# FICTIONAL DEMO DOSSIER — for testing KEvidence step 0 only

This document is invented for software testing. It does not describe a real product, applicant or dossier, and it is deliberately incomplete so that the data-gap analysis has something to find.

## Section II — Identity, characterisation and conditions of use

### 2.1.1 Name of the additive
Name of the additive: Vanillin (one active substance; not a preparation)
Trade name: DemoVan 99

### 2.1.2 Proposal for classification
Intended effect: to add flavour to feed.
Proposed category: sensory additives; functional group: flavouring compounds.
Other uses: vanillin is authorised as a food flavouring in the EU (FL no 05.018) and evaluated by JECFA.

### 2.1.3 Qualitative and quantitative composition
Composition: vanillin ≥ 99.5 % (w/w); loss on drying ≤ 0.5 %.
Specification: assay (HPLC) not less than 99.5 %.
Batch analysis (certificates of analysis attached, issued 2025):
Batch No. | DV2501 | DV2502 | DV2503
Assay (HPLC, %) | 99.8 | 99.7 | 99.9
Loss on drying (%) | 0.10 | 0.12 | 0.09

### 2.1.4 Impurities
Residual chemicals from synthesis: guaiacol < 0.05 %, glyoxylic acid not detected (LOD 0.01 %).
Heavy metals: lead < 0.5 mg/kg; arsenic < 0.1 mg/kg (LOQ 0.1 mg/kg), three batches.
The batches comply with specification.

### 2.1.5 Physical state of each form of the product
Appearance: white crystalline powder.
Bulk density: 0.55 g/cm3.
Dusting potential (Stauber-Heubach, DIN 55992): 120, 140 and 135 mg/m3 in three batches.

## 2.2 Characterisation of the active substance
Generic name: vanillin
IUPAC name: 4-hydroxy-3-methoxybenzaldehyde
Synonyms: vanillic aldehyde
CAS No: 121-33-5
EC number: 204-465-2
Molecular formula: C8H8O3
Molecular weight: 152.15 g/mol
Structural formula: see Figure 1.
Origin: produced by chemical synthesis from guaiacol and glyoxylic acid.
Purity: ≥ 99.5 %.
Melting point: 81–83 °C.
Solubility in water: 10 g/L at 25 °C.

## 2.3 Manufacturing process
The active substance is produced by chemical synthesis: condensation of guaiacol with glyoxylic acid, oxidation and decarboxylation, followed by purification by distillation and crystallisation. A flow chart is provided in Annex 3.
No antimicrobial substances are used in the production process.

## 2.4 Physico-chemical and technological properties
Shelf life: three batches stored in the original packaging at 25 °C for 24 months; recovery 99 % at the end of the storage period compared with the initial value.
Stability in premixtures and feed: not required for flavouring compounds.
Homogeneity: not required for flavouring compounds.

## 2.5 Conditions of use
Target species: all animal species.
Recommended use level: up to 25 mg/kg complete feed (12% moisture), via premixture.
No withdrawal period.

## 2.6 Methods of analysis
The assay is determined by HPLC-UV (in-house method, validated).