Dextra's Magazine September 2017 Dextra Magazine September 2017 | Page 22

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:

•The hazard classification has been updated, providing more detailed definition of toxicological criteria and establishing new points in regards to the toxicity to aquatic organisms or sensitizing properties, for instance.

•Semio-chemicals are described as active substances emitted by plants, animals and other organisms for intra- and inter-species

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.

•Naturally occurring active substances with no hazard classification and not identified as priority substances under Directive 2000/60/EC, as endocrine disruptor or as neurotoxic or immunotoxic, are considered as low risk even if they are persistent (half-life in soil of more than 60 days) or their bio-concentration factor is higher than 100.

•Micro-organisms are excluded from the restrictions set in point 5 of Annex II and therefore are considered as low-risk active unless at strain level it has demonstrated multiple resistance to anti-microbials used in human or veterinary medicine.

•Finally, Baculoviruses are also considered as low-risk substances unless at strain level they have demonstrated adverse effects on non-target insects. According to the new Regulation, Baculoviruses are host-specific family of viruses for which there is no scientific evidence that have any adverse effect on animals or humans.

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.