Food for special medical purposes

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About Us

We are a trade association bringing together companies within the Irish Food for Special Medical Purposes (FSMPs) sector. The sector consists of manufactures of high-quality specialist nutritional products, designed to meet the needs of people with tailored nutritional and medical requirements.

Our Objectives

  • To be a central point for FSMPs communications in Ireland
  • To bring companies with a presence on the Irish FSMPs market together by developing united industry positions on relevant technical, regulatory, or other issues relevant to the Irish market.
  • To provide accurate information on the Irish FSMPs sector through industry expertise to all relevant stakeholders
  • To place Irish sector voice at centre of EU and International FSMPs discussions

What are Foods for Special Medical Purposes (FSMPs)?

FSMPs are defined in Article 2(2)(g) of the FSG 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.

We represent the following companies

Abbott
Nutricia
Fresenius
Vitaflo

Our member products

FSMPs available to patients in Ireland include Enteral Tube Feeds (ETF) and Oral Nutritional Supplements (ONS) formulated for both adult and paediatric patients at risk of disease-related malnutrition, and specialised products intended for use in the dietary management of a range of conditions such as (but not limited to), Inborn Errors of Metabolism, Drug Resistant Epilepsy, Renal Disease and complex Food Allergy in infants and children. 

 

Regulation

In Ireland, the rules for the composition, labelling and marketing of FSMPs are based on European Union legislation, or equivalent set out in Codex Alimentarius. Primary EU legislation includes;

  • Regulation EU (No) 609/2013 which establishes the general provisions for categories of food considered as essential for certain vulnerable groups of the population, including FSMPs.
  • Commission Delegated Regulation (EU) 2016/128 supplements Regulation (EU) No 609/2013 on the specific compositional and information requirements for FSMPs, which can only be placed on the market when they comply with this legislation. This specific legislation for
  • example covers; the compositional requirements and classification of FSMPs, labelling, presentation, advertising and commercial practices of infant FSMPs, permitted nutrition and health claims, nutrition declaration requirements, and notification.
  • 2017/C 401/01 Commission Notice on classification of Foods for Special Medical Purposes
  • As with all foods, Specialised Nutrition products must also comply with relevant legislation covering hygiene, labelling, including nutritional labelling - additives, contaminants, weights and measures, nutrition and health claims and advertising where appropriate i.e., General Food Law Regulation (EC No 178/2002), Food Information to the Consumer (FIC) Regulation 1169/2011 and Nutrition and Health Claims Legislation (EC No 1924/2006).

There is also further national legislation in Ireland:

  • Statutory Instrument (S.I.) No 425/2019: This regulation gives effects to Regulation (EU) No. 609/2013 on food intended for infants and young children, foods for special medical purposes, and total diet replacement for weight control as amended by Commission Delegated Regulation EU 2017/1091. They also give effect to the Commission Delegated Regulation EU 2016/128 supplementing EU No 609/2013 as regards to the specific compositional and information requirements for Foods for Special Medical Purposes.
  • Statutory Instrument (S.I) No 852/2007: This regulation gives effect to the Commission Directive 2006/141/EC on compositional, labelling, marketing and informational requirements for infant formulae and follow-on formulae.

Useful Resources

Guidance for Foods governed under Regulation EU No 609/2013 for foods for specific groups.

The FSAI published a guidance note that was developed to provide guidance on the implementation of these regulations in Ireland. This guidance note was developed by a working group composed of experts within the Food Safety Authority of Ireland (FSAI), enforcement officers from the Department of Agriculture, Food and the Marine (DAFM) and Health Service Executive (HSE), with invited comment from manufacturers of infant formula, follow-on formula and Food for Special Medical Purposes (FSMPs) -including Dairy Industry Ireland members. This can be found on their website here (published in December 2021).

Malnutrition and Oral Nutritional Supplements

DII worked with International Special Dietary Foods Industries (ISDI) to produce a series of short, animated videos and factsheets to raise awareness of oral nutritional supplements (ONS) and the benefits they deliver in the context of adult malnutrition. - Understanding adult malnutrition: video, factsheet -  Screening for malnutrition in adults: video, factsheet - Managing adult malnutrition: video, factsheet -  Understanding ONS: video, factsheet - Introducing a patient to the benefits of ONS: video, factsheet

- iFSMPs – Infant Foods for Special Medical Purposes

An Educational Resource Explaining the Category and Its Regulation in Ireland and the European Union.

 

For more information contact:

Alice Moffitt MSc RNutr

Email: alice.moffitt@ibec.ie