Exact wording
- Why it matters
- Makes the proposition concrete enough to assess.
Use VARUNÉ Bio’s evidence map to connect a material, a result and a development claim. Build a record your team can investigate and improve.
One exact development statement
Record the material, result and interpretation
Export the brief and identify the next evidence
Resource scopeR&D resource. The worksheet organises a local development record; its worked example is fictional.
An open research resource
Organise one proposed statement, its evidence and the next decision. You can leave unknowns visible.
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A useful evidence map begins with one exact sentence and the decision behind it.
A paper can be relevant to a subject without supporting every statement made about that subject. Before adding references, write the proposed wording, identify its audience and explain where it would appear. A technical discussion with a formulator and a statement on a consumer product may raise different questions.
Include the impression created by nearby images or comparisons. Then ask a practical question: what would a reasonable reader believe has been demonstrated? That is the proposition your evidence needs to address.
| Record | Why it matters |
|---|---|
| Exact wording | Makes the proposition concrete enough to assess. |
| Audience and placement | Identifies who will interpret it and in what context. |
| Intended use and market | Defines questions that may need specialist review. |
| Decision | Explains whether you are selecting a material, planning work or considering public communication. |
An ingredient name is a starting point. The preparation, formulation and batch make the record useful.
Record the subject of the evidence and the subject of the proposed statement separately. Is one a crude preparation and the other a purified fraction? Has a material been incorporated into a different vehicle? Are the tested and proposed concentrations actually known?
Use identifiers that make those differences visible. If the relationship is uncertain, leave it uncertain. A shared name should not fill a missing preparation history. The European Commission also makes a separate regulatory point: an INCI entry in CosIng does not itself establish that an ingredient is permitted or approved for use.
The strength of an appraisal depends partly on what was available to examine.
Keep the citation or record reference together with a precise location, such as a figure, table or methods section. State whether you inspected the full text and supporting material, an abstract, a supplier summary or no underlying record.
For original work, link the conclusion to its underlying records in your controlled files. For published work, preserve the authors’ reported conditions and limitations. If the material is a hypothetical example, mark it as such at the start. None of these categories can silently substitute for another.
| Access recorded | Useful next question |
|---|---|
| Full text available | Were the relevant methods, results and supporting materials inspected? |
| Abstract only | Which methods or uncertainty cannot yet be assessed? |
| Supplier summary | Can the underlying study and tested preparation be inspected? |
| Original research record | Can the observation be traced to the experiment and analysis? |
| Hypothetical example | Is it unmistakably excluded from real substantiation? |
Write down where the observation was made before deciding where it applies.
Record the model or test surface, preparation state, exposure conditions, comparator and measurement time. Then place the proposed use alongside it. This makes the transfer question visible instead of hiding it inside a broad word such as performance.
For a hydration question, an inert film, a laboratory skin model and a human-use assessment are different evidence contexts. A useful map asks which part of the intended outcome each context addresses and what bridge remains to be established. The worksheet flags a selected laboratory-to-human transfer for review; it does not determine whether that transfer is justified.
Define the proposed function
Choose useful alternatives
Account for competing explanations
Advance, revise or stop
Explanatory framework - not an experimental result.
| Evidence context | Question to preserve |
|---|---|
| Material or inert-surface measurement | What property was measured under those conditions? |
| Biological model | Which aspect of the intended use does this model represent? |
| Human-use evidence | Does the population, formulation and use match the proposed statement? |
Capture the result closely enough that another reader can check it.
Record the endpoint, units, timing, comparison and uncertainty reported in the source. Identify what was independently prepared, sampled or observed. If an effect size, analysis detail or limitation is missing, write “not reported” rather than filling the space with an estimate.
Keep observation and interpretation in separate fields. “The instrument reading changed” is an observation only when the underlying record supports it. What caused that change and what it means for a product are further questions. Reporting guidance should fit the study type; CONSORT, for example, addresses randomised trials and is not a universal score for every experiment.
The important work often sits between the result and the final sentence.
Build a chain from the verified observation to the proposed interpretation, then to the intended material, use and wording. Label each link with the evidence or assumption it depends on. If the chain changes preparation, formulation, model or population, show that change.
This is a map of reasoning, not a hierarchy in which every study must climb the same ladder. The question is whether the particular evidence fits the particular statement. The 2017 technical document on cosmetic claims discusses this relationship as nonbinding working-group best practice; it is not an official Commission position or a product-specific legal decision.
What exactly was tested?
Where and under what conditions?
What changed in the measurement?
What can the result support?
Explanatory framework - not an experimental result.

Move from the characterised material to the measured function and the claim it can actually support.
A strong alternative explanation helps identify the comparison that matters.
Ask what else could produce the observed endpoint. In a film experiment, consider whether ordinary differences in deposited mass, thickness, solids, salts or handling could account for the result. In an assay, ask whether interference or the comparator choice could change its interpretation.
