Two Views of Safety

“Do you think when two representatives holding diametrically opposing views get together and shake hands, the contradictions between our systems will simply melt away? What kind of a daydream is that?”—Nikita Khrushchev

In its second year, Sustainable Fragrances 2010, held May 20–21 in Virginia, drew 102 attendees, up from 72 the previous year. It is clearly a subject of growing interest—but what exactly is sustainability and how do we get it in fragrances? In the broadest sense, it can embrace renewable resources, reduced carbon footprint, natural or organic sourcing, social responsibility—with a presumption of human and environmental safety and regulatory compliance.

Opposing approaches to safety can be exemplified by the activities of DfE (Design for the Environment, part of the Environmental Protection Agency) and EWG (Environmental Working Group). The meeting opened with a preconference seminar on the DfE Criteria for Fragrances, which had just been released to stakeholders in draft form. The complete criteria is now posted on the DfE website.¹ The complete criteria will be uploaded after a complete review is finished. The last conference speaker was from EWG, and, by coincidence, EWG had just released a scathing critique of the fragrance industry.

The Research Institute for Fragrance Materials (RIFM) has long been the standard bearer for fragrance safety. The science established by the external and independent Expert Panel is transformed into standards by The International Fragrance Association (IFRA).

RIFM has a risk-based approach, with safe use based on product categories and specifics publicly available on the IFRA website (www.ifraorg.org). There are no dark secrets in the RIFM/IFRA assessments.

RIFM has current initiatives in environmental and respiratory safety, and quantitative risk assessment (QRA) for skin sensitization. The guiding principles are laid out in key papers, and the results are published in peer review journals. Despite the RIFM’s best efforts, some critics distrust it because it is funded by industry, the science is risk-based and perfume formulas are confidential.

The DfE and EWG have tackled the fragrance safety issue from a hazard rather than risk perspective. DfE began a fragrance project as an extension of its previous work certifying surfactants and solvents for its seal. The RIFM actively participated in the process with DfE but was not consulted in the EWG project. A very scientific document emerged from DfE, and a controversial one from the EWG.

Announcements heralding the EWG report had a distinctly tabloid feel:^{2, 3} “Secret chemicals revealed in celebrity perfumes, teen body sprays” and “Not So Sexy—Hidden Chemicals in Perfumes and Colognes.” In the body of the complete report,⁴ the following is typical: “The average fragrance product tested contained 14 secret chemicals not listed on the label.” Secret chemicals!

By self-publishing and skirting the discipline a peer-reviewed scientific journal would entail, EWG was able to make what could be considered scientifically questionable claims. For example, the assertion that fragrances are endocrine disruptors is based on results from animal testing that may not carry over to humans, or from exposure levels thousands of times what a consumer would experience. The weight of evidence of the best current science does not support the EWG position.

Why are these chemicals secret? Well, the European Union for years has required labeling of 26 fragrance allergens (Figure 1). No other fragrance materials are labeled. In the U.S., no individual fragrance ingredients must be labeled, just the word “fragrance” appears on the label. So if some materials are on the label and others are not, it is because regulations are being followed—not a secret conspiracy. EWG knows this, as is quite evident in reading its report, but still describes fragrance as “a complex mix of clandestine compounds …”

Figure 2 is the list of “secret chemicals” in the EWG—it’s a list of a lot of very standard ingredients.

The EWG report relies heavily on PubMed as its source on published data. In addition to publishing in peer-reviewed literature, which would be found in a correct PubMed search, RIFM has the world’s foremost fragrance safety database, available through subscription. EWG has not availed itself of this unrivaled resource. Materials like hedione or dihydro-alpha-terpineol, where EWG claims a dearth of published data, actually have RIFM monographs. RIFM peer-reviewed publications reference all data—RIFM-sponsored, company-sponsored, open literature—and which are all referenced in the database, and any study practicing due diligence should have considered them.

The DfE Criteria were the result of years of work, with the participation of a wide range of stakeholders—including governments, NGOs, fragrance and consumer goods companies and consultants. Anyone with an interest in the process was free to join. Discussion on controversial points was lively, and the nature of the criteria took dramatic turns as difficult points were addressed. The results, issued in draft, are a model of precision, replacing the rather fuzzy guidelines that had preceded them.

DfE Environmental Toxicity & Fate (ET&F) involves conformance on acute aquatic toxicity, persistence (biodegradation), and bioaccumulation determined by data (preferred) or models such as EPI (Estimation Program Interface) Suite. Complete formula disclosure is required, but only to a third party certifier. Details are given on test protocols with acceptable values for a variety of human health concerns. With a 36-page draft document, the above points are just the tip of its thoroughness.

If there is one valid criticism of the DfE Criteria, it is that it is hard for many to understand. Finding materials that conform requires a highly skilled regulatory expert, and indeed a consortium has been formed to use such a person to wade through the details.⁵ And this could lead easily to a fundamental question—How would ingredient disclosure help a consumer, or even a physician, assess the safety of a product? If you knew your product was category 2 and had 0.012% 3,7-dimethyl1,3,7-octatriene, what would you do? A detailed description of how to create fragrances for DfE and NPA (Natural Products Association) standards has been provided by Corley.⁶

Where is the high ground in sustainable fragrances? There are some goals that everyone embraces: careful stewardship of resources, reduction of carbon footprint, social responsibility, and safety for both humans and the environment. Most of the Sustainable Fragrances 2010 conference speakers considered those issues and more—natural ingredients, green sourcing, meeting standards, regulatory conformance, to name but a few.

Regarding the question of safety, a few conclusions are reasonable based on a detailed knowledge of the industry:

1. Disclosure of fragrance formulas isn’t going to help anyone.
2. The work of the RIFM and the IFRA Standards guarantee a high degree of safety and are being constantly improved.
3. The DfE Criteria are very restrictive, making perfume creation difficult, but offer a clear path to earning a government-endorsed, voluntary seal for specific products.
4. EWG uses what looks like real science, but it is seriously flawed and biased.

The EWG report was immediately repudiated by the industry through the Personal Care Products Council,⁷ The Fragrance Materials Association⁸ and RIFM.⁹ Unfortunately, it is harder to explain science than to invoke emotions. The hardest part of convincing the public that fragrances are safe, or that any chemical is safe, is the low level of scientific literacy in society. John Bailey, chief scientist, Personal Care Products Council, said it well: “Cosmetic and personal care product manufacturers take their safety responsibilities very seriously. Cosmetic ingredients are carefully selected for safety and suitability for their specific applications, and consumers can be confident in the safety of their products.” Amen.

References

1. epa.gov/dfe/pubs/projects/gfcp/index.htm
2. www.ewg.org/notsosexy
3. www.ewg.org/Secret_chemicals_in_popular_perfumes
4. www.ewg.org/files/SafeCosmetics_FragranceRpt.pdf
5. For Consortium information: Contact Hans van Bergen at [email protected]
6. J Corley, Opinion: Formulating Fragrances for NPA and DfE, Perfumer & Flavorist, 35 9 (2010)
7. www.personalcarecouncil.org/newsroom/20100512
8. fmafragrance.org/sub_pages/100511_CSCreport_statement.pdf
9. www.rifm.org/news/news_detail.asp?id=43

(All sites accessed Sept. 9, 2010)

Steve Herman is president of Diffusion LLC, a consulting company specializing in regulatory issues, intellectual property, and technology development and transfer. He is a principal in PJS Partners, offering formulation, marketing and technology solutions for the personal care and fragrance industry. He is an adjunct professor in the Fairleigh Dickinson University Masters in Cosmetic Science program and is a Fellow in the Society of Cosmetic Chemists.