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ANNEXU.K.

Point 5 of Annex II to Regulation (EC) No 1107/2009 is replaced by the following:

5.Low-risk active substances

5.1.Active substances other than micro-organisms

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.Micro-organisms

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.