Three years ago, the two parts of the ISO 16128 standard "Guidelines on technical definitions and criteria for natural and organic cosmetic ingredients and products" were published. The aim of this series of standards is to harmonize the principles and criteria of natural and organic cosmetics in the world. There are already many products claiming natural or organic percentages according to ISO 16128 on the market, but on manufacturers’ side, some difficulties in interpretation remain.
In order to answer the questions of manufacturers, the ISO working groups have written a technical report, which was published at the end of August 2021. This technical report TR 23750 consists of a series of 82 questions and answers, either to clarify some points of the standard, to explain more precisely the main principles of ISO 16128 or to give examples of calculations.
As professional association for cosmetic companies, COSMED is part of the AFNOR/ISO cosmetics working groups and has been contributing to the development of ISO 16128 series of standards since the beginning. This review will highlight 5 issues where TR23750 brings some clarifications.
The standard provides definitions of a natural ingredient, a derived natural ingredient, an organic ingredient, a derived organic ingredient. Four indexes can be attributed to each cosmetic ingredient: the natural index, the natural origin index, the organic index, the organic origin index.
The index is 1 when the ingredient meets the definition and 0 when the ingredient does not meet the definition. If the ingredient is complex, such as a plant extract in a solvent, the index will need to be calculated.
For example, formulation water is natural, but not organic. Its 4 indices are therefore determined as follows: Natural index = 1; Natural origin index = 1; Organic index = 0; Organic origin index = 0.
Once these four indices have been determined for each of the ingredients in the formula, it is possible to calculate the contents of the mixture, obtaining a result in the form of a percentage. There are eight contents: natural content, calculated from the natural indexes of the ingredients; natural origin content, calculated from the natural origin indexes; organic content, calculated from the organic indexes; organic origin content, calculated from the organic origin indexes. Each content can be calculated by including or excluding the formulation water.
INDEXES AND CALCULATIONS IN ISO 16128
COSMED | France
Marie Magnan is regulatory affairs manager at COSMED and specialised in cosmetic regulations in the EU and Asia-Oceania. COSMED, the French Professional Association for SMEs in the cosmetic field, counts more than 920 members. Cosmed Regulatory Monitoring is a tool that helps companies to be informed of cosmetic regulation in Europe and abroad, thanks to an extensive database on 120 countries, real-time alerts and assistance.
In several questions and answers, the new technical report provides clarification on raw materials, especially on the distinction between single ingredient and mixture.
Indeed, a cosmetic raw material may be either a single ingredient, i.e., a substance, or a mixture of substances. For substances, ISO 16128 uses the definition written in European REACH and cosmetics regulations: a chemical element and its compounds in the natural state or the result of a manufacturing process, excluding any solvent which may be separated without affecting the stability of the substance or changing its composition. Single ingredients are characterized by their various indexes.
When single ingredients are mixed with solvents, additives, or other ingredients, they are a mixture and are characterized by their contents. The calculation method for contents is described in ISO 16128, part 2.
For example, a fragrance is a mixture of natural, derived natural and non-natural ingredients, which has a natural content and a natural origin content. Then, the contents (in percentages) of this mixture are included in the formula to calculate the contents of finished cosmetics.
INGREDIENTS AND MIXTURES
In the definition of a natural ingredient, the origin of the ingredient and the process must be considered. To be defined as natural, the ingredient must be natural and obtained through physical processes. To obtain a derived natural ingredient, the natural origin of final ingredient must be more than 50% and it may have been subject to chemical reaction. In the definition of a derived natural ingredient with various reaction steps, every step before the last chemical transformation must be considered. As far as possible, ISO 16128 recommends the chemical process to be in line with green chemistry principles.
It is often difficult for manufacturers to discern whether the process they use will produce a natural, derived natural or non-natural ingredient. Some are listed in the standard, but those lists are only informative and non-exhaustive.
Therefore, the Technical Report gives more explanations on some processes and on principles to assess processes.
Among physical extraction processes to obtain a natural ingredient, micro-waves, sonication, and ultrasounds can be used, as long as there is no chemical modification. Supercritical CO2 extraction can also be used to obtain a natural ingredient.
As for the green chemistry principles, they are not mandatory but represent best practice. Consequently, processes like nitration, nitrosation, nitrification, halogenation, silylation, sulfonation, processes known as releasing nitrosamines, ionizing irradiation may not be consistent with these principles. With help from the ingredient manufacturer, an evaluation of the process in relation to the green chemistry principles should be done.
Dialogue between ingredient and cosmetic manufacturers is strongly encouraged.
The company that formulates the cosmetic products relies on the certificates of its ingredient suppliers. There are sometimes disparities between indexes of a same raw material, depending on the interpretation of different suppliers.
Indeed, the ingredient manufacturer may also be lost on how to define, interpret, and justify each ingredient in relation to these standards.
Therefore, ingredient manufacturers are recommended to provide cosmetic manufacturers with information related to composition, origin, and processing of ingredients, including information related to green chemistry. The indexes can be determined by ingredient manufacturers, but if not, the cosmetic manufacturer should have all the relevant information to determine the indexes. For each ingredient, cosmetic manufacturers shall be able to check the category and index based on the information provided.
ISO 16128 deals with ingredients and cosmetic products, not with human or environmental safety, socio-economic considerations, characteristics of packaging materials or regulatory requirements applicable to cosmetics. It does not provide certification for companies.
Besides, this series of standards does not address product communication, for example claims and labelling: it does not define what a natural or organic cosmetic is, but the calculation of content as a percentage can be claimed on the packaging. ISO 16128 being a technical standard, the calculations of indexes and contents could be used as a claim support.
The knowledge of the functioning and the principles of the ISO 16128 standard series is thus essential to label confirmed claims on cosmetics.
With the rise of natural and organic trends around the world, consumers have become increasingly demanding with brands for verified natural and organic claims. Around the world, the perception of naturalness varies greatly from country to country. Thus, the availability of ISO 16128 as a reference system at an international level is welcome.
Actually, a survey has been made among the members of ISO technical committee of cosmetics. For a majority, either the standard has been or is on the process to be implemented or it is widely used and recognised.
Yet, a standard remains voluntary in all cases. It only becomes mandatory if it is included in national legislation.
ISO 16128 SERIES