The EU Commission has just set new approval criteria for low risk active substances, amending Annex II Point 5 of Regulation (EC) 1107/2009. These new criteria entered into force on 28 August 2017 (Regulation (EU) 2017/1432).
Two categories are introduced (active substances other than micro-organisms and micro-organisms) and the criteria are clarified.
A major benefit for active substances identified as low risk is that they are approved for 15 years instead of the normal 10 years for first approval. As a result, the maximum authorisation period for products based on these substances are also longer: up to 15 years. In addition, longer data protection up to 15 years can be granted accordingly and there are advertising provisions for low-risk products.
Currently, only 10 active substances are officially recognised as low risk active substances in accordance with Regulation (EC) 1107/2009 (Bacillus amyloliquefaciens strain FZB24, Cerevisane, COS-OGA, Ferric phosphate, Isaria fumosorosea Apopka strain 97 (formerly Paecilomyces fumosoroseus), Mild Pepino Mosaic Virus isolate VC 1, Mild Pepino Mosaic Virus isolate VX 1, Pepino mosaic virus strain CH2 isolate 1906, Saccharomyces cerevisiae strain LAS02 and Trichoderma atroviride strain SC1).
To download: Commission Regulation (EU) 2017/1432 of 7 August 2017 amending Regulation (EC) No 1107/2009 of the European Parliament and the Council concerning the placing of plant protection products on the market as regards the criteria for the approval of low-risk active substances
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