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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 and animal health,
and the environment.
In light of new scientific and technical evidence, the competent
authority considered that Famoxadone may no longer satisfy the criteria for
approval provided for in Art. 4 of the Regulation. The competent authority
therefore undertook a review of the GB approval of Famoxadone under Article
21(1) of the Regulation.
The review considered human health concerns for non-dietary exposure
(i.e., Art. 4(3)(b) of the Regulation) and the high risk to mammals and
aquatic organisms, as well as the unresolved risk to birds (i.e., Art.
4(3)(e) of the Regulation).
The competent authority concluded that Famoxadone failed to meet the
approval criteria provided for in Art. 4 of the Regulation and, in accordance
with Art. 21(5)(b), decided to withdraw approval in GB.
Existing authorisations for sale and supply of plant protection
products containing Famoxadone in GB will be withdrawn six months after
withdrawal of the active substance approval. In accordance with Art. 21(7) of
Assimilated Regulation No. 1107/2009, a grace period for storage, disposal
and use of those products will expire twelve months later.; Protection of
human health or safety; Protection of animal or plant life or health;
Protection of the environment
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