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On 15 June 2009, it is agreed to initiate the procedure to prohibit the placing on the market and disposal of any product containing dimethylfumarate on the market, pursuant to Commission Decision 2009 /251/EC of 17 December 2009. March 2009.
On January 7, 2010, the resolution that terminates this procedure is adopted with a period of validity of 1 year, published in the "BOE" of 28 January 2010, and adopted in accordance with Article 15 of the Royal Decree 1801/2003, of December 26, which allows extension for additional periods not exceeding one year.
Subsequently, the Resolution of 13 March 2010 and the Resolution of 4 March 2011 extend the effectiveness of that resolution until 15 March 2012.
The validity of Decision 2009 /251/EC of 17 March was limited to one year, which was extended first by Decision 2010 /153/EU of 11 March 2010, second by Decision 2011 /135/EU of 1 March 2011, and recently by Decision 2012/48/EU of 26 January 2012.
It is currently under consideration to incorporate into Regulation 1907 /2006/EC of the European Parliament and of the Council a permanent restriction on the use of dimethyl fumarate in products. Since this measure will deal with the same problem as the Resolution of 7 January 2010 (transposition of Decision 2009 /251/EC), for reasons of legal certainty the said Resolution should be applicable until the entry into force of this measure. permanent restriction introduced by Regulation 1907/2006.
The reasons for the decision and therefore the resolution remain valid, and therefore in the absence of a permanent measure in relation to consumer products containing dimethylfumarate, it is necessary to prolong the validity of the measure.
Consequently, it is necessary to prolong the effectiveness of the Resolution of 7 January 2010 to ensure that all Autonomous Communities maintain the prohibition laid down by that Resolution, in accordance with the Article 13 of Directive 2001 /95/EC of 3 December 2001 on the general safety of products.
This Presidency, in accordance with all of the above, exercising the powers conferred on it by Article 9 of Royal Decree 1087/2003, of 29 August, in the wording given by the fifth final provision of the Royal Decree 200/2012, of 23 January 2012, and on the basis of the provisions of Articles 69.1 and 72 of Law 30/1992, of 26 November of Legal Regime of Public Administrations and of the Common Administrative Procedure, as amended by Law 4/1999, of 13 of January, and Articles 11 and 15 of Royal Decree 1801/2003 of 26 December 2003 on the general security of the products, resolves:
Prolong the effectiveness of the Resolution of 7 January 2010 until the entry into force of the Commission Regulation amending Annex XVII to Regulation 1907 /2006/EC as regards dimethylfumarate, or up to 15% of the March 2013, whichever is the first of both dates.
This resolution puts an end to the administrative route and against it, it is possible to institute a potestative remedy of replacement, within one month, in accordance with the provisions of Law 4/1999, of January 13, amendment of Law 30/1992, of 26 November, of the Legal Regime of Public Administrations and of the Common Administrative Procedure, and Law 6/1997 of 14 April, the organization and operation of the General Administration of the State.
Communicate this Resolution to the Autonomous Communities for execution and notification to those concerned.
Madrid February 27, 2012. -President of the National Consumer Institute, Pilar Farjas Abadia.