The aim is to specify a discriminating question. “There may be confounders” is too vague to guide work. “Would the difference remain when deposited mass is matched?” identifies a condition that a reviewed design could investigate. The appropriate controls and analysis still depend on the material and method.
| Alternative explanation | More useful next question |
|---|---|
| Different deposited amount | Was the comparison made on a suitable matched basis? |
| Contribution from the vehicle | What does the vehicle comparison establish? |
| Measurement interference | Could the test system register something other than the intended endpoint? |
| Different preparation history | Are handling and material changes documented well enough to interpret the comparison? |
Evidence and public wording need to be considered together.
A scientific mechanism discussed in a research context can take on a different meaning when used to promote a product. Record the intended use and market rather than treating wording as a final cosmetic edit.
The FDA explains that claims and other aspects of presentation can establish intended use. Its examples include claims about changing melanin production and regenerating cells. These are reasons to seek a product-specific US classification review, not a reason for this worksheet to classify a product automatically. GB, EU and other market decisions also require their own current context.
Narrow wording makes the next research question easier to see.
Begin with the actual subject, system and endpoint. Preserve meaningful conditions and uncertainty. If the source only supports a material-level observation, do not write the missing product-level conclusion into the sentence.
The comparison below is fictional. It shows how to frame the information to retrieve; it does not report an experiment, establish a benefit or provide approved claim language.
| Fictional proposed statement | What the record would need to establish |
|---|---|
| “This ingredient improves skin hydration.” | Which preparation and finished formulation, which users and use conditions, and which relevant evidence support the statement? |
| “Preparation H-01 showed a change in film mass under the reported laboratory conditions.” | The original result, comparator, conditions, units and uncertainty must first be inspected and verified. |
| “Whether H-01 offers a useful hydration benefit remains an open research question.” | A clear distinction between the research question and any established observation. |
The best next step addresses a consequential gap.
Turn the largest unresolved inference into a bounded work item. State the question, proposed measure, comparison and decision consequence. If a result could not change the next decision, reconsider whether it is the right work to prioritise.
Give the work item an accountable role and identify what must happen first: access to the source, material characterisation, method review, rights, facilities or a specialist assessment. Keep proposed thresholds and resources visibly provisional until justified. This avoids presenting a research plan as a completed milestone.
| Gap | Possible next decision |
|---|---|
| Underlying methods unavailable | Obtain and appraise the full source before selecting the material. |
| Tested and proposed preparations differ | Establish whether a defensible identity relationship exists. |
| Endpoint does not address intended use | Decide which additional evidence context would answer the actual question. |
| Public wording raises a classification question | Obtain the relevant specialist review before using that wording. |
Follow one fictional record all the way to its unresolved decision.
Imagine a team considering the sentence “H-01 improves skin hydration”. The only available information is a summary describing a laboratory film test on an inert surface. The underlying methods and results have not been inspected. H-01 is a fictional code, and there are no measurements or Bio results in this example.
The useful outcome is a better decision record: obtain the underlying source, identify the tested preparation, appraise the measurement and only then decide whether a human-use question is worth pursuing. Loading the example into the worksheet preserves those gaps. It does not create evidence.
| Part of the record | Fictional entry | Consequence |
|---|---|---|
| Source access | Summary only | Underlying methods and results remain to be checked. |
| Tested subject | Preparation H-01 | Composition and preparation history remain unknown. |
| System | Inert laboratory surface | A human-use transfer requires explicit consideration. |
| Target statement | Skin hydration in use | The proposed outcome extends beyond the recorded context. |
| Actual result | Not available | No performance conclusion can be entered. |
| Next decision | Appraise source and identity first | Further work depends on what that appraisal establishes. |
The worksheet organises your reasoning and identifies selected gaps in the information you enter.
Start blank or load the fictional example. You can leave fields unknown and still download the record. Prompts describe missing information or selected transfer questions; they are not an efficacy score, an evidence-quality rating or approval to publish. An absence of prompts does not establish that the reasoning is complete.
Entries are held in this browser session. Download a JSON copy for your own records or use the print view for a discussion. Keep confidential source documents and identity keys in your controlled files, and use non-identifying references here. Review downloaded files before sharing them.
External work is identified below. Access notes describe the material inspected for this page; company research questions and proposed work are not presented as findings from these sources.
Best-practice discussion of evidence-to-claim reasoning and avoiding unsupported ingredient-to-product extrapolation.
Scope and limitations: Nonbinding working-group best practice; explicitly not an official Commission position or legal determination. PDF text accessed; no human regulatory review completed.
Open original sourceINCI/CosIng entries do not themselves establish permission or approval.
Scope and limitations: No specific Bio material queried or authorised; substance-specific checks remain required.
Open original sourceIntended-use classification and examples including sun protection, melanin-production and cell-regeneration claims.
Scope and limitations: Federal overview; current drug routes, state law and product-specific advice are outside this determination.
Open original sourceTruthful labelling and intended-use claims.
Scope and limitations: Not a review of any Bio label, advertisement or product.
Open original sourceStudy-type appropriate reporting-checklist entry point for randomised trials.
Scope and limitations: Reporting completeness is not a numerical bias or efficacy score; method must fit study design.
Open original source