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You are here: EPA Home » DfE » DfE's Standard and Criteria for Safer Chemical Ingredients

DfE's Standard and Criteria for Safer Chemical Ingredients

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On this page you will find:

DfE's Standard for Safer Products (SSP)
    Implementation and Compliance Schedules
Criteria for Safer Chemical Ingredients
Master Criteria
Functional-Class Criteria
    Chelating and Sequestering Agents
    Fragrances
    Processing Aids and Additives
    Solvents
    Surfactants
Criteria for Direct Release Products
Criteria for Ice-Melt Products
Criteria for Innovative Industrial Product Recognition
Criteria for Inorganic- and Mineral-based Products
Criteria for Microorganism-based Products
Criteria for Personal Care Products
Criteria for Safer Marine Lubricants
Criteria for Specialized Industrial Products
CleanGredients®

DfE's Standard for Safer Products

The DfE "Standard for Safer Products" comprises the requirements products and their ingredients must meet to earn the EPA Design for the Environment label. Newly added to the Standard are provisions for the DfE Safer Chemical Ingredients List, including clarifications to the ingredient criteria that enable listing the range of chemicals in DfE-labeled products.

Other changes in the recent update to the Standard address:

  • Colorants, Polymers, and Preservatives that as part of their functionality tend to persist; 
  • Specialized Industrial Products and their high-performance ingredients that do not meet the DfE criteria;
  • Potential sensitizing chemicals in fragrances used in consumer and industrial products;
  • Volatile organic chemicals (VOCs) exempted from product-specific VOC restrictions issued by the California Air Resources Board (CARB); and
  • Concentrates outside the DfE pH range for closed dilution-controlled application systems. 

The full set of changes is described in the Notice for the DfE Safer Chemical Ingredients List and Accompanying Changes to the Standard (PDF) (150 pp, 20K).

Read the updated Standard for Safer Products (PDF) (43 pp, 351K) September 2012 Revision.

Partnerships established under the 2009 DfE Standard for Safer Cleaning Products (PDF) (30 pp, 162K) will be verified for compliance with the 2012 DfE Standard for Safer Products in 2013.

Implementation and Compliance Schedules

To ensure good partnership standing and compliant products, please read the DfE Implementation and Compliance Schedules (PDF) (4 pp, 47K).

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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 Products (SSP) (PDF) (43 pp, 351K).

Master Criteria

DfE Master Criteria for Safer Ingredients v2.1 (PDF) (33 pp, 269K)

The DfE Master Criteria establishes thresholds for safer ingredients by defining the "low concern" end of the ingredient hazard spectrum. If there are no functional-class criteria for an ingredient, it is evaluated against the Master Criteria as described in section 5.2 of the DfE Standard. Read the DfE Master Criteria for Safer Ingredients v2.1 (PDF) (33 pp, 269K).

A document with highlighted changes to version 2.0 (PDF) (35 pp, 302K) of the DfE Master Criteria for Safer Ingredients is also available.

Functional-Class Criteria

Functional-class criteria define the safer end of the ingredient hazard spectrum. Using the Master Criteria as a base, the functional-class criteria tailor health and environmental endpoints for key distinguishing characteristics to the specific functional class. Developing functional-class criteria improves the general understanding of the safer ingredient characteristics in the class and helps identify green-chemistry opportunities and successes.

Criteria for Chelating and Sequestering Agents

DfE Criteria for Chelating and Sequestering Agents (PDF) (34 pp, 495K)

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.

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

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Criteria for Fragrances

DfE Criteria for Fragrances v2.1 (PDF) (34 pp, 257K)

The DfE Criteria for Fragrances were developed by the DfE Program and a group of stakeholders that included the fragrance industry, cleaning product formulators, environmental non-governmental organizations, and others. 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.

Following publication of the DfE Criteria for Fragrances (Version 2.0) in 2010, the fragrance industry worked with DfE and product manufacturers to implement a pilot of the criteria. Through the pilot, DfE learned that the criteria were set too ambitiously for fragrance materials, and that some simple changes would make the formulation of a fragrance for a DfE-labeled product much more straightforward. DfE has developed version 2.1 of the criteria to account for what was learned during the pilot.

The DfE Criteria for Fragrances (Version 2.1) considers a range of human and environmental health endpoints. To be considered safer ingredients and allowed in a DfE-labeled product, fragrance chemicals must be evaluated and meet all requirements for each hazard endpoint.

