Document ID: EPA-HQ-OPPT-2015-0047-0016
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2015-11-12T05:00Z

Response to Comments on Changes to the DfE Program and Label, Notably the New Fragrance-free Safer Choice Label
                               October 19, 2015
                                       
On March 6, 2015, the U.S. EPA Design for the Environment (DfE) Program issued program enhancements, changing its name and label and making corresponding changes to its Standard for Safer Products.  The new name for the program and label became Safer Choice and the qualifications for the label are contained in the renamed Safer Choice Standard. The program requested comments on a new Fragrance-free label and associated changes to the Standard.  (Comments were not requested on the new name and other labels since those program elements had already been the subject of extensive public comment, a summary of which is available at http://www.regulations.gov/#!docketDetail;D=EPA-HQ-OPPT-2013-0426. While our responses in this document will be confined to comments on the Fragrance-free label and fragrances-related matters, we will respond separately to other comments not previously addressed by the program.  These responses will be posted to a Question and Answer page on our web site.)  

The Safer Choice program received 14 sets of comments, representing 28 organizations or individuals (and not including discrete trade association members), two sets of which arrived after the comment period, which ran from March 6 to May 5, 2015.  The program thanks everyone who took time to submit comments, as well as those who shared their support and ideas less formally.  

Of the 14 comment sets Safer Choice received, opinion on the Fragrance-free label was split between those who favor the label and those who don't.  What follows is a brief description of the Safer Choice program, our reasoning for introducing the Fragrance-free label, and a summary of the comments that expressed concerns about the label or related matters, with our responses to those comments. 

The Safer Choice program offers a unique science-based approach to labeling products that are safer for human and environmental health. The Safer Choice label indicates that a product contains only the safest possible functional ingredients and will maintain that status as innovations in chemistry occur.  Safer Choice is especially qualified to advance safer chemistry and safer products through its label.  In its product reviews, the program uses its scientific expertise in assessing chemicals, acquired over decades.  The program evaluates the physical-chemical properties and hazard characteristics of each intentionally added ingredient which often lack experimental data, within its distinct functional class and compares toxicity and fate profiles to identify the safest ingredients.  Importantly, the program fills data gaps using analytic methods and models the Agency has developed and refined over time. This capability helps enhance our confidence in the profile of safer chemicals and also ensure that problematic chemicals that are data poor -- and not yet on prohibited lists -- are not present in labeled products.
 
The Safer Choice program introduced the Fragrance-free label as a companion to the other new Safer Choice labels.  The Agency believes that the label offers an important public health service for those individuals, especially children, who can or might be sensitized or allergic to fragrances.  Many public and children's health advocates and members of the medical community, especially lung and respiratory specialists, recommend use of non-fragranced products, in part, so that sensitized individuals are less likely to be exposed to fragrances and potentially suffer negative reactions.  Some members of the product manufacturing industry have also indicated that some consumers prefer fragrance-free products and that these products should be available to consumers, especially those with allergies. Safer Choice believes that the availability of a Fragrance-free label, along with our standard labels for fragranced products, serves a broad spectrum of consumer, public health, and business interests.    

The purpose of the Safer Choice Fragrance-free label is to help consumers identify products that do not contain fragrances, either to impart a scent or to mask other scents.  Since there are a number of terms used in this space, e.g., "fragrance-free," and "unscented," and the meaning of these terms varies and is not formally defined by law or regulation (as one industry commenter stated), EPA saw an opportunity and responsibility to add clarity to the terminology and provide certainty for consumers seeking a product without any added fragrance ingredients.

The program has engaged in extensive dialogue with the fragrances industry and their product-manufacturer customers over many years. Since the Fragrance-free label simply denotes the absence of fragrance materials, the Agency did not seek additional dialogue with the fragrances industry or others before the Federal Register notice requesting comment on the Fragrance-free label issued. We address the comments received on the label and fragrances-related issues in the following section.  

Comments on the Fragrance-free Label

Comment 1.  Several commenters were concerned that the Fragrance-free label is duplicative because manufacturers already make claims about fragrances.

EPA Response.  The Safer Choice Fragrance-free label is intended to help consumers identify products that do not contain fragrances, either to impart a scent or to mask other scents.  The label is a factual indicator that the product does not contain fragrance materials.  Since there are a number of terms used in this space, e.g., "fragrance-free" and "unscented," and the meaning of these terms varies and is not formally defined, EPA saw a need to add clarity to the terminology.  Further, a Safer Choice certification that a product is fragrance-free indicates that a 3[rd]-party has determined the product's ingredients contain no fragrance materials as defined in the Safer Choice Standard. This provides certainty for consumers seeking a product without added fragrance.

