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DfE's Standard and Criteria for Safer Chemical Ingredients

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On this page you will find:

DfE's Standard for Safer Cleaning Products
DfE Criteria for Safer Chemical Ingredients
DfE Master Criteria
Functional-Class Criteria
    DfE Criteria for Surfactants
    DfE Criteria for Solvents
    DfE Criteria for Chelating and Sequestering Agents
    DfE Criteria for Fragrances
Criteria for Environmental Toxicity and Fate for Chemicals in Direct Release Products
DfE Considerations for Microorganism-based Products
DfE Criteria for Ice-Melt Products
CleanGredients®

DfE's Standard for Safer Cleaning Products

EPA has enhanced its "Standard for Safer Cleaning Products," which comprises the requirements products must meet to earn the EPA Design for the Environment label. Among the enhancements is a first-of-its-kind requirement that labeled products list all non-trade secret ingredients on the product label or in an easily accessible place stated on the label.

Other enhancements to the Standard include:

  • Packaging must meet minimum initial sustainability measures, based on the Sustainable Packaging Coalition criteria, and those measures must improve over time.
  • Products that involve prolonged dermal contact must adhere to a stricter set of requirements.
  • Volatile organic compound levels in labeled products must be no greater than those allowed under the most protective government criteria.
The full set of enhancements is summarized in DfE's Response to Comments (PDF) (21pp, 75K).

Read the updated Standard for Safer Cleaning Products (PDF) April 2011 Revision (37 pp, 258K).

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DfE Criteria for Safer Chemical Ingredients

Each ingredient in a formulation has a function in making a product work - whether it is to aid in cleaning by reducing surface tension (surfactants), dissolve or suspend materials (solvents), reduce water hardness (chelating agents), or provide a scent (fragrances). Within these "functional classes," many ingredients share similar toxicological and environmental fate characteristics. As a result, DfE focuses its review of formulation ingredients on the key (environmental and human health) characteristics of concern within a functional class. This approach allows formulators to use those ingredients with the lowest hazard in their functional class, while still formulating high-performing products.The DfE Safer Product Labeling Program evaluates each ingredient in a formulation against the following Master and Functional-Class Criteria documents, as appropriate. These documents define the characteristics and toxicity thresholds for ingredients that are acceptable in DfE-labeled products. The Criteria are based on EPA expertise in evaluating the physical and toxicological properties of chemicals, and while they incorporate authoritative lists of chemicals of concern, they go far beyond these lists. DfE applies the Criteria using EPA research and analytical methods to ensure that DfE-labeled products contain only the safest possible ingredients. All Criteria documents are part of DfE's Standard for Safer Cleaning Products (SSCP).

DfE Master Criteria

In establishing thresholds for safer ingredients, the Master Criteria delineate the "low-concern" end of the ingredient hazard spectrum, therefore guiding and ensuring best-in-class ingredient choices for DfE-labeled products. The development of the Master Criteria (the successor to the General Criteria/Screen), has made the core of the DfE review process and safer chemical standard more transparent and ready for third-party implementation. All ingredients for which DfE has not yet developed functional-class criteria are evaluated against the Master Criteria.Read the DfE Master Criteria for Safer Ingredients (PDF) (31 pp, 227K).

Functional-Class Criteria

Functional-class criteria define and more fully explore the safer end of specific ingredient-class continuums. Using the Master Criteria as a guide, the functional-class criteria tailor the health and environmental endpoints in the Master Criteria in a way appropriate to the specific functional class, designate key distinguishing characteristics and adjust thresholds as necessary. Developing the Criteria improves the general understanding of the characteristics of safer ingredients in the class and helps identify green-chemistry opportunities and successes.

DfE Criteria for Surfactants

Surfactants in cleaning products are distinguished by their rate of biodegradation, degradation products, and level of aquatic toxicity. The DfE Criteria for Surfactants combine these hazard characteristics, and requires that surfactants with higher aquatic toxicity demonstrate a faster rate of biodegradation without degradation to products of concern. Surfactants that meet the Criteria are acceptable for use in a DfE-labeled cleaning product; surfactants in products which typically by-pass sewage treatment must meet the Criteria for Environmental Fate & Toxicity for Chemicals in Direct Release Products .

