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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.


Positive Lists

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.

Traditional Herbal Medicinal Products


The Traditional Herbal Medicinal Products Directive, 2004/24/EC, was established to provide a regulatory approval process for herbal medicines in the European Union (EU), and came into force on 30 April 2004 . To read the ANH briefing paper on the EU Traditional Herbal Medicinal Products Directive, click here. 

Nutrition and Health Claims Regulations

Regulation No 1924/2006 applies to foods (and food supplements), and seeks to harmonise commercial nutrition and health claims made on labels and in advertising throughout the European Community, in order to ensure the effective functioning of the internal market, whilst providing a high level of consumer protection. To view the ANH briefing paper on the Nutrition and Health Claims Regulations, click here.

Labelling, Allergens & GM


Good Labelling Practice

Understanding correct labelling practices is key to understanding the amount of minerals you are receiving from your food supplements. All of Nutri’s mineral products are listed and labelled with the elemental amount of the minerals that are contained in the product. For example, 1000mg of calcium citrate provides 210mg elemental calcium, which may lead some consumers to believe that they are getting 1000mg of elemental calcium when in fact 790mg of this is citrate.


The correct way to label is as follows:

Calcium (citrate) 210mg


Labelling Legislation

In recent years legislation has been adopted by the food industry covering traceability and labelling requirements for allergens and genetically modified (GM) materials.

Nutri seek to procure only the finest and most efficacious products and in doing so we liaise closely with our carefully sourced external suppliers. As part of our quality control programme we obtain information on allergens and GM ingredients from our suppliers in order to correctly label our products. Our confidence is your assurance that the label reflects the true nature of the product.


Allergens (Directive 2003/89/EC)

As from November 2005, companies are required to declare potential allergenic ingredients on food product labels. This also applies to food supplements. The most common food allergens (and products thereof) and those that legally have to be declared on labels are listed below. Although we seek to use ingredients of non-allergenic potential, a few of our products do contain some of those listed. These are indicated on the label using the statement –This product contains ingredients derived from ‘X’. For those products that do not carry a caution, you can be assured that none of the below allergens are present.


Cereals containing gluten




Sesame seeds
Sulphur dioxide and sulphites



Genetically Modified Ingredients (GM)

As from April 2004, companies are required to declare the presence of GM materials on food product labels.  This also applies to food supplements. Despite the audit trail, accidental or inadvertent presence of GM material can still occur in a non-GM crop. This can occur through transference in nature e.g. via wind-borne pollen. Because of this we have opted not to label our products as ‘non-GM’. This statement is based on our wish to provide customers with choice and not out of any belief that GM ingredients, approved for sale, are unsafe.


Our suppliers actively seek ingredients of non-GM origin and are continuously striving to find alternatives to those few that remain. A very minor number of products contain GM-derived ingredients and these are indicated on the label using the statement – Contains ‘X’ produced from genetically modified ‘X’.

Codex Alimentarius


What is Codex?

There is presently a lot of information circulating on the internet about Codex Alimentarius (latin for “food code”) - and its potential imminent impact on the banning of food (dietary) supplements including vitamins, minerals and herbs - that is inaccurate. Codex Alimentarius is collection of internationally recognized standards, codes of practice, guidelines and other recommendations relating to foods, food production and food safety. It is claimed that Codex is the biggest threat to the natural products industry - a common misconception that is unfortunately drawing attention away from the real threats! 


Will Codex ban food supplements?

Last year there was a rumour circulating that Codex was to come into force on 31st December 2009, banning a wide variety of food supplements – this was incorrect - and is actually when the EU Food Supplements Directive (FSD) came into effect. The FSD effectively bans any vitamin and mineral forms that are not present on the EU’s "positive list" of vitamins and minerals, and will also limit the amounts of vitamins and minerals that you can include in food supplements (see information above). These restrictions, however, are not the result of Codex, but are the effects of the EU Directive.


In fact, the restrictions occurring in Europe are actually forming the basis for the Codex Guideline on Vitamin and Mineral Supplements; therefore, rather than Codex restricting food supplements, it is the various EU Directives and Regulations that will end up having a major bearing on Codex.


Another misinformed, but undoubtedly well-meaning, action is the petition to the UK gorvernment on Codex at No 10 Downing Street, London. This petition indicates that Codex will cause all herbal, vitamin and mineral food supplements to become “prescription only”. This again is not the case – and for more information on Codex, the EU Food Supplements Directive and the ANH campaign, go to www.anhcampaign.org.

For more information on any of the legislative issues raised here, please contact the nutrition department on 0800 212 742 and select option 3.

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