The Repurposing Life

Understanding Food Chemical Additives and Packaging

The Food and Drug Administration (FDA) regulates the safety of food chemical additives and their packaging. They also regulate how most food is processed, packaged, and labeled. The Centralized Online Submission Module (COSM) provides a web–based real–time user interface tool. It walks users through a step–by–step process. This process helps assemble and send fully electronic submissions to Offices in the Human Foods Program (HFP).

The FDA maintains educational information, databases, and listings related to food allergens, ingredients, and food additives. It also includes color additives and generally recognized as safe (GRAS) substances. It also provides consumer information on ingredients and packaging.

Genetically engineered foods (GMO) have been available to consumers since the early 1990s. Foods produced from new genetically engineered plant varieties must meet the same food safety requirements. These are the standards as foods derived from traditionally bred plants. Creating food made with cultured animal cells is an emerging area of food science. This involves taking a small number of cells from living animals. These cells are grown in a controlled environment.

Packaging

Consumers can access information, inventories and databases related to food packaging and other substances that come into contact with food. The FDA provides regulatory information about irradiated food and packaging. Irradiation is used to increase shelf–life and reduce harmful bacteria in meat, poultry, vegetables and other foods.

Cosmetic Ingredients

The Federal Food, Drug, and Cosmetic Act (FD&C Act) does not need FDA approval for cosmetic products and ingredients. This must happen before they go on the market. The exception is for color additives that are not intended for use as coal tar hair dyes. Nonetheless, they must be safe for consumers under labeled or customary conditions of use. Companies and individuals who market cosmetics have a legal responsibility for the safety of their products and ingredients. They do not have an obligation. Cosmetics manufacturers are encouraged to self–report.

Common cosmetic ingredients of concern for consumers include: allergens, alpha hydroxy acids (AHA), and beta hydroxy acids (BHA). Others are diethanolamine (DEA), fragrances, and latex. There are also concerns about parabens, phthalates, and per– and polyfluoroalkyl substances (PFAS). Additionally, consumers worry about prohibited and restricted ingredients, talc, and nanotechnology.

When scientists talk about nanotechnology, they usually refer to materials of extremely small size (dimensions between 1 and 100 nanometers). Yet, the FDA does not have a legal definition for the use of nanotechnology (nanoscale materials) in cosmetics.  

Firms that market cosmetics have a legal responsibility, but not an obligation. They must make sure that their use of nanoscale materials is safe under labeled or customary conditions of use. They also need to verify that these materials are properly labeled. Cosmetics manufacturers are encouraged to self–report. Under U.S. law, cosmetic products and ingredients do not need FDA approval before they go on the market.

The FDA’s related resources give details about “alcohol free” cosmetics, “organic” cosmetics, potential contaminants, product testing and “trade secret” ingredients. Cosmetics marketed to consumers must have an ingredient list. But under the law, listing the ingredients can’t force a company to reveal “trade secrets.”

A trade secret can consist of any commercially valuable plan, formula, or process. It is also a device used for making, preparing, compounding, or processing trade commodities. This should be a product of either innovation or significant effort. A direct relationship must exist between the trade secret and the productive process. This is under Title 21, Code of Federal Regulations (CFR), Part 20.61(a).

Environmental Decisions

The FDA assesses the environmental impact of its regulatory actions. Manufacturers must include an environmental assessment with their petitions and notifications, unless exempt. As found in the Code of Federal Regulations Citations for Color Additives, Food Ingredients, and Packaging.

Safer Chemical Ingredients List

The Environmental Protection Agency’s (EPA) Safer Chemical Ingredients List (SCIL) is a list of chemical ingredients. It is arranged by functional–use class. The Safer Choice Program has evaluated these chemicals and determined them to be safer than traditional chemical ingredients. The spreadsheet Safer Chemical Ingredients List (XLS) (477 KB) can be downloaded.

Before a chemical is included on the SCIL, a third-party profiler performs detailed research. They gather hazard information from a broad set of resources. This includes identifying and evaluating all available toxicological and environmental fate data. The list is not intended to be exclusive. This list does not include confidential chemicals (“trade secret” information).

Overview

These chemicals are grouped by their functional–use class. Functional use classes include antimicrobial actives, chelating agents, and colorants. They also include defoamers, emollients, enzymes, and enzyme stabilizers. Fragrances, oxidants, oxidant stabilizers, and polymers are included. Preservatives and antioxidants, processing aids, and additives are part of this class. Skin conditioning agents, solvents, specialized industrial chemicals, and surfactants are included too. Some chemicals are uncategorized.