Standard Surfactant Criteria

Acute Aquatic Toxicity
(L/E/IC50 Value)1

Rate of Biodegradation

≤1 ppm

May be acceptable if biodegradation2 occurs within a 10-day window without products of concern3

>1 ppm and ≤10 ppm

Biodegradation2 occurs within a 10-day window without products of concern3
>10 ppm Biodegradation2 occurs within 28 days without products of concern3

1. In general, there is a predictable relationship between acute aquatic toxicity and chronic aquatic toxicity for organic chemicals, i.e. chemicals that have high acute aquatic toxicity also have high chronic aquatic toxicity. Since acute aquatic toxicity data are more readily available, the DfE Criteria use these data to screen chemicals that may be toxic to aquatic life.
2. Generally, >60% mineralization (to CO2 and water) in 28 days.
3. Products of concern are compounds with high acute aquatic toxicity (L/E/IC50 ≤ 10ppm) and a slow rate of biodegradation (greater than 28 days).

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DfE Criteria for Solvents

With cleaning solvents, there are potential concerns for the following hazards: carcinogenicity, acute mammalian toxicity, reproductive and developmental toxicity, repeated-dose toxicity, neurotoxicity, and environmental fate and toxicity. The DfE Criteria for Solvents (PDF) (13 pp, 454K) were developed for the alcohol, ester, ethylene glycol ether, and propylene glycol ethers solvent classes. Structural definitions of these classes are included in the Criteria document.

DfE Criteria for Chelating and Sequestering Agents

These Criteria were developed to identify safer chelating and sequestering agents, which have preferred human and environmental health profiles. DfE developed the Criteria with a group of stakeholders that included chelating agent manufacturers, cleaning product formulators, environmental non-governmental organizations, certification groups, industry associations, and others. Chelating and sequestering agents that pass these Criteria can be included in cleaning products eligible for recognition under the DfE Safer Product Labeling Program.

The Criteria for Chelating and Sequestering Agents sets a high bar to which some product manufacturers may need to adapt. To allow time for formulation changes, DfE has developed the following implementation schedule.

December 31, 2011

     

Product manufacturers who submit products on or after this date must meet the new criteria. The new criteria would apply as follows:
To candidate partners and products as a condition of partnership;
To existing partners with candidate products as a condition of adding the products to the partnership; and
To existing partners and products within one year from this date, effective on the anniversary of their partnership and coinciding with their annual audit.

Now to
December 31, 2011

       

Chelating agents in candidate products will be reviewed based on the new Criteria and manufacturers will be informed of product review status. The purpose of this interim review is to give fair notice to the ingredient and product formulating communities and to guide their transition to safer alternatives, as necessary.

Read the DfE Criteria for Chelating and Sequesting Agents (PDF) (34 pp, 495K).

DfE Criteria for Fragrances

The DfE Criteria for Fragrances was developed by the DfE Program and a group of stakeholders that included the fragrance industry, cleaning product formulators, environmental non-governmental organizations, and others. These Criteria are designed to identify safer aroma chemicals and fragrance formulations for use in cleaning products. While Version 1 of the Criteria focused on human health considerations associated with fragrances, Version 2 of the Criteria addresses both human health, and environmental fate and effects.

More than 2,000 chemical substances with diverse chemical structures, and therefore diverse human and environmental health profiles, are used in formulation by the fragrance industry. To identify safer chemicals for this diverse set of raw materials, a range of human and environmental health endpoints serve as the basis for screening out fragrance raw materials of concern. A fragrance must meet all requirements for each hazard endpoint in order to meet the Criteria.

Given the complexity of fragrance formulations, DfE recognizes that implementing the Criteria may be challenging for formulators and their suppliers. DfE's third-party profilers will begin using the Criteria to evaluate fragrances in candidate products for recognition and providing feedback to formulators. DfE will require that labeled and candidate products meet the Criteria according to the following schedule.

September 30, 2012**

Product manufacturers who submit products on or after this date have to meet the new criteria. The new criteria would apply as follows:
To candidate partners and products as a condition of partnership;
To existing partners with candidate products as a condition of adding the products to the partnership; and
To existing partners and products within one year from this date, effective on the anniversary of their partnership and coinciding with their annual audit.
Now to
September 30, 2012

During this transition period, the new Criteria will be used to provide feedback to manufacturers on product status. The purpose of this extended interim review is to give fair notice to the ingredient and product formulating communities and to guide their transition to safer alternatives, as necessary.

