Overview
ISO 16128-2:2017/Amd 1:2022 is an International Organization for Standardization (ISO) amendment to Part 2 of ISO 16128 - Guidelines on technical definitions and criteria for natural and organic cosmetic ingredients. Part 2 defines practical criteria for ingredients and products, and Amendment 1 (published 2022) clarifies and corrects calculation formulas, variable definitions and worked examples used to determine natural index and organic index values in cosmetic formulations. The document was prepared by ISO/TC 217 (Cosmetics) and is guidance for the cosmetics sector.
Key topics and technical requirements
- Revision of calculation formulas: Amendment 1 updates legends and variable definitions used to calculate indices for natural and organic content (natural index I, organic index Io and organic origin index). The amendment clarifies how solvent masses are classified and summed in the formulas.
- Solvent categorization: Definitions and mass categories clarified for solvents such as:
- natural but not organic solvents
- derived-natural but not derived-organic solvents
- derived-organic solvents
- total mass introduced (ingredients and ingredient solvents)
- Fresh/dry ratio correction: The amendment clarifies that the ratio k should be interpreted as fresh/dry (not dry/fresh) in relevant formulae.
- Worked examples corrected: Annex B examples (e.g., extraction of organic fresh flowers to produce hydrolate) are revised to show corrected calculations of organic index values (one example yields Io = 0.25), which helps users apply the formulas to real extraction and formulation scenarios.
- Guidance nature: The standard provides guidance rather than regulatory requirements; users should combine it with applicable national/regional rules and certification schemes.
Applications and practical use
- Cosmetic formulators use the guidelines to quantify the proportion of natural and organic content in formulas and to support product claims.
- Ingredient suppliers reference the criteria to classify ingredient origins and to provide consistent data to customers.
- Certification bodies and auditors apply the index calculations during certification, label verification and compliance checks.
- Regulatory and quality teams use the standard to harmonize internal specifications, documentation and marketing claims related to “natural” and “organic” cosmetics.
- Laboratories and R&D groups use the worked examples to validate calculation methods when analysing product composition.
Who should read this
- Cosmetic manufacturers, product developers, ingredient suppliers, certification bodies, quality managers and regulatory affairs professionals operating in natural/organic personal care markets.
Related standards
- ISO 16128-1 (technical definitions and criteria - Part 1) - consult together for full context on definitions and methodology.
- Regional organic/cosmetic labeling standards and certification schemes (use in conjunction with ISO guidance).
Note: ISO 16128-2 and its amendment are voluntary guidance documents intended to increase transparency and consistency in assessing natural/organic content in cosmetic products.