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Annex

United Kingdom

Original text. Later amendments are not shown.

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:

  1. (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;

  2. (b)

    it has been identified as priority substance under Directive 2000/60/EC;

  3. (c)

    it is deemed to be an endocrine disruptor;

  4. (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.’