ISO Issues Natural and Organic Cosmetic Guidelines

In February this year, the International Standards Organization issued ISO 16128-1, Guidelines of technical definitions and criteria for natural and organic cosmetic ingredients and products (available to purchase here).  The description of the guidelines says:

ISO 16128-1:2016 provides guidelines on definitions for natural and organic cosmetic ingredients.

In addition to natural and organic ingredients, other ingredient categories which may be necessary for natural and organic product development are defined with associated restrictions.

ISO 16128 does not address product communication (e.g. claims and labelling), human safety, environmental safety and socio-economic considerations (e.g. fair trade), and the characteristics of packaging materials or regulatory requirements applicable for cosmetics.

Natural Ingredients

Natural ingredients are defined as ones that come from plants, animals, micro-organisms or minerals by various processes (which are defined in Annex A of the documents).

Minerals may be natural when they are inorganic substances naturally occurring in the earth.

Water is considered natural.

Organic ingredients are natural ingredients that are farmed or wild harvested in compliance with local organic regulations (or the ISO standard).

Aromatic natural raw materials are not covered in ISO 16128, but are defined in ISO 9235 (available to purchase here).

Derived Natural Ingredients

When natural and/or organic ingredients are modified, and at least 50% of the resulting product is of natual origin, it’s a derived natural product.  The acceptable processes are included in the document as Annex B.

Derived Mineral Ingredients

When minerals are chemically processed but have the same chemical composition as natural mineral ingredients, they are considered derived mineral ingredients.  A list of derived mineral ingredients is in the document as Annex D.

Non-Natural Ingredients

Any ingredient obtained from fossil fuels (petroleum products) is not considered natural.

A derived natural or mineral ingredient that contains more than 50% (by molecular weight) of fossil fuel origin is not considered natural.

Legality of the ISO Standard

This ISO standard is a guideline.  It is does not have legal weight in the US, and is not accepted or adopted by the FDA.  It does, however, give a good starting point for determining if your products are actually “natural” or not, and would be an excellent marketing or public relations tool. For example, “My products only use ingredients that are natural according to the ISO standard for natural cosmetic ingredients.”

The actual guidelines are copyrighted and are only available to purchase ($88, here).  If you are interested in making natural products, I highly recommend that you get the guideline and become familiar with it.

Comments

  1. Hi Marie:

    Thanks for posting this. Can you post Annex A that is referred to? The new processes that are used involve heavy laboratory involvement, and sometimes, even the use of GMO (microorganisms, including E. coli, Pseudomonas and Aspergillus niger) in the production of isolates and aromachemicals that are labeled “natural”. A few years ago the Natural Perfumers Guild adopted stringent requirements for natural isolates that exceed ISO 9235, limiting the isolates to those fractionally distilled and identifying the parent source.

    For your reference, one GMO “natural” vanillin citation is http://www.jbc.org/content/273/7/4163.full Many perfumers and flavorists are using a gamut of “natural” items in their products, unaware, because of false labeling, that they are anything but natural. Years ago, anything produced in a lab was labeled “artificial”, but lobbying and marketing have taken over, and the public is the victim.

    1. Author

      I’m sorry, but I can’t post the contents of the document as it is copyrighted and strictly licensed.

      Annex A lists the ingredient solvents that may be used (water, natural, derived) and the category of the resulting final ingredient (natural, derived, mixture).

      Annex B contains a list of chemical and biological processes for derived natural, derived organic and derived mineral ingredients (things like sulphatation, oxidation, hydrolysis, etc).

      I realize there are different standards, especially for aromatic materials. My goal is to let people know that the ISO has at least issued some standards. Thanks for pointing out the additional resources.

  2. Thank you sharing these ISO guidelines! Do you have additional insight as to if or when these ISO guidelines may be accepted or adopted by the FDA? And if they will ever have legal weight in US?
    Thanks again Marie!

    1. Author

      The FDA has been involved with “international standardization” for cosmetics, but has not yet accepted any of the cosmetic-related ISO standards. They are “looking” at the cosmetic GMP standards, but I expect that they will be more likely to write their own than accept the ISO standard (just my opinion). They are looking at reviewing their guidelines for “natural” food, but nothing yet. Within the last year or so (maybe two?) the FDA responded to a lawsuit concerning natural cosmetics and their statement to the court was that they were unlikely to come up with a standard for natural cosmetics because of the number of differing stakeholders. So … in my opinion it will be a long time before the FDA has a regulatory standard for “natural cosmetics”.

  3. I just want to do soap, will I need to go through all of these steps in order to make Soap?

    1. Author

      No, you don’t have to go through all these steps. These are the international guidelines for “natural and organic cosmetics” which should give you an idea of what is expected at the professional, international level.

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