Guidance on registration - ECHA - Europa

<strong>Guidance</strong> on registration
Version 2.0 May 2012 53
information on manufacture, uses, risk management measures and resulting exposures.
Table 2 below presents an overview of the standard information requirements defined in
REACH (Annex VII to X). For each tonnage band, REACH defines the minimum information that
the registrant has to provide on the intrinsic properties of the substance. For the lowest
tonnage level, the standard information requirements are defined in Annex VII, and when a
new tonnage level is reached, the requirements of the corresponding Annex have to be added.
These standard requirements may, however, be adapted (waived or increased) when
appropriately justified according to the criteria set out in Annexes VII to XI. Therefore, for
each substance the precise information requirements may differ depending on the
available information on intrinsic properties as well as on tonnage, use and
exposure.
Where available data are not adequate to meet the requirements of REACH, additional testing
may need to be generated. It should be noted that any study required to fulfil the information
requirements defined in Annex IX and X (see Table 2) should not be conducted by the
registrant at the stage of registration. Instead the registrant will have to develop a testing
proposal and include it in his registration dossier.
It has to be stressed that where possible the registrant is obliged to share or generate
data with other registrants of the same substance, instead of generating data by himself, if
this would involve animal experiments (see section 4.1 on data sharing).
Where tests on substances are required to generate information on intrinsic properties of
substances, they must be conducted in accordance with the test methods laid down in
Commission Regulation (EC) No 440/2008 and its amendments or in accordance with other
international test methods recognised by the Commission or ECHA. Ecotoxicological and
toxicological tests and analyses must be carried out in compliance with the principles of good
laboratory practice or other international standards recognised as being equivalent by ECHA or
the Commission and with the provisions of Directive 86/609/EEC on the protection of animals
used for experimental and other scientific purposes.
Information on intrinsic properties of substances may be generated by using sources of
information other than in vivo testing, The registrant may use a variety of alternative methods
such as in vitro tests, (Q)SARs ((Quantitative) Structure Activity Relationships), grouping or
read-across, provided that the use of alternative methods is justified. All these different
sources of information can also be used in a weight of evidence approach.
Available guidance
The <strong>Guidance</strong> on information requirements and chemical safety assessment explains in detail
the process for information gathering and data generation. The following chapters may be
particularly useful for the reader:
Part B: Hazard Assessment
Chapter R.2: Framework for Generation of Information
Chapter R.3: Information Gathering
Chapter R.4: Evaluation of available information
Chapter R.5: Adaptation of information requirements
Chapter R.6: QSARs and grouping of chemicals
Chapter R.7: Endpoint specific guidance
Practical <strong>Guidance</strong> on alternative methods for the generation of information on intrinsic
properties of substances can also be found in the following documents:
Practical Guide 1: How to report in vitro data
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