Botanical Names in Ingredient Declarations

inci-herbsThere has been considerable discussion over the years on how botanicals should be listed in the ingredient declaration for cosmetics. Based on some fairly recently posted information on the FDA website, it is now clear that common names are required, and when used as a secondary listing, Latin names are accepted.

Although the “INCI name” (which usually means the Latin name) is commonly thought to be required, it isn’t – it’s optional.

Important Note: This information applies to soap and cosmetic regulations in the United States.  Most other countries require that the Latin name for botanicals is used in the ingredient declaration.

Actual Law and Regulation

The actual law and regulation governing the way ingredients should be identified in cosmetic ingredient declarations comes from several sources.

Fair Packaging and Labeling Act

The Fair Packaging and Labeling Act was enacted in 1967.  It sets specific requirements for the labeling of consumer commodities (that is, products that are used by consumers and generally used up over time).  The FPLA directs the Federal Trade Commission and the Food and Drug Administration to issue regulations to implement the requirements outlined in the FPLA.  The FDA is responsible for the regulations applying to foods, drugs and cosmetics.

The FPLA specifies that when the ingredients must be listed, the common or usual name is used.

Code of Federal Regulations

Chapter 21 of the Code of Federal Regulations deals with food, drugs and cosmetics.  Chapter 21, Part 701.3, specifies that “The label on each package of a cosmetic shall bear a declaration of the name of each ingredient…” and later clarifies how the ingredient should be identified.

For botanicals, the name should be either as identified in  the CTFA Cosmetic Ingredient Dictionary, Second Ed (1977) – which listed botanicals by their common English name – or if not listed there, the name generally recognized by consumers. Either way, the correct wording is the common name, which complies with the FPLA requirements.

How Did the Latin Name Get Included?

In 1995, the CTFA (now Personal Care Products Council) published in 6th edition of the Cosmetic Ingredient Dictionary, which used the Latin genus and species names of botanicals in parenthesis along with the common name  (i.e. Peppermint (Mentha peperita) Oil).

Then, in the 8th edition, published several years later, PCPC again changed the way botanicals were identified.  In that edition, botanicals were named first by the Latin genus and species and then with the common name in parenthesis (i.e. Mentha peperita (Peppermint) Oil).

The goal, I think, was to standardize and harmonize the ingredient naming standards between the US and other countries, which were going toward requiring the Latin names for ingredients.

Most people, including myself, figured that the PCPC and the FDA were on the same page and that, so long as the common name was included, any of the different versions were okay to use.

Are the Regulations Changed?

It appears that when it comes to using the Latin name for botanicals in ingredient listings, the FDA and PCPC aren’t on the same page after all . In the last several months, the FDA posted several documents on their website that give some insight into their position. (You can see the documents list here.)

In March 1995, the CTFA wrote the FDA in preparation of their upcoming 6th edition of the Cosmetic Ingredient Dictionary, requesting that the FDA agree not to take action against labelers using the Latin genus and species to identify botanicals. They sent a follow-up letter changing the original request, asking that dual names be allowed as part of a “transition period”.

In June, 1995, the FDA responded.  The section concerning the Latin names for botanicals is quoted here [emphasis added]:

The use of Latin names as the primary identifying term for plant extract ingredients, with the current common name appearing imbedded in parenthesis, would not be consistent with the FPLA. The statute requires the use of the common or usual name, and there is no way that such a requirement can be considered to be met by the placement of the recognized common or usual name in parentheses after the Latin name.  Nor is the agency willing to accept the Latin name as the common or usual name of such ingredients.

Later in the document, the FDA went on to say:

If the CTFA petitions the agency to amend the cosmetic ingredient labeling regulations to specifically provide for the declaration of plant extracts by their common or usual name followed in parenthesis by their Linne INCI name in the ingredient statement, we would be unlikely to object during consideration of the petition to products intended for sale and distribution in the United States that bear such a dual declaration in the ingredient statement.

Following that exchange, in 1996, the CTFA filed an official Citizen Petition to the FDA to have the regulations changed to have the 6th edition recognized as the official source of ingredient names, including that the Latin genus and species be required in parenthesis when identifying botanical ingredients.

The FDA’s response, in July, 1997, said:

The purpose of this letter is to advise you, in accordance with 21 CFR 10.30 (e), that we have not been able to reach a decision on your petition within the first 180 days of the filing of the petition, because of the limited availability of resources and other agency priorities.

