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Trace Materials

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What are trace materials?
In addition to the ingredients that are added to a product to create its functionality, there are often other unique substances present in small quantities in the final formulation. Here at Seventh Generation we call these substances trace materials.

Trace materials may be present in our cleaning products at percent levels, at parts per million (ppm) levels, or even at parts per billion (ppb) levels. We classify trace materials into two different categories: trace constituents and incidental ingredients.

What are trace constituents?
Trace constituents can sometimes be byproducts of chemical reactions that occur during the manufacturing of many of our products. Two examples of this are 1,4-dioxane (present in the surfactant sodium laureth sulfate) and formaldehyde. Seventh Generation sets strict limits on the concentrations of these byproducts, negating any risk of human health or environmental hazard. In the case of 1,4-dioxane, we require that our suppliers vacuum strip the sodium laureth sulfate in order keep the levels of this byproduct below 5ppm in the raw material.

Trace constituents can also be naturally occurring impurities in the raw materials we source. This can happen because we use plant and mineral-derived raw materials. An example of this is sodium chloride, or salt. The salt used in our products is obtained from natural sources; however, even after purification, magnesium chloride and calcium chloride can be present as trace constituents at extremely low concentrations in our final product. These trace constituents do not pose any human health or environmental hazard.

What are incidental ingredients?
The second category of trace materials are incidental ingredients. Although manufacturers of cleaning products are not required to list their ingredients, Seventh Generation has chosen to disclose all of our cleaning product ingredients according to the Federal Food, Drug and Cosmetic Act (FDCA).
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The FDCA requires the label on each package of a product to declare the name of every ingredient greater than 1% in the final formulation in descending order of predominance, except fragrances and flavors which may be listed as fragrance or flavor. Ingredients present below 1% can be listed in any order desired by the manufacturer. To make it easier for our consumers to understand, Seventh Generation groups ingredients by function and lists the functions in order of predominance.
However, the FDCA allows exceptions for what are called incidental ingredients. Incidental ingredients as defined by the FDCA are:

• Substances that have no technical or functional effect in the [product] but are present by reason of having been incorporated into the [product] as an ingredient of another [product] ingredient.

• Processing aids, which are as follows:

• Substances that are added to a [product] during the processing of such [product] but are removed from the [product] in accordance with good manufacturing practices before it is packaged in its finished form.

• Substances that are added to a [product] during processing for their technical or functional effect in the processing, are converted to substances the same as constituents of declared ingredients, and do not significantly increase the concentration of those constituents. (iii) Substances that are added to a [product] during the processing of such [product] for their technical and functional effect in the processing but are present in the finished [product] at insignificant levels and do not have any technical or functional effect in that [product]. 21 CFR §701.3(l).
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Two examples of incidental ingredients in our products include:

• Preservatives are often added to the raw materials we purchase. For example, the biodegradable, plant-derived surfactants that we use are subject to microbial contamination. To prevent this, the manufacturers add a preservative to them. By the time we add other substances to the surfactant to make a product, the level of preservative present is too small to be effective. Therefore such preservatives are incidental ingredients. Indeed, we have to add our own preservative to our products to protect them from microbial degradation!

• The hydrogen peroxide we use in some of our products contain stabilizers added by our suppliers to prevent the peroxide from decomposing. As with preservatives, these stabilizers are considered incidental ingredients.

What are we doing to find out as much as possible about trace materials in our raw materials?
In an effort to continuously maintain the authenticity of our products, we are working with all of our suppliers to identify as many trace materials in the ingredients they supply us as possible.

 

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