Earlier this month, the Environmental Law Resource addressed how to make valid confidentiality claims for chemical information in a REACH registration dossier, and reminded readers that the first wave of REACH registration dossiers must be submitted by November 30, 2010. In particular, the November 30 deadline applies to substances that are manufactured in or imported into the EU in volumes of 1 metric ton or more annually and to certain compounds that are particularly hazardous to human health or the aquatic environment. However, upcoming confidentiality issues and deadlines related to chemicals in the EU are not limited to REACH; there are also similar issues for chemicals under the EU’s Regulation on the Classification, Labeling and Packaging of Substances and Mixtures (CLP Regulation).
First, some background on the CLP Regulation. It introduces the United Nations’ globally harmonized system for classification and labeling of chemicals into Europe. It also requires, by January 3, 2011, companies that manufacture, import, use, or distribute chemical substances or mixtures to notify the European Chemicals Agency about the classifications of and labels for any substance or mixture, regardless of its annual tonnage, before they place it on the European Union’s market. For each substance, information on the classification and labelling will be published.
The link between REACH and the CLP regulation is that both contain hazard communication tools: the CLP establishes labeling rules and REACH establishes rules for Safety Data Sheets. Moreover, the CLP Regulation amended some of the Safety Data Sheet requirements in REACH, and these changes will be phased in over the next 5 years.
On August 13, 2010, the European Chemicals Agency issued an alert explaining that companies not required to register by the November 30, 2010 REACH registration deadline but still obligated to notify regulators on the classification and labelling of substances under the CLP Regulation can, in certain cases, keep the substances name confidential.
To restate, regulated entities with substances that are to be registered after the November 30 REACH deadline, but which must still provide the European Chemicals Agency information about their classifications and labels by January 3, 2011, can claim their chemical’s International Union of Pure and Applied Chemistry (IUPAC) name to be confidential under certain circumstances. Specifically, chemical manufacturers, importers, or distributors can do so if their chemical is new to the European market; if it is an intermediate (i.e., used to make other chemicals); if it is used for scientific research and development; or if it is used in product of process research and development.