FSMP and “modification of the normal diet”
Do food supplements and fortified foods count? (Commission Notice 2017/C 401/01 §§60–68)

Yes. Under the Commission Notice on the classification of Food for Special Medical Purposes (OJ C 401, 25.11.2017, p. 1–12; CELEX 52017XC1125(01)), §§60–66, the concept of “modification of the normal diet” in Article 2(2)(g) of Regulation (EU) No 609/2013 includes food supplements within Directive 2002/46/EC and fortified foods under Regulation (EC) No 1925/2006. §§67–68 then set pragmatic factors for deciding when patients’ dietary management cannot be achieved by that modification alone — and when a product can be FSMP at all.

1. What the FSMP definition requires

Article 2(2)(g) of Regulation 609/2013 defines FSMP as food specially processed or formulated and intended for the dietary management of patients — including infants — under medical supervision, whose dietary management cannot be achieved by modification of the normal diet alone. The definition is to be read narrowly and as a whole (Notice §6 and the definitional elements): a “capsule for the sick” or the slogan “use under medical supervision” is not enough. Inability to meet the need by modifying the normal diet alone is a necessary condition.

Section 3 of the Notice describes the misclassification incentive: FSMP may refer to dietary management of a disease, whereas ordinary foods and supplements need authorised health claims under Regulation 1924/2006. That explains commercial pressure; it does not rewrite the definition.

2. The §§60–66 answer: supplements and fortified foods count

§60 asks the question directly: does “modification of the normal diet” include food supplements and fortified foods — i.e. must they be taken into account when assessing whether patients’ needs can be met without FSMP?

§61 answers: the concept is not separately defined, but must be interpreted broadly as any adjustment to the diet through consumption of foodstuffs other than FSMP, and therefore includes use of food supplements or fortified foods.

§§62–64 reconstruct the legislative history (the Directive 1999/21/EC definition, adopted before the food-supplements Directive and the fortification Regulation): “modification of the normal diet” meant adjustments via foods for normal consumption, completed by other “foods for particular nutritional uses” different from FSMP.

§65 is decisive for supplement operators. Food supplements are defined in Article 2(a) of Directive 2002/46/EC as foodstuffs whose purpose is to supplement the normal diet. In supplementing the normal diet they become part of the normal diet and thus are apt to modify it. The same reasoning applies to foods covered by Regulation 1925/2006: adding vitamins, minerals or other substances does not change their status as normal food that is part of the normal diet and apt to modify it.

§66 closes the gap after abolition of “food for particular nutritional uses”: the present wording (“by modification of the normal diet alone”) still describes, more simply, all ways to manage patients’ diet through foods other than FSMP, including through food supplements and fortified foods.

3. The §§67–68 pragmatic assessment

§67 recalls that the FSMP definition is interpreted narrowly, but when asking whether dietary management cannot be achieved by modification alone, operators and authorities must weigh practical considerations — not only a theoretical meal plan on paper.

§68 (and the Notice’s surrounding assessment) recognises that alternatives may exist in theory yet be unrealistic or impractical. Factors include, in particular:

• availability of other products, including supplements with the same or very similar composition — the Notice’s example is a dose-form micronutrient product that is hard to call FSMP when supplements with the same or very similar composition exist;
• practical difficulty of modifying the diet without FSMP;
• consumption patterns, severity of the condition, and safety / risk of deficiency if the product is replaced by ordinary foods alone.

The test is not absolute impossibility. It is whether, for a typical patient with the relevant disease/disorder/condition, meeting needs exclusively with foods other than FSMP is impossible, impractical, unsafe or nutritionally/clinically disadvantageous. If supplements or fortified foods can do the job, the product fails the last limb of the FSMP definition.

4. Operator decision map

5. Claims, mandatory information and labelling

Article 7 of Delegated Regulation (EU) 2016/128 bans nutrition and health claims on FSMP. Mandatory information about the disease, disorder or medical condition is a category duty, not a back door into Regulation 1924/2006 claims. On supplements the reverse applies: disease references on the label or in advertising risk a medicinal or unauthorised health claim.

On repeating nutrition information: Article 6(2) of Regulation 2016/128 is an absolute derogation from Article 30(3) FIC — a ban on repeating mandatory nutrition elements, not producer discretion. Deeper piece: repeating nutrition information on FSMP labels.

6. Polish practice: GIS, hub and pathways

In Poland, food supplements follow GIS notification (Article 29 of the Food and Nutrition Safety Act). That is not an “FSMP authorisation” and does not cure misclassification. FSMP has its own documentation and labelling duties. Orientation hub: Supplement vs FSMP. This article does not invent GIS/URPL outcomes in individual cases — classification is product-specific under the EU definition and the §§67–68 evidence.

The Notice (§6) is guidance. Only the CJEU binds finally. Article 3 of Regulation 609/2013 empowers the Commission to decide whether a given food is correctly classified as FSMP by implementing acts — a complementary tool for Member-State divergence, not a standing registration of every product.

7. Operator checklist

1. Definition as a whole. Read Art. 2(2)(g) of Reg. 609/2013 in full — do not lift “medical supervision” alone.
2. Include supplements and fortification. §§60–66: they are part of modification of the normal diet.
3. Composition-competition map. Note whether supplements with the same or very similar composition exist (especially dose-form micronutrients).
4. §§67–68 factors. Document practical difficulty, consumption patterns, safety — not only a theoretical diet sheet.
5. Claims. On FSMP: Art. 7 ban. On supplements: only 1924/2006; disease on the label is a red flag.
6. Pathway. Supplement → Art. 29 GIS. FSMP → category notification. Do not confuse them.
7. Notice status. Guidance, not a judgment; cross-border disputes → Art. 3 FSG.

Glossary

Modification of the normal diet

Under Notice §§60–66: any dietary adjustment through foods other than FSMP, including supplements and fortified foods.

FSMP

Food for Special Medical Purposes — Art. 2(2)(g) of Reg. 609/2013.

Notice 2017/C 401/01

Commission guidance on FSMP classification (OJ C 401, 25.11.2017); CELEX 52017XC1125(01).

Art. 7 Reg. 2016/128

Ban on nutrition and health claims on FSMP.

Conclusion

“Modification of the normal diet” in the FSMP definition includes food supplements and fortified foods — that is what §§60–66 of Notice 2017/C 401/01 say. An operator who omits those products from the assessment omits a definitional condition. §§67–68 demand pragmatic evidence: if similar-composition supplements exist, classifying a micronutrient capsule as FSMP is hard to defend. Claims on FSMP are banned (Art. 7), and GIS supplement notification is not the FSMP pathway.

Primary sources

1. Commission Notice on the classification of Food for Special Medical Purposes (2017/C 401/01; OJ C 401, 25.11.2017, p. 1–12; CELEX 52017XC1125(01)), especially §§3, 6, 60–68.
2. Regulation (EU) No 609/2013: Art. 2(2)(g) (FSMP definition), Art. 3 (implementing acts on classification).
3. Directive 2002/46/EC: Art. 2(a) (food-supplement definition).
4. Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods.
5. Delegated Regulation (EU) 2016/128: Art. 6(2) (ban on repeating nutrition elements), Art. 7 (claim ban on FSMP).
6. Regulation (EU) No 1169/2011: Art. 30(3) (context for the Art. 6(2) Reg. 2016/128 derogation).
7. Regulation (EC) No 1924/2006 — nutrition and health claims (for foods other than FSMP).
8. Polish Act of 25 August 2006 on food and nutrition safety — Art. 29 (supplement notification).