means the person who manufactures the active substance himself or who contracts out the manufacturing to another party or a person designated by the manufacturer as his sole representative for the purpose of compliance with this Regulation.
eu/reg/2011/188
Key facts
Type
Regulation · Commission Regulation (EU) No 188/2011 · EEA relevant
1.The Commission shall, at the latest 6 months after receipt of the conclusion of the Authority, submit to the Standing Committee on the Food Chain and Animal Health, hereinafter ‘the Committee’, a draft review report to be finalised at its meeting.The applicant shall be given the possibility to submit comments on the draft review report within a period, of up to 30 days, set by the Commission.
2.On the basis of the draft review report and taking into account any comments submitted by the applicant within the period set by the Commission in accordance with paragraph 1, an act shall be adopted in accordance with the procedure referred to in Article 19(2) of Directive 91/414/EEC, providing that:
(a)an active substance is included in Annex I to Directive 91/414/EEC subject to conditions and restrictions, where appropriate;
(b)an active substance is not included in Annex I to that Directive.