Health Claims and Product Development:

Why the Intended Product Claims Should Be Defined Before the Formulation

A formulation can support the intended communication only when the claim, the substance concerned, the conditions of use, the product matrix, the intake and the shelf life all align. Checking claims only at the final artwork stage confuses copy approval with product development.

Executive summary:

The intended communication must be established before the formulation decision because it creates specific requirements for substance identity, minimum content, reference quantity, dosage form and accompanying labelling. Finding a similar statement in the EU Register is not enough. The authorised substance–effect relationship, all conditions of use, the product as actually consumed, the analytically substantiated quantity throughout the intended shelf life, and the overall impression created by the product name, design and advertising must all be assessed. Development ready for internal approval brings the claim, formulation, specification, stability strategy and communication materials into the same controlled version.

The claim is part of the product brief

In many projects, communication about product effects is initially treated as a marketing and artwork task. The formulation develops in parallel: product development optimises taste, processing and cost; purchasing qualifies raw materials; and Regulatory Affairs receives the proposed statements shortly before print approval. It is often at this stage that an attractive positioning proves to have no permissible claim, or that the already established formulation fails to meet the claim’s conditions.

Regulation (EC) No 1924/2006 covers more than explicitly worded promises. Images, symbols, product names or the overall presentation can also convey a claim. Nutrition claims are permitted only if they are listed in the Regulation’s Annex and meet the relevant conditions. Health claims generally require authorisation; general rules such as the prohibition of misleading information, scientific substantiation and consumer understanding also apply. [1] The first development question is therefore not: ‘What sentence can we put on the front?’ It is: ‘What nutritional or health message should this specific product convey, and in what context of use?’

The EU Register is an essential working tool, but it does not provide automatic clearance. It lists authorised and non-authorised health claims, conditions of use, restrictions and the relevant legal acts; authorised general function claims are set out in particular in Regulation (EU) No 432/2012. [2] A search result does not establish whether the substance concerned meets the actual specification, whether the required quantity is achieved or whether the proposed wording retains the meaning of the authorised relationship.

This distinction matters commercially. A communication concept may focus on ‘energy’, ‘the immune system’ or ‘recovery’, yet lead to very different formulations. An early decision on claims translates a broad benefit area into legally and technically defined product parameters. It may also establish that the intended message cannot be substantiated reliably in the proposed matrix. Such a negative decision is not a failure of Regulatory Affairs; it prevents investment in a commercial concept built around a formulation that cannot subsequently be used as intended.

An authorised statement creates a measurable formulation requirement

Many authorised health claims for vitamins and minerals require the food to meet at least the conditions for the nutrition claim ‘source of’. For conventional foods, whether this threshold is met depends on the reference quantity. As a general guide, the EU Food Information to Consumers Regulation specifies 15 per cent of the nutrient reference value per 100 g or 100 ml for products other than beverages, 7.5 per cent per 100 ml for beverages, or 15 per cent per portion where the package contains only a single portion. It also governs the nutrition declaration and the declaration of nutrients highlighted voluntarily. [3]

The claim therefore cannot be separated from the matrix. The same vitamin C content may require different assessment and declaration in a shot, a 500 ml drink, a powder for reconstitution or a food supplement. The form in which it is consumed also matters: the Claims Regulation refers to the food ready for consumption in accordance with the manufacturer’s instructions and to the quantity reasonably expected to be consumed. [1] Dilution factor, portion definition and recommended intake are therefore formulation inputs, rather than wording details to be added later.

Where a conventional food is deliberately fortified with vitamins or minerals to enable a claim, Regulation (EC) No 1925/2006 and its permitted substances and compounds also become relevant. Food supplements are subject to the product-specific rules of Directive 2002/46/EC. [4] The communication decision can therefore affect substance form, dosage, product category, mandatory information and national risk assessment simultaneously. An inexpensive raw material is not a suitable substitute if its chemical form is not permitted, its specification is inadequate or its stability in the selected matrix has not been demonstrated.

