EPA’s Safer Choice Interim Fragrances Criteria

EPA's Safer Choice Interim Fragrances Criteria

The Safer Choice Interim Fragrances Criteria (IFC) does not allow listed CMRs, PBTs, and known respiratory sensitizers
to be used as discrete fragrance chemicals in Safer Choice products. (Natural Complex Substances (NCSs), including
essential oils and extracts, are chemical mixtures subject to special requirements that allow only very low levels of
listed chemicals, as discussed below.) If used, EU-restricted dermal sensitizers must be listed on product packaging (as
described under "Sensitizers," below). The IFC will remain in effect until new fragrances criteria are
developed and implemented, following a public input process. For any products labeled under the IFC,
compliance with any new fragrances criteria would not be required until partnership renewal, at least one year after
the implementation date. (With adequate justification and based on a fixed implementation schedule, partners may be
granted a one-year extension of the deadline under any new fragrances criteria.)

Listed CMRs and PBTs:

Under the interim criteria, each fragrance material1 CAS# is checked against authoritative lists of carcinogens, mutagens,
or reproductive toxicants (CMRs); persistent, bioaccumulative, and toxic chemicals (PBTs); and relevant EU risk or hazard
phrases. If a fragrance material CAS# is included on one of the authoritative lists below, it is not allowed to be added to
a fragrance formulation as a discrete fragrance material under the IFC, regardless of its use level in the final product.
(Please see the NCS section below for information on how the criteria treats listed chemicals in NCSs.)

For CMRs:

• International Agency for Research on Cancer (IARC). Agents Classified bv the IARC Monographs. Designated
Group 1, 2A, or 2B.

• US EPA. Integrated Risk Information System (IRIS), Chemicals carcinogenic to humans, likely to be carcinogenic to
humans, or suggestive evidence of carcinogenic potential (2005 Guidelines).

• California Office of Environmental Health Hazard Assessment (OEHHA). Proposition 65 List of Chemicals Known to the
State to Cause Cancer or Reproductive Toxicity.

• European Commission Hazard Phrases fAnnex VI to the CLP Regulation1) or Risk Phrases fAnnex VI to the DSD
Regulation1) indicating possible carcinogenic, mutagenic, or reproductive toxicity: H350, H350i, H351, H340, H341,
H360, H361, H362, R45, R49, R40, R46, R68, R33, R60, R61, R62, R63, R64.

For PBTs:

• US EPA. Toxic Release Inventory CTRII. Designated PBT.

• EU REACH. Substances of Very High Concern due to PBT, vPvB, or vPvT.

• Stockholm Convention Persistent Organic Pollutants fPOPsl.

• OSPAR List of Substances of Possible Concern. Hazardous Substances List - Sections A-D.

• Chemicals determined to exceed the Safer Choice thresholds for persistence, bioaccumulation. and aguatic
toxicity when addressed through the TSCA Work Plan Chemical process.

[Note that Safer Choice makes a limited exception for some chemicals on PBT lists based on new data.]

Sensitizers:

If a fragrance material CAS# is included on the list below, it is not allowed under the interim criteria, regardless of its use level
in the final product.

• European Commission Hazard Phrases fAnnex VI to the CLP Regulation) or Risk Phrases fAnnex VI to the DSD
Regulation1) indicating possible respiratory sensitization: H334, R42.

1 For the purposes of the IFC, fragrance materials are discrete substances, obtained by chemical synthesis or derived from a
natural source, present in a fragrance at any level. Fragrance materials are materials whose primary function is to impart or
mask a scent. This definition does not include auxiliary materials such as solvents and preservatives (covered under "Non-
Fragrance Materials" below).

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Fragrance materials from another authoritative source referenced below - a list of 26 dermal sensitizers from Annex III
of the EU Cosmetics Regulation - are allowed but must be disclosed in accordance with the Safer Choice Standard,
section 5.6.1. These provisions, as previously proposed and finalized through public comment, address sensitizers in
Safer Choice products and, although linked to the no-longer-active version 2.1 criteria, will be part of the IFC. Please
note: When a product contains a listed dermal sensitizer, Safer Choice will treat industrial and institutional products the
same as consumer products and require disclosure. Manufacturers should list any of the 26 dermal sensitizers in a
product on the product label. Safer Choice will not require on-pack listing at the time of partnership or at audit, but
asks manufacturers to include the listing on-pack as soon as practicable. In the meantime, the presence of any of the
listed dermal sensitizers must be disclosed—preferably on the company's website—as part of the Safer Choice
ingredient disclosure requirements at section 3.8 of the Safer Choice Standard2.

• Dermal Sensitizers from Annex III of the EU Cosmetics Regulation
Lists of Banned Fragrance Materials:

Further, under the IFC, fragrance materials banned by the European Union (EU), Canada and the International Fragrance
Association (IFRA) are not allowed:

• European Union fEUI Annex II (EU Cosmetics Regulation).

• Health Canada Cosmetic Ingredient Hotlist - prohibited chemicals.

• International Fragrances Association flFRAI Standards, current IFRA Code of Practice amendment - prohibited
chemicals.

Non-Fragrance Materials in Fragrance Formulations:

Fragrance houses should separately indicate any non-fragrance materials when submitting fragrance formulations.

• Carriers: Carriers act as solubilizers in the fragrance formulation and may include solvents or surfactants. Safer
Choice evaluates carriers against the appropriate criteria (e.g., the Safer Choice Criteria for Solvents or Criteria
for Surfactants').

• Odor Eliminators: Odor eliminators will be evaluated against the Safer Choice Master Criteria.

• Preservatives: Preservatives will be evaluated against the Safer Choice Criteria for Colorants. Polymers.

Preservatives, and Related Chemicals.

Natural Complex Substances (NCSs) Including Essential Oils (EOs) and Extracts:

Authoritative lists do not typically include NCSs. Some NCSs contain components that are listed CMR/PBTs. NCSs that contain
listed CMRs or PBTs totaling 10% or more of the NCS are not allowed under the IFC.

1) To be considered under the interim criteria, NCS component information must be available from at least one of
the following sources:

a. IFRA Labeling Manual;

b. EO University Database: or

c. Fragrance house analytical data.

The NCS CAS# must also be listed on TSCA inventory.

2) From one of the three sources referenced above, Safer Choice must be able to confirm that there are no listed
CMR/PBTs present at or above 10% (individually or in aggregate) in the NCS. If the IFRA Labeling Manual and/or EO
University analysis indicates that CMR/PBTs are present at or above 10% in the NCS, fragrance houses have the option
to provide batch-specific analytical data demonstrating that their NCS meets this threshold.

Questions?

Please contact saferchoice@epa .gov.

2 To implement ingredient disclosure, Safer Choice will ensure that product manufacturers are aware of the sensitizing
fragrance chemicals in their products.

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