Food Supplements Directive 2002/46/EC
Phase 1: The Positive List of Vitamin & Mineral Substances
The Food Supplements Directive (FSD) 2002/46/EC came into force in July 2002 and was implemented in England by the Food Supplements (England) Regulations 2003. The directive and these regulations have applied in full since 1 August 2005. The FSD applies across Europe and one of the main reasons for this directive is to achieve trade harmonisation throughout the EU.
One of the provisions of this directive is for “positive” lists of nutrients and their sources that can be included in food supplements. The first list covers the vitamins and minerals that may be used in food supplements (such as vitamin C, calcium, iron), and the second list covers the chemical forms (sources) of those vitamins and minerals that may be used. The original lists did not contain many forms, however these lists can be and have been added to following a favourable opinion on individual nutrients or nutrient sources from the European Food Safety Authority (EFSA) after consideration of a dossier containing safety data.
Only one dossier is required per nutrient substance for assessment by EFSA, therefore it has been possible for manufacturers to collaborate and provide a dossier for assessment with information collated from a number of sources. Manufacturers are not required to submit dossiers for individual products or for an individual operator’s use of a substance.
Where dossiers for nutrient substances were submitted before 12 July 2005, a derogation applied in the UK for those substances allowing them to continue to be used in food supplements until 31 December 2009, providing EFSA had not given an unfavourable opinion.
End of Derogation Period
The derogation has now expired, and all substances given positive opinions by EFSA have been added to the second list. However, substances given either a negative opinion, or substances whose dossiers lacked evidence, have not been added and are therefore unable to be used in food supplements. Nutri have made minor changes to products within the range affected by this legislation, in order to be compliant. All product changes can be found on the “product changes” section of the website, or just click here.
Natural Sources of Vitamins & Minerals
On 10th August 2007 the European Commission announced that all natural sources of vitamins and minerals will escape the Directive and will be regulated foods. Dr Rob Verkerk from the Alliance for Natural Health said "....this decision effectively opens the door to functional foods and supplements containing nutrients derived from natural sources".
To view the ANH Briefing paper on the Food Supplements Directive click here.
Phase 2: Maximum Permitted Levels
The Directive will also dictate the maximum dose levels of all nutrients - it will be illegal to market supplements which contain higher levels than these. Controversy currently centres on this issue, because, under pressure from the pharmaceutical lobby and from the French and German Governments, this provision of the Directive could be interpreted by EU in a restrictive manner so that only low dose supplements would be allowed. This would see huge numbers of safe, popular and effective higher potency supplements removed from the UK market.
EFSA has been working with Member States since 2006 to prepare a draft list of permitted levels. The UK had already addressed this issue via the Expert Group on Vitamins and Minerals, which reported in 2003 (click here to see a copy of this report). The government has argued that the approach used by this group is consistent with World Health Organisation (WHO) and Food and Agriculture Organisation (FAO) methods and that maximum levels should be based on risk of harm rather than reference to a theoretically adequate level of intake (such as the Recommended Daily Amount). They have also argued that regulation should be flexible for vitamins and minerals for which there is no evidence of adverse effects.
The draft list was supposed to have been published last year, but it is now expected to be published sometime in 2010.
If you are concerned about this issue, you can help by getting involved in the ANH (Alliance for Natural Health) campaign, by signing their petition here. The ANH petition aims to positively influence the approach the European Commission is taking in its efforts to limit the maximum available dosages of vitamin and mineral food supplements across the 27 Member States of Europe.
To view the ANH briefing paper on Maximum Permitted Levels, click here.
Phase 3: Other Ingredients
By July 2007, the European Commission was meant to have issued its intention for dealing with ingredients other than vitamins and minerals (e.g. botanical herbs, amino acids, essential fatty acids etc.), however, they missed this deadline.