Design for the Environment Safer Product Recognition Program Elements:
A Discriminating and Protective Approach to
Product Review and Recognition
June 2009
Situated in the U.S. EPA's Office of Pollution Prevention and Toxics (OPPT), the Design for
the Environment (DfE) Safer Product Recognition Program (also known as the Formulator
Program) is a product formulator's gateway to OPPT's unique chemical expertise, information
resources, and guidance on greener chemistry. The program gathers hazard information on
chemical ingredients and works with OPPT's science experts to assess this information and
compare the relative safety of chemicals.
The DfE Program promotes green chemistry through informed substitution, the considered
transition from a chemical of particular concern to safer chemicals or non-chemical alternatives.
DfE informs substitution by bringing together key stakeholders and the best available
information to address critical areas of environmental and health protection. DfE works with the
cleaning industry and other industry sectors to compare and improve the human health and
environmental profiles of existing and alternative products, while maintaining high performance
and cost competitiveness.
Since 1997, DfE has offered recognition to those companies who design for the environment
and human health by using only safer chemicals. To date, over 1000 chemical products have
been recognized by the program. A complete list of partner companies and products can be
found at: http://www.epa.gov/dfe/pubs/proiects/formulat/formpart.htm.
What Makes DfE Safer Product Recognition Review Unique? The DfE Program is distinct
from all other product recognition or ecolabeling programs because of two defining
characteristics: its assessment methodology and its technical review team. The DfE technical
review team has many years of experience and is highly skilled at assessing chemical hazards,
applying predictive tools, and identifying safer substitutes for chemicals of concern.
The review team applies the DfE assessment methodology by carefully reviewing each product
component1, starting with the chemical component's structure, to determine its key health and
environmental characteristics. (The review includes all chemicals, including those in
proprietary raw material blends, which manufacturers share with DfE in confidentiality). The
review team then compares an ingredient's characteristics to other chemicals in the same use
class2, considers possible negative synergies between ingredients, and places the ingredient on a
continuum of improvement relative to other similar chemicals.
UlS.EFA
1	A component is a chemical as identified by its Chemical Abstract Service (CAS) number. An ingredient may be
one component or a blend of multiple components.
2	Ingredient class refers to the functionality of the product, e.g., surfactant, solvent, dye fragrance, etc...
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Continuum of Improvement
Formula Ingredient by Use Class
Of Concern
111 % ( Improved J IHl
Characteristics
of Ingredient
of Concern
Characteristics
of Improved
Ingredient
Characteristics
of Sustainable
Ingredient
Through its review team and methodology, DfE provides information to formulators that helps
them select from among the safest chemicals in an ingredient class. The approach is adaptable
to changing circumstances and new information, emphasizing continuous improvement as the
opportunities for safer formulations grow with chemical innovation.
How Does DfE's Component-Based Review Compare with Other Product-Based
Approaches? The following examples showcase some of the key benefits of DfE's component-
based review and the extra measure of protection it often provides:
DfE uncovers chemicals of concern that can be masked by raw material blends or by dilution in
water. By focusing at the component level and on key inherent characteristics, DfE is able to
carefully scrutinize formulations and make meaningful calls on potential concerns. For
example, a surfactant that is acutely toxic to aquatic organisms and environmentally persistent
can appear to pose a low concern when blended with other less toxic and less persistent
surfactants. Similarly, water, typically the largest percentage ingredient even in concentrates,
can mask the effects of a hazardous chemical.
DfE spots negative synergies between product components. These potentially dangerous
chemical combinations pose concerns for both acute and longer-term effects. For example,
oxidizing agents, such as peroxides, can react with certain terpenes commonly used as
fragrances and solvents; the products of these reactions have tested positive for dermal
sensitization in rodent studies and human patch testing. In another example, mixing nitrosating
agents with amines will create nitrosamines, potent carcinogens.
DfE uses its expert knowledge and predictive tools to supplement lists of chemicals of concern.
Few chemicals in commerce have been adequately tested, especially for chronic effects, like
cancer and developmental toxicity and thus lists of chemicals with these effects are partial at
best. DfE uses its knowledge of the structural similarities between chemicals and its predictive
models to flag product components with similar potential effects.
DfE screens all fragrances and dyes for chemicals that may pose serious health or
environmental effects. Some of the chemicals of most potential concern in formulated products
are those in fragrances and dyes. Chemical ingredients in these classes can include sensitizers,
carcinogens, and environmentally toxic and persistent compounds. Small quantities don't
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necessarily mean small hazards: A person, once sensitized to a chemical, can have an allergic
response even if exposed at levels below those that initially induced sensitization.
DfE recommends safer substitutes for chemicals of concern. Sustainability requires innovation
and continuous improvement. The DfE program works directly with EPA's Green Chemistry
specialists to identify and recommend safer chemicals to its formulator partners, continuously
raising the bar and redefining the meaning of environmentally preferable products.
DfE General Screen for Safer Ingredients
As of January 2009, DfE has completed its General Screen for Safer Ingredients. With the
development of the General Screen, the core of the DfE review process and the standard to
which it applies is transparent and ready for third-party implementation. In establishing
thresholds for green ingredients, the General Screen delineates the safer or "low-concern" end of
the ingredient spectrum, guiding and ensuring best-in-class ingredient choices for DfE-
recognized products. The General Screen covers the following human health and environmental
attributes:
	Acute mammalian toxicity
	Carcinogenicity
	Environmental toxicity and fate
	Genetic toxicity
	Neurotoxicity
	Repeated dose toxicity
	Reproductive and developmental toxicity
	Respiratory sensitization
	Skin sensitization.
All components in DfE-recognized products will be screened against the General Screen or
against the ingredient-class screen, as available and appropriate. Ingredient-class screens define
and more fully explore the green end of specific ingredient-class continuums. Using the general
screen as a template, the ingredient-class screens tailor the health and environmental endpoints in
the General Screen in a way appropriate to the specific class, designating key, distinguishing
characteristics and adjusting thresholds, as necessary. Developing the screens improves the
general understanding of the characteristics of safer ingredients in the class and helps identify
green-chemistry opportunities and successes.
DfE currently has specific ingredient-class screens for surfactants and solvents. An ingredient-
class screen for fragrances will be available sometime in 2009.
DfE Screen for Solvents. With solvents, there are potential concerns for the following
endpoints: carcinogenicity, acute mammalian toxicity, reproductive and developmental toxicity,
repeated-dose toxicity, neurotoxicity, and environmental fate and toxicity. Phase I of the
solvents screen should be applied only to alcohols, esters, ethylene glycol ethers, and propylene
glycol ethers. DfE's next step is to expand the solvents screen to additional solvent classes used
in products, such as terpenes, amines, and amides; these will be known as Phase II solvent
classes.
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Phase I Solvent Classes
Alcohols
Esters
Ethylene Glycol Ethers (EGEs)
Propylene Glycol Ethers (PGEs)
Attributes of Concern for Phase I
Solvents
Carcinogenicity
Neurotoxicity
Acute Mammalian Toxicity
Reproductive and Developmental
Toxicity
Repeated-Dose Toxicity
Environmental Fate and Toxicity
DfE Screen for Surfactants^ Surfactants in formulated products are distinguished by their rate
of biodegradation and level of aquatic toxicity. The DfE Screen for Surfactants combines those
two hazard characteristics, and requires that surfactants with higher aquatic toxicity demonstrate
a faster rate of biodegradation. Surfactants that meet the relevant screen for product use are
acceptable for use in a DfE-recognized product.