Nor is the legal minimum threshold automatically a robust manufacturing target. Raw-material variability, process losses, interactions with the matrix and degradation during storage may mean that a product appears eligible for a claim on paper at filling but falls below the threshold later. The Commission’s guidance on official compliance checks of declared nutrient values addresses the relevant minimum or maximum limit for claims and, on the critical side, generally allows only for measurement uncertainty. [5] The technical implication for development is that the target value needs a justified margin, derived from raw-material data, process trials, analysis, packaging and shelf life rather than chosen as a blanket allowance.

This is more than a laboratory issue. A large overage can alter taste, colour, solubility and cost or, for certain nutrients, call into question a safe dosage appropriate to the target market. A small overage, by contrast, increases the risk that compliance with the claim condition can no longer be demonstrated during shelf life. A viable formulation must navigate between these extremes, controlling both the minimum requirement for the communication and the upper safety and quality limits.

Wording, the subject of the claim and the overall impression must align

The wording of authorised claims may be adapted provided that the meaning remains the same for consumers. This flexibility does not permit the scientifically assessed relationship to be broadened. The Commission’s guidelines on Article 10 also clarify that general references to health or well-being may be used only alongside an appropriate specific health claim. The required accompanying information—including the reference to a balanced diet and healthy lifestyle, and the quantity and pattern of consumption required for the claimed effect—must also form part of communication planning. [6]

Shifting the subject of a claim is particularly prone to error. Where a claim is authorised for vitamin D, the design must not imply that a plant extract highlighted alongside it, or the product as a whole, produces the same effect. An asterisk does not reliably resolve this attribution issue. Germany’s Working Group of Food Chemistry Experts has expressly stated for such presentations that the effect must not be attributed to other ingredients without an appropriate authorisation, or indirectly to the food as a whole. [7] This administrative position does not create a new category of claim, but illustrates how the EU prohibition is applied in enforcement practice to product names, imagery and spatial placement.

For a functional drink containing vitamin B6 and a prominently named plant extract, the following may therefore apply: the established legal position is that the authorised effect may be communicated only under its conditions of use and in relation to the substance for which it is authorised. Supplier statements such as ‘traditionally used for balance’, a marketing dossier or successful use in other markets do not demonstrate EU authorisation. Food Essentials’ professional assessment is that the front-of-pack concept should already be rejected or restructured if consumers are likely to attribute the claimed effect to the extract or the overall formula. A formally correct footnote cannot remedy a contradictory main message.

Following the CJEU judgment, botanicals leave no room for blanket assumptions about transitional provisions

Development briefs still frequently describe botanical claims as ‘on hold’ and therefore usable. At the latest since the Court of Justice of the European Union’s judgment in Novel Nutriology, this simplification is no longer defensible. In 2025, the Court held that health claims relating to botanical substances may generally not currently be used to advertise a food until the Commission has completed its assessment and included them in the lists of authorised claims—unless the specific use is covered by a transitional provision. [8]

In practice, this means neither that all botanical communication is automatically prohibited nor that inclusion on an on-hold list is sufficient. A documented assessment is required of the specific claim, its history, the applicable transitional provision, the target market and the overall impression. Product development must therefore not simply adopt the extract quantity recommended by a supplier for a principal botanical claim. If the intended claim lacks a legal basis, a higher dosage does not produce a better claim; it may merely add cost, sensory problems and product-classification risks.

Approval must cover packaging, online shops and professional communication

Claims do not appear only on labels. Product detail pages, marketplace copy, paid advertisements, newsletters, presentations, trade-fair materials, influencer briefs and materials for distribution partners may constitute commercial communication. The CJEU has ruled that the Claims Regulation also covers commercial communication addressed exclusively to healthcare professionals where the advertised food is intended for final consumers. [9] A technically worded sales document is therefore not outside the claims regime simply because of its intended audience.

The most useful unit for internal approval is consequently a set of claims, rather than a single artwork. This set links each statement to the substance concerned, its permissible meaning, conditions of use and required accompanying information. It also identifies the media and markets covered by the approval. Product name, short claim, extended wording, imagery and consumption instructions must convey the same promised effect. If marketing subsequently changes ‘contributes to normal function’ to ‘activates’, or turns a substance-specific statement into a benefit of the whole product, the change is not merely textual; it may exceed the approved meaning.

