Changes to the Standard to Implement the Safer Choice Label

2/10/15

Implementation of a New Label for the DfE Safer Product Labeling Program and Supporting

Modification s to the DfE Standard for Safer Products , now to be known as the “Safer Choice

Standard

, ” including the Designation of a Fragrance

- F ree L abel

This document explains several important changes to EPA’s Safer Product Labeling Program (SPLP), as well as a number of conforming changes to the program’s Standard for Safer Products, including : a new label 1 and name for the EPA SPLP; a n a ssociated fragrance

- free

label ; and related changes to the standard that qualif ies products for the l abel

. With this

document EPA is finalizing the new label for immediate use. While effective immediately, the Agency is requesting comment on the other changes described in this document, including a

new , optional fragrance

- free certification

.

Redesigned Label

The EPA Design for the Environment (DfE) Safer Product Labeling Pro gram has redesigned its

label to better communicate the program’s human health and environmental protection goals

, increase consumer and institutional/industrial purchaser understanding and recognition of products bearing the l abel , and encourage innovation and the development of safer chemicals and

chemical

- based products

. The label ’s new name “ Safer Choice

, ” with the accompanying wording (or “ t agline ”) “ Meets U.S. EPA Safer Product Standards ” (which is part of the label), and design w ere developed over many months based on input and feedback from a diverse set of stakeholders and the general public

.

This input and feedback includ ed more than 1700 comments on EPA’s website, six consumer focus group sessions in three geographic markets , a nd a national online survey. EPA gave considerable weight to consumer and stakeholder feedback in tailor ing and select ing the new label

, to ensure that the Agency achiev ed, and continue s to achieve, its redesign goals. (Summaries of the focus group sessions and online survey results are available at www.epa.gov/saferchoice/ [insert full link].)

As part of the newly named Safer Choice Program , t he new label will be implemented through

a small family of labels, with very similar content, design and color , but tailored for partnership types and product end

- users. Presented h ere are: the primary label, intended for use on consumer products; the label for industrial and institutional products; and the new f ragrance

- free label

.

1 Because many stakeholders use the terms “label” and “logo” i nterchangeably , for the purposes of this document, EPA will use these two terms as synonyms. The DfE label means the certification provided to product manufacturers under the program’s standard and might refer to any of the three new logos described in this document.2

Please note that EPA is not making any changes to the requirements that must be met to qualify for partnership and use of the new Safer Choice label

.

For consumer products (primary mark):

For institutional and industrial products:

For fragrance

- free products:

The Fragrance

- free L abel

. Health and environmental s takeholders have expressed the need for products that are certified to

be fragrance

- free products for individuals with fragrance allergies or sensitization concerns

. In response to these needs, EPA developed a n option for a f ragrance

- free label that would allow purchasers to identify fragrance

- free products and know that the claim has been ve rified by a

trusted source. When presented with a fragrance

- free concept in the Agency’s focus group

sessions on the label redesign , consumers clearly felt a fragrance

- free label would be useful and thought it filled an important need in the marketplace. P roduct manufacturers also responded favorably, stating that it would help them serve a small but significant subset of consumers

.3

Manufacturers of f

ragrance s indicated that fragrance

- free products could serve those individuals

with concerns for fragrance s

.

With this document

, EPA is introducing a f ragrance

- free certification a s a companion to the new

Safer Choice label

. EPA recognizes that consumers , institutional purchasers and product

manufacturers care about the use of fragrances in cleaning, personal care and other products. At the same time, we know that many fragrance materials may be associated with sensitization and allergenic responses and lack toxicological data

. N ote that the term “fragrance” refers to a formulated product that contains multiple scent and other chemicals (e.g., carriers, stabilizers and preservatives) , while “fragrance materials” are solely the scent and masking components in the fragrance

.

I f a product qualifies for the Safer Choi ce l abel and does not use any fragrance materials, as defined below, the program will allow the manufacturer to add a “ f ragrance

- free” notation to the

Safer Choice label. In the world of non

- fragranced products, two descriptive terms are commonly used on labels: “Unscented” and “Fragrance

- free.” Unscented generally means that, while fragrance materials are not used to impart a scent, a product may contain chemicals that

n eutralize or mask the odors of other ingredients. Fragrance

- free means that neither fragrance materials nor masking scents are used in the product. EPA is using the broader “fragrance

- free” designation with its Safer Choice label to help ensure that cons umers and purchasers seeking to avoid exposure to fragrance chemicals can identify and select such products.

