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Safer Choice

Safer Choice Standard and Criteria

Safer Choice Standard

Overview

The Safer Choice Standard, formerly known as DfE's Standard for Safer Products (or the "DfE Standard") identifies the requirements products and their ingredients must meet to earn the Safer Choice label.

Read the most recent version of the Safer Choice Standard (Revised February 2015).

Changes to the Safer Choice Standard

The Safer Choice Standard was revised in February 2015. The Safer Choice Standard now includes provisions for the Safer Choice label, an associated fragrance-free label, and changes to the standard to implement the Safer Choice label.

Read the Changes to the Standard to Implement the Safer Choice Label.

Read the Notice of Availability and Request for Comments.

Implementation and compliance schedules

To ensure your products are compliant with the most recent version of the Safer Choice Standard, please read the Safer Choice Implementation and Compliance Schedules.

Guidance for meeting ingredient disclosure and packaging requirements

Criteria for Safer Chemical Ingredients

Each chemical 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), or reduce water hardness (chelating agents). Within these "functional classes," many ingredients share similar toxicological and environmental fate characteristics. As a result, Safer Choice 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 Safer Choice 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 Safer Choice 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. Safer Choice applies the criteria using EPA research and analytical methods to ensure that Safer Choice products contain only the safest possible ingredients. All criteria documents are part of the Safer Choice Standard.

Safer Choice Product-Class Criteria

In addition to the product and ingredient criteria in the Safer Choice Standard, supplemental requirements are necessary to ensure that certain classes of products achieve best-in-class status and qualify to carry the Safer Choice label. These supplemental requirements are set forth in the criteria documents below.

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, Safer Choice 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 Safer Choice direct release products.

Supplemental criteria for chemicals in direct release products
Acute Aquatic Toxicity Value (L/E/IC50) Chronic Aquatic Toxicity Value (LOEC) Persistence1 (measured in terms of rate of biodegradation) Bioaccumulation Potential Status
If acute aquatic toxicity ≤10 ppm... OR chronic toxicity ≤1 ppm... Not acceptable
If acute aquatic toxicity >10 ppm and <100 ppm... AND chronic aquatic toxicity >1 ppm... ...AND biodegradation2 occurs within a 10-day window without degradation products of concern3... ...AND BCF/BAF <1,0004... Acceptable
...AND biodegradation2 does not occur within a 10-day window and/or results in degradation products of concern3... Not acceptable
If acute aquatic toxicity ≥100 ppm... AND chronic aquatic toxicity ≥10 ppm... ...AND biodegradation2 occurs within 28 days without degradation products of concern3... ...AND BCF/BAF <1,0004... Acceptable
...AND biodegradation2 does not occur within 28 days and/or results in degradation products of concern3... Not acceptable
1. Insoluble, inert, metal-containing, or inorganic compounds may be inherently persistent and are therefore considered recalcitrant, meaning resistant to degradation or elemental. For direct release applications, recalcitrant chemicals may be acceptable if they are measured or predicted to have low aquatic toxicity; both acute (≥100 ppm) and chronic (≥10 ppm) values will be considered.
2. Generally, >60% mineralization (to CO2 and water) in a Ready Biodegradation test.
3. Products of concern are compounds with high acute or chronic aquatic toxicity (L/E/IC50 ≤ 10ppm or LOEC ≤1 ppm) and a slow rate of biodegradation (greater than 28 days).
4. Category for Persistent, Bioaccumulative and Toxic New Chemical Substance. November 4, 1999. Federal Register Notice, volume 64, issue 213.

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Criteria for fragrance-free products

From Safer Choice Standard Section 3.9 (pg. 11): "For products that qualify for the Safer Choice label, manufacturers may request an additional certification—the Fragrance-free label—to indicate that a product contains no fragrance materials. To qualify as fragrance-free, a product must only contain ingredients on or eligible for the Agency’s Safer Chemical Ingredients List (SCIL) and must not contain any fragrance materials. Chemicals with dual functionality, i.e., that function both as a fragrance and something else, are not allowed in fragrance-free products."

Please read "Safer Choice Label – Fragrance-Free" for further details.

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Criteria for ice-melt products

An ice-melt product under Safer Choice 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 Safer Choice partner provided that they agree to certain terms in their partnership agreement and that their product has the characteristics specified below. Safer Choice ice-melt products must:

  1. Pass the appropriate Safer Choice Criteria.
  2. Reduce sodium (Na) and chloride (Cl) use by at least 30% (under comparable use scenarios).
  3. Be labeled under a Safer Choice 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 (211 pp, 6142 K, About PDF) Exit for reduction in corrosivity to steel (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 (211 pp, 6142 K, About PDF) Exit.

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Criteria for innovative industrial product recognition

This criteria is applicable when Safer Choice is asked to label a product that replaces a high-profile problematic chemical (or chemicals) with a formulation that is significantly safer and high-functioning, but whose ingredients are not limited to chemicals that meet the Criteria for Safer Chemical Ingredients or may not be the safest available because of a need to provide certain critical formulary functionality. In these cases, Safer Choice may offer the company an Innovative Industrial Product (IIP) recognition letter in lieu of the Safer Choice label, 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, the Criteria for Safer Chemical Ingredients;
  • 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 Criteria for Safer Chemical Ingredients (these chemicals must be part of the company’s continuous improvement plan); and
  • An applicant must verify product ingredients (per Safer Choice audit requirements) and notify Safer Choice 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 Safer Choice 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 Safer Choice label on the product or packaging.

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Criteria for inorganic- and mineral-based products

To label innovative, safer products, the Safer Choice review focuses on the evaluation of wet-chemical ingredients and formulations. Safer Choice assesses ingredients based on its safer chemical criteria and in comparison to other products/ingredients for similar uses. The Safer Choice Criteria inform on what chemistry is safer by comparing substances, within functional use classes (surfactants, solvents, etc.), against an array of toxicological endpoints. Safer Choice 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 Safer Choice 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. Safer Choice 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. Safer Choice 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 Safer Choice has separate criteria).

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

  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 Criteria for Safer Chemical Ingredients.
  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 Safer Choice Standard, 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, Safer Choice carefully considers the identity and potential hazards and risks of the microbial species, as informed by its Checklist for Formulations Containing Microorganisms, in combination with other considerations like purity of strain, ingredient functionality and product performance, as described in its Considerations for Microorganism-based Products.

Please note: microbial-based products intended for use in indoor environments are not eligible for partnership. Non-microbial ingredients will be reviewed based on their respective component-class criteria.

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Criteria for personal care products (PCP)

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

Safer Choice 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:

  • those that are “leave-on” in nature and result in prolonged dermal contact, like lotions and deodorants, and
  • 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 categorizes personal care products into two groups based on whether section 4.5 applies or does not apply. While Safer Choice has reviewed and labeled rinse-off personal care products, like hand soaps, Safer Choice 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., lotion, moisturizer, cream, oil, serum)  
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) (136 pp, 2317 K, About PDFExit , who wish to qualify for the Safer Choice label, must comply with the Safer Choice Standard and 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 Safer Choice Master Criteria 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

      Limitations 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 aquatically toxic* (LC/EC50 <1.0 mg/L or NOEC/LOEC <0.1 mg/L).

      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 the Criteria for Environmental Toxicity and Fate for Chemicals in Direct Release Products, based on the biodegradation testing in OECD 306.

  3. Renewable content[1]. 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."

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Criteria for specialized industrial products

Specialized Industrial Products (SIPs) are a distinct subgroup of products that meet tailored criteria under the Safer Choice Program. Safer Choice 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 Safer Choice 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.

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