ECHA publishes five guidance documents

News Alert
ECHA/NA/10/80
Media enquiries: ECHA Press

Helsinki, 16 December 2010 - ECHA has issued an update of the Guidance on Information Requirements and Chemical Safety Assessment (Chapters R.8, R.18 and R.5) as well as an update of the Guidance on Intermediates. Companies are invited to consider the need to update their registrations dossiers in line with this guidance. A new Guidance on the Communication of Information on the Risks and Safe Use of Chemicals was also published.

Chapter R.8 "Characterisation of dose [concentration]-response for human health"

Derived No Effect Levels (DNELs) and Derived Minimal Effect Levels (DMELs) are used in the assessment of risks to humans. The update of this Guidance provides additional information on how to establish a DNEL or a DMEL from human data. It deals with the specificities of human data when used as the starting point for the derivation of DNEL/DMEL and explains in detail how to evaluate the data, extract the dose descriptors and derive the DNEL/DMEL where relevant human studies are used. The updated Guidance also presents the criteria to be applied when human and animal data are available for the same endpoint and exposure pattern.

Chapter R.18 "Exposure scenario building and environmental release estimation for the waste life stage"

This guidance explains how an environmental release assessment for the waste life stage can be carried out, and which information on waste treatment should be communicated down the supply chain. The guidance includes workflows on how to structure information on the waste life stage of a substance and on how to calculate release rates in order to show that risks from the waste life cycle stage are controlled. It proposes default values for the parameters determining the release assessment such as the fractions of a substance becoming waste at the different life cycle stages and default release factors. It also explains possibilities and limits for refining such values.

The update provides more practical and detailed advice on how to carry out the assessment of the waste stage where required; on the estimation of releases; and on the derivation of conclusions on suitable waste treatments. The document has also been aligned with recent updates of other guidance documents (e.g. Environmental Exposure Estimation).

Chapter R.5 "Adaptation of information requirements"

The update reflects the revision of the general rules for adapting the testing regime to the REACH Regulation regarding substance-tailored exposure-driven testing. Under certain conditions testing according to the information requirements listed in some of the Annexes may be omitted, based on exposure scenarios developed in the Chemical Safety Report. The guidance explains how this can be justified. Additionally, the terminology concerning 'exposure based adaptation' was reviewed and streamlined throughout the guidance.

Guidance on intermediates

This update explains various parts of REACH related to strictly controlled conditions and the definition of intermediates. A "light" registration is required for certain isolated intermediates as long as they are being manufactured under strictly controlled conditions. It explains what strictly controlled conditions means, clarifies the principles of rigorous containment and minimisation of exposure and describes the role of personal protection equipment within the concept of strictly controlled conditions. Illustrative examples are provided. The guidance also includes a format for providing information on risk management measures in a registration dossier and the definition of intermediates as agreed by the European Commission, Member States and ECHA on 4 May 2010.

Guidance on the communication of information on the risks and safe use of chemicals

This new guidance is intended to be used mainly by Member State Competent Authorities in communicating about the risks of chemicals, specifically in the context of the REACH Regulation. Member State Competent Authorities are required under Article 123 of REACH to inform the general public about the risks arising from substances where this is considered necessary for the protection of human health or the environment.