ISO 16128 Cosmetics - Guides to Technical Definitions and Criteria for Natural and Organic Cosmetic Ingredients and Products

The standard “ISO 16128 Cosmetics - Guides to technical definitions and criteria for natural and organic cosmetic ingredients and products” developed by the International Organization for Standardization (ISO) essentially consists of two parts published under the same title:

• The standard “ISO 16128-1 Part 1: Definitions for ingredients” describes guidelines for definitions for natural and organic cosmetic ingredients. In addition to natural and organic ingredients, this standard defines other ingredient categories that may be necessary for natural and organic product development, with associated restrictions. The ISO 16128 standard does not address product communication (e.g. claims and labeling), human safety, environmental safety and socio-economic aspects (e.g. fair trade), nor does it address the characteristics of packaging materials or regulatory requirements applicable to cosmetics.

Natural ingredients are cosmetic ingredients derived solely from plants, animals, microorganisms or minerals, and are derived from these materials,

• Physical processes (e.g. grinding, drying, distillation)
• Fermentation reactions that occur in nature and lead to naturally occurring molecules, and
• Traditional ones without intentional chemical modification (e.g. extraction using solvents)

The annex to this standard includes a definition of solvents and categories of extracts obtained using solvents for ingredient processing and manufacture (Annex A). The following materials and materials resulting from them are considered under the general heading of natural origin:

• Plants, including fungi and algae (ingredients derived from genetically modified plants may be considered natural ingredients in certain parts of the world)
• Minerals
• Animals
• Microorganisms.

Components derived from fossil fuels are excluded from the definition.

Natural mineral compounds are inorganic substances (i.e., noncarbonate and carbonate salts) that occur naturally in the earth's crust and have a unique chemical formula and a consistent set of physical properties (e.g., crystalline structure, hardness, colors).

Organic ingredients are natural ingredients originating from organic farming methods or wild harvesting in accordance with national legislation or equivalent international standards where applicable.

Water is considered natural. However, the following defined types of water can be treated differently:

• Constituent water is the liquid (juice) content of fresh plants.
• Reconstitution water is equivalent to the water contained in the original material and is used to restore the dry material to its original content.
• Extraction water is water used to physically remove components from a mixture of materials.

Neither ISO 16128-1 nor ISO 16128-2 address product communication (e.g. claims and labelling), human safety, environmental safety, socio-economic issues (e.g. fair trade), characteristics of packaging materials or regulatory requirements applicable to cosmetics. This standard is based on and improves upon ISO 16128-1. However, it is intended to be used in conjunction with ISO 16128-1.

The approach to determining the natural, natural origin, organic and organic origin indices for cosmetic ingredients is as follows: This standard applies to ingredients as defined chemical substances or animal, mineral, microorganism or plant materials (in whole, in part or as an extract). In the case of a mixture of two or more ingredients, each ingredient contribution is taken separately.

When a solvent is partially evaporated, the producer of the extract may use industry best practices (e.g., measurement by instrumentation, characterization of solvent volatility, published values ​​of evaporation rates) to determine the indices of the extract. The approach and rationale for this determination should be made available to interested parties upon request. The calculation of extract indices follows the conventions described in this standard. In the case of extracts, the following principles apply when determining the indices:

• The indices of the finished extracts should reflect the starting materials (i.e., the component solvents and the unextracted mass).
• Extracts can be produced from fresh or dried materials.
• The extraction procedure ends with the separation of the extract from the insoluble residue (e.g. in filtration). If further processing is performed (e.g. dilution, preservation), their contribution to the indices is treated as the addition of new components.
• The final extract (e.g. in the case of concentration) cannot show more organic or natural content than the starting materials.
• Dry herbs are allowed to be reconstituted with water to their original fresh mass. Reconstitution water must be present in the finished extract to count towards its natural or organic content.
• When calculating the organic index, regeneration water is considered organic, while any excess extraction water is considered natural.
• An extract obtained from non-organic plants has an organic index and an organic origin index of 0.
• The component solvents are defined in the annex of the ISO 16128-1 standard.
• It is allowed to use non-natural ingredients (e.g. alcohol denaturants) in component solvents. However, if the mixture contains a non-natural component solvent, then the entire mixture is not natural.

The naturalness index is a value that indicates the extent to which a cosmetic ingredient complies with the definition of a natural ingredient in the ISO 16128-1 standard. The value is assigned to each ingredient according to the following guideline: Naturalness index = 1: The ingredient complies with the definition of a natural ingredient. The naturalness indexes of the constituent water, reconstitution water, extraction water and formulation water are each considered as 1. Naturalness index = 0: The ingredient does not comply with the definition of a natural ingredient. The naturalness index of the extract is calculated according to the given formula. For example, the naturalness index of extracts of natural ingredients is 1 if the solvents used (including water) are natural.

The natural origin index is a value that indicates the extent to which a cosmetic ingredient complies with the definitions of natural ingredients, derived natural ingredients or derived mineral ingredients in the ISO 16128-1 standard.

Our organization has a strong staff that closely follows the developments in the world in the field of science and technology and constantly improves itself. Among the numerous test, measurement, analysis and evaluation studies provided for businesses in various sectors, there are also testing services in accordance with the standard “ISO 16128 Cosmetics - Guides to technical definitions and criteria for natural and organic cosmetic ingredients and products”.