Monday, May 16, 2011

ECHA Says Vast Majority of Intermediate Registrations Under REACH Do NOT Meet Requirements

In a rather stunning announcement, the European Chemicals Agency (ECHA) has issued a news release saying that the vast majority - 86% of the over 400 registration dossiers for intermediates screened - "seem not to contain sufficient information to demonstrate that these conditions are fulfilled."  Intermediates are substances that are manufactured for use in manufacturing other substances (and meet the definitions stipulated by REACH Article 3(15)), and that are manufactured and/or used under "strictly controlled conditions."  As intermediates they benefit significantly from reduced data requirements for registration.

ECHA is encouraging registrants of intermediates "to proactively reassess and, where necessary, update their registration dossiers."  If ECHA concludes that the dossier provided based on the intermediate requirements is insufficient, they may require "that a standard dossier be prepared instead."  Standard dossier data requirements will depend on the tonnage band of the production, but generally will include significantly more data - and more expensive data - then the intermediates dossier.

In order to demonstrate that a substance’s use fulfils the criteria of an isolated intermediate, a registrant should provide information on the identity of the transformation products resulting from the use of the substance and/or information on the manufacturing processes related to the registered substances. The registration dossier for an intermediate shall also include sufficiently detailed information on the risk management measures describing how strictly controlled conditions are ensured, including a description of the technical means used to rigorously contain the substance. This will enable ECHA to verify the intermediate status. 

ECHA says that it has "already communicated with registrants of a number of intermediate dossiers on missing or doubtful information, by inviting them to update the dossiers."  But they also are encouraging other registrants to reassess their dossiers and document that they are taking steps to provide any needed updates so that "that documentation can then be shown to inspectors on demand."

The ECHA announcement can be read here.

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