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Point 5 of Annex II to Regulation (EC) No 1107/2009 is replaced by the following:
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;
it has been identified as priority substance under Directive 2000/60/EC;
it is deemed to be an endocrine disruptor;
it has neurotoxic or immunotoxic effects.
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.