Trace Ingredients

• 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?

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. Does anyone else refer to them as trace materials? This sounds like we coined the term.

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 ingredients of our products. One example of this is 1,4-dioxane. Seventh Generation sets strict limits on the concentration of this byproduct in order to prevent human health or environmental hazards.

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 trace constituents found in sodium chloride, or common table 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).

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.
   3. 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.fda.gov/Cosmetics/CosmeticLabelingLabelClaims/CosmeticLabelingManual/ucm126444.htm

Preservatives of raw materials are one example of an incidental ingredient in our products. Preservatives are often added to raw materials to prevent contamination and spoilage. When preserved ingredients are used to make products the level of ingredient preservative present in the finished product is too small to be effective. Therefore such preservatives are 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 work with all of our suppliers to identify as many trace materials in the ingredients they supply us as possible.

Fragrances

Fragrance 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 they are allergic to. At Seventh Generation we believe you have a Right to Know what is in the products you buy. That is why we list all the fragrance ingredients we use in our products right on the label.

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 and allergies we have decided to voluntarily list any of the 16 fragrance allergens found in our fragrance blends. When a fragrance allergen is present in a Seventh Generation cleaner it is because that allergen naturally occurs as a component of the essential oils used to fragrance our cleaners.

Table 1 lists all the 26 allergens designated by the EU.

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

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 why? 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 and detergent manufacturers to list fragrance allergens in rinse-off cosmetics such as shampoos or detergents.

(1)European Union cosmetics directive 76/768/EEC-7th amendment (Council Directive 2003/15/EC). Official Journal of the European Union. Brussels, Belgium. 2003.