FSA Enforcement Letter (ENF/E/09/016), 2 April 2009

SUPPLEMENTS - EC Food Supplements Directive 2002/46/EC: Article 4(6) Derogation Period Ending on 31 December 2009 – Technical Issues

This letter is to update interested parties on vitamin and mineral substances permitted for use in food supplements and the current situation in respect of substances which are subject to the derogation provided by Article 4(6) of the EC Food Supplements Directive 2002/46/EC. These are outlined below.

• Substances benefiting from the derogation which receive a favourable opinion from the European Food Safety Authority (EFSA) and, subject to a decision by the European Standing Committee on the Food Chain and Animal Health (SCoFCAH), will be added to the list in Annex II to the Directive, permitting their continued use in food supplements beyond 31 December 2009.
• Substances which do not receive a favourable opinion from EFSA will not be added to the list in Annex II to the Directive and will not be permitted to be present in food supplements after 31 December 2009. Any food supplements containing these substances which are on the market after this date would no longer comply with the Directive and would need to be removed from the market.
• Substances which receive unfavourable opinions from EFSA, such as the six vanadium substances which were the subject of my letter 10 November 2008 [See EU Food Law News, 10 November 2008], no longer fulfil a legal condition for maintaining the derogation and it becomes an offence under the Food Supplements (England) Regulations 2003, as amended, to sell any products containing such substances.

A number of vitamin and mineral substances subject to the derogation have already received EFSA opinions. The European Commission has indicated that it currently expects that EFSA will have completed their assessment of the remaining substances by the end of May 2009 and has confirmed that no extension to the derogation period is planned.

The substances for which SCoFCAH consideration is pending at the time of writing are listed at Annex A. As mentioned in my letter to food supplements industry colleagues of 17 February, a draft Commission Regulation prepared with a view the addition of these substances to Annex II of the Food Supplements Directive was subject to an exchange of views (but not a vote or opinion) at a meeting of the SCoFCAH General Food Law Section on 20 February. Further discussion at expert level is required before the draft Regulation can be considered again by SCoFCAH.

Industry stakeholders voluntarily withdrew 178 dossiers from the assessment process. These dossiers relate to 145 individual substances for which no other dossiers were submitted. As such, these 145 substances, which are listed at Annex B, will not be permitted in food supplements after the derogation expires on 31 December 2009, unless new dossiers are submitted which complete the full safety assessment process by that time. It should, however, be noted that 3 of these substances, as indicated in the Annex, are considered by the Medicines and Healthcare Products Regulatory Agency (MHRA) to be medicinal and for this reason are not permitted to be present in food supplements in the UK.

As confirmed in an EFSA statement released on 28 April 2008 [See: http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178703725274.htm], a further 120 dossiers contained insufficient data for EFSA to assess safe use of the substances to which they relate. 85 of these dossiers relate to 76 individual substances for which no other dossiers were submitted. As such, these 76 substances, as listed at Annex C, will not be permitted in food supplements after the derogation expires on 31 December 2009, unless new dossiers are submitted which complete the full safety assessment process by that time.

The Agency will continue to keep interested parties informed of progress on this issue during 2009. In the meantime, food supplements businesses are 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. As interested parties may be aware, the European Commission maintains a list of dossiers submitted under the derogation which provides links to EFSA opinions where appropriate. This can be found on the European Union website at: http://ec.europa.eu/food/food/labellingnutrition/supplements/food_supplements.pdf

EFSA also maintains a searchable ‘register of questions’ which interested parties can use to follow the progress of dossiers through the assessment process and view the final published opinions. This can be found on the EFSA website at: http://registerofquestions.efsa.europa.eu/roqFrontend/questionsList.jsf?nocache=1232721334485