Comment 2.  Several commenters assert that consumers might view products without the Fragrance-free label as not as safe.  

EPA Response. Focus group participants found all versions of the Safer Choice label to effectively communicate that products have met EPA standards for safer ingredients.  We did not test whether consumers view products without the Fragrance-free label as less safe, nor did any participants assert that products without the Fragrance-free label would be perceived as less safe.

Comment 3. Some commenters also felt that chemicals that serve a dual function -- as a fragrance and something else -- should be allowed in products that are candidates for the Fragrance-free label.

EPA Response.  Since the goal of a Fragrance-free label is to inform purchasers that the product does not contain any fragrance chemicals, the Safer Choice program defined its fragrance-free certification to cover any ingredient that can be used as a fragrance based on technical information on its physical-chemical properties, historical use, and input from fragrance industry stakeholders.  It is a chemical's fragrance properties or lack thereof -- not its designation as a fragrance or something else -- that is critical to fragrance-sensitive individuals or those seeking a product without fragrance.  Importantly, the program will not simply rely on a list of "fragrance materials" (e.g., the IFRA Transparency List at http://www.ifraorg.org/en-us/ingredients#.VZr6RovhF7Y, which includes non-fragrance chemicals like carriers and other functional components) to verify a product's fragrance-free status. The program will use available technical resources, including fragrance industry stakeholders, as needed, to help make the fragrance-free determination.  Of note, many consumers, public health advocates, and others want assurances from a reliable, independent source that a product does not contain any fragrance materials and value the Fragrance-free label. The program will take steps to communicate the meaning of the new Fragrance-free label and monitor its use in the marketplace.

Comment 4.  Several commenters questioned whether the Safer Choice labels complied with the Federal Trade Commission Green Guides.

EPA Response.  The Agency worked closely with the Federal Trade Commission in developing its Safer Choice labels.  Safer Choice shared information with the FTC from its public outreach efforts.  The FTC offered insights on interpreting the public comments and reactions to draft labels and guidance in selecting final designs and wording that communicated effectively, would not be misleading, and would meet the intentions of the Green Guides. Further, the Agency is engaged in public education to ensure that the label is not misleading to consumers and other purchasers.

Comment 5. Several commenters said that fragrance chemicals do not lack toxicological data and there is no scientific basis for the conflation of sensitizers and fragrances.

EPA Response.  Product manufacturers have indicated that some consumers prefer fragrance-free products and that these products should be available to consumers, especially to those with allergies.  There is evidence of a relationship between certain fragrances and sensitization potential in the data available to the Agency (see, for example, the European Chemicals Agency list of sensitizers in the CLP Annex VI, which contains fragrance chemicals).  The Safer Choice fragrance-free label responds to demand from consumers, health advocates, and others for a clear, reliable, objectively determined designation that a product does not contain fragrances.  The label does not connote an Agency position on the relationship between fragrances and health effects, which derive from diverse chemical classes, and sensitization.  

Comment 6.  Several commenters felt that they should have received advanced notice and an opportunity to comment on the Fragrance-free label prior to the current request for comments.

EPA Response.  The Agency received input from a diverse group of stakeholders in its label redesign process. While we did not specifically discuss the Fragrance-free label with the fragrance industry, we did provide the industry advance notice of the fragrance-free label.The program has engaged in extensive dialogue with the industry and their product-manufacturer customers over many years to better understand fragrance materials and the industry.

Given that the Fragrance-free label simply denotes the absence of fragrance materials in a product, the Agency believes that the Federal Register notice of availability provided a sufficient opportunity to comment and does not believe that other advance notice was needed. 

Comment 7.  Two commenters stated that the Agency's explanation for inclusion of the Fragrance-free label does not meet data quality standards. 

EPA Response. The Agency has followed data quality standards in developing the Fragrance-free label and the criteria for its implementation, helping to ensure that the label has integrity and objectivity and offers value to certified entities and consumers alike.  In introducing the Fragrance-free label, the Agency's statement that "...many fragrance materials may be [emphasis added] associated with sensitization and allergenic response and lack toxicological data" (that is readily available) reflects our sense of the fragrance chemical profiles after the review of hundreds of fragrance chemicals and the data available in the public literature.  We continue to encourage those with data on fragrances to share it with the Agency to enhance our understanding of fragrance materials.

