(1)

Regulation (EC) No 1107/2009 aims at facilitating the placing on the market of plant protection products containing low-risk active substances by setting criteria for identification of low-risk active substances and accelerating the authorisation procedure for low-risk products.

(2)

Directive 2009/128/EC of the European Parliament and of the Council (2) promotes integrated pest management with priority for the use of plant protection products and other non-chemical techniques having the least side effects on human health, non-target organisms and the environment. In particular, its Article 12 provides for use of low-risk plant protection products to be considered in the first place in case of use of plant protection products in certain specific areas such as those used by the general public.

(3)

In accordance with Article 22 of Regulation (EC) No 1107/2009, point 5 of Annex II to that Regulation applies to the identification of low-risk active substances complying with the criteria of Article 4 of that Regulation.

(4)

Point 5 of Annex II refers to a number of hazard categories laid down in Regulation (EC) No 1272/2008 of the European Parliament and of the Council (3). For the sake of clarity and to reflect the contemporaneous application of that Regulation, it is appropriate to provide more details as regards those hazard categories.

(5)

In accordance with Article 16 of Directive 2000/60/EC of the European Parliament and of the Council (4), substances presenting a significant risk to or via the aquatic environment are defined as priority substances at Union level and listed in Annex X to that Directive. Therefore such listed priority substances should not be considered as low-risk active substances.

(6)

The criteria pertaining to persistence and bioconcentration, in light of current scientific and technical knowledge, could prevent approval as low-risk substances, of certain naturally occurring substances presenting considerably less of a risk than other active substances, such as certain botanicals or minerals. It is therefore appropriate to allow for the approval of such substances as being of low-risk, in cases where they comply with Article 22 of Regulation (EC) No 1107/2009.

(7)

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 (5). In light of current scientific and technical knowledge it is also appropriate to provide that semio-chemicals should be considered as low-risk substances.

(8)

Active substances in the meaning of Article 2 of Regulation (EC) No 1107/2009 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.

(9)

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 283/2013 (6). Consequently, micro-organisms 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 antimicrobials used in human or veterinary medicine.

(10)

It should be clearly indicated that baculoviruses which are a host-specific family of viruses infecting exclusively arthropods and occurring predominantly in the insect 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 (7). A baculovirus should be considered of low-risk unless at strain level it has demonstrated adverse effects on non-target insects.

(11)

Point 5 of the Annex II to Regulation (EC) No 1107/2009 should therefore be amended accordingly.

(12)

The amended criteria reflect the current state of scientific and technical knowledge and clarify the existing criteria in point 5. The new criteria should therefore apply as soon as possible, except where the relevant Committee has voted on the draft Regulation presented to it without that Regulation having been adopted by the Commission by 28 August 2017.

(13)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,