Germany and Austria apply the same core EU rules to nutrition and health claims. Alongside the legislation, the Austrian health ministry expressly refers to implementation guidance and recommendations on flexibility of wording. [10] This does not remove the need to consider national enforcement practice, language and overall presentation in the target market. Switzerland is certainly not an automatic extension of an EU assessment. Permitted nutrition and health claims there are set out in Annexes 13 and 14 of the Swiss Ordinance on Food Information; health claims not listed require authorisation by the FSVO. The Swiss authority also emphasises that EU on-hold claims have no special status in Switzerland. [11]

A ‘DACH claim’ should therefore not be managed as a single dataset without a country-specific decision. Substance identity, analytical results and stability data may be shared. The legal basis, wording, mandatory accompanying information, language and approval for particular media must remain clearly assigned to each market.

Claim approval needs to match the formulation version

A robust product file links the approved claim to the formulation actually manufactured, the relevant raw-material specifications, the manufacturing process, the declared intake, the stability evidence and the communication materials concerned. The objective is not to file as many documents as possible. Each approval must clearly identify its underlying assumptions and the changes that would trigger reassessment.

If the vitamin source changes, the overage is reduced, the portion size changes, the powder is diluted further or the shelf life is extended, the claim assessment must be checked again against the current product version. The same applies to a new front-of-pack hierarchy, an additional plant extract or a changed product name. Change control that compares only formulation and specification, without addressing the approved subject of the claim, overlooks a significant part of the requirements for lawfully placing the product on the market.

The previous technical article on product categories showed why dosage form, dosage, intended purpose and communication jointly determine the regulatory framework. With health claims, this connection becomes operational: the communication establishes a measurable product specification, and the product specification limits what may actually be said.

Conclusion

Clarifying claims before formulation does not mean allowing marketing to dictate product development. It means translating the intended benefit promise into legal, technological and analytical requirements in time. Only then can a decision be made on whether the claim fits the category and matrix, which substance form and quantity are required, what margin remains viable until the end of shelf life, and which communication can be approved for packaging and other channels.

A late artwork check can correct spelling, mandatory information and individual phrases. It cannot repair a missing legal basis for a claim, an unsuitable matrix or an unstable formulation. Food Essentials helps companies bring claim strategy, formulation development, the evidence plan and communication approval into one coordinated development version.

Where the intended effect communication, raw-material concept and product format do not yet fit together reliably, Food Essentials can use a focused claims and formulation review to structure permissible messages, critical formulation parameters and the evidence required before the next development round.

Wishing you a pleasant Sunday, Andreas Gebhart

References

All sources checked on 14 August 2026.

1. VO (EG) 1924/2006, Art. 1–10 und 12–14 sowie Anhang.
2. VO (EU) 432/2012, Art. 1–2 und Anhang sowie Europäische Kommission: EU Register of Health Claims.
3. VO (EU) 1169/2011, Art. 7, 30–34 und 36 sowie Anhang XIII.
4. VO (EG) 1925/2006, Art. 3–8 sowie Anhänge I–III und RL 2002/46/EG, Art. 2–6 sowie Anhänge I–II.
5. Europäische Kommission: Leitlinie zu Toleranzen bei deklarierten Nährwerten.
6. Durchführungsbeschluss 2013/63/EU, Anhang.
7. ALS/ALTS, Beschluss 2023/92/03.
8. EuGH, C-386/23, Novel Nutriology.
9. EuGH, C-19/15, Innova Vital.
10. BMSGPK Österreich: Nährwert- und gesundheitsbezogene Angaben bei Lebensmitteln.
11. LIV, Art. 29–35 sowie Anhänge 13–14 sowie BLV: Nährwert- und gesundheitsbezogene Angaben.

Note: This article provides professional information and does not constitute legal advice. The specific product, the complete communication, the target market and the legislation in force at the time of the decision are decisive. Image: AI-generated.