Fragrance

- free certification . To qualify for the program’s f ragrance

- free label, a product must first meet all requirements in the Safer Choice Standard and safer ingredient criteria. EPA will review the product ingredients to ensure that the product contains no fragrance materials. T he fragrance

- free certification will mean that : 1) the product only contains ingredients on or eligible for the Safer Chemical Ingredients List (SCIL)

— the program’s list of ingredients that meet our safer chemical criteria and are generally acceptable for use in Safer Choice labeled products

— and 2) the product does not co ntain chemicals on the International Fragrances Association (IFRA) Transparency L ist of fragrance chemicals intended to impart or mask a scent 2

. Product manufacturers and fragrance professionals regard the IFRA Transparency List as the comprehensive list of materials used by perfumers and the fragrance industry.

It is important to note that p roducts that qualify for the DfE fragrance

- free certification may still
have an odor and not be on the IFRA Transparency List

. S ome product ingredients, such as
surfactants or solvents , carry an odor. Only c hemicals recognized as having dual functionality

— e.g., that are intentionally use d as a solven t and/or as a fragrance

— would be ineligible for use in products seeking the fragrance

- free certification. EPA will work with manufacturers on a case

by

- case basis t o determine whether a chemical has “dual functionality

. ”

Submission of Comments. If you have comments on the changes described in this document, please submit them to the EPA docket : EPA

- HQ

- OPPT

- 2015

- 0047 . While your

2 EPA is developing a list of fragrance chemicals that are acceptable for use in Safer Choice labeled products (that would not be certified as fragrance

- free). The list will be a subset of the IFRA Transparency List.4

comments are welcome on any aspect of the program addressed in this document , we ask that you especially consider commenting on the new fragrance

- free label. All changes
described in this document are effective immediate ly, but w e w ill consider additional changes to the program based on your comments, as appropriate.

__________________

The Safer Choice Standard

. As a result of the label redesign and recent program developments
EPA is making a number of changes to the S tandard , described below.

Changes to the Safer Choice Standard

Title page : To reflect the program’s new label, t he title of the standards document will change
from “ EPA’s DfE Standard for Safer Products (DfE Standard) ” to “ EPA’s Safer Choice
Standard ” (formerly, the ‘ DfE Standard for Safer Products ’ 3 ).

Sec. 2.1 Definitions

To align the Standard s with the Interim Fragrances Criteria 4 , the definition of “ Fragrance 2.1.37 ”

and “ Fragrance raw material 2.1.38 ” will be deleted and replaced by a new definition for “Fragrance Materials 2.1.37

. ” The original definitions, dating from the first iteration of the Standard (2009), were overly broad

. Since then, EPA has worked extensively on fragrances and with the fragrance industry to enhance its understanding of this industry. T he revised definition

will read as follows:

Sec. 2.1.37 Fragrance materials : D iscrete substances obtained by chemical synthesis or derived

from a natural source and present in a fragrance at any level. Fragrance materials are materials

whose function is to impart or mask a scent and may include chemicals with dual functionality

— scent and another function

. ( This definition does not include auxiliary materials such as solvents and preservatives that do not function as a fragrance or to mask a scent .)

3 For the purposes of institutional procurement requirements, state green purchasing specifications, etc., the Safer

Choice label is equivalent to the DfE Safer Product label. Note that the logo for institutional products includes “DfE” in the web address to provide continuity with the previous name.

