# Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 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 Two, Division 2.6: Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version)

Extent: E+W+S+N.I.

As regards Directive 2004/10/EC, the Commission should be empowered to adapt Annex I to technical progress. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2004/10/EC, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Accordingly, Directive 2004/10/EC is hereby amended as follows:
1.. the following Article shall be inserted:
‘Article 3a The Commission may adapt Annex I to technical progress, with regard to principles of GLP.
Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 4(2).’;
2.. Article 4 shall be replaced by the following:
‘Article 4 1. The Commission shall be assisted by the Committee established by Article 29(1) of Council Directive 67/548/EEC.
2. 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.’;
3.. in Article 5(2) the third subparagraph shall be replaced by the following:
‘The Commission may adopt implementing measures to introduce necessary technical adaptations of this Directive.
Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 4(2).
In the case referred to in the third subparagraph, the Member State which adopted the safeguard measures may maintain them until the entry into force of those adaptations.’

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Source: https://www.legislation.gov.uk/eur/2009/219/annex/division/2/division/2.6 (the official version)
Page: https://openlegislation.uk/eu-regulation-2009-219/annex/division-2/division-2.6
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.