Q. What is the legislation concerning food supplements?
Directive 2002/46/EC on food supplements, 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 2) .
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?
A food supplement product to be placed or marketed on the Irish market as food and where no medicinal claim is made falls within the remit of food supplements legislation and is regulated under S.I. No. 506 of 2007 as amended. FSAI follows up on all such products, including those where maximum doze levels exceed those set out in S.I. No. 540 of 2003 on the Medicinal Products (Prescription and Control of Supply) Regulations 2003.
However the Health Products Regulatory Authority (HPRA – formerly the Irish Medicine Board) is the competent regulator for medicines in Ireland. HPRA is responsible for determining whether a product is considered to be a medicinal product. Any product on which a medicinal claim is made or alluded to is subject to medicinal product legislation. For further information see: https://www.hpra.ie/.
Maximum levels of 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 Health Products Regulatory Authority).
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 Health Products Regulatory Authority
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 be notified to the FSAI using our online notification system
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.
If a product contains 1500mg or more of glucosamine, there are specific labelling requirements set by the Health products Regulatory Authority (HPRA). For further details, the HPRA 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
||Possible Adverse effects
||Yellowing of skin after sustained high intakes
||High levels can result in high blood calcium levels, alkalosis and kidney impairment. Symptoms include stomach pain, high blood pressure, headaches and tissue calcification.
||Acute toxicity is associated with vomiting, diarrhoea, haemorrhage and blood loss.
||High intakes may affect fertility
||High intakes may effect the gastrointestinal system
||Intakes higher than 1mg a day may mask symptoms of vitamin B12 deficiency while pernicious anemia caused by the deficiency progresses undetected
||At high doses it is toxic to kidney, muscle and nervous system
||Acute iron poisoning is associated with severe gastrointestinal damage
||High intakes can cause diarrhoea
||High consumption can affect the nervous system
||High levels may cause gout like symptoms and joint pain
||High intakes can damage the liver and cause severe gastrointestinal problems, nausea and vomiting
||High levels can result in increased nickel sensitization
||High intakes may cause diarrhoea and gastrointestinal disturbances
||High levels may result in diarrhoea and mild gastrointestinal symptoms.
||Very high intakes can result in increased heart and breathing rates. It also may cause irritation of the gastrointestinal tract.
||High intakes can cause changes in the nails and hair as well as affect the nervous system
||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.
||At very high doses can affect the nervous system
||High intakes may result in gastrointestinal effects
||Continuous high intakes can cause headaches, liver damage (including cirrhosis), bone damage, diarrhoea, vomiting and, during pregnancy, birth defects
||Very high intakes can cause diarrhoea and may cause urinary tract problems
||Continuous high intakes can cause kidney damage and bone deformity
||Very high doses can cause headache, fatigue, gastrointestinal distress, double vision and muscle weakness.
||High intakes can cause bone pain, muscle weakness, numbness, or other symptoms of nerve disorder
||High doses may result in cell damage and blood disorders
||High consumption levels may result in gastrointestinal effects
||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 Health Products Regulatory Authority.
Last reviewed: 8/3/2016