How to Make Valid Confidentiality Claims under EU's REACH Law
This post was written by David Wagner.
On July 30, the European Chemicals Agency (ECHA) released a new guidance manual that gives step-by-step instructions on how to make confidentiality claims for chemical information in a REACH registration dossier. This includes how to make confidentiality claims for chemical names and the estimates of the amount produced. The manual also outlines the procedure that ECHA will follow to assess a registrant’s confidentiality claims and to potentially reject them by formal decisions, as well as the appeal procedure for rejected claims.
The manual explains that, in certain circumstances the International Union of Pure and Applied Chemistry chemical name can be claimed as confidential but registrants who take this approach must provide a “public name” for the chemical. ECHA broadly explains that the public name should disclose a maximum amount of information on the chemical structure of the substance, while protecting those features of the chemical structure that are considered confidential and the disclosure of which would potentially harm the registrant. If you are not clear about what that means, stay tuned. ECHA stated that it is analyzing various naming systems and plans to issue a practical guide on how to derive a “public name”.
Keep in mind that, by November 30, 2010, REACH registration dossiers must be submitted for substances manufactured in, or imported into, the EU in volumes of 1,000 metric tons or more per year, and for some hazardous substances at lower volumes.
