A specific claim “somewhere on the pack” is not enough. In its judgment of 30 January 2020 in Case C-524/18 Dr. Willmar Schwabe v Queisser Pharma (CELEX 62018CJ0524; ECLI:EU:C:2020:60), the Court of Justice held that the “accompanying” requirement in Article 10(3) of Regulation (EC) No 1924/2006 has both a substantive and a visual dimension. A general reference on the front and specific claims only on the back — with no clear cross-reference (such as an asterisk) — do not satisfy Article 10(3).
1. What Article 10(3) says
Article 10(1) of Regulation 1924/2006 prohibits health claims that do not meet Chapter II and IV and are not listed under Articles 13 and 14. Article 10(3) is a narrow derogation: reference to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being may be made only if accompanied by a specific health claim included in the lists provided for in Article 13 or 14.
Implementing Decision 2013/63/EU (Annex point 3) sets the practice: the specific authorised claim should appear “next to” or “following” the general statement; it should bear some relevance to that reference; the FBO must demonstrate the link. The broader the slogan (“for good health”), the more listed claims may potentially pair with it — but the link still has to be shown; any random Register entry will not do.
2. Facts in C-524/18
The dispute concerned a food supplement combining, among other things, B-vitamins and zinc. The pack carried a slogan along the lines of “B vitamins and zinc for the brain, nerves, concentration and memory” — treated as a general reference under Article 10(3) — while the specific claims for the individual vitamins and zinc appeared on the other side of the packaging. A competitor (Schwabe) challenged the front-of-pack presentation. The Bundesgerichtshof referred questions on the scope of “accompanying” and on whether a general reference needs its own scientific substantiation.
3. Holding: front without a cross-reference ≠ accompanying
In operative point 1 the Court ruled that the accompanying requirement in Article 10(3) is not satisfied where the packaging contains a reference to general, non-specific health benefits on the front, while the specific health claim intended to accompany it appears only on the back and there is no clear reference — such as an asterisk — between the two.
Reasoning (§40): “accompanying” requires not only that the specific claim specify the content of the general wording, but also that the location of both claims on the packaging enable an average consumer (reasonably well informed, attentive and circumspect) to understand the link. Hence two dimensions: substantive and visual.
§47: the visual dimension means the consumer’s immediate perception of a direct visual link — in principle through spatial proximity or immediate vicinity.
§§48–49: exception — where the specific claims, because of their size or length, cannot appear in their entirety on the same side as the general reference, the direct visual-link requirement may exceptionally be met by an explicit cross-reference (e.g. an asterisk), provided it ensures, clearly and perfectly comprehensibly for the consumer, that the content of the claims and the reference match. Whether a given asterisk works is for the national court.
4. Second question: scientific evidence
In operative point 2 the Court held that general references under Article 10(3) must be justified by scientific evidence within the meaning of Articles 5(1)(a) and 6(1). It suffices that they are accompanied by specific claims on the Article 13 or 14 lists — because those claims have already been assessed and authorised. There is no need for a separate EFSA dossier for the wellbeing slogan itself, provided the Article 10(3) pair (including the visual dimension) is real.
That is not a free pass for “anything general”. The slogan remains a health claim in the regulation’s broad sense; the Article 10(3) derogation is interpreted strictly (§56: derogation from the Article 10(1) principle).
5. Operator decision map
| Question | If YES | If NO |
|---|---|---|
| Is there a general slogan on the front / in ads (wellbeing, “for immunity”, “for energy”, “for the brain…”)? | Enter Article 10(3) | Check whether it is an unauthorised specific claim (Article 10(1)) |
| Is it paired with a Register claim (Art. 13/14) with a substantive link? | Run the visual test | Remove the slogan or add a lawful pair |
| Is the pair “next to” / “following”, or linked by a clear asterisk (only if it cannot fit on the same side)? | Document the layout | Front + back with no cross-reference = C-524/18 breach |
| Are the specific claim’s conditions of use (dose) met? | Also check Article 10(2) on the label | An Article 10(3) pair does not cure a failed use condition |
| Are you conflating this with Article 10(2) (particulars (a)–(d))? | Read C-657/24 separately | Keep the regimes separate |
6. Educational example (not a SKU)
Hypothetical example: “Supports immunity” on the front with no specific claim in visual range — Article 10(3) breach. The same phrase next to an authorised vitamin C immune-function claim, at the dose required by the conditions of use — a possible Article 10(3) construction if the layout meets C-524/18 proximity. “Immunity” on the front and vitamin C only in small print on the reverse with no asterisk — the layout the operative part treats as non-compliant.
7. What the judgment does not decide
- It does not replace Article 10(2) (mandatory particulars (a)–(d)) — a separate regime; after C-657/24, press advertising is not “labelling” for repeating those particulars if they are already on the label. See C-657/24 Kyberg.
- It does not settle “on-hold” botanical claims — that is C-386/23 Novel Nutriology (and GIS notices). Article 10(3) is not a back door for botanicals without a listed pair or Article 28(6).
- Novel-food status, additive status or a GIS notification does not “unlock” claims.
8. Operator checklist
- Map general slogans on pack, PDP, ads and marketplace — same 1924/2006 regime.
- Pair with a Register claim (Art. 13/14) with a real link; document it (Decision 2013/63 point 3).
- Visual layout: next to / following; front+back only with a clear cross-reference when content cannot fit on one side (C-524/18 §48).
- Conditions of use of the specific claim (amount per portion) must be met.
- Article 10(2) on the product label — separate from the Article 10(3) pair.
- Do not confuse with Kyberg: no-repeat of (a)–(d) in press ads does not waive Article 10(3).
Glossary
- General claim (Article 10(3))
- Reference to general, non-specific benefits for overall good health / wellbeing — not itself on the Art. 13/14 lists, but only with a specific pair.
- Accompanying
- Substantive dimension (clarifying content) + visual dimension (proximity or clear cross-reference) — C-524/18 §§40, 47–48.
- Decision 2013/63/EU
- Commission guidelines on Article 10; Annex point 3: “next to” or “following”; relevance; burden on the FBO.
Conclusion
Article 10(3) is not a licence for wellbeing slogans “somewhere on the tin”. C-524/18 requires an Article 13/14 pair and a layout that lets the average consumer see the link at once — in principle spatial proximity; an asterisk only exceptionally when the claims cannot fit on the same side. Front without a cross-reference to the reverse = operative-part failure. The scientific-evidence duty is met precisely through the authorised specific pair — provided accompanying is real.
Primary sources
- CJEU judgment of 30 Jan 2020, C-524/18, Dr. Willmar Schwabe — CELEX 62018CJ0524; ECLI:EU:C:2020:60; operative points 1–2; reasoning §§40, 47–50, 56, 59.
- Regulation (EC) No 1924/2006 — Arts 5(1)(a), 6(1), 10(1) and (3), 13 and 14; CELEX 32006R1924.
- Commission Implementing Decision 2013/63/EU — Annex point 3 (general references); CELEX 32013D0063; OJ L 22, 25.1.2013, p. 25.
- CJEU C-657/24 (Kyberg) — Article 10(2); contrast with Article 10(3); CELEX 62024CJ0657.
- CJEU C-386/23 (Novel Nutriology) — botanicals / Articles 10(1) and (3); CELEX 62023CJ0386.