During annual audits in 2013, DfE partners will receive formal notice of the version 2.1 criteria and must meet the criteria no later than the end of 2014. Compliance will be confirmed during 2015 audits. During this interim period, DfE will continue its current policy that no listed carcinogens, mutagens, or reproductive toxicants (CMRs), and no listed persistent, bioaccumulative and toxic compounds (PBTs) will be allowed.

Read the DfE Criteria for Fragrances v2.1 (PDF) (34 pp, 257K).

A document with highlighted changes to version 2.0 (PDF) (43 pp, 425K) of the DfE Criteria for Fragrances is also available.

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Criteria for Processing Aids and Additives

Criteria for Processing Aids and Additives (PDF) (5 pp, 64K)

A large set of chemicals that play supporting roles in product formulations, DfE will now group processing aids as a class, with tailored criteria for each subclass. These chemicals (often considered commodity or generic ingredients) are diverse in structure and function, but have in common, beyond their formulary supporting roles, that their chemical characteristics and long-standing safe use make them a low hazard concern. For example, physical-chemical properties (like simple acids, when controlled for product pH) or essential functionality in humans (like polysaccharides) can indicate low hazard. Like colorants, polymers and related chemicals, processing aids are often data-poor. Yet, they are very common ingredients in cleaning and other products and frequently provide multiple functional attributes.

Read the Criteria for Processing Aids and Additives (PDF) (5 pp, 64K).

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Criteria for Solvents

DfE Criteria for Solvents (PDF) (13 pp, 454K)

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.

Read the DfE Criteria for Solvents (PDF) (13 pp, 454K).

Read the DfE Criteria for VOC-Exempt Solvents (PDF) (1 pp,13 K).

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

Certain products intended for use outdoors are likely to bypass sewage treatment, limiting 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)
Bioaccumulation Potential Status
1 If ≤10 ppm...   …and BCF/BAF <1000. Not acceptable
2 If >10 ppm and <100 ppm... ...biodegradation2 occurs within a 10-day window without products of concern3... Acceptable
4 If ≥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 [Rand, G.M., ed. Fundamentals of Aquatic Toxicology. 2nd ed. 1995, Taylor & Francis: Washington, DC.]. Since acute aquatic toxicity data are more readily available, DfE uses these data to screen chemicals that may be toxic to aquatic life. Where measured chronic toxicity data is available, it will be assessed with other data and applied in the screen based on the relationship between acute and chronic aquatic toxicity.
2. Generally, >60% mineralization (to CO2 and water) in a Ready Biodegradation test.
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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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.
  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.

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Criteria for Innovative Industrial Product Recognition

Context: DfE is asked to label a product that replaces a high-profile problematic chemical with a formulation that is significantly safer and high-functioning, but whose ingredients are not limited to chemicals that meet the DfE safer chemical criteria. Further, it may not be possible to determine if some of the ingredients are the safest available to provide certain necessary formulary functions. In these cases, DfE may offer the company an Innovative Industrial Product (IIP) recognition letter in lieu of the label (or even the label for Specialized Industrial Products because of the uncertainty as to where some of the ingredients fall on the continuum of improvement), provided that the formulation meets the criteria specified below.

Criteria for Innovative Industrial Product Letter Recognition:

  • The product must be intended for use in an industrial application [1] ;
  • The product must replace a chemical of significant problematic status (e.g., a known human carcinogen or other widely used CMR or PBT);
  • The product meets high-level performance standards, in some cases these may be critical design specifications that affect human health and safety;
  • All ingredients in the product must meet, or have as a goal to meet, DfE safer chemical ingredient criteria;
  • It is acceptable for some ingredients—but not more than 10 percent (on a weight-by-weight basis) in the formulation--not to meet the DfE safer chemical criteria (these chemicals must be part of the company’s continuous improvement plan); and
  • An applicant must verify product ingredients (per DfE audit requirements) and notify DfE before making any changes to the formulation.

Other Conditions of Recognition:

The recognition is limited to three years; however, the company may resubmit the formulation for review and DfE may decide to renew the recognition (the status of the company's continuous improvement efforts would be a factor in that decision, as appropriate). The company may use the letter of recognition to promote the product, but may not use the DfE logo on the product or packaging.

_____________________________________
[1] Renewable content means the use of farm- or agriculture-based products, like vegetable oils and animal fats.

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Criteria for Inorganic- and Mineral-based Products

To label innovative, safer products, the DfE review focuses on the evaluation of wet-chemical ingredients and formulations. DfE assesses ingredients based on its safer chemical criteria and in comparison to other products/ingredients for similar uses. The DfE criteria inform on what chemistry is safer by comparing substances, within functional use classes (surfactants, solvents, etc.), against an array of toxicological endpoints. DfE allows the use of its label on those products whose ingredients derive entirely from the safer end of the human health and environmental spectrum.

