Foods for Special Medical Purposes
See below the European Union and national legislation regarding dietary foods for special medical purposes.
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What is a food for special medical purposes?
Food for special medical purposes (FSMPs) are defined Regulation (EU) No 609/2013 as "food specially processed or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision; it is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved by modification of the normal diet alone”.
There are three different types of FSMPs as set out in article 2.1 of Commission Delegated Regulation (EU) 2016/128. Food for special medical purposes is classified in the following three categories:
a) nutritionally complete food with a standard nutrient formulation which, used in accordance with the manufacturer's instructions, may constitute the sole source of nourishment for the persons for whom it is intended;
b) nutritionally complete food with a nutrient-adapted formulation specific for a disease, disorder or medical condition which, used in accordance with the manufacturer's instructions, may constitute the sole source of nourishment for the persons for whom it is intended;
c) nutritionally incomplete food with a standard formulation or a nutrient-adapted formulation specific for a disease, disorder or medical condition which is not suitable to be used as the sole source of nourishment.The food referred to in points (a) and (b) of the first subparagraph may also be used as a partial replacement or as a supplement to the patient's diet.
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EU legislation
Commission Delegated Regulation (EU) 2016/128 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes (OJ L 25, 2.2.2016, p. 30). Regulation (EU) 2016/128 has applied since 22 February 2019, except in respect of food for special medical purposes developed for infants, for which it applies from 22 February 2020.
As amended by:
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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)
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Labelling requirements
Food for special medical purposes must comply with Regulation (EU) 1169/2011 and the following statements/warning preceded by the words ‘important notice’ or equivalent must appear on the label:
- product must be used under medical supervision;
- whether the product is suitable for use as the sole source of nourishment;
- whether product is intended for a specific age group;
- whether 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 statement “For the dietary management of (the disease, disorder or medical conditions for which the product is intended)”;
- precautions and contra-indications;
- a description of what makes the product useful in relation to the disease, disorder or medical condition, relating to the special processing and formulation, the nutrients and the product rationale;
- a warning that the product is not for parenteral use.
- instructions for appropriate preparation, use and storage of the product after opening of the container as appropriate.
By way of derogation from Article 30(3) of Regulation (EU) No. 1169/2011, the information included in the mandatory nutrition declaration for food for special medical purposes shall not be repeated on the labelling.
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Food for Special Medical Purposes for Infants
Article 8 of Commission Delegated Regulation (EU) 2016/128 outlines the specific requirements on the labelling, presentation, advertising, and promotional and commercial practices of FSMPs developed to satisfy the nutritional requirements of infants similar to that of infant formula and follow-on formula.
For example:
- Labelling must not include pictures of infants, or other pictures or text which may idealise the use of the product, with the exception of graphics for easy identification or illustrating preparation methods.
- Labelling must be designed so that consumers can make a clear distinction between such products and infant formula.
- Advertising must be restricted to publications specialising in baby care and scientific publications.
- There must be no point-of-sale advertising, free samples, or any other promotional device directly to the consumer at the retail level.
- Manufacturers and distributors must not directly provide, to the general public or to pregnant women, mothers or members of their families, free or low-priced products, samples or any other promotional gifts.
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Nutrition and Health Claims
Nutrition and health claims shall not be made on food for special medical purposes.
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Notification Obligation
Foods for special medical purposes placed on the Irish market must be notified to the FSAI using the online FSAI Food Notification System.
The duty falls on the food business operator to send a model of the label used for the product, and of any other information the competent authority may reasonably request to establish compliance with Regulation (EU) 2016/128, unless a Member State exempts the food business operator from that obligation under a national system that guarantees an efficient official monitoring of the product concerned.
If you intend to place a food for special medical purpose product 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 for special medical purpose you sell has not been notified, you will need to complete the notification yourself.
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Import and Export Requirements
Information can be found here on food import requirements, including foods for special medical purposes.
FSMPs intended for export to countries outside of the European Union must meet the requirements of Article 12 Regulation (EC) No 178/2002 and the appropriate compositional requirements in Article 2 of Commission Delegated Regulation (EU) 2016/128 or the equivalent set out in the Codex Alimentarius. Further information on the export if FSMPs to third countries can be found in Guidance Note 38: Guidance for Foods governed under Regulation EU No 609/2013. -
Enforcement
The FSAI, the HSE and DAFM are responsible for the enforcement of applicable food legislation. Enforcement is the responsibility of the FSAI and is carried out by the HSE and DAFM under service contract, through the Environmental Health Service of the HSE and Dairy Controls and Certification Division of DAFM and official laboratories.
The Health Service Executive (HSE) enforces the applicable food legislation under service contract with the FSAI and undertakes routine and coordinated programmes on the sampling and analysis of relevant food products to check for compliance.
If non-compliant FSMPs are identified during official controls, appropriate enforcement action may be taken. This may include prosecution and product withdrawal/recall as appropriate.
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Guidance Documents
This guidance provides competent authorities, manufacturers and retailers of infant formula, follow-on formula, and food for special medical purposes (FSMPs), guidance on the implementation of Regulation (EU) No 609/2013 Foods for Specific Groups, Commission Delegated Regulation (EU) 2016/127, Commission Delegated Regulation (EU) 2016/128 and Statutory Instrument (S.I). No. 425 of 2019.
Further guidance on the definition and classification of an FSMP.