NEW REGULATION
Regulation (EU) 2017/1432
"Low Risk Active Substances"
A major benefit for active substances identified as low risk is its approval for 15 years for first approval - instead of the normal 10 years -.
This extension results in a longer authorization period for products based on these substances as well, 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.
However, under the Regulation EC 1107/2009 only 10 active substances have been officially acknowledged as low risk active substances: 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.
The new Commission Regulation (EU) 2017/1432, published on 7 August 2017 and under application from 28 August 2017, amends Regulation (EC) No 1107/2009, and specifically point 5 of Annex II, i.e. the criteria for low risk substances classification.
The main changes established in the new Regulation, are described below:
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communication and considered to have a target-specific and non-toxic mode of action and to be effective at very low rates.
According to the new Regulation, semio-chemicals are classified as low-risk chemicals where they don't correspond to any of the categories listed in points 1 to 6.
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With this new Regulation, the European Parliament and Council have tried to use the current scientific and technical knowledge to promote the use of active substances with lower risks by establishing clearer and updated indications for companies to determine whether an active substance can be classified as low risk or not.