A new guidance out of Europe provides a pathway toward exempting certain substances from the European Union’s strict controls on toxic chemicals. The document — “Guidance on the Preparation of an Application for Authorization” — appeared in the Jan. 28 edition of the Official Journal of the European Union, a catalog of new laws, regulations and guidances analogous to the Federal Register in the United States.

The massive, 121-page document serves as a step-by-step instruction manual for seeking authorization to use chemicals banned from general use: those identified as Substances of Very High Concern and appearing in Annex XIV of the EU’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulations. Once a chemical is added to Annex XIV, it cannot be used after a certain date by manufacturers, importers or downstream users unless an authorization has been granted for a particular use of that substance.

The guidance comes from the European Commission and is the first to describe the hurdles companies will have in seeking an exemption.The document contains sections on how to file an authorization request, what documents need to go with the application and the steps in the review process itself. It also outlines the process for identifying safer alternatives to Annex XIV substances and converting operations to use the replacement chemicals, one of the primary goals of REACH.

Certain aspects of the process are not addressed by the guidance, as they either are covered by other guidances or because they vary for each chemical. For example, the time it takes between a chemical’s inclusion in Annex XIV and its ban from usage may vary depending on how widespread its use is and how toxic its effects are. The guidance noted that there is no tonnage requirement to seek authorization for a chemical.

For more information, see the next edition of the Community Right-To-Know Manual newsletter.