The standard DfE review is not oriented to evaluating a product composed solely of inorganic materials or minerals, which are typically inert and function via friction rather than chemical activity. DfE recognizes, however, that these products may substitute for chemical-based products that contain ingredients of potential concern and may generate significant direct and collateral human health and environmental benefits. DfE has therefore developed evaluation criteria that may make it possible to label these products (e.g., cleaners made of crushed glass or stones; not, however, sodium-chloride-based or similar ice melt products for which DfE has separate criteria at http://www.epa.gov/dfe/pubs/projects/gfcp/index.htm#icemelt).

A decision to allow use of the DfE label will be based on the following criteria (in addition to the other applicable elements in the DfE Standard for Safer Products (SSP)):

    1. Hazard profile. - The hazard profile of the inorganic or mineral materials: Ingredients must not raise any toxicological concerns. Consider, for example, if the material is asbestiform or fibrous, or if potential impurities are present (e.g., problematic metals or crystalline silica). - The hazard profile of the non-mineral-based ingredients: Ingredients must pass the appropriate DfE safer chemical criteria.
    2. Recycled content. Product must be composed of at least 95% recycled materials. If the product includes a plastic handle or other plastic part, it must also be reusable and/or composed of at least 95% recycled content.
    3. Manufacturing/sustainability. Candidate partner must provide information and/or data to demonstrate that only permissible air, land or water releases occur during the product's manufacturing process (e.g., via environmental release permits or waste manifests). They must also report on energy and water use as indicia of resource conservation and a baseline for continuous improvement.
    4. Safer substitution. Product must have the potential to meet the same functional need as chemical-based products currently in use.
    5. Exposure and release. - Product in use must not generate particles that are inhalable (10 microns or less). - Product must not produce potential waste products of concern (candidate must submit an analysis of the byproducts generated).
    6. Packaging. Packaging must comply with the DfE SSP, section 4.2.6. Any paperboard in the packaging should be made of or work toward 100% recycled content.
    7. Performance. Product must perform well in comparison to a leading brand without damaging surfaces.

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Criteria 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 (PDF) (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.

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Criteria for Personal Care Products

In April 2011, DfE finalized section 4.5 of the DfE Standard for Safer Products:  “Products Designed for Dermal Contact.”  With the increased interest in the DfE label from personal care product manufacturers, the question has arisen whether all personal care products should be reviewed under section 4.5.

DfE intended that the heightened requirements in section 4.5, developed in consultation with the Food and Drug Administration, would apply only to certain classes of personal care products— a) those that are “leave-on” in nature and result in prolonged dermal contact, like lotions and deodorants, and b) those that, regardless of length of exposure, are made to come into contact with infants and children, whose bodies are developing and particularly sensitive to certain chemicals.   In both cases, formulators may address the restriction on sensitizers (including ingredients that lack sensitization data) by listing them on the product label or by providing whole product sensitization testing.

The following matrix groups personal care products into two groups based on whether section 4.5 applies or does not apply.  While DfE has reviewed and labeled rinse-off personal care products, like hand soaps, DfE has yet to label a leave-on product subject to section 4.5.

Section 4.5 Applies (leave-on PCP) Section 4.5 Doesn't Apply (rinse-off PCP)
· Aftershave · Body wash
· Astringent/toner · Bubble bath and bath salts
· Cleaning wipes that don’t require rinsing after use · Hair Conditioner
· Cuticle cream, lotion, and oil · Exfoliant products (if rinsed off)
· Deodorant and antiperspirant · Face wash
· Hair shine products · Hair dye, color, and bleach
· Hair spray · Hair relaxants 
· Hair styling products (e.g., balm, gel, mousse) · Makeup remover (if rinsed off)
· Leave-on hair conditioner · Moisturizing products (if rinsed off)
· Lip products 

· Nail polish remover
· Makeup and bronzers (e.g., foundation, concealer, bronzer, mascara, eyeliner, eye shadow, blush) · Shampoo
· Makeup remover (if left on) · Shaving cream, gel, and foam
· Massage oil · Soap and cleansers
· Nail polish

 
· Skin care products (e.g., lotions, moisturizers, creams, oils, serums)  
· Sunless tanning products  

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Criteria for Safer Marine Lubricants

Manufacturers of marine lubricants subject to the Office of Water Vessel  General Permit (VGP) requirements for environmentally acceptable lubricants (EALs) (at http://www.epa.gov/npdes/pubs/vgp_draft_permit2011.pdf), who wish to qualify for the Design for the Environment (DfE) label, must comply with the DfE Standard for Safer Products and ingredient criteria, with the limited exceptions and additional requirements specified below. 