** DfE has extended the date for compliance with its criteria for fragrances an additional 9 months, from December 31, 2011 to September 30, 2012.

Read the DfE Criteria for Fragrances (PDF) (39 pp, 876K).

The DfE Criteria for Fragrances - Human Health (PDF) (19 pp, 418K) are effective until September 30,2012.

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Criteria for Environmental Toxicity and Fate for Chemicals in Direct Release Products

Certain products intended for use outdoors are likely to bypass sewage treatment, llimiting the time for degradation prior to entering sensitive environments. For these products, like boat cleaners and graffiti removers, DfE has raised the bar in its standard environmental criteria to address the potential for immediate contact with aquatic life. Any ingredients (including surfactants, preservatives, solvents, etc.) that have aquatic toxicity values <10 mg/L are not allowed in DfE-recognized direct release products.

Criteria for Direct Release Product

  Acute Aquatic Toxicity Value (L/E/IC50)1 Persistence
(Measured in terms of rate of biodegradation)		 Status
1 ≤10 ppm   Not acceptable
2 >10 ppm and <100 ppm Biodegradation2 occurs within a 10-day window without products of concern3 Acceptable
3 ≥100 ppm Biodegradation2 occurs within 28 days without products of concern3 Acceptable
1. In general, there is a predictable relationship between acute aquatic toxicity and chronic aquatic toxicity for organic chemicals, i.e.
chemicals that have high acute aquatic toxicity also have high chronic aquatic toxicity.   Since acute aquatic toxicity data are more readily available, the DfE Criteria use these data to screen chemicals that may be toxic to aquatic life.
2. Generally, >60% mineralization (to CO2 and water).
3. Products of concern are compounds with high acute aquatic toxicity (L/E/IC50 ≤ 10ppm) and a slow rate of biodegradation (greater than 28 days).

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DfE Considerations for Microorganism-based Products

Microorganism-based products are a distinct class and subject to tailored evaluation criteria. In its review, DfE carefully considers the identity and potential hazards and risks of the microbial species, as informed by its Checklist for Formulations Containing Microorganisms PDF (7 pp, 29K), in combination with other considerations like purity of strain, ingredient functionality and product performance, as described in its Considerations for Microorganism-based Products (5 pp, 876K). Please note that microbial-based products intended for use in indoor environments are not eligible for partnership, as explained in the Considerations document. Non-microbial ingredients will be reviewed based on their respective component-class criteria.

DfE Criteria for Ice-Melt Products

An ice-melt product under DfE is, as the name implies, one that melts ice and snow at temperatures below the freezing point of water, and not simply a product that aids traction like sand. A manufacturer of a safer ice-melt product may become a DfE partner provided that they agree to certain terms in their partnership agreement and that their product has the characteristics specified below.DfE ice-melt products must:
  1. Pass the appropriate DfE safer chemical criteria (see http://www.epa.gov/dfe/pubs/projects/gfcp/index.htm#GeneralScreen ).
  2. Reduce sodium (Na) and chloride (Cl) use by at least 30% (under comparable use scenarios).
  3. Be labeled under a DfE partnership agreement in which the product manufacturer has agreed to a customer education/training plan to ensure proper product use and application rates (and reductions in Na and Cl).
  4. Not contain cyanide as an anti-caking agent.
  5. Function at temperatures < 0 F.
  6. Comply with Pacific NW Snow Fighters' criteria for reduction in corrosivity to steel (see http://onlinepubs.trb.org/Onlinepubs/nchrp/nchrp_rpt_577.pdf : to be acceptable, a corrosion-inhibition chemical product must prove to have a percent effectiveness value of at least 70% less than Sodium Chloride).
  7. Meet performance levels as evaluated under the Pacific NW Snow Fighters' criteria.

CleanGredients®

Formulators who subscribe to the CleanGredients® Link to EPA's External Link Disclaimer database can find a list of surfactants, solvents, chelating and sequestering agents, and fragrances that meet DfE's Criteria. Suppliers who subscribe can have their chemicals reviewed against the appropriate criteria and listed in the database. Nearly 300 formulators Link to EPA's External Link Disclaimer are finding safer ingredients on CleanGredients® Link to EPA's External Link Disclaimer .

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