Clarified Prop 65 Aloe Vera Listing Largely Resolves Cosmetic Concerns
This article was originally published in The Rose Sheet
Executive Summary
An April proposal from California OEHHA to add "Aloe vera, whole leaf extract" to the Prop 65 list of recognized carcinogens raised alarm in the personal-care sector. To industry's relief, the listing has been clarified in its final form to exclude the decolorized form of the ingredient predominantly used in cosmetics.
California's Office of Environmental Health Hazard Assessment has added "Aloe vera, non-decolorized whole leaf extract" to the Prop 65 inventory of chemicals recognized as causing cancer, clarifying the listing to avoid implicating cosmetic manufacturers that use other non-carcinogenic forms of the ingredient.
Effective Dec. 4, the listing stems from research conducted by the National Toxicology Program that linked non-decolorized whole leaf extract of the Aloe barbadensis Miller plant to tumor formation in rodents.
The finding led the World Health Organization's International Agency for Cancer Research to classify the substance as possibly carcinogenic, which in turn prompted OEHHA's April proposal for an automatic Prop 65 listing under California's controversial "labor code" mechanism (Also see "California Proposes Adding Aloe Vera To Prop 65 List" - HBW Insight, 15 May, 2015.).
However, OEHHA initially planned to identify the substance of concern simply as Aloe vera, whole leaf extract, a move that could have exposed large numbers of cosmetic firms to unwarranted Prop 65 litigation.
"While the forms of Aloe in use in the cosmetics industry should not be the form of Aloe that was listed on Prop 65, it is always prudent to check with your raw material supplier to confirm that none of the materials you are using are in fact the Prop 65 listed material." – ICMAD
In June comments on the proposed listing, the Personal Care Products Council contended that the carcinogenic effects observed in the NTP bioassay were attributed to high levels of anthraquinones present in the latex portion of the Aloe leaf, and noted that anthraquinones are removed by the decolorizing process (Also see "AHPA Condemns Prop 65 ‘Labor Code’ Mechanism, Deference To IARC" - HBW Insight, 16 Jul, 2015.).
The trade group said that while Aloe vera-derived ingredients are widely used by the cosmetics industry, non-decolorized whole leaf extract of Aloe barbadensis Miller is not. It urged for "non-decolorized" to be added to the listing to avoid consumer confusion and misinformed lawsuits.
OEHHA's final listing reflects that recommendation.
The Independent Cosmetic Manufacturers and Distributors submitted similar comments to OEHHA calling for the non-decolorized clarification.
In a Dec. 7 industry alert, the trade association says that "while the forms of Aloe in use in the cosmetics industry should not be the form of Aloe that was listed on Prop 65, it is always prudent to check with your raw material supplier to confirm that none of the materials you are using are in fact the Prop 65 listed material."
Such due diligence should help ensure "that you are prepared in the event you do receive a 60 Prop 65 notice," the group adds.
In a Dec. 4 post to Hyman, Phelps and McNamara's FDA Law Blog, director Riette van Laack notes that affected businesses now have one year to reformulate products for sale in California or provide 'clear and reasonable' warnings to consumers in the state, either on product labeling or at point of sale.
"If the past is any indication, plaintiff attorneys will be ready with notices of violation when the 12 month period expires," she adds.
Other industry organizations challenged the scientific rationale behind the Aloe vera listing and the relevance of the NTP's findings to products designed for human use that contain significantly lower dose concentrations of the substance in question and often pose entirely different exposure pathways.
Groups including the American Herbal Products Association and Natural Products Association also seized on the opportunity to contest the labor-code mechanism under Prop 65, which does not allow for discussion of the scientific data informing a listing. NPA Executive Director and CEO Dan Fabricant likened it to "a reflexive action without any input, thought or evaluation of evidence" (Also see "NPA Presents Strong If Possibly Futile Case Against Prop 65 Aloe Vera Listing" - HBW Insight, 12 Jun, 2015.).
Goldenseal Root Powder Also Listed
Simultaneous with the Aloe vera addition, OEHHA is listing Goldenseal root powder under Prop 65, consistent with its April proposal.
The Environmental Working Group's Skin Deep database lists more than 90 cosmetic products alleged to contain Hydrastis canadensis (goldenseal) root extract, though the majority are from a single brand.
It isn't clear how goldenseal root extract, which EWG rates a 1 (low hazard) on its 1-10 Skin Deep scale, relates to goldenseal root powder. Clarification from cosmetic trade groups could not be obtained immediately.
Neither PCPC nor ICMAD addressed the goldenseal listing in their comments to OEHHA.