The data requirements and the administrative procedure needed for the registration of biological plant protection products and their active ingredients (micro-organisms including viruses, plant extracts, and semiochemicals) are described for the European Union, the USA, Canada and Australia and compared between these systems. Experiences from registration procedures are compared. While data requirements and formalities are rather similar in all systems considered, the time span needed for evaluation and the possibility to predict this time span are quite different. Alternative regulatory measures existing in different regulatory systems are described and initiatives for the facilitation are presented.
- Member State
- Data Requirement
- European Food Safety Authority
- Plant Protection Product
- National Registration
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DG Sanco is the Health and Consumer Protection Directorate General
Currently, the list includes the following substances: castor oil, cedar oil, cinnamon and cinnamon oil, citric acid, citronella and citronella oil, cloves and clove oil, corn gluten meal, corn oil, cottonseed oil, dried blood, eugenol, garlic and garlic oil, geraniol, gernanium oil, lauryl sulfate, lemongrass oil, linseed oil, malic acid, mint and mint oil, peppermint and peppermint oil, 2-phenethyl propionate (2-phenylethyl propionate), potassium sorbate, putrescent whole egg solids, rosemary and rosemary oil, sesame (includes ground sesame, plant) and sesame oil, sodium chloride (common salt), sodium lauryl sulfate, soybean oil, thyme and thyme oil, white pepper and zinc metal strips.
We warmly thank A. Fjelsted (Danish EPA), William R. Schneider (US EPA), M. Busschers and J. Meeussen (Board for the Authorization of Pesticides; The Netherlands) and Herbert Köpp (BVL, Germany) for their comments.
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Hauschild, R., Speiser, B., Tamm, L. (2011). Regulation According to EU Directive 91/414: Data Requirements and Procedure Compared with Regulation Practice in Other OECD Countries. In: Ehlers, RU. (eds) Regulation of Biological Control Agents. Springer, Dordrecht. https://doi.org/10.1007/978-90-481-3664-3_2
Publisher Name: Springer, Dordrecht
Print ISBN: 978-90-481-3663-6
Online ISBN: 978-90-481-3664-3
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