Legal pitfalls of CRM production and distribution

The huge market of commercially traded chemical substances and their subsequent deliberate or accidental diffusion into the environment has triggered an increase in environmentally related legislation regarding chemical substances. In this context, laboratories require suitable calibration standards and matrix certified reference materials (CRMs) for method development, validation and quality control in order to survey related threshold and limit values. Unfortunately, CRMs are subject to the same technical trade barriers as they should help to overcome. Similar problems exist when the production of a CRM touches intellectual property rights (IPR), e.g. in case of GMOs, or when regionally banned veterinary drugs have to be monitored. Another often under-estimated problem is the liability and legal responsibility of the CRM-producer. This paper discusses different aspects of these legal pitfalls and suggests some approaches to overcome these difficulties.Presented at BERM-9, the 9th International Symposium on Biological and Environmental Reference Materials, 15–19 June 2003, Berlin, Germany