Please be assured that your Petition is under active review at the present time, and a more substantial response reflecting the agency’s determination of the merits of the several elements of the Petition will be forthcoming as soon as possible.

No further documents seem to be available on the FDA website concerning the status of the matter.

Note that PCPC continued to issue new editions of the Cosmetic Ingredient Dictionary, and as of the 8th edition, changed the nomenclature for botanicals to the Latin name with the common name in parenthesis – although that is clearly contrary to the FPLA.

What Does the FDA Want and Expect?

It’s very clear that the FDA, in accordance with the Fair Packaging and Labeling Act, wants the common name as the primary name used for botanical ingredients in the ingredient declaration.

That they “wouldn’t object” to having the Latin name as a secondary name (in parenthesis) is confirmed in a 2011 video on cosmetic labeling in which it is stated that the Latin name may be used that way, but they common name should be used first. (The quote is at about 12:16 into the video.)

So, bottom line, the FDA wants and expects the common name for any botanical ingredients.  If you want to include the Latin genus and species, you can do so – but only if it is in parenthesis embedded inside the common name.

Doesn’t that make labeling a little easier?

Comments

  1. Hi Marie

    Since you have avid fans/followers all over the world, just wanted to note that these are the US requirements. In Canada and I believe in Europe, it is the INCI that is required to be on the labels. Anyone who is new to soap and cosmetic making should check with the governing body of their country.

    Thanks for all you do!

    1. Author

      You are so absolutely right! I will modify the post accordingly.

  2. Thanks for keeping us informed on labeling. I want my labels to be as close to compliance as I can get them. It seems the rules are ever changing making that a difficult thing to do. I took advantage of your label review service and can’t thank you enough for your expert advice. It was money well spent!

    1. Author

      It appears that the FDA want the common name and, if you are using the Latin name, it should be in parenthesis. That’s different than the method of putting a slash between them.

      If you really want to save space, you can just use the common name (provided you are in the US, of course).

  3. I have sold my private label shampoo in my salon foe several years. I am considering the possibility of selling it on e bay and Amazon. I don’t want to use the name of the salon on the product. I know I had to search for and reserve the name of the business but what about the name of the product. Could you please tell me what the requirements are?

    1. Author

      There aren’t any requirements for the name of the product, other than the fact that you can’t use a name that has been trademarked by someone already.

  4. is there a book to purchase INCI DICTIONARY? I am now confused on labeling as I have read tons of other people’s post and how you should do things and it’s almost as everyone is different I want to start labeling my products and want to make sure I do it the correct way

    1. Author

      The Cosmetic Ingredient Dictionary can be purchased from the Personal Care Products Council (it’s $1,190.00 for non-PCPC members). However, most suppliers of cosmetic ingredients will (or should) provide you with the correct ingredient name(s) to be placed in the ingredient declarations. Where you get an INCI name of “xxx (and) yyy (and) zzz”, remember that you must list “xxx” and “yyy” and “zzz” in the ingredient list individually in descending order of predominace based on their percentage of the WHOLE. So you may need to get additional information from the supplier concerning the percentage of each component so you can list them correctly.

      Botanical ingredients, which are listed in the Cosmetic Ingredient Dictionary by their Latin names, must be listed in the ingredient declaration by their common English name (the FDA has NOT accepted the CID on this point). See Ingredient Names on the FDA website for more information and links to their letters to PCPC on the subject.

  5. I am SO confused about the labelling for macerated/infused oils and hope you might help! We are in the UK and have spent hours trawling the WWW but can’t find any clear advice!
    We currently make a range of creams, all have been tested and certified. I have infused one of our oils with Calendula petals and another batch with Comfrey leaves.
    Do we add the INCI name of the botanical at the end of the list of ingredients or do we list it with the oil and add an hyphon?
    I am sure that we will not have to have the recipes reassessed or do we?
    Do hope to hear from you

    1. Author

      I can’t say for the UK, but my understanding is that in the US the an “extract” or “infused oil” is considered a blended ingredient, so the carrier and the botanical matter must be listed separately (normally
      as something like “calendula leaf extract”). There would probably less than 1% actually in the product, so the extract could be listed at the end of the ingredients present at more than 1%, and then carrier would go in descending order based on the quantity in the product.

      As for getting the recipe retested … I don’t know the regulations. I would think that it might be needed on the basis that adding botanical matter in whatever form has the potential to add bacterial or other matter to the cream, which could affect the preservation system. You should check with someone who is more familiar with the testing, certification and registration rules in the UK.

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