Article by: Perry Romanowski

When you look at the back of a cosmetic product label, you will see all of the raw materials included on the list of ingredients (LOI).  At least you should.  We’ve previous talked about the rules for cosmetic labeling and how you are supposed to use the concentration to list ingredients in order above the 1% line.  But someone posted an interesting question on the SCC Linked In page.  Specifically, they wanted to know whether there was some lower limit to meet before you have to list an ingredient.


Cosmetic Labeling Rules

The short answer is No, there is no lower limit.  If you know that an ingredient is in your formula then you should list it.  This includes all intentionally added ingredients by you, and even the intentionally added ingredients from your raw material supplier.  For example, if you are buying a surfactant in which the supplier has put a preservative, you are required to list that preservative on your LOI no matter how minuscule the amount.  However, if there is some unintentional ingredient then you don’t have to list that.  For example, companies do not have to list 1,4 Dioxane or Lead even though the raw material might contain trace levels of these impurities.

Impurities do not have to be listed.  Intentionally added ingredients do.

Cost Savings

Which raises an interesting point.  Many exotic cosmetic raw materials like natural herbs and extracts are incredibly expensive.  However, they also go a long way to help sell your product so companies like to include those ingredients in their LOI.  The problem is if they put too much of the ingredient in the formula it could have a negative impact on performance, odor, or just lead to a formula that costs too much.  So one of the strategies of cosmetic companies is to put a very small amount of the “feature” ingredient in the formula; say 0.001%.  And when they look for cost savings projects, that level might be cut down to 0.0001%.

The reason you can do this is because the reality is that most of these “feature” ingredients do not have a consumer noticeable effect.  When you reduce the level, it’s unlikely that anyone will notice except maybe your accounting department.



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    And what about in EU?

    According to art. 19 reg. 1223/2009 only impurities and technical substances no more present in the finished product (such as solvents) cannot be listed. But looking at the substance definition at art.1

    “‘substance’ means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition”

    “any additive necessary to preserve” don’t put raw material preservatives in the same substance of the raw material avoiding to list it?

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    Do you think this could be an argument for not including the preservatives in raw materials?
    From the 15th edition of the International Cosmetic Ingredient Dictionary and handbook

    5. Incidental Ingredients – Incidental ingredients contained in cosmetic raw materials are not included in the INCI name.
    Incidental ingredients include antioxidants, preservatives, or processing aids that are present for a specific function in a raw material, but are not intended to have a technical or functional effect in the finished cosmetic and are present at an insignificant level in the finished cosmetic product. For more information on requirements for incidental ingredients in the U.S., see 21 CFR 701.3 (l)(1) and (2).

    1. Avatar
      Perry Romanowski

      Yes, an argument could be made for not listing preservatives. It’s just that if they are present in an insignificant level in the finished product then you still need some other preservative to preserve your product. If you know that the preservatives from your raw material are preserving the finished product then they are not in your formula at an insignificant level. But I’m not a lawyer and this is more of a legal question.

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    Does anybody know if the stabilizers in Hydrogen Peroxide (for ex stannates) need to listed in the EU?

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      Dear David, I have the same problem. I am using Hydrogen Peroxide for leave-on product, but it contains Etidronic Acid as a stabilizer. The main problem is, that Etidronic Acid is not allowed as main ingredient in leave-on skin products (EU) so, if I label it, the customer will refuse the product.

      Does anybody have any suggestions?

      Thank you for your replay.

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    Hey, I don’t think you have to add the preservatives or other “processing aids” added by the manufacturer of the raw materials to your ingredient statement in the US. We do this for our EU ingredient statements but not the US. All of our clients do it this way too. Unless the regulations have changed in the US and nobody told us I don’t believe you have to list those.

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      Perry Romanowski

      This is a common misconception. Indeed you DO have to list preservatives put in your raw materials. At least according to the PCPC who is responsible for such things.

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        I don’t think that’s correct. According to the Cosmetic Labeling Manual from the FDA Preservatives in raw materials are considered incidental ingredients and don’t need to be listed:

        “4. A substance added to a cosmetic as a component of a cosmetic ingredient and having no technical or functional effect in the finished cosmetic. Example: Preservative of a raw material added to a cosmetic as an ingredient at a concentration which reduces the preservative to a level at which it is no longer effective.”

        Here’s the link:

        Now, if there is a preservative in a surfactant that is in the product at 30% perhaps that would not qualify as “no longer effective”…

        I didn’t look at the PCPC sources because my attention span right now is not what it should be… Do they say something different?

        1. Avatar
          Perry Romanowski

          Well, you raise a very good point. I will have to investigate further. In the company I worked for we had to list even preservatives that came in raw materials but perhaps we were doing it wrong.

          I should say that the FDA information is a little out of date. In section 701.3c they say…

          “The currently recognized edition of the CTFA (Cosmetic, Toiletry and Fragrance Association, Inc.) Cosmetic Ingredient Dictionary is the second edition published in 1977. This edition is recognized only in part, i.e., not all names listed in the second edition have been adopted.

          The third edition of the CTFA Cosmetic Ingredient Dictionary published in 1982 and the Supplement published in 1985 have not yet been recognized. However, FDA has informed the CTFA that the agency will not take regulatory action against products labeled in accordance with these editions while their review is in progress.”

          The PCPC is now up to the 12th or 13th edition and that is what people are using.

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