For laboratories: EU decisions worth knowing

For example, Commission Decision 2005/174/EC of 28 February 2005 establishing guidelines to supplement Annex II, Part B, to Directive 90/219/EEC. Annex II, Part B, to Directive 90/219/EEC sets out the criteria that must be met with regard to the safety of genetically modified organisms for human health and the environment. The Commission Decision is addressed to the Member States and contains decision-making guidelines in the annex. These guidelines include general criteria for describing organisms and specific criteria, such as pathology or toxicity.
Commission Decision 2000/608/EC of September 27, 2000, on guidelines for risk assessment pursuant to Annex III to Directive 90/219/EEC is also relevant for laboratory operations. It contains criteria for risk assessment, such as procedures for determining potentially harmful properties (hazards) of a GMO and the preliminary classification of the GMO into classes. A second procedure determines the final classification and the containment measures required for the activity.
Even though decisions of the European Commission are primarily directed at the Member States, and project managers, operators, and BBS at the facilities can assume that the legislature has properly implemented the requirements of European law into the Genetic Engineering Act and the Genetic Engineering Safety Ordinance, it may nevertheless be helpful to occasionally review the Commission's decisions. This is particularly true when a question is not explicitly regulated in national regulations. Therefore, an interpretation of national laws that conforms to European law always requires consideration of European law.

This publication can also be found on the website of the law firm Dr. Kauch .