Category 1	Single substances, chemically characterised; sources consisting of, isolated from or produced from material of inorganic mineral origin
1.1	Chemical name (i.e. unequivocal trivial name), and chemical name according to IUPAC nomenclature rules
1.2	CAS number, E Number (where appropriate), EC (or EINECS) number, and other identification numbers, as available from established scientific sources.
1.3	Synonyms, trade names, abbreviations
1.4	Molecular and structural formulae
1.5	Molecular weight (or atomic weight for elements) (g/mol, Da)
1.6	Particle size, shape and distribution, if applicable
1.7	Spectroscopic data (printout) such as IR, UV‐VIS, NMR or MS spectra or other data
1.8	Description of physical and chemical properties: appearance, melting point, boiling point, specific gravity, stereochemistry (if any)
1.9	Solubility (reference e.g. JECFA general method for solubility (JECFA, 2006)) in water and other common solvents
1.10	Influence of pH on solubility; ionisation constant(s)
1.11	Octanol‐to‐water partition ratio (KOW)
1.12	Other data that the applicant considers may be useful to support the identity of the substance
Category 2	Mixtures of simple substances, chemically characterised
2.1	Chemical name, when appropriate, according to IUPAC nomenclature rules
2.2	Chemical composition: identity of the components of the mixture, as required for item 1
2.3	CAS number, E Number (where appropriate), EC (or EINECS) number, and other identification numbers, as available from established scientific sources
2.4	Synonyms, trade names, abbreviations
2.5	Proportion of each component in the mixture
2.6	Molecular and structural formulae of each component in the mixture
2.7	Molecular weight (or atomic weight for elements) (g/mol, Da) of each component in the mixture
2.8	Spectroscopic and chromatographic data (printout of spectra/chromatogram) which allow the identification of the components of the mixture
2.9	Description of physical and chemical properties: appearance, stereochemistry, of each component (unless not applicable)
2.10	Solubility (reference e.g. JECFA general method for solubility (JECFA, 2006)) in water and other common solvents
2.11	Particle size, shape and distribution, if applicable
2.12	Other data that the applicant considers may be useful to support the identity of the substance
Category 3	Complex mixtures not derived from botanical sources, possibly not fully chemically characterised (chemical characterisation extent depending on the proposed use and use levels)
3.1	Starting materials or source materials
3.2	Species, in case of animal origin
3.3	Chemical name, when appropriate, according to IUPAC nomenclature rules of each component
3.4	CAS number, E Number (where appropriate), EC (or EINECS) number, and other identification numbers, as available from established scientific sources of each component. A mixture should also be identified with appropriate identification number(s), if any available, from established scientific sources
3.5	Synonyms, trade names, abbreviations
3.6	Chemical description, the level of principal components in so far as these are known and level of unidentified components
3.7	Description of physical and chemical properties
3.8	Solubility (reference e.g. JECFA general method for solubility (JECFA, 2006)) in water and other common solvents
3.9	Particle size, shape and distribution, if applicable
3.10	Other data that the applicant considers may be useful to support the identity of the substance
Category 4	Sources consisting of, isolated from, or produced from animals and parts thereof
4.1	Scientific (Latin) name (zoological family, genus, species, subspecies, breed, if applicable)
4.2	Synonyms that may be used interchangeably with the scientific name
4.3	Common names (if a trivial or common name is used extensively, it should be linked to the scientific name and part used)
4.4	Part used
4.5	Geographical origin (continent, country, region)
Category 5	Sources of botanical origin
In addition to information listed in 1–3 and 5
5.1	Scientific (Latin) name (botanical family, genus, species, subspecies, variety with author's name, chemotype, if applicable)
5.2	Synonyms (botanical name) that may be used interchangeably with the preferred scientific name
5.3	Common names (if a trivial or a common name is used extensively in the monograph, it should be firmly linked to the scientific name and part used)
5.4	Part used (e.g. root, leaf, seed)
5.5	Geographical origin (continent, country, region)
5.6	Growth and harvesting conditions (wild or cultivated; cultivation practices, time of harvest in relation to both season and stage of the plant growth)
Furthermore, data on the chemical composition of the plant‐derived proposed source should be provided with emphasis on the concentrations of relevant constituents of relevance; this includes the concentrations of the following:
5.7	Compounds classified according to their chemical structure (e.g. flavonoids, terpenoids, alkaloids)
5.8	Constituents being characteristic for the food additive (chemical fingerprint, markers)
5.9	Constituents that provide reasons for concern due to their chemical, pharmacological or toxicological properties
5.10	Information on maximum levels for microorganisms and possible contaminants, including heavy metals, mycotoxins, pesticide residues, and polycyclic aromatic hydrocarbons (PAHs), should be provided (EFSA Scientific Committee, 2009)
