1) Chemical identity;

2) Physical form;
3) Molecular weight;
4) Characterisation and purity of the chemical
including isomer composition;
5) Characterisation of the impurities or accompanying
contaminants;
6) Solubility;
7) Partition coefficient (Log Pow);
8) Relevant physical and chemical specifications;
9) Homogeneity and stability.

THE SCCS NOTES OF GUIDANCE FOR THE TESTING OF COSMETIC INGREDIENTS

AND THEIR SAFETY EVALUATION
9th revision
 The precise chemical nature of the substance under consideration
and its structural formula must be given. The Chemical Abstracts
Service (CAS) number of the chemical, the International
Nomenclature of Cosmetic Ingredients (INCI) name or Common
Ingredient Nomenclature (CIN, as in Regulation (EC) No 1223/2009)
name and the EC number should be provided.

 With regard to substances that cannot be identified in terms of their

structural formula, sufficient information should be provided on the
method of preparation (including all physical, chemical, enzymatic,
(bio)technological or microbiological steps) and the materials used
in their preparation to enable assessment of the probable structure
and activity of the compound(s).
 For the safety evaluation of a natural substance (e.g. an extract),
complete information should be provided on the origin of the raw
material (e.g. part of a plant), extraction method and any additional
processes and/or purification steps used.

 In the case of a mixture used as “raw material”, all substances must

be given in the qualitative and the quantitative formula. These could
be: main components, preservatives, antioxidants, chelators,
buffering agents, solvents, other additives and/or additional
external contamination.

 When a salt or ester of a substance will be used as a cosmetic

ingredient, this must be clearly specified in the dossier. The physical
and chemical properties of the specific salts/esters must be
provided. And the same specific substances must be used in the
toxicological studies performed for the safety evaluation. Any
deviations will need to be justified.
 Physical form
A description of the physical form should be given: powder, paste,
gel, liquid. For nanoparticles, further information should be given,
including the particle size and its distribution.
For polymer ingredients, molecular weight distribution should be
provided.

 Molecular weight
The MW of each substance should be given in Daltons. In the case
of mixtures, the MW must be given for each of the constituents.

 Identification and purity of the chemical and isomer composition

The experimental conditions of the techniques used for the
chemical characterisation (UV, IR and NMR spectroscopy, Mass
Spectrometry, chromatographic techniques, elemental analysis,
etc.) as well as the resulting spectra, chromatograms etc. should be
provided.
 Characterisation of the impurities or accompanying contaminants
In addition to the purity of the substance under consideration, an
identification of the nature of impurities that may be present must
be stated, along with their concentrations. Impurities should be
characterised and quantified by an appropriate analytical method,
e.g. by HPLC-PDA, LC-MS/GC-MS, NMR spectroscopy etc., using
reference standards where appropriate.

Relevant physicochemical specifications

 A typical physicochemical data set consists of:

- Physical state (solid, liquid, gas)

- Organoleptic properties (colour, odour, taste if relevant)
- Solubility properties in water and relevant solvents, including
receptor fluids (at … °C)
- Partition coefficient (Log Pow, at … °C), if applicable
- Flash point
- Physical properties depending on the physical state
 Solubility
The solubility of the substance in water and/or in any other relevant organic
solvent should be stated (in g/l at … °C). Some substances are sparingly soluble
or insoluble in aqueous medium or other solvents.

Partition coefficient (Log Pow)

 The n-octanol / water partition coefficient should be given, specifying pH
and temperature.
 In case of a calculated value, the method used for estimation should be
specified.

 Homogeneity and stability

 Homogeneity data of the test solutions with respect to the content of the test
substance, under experimental conditions, should be provided.
 The stability of the test substance under the experimental conditions of
various studies and under conditions of use should be reported. In addition,
the stability of the test substance under storage conditions as well as in
typical cosmetic formulations should also be provided.