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Objective and rationale, including the nature of urgent problems
where applicable: Active substances must be approved before they can
be used in plant protection products. Assimilated Regulation No. 1107/2009
(concerning the placing of plant protection products on the market, "the
Regulation") lays down criteria for approval in Art. 4 and Annex II.
These criteria must be satisfied in order to protect human health, animal
health, and the environment.
In light of new scientific and technical evidence, concern was raised
that indoxacarb may no longer satisfy the criteria for approval in GB
provided for in Article 4 of the Regulation. The competent authority
undertook a review of the GB approval of indoxacarb under Article 21(1) of
the Regulation. The review considered the impact of new toxicological
reference values on dietary and non-dietary risks to human health (i.e., Art
4(2)(a) and Art. 4(3)(b) of the Regulation).
The review found that non-dietary exposure for representative uses
was above acceptable limits for operators in oilseed rape, brassicas and pome
fruit; for workers in brassicas, pome fruit and protected cucurbits and
fruiting vegetables; and for residents and bystanders in pome fruit.
The competent authority concluded that indoxacarb failed to meet the
approval criteria provided for in Article 4 of the Regulation and, in
accordance with Article 21(5)(b), the decision was taken to withdraw the
approval of the active substance Indoxacarb in GB.
Existing GB authorisations for sale and supply of plant protection
products containing indoxacarb will be withdrawn six months after withdrawal
of the active substance approval. In accordance with Article 21(7) of
Assimilated Regulation No. 1107/2009, a grace period for storage, disposal
and use of those products will expire 12 months later.; Protection of human
health or safety; Protection of animal or plant life or health; Protection of
the environment
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