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Two Views of Safety

By: Steve Herman
Posted: November 5, 2010, from the November 2010 issue of GCI Magazine.

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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