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Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny — Part Four
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Regulation (EC) No 596/2009 of the European Parliament and of the Council, Division 5.9. is up to date with all changes known to be in force on or before 26 April 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
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As regards Regulation (EC) No 178/2002, the Commission should be empowered in particular to adopt provisions relating to the number and names of the Scientific Panels, the rules of procedure for submitting a request for an opinion to the Authority and the criteria for inclusion of an institute on the list of competent organisations designated by the Member States. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 178/2002, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Accordingly, Regulation (EC) No 178/2002 is hereby amended as follows:
the second subparagraph of Article 28(4) shall be replaced by the following:
‘The number and names of the Scientific Panels may be adapted in the light of technical and scientific development by the Commission, at the Authority’s request. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 58(3).’;
Article 29(6) shall be replaced by the following:
‘6.The implementing rules for the application of this Article shall be established by the Commission after consulting the Authority. Those rules shall specify in particular:
(a)the procedure to be applied by the Authority to the requests referred to it;
(b)the guidelines governing the scientific evaluation of substances, products or processes which are subject under Community legislation to a system of prior authorisation or entry on a positive list, in particular where Community legislation makes provision for, or authorises, a dossier to be presented for this purpose by the applicant.
The measure referred to in point (a), designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 58(3).
The guidelines referred to in point (b) shall be adopted in accordance with the regulatory procedure referred to in Article 58(2).’;
Article 36(3) shall be replaced by the following:
‘3.The Commission, after consulting the Authority, shall lay down rules establishing the criteria for inclusion of an institute on the list of competent organisations designated by the Member States, arrangements for setting out harmonised quality requirements and the financial rules governing any financial support. Those measures, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 58(3).
Other implementing rules for the application of paragraphs 1 and 2 shall be laid down by the Commission, after consulting the Authority, in accordance with the regulatory procedure referred to in Article 58(2).’;
paragraphs 2 and 3 of Article 58 shall be replaced by the following:
‘2.Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3.Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’.
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