Challenges in Creating NPA- and WFM-compliant Natural Formulations

Jan 14, 2014 | Contact Author | By: Victoria Cherepanov and Nava Dayan, PhD, Innovation KDC and Dr. Nava Dayan LLC
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Title: Challenges in Creating NPA- and WFM-compliant Natural Formulations
naturalx certifying organizationsx preservationx choice of emulsifiersx surfactantx
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Keywords: natural | certifying organizations | preservation | choice of emulsifiers | surfactant

Abstract: Where does the formulation chemist begin when facing a marketing request for a product stamped with a “natural” label claim? The first step is to identify the certifying organization or government under which the formulation is to be sold, followed by the choice of preservatives. The basic approach to composing natural products is outlined here.

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V Cherepanov and N Dayan, Challenges in Creating NPA- and WFM-compliant Natural Formulations, Cosm & Toil 129(6) 42-49 (Jul/Aug 2014)

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In order to clearly observe the steps required by the formulation chemist in working with naturally derived ingredients, hereafter simply called naturals, one must begin not with the chemist but with the proposition of marketing request. So, where does the formulation chemist begin when facing a marketing request for a product stamped with a “natural” label claim? The first step is to identify the certifying organization or government under which the formulation is to be sold, to determine whose definition of natural should be considered. Since there is no globally unified definition for what constitutes natural, this information should be outlined and learned at the earliest stages of development to smooth the subsequent path toward intelligent formulation.

In an effort to illustrate the path to meet the challenges of formulating natural products, this article will concentrate on complying with the two primary authorizing organizations in the North American market—Whole Foods Markets (WFM) and the Natural Product Association (NPA). Though these two organizations will be the main focus, readers are reminded that any product sold in the United States must first comply with U.S. Food and Drug Administration (FDA) regulations and pass all necessary safety and regulatory-related tests. Considering this, a regulatory expert as well as a toxicologist should be involved in advising product developers of the necessary requirements, tests, costs and overall timeline to completion.

Composing Leave-on Products

The formulating process for leave-on naturals is, at its base, similar to that for conventional emulsions. However, one key difference is the choice of preservative system since most preservatives currently used are synthetic—yet the prevention of microbial growth is essential. The industry often uses parabens, methylchloroisothiazolinone and methylisothiazolinone in conventional products. These will typically not affect the physical properties or stability of formulations. In contrast, when natural preservatives are used, pH may play an important role in maintaining the efficacy of the preservatives since some preservatives will be effective only at a relatively narrow pH range. Therefore, it is recommended that when selecting ingredients for natural products, the formulator should begin by building from the preservative system; a suggested order of ingredient selection is as follows: 1) preservative or preservation system, chosen based on compliance with the natural association; 2) emulsifiers; 3) oil phase components; 4) antioxidants; 5) viscosity builders and stability modifiers; and 6) benefit ingredients to support intended claims. In addition, cost restrictions must be taken into consideration.

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Table 1. Oxidative stability index (OSI*) of emollients

Emollient
OSI
Almond oil 7.6
Borage oil 4.7
Castor oil 21.6
High oleic safflower oil 12.0
Jojoba oil 34.0
Olive oil 3.9
Macadamia oil 72.0
Soybean oil 6.0

*The OSI is determined as the number of hours before the test emollient begins rapid oxidation at 110°C; larger values represent higher oxidative stability.

Formula 1. WFM-compliant lotion

Water (aqua) 78.00% w/w
Glycerin 3.00
Corn Starch 1.00
Xanthan Gum 3.00
Glyceryl Stearate (and) Cetearyl Alcohol (and) Sodium Stearoyl Lactylate 4.50
Caprylic/Capric Triglyceride 4.00
Squalane 2.00
Macadamia Oil 3.00
Cocoa Butter 0.50
Tocopheryl Acetate 0.50
Ethylhexylglycerin (and) Phenoxyethanol 1.00
Bisabolol 0.10
Essential Oil 0.10
Extracts 2.00
  100.00

Note: This formulation was not tested for coherency and stability.

 

Formula 2. NPA-compliant Lotion

Water (aqua) 76.40%w/w
Glycerin 3.00
Corn Starch 1.00
Xanthan Gum 3.00
Methyl Glucose Sesquistearate 4.50
Caprylic/Capric Triglyceride 4.00
Squalane 2.00
Macadamia Oil 3.00
Cocoa Butter 0.50
Tocopheryl Acetate 0.50
Sodium Benzoate 0.20
Benzyl Alcohol 0.20
Dehydroacetic Acid 0.50
Bisabolol 0.10
Essential Oil 0.10
Extracts 1.00
  100.00

Note: This formulation was not tested for coherency and stability.

Formula 3. NPA-compliant Rinse-off Formulation

Water (aqua) 72.71% w/w
Decyl Glucoside 5.00
Sodium Benzoate 0.59
Coco-glucoside (and) Glyceryl Oleate 3.00
Citric Acid 0.80
Lauryl Glucoside 3.00
Glycerin 2.00
Sodium Coco-sulfate 8.00
Sodium Chloride 0.20
Sodium Cocoglucoside Tartrate 3.00
Extracts 1.00
Dehydroacetic Acid 0.40
Fragrance (parfum) 0.30
  100.00

Note: This formulation was not tested for coherency and stability.

Formula 4. WFM-compliant, Rinse-off Formulation

Water (aqua) 71.12% w/w
Xanthan Gum 1.00
Glycerin 4.00
Decyl Glucoside 15.00
Disodium Cocoamphoacetate 5.00
Caprylyl/Capryl Glucoside 2.00
Citric Acid 0.28
Phenoxyethanol 0.50
Sodium Benzoate 0.20
Potassium Sorbate 0.20
Fragrance (parfum) or Natural Flavor 0.50
Extracts 0.20
  100.00

Note: This formulation was not tested for coherency and stability.

 

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