
Article 1 
Annex II to Regulation (EC) No 1107/2009 is amended in accordance with the Annex to this Regulation.
Article 2 
Point 5 of Annex II to Regulation (EC) No 1107/2009, as amended by the present Regulation, shall apply as of 28 August 2017, except for procedures where the Committee has voted on the draft Regulation presented to it without that draft Regulation having been adopted by 28 August 2017.
Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 7 August 2017.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX

Point 5 of Annex II to Regulation (EC) No 1107/2009 is replaced by the following:
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5.  5.1.  5.1.1. An active substance, other than a micro-organism, shall not be considered as being of low-risk where it corresponds to any of the following:

((a)) it is or has to be classified in accordance with Regulation (EC) No 1272/2008 as any of the following:

— carcinogenic category 1A, 1B or 2,
— mutagenic category 1A, 1B or 2,
— toxic to reproduction category 1A, 1B or 2,
— skin sensitiser category 1,
— serious damage to eye category 1,
— respiratory sensitiser category 1,
— acute toxicity category 1, 2 or 3,
— specific Target Organ Toxicant, category 1 or 2,
— toxic to aquatic life of acute and chronic category 1 on the basis of appropriate standard tests,
— explosive,
— skin corrosive, category 1A, 1B or 1C;
((b)) it has been identified as priority substance under Directive 2000/60/EC;
((c)) it is deemed to be an endocrine disruptor;
((d)) it has neurotoxic or immunotoxic effects.
 5.1.2. An active substance, other than a micro-organism, shall not be considered as being of low-risk where it is persistent (half-life in soil is more than 60 days) or its bio-concentration factor is higher than 100.
However, a naturally occurring active substance which does not correspond to any of points (a) to (d) of point 5.1.1 may be considered as being of low-risk, even if it is persistent (half-life in soil is more than 60 days) or its bio-concentration factor is higher than 100.
 5.1.3. An active substance, other than a micro-organism, emitted and used by plants, animals and other organisms for communication, shall be considered as being of low- risk where it does not correspond to any of points (a) to (d) of point 5.1.1.
 5.2.  5.2.1. An active substance which is a micro-organism may be considered as being of low-risk unless at strain level it has demonstrated multiple resistance to anti-microbials used in human or veterinary medicine.
 5.2.2. Baculoviruses shall be considered as being of low-risk unless at strain level they have demonstrated adverse effects on non-target insects.
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