L 29416 Official Journal of the European Union 11.11.2009 COMMISSION DECISION of 3 November 2009 relating to the draft Regional Legislative Decree declaring the Autonomous Region of Madeira to be an Area Free of Genetically Modified Organisms, notified by the Republic of Portugal pursuant to Article 95(5) of the EC Treaty (notified under document C(2009) 8438) (Only the Portuguese text is authentic) (Text with EEA relevance) (2009/828/EC) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, and in particular Article 95(6) thereof, Whereas: ®) PROCEDURE In a letter dated 5 May 2009, the Portuguese Permanent Representation to the European Union notified the Commission, in accordance with Article 95(5) of the EC Treaty, a draft Regional Legislative Decree (hereinafter: ‘the draft decree’) declaring the Autonomous Region of Madeira to be an Area Free of Genetically Modified Organisms (GMOs). The draft decree was accompanied by an explanatory statement and a document setting out the arguments reasoning and justifying the declaration of the Autonomous Region of Madeira as an Area Free from GMOs. By a letter of 26 June 2009, the Commission informed the Portuguese authorities that it had received the notifi- cation under Article 95(5) of the EC Treaty and that the six-month period for its examination pursuant to Article 95(6) had begun following this notification. The Portuguese notification contained no scientific literature, studies, or any other scientific information that would support the respective argumentation. Therefore the Commission asked Portugal by that letter to complement its notification with more concrete information in the form of relevant scientific literature which would indicate the evidence relating to the protection of the environment or the working environment on grounds of a problem specific to the region of Madeiras. Portugal submitted complementary information on 31 July 2009. The Commission published a notice regarding the request in the Official Journal of the European Union (') to inform () O] C 139, 19.6.2009, p. 2. the other parties concerned of the draft national measure that Portugal intended to adopt. Bulgaria, Czech Republic, Denmark, France, Latvia, Malta and Romania submitted their comments. COMMUNITY LEGISLATION Article 95(5) and (6) of the Treaty provides: ‘5. (...) If, after the adoption by the Council or by the Commission of a harmonisation measure, a Member State deems it necessary to introduce national provisions based on new scientific evidence relating to the protection of the environment or the working environment on grounds of a problem specific to that Member State arising after the adoption of the harmo- nisation measure, it shall notify the Commission of the envisaged provisions as well as the grounds for intro- ducing them. 6. The Commission shall, within six months of the notifications as referred to in paragraphs 4 and 5, approve or reject the national provisions involved after having verified whether or not they are a means of arbitrary discrimination or a disguised restriction on trade between Member States and whether or not they shall constitute an obstacle to the functioning of the internal market. In the absence of a decision by the Commission within this period the national provisions referred to in paragraphs 4 and 5 shall be deemed to have been approved. When justified by the complexity of the matter and in the absence of danger for human health, the Commission may notify the Member State concerned that the period referred to in this paragraph may be extended for a further period of up to six months.’