if relevant, the chemical safety
report has been reviewed by an assessor;
(ix) proposals for further testing, if relevant;
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