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Food Supplements

Q. What is the legislation concerning food supplements? 

Directive 2002/46/EC on food supplements which came into force in June 2002 , and is amended by Directive 2006/37/EC and  Regulation 1170/2009/EC , concerns food supplements marketed as foodstuffs and presented as such in a pre-packaged form to the ultimate consumer. In order to ensure a high level of protection for consumers and to facilitate their choice, the products that will be put on the market must be safe and bear adequate and appropriate labelling. This legislation is transposed into Irish law by European Communities (Food Supplements) Regulations, 2007 (S.I. No. 506 of 2007).

The FSAI have produced a guidance document on this legislation -  Guidance Note No. 21 Food Supplements Regulations and Notifications (Revision 1) .

Q. Is there a legal definition of a food supplement? 

 Directive 2002/46/EC defines a "food supplement" as "foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities".

Q. Who regulates food supplements in Ireland? 

The Food Safety Authority of Ireland (FSAI) is the national body with responsibility for the enforcement of food safety legislation. In Ireland, vitamins, minerals and other substances sold as food supplements are regulated as food unless the product is considered a medicine (by virtue of its composition, concentration, labelling and presentation or when medicinal claims are made in relation to the product).

Food supplements with vitamin and mineral levels at or above prescription levels are considered medicinal products and under the remit of the Irish Medicines Board. The prescription levels can be found in Medicinal Products (Prescription and Control of Supply) Regulations, 2003 (S.I. No. 540 of 2003). Maximum levels for vitamins and minerals in food supplements are currently being established at European level and will be regulated under food legislation.

Herbal supplements are regulated under food legislation unless the product contains a herbal substance which is subject to medicinal control (and therefore under the remit of the Irish Medicines Board).

Q. What does the food supplements legislation specify? 

  • Only vitamins and minerals listed in the Annex to  Directive 2002/46/EC , as amended by  Regulation 1170/2009/EC , may be used in the manufacture of food supplements
  • The amount of the nutrients or substances with a nutritional or physiological effect present in the product shall be declared on the labelling in numerical form
  • The amounts of the nutrients or other substances declared shall be those per portion of the product as recommended for daily consumption on the labelling
  • The vitamins and minerals in the product shall be expressed as a percentage of the RDA values according to Schedule 1 of S.I. No. 65 of 2005 
  • The portion of the product recommended for daily consumption shall be declared
  • Declaration of a vitamin or mineral on the product label should only be because that vitamin or mineral is present in a significant amount.

Q. Does this legislation apply to medicinal products? 

No. The legislation does not apply to medicinal products as defined by Directive 2004/27/EC . Medicinal products come under the jurisdiction of the Irish Medicines Board.

Q. Who inspects the labelling of food supplements? 

Environmental Health Officers (EHOs) inspect manufacturing and retail establishments. The auditing of compliance of available food supplements on the market will come under their remit.

Q. What is the procedure for introducing a new food supplement under this legislation? 

Any new food supplement to be introduced onto the market in Ireland for the first time must notify the FSAI.

Access online notification system 

or 

Download a copy of the notification form 

If you are sending in a hard copy of the notification form, a copy of the proposed label should also be submitted.

Q. Under the legislation is there a requirement for warnings on the supplement label? 

The labelling, presentation and advertising must not attribute to food supplements the property of preventing, treating or curing disease, or refer to such properties. The following warnings must also be included on the label:

  • A warning not to exceed the stated recommended daily dose
  • A statement to the effect that food supplements should not be used as a substitute for a varied diet
  • A statement to the effect that the products should be stored out of the reach of young children.

In addition, as good practice, manufacturers can provide information for consumers on who the product is suitable for etc. Examples of these warnings could be (a) not to be consumed by pregnant or lactating women (b) not suitable for children (c) not to be taken if on certain types of medication, (d) not to be consumed if allergic to fish*.

* Legislation (Directive 2003/89/EC as amended) is now in place and requires that all allergens, as listed in the Annex to the Directive, are labelled on foods to inform consumers.

If a product contains 1500mg or more of glucosamine, there are specific labelling requirements set by the Irish Medicines Board. For further details, the Irish Medicines Board should be contacted.

