ECHA Clarifies the Definition of Intermediates
In a June 1, 2010, press release, the European Chemicals Agency (ECHA) announced that Member States have alerted ECHA and the European Commission (EC) “to industry positions on intermediates, which appear not to be in line with the definition of intermediates in [the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) legislation] and the guidance on intermediates.” The purpose of the guidance document, agreed among all authorities, is to explain to industry when a chemical substance can be solely registered as an intermediate and when a standard registration is required. ECHA’s press release is available online.
The Definitions Document
Based on interpretation issues, ECHA has published additional guidance, Definition of intermediates as agreed by Commission, Member States and ECHA on 4 May 2010. This document reiterates that an intermediate is a substance used in the manufacturing of another substance whereby the intermediate is itself transformed into that other substance. It also clarifies that substances used in the production of articles cannot be regarded as intermediates. The document contains a number of examples intended to help industry in determining whether their substances are intermediates. According to ECHA, the definition “is coherent with the approach taken on intermediates under the previous European chemicals legislation.” The definitions document is available online.
The document includes specific examples of what are and are not intermediates, as defined by REACH, in the following categories: substances used as reactants; substances used as catalysts; substances used as processing agents; intermediates and substances in mixtures; substances used as curing agents; substances used as surface treating agents; and substances used as desiccants.
The document was agreed between the EC, ECHA, and the Member State Competent Authorities. It will be reflected in an update of the guidance on intermediates, which is in process and planned for publication after November 30, 2010.
The EC, industry stakeholders, and ECHA have in the context of the Directors’ Contact Group identified practical solutions for companies facing difficulties for the first registration deadline, which includes companies having to register intermediates or that have already incorrectly registered substances as intermediates. These solutions have yet to be placed in the public domain.
According to the definitions document, a substance is an intermediate if the following conditions are met: the substance is manufactured to be itself converted into another substance on an industrial site; and the outcome of the chemical processing is another manufactured substance on its own but not another substance in an article.