20.3.2008 Official Journal of the European Union L 81[45 DIRECTIVE 2008/27/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 March 2008 amending Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, as regards the implementing powers conferred on the Commission THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty (), Whereas: (1) Directive 2001/18/EC of the European Parliament and of the Council (}) provides that certain measures are to be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (*). (2)  Decision 1999/468/EC has been amended by Decision 2006/512/EC, which introduced the regulatory procedure with scrutiny for the adoption of measures of general scope and designed to amend non-essential elements of a basic instrument adopted in accordance with the procedure referred to in Article 251 of the Treaty, inter alia, by deleting some of those elements or by supplementing the instrument with new non-essential elements. (3)  In accordance with the statement by the European Parliament, the Council and the Commission (%) concerning Decision 2006/512/EC, for the regulatory procedure with scrutiny to be applicable to instruments adopted in accordance with the procedure referred to in Article 251 of the Treaty which are already in force, those instruments must be adjusted in accordance with the applicable procedures. () O] C 161, 13.7.2007, p. 45. (%) Opinion of the European Parliament of 14 November 2007 (not yet published in the Official Journal) and Council Decision of 3 March 2008. (®) OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation (EC) No 1830/2003 (O] L 268, 18.10.2003, p. 24). () O] L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (O] L 200, 22.7.2006, p. 11). () O] C 255, 21.10.2006, p. 1. (4  The Commission should be empowered to adopt the measures necessary for the implementation of Directive 2001/18/EC. Those measures are designed to adapt certain annexes, establish criteria for the notification and fix minimum thresholds. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2001/18/EC, inter alia, by supple- menting 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. (5)  Directive 2001/18/EC should therefore be amended accordingly. (6)  Since the amendments made to Directive 2001/18EC by this Directive are technical in nature and concern committee procedure only, they do not need to be transposed by the Member States. It is therefore not necessary to lay down provisions to that effect, HAVE ADOPTED THIS DIRECTIVE: Article 1 Amendments Directive 2001/18/EC is hereby amended as follows: 1. Article 16(2) and (3) shall be replaced by the following: ‘2. The criteria and information requirements referred to in paragraph 1, as well as any appropriate requirements for a summary of the dossier, shall be established. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted, after consultation of the relevant Scientific Committee, in accordance with the regulatory procedure with scrutiny referred to in Article 30(3). The criteria and information requirements shall be such as to ensure a high level of safety of human health and the environment and shall be based on the available scientific evidence concerning such safety and on experience gained from the release of comparable GMOs. The requirements set out in Article 13(2) shall be replaced by those adopted in accordance with the first subparagraph, and the procedure set out in Article 13(3), (4), (5) and (6) and Articles 14 and 15 shall apply.