Food Supplements

EU legislation

Directive 2002/46/EC (OJ L183, p51, 12/07/2002) of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements

Amended by

Consolidated version Directive 2002/46/EC (as at 30 September 2022)
Directive 2006/37/EC (OJ L94, p32, 01/04/2006) of 30 March 2006 amending Annex II to Directive 2002/46/EC of the European Parliament and of the Council as regards the inclusion of certain substances
Commission Regulation (EC) No 1170/2009 (OJ L314, p36, 01/12/2009) of 30 November 2009 amending Directive 2002/46/EC as regards the lists of vitamin and minerals and their forms that can be added to foods, including food supplements
Commission Regulation (EU) No 1161/2011 (OJ L296, p29, 15/11/2011) of 14 November 2011 amending Directive 2002/46/EC as regards the lists of mineral substances that can be added to foods
Commission Regulation (EU) No 119/2014 (OJ L39, p44, 8/02/2014) of 7 February 2014 amending Directive 2002/46/EC as regards chromium enriched yeast used for the manufacture of food supplements
Commission Regulation (EU) No 2015/414 (OJ L68, p26, 13/3/2015) of 12 March 2015 amending Directive 2002/46/EC as regards (6S)-5- methyltetrahydrofolic acid, glucosamine salt used in the manufacture of food supplements
Commission Regulation (EU) 2017/1203 (OJ L 173, 6.7.2017, p. 9–11) of 5 July 2017 amending Directive 2002/46/EC as regards organic silicon (monomethylsilanetriol) and calcium phosphoryl oligosaccharides (POs-Ca®) added to foods and used in the manufacture of food supplements

National legislation

European Communities (Food Supplements) Regulations 2007, (S.I. No. 506 of 2007)

Amended by

European Communities (Food Supplements) (Amendment) Regulations 2010 (S.I. 355 of 2010)
European Communities (Food Supplements)(Amendment) Regulations 2015 (S.I. No. 282 of 2015)
European Communities (Food Supplements) (Amendment) Regulations 2018 (S.I. No. 225 of 2018)

A 'food supplement' is defined in EU and Irish legislation 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"

Ingredients permitted in food supplements

The Annexes to Directive 2002/46/EC list the vitamins and minerals and their chemical forms, permitted for use in the manufacture of food supplements. Additional vitamins and minerals may be considered for inclusion in the list following the evaluation of an appropriate scientific dossier concerning the safety and bioavailability of the individual substance by the European Food Safety Authority (EFSA).

Directive 2002/46/EC envisages the setting of maximum levels for vitamins and minerals in food supplements, however levels have not yet been set. To ensure that food supplements are safe for consumption, the manufacturer must take account of the upper safe levels established by scientific risk assessment and data on vitamin and minerals intake from other foods, while also taking due account of what is considered an adequate vitamin and mineral intake for an average person.

Ingredients not permitted in food supplements

The following substances are not permitted as ingredients in the manufacture of food supplements:

Ephedra herb and its preparations originating from Ephedra species. See Annex III to Regulation (EC) No 1925/2006
Medicinal ingredients. For further details see Health Products Regulatory Authority (HPRA) webpages on: Herbal Medicines and Classification of Medicines.
Unauthorised Novel foods.For further information on the rules governing novel foods see the Novel foods section or the Novel Food catalogue on the website of the European Commission.
Flavourings and certain food ingredients with flavouring properties listed in the Annex III to Regulation (EC) No 1334/2008

Labelling requirements for food supplements

The main legislation setting out the mandatory information that must be provided to the consumer is Regulation (EU) No 1169/2011 on the provision of food information to consumers (FIC). Further information on the requirements of this legislation is available in Food Information. In addition to these general rules, Directive 2002/46/EC sets out specific information which the labels of food supplements must provide. These include:

the names of the categories of nutrients or substances that characterise the product or an indication of the nature of those nutrients or substances,
the portion of the product recommended for daily consumption
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 and
a statement to the effect that the products should be stored out of the reach of young children

Food supplements are only allowed to be sold in pre-packed forms under the name ‘Food Supplement’. The legislation specifies that the labelling, presentation and advertising of food supplements:

must not attribute to food supplements the property of preventing, treating or curing a human disease, or refer to such properties
must not include any wording stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients in general

The label must declare the amount of the nutrients or substances with a nutritional or physiological effect present in the product. These must be declared in numerical form and per portion of the product as recommended for daily consumption. Information on vitamins and minerals must also be expressed as a percentage of the reference intake values listed in Part A of Annex XIII to Regulation (EU) No 1169/2011.

Nutrition and Health Claims

Any nutrition or health claims made about food supplements must comply with Regulation (EC) No. 1924/2006 on nutrition and health claims made on foods.
All permitted and non-authorised nutrition and health claims are listed in a EU Register of nutrition and health claims made on foods, which includes the wording of claims and the conditions applying to them, together with any restrictions.

For more information on using nutrition and health claims, see the section on our website on Nutrition and Health Claims.

Notification Obligation

Food supplements marketed in Ireland for the first time must be notified to the FSAI using the online notification form.

The duty to notify the FSAI falls on the manufacturer if the product is manufactured in Ireland and on the importer if the product is imported into Ireland. If you intend to place a food supplement on the market in Ireland, you should check with your supplier to verify if they have already notified the product. If they have already done so, you do not need to submit a duplicate notification, but you should request a copy of the notification number(s) from the supplier to keep as part of your records.

If the food supplement(s) you sell have not been notified, you will need to complete the notification yourself.

Importing Food Supplements

Inspections

Environmental Health Officers of the Health Service Executive supervise establishments manufacturing and marketing food supplements in Ireland. The FSAI in collaboration with the Environmental Health Service developed an Aide Memoire for Food Supplement Establishment Inspections and a Checklist for Food Supplement Establishment Inspections for use in official control inspections in food supplement manufacturing/marketing establishments.

These documents should be read in conjunction with Guidance Note 21 Food Supplements Regulations (Revision 2)

If noncompliant food supplements are identified during official controls, appropriate enforcement action may be taken. This may include prosecution and product withdrawal/recall as appropriate.