Comment 8.  One commenter said that the program's definition of fragrance-free could lead to confusion because products with `fragrance-free,' `scent-free,' or similar phrases on their label can earn the Safer Choice label and maintain their fragrance claims.

EPA Response.  Only products that qualify for the Safer Choice and Fragrance-free label will be allowed to make `fragrance-free' or similar claims in association with use of the label.  Under the terms of EPA/Safer Choice partnership, which govern label use, companies must submit all labels to the program for review and approval before they can be displayed on products.  

To qualify for the Fragrance-free label, a company must first have their product certified to the Safer Choice Standard and then request the supplemental fragrance-free certification.  Since the program reviews all product labels, manufacturers who only seek the Safer Choice label and do not request the supplemental fragrance-free certification will not be permitted to make fragrance-free or similar claims on Safer Choice-labeled products.  On the other hand, manufacturers whose products qualify for the fragrance-free label have the following options: they may use the fragrance-free label or the standard Safer Choice label, with or without a fragrance-free claim; or, they may simply make a fragrance-free claim and not use the fragrance-free or standard Safer Choice label.

Comment 9.  Two commenters suggest that because of the inherent toxicity of fragrances, they should not be allowed in any Safer Choice-labeled products.

EPA Response. Given our review and understanding of hundreds of fragrance materials, the Agency is not able to broadly characterize their hazard profiles. Product manufacturers have informed us that while a small but significant minority of the population needs or wants fragrance-free products, a substantial percentage of consumers want safer products that also contain fragrances.  The Safer Choice program gives consumers options to select fragranced or fragrance-free products, while protecting human and environmental health. 

Comment 10.  One commenter questions whether the term "fragrance" is adequately defined in the Safer Choice Standard and suggests that it be replaced with "fragrance material."

EPA Response.  The term "fragrance material" is defined in the Safer Choice Standard in sec. 2.1.37 as follows:
   
   Fragrance materials: Discrete 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.) 

The term fragrance materials encompasses the term fragrance and the terms are interchangeable when reading and interpreting the Safer Choice Standard.  The program will add a notation to the Standard to clarify this point.

Comment 11.  One commenter asks why fragrances are "called out" in section 5.6.1 of the Safer Choice Standard, which addresses sensitizers, and continues saying "the criterion infers that little data on sensitization exists for fragrance materials." 

EPA Response.  Sensitizers are included as a subsection of Fragrances in the Standard since a number of fragrance materials have been identified and listed as sensitizers (see the European Chemicals Agency list of sensitizers in the CLP Annex VI) and the program has developed criteria under which they may be used in labeled products.  It was not the Agency intention to imply that little data on sensitization exists for fragrances, but many fragrance materials lack publicly available hazard data.

Comment 12.  Regarding section 5.6.1, which covers sensitizers, one commenter requests clarification on the meaning and implementation of the following criterion: `the subject of good faith exploration of alternatives.' 

EPA Response.  Given the diverse fragrance chemical palette, Safer Choice expects fragrance formulators to carefully consider their ingredient selections; when a potential sensitizer is part of a formulation, fragrance formulators should explore whether the scent might be formulated without that ingredient.  The fragrance formulator must report to the program on its chemical selection process.  In evaluating products for the label, Safer Choice reviews any fragrance formulation and potential sensitizers receive heightened scrutiny and evaluation against the section 5.6.1 criteria, which must be addressed in the chemical's hazard dossier.

Comment 13.  One commenter asks whether, at a future time when the program issues new Fragrances criteria (i.e., for qualifying fragrances for use in labeled scented products), it will allow manufacturers additional time -- to show that its fragrances meet the criteria or to reformulate -- based on `adequate justification' and what that justification might be.

EPA Response. The program cannot speculate as to what new fragrances criteria might require and how they might be implemented. If new fragrance criteria are proposed, the program will seek public comment before finalizing them, and will allow appropriate time for implementation, as it has done with other revisions to the Standard and criteria.  

In Conclusion

The Agency has carefully considered the comments received on the Fragrance-free label and other aspects of the Safer Choice program. The Safer Choice program will continue to offer eligible product manufacturers use of the Fragrance-free and other program labels on qualifying products.  Also, the program is seeking ways to enhance the transparency of fragrances, so that consumers can make more informed purchasing decisions. In that regard, we are encouraged to see some product manufacturers taking a leadership role by disclosing the ingredients in fragrances.