Some of the chemicals in these functional use classes are not on the Toxic Substances Control Act (TSCA) inventory. Thus, they are not authorized for TSCA uses. Some chemicals listed in these functional use classes do not have authorization. They are not authorized for the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). They also lack authorization for other regulated uses. People using regulated substances are expected to find out independently whether such use is authorized.

About the List

The Safer Choice Standard and the Criteria for Safer Chemical Ingredients are protective. They handle a range of potential toxicological effects. These include carcinogens, mutagens, reproductive or developmental toxicants, and persistent, bioaccumulative and toxic chemicals. They also cover systemic or internal organ toxicants, asthmagens, sensitizers, and chemicals on authoritative lists of chemicals of concern.

Chemicals that show endocrine activity are closely evaluated. Those linked to toxicological hazards are not allowed. Impurities can be found in chemicals used in Safer Choice products. This is because the safer chemicals list does not include impurities. Chemicals on the SCIL are marked with a green circle, a green half–circle, a yellow triangle or a gray square.

Green Circle—the chemical has been verified to be of low concern based on experimental and modeled data.

Green Half–Circle—the chemical is expected to be of low concern based on experimental and modeled data. Extra data would strengthen our confidence in the chemical’s safer status.

Yellow Triangle—the chemical has met Safer Choice Criteria for its functional ingredient–class but has some hazard profile issues. Specifically, a chemical with this code does not have a low level of hazard concern for all human health endpoints. It also does not have a low level of hazard for environmental endpoints. (See Safer Choice Criteria). It is a best–in–class chemical and among the safest available for a particular job. Nevertheless, the role fulfilled by the chemical should be considered an area for safer chemistry innovation.

Gray Square—this chemical is not acceptable for use in products that are candidates for the Safer Choice label. Any presently certified products that contain it need to reformulate per Safer Choice Compliance Schedules. Manufacturers must supply information. This information should justify continued listing of this chemical on SCIL. It should also justify its use in Safer Choice–certified products. Unless information provided to EPA adequately justifies continued listing, this chemical will be removed 12 months after gray square designation.

Note: Some functional class listings contain both green circle and yellow triangle chemicals. The yellow triangle chemicals fill a functional need not met by the available green circle chemicals. For example, yellow triangle preservatives are needed to meet the full range of antimicrobial efficacy. Yellow triangle solvents are necessary to meet restrictions on volatile organic compounds (VOCs) in certain product classes.

Additional Resources

The next sources offer extra information on the chemicals in cleaning products:

1. ChemView: the EPA’s centralized database of information on chemicals exposed to TSCA. It includes assessments, regulatory actions, and health and safety data.
2. CleanGredients®: this database of safer chemicals supports the Safer Choice Program. It provides a list of chemicals arranged by part class. These chemicals meet the Safer Choice Criteria.
3. Household and Commercial Products Association (HCPA) Ingredient Dictionary 

Cleaning Product Ingredient Safety Initiative

The Cleaning Product Ingredient Safety Initiative (CPISI) is an online database. It was designed by the American Cleaning Institute (ACI). The purpose is to offer a resource. People can access and understand information related to the safety of ingredients in household cleaning products. Click here for ingredient environmental health data.

CPISI provides the following:

• A searchable inventory of ingredients in U.S. household cleaning products produced by members of ACI.
• Exposure information for each ingredient within each product category in which it is used.
• Hazard information for each ingredient.
• No–effect values derived from regulatory benchmarks, published assessments, or available hazard data for oral, dermal, and inhalation exposure pathways (where these are derived) applicable to potential systemic, reproductive, or developmental impacts from daily exposure

History Of CPISI

ACI developed CPISI to shed light on the safe use of ingredients in our members’ products. The first step involved compiling a comprehensive inventory of ingredients. This inventory was used by members in the formulation of home cleaning products sold in the U.S. The inventory was then made publicly available.

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Sources:
EWG Skin Deep® Cosmetics Database
https://www.ewg.org/skindeep/
EWG VERIFIED™. When a product is EWG VERIFIED™, it means it meets EWG’s strict, scientific standards for transparency and health.
Food Ingredients & Packaging | FDA
https://www.fda.gov/food/food-ingredients-packaging
Cosmetic Products & Ingredients | FDA
Product Information
https://www.fda.gov/cosmetics/cosmetic-products-ingredients
Safer Chemical Ingredients List | US EPA
The Safer Chemical Ingredients List (SCIL)
https://www.epa.gov/saferchoice/safer-ingredients
Cleaning Product Ingredient Safety Initiative
The Cleaning Product Ingredient Safety Initiative (CPISI)
https://www.cleaninginstitute.org/industry-priorities/science/cleaning-product-ingredient-safety-initiative
Ingredient Safety | Consumer Healthcare Products Association – CHPA
https://www.chpa.org/our-issues/other-issues/ingredient-safety