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When do you need a feed claims dossier? Learn how to substantiate claims with scientific literature, formulation and dose, and organise the evidence.
A defensible claim is more than a sentence that sounds legally acceptable.
A brand should be able to explain why the statement is true for the specific product, at the specific dose and in the specific animal species.
That is the purpose of claim substantiation documentation, often called a claims substantiation dossier, a scientific dossier or simply a substantiation dossier.
At FoodUP, we use the term “marketing claims substantiation dossier” because it reflects the practical objective: collecting and organising the evidence needed to support a claim.
The principal basis is Article 13 of Regulation (EC) No 767/2009.
It permits certain claims concerning properties, functions, the presence of substances or processing, provided they are objective, verifiable and understandable to the feed user.
The person responsible for labelling must hold scientific substantiation and provide the relevant supporting evidence when requested by the competent authority.
“The ingredient supplier says so” or “our competitors make the same claim” is therefore insufficient.
No. Regulation 767/2009 requires substantiation and evidence, not a mandatory file called a “substantiation dossier”.
FEDIAF's guidance on pet food labelling and claims provides a more practical framework for organising such documentation.
A dossier is therefore structured compliance documentation, not an official form with a single prescribed template. Its purpose is to demonstrate clearly and logically that the claim has both scientific and product-specific support.
It is best prepared before market communication begins. Article 13 requires the scientific substantiation to be available when the feed is placed on the market.
Waiting for a question from an authority is a poor starting point.
A useful sequence is:
claim → evidence strategy → literature review → formula and dose assessment → dossier → communication approval → launch.
This avoids launching a campaign only to discover later that its promise cannot be substantiated.
There is no universal template for all products, but a robust dossier should answer the following questions.
Identify:
The subject of assessment is a claim attached to a specific product.
“Immunity” or “joints” is not specific enough.
The dossier should work with the exact intended wording, for example: “supports the maintenance of normal joint condition in adult dogs”.
This makes it possible to determine whether the collected evidence matches the scope of the promise.
Identify the ingredient, combination of ingredients or product characteristic responsible for the claimed effect. Then assess it against:
This is a crucial stage: the literature may concern a similar ingredient without supporting the product actually being sold.
A professional dossier should explain how the evidence was identified.
Depending on the subject, sources may include:
Record the search terms, date ranges and selection criteria so the review can be reproduced and audited.
A dossier should do more than collect PDFs.
Assess each relevant publication for:
Only then can the strength of the evidence be judged.
FoodUP prepares documentation according to product complexity, from simple formulas to advanced products with multiple ingredients and extensive communication.
The scope may include a literature review, evidence quality assessment, dose and product analysis, assessment of permissible claim wording and a final dossier for your compliance records.
Contact: team@foodup.com.pl.
If you are still designing the product, read: Your own pet supplement brand: from idea to shelf.
This important element is often overlooked. Reliable documentation should not present only supportive studies when credible contradictory findings exist.
Selecting favourable publications alone is commonly called cherry-picking and weakens the overall assessment.
Include:
The conclusion should be proportionate to the actual strength of the evidence.
This is the central question.
For example, a study may test an extract standardised to 10% of an active constituent, given to dogs at 200 mg/day.
The product may contain another manufacturer's extract, standardised to 2%, at a daily dose of 30 mg.
The same botanical name alone is insufficient to assume that the reported effect transfers in full. The assessment concerns relevance, not merely the existence of a publication.
Stronger wording requires stronger evidence. “May support” and “proven to improve” are not equivalent.
The dossier should conclude what level of communication can actually be substantiated.
Sometimes the literature supports a moderate statement about support but does not justify a stronger assertion of improvement. Even cautious wording still needs appropriate substantiation.
This is where regulatory and marketing teams need to agree.
Consider separately the risks of:
The dossier then becomes a decision-making document as well as an evidence record.
When assessing the boundary with medicinal presentation, also consider Article 4 of Regulation (EU) 2019/6: the definition of a veterinary medicinal product includes substances presented as having properties for treating or preventing disease in animals.
Provide a complete list of the sources used.
Depending on the organisation, supporting documents may include:
This matters for cost. A product containing one well-characterised ingredient with a moderate claim may require considerably less work than a complex formula with several ingredients, a distinct functional narrative and multiple claims.
Scale the scope to:
Documentation should not be permanently closed on launch day.
Review it when:
Recording the review date and outcome is good practice.
An authority may ask: “What supports your statement that the product supports X?”
A sound answer should not be “the ingredient manufacturer told us”.
It should lead to an organised package showing:
That is when the dossier fulfils its practical purpose.
No. The type and strength of evidence depend on the claim. Existing knowledge and literature may be sufficient in some cases; original studies may be important, or necessary, for stronger promises.
Generally, an ordinary compound feed does not require a claim dossier approved before marketing for each product. The responsible operator must nevertheless possess suitable substantiation and provide it when requested.
It can form part of the dossier, but should not normally be the only basis. Its quality and relevance to the actual product, dose and claim must be assessed.
A reliable assessment should consider relevant evidence even when it does not support the proposed claim. Otherwise, the risk of selective presentation increases.
Yes, particularly after changes to the formula, supplier, dose or claim, and when important new scientific data become available.
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