L 262/40 Official Journal of the European Union 6.10.2009 DIRECTIVES DIRECTIVE 2009/107/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 September 2009 amending Directive 98/8/EC concerning the placing of biocidal products on the market as regards the extension of certain time periods (Text with EEA relevance) 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) Article 16(1) of Directive 98/8/EC (*) provides for a tran- sitional period of 10 years, commencing on 14 May 2000, the date of entry into force of that Directive, during which Member States may apply their national rules or practices for placing biocidal products on the market and, in particular, authorise the marketing of biocidal products containing active substances that are not yet included in the positive list set out in that Directive, that is Annexes I, IA or IB thereto. (2)  Article 16(2) of Directive 98/8/EC establishes a 10-year work programme, also commencing on 14 May 2000, during which all the active substances contained in biocidal products that were present on the market () OJ C 182, 4.8.2009, p. 75. (%) Opinion of the European Parliament of 24 March 2009 (not yet published in the Official Journal) and Council Decision of 27 July 2009. () O] L 123, 24.4.1998, p. 1. before that date are to be systematically examined and, if found acceptable from the point of view of human and animal health and the environment, are to be included in the positive list set out in that Directive. Paragraphs 1(c)(i) and 2(c)(i) of Article 12 of Directive 98/8/EC provide for the protection of all information submitted for the purposes of that Directive for a period of 10 years, also commencing on 14 May 2000, unless a shorter period of protection has been granted in a particular Member State, in which case that shorter period of protection will apply on its territory. That protection concerns only information submitted in support of the inclusion in the positive list set out in Directive 98/8/EC of active substances used in biocidal products that were present on the market before the date of entry into force of Directive 98/8/EC (the ‘existing’ active substances). Once an existing active substance has been evaluated and included in the positive list set out in Directive 98/8/EC, its market is considered as harmonised, and the transi- tional rules for the placing on the market of products containing the active substance are replaced by the provisions of that Directive. In accordance with Article 16(2) of Directive 98/8/EC, the Commission has submitted a report on the progress achieved with the 10-year work programme, two years before its completion. It is expected, based on the findings of that report, that the review of a significant number of active substances will not be finalised by 14 May 2010. Furthermore, even for the active substances for which a decision on their inclusion in the positive list set out in Directive 98/8/EC has been adopted by 14 May 2010, a sufficient time period is necessary for Member States to transpose the relevant acts and to grant, cancel or modify authorisations for the relevant products, in order to comply with the harmonised provisions of Directive 98/8/EC. There is a serious risk that, at the end of the transitional period on 14 May 2010, national rules will no longer apply, while the relevant harmonised rules will not yet have been adopted. An extension of the 10-year work programme is therefore considered necessary, to permit the finali- sation of the review of all active substances notified for evaluation.