However, the rules on classification and labelling themselves are provided elsewhere. Determination of Predicted No-effect-Effect levels (PNEC) in Chapter R.10 and the corresponding chapters of integrated testing strategies for the environment endpoints (Sections R.7.8 to R.7.11 in Chapter R.7b and R.7c).These sections in Chapter R.7 also include information on how to derive appropriate information for classification and labelling of the substance.See current Annex VI to Directive 67/548 and future Guidance on Classification, Packaging and Labelling related to the future GHS system. However, the guidance on classification and labelling itself is provided elsewhere. These Sections in Chapter R.7 also include information on how to derive appropriate information for classification and labelling of the substance. Determination of Derived No-Effect-Levels (DNEL) (or other qualitative or semi-quantitative measures of potency of the substance) in Chapter R.8 and the corresponding chapters of integrated testing strategies for the relevant human health endpoints (Sections R 7.2 to R.7.7 in Chapter 7a).Physico-chemical properties in Section R.7.1.Each of the sections in Part B corresponds to the more in-depth guidance contained in Chapters R.2 to R.10. Part B also provides concise guidance on how to characterise hazards, including where possible derivation of DNELs and PNECs. This covers information requirements on intrinsic properties of a substance under REACH, including information gathering, non-testing approaches and the so-called 'integrated testing strategies' for generating the relevant and required information on each endpoint. Part B contains concise guidance on hazard assessment. Structure of the Guidance on Information Requirements and Chemical Safety Assessment It also describes the process of chemical safety assessment additionally required for substances produced/imported in amounts of more than 10t per year.įigure 3 below illustrates to which steps in the overall process a particular guidance element is related.įigure 3: Relationship between the process steps and the guidance elements The links between the concise guidance and the supporting reference guidance are illustrated in Figure 1.įigure 2: Overall process related to information requirements and chemicals safety assessment under REACH.įigure 2 above presents an overview of the overall process of collecting and assessing existing information on the intrinsic properties of a substance, including identification of needs to generate new data. The purpose of the reference guidance is to provide in-depth scientific and technical advice. This includes information collection processes, communication processes and assessment processes. The purpose of the concise guidance is to support the processes needed to meet the information requirements on intrinsic properties of substances to be registered, and where relevant to carry out a chemicals safety assessment. The Guidance consists of two major parts: Concise guidance (Part A to F) and supporting reference guidance (Chapters R.2 to R.20). 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. It also sets out the basic principles for authorities preparing a risk assessment. 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. The Guidance also aims to assist industry in conducting Chemical Safety Assessments and preparing Chemical Safety Reports, when required.
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