Acute Aquatic Toxicity
Value (L/E/IC50)a'b
Persistence
(Measured in terms of level of
biodegradation)
Bioaccumulation
Potential
1
If <1 ppm...
.. .then may be acceptable if the component
meets the 10-day window as measured in a
ready biodegradation test0 without
degradation products of concernd...
... and BCF <1000.
2
If >1 ppm and <10 ppm...
.. .then if the component must meet the 10-
day window as measured in a ready
biodegradation test without degradation
products of concernd ...
3
If >10 ppm and <100
ppm...
.. .then the component must meet the 28-day
pass level as measured in a ready
biodegradation test without degradation
products of concernd...
4
If >100 ppm...
.. .then the component need not meet the 28-
day pass level as measured in a ready
biodegradation test if there are no
degradation products of concernd and half-
life < 180 days...
a 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. [18] Since acute aquatic toxicity data are more
readily available, the DfE Screens use 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.
bData, whether estimated or measured, are required for each of the following groups of organisms algae, aquatic invertebrates and fish
(all fresh water). Data for marine species may be added when available.
c A case-by-case approach focusing on rate of biodegradation and degradation products of concern will be implemented for chemicals
toxic to aquatic organisms at < Ippm.
d Degradation products of concern are compounds with high acute aquatic toxicity (L/E/IC50 <10ppm) which mineralize <60% in 28
days.
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DfE Screen for Direct Release Surfactants and Other Ingredients. Certain products that are
intended for use outdoors are likely to bypass sewage treatment, shortening 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 surfactant screen to address the potential
for immediate contact with aquatic life. Any ingredients (including surfactants, preservatives,
solvents, etc.) that have acute aquatic toxicity median lethal values <1 mg/L are not allowed
in DfE-recognized direct release products.

