On May 9, 2011, two EU environmental groups, the International Chemical Secretariat (ChemSec) and ClientEarth, announced that they had initiated a lawsuit against the European Chemicals Agency (ECHA). The groups filed the lawsuit in the General Court of the EU with the goal of forcing ECHA to publicly disclose the names of companies manufacturing or importing chemicals currently listed on ChemSec’s so-called “Substitute It Now!” list or “SIN List.” The groups also seek volume information. ChemSec and ClientEarth want the names and volume information so that they can pressure ECHA and the companies to substitute the chemicals for ones that supposedly are “safer.” The groups submitted their initial request on December 1, 2010, and after a series of escalating and more formal requests, ECHA issued its final denial on March 7, 2011. Now, in response to the lawsuit, ECHA has announced that it will release some of the information. A spokesperson for the groups says that they intend to pursue the case in light of ECHA’s inadequate response. Additional details are set out below.
ECHA received the names and volume information when the companies submitted their registration dossiers in partial fulfillment of their obligations under the regulation, “Registration, Evaluation, Authorisation, and Restriction of Chemicals” (REACh). For readers less familiar with the regulation of chemicals, REACh is the primary EU chemical control law. It applies to most chemicals, except for those used in pharmaceuticals, pesticides, or other products regulated under different EU laws. Companies that manufacture or import nonexempt chemicals in the EU above 1 metric ton per year are required to submit a registration dossier to ECHA. The dossier includes certain data and other information about the chemical, its uses, as well as the manufacturer or importer. ECHA and the EU countries (called Member States) review the dossier to decide whether a chemical should be banned or its use limited through the so-called restriction or authorization processes established under REACh. Additional testing or other information may also be requested.
The SIN List is an inventory of chemicals that ChemSec developed. Chemicals on the list purportedly meet the criteria established under REACh for identifying Substances of Very High Concern (SVHC). SVHCs are those chemicals that may be especially harmful to human health or the environment and thus may be considered for the REACH authorization process, which expressly contemplates substitution of such chemicals for those that are “safer.”
The lawsuit is currently pending before the General Court of the European Union. The General Court handles cases filed by private individuals, companies and some organizations, and cases relating to competition law (antitrust for American readers). The General Court provides the first level of judicial review. Afterwards, a case can be appealed to the European Court of Justice. The Court of Justice interprets EU law to ensure the law is applied consistently in all EU countries. The Court of Justice also settles legal disputes between EU governments and EU institutions. Individuals, companies, or organizations can also bring cases before the Court if they feel their rights have been infringed by an EU institution. The Court of Justice has one judge per EU country.
A copy of the legal compliant, called an Application for Annulment, is available here. In it, ChemSec and ClientEarth include numerous allegations challenging the substantive basis and procedures ECHA used in delaying its response and ultimately denying the groups’ request. A discussion of the legal principles set out in the complaint and an evaluation of the merits of the allegations are beyond the scope of this post. However, they may be reviewed more closely in a subsequent post.
In response to the lawsuit, ECHA announced on May 11, 2011, that it will begin to publish certain information from the registration dossier contained in the safety data sheet (SDS), including company names. In addition to the company’s name, ECHA said that it will also make further elements contained in the SDS publicly available such as the REACH registration number and whether the substance meets some of the SVHC criteria. However, ECHA noted that companies will be able to keep the information confidential, provided that a valid justification is given and accepted by ECHA. According to the agency, providing this information will require significant revisions to ECHA’s databases so it is currently unable to commit to releasing the information in the immediate future. ChemSec and ClientEarth have stated publicly that they find ECHA’s response inadequate and plan to proceed with their lawsuit.