REACH Update: Establishing REACH Penalties

By: Annelie Struessmann, PhD, CONUSBAT

Posted: April 7, 2009

Article 126 of the REACH regulation requests that EU member states establish penalties for infringements of REACH and ensure their implementation. The deadline for identification and implementation was Dec. 1, 2008, and a European Chemicals Agency (ECHA) press release dated Dec. 8, 2008, reported that not all member states had yet finalized their penalty legislation.

In response, the ECHA has provided a "Forum for Exchange of Information on Enforcement"—a general strategy to be used by member states as a framework for developing their individual penalties. This forum is a body of ECHA that is responsible for coordinating the enforcement of REACH in the EU and the European Economy Area (EEA) member states; its specific tasks are set forth in Article 77(4) of the REACH regulation. The forum’s strategy document is expected to be published on the ECHA Web site but is not yet available.

First, the forum agreed to focus on preregistration, registration and safety data sheets for phase-in substances. The targeted groups for inspection will include manufacturers, importers and only representatives appointed by non-EU manufacturers. The project will be carried out by more than 20 members states, Norway and Iceland. The need for a second coordinated enforcement effort is projected for 2010 and in addition, the forum has agreed to continue its coordination activities by developing minimum criteria for REACH inspections.

In the ECHA's newsletter from January/February 2009, the group notes the first enforcement project will begin soon and expects  results for March 2010. The minimum criteria for REACH inspection will be developed by the end of 2009 mainly to ensure that inspectors in all member and EEA states are taking similar criteria into account. A special information system will be established to alert inspectors in the different states regarding cases of non-compliance. Article 126 of REACH maintains that penalties implemented by the member states must be effective, proportionate and dissuasive.

Meanwhile, the largest countries in Europe have either determined or published their enforcement rules. Germany published its "REACH Anpassungsgesetz" in May 2008, defining all authorities responsible for implementing and controlling the provisions of REACH. Rules for penalties are included, such as: two years in prison or a monetary penalty for incomplete or inaccurate registration dossiers or chemical safety reports (CSR); five years in prison or a monetary penalty if the life or health of an individual was endangered by the infringement, or if goods of substantial value belonging to others were jeopardized; and a fine up to €100,000 if the damage was caused by negligence.