FSA Enforcement Letter (ENF/E/09/032), 28 July 2009
I refer to the letter of 2 April updating interested parties concerning the vitamin and mineral substances subject to the derogation provided by Article 4(6) of the EC Food Supplements Directive 2002/46/EC which ends on 31 December 2009. [See EU News item, 2 April 2009]
During June 2009 the European Food Safety Authority (EFSA) completed its assessment of all the dossiers submitted under the provisions of the derogation. . A press release giving more details of the EFSA work on this can be found at: http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1211902720098.htm
Please find attached an updated version of the draft European Commission Regulation intended to amend the Food Supplements Directive to add the substances which received a favourable opinion from EFSA to those already listed in the Directive [Available on this site. See: Draft Supplements Amending Directive]. It is understood that the draft Regulation reflects all the substances for which EFSA gave positive opinions. This version was tabled at the meeting of the General Food Law Section of the Standing Committee on the Food Chain and Animal Health (SCoFCAH) on 15 July and received a favourable vote.
The draft Regulation will now go forward for consideration under the ‘regulatory procedure with scrutiny’ which comprises consideration by a Scrutiny Committee and then the European Parliament and Council. If the Regulation is enacted, amendments to the national legislation which implements the Food Supplements Directive in the United Kingdom will be required.
The Agency will continue to keep interested parties informed of progress on these issues. In the meantime, food supplements businesses are being encouraged to consider whether any of the products they manufacture or sell are likely be affected when the derogation period ends and to take appropriate action.