Acute Aquatic
Toxicity Value
(L/E/IC50)1
Persistence
(Measured interns of rate of biodegradation | Status
via a ready biodegradation test)
1
<1 ppm
i Not acceptable
2
>1 ppm and <10 ppm
Biodegradation2 must occur within a 10-da\ Could be
window without products of concern3 I improved

>10 ppm and <100
Biodegradation2 occurs within 28 days Could be
without products of concern3 improved
ppm
Biodegradation2 occurs within a 10-day . ,,
window without products of concern3
4 J >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 Screens use these data to screen chemicals that may be toxic to
aquatic life.
2.	Generally, >60% mineralization (to C02 and water).
3.	Products of concern are compounds with high acute aquatic toxicity (L/E/IC50 < lOppm) and a slow rate of
biodegradation (greater than 28 days).
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Additional Considerations. The following matrix highlights additional elements reviewed by
the DfE Formulator Program team. The matrix should help purchasing entities and others
understand what DfE considers in its review, what its recognition means, and how they should
view products that carry the DfE logo. DfE compares and balances product characteristics in
determining the appropriateness and type of DfE recognition.
Review elements
Assessment Approach
Comments
Alkylphenol
ethoxylates (APEs)
DfE-recognized products do not contain
APEs. APEs, like all surfactants, are
compared based on their key distinguishing
characteristics:
1)	Rate of biodegradation,
2)	Aquatic toxicity, and
3)	Degradation products.
APEs do not have acceptable profiles because
they degrade to products that are increasingly
toxic and have potential for interaction with
the endocrine system.
DfE has identified surfactants
that are safer than APEs, and
have comparable performance
and price. In the context of its
product reviews, DfE provides
this information on safer
substitutes to its formulator
partners.
See also the section titled
'Surfactants'.
Chelating and
Sequestering Agents
A stakeholder group is developing a Screen
for Safer Chelating Agents in Cleaning
Products. The Chelant Screen will be based
on the DfE General Screen, but will reflect the
key health, environmental, and performance
characteristics of chelants. Until such a screen
is finalized (in 2009), DfE prefers chelating
agents with low toxicity and rapid
biodegradation. Currently, inorganic
phosphates that contribute to eutrophication,
and NT A, a potential carcinogen, are not
acceptable in DfE recognized products.
Other chelants/sequesterants that are not
readily biodegradable, may be accepted under
continuous improvement.
See 'Eutrophication' for
explanation of phosphate
criterion.
Continuous improvement means
that the chemical is of
borderline concern by DfE
standards and should be
formulated out of the product
within the three year Partnership
Agreement timeline.
Compostability
DfE considers wipe composition and ability to
decompose under mesophilic conditions (20 -
45C) as key characteristics for disposable
wipes when they are the intended method of
application for a formulation. At a minimum,
wipes must be made entirely of compostable
material.
'Compostable' and 'mesophilic'
are defined in section 3.1.2 of
the ASTM Standard Guide to
Assess the Compostability of
Environmentally Degradable
Nonwoven Fabrics D6094-97.
Concentrates
Liquid laundry detergents must be at least a
2X concentrate to achieve DfE recognition.
Many manufacturers are
producing products in
concentrated form to reduce
their transportation footprint and
reduce greenhouse gas
emissions. DfE commends this
approach.
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Review elements
Assessment Approach
Comments
Energy Efficiency
DfE-encourages the use of energy saving
technologies including the use of concentrates
and detergents that work in cold water. DfE
considers energy efficiency by comparing
product efficiency to that typical of the class,
recognizing the importance of reducing
energy use and generation of greenhouse
gases. DfE expects that energy effiecient
products would continue to meet all other
program criteria.

Flammability
DfE takes note of product flashpoint as
appropriate and seeks to ensure low concerns
for combustibility.
Flashpoint is generally not a
concern when dealing with
water-based mixtures.
Flammable liquids are regulated
by:
>	49CFR173.120 (a)(5) -
Flammable Liquid
Definition
>	49CFR173.150 (e) Aqueous
Solutions of Alcohol
>	40CFR261.21 (a) (1)
Characteristic of Ignitability


Fluorosurfactants
Based on EPA's concerns for persistence,
bioaccumulation in humans, and potential
toxicity, DfE-recognized products do not
contain any fluorosurfactants that have a
fluorinated chain of eight or more carbons
(C8). All fluorosurfactants that do not have a
C8 or longer chain will be reviewed on a case-
by-case basis by DfE.
The ideal, green chemistry
surfactant and surface treatment
chemical, including wetting and
leveling agents, would be a
chemical that readily degrades
to non-toxic degradants, has low
toxicity, does not persist, or
metabolize to chemicals of
concern in humans or other
species, and performs well when
compared to traditional wetting
agents.
Flushability
To be an acceptable wipe for a DfE-
recognized formulation, a wipe must be
"flushable". Flushablility is established if the
wipe can pass through the toilet and drainline
system, be transported in wastewater
conveyance systems, and be compatible with
wastewater treatment systems where they
exist, or in some regions, discharges of
untreated wastewater. An example of an
acceptable test protocol is the Guidance
Document for Assessing the Flushability of
Nonwoven Consumer Products, published by
INDA, the U.S.-based association of
nonwoven fabrics industry and ED ANA, the
European-based international association
serving the nonwovens and related industries.

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Review elements
Assessment Approach
Comments
Formulary Efficiency
DfE considers formulary efficiency by
evaluating the functionality of each
ingredient, its contribution to product
performance, and the opportunity for
elimination of unnecessary ingredients.
The principle of informed
substitution recognizes the value
of formulary efficiency, which
might include the replacement
of chemicals of concern with
safer chemicals or non-chemical
alternatives (e.g., biological or
mechanical), provided that
product performance is not
compromised.
Fragrances
DfE works directly with fragrance houses to
improve their formulations. Components are
screened for:
1)	Sensitization,
2)	Carcinogenicity,
3)	Mutagenicity,
4)	Reproductive toxicity,
5)	Environmental persistence,
6)	Aquatic toxicity, and
7)	Other hazard characteristics.
Following IFRA's Code of
Practice may not be sufficiently
protective when a fragrance is
added to a cleaning product. A
stakeholder group convened by
GreenBlue has proposed a set of
criteria for defining safer
fragrances in cleaning products.
Those criteria are under review
at EPA. A final screen should
be proposed in 2009.
Irritation and
corrosivity
To minimize potential for dermal and eye
irritation or injury, product pH should be > 2
and < 11.5. Depending on percentage in the
formulation, DfE limits components that are
suspected or known severe skin and eye
irritants.
Most cleaning products have
ingredients, like surfactants, that
are expected skin and eye
irritants, especially at
concentrated levels. OSHA
requires product-level irritation
information on all MSDSs, if
any positive results are
available.
Labeling
Requirements
Our partnership agreement requires each
partner company to provide its customers with
information on environmental and worker
safety matters.
OSHA, DOT, and other
authorities require
manufacturers to provide
handling and other worker
safety information.
Laundry Systems
A cleaning system, such as a laundry system,
is not eligible for recognition unless every
component meets the DfE Criteria.
DfE recognition of the system is void and in
violation of the partnership agreement if DfE-
labeled components are used in combination
with non-labeled components.

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Review elements
Assessment Approach
Comments
d-limonene
d-limonene is a terpene often used as a
solvent. Its oxidation products have tested
positive for dermal sensitization but may be
used in a DfE-recognized product in
concentrations at which the potential
oxidation products may be present at 20
millimoles per liter (mmol/L) or less
(corresponding to a d-limonene concentration
of 1.36 % or less, as a percent by weight) in
an overall formulation. Because of their high
potential toxicity to aquatic organisms, d-
Limonene should not be used in products that
will be directly released to the environment.
Also, products that contain d-Limonene
should not also contain oxidizers, like
hydrogen peroxide, which may accelerate the
formation of d-Limonene oxidation products
and harm product integrity.
For more information, see short
profile on d-Limonene.
Ozone-depleting
compounds
DfE-recognized products do not contain
ozone-depleting compounds.
htto://www.era.eov/ozone/science/ods/index.
html
The Montreal Protocol (1987)
initiated the phase-out of
HCFCs and banned almost all
CFCs, including those used as
propellants in aerosol products.
Packaging
Product manufacturers must explain how
packaging is designed for increased
sustainability by addressing recycled content,
recyclability, reduced-space packaging,
refillable packaging, or other parameters.
For more information see
http ://www. sustainablepackagin
g.org/
pH
Product pH should be > 2 and < 11.5.

Phosphates
DfE-recognized products do not contain
inorganic phosphates (known to be present or
intentionally added), because of their potential
to cause eutrophication.
Certain inorganic phosphates
have produced exponential
growth of green algae at levels
as low as 50 parts per billion.
Testing may be used to rebut the
presumption that phosphates
accelerate algal growth.
Photochemical Smog,
Tropospheric Ozone
Production, and
Indoor Air Quality
DfE seeks to minimize VOCs and limits
components that are also Hazardous Air
Pollutants (HAPs) or are on EPA's Toxics
Release Inventory (TRI). DfE strives to
optimize the health and environmental
preferability of products. The lowest possible
VOC-level may not correspond to the safest
formulation.
At a minimum, DfE limits product VOC
content as prescribed by EPA's Office of Air
and Radiation, as applicable (see 40 CFR 59,
Subpart C).

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Review elements
Assessment Approach
Comments
Phthalates
DfE-recognized products do not contain
phthalates of concern.

Product Performance
Testing
To ensure a baseline measure of performance,
DfE asks all partners to demonstrate that their
products perform effectively. Potential
partners may submit appropriate test results as
specified in Appendix I or provide equivalent
performance tests agreed upon by DfE.

Residuals
Residuals of concern shall be limited to less
than 0.01% (by weight) or lOOppm in the
formulation. For ingredients known to contain
residuals of concern, DfE's goal will be to
limit those residuals to the lowest practicable
levels. Dilution will not be considered in
calculating the percentage of residuals in
concentrates. Formulators should understand
that residuals may be present and should
encourage chemical manufacturers to
carefully monitor and control processes to
limit residuals of concern.
A residual is a "residual of concern" if it fails
to meet the criteria in the General Screen for
carcinogenicity, mutagenicity, reproductive
toxicity and other human health effects, or
fails to meet the criteria for persistence,
bioaccumulation and toxicity, as defined by
the Final PB&T Rule
(http://www.epa.gov/fedrgstr/EPA-
WASTE/1999/October/Day-29/f28169.htm).

Toxic elements
DfE-recognized products do not contain toxic
elements, for example lead, cadmium, arsenic,
zinc and copper.
Unavoidable, de minimis levels
may be present, e.g., from
inorganic materials mined from
the earth.
Training
Our Partnership Agreement requires each
partner company to provide its customers with
information on environmental and worker
safety matters.
OSHA, DOT, and other
authorities require
manufacturers to provide
handling and other worker
safety information.
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Review elements
Assessment Approach
Comments
Verification
The Partnership Agreement between
EPA/DfE and the partner company affirms
that those ingredients disclosed to EPA during
the product review process are in fact the only
ingredients intentionally added or known to
be present.
DfE uses multiple quality assurance steps in
its product review process. These steps
include profiling by a qualified third party,
expert Agency workgroup assessment, and
detailed technical review oversight.
Under the terms of the
Partnership Agreement, DfE
may require partners to submit
bills of lading to verily product
ingredients.
Wipes
Wipes impregnated with a formulation must
meet criteria for the ingredients used in the
formulation and for the materials composing
the wipes. See details under 'Compostability'
or 'Flushability'.

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Appendix I: Product Performance Testing under EPA's Design for the Environment
Formulator Program
DfE believes performance testing requirements should be product category specific, and will
accept any valid and scientifically sound method of demonstrating product performance.
Examples of performance requirements that are acceptable to DfE include but are not limited to:
Carpet Cleaners - Perform equal to or better than nationally recognized carpet cleaners in the
same category using CSPA DCC-03 and AATCC Test Method 171-1995 or equivalent method
agreed upon by EPA DfE.
Compostabilitv - Meets user requirements for the compostability of environmentally degradable
nonwoven fabrics as described in ASTM D6094-97.
Glass Cleaners - Meets user requirements for cleaning, streaking and smearing when tested
according to CSPA method DCC-09 or equivalent method agreed upon by EPA DfE.
General Purpose Cleaners - Meets user requirements for soil removal on relevant substrates
when tested according to ASTM method D4488-95, ASTM G122 - 96(2002), CAN/CGSB 2-GP-
11, Method 20.3, or equivalent method agreed upon by EPA DfE.
Hand Dishwashing Detergents - Meets user requirements for foam stability when tested
according to the CSPA method DCC-10 or equivalent method agreed upon by EPA DfE.
Laundry Detergents - Meets user requirements for home laundering pre-wash spotter stain
removal as specified in DCC-11 or equivalent method agreed upon by EPA DfE.
Oven Cleaners - Meets user requirements for the efficacy of oven cleaners as described by CSPA
DCC-12 or equivalent method agreed upon by EPA DfE.
Resilient Floor Cleaners - Meets user requirements for soil removal on Resilient Flooring and
Washable Walls as specified by ASTM D4488 - 95(2001)el.or ceramic tile as specified by
ASTM D5343 - 06 or equivalent method agreed upon by EPA DfE.
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