ANNEX IIU.K.Procedure and criteria for the approval of active substances, safeners and synergists pursuant to Chapter II

2.General decision-making criteriaU.K.

2.1.Article 4 shall only be considered as complied with, where, on the basis of the dossier submitted, authorisation [F1by at least one competent authority] is expected to be possible for at least one plant protection product containing that active substance for at least one of the representative uses.U.K.

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2.2.Submission of further informationU.K.

In principle an active substance, safener or synergist shall only be approved where a complete dossier is submitted.

In exceptional cases an active substance, safener or synergist may be approved even though certain information is still to be submitted where:

(a)

the data requirements have been amended or refined after the submission of the dossier; or

(b)

the information is considered to be confirmatory in nature, as required to increase confidence in the decision.

2.3.Restrictions on approvalU.K.

Where necessary, the approval may be subject to conditions and restrictions as referred to in [F2Article 6(1)].

Where the [F3assessing competent authority] considers that the dossier provided lacks certain information, to the effect that the active substance could only be approved subject to restrictions, it shall contact the applicant at an early stage to obtain more information which may possibly enable these restrictions to be removed.

Textual Amendments