Q. In what format should the vitamins and minerals be indicated on the label of food supplements? 

S.I. No. 506 of 2007 allows for either the common name e.g. Vitamin C, Zinc, or the chemical name e.g. L-ascorbic acid, Zinc Gluconate, of the vitamin and mineral to be used. However, from a consumer point of view it would be useful to include both the common name and the chemical name.

Q. Is there a danger of consuming excess levels of vitamins/minerals? 

Yes. Excess intakes of some vitamins and minerals cause adverse effects (see below for examples). Pregnant and lactating women should not consume food supplements unless medically advised to do so.

It is of paramount importance that food supplement labels include clear instructions about the use of the product, in particular the quantity to be consumed. Consumers should be warned against exceeding suggested quantities to be consumed, if such a practice could have detrimental effects on their health. This is also of great importance with children as they have lower requirements compared to adults. In general, one should not need to consume supplements with nutrient levels above 100% of the recommended daily allowance. It is important to keep any supplements tightly capped and away from children's reach.

Examples of adverse effects of high intakes of nutrients 

Vitamin/Mineral  Possible Adverse effects 
β carotene Yellowing of skin after sustained high intakes
Calcium High levels can result in high blood calcium levels, alkalosis and kidney impairment. Symptoms include stomach pain, high blood pressure, headaches and tissue calcification.
Chromium Acute toxicity is associated with vomiting, diarrhoea, haemorrhage and blood loss.
Cobalt High intakes may affect fertility
Copper High intakes may effect the gastrointestinal system
Folic Acid Intakes higher than 1mg a day may mask symptoms of vitamin B12 deficiency while pernicious anemia caused by the deficiency progresses undetected
Germanium At high doses it is toxic to kidney, muscle and nervous system
Iron Acute iron poisoning is associated with severe gastrointestinal damage
Magnesium High intakes can cause diarrhoea
Manganese High consumption can affect the nervous system
Molybdenum High levels may cause gout like symptoms and joint pain
Niacin High intakes can damage the liver and cause severe gastrointestinal problems, nausea and vomiting
Nickle High levels can result in increased nickel sensitization
Pantothenic Acid High intakes may cause diarrhoea and gastrointestinal disturbances
Phosphorus High levels may result in diarrhoea and mild gastrointestinal symptoms.
Potassium Very high intakes can result in increased heart and breathing rates. It also may cause irritation of the gastrointestinal tract.
Selenium High intakes can cause changes in the nails and hair as well as affect the nervous system
Sodium chloride Toxicity can result in vomiting, ulceration of the gastrointestinal tract, muscle weakness and kidney damage. High intakes increase calcium excretion and risk of kidney stone formation. May also increase blood pressure.
Thiamin At very high doses can affect the nervous system
Tin High intakes may result in gastrointestinal effects
Vitamin A Continuous high intakes can cause headaches, liver damage (including cirrhosis), bone damage, diarrhoea, vomiting and, during pregnancy, birth defects
Vitamin C Very high intakes can cause diarrhoea and may cause urinary tract problems
Vitamin D Continuous high intakes can cause kidney damage and bone deformity
Vitamin E Very high doses can cause headache, fatigue, gastrointestinal distress, double vision and muscle weakness.
Vitamin B6 High intakes can cause bone pain, muscle weakness, numbness, or other symptoms of nerve disorder
Vitamin K3 High doses may result in cell damage and blood disorders
Vanadium High consumption levels may result in gastrointestinal effects
Zinc High levels can cause gastrointestinal effects including cramping and nause. May also cause a deficiency in copper as interferes with copper absorption.

Q. Are there any potential food supplement ingredients that are considered medicines in Ireland? 

Some herbs are considered medicines as there are a number of plants listed in Schedule I of the Medicinal Products (Prescription and Control of Supply) Regulations, 2003, as amended (SI no. 540 of 2003). A copy of these regulations can be found at the following link www.irishstatutebook.ie
There are also a number of herbal ingredients that are currently subject to a voluntary withdrawal from the Irish market by the Industry and are not subject to prescription status. Examples of such are Kava Kava and Greater Celadine.

For any queries with regards to herbal ingredients, please contact the Irish Medicines Board.

Last reviewed: 19/12/2013

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