4 DfE’s Interim Fragrances Criteria (PDF) clarify which fragrance chemicals may be used in DfE products and
provide a level and consistent set of requirements for DfE Formulator Partners and manufacturers of fragrances . Under the interim criteria, listed carcinogens, mutagens, or reproductive/developmental
toxicants (CMRs); listed persistent, bioaccumulative, and toxic compounds (PBTs); and listed respiratory

sensitize rs are not allowed. To advance transparency, product manufacturers must disclose dermal

sensitizers. Non

- fragrance materials present in fragrance formulations will be evaluated under their appropriate DfE functional class criteria (e.g., solvents).5

Sec. 3 General Requirements :

A new section entitled “Fragrance

- free Label” is being added, t o read as follows:

Sec. 3.9 Fragrance

- free Label

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)

— the list of ingredients that meet the Safer

Choice safer chemical criteria and are acceptable for use in labeled products

. T he ingredients

must not include fra grances materials

. Fragrance materials with dual functionality, including use

as a fragrance, are not allowed in fragrance

- free products.

Sec. 4.2.2.1 Concentrates in closed dilution

- controlled systems

The program allows labeling of concentrated products that exceed the normal pH limits (2 to 11.5) if they otherwise comply with the Standard

, are used in closed dilution

- controlled systems

, and meet the other safeguards in th is provision. Without the dilution

- controlled system and othe r safeguards, these products would represent a corrosivity and handling hazard

. Using the safer

choice l abel on the package of such products would be inappropriate and might confuse users regarding the proper handling practices

. Consequently, a new subsection e) will be added to

address label u se , to read as follows:

e) the l abel is not used on the product (or packaging) when it is a concentrate (but may be used in promotional materials).

Sec. 4.5 Products Designed for Dermal Contact

Some products that meet EPA’s Safer Product Standard may also be subject to other agencies’ statutes and laws, such as those products designed for dermal contact

. Two sentence s , therefore,

will be added to the end of the first paragraph to underscore the applicability of existing laws, to

read as follows:

... It is important to note that compliance with the terms of this section does not alter a company’s obligations under the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling
Act , as applicable . If a product qualifie s for the label under sec. 4.5

, it m ay need to carry a statement that indicates that FDA has not r eviewed the product under this provision.

Sec. 5.6 Fragrances

Introduced in the 2012 enhancements to the Standard, version 2.1 of the Criteria for Fragrances
is not being implemented because of difficulties that have arisen in applying the criteria. Numerous attempts among manufacturer partners, manufacturers of fragrance s, and the program6

to implement the criteria revealed the likely root cause: the unavailability of human and

environmental health information . Consequently

, the program will leav e in place the Interim Fragrances Criteria 5 and reference s to the version 2.1 criteria will be deleted from the Standard

.

Also, to further unify our ap proach to the review of fragrances, the program is aligning across product types the requirements applied to labeled products that contain sensitizers that exceed

the de minimis level (0.01% ) in the end

- use product. Specifically, w e will a pply the approach for consumer products , as it currently appears in the Standard, to all products , and most notably, requiring notice for sensitizers that exceed the de minimis level , preferably on the product label

. As a result, sections 5.6.1 and 5.6.2 will be combined to read as follows:

Sec. 5 .6.1 Sensitizers in Labeled Products

Each fragrance material that is a skin sensitizer is limited to no more than 0.01% in the final product. EPA will allow manufacturers to use a skin sensitizer at a higher level in certain limited

situations.

N otwithstanding the provisions in section 3.8 on ingredient communication for fragrances, the final product may contain sensitizers if the manufacturer discloses on the product label each sensitizing ingredient present in th e final product at greater the 100 ppm and provides evidence

to EPA that the fragrance (or its ingredients) are:

 critical to the fragrance essence or product identity;

 otherwise in compliance with the fragrances criteria 6 ;

 the subject of good faith explor ations of alternatives; and

 subject to a monitoring system that would alert the Agency if a user reports any adverse effects from the product.

Alternatively, the manufacturer may demonstrate that the formulated product does not cause a sensitization resp onse through appropriate testing (see test methods listed in Master Criteria ) and limit the amount of fragrance materials in the product to the level i n the t est sample.

Sec. 6 Use of the Mark

This section contains multiple editorial changes, to conform to the new Safer Choice name and logo, as stated below. Sec. 6.2 contains illustrations of the three new logos , geared to product class: 1) consumer; 2) institutional and industrial; and 3) fragrance

- free.

