FSA Interested Parties Letter (ENF/E/08/072; NFAS 563), 10 November 2008

SUPPLEMENTS - Food Supplements: Opinion Issued by European Food Safety Authority on Six Nutrient Sources Containing Vanadium

For previous news items on this subject, see:

• 27 February 2008 SUPPLEMENTS - Unfavourable Opinion Issued by European Food Safety Authority on Six Nutrient Sources Containing Vanadium
• 26 February 2008 SUPPLEMENTS - EFSA issues opinion on nutrient sources containing vanadium

I wrote on 27 February this year regarding a European Food Safety Authority (EFSA) opinion which had been published concerning the use, in food supplements, of six chemical sources of vanadium as listed below.

• Ammonium monovanadate
• Bisglycinato oxo vanadium
• Bismaltolato oxo vanadium
• Vanadium citrate
• Vanadium pentoxide
• Vanadyl sulphate

In my letter, I undertook to provide stakeholders with further information in due course. The Food Standards Agency sought further clarification from the European Commission on the interpretation of the EFSA opinion and the status of these substances with regard to the derogation allowing their use in food supplements.

The Commission has advised the Agency that the EFSA opinion has to be viewed not as “inconclusive” due to insufficient data, but as unfavourable, and that a legal condition for maintaining the derogation for these substances is therefore no longer fulfilled. The consequence is that it is now an offence under the Food Supplements (England) Regulations 2003 as amended to sell any products containing these six vanadium sources.

EFSA was clear that its opinion on the above six substances did not in any way represent a view on vanadium itself. It should be noted that a total of ten sources of vanadium currently remain subject to the derogation (see http://ec.europa.eu/food/food/labellingnutrition/supplements/food_supplements.pdf ) afforded by Article 4(6) of the Food Supplements Directive 2002/46/EC and may continue to be used in food supplements in the UK in the absence of an unfavourable opinion from EFSA. These sources of vanadium and their status under the derogation are detailed in the Annex to this letter.

Enforcement authorities should ensure that account is taken of the above during, and when planning, food law enforcement activities and that enforcement action is in line with the principles of proportionality and consistency set out in the Food Law Code of Practice.

Annex

Vanadium Substances Remaining Subject to the Derogation Under Article 4(6) of The EC Supplements Directive 2002/46/EC as at 10 November 2008

As at 10 November 2008, ten sources of vanadium remain subject to the derogation afforded by Article 4(6) of the Food Supplements Directive 2002/46/EC, which ends on 31 December 2009. These ten substances and their status under the derogation are as follows:

Two of the ten sources of vanadium which remain subject to the derogation are currently awaiting assessment by EFSA and, in the absence of an unfavourable opinion from EFSA, may be present in food supplements on the UK market. These are:

• Bio-transformed vanadium
• Vanadium enriched yeast

Eight of the ten sources of vanadium which remain subject to the derogation, as detailed in the lists below, may continue to be present in food supplements on the market until the end of the derogation period on 31 December 2009.

Dossiers Withdrawn from EFSA Assessment Process by Submitter

• Vanadium ascorbate
• Vanadium glycinate
• Vanadium aspartate
• Vanadium picolinate
• Vanadium oxide

EFSA Unable to Assess Safe Use Due to Insufficient Data

• Sodium metavanadate
• Vanadium amino acid chelate
• Vanadium sulphate

Five of these substances have been withdrawn from the EFSA assessment process by those who submitted dossiers. The dossiers for the other three substances contained insufficient data for EFSA to assess.