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EU to amend criteria for the approval of low-risk pesticides
Apr. 28, 2017
The European Commission proposed to amend criteria for identification of low-risk pesticide active substances and accelerating the authorisation procedure for low-risk products.
According to EC, semio-chemicals, which are substances emitted by plants, animals and other organisms which are used for intra and inter-species communication, have a target specific and non-toxic mode of action and are naturally occurring. They are generally effective at very low rates, often comparable to levels that occur naturally. In light of current scientific and technical knowledge it is also appropriate to provide that semiochemicals should be considered as low-risk substances.
Active substances include micro-organisms whose properties differ from those of chemical substances. It is appropriate that the low risk criteria applicable to micro-organisms are provided for based on the current scientific and technical knowledge.
Micro-organisms which are to be included in plant protection products are assessed at strain level in conformity with specific data requirements laid down in part B of the Annex to Commission Regulation (EU) No 283/20136. Consequently, microorganisms should be identified and characterised at strain level also when assessed for compliance with the criteria concerning low-risk substances as toxicological properties of different strains belonging to the same species of micro-organism can vary greatly. A micro-organism may be considered to be of low-risk unless at strain level it has demonstrated multiple resistance to anti-microbials used in human or veterinary medicine.
It should be clearly indicated that baculoviruses which are a host specific family of virus infecting exclusively arthropods and occurring predominantly in the insects order of Lepidoptera, are to be considered as low-risk substances as there is no scientific evidence that baculoviruses have any negative effect on animals and humans. A baculovirus should be considered of low-risk unless at strain level it has demonstrated adverse effects on non-target insects.
This Regulation shall be binding in its entirety and directly applicable in all Member States and enter into force on the twentieth day following that of its publication in the Official Journal of the European Union on April 24.
Source: European Commission
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