EU Legislation

Commission Directive 1999/21/EC (OJ L91, 7/04/1999, p29) of 25 March 1999 on dietary foods for special medical purposes.

Corrected by

Corrigendum (OJ L2, p79, 07/04/1999) to the Commission Directive 1999/21/EC on dietary foods for special medical purposes

Adapted

Commission Directive 2006/82/EC of 23 October 2006 adapting Directive 91/321/EEC on infant formulae and follow-on formulae and Directive 1999/21/EC on dietary foods for special medical purposes, by reason of the accession of Bulgaria and Romania

Amended by:

Commission Directive 2006/141/EC (OJ L401, p1, 30/12/2006 ) of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC

Consolidated version of Directive 1999/21/EC ( as at 1 July 2013)

National Legislation

European Union (Food Intended For Infants And Young Children, Food For Special Medical Purposes, And Total Diet Replacement For Weight Control) Regulations 2019 (S.I. No. 425/2019)

European Communities (Dietary Foods for Special Medical Purposes) Regulations 2009 (S.I. No. 187 of 2009)

Amended by:

European Communities (Dietary Foods for Special Medical Purposes)(Amendment) Regulations 2013 (S.I. No. 382 of 2013)

General provisions

S.I. No. 187 of 2009 gives further effect to Commission Directive 1999/21/EC on dietary foods for special medical purposes, as amended by Corrigendum of 5th January 2000 and by Commission Directive 2006/82/EC .

“dietary foods for special medical purposes” are defined in the Regulations as meaning "a category of foods for particular nutritional uses specifically processed or formulated and intended for the dietary management of patients and to be used under medical supervision. They are intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet, by other foods for particular nutritional uses, or by a combination of the two"

A food business operator placing a dietary food for special medical purposes on the market in Ireland, must notify the Food Safety Authority of Ireland (FSAI) of that placing on the market by forwarding to it a model of the label used for that product. The notification form can be found here.

Dietary foods for special medical purposes may be placed on the market only if they comply with the provisions laid down in the S.I. However, certain transitional derogations are permitted for dietary foods for special medical purposes intended specifically for infants

Transitional arrangements for dietary foods for special medical purposes intended specifically for infants

Schedule 1 to the SI sets out the essential composition of foods for special medical purposes. However, in relation to dietary foods for special medical purposes intended specifically for infants, the requirements of Regulation 4(4), (5) and (6) and Regulation 5(3) of the European Communities (Infant Formulae and Follow-On Formulae Regulations 2007 (S.I. No. 852 of 2007) will not apply mandatorily to dietary foods for special medical purposes intended specifically for infants until 1 January 2012. Prior to that date, such foods shall, in the alternative, comply with the requirements of Regulations 4(3) and 5(3) of the European Communities (Infant Formulae and Follow-On Formulae Regulations 2004 (S.I. No. 242 of 2004).

Table 1 of Schedule 1 to S.I. 187 of 2009 sets out the values for vitamins, mineral and trace elements in nutritionally complete foods intended for use by infants. However, by way of a transitional period the SI permits trade in products containing manganese at the following values until 31 December 2009:

Manganese (mg) Per 100 kJ Minimum 0.012 Maximum 0.05
Manganese (mg) Per 100kcal Minimum 0.05 Maximum 0.2

Labelling of dietary foods for special medical purposes

The information required to be given by the Regulations must be given in the English language and may, in addition, be given in the Irish language. The name under which dietary foods for special medical purposes are sold shall be:

“Food(s) for special medical purposes”. The other names listed in Article 4 of Directive 1999/21/EC, or any of them, may also be included in addition.

The labelling of dietary foods for special medical purposes must bear, in addition to the particulars provided for in Article 3 of Directive 2000/13/EC on the labelling, presentation and advertising of foodstuffs, the following mandatory particulars:

the available energy value expressed in kJ and kcal, and the content of protein, carbohydrate and fat, expressed in numerical form, per 100g or per 100ml of the product as sold and where appropriate per 100g or per 100ml of the product ready for use in accordance with the manufacturer’s instructions. This information may in addition be provided per serving as quantified on the label or per portion, provided that the number of portions contained in the package is stated;
the average quantity of each mineral substance and each vitamin mentioned in Schedule 1 to S.I. 187 of 2009 present in the product, expressed in numerical form per 100g or per 100ml of the product as sold and where appropriate per 100g or per 100ml of the product ready for use in accordance with the manufacturer’s instructions. This information may in addition be provided per serving as quantified on the label or per portion, provided that the number of portions contained in the package is stated;
selectively the content of components of protein, carbohydrate and fat and/or of other nutrients and their components the declaration of which would be necessary for the appropriate intended use of the product, expressed in numerical form, per 100g or per 100ml of the product as sold and where appropriate per 100g or per 100ml of the product ready for use in accordance with the manufacturer’s instructions. This information may in addition be provided per serving as quantified on the label or per portion, provided that the number of portions contained in the package is stated;
information on the osmolality or the osmolarity of the product where appropriate;
information on the origin and the nature of the protein and/or protein hydrolysates contained in the product.

The labelling of dietary foods for special medical purposes must in addition bear the following mandatory particulars, preceded by the words ‘important notice’ or their equivalent:

a statement that the product must be used under medical supervision;
a statement whether the product is suitable for use as the sole source of nourishment;
a statement that the product is intended for a specific age group, as appropriate;
where appropriate, a statement that the product poses a health hazard when consumed by persons who do not have the diseases, disorders or medical conditions for which the product is intended.

The labelling of dietary foods for special medical purposes must also include:

the statement “For the dietary management of ....”, where the blank shall be filled in with the diseases, disorders or medical conditions for which the product is intended;
where appropriate, a statement concerning adequate precautions and contra-indications;
a description of the properties and/or characteristics that make the product useful in particular, as the case may be, relating to the nutrients which have been increased, reduced, eliminated or otherwise modified and the rationale of the use of the product;
where appropriate, a warning that the product is not for parenteral use.

The labelling of dietary foods for special medical purposes shall bear instructions for the appropriate preparation, the use and the storage of the product after the opening of the container, as appropriate.

Notification

Notification of dietary foods for special medical purposes is a statutory requirement under the Commission Directive 1999/21/EC and S.I. No. 64 of 2001, which cover the enforcement of food legislation in the area of Dietary Foods for Special Medical Purposes (FSMPs). The duty to notify falls on the manufacturer if the product is manufactured in Ireland and on the importer if the product is imported into Ireland.

Please notify your products online through the FSAI food notification system.

(Note: For future reference, the system can also be easily accessed on the FSAI homepage under Quick Links> Food Notifications.)