Category 6	Sources consisting of, isolated from, or produced from cell culture or tissue culture derived from animals, plants, fungi or algae
6.1	Biological source (taxonomic information on family, genus, species, subspecies, variety)
6.2	Organ and tissue or part of the organism sourced
6.3	Laboratory or culture collection sourced
6.4	Information on the identity of cells
6.5	Cells or tissue substrate used as a Novel Food
6.6	Type of culture
Category 7	Natural, derivatised and synthetic polymers
7.1	Chemical name (i.e. unequivocal trivial name) and chemical name according to IUPAC
7.2	CAS number, E Number (where appropriate), EC (or EINECS) number, and other identification numbers, as available from established scientific sources
7.3	Synonyms, trade names, abbreviations
7.4	Chemical and structural formula
7.5	Molecular weight (or atomic weight for elements) (g/mol, Da) or number average molecular weight and weight average molecular weight (if feasible)
7.6	Structural formulae of monomers and starting materials, other agents involved in the polymerisation
7.7	Degree of substitution, percentages of substituted groups (where appropriate)
7.8	Description of physical and chemical properties
7.9	Solubility (reference e.g. JECFA general method for solubility (JECFA, 2006)) in water and other common solvents
7.10	Particle size, shape and distribution, if applicable
7.11	Other data that the applicant considers may be useful to identify the mixture and its components
Category 8	Sources containing microorganisms or derived from microorganism, fungi or algae
The following information is required for substances of microbial origin:
8.1	The microbial origin of food additives produced by fermentation or cultivation, including: name of the microorganism; taxonomic classification of the microorganism; history of modification of the production organism
8.2	Whether the microorganism fulfils the requirements for a Qualified Presumption of Safety (QPS) (EFSA, 2007b and subsequent updates, e.g. EFSA BIOHAZ Panel, 2018). In such cases, no further data on the microorganism itself are required
8.3	Information on residual levels of toxins
8.4	Information on the production process
8.5	Information on the identity of residual intermediates or microbial metabolites in the final product
8.6	Other relevant information as recommended by applicable guidance documents (EFSA GMO Panel, 2011; EFSA FEEDAP Panel, 2018)
Category 9	Nano‐sized materials, engineered and unintentionally produced
In addition to the information listed in 1–3 and 7, the information reported in Table 1 of the EFSA draft Guidance on risk assessment of nanoscience and nanotechnologies is required (EFSA Scientific Committee et al., 2018) and subsequent updates and EFSA draft guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles (EFSA 2021, to be finalised by 2021) 30 :
9.1	Chemical composition, identity: information on chemical composition of the ENM including purity, nature of any impurities, coatings or surface moieties, encapsulating materials, processing chemicals, dispersing agents and/or other formulants (e.g. stabilisers)
9.2	Particle size (primary/secondary): information on primary particle size, size range, and number size distribution (indicating batch‐to‐batch variation, if any). The same information needed for secondary particles (e.g. agglomerates and aggregates), if present. Two methods to be used, one being electron microscopy
9.3	Physical form and morphology: the information should indicate whether the ENM is present in a particle‐, tube‐, rod‐shape, crystal or amorphous form, and whether it is in free particulate form or in an agglomerated/aggregated state as well as whether the preparation is in the form of a powder, solution, suspension or dispersion
9.4	Particle and mass concentration: information on concentration in terms of particle number, and particle mass per volume when in dispersion and per mass when as dry powder
9.5	Specific surface area: information on specific surface area of the ENM, essential for dry powders
9.6	Surface chemistry: information on ENM surface, including any chemical/biochemical modifications that could modify the surface reactivity, or add a new functionality
9.7	Surface charge: information on zeta potential of the ENM
9.8	Redox potential: conditions under which redox potential was measured need to be documented
9.9	Solubility and partition properties: information on solubility of the ENM in relevant solvents and their partitioning between aqueous and organic phase (e.g. as log KOW if appropriate)
9.10	pH: essential for liquid dispersions (e.g. aqueous suspensions)
9.11	Viscosity: information on viscosity of liquid dispersions
9.12	Density and pour density: information on density/porosity of unformulated ENM and pour density (essential for granular materials)
9.13	Dustiness: information on dustiness of powder products, such as spices, creamers, and soup powders
9.14	Chemical reactivity, catalytic activity: information on relevant chemical reactivity or catalytic activity of the ENM and of any surface coating of the ENM
9.15	Photocatalytic activity: information on photocatalytic activity of relevant materials used in food packaging, coatings and printing inks, and internal reactions