Office of Environmental Health Hazard Assessment (OEHHA) on December 4, 2015
added Aloe vera,
non-decolorized whole leaf extract and goldenseal root powder to its list of
"chemicals known to the State of California to cause cancer" for
purposes of the state's Proposition 65. This action follows on OEHHA's April
2015 notice of intent to list these substances under its so-called "Labor
Code listing mechanism." In both the April proposals and last week's
formal notice of listing, OEHHA identified these substances as "natural
constituents" of the Aloe vera plant (syn. A barbadensis) and the goldenseal plant (Hydrastis canadensis),
American Herbal Products Association (AHPA) submitted
comments on June 9, 2015 to OEHHA to oppose these listings. These comments,
among other details, opposed OEHHA's use of the so-called Labor Code listing
mechanism; requested that the listings, if adopted, be relevant only to oral
routes of exposure since the purported bases of the listings were oral
administration in rodents; and asserted that there should be no listing of
goldenseal based only on a single carcinoma as observed in one test animal fed
goldenseal root powder at a dosage of 2.5 percent of the animal's diet over
nearly its entire lifetime, equivalent to between about 72,000 and 116,000
milligrams per day for a 60 kilo human, while the standard adults dose of
goldenseal is 2 grams daily and the herb is used only sporadically.
International Aloe Science Council (IASC) also submitted
comments to OEHHA on May 21, 2015 regarding the listing of the Aloe vera ingredient. These
comments advocated for the addition of the term "non-decolorized" to
the chemical name to maintain nomenclature consistency with the scientific
research upon which the listing of the Aloe vera substance is based. For additional
clarity, IASC asked for the specification in the listing itself of the aloe
vera ingredients that are not
included in the listing, as identified in the April 2015 notice of intent to
list. IASC also sought to specify the relevant route of exposure (ingestion) in
the listing as reflected in the scientific research.
adopted only one of these recommendation by adding the word
"non-decolorized" to the description of the Aloe vera ingredient. AHPA
and IASC's other comments were completely ignored.
Possible impacts on trade
a new substance is added to Proposition 65, companies that market products that
represent an "exposure" to the substance generally have one year to
ensure products comply with Proposition 65 requirements by either reformulating
products or providing a "clear and reasonable warning" for each such
product as soon as that one year time has passed, unless otherwise exempted.
Thus, currently marketed products that contain these ingredients are not yet
required to provide such warnings.
is an exception to this requirement for ingredients that are "naturally
occurring" in foods and in other consumer products prepared with food
ingredients, such as cosmetics. OEHHA's regulations clarify that an exposure to
a Prop 65 listed chemical does not occur, such that no warning is required, in
the following situations:
For a food, when the chemical is naturally occurring
in the food and is a natural constituent of the food;1, 2
For a consumer product other than food, when the
chemical is a naturally occurring chemical in food, and the food was used
in the manufacture, production, or processing of the consumer product.3
clarification by OEHHA that these ingredients are "natural
constituents" of their botanical sources may suggest that the above
described "naturally occurring" exemption will apply to products that
contain goldenseal root powder or non-decolorized whole leaf extract of Aloe vera. But AHPA is aware
of a 60-day notice brought by one private plaintiff against several marketers
of pennyroyal oil due to absence of warnings for the naturally-occurring
presence of pulegone, another substance listed as a carcinogen.
unknown at this time is whether any plaintiff will target other goldenseal
ingredients, such as extracts of the root. On the other hand, it may be
unlikely that any plaintiff will identify the aloe listing as relevant to
products that contain Aloe
vera leaf extract that has been decolorized and that is accurately
labeled as such, or is accurately labeled as one of the aloe ingredients that
is not included, as specified in the April 2015 notice of intent to list.
and IASC will be in active communication with experts and authorities on
enforcement of California's Proposition 65 and will provide additional guidance
as information is collected and reviewed.
Possible upcoming "Labor Code" listings
route that leads a substance to a so-called Labor Code listing by OEHHA
generally starts in Lyon, France, when the International Agency for Research on
Cancer (IARC) makes a determination that the substance is carcinogenic to
humans or is probably or even possibly carcinogenic to humans. The latter,
IARC's Group 2B, was applied in 2013 to both goldenseal root powder and the
listed Aloe vera
the other hand, the more stringent Group 2A listing (i.e., "probably
carcinogenic in humans") was subsequently applied by IARC to glyphosate
(the active ingredient in the herbicide Roundup®), and in fact OEHHA has
already proposed to list this as "a chemical known to the State of
California to cause cancer." More recently, IARC classified red meat in
Group 2A and processed meat in the most severe classification, Group 1
("Carcinogenic in humans").
has yet to issue a notice of intent to list either red meat or processed meat
as "a chemical known to the State of California to cause cancer"
based on the recent IARC classifications. If a proposed listing is not
forthcoming, OEHHA will have inconsistently applied its purported obligation to
propose a listing based on these IARC conclusions under the so-called Labor
Code listing mechanism, which could be considered to be arbitrary and
capricious from a legal standpoint.
1 Title 27 California Code of Regulations §25501(a)(1).
2 Note that other rules apply to a Prop 65 listed chemical
that is a "contaminant" (see CA HSC §25501(a)(4)), though this is not
relevant to pulegone or other naturally-occurring constituents.
3 Title 27 California Code of Regulations §25501(b).