2.

The Authority, where appropriate shall organise a consultation of experts, including experts from the rapporteur Member State. Within 120 days of the end of the period provided for the submission of written comments, the Authority shall adopt a conclusion in the light of current scientific and technical knowledge using guidance documents available at the time of application on whether the active substance can be expected to meet the approval criteria provided for in Article 4 and shall communicate it to the applicant, the Member States and the Commission and shall make it available to the public. In the event of a consultation as provided for in this paragraph, the 120-day period shall be extended by 30 days. Where appropriate, the Authority shall address in its conclusion the risk mitigation options identified in the draft assessment report.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.