Trace Materials
What are trace materials?
What are trace constituents
What are incidental ingredients
What are we doing to find out as much as possible about trace materials in our raw materials?

About Preservatives

Fragrances
Why do we list linalool and d-limonene on some of our labels?
At what concentration are they present in our products?

Trace Materials

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.

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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.
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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).

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:

1. 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.
2. Processing aids, which are as follows:
   1. 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.
   2. 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).

A great website to visit for a quick and easy overview of the Cosmetic Labeling Guide is http://www.cfsan.fda.gov/~dms/cos-lab3.html#clgl9
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.

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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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Preservatives

You have the right to know what makes our cleaning products SAFE for people and the environmental as well as EFFECTIVE at getting the job done. We have recently made some changes to the preservative system that we are using in some of our product formulations, and wanted to share some of the details about the old versus the new system – and our ongoing search for a wholly authentic, natural preservative.

Some of our product formulations require the use of a preservative, which helps prevent microorganism growth (see list below for products using a preservative). This is especially important in natural product formulations, as biologically-based formulas are more susceptible to spoilage. Currently there are no known natural preservatives that have been proven safe and effective in cleaning products like ours. However we have been working on improving the authenticity of our preservative system and are diligently searching for a wholly natural preservative system.

In the past, we have used the preservative hexahydro-1,3,5-tris (2-hydroxyethyl)-s-triazine (THT). We know that this preservative is synthetic (petroleum-derived), as well as a formaldehyde donor. Formaldehyde is an allergen and known carcinogen when inhaled, however it is not a carcinogen when applied to the skin, the most likely route of exposure from a cleaning product. We believe that finding a naturally-derived alternative to THT is important, and therefore are currently working to remove the THT from our products.

We are happy to share that we have found an alternative, synthetic preservative which is a combination of methyl-4-isothiazolin-3-one and 1,2-benzisothiazolin-3-one (MIT/BIT) which is not a formaldehyde donor. MIT/BIT is a synthetic preservative, however it is biodegradable, and has been proven to be non-irritating at the use level in our products. Not all of our products have converted to this new preservative system yet, but we are working on transitioning all of our preserved products to MIT/BIT.

We believe it is important for you to know what preservatives we are using, and to understand why. While we know that this transition to MIT/BIT as our new preservative system does not solve all of our authenticity challenges, we feel confident this is the best option for us at this point in time, and that it is both safe and effective for you and your family. Please stay tuned as we continue our search for a safe, effective and natural preservative system.

Which Seventh Generation products have preservatives?

• Seventh Generation Laundry Powder and Automatic Dishwasher Powder do not require preservatives because they do not contain water, so microbes cannot grow in them.
• Seventh Generation Carpet Spot & Stain Remover, Kitchen Cleaner, and Shower Cleaner do not use preservatives, because they contain hydrogen peroxide that destroys microbes and act as the preservative.
• Seventh Generation’s Toilet Bowl Cleaner and Automatic Dishwasher Gel also do not require a preservative.
• Seventh Generation Dishwashing Liquid, Concentrated Laundry Liquid, Fabric Softener, All Purpose Cleaner, and Glass Cleaner do require a preservative.

Fragrances

Why do we list linalool and d-limonene on some of our labels?
Scent formulas are often protected as trade secrets. That means you’ll often see the generic term "fragrance" or "perfume" on a label without information about the actual chemicals used and the amounts. Of course, this makes it difficult for consumers to avoid products containing ingredients that may cause allergic reactions.

The European Union (EU) designated 26 fragrance allergens (16 occurring in natural complex substances such as essential oils) as requiring labeling on cosmetic and detergent products. This labeling must occur if the concentration of the designated ingredient exceeds 100 parts per million (ppm), or 0.01% for a rinse-off product, and 10 ppm, or 0.001% for a leave-on product. To help our consumers with sensitive skin, allergies, or asthma, Seventh Generation has decided to voluntarily list any of the 16 fragrance allergens found in essential oils that are present in its cleaners, using their International Nomenclature of Cosmetic Ingredients (INCI) names. When a fragrance allergen is present in a Seventh Generation cleaner it is because that allergen occurs in nature, as a component of the essential oils we use to fragrance our cleaners.

It is difficult to fully comprehend the criteria used for the inclusion of these chemicals. Not everyone agrees with the selection of the 26 allergens.(2) Nonetheless, such labeling is a start and if consumers know what chemicals they are allergic to then they can avoid or cautiously use the suspect products. Table 1 lists all the 26 allergens designated by the EU.

Once it is known with certainty just what chemicals are used frequently in fragrances and whether or not they are common allergens, selective and rational labeling will make even more sense.

Table 1: List of 26 fragrance allergens designated by the EU

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At what concentration are they present in our products?
Each of our scented cleaners contains a different level of essential oils and botanical extracts. We only list fragrance allergens designated by the European Union on the product packaging if the concentration of these components in the final formulation is equal to or greater than 0.01% (100 ppm). This is the level at which the European Union requires cosmetic manufacturers to list fragrance allergens in rinse-off cosmetics such as shampoos.
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(1)European Union cosmetics directive 76/768/EEC-7th amendment (Council Directive 2003/15/EC). Official Journal of the European Union. Brussels, Belgium. 2003.
(2)Basketter DA, McFadden J. Current perspectives on fragrance allergy J Environ Dermatol 2005;12:178-83.