5 See f ootnote no. 4

.
6 See footnote no. 4

.7

Sec. 6.1 Terms of Use

Sec. 6.1.1 The partner may use the Safer Choice logo, as shown in sec. 6.2, on containers or container packaging of products that qualify for the label (“ q ualifying p roducts ”) or on advertising related solely to these products, provided that EPA has reviewed and approved the intended logo use. The partner shall not use the logo or describe EPA’s recognition on any general company materials, non

- qualifying products or associa ted literature, or advertising not specific to the qualifying products. T he partner is not permitted to use the EPA official seal or logo at any time.

Sec. 6.1.2 Use of the Safer Choice l abel must include the EPA web address, www.epa.gov/saferproducts

, as shown in sec. 6.2. Additionally, when advertising the qualifying products or informing consumers about them , the partner must include the endorsement

disclaimer , which appears be low. The partner and EPA shall work to find an appropriate place

to include the disclaimer (e.g., the company’s web site) connected with advertising the qualifying products

.

EPA/Safer Choice recognition does not constitute endorsement of this product. The Safer Choice logo signifies that the product’s formula, as [company name] has represented it to the EPA, contains ingredients with more positive human health and environmental characteristics than conventional products of the same type. EPA/Safer

Choice relies solely on [ the company name], its integrity and good faith, for information

on the product’s composition, ingredients and attributes. EPA/Safer Choice has not independently identified, that is, via chemical analysis, the ingredients in th e product formula, nor evaluated any of [ the company name’s] non

- ingredient claims. EPA/Safer Choice provides its evaluation only as to the product’s human health and environmental

characteristics , as specified in the Standard and based on currently available information and scientific understanding.

Sec. 6.1.3 The partner and EPA acknowledge that under 5 C.F.R sec. 2635.702(c), EPA will not endorse the purchase or sale of the partner’s commercial products and services. The partner agrees to ensure that promotional materials describing or resulting from the partner ship agreement do not contain statements implying that EPA endorses the purchase or sale of commercial products or services

.

Sec. 6.1.4 The partner shall make available to EPA/Safer Choice for review and approval any materials, including press releases, p romotional materials, and advertisements, the partner develops in connection with the partnership, and especially information that describes the Safer Choice program or characterizes the program’s position on issues related to a specific product

sector.8

S ec. 6.1.5 The partner must discontinue use of the Safer Choice logo or any other EPA/Safer Choice recognition within 30 days under the following circumstances: If the partner stops formulating the qualifying product(s) using the agreed

- on ingredients; on the termination of the partnership agreement; or, if so notified by EPA in writing.

Sec. 6.2 Illustrations of the EPA/Safer Choice Certification Mark

For consumer products (primary mark):

For institutional and industrial products:

For fragrance

- free products:

T he Partnership Agreement . Section 8 of the Agreement will be revised to read as follows:

[Company name] may use the appropriate Safer Choice logo, shown on Attachment A to this Agreement, on containers or container packaging of Qualifying Products or on advertising related solely to these products, provided that EPA/Safer Choice has reviewed a nd approved the intended use. [Company name] agrees to not use the logo or describe EPA/Safer Choice recognition on any general [Company name] materials, non

- Qualifying Products or associated9

literature, or advertising not specific to the Qualifying Produ cts. [Company name] is not permitted to use the EPA official seal or logo at any time.

Use of the Safer Choice logo must be accompanied by the program web address

-- www.epa.gov/dfe /saferproducts

— in close proximity to the logo , as shown in Attachment A.

A dditionally, when advertising the qualifying products or infor ming consumers about them, [the Company name] must include the endorsement disclaimer, which appears below. [The Company name] and EPA shall work to find an appropriate place to include the disclaimer (e.g., the company’s web site) connected with advertising the qualifying products. Insert disclaimer language and remaining provisions as they appear in sec. 6.2, above.

Miscellaneous

The words “Design for the Environment” or “DfE” have change d to “Safer Choice” or simply “the program.”

To better align the Standard with the program’s mission to facilitate the adoption of source reduction by businesses and improve the human health and environmental profile of a broad range of products, use of the word “cleaning” has been deleted, as appropriate, throughout the

document. The term “cleaning,” as in “cleaning product,” is too narrow to represent the breadth of labeled products under the program

.