US EPA

1005630 

Technical Report 

Guidance on information requirements and chemicals safety assessment 

European Chemicals Agency :: ECHA 

2008 

European Chemicals Agency 

Helsinki, Finland 

http://echa.europa.eu/web/guest/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment
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has individual parts 1069570 : Concise guidance, parts A-G
has individual parts 1069580 : Supporting reference guidelines, chapters R12-R20
has individual parts 1069589 : Supporting reference guidelines, chapters R7-R11
has individual parts 1069591 : Supporting reference guidelines, chapters R2-R6

This guidance describes the information requirements under REACH with regard to substance properties, exposure, use and risk management measures, in the context of the chemical safety assessment. It is part of a series of guidance documents that are aim to help all stakeholders with their preparation for fulfilling their obligations under the REACH Regulation.

The Guidance covers:

the collection of available information regarding the intrinsic properties of substances to be registered
the assessment of this information against the requirements specified by REACH,
the identification of data gaps and
the generation of the additional information required to fill the data gaps.

The Guidance also aims to assist industry in conducting Chemical Safety Assessments and preparing Chemical Safety Reports, when required. A CSR may be required as part of a registration dossier (for non intermediates > 10 t/a), as part of an authorisation application, or as part of downstream user obligations. It also sets out the basic principles for authorities preparing a risk assessment. This may be needed in support of a restriction proposal, of a proposal to include substances into the authorisation regime, or as part of a Substance Evaluation.

The Guidance consists of two major parts: Concise guidance (Part A to G) and supporting reference guidance (Chapters R.2 to R.20).