Foods for particular nutritional uses must meet the requirements applicable to commonplace food but in addition must also comply with special compositional and production requirements. This applies also to dietary foods for special medical purposes, which are used for the dietary management of patients under medical supervision.
Food for special medical purposes (FSMP) may be the total diet or just an add-on or partial replacement to the diet 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. In Poland, this is the only category of food that can be reimbursed under the public scheme (72 FSMPs are currently reimbursable).
The compositional and content requirements for FSMPs as regards vitamin and mineral levels are laid down in Appendix 19 to the Health Minister regulation of 16 September 2010 on foods for particular nutritional uses by reference to minimum and maximum values per 100 kj and 100 kcal (compositional requirements can also be found in Commission Delegated Regulation (EU) 2016/128).
Foods for special medical purposes must be labelled to provide a great deal of details that comply not only with the general guidance in §3 of the Health Minister Regulation but also with special disclosure requirements laid down in §38 (2) (1)-(11) of that regulation.
The law allows dissemination of any useful information or recommendations about foods for particular nutritional uses, provided such information or recommendations are addressed solely to qualified medical, pharmaceutical or diet professionals (Article 24(4) of the Food and Nutrition Safety Act). Food labels cannot suggest that any food has properties allowing it to prevent or heal diseases. Despite the repeal of Article 46, this continues to be a requirement under other legislation (such as the Competition and Consumers Protection Act).
It is sometimes uncertain whether a foodstuff is an FSMP or belongs to some other category (food supplements or vitamin- or mineral-enriched foods, see Article 24(2)(1)-(3)). This is an important matter because the right classification of a foodstuff is a duty of whoever first places or intends to first place it on the market (Article 17(1) of Regulation 178/2002).
If the Chief Sanitary Inspector forms any suspicion about the subject matter or content of a food notification, e.g. as to the product classification proposed by the notifying entity, he should (not just may) conduct an inquiry (see judgment of Warsaw Provincial Administrative Court, 3 Feb 2015, case no. VII SA/Wa 1411/14).
Food classification decisions can be aided by Scientific and technical guidance on foods for special medical purposes in the context of Article 3 of Regulation (EU) No 609/2013. Reference should also be made to acknowledged scientific and medical standards and the decision should be based on analysis of basic product properties (intended uses, form, composition).
Polish case law makes it clear that dietary foods should generally be used in patients with impaired digestive, absorption, metabolic or excretion capacity.
For that reason, judges have denied the dietary food classification of a product which was recommended for pre-flue or flue conditions, common colds and immunodeficiencies (the product contained magnesium, zinc, vitamin C and a mixture of extracts from African geranium, European elder, chamomile flower, lime blossom, marshmallow roots, and thyme herb). According to the court, a general malaise does not require the introduction of a special diet (see judgment of Warsaw Provincial Administrative Court, 28 Apr 2016, case no. VII SA/Wa 1414/15).
However, even a slight nutritional value may be enough to classify the product as dietary food for special medical purposes. This is how Łódź Provincial Administrative Court decided the case of a product intended for dietary purposes in functional impairments of liver physiology caused by adverse external factors such as incorrect or stodgy diet, alcohol or drugs (see judgment of Łódź Provincial Administrative Court, 28 Feb 2013, case no. III SA/Łd 1052/12).
Check what we refer to:
- Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 – link;
- 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 – link;
- Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety – link;
- The Food and Nutrition Safety Act of 25 August 2006 (Journal of Laws of 2017, item 149);
- The Health Minister regulation of 16 September 2010 on foods for particular nutritional uses (Journal of Laws of 2015, item 1026);
- The Act of 12 May 2011 on reimbursement for drugs, foodstuffs for particular nutritional uses and medical devices (Journal of Laws of 2017, item 1844);
- Schedule to Health Minister announcement of 2018-02-26 (item. 13) – List of reimbursable drugs, foodstuffs for particular nutritional uses and medical devices as at 2018-03-01;
- Scientific and technical guidance on foods for special medical purposes in the context of Article 3 of Regulation (EU) No 609/2013 – link.