It is noteworthy that the chemicals in marine lubricants typically include as part of their functionality the ability to resist degradation and be effective over long periods under adverse conditions. These chemicals also can be complex molecules and mixtures and often lack measured toxicity data. To identify the safest available chemicals given their functional characteristics, the toxicity thresholds in the DfE Master Criteria (at http://www.epa.gov/dfe/pubs/projects/gfcp/index.htm#Master) will be used to evaluate human health endpoints, and the thresholds below will be used for environmental endpoints.

  1. Human and environmental health requirements.  Candidate products for EAL marine lubricant status must meet, at a minimum, the following ingredient data and hazard limit requirements:

      1. For Acute Mammalian Toxicity (section 5.1 of the Master Criteria), Neurotoxicity (5.4), Repeated Dose Toxicity (5.5), Respiratory Sensitization (5.7), and Skin Sensitization (5.8), the following data requirements apply:

        Data requirements:  Screen specified R-Phrases, H-Phrases, and Authoritative Lists for each chemical present in a mixture. Chemicals with new data not yet reviewed by authoritative bodies will be subject to review.

      2. For Carcinogenicity (section 5.2 of the Master Criteria), Genetic Toxicity (5.3), and Reproductive and Developmental Toxicity (5.6), the following data requirements apply:

        Data requirements:  Screen specified R-Phrases, H-Phrases, and Authoritative Lists.  All available data, measured and/or estimated, for the chemical or a suitable analog will be reviewed against the criteria using a weight-of-evidence approach.

      3. Environmental Toxicity and Fate

      Limitation on Persistent, Bioaccumulative and Toxic chemicals:  Acceptable chemicals must not be persistent (half-life > 60 days), bioaccumulative (BCF/BAF  1,000), and aquatically toxic* (LC/EC50 < 10 mg/L or NOEC/LOEC < 1 mg/L). 

      Limitation on very Persistent and very Bioaccumulative chemicals:  Acceptable chemicals must not be very persistent (half-life > 180 days or recalcitrant) and very bioaccumulative (> 5,000).

      Limitation on very Persistent and very Toxic chemicals:  Acceptable chemicals must not be very persistent (half-life > 180 days or recalcitrant) and very aquatically toxic* (LC/EC50 < 1.0 mg/L or NOEC/LOEC < 0.1 mg/L).

      Data requirements:  Screen specified R-Phrases, H-Phrases, and Authoritative Lists.  All available data, measured and/or estimated, for the chemical or a suitable analog will be reviewed against the criteria using a weight-of-evidence approach.

  2. Direct environmental release. Ingredients in lubricants that are intended for use in applications that result in their immediate discharge to the environment, bypassing sewage treatment systems, must meet DfE’s criteria for Environmental Toxicity and Fate for Chemicals in Direct Release Products (at http://www.epa.gov/dfe/pubs/projects/gfcp/index.htm#Toxicity), based on the biodegradation testing in OECD 306.

  3. Renewable content [2] .  Products must meet the following renewable content requirements:

      1. Hydraulic fluid, transmission fluid, gear oil and grease: at least 65 percent.

      2. Two-stroke oil: at least 50 percent.

  4. Performance.  Products must demonstrate acceptable performance.  For example, pass the ASTM D 665 test— “Standard Test Method for Rust Preventing Characteristics of Inhibited Mineral Oil in the Presence of Water.”
_____________________________________
[2] Renewable content means the use of farm- or agriculture-based products, like vegetable oils and animal fats.

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Criteria for Specialized Industrial Products

Criteria for Specialized Industrial Products (PDF) (4 pp, 58K)

Specialized Industrial Products (SIPs) are a distinct subgroup of products that meet tailored criteria under DfE's Safer Product Labeling Program. DfE is using the term "specialized" for this subset of I/I products to distinguish them based on performance requirements from other, more common I/I products, like cleaners and detergents, and to indicate that they require certain ingredients with special, high-performance functionalities. Nevertheless, to earn the DfE label, a candidate product and its ingredients must meet the general SIP criteria, in section II, as well as the subclass-specific requirements, in section III.

Read the Criteria for Specialized Industrial Products (PDF) (4 pp, 58K).


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 200 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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