The development of biobased products like plant protection products, pharmaceutical or other natural platform chemicals, or biotechnological techniques can be divided into three phases: (1) invention and research resulting in at least a proof of principle. (2) Development of a prototype / product, which can extensively be tested and would be ready for market. (3) Market release and commercial product. While the first two phases are covered within the different BioSC projects, the step from a prototype to registered / approved product within the EU or Germany is still the bottleneck in developing a value chain. The authorization of plant protection products is lined out in Regulation EC 1107/2009. For chemicals Regulation EC 1907/2006 (REACH) is setting the legal frame Registration, Evaluation, Authorization and Restrictions of chemicals.
During the past years in almost every BioSC project (SEED- and BOOST-project) new product ideas were developed. And more important, in the running FocusLabs innovative approaches are made from which new techniques and products for the bioeconomy will be developed. The proposed White Paper should make first an inventory of the different products which have already been developed or are in the pipeline. Based on this inventory, the different products should be categorized in groups with similar requirements for regulation. For each group a authorization strategy will be developed which then can be applied to single products. In close cooperation with BioSC core groups / projects an assessment will be made and which strategy could be followed for authorization. All steps (WP1 – WP3) will be accompanied by external experts in regulatory affairs (WP4), so that important issues can be addressed.
The final aim is to provide the BioSC core groups with a strategy for regulatory affairs, giving them information on data requirements, regulations to follow, or studies which would be necessary.
Dr. Thorsten Kraska & Prof. Dr. Ralf Pude, Renewable Resources, University of Bonn
01.11.2019 - 29.02.2020
RegAff is is part of the NRW-Strategieprojekt BioSC and thus funded by the Ministry of Culture and Science of the German State of North Rhine-Westphalia.