EPA's Safer Choice Criteria for Colorants, Polymers, Preservatives, and Related
Chemicals
The Safer Choice approach to product review and labeling focuses on identifying the
safest possible chemical ingredients, within a functional class context, that are
necessary for a product to perform well. The general requirements in the Safer
Choice Master Criteria for Safer Chemical Ingredients serve as the reference set of
benchmarks on which Safer Choice bases its chemical ingredient-specific criteria.
The criteria also constitute a baseline set of toxicity parameters, with functionality-
driven tailoring, that all ingredients without component- specific criteria must address
to be considered for use in Safer Choice products.
While EPA has used the stringent and comprehensive elements of the Master Criteria
to evaluate ingredient classes, its experience in implementing the Safer Choice
Program has demonstrated that most functional classes require a tailored approach.
For example, colorants, polymers, and certain preservatives have as part of their
functionality the ability to resist degradation. They also typically lack a complete set
of measured toxicity data, for which Safer Choice substitutes data based on predictive
models, estimation techniques, and expert judgment. EPA has therefore adapted its
criteria for colorants, polymers, preservatives, and related chemicals (e.g.,
defoamers) to accommodate specific functional-class characteristics, like persistence,
permitting the listing of the safest chemicals in those classes.
Although modifying the Master Criteria to some extent, the provisions serve largely to
clarify, elaborate on, and make more transparent the technical considerations involved
in evaluating chemicals in the functional classes without tailored criteria. The
approach Safer Choice has adopted retains the human health safety thresholds from
the Master Criteria, but allows flexibility in environmental toxicity and fate endpoints,
as appropriate to chemicals that persist as part of their functionality. To address the
lack of data common to many of these chemicals, Safer Choice relies on a mix of
estimated, measured and authoritative list-based data elements. (Please note that
any modifications to the component-class criteria will not alter the prohibition on the
use of listed carcinogens, mutagens or reproductive or developmental toxicants, or
persistent, bioaccumulative and toxic chemicals in Safer Choice products.)
Colorants, Polymers, Preservatives, and Related Chemicals (extract from the
Safer Choice Standard, section 5.8)
Colorants (including pigments and optical brighteners), polymers, and certain
preservatives (including antioxidants) (and other chemicals referenced in section 5.14)
include as part of their functionality the ability to resist degradation and be effective
over long periods. They also can be complex molecules and mixtures and often lack

-------
measured toxicity data. To identify the safest available chemicals in each class given
their functional characteristics, the toxicity thresholds in the Master Criteria will be
used to evaluate human health endpoints, and the thresholds in section 5.8.3 will be
used for environmental endpoints. Data on these chemicals will be required as per
5.8.3, unless noted otherwise.
5.1	Polymers
To be acceptable for labeled products, polymers must have low-concern
characteristics.1 Also, the requirements of this section apply to the low molecular
weight components of polymers (typically less than 1,000 daltons). Safer Choice
encourages the use of degradable polymers whenever possible; only those that do
not degrade into CMRs or PBTs will be allowed.
Special conditions for certain categories of polymer: In addition to the requirements in
5.8.3, polymers that are respirable or water-absorbing must be in solution. Anionic
polymers used as chelating agents must meet the requirements in the Safer Choice
Criteria for Chelating Agents, except section 5.9, Environmental Toxicity and Fate,
which must be addressed as per 5.8.3. Perfluoroalkyl polymers, allowed only in floor
finishes, must, at a minimum, be limited to fluorinated carbon-chain lengths of less
than eight atoms.
5.2	Preservatives
Preservatives have biocidal properties and time-sensitive functionality. Safer Choice
will allow use only at the lowest effective level. In addition to the CMR and PBT
prohibitions in 5.2, preservatives that release CMRs or PBTs or whose reaction
byproducts are CMRs or PBTs will not be allowed.
5.8.3 Special requirements
For colorants, polymers, and preservatives, the toxicological endpoints in the Master
Criteria will be addressed as follows:
1)	For Acute Mammalian Toxicity (section 5.1 of the Master Criteria),
Neurotoxicity (5.4), Repeated Dose Toxicity (5.5), and Skin Sensitization (5.8),
the following apply.
Data requirements: Screen Authoritative Lists. Chemicals with new measured
data not yet reviewed by authoritative bodies may be subject to review.
2)	For Carcinogenicity (section 5.2 of the Master Criteria), Genetic Toxicity (5.3),
1 Described in the Sustainable Futures' Interpretive Assistance Document for Assessment of Polymers
(http://www.epa.gov/oppt/sf/pubs/iad polymers iune2013.pdf).

-------
and Reproductive and Developmental Toxicity (5.6), and Respiratory
Sensitization (5.7), the following apply:
Data requirements: Screen specified R-Phrases and Authoritative Lists.
Available data, measured and/or estimated, for the chemical and/or a suitable
analog may 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 Authoritative Lists. Available data, measured
and/or estimated, for the chemical and/or a suitable analog may be reviewed
against the criteria using a weight-of-evidence approach.
*Excludes